GUIDANCE
Guidance for implementation of Regulation
(EU) No 649/2012 concerning the export
and import of hazardous chemicals
Draft Version 1.0
May 2014
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
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LEGAL NOTE
This document contains guidance on Regulation (EC) No 649/2012 (henceforth: the PIC
Regulation) explaining the obligations under this regulation and how to fulfil them. However,
users are reminded that the text of the PIC Regulation is the only authentic legal reference and
that the information in this document does not constitute legal advice. The European
Chemicals Agency (ECHA) does not accept any liability with regard to the contents of this
document.
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Guidance for implementation of Regulation (EU) No 649/2012 concerning the export
and import of hazardous chemicals
Reference: XXXXXX
ISBN:
Publ.date: Month 201y
Language: EN
© European Chemicals Agency, 201y
Cover page © European Chemicals Agency
Reproduction is authorised provided the source is fully acknowledged in the form
“Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written
notification is given to the ECHA Communication Unit ([email protected]).
If you have questions or comments in relation to this document please send them (indicating
the document reference, issue date, chapter and/or page of the document to which your
comment refers) using the Guidance feedback form. The feedback form can be accessed via
the ECHA Guidance website or directly via the following link:
https://comments.echa.europa.eu/comments_cms/FeedbackGuidance.aspx
European Chemicals Agency
Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland
Visiting address: Annankatu 18, Helsinki, Finland
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
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Preface
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This document describes specific provisions for export and import of certain hazardous
chemicals under Regulation (EC) No 649/2012 the so-called Prior Informed Consent (PIC)
Regulation (henceforth the “PIC Regulation”).
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The recast PIC Regulation gives ECHA a mandate to provide assistance and technical and
scientific guidance on the PIC Regulation for industry and authorities1. Two guidance
documents2 for previous regulation on import and export of hazardous chemicals3 had been
drafted by the European Commission and endorsed by the REACH Committee. Part of the
content of both documents remained to a large extent relevant after entry into operation of the
new PIC Regulation. Therefore, ECHA has used this part of the content as a basis for some of
the text of the present document. At the same time, the new information resulting from the
changes introduced in the recast PIC Regulation has been included in this guidance.
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All current ECHA guidance documents can be obtained via the website of ECHA
(http://echa.europa.eu/support/guidance).
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This guidance document relates to the Regulation (EC) No 649/2012 of the European
Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous
chemicals4.
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Article 6 (1) (c) and (d) of the PIC Regulation: “where appropriate, provide, with the agreement of the
Commission and after consultations with Member States, assistance and technical and scientific guidance
and tools for the industry in order to ensure the effective application of this Regulation” … “provide, with
the agreement of the Commission, the designated national authorities of the Member States with
assistance and technical and scientific guidance in order to ensure the effective application of this
Regulation”.
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(i) TECHNICAL GUIDANCE NOTES FOR IMPLEMENTATION OF REGULATION (EC) No 689/2008 - The
general guidance for DNAs and industry, published in 22 official EU languages, excluding Croatian.
This document was endorsed by the REACH Committee on 20 October 2010 and published in the
Official Journal of the European Union on 1 March 2011;
(ii) Technical notes for guidance – document available only in English and only to DNAs (once they log
into the EDEXIM Database). This guidance was finalised in April 2012 by addressing the comments
received from Member States during and after the DNA meeting.
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Regulation (EU) No 689/2008 of the European Parliament and of the Council of 17 June 2008
concerning the export and import of dangerous chemicals; OJ L 204 31,7.2008 p 1.
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Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning
the export and import of hazardous chemicals (recast); OJ L 201 27.07.2012 p 60.
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
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1. INTRODUCTION ........................................................................................................... 7
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2. UNDERSTANDING THE PIC REGULATION ........................................................................ 7
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2.1 The Rotterdam Convention .................................................................................... 8
2.2 The PIC Procedure under the Convention ................................................................. 8
2.3 Information exchange under the Convention ............................................................ 9
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2.3.1 Notification of final regulatory action ................................................................................. 9
2.3.2 Export notification .......................................................................................................... 10
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2.4 Relationship to other international chemicals legislation ............................................ 10
2.5 Participation of the European Union in the Rotterdam Convention ............................... 11
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3. DEFINITIONS .............................................................................................................. 11
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4. SCOPE ........................................................................................................................ 14
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4.1 Chemicals included ............................................................................................... 15
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
Chemicals subject to the PIC procedure ............................................................................
Banned or severely restricted chemicals ............................................................................
All exported chemicals as regard their classification, labelling and packaging .........................
Overview of Annex I to the PIC Regulation ........................................................................
Articles .........................................................................................................................
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4.2 Chemicals exempted from the PIC Regulation .......................................................... 18
4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.2.8
4.2.9
Narcotic drugs and psychotropic substances ......................................................................
Radioactive materials ......................................................................................................
Wastes..........................................................................................................................
Chemical weapons ..........................................................................................................
Food and food additives ..................................................................................................
Feedingstuffs .................................................................................................................
Genetically modified organisms ........................................................................................
Medicinal products ..........................................................................................................
Chemicals exported for research or analysis ......................................................................
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5. KEY ACTORS ............................................................................................................... 21
5.1 Designated National Authorities .............................................................................. 21
5.2 Exporters and importers ........................................................................................ 23
6. OBLIGATIONS UNDER THE PIC REGULATION .................................................................. 24
6.1 Export notifications forwarded to third countries ....................................................... 24
6.1.1 Who has to notify? .........................................................................................................
6.1.2 What to notify? ..............................................................................................................
6.1.3 Information requirements ................................................................................................
6.1.4 Timelines ......................................................................................................................
6.1.5 The procedure................................................................................................................
6.1.6 Incompliant export notifications .......................................................................................
6.1.7 Following up export notifications ......................................................................................
6.1.8 When is a new notification required? .................................................................................
6.1.9 Emergency situation .......................................................................................................
6.1.10 When is a notification no longer required? .......................................................................
6.1.11 Request for additional information ..................................................................................
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6.3
6.4
6.5
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Export notifications from Parties and other countries ................................................. 33
Information on quantities of chemicals exported and imported ................................... 33
Participation in the PIC notification procedure .......................................................... 34
Information on banned or severely restricted chemicals not qualifying for PIC notification
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6.6 Obligations in relation to the import of chemicals ...................................................... 35
6.7 Obligations in relation to export of chemicals other than export notification ................. 36
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6.7.1 Explicit consent .............................................................................................................. 38
6.7.1.1 What chemicals are subject to explicit consent requirement? ..................................................................38
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6.7.1.2 Seeking an explicit consent .................................................................................................................38
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6.7.1.3 Possible forms of explicit consent ........................................................................................................39
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6.7.1.4 The process of requesting explicit consent ............................................................................................39
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6.7.1.5 Explicit consent for mixtures containing substances from Part 2 or 3 of Annex I ........................................40
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6.7.1.6 Timelines..........................................................................................................................................43
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6.7.1.7 Validity of the explicit consent .............................................................................................................43
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6.7.1.8 Waiver .............................................................................................................................................43
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6.8 Quality of exported products .................................................................................. 46
6.9 RIN in the customs declaration ............................................................................... 46
6.10 Information on transit movements ........................................................................ 47
6.11 Information to accompany exported chemicals ....................................................... 47
6.11.1
6.11.2
6.11.3
6.11.4
6.12
6.13
6.14
6.15
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Content of the label ......................................................................................................
Timelines for classification, labelling, packaging and updating of CLP hazard labels ...............
Hazard pictograms used in the EU ..................................................................................
Safety data sheet (SDS) ................................................................................................
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Obligation of the authorities of the Member States for controlling import and export ... 51
Exchange of information ...................................................................................... 52
Technical assistance ............................................................................................ 52
Monitoring and reporting ..................................................................................... 52
Updating of Annexes ........................................................................................... 53
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7. EPIC – AN IT APPLICATION FOR SUBMISSION OF INFORMATION ............................ 54
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8. EXAMPLES ................................................................................................................ 56
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APPENDIX 1. ANNEX I TO REGULATION (EC) NO 649/2012 ......................................... 63
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APPENDIX 2. ANNEX V TO REGULATION (EC) NO 649/2012......................................... 78
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APPENDIX 3. OVERVIEW OF EXPORTERS’ MAIN TASKS IN ORDER TO COMPLY WITH
REGULATION (EC) NO 649/2012 ............................................................................ 80
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APPENDIX 4. EXAMPLES OF EVIDENCE THAT CAN JUSTIFY THE GRANTING OF A
WAIVER TO THE REQUIREMENT FOR EXPLICIT CONSENT ....................................... 82
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APPENDIX 5. LIST OF RECOMMENDED LANGUAGES FOR THE LABELLING OF EXPORTS
TO CERTAIN COUNTRIES ........................................................................................ 84
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APPENDIX 6. LIST OF EU DESIGNATED NATIONAL AUTHORITIES FOR REGULATION
(EC) NO 649/2012 .................................................................................................. 91
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APPENDIX 7. LIST OF OECD COUNTRIES TO WHICH WAIVER FOR EXPLICIT CONSENT
COULD BE APPLIED ................................................................................................. 99
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APPENDIX 8. GLOSSARY/LIST OF ACRONYMS .............................................................. 104
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Figure 1: Export notification procedure for Annex I Part 1 chemicals to all countries (except exports
pursuant to Article 8 (6)). ............................................................................................................ 30
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Figure 2: Special RIN request procedure: Article 2 (3) or Article 14 (6) (b) in conjunction with Article 8
(6) or an emergency export according to Article 8 (5). .................................................................... 38
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Figure 3: Article 14 (6) (a) procedure for Annex I Part 3 chemicals to all countries and for Annex I Part 2
chemicals for non-OECD countries. Article 14 (7) procedure for chemicals listed in Part 2 or 3 of Annex I.
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Figure 4: Article 14 (6) procedure for Annex I Part 2 chemicals exported to OECD countries. .............. 44
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1. INTRODUCTION
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The aim of this document is to assist Designated National Authorities (DNAs) and industry in
day-to-day application of the PIC Regulation.
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The guidance opens in section 2 with an introduction to the Rotterdam Convention, including
its basic principles and mechanisms. This section includes also information about the areas in
which the Regulation (EU) No 649/2012 goes beyond the requirements of the Rotterdam
Convention. The guidance continues in sections 3 and 4 with an explanation of key definitions
and presentation of the scope of the Regulation. Section 5 defines the key actors (Designated
National Authorities, exporters and importers). Subsequently, section 6 of the guidance
outlines the obligations of exporters and authorities under the PIC Regulation by explanation of
requirements of each provision. Section 7 then provides certain information about the ePIC
application. Finally, section 8 provides some examples that demonstrate how the requirements
of the PIC Regulation play out practically in a range of cases.
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2. UNDERSTANDING THE PIC REGULATION
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The PIC Regulation is the regulation of the European Parliament and of the Council concerning
the export and import of hazardous chemicals. It applies to industrial chemicals, pesticides and
biocides that are banned or severely restricted for health or environmental reasons. It places
obligations on companies who wish to export these chemicals to non-EU countries. The export
of such chemicals is subject to two types of requirements: export notification and explicit
consent. The latter requirement applies only in certain cases (see sub-section 6.7.1 of this
guidance document).
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The aim of the PIC Regulation is to promote shared responsibility and cooperation in the
international movement of hazardous chemicals, and to protect human health and the
environment by providing developing countries with information on how to store, transport,
use and dispose of such chemicals safely. The PIC Regulation implements within the EU the
Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade (henceforth the ‘Convention’). The European
Union (EU) ratified the Convention on 20 December 2002 and fully implemented its provisions
through a series of regulations which were developed over time5.
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It is important to note that the EU decided to include a number of additional provisions into the
PIC Regulation that go beyond the Convention requirements. The scope of the PIC Regulation
is for example, extended beyond the chemicals that are subject to the prior informed consent
procedure under the Convention to chemicals banned or severely restricted at the EU level
(see the sub-section 4.1.2 of this guidance document). Similarly, the requirements for export
notification and for explicit consent (see sub-sections 6.1 and 6.7.1 of this guidance document)
are extended to all countries rather than applying only to those countries that are Party to the
Convention. Furthermore, an export notification for chemicals listed in Annex I of the PIC
Regulation is required irrespective of their intended use in the importing country.
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To fully understand the provisions and mechanisms of the PIC Regulation, the reader should be
introduced to the basic principles and key elements of the Rotterdam Convention.
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2.1 The Rotterdam Convention
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The Convention was adopted on 10 September 1998 at the Diplomatic Conference held in
Rotterdam. It entered into force on 24 February 2004 and became legally binding for its
Parties6. The Convention is the response of United Nations Environment Programme (UNEP)
and Food and Agriculture Organisation (FAO) to the concerns raised by the increased
production, trade and use of chemicals during the 1960s and 1970s. These concerns were
related to the risk that the use of hazardous chemicals and pesticides could pose to the human
health and the environment. In addition, the regulatory systems and infrastructure of some
countries (particularly developing countries) were not adequate to manage such chemicals
safely.
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The overall objective of the Convention is to promote shared responsibility and cooperative
efforts among Parties in the international trade of certain hazardous chemicals in order to
protect human health and the environment from potential harm and contribute to the
environmentally sound use of chemicals. To achieve this objective the Convention includes two
key provisions:
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the prior informed consent (PIC) procedure;
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information exchange.
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Under the Rotterdam Convention the Parties designate one or more national authorities to
perform administrative functions required by the Convention. The so-called Designated
National Authorities (DNAs) are the contact points between a Party and the Secretariat of the
Convention (provided jointly by UNEP and FAO) and between different Parties. DNAs have a
crucial role in implementation of the Convention and dissemination of the information about
the Convention at the national level.
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The chemicals covered by the Rotterdam Convention are pesticides and industrial chemicals
that have been banned or severely restricted for health or environmental reasons by
participating Parties. These chemicals are listed in Annex III of the Convention. The
Convention also establishes a mechanism for including further chemicals into the Annex III,
provided that certain criteria are met. For the current list of chemicals included in the Annex
III please consult the Rotterdam Convention website www.pic.int (click on “databases, Annex
III chemicals to go e.g. to
http://www.pic.int/TheConvention/Chemicals/AnnexIIIChemicals/tabid/1132/language/enUS/Default.aspx).
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2.2 The PIC Procedure under the Convention
The PIC procedure is a mechanism for formally obtaining and disseminating the decisions
of importing Parties as to whether or not they will allow for future import of such chemical.
The key principle is that the shipment of these chemicals will not take place without the prior
informed consent of the importing Party.
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Under the Convention Parties are countries or regional economic integration organisations that have
ratified, accepted, approved or acceded to the Convention.
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The prior informed consent (PIC) procedure applies to the chemicals listed in Annex III of the
Convention. For each of the chemicals listed in Annex III of the Convention, a decision
guidance document (DGD) is prepared by a subsidiary body - the Chemical Review Committee
(CRC), composed of government-designated experts in chemical management. After approval
by the Conference of Parties (COP)7, the DGD is distributed to all Parties. It contains basic
information about the chemical, i.e. its characteristics and a summary of information related to
hazards and risks connected with the use of that chemical. For chemicals that are banned or
severely restricted, it also includes details of the final regulatory actions that led to the
chemical being included in Annex III of the Convention (see sub-section 2.3.1 of this guidance
document). DGDs are available on the Convention website8.
Information contained in DGDs helps Parties to assess the risks related to handling and use of
chemicals taking into account the local conditions. Based on such an assessment the Parties
can take more informed decisions on whether to accept or refuse import or to allow import
under certain conditions. These decisions are known as import responses. Every six months
the Secretariat informs all Parties of the import responses (as well as about the Parties that
failed to respond) via so-called PIC Circulars.
The PIC Circulars also include information about the proposals for hazardous pesticide
formulations submitted by Parties as well as an up-to-date list of the chemicals subject to the
PIC procedure. PIC Circulars are published by the Secretariat twice a year (in June and
December), sent to all DNAs and posted on the Convention website.
Import decisions taken by Parties must be neutral. This means that if the Party decides to
refuse imports of a chemical, it must also stop the domestic manufacture of this chemical for
domestic use, as well as refuse imports from any other sources.
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All Parties are obliged to ensure that their exporters comply with any import decisions, i.e.
export of chemicals subject to the PIC procedure is not contrary to a decision of an importing
Party. This means that an export cannot proceed if the importing Party has indicated that it
does not wish to receive imports of these chemicals. Furthermore, if the importing Party has
indicated that export is allowed under certain condition(s), the exporting Party must also
comply with these condition(s). For more specific information on import responses from Parties
to the Convention please consult the Database of Import Responses9.
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2.3 Information exchange under the Convention
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2.3.1 Notification of final regulatory action
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The other integral part of the Rotterdam Convention is the exchange of information among
Parties. Under Article 5 of the Convention, Parties have to notify the Secretariat when they
adopt a final regulatory action to ban or severely restrict a chemical for health or
environmental reasons by submitting so-called PIC notification. The purpose of such a
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The Conference of Parties (COP) is the body responsible for making decisions concerning amendments
to the Convention. It is composed of those countries or regional economic organisations that have
ratified, accepted, approved or acceded to the Convention.
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notification is to share the information on hazardous chemicals with the Secretariat and all
Parties and to identify candidate chemicals for the PIC procedure.
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To learn how the notification of banned or severely restricted chemicals under the Convention
functions at the EU level, please consult sub-section 6.4 of this guidance document.
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Another key pillar of the Convention relates to the exchange of information among Parties
about potentially hazardous chemicals that may be exported. A Party that plans to export the
chemical that is banned or severely restricted for use within their own territory must inform
the importing Party that such export will take place. This must be done before the first
shipment in each calendar year until the chemical becomes subject to the PIC procedure and
the importing Party has provided an import response which has been distributed to all Parties.
This procedure is known as an export notification.
The Secretariat verifies the completeness of the notification according to Annex I of the
Convention. If the notification meets the information requirements, a summary of the final
regulatory action is prepared and published in the PIC Circular. Such a summary includes a
scope, reason for and expected effect of the regulatory action together with the information on
hazards and risks posed by the chemical to human health and the environment.
After notifications for the same chemical from at least two different PIC regions10 have been
submitted to the Secretariat, the information will be evaluated by the CRC. The CRC reviews
the notifications according to the criteria set out in Annexes I and II of the Convention. In case
the notifications meet the above-mentioned criteria, the CRC may recommend to the COP that
the chemical be listed in Annex III of the Convention and subject to the PIC procedure. The
CRC then drafts a DGD, which is based on the information contained in the notifications and
supporting documentation. The final decision to add the chemical to Annex III of the
Convention and adopt the DGD is made by the Conference of the Parties.
2.3.2 Export notification
The export notification differs from the PIC procedure, as it does not ask Parties for a
decision related to future import of the chemical. It only informs Parties that the shipment of
a chemical that is banned or severely restricted in the exporting Party is foreseen.
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In addition, exports of banned or severely restricted chemicals, as well as chemicals subject to
the PIC procedure, need to be appropriately labelled and accompanied by basic health and
safety information in the form of a safety data sheet (SDS).
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2.4 Relationship to other international chemicals legislation
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The Stockholm Convention on Persistent Organic Pollutants (POPs) is another international
legislation in the field of chemicals management. It requires the elimination or restriction of
production and use of POPs (i.e. certain industrial chemicals and pesticides). Some of these
chemicals are also subject to the Rotterdam Convention, e.g. polychlorinated biphenyls (PCBs),
aldrin, dieldrin, DDT, chlordane, hexachlorobenzene, toxaphene and heptachlor.
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The substances are included in the Stockholm Convention based on their properties (toxicity,
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Southwest Pacific) are used only for the determination of requirements given in paragraph 5 of Article 5
of the Convention.
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potential for bioaccumulation, environmental persistence, and transboundary movement to
locations remote from their release). They are not included in the Stockholm Convention as a
result of any national final regulatory action to ban or to severely restrict their use. However,
chemicals subject to such a final regulatory action and demonstrating one or more of the
above-mentioned properties could also be candidates for inclusion in the Rotterdam
convention. Therefore, certain chemicals will be subject to both Conventions.
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For more information about chemicals targeted by the Stockholm Convention please view the
Stockholm Convention website at www.pops.int.
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2.5 Participation of the European Union in the Rotterdam
Convention
Participation of the EU in the Convention is a joint responsibility of the European Commission
and the Member States. The Commission acts as a common designated authority for the
administrative functions of the Convention (the PIC procedure) and works in close cooperation
with the DNAs of the Member States (see Article 5 of the PIC Regulation). These administrative
functions include:
− transmission of EU export notifications to Parties and other countries;
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− submission of PIC notifications to the Secretariat;
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− transmission of information concerning other
chemicals not qualifying for PIC notification;
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− submission of EU import responses for chemicals subject to PIC procedure to the
Secretariat and
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− exchange of information with the Secretariat.
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final
regulatory
actions
involving
The Commission also coordinates the EU input on all technical issues related to the
Convention, the COP and its subsidiary bodies such as for example the CRC.
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3. DEFINITIONS
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Before continuing to describe in more detail the scope of the PIC Regulation it may be useful to
clarify some of the terms:
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Article 3 (1): ‘chemical’ means a substance, whether by itself or in a mixture, or a mixture,
whether manufactured or obtained from nature, but does not include living organisms, which
belongs to either of the following categories:
(a) pesticides, including severely hazardous pesticide formulations;
(b) industrial chemicals;
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Note that the term ‘chemical’ covers both substances on their own or in mixtures.
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Article 3 (2): ‘substance’ means any chemical element and its compounds as defined in point
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The REACH Regulation defines substance as “a chemical element and its compounds in the
natural state or obtained by any manufacturing process, including any additive necessary to
preserve its stability and any impurity deriving from the process used, but excluding any
solvent which may be separated without affecting the stability of the substance or changing its
composition”.
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Article 3 (3): ‘mixture’ means a mixture or solution as defined in point 8 of Article 2 of
Regulation (EC) 1272/200812.
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Regulation (EC) No 1271/2008 (the CLP Regulation) defines mixture as “a mixture or solution
composed of two or more substances”. For the purposes of export notification and explicit
consent requirements, mixtures fall within the scope of the PIC Regulation where one or more
Annex I chemical(s) is/are present in a concentration that triggers labelling under the CLP
Regulation, irrespective of the presence of any other substances. In contrast, the requirements
of Article 17 (Information to accompany exported chemicals) apply to all mixtures classified as
hazardous under EU legislation, irrespective of whether or not this is due to the presence of
Annex I chemicals.
The provisions of the PIC Regulation apply also to articles containing certain chemicals. Article
3 (4) of the PIC Regulation defines an ‘article’ as a “finished product containing or including a
chemical the use of which has been banned or severely restricted by EU legislation in that
particular product” where that product does not fall under definition of ‘substance’ or ‘mixture’.
This definition is quite specific and needs to be read in conjunction with the relevant provisions
applicable to articles (Article 15 of the PIC Regulation - Export of certain chemicals and
articles), which further limit its scope. The requirements of the PIC Regulation for articles are
described in more details in sub-sections 4.1.5 and 6.1 of this guidance document.
Article 3 (14): ‘severely hazardous pesticide formulation’ means a chemical formulated for
use as a pesticide that produces severe health or environmental effects observable within a
short period of time after single or multiple exposure, under conditions of use.
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This definition covers a group of pesticides called severely hazardous pesticide formulations
(SHPFs). These are pesticide formulations found to cause problems (severe health or
environmental effects observable within a short period of time after single or multiple
exposures) under the conditions of use in a developing country or a country with an economy
in transition. In some of these countries the conditions of use mentioned in this definition may
not allow for using certain pesticide formulations safely. However, the same formulations may
be used safely in developed countries and thus would not be identified as candidates for
inclusion under the Convention.
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Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93
and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and omission of
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
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Article 3 (10): ‘banned chemical’ means either of the following:
(a) a chemical all uses of which within one or more categories or subcategories have been
prohibited by final regulatory action by the Union in order to protect human health or
the environment;
(b) a chemical that has been refused approval for first-time use or has been withdrawn by
industry either from the Union market or from further consideration in a notification,
registration or approval process and where there is evidence that the chemical raises
concern for human health or the environment;
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In simple terms: a ban is where all uses of a chemical within one or more use subcategories or
categories have been prohibited, the chemical was never approved or was withdrawn.
Article 3 (11): ‘severely restricted chemical’ means either of the following:
(a) a chemical virtually all uses of which within one or more categories or subcategories
have been prohibited by final regulatory action by the Union in order to protect human
health or the environment, but for which certain specific uses remain allowed;;
(b) a chemical that has, for virtually all uses, been refused for approval or been withdrawn
by industry either from the Union market or from further consideration in a
notification, registration or approval process and where there is evidence that the
chemical raises concern for human health or the environment;
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In simple terms: a severe restriction is where virtually all use of a chemical within one or more
use subcategories or categories has been prohibited, approval was refused or the chemical was
withdrawn, but for which certain uses are still permitted.
Whilst it is relatively easy to assess when a final regulatory action is a ban, it may be more
difficult to determine when a final regulatory action is a severe restriction. Where some uses
have been prohibited a case by case assessment is needed as to whether this may constitute a
prohibition of virtually all use.
If all but one or two uses of an extensive range of uses have been prohibited and the
remaining uses are relatively small, this may be considered as a severe restriction. However, if
all but one or two uses of an extensive range of uses have been prohibited and those
remaining are major uses, this may not constitute a severe restriction, especially if the
prohibited uses were moderate or minor.
Article 3 (20): ‘Party to the Convention’ or ‘Party’ means a State or a regional economic
integration organisation that has consented to be bound by the Convention and for which the
Convention is in force
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The definition refers to Parties to the Convention. However, it should be noted that the core
provisions of the PIC Regulation, which relate to export notification, explicit consent, export
bans and information to accompany exports (Articles 8, 14, 15 and 17 of the PIC Regulation)
apply to exports to all countries irrespective of whether or not they are Parties to the
Convention.
