Grasse, November 30, 2016
Dear PRODAROM Members,
In France, articles 7 to 12 of Decree 2014-128 of 14/02/14 related to toxicovigilance, are dealing with the
regulatory declaration of hazardous mixtures to the appointed body under the framework of article 45 of
Regulation 1272/2008 (CLP)1. This decree has been recently amended by Decree 2016-196 of
25/02/2016: the entry into force of 1st January 2016 and deadline of 30 January 2016 has been postponed
respectively to 1st January 2017 and 30 January 20172. Another legal text “Arrêté of 21 March 2016” has
been published and is related to official body receiving declarations of chemical products according to
articles L. 4411-4 Labour Code and R. 1342-13 Public Health Code3.
The reporting obligations, previously required for some specific mixtures (i.e. very toxic, toxic, corrosive
and CMR 1 or 2 pursuant to Directive 1999/45/EC) have been extended to all physical and human health
hazards and are subject to different timelines. New mixtures shall be declared to the appointed body within
30 days after their placing on the French market. Decree n° 2014-128 of 14 February 2014 establishes
the regulatory provisions relating to mandatory declaration of hazardous mixtures, depending on their
classifications.
The regulatory requirements, which are detailed in the additional information section below, are not fully
in line with the upcoming European measures of harmonisation under article 45 of CLP (for instance: no
mention about possibility of limited declaration for industrial mixtures). The legal text (Arrêté), specifying
means of declaration according to Decree 2014-128, is not yet published. PRODAROM is currently asking
government to amend its requirements or to postpone, one more time, upcoming entry into force and
deadline of 1st January 2017 and 30 January 2017. PRODAROM will keep you informed if French
authorities finally agree for new postponement and/or limited declaration for industrial mixtures.
Additional information on the application of the provisions, the reporting of the modifications and
exemptions are provided below.
If you have any further questions, please write to Jean-François Goursot ([email protected]) at
PRODAROM.
Best regards,
PRODAROM
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Additional information
Decree 2016-196 of 25/02/2016:
1) Application of the provisions:
The application of the provisions is being phased in on the following schedule:
1.1.
Regulatory declarations as of 1 April 2014:
As of 1 April 2014, products classified as hazardous pursuant to EC Regulation No. 1272/2008 known as
the "CLP" Regulation and having at least one of the following classifications shall be declared:
 acute toxicity, category 1, 2, or 3 (H300, H301, H310, H311, H330, H331)
 specific target organ toxicity following single exposure, category 1 (H370)
 specific target organ toxicity following repeated exposure, category 1 (H372)
 carcinogenicity, category 1A or 1B (H350)
 germ cell mutagenicity, category 1A or 1B (H340)
 reproductive toxicity, category 1A or 1B (H360)
 skin corrosion, category 1 (H314)
1.2.
Regulatory declarations as of 1 January 2017
As of 1 January 2017, products classified as hazardous pursuant to EC Regulation No. 1272/2008 and
having at least one of the following classifications shall be declared. These classifications are added to
the preceding classifications:
 respiratory sensitization, category 1 (H334)
 skin sensitisation, category 1 (H317)
 carcinogenicity, category 2 (H351)
 germ cell mutagenicity, category 2 (H341)
 reproductive toxicity, category 2 (H361)
All mixtures classified according to these classifications and put on market before the 1st of January 2017
shall be declared at the latest on 30 January 2017. The French legislator has not provided a cut-off date
for this retrospective action. Declarations shall be made for products being still on the market on January
2017.
1.3.
Regulatory declarations as of 1 January 2019
As of 1 January 2019, all of products classified as hazardous because of their effects on human health
shall be declared. The following classifications are added to the preceding classifications (see above):
 acute toxicity, category 4 (H302, H312, H332)
 skin irritation, category 2 (H315)
 eye irritation, category 2 (H319)
 specific target organ toxicity following single exposure, category 2 or 3 (H335, H336, H371)
 specific target organ toxicity following repeated exposure, category 2 (H373)
 aspiration toxicity, category 1 (H304)
 serious eye damage, category 1 (H318)
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
reproductive toxicity, additional category : effects on or via lactation (H362)
All mixtures classified for these hazards and put on the market before the 1st of January 2019 shall be
declared on 30 January 2019 at the latest.
1.4.
Regulatory declarations as of 1 June 2022
As of 1 June 2022, all products classified as hazardous because of their physical hazards shall be
declared. Only products classified solely for their effects on the environment will not have to be mandatorily
declared after that date (except for biocides). All mixtures classified for these hazards and put on market
before the 1st of June 2022 shall be declared at the latest on 30 June 2022.
2) Reporting of modifications:
The appointed body must be informed about withdrawal from the market, modification of trade name,
modification in composition or classification of mixtures for which a declaration has been made. This
information shall be sent within 30 days.
3) Exemptions:
The provisions shall not apply to:
1) products intended for health purposes for humans and cosmetic products
2) veterinary medicinal products
3) radioactive substances and mixtures
4) food and their components
5) feed and their components
6) substances and mixtures for research and development that are not placed on the market to the public
7) waste
4)
Information to provide for declaration of hazardous mixtures under the harmonisation of
poison centre information (CLP article 45) (Att. 01)
In order to perform a declaration the following information is required under the French Decree:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
Existing names of the mixture concerned.
Qualitative and quantitative composition of the mixture; [when a mixture contains one or more
mixtures whose composition is not known by the declarant brand name and contact details of the
supplier of the mixture should be provided as well as safety data sheet when required under the
provisions of Article R. 4411-73 of the Labour Code.
Types of commercial packaging.
Types of uses.
Physical properties.
Nature and characteristics of harmful effects.
Special safety measures.
Safety data sheet when required under the provisions of Article R. the 4411-73 the Labour Code.
Label referred to in Article 17 of Regulation (EC) No 1272/2008 of the European Parliament and of
the Council December 16, 2008.
The documents required should be written in French. They are transmitted electronically or, if not possible,
by any means, according to the procedures laid down by "Arrêté". This Arrêté is not still published to date.
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The « declaration-synapse » is the on-line tool for declarations. More info can be found on the INRS
dedicated web site: https://www.declaration-synapse.fr/synapse/jsp/index.jsp
The registration to the Declaration-Synapse service is a prerequisite to any declaration. The registration
requires the provision of a PRIS V1 or RGS** or RGS*** electronic certificate. When duly registered, each
declarant is provided with a personal space entitled « My declarations ».
The Declaration-synapse offers a “mass-import” function. However, this way to process has yet not been
tested by colleagues in the fragrance industry. Companies might be required to adapt their in-house IT
system. However, IT issues are unfortunately expected.
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