3.9.2013

ENOfficial Journal of the European Union

L 234/1

II(Non-legislative acts)

REGULATIONSCOMMISSION DELEGATED REGULATION (EU) No 837/2013
of 25 June 2013
amending Annex III to Regulation (EU) No 528/2012 of the European Parliament and of the Council
as regards the information requirements for authorisation of biocidal products(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 of
biocidal products (1), and in particular Article 85 thereof,
Whereas:(1)

Pursuant to Article 19(1) of Regulation (EU) No
528/2012 a biocidal product may be authorised if theactive substances in the product have been approved inaccordance with Article 9 of that Regulation.

(2)

A biocidal product may be authorised even if one ormore of the active substances contained therein has
been manufactured in a different location or according
to a different process, including from different starting
materials, than those of the substance evaluated forapproval pursuant to Article 9 of Regulation (EU) No
528/2012.

(3)

In such cases, for the purpose of ensuring that the active
substance contained in a biocidal product does not havesignificantly more hazardous properties than thesubstance which has been evaluated for the purpose ofapproval, it is necessary to establish technical equivalence
pursuant to Article 54 of Regulation (EU) No 528/2012.

(4)

It is therefore appropriate to include proof of estab­lishment of technical equivalence in the information
requirements for authorisation of biocidal products
listed in Annex III to Regulation (EU) No 528/2012,(1) OJ L 167, 27.6.2012, p. 1.

HAS ADOPTED THIS REGULATION:

Article 1
Annex III to Regulation (EU) No 528/2012 is amended asfollows:(1) In the table in title 1, the following entry 2.5 is inserted:"2.5 Where the biocidal product contains an active
substance that has been manufactured in locations oraccording to processes or from starting materials otherthan those of the active substance evaluated for thepurpose of approval pursuant to Article 9 of thisRegulation, evidence has to be provided thattechnical equivalence has been established inaccordance with Article 54 of this Regulation or has
been established, following an evaluation having
started before 1 September 2013, by a competentauthority designated in accordance with Article 26 of
Directive 98/8/EC."(2) In the table in title 2, the following entry 2.5 is inserted:"2.5 Where the biocidal product contains an active
substance that has been manufactured in locations or
according to processes or from starting materials otherthan those of the active substance evaluated for thepurpose of approval pursuant to Article 9 of thisRegulation, evidence has to be provided thattechnical equivalence has been established inaccordance with Article 54 of this Regulation or has
been established, following an evaluation having
started before 1 September 2013, by a competentauthority designated in accordance with Article 26 of
Directive 98/8/EC."
Article 2This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of theEuropean Union.

L 234/2

ENOfficial Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 June 2013.
For the Commission
The President
José Manuel BARROSO

3.9.2013