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4. SCOPE
The scope of the PIC Regulation goes beyond the requirements of the Convention in order to
achieve a higher level of protection of human health and the environment.
Firstly, it has been extended to include all chemicals banned or severely restricted at the EU
level.
Secondly, the two use categories under the Convention (pesticides and industrial chemicals)
have been divided further under the PIC Regulation into four subcategories:

pesticides
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pesticides used as plant protection products (PPPs) covered by Regulation
(EC) No 1107/200913;
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other pesticides, such as biocidal products under Directive 98/8/EC 14 and
disinfectants and parasiticides covered by Directives 2001/82/EC and 2001/83/EC;
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industrial chemicals
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chemicals for use by professionals;
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chemicals for use by the general public;
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The use of these subcategories implies that under the PIC Regulation, more chemicals are
subject to export notification than would be the case if only the Convention’s categories were
followed. For example: Virtually all uses of chemical X are prohibited within the EU as a plant
protection product (PPP). However, the same chemical X within the EU has also another
important use as a biocide (and has been authorised within the EU in this subcategory). It will
therefore be severely restricted under the PIC Regulation. In contrast, to qualify as “severely
restricted” under the Convention, “virtually all uses” of the chemical X within the whole
pesticide category would have to be prohibited.
Furthermore, EU exporters are obliged to make export notifications forchemicalsfor chemicals
listed in Annex I irrespective of the intended use declared on the export notification and
whether or not that use is banned or severely restricted within the EU. The reasoning behind is
that the exporters cannot guarantee that the intended use declared on the export notification
will correspond to how the chemical will actually be used in the importing country.
Finally, with regards to the requirement for explicit consent, the list of chemicals subject to
this requirement extends beyond the list of chemicals subject to the PIC procedure under the
Convention. Therefore, all chemicals which qualify for PIC notification in any of the two
Convention categories (pesticides and industrial chemicals) require the explicit consent of the
importing country in order for their export to take place.
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concerning the placing of plant protection products on the market;
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The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is applicable from 1 September
2013, with a transitional period for certain provisions. It repealed the Biocidal Products Directive
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4.1 Chemicals included
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The PIC Regulation covers the following chemicals, whether that chemical is a substance on its
own or a substance contained in a mixture in a concentration that triggers a labelling
obligation under the CLP Regulation or a mixture:
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a) chemicals subject to the PIC procedure;
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b) certain hazardous chemicals that are banned or severely restricted within the EU or a
Member State;
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Furthermore, in order to be exported, all chemicals must comply with the labelling and
packaging obligations described in the CLP Regulation.
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The next sub-sections of this guidance document (4.1.1, 4.1.2 and 4.1.3) describe each of the
above-mentioned groups of chemicals and briefly indicate the sets of provisions that apply to
each of them under the PIC Regulation.
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4.1.1 Chemicals subject to the PIC procedure
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Chemicals that are subject to the prior informed consent (PIC) procedure under the Rotterdam
Convention (see sub-section 2.2 of this guidance) belong to this group. They are listed in Parts
2 and 3 of Annex I to the PIC Regulation.
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These chemicals require annual export notification according to Article 8 of the PIC Regulation,
irrespective of the expected use of the chemical in the importing country, unless an applicable
import response is shown in the latest PIC Circular or the importing country has waived the
right to be notified.
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Such chemicals also require the explicit consent of the importing country pursuant to Article 14
(6) of the PIC Regulation, unless the latest PIC Circular indicates that the importing country
has provided a positive import response or a waiver to the explicit consent provision has been
granted15. For further details on granting of a waiver, please refer to sub-section 6.7.1.8 of this
guidance).
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Legal reference: Article 2 (1) (a) of the PIC Regulation
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4.1.2 Banned or severely restricted chemicals
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The chemicals referred to in this sub-section are banned or severely restricted within the EU or
a Member State. Such chemicals fall into the following groups:
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− Chemicals banned or severely restricted within the EU in a subcategory of a
Convention use category (e.g. subcategory “plant protection products” of the category
“pesticides”).
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Such chemicals are subject to annual export notification, irrespective of the expected use of
the chemical, unless the chemical is subject to the PIC procedure and an applicable import
response is shown in the latest PIC Circular or the importing country has waived the right to
be notified.
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The waiver can be granted in accordance with Article 14 (7) by the DNA, in consultation with the
Commission assisted by ECHA, following unsuccessful attempts over 60 days to get a reply and provided
that one of the conditions given by Article 14 (7) is met.
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− Chemicals banned or severely restricted within the EU in a Convention use
category (for example category “pesticide”).
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These chemicals qualify for PIC notification. They are also subject to annual export
notification, irrespective of the expected use of the chemical, unless the chemical is subject
to the PIC procedure and an import response is shown in the latest PIC Circular or the
importing country waives the right to be notified.
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Furthermore, exports of such chemicals are subject to the explicit consent of the importing
country according to Article 14 (6) of the PIC Regulation, unless they are subject to the PIC
procedure under the Rotterdam Convention and the latest PIC Circular indicates that the
importing country has given the consent to import.
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A waiver to the requirement for explicit consent may be granted under Article 14 (7) of the
PIC Regulation (see sub-section 6.7.1.8 of this guidance).
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In cases where such chemicals are to be exported to OECD countries16 where they are
known to be licensed, registered or authorised, the exporter’s DNA may (at the request of
the exporter and on a case-by-case basis) decide in consultation with the Commission, that
no explicit consent is required and allow exports to proceed. A list of OECD countries to
which waivers for explicit consent could be applied is provided in Appendix 6 of this
guidance document.
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− Chemicals prohibited within the EU and banned from export
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These are the chemicals that are prohibited within the EU and subject to export ban
according to Article 15 (2) of the PIC Regulation, as they are listed in Annexes A or B to the
Stockholm Convention. These chemicals are listed in Annex V to the PIC Regulation.
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Note however, that according to Article 2 (3) the export of chemicals listed in Annex V is
possible if they are exported for the purpose of research or analysis in quantities of below
10 kilograms per exporter, per year and per importing country. In such cases the exporter
must follow the special RIN17 procedure. The provisions of Article 2 (3) and the special RIN
procedure are described in sub-section 4.2.9 of this guidance.
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− Chemicals banned or severely restricted by a Member State
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Such chemicals may be subject to national PIC notification or information exchange, i.e. the
provision of relevant information to the PIC Secretariat for wider dissemination to other
countries, both routed through the Commission according to Articles 11 (8) and 12 of the
PIC Regulation.
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Legal reference: Article 2 (1) (b) of the PIC Regulation
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When exported, chemicals that are classified as hazardous within the EU must be packaged
and labelled as though they were being placed on the EU market (see Articles 14 (10), 14 (11)
and 17 of the PIC Regulation), unless those provisions would conflict with any specific
requirements of importing Parties or other countries. To learn more about the information to
accompany exported chemicals, please consult sub-section 6.11 of this guidance document.
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Legal reference: Article 2 (1) (c) of the PIC Regulation
4.1.3 All exported chemicals as regard their classification, labelling and
packaging
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Member countries of the Organisation for Economic Cooperation and Development (OECD).
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Reference identification number.
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The PIC Regulation applies to individual chemicals or groups of chemicals which are included in
Annex I to the Regulation and to mixtures containing such chemicals in a concentration that
triggers labelling obligations under the CLP Regulation, as well as to articles containing these
chemicals in an unreacted form (see sub-section 4.1.5 of this guidance).
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Part 1: List of chemicals subject to export notification
This part lists the chemicals or chemical groups that are subject to export notification. This
comprises all of the chemicals that are banned or severely restricted within the EU in at least
one of the use subcategories (i.e. pesticide used as a PPP, other pesticide such as a biocidal
product, industrial chemical for use by professionals, or industrial chemical for use by the
public). It also includes the chemicals that qualify for PIC notification and the chemicals subject
to the PIC procedure (except some chemicals which are listed in part 3 but are excluded from
Part 1 as they are subject to an export ban).
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Part 2: List of chemicals qualifying for PIC notification
These chemicals qualify for PIC notification because they are banned or severely restricted
within the EU in a Convention use category (pesticide or industrial chemical). Apart from the
export notification requirement, in order for export to be allowed the explicit consent of the
importing country is also required (see sub-section 6.7.1 of this guidance document).
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Part 3: List of chemicals subject to the PIC procedure
This part lists the chemicals or chemical groups that are subject to the PIC procedure (being
listed in Annex III to the Rotterdam Convention). The entries in Part 3 are subject to the
export notification requirement, and additionally to the explicit consent, except where an
import response is published in the PIC Circular and certain criteria are met.
The chemicals listed in Annex I are assigned to one or more of three groups set out as Part 1,
Part 2 and Part 3 of that Annex. A different set of provisions apply to the chemical depending
on its location in Annex I. Annex I also indicates the different use categories or subcategories
for each entry.
Please note that the lists of chemicals in the various parts of Annex I overlap. All the
chemicals found in Parts 2 and 3 are also listed in Part 1 (except for POPs listed in Part 3 but
excluded from Part 1 as they are subject to export ban according to the provisions of the
Stockholm Convention). Chemicals subject to export ban (at the time of drafting) are listed
in Appendix 2 to this guidance document.
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For chemicals that are banned or severely restricted within the EU, the most important sources
of relevant regulatory actions currently are:
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Regulation (EC) No 1107/2009 concerning the placing of plant protection products on
the market;
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Regulation (EU) No 528/2012 concerning the making available on the market and use
of biocidal products;
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Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH).
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Annex I to the PIC Regulation is updated regularly as a result of regulatory actions under EU
legislation, and developments under the Rotterdam Convention. An updated list is available on
the dedicated section of ECHA website. This list as at the time of publication of this guidance
document is also reproduced as Appendix 1 to this guidance.
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4.1.5 Articles
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The export of articles containing certain Annex I chemicals is also subject to the export
notification requirements. According to Article 15 (1) of the PIC Regulation, an export
notification is required for finished products containing or including any of the following:
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substances listed in Part 2 or Part 3 of Annex I in unreacted form18, the use of which
has been banned or severely restricted by EU legislation in that particular product, or
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mixtures containing such substances in a concentration that triggers labelling
obligations under the CLP Regulation irrespective of the presence of any other
substances.
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There are unlikely to be many such articles. An example might be wooden posts treated with
creosote, which is severely restricted for such uses and could present a risk of release during
use and/or disposal. Another example might be fever thermometers and other measuring
devices that contain mercury and that are subject to restriction as set out in Annex XVII to the
REACH Regulation19. The concentration of the listed chemical does not matter. Export
notification would be required regardless of concentration.
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Furthermore, the export of certain chemicals and articles listed in Annex V of the Regulation,
the use of which is completely prohibited in the European Union, is not allowed. As regards
export bans, Article 15 (2) applies to articles that are listed in Annex V to the PIC Regulation.
Part 2 of Annex V contains one type of such article, namely mercury-containing cosmetic
soaps, which fulfil the definition of ‘article’ in Article 3 (4) of the PIC Regulation.
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It should be underlined that the export ban does not extent to articles containing or including
any of the POP chemicals listed in Annex V. Please note that future decisions taken under the
Stockholm Convention could lead to more chemicals and articles being listed in Annex V to the
PIC Regulation.
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4.2.1 Narcotic drugs and psychotropic substances
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Narcotic drugs and psychotropic substances covered by Regulation (EC) No 111/2005 laying
down rules for the monitoring of trade between the Community and third countries in drug
precursors.
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Radioactive materials and substances covered by Council Directive 96/29/Euratom laying down
basic safety standards for the protection of the health of workers and the general public
against the danger arising from ionizing radiation.
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Legal reference: Article 2 (2) (a) of the PIC Regulation
4.2.2 Radioactive materials
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4.2.3 Wastes
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Wastes covered by Waste Framework Directive 2008/98/EC 20. The Directive defines waste as
any substance or object which the holder discards or intends or is required to discard. This
may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from
professional business or from industry (e.g. tyres, slag, window frames that are discarded).
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Legal reference: Article 2 (2) (c) of the PIC Regulation
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4.2.4 Chemical weapons
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Chemical weapons covered by Regulation (EC) No 428/2009 setting up a Community regime
for the control of exports, transfer, brokering and transit of dual-use items.
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Legal reference: Article 2 (2) (d) of the PIC Regulation
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4.2.5 Food and food additives
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Food and food additives covered by Regulation (EC) No 882/2004 on official controls
performed to ensure verification of compliance with feed and food law, animal health and
animal welfare rules.
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Legal reference: Article 2 (2) (e) of the PIC Regulation
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4.2.6 Feedingstuffs
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Feedingstuffs covered by Regulation (EC) No 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety, including additives, whether processed, partially
processed or unprocessed, intended to be used for oral feeding to animals.
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Legal reference: Article 2 (2) (f) of the PIC Regulation
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4.2.7 Genetically modified organisms
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Genetically modified organisms covered by Directive 2001/18/EC on the deliberate release into
the environment of genetically modified organisms.
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Legal reference: Article 2 (2) (g) of the PIC Regulation
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4.2.8 Medicinal products
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Proprietary medicinal products for human use and veterinary medicinal products covered by
Directive 2001/83/EC on the Community code relating to medicinal products for human use
and Directive 2001/82/EC on the Community code relating to veterinary medicinal products
respectively. Please note that chemicals belonging to this category are excluded from the PIC
Regulation provisions with the exception of biocidal products, disinfectants, insecticides and
parasiticides that are considered pesticides within the meaning of the definition provided by
the FAO International Code of Conduct on the Distribution and Use of Pesticides21. In cases of
any doubts, it should be assumed that the PIC Regulation applies.
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Legal reference: Article 2 (2) (h) and Article 3 (5) (b) of the PIC Regulation
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Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste
and repealing certain Directives; OJ L 312, 22.11.2008, p. 3–30.
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4.2.9 Chemicals exported for research or analysis
Chemicals exported for research or analysis in quantities that are unlikely to affect human
health or the environment22 and that in any event do not exceed 10 kilograms from each
exporter to each importing country per calendar year.
Research and analysis should be understood as meaning analysis and scientific research by
e.g. academia, authorities and companies. However, shipment of a chemical to be kept as
stock to be subsequently sold in the importing country for that purpose is excluded.
Exporters of such chemicals must obtain a special reference identification number (RIN) and
provide this number in their export declaration (box 44 of the Single Administrative
Document). This administrative procedure is known as a special RIN request.
The exporter first checks if Article 2 (3) applies to the export. If so, the exporter requests a
special RIN from his DNA. Provided that Article 2 (3) of the PIC Regulation applies, the DNA
approves the request and activates the RIN, which should be used by the exporter on the
customs declaration.
The special RIN request procedure is also illustrated by
Figure 2.
A Reference identification number (RIN) is generated by the ePIC application23 as part
of the export notification procedure. A RIN is the unique identifier for each export notification
(and is associated to an exporter, a substance and a calendar year). It is a string of 10
alphanumeric characters: nine randomly generated preceded by a first digit which is always
either a “1” or a “0” and categorises the type of notification (in order to facilitate customs
controls). “1” indicates a “standard” export notification whereas a “0” indicates a special RIN
request. Note that RINs are not required for exports of chemicals that are not subject to the
PIC Regulation.
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The limit of 10 kg applies to the Annex I chemicals by itself or 10 kilograms of the substance in
a mixture, including as an individual chemical within a generic group listed in Annex I.
However, if the exporter expects to export larger quantities to the same importing country
during the course of a calendar year, he is required to follow the provisions of the PIC
Regulation, including the export notification provisions.
Multiple exports of chemicals for research and analysis in quantities of below 10 kilograms may
occur in high numbers at a given moment in time. In that case, the exporter may submit a socalled bulk special RIN request24 whereby several substances and/or countries can be
selected simultaneously.
Legal reference: Article 2 (3) of the PIC Regulation
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It should be noted that in some cases quantities below 10 kilograms could affect human health and the
environment despite the fact that chemicals for research and analysis will probably be intended for used
only by trained personnel or by people supervised by such personnel.
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An IT application for processing and management of legal requirements of the PIC Regulation,
Please note that “bulk special RIN request” does not apply to the Annex V chemicals exported in
quantities at below 10 kilograms for research and analysis.
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5. KEY ACTORS
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Before explaining the obligations, it is important to have a clear understanding of the different
roles under the PIC Regulation. The sub-sections below define the key actors.
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5.1 Designated National Authorities
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Article 4 (Designated national authorities of the Member States) requires Member States to
designate one or more national authorities to act on their behalf with regard to carrying out
the administrative functions required by the PIC Regulation. Designated National Authorities
(DNAs) participate in the Convention work and, together with the Commission, take the
necessary initiatives to ensure appropriate representation of the EU in various bodies
implementing the Convention, e.g. COP.
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The Member States are also obliged to designate the authorities such as customs authorities
with the responsibility for controlling imports and exports of chemicals listed in Annex I (Article
18 of the PIC Regulation - Obligations of the authorities of the Member States for controlling
import and export).
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Given the highly technical nature of tasks allocated to DNAs under the PIC Regulation, the
Member States usually nominate institutions of governmental administration or agencies that
already have experience and responsibilities for managing chemicals and/or pesticides at a
national level. For each exporter intending to export chemicals subject to the PIC Regulation,
the Designated National Authority (DNA) established in his Member State is the primary
contact point. Similarly, DNAs are the key point of contact between Member States. The tasks
of the Member States (realised by their respective DNAs) can be divided into four groups:
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Requesting explicit consents from the DNA/appropriate authority of the importing country
for exports of chemicals listed in Parts 2 and 3 of Annex I. In case of export of Annex I
Part 2 chemicals to OECD countries, deciding in consultation with the Commission whether
the requirement for explicit consent may be waived on the basis of the chemical being
licensed, registered or authorised in the OECD country (Article 14 (6));
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Consulting the Commission and taking decisions on granting of the waivers for export of
chemicals listed in Parts 2 and 3 of Annex I in case no response has been received within
60 days of a request for explicit consent (Article 14 (7));
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Assisting the Commission in its periodic review of explicit consents and waivers (Article 14
(8));
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Forwarding export notifications received from third countries to ECHA (Article 9 (2));
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In case it is the concerned Member State in the adoption of national regulatory actions,
providing the Commission with relevant information so that it can consult other Member
States. The submitting Member State is also obliged to consider any comments received
before informing the COM whether a PIC notification should be forwarded to the
Secretariat or whether the information should instead be forwarded under the information
exchange provisions (Article 11 (8));
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For PIC chemicals, where relevant, informing the Commission of national regulatory
actions so that this information can be taken into account in EU import decisions (Article
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Forwarding to those concerned within its jurisdiction the information on chemicals and on
decisions of importing parties regarding import conditions applicable to those chemicals
(Article 14 (1) and (3)).
Enforcement
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Ensuring that exporters meet their obligations and to take measures to ensure compliance,
including the establishment of penalties for infringements (Article 28);
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to ECHA (Article 8 (2)).
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On the basis of reports from exporters and importers, providing ECHA with annual
aggregated reports on trade in chemicals listed in Annex I using the format set out in
Annex III (Article 10 (3));
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Proving the Commission with regular monitoring reports on the operation of the various
procedures (Article 22), including activities controlling compliance of exporters (Article 18
(1)).
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On request, providing importing countries with additional information related to exported
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On request, assisting the Commission in compiling additional information with respect to
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Advising and assisting importing countries, upon request, in obtaining additional
information to help them make an import response for PIC chemicals (Article 14 (5));
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Forward to the Commission (with a copy to ECHA) any information required by an
importing Party to the Convention that has been provided by the exporter concerned prior
to each transit movement of a chemical listed in Part 3 of Annex I (Article 16 (3));
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Facilitating, together with the Commission and with the support of ECHA, the exchange of
information (Article 20) and cooperating in promoting technical assistance (Article 21).
Monitoring and reporting
Provision and exchange of information
The list of EU Designated National Authorities for Regulation (EC) 649/2012 as at the time of
publication of this guidance is provided in Appendix 5. Addresses for both EU and non-EU
DNAs are available on the dedicated section of ECHA website.
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5.2 Exporters and importers
Article 3 (18): ‘exporter’ means any of the following persons, whether natural or legal:
(a) the person on whose behalf an export declaration is made, that is to say the person
who, at the time the declaration is accepted, holds the contract with the consignee in
a Party or other country and has the power to determine that the chemical be sent out
of the customs territory of the Union;
(b) where no export contract has been concluded or where the holder of the contract does
not act on its own behalf, the person who has the power to determine that the
chemical be sent out of the customs territory of the Union;
(c) where the benefit of a right to dispose of the chemical belongs to a person established
outside the Union pursuant to the contract on which the export is based, the
contracting party established in the Union;
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An exporter of a chemical is a natural or legal person holding the export contract, or in the
absence of a contract, is the person having the power to determine the export of the chemical
from the customs territory of the EU 25 (irrespective of from which Member State the export is
leaving the customs territory).
The EU customs territory also includes zones where special customs rules apply, for example
free zones. Goods placed within free zone are free of import duties, VAT and other import
charges. Free zone treatment applies to both non-EU and EU goods. Non-EU goods stored in
a free zone are considered as not yet imported into the EU customs territory whereas certain
EU goods stored in free zones can be considered as already exported.
On importation, free zones are mainly for storage of non-EU goods until they are released for
free circulation. No import declaration has to be lodged as long as the goods are stored in
the free zone.
On exportation, the export procedure allows exit of EU goods from the EU customs territory.
From a customs point of view, exported EU goods change their status to non-EU goods. For
non-EU goods, the operation is called ‘re-exportation’.
All shipments from the EU-customs territory to third countries are considered to be an
export. This applies to EU goods as well as to non-EU goods, for which the export is a reexportation. This interpretation is also supported by the definition of export in Article 3 (16)
(b) of the PIC Regulation, where re-export is also mentioned. The only exception where the
shipment is not considered to be an export is the transit movement.
Based on the above, all shipments (except those in transit) leaving the EU-customs territory,
which include free zones (e.g. customs warehouses) have to comply with requirements of
the PIC Regulation.
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In cases where the exporter is not established in the EU, the contracting party established in
the EU is responsible for fulfilling the obligations of the exporter. In simple terms, an exporter
can be the person who:
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The ‘customs territory of the Union’ is determined in Article 3 of Council Regulation (EEC) No 2913/92
establishing the Community Customs Code.
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− is shown on the shipping documents as the person that holds the export contract with
the consignee in a Party or other country;
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− provides the chemical to a person established outside of the EU who has the right to
dispose of this chemical.
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The application of this definition may be more complex in the context of Articles 8 (1) and 8
(2) of the PIC Regulation (Export notifications forwarded to Parties and other countries), which
require the exporter to notify the DNA of the Member State in which he is established. Some
chemical manufacturers (and possibly also distributors) may supply chemicals to traders who
are not established in the EU and who may sell these on to customers in third countries. There
appear to be two possible scenarios:
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1) An EU chemical manufacturer or distributor supplies the chemical to a non-EU
trader/dealer and delivers free on board to the ship.
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2) An EU chemical manufacturer or distributor supplies the chemical to a non-EU
trader/dealer ex works, i.e. the trader picks up the shipment at the factory.
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In such circumstances the contracting party that is established in the EU, namely the chemical
manufacturer or distributor, assumes responsibility for completing the export notification and
delivering it to his national DNA. In order to complete the notification, the contracting party
must have access to information on the identity and address of the importer. The information
requirements for export notification are given in Annex II of the PIC Regulation.
Article 3 (19): ‘importer’ means any natural or legal person who at the time of import into the
customs territory of the Union is the consignee for the chemical;
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The PIC Regulation defines import as physical introduction of a chemical into the EU customs
territory (unless the chemical is subject to the external EU transit procedure for movement of
goods through the EU customs territory and thus does not remain in the EU).
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6. OBLIGATIONS UNDER THE PIC REGULATION
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6.1 Export notifications forwarded to third countries
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Export notification is a mechanism that enables exchange of information about banned or
severely restricted chemicals among countries. Via such a notification, the importing country is
alerted that it is receiving imports of a chemical that has been banned or severely restricted in
the exporting country. In simple terms, the export notification informs the importing country
that a shipment of the chemical that has been banned or severely restricted in the exporting
country is being sent to it. The provisions for export notification are outlined in Article 8 of the
PIC Regulation (Export notifications forwarded to Parties and other countries).
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6.1.1 Who has to notify?
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The export notification obligation applies to each EU-based exporter intending to export a
specific chemical subject to notification from the EU to a third country (whether or not this
country is a Party to the Convention). This obligation applies irrespective of the end-use of a
chemical in the country of destination.
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6.1.2 What to notify?
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The export notification applies to:
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all chemicals listed in Part 1 of Annex I to the PIC Regulation26;
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mixtures containing chemicals listed in Part 1 of Annex I, if the concentration of the
chemical triggers labelling obligation under the CLP Regulation;
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articles as defined in Article 3 (4) of the PIC regulation, i.e. finished products containing
or including in unreacted form:
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− a chemical listed in Part 2 or Part 3 of Annex I, the use of which has been banned
or severely restricted by EU legislation in that particular product, or
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− mixtures containing such chemicals in a concentration that triggers labelling
obligations under the CLP Regulation.
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A separate export notification must be submitted for each substance, mixture or article
concerned and a separate RIN will subsequently be issued.
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6.1.3 Information requirements
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The information required to accompany the export notification is specified in Annex II to the
PIC Regulation. The text of Annex II is given below:
Annex II to Regulation (EC) No 649/2012
EXPORT NOTIFICATION
The following information is required pursuant to Article 8:
1. Identity of the substance to be exported:
(a) name in nomenclature of the International Union of Pure and Applied Chemistry;
(b) other names (e.g. ISO name, usual names, trade names, and abbreviations);
(c) European Inventory of Existing Chemical Substances (EINECS) number and
Chemical Abstracts Services (CAS) number;
(d) CUS number (European Customs Inventory of Chemical Substances) and Combined
Nomenclature Code;
(e) main impurities of the substance, when particularly relevant.
