EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11949 -2015  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the 
authorisation of same biocidal products in accordance with Regulation (EU) No 
528/2012 of the European Parliament and of the Council  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the 
authorisation of same biocidal products in accordance with Regulation (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 t he 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 available on the market and use of biocidal 
products1, and in particular Article 17(7)  thereof , 
Whereas:  
(1) In Commission Implementing Regulation (EU) No 414/20132 it is necessary to clarify 
that an individual product covered under a biocidal product family authorisation is also 
eligible as a related reference product  with a view to obtain a n authorisation for a  same 
product .  
(2) References to applications for registration are now obsolete as this procedure is no 
longer applicable since the repeal of Directive 98/8/EC  of the European Parliament 
and of the Council3 and should therefore be deleted.   
(3) To respond  to the needs of economic operators , in particular small and medium -sized 
enterprises , Article 3 of Implementing Regulation (EU) No 414/2013 should provide 
for the possibility to apply for national authorisation  of same products in cases where  
the related reference product  has been authorised by  Union  authorisation  or is the 
subject of an application for such an authorisation.  
(4) It is necessary to clearly identify  and to further specify the procedure for the 
submission of application s for authoris ation of a same product  and for acceptance of 
such applications where the related reference product has been authorised under the 
simplified authorisation procedur e set out in Article 26 of Regulation (EU) No 528/12 
or is the subject of an application for such an authorisation . 
(5) In order to bring further predictability , guidelines on the details related to the handling 
of the applications covered by Implementing Regulation  (EU) No 414/2013 should be 
developed by the European Chemicals Agency (‘the Agency’)  and regularly updated 
on the basis of experience and scientific or technica l progress.  
                                                 
1 OJ L 167, 27.6.2012, p. 1.  
2 Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the 
authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council  (OJ L 125, 7.5.2013, p. 4 ). 
3 Directive 98/8/EC of the European Parli ament 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 ).  
EN 3   EN (6) To make the text clearer and unambiguous, the wording of Articles 5 and 6 should be  
amend ed.  
(7) Implementing Regulation (EU) No 414/2013 should therefore be amended 
accordingly . 
(8) 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  
Implementing Regulation (EU) No 414/2013 is amended as follows : 
(1) Article 1 is  replaced by the following:  
‘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  single biocidal product , biocidal 
product family , or individual product of a biocidal product family  which has been authorised 
or registered in accordance with Directive 98/8/EC of the European Parliament and of the 
Council * or Regulation (EU) No 528/2012, or for which an application for such authorisation 
has been submitted (the ‘related reference product’), with regard to all the latest information 
submitted in relation to the authorisation or registration, except information which can be the 
subject of an administrative change in accordance with Commission  Implementing Regulation 
(EU) No 354/2013 **. 
_________________________  
* 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).  
** Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of 
biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council (OJ L 109, 9.4.2013, p.4). ’ 
(2) In Article 3 , the follo wing paragraph 1a is inserted . 
‘1a. Where the related reference product has been authorised by Union authorisation or is 
the subject of an application for such an authorisation, applications for national authorisation 
of a same product shall  be submitted in accordance with Article 29(1) of Regulation (EU) No 
528/2012 to the competent authority of the Member State in which the n ational authorisation 
is sought .’.  
(3) The following  Article 4a is inserted : 
‘Article 4a 
Submission and acceptance of ap plications under the simplified procedure  
1. Where the related reference product has been authorised in accordance with Article 
26(3) of Regulation (EU) No 528/2012 or is the subject of an application for such an 
authorisation, applications for authorisation of a same product shall be submitted in 
accordance with Article 26(1) of Regulation (EU) No 528/2012 to the competent  
EN 4   EN authority that has granted or is requested to grant the authorisation of the related 
reference product.  
2. The competent authority shall acce pt the application in accordance with Article 26(2) 
of that Regulation .’. 
(4) The following  Article 4b is inserted : 
‘Article 4b 
Guidance on handling applications for authorisation of same products  
1. The Agency shall, after consulting the Member States, the Commission and 
interested parties  [Please specify ], draw up guidelines on the details related to the 
handling of applications covered by this Regulation.  
2. Where necessary, t hose guidelines shall be updated taking into account the 
contributions from Member States and interested parties  on its implementation as 
well as scientific and technical progress. ’. 
(5) Article 5 is replaced by the following : 
‘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 whether to grant or refuse authorisation of a same product in 
accordance with Article  19 of that Regulation within 60 days from the validation of the 
application in accordance w ith Article  3 of this Regulation , or, where applicable, from the 
subsequent date of adoption of the corresponding decision concerning the related reference 
product .’. 
(6) In Article 6 , paragraph 2  is replaced by the following : 
‘2. If the Agency recommends the authorisation of the same product , the opinion shall 
contain at least both the following 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 characte ristics, 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 same product .’. 
(7) The following  Article 6a is inserted : 
‘Article 6a 
Evaluation and decision on applications under the simplified procedure  
1. By way of derogation from Article 26(3) and (4) of Regulation (EU) No 528/2012, 
the receiving competent authority shall decide whether to grant or refuse 
authorisation of a same pro duct in accordance with Article 25 of that Regulation 
within 60 days from the acceptance of the application in accordance with Article  
EN 5   EN 4a(2) , or, where applicable, from the subsequent date of adoption of the 
corresponding decision concerning the related re ference product.  
2. The evaluation shall include a check that the information indicated in Article 2 has 
been submitted and 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.  
3. Where  the product authorised through this procedure is intended to be made 
available on the market of other Member States , Article 27 of Regulation (EU) No  
528/2012  shall apply .’. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker