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RS 0.813.151.4 Agreement of 5 October 2015 between the Swiss Federal Council and the Government of the Principality of Liechtenstein on cooperation in the field of authorisation procedures for biocidal products in accordance with the Regulation (EU) n

Original Language Title: RS 0.813.151.4 Accord du 5 octobre 2015 entre le Conseil fédéral suisse et le Gouvernement de la Principauté de Liechtenstein sur la collaboration dans le domaine des procédures d’autorisation des produits biocides conformément au Règlement (UE) no

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0.813.151.4

Translation 1

Agreement

Between the Swiss Federal Council and the Government of the Principality of Liechtenstein on cooperation in the field of authorisation procedures for biocidal products in accordance with the Regulation (EU) n O 528/2012 of the European Parliament and of the Council concerning the making available on the market and the use of biocidal products

Concluded on 5 October 2015

Entered into force on 4 November 2015

(State on 4 November 2015)

The Swiss Federal Council and the Government of the Principality of Liechtenstein,

Having regard to the commitment of Liechtenstein as a Contracting Party to the Agreement of 2 May 1992 on the European Economic Area ('the EEA Agreement ') 2 , as adapted by the Protocol of 17 March 1993, to allow the making available on the market and the use of biocidal products in accordance with the Regulation (EU) n O 528/2012 3 As well as taking into account the implementing acts and delegated acts adopted by the European Commission in accordance with the EEA Agreement and the list of the Union of approved active substances referred to in Art. 9, para. 2, Regulation (EU) n O 528/2012,

Whereas Switzerland has settled the placing on the market and use of biocidal products by the order of 18 May 2005 on biocidal products 4 As well as by the DFI enforcement order of 15 August 2014 on biocidal products 5 ,

Given that few applications for authorisation of biocidal products or requests for the evaluation of biocidal products or active substances will be submitted in the Principality of Liechtenstein under the Regulation (EU) n O 528/2012, since both the industry and the relevant market are restricted,

Agreed to the following:

Art. 1 Purpose

1 On the mandate of the Government of the Principality of Liechtenstein, the Swiss Agency for the receipt of notifications of chemicals, hereinafter referred to as the "receiving body", in cooperation with the competent evaluation bodies of the Federal Office of The Environment (OFEV), the Federal Office of Public Health (OFSP), the Federal Office for Agriculture (OFAG), the Federal Office for Food Safety and Veterinary Affairs (OSAV) and the State Secretariat for the Economy (SECO), below "Evaluation bodies", validates and assesses, for the purpose of making available on the market and Use of biocidal products and active substances:

A.
Applications for authorisation of biocides received by the Liechtenstein Office for the Environment (AU);
B.
Applications for evaluation of biocidal products or active substances accepted by the AU.

2 Applications shall be validated and evaluated in accordance with the relevant provisions of the EEA Agreement, in particular chemicals legislation.

Art. 2 Definitions

1 "Biocidal products" means biocidal products and families of biocidal products within the meaning of s. 3, para. 1, let. A and s, of the Regulation (EU) n O 528/2012.

2 "Authorization" means:

A.
The national authorization of a biocidal product;
B.
National authorisation for a biocidal product granted under the simplified procedure;
C.
Sequential mutual recognition;
D.
The simultaneous mutual recognition of the authorisation of a biocidal product in a State party to the EEA Agreement;
E.
Authorisation by the Union of a biocidal product;
F.
Authorisation of the same biocidal product;
G.
The parallel trade authorization of a biocidal product;
H.
The renewal, cancellation or modification of any of the aforementioned authorizations.
Art. 3 Jurisdiction and procedure

1 Enforcement of the Regulation (EU) n O 528/2012 is the responsibility of the AU, subject to paras. 2 to 4.

2 The receiving body and the evaluation bodies validate and evaluate applications for authorisation of biocidal products and evaluation applications in accordance with the procedures laid down in the Regulation (EU) n O 528/2012 and within the applicable deadlines. Any questions will be clarified directly between the applicant and the receiving body.

3 The receiving body shall inform the AU in writing of the results of validation and evaluation. It shall also issue a written recommendation concerning the acceptance or rejection of the application for the authorisation of a biocidal product or an active substance by specifying the recitals.

4 The receiving body shall record in the register of biocides the information which must be included under s. 71 Regulation (EU) n O 528/2012, provided that an agreement with the European Union gives it the right to do so.

Art. 4 Billing

1 The receiving body charges to the AU the costs incurred on the basis of the order of 18 May 2005 on the emoluments relating to chemicals 1 .

2 Billing takes place once validation or evaluation is complete.


Art. 5 Function secret and confidentiality

1 The employees and servants of the receiving body, the evaluation bodies and the AU shall be obliged to preserve the secrecy of office in the execution of this Agreement.

2 Information relating to the secret of manufacture or trade secret, or whose disclosure would threaten the private sphere or the security of the person concerned according to the Regulation (EU) n O 528/2012 are treated confidentially.

3 Information on applications which have been submitted in another State party to the EEA Agreement must be treated confidentially if the body that has received the request has qualified this information as confidential.

Art. 6 Application and Interpretation of the Agreement

Matters relating to the application and interpretation of this Agreement shall be settled by diplomatic means between the two Contracting Parties.

Art. 7 Repeal of the current agreement

The Agreement of 18 March 2011 between the Swiss Federal Council and the Government of the Principality of Liechtenstein on cooperation in the field of the authorisation process for biocidal products in accordance with Directive 98 /8/EC of the European Parliament And the Council on the placing on the market of biocidal products 1 Is repealed.


Art. 8 HYPERLINK "https: //www.admin.ch/opc/en/classified-compilation/20102998/index.html" \l "a6 "

This Agreement shall enter into force thirty days after the signature by both parties and shall be concluded for an indefinite period. It may be denounced by each party through diplomatic channels by observing a six-month written notice.

In witness whereof, The Plenipotentiaries have signed this Agreement.

Bern, 21 September 2015

For the Swiss Federal Council:

Alain Berset

Vaduz, October 5, 2015

For the Government of the Principality of Liechtenstein:

Marlies Amann-Marxer



RO 2015 4069


1 Original German text
2 FF 1992 IV 655
3 Regulation (EU) n O 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and the use of biocidal products, OJ L 167, 27.6.2012, p. 1; last amended by Regulation (EU) n O 334/2014, OJ L 103, 5.4.2014, p. 22.
4 RS 813.12
5 RS 813.121