2.
Identity of the mixture to be exported:
(a) trade name and/or designation of the mixture
(b) for each substance listed in Annex I, percentage and details as specified under point
1;
(c) CUS number (European Customs Inventory of Chemical Substances) and Combined
Nomenclature Code
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be exported under certain circumstances related either to their use or to their concentration.
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Identity of the article to be exported:
(a) trade name and/or designation of the article;
(b) for each substance listed in Annex I, percentage and details as specified under point
1.
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Information on the export:
(a) country of destination;
(b) country of origin;
(c) expected date of first export this year;
(d) estimated amount of the chemical to be exported to the country concerned this
year;
(e) intended use in the country of destination, if known, including information on the
category(ies) under the Convention under which the use falls;
(f) name, address and other relevant particulars of the natural or legal
person;
importing
(g) name, address and other relevant particulars of the exporter.
5.
Designated national authorities:
(a) the name, address, telephone and telex, fax number or e-mail of the designated
authority in the Union from which further information may be obtained.
(b) the name, address, telephone and telex, fax number or e-mail of the designated
authority in the importing country.
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Information on precautions to be taken, including category of danger and risk and
safety advice.
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A summary on physico-chemical, toxicological and ecotoxicological properties.
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Use of the chemical in the Union:
(a) uses, category(ies) under the Convention and Union subcategory(ies) subject to
control measure (ban or severe restriction);
(b) uses for which the chemical is not severely restricted or banned (use categories and
subcategories as defined in Annex I of the Regulation);
(c) estimation, where available, of quantities of the chemical produced, imported,
exported and used.
9.
Information on precautionary measures to reduce exposure to, and emission of, the
chemical.
10. Summary of regulatory restrictions and reasons for them.
11. Summary of information specified in points 2 (a), (c) and (d) of Annex IV.
12. Additional information provided by the exporting Party because considered of concern or
further information specified in Annex IV when requested by the importing Party.
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The exporter must follow the export notification procedure when exporting a chemical for the
first time and for the first export in each subsequent year. Subsequent exports of the same
chemical, to the same country within the same calendar year do not need to be notified, unless
otherwise required by importing countries. However, the export of the same chemical to
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another third country will be considered as a “first export” and therefore subject to the export
notification procedure.
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The exporter must submit an export notification to his DNA (i.e. to the designated national
authority of the Member State in which he is established) at least 35 days before the first
export is due to take place. Thereafter the exporter must notify his DNA of the first export of
the chemical each calendar year no later than 35 days before the export takes place. However,
it is recommended to submit the notification as early as possible to the DNA to allow enough
time for processing. Note that except in an emergency (see sub-section 6.1.9 of this guidance)
the ePIC application will not allow submission of export notifications later than 35 days before
the expected date of export specified in Article 8 (2) of the PIC Regulation.
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Once the DNA has confirmed that the draft notification is complete, he must forward it to ECHA
no later than 25 days before the expected date of export. After approval, ECHA transmits
the final notification to the DNA or other appropriate authority of the importing country no
later than 15 days before the first intended date of export (and thereafter no later than
15 days before the first export in any subsequent calendar year).
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6.1.5 The procedure
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The export notification procedure consists of the following steps:
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1) Submission of an export notification
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The exporter creates and submits an export notification for a substance or mixture or article to
his DNA via ePIC. A reference identification number (RIN) is issued as a result of this process.
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The DNA checks the compliance of the submitted information with Annex II to the PIC
Regulation (Export notification). The DNA should as far as possible verify the following:
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 Is the notification complete?
2) Processing by the DNA
If not, the export cannot proceed. In such a situation the DNA should alert the exporter
without undue delay so that any missing necessary information can be provided and the
export is not unreasonably delayed. At the stage of processing of export notification, the
exporter is able to track the status of his export notification. A notification is only considered
complete once it has been fully processed (i.e. checked and accepted by both his DNA and
ECHA).
 In the case of a chemical listed only in Part 1 of Annex I, has the country of destination
waived the right to be notified?
If so, the notification need not be forwarded and the exporter can be informed by the DNA
that he need not submit any further notifications for export of that chemical to the country
concerned (until further notice). However, the exporter must obtain a special RIN for that
chemical and provide this number in his export declaration.
 Is the notified chemical covered by a generic group listed in Annex I?
The exporter should preferably identify the specific chemical involved and should forward
the precise name with the notification. Separate notification should be submitted for
individual chemicals within a generic group, if the classification and labelling is different
from a generic group.
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 Does the notification relate to a mixture?
Since mixtures tend to be differently composed and are therefore individually classifiable
and labelled, in principle every mixture containing an Annex I chemical(s) to the extent that
this triggers labelling should be notified. However, a single notification covering several
mixtures containing the same Annex I chemical(s) would be acceptable provided that the
only difference between those mixtures is, for example, their colour and that there are no
differences in the classification and labelling of the mixtures and the uses remain the same.
Whenever changes in the concentration of Annex I chemical(s) in a mixture trigger new
labelling requirements, a new notification is needed.
 For a chemical qualifying for PIC notification listed in Part 2 of Annex I, has the country of
destination given its explicit consent?
If so, the export notification is forwarded (unless the importing country has waived a right
to notification). If not, and consent has not already been sought, the DNA should seek
explicit consent from the DNA or another appropriate authority in the country of destination.
The official export notification is forwarded to the importing country by ECHA. The DNA may
attach a draft copy of the export notification to the request for consent to help the importing
country in making a decision. The exporter is then informed accordingly. Note that in the
absence of an explicit consent, the RIN for a part 2 or 3 chemical cannot be activated for
customs clearance.
 In case of a chemical listed only in Part 3 of Annex I, does an import decision of the country
of destination appear in the latest PIC Circular and if so, what does it say?
The first thing to be checked is whether the expected use on the export notification matches
the use category for which the chemical is subject to the Rotterdam Convention. If the two
do not match, an explicit consent is required.
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If there is no import decision in the PIC Circular or the decision is otherwise
unclear as to whether the importing country consents, explicit consent is required. If
such consent has not already been obtained or sought (see status list of explicit
consents on ePIC), the DNA should seek explicit consent from the DNA or another
appropriate authority in the country of destination.
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If the import decision in the PIC Circular gives consent, export notification is
no longer required for the respective use category, unless the country of destination
has indicated that it still wishes to receive an export notification. In cases where the
chemical is a double-use chemical, and the intended use is not covered by the import
decision, an export notification still needs to be submitted and explicit consent
sought.
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If there is a negative import decision (no consent for the respective Convention
use category) and the intended use is for that category, the export cannot proceed.
Please note that the negative import decision relates to the use category given in the
Convention. Therefore, it is still possible to export for the other use category if the
chemical is a double-use chemical (for example ethylene oxide) provided that the
explicit consent was obtained.
 Certain Annex I chemicals listed in case they have impurities (e.g. diclofol and maleic
hydrazine and its salts).
In case of the above-mentioned chemicals an export notification is only required if the
purity requirements are not met. Note also that some Annex I chemicals (e.g. benzene)
may be present as impurities in other chemicals like petroleum distillates at concentrations
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that trigger labelling obligations and thus require notification.
If there are issues with any of the above-mentioned requirements, the DNA returns the draft
notification to the exporter without undue delay.
When assessing the completeness of a notification, the DNA also needs to take into account
the following:

In principle, the exporter is obliged to provide all the information required. However, in
practice he may not always be in a position to do so. As a minimum, the exporter
should be expected to provide information under the following sections of Annex II: 1,
2, 3, 6 and 7. For sections 4 and 5 of Annex II the provision of safety data sheet (SDS)
would suffice;

The exporter is not obliged to attach an SDS with the export notification (any claim that
he is, is not supported by the legal text of the PIC Regulation). However, it is strongly
recommended that when creating an export notification, the exporter provides a copy
of the SDS in the official language of the importing country as well as an English
version (if available) in order to facilitate processing of the notification by ECHA;

The exporter must send an SDS to each importer when the chemical is exported (see
Article 17 (3) of the PIC Regulation). In this case the information on the label and on
the SDS must as far as practicable be given in the official language of the country of
destination (Atricle 17 (4)). Appendix 4 to this guidance provides a list of
recommended languages for the labelling of exports to certain countries.
Note that the DNAs may charge the exporter an administrative fee to cover the costs incurred
in carrying out the export notification procedure.
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3) Processing by ECHA
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ECHA also checks the export notification and, if it is the first yearly notification, it is
transmitted to the importing country (otherwise it is stored in ePIC) along with the
confirmation of the receipt form and, if submitted by the exporter, a copy of the SDS for the
chemical. The final notification is stored on ePIC and is available to the exporter and DNAs. If
the RIN can be activated at this stage, its active period will be communicated in the message
sent (directly by ePIC) to the exporter and to his DNA.
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Exporters are required to quote active RINs in their export declarations, thereby reducing the
paper burden since supporting documents need no longer be submitted. The export can
proceed upon expiry of the time limit specified in Article 8 (2) and as determined by the
validity of the RIN. The list of chemicals concerned will be available to the public and DNAs on
a dedicated section of the ECHA website.
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Figure 1 as well as Example 1 and Example 2 in section 8 of this guidance illustrate the
procedure for an export notification for the chemicals listed in Part 1 of Annex I. Additional
information on how to technically fill in the information and submit the export notification is
given in the ePIC User Manual available on the dedicated ECHA website section.
In simple wording, an “active” RIN means a RIN that has customs clearance. Note however,
that not all RINs are activated when the export notification is processed. For example, in case
of chemicals also listed in Part 2 or 3 of Annex I, the RIN may not be activated, as the explicit
consent of the importing country needs to be obtained first. The RIN active period may also be
subject to changes during the calendar year due to the presence/absence of an explicit consent
and to its validity period (see sub-section 6.7.1.7 of this guidance document).
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Exporter creates and submits an
export notification in ePIC
(inactive RIN assigned automatically)
DNA asks
exporter to
correct and
resubmit
DNA checks if the notification complies with Annex
II of the PIC Regulation
Notification rejected
(for example: special
RIN was required
instead of notification)
Notification approved
Notification
incomplete
ECHA asks
exporter to
correct and
resubmit
ECHA checks the notification
Notification rejected
Notification approved
ECHA forwards the
notification to
importing country
(if it is a first yearly
notification; otherwise
stored in ePIC)
Notification
incomplete
RIN activated on the
expected date of export
(for Annex I Part 1
chemicals)
Export can proceed for substances only
listed in Annex I and not being subject
to Article 14(6)
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Figure 1: Export notification procedure for Annex I Part 1 chemicals to all countries (except exports
pursuant to Article 8 (6)).
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6.1.6 Incompliant export notifications
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The exporter is responsible for the contents of an export notification, therefore only the
exporter can edit a notification (in case information is either missing or incorrect). The DNA is
responsible for checking the notification’s compliance with Annex II of the PIC Regulation but
cannot modify the contents of the notification. Therefore, in case of incompliance of the
notification with the Regulation requirements, it needs to be sent back to the exporter.
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In case an export notification is found to be incompliant, different scenarios are possible.
These scenarios are mainly based on how far in advance of the export the notification is
submitted and subsequently checked by the DNA.
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It is possible for the DNA or ECHA to request a re-submission of the export notification, if
the notification was submitted long in advance of the 35-days deadline and a re-submission is
possible before this deadline. This implies that the RIN and the expected date of export remain
the same.
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Exceptionally, where the circumstances of the case allow, the DNA may allow the exporter to
make a re-submission less than 35 days before the expected date of export, if the information
can be re-submitted, checked and forwarded within the deadlines of the PIC Regulation.
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The DNA will reject an export notification that is not required and request the submission of
a special RIN request in its place. This could be the case if the importing country has waived
the right to receive notifications or if the export is for <10kg for research and analysis
purposes.
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The DNA will also reject an incomplete or incompliant export notification when:

the notification cannot be re-processed within the legal timeframe, or

the DNA had suggested an informal deadline to the exporter for correcting the export
notification and this deadline was not met (once again, leading to the notification not
being processed within the legal timeframe).
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If one of the above-mentioned scenarios occurs, the exporter will have to submit a new export
notification, a new RIN will be assigned to it and the day-count will go back to 35 days prior to
the expected date of export as for any newly submitted export notification.
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ECHA has to follow up notifications if there is no acknowledgement of receipt of a first export
notification made after the chemical is included in Part 1 of Annex I from the importing country
within 30 days of the dispatch of the notification. In such cases, ECHA must submit a second
notification and make (on behalf of the Commission) reasonable efforts to ensure that the DNA
or other appropriate authority of the importing country receives the second notification. Note
however, that this has no direct impact on the export proceeding.
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Whenever there is a change in EU legislation concerning the marketing and use or labelling of
the chemical, or the composition of a mixture is changed insofar as the concentration of the
chemical(s) concerned is different (for example to the extent that the required labelling is
altered) a new export notification must me submitted. The new notification must indicate that
it is a revision of a previous notification.
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Legal reference: Article 8 (4) of the PIC Regulation
6.1.7 Following up export notifications
Legal reference: Article 8 (3) of the PIC Regulation
6.1.8 When is a new notification required?
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6.1.9 Emergency situation
If the export relates to a public health or environmental emergency, where a delay could
worsen the situation in the importing country, the DNA of the exporter’s Member State (in
consultation with the Commission and assisted by ECHA) may decide to waive entirely or partly
the waiting period or notification requirements. Such exemption can be granted at a reasoned
request of the exporter or the importing country. If there is no dissenting response from the
Commission within 10 days of the DNA of the exporter’s Member States sending it details of
the request, a decision is considered to have been made.
Please note that exporters of chemicals exempted from the export notification obligation due
to an emergency situation must anyway obtain a special RIN and provide that RIN in his export
declaration. In order to distinguish these special RIN requests from those referring to exports
to which the regulation does not apply (Article 2 (3) and 8 (6)) and to allow for the
Commission to approve them, in ePIC these special RINs must be requested using the
standard notification form as opposed to the special RIN request. There is a check-box in the
notification form which allows the submission of these requests which do not need to be
submitted 35 days before export and will not be subject to the explicit consent procedure; they
will however be fully processed and sent to the importing country. Please consult
Figure 2 which illustrates the special RIN request in an emergency situation.
Legal reference: Article 8 (5) and Article 19 (2) of the PIC Regulation
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6.1.10 When is a notification no longer required?
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26
The export notification obligations cease when all the conditions of Article 8 (6) are met,
namely:
27
a) a chemical becomes subject to the PIC procedure;
28
29
b) the importing Party to the Convention has given an import response (indicating whether
or not it consents to import);
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31
c) the Commission has been informed about that response by the Secretariat and has
forwarded that information to the Member States and ECHA.
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The exporter of chemicals for which the abovementioned obligations have ceased must
nevertheless obtain a special RIN and provide it in his export declaration. Note however, that
an export notification will still be required if the importing Party to the Convention continues to
require one. The requirement for export notification also ceases when the DNA of the importing
Party officially waives the right to receive export notification. The Commission must receive
such information from the Secretariat or from the DNA of the importing Party. The Commission
subsequently forwards this information to ECHA (in order for it to be made available on ePIC)
and to the Member States. The information is also included in the latest PIC Circular accessible
on the Rotterdam Convention website.
Legal reference: Article 8 (6) and Article 19 (2) of the PIC Regulation
6.1.11 Request for additional information
The authorities of the importing country may respond to an EU export notification and request
additional information. This information must be provided by the exporter, the relevant DNA or
ECHA.
Legal reference: Article 8 (7) of the PIC Regulation
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6.2 Export notifications from Parties and other countries
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When ECHA receives an export notification concerning the export of a chemical to the EU from
a third country, the marketing or use of which is banned or severely restricted in the country
of origin it will make it available within ePIC database within 15 days of the receipt of such a
notification. ECHA acknowledges receipt of the first notification received for each chemical from
the third country on behalf of the Commission. ECHA will make the notification together with
all accessible information available to the DNA of the Member States receiving the import
within 10 days of its receipt. Upon request, other Member States are entitled to receive copies
of such export notifications.
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If a DNA of a Member State receives an export notification from a third country directly, it
must send this notification forthwith to ECHA together with all available information. However,
the DNA need not forward the notification if it is incompliant with Article 9 (for example,
because it has been triggered by “a significant new use rule” as under the US TSCA - Toxic
Substances Control Act or because of non-registration in the country of origin, etc. rather than
a ban/severe restriction for health or environmental reasons). In such cases, a summary of the
notification may suffice if the Member State considers that other Member States should be
informed. Where additional information is needed, the Member State concerned should seek
this directly from the authorities in the exporting country (with a copy sent to ECHA for
information).
20
Legal reference: Article 9 of the PIC Regulation
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6.3 Information on quantities of chemicals exported and
imported
24
During the first quarter of each year the exporter of:
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
substances listed in Annex I to the PIC regulation;
26
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
mixtures containing Annex I substances in a concentration that triggers labelling
obligation under the CLP Regulation irrespective of the presence of any other
substances; or
29
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
articles containing substances listed in Part 2 or 3 of Annex I in unreacted form, or
mixtures containing such substances in a concentration that triggers labelling obligation
under the CLP Regulation irrespective of the presence of any other substances
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has to inform his DNA of the quantities of that chemical exported (as a substance, in mixtures
and/or in articles) to each importing country for the previous year. Information should include
a list of the names and addresses of each importer to which shipment took place. In cases of
mixtures and articles it is the quantity of Annex I chemical(s) that should be reported.
The definition of ‘article’ implies that information on export is only required if the use of the
chemical in the particular article is banned or severely restricted by the EU legislation, and
not in all other articles where the substance might be used without restriction.
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42
Any exports of chemicals listed under Parts 2 or 3 of Annex I that proceed with the approval of
the DNA of the exporter and of the Commission assisted by ECHA but in the absence of explicit
consent from the importing Party or other country shall be listed separately (see Article 14 (7)
of the PIC Regulation).
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Similarly, each EU-based importer is obliged to provide the same information for quantities of
chemicals placed on the internal market. The DNAs compile and aggregate the information
received from exporters and importers using the format set out in Annex III to the PIC
Regulation. The aggregated reports for the preceding calendar year must be then submitted by
the DNAs to ECHA (preferably by the end of May of the following year, and by the end of June
at the very latest). Nil returns should also be reported to ECHA. ECHA will assist the DNAs in
collecting the data and will summarise it at Union level. An overall summary of the nonconfidential information will be published on the dedicated section of the ECHA website.
Legal reference: Article 10 of the PIC Regulation
12
6.4 Participation in the PIC notification procedure
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20
Chemicals that qualify for PIC notification (i.e. those banned or severely restricted in the EU
within a Convention use category) are included in Part 2 of Annex I. After inclusion, they must
be notified by the Commission to the Secretariat no later than 90 days after the date on which
the final regulatory action is to be applied. Normally, such regulatory action should be
underpinned by an EU risk evaluation identifying concerns for human health or the
environment. However, if no evaluation was possible (e.g. because no dossier was presented
or defended), alternative evaluations may be used to support an EU notification, if they are
relevant for the conditions and circumstances in the EU.
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24
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26
The notification has to contain the information listed in Annex IV to the PIC Regulation
(Notification of the Secretariat of the Convention of a banned or severely restricted chemical).
If the Commission does not have this information at hand, it can request identified exporters
or importers to provide such information within a 60 days of the request. The notification has
to be updated when there is a change in the regulatory action banning or severely restricting
the chemical.
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29
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31
Proposed additions to Part 2 of Annex I will be decided by a regulatory committee procedure
and then formally adopted by means of Commission Regulation amending Annex I. No EU PIC
notification will be submitted unless and until the relevant amendment has been adopted.
DNAs and stakeholders will be consulted on draft notifications before the Commission submits
the final versions to the Secretariat.
32
Prioritisation for notification
33
In determining priorities for notification, the Commission will take into account:
34
35
− whether the chemical is already subject to the PIC procedure (i.e. is already listed in
Part 3 of Annex I);
36
37
− the extent to which the information requirements of Annex IV to the Convention can be
met;
38
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− the severity of the risks presented by the chemical, in particular for developing
countries.
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Information on PIC notification from other Parties
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When the Commission receives information about PIC notifications from other Parties to the
Convention, it must circulate these immediately to all Member States and ECHA. Where
appropriate, the Commission evaluates in close cooperation with Member States and ECHA the
need to propose relevant EU measures to prevent any unacceptable risk to human health or
the environment.
47
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Notifications submitted by the Member States
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8
9
Member States may also submit, via the Commission, notifications of chemicals banned or
severely restricted by national regulatory actions. In such cases the procedure laid down in
Article 11 (8) of the PIC Regulation must be followed. The Member State concerned provides
the relevant information to the Commission, which will circulate this to all Member States. The
latter have four weeks to comment on a possible PIC notification. Ultimately, the submitting
Member State decides whether or not to ask the Commission to forward the notification to the
Secretariat or to provide the Secretariat with information pursuant to Article 12 of the PIC
Regulation.
10
11
Legal reference: Article 11 of the PIC Regulation
13
6.5 Information on banned or severely restricted chemicals
not qualifying for PIC notification
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15
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18
19
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21
Apart from a PIC notification, the Regulation provides other means for disseminating
information about banned or severely restricted chemicals using the Convention’s provisions
on exchange of information. These alternative means are relevant, for example, to chemicals
that are banned or severely restricted within the EU only in a use subcategory and thus do not
qualify for PIC notification. These means are also relevant to chemicals banned or severely
restricted by national regulatory actions in one or more Member States when those Member
States concerned conclude, following the consultation procedure referred to above, that PIC
notification would not be appropriate.
22
23
24
25
In such cases, instead of a PIC notification being done, the dissemination of information is
ensured by the Commission providing relevant information to the PIC Secretariat so that other
Parties to the Convention can be made aware. The information to be provided by the
Commission will be essentially factual, including:
12
26

identity of chemical;
27
28

reference to the relevant regulatory action and underlying reasons for it, as stated in
that action;
29

(where appropriate) a summary of available underpinning risk evaluation, etc.
30
31

(where appropriate) an explanation of why no PIC notification is being made pursuant
to Article 11.
32
Legal reference: Article 12 of the PIC Regulation
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6.6 Obligations in relation to the import of chemicals
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40
The PIC Regulation requires Member States to control the import of chemicals listed in Annex I
and to designate authorities, e.g. customs, with this responsibility (Article 18 of the PIC
Regulation). While the PIC Regulation does not include any detailed provisions on restrictions
or prohibition at importation, it establishes a procedure through which the Commission, in
close cooperation with the Member States, can evaluate and take import decisions regarding
chemicals covered by the PIC procedure.
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The Commission receives Decision Guidance Documents (DGDs) from the PIC Secretariat,
which it circulates to the Member States and ECHA. Within nine months of the date of dispatch
of the DGD by the Secretariat, the Commission adopts an EU import decision (by means of an
implementing act) for the chemical concerned, and relating to the use category or categories
for the chemical specified in the DGD. Before adopting the decision, the Commission obtains
the opinion of the Member States using the advisory committee procedure via a vote in the
committee established pursuant to Article 133 of the REACH Regulation (Committee
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procedure).
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Import decisions are based on already existing EU legislation and apply this legislation in the
context of the Rotterdam Convention. The decision on whether a chemical is allowed to be
imported and/or used and/or placed on the market of the EU territory is made in a legal act
regulating the import, use or placing on the market of the chemical in question, e.g. the
REACH Regulation or the legislation on plant protection or biocidal products. Therefore, the PIC
Regulation does not include any detailed provisions as regards restriction or prohibition at
importation.
The import decision is communicated to the Secretariat of the Rotterdam Convention and
exporting Parties are requested to respect this decision. The decision is also made available
to the public, in particular those concerned, by the DNAs in the Member States. It is also
published in the regular PIC Circular, produced by the Secretariat and on the Convention
website (http://www.pic.int).
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10
11
12
13
14
15
Where relevant, the import decision will also mention different and more specific national rules
if so requested by the Member State(s) concerned. Import decisions will relate to the use
category or categories specified in the DGD for the chemical concerned. DNAs have to make
import decisions available to those concerned within its competence, in accordance with its
legislative and administrative measures. When evaluating the information contained in a DGD,
the Commission in close cooperation with the Member States and ECHA will consider the need
to propose EU measures to reduce risks to human health and the environment, if necessary.
16
Legal reference: Article 13 of the PIC Regulation
17
18
20
6.7 Obligations in relation to export of chemicals other than
export notification
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22
23
24
EU exporters must comply with the import decisions (both interim and final) taken by third
countries, which are published every six months in the PIC Circular issued by the Secretariat.
The Commission forwards the PIC Circulars and any other relevant information it receives to
the DNAs, ECHA and European industry associations.
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26
27
28
The latest PIC Circulars will be publicly available on the dedicated section of the ECHA website.
ECHA will also provide all interested parties with that information upon request. Import
decisions are also available from the DNAs. The obligation to comply with an import decision
starts six months after the Secretariat has distributed the information.
29
30
31
For the export of chemicals listed in Part 3 of Annex I for which the import decision published
in the latest PIC Circular consents to import, it is not necessary to notify the export, unless the
importing Party requires otherwise (see Article 8 (6) of the PIC Regulation).
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33
However, exporters have to provide a RIN (import decision reference identification number) in
their customs declaration. This RIN can be obtained by a special RIN request, namely:
19
34
35
1. The exporter first checks if Article 2 (3) or Article 14 (6) (b) in conjunction with Article 8
(6) applies to the export. If so, the exporter request a special RIN from his DNA;
36
2. Provided that all requirements are met, the exporting DNA approves the request;
37
3. The RIN is activated and it has to be used by the exporter on the customs declaration.
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2
Figure 2 illustrates the procedure of requesting a special RIN.
