EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Dec.12-Doc.3.7 Rev.3 
[…](2012) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
specifying a procedure for the authorisation of same biocidal products in accordance 
with Regulation (EU) No 528/2012 of the Eu ropean Parliament and of the Council 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
specifying a procedure for the authorisation of same biocidal products in accordance 
with Regulation (EU) No 528/2012 of the Eu ropean Parliament and of the Council 
(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 22 May 2012 concerning the making avai lable 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) Where applications are submitted to the same competent authority or to the Agency for 
two or more authorisations 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 theref ore appropriate to provide for an adapted 
authorisation procedure for such cases.  
(3) The terms and conditions relating to the making available on the market and use of a 
biocidal product should be ba sed on the evaluation made of the product. It is therefore 
appropriate to require that biocidal produc ts 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 the details on which the products 
differ. 
(4) Since this Regulation specifies a pro cedure provided for by Regulation (EU) 
No 528/2012, which applies from 1 Septembe r 2013, this Regulation should also apply 
from that date. 
(5) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                
 
1 OJ L 167, 27.6.2012, p. 1. EN 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Subject matter 
This Regulation lays down the procedure applicable where an authorisation is sought for a 
product (the 'same product') which is identical to  another biocidal product or product family 
which has been authorised or registered  in accordance with Directive 98/8/EC or 
Regulation (EU) No 528/2012, or for which an  application for such registration or 
authorisation has been submitted (the 'related refe rence product'), with regards to all the latest 
information submitted in relation to the authorisation or registration, except information which can be the subject of an administ rative change in accordance with Commission 
implementing Regulation (EU) No  XX/XX [the Regulation on Cha nges of Biocidal Products]. 
Article 2 
Content 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 shall contain the following information: 
(a) the authorisation number or, for not yet approved related reference products, the 
application number in the Register for Bi ocidal Products of th e related reference 
product; 
(b) an indication of the proposed differences between the same product and the related 
reference product, and evidence that the pr oducts are identical on all other aspect; 
(c) where required by Article 59(1) of Regulat ion (EU) No 528/2012, letters of access to 
all the data supporting the authorisat ion of the related reference product; 
(d) a draft summary of the biocidal produc t characteristics for the same product. 
Article 3 
Submission and validation of applicati ons for national authorisation 
1. Where the related reference product has been or is expected to be authorised by 
national authorisation, applic ations for authorisation of a same product shall be 
submitted in accordance with Article 29(1) of Regulation (EU) No 528/2012 to the competent authority that has granted or is requested to grant the national authorisation of the related reference product. 
2. By way of derogation from paragraphs 2 and 4 of Article 29 of Regulation (EU) 
No 528/2012, the competent authority shall vali date the application within 30 days of 
accepting it, provided that the information i ndicated in Article 2 has been submitted.  
The validation shall include a check that the proposed differences between the same 
product and the related refere nce product concern merely information which can be 
the subject of an administrative ch ange in accordance with Commission EN 4   EN implementing Regulation (EU) No XX/XX [t he Regulation on Changes of Biocidal 
Products]. 
Article 4 
Submission and validation of applica tions for Union authorisation 
1. Where the related reference product has been or is expected to be authorised by 
Union authorisation, applica tions 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 confirmation that the biocidal product 
would have similar conditions of use across the Union or a reference to an evaluating 
competent authority. 
3. For the purposes of the application of this Article, Article 43(2) of Regulation (EU) 
No 528/2012 shall be read as requiring th e Agency to inform the applicant only. 
4. By way of derogation from the first and s econd subparagraphs of Article 43(3) of 
Regulation (EU) No 528/2012, the Agency shall validate the application within 
30 days of accepting it provided that the info rmation 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 refere nce product concern merely information which can be 
the subject of an administrative ch ange in accordance with Commission 
implementing Regulation (EU) No XX/XX [t he Regulation on Changes of Biocidal 
Products]. 
6. For the purposes of the application of this Article, all references to the evaluating 
competent authority in the third subparagra ph of Article 43(3) and in Article 43(4) 
and (5) of Regulation (EU) No 528/2012 sha ll be read as referring to the Agency . 
Article 5 
Evaluation and decision on applicati ons for national authorisation  
By way of derogation from Article 30 of  Regulation (EU) No 528/2012, the competent 
authority shall decide whether to grant or refuse auth orisation of a same product in 
accordance with Article 19 of that Regulation within 30 days from the validation of the 
application in accordance with Article 4, or, wh ere applicable, from the subsequent date of 
adoption of the corresponding decision c oncerning the related reference product. 
Article 6 
Evaluation and decision on applicat ions for Union authorisation  
1. By way of derogation from Article 44( 1), (2) and (3) of Regulation (EU) No 
528/2012 the Agency shall prepare and subm it to the Commission an opinion on the 
application within 30 days from the validat ion of the application in accordance with 
Article 4 of this Regulation, or, where applicable, on the subsequent date of EN 5   EN submission of an opinion on the related re ference product in accordance with 
Article 44(3) of Regulation (EU) No 528/2012. 
2. If the Agency recommends the authoris ation of the biocidal product, the opinion 
shall contain at least both the following elements: 
(a) a statement on whether the conditi ons laid down in Article 19 of 
Regulation (EU) No 528/2012 are fulfille d, 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 which should 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 of which 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 Comm ission implementing Regulation (EU) 
No XX/XX [the Regulation on Changes of Biocidal Products] independently of each 
other.  
Authorisations of a same pr oduct or of a related referen ce product may be changed or 
cancelled independently of each other. 
However, in the evaluation of a proposed change of a same product or of a related 
reference product, the receiving competent au thority or, where relevant, the Agency 
shall consider the appropria teness of cancelling or ame nding the authorisation of 
other products to which the product is linked in the Register for Biocidal Products as 
referred to in the second subparagraph of paragraph 1. 
Article 8 
This Regulation shall enter into force on the twentieth 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. EN 6   EN Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO