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3.9.2013 Official
Journal
of
the
European
Union L
234/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION 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,
HAS ADOPTED THIS REGULATION:
Having regard to the Treaty on the Functioning of the European
Article 1
Union,
Annex III to Regulation (EU) No 528/2012 is amended as
follows:
Having regard to Regulation (EU) No 528/2012 of the
European Parliament and of the Council of 22 May 2012
(1) In the table in title 1, the following entry 2.5 is inserted:
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular Article 85 thereof,
"2.5 Where the biocidal product contains an active
substance that has been manufactured in locations or
Whereas:
according to processes or from starting materials other
than those of the active substance evaluated for the
purpose of approval pursuant to Article 9 of this
Regulation, evidence has to be provided that
(1) Pursuant
to
Article
19(1)
of
Regulation
(EU)
No
528/2012 a biocidal product may be authorised if the
technical equivalence has been established in
active substances in the product have been approved in
accordance with Article 54 of this Regulation or has
accordance with Article 9 of that Regulation.
been established, following an evaluation having

started before 1 September 2013, by a competent
authority designated in accordance with Article 26 of
Directive 98/8/EC."
(2) A
biocidal
product
may
be
authorised
even
if
one
or
more of the active substances contained therein has
been manufactured in a different location or according
(2) In the table in title 2, the following entry 2.5 is inserted:
to a different process, including from different starting
materials, than those of the substance evaluated for
approval pursuant to Article 9 of Regulation (EU) No
"2.5 Where the biocidal product contains an active
528/2012.
substance that has been manufactured in locations or
according to processes or from starting materials other
than those of the active substance evaluated for the
(3)
In such cases, for the purpose of ensuring that the active
purpose of approval pursuant to Article 9 of this
substance contained in a biocidal product does not have
Regulation, evidence has to be provided that
significantly more hazardous properties than the
technical equivalence has been established in
substance which has been evaluated for the purpose of
accordance with Article 54 of this Regulation or has
approval, it is necessary to establish technical equivalence
been established, following an evaluation having
pursuant to Article 54 of Regulation (EU) No 528/2012.
started before 1 September 2013, by a competent
authority designated in accordance with Article 26 of
Directive 98/8/EC."
(4) It
is
therefore
appropriate
to
include
proof
of
estab
lishment of technical equivalence in the information
requirements for authorisation of biocidal products
Article 2
listed in Annex III to Regulation (EU) No 528/2012,
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
( 1 ) OJ L 167, 27.6.2012, p. 1.
European Union.

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L 234/2
EN
Official Journal of the European Union
3.9.2013
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

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Document Outline

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