*
Exporter checks whether Article 2 (3) or Article 14
(6) (b) in conjunction with Article 8 (6) applies to the
export, or if it is an emergency export according to
Article 8 (5)
Exporter submits special RIN request in ePIC
database
DNA checks compliance with the above-mentioned
Articles
Emergency export according to
Article 8 (5)
Waiver referred to in Article 2 (3) or Article 14 (6) in
conjunction with Article 8 (6)
COM checks the special RIN request
Request approved
Request not approved
Request approved
Exporter gets an active RIN
Export can proceed
*
Please note: In case of waivers referring to Article 2 (3) or Article 14 (6) (b) in conjunction with
Article 8 (6) the submission must be made using the “special RIN request” functionality.
In case of emergency export (Article 8 (5)) the special RIN must be submitted using the
standard export notification form (where all constraints on submission time and availability of
explicit consent have been waived). This is in order to allow for the Commission assessment of
the request.
3
4
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Figure 2: Special RIN request procedure: Article 2 (3) or Article 14 (6) (b) in conjunction with Article 8
(6) or an emergency export according to Article 8 (5).
3
6.7.1 Explicit consent
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5
6
7
Article 14 of the PIC regulation Requires the explicit consent of the country of destination prior
to the export of chemicals listed in parts 2 and 3 of Annex I (unless a positive import response
is available in the latest PIC Circular):
Article 14 (6):
Substances listed in Part 2 or 3 of Annex I or mixtures containing such substances in a
concentration that triggers labelling obligations under Regulation (EC)1272/2008 irrespective
of the presence of any other substances shall, regardless of their intended use in the importing
Party or other country, not be exported unless either of the following conditions is fulfilled:
(a) explicit consent to import has been sought and received by the exporter through the
designated national authority of the exporter’s Member State in consultation with the
Commission, assisted by the Agency, and the designated national authority of the
importing Party or an appropriate authority in an importing other country;
(b) in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the
Secretariat (…) indicates that the importing Party has given consent to import;
8
9
10
6.7.1.1 What chemicals are subject to explicit consent requirement?
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12
13
With limited exemptions that are identified below, the PIC Regulation goes beyond the
Convention and requires that the explicit consent of the importing country must be obtained
before export of:
14
− chemicals subject to PIC procedure (i.e. those listed in Part 3 of Annex I);
15
− chemicals qualifying for PIC notification (i.e. those listed in Part 2 of Annex I);
16
17
− mixtures containing substances from Part 2 or 3 of Annex I in a concentration that
triggers labelling obligations under the CLP Regulation.
18
19
6.7.1.2 Seeking an explicit consent
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25
For some chemicals listed in Part 3 of Annex I, the importing countries may have failed to
provide an import response to the Convention Secretariat meaning that the latest PIC Circular
may not indicate any response from the importing Party as to whether or not future imports of
the chemical(s) in question is allowed. It might be also that the latest PIC Circular contains
only an interim decision of the importing Party regarding the chemical. In the absence of an
official import response, an explicit consent is required for the export to proceed.
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27
28
Additionally, for some chemicals listed in Part 2 of Annex I there may be no applicable explicit
consent or waiver available in the explicit consent list in ePIC . Once again, as an explicit
consent is required in order for the export to proceed, a new request is necessary.
Explicit consent has to be sought and received through the exporter’s DNA and the DNA
(or other competent authority) of the importing country. It is advised that the exporter or
importer should not make any direct contact with the authorities of the importing country
until after the exporter’s DNA has made a formal approach.
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31
32
Information on DNAs and (for non-Parties) other relevant authorities is available in ePIC.
Where there are problems in identifying the authorities in the importing country, or when it is
otherwise difficult to obtain a reply, the Commission may be able to assist. The DNA of the
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Member State of export should inform the Commission and ECHA if it receives updated
information on DNAs from third parties.
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To increase the probability of getting a reply to a request for explicit consent, DNAs are
encouraged to use as far as possible the official UN languages regime and to request explicit
consent in whichever of these languages is the most relevant to the importing country. The
templates for explicit consent request forms and the explanatory notes (describing the EU
process) in the most common languages (English, French and Spanish) can be found in the
dedicated section of ePIC.
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Explicit consent can take different forms. For example, it could be in the form of an official
import decision transmitted via the Secretariat giving the importing country’s clear consent to
imports (in the case of a chemical that is subject to the PIC procedure), or an e-mail or letter
or confirmation from the appropriate authorities in the importing country.
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Each document used as a basis for authorisation of an export of a chemical for which explicit
consent is required gets a unique identifier (explicit consent identifier) and is uploaded and
stored on ePIC. Once the explicit consent is received by a DNA for a chemical, the DNA uploads
it on ePIC. If an applicable explicit consent is available, the DNA does not need to make a new
request. If the terms of an explicit consent are broad enough, it can form the basis for the
activation of several RINs (from different exporters and/or Member States).
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22
6.7.1.4 The process of requesting explicit consent
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25
The process of requesting explicit consent always starts with an export notification that is
created and submitted by the exporter in ePIC (see sub-section 6.1.5 of this guidance
document). Subsequently, the process involves the following steps:
6.7.1.3 Possible forms of explicit consent
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1) DNA checks if an explicit consent exists
28
29
30
The ePIC database will suggest potentially matching existing explicit consents (or existing
negative responses). The DNA may select one, if applicable to the notification or propose
another if it believes that there is a better option that was not proposed by the system.
31
 If an applicable explicit consent exists:
32
33
34
There is no need to request a new consent from this importing country again.
The DNA should approve the export notification (if the information requirements are
met) and forward it to ECHA;
35
 If no explicit consent exists:
36
37
38
If no applicable explicit consent or positive import decision is available, the exporter’s
DNA needs to make a new request for consent to the appropriate DNA in the
importing country.
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In the meantime, ECHA will process and send the export notification27. The RIN
however will not be activated for customs clearance and the export cannot proceed
until the consent is given.
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2) In case a new request for explicit consent is needed:
44
- The DNA will find all the necessary forms and contact details in ePIC. A standard
27
There is no direct link between the explicit consent and export notification requirements. Both
obligations have to be fulfilled, but they are independent and can be met separately. There is thus no
reason why the forwarding of an export notification should be delayed pending receipt of explicit consent,
where required.
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form (and explanatory note) that the exporter’s DNA can use to seek the consent is
available on ePIC;
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4
- A request for explicit consent is sent by the DNA (outside ePIC) and is subsequently
recorded in the ePIC system by the DNA;
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6
7
8
- When sending the request to the importing country, the DNA should explain the
context (e.g., that this is an internal EU requirement that goes beyond the obligation
laid down in the Convention). A standard form (and explanatory note) that the
exporter’s DNA can use to seek the consent is available on ePIC;
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10
11
- Should no response be received within 30 days of issuing the request, ECHA (on
behalf of the Commission) will send a reminder to the DNA of the importer. In the
absence of a response, a total of two reminders will be sent by ECHA.
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3) Once a consent is received:
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15
- The DNA will upload the explicit consent to ePIC and extract as much metadata 28 as
is relevant and/or available;
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- ECHA will double-check the extracted metadata (as a one-off process). This step
both (i) ensures that no human error was made and (ii) guarantees consistency in
the interpretation of consents across all EU Member States. If there is no objection to
the metadata, the consent will be published on the explicit consent list;
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- The consent will then be available for RIN activation (or disabling if the consent is
negative);
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- The export can proceed for positive consent;
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24
- The consent is applicable to the export notification for which it was requested but
may also apply to other notifications.
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28
29
30
More detailed information on how to fill in the necessary information and submit the request
for explicit consent is provided in the ePIC User Manual which is available on the ECHA
website. Please consult Figure 3 that illustrates the process of requesting an explicit consent.
This figure also includes the waiver request under Article 14 (7) for chemicals listed in Part 2
or 3 of Annex I.
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32
6.7.1.5 Explicit consent for mixtures containing substances from Part 2 or 3 of Annex I
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35
36
The obligation to get explicit consent also applies to the export of mixtures containing
substances from Part 2 or Part 3 of Annex I in concentrations that could trigger labelling
obligations under the CLP Regulation. A separate explicit consent must be requested for each
mixture and a separate explicit consent RIN is subsequently issued for each mixture.
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In an effort to facilitate implementation of this provision, the explicit consent request includes
various questions for the DNA in the importing country to answer. One of these questions is:
“do you consent to the import of other mixtures containing the same Annex I substance?” In
most cases the importing DNA answers “no” to this question, which then triggers the need for
28
For example: explicit consent response (positive or negative), use category of the chemical (industrial
or pesticidal), information on the identity of the chemical (substance or mixture?), validity period of the
explicit consent, etc.
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a separate explicit consent request for any other mixture, whereas in case of a positive reply,
DNAs and ECHA can directly approve exports of other mixtures containing the substance.
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4
5
6
7
Since a mixture includes more than one substance, it is necessary to check for each substance
whether an obligation to obtain explicit consent exists. If at least one substance triggers that
obligation, a request for explicit consent must be submitted. An importing country may give an
unspecific reply that registered29 chemicals are allowed to be imported.
Example: If substance A of a mixture AB is listed in Annex I of the PIC Regulation and is
registered in the importing country, the export can proceed even if substance B is not
registered, provided it is not listed in Annex I. The request for explicit consent was triggered
by substance A, not substance B.
29
“Registered” in this context means licensed or authorised in the importing Party or other country. See
also Article 14 (6) and (7) of the PIC Regulation.
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Exporter creates and saves export notification in ePIC
(inactive RIN assigned automatically)
DNA verifies notification and checks if the importing country
has given an import decision or explicit consent
No import decision or
consent available
Consent or import
decision with
conditions that are not
met
Requirements
of Article 8(6)
not met
DNA requests explicit consent from importing country’s DNA
No response
after 30 days
No consent
Export in compliance
with import decision or
consent
Consent
Requirements of
Article 8(6) met
Export
notification
required
No export
notification
required
Renewed request to importer’s DNA by ECHA
No response after
additional 30 days
Special RIN
must be
obtained for
the exported
chemical
according to
Article 19 (2)
Consent
Check by DNA in consultation with COM
assisted by ECHA if condition (a) or (b) of
Article 14 (7) is met and possible impacts
on health and environment in importing
country.
Both conditions
(a) and (b) of
Article 14 (7) are
not met or health
and
environmental
impacts
considered
unacceptable
Condition (b) of
Article 14 (7) is
met but the
chemical is
classified as CMR
Cat. 1A or 1B or
the chemical is
identified as PBT/
vPvB
Export not allowed
Condition (a) or
(b) of Article 14
(7) is met and
health and
environmental
impacts
considered
available
Export can proceed
1
2
3
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chemicals for non-OECD countries. Article 14 (7) procedure for chemicals listed in Part 2 or 3 of Annex I.
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6.7.1.6 Timelines
It is recommended that explicit consent be sought as far in advance of export as possible.
Exporters of chemicals that require a request for explicit consent are encouraged to submit
their export notifications to their DNAs well in advance of the intended date of export.
A draft copy of the export notification (available on ePIC) would be a means of providing the
necessary information to enable the importing country to take a decision. To facilitate the
process for the DNA or other relevant authority in the importing country, it would be useful for
exporters to submit copies to the DNA of the exporter of any registrations or authorisations
which the importing country has issued for the chemical. The exporter’s DNA could then upload
this documentation on ePIC and attach it to the request for consent.
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Once explicit consent has been obtained by one exporter’s DNA, it is potentially not necessary
to make new requests for subsequent exports by any EU exporter, whilst that consent remains
valid. To reflect the reality that an importing country’s views could evolve over time, the
validity of explicit consent is limited to three calendar years (unless otherwise specified in the
explicit consent). Conditions specified by importing countries should be communicated by the
DNA receiving the explicit consent to all exporters by posting them in the ‘notes’ field of the
non-confidential explicit consent available on the ECHA website. At the end of the third year, a
new request for explicit consent must be made to the DNA of the importing Party or the
relevant authority of the other importing country by the DNA of the exporter. Pending
response to the new request, exports of the relevant chemical may continue for an additional
period of 12 months.
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The Regulation provides for two possible exemptions to the requirement that explicit consent
must be obtained prior to export of chemicals subject to the PIC Procedure or qualifying for
PIC notification:
In the case of chemicals for which an explicit consent is required in addition to submitting an
export notification (i.e. Part 2 chemicals and certain Part 3 chemicals for which an import
decision does not exist) the validity of the explicit consent may vary and will in most cases be
different from the validity of the RIN. By default, a RIN remains valid until the 31 December of
the year for which the notification was made, it will then expire. In this case, a new export
notification must be made during the subsequent year and a new RIN will be issued. This new
RIN will immediately be activated upon processing of the export notification, provided that all
conditions are met. There will be no need to request a new consent until the explicit consent
expires at the end of the third year from when it was obtained (unless otherwise stated by the
terms of the consent).
6.7.1.8 Waiver
1) Export of chemicals from Part 2 of Annex I to OECD countries
Where a chemical qualifying for PIC notification is to be exported to OECD countries, the
requirement for explicit consent may be waived. This decision is to be taken by the exporter’s
DNA, at the request of the exporter, in consultation with the Commission and on a case-bycase basis. The basis for the decision being that the chemical is, at the time of importation into
the OECD country, licensed, registered or authorised in that OECD country. This procedure is
illustrated by Figure 4. For a list of OECD countries please consult Appendix 6 to this
guidance document.
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Exporter submitted an export notification
and a waiver request which includes the
documentation to be assessed by the DNA and COM
DNA verifies the notification and asses together with
COM if alternative evidence allows for waiving the
required consent
No evidence
available
Please refer to Figure 3
for “standard” waiver
process according to
Article 14 (7)
After final check and
approval ECHA sends
the notification to the
importing country
Substance is licensed,
registered or
authorised in importing
OECD - country
Substance can be
exported on the
expected day of export
Export can proceed
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Figure 4: Article 14 (6) procedure for Annex I Part 2 chemicals exported to OECD countries.
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2) Waiver under Article 14 (7) for chemicals listed in Part 2 or 3 of Annex I
The decision to waive the requirement for explicit consent may be taken by the exporter’s
DNA, in consultation with the Commission, assisted by ECHA and on a case-by-case basis, if:
 there is no evidence from official sources of final regulatory action to ban or severely
restrict the use of chemical taken by the importing Party or other country, and if
 despite all reasonable efforts, no response has been received within 60 days of a
request for an explicit consent for a chemical subject either to the PIC procedure or
qualifying for PIC notification.
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In addition, one of the two following conditions of Article 14 (7) must be met, namely:
Article 14 (7) (a) and (b):
(a) there is evidence from official sources in the importing Party or other country
that the chemical is licensed, registered or authorised; or
(b) the intended use declared in the export notification and confirmed in writing by
the importer is not a category for which the chemical was listed in Part 2 or 3 of
Annex I, and there is evidence from official sources that the chemical has in the
last five years been used in or imported into the importing Party or other country
concerned.
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For chemicals listed in Part 3 of Annex I, an export based on the fulfilment of the condition (b)
is not allowed, if:
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the chemical has been classified as carcinogenic category 1A or 1B, mutagenic
category 1A or 1B or toxic for reproduction category 1A or 1B (CMR Cat. 1A or 1B)
according to the CLP Regulation; or
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the chemical fulfils the criteria of Annex XIII to the REACH Regulation for being
persistent, bioaccumulative and toxic (PBT) or very persistent and very
bioaccumulative (vPvB).
Please consult Figure 3 where the waiver request under Article 14 (7) for chemicals listed in
Part 2 or 3 of Annex I is illustrated (as part of the explicit consent workflow).
Examples of the type of evidence required to justify a waiver are provided in Appendix 3 to
this guidance document.
For further information on classification criteria of CMR substances and mixtures it is
recommended to consult the Guidance on the Application of the CLP Criteria available on the
ECHA website. For more information on PBT/vPvB identification, please consult Annex XIII of
the REACH Regulation (Criteria for the identification of persistent, bioaccumulative and toxic
substances, and very persistent and very bioaccumulative substances). It may be also useful
to consult the ECHA Guidance on Information Requirements and Chemical Safety Assessment
Part C: PBT Assessment.
When deciding on the export of chemicals listed in Part 3 of Annex I, the DNA must in
consultation with the Commission assisted by ECHA take into consideration possible impacts on
human health and the environment in the importing Party or other country and submit
relevant documentation to ECHA, to be made available by ePIC.
Validity of the waiver
Waivers can be granted for a maximum period of 12 months, after which time explicit consent
is required, unless a response to the initial request for explicit consent has been received in
the meantime (see Article 14 (8) (b) of the PIC Regulation). The same period of 12 months
applies for the validity of the “OECD waiver” granted pursuant to Article 14 (6) of the PIC
Regulation.
After the maximum period of 12 months has expired, if no response to the request for explicit
consent has been received, the exporter will once again need to seek explicit consent through
the exporter’s DNA, which means that the above-mentioned procedure starts again from the
beginning.
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is granted or on the day specified in the decision on granting the waiver.
6.8 Quality of exported products
Articles 14 (10) and (11) of the PIC Regulation impose requirements about the useful life of
chemicals and their packaging, storage conditions and stability. These requirements are mainly
relevant for pesticides.
An exporter must ensure that exported products are not exported within 6 months of their
expiry date, when such a date exists or can be inferred from the production date, unless the
chemical’s intrinsic properties render this impracticable.
In the case of pesticides, the size and packaging of containers must be optimised to reduce the
risks of creating obsolete stocks, and the label has to contain specific information about
storage conditions and stability under the climatic conditions of the importing country. In
addition, the exported pesticide must comply with the purity specification laid down in the EU
legislation.
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6.9 RIN in the customs declaration
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Exporters are obliged to include the relevant reference identification number (RIN) from their
export notification in their customs declarations for export notifications.
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This RIN should be entered either in box 44 of the Single Administrative Documents (SAD), or
in the corresponding data element in an electronic export declaration, as referred to in
Regulation (EEC) No 2913/92 establishing the Community Customs Code.
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Please note that Y915 is the TARIC code indicating the requirement for a RIN. If the code
Y915 is contained in Box 44 of the SAD, it should be accompanied by a RIN. Hence, Box 44
should contain the Y915 code and a RIN.
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There are other related TARIC measures associated with the PIC Regulation and these are
listed below with their TARIC codes:
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 Y916 - This measure indicates that the chemical to be exported is not subjected to the
provisions of Regulation EC 649/2012, Annex I (relating to restrictions on export). No
restriction applies.
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 Y917 - This measure indicates that the chemical to be exported is not subject to the
provisions of Regulation EC 649/2012, Annex V (relating to prohibitions on the export of
certain chemicals). No prohibition applies.
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 Y919 - This measure indicates that the chemical to be exported is subjected to the
provisions of Article 2 (3) of Regulation 649/2012 which exempts the export from all
provisions subject to the condition that the chemical is exported for the purpose of
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Tarif Intégré de la Communauté – i.e. Integrated Community Tariff is a multilingual database in which
are integrated all measures relating to EU customs tariff, commercial and agricultural legislation. More
information on tariff and non-tariff measures which are applicable for commodity codes is available at the
website of Commission's Taxation and Customs Union Directorate-General:
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research or analysis in quantities not more than 10kgs. In the case of Y919, this should be
accompanied by a ‘special RIN’ (see sub-section 4.2.9 of this guidance document).
If a RIN is entered in Box 44, customs officers should consult the customs interface of ePIC
and check the status of the export. If the RIN is active for the given export, the export should
be cleared as normal. Where customs officers identify any problem regarding the TARIC code
or the RIN provided in Box 44, the export should not be allowed to proceed and the chemicals
must be taken back by the exporter.
Legal reference: Article 19 (1) of the PIC Regulation
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6.10 Information on transit movements
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In case a Party to the Convention requires information on transit movements of a chemical
subject to the PIC procedure, the exporter must, insofar as possible, provide his DNA with the
information laid down in Annex VI to Regulation (EC) No 649/2012 30 days before the first
transit movement is due to take place, and at least 8 days before each subsequent movement.
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The DNA of the exporter’s Member State will forward the information, together with any
available additional information, to the Commission (with a copy to ECHA), which will forward
it to the DNA in the requesting importing Party no later than 15 days before the first transit
movement and prior to each subsequent movement.
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Legal reference: Article 16 of the PIC Regulation
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6.11 Information to accompany exported chemicals
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Exporters of all hazardous chemicals, as defined by EU legislation, must package and label
their products in the same way as if they were to be marketed in the European Union unless
the importing country has its own specific requirements, taking into account also relevant
international standards. The relevant EU rules are laid down in the following legal acts:
− The CLP Regulation - Regulation (EC) No 1272/2008 of the European Parliament and
of the Council of 16 December 2008 on classification, labelling and packaging of
substances and mixtures, amending and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC) No 1907/2006;
− The Dangerous Substances Directive (DSD)31 - Council Directive 67/548/EEC of 27
June 1967 on the approximation of laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous substances;
− The Dangerous Preparations Directive (DPD)32 - Directive 1999/45/EC of the
European Parliament and of the Council of 31 May 1999 concerning the approximation
of the laws, regulations and administrative provisions of the Member States relating to
the classification, packaging and labelling of dangerous preparations;
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with effect from 1 June 2015.
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with effect from 1 June 2015.
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− The Biocidal Product Regulation (BPR) - Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012 concerning the making
available on the market and use of biocidal products;
− The Plant Protection Products Regulation - Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009 concerning the placing of
plant protection products on the market.
6.11.1 Content of the label
According to Article 17 of the CLP Regulation, substances or mixtures classified as hazardous
and contained in packaging must bear a label including the following information:
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the name, address and telephone number of the supplier(s)33;
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the nominal quantity of the substance or mixture in the package made available to
the general public, unless this quantity is specified elsewhere on the package;
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product identifiers for substance or mixture as specified in Articles 18 (2) or 18 (3) of
the CLP Regulation; as a general rule, the same product identifier(s) as selected for
the label must be used in the SDS for a substance or mixture;
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where applicable:
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hazard pictograms, i.e. a pictorial presentation to communicate information on
the hazard concerned (see also the definition provided in CLP Article 2(3));
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signal words indicating the relative level of severity of a particular hazard (see
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hazard statements describing the nature and severity of the hazards of a
substance or mixture (see CLP Article 21);
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precautionary statements giving advice on measures to prevent or minimise
adverse effects to human health or the environment arising from the hazards of
a substance or mixture (see CLP Article 22);
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a section for supplemental information to incorporate additional labelling
information over and above that listed in CLP Article 17(a) to (g);
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The information on the label also has to include the expiry date (for different climate zones if
necessary) and the production date, where appropriate. The detailed legal requirements for
labelling of substances and mixtures are provided in Title III of the CLP Regulation.
It is also recommended to consult the Guidance on labelling and packaging in accordance with
Regulation (EC) No 1272/2008 available on the ECHA website.
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According to Article 2 (26) of the CLP Regulation ‘supplier’ means “any manufacturer, importer,
downstream user or distributor placing on the market a substance, on its own or in a mixture, or a
mixture”.
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6.11.2 Timelines for classification, labelling, packaging and updating of CLP
hazard labels
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The CLP Regulation sets out a phased transitional period during which the rules of both CLP
and the previous legislation on classification, labelling and packaging, i.e. the DSD and DPD
directives, are applicable in parallel.For substances, the deadline for classification, labelling and
packaging according to the CLP Regulation was 1 December 2010. Nevertheless, substances
still need to also be classified according to DSD until 1 June 2015. Substance classification
according to DSD is necessary to allow mixture classification according to DPD to be continued
until mixtures themselves are classified according to CLP; these DSD classifications have to be
indicated in the Safety Data Sheet (in sub-section 2.1) until 1 June 2015.
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Hazard pictograms pursuant to the CLP Regulation, which implements the Globally Harmonised
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PHYSICAL HAZARDS:
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For mixtures, the deadline for classification, labelling and packaging according to the CLP
Regulation is 1 June 2015. Until then, they need to be classified, labelled and packaged
according to DPD but may, voluntarily, be classified, labelled and packaged in accordance with
CLP before that date. In cases where a mixture has already been classified, labelled and
packaged according to CLP before 1 June 2015, only the CLP label must appear on the
package, and not the label according to DPD and information on DPD labelling should not
appear in Section 3.2 of the SDS, but information on the classification under DPD as well as
under CLP must be given in Section 2.1 and 3.2 of the SDS until 1 June 2015 (see also the
ECHA Guidance on the compilation of safety data sheets).
Where a mixture is already classified, labelled and packaged according to the DPD rules and
placed on the market before 1 June 2015, i.e. it is already in the supply chain by that date, the
manufacturer, importer, downstream user or distributor may postpone its re-labelling and
repackaging according to the CLP rules until 1 June 2017. This means that the mixture can be
sold further in the supply chain with the DPD label until 1 June 2017.
Legal reference: Article 61 of the CLP Regulation
6.11.3 Hazard pictograms used in the EU
GHS01
GHS02
GHS03
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HEALTH AND ENVIRONMENTAL HAZARDS:
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The complete list of the CLP/GHS hazard pictograms for each hazard class and hazard
category, is given in Annex V to the CLP Regulation. The GHS pictograms are provided free of
charge for download from the website of United Nations Economic Commission for Europe
(UNECE): http://www.unece.org/trans/danger/publi/ghs/pictograms.html.
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which implements the Globally Harmonised System of Classification and Labelling (GHS).
6.11.4 Safety data sheet (SDS)
Article 31 (1) of the REACH Regulation requires the supplier of a substance or a mixture to
provide an SDS whenever:
a substance:
− meets the criteria for classification as hazardous in accordance with the Regulation on
classification, labelling and packaging of substances and mixtures (CLP Regulation); or
− is persistent, bioaccumulative and toxic (PBT) or very persistent and very
bioaccumulative (vPvB) in accordance with Annex XIII of the REACH Regulation; or
− is included in the candidate list of substances which may be subjected to authorisation.
or a mixture
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Preparations Directive (DPD)34
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The PIC Regulation requires that an SDS formatted in accordance with Annex II of the REACH
Regulation must accompany exported chemicals. The exporter must send an SDS to each
importer together with the chemical. The information on the label and on the safety data sheet
must, insofar as possible, be provided in the official languages, or in one or more of the
principal languages, of the country of destination or of the area of intended use (see
Appendix 4 to this guidance document for a list of languages). For more detailed information
please consult the Guidance on the compilation of safety data sheets available on the ECHA
website.
