ATTACHMENT B

In Annex 1, Product Sectors, the following Chapter 18 on Biocidal products shall be introduced:

‘CHAPTER 18

BIOCIDAL PRODUCTS

SCOPE AND COVERAGE

The provisions of this Sectoral Chapter apply to biocidal products as defined in Directive 98/8/EC, with the exemption of:

— biocidal products which are or which contain genetically modified or pathogenic micro-organisms, and

— avicides, piscicides and biocides for control of other vertebrates.

Commission Directives to include active substances to the Annex I, IA or IB are part of this Chapter.

Switzerland will be free to limit access to its market according to the requirements of its legislation existing at the date of entry into force of this Chapter concerning:

— biocidal products containing octylphenol or its ethoxylates, and

— aerosol dispensers containing substances stable in the air.

The Parties shall jointly review the situation in 2013.

SECTION I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)

European Union 1. 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 L 123, 24.4.1998, p. 1), as last amended by Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 (OJ L 262, 6.10.2009, p. 40), hereinafter referred to as “Directive 98/8/EC” 2. Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (OJ L 228, 8.9.2000, p. 6) 3. Commission Regulation (EC) No 1687/2002 of 25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000 (OJ L 258, 26.9.2002, p. 15) 4. Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3) Switzerland 100. Federal Law of 15 December 2000 for the Protection against Dangerous Substances and Preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197) 101. Federal Law of 7 October 1983 relating to the Protection of the Environment (RO 1984 1122), as last amended on 20 March 2008 (RO 2008 3437) 102. Ordinance of 18 May 2005 concerning the placing on the market and the use of biocidal products (Ordinance on Biocidal Products) (RO 2005 2821), as last amended on 2 November 2009 (RO 2009 5401)

SECTION II

Conformity assessment bodies

For the purposes of this Chapter, “Conformity Assessment Bodies” means the competent authorities of the Member States of the European Union and Switzerland for placing biocidal products on the market.

The contact details of the competent authorities of the Member States and of Switzerland can be found on the websites indicated below.

Member States

Biocides: “Competent Authorities and other Contact Points” http://ec.europa.eu/environment/biocides/pdf/ca_contact.pdf

Switzerland

Federal Office of Public Health, Notification Authority for Chemicals www.bag.admin.ch/biocide

SECTION III

Supplementary provisions

For the purpose of paragraphs 2-5 of this Section, any reference to Directive 98/8/EC shall, as far as Switzerland is concerned, be understood to equally refer to the equivalent Swiss provisions.

1. Inclusion of active substances in Annex I, IA or IB

Article 11 of Directive 98/8/EC shall apply between the Parties with the following adaptations:

inclusion or subsequent changes to the inclusion, of an active substance in Annex I, IA or IB shall also be considered where an applicant has forwarded the required dossier to the competent authority of Switzerland, and where the receiving competent authority has sent the required evaluation to the Commission.

2. Mutual recognition of authorisations between Member States and Switzerland

1. Without prejudice to Article 12 of Directive 98/8/EC, a biocidal product that has already been authorised or registered in one Member State or in Switzerland shall be authorised or registered in another Member State or in Switzerland within 120 days, or 60 days respectively, of an application being received by the other Member State or by Switzerland, provided that the active substance of the biocidal product is included in Annex I or IA to Directive 98/8/EC and conforms to the requirements thereof. For the mutual recognition of authorisations, the application shall include a summary of the dossier as required in Article 8(2)(a) and Annex IIB, Section X of Directive 98/8/EC and a certified copy of the first authorisation granted. For mutual recognition of registration of low-risk biocidal products, the application shall include the data requirements of Article 8(3) of Directive 98/8/EC, except for the efficacy data for which a summary shall suffice. The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with the Parties’ law, relating to the conditions for distribution and use of biocidal products intended to protect the health of the distributors, users and workers concerned. This mutual recognition procedure shall be without prejudice to measures taken by Member States and by Switzerland pursuant to the Parties’ law intended to protect the health of workers.

