Specifying a Procedure for the Authorisation of Same Biocidal Products

CA-Sept12-Doc.4.3

PA&MRFG-Sept12-Doc.9

ENEN

COMMISSION IMPLEMENTING REGULATION (EU) No …/..

of XXX

specifying a procedure for the authorisation of same biocidal products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22May 2012 concerning the making available on the market and use of biocidal products[1], and in particular Article 17(7) thereof,

Whereas:

(1)Regulation (EU) No 528/2012 specifies procedures for applying for and granting authorisation of biocidal products.

(2)In a case where applications are submitted to the same competent authority or to the Agency for two or more authorisations of the same biocidal product, the authorisations can be granted based on one single product evaluation and, as the case may be, comparative assessment. It is therefore appropriate to provide for an adapted authorisation procedure for such cases.

(3)Products covered by the adapted authorisation procedure should be identical to ensure that one single evaluation can establish compliance with the conditions for authorisation laid down in Article19(1) of Regulation (EU) No 528/2012. It is therefore appropriate to define same biocidal products for the purpose of this Regulation as products having been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process, being identical in specification and content in respect of active and non-active substances, and being identical in packaging size, material and form.

(4)The terms and conditions relating to the making available on the market and use of a biocidal product should be based on the evaluation made of the product. It is therefore appropriate to require that biocidal products authorised in accordance with this Regulation are authorised on the same terms and conditions as the evaluated biocidal products to which they refer, with the exception of trade name, name of the authorisation holder, date of authorisation, authorisation number and, as the case may be, suffix.

(5)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1
Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)"reference biocidal product" means a biocidal product which has been authorised or registered in accordance with Directive 98/8/EC or Regulation(EU) No528/2012, or for which an application has been submitted in accordance with Article 26, Article 29, Article33 or Article34 of that Regulation;

(b)"same biocidal product" means a biocidal productwhich

has been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;

is identical in specification and content in respect of active and non-active substances; and

is identical in packaging size, material and form;

in relation to a reference biocidal product.

Article 2
Content of applications

An application for authorisation of a same biocidal product shall contain:

(i)the authorisation number or, for not yet approved reference biocidal products, the application numberof the reference biocidal product to which the same biocidal product relates;

(ii) evidence that the criteria indicated in Article1(b) of this Regulation are met;

(iii) a letter of access to all the data submitted for the authorisation of the related reference biocidal product;

(iv)a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2) of Regulation(EU) No528/2012, as applicable.

Article 20(2) and 20(3) of Regulation (EU) No 528/2012 shall apply.

Article 3
Submission of applications

Applications for authorisation of a same biocidal product shall be submitted to the competent authoritythat has granted or is requested to grant the authorisation of the related reference biocidal product, or, in the case of Union authorisation, to the Agency.

Article 4
Validation of applications

Within 30 days of receiving an application the competent authority or, in the case of Union authorisation, the Agency,shall validate the application, provided that the information indicated in Article2 of this Regulation has been submitted and that the relevant fee has been paid.

Article 5
Criteria for authorising same biocidal products

A same biocidal product shall be authorised if:

(a) the related reference biocidal product is authorised;

(b) the criteria indicated in Article1(b) of this Regulation are met; and

(c) the information indicated in Article2 of this Regulation has been submitted.

Article 6
Content of authorisations

The content of an authorisation of a same biocidal product shall be identical with that of the related reference biocidal product.

By derogation from the previous paragraph, the information included in the authorisation of a same biocidal product in accordance with Article22(a), 22(b), 22(c) for the date of authorisation, 22(d) and 22(f) of Regulation(EU) No528/2012 may differ from that of a reference biocidal product.

Article 7
Decision on applications for national authorisation

The competent authority shall decide whether to grant or refuse authorisation within 30 days fromthe acceptance of an application as valid in accordance with Article4 of this Regulation, or, if applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference biocidal product.

Article 8
Decision on applications for Union authorisation

1. The Agency shall prepare and submit to the Commission an opinion on the application within 30 days from the acceptance of an application as valid in accordance with Article4 of this Regulation, or, if applicable, on the subsequent date of submission of an opinion on the related reference biocidal product in accordance with Article44(3) of Regulation (EU) No 528/2012.
2. Within 30 days of submitting its opinion to the Commission, the Agency shall transmit to the Commission, in all the official languages of the Union, the draft summary of the biocidal product characteristics, as referred to in Article 22(2), where applicable.
3. On receipt of the opinion of the Agency, the Commission shall adopt either an implementing regulation granting the Union authorisation to the biocidal product or an implementing decision stating that the Union authorisation of the biocidal product has not been granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article82(3).

Article 9
Cancellation or amendment of authorisations

A cancellation or amendment of the authorisation of a reference biocidal product shall not automatically affect the authorisation of relatedsame biocidal products, and vice versa.

The Register for Biocidal Products shall, however, show a link between reference biocidal products andrelated same biocidal products. Competent authorities and the Commission shall assess the appropriateness of cancelling or amendinganyrelated authorisation when taking decisions in accordance with Article48(1)(a) or Article48(1)(b) ofthe Regulation (EU) No 528/2012.

Article10

This Regulation shall enter into force on the […] day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2013

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Commission

The President
[…]
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On behalf of the President
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[Position]

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[1]OJ L […], […], p. […].