HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 327/34
EN
Official Journal of the European Union
27.11.2012
COMMISSION DIRECTIVE 2012/43/EU
of 26 November 2012
amending certain headings of Annex I to Directive 98/8/EC of the European Parliament and of the
Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
only one of the factors that can be decisive. Furthermore,
lower purity of an active substance does not necessarily
compromise its hazard profile.
Having regard to the Treaty on the Functioning of the European
Union,
(5) It is therefore appropriate to replace the existing
reference to minimum purity in the headings of Annex
Having regard to Directive 98/8/EC of the European Parliament
I to Directive 98/8/EC by a reference to the minimum
and of the Council of 16 February 1998 concerning the placing
degree of purity of the active substance used for the
of biocidal products on the market (
evaluation made in accordance with Article 11 of the

1 ), and in particular Articles
11(4) and 16(2) thereof,
Directive, and indicate that, in the product placed on
the market, the active substance may be of a different
purity provided that it has been proven technically
Whereas:
equivalent with the evaluated substance.
(6) The
first
row
of
Annex
I
to
Directive
98/8/EC
established
(1) Commission
Regulation
(EC)
No
1451/2007 of
by Commission Directive 2006/140/EC also contains the
4 December 2007 on the second phase of the 10-year
heading ‘Deadline for compliance with Article 16(3)
work programme referred to in Article 16(2) of Directive
(except for products containing more than one active
98/8/EC of the European Parliament and of the Council
substance, for which the deadline to comply with
concerning the placing of biocidal products on the
Article 16(3) shall be the one set out in the last of the
market ( 2 ) provides detailed rules for the evaluations of
inclusion decisions relating to its active substances)’.
existing active substances. Article 15(2) of the Regulation
provides for peer reviews by experts from the Member
States prior to the Commission decisions on inclusion in
(7) According
to
Article
4(1)
of
Directive
98/8/EC,
a
Annex I.
Member State receiving an application for mutual recog
nition of an existing authorisation has a period of 120
days to authorise the product through mutual recog
(2) Pursuant
to
Article
10(2)(i)
of
Directive
98/8/EC,
nition. However, if the first authorisation of a product
inclusion of an active substance in Annex I shall,
is granted less than 120 days before the deadline for
where appropriate, be subject to requirements on the
compliance with Article 16(3) of the Directive for that
minimum degree of purity and the nature and
product, a Member State receiving a complete application
maximum content of certain impurities.
for mutual recognition of that authorisation cannot
comply with the deadline for compliance with
Article 16(3) of the Directive if it uses the 120-day
(3) The
first
inclusion
in
Annex
I
was
decided
in
period provided for by Article 4(1) of the Directive,
Commission Directive 2006/140/EC of 20 December
even if the complete application for mutual recognition
2006 amending Directive 98/8/EC of the European
was submitted without delay after the granting of the
Parliament and of the Council to include sulfuryl
first authorisation.
fluoride as an active substance in Annex I thereto ( 3 ).
That Directive defined the headings of Annex I to
(8)
For products for which the first authorisation is granted
Directive 98/8/EC. Those headings include ‘Minimum
later than 120 days before the original deadline for
purity of the active substance in the biocidal product
compliance with Article 16(3) of Directive 98/8/EC, it
as placed on the market’.
is therefore appropriate to extend Member States’
deadline for complying with Article 16(3) of the
Directive by mutually recognising the first authorisation
(4) In the context of the peer reviews provided for by
to 120 days after the submission of the complete appli
Article 15(2) of Regulation (EC) No 1451/2007,
cation for mutual recognition, provided that the
Member States experts have developed a method for
complete application for mutual recognition has been
establishing the similarity of the chemical compositions
submitted within 60 days of the granting of the first
and the hazard profiles, known as ‘technical equivalence’,
authorisation.
of substances falling within the same definition but being
produced from different sources or manufacturing
processes. For this establishment, the degree of purity is
(9) Furthermore, in a situation where a Member State
proposes, within the deadline for compliance with
Article 16(3) of Directive 98/8/EC, to derogate from
( 1 ) OJ L 123, 24.4.1998, p. 1.
( 2 ) OJ L 325, 11.12.2007, p. 3.
mutual recognition of an authorisation in accordance
( 3 ) OJ L 414, 30.12.2006, p. 78.
with Article 4(4) of the Directive, that Member State’s

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EN
27.11.2012 Official
Journal
of
the
European
Union L
327/35
compliance with Article 16(3) of the Directive within
Directive by 31 March 2013 at the latest. They shall
that deadline can be impossible, and will depend on
forthwith communicate to the Commission the text of those
the date when the Commission decision on the matter
provisions.
is adopted in accordance with the second subparagraph
of Article 4(4) of the Directive. In such cases, the
When Member States adopt those provisions, they shall contain
deadline should therefore be suspended until a reasonable
a reference to this Directive or be accompanied by such a
period after the Commission decision has been adopted.
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.
(10) For
products
for
which
one
or
more
Member
States
have
proposed to derogate from mutual recognition in
2. Member
States
shall
communicate
to
the
Commission
the
accordance with Article 4(4) of Directive 98/8/EC, it is
text of the main provisions of national law which they adopt in
therefore appropriate to extend Member States’ deadline
the field covered by this Directive.
for complying with Article 16(3) of the Directive by
mutually recognising the first authorisation to 30 days
after the adoption of the Commission decision.
Article 3
This Directive shall enter into force on the twentieth day
(11) The
measures provided for in this Directive are in
following that of its publication in the Official Journal of the
accordance with the opinion of the Standing
European Union.
Committee on Biocidal Products,
Article 4
HAS ADOPTED THIS DIRECTIVE:
This Directive is addressed to the Member States.
Article 1
Annex I to Directive 98/8/EC is amended in accordance with
Done at Brussels, 26 November 2012.
the Annex to this Directive.
Article 2
For the Commission
1. Member
States
shall
bring
into
force
the
laws,
regulations
The President
and administrative provisions necessary to comply with this
José Manuel BARROSO

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L 327/36
ANNEX
In Annex I to Directive 98/8/EC, the first row, which contains the headings to all entries, shall read as follows:
Deadline for compliance with Article 16(3), unless
‘No
Common
IUPAC Name
Minimum degree of purity of the
Expiry date of
Name
Identification Numbers
active substance (*)
Date of inclusion
one of the exceptions indicated in the footnote to
this heading applies (**)
inclusion
Product type Specific
provisions
(***)
EN

(*) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or
different purity if it has been proven technically equivalent with the evaluated substance.
(**) For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first
authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the
granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for
which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in
accordance with the second subparagraph of Article 4(4).
(***) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm’
Off
icial
Jour
nal
of
the
European
Union
27.11.2012

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