# L_2007032EN.01017401.xml

| 6.2.2007 | EN | Official Journal of the European Union | L 32/174 |
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6.2.2007

EN

Official Journal of the European Union

L 32/174

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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,

Having regard to the Treaty establishing the European Community,

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. |
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(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 implementation 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. |
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(2)

Commission Regulations (EC) No 1896/2000 and (EC) No 2032/2003 lay down the detailed rules for the implementation 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.

| (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. |
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(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.

| (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 been submitted by individual Member States to the Commission together with information demonstrating a need for further use of the substances concerned. |
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(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 been submitted by individual Member States to the Commission together with information demonstrating a need for further use of the substances concerned.

| (5) | Finland, Denmark, Norway and Iceland have submitted information demonstrating the absence of suitable alternatives 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. |
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(5)

Finland, Denmark, Norway and Iceland have submitted information demonstrating the absence of suitable alternatives 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.

| (6) | The Czech Republic has submitted information demonstrating the highly prevalent use of sodium N-chlorobenzenesulphonamide/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 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 disinfectants. |
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(6)

The Czech Republic has submitted information demonstrating the highly prevalent use of sodium N-chlorobenzenesulphonamide/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 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 disinfectants.

| (7) | Greece has submitted information demonstrating the prevalent use of temephos for mosquito nuisance and 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. |
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(7)

Greece has submitted information demonstrating the prevalent use of temephos for mosquito nuisance and 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.

| (8) | The United Kingdom has submitted information demonstrating the need for temporary continuation of use of ammonia as a veterinary hygiene biocidal product to prevent infections by coccidia, cryptosporidium and 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 evaluation under the Directive's review programme. |
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(8)

The United Kingdom has submitted information demonstrating the need for temporary continuation of use of ammonia as a veterinary hygiene biocidal product to prevent infections by coccidia, cryptosporidium and 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 evaluation under the Directive's review programme.

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(9)

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

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:

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

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

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

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; |
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(c)

all appropriate risk reduction measures are imposed when granting approval;

| (d) | such biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the restricted use conditions; |
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(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. |
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(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 Commission annually on the application of paragraph 1 and in particular on the actions taken pursuant to point (e).

Article 3

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

Done at Brussels, 20 December 2006.

For the Commission

Stavros DIMAS

Member of the Commission

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

1

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ANNEX

List of authorisations referred to in Article 1

| Column A | Column B | Column C | Column D |
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| Active substance | Member State | Dates | Use |
| Pine tar | Finland | 14.5.2010 | As wood protection product for buildings, vessels and articles that belong to the cultural heritage of the applicant Member States |
| EC no 232-374-8
  CAS no 8011-48-1 | Denmark | 14.5.2010 |
| Sodium N-chlorobenzene-sulphonamide/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 | Greece | 1.11.2007 | For nuisance and public health mosquito (Culicidae) control |
| Ammonia
  EC no 231-635-3
  CAS no 7664-41-7 | United Kingdom | 14.5.2008 | Veterinary hygiene biocidal pro-duct for the prevention of infe-ctions by coccidia, cryptosporidia and nematodes in livestock; only when no other means with similar effect can be used |

Column A

Column B

Column C

Column D

Active substance

Member State

Dates

Use

Pine tar

Finland

14.5.2010

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

EC no 232-374-8

CAS no 8011-48-1

Denmark

14.5.2010

Sodium N-chlorobenzene-sulphonamide/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

Greece

1.11.2007

For nuisance and public health mosquito (Culicidae) control

Ammonia

EC no 231-635-3

CAS no 7664-41-7

United Kingdom

14.5.2008

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

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