Commission Findings on the Acceptance of Declarations of Interest Submitted Pursuant To

CA-Sept16-Doc.5.7

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

Directorate E – Food and feed safety, innovation E4 - Pesticides and Biocides

Commission findings on the acceptance of declarations of interest submitted pursuant to Articles 15(a) of Regulation (EU) No 1062/2014

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11 E-mail: [email protected] Contents

2 Declarations of interest submitted pursuant to Article 15(a) of Regulation (EU) No 1062/2014

In accordance with Article 15(a), the declaring company shall demonstrate that the following conditions are met:

1. the person placing the product on the market has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012;

2. that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified;

3. that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission.

Furthermore, pursuant to Article 16(6), if the following conditions apply:

(a) the relevant active substance is already included in the review programme;

(b) one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all the data required for the evaluation of the product-type;

(c) the participant which has submitted that dossier indicates an interest to support the substance/product-type combination. the substance/product-type combination subject of the declaration of interest shall be considered as notified by a participant, and shall not be eligible for additional notification.

The declarations of interest submitted pursuant to Article 15(a) have been examined individually and, after consultation of the Member States, the Commission came to the conclusions detailed thereafter.

3 Copper sulphate pentahydrate for product-type 3

Manica Spa submitted a declaration of interest to notify the active substance Copper sulphate pentahydrate (EC 231-847-6, CAS 7758-99-8) for use in biocidal products of product-type 3 pursuant to Article 15(a) of Regulation (EU) No 1062/2014.

The declaring company has however not demonstrated that it had relied on guidance published by, or written advice received from the Commission or a Competent Authority, which would have given the company objectively justified reasons to believe that its biocidal product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012.

Furthermore, the mode of action of copper sulphate pentahydrate in PT3 products described in the submitted information is the same as for its use for product-type 2 already approved for that active substance, as it is interacting with the protein of the enzyme and inhibits its activity. It cannot be concluded that the effect could have been legitimately considered indirect, and the case cannot be considered similar to the one which was subject to the Söll case1. In addition, the application for approval for product-type 2 was submitted by Manica Spa.

Considering the conditions set out in Article 15(a) of Regulation (EU) No 1062/2014 are not met, the declaration of interest to notify the active substance Copper sulphate pentahydrate for use in product-type 3 submitted by Manica Spa is therefore not admissible.

1 Case C-420/10, Söll GmbH v Tetra GmbH

4 Polymer of (2-propenoic acid, 2-(dimethylaminio) ester, homopolymer, with 1- bromotetradecane) combined with an Acrylic Resin, including quaternary ammonium groups causing a cationic surface for product-types 2 and 4

Croda Europe Ltd submitted a declaration of interest to notify the active substance Polymer of (2-propenoic acid, 2-(dimethylaminio) ester, homopolymer, with 1-bromotetradecane) combined with an Acrylic Resin, including quaternary ammonium groups causing a cationic surface for use in biocidal products for product-types 2 and 4 pursuant to Article 15(a) of Regulation (EU) No 1062/2014.

The declaring provided the following justification:

Croda has submitted this Declaration of Interest based on guidance published by the Commission (Commission implementing Decision (EU) 2015/411) where the final paint product containing the active substance as a dried surface is the biocidal product which is generated 'in situ' and is in scope of Regulation (EU) No 528/2012.

In recent discussion with the Netherlands (CTGB) the quaternary ammonium polymer, as described in the Active Substance Name, was described as 'passive' active, showing no efficacy in the liquid state.

The 'Acrylic Resin' used in the Active substance name refers to the acrylic polymer which companies with the quaternary ammonium polymer to form the active dried surface of the paint creating the biocidal product. The quaternary ammonium groups in the Active Substance name are part of the quaternary polymer, not part of the 'Acrylic Resin'.

The Netherlands have recommended that discussion on the final name for the active substance should be referred to the Working Group on Analytical methods and Physico- Chemical properties. Croda awaits the outcome of this discussion"

A discussion was initiated at the 54th Competent Authorities meeting of December 2013 by the Dutch Competent Authority on this new technology23, as the Dutch Competent Authority considered that this technology was under the scope of the Biocidal Product Regulation as a biocidal product, but the contesting company (later acquired by Croda Europe Ltd) disagreed with this position.

The Netherlands therefore requested, under Article 3(3) of the BPR, that the Commission decides whether the product is a biocidal product or not. Commission Implementing Decision (EU) 2015/411 of 11 March 20154 clarified which product had to be considered a biocidal product, and clarified that "the paints, in which the cationic polymeric binders with

2 CA-Dec13-Doc.7.1 - Letter from NL to CION on article 3.3 AM Coatings.pdf

3 CA-Dec13-Doc.7.1a - Confidential - AM Coatings input (restricted access on Circabc)

4 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32015D0411

5 quaternary ammonium compounds are incorporated by paint manufacturers with a view to confer to those paints a biocidal function, shall be considered biocidal products". This decision confirmed the position of the Dutch Competent Authority, and also confirmed the guidance given in entry 2.5.2.1 of the former Manual of Decision, added in December 2004, that disinfecting paints are biocidal products.

Lastly, the Review Regulation (EU) No 1062/2014 regulates the organisation of the review programme of existing active substances as defined under Article 3(1)(d) of the Biocidal Product Regulation (EU) No 528/2012, which was on the EU market before 14th May 2000 as an active substance in biocidal products. No evidence has been provided that this technology was on the EU market before 14th May 2000, which would not seem to be the case as this technology was considered as innovative in 2013. The opinion of the European Chemicals Agency of 9th April 20145 gave some indications regarding the definition of the active substance which would eventually have to be approved when an application for approval would be submitted.

The declaring company has therefore not demonstrated that it had relied on guidance published by, or written advice received from the Commission or a Competent Authority, which would have given the company objectively justified reasons to believe that its biocidal product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-types were one for which the active substance had been notified.

Considering the conditions set out in Article 15(a) of Regulation (EU) No 1062/2014 are not met, the declaration of interest to notify the active Polymer of (2-propenoic acid, 2- (dimethylaminio) ester, homopolymer, with 1-bromotetradecane) combined with an Acrylic Resin, including quaternary ammonium groups causing a cationic surface for use in biocidal products for product-types 2 and 4 submitted by Croda Europe Ltd is therefore not admissible.

5 https://echa.europa.eu/documents/10162/21680461/bpc_opinion_polymeric_binder_art_75_1_en.pdf