2. If, in accordance with Article 5 of Directive 98/8/EC, a Member State or Switzerland establishes that: (a) the target species is not present in harmful quantities; (b) unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated; or (c) the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorised or in Switzerland, and an unchanged authorisation may therefore present unacceptable risks to humans or the environment, the Member State or Switzerland may request that certain conditions referred to in Article 20(3)(e), (f), (h), (j) and (l) of Directive 98/8/EC be adjusted to the different circumstances, so that conditions for issue of an authorisation laid down in Article 5 of Directive 98/8/EC are satisfied.

3. Where a Member State or Switzerland believes that a low-risk biocidal product which has been registered by another Member State or by Switzerland does not comply with the definition provided for in Article 2(1)(b) of Directive 98/8/EC, it may provisionally refuse registration thereof and shall immediately communicate its concerns to the competent authority responsible for the verification of the dossier. If, within a maximum period of 90 days, an agreement is not reached between the authorities concerned, the matter will be forwarded to the Commission for a decision in accordance with the procedure laid down in paragraph 4.

4. Notwithstanding paragraphs 2 and 3, where a Member State or Switzerland believes a biocidal product authorised by another Member State or Switzerland cannot meet the conditions set out pursuant to Article 5(1) of Directive 98/8/EC and consequently proposes to refuse the authorisation or the registration or to restrict the authorisation under certain conditions, it shall notify the Commission, other Member States, Switzerland and the applicant and shall provide them with an explanatory document containing the name of the product and its specification and setting out the grounds on which it proposes to refuse or to restrict the authorisation. The Commission shall prepare a proposal on these matters in accordance with Article 27 of Directive 98/8/EC for a decision in accordance with the procedure laid down in Article 28(2) of Directive 98/8/EC.

5. If the procedure laid down in paragraph 4 leads to the confirmation of a refusal of a second or subsequent registration by a Member State or by Switzerland, the Member State that had previously registered the low-risk biocidal product or Switzerland shall, where deemed appropriate by the Standing Committee, take this refusal into consideration and review its registration according to Article 6 of Directive 98/8/EC. If this procedure confirms the initial registration, the Member State or Switzerland having introduced the procedure shall register the low-risk biocidal product concerned.

6. By way of derogation from paragraph 1, Member States or Switzerland may refuse mutual recognition of authorisations granted for product types 15, 17 and 23 of Annex V to Directive 98/8/EC provided that such a limitation can be justified and does not jeopardise the purpose of this Chapter. Member States and Switzerland shall inform each other and the Commission of any decision taken in this respect and indicate the reasons therefor.

3. Market access

The applicant shall indicate his name or trade name and address on the label of biocidal products. It will be sufficient, for the purposes of Article 8 of Directive 98/8/EC, if the applicant for an authorisation has a permanent office either within the European Union or Switzerland. The Parties agree that authorisations and other decisions relating to the application of this Chapter may be notified by the competent authorities directly to the applicant in the territory of the other Party.

4. Information exchange

In accordance with Article 9 of this Agreement, the Parties shall in particular exchange information referred to in Article 18 of Directive 98/8/EC. Confidential information shall be defined and treated in accordance with Article 19 of Directive 98/8/EC.

5. Safeguard clause

Where a Member State or Switzerland has valid reasons to consider that a biocidal product which it has authorised, registered or is bound to authorise or register pursuant to Article 3 or 4 of Directive 98/8/EC constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory. It shall immediately inform the Commission, the other Member States and Switzerland of such action and give reasons for its decisions. A decision shall be taken on the matter within 90 days in accordance with the procedure laid down in Article 28(3). If Switzerland disagrees with the Commission Decision, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action, including the possibility to call an expert meeting. If a settlement is not reached within 90 days, either party may suspend the Biocidal products Chapter in part or in full.

Recourse to this safeguard clause should be an exception.

6. Transitional period

Article 16(1) of Directive 98/8/EC shall apply between the Parties, with the transitional period up to 14 May 2014 for Switzerland.’