EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals
CA-Nov14-Doc.7.7
58th meeting of representatives of Members States Competent
Authorities for the implementation of Regulation 528/2012
concerning the making available on the market and use of biocidal
products
This document is an attempt to provide guidance in the interest of consistency, and has been
drafted by the Commission services responsible for biocidal products with the aim of finding
an agreement with all or a majority of the Member States' Competent Authorities for biocidal
products. Please note, however, that Member States are not legally obliged to follow the
approach set out in this document, since only the Court of Justice of the European Union can
give authoritative interpretations on the contents of Union law.
Subject:
Status of the Manual of Decisions under the BPR
1.- Background and purpose of the document
The Manual of Decisions (the MoD) for the implementation of Directive 98/8/EC of the
European Parliament and of the Council of 16 February 1998 concerning the placing of
biocidal products on the market (the BPD), as last modified on 17 January 2014 is a collection
of agreements reached between the Commission and the Member States Competent
Authorities for the implementation of the BPD between 2003 and 2013. These agreements are
presented in the form of questions and answers (Q&As).
On 1 September 2013, Regulation (EU) No 528/2012 concerning the making available on the
market and use of biocidal products (the BPR) came into application, thereby repealing the
BPD.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: [email protected]
In addition, the judgement of the European Court of Justice delivered on 1 March 2012 in the
Söll Case1 (the Söll case) has clarified the concept of ‘biocidal products’.
Several Member States and stakeholders have requested the Commission to clarify the status
of some of the Q&As contained in the MoD in the light of the Söll case as well as the status
of the MoD itself now that the BPD has been repealed and replaced by the BPR.
The purpose of this note is to address these requests.
2.- Discussion points and proposed way forward
Considering that:

Q&As agreed back in 2003 in the context of the preparatory actions for the
establishment of the review programme have served their purposes and are in many
cases no longer relevant.

Q&As agreed on borderline between the BPD and other legislative frameworks (such
as cosmetics, veterinary medicinal products, etc…) have in most cases been clarified
through ad hoc guidance documents.

Q&As agreed on treated articles and materials in contact with food have to be reexamined in the light of Article 58 of the BPR, which provides specific provisions on
treated articles.

Q&As agreed on the on-site formulation and use of biocidal products have to be reexamined in the light of Article 17 of the BPR, which provides specific provisions on
the use of biocidal products.

Q&As agreed on in situ-generation of active substances have to be re-examined in the
light of Article 3(1)(a) second indent of the BPR, which provides a different definition
of biocidal products compared to the BPD, and of the Söll Case.

Q&As agreed on the mode of action of biocidal products have to be re-examined in
the light of the Söll Case.
It appears that most of the Q&As of the MoD are no longer relevant or need to be reexamined in the light of the BPR and of the Söll Case.
Therefore, all Q&As of the MoD shall be considered as no longer applicable as from the date
of publication of this new guidance by the Commission.
This new guidance, in so far as it reviews a previous guidance on which persons placing
products on the market may have relied and gave them objectively justified reasons to believe
that their products were excluded from the scope of the BPD, shall open the possibility for
such persons to submit a declaration of interest to notify a substance/product-type
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Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling from the Landgericht
Hamburg — Germany) — Söll GmbH v Tetra GmbH (Placing on the market of biocidal products — Directive 98/8/EC — Article
2(1)(a) — Concept of ‘biocidal products’ — Product causing flocculation of harmful organisms without destroying or deterring them
or rendering them harmless).
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combination pursuant to Article 16(1)(a) of the Commission Delegated Regulation (EU) No
1062/2014 of 4 August 2014 on the work programme for the systematic examination of all
existing active substances contained in biocidal products referred to in Regulation (EU) No
528/2012 of the European Parliament and of the Council.
Before doing so, these persons may however submit a request through the ECHA helpdesk to
check whether a different answer would be provided today under the BPR or in the light of
the Söll case.
In addition, in accordance with Article 3(3) of the BPR, Member States competent authorities
for the implementation of the BPR may also request, at their own initiative or upon request of
a stakeholder, the Commission to clarify whether a specific product or group of products is a
biocidal product or a treated article or neither.
Finally, Member States can also use the HelpEx tool to get re-confirmed some of the Q&As,
which may be still of relevance today, and which, once-reconfirmed, could be made publicly
available by ECHA.
3.- Action requested
The Commission services invite the CA meeting to endorse the proposals outlined in this
paper.
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