Legal reference: Article 17 of the PIC Regulation
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6.12 Obligation of the authorities of the Member States for
controlling import and export
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The Member States have to designate authorities such as customs offices to control imports
and exports of chemicals listed in Annex I. Together with the Commission supported by ECHA,
Member States must coordinate their enforcement activities in relation to exporters and
monitor exporters’ compliance with the PIC Regulation. It is envisaged that Member States,
the Commission and ECHA should act in a coordinated and targeted way. ECHA is seeking to
facilitate this through providing guidance on the PIC Regulation as well as IT manuals,
webinars and training on the use of ePIC. The network of DNAs and other authorities
responsible for enforcement is coordinated by the ECHA Forum for Exchange of Information on
Enforcement.
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The following basic checklist might be useful as regards what control of exports should cover:
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Is the chemical banned for export (i.e. included in Annex V to the PIC Regulation)?
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Is the chemical being exported subject to export notification (specifically listed in
Annex I or in a generic group listed in annex I)?
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Has an annual export notification been submitted by the exporter and accepted by the
DNA?
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Does the chemical appear in Part 3 of Annex I (List of chemicals subject to the PIC
procedure)? Does the latest PIC Circular show the consent of the importing country or
is there evidence that explicit consent has otherwise been given?
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Is the chemical listed in Part 2 of Annex I (List of chemicals qualifying for PIC
notification)? Is there evidence that the explicit consent of the importing country has
been given?
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(11) and 17 (hazard pictograms, precautionary statements, language, etc.)?
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Is the shipment accompanied by a safety data sheet (SDS) in a language that is
expected to be understandable in the importing country?
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reports on the operation of procedures according to Article 22 (1) of the PIC Regulation.
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The Commission assisted by ECHA and the Member States are to facilitate the provision of
information to other countries about chemicals subject to the PIC Regulation. The Regulation
acknowledges the need for certain confidentiality safeguards. However, in line with the
Convention, Article 20 (3) of the PIC Regulation defines what information shall not be regarded
as confidential. These are the following information:
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Annex IV (information requirements for PIC notification);
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names of individual exporters and importers are not shown (though this information will of
course be included in the export notifications transmitted to importing countries). Similarly,
summary reports produced by ECHA pursuant to Articles 10 and 22 will contain aggregated
information so that individual exporters are not identifiable.
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Legal reference: Article 20 of the PIC Regulation
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The Commission, the Member States and ECHA have to cooperate in promoting technical
assistance, in particular with a view to enabling developing countries and countries with
economies in transition to implement the Convention.
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Legal reference: Article 21 of the PIC Regulation
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Article 22 of the PIC Regulation (Monitoring and reporting) foresees monitoring and reporting
on the functioning and implementation of the Regulation by Member States, the European
Commission and ECHA.
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Both the Member States and the Commission will monitor developments under the Regulation.
The Member States and ECHA must regularly (every three years) send information on the
operation of the various procedures to the Commission. These reports cover elements such as:
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Based on these submissions, the Commission in turn compiles a report, incorporating a
synthesis of the information provided in the reports from Member States and ECHA. Such
summary report on the overall functioning of the Regulation is then forwarded by the
Commission to the European Parliament and to the Council. Again, there are provisions to
protect the confidentiality and ownership of data (see Article 22 (3)).
6.16 Updating of Annexes
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According to Article 23 (1) of the PIC Regulation, at least once a year the Commission is
required to review, on the basis of the development in EU law and under the Convention, the
list of chemicals in Annex I to the PIC Regulation.
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To amend Annex I, the Commission adopts a separate delegated act with respect to chemicals
that are proposed to be included in this Annex. The power to adopt delegated acts was
conferred to the Commission by the European Parliament and the Council for a period of five
years (starting from 1 March 2014).
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Prior to the adoption of the delegated act, the Commission will consult the relevant
stakeholders: representatives of the Member States, of ECHA, of the chemical industry and of
the civil society. During such consultation the Commission will take into account the comments
of the stakeholders and decide whether to amend Annex I to the PIC Regulation. If it does, it
will require the involvement of the Standing Committee35.
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When new chemicals are included in the various parts of Annex I this will then trigger as
appropriate export notification requirements, submission of a PIC notification, explicit consent
for export requirements, and the obligation to respect other countries’ import decisions for
chemicals subject to the PIC procedure. The following measures to update Annexes have to be
adopted by the same procedure:
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− inclusion of a chemical in Part 1 or 2 of Annex I pursuant to Article 23 (2) following final
regulatory action at EU level, and other amendments of Annex I, including modifications
to existing entries;
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− inclusion of a chemical subject to Regulation (EC) No 850/2004 36 on persistent organic
pollutants in Part 1 of Annex V;
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− inclusion of a chemical already subject to an export ban at EU level in Part 2 of Annex
V;
32
− modifications to existing entries in Annex V;
33
− amendment of Annexes II, III, IV and VI.
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36
Inclusion of chemicals or articles not yet banned for export into Annex V Part 2 (meaning a ban
of exports) will necessitate a co-decision by the European Parliament and the Council upon a
proposal by the Commission.
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Legal reference: Article 23 of the PIC Regulation
38
35
The Standing Committee is a body chaired by the Commission that consist of representatives from all
Member States.
36
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on
persistent organic pollutants and amending Directive 79/117/EEC; OJ L 158, 30.4.2004, p. 7.
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7. ePIC – AN IT APPLICATION FOR SUBMISSION OF
INFORMATION
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Many tasks relating to the day-to-day implementation of the PIC Regulation are carried out by
using an IT application called ePIC. ePIC is an important IT-tool for fulfilling the obligations
under PIC and for information exchange. The ePIC application is used by European
stakeholders involved in the respective activities. In addition, certain information from ePIC
will be published on the dedicated section of the ECHA website and will therefore be available
to stakeholders from third countries.
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ePIC was built to replace the previous submission system, EDEXIM (the European Database for
Export and Import of dangerous chemicals), due to the increasing numbers of notifications to
process and to the increasing demand for additional features to facilitate the day-to-day work
of stakeholders.
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ePIC comprises four distinct interfaces which are tailored to the needs of the different user
groups:
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i.
the DNA interface for use by Member States, to manage implementation of the
Regulation, in particular export notifications (Article 8), requests for explicit consent
(Article 14), special RIN requests (Article 19 (2)) and waivers (Article 14 (7));
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ii.
the industry interface used by EU exporters to notify (and subsequently follow-up on)
planned exports, submit special RIN requests, submit waiver requests and provide
necessary information in accordance with the legal requirements of the Regulation;
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iii.
the customs interface, designed to assist customs in controlling trade in hazardous
chemicals;
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iv.
the administrative interface (used by ECHA) for processing and storing import and
export notifications as well as performing all related activities.
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The main objective of ePIC is to serve as a platform to fulfil obligations and to provide the user
with information on the implementation of the PIC Regulation within the European Union
related to:
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− export notification for chemicals listed in Annex I of the Regulation,
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− import decisions taken by countries on request for chemicals listed in Part 2 or 3 of
Annex I of the Regulation; and
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− import decisions made by countries participating in the international PIC procedure
under the Convention for chemicals listed in Part 3 of Annex I of the Regulation.
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The industry interface allows exporters to notify their DNAs directly and on-line of planned
exports of Annex I chemicals. Once the exporter has created and saved an export notification,
an inactive export reference identification number (RIN) is assigned to the export. After
submission by the exporter, the DNA will handle the export notification without undue delay
and, if complete and correct, forward it to ECHA. Pending processing of the export notification
by the DNA and ECHA, the exporter has the possibility of tracking the status of his export
notification. ePIC informs the exporter after final approval of the notification, including the
period of validity of the notification. For substances not requiring an explicit consent, the RIN
will be active (i.e. the export will be allowed) as from the export date indicated by the exporter
or the earliest possible date in compliance with the time limits prescribed by the Regulation.
For those exports where explicit consent is required, the RIN will only be activated if the
respective conditions are met.
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The ePIC application also assigns each explicit consent an internal identification number, i.e.
the explicit consent reference identification number which is associated with the notification
during processing. DNAs and the Commission have access to the list of explicit consents. If no
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explicit consent is available, ePIC will notify the exporter that the export is not yet allowed.
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The information taken from ePIC and published on the dedicated section of the ECHA website
will be available to the general public. This information enables activities such as:
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5
-
a check for existing export notifications for the first annual export of certain hazardous
chemicals to the country of destination;
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-
display of information on third country import decisions for chemicals listed in Part 2 or
3 of Annex I to the PIC Regulation;
8
-
display of statistics on registered export notifications from the European Union.
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In an effort to facilitate procedures for the exporter, ePIC works on the basis of one single
reference identification number obtained either by submitting a notification or by submitting a
special RIN request. Submission of a notification is mandatory for Annex I Part 1 and Part 2
chemicals and for Annex I Part 3 chemicals for which no import decision exists.
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17
For Annex I Part 3 chemicals for which an import decision that consents to the import is
published in the PIC Circular, the option for retrieving the RIN that has to be provided in the
customs declaration is the procedure called “special RIN request”. A special RIN request should
also be made for all exports falling under the Article 2 (3) exemption, i.e. chemicals exported
for the purpose of research and analysis in quantities of 10 kg or less.
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19
The use and terminology of the reference identification numbers used in the ePIC application is
for practical reasons different from that in the PIC Regulation. The details are as follows:
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
the export reference identification number mentioned in the Regulation equals the
reference identification number (RIN) obtained by submitting an export notification;
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
the explicit consent reference identification number mentioned in the Regulation equals
the explicit consent identifier used by ePIC for identification of each explicit consent and
waiver. There is no need to provide this number in the customs declaration since the
relevant explicit consent is attached to the export notification and can be identified via
the RIN;
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29

the import decision reference identification number is a RIN obtained either by the
special RIN request for Annex I Part 3 chemicals for which an import decision that
consents to the import is published in the PIC Circular.
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8. EXAMPLES
This section provides practical examples that outline the steps to be taken by exporters in a
number of possible scenarios.
Example 1 outlines several requirements concerning the information to be provided in customs
declarations and to DNAs, as well as packaging and labelling obligations that must be
respected whenever Annex I chemicals are exported. To avoid repetition, these requirements
are not detailed in full after Example 1 but simply referenced.
First, an exporter of an Annex I chemical will be allocated a RIN by ePIC and must include this
number in his customs declaration.
Secondly, during the first quarter of the following year the exporter must report to his DNA the
quantities of:

Annex I chemicals,
17

certain mixtures containing Annex I substances
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
certain articles containing substances listed in Parts 2 or 3 of Annex I,
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which the exporting company has shipped pursuant to the PIC Regulation. Furthermore, the
exporter must also report the names and addresses of each importer to whom the shipment
was made.
Finally, exporters of all hazardous chemicals, as defined by EU legislation, must package and
label their products according to EU legislation.
In addition, an SDS must be sent to each importer. The information in the SDS must (insofar
as possible) be provided in the official language(s), or in one or more of the principal
languages, of the country of destination or of the area of intended use (see Appendix 4 to
this guidance document for a list of languages). It is also strongly recommended that the
exporter attach an English version of the SDS (if available) when creating an export
notification to facilitate processing of the notification by ECHA.
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34
Example 1
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39
An exporter in one of the EU Member States intends to export for the first time
hexachloroethane to country A.
Hexachloroethane is listed in Part 1 of Annex I to the PIC Regulation, as it is severely restricted
for industrial use.
40
41
42
–
The exporter creates and submit an export notification via ePIC, supplying the
information set out in Annex II to the Regulation to his DNA at least 35 days before
the export. ePIC assigns the export notification an inactive RIN.
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44
–
The exporter provides an English version of the SDS when creating an export
notification to facilitate processing of the notification by ECHA and the DNA.
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–
The DNA checks the export notification. As the notification is considered to be
complete, the DNA forwards it to ECHA for further processing and (presumed)
acceptance.
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Having verified that no EU export notification has already been made for that
calendar year, ECHA sends the notification to country A
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The exporter is informed by ePIC that the export notification has been processed and
that the RIN will be activated (i.e. export can take place) as from the expected date
of export which was declared on the export notification. This RIN must be included in
the customs declaration.
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–
The chemical is packaged and labelled as if it were to be marketed in the EU, as it
has been established that the importing country does not have its own specific
requirements. The exporter sends an SDS in the official language of Country A
(whose official language is not English) to the importer.
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10
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The information on the label is also provided in the official language used by country
A (see Appendix 4 for further guidance on languages).
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14
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The expiry and production dates are indicated on the label, which also contains
specific information on storage conditions and stability under the climatic conditions
of country A. The chemical is not exported later than six months before the expiry
date.
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16
–
During the first quarter of the next year, the exporter informs his DNA of the
quantities of the chemical shipped to country A during the preceding year.
17
18
Example 2
19
20
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22
Company “Chemoproducts” wants to ship boron trichloride to country B.
Boron trichloride is not listed in Annex I to the Regulation, but it is classified as hazardous
according to Annex VI of Regulation (EC) 1272/2008 (the CLP Regulation).
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24
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The exporter does not need to provide any information to his DNA. The export may
take place without export notification or consent from the importing country.
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–
The requirements relating to packaging and labelling of exports, the expiry date of
the chemicals, and the provision of SDSs apply, as outlined in Example 1.
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Example 2
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33
“ABC Chemicals” intends to export chloroform to country C.
Chloroform is listed in Part 1 to Annex I to the PIC Regulation and has been exported to
country C by another company earlier in the year, but was never exported by “ABC Chemicals”
before.
34
35
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The exporter must submit an export notification supplying the information set out in
Annex II to the PIC Regulation to his DNA at least 35 days before the export.
36
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–
After having saved and submitted the export notification, the exporter gets the RIN,
which is not activated at this stage.
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–
Having established that the export notification is complete and correct the DNA
forwards the export notification to ECHA for further processing. ECHA checks the
notification and approves it, which activates the RIN for the export as from the
expected date of export. Given that an EU export notification has already been made
for that calendar year, the export notification is stored in ePIC without being sent to
the importing country.
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–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
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Example 4
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Company “LongShip” intends to export PCTs to country D, which is a Party to the Convention.
PCTs are subject to the PIC procedure under the Rotterdam Convention and therefore listed in
Parts 1 and 3 of Annex I to the Regulation. Country D has reported an import decision in the
latest update of the PIC Circular, giving consent.
7
8
9
–
The exporter does not need to submit an export notification and can proceed with
the export provided that the expected use in the importing country corresponds to
the category for which the substance was listed in Annex III to the Convention.
10
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–
The exporter must submit a special RIN request to his DNA. Once it has been
approved, the exporter will be provided with a RIN which he can add to his customs
declaration.
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14
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–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
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Example 5
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25
Company “KillingPest”, based in one of the EU Member States, intends to import parathion
from country E to produce a pesticide, and then export the mixture to country F.
Parathion is banned in the EU for use as a pesticide (both as plant protection product and as
biocide). The substance is listed in Part 1 of Annex I to the PIC Regulation as well as Part 3
(being subject to the PIC procedure in the pesticides category). In the latest PIC Circular the
import decision for the EU is ‘no consent’ for the pesticide use category. The import decision
for country F is ‘consent’.
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Notwithstanding the EU import decision, the company may import the substance for
industrial processing to produce a pesticide as this will not be marketed within the
EU.
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Since country F has given consent to import, the export may proceed. There is no
need for an export notification.
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–
The exporter must submit a special RIN request to his DNA. Once it has been
approved, the exporter will be provided with a RIN which he can add to his customs
declaration.
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–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
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–
The size and packaging of containers are optimised to minimise the risks of creating
obsolete stocks.
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Example 6
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An exporter wishes to export for the first time chlordimeform to country G, which is a Party to
the Convention.
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48
Chlordimeform is listed in parts 1 and 3 of Annex I to the PIC Regulation since it is subject to
the PIC procedure in the pesticide category. No import decision for country G is listed in the
latest PIC Circular.
–
The exporter must submit an export notification supplying the information set out in
Annex II to the PIC Regulation to his DNA at least 35 days before the export.
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After having saved and submitted the export notification, the exporter gets the RIN,
which is not yet active at this stage.
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6
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The export cannot proceed unless the DNA in country G has given its explicit consent
to import of chlordimeform. The exporter’s DNA establishes from ePIC that no such
consent already exists. The exporter’s DNA will have to seek this consent from the
DNA in country G (the Commission is ready to help if needed).
7
8
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No response was received within 30 days and ECHA sent a reminder. In the absence
of a response within a further 30 days, ECHA sent a further reminder.
9
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Despite all reasonable efforts, no response was received within 60 days.
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The exporter's DNA in consultation with the Commission assisted by ECHA decides
that the export can proceed as there is no evidence from official sources of final
regulatory action to ban or severely restrict the use of chlordimeform taken by
country G, and one of the following conditions is met:
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15
a) there is documentary evidence that chlordimeform is licensed, registered or
authorised in country G for pesticidal use, or
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20
b) the intended use declared by the exporter in the export notification and
confirmed in writing by the importer from country G is not a category for which
chlordimeform is listed in Part 2 or 3 of Annex I, and there is evidence from an
official source that chlordimeform has in the last five years been used in or
incorporated into the country G.
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22
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As authorisation for exports can only be granted for a maximum period of 12
months, upon expiry of this period explicit consent from country G will have to be
requested again. The conditions outlined in this paragraph also apply to Example 7
below.
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Depending on the final result of the request for explicit consent procedure, the
export may be allowed and the RIN may be activated by ECHA. Otherwise the RIN
will remain inactive.
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Annual export notification by the exporter will continue to be required, even if explicit
consent is obtained, unless country G waived its right to receive such notifications.
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–
Should the export proceed, either under an explicit consent or under a waiver, the
requirements relating to the information to be provided in customs declarations and
to the relevant DNA, as well as to packaging and labelling of exports, the expiry date
and the provision of SDSs apply, as outlined in Example 1.
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35
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The size and packaging of containers are optimised to minimise the risks of creating
obsolete stocks.
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Example 7
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Company “Buy and Sell” wants to export for the first time a pesticide containing nitrofen to
country H.
Nitrofen is listed in Parts 1 and 2 of Annex I to the Regulation. It is banned for plant protection
use within the EU and the relevant regulatory action has been notified to the PIC Secretariat.
Country H is a Party to the Convention. However since the chemical is not subject to the PIC
procedure, no import decision for the chemical exists.
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The exporter submits an export notification supplying the information set out in
Annex II to the PIC Regulation to his DNA at least 35 days before the export.
47
48
–
After having saved and submitted the export notification, the exporter receives the
RIN, which is not yet activated at this stage.
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As with Example 6 above, the export cannot proceed unless the DNA in country H
has given its explicit consent to importing nitrofen. The difference in this case is that,
since the chemical is not subject to the PIC Procedure, an import decision has
certainly not been published in the latest PIC Circular. The same conditions as
outlined in Example 6 apply, including the requirement to seek explicit consent, the
possibility of requesting a time-limited waiver, and the need for explicit consent
thereafter.
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Depending on the final result of the request for explicit consent procedure, the
export may be allowed and the RIN may be activated by ECHA. Otherwise the RIN
will stay inactive.
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Should the export proceed, the requirements relating to the information to be
provided in customs declarations and to the relevant DNA, as well as to packaging
and labelling of exports, the expiry date and the provision of SDSs apply, as outlined
in Example 1.
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16
–
The size and packaging of containers are optimised to minimise the risks of creating
obsolete stocks.
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Annual export notification by the exporter will continue to be required, even if explicit
consent is obtained, unless country H waived its right to receive such notifications.
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Example 8
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Company “Exterminator” wishes to export dimethenamid to country M, which is an OECD
country.
Dimethenamid is banned in the EU for use as a pesticide. It is listed in Parts 1 and 2 of Annex I
to the Regulation and therefore, explicit consent from the importing country would normally be
required. Since the chemical is not subject to the PIC procedure, no import decision for the
chemical exists.
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The exporter must submit an export notification supplying the information set out in
Annex II to the PIC Regulation to his DNA at least 35 days before the export.
30
31
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After having saved and submitted the export notification to the DNA, the exporter
gets the RIN, which is not yet activated at this stage.
32
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As DNA considers the export notification complete and correct, it is forwarded to
ECHA for further processing and (eventual) acceptation. If the notification is correct
and no EU export notification has been made yet for that calendar year, ECHA
forwards it to country M. If the export notification has already been made for that
year, the export notification is stored in ePIC without being sent.
37
38
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Dimethenamid is listed in part 2 of Annex I and consequently the export cannot
proceed unless explicit consent to import has been sought and received.
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However, since the country M is an OECD country, the exporter may consider
applying for a waiver and may, therefore, provide documentary evidence that the
substance is licensed, registered or authorised in country M.
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Provided that this evidence was presented, the DNA may decide in consultation with
the Commission that the export can proceed without the explicit consent of the
importing country.
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In case the DNA, in consultation with the Commission, decides that explicit consent
to importation is required, it must be obtained from the DNA in country M, as per
example 7 above.
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Depending on the final result of the request for explicit consent procedure, the
export may be allowed and the RIN may be activated by ECHA. Otherwise the RIN
will stay inactive, if no reply is received.
4
5
6
–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
7
8
–
The size and packaging of containers are optimised to minimise the risks of creating
obsolete stocks.
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10
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Annual export notification by the exporter will continue to be required, even if explicit
consent is obtained, unless country M waives its right to receive such notifications.
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12
Example 9
13
Company “XYZ” intends to export 1,2-dibromoethane (EDB) to country J for industrial use.
14
15
16
EDB is listed in Parts 1 and 3 of Annex I to the Regulation. It is banned for plant protection use
within the EU and is listed in the PIC procedure in the pesticides category. In the latest PIC
Circular the import decision for country J is ‘consent’ for use as a pesticide.
17
18
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Since the substance is subject to the PIC procedure for pesticide use but not for
industrial use, country J has not established a decision giving consent to import of
EDB for industrial uses. Consequently, the exporter must submit an export
notification and must obtain explicit consent to import for industrial use. In order to
do so, the same procedure as outlined in examples 6 or 7 should be followed.
22
23
24
–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
25
26
Example 10
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28
Company “Pest Products” intends to export “Fungicide X” - a fungicide mixture containing
pentachlorophenol (60% active ingredient) to country K.
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Pentachlorophenol is listed in Parts 1 and 3 of Annex I to the PIC Regulation, being subject to
the PIC procedure in the pesticides category. Country K is not a Party to the Convention so
there are no import decisions for that country listed in any PIC Circular. Another EU company
has exported another mixture (with 30% pentachlorophenol) earlier in the year having
obtained through his DNA the explicit consent of country K's authorities. The explicit consent
does not cover all mixtures containing pentachlorophenol, only that particular mixture.
35
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The exporter must submit an export notification supplying the information set out in
Annex II to the Regulation to his DNA at least 35 days before the export. This will be
forwarded to ECHA, which will submit it as an EU export notification.
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However, the export cannot proceed until the appropriate authorities in country K
give a further explicit consent in respect of “Fungicide X” since the existing explicit
consent was limited to a different formulation. To obtain such consent, the same
procedure as outlined in examples 6 or 7 must be followed.
42
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44
–
The requirements relating to the information to be provided in customs declarations
and to the relevant DNA, as well as to packaging and labelling of exports, the expiry
date and the provision of SDSs apply, as outlined in Example 1.
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The size and packaging of containers are optimised to minimise the risks of creating
obsolete stocks.
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Example 11
Company “Laboratory Analysis Products” intends to export 100g of nitrofen for use in analysis
in a laboratory to country L.
Nitrofen is listed in Parts 1 and 2 of Annex I to the Regulation, and therefore explicit consent
from the importing country would normally be required. Since the quantity of nitrofen intended
to be exported in 2015 to country L is less than 10 kg and not considered likely to affect health
or the environment as it is used under laboratory conditions for analysis, the export falls under
Article 2 (3) of the PIC Regulation and is therefore exempted from its provisions.
However, a special RIN request must be submitted in order to obtain a RIN which will be used
for customs clearance.
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14
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The exporter submits (via ePIC) a special RIN request to his DNA before the export is
intended to take place.
15
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After approval by the DNA, the exporter is provided with an active RIN.
16
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The exporter includes the RIN in his customs declaration.
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Please note:
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Annex I to the PIC Regulation is updated regularly as a result of regulatory actions
under EU legislation, and developments under the Rotterdam Convention. The most
up-to-date list is available on the dedicated section of the ECHA website;
–
Annex I list does not contain the substances listed in Annex V subject to export ban.
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5
6
List of chemicals subject to export notification procedure
(referred to in Article 8)
7
8
9
10
11
12
13
14
15
16
17
It should be noted that where chemicals listed in this part of the Annex are subject to the PIC
procedure, the export notification obligations set out in Article 8 (2), (3) and (4) shall not
apply provided that the conditions laid down in points (b) and (c) of the first subparagraph of
Article 8(6) have been fulfilled. Such chemicals, which are identified by the symbol ‘#’ in the
list below, are listed again in Part 3 of this Annex for ease of reference.
It should also be noted that where the chemicals listed in this part of the Annex qualify for PIC
notification because of the nature of the Union’s final regulatory action, those chemicals are
also listed in Part 2 of this Annex. Such chemicals are identified by the symbol ‘+’ in the list
below.
