HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 117/18
EN
Official Journal of the European Union
27.4.2013
DECISIONS
COMMISSION DECISION
of 25 April 2013
concerning the non-inclusion of formaldehyde for product-type 20 in Annex I, IA or IB to
Directive 98/8/EC of the European Parliament and of the Council concerning the placing of
biocidal products on the market
(notified under document C(2013) 2284)
(Text with EEA relevance)
(2013/204/EU)
THE EUROPEAN COMMISSION,
excluded from the scope of Directive 98/8/EC by virtue
of Article 1(2)(o) of that Directive. The Commission
stated that it would not decide to include formaldehyde
Having regard to the Treaty on the Functioning of the European
for product-type 20 in Annex I, IA or IB to Directive
Union,
98/8/EC. It therefore invited the applicants to discontinue
their participation in the review programme in
Having regard to Directive 98/8/EC of the European Parliament
accordance with Article 11(1) of Regulation (EC) No
and of the Council of 16 February 1998 concerning the placing
1451/2007 and apply for authorisation of the reference
of biocidal products on the market (
products in accordance with Regulation (EC) No

1 ), and in particular
Article 16(2) thereof,
1831/2003, for which it offered practical help, as well
as its best efforts to avoid market disruption during the
transition from one regulatory regime to the other.
Whereas:
(5)
Following the Commission’s advice, one of the applicants
(1) Commission
Regulation
(EC)
No
1451/2007 of
informed the Commission of its intention to discontinue
4 December 2007 on the second phase of the 10-year
its participation in the review programme in accordance
work programme referred to in Article 16(2) of Directive
with Article 11(1) of Regulation (EC) No 1451/2007 on
98/8/EC of the European Parliament and of the Council
10 September 2009. The other applicant chose to remain
concerning the placing of biocidal products on the
in the review programme despite the advice.
market ( 2 ) establishes a list of active substances to be
assessed, with a view to their possible inclusion in
(6) The
Commission
repeated
its
position
in
a
letter
of
Annex I, IA or IB to Directive 98/8/EC.
25 May 2010 to Germany and the remaining applicant.
By letter of 17 August 2010, Germany replied that the
remaining applicant declined to discontinue its partici
(2)
Formaldehyde (EC No 200-001-8, CAS No 50-00-0) is
pation in the review programme, which gave Germany
included in that list for use in, inter alia, product-type 20,
no other option but to continue the evaluation.
preservatives for food or feedstocks, as defined in Annex
V to Directive 98/8/EC.
(7) As
confirmed
by
Regulation
(EU)
No
528/2012
of
the
European Parliament and of the Council of 22 May 2012
(3) Two
companies
(‘the
applicants’)
submitted
a
dossier
to
concerning the making available on the market and use
Germany for the evaluation of formaldehyde for use in
of biocidal products ( 4 ), products used for the preser
product-type 20 by 31 October 2008 in accordance with
vation of food or feed are covered by Regulation (EC)
Article 9 of Regulation (EC) No 1451/2007. Pursuant to
No 1831/2003 and Regulation (EC) No 1333/2008 of
Article 11 of Directive 98/8/EC, the dossiers made
the European Parliament and of the Council of
reference to two products containing formaldehyde (the
16 December 2008 on food additives ( 5 ). Therefore,
‘reference products’).
such products are excluded from the scope of Directive
98/8/EC by virtue of Article 1(2)(o) of that Directive.
Therefore, in the interest on legal certainty, it should
(4) In
a
series
of
meetings
and
letters,
the
Commission
be decided that formaldehyde will not be included in
informed the applicants and Member States that it
Annex I, IA or IB to the Directive for product-type 20.
considered the reference products to be included in the

scope of Regulation (EC) No 1831/2003 of the European
Parliament and of the Council of 22 September 2003 on
(8) Formaldehyde
is
not
known
to
be
used
as
a
food
additives for use in animal nutrition ( 3 ), and hence
additive, and not approved for such use in accordance
with Regulation (EC) No 1333/2008.
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
( 4 ) OJ L 167, 27.6.2012, p. 1.
( 3 ) OJ L 268, 18.10.2003, p. 29.
( 5 ) OJ L 354, 31.12.2008, p. 16.

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EN
27.4.2013 Official
Journal
of
the
European
Union L
117/19
(9) Two
applications
for
authorisation
of
formaldehyde
as
a
Article 2
feed additive in accordance with Regulation (EC) No
1831/2003 are currently under assessment. The phase-
Products placed on the market as biocidal products for use as
out period for products containing formaldehyde and
feed preservatives and containing formaldehyde shall no longer
used for the preservation of feed and placed on the
be placed on the market with effect from 1 July 2015.
market as biocidal products should take into account
the time necessary to regulate such products in
accordance with Regulation (EC) No 1831/2003.
Article 3
This Decision is addressed to the Member States.
(10) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
Committee on biocidal products,
Done at Brussels, 25 April 2013.
HAS ADOPTED THIS DECISION:
Article 1
For the Commission
Formaldehyde (EC No 200-001-8, CAS No 50-00-0) shall not
be included in Annex I, IA or IB to Directive 98/8/EC for
Janez POTONIK
product-type 20.
Member of the Commission

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Document Outline

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