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Official Journal of the European Union

7.5.2013

COMMISSION IMPLEMENTING REGULATION (EU) No 414/2013
of 6 May 2013
specifying a procedure for the authorisation of same biocidal products in accordance withRegulation (EU) No 528/2012 of the European Parliament and of the Council(Text with EEA relevance)
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the EuropeanUnion,
Having regard to Regulation (EU) No 528/2012 of theEuropean Parliament and of the Council of 22 May 2012
concerning the making available on the market and use ofbiocidal products (1), and in particular Article 17(7) thereof,
Whereas:
(1)

(2)

(3)

(4)

(5)

Regulation (EU) No 528/2012 specifies procedures for
applying for and granting authorisation of biocidalproducts.
Where applications are submitted to the same receiving
competent authority or to the Agency for two or moreauthorisations of biocidal products with the same
properties, the authorisations may be granted based on
one single product evaluation and, as the case may be,comparative assessment. It is therefore appropriate toprovide for an adapted authorisation procedure forsuch cases.
The terms and conditions relating to the making
available on the market and use of a biocidal productshould 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 theevaluated biocidal products to which they refer, with theexception of the details on which the products differ.
Since this Regulation specifies a procedure provided forby Regulation (EU) No 528/2012, which applies from
1 September 2013, this Regulation should also apply
from that date.
The measures provided for in this Regulation are inaccordance with the opinion of the Standing
Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1
Subject matter
This Regulation lays down the procedure applicable where anauthorisation is sought for a product (the ‘same product’) which(1) OJ L 167, 27.6.2012, p. 1.

is identical to another biocidal product or product family which
has been authorised or registered in accordance with Directive
98/8/EC of the European Parliament and of the Council (2) orRegulation (EU) No 528/2012, or for which an application forsuch registration or authorisation has been submitted (the‘related reference product’), with regards to all the latest
information submitted in relation to the authorisation or regis­
tration, except information which can be the subject of an
administrative change in accordance with Commission Imple­
menting Regulation (EU) No 354/2013 of 18 April 2013 onchanges of biocidal products authorised in accordance withRegulation (EU) No 528/2012 of the European Parliamentand of the Council (3).
Article 2Content of applications
By way of derogation from Article 20(1) of Regulation (EU)No 528/2012 and the information requirements in Article 43(1)thereof, an application for authorisation of a same product shallcontain the following information:(a) the authorisation number or, for not yet approved related
reference products, the application number in the Registerfor Biocidal Products of the related reference product;(b) an indication of the proposed differences between the same
product and the related reference product, and evidence thatthe products are identical on all other aspects;(c) where required by Article 59(1) of Regulation (EU) No
528/2012, letters of access to all the data supporting theauthorisation of the related reference product;(d) a draft summary of the biocidal product characteristics forthe same product.
Article 3
Submission and validation of applications for nationalauthorisation
1.
Where the related reference product has been authorisedby national authorisation or is the subject of an application forsuch an authorisation, applications for authorisation of a same
product shall be submitted in accordance with Article 29(1) ofRegulation (EU) No 528/2012 to the competent authority thathas granted or is requested to grant the national authorisationof the related reference product.
(2) OJ L 123, 24.4.1998, p. 1.
(3) OJ L 109, 19.4.2013, p. 4.

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2.
By way of derogation from paragraphs 2 and 4 of
Article 29 of Regulation (EU) No 528/2012, the competentauthority shall validate the application within 30 days of
accepting it, provided that the information indicated in
Article 2 has been submitted.

The validation shall include a check that the proposed
differences between the same product and the related
reference product concern merely information which can bethe subject of an administrative change in accordance withImplementing Regulation (EU) No 354/2013.

Article 4
Submission and validation of applications for Union
authorisation
1.
Where the related reference product has been authorised
by Union authorisation or is the subject of an application forsuch an authorisation, applications for authorisation of a same
product shall be submitted to the Agency in accordance with
Article 43(1) of Regulation (EU) No 528/2012.

2.
However, the application shall not include a confirmationthat the biocidal product would have similar conditions of use
across the Union or a reference to an evaluating competentauthority.

3.
For the purposes of the application of this Article,
Article 43(2) of Regulation (EU) No 528/2012 shall be readas requiring the Agency to inform the applicant only.

4.
By way of derogation from the first and second subpara­graphs of Article 43(3) of Regulation (EU) No 528/2012, theAgency shall validate the application within 30 days ofaccepting it provided that the information indicated in
Article 2 has been submitted.

5.
The validation shall include a check that the proposed
differences between the same product and the related
reference product concern merely information which can be
the subject of an administrative change in accordance with
Implementing Regulation (EU) No 354/2013.

6.
For the purposes of the application of this Article, allreferences to the evaluating competent authority in the third
subparagraph of Article 43(3) and in Article 43(4) and (5) ofRegulation (EU) No 528/2012 shall be read as referring to theAgency.

Article 5
Evaluation and decision on applications for national
authorisation
By way of derogation from Article 30 of Regulation (EU) No
528/2012, the receiving competent authority shall decide

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whether to grant or refuse authorisation of a same product inaccordance with Article 19 of that Regulation within 60 days
from the validation of the application in accordance withArticle 3, or, where applicable, from the subsequent date ofadoption of the corresponding decision concerning the related
reference product.

Article 6
Evaluation and decision on applications for Union
authorisation
1.
By way of derogation from Article 44(1), (2) and (3) ofRegulation (EU) No 528/2012 the Agency shall prepare andsubmit to the Commission an opinion on the application
within 30 days from the validation of the application inaccordance with Article 4 of this Regulation, or, where appli­
cable, on the subsequent date of submission of an opinion on
the related reference product in accordance with Article 44(3) ofRegulation (EU) No 528/2012.

2.
If the Agency recommends the authorisation of thebiocidal product, the opinion shall contain at least both thefollowing elements:(a) a statement on whether the conditions laid down in
Article 19 of Regulation (EU) No 528/2012 are fulfilled,
and a draft summary of biocidal products characteristics,
as referred to in Article 22(2) of that Regulation;(b) where relevant, details of any terms and conditions whichshould be imposed on the making available on the market
and use of the biocidal product.

Article 7
Authorisations and changes of same products
1.
A same product shall have a different authorisation
number than that of the related reference product.

On all other aspects, the content of the authorisation of a same
product shall be identical with that of the related reference
product except in terms of the information in respect ofwhich the products differ. The Register for Biocidal Products
shall show a link between same products and related
reference products.

2.
Changes of a same product or of a related reference
product shall be notified or applied for in accordance with
Implementing Regulation (EU) No 354/2013 independently ofeach other.

Authorisations of a same product or of a related reference
product may be changed or cancelled independently of eachother.

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However, in the evaluation of a proposed change of a same
product or of a related reference product, the receiving
competent authority or, where relevant, the Agency shallconsider the appropriateness of cancelling or amending theauthorisation of other products to which the product islinked in the Register for Biocidal Products as referred to in
the second subparagraph of paragraph 1.

7.5.2013

Article 8This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of theEuropean 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, 6 May 2013.
For the Commission
The President
José Manuel BARROSO