EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
CA-Sept15-Doc.7.9
61st meeting of Representatives of Members States Competent
Authorities for the implementation of Regulation (EU) No
528/2012 concerning the making available on the market and use
of biocidal products
New authoritative guidance in the meaning of Article 15 of Regulation (EU)
No 1062/2014
Repeal of earlier guidance provided by the Commission
In Case C-420/101, the European Court of Justice Court ruled that:
“The concept of ‘biocidal products’ set out in Article 2(1)(a) of Directive 98/8/EC2 must be
interpreted as including even products which act only by indirect means on the target
harmful organisms, so long as they contain one or more active substances provoking a
chemical or biological action which forms an integral part of a causal chain, the objective of
which is to produce an inhibiting effect in relation to those organisms.”
In view of this ruling, the guidance provided in the Manual of Decision3 (MoD) indicating
that products acting only by indirect means on the target harmful organisms should not be
regarded as biocidal products4 must be reconsidered.
Furthermore, as Directive 98/8/EC (the BPD) has now been repealed and replaced by
Regulation (EU) No 528/2012 (the BPR)5, on the occasion of the 58th CA Meeting6, an
agreement has been reached with Member States' Competent Authorities that this Manual of
Decision shall be considered as no longer applicable.
1
Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling:
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).
2
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 (OJ 1998 L 123, p. 1).
3
https://circabc.europa.eu/w/browse/d0155521-069e-4e8c-91cc-126006d32a83
4
See for instance item 2.3.17 of the Manual of Decision on Nutrients for beneficial micro-organisms.
5
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 (OJ L 167, 27.6.2012, p. 1).
6
CA-Nov14-Doc.7.7 - Manual of decisions.doc
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11
E-mail: [email protected]
The purpose of this note is to formally alert stakeholders that the guidance provided by the
Manual of Decision no longer stands and to offer a legal remedy for those who had objective
justified reasons to believe that their product was excluded from the scope of the biocides
legislation on the basis of that guidance.
This note should be regarded as a new authoritative guidance published by the Commission
within the meaning of Article 15 of Regulation (EU) No 1062/20147 upon its publication on
CIRCABC.
Pursuant to Article 16(1) of Regulation (EU) No 1062/2014, persons placing biocidal
products on the market and having relied on the guidance previously provided by the Manual
of Decision to conclude that their products where out of the scope of the biocides legislation,
shall then be entitled to submit a declaration of interest 8 to notify a substance/product-type
combination at the latest by 1 October 2016 when their products now fall under the scope of
the BPR.
This declaration shall be submitted through the Register of Biocidal Products to the
Commission.
Before submitting their declaration of interest, companies may wish to seek confirmation that
their products now falls within the scope of the BPR. In such case, they may submit a request
to their national helpdesk or to the ECHA helpdesk.
7
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 (OJ L 294, 10.10.2014, p. 1).
8
https://comments.echa.europa.eu/comments_cms/BiocidesDoINotifySubstance.aspx
2