CHEMICAL
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
1,1,1-Trichloroethane
71-55-6
200-756-3
2903 19 10
i(2)
b
1,2-Dibromoethane
(Ethylene dibromide)
#
1,2-Dichloroethane
(ethylene dichloride)
#
Cis- 1,3dichloropropene ((1Z)1,3-dichloroprop-1ene)
1,3-dichloropropene
(1) +
2-aminobutane
106-93-4
203-444-5
2903 31 00
p(1)-p(2)
b-b
107-06-2
203-458-1
2903 15 00
p(1)-p(2)
i(2)
b-b
b
10061-01-5
233-195-8
2903 29 00
p(1)-p(2)
b-b
542-75-6
208-826-5
2903 29 00
p(1)
b
13952-84-6
237-732-7
2921 19 80
p(1)-p(2)
b-b
2-Naphthylamine
(naphthalen-2-amine)
and its salts +
91-59-8,
553-00-4,
612-52-2
and others
120-23-0
202-080-4
209-030-0
210-313-6
and others
204-380-0
2921 45 00
i(1)
i(2)
b
b
2918 99 90
p(1)
b
93-76-5 and
others
202-273-3
and others
2918 91 00
p(1)-p(2)
b-b
2-Naphthyloxyacetic
acid
2,4,5-T and its salts
and esters
#
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
64
Draft Version 1.0
CHEMICAL
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
4-Aminobiphenyl
(biphenyl-4-amine)
and its salts
+
4-Nitrobiphenyl
+
92-67-1,
2113-61-3
and others
202-177-1
and others
2921 49 80
i(1)
i(2)
b
b
92-93-3
202-204-7
2904 20 00
i(1)
i(2)
b
b
Acephate
+
Acifluorfen
30560-19-1
250-241-2
2930 90 85
p(1)-p(2)
b-b
50594-66-6
256-634-5
2916 39 00
p(1)-p(2)
b-b
Alachlor
+
Aldicarb
+
Ametryn
15972-60-8
240-110-8
2924 29 95
p(1)
b
116-06-3
204-123-2
2930 90 85
p(1)-p(2)
sr-b
834-12-8
212-634-7
2933 69 80
p(1)-p(2)
b-b
Amitraz
+
Anthraquinone
+
Arsenic compounds
33089-61-1
251-375-4
2925 29 00
p(1)-p(2)
b-b
84-65-1
201-549-0
2914 61 00
p(1)-p(2)
b-b
p(2)
sr
Asbestos Fibres + :
1332-21-4
and others
Crocidolite #
Amosite #
Antophyllite #
Actinolite #
Tremolite #
Chrysotile +
12001-28-4
12172-73-5
77536-67-5
77536-66-4
77536-68-6
12001-29-5
or
132207-32-0
1912-24-9
217-617-8
2642-71-9
86-50-0
Atrazine
+
Azinphos-ethyl
Azinphos-methyl
+
Benfuracarb
+
Bensultap
+
Benzene
(3)
Benzidine and its salts
+
Benzidine derivatives
+
Bifenthrin
2524
2524
2524
2524
2524
2524
10
90
90
90
90
90
00
00
00
00
00
00
i
i
i
i
i
i
b
b
b
b
b
b
2933 69 10
p(1)
b
220-147-6
2933 99 90
p(1)-p(2)
b-b
201-676-1
2933 99 90
p(1)
b
82560-54-1
2932 99 00
p(1)
b
17606-31-4
2930 90 85
p(1)-p(2)
b-b
71-43-2
200-753-7
2902 20 00
i(2)
sr
92-87-5,
36341-27-2
and others
-
202-199-1
252-984-8
and others
-
2921 59 90
i(1)-i(2)
i(2)
sr-b
b
2916 20 00
p(1)
b
82657-04-3
Binapacryl
#
485-31-4
207-612-9
2916 19 50
p(1)-p(2)
i(2)
b-b
b
Butralin
+
Cadmium and its
Compounds
33629-47-9
251-607-4
2921 49 00
p(1)
b
7440-43-9
and others
231-152-8
and others
i(1)
sr
Cadusafos
+
95465-99-9
n.a.
8107
3206 49 30
and others
2930 90 85
p(1)
b
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
CHEMICAL
65
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Calciferol
50-14-6
200-014-9
2936 29 90
p(1)
b
Captafol
#
2425-06-1
219-363-3
2930 50 00
p(1) –p(2)
b-b
Carbaryl
+
Carbofuran
+
Carbon tetrachloride
63-25-2
200-555-0
2924 29 95
p(1)-p(2)
b–b
1563-66-2
216-353-0
2932 99 85
p(1)
b
56-23-5
200-262-8
2903 14 00
i(2)
b
Carbosulfan
+
Cartap
55285-14-8
259-565-9
2932 99 85
p(1)
b
2930 20 00
p(1)-p(2)
b-b
Chinomethionat
2439-01-2
219-455-3
2934 99 90
p(1)-p(2)
b-b
Chlorate +
7775-09-9
10137-74-3
6164-98-3
231-887-4
233-378-2
228-200-5
2829 11 00
2829 19 00
2925 21 00
p(1)
b
p(1)-p(2)
b-b
2933 99 90
p(1)
b
Chlordimeform
#
15263-53-3
Chlorfenapyr
+
Chlorfenvinphos
122453-73-0
470-90-6
207-432-0
2919 90 90
p(1)-p(2)
b-b
Chlormephos
24934-91-6
246-538-1
2930 90 85
p(1)-p(2)
b-b
Chlorobenzilate
#
510-15-6
208-110-2
2918 18 00
p(1)-p(2)
b-b
Chloroform
67-66-3
200-663-8
2903 13 00
i(2)
b
Chlorthal-dimetyl
+
Chlozolinate
+
Cholecalciferol
1861-32-1
217-464-7
2917 39 95
p(1)
b
84332-86-5
282-714-4
2934 99 90
p(1)-p(2)
b-b
67-97-0
200-673-2
2936 29 90
p(1)
b
Coumafuryl
117-52-2
204-195-5
2932 29 85
p(1)-p(2)
b-b
Creosote and Creosote
related substances
8001-58-9
61789-28-4
84650-04-4
90640-84-9
65996-91-0
90640-80-5
65996-85-2
8021-39-4
122384-78-5
535-89-7
232-287-5
263-047-8
283-484-8
292-605-3
266-026-1
292-602-7
266-019-3
232-419-1
310-191-5
208-622-6
2707 91 00
i(2)
b
2933 59 95
p(1)
b
Cyanamide
+
Cyanazine
420-04-2
206-992-3
2853 00 90
p(1)
b
21725-46-2
244-544-9
2933 69 80
p(1)-p(2)
b-b
Cyhalothrine
68085-85-8
268-450-2
2926 90 95
p(1)
b
DBB (Di-µ-oxo-di-nbutylstanniohydroxyborane/
dioxastannaboretan-4ol)
75113-37-0
401-040-5
2931 00 95
i(1)
b
Crimidine
3807 00 90
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
66
Draft Version 1.0
CHEMICAL
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Diazinon
+
Dichlobenil
+
Dicloran
+
Dichlorvos
+
Dicofol
+
Dicofol containing <
78% p,p'-Dicofol or 1
g/kg of DDT and DDT
related compounds
+
Dimethenamid
+
Diniconazole-M
+
Dinitro-ortho-cresol
(DNOC) and its salts
(such as ammonium
salt, potassium salt
and sodium salt)
#
Dinobuton
333-41-5
206-373-8
2933 59 10
p(1)
b
1194-65-6
214-787-5
2926 90 95
p(1)
b
99-30-9
202-746-4
2921 42 00
p(1)
b
62-73-7
200-547-7
2919 90 90
p(1)-p(2)
b
115-32-2
204-082-0
2906 29 00
p(1)-p(2)
b-b
115-32-2
204-082-0
2906 29 00
p(1)-p(2)
b-b
87674-68-8
n.a.
2934 99 90
p(1)
b
83657-18-5
n.a.
2933 99 80
p(1)
b
534-52-1
2980-64-5
5787-96-2
2312-76-7
208-601-1
221-037-0
219-007-7
2908 99 90
p(1)-p(2)
b-b
973-21-7
213-546-1
2920 90 10
p(1)-p(2)
b-b
Dinoseb and its salts
and esters
#
Dinoterb
+
Diphenylamine
88-85-7
and others
201-861-7
and others
2908 91 00
2915 36 00
p(1)-p(2)
i(2)
b-b
b
1420-07-1
215-813-8
2908 99 90
p(1) -p(2)
b-b
122-39-4
204-539-4
2921 44 00
p(1)
b
Dustable powder
formulations
containing a
combination of:
Benomyl at or above
7%,
Carbofuran at or above
10%
and Thiram at or
above 15%
#
Endosulfan
#
Ethafluralin
+
Ethion
Ethoxyquin
+
Ethylene oxide
(Oxirane)
#
Fenarimol
+
Fenitrothion
+
Fenpropathrin
3808 99 90
17804-35-2
1563-66-2
241-775-7
216-353-0
2933 99 90
2932 99 85
137-26-8
205-286-2
2930 30 00
115-29-7
204-079-4
55283-68-6
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
p(1)
p(2)
b
b
2920 90 85
p(1)-p(2)
b
259-564-3
2921 43 00
p(1)
b
563-12-2
209-242-3
2930 90 99
p(1)-p(2)
b-b
91-53-2
202-075-7
2933 49 90
p(1)
b
75-21-8
200-849-9
2910 10 00
p(1)
b
60168-88-9
262-095-7
2933 59 95
p(1)
b
122-14-5
204-524-2
2920 19 00
p(1)
b
39515-41-8
254-485-0
2926 90 95
p(1)-p(2)
b-b
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
CHEMICAL
67
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Fenthion
+
Fentin acetate
+
Fentin hydroxide
+
Fenvalerate
55-38-9
200-231-9
2930 90 85
p(1)
sr
900-95-8
212-984-0
2931 00 95
p(1)-p(2)
b-b
76-87-9
200-990-6
2931 00 95
p(1)-p(2)
b-b
51630-58-1
257-326-3
2926 90 95
p(1)
b
Ferbam
14484-64-1
238-484-2
2930 20 00
p(1)-p(2)
b-b
Fluoroacetamide
#
640-19-7
211-363-1
2924 12 00
p(1)
b
Flurenol
467-69-6
207-397-1
2918 19 85
p(1)-p(2)
b-b
Flurprimidol
+
Furathiocarb
56425-91-3
n.a.
2933 59 95
p(1)
b
65907-30-4
265-974-3
2932 99 85
p(1)-p(2)
b-b
Guazatine
+
Hexachloroethane
108173-90-6
115044-19-4
67-72-1
236-855-3
3808 99 90
p(1)-p(2)
b-b
200-666-4
2903 19 80
i(1)
sr
Hexazinone
51235-04-2
257-074-4
2933 69 80
p(1)-p(2)
b-b
Iminoctadine
13516-27-3
236-855-3
2925 29 00
p(1)-p(2)
b-b
Indolylacetic acid
+
Isoxathion
87-51-4
201-748-2
2933 99 80
p(1)
b
18854-01-8
242-624-8
2934 99 90
p(1)
b
Malathion
121-75-5
204-497-7
2930 90 99
p(1)
b
(a) Maleic hydrazide,
and its salts, other
than choline,
potassium and sodium
salts;
(b) Choline, potassium
and sodium salts of
maleic hydrazide
containing more than
1 mg/kg of free
hydrazine expressed
on the basis of the
acid equivalent
Mercury compounds,
including inorganic
mercury compounds,
alkyl mercury
compounds and
alkyloxyalkyl and aryl
mercury compounds
except mercury
compounds listed in
Annex V
#
Methamidophos
(2) +
123-33-1
204-619-9
2933 99 90
p(1)
b
61167-10-0,
51542-52-0,
28330-26-9
257-261-0
248-972-7
2933 99 90
62-38-4,
26545-49-3
and others
200-532-5
247-783-7
and others
2852 00 00
p(1)- p(2)
b-b
10265-92-6
233-606-0
2930 50 00
p(1)
b
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
68
Draft Version 1.0
CHEMICAL
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Methamidophos
(Soluble liquid
formulations of the
substance that exceed
600 g active
ingredient/l)
#
Methidathion
10265-92-6
233-606-0
2930 50 00
3808 50 00
p(2)
b
950-37-8
213-449-4
2934 99 90
p(1)-p(2)
b-b
Methomyl
16752-77-5
240-815-0
2930 90 99
p(1)-p(2)
b–b
Methyl bromide
+
Methyl-parathion
+#
74-83-9
200-813-2
2903 39 11
p(1)-p(2)
b-b
298-00-0
206-050-1
2920 11 00
p(1)-p(2)
b-b
Metoxuron
19937-59-8
243-433-2
2924 21 90
p(1)-p(2)
b-b
Monocrotophos
#
6923-22-4
230-042-7
2924 12 00
p(1)-p(2)
b-b
Monolinuron
1746-81-2
217-129-5
2928 00 90
p(1)
b
Monomethyl-dibromodiphenyl methane
Tradename: DBBT
+
Monomethyl-DichloroDiphenyl methane;
Tradename: Ugilec
121 or Ugilec 21
+
MonomethylTetrachlorodiphenyl
methane; Tradename:
Ugilec 141
+
Monuron
99688-47-8
402-210-1
2903 69 90
i(1)
b
-
400-140-6
2903 69 90
i(1) – i(2)
b-b
76253-60-6
278-404-3
2903 69 90
i(1) – i(2)
b-b
150-68-5
205-766-1
2924 21 90
p(1)
b
Nicotine
+
Nitrofen
+
Nonylphenols
C6H4(OH)C9H19
+
54-11-5
200-193-3
2939 99 00
p(1)
b
1836-75-5
217-406-0
2909 30 90
p(1)-p(2)
b-b
25154-52-3
(phenol,
nonyl-),
246-672-0
2907 13 00
i(1)
sr
84852-15-3
(phenol, 4nonyl-,
branched)
284-325-5
11066-49-2
(isononylphen
ol),
234-284-4
90481-04-2,
(phenol,
nonyl-,
branched),
291-844-0
104-40-5(pnonylphenol)
and others
203-199-4
and others
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
CHEMICAL
Nonylphenol
ethoxylates
(C2H4O)nC15H24O
+
69
CAS No
Einecs No
Subcategory
(*)
Use
limitation
(**)
3402 13 00
i(1)
p(1)-p(2)
sr
b-b
CN Code
Countries
for which no
notification
is required
9016-45-9,
26027-38-3,
68412-54-4,
37205-87-1,
127087-87-0
and others
32536-52-0
251-087-9
2909 30 38
i(1)
sr
1113-02-6
214-197-8
2930 90 85
p(1)-p(2)
b-b
Oxydemeton-methyl
+
Paraquat
+
Parathion
#
301-12-2
206-110-7
2930 90 85
p(1)
b
4685-14-7
225-141-7
2933 39 99
p(1)
b
56-38-2
200-271-7
2920 11 00
p(1)-p(2)
b-b
Pebulate
1114-71-2
214-215-4
2930 20 00
p(1)-p(2)
b-b
Pentachlorophenol and
its salts and esters
#
Perfluorooctane
sulfonates
(PFOS)
C8F17SO2X
(X = OH, Metal salt
(O-M+), halide, amide,
and other derivatives
including polymers)
+
Permethrin
87-86-5 and
others
201-778-6
and others
p(1)-p(2)
b-sr
1763-23-1
2795-39-3
and others
n.a.
2908 11 00
2908 19 00
and others
2904 90 20
2904 90 20
and others
i(1)
sr
52645-53-1
258-067-9
2916 20 00
p(1)
b
Phosalone
+
Phosphamidon
(Soluble liquid
formulations of the
substance that exceed
1000 g active
ingredient/l)
#
2310-17-0
218-996-2
2934 99 90
p(1)
b
13171-21-6
(mixture,
(E)&(Z)
isomers)
23783-98-4
((Z)-isomer)
236-116-5
2924 12 00
3808 50 00
p(1)-p(2)
b-b
Please refer
to PIC Circular
at
www.pic.int/
Octabromodiphenyl
ether
+
Omethoate
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
297-99-4
((E)-isomer)
Polybrominated
biphenyls (PBB) except
hexabromo-biphenyl
#
Polychlorinated
terphenyls (PCT)
#
Procymidone
+
Propachlor
+
Propanil
13654-09-6
27858-07-7
and others
237-137-2
248-696-7
and others
2903 69 90
i(1)
sr
Please refer to
PIC Circular at
www.pic.int/
61788-33-8
262-968-2
2903 69 90
i(1)
b
Please refer to
PIC Circular at
www.pic.int/
32809-16-8
251-233-1
2925 19 95
p(1)
b
1918-16-7
217-638-2
2924 29 98
p(1)
b
709-98-8
211-914-6
2924 29 98
p(1)
b
Propham
122-42-9
204-542-0
2924 29 95
p(1)
b
Propisochlor
+
86763-47-5
n.a.
2924 29 98
p(1)
b
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
70
Draft Version 1.0
CHEMICAL
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Pyrazophos
+
Quintozene
+
Scilliroside
13457-18-6
236-656-1
2933 59 95
p(1)-p(2)
b-b
82-68-8
201-435-0
2904 90 85
p(1)-p(2)
b-b
507-60-8
208-077-4
2938 90 90
p(1)
b
Simazine
+
Strychnine
122-34-9
204-535-2
2933 69 10
p(1)-p(2)
b-b
57-24-9
200-319-7
2939 99 00
p(1)
b
Tecnazene
+
Terbufos
117-18-0
204-178-2
2904 90 85
p(1)-p(2)
b-b
13071-79-9
235-963-8
2930 90 85
p(1)-p(2)
b-b
Tetraethyl lead
#
78-00-2
201-075-4
2931 00 95
i(1)
sr
Tetramethyl lead
#
75-74-1
200-897-0
2931 00 95
i(1)
sr
Thallium sulphate
7446-18-6
231-201-3
2833 29 90
p(1)
b
Thiobencarb
+
Thiocyclam
28249-77-6
248-924-5
2930 20 00
p(1)
b
31895-22-4
250-859-2
2934 99 90
p(1)-p(2)
b-b
Thiodicarb
+
Tolylfluanid
+
Triazophos
59669-26-0
261-848-7
2930 90 85
p(1)
b
731-27-1
211-986-9
2930 90 85
p(1)
b
24017-47-8
245-986-5
2933 99 90
p(1)-p(2)
b-b
2931 00 95
p(2)
b
All tributyltin
compounds, including:
Tributyltin oxide
Tributyltin fluoride
Tributyltin
methacrylate
Tributyltin benzoate
Tributyltin chloride
Tributyltin linoleate
Tributyltin
naphthenate
#
Trichlorfon
+
Tricyclazole
+
Tridemorph
56-35-9
1983-10-4
2155-70-6
4342-36-3
1461-22-9
24124-25-2
85409-17-2
200-268-0
217-847-9
218-452-4
224-399-8
215-958-7
246-024-7
287-083-9
2931
2931
2931
2931
2931
2931
2931
00
00
00
00
00
00
00
95
95
95
95
95
95
95
52-68-6
200-149-3
2931 00 95
p(1)-p(2)
b-b
41814-78-2
255-559-5
2934 99 90
p(1)
b
24602-86-6
246-347-3
2934 99 90
p(1)-p(2)
b-b
Trifluralin
1582-09-8
216-428-8
2921 43 00
p(1)
b
Triorganostannic
compounds other than
tributyltin compounds
+
Tris (2,3Dibromopropyl)
phosphate
#
-
-
2931 00 95
and others
p(2)
i(2)
sr
sr
126-72-7
204-799-9
2919 10 00
i(1)
sr
Countries
for which no
notification
is required
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Please refer to
PIC Circular at
www.pic.int/
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
71
CHEMICAL
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
CAS No
Einecs No
CN Code
Subcategory
(*)
Use
limitation
(**)
Tris-aziridinylphosphinoxide
(1,1’,1’phosphoryltriaziridine)
+
Vamidothion
545-55-1
208-892-5
2933 99 90
i(1)
sr
2275-23-2
218-894-8
2930 90 85
p(1)-p(2)
b-b
Vinclozolin
+
Zineb
50471-44-8
256-599-6
2934 99 90
p(1)
b
12122-67-7
235-180-1
2930 20 00
or
3824 90 97
p(1)
b
Countries
for which no
notification
is required
(*) Sub-category: p(1) — pesticide in the group of plant protection products, p(2) — other pesticide
including biocides. i(1) — industrial chemical for professional use and i(2) — industrial chemical for
public use.
(**) Use limitation: sr — severe restriction, b — ban (for the sub-category or sub-categories concerned)
according to Union legislation.
(1) This entry does not affect the existing entry for cis-1,3-dichloropropene (CAS No 10061-01-5).
(2) This entry does not affect the existing entry for soluble liquid formulations of methamidophos that
exceed 600 g active ingredient/l.
(3) Except motor fuels subject to Directive 98/70/EC of the European Parliament and of the Council of 13
October 1998 relating to the quality of petrol and diesel fuels (OJ L 350, 28.12.1998, p. 58).
CAS No = Chemical Abstracts Service Registry Number.
(#) Chemical subject or partially subject to the PIC procedure.
(+) Chemical qualifying for PIC notification.
PART 2
List of chemicals qualifying for PIC notification
(referred to in Article 11)
This list comprises chemicals qualifying for PIC notification. It does not include chemicals that
are already subject to the PIC procedure, which are listed in Part 3 of this Annex.
33
Chemical
CAS No
Einecs No
CN code
Category*
Use limitation**
1,3-dichloropropene
542-75-6
208-826-5
2903 29 00
p
b
2-Naphthylamine
(naphthalen-2-amine) and
its salts
91-59-8,
553-00-4,
612 52-2
and others
92-67-1,
2113-61-3
and others
202-080-4,
209-030-0,
210-313-6
and others
202-177-1
and others
2921 45 00
i
b
2921 49 80
i
b
4-Aminobiphenyl (biphenyl4-amine) and its salts
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
72
Draft Version 1.0
Chemical
CAS No
Einecs No
CN code
Category*
Use limitation**
4-Nitrobiphenyl
92-92-3
202-204-7
2904 20 00
i
b
Acephate
30560-19-1
250-241-2
2930 90 85
p
b
Alachlor
15972-60-8
240-110-8
2924 29 95
p(1)
b
Aldicarb
116-06-3
204-123-2
2930 90 85
p(1)-p(2)
sr-b
Amitraz
33089-61-1
251-375-4
2925 29 00
p
b
Anthraquinone
84-65-1
201-549-0
2914 61 00
p
b
Asbestos Fibres: Chrysotile
2524 90 00
i
b
Atrazine
12001-29-5
or 132207-32-0
1912-24-9
217-617-8
2933 69 10
p
b
Azinphos-methyl
86-50-0
201-676-1
2933 99 80
p
b
Benfuracarb
82560-54-1
n.a.
2932 99 00
p
b
Benzidine and its salts
912-87-5
202-199-1
2921 59 90
i
sr
Benzidine derivatives
—
—
Butralin
33629-47-9
251-607-4
2921 49 00
p
b
Cadusafos
95465-99-9
n.a.
2930 90 99
p
b
Carbaryl
63-25-2
200-555-0
2924 29 95
p
b
Carbofuran
1563-66-2
216-353-0
2932 99 00
p
b
Carbosulfan
55285-14-8
259-565-9
2932 99 00
p
b
Chlorate
231-887-4
233-378-2
2829 11 00
2829 19 00
2933 99 90
p
b
Chlorfenapyr
7775-09-9
10137-74-3
122453-73-0
p
sr
Chlorthal-dimethyl
1861-32-1
217-464-7
2917 39 95
p
b
Chlozolinate
84332-86-5
282-714-4
2934 99 90
p
b
Cyanamide
420-04-2
206-992-3
2853 00 90
p(1)
b
Diazinon
333-41-5
206-373-8
2933 59 10
p
sr
Dichlobenil
1194-65-6
214-787-5
2926 90 95
p
b
Dicloran
99-30-9
202-746-4
2921 42 00
p
b
Dichlorvos
62-73-7
200-547-7
2919 90 00
p
b’
Dicofol
115-32-2
204-082-0
2906 29 00
p
b
Dicofol containing < 78%
p,p’-Dicofol or 1 g/kg of DDT
and DDT related compounds
Dimethenamid
115-32-3
204-082-0
2906 29 00
p
b
87674-68-8
n.a.
2934 99 90
p
b
Diniconazole-M
83657-18-5
n.a.
2933 99 80
p
b
Dinoterb
1420-07-1
215-813-8
2908 99 90
p
b
Endosulfan
115-29-7
204-079-4
2920 90 85
p(1)-p(2)
b
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
73
Chemical
CAS No
Einecs No
CN code
Category*
Use limitation**
Ethalfluralin
55283-68-6
259-564-3
2921 43 00
p
b
Ethoxyquin
91-53-2
202-075-7
2933 49 90
p
b
Fenarimol
60168-88-9
262-095-7
2933 59 95
p
b
Fenitrothion
122-14-5
204-524-2
2920 19 00
p
sr
Fenthion
55-38-9
200-231-9
2930 90 85
p
sr
Fentin acetate
900-95-8
212-984-0
2931 00 95
p
b
Fentin hydroxide
76-87-9
200-990-0
2931 00 95
p
b
Flurprimidol
56425-91-3
n.a.
