Commission Decision of 20 December 2006 concerning the extension of the deadline for placing on the market of biocidal products containing certain active substances not examined during the ten-year work programme referred to in Article 16(2) of Directive 98/8/EC (notified under document number C(2006) 6707)
Date: 2006-12-20
Institutions: European Commission
Subjects: EU Member State, animal health, chemical product, derogation from EU law, environmental protection, marketing, public health

L 32/174

EN

Official Journal of the European Union

6.2.2007

COMMISSION DECISION

of 20 December 2006

concerning the extension of the deadline for placing on the market of biocidal products containing
certain active substances not examined during the ten-year work programme referred to in Article 16
(2) of Directive 98/8/EC

(notified under document number C(2006) 6707)

(Only the Czech, Danish, English, Finnish, Greek and Swedish text is authentic)

(2007/70/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Commission together with information demonstrating a
need for further use of the substances concerned.

Having regard to the Treaty establishing the European Commu-
nity,

Having regard to the European Parliament and Council Directive
98/8/EC of 16 February 1998 concerning the placing of biocidal
products on the market (1), and in particular Article 16 (2)
thereof,

Whereas:

(1) Article 16(2) second subparagraph, and (3) of Directive 98/
8/EC (hereinafter referred to as 'the Directive') provide that,
where the requisite information and data for the evaluation
of an active substance have not been submitted within the
prescribed period, it may be decided not to include the
active substance in Annexes I, IA or IB of the Directive.
Following such a decision, Member States should withdraw
all authorisations for biocidal products containing the
active substance.

(2) Commission Regulations (EC) No 1896/2000 and (EC) No
2032/2003 lay down the detailed rules for the implemen-
tation of the first and second phase of the 10-year work
programme referred to in Article 16(2) of the Directive.
Article 4(2) of Commission Regulation (EC) No 2032/2003
specifies 1 September 2006 as the date with effect from
which Member States shall cancel existing authorisations
for biocidal products containing active substances
in
respect of which there has been neither an accepted
notification nor an expression of interest by a Member
State.

(5)

(6)

Finland, Denmark, Norway and Iceland have submitted
information demonstrating the absence of suitable alter-
natives to pine tar with regard to its use as a wood
protection product on historical wooden buildings, vessels
and articles. An extension of the phase-out period for this
substance seems appropriate in order to preserve the
cultural heritage of these Member States and countries.

The Czech Republic has submitted information demon-
strating the highly prevalent use of sodium N-chloroben-
zenesulphonamide/Chloramine B as a disinfectant by the
Czech armed forces and public health services.
Its
substitution by other, notified substances might prove
problematic if it were to happen by the end of the phase-
out period, especially where public procurement proce-
dures need to be carried out. An extension of the phase-out
period for this substance seems appropriate to allow for a
switch to other disinfectants.

(7) Greece has

submitted information demonstrating the
temephos for mosquito nuisance and
prevalent use of
public health control by public authorities. Its substitution
by other, notified substances might prove problematic if it
were to happen by the end of
the phase-out period,
especially where public procurement procedures need to be
carried out. An extension of the phase-out period for this
substance seems appropriate to allow for a switch to other
available substances.

(3) Article 4a of Commission Regulation (EC) No 2032/2003,
as amended by Commission Regulation (EC) No 1048/
2005,
lays down the conditions under which Member
States may apply to the Commission for an extension of the
phase-out period laid down in its Article 4(2) and the
conditions for granting such an extension.

(8)

(4)

For some of the active substances for which use in biocidal
products shall be prohibited after 1 September 2006,
applications for extension of this phase-out period have
to the
been submitted by individual Member States

(1) OJ L 123, 24.4.1998, p. 1.

infections by coccidia,

The United Kingdom has submitted information demon-
strating the need for temporary continuation of use of
ammonia as a veterinary hygiene biocidal product
to
cryptosporidium and
prevent
nematodes in livestock. An extension of the phase-out
period for this substance seems appropriate to permit its
gradual replacement by other available substances that are
notified for
review
programme.

evaluation under

the Directive's

(9)

The measures provided for
in this Decision are in
accordance with the opinion of the Standing Committee
on Biocidal Products,

6.2.2007

EN

Official Journal of the European Union

L 32/175

HAS ADOPTED THIS DECISION:

Article 1

By derogation from Article 4(2) of Commission Regulation (EC)
No 2032/2003, the Member States listed in column B of the
Annex to this Decision may grant or maintain an existing
approval
for placing on the market of biocidal products
containing substances listed in column A of the Annex, for the
essential uses listed in column D and until the dates stated in
column C of that Annex.

Article 2

1. Member States making use of the derogation provided for
in Article 1 of this Decision shall ensure that the following
conditions are complied with:

(d)

such biocidal products remaining on the market after
1 September 2006 are relabelled in order to match the
restricted use conditions;

(e) where appropriate, Member States shall ensure that
alternatives for such uses are being sought by the
holders of the approvals or by the Member States
concerned, or that a dossier is being prepared for
submission in accordance with the procedure laid
down in Article 11 of Directive 98/8/EC by 14 May
2008 at the latest.

2.

The Member States concerned shall inform the Commis-
sion annually on the application of paragraph 1 and in
particular on the actions taken pursuant to point (e).

Article 3

continued use is only possible under the conditions
that products containing the substance are approved
for the intended essential use;

the
This Decision is addressed to the Republic of Finland,
Kingdom of Denmark, the Czech Republic, the Hellenic Republic
and the United Kingdom of Great Britain and Northern Ireland.

the continued use is only accepted so far as it has no
unacceptable effect on human or animal health or on
the environment;

(c)

all appropriate risk reduction measures are imposed
when granting approval;

Done at Brussels, 20 December 2006.

For the Commission
Stavros DIMAS
Member of the Commission

(a)

(b)

L 32/176

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Official Journal of the European Union

6.2.2007

ANNEX

List of authorisations referred to in Article 1

Column A

Column B

Column C

Active substance

Member State

Dates

Column D

Use

Pine tar

EC no 232-374-8
CAS no 8011-48-1

Finland

Denmark

14.5.2010

14.5.2010

As wood protection product for build-
ings, vessels and articles that belong to
the cultural heritage of the applicant
Member States

Sodium N-chlorobenzene-sulpho-
namide/Chloramine B
EC no 204-847-9
CAS no 127-52-6

Czech Republic

1.11.2007

Disinfectant for use by the public health
service, the public veterinary service and
the armed forces (civilian purposes) of
the applicant Member State

Temephos
EC no 222-191-1
CAS no 3383-96-8

Ammonia
EC no 231-635-3
CAS no 7664-41-7

Greece

1.11.2007

For nuisance and public health mosquito
(Culicidae) control

United Kingdom

14.5.2008

Veterinary hygiene biocidal pro-duct for
the prevention of infe-ctions by coccidia,
cryptosporidia and nematodes in live-
stock; only when no other means with
similar effect can be used