2933 59 95
p
b
Guazatine
236-855-3
3808 99 90
p
b
Indolylacetic acid
108173-90-6,
115044-19-4
87-51-4
201-748-2
2933 99 80
p
b
Methamidophos (1)
10265-92-6
233-606-0
2930 50 00
p
b
Methyl bromide
74-83-9
200-813-2
2903 39 11
p
b
Methyl parathion #
298-00-0
206-050-1
2920 11 00
p
b
Monomethyl-dibromodiphenyl methane
Tradename: DBBT
Monomethyl-DichloroDiphenyl methane;
Tradename:
Ugilec 121 or Ugilec 21
99688-47-8
401-210-1
2903 69 90
i
b
—
400-140-6
2903 69 90
i
b
MonomethylTetrachlorodiphenyl
methane;
Tradename: Ugilec141
Nicotine
76253-60-6
278-404-3
2903 69 90
i
b
54-11-5
200-193-3
2939 99 00
p
b
Nitrofen
1836-75-5
217-406-0
2909 30 90
p
b
Nonylphenols
C6H4(OH)C9H19
25154-52-3
(phenol,
nonyl-),
84852-15-3
(phenol, 4nonyl-,
branched),
11066-49-2
(isononylphenol)
,
90481-04-2,
(phenol, nonyl-,
branched),
104-40-5(Pnonylphenol)
and others
9016-45-9,
26027-38-3,
68412-54-4,
37205-87-1,
127087-87-0
and others
246-672-0
2907 13 00
i
sr
3402 13 00
i
p
sr
b
Nonylphenol ethoxylates
(C2H4O)nC15H24O
284-325-5
234-284-4
291-844-0
203-199-4
and others
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
74
Draft Version 1.0
Chemical
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
CAS No
Einecs No
CN code
Category*
Use limitation**
Octabromodiphenyl ether
32536-52-0
251-087-9
2909 30 38
i
sr
Oxydemeton-methyl
301-12-2
206-110-7
2930 90 85
p
b
Paraquat
1910-42-5
217-615-7
2933 39 99
p
b
Pentabromodiphenyl ether
32534-81-9
251-084-2
2909 30 31
i
sr
Perflurooctane sulfonates
1763-23-1
n.a.
2904 90 20
i
sr
(PFOS) C8F17SO2X (X =OH,
Metal Salt (O-M+),
halide,amide,and other
derivatives including
polymers)
Phosalone
2795-39-3
and others
2310-17-0
218-996-2
2934 99 90
p
b
Procymidone
32809-16-8
251-233-1
2925 19 95
p
b
Propachlor
1918-16-7
217-638-2
2924 29 98
p
b
Propisochlor
86763-47-5
n.a.
2924 29 98
p
b
Pyrazophos
13457-18-6
236-656-1
2933 59 95
p
b
Quintozene
82-68-8
201-435-0
2904 90 85
p
b
Simazine
122-34-9
204-535-2
2933 69 10
p
b
Tecnazene
117-18-0
204-178-2
2904 90 85
p
b
Thiobencarb
28249-77-6
248-924-5
2930 20 00
p
b
Thiodicarb
59669-26-0
261-848-7
2930 90 85
p
b
Tolylfluanid
731-27-1
211-986-9
2930 90 85
p
sr
Trichlorfon
52-68-6
200-149-3
2931 00 95
p
b
Tricyclazole
41814-78-2
255-559-5
2934 99 90
p
b
Trifluralin
1582-09-8
216-428-8
2921 43 00
p
b
Triorganostannic compounds
other than tributyltin
compounds
Vinclozolin
—
—
2931 00 95
and others
p
sr
50471-44-8
256-599-6
2934 99 90
p
b
2904 90 20
and others
(*) Category: p — pesticides; i — industrial chemical.
(**) Use limitation: sr — severe restriction, b — ban (for the category or categories concerned).
CAS No = Chemical Abstracts Service Registry Number.
(1) This entry does not affect the entry in Annex I Part 3 for soluble liquid formulations of
methamidophos that exceed 600 g active ingredient/l.
(#) Chemical subject or partially subject to the PIC procedure.
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
1
2
3
4
5
6
7
75
PART 3
List of chemicals subject to the PIC procedure
(referred to in Articles 13 and 14)
(The categories shown are those referred to in the Convention)
HS code
Chemical
Relevant CAS
HS code
Mixtures
number(s)
Pure substance
containing
Category
substance
2,4,5-T and its salts
93-76-5 #
2918.91
3808.50
Pesticide
Aldrin (*)
309-00-2
2903.52
3808.50
Pesticide
Binapacryl
485-31-4
2916.19
3808.50
Pesticide
Captafol
2425-06-1
2930.50
3808.50
Pesticide
Chlordane (*)
57-74-9
2903.52
3808.50
Pesticide
Chlordimeform
6164-98-3
2925.21
3808.50
Pesticide
Chlorobenzilate
510-15-6
2918.18
3808.50
Pesticide
DDT (*)
50-29-3
2903.62
3808.50
Pesticide
Dieldrin (*)
60-57-1
2910.40
3808.50
Pesticide
Dinitro-ortho-cresol
534-52-1,
2908.99
3808.91
Pesticide
(DNOC) and its salts
2980-64-5,
3808.92
(such as ammonium
5787-96-2,
3808.93
salt, potassium salt
2312-76-7
and esters
and sodium salt)
Dinoseb and its salts
88-85-7 #
2908.91
3808.50
Pesticide
106-93-4
2903.31
3808.50
Pesticide
107-06-2
2903.15
3808.50
Pesticide
75-21-8
2910.10
3808.50
Pesticide
and esters
1,2-dibromoethane
(EDB)
Ethylene
dichloride
(1,2-dichloroethane)
Ethylene oxide
3824.81
Fluoroacetamide
640-19-7
2924.12
3808.50
Pesticide
HCH (mixed
608-73-1
2903.51
3808.50
Pesticide
Heptachlor (*)
76-44-8
2903.52
3808.50
Pesticide
Hexachlorobenzene
118-74-1
2903.62
3808.50
Pesticide
Lindane (*)
58-89-9
2903.51
3808.50
Pesticide
Mercury compounds,
10112-91-1,
2852.00
3808.50
Pesticide
including inorganic
21908-53-2 and
mercury compounds,
others
alkyl mercury
See also:
compounds and
www.pic.int/
isomers)
(*)
alkyloxyalkyl and
aryl mercury
compounds
Monocrotophos
6923-22-4
2924.12
3808.50
Pesticide
Parathion
56-38-2
2920.11
3808.50
Pesticide
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
76
Draft Version 1.0
HS code
Chemical
Relevant CAS
HS code
Mixtures
number(s)
Pure substance
containing
Category
substance
Pentachlorophenol
87-86-5 #
and its salts and
2908.11
3808.50
2908.19
3808.91
esters
Pesticide
3808.92
3808.93
3808.94
3808.99
Toxaphene (*)
8001-35-2
—
3808.50
Pesticide
Dustable powder
17804-35-2
—
3808.92
Severely
formulations
1563-66-2
hazardous
containing a
137-26-8
pesticide
combination of:
formulation
Benomyl at or above
7 %, Carbofuran at
or above 10 % and
Thiram at or above
15 %
Methamidophos
10265-92-6
2930.50
3808.50
Severely
(soluble liquid
hazardous
formulations of the
pesticide
substance that
formulation
exceed 600 g active
ingredient/l)
Methyl-parathion
298-00-0
2920.11
3808.50
Severely
(emulsifiable
hazardous
concentrates (EC) at
pesticide
or above 19,5 %
formulation
active ingredient and
dusts at or above
1,5 % active
ingredient)
Phosphamidon
2924.12
3808.50
Severely
(soluble liquid
hazardous
formulations of the
pesticide
substance that
formulation
exceed 1 000 g
active ingredient/l)
Mixture (E) & (Z)
13171-21-6
isomers
(Z)-isomer
23783-98-4
(E)-isomer
297-99-4
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
Draft Version 1.0
77
HS code
Chemical
Relevant CAS
HS code
Mixtures
number(s)
Pure substance
containing
Category
substance
Asbestos fibres:
2524.10
6811.40
2524.90
6812.80
Industrial
Crocidolite
12001-28-4
2524.10
6812.91
Actinolite
77536-66-4
2524.90
6812.92
Anthophyllite
77536-67-5
2524.90
6812.93
Amosite
12172-73-5
2524.90
6812.99
Tremolite
77536-68-6
2524.90
6813.20
— (hexa-) (*)
36355-01-8
—
3824.82
Industrial
— (octa-)
27858-07-7
— (deca-)
13654-09-6
Polychlorinated
1336-36-3
—
3824.82
Industrial
61788-33-8
—
3824.82
Industrial
Tetraethyl lead
78-00-2
2931.00
3811.11
Industrial
Tetramethyl lead
75-74-1
2931.00
3811.11
Industrial
2931.00
3808.99
Pesticide
Polybrominated
biphenyls (PBB)
biphenyls (PCB) (*)
Polychlorinated
terphenyls (PCT)
All tributyltin
compounds,
including:
Tributyltin oxide
56-35-9
2931.00
3808.99
Tributyltin fluoride
1983-10-4
2931.00
3808.99
Tributyltin
2155-70-6
2931.00
3808.99
Tributyltin benzoate
4342-36-3
2931.00
3808.99
Tributyltin chloride
1461-22-9
2931.00
3808.99
Tributyltin linoleate
24124-25-2
2931.00
3808.99
Tributyltin
85409-17-2
2931.00
3808.99
126-72-7
2919.10
3824.83
methacrylate
naphthenate
Tris (2,3-
Industrial
dibromopropyl)
phosphate
1
2
3
4
5
6
7
8
9
(*) These substances are subject to an export ban in accordance with Article 15 (2) of and Annex V to
this Regulation.
(#) Only the CAS numbers of parent compounds are listed.
Guidance for implementation of Regulation (EU) No 649/2012 concerning the
export and import of hazardous chemicals
78
1
2
3
4
5
6
7
8
9
Draft Version 1.0
Appendix 2. Annex V to Regulation (EC) No 649/2012
CHEMICALS AND ARTICLES SUBJECT TO EXPORT BAN
(referred to in Article 14)
Annex V Part 1 - Persistent organic pollutants (POPs) as listed in Annexes A and B of the
Stockholm Convention on Persistent Organic Pollutants according to the provisions thereof.
Name of the chemical
CAS No
CN code
Aldrin
206-215-8
309-00-2
2903 59 90
Chlordane
200-349-0
57-74-9
2903 52 00
Chlordecone
205-601-3
143-50-0
2914 70 00
Dieldrin
200-484-5
60-57-1
2910 40 00
DDT (1,1,1-trichloro-2,2-bis (p-chlorophenyl) ethane
200-024-3
50-29-3
2903 62 00
Endrin
200-775-7
72-20-8
2910 90 00
Heptabromodiphenyl ether
C12H3Br7O
273-031-2
68928-80-3
and others
2909 30 38
Heptachlor
200-962-3
76-44-8
2903 52 00
Hexabromobiphenyl
252-994-2
36355-01-8
2903 69 90
Hexabromodiphenyl ether
C12H4Br6O
253-058-6
36483-60-0
and others
2909 30 38
Hexachlorobenzene
204-273-9
118-74-1
2903 62 00
200-401-2,
206-270-8,
206-271-3,
210-168-9
58-89-9,
319-84-6,
319-85-7,
608-73-1
Mirex
219-196-6
2385-85-5
2903 59 80
Pentabromodiphenyl ether
C12H5Br5O
251-084-2
and others
32534-81-9
and others
2909 30 31
Pentachlorobenzene
210-172-0
608-93-5
2903 69 90
Polychlorinated biphenyls (PCBs)
215-648-1
and others
1336-36-3
and others
2903 69 90
Tetrabromodiphenyl ether
C12H6Br4O
254-787-2
and others
40088-47-9
and others
2909 30 38
Toxaphene (camphechlor)
232-283-3
8001-35-2
3808 50 00
Hexachlorocyclohexanes,
including Lindane
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Annex V Part 2 - Chemicals other than persistent organic pollutants as listed in Annexes A
and B of the Stockholm Convention on Persistent Organic Pollutants according to the provisions
thereof.
Description of
chemicals/article(s) subject to
export ban
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Additional details, where relevant (e.g. name of
chemical, EC No, CAS No, etc.)
Cosmetic soaps containing mercury
CN codes 3401 11 00, 3401 19 00, 3401 20 10, 3401 20 90,
3401 30 00
Mercury compounds except compounds
exported for research and development,
medical or analysis purposes
Cinnabar ore, mercury (I) chloride (Hg2Cl2, CAS No 10112-91-1),
mercury (II) oxide (HgO, CAS No 21908-53-2);
CN code 2852 00 00
Metallic mercury and mixtures of metallic
mercury with other substances, including
alloys of mercury, with a mercury
concentration of at least 95 % weight by
weight
CAS No 7439-97-6
CN code 2805 40
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Appendix 3. Overview of exporters’ main tasks in order to
comply with Regulation (EC) No 649/2012
1.
To notify the DNA of the Member State concerned no later than 35 days prior to the first
export of any chemical (either as substance itself or in mixture) listed in Part 1 of Annex I;
and no later than 35 days prior to the first export in each subsequent calendar year
(Article 8), unless the conditions for waiving this obligation are fulfilled;
2.
To notify within the same time limits the DNA of the Member State concerned prior to the
first export of any article containing in unreacted form a chemical listed in Part 2 or 3 of
Annex I; and the first export in each subsequent calendar year (Articles 15 (1) and 8
refer), unless conditions for a waiver are fulfilled;
3.
To respect the import responses of importing countries in relation to PIC chemicals listed
in Part 3 of Annex I (Article 14 (4));
4.
Not to export chemicals and articles listed in Annex V (Article 15 (2)), unless such
chemicals fall under the provisions of Article 2 (3) of the PIC Regulation (chemicals
exported for the purpose of research or analysis in quantities that are unlikely to affect
human health or the environment and that in any event do not exceed 10 kg from each
exporter to each importing country per calendar year). It should also be stressed that
certain chemicals listed in Annex V Part 2 can be exported under specific conditions related
to their use or concentration.
5.
Not to proceed with exports of chemicals (either as substances or in mixtures) listed in
Parts 2 or 3 of Annex I without obtaining from the DNA of the Member State concerned an
authorisation. This authorisation may be based on the explicit consent of the
DNA/appropriate authority of the importing country or on the application of a waiver
pursuant to Article 14 of Regulation (EC) 649/2012;
6.
To include the relevant reference identification number in the customs declaration for the
export - box 44 of the Single Administrative Documents or corresponding data element in
an electronic export declaration (Article 19 (1));
7.
To indicate the respective CUS number (European Customs Inventory of Chemical
Substances) and Combined Nomenclature Code on customs declarations;
8.
To provide to the DNA of the Member State concerned any information required by an
importing Party to the Convention no later than 30 days before the first transit movement
of a chemical listed in Part 3 of Annex I takes place and no later than eight days before
each subsequent transit movement (Article 16);
9.
To ensure that all exported hazardous chemicals and mixtures are packaged and labelled
in accordance with the provisions on packaging and labelling established in, or pursuant to
the CLP Regulation, REACH Regulation, Biocidal Products Regulation or any other relevant
EU legislation (Article 17 (1));
10. Where appropriate, to indicate expiry and production dates on the label (Article 17 (2));
11. Insofar as possible, to ensure that the information on the label and on the safety data
sheet (SDS) is given in the official language(s), or in one or more of the principal
languages of the importing country (Article 17 (4));
12. To provide an SDS to each importer (Article 17 (3)). Insofar as possible, the information in
the SDS should be given in the official/principal language(s) of the importing country;
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13. Not to export chemicals later than six months before their expiry date, where applicable.
In the case of pesticides, to ensure that the size and packaging of containers is such as to
minimise risks of creating obsolete stocks. In addition, to include on the label appropriate
information on storage conditions and stability. The purity specifications laid down in EU
legislation must be respected (Articles 14 (10) and 14 (11));
14. To provide on request the importing countries with available additional information on
exported chemicals (Article 8 (7));
15. Before 31 March of each year, to provide to the DNA of the Member State concerned an
annual report for the preceding year on quantities of chemicals listed in Annex I exported
from that Member State (similar obligation imposed on importers as regards imports).
Exports made under waivers pursuant to Article 14.7 are to be listed separately. Any
additional necessary information also has to be provided upon request (Article 10);
16. Where a chemical qualifies for PIC notification, but information is insufficient to meet the
requirements of Annex II, to provide all relevant available information to the Commission
upon request within 60 days of the request (similar obligation imposed on importers)
(Article 11 (4)).
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Appendix 3. Examples of evidence that can justify the
granting of a waiver to the requirement for explicit consent
Article 14 (7) provides for the granting of a waiver to the requirement for explicit consent in
cases where, despite all reasonable efforts, no response is received to a request for explicit
consent within a 60 day period. The decision to grant such a waiver must be based on
evidence that the chemical is licensed, registered or authorised for use in the importing
country. To provide guidance on what types of evidence may be used, examples drawn from
experience and practice to date are identified below:
1.
Registration certificate confirming that the chemical is authorised in the
importing country
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These certificates normally apply to pesticides. There are a number of different possibilities
under this example since registration certificates can contain different conditions. The
registration always relates to a specific active substance or mixture from a defined
company, but sometimes the certificate is in the name of a local manufacturer only. In
other instances it may specify not only a named foreign manufacturer but also a specific
country of origin. Practice to date on how such registrations should be treated for the
purposes of explicit consent has varied.
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25
One Member State had accepted a registration of a specific mixture or named foreign
manufacturer as explicit consent and posted the information on the Database as consent
for that mixture (and concentration of the Annex I substance) without qualification.
Another Member State had taken the view that as such registrations are limited to a
particular source only; though they may have been accepted as explicit consent for that
source, such information had not been listed on the Database and the requests were not
listed at all or shown as ‘pending’.
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The latter approach could be considered to lack transparency and create a misleading
picture of the situation. DNAs have agreed that such cases should be listed (if necessary
with the identity of the exporter and the mixture name protected, if commercial
confidentiality needs to be preserved). Such listings already occur for other similar cases
where ‘consent’ is not generally applicable such as those where consent is limited to a
specific shipment. DNAs also agreed that where the registration certificate is companyspecific, this should be expressly stated in the Database listing so that it would be clear to
all that the consent is not valid for other exporters.
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For such certificates to be deemed a valid justification for granting a waiver to the
requirement for explicit consent, the Annex I chemical(s) triggering the request for explicit
consent should be explicitly mentioned in the registration document or certificate.
Alternatively, if that is not the case (e.g. because the chemical concerned is not the active
ingredient), there should be evidence provided by the exporter or importer demonstrating
that the authority providing registration of the mixture was aware or actively informed that
the mixture contains an Annex I chemical(s) (e.g. it is identified in the submitted
registration application and supporting documents such as the relevant SDS, etc.).
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46
In this regard particular care should be taken with so-called 'hygiene certificates' that are
sometimes issued by the health authorities in importing countries, since 'hygiene
certificates' may only confirm the conformity of production or product with certain sanitary
requirements, without checking whether the chemical ingredients are specified and
authorised.
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In determining whether to accept such import licences as evidence upon which a decision
to grant a waiver to the requirement for explicit consent can be based, DNAs should follow
the same approach as that outlined above for registration certificates.
3.
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Import licence issued for the chemical/mixture
One Member State reported a case that has many parallels with registration certificates.
Since the licence was restricted to a named source of supply, it had elected to accept the
licence as evidence that the chemical was used in the importing country, but not to post
the information in the Database. The same approach should be followed as with
registration certificates, i.e. that such cases should be listed in the Database and that in
cases where the licence was company-specific this should be expressly mentioned in the
Database listing so that it would be clear to all that the consent does not extend to other
exporters.
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Statement from the importing country that the chemical is not subject to the PIC
procedure and therefore no consent is required
In cases where, in response to a request for consent, the importing country has elected
not to exercise its option to refuse import or impose any conditions but simply replied that
none was needed as the chemical was not a PIC chemical, this can be interpreted as
explicit consent provided that the exchanges are in writing.
4.
Statement from the importing country that the chemical is not subject to any
restrictions and that it can thus be imported without any requirements
In cases where, in response to a request for consent, the importing country has elected
not to exercise its option to refuse import or impose any conditions but simply replied that
the use of the chemical is not restricted in the importing country and that, therefore,
imports can proceed without any requirements or with customs formalities only, this can
be interpreted as explicit consent provided that the exchanges are in writing.
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Appendix 4. List of recommended languages for the labelling
of exports to certain countries
Country
Official language
Other languages used in
international
communication
Afghanistan
Pashto, Afghan Persian, Dari
English
Albania
Albanian
English
Algeria
Arabic
French
Andorra
Catalan
Spanish, French, Portuguese
Angola
Portuguese
French
Antigua and Barbuda
English
Argentina
Spanish
English, Italian, German, French
Armenia
Armenian
English, Russian
Australia (and External
Territories)
English
Azerbaijan
Azerbaijani (Azeri)
Bahamas
English
Bahrain
Arabic
English
Bangladesh
Bangla (Bengali)
English
Barbados
English
Belarus
Belarussian, Russian
English, Polish
Belize
English
Spanish
Benin
French
Bhutan
Dzongkha
English
Bolivia
Spanish, Quechua, Aymara
English
Bosnia and Herzegovina
Bosnian, Croatian, Serbian
Botswana
English
Brazil
Portuguese
English, Spanish
Brunei Darussalam
Malay
English
communications
English, Russian
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Burkina Faso
French
Burundi
French, Kirundi
Cambodia
Khmer
Cameroon
English, French
Canada
English, French
Cape Verde, Republic of
Portuguese
Central African Republic
French
Ceuta, Melilla
Spanish
Chad
French, Arabic
Chile
Spanish
English, German
China (People's Republic of)
Standard Mandarin Chinese
English
Colombia
Spanish
English
Comoros
Arabic, French
Congo (Republic of)
French
Cook Islands
English, Cook Islands Maori
(Rarotongan)
Costa Rica
Spanish
Côte d'Ivoire
French
Cuba
Spanish
Curaçao
Papiamentu, Dutch
Democratic People's Republic
of Korea
Korean
Democratic Republic of Congo
French
Djibouti
French, Arabic
Dominica
English
Dominican Republic
Spanish
English
Ecuador
Spanish
English
Egypt
Arabic
English, French
El Salvador
Spanish
French
English, French
French
English
English
English
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Equatorial Guinea
Spanish
French
Eritrea
Arabic, Tingrinya, English
Ethiopia
Amharic, Arabic, English
Federated States of
Micronesia
English
Falkland Islands (Malvinas)
English
Faroe Islands
Faroese, Danish
Fiji
English, Fijian
French Polynesia
Polynesian, French
Gabon
French
Gambia
English
Georgia
Georgian
Ghana
English
Greenland
Greenlandic (East Inuit), Danish
Grenada
English
Guatemala
Spanish
Guinea
French
Guinea-Bissau
Portuguese
Guyana
English
Haiti
French, Creole
English
Honduras
Spanish
English
Hong Kong
Cantonese, English
Iceland
Icelandic
India
Hindi, English
Indonesia
Bahasa Indonesia
English, Dutch
Iran
Persian
English, French
Iraq
Arabic, Kurdish
English
Israel
Hebrew
English
French
English, Russian
English
English
French
English
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Jamaica
English
Japan
Japanese
English
Jordan
Arabic
English
Kazakhstan
Kazakh, Russian
English
Kenya
Kiswahili, English
Kiribati
English
Korea, Democratic People’s
Republic of
Korean
Korea, Republic of
Korean
English
Kosovo (under UNSCR
1244/99)
Albanian, Serbian
English
Kuwait
Arabic
English
Kyrgyzstan
Kyrgyz, Russian
English
Laos
Lao
English, French
Lebanon
Arabic
French, English
Lesotho
Sesotho, English
Liberia
English
Libya
Arabic
Italian, English
Liechtenstein
German
French
Macedonia
Macedonian, Albanian
English
Madagascar
French, Malagasy
English
Malawi
English, Chichewa
Malaysia
Bahasa Malaysia
English
Maldives
Dhivehi
English
Mali
French
Marshall Islands
Marshallese, English
Mauritania
Arabic
Mauritius
English
Mexico
Spanish
French
English
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Moldova, Republic of
Moldovan
English, Russian
Monaco
French
English, Italian
Mongolia
Khalkha Mongol
English, Russian
Montenegro
Montenegrin
English
Morocco
Arabic, Tamazight
French
Mozambique
Portuguese
English
Myanmar
Burmese
English
Namibia
English
German
Nauru
Nauruan
English
Nepal
Nepali
English
New Caledonia
French
New Zealand (and Associated
Territories)
English, Maori, New Zealand Sign
Language
Nicaragua
Spanish
Niger
French
Nigeria
English
Norway (and Dependency)
Norwegian
English
Oman
Arabic
English
Pakistan
Urdu, English
Palestine, State of
Arabic
English
Panama
Spanish
English
Papua New Guinea
Tok Pisin, Hiri Motu
English
Paraguay
Spanish, Guarani
English
Peru
Spanish, Quechua, Aymara
English
Philippines, Republic of the
Tagalog (Philipino), English
Puerto Rico
Spanish, English
Qatar
Arabic
English
Russian Federation
Russian
English
English
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Rwanda
Kinyarwanda, French, English
Saint Kitts and Nevis
English
Saint Lucia
English
Saint Vincent and The
Grenadines
English
Samoa
Samoan
English
San Marino
Italian
French, English
Sao Tome and Principe
Portuguese
French
Saudi Arabia
Arabic
English
Senegal
French
Serbia
Serbian
Seychelles
English, Creole, French
Sierra Leone
English
Singapore
Mandarin, Malay, Tamil, English
Sint Maarten
English, Dutch
Solomon Islands
Melanesian pidgin, English
Somalia
Somali, Arabic
South Africa
IsiZulu, Afrikaans, English
Sri Lanka
Sinhala
Sudan
Arabic, English
Suriname
Dutch
Swaziland
Siswati, English
Switzerland
French, German, Italian
English, Portuguese, Spanish
Syrian Arab Republic
Arabic
English, French
Taiwan
Mandarin Chinese
English
Tajikistan
Tajik
English, Russian
Tanzania, United Republic of
Swahili, English
Thailand
Thai
English
Spanish
English, Italian
English
English
English
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Togo
French
Tonga
Tongan, English
Trinidad and Tobago
English
French, Spanish
Tunisia
Arabic
French
Turkey
Turkish
English
Turkmenistan
Turkmen
English, Russian
Tuvalu
Tuvaluan, English
Uganda
English
Ukraine
Ukrainian
English, Polish, Russian
United Arab Emirates
Arabic
English
United States of America (and
External Territories)
English
Uruguay
Spanish
English
Uzbekistan
Uzbek
English, Russian
Vanuatu
Bislama, English, French
Vatican City State (Holy See)
Italian, Latin
Venezuela, Bolivarian
Republic of
Spanish
English
Vietnam
Vietnamese
English, French
Wallis and Futuna Islands
French
Yemen
Arabic
Zambia
Bemba, English
Zimbabwe
English
English
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Appendix 5. List of EU Designated National Authorities for
Regulation (EC) No 649/2012
For the latest information on contact details of EU DNAs, please consult the dedicated section
of the ECHA website.
Member Country
DNA address
AUSTRIA
DNA Industrial Chemicals (C)
Department VI/5, Chemicals Policy
Federal Ministry of Agriculture, Forestry, Environment
and Water Management
Stubenbastei 5
Vienna 1010, Austria
Attn: Mrs Helga Schrott
Phone: +43 1 51522 2327
Fax: +43 1 51522 7334
e-mail: [email protected]
BELGIUM
DNA Industrial Chemicals and Pesticides (CP)
Inspecteur de l'environnement
SPF Santé Publique, Sécurité de la Chaîne Alimentaire et
Environnement
Place Victor Horta 40 boite 10
B-1060 BRUXELLES, Belgium
Attn: Mrs Mara Curaba
Phone: +32 2 5249592
Fax: +32 2 5249603
e-mail: [email protected]
BULGARIA
DNA Industrial Chemicals and Pesticides (CP)
Expert
Preventive Activities Directorate - Hazardous Chemicals
Department
Ministry of Environment and Water
67, William Gladstone Str.
Sofia 1000, Bulgaria
Attn: Mrs Parvoleta Luleva
Phone: +359 2 940 6021
Fax: +359 2 980 3317
e-mail: [email protected]
CROATIA
DNA Industrial Chemicals and Pesticides (CP)
Head of the Department for Dangerous Chemicals
Directorate of Sanitary Inspection
Ministry of Health and Social Welfare
10000 Zagreb, Ksaver 200 a
Croatia (Hrvatska)
Attn: Mrs Biserka Bastijanćić-Kokić
Phone: +385 1 4607 564
Fax: +385 1 4698 484/4607 631
e-mail: [email protected] or
[email protected]; [email protected];
[email protected]
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CYPRUS
CZECH REPUBLIC
Industrial Chemicals and Pesticides (CP)
Department of Labour Inspection
Ministry of Labour and Social Insurance
12 Apellis Street
Nicosia 1493, Cyprus
Attn: Dr Tasoula Kyprianidou-Leontidou,
Dr Maria Orphanou
Phone: +357 22 40 5623/+357 22 40 5608
Fax: +357 22 66 3788
e-mail: [email protected];
[email protected]
DNA Industrial Chemicals and Pesticides (CP)
Department of Environmental Risks
Ministry of Environment
Vrsovicka 65
Prague 10 10000
Czech Republic
Attn: Mrs Michaela Vytopilová,
Mrs. Milada Vomastkova
Phone: +420 267122026
Fax: +420 267126026
e-mail: [email protected];
[email protected]
DENMARK
DNA Industrial Chemicals and Pesticides (CP)
Special Adviser
Chemical Division
Danish Environmental Protection Agency (Danish EPA)
Strandgade 29
Copenhagen K DK-1401,Denmark
Attn: Mr Lars Fock
Phone: +45 7254 4100 / +45 7254 4285 direct
Fax: +45 3332 2828
e-mail: [email protected], [email protected]
ESTONIA
DNA Industrial Chemicals and Pesticides (CP)
Manager
Department of Chemical Safety
Gonsiori 29,15207, Tallinn, Estonia
Attn: Mrs Enda Veskimae
Phone: +372 626 9388
Fax: +372 626 9395
e-mail: [email protected];
[email protected]
FINLAND
DNA Industrial Chemicals and Pesticides (CP)
Senior Advisor
Finnish Environment Institute
Centre for Sustainable Consumption and Production
Mechelininkatu 34a P.O Box 140,
FI-00251 Helsinki, Finland
Attn: Mr Timo Seppälä
Phone: +358 400 148 643
Fax: +358 9 5490 2491
e-mail: [email protected];[email protected]
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DNA Industrial Chemicals and Pesticides (CP)
Senior Advisor
Finnish Environment Institute
Mechelininkatu 34a P.O Box 140, FI-00251 Helsinki
Finland
Attn: Ms Emma Nurmi
Phone: +358 407 401 687
Fax: +358 9 5490 2491
e-mail: [email protected]
FRANCE
GERMANY
DNA Industrial Chemicals and Pesticides (CP)
Ministère de l'écologie, du développement durable, des
transports et du logement
Direction Générale de la Prévention des Risques (DGPR).
Bureau des substances et préparations chimiques
ARCHE NORD
92055 La défense Cedex, France
Attn: Ms Sophie Paultre
Phone: +33 1 40 81 8709
Fax: +33 1 40 81 2072
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
(BauA)
Bundesstelle Chemikalien / Zulassung Biozide
Friedrich-Henkel-Weg 1-25 Postrach 170202,
postcode D44061, Dortmund, Germany
Attn: Ms Andrea Engelhardt,
Ms Charlotte Hoffmann,
Ms Inge Kretschmann-Scholz
Phone: +49 231 9071 2514
Fax: +49 231 9071 2679
e-mail: [email protected]
DNA Pesticides (P)
Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit (BVL)
Abteilung Pflanzenschutzmittel
Messeweg 11-12
Braunschweig D-38104, Germany
Attn: Ms Mirijam Seng
Phone: +49 531 299 3614
Fax: + 49 531 299 3002
e-mail: [email protected]
GREECE
DNA Industrial Chemicals (C)
Ministry of Economy and Finance
General Chemical State Laboratory
Directorate of Environment
16, An Tsoha str.,
115 21 Athens
Attn: Ms Eleni Foufa
Phone: + 30 210 6479287
Fax: + 30 210 6466917
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e-mail: [email protected]; [email protected]
DNA Pesticides (P)
Agronomist
Department of Pesticides
Directorate of Plant Produce Directorate of Plant Produce
Protection
Ministry of Rural Development and Food
150, Sngrou Av.
Kalithea 176 71, Greece
Attn: Mr Dionyssios Charalambus Vlachos
Phone: +30 210 928 7238
Fax: +30 210 921 2090
e-mail: [email protected]; [email protected]
DNA Industrial Chemicals (C)
Director General
National Institute of Chemical Safety
Nagyvarad tér 2.
P.O. Box 839/4
Budapest H-1437, Hungary
Attn: Mr Jenő Major, PhD
Phone: +361 476 1195
Fax: +361 476 1227
e-mail: [email protected]
e-mail Cc: [email protected];
[email protected]
HUNGARY
DNA Pesticides (P)
Directorate of Plant Protection, Soil Conservation and
Agri-environment
National Food Chain Safety Office
Buaorsi int 141-145
Budapest 1118, Hungary
Attn: Ms Agnes Petho
Phone: +36 1 309 1085
Fax: +36 1 246 2960
e-mail: [email protected]; [email protected]
DNA Pesticides (P)
The Director
National Food Chain Safety Office
Directorate of Plant Protection and Soil Consevation
Budaorsi út 141-145
Budapest H-1118, Hungary
Attn: Dr Jordan Laszlo
Phone: +36 1 309 1037
Fax: +36 1 246 2942
e-mail: [email protected]
IRELAND
DNA Industrial Chemicals (C)
Technology, Trade and Marketing Unit
Chemicals Business and Services Division
Health and Safety Authority
Floor 3, Hebron House, Hebron Rd.
Kilkenny, CO. Kilkenny, Ireland
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Attn: Dr Sharon McGuinness
Phone: +353 1 890 289/389
Fax: +353 1 614 7020
e-mail: [email protected]
e-mail Cc: [email protected];
[email protected]; [email protected]
DNA Pesticides (P)
Head of Service
Department of Agriculture and Food
Pesticide Control Service
Backweston Campus Young's Cross Celbridge
Co.Kildare, Ireland
Attn: Mr Dermot Sheridan
Phone: +353 1 615 7616
Fax: +353 1 615 7575
e-mail: [email protected];
[email protected]
DNA Industrial Chemicals and Pesticides (CP)
Researcher
Centro Nazionale Sostanze Chimiche
Istituto Superiore di Sanita
Via Regina Elena, 299
Rome 00161, Italy
Attn: Dr Leonello Attias
Phone: +39 06 499 02061
Fax: +39 06 499 02286
e-mail: [email protected]; [email protected]
ITALY
LATVIA
DNA Industrial Chemicals and Pesticides (CP)
Ministero della Salute
Dipartimento della sanità pubblica e dell’innovazione
DG della prevenzione
Viale Giorgio Ribotta 5,
00144 Roma, Italy
Attn: Dr Pietro Pistolese, Luigia Scimonelli
Phone: +39 06 59 94 3439
Fax: +39 06 59 94 6376
e-mail: [email protected]; [email protected];
[email protected]
DNA Industrial Chemicals (C)
The Latvian Environment, Geology and Meteorology
Centre
165, Maskava Str
Riga LV-1019, Latvia
Attn: Ms Sibilla Lerha
Phone: +371 67032028
Fax: +371 67145154
e-mail: [email protected]
DNA Pesticides (P)
State Plant Protection Service
Plant Protection Department
Lielvardes iela 36/38,
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Riga, LV-1006, Latvia
Attn: Mr Vents Ezers
Phone: +371 67550945
Fax: +371 67185479
e-mail: [email protected]
Industrial Chemicals and Pesticides (CP)
Chief Specialist of Chemical Substances Division
Environmental Protection Agency
A. Juozapaviciaus St 9
Vilnius LT-09311, Lithuania
Attn: Mr Vytautas Danilevicius
Phone: +370 5 212 6099
Fax: +370 5 212 3507
e-mail: [email protected]; [email protected]
LITHUANIA
LUXEMBOURG
MALTA
NETHERLANDS
DNA Industrial Chemicals and Pesticides (CP)
Head of Chemical Substances Division
Chemical Substances Division
Ministry of Environment
A. Jaksto St. 4/9
Vilnius LT-01105, Lithuania
Attn: Mrs Marija Teriosina
Phone: +370 5 266 3501
Fax: +370 5 266 3502
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Attaché du Gouvernement
Ministère du Développement durable et des
Infrastructures
Département de l'Environnement
4 Place de l'Europe, LUXEMBOURG
Attn: Mr Paul Rasqué
e-mail: [email protected]
DNA Pesticides (P)
Pharmacist
Agricultural Services and Rural Development
Agricultural Research and Development Centre
Marsa CMR 02
Attn: Mr Javier Fenech
Phone: + 356 259 04 156
Fax: + 356 25904 120
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
The Director
Chemicals, Waste and Radiation Protection Directorate
Ministry of Housing Spatial Planning and the Environment
Rijnstraat 8, IPC 645
P.O. Box 20951, 2500 EZ Den Haag, Netherlands
Attn: Mr Hans Meijer
Phone: +31(0)70 456 6253
e-mail: [email protected];
[email protected];
[email protected]
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POLAND
DNA Industrial Chemicals and Pesticides (CP)
Senior Specialist
Risk Assessment Department
Bureau for Chemical Substances
Dowborczyków Street 30/34
Lodz 90-019, Poland
Attn: Mrs Magdalena Frydrych
Phone: +48 42 2538413
Fax: +48 42 2538 444
e-mail: [email protected];
[email protected]
PORTUGAL
DNA Industrial Chemicals and Pesticides (CP)
Agência Portuguesa do Ambiente
Rua da Murgueira 9/9A Zambujal
AP 7585
Amadora 2611-865, Portugal
Attn: Mr João Carvalho
Phone: +351 21 472 8200
Fax: +351 21 471 9074
e-mail: [email protected];
[email protected]
ROMANIA
DNA Industrial Chemicals and Pesticides (CP)
Counselor, senior adviser
Official Contact Points (OCP) for Rotterdam Convention
and PIC Regulation
Ministry of Environment and Climate Change – DNA RO
Department of Waste and Dangerous Chemicals
Libertatii Blvd. 12, district 5, Bucharest 040129,
Romania
Attn: Dr Maria Olteanu
Phone: +40 21 408 95 82
Fax: +40 21 316 02 98
e-mail: [email protected]
DNA Industrial Chemicals (C)
State Counselor
Department of Sensitive Goods Trading Management
Ministry of Economy of the Slovak Republic
Mierová 19
Bratislava 212 827 15, Slovakia
Attn: Ing. Jana Talábová
Phone: +421 2 4854 2164
Fax: +421 2 4342 3915
e-mail: [email protected]
SLOVAKIA
DNA Industrial Chemicals and Pesticides (CP)
Senior Officer
Plant Comodities
Ministry of Agriculture
Dobrovicova 12
Bratislava 812 66, Slovakia
Attn: Mrs Bronislava Skarbová
Phone: +421 2 59266 402
Fax: +421 2 59266 358
e-mail: [email protected]
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SLOVENIA
SPAIN
SWEDEN
DNA Industrial Chemicals and Pesticides (CP)
Secretary
Chemicals Office
Ministry of Health
Ajdovscina 4
Ljubljana 1000, Slovenia
Attn: Ms Karmen Krajnc
Phone: +386 1 478 6054
Fax: +386 1 478 6266
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Jefe de Area de Riesgos Ambientales
Dirección General de Calidad y Evaluación Ambiental y
Medio Natural / Subdirección General de Calidad del Aire
y Medio Ambiente Industrial
Ministerio de Agricultura, Alimentación y Medio Ambiente
Plaza San Juan de la Cruz s/n
Madrid 28071, Spain
Attn: Ms Marina Paz Sánchez, Ms Marta Portolés Méndez
Phone: +34 91 4535401
Fax: +34 91 4530582
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
The National Chemicals Inspectorate (KemI)
Esplanaden 3A
P.O. Box 2
Sundbyberg S-172 13, Sweden
Attn: Ms Eva Sandberg/Mrs Inger Lindqvist
Phone: +46 8 5194 1100
Fax: +46 8 735 7698
e-mail: [email protected]; [email protected];
[email protected]
DNA Industrial Chemicals and Pesticides (CP)
Head of Pesticides and Chemicals
Department for Environment, Food and Rural Affairs
Foss House Room 301 1-2 Peaseholme Green
York Y01 7PX, United Kingdom
Attn: Mr David P. Williams
e-mail: [email protected]
UNITED KINGDOM
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DNA Industrial Chemicals and Pesticides (CP)
Chemicals Regulation Directorate
Health & Safety Executive (HSE)
Redgrave Court, Merton Road
Bootle, Merseyside L20 7HS, United Kingdom
Attn: Dr Gary Dougherty, Ms Alison McCoy,
Mr Steve Carey
e-mail: [email protected]
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Appendix 6. List of OECD countries to which waiver for
explicit consent could be applied
Member Country
AUSTRALIA
DNA address
DNA Industrial Chemicals (C)
Assistant Secretary
Department of Sustainability, Environment, Water,
Population and Communities
Environment Protection Branch
GPO Box 787,
Canberra ACT 2601, Australia
Attn: Mr Andrew McNee
Phone: +61 2 6274 1622;
Fax: +61 2 6274 1164;
e-mail: [email protected]
DNA Pesticides (P)
Manager
Agvet Chemical Policy
Department of Agriculture, Fisheries and Forestry
P.O. Box 858,
Canberra, ACT 2601, Australia
Attn: Dr Donald Ward
Phone: +61 2 6272 5566;
Fax: +61 2 6272 5697;
e-mail: [email protected]
DNA Industrial Chemicals (C)
Director
Chemical Production Division
Environment Canada
351 St. Joseph Boulevard, 11th Floor,
Gatineau, Quebec K1A 0H3, Canada
Attn: Ms Lucie Deforges
Phone: +1 819 994 4404
Fax: +1 819 994 5030
e-mail: [email protected]; [email protected]
CANADA
CHILE
DNA Pesticides (P)
Director General
Policy, Communications & Regulatory Affairs Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive,
Ottawa K1A 0K9, Canada
Attn: Ms Trish MacQuarrie
Phone: +1 613 736 3660
Fax: +1 613 736 3659
e-mail: [email protected];
[email protected]
DNA Industrial Chemicals (C)
Subsecretario de Salud Pública
Ministerio de Salud
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Mac Iver 459 Piso 8
Santiago 8320101, Chile
Attn: Sra Sandra Isabel Cortés Arancibia
Phone: +56 2 574 0493
Fax : +56 2 664 9150
e-mail: [email protected]; [email protected]
DNA Pesticides (P)
Jefe de la División de Asuntos Internacionales
Servicio Agrícola y Ganadero
División de Asuntos Internacionales
4088, Avenida Bulnes 140, Piso 5
Santiago, Chile
Attn: Mr Miguel Peña Bizama
Phone: +56 2 345 1575
Fax: +56 2 345 1578
e-mail: [email protected]; [email protected];
[email protected]
ICELAND
DNA Industrial Chemicals and Pesticides (CP)
Environment Agency
Sudurlandsbraut 24 108 Reykjavik
Attn: Mr. Haukur R. Magnùsson
Phone: + 354 591 2000
Fax: + 354 591 2010
e-mail: [email protected]; [email protected]
DNA Industrial Chemicals (C)
Ministry of the Environment
Hazardous Substances Division
5 Kanfei Nesharim St. P.O. Box 34033 Jerusalem 95464
Attn: Ms Romy Even Danan
Phone: + 972 2 655 37 66
Fax: + 972 2 655 37 63
[email protected]
ISRAEL
JAPAN
DNA Pesticides (P)
Head, Chemistry Department
Pesticides, Animal Feed
PPIS, Ministry of Agriculture and Rural Development
Jerusalem
Attn: Rina Ashkenazy
Tel: +972 3 9681562
Fax: +972 3 9681582
[email protected]
DNA Industrial Chemicals (C)
Senior Coordinator
Global Environment Division, International Cooperation
Bureau
Ministry of Foreign Affairs
2-2-1 Kasumigaseki, Chiyoda-ku
Tokyo 100-8919, Japan
Attn: Ms Mayuka Ishida
Phone: +81 3 5501 8000 (Ext 3280)
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Fax: +81 3 5501 8244
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Comisionada de Evidencia y Manejo de Riesgos
Secretaría de Salud
Comisión Federal para la Protección contra Riesgos
Sanitarios (COFEPRIS)
Monterrey 33, 9° piso
Colonia Roma
Delegación Cuauhtémoc
México, D.F. C.P. 06700, Mexico
Attn: M.en C. Rocío Alatorre Eden-Wynter
Phone: + 52 55 5080 5200 ext. 1030 y 1403
Fax: + 52 55 5514 8557
e-mail: [email protected]
MEXICO
DNA Industrial Chemicals and Pesticides (CP)
Director General
Dirección General de Gestión integral de materiales y
actividades riesgosas
Subsecretaria para la proteccion y gestion del ambiente
Secretaría de Medio Ambiente y recursos naturales
Delegacion Alvaro Obregon
Av. Revolución 1425 Col. Tlacopac San Angel
México D.F. 01040, Mexico
Attn: Sr Eduardo Enrique Gonzalez Hernandez
Phone: +5255 5624 3612
Fax: +5255 5624 3675
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Director Ejecutivo de Operación
Internacional Comisión Federal para la Protección
contra Riesgos Sanitarios (COFEPRIS)
Secretaría de Salud Monterrey N§. 33, 9° piso Colonia
Roma, Delegación Cuauhtémoc México, C.P. 06700
Mexico
Attn: Mr. David Baca Grande
Phone: +5255 5080 5200 ext. 1296
Fax: +5255 5208 2974
e-mail: [email protected];
[email protected]; [email protected];
[email protected];
NEW ZEALAND
DNA Industrial Chemicals and Pesticides (CP)
Senior Advisor
Hazardous Substances
Environment Protection Authority
P.O. Box 131
Wellington 6140
New Zealand
Attn: Ms Susan Collier
Phone: +64 4 916 2426
Fax: +64 4 914 0433
e-mail: [email protected]
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DNA Industrial Chemicals and Pesticides (CP)
Ministry for Primary Industries
P.O. Box 2526
Wellington 6140
New Zealand
Attn: Mr Warren Hughes
Phone: +64 4 894 2560
Fax: +64 4 463 2675
e-mail: [email protected]
DNA Industrial Chemicals
Section for Risk Evaluation of Chemicals
Climate & Pollution Agency
P.O. Box 8100 Dep
Oslo N-0032
Attn: Ms Christina Charlotte Tolfsen
Phone: +47 22 573738
Fax: +47 22 676706
e-mail: [email protected]; [email protected]
NORWAY
DNA Pesticides
Senior Executive Officer
National Registration Section
Norwegian Food Safety Authority
Felles Postmottak, Postboks 383
Brumunddal 2381, Norway
Attn: Ms Marit Randall
Phone: +47 64 94 4363
Fax: +47 64 94 4410
e-mail: [email protected]
DNA Industrial Chemicals and Pesticides (CP)
Higher Executive Officer
Department of Climate Change and Pollution Control
Ministry of the Environment
8013 DEP
Oslo 0030, Norway
Attn: Mr Aksel Erik Hillestad
Phone: +47 22 245803
Fax: +47 22 249563
e-mail: [email protected]
REPUBLIC OF KOREA
DNA Industrial Chemicals (C)
Deputy Director Chemicals Management Division Ministry
of Environment Building #6,
Government complex-Seojong,
11 Doum 6-ro. Seojong special Self-Governing City
339-012 Republic of Korea
Attn: Mr Pil Koo Yim; Ms Moon hee Kim
Phone: 82-44-201-6782/78
Fax: + 82 44 201 6786
[email protected]; [email protected]
DNA Pesticides (P)
Director
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Agro-materials Management Division
Rural Development Administration
150 Suin-ro, Gwonseon-gu, Suwon
Republic of Korea
Attn: Kwang-ha, Lee
Tel: + 82 31 299 2590
Fax: + 82 31 299 2607
[email protected]; [email protected];
[email protected]; [email protected]
SWITZERLAND
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DNA Industrial Chemicals and Pesticides (CP)
Scientific Officer
Waste Management, Substances and Biotechnology
Division, Federal Office for the Environment
Berne 3003, Switzerland
Attn: Ms Sarah Maillefer
Phone: +41 31 322 8344
Fax: +41 31 323 0369
e-mail: [email protected]
TURKEY
DNA Industrial Chemicals and Pesticides (CP)
Head of Department
General Directorate of Environmental Management &
Chemicals Management Department
Ministry of Environment and Forest
Cevre ve Orman Bakanligi Bestepe
Ankara 06560
Attn: Mr Abdullah Uluirmak
Phone: + 90 312 207 6464
Fax: +90 312 287 3827 / 207 6446
e-mail: [email protected]
UNITED STATES
DNA Industrial Chemicals and Pesticides (CP)
The Assistant Administrator
Prevention, Pesticides and Toxic Substances
Environmental Protection Agency, 7101M
Ariel Rios Building 1200 Pennsylvania Avenue, N.W.
Washington, D.C 20460
Phone: +1 202 564 2902
Fax: +1 202 564 0512
e-mail: [email protected]; [email protected]
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Appendix 8. Glossary/list of acronyms
BPR
Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2012
concerning the making available on the market and use
of biocidal products
C&L
Classification and Labelling
CAS
Chemical Abstracts Service Registry
CUS
European Customs Inventory of Chemical Substances
CN
Combined Nomenclature
CLP
Regulation (EC) No 1272/2008 on classification,
labelling and packaging of substances, mixtures,
amending and repealing Directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No
1907/2006
CMR
means a substance or mixture that is carcinogenic,
mutagenic or toxic to reproduction
Convention
Rotterdam Convention on the Prior Informed Consent
Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade
CoP
Conference of Parties to the Rotterdam Convention
CRC
Chemical Review Committee of the Rotterdam
Convention
DGD
Decision Guidance Document
DNA
Designated National Authority
DPD
Dangerous Preparations Directive (1999/45/EC)
DSD
Dangerous Substances Directive (67/548/EEC)
EC
European Community
ECHA
European Chemicals Agency
EEC
European Economic Community
ePIC
IT application for processing and management of legal
requirements of the PIC Regulation
EU
European Union
FAO
Food and Agriculture Organization of the United Nations
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Forum
Forum for Exchange of Information on Enforcement
established by Regulation (EC) No 1907/2006
GHS
Globally Harmonised System of Classification
and Labelling
Hazard Statement
means a phrase assigned to a hazard classand category
that describes the nature of hazard s of a hazardous
substance or mixture, including where appropriate,
the degree of hazard
MSCA
Member State Competent Authority
OECD
Organisation for Economic Cooperation and
Development
PBT
Persistent, Bioaccumulative, Toxic substances
PCBs
Polychlorinated biphenyls
PCTs
Polychlorinated terphenyls
PIC
Prior Informed Consent
POPs
Persistent Organic Pollutants
PPP
means plant protection product
Precautionary Statement
means a phrase (according to the CLP Regulation) that
describes recommended measure(s) to minimise or
prevent adverse effects resulting from exposure to a
hazardous substance
or mixture due to its use or disposal
REACH
Regulation (EC) No 1907/2006 concerning the
Registration, Evaluation, Authoriation and Restriction
of Chemicals
RIN
Reference Identification Number
SDS
Safety Data Sheet
SHPF
means severely hazardous pesticide formulation
TARIC
Tarif Intégré de la Communauté – i.e.,
Integrated Community Tariff (of the European Union)
UNECE
United Nations Economic Commission for Europe
UNEP
United Nations Environment Programme
vPvB
very Persistent and very Bioaccumulative substances
Guidance on Prior Informed Consent (PIC) Procedure
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EUROPEAN CHEMICALS AGENCY
ANNANKATU 18, P.O. BOX 400,
FI-00121 HELSINKI, FINLAND
ECHA.EUROPA.EU
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