# L_2007094EN.01002301.xml

| 4.4.2007 | EN | Official Journal of the European Union | L 94/23 |
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4.4.2007

EN

Official Journal of the European Union

L 94/23

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COMMISSION DIRECTIVE 2007/20/EC

of 3 April 2007

amending Directive 98/8/EC of the European Parliament and of the Council to include dichlofluanid as an active substance in Annex I thereto

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

Whereas:

| (1) | Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes dichlofluanid. |
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(1)

Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes dichlofluanid.

| (2) | Pursuant to Regulation (EC) No 2032/2003, dichlofluanid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. |
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(2)

Pursuant to Regulation (EC) No 2032/2003, dichlofluanid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.

| (3) | In accordance with Article 5(2) of Regulation (EC) No 2032/2003, the United Kingdom was designated as Rapporteur Member State. The United Kingdom submitted the competent authority report, together with a recommendation, to the Commission on 13 September 2005 in accordance with Article 10(5) and (7) of that Regulation. |
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(3)

In accordance with Article 5(2) of Regulation (EC) No 2032/2003, the United Kingdom was designated as Rapporteur Member State. The United Kingdom submitted the competent authority report, together with a recommendation, to the Commission on 13 September 2005 in accordance with Article 10(5) and (7) of that Regulation.

| (4) | The competent authority report has been reviewed by the Member States and the Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 28 November 2006, in an assessment report. |
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(4)

The competent authority report has been reviewed by the Member States and the Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 28 November 2006, in an assessment report.

| (5) | The review of dichlofluanid did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks (SCHER). |
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(5)

The review of dichlofluanid did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks (SCHER).

| (6) | It appears from the various examinations made that biocidal products used as wood preservatives and containing dichlofluanid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, in particular with regard to the uses which were examined and detailed in the assessment report. It is therefore appropriate to include dichlofluanid in Annex I to Directive 98/8/EC, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing dichlofluanid can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
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(6)

It appears from the various examinations made that biocidal products used as wood preservatives and containing dichlofluanid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, in particular with regard to the uses which were examined and detailed in the assessment report. It is therefore appropriate to include dichlofluanid in Annex I to Directive 98/8/EC, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing dichlofluanid can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (7) | It is important that the provisions of this Directive should be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance dichlofluanid and also to facilitate the proper operation of the biocidal products market in general. |
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(7)

It is important that the provisions of this Directive should be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance dichlofluanid and also to facilitate the proper operation of the biocidal products market in general.

| (8) | In the light of the findings of the assessment report, it is appropriate to require that products authorised for industrial use must be used with appropriate personal protective equipment and that instructions are provided to indicate that treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and allow losses to be collected for re-use or disposal, in accordance with Article 10(2)(i)(d) of Directive 98/8/EC. |
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(8)

In the light of the findings of the assessment report, it is appropriate to require that products authorised for industrial use must be used with appropriate personal protective equipment and that instructions are provided to indicate that treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and allow losses to be collected for re-use or disposal, in accordance with Article 10(2)(i)(d) of Directive 98/8/EC.

| (9) | A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
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(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

| (10) | After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing dichlofluanid to ensure that they comply with Directive 98/8/EC. |
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(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing dichlofluanid to ensure that they comply with Directive 98/8/EC.

| (11) | Directive 98/8/EC should therefore be amended accordingly. |
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(11)

Directive 98/8/EC should therefore be amended accordingly.

| (12) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(12)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, by 29 February 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 March 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 3 April 2007.

For the Commission

Stavros DIMAS

Member of the Commission

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(1)  
  OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/140/EC (OJ L 414, 30.12.2006, p. 78).

1

(2)  
  OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

2

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ANNEX

The following entry ‘No 2’ shall be added in the table in Annex I to Directive 98/8/EC

| No | Common name | IUPAC name
  Identification numbers | Minimum purity of the active substance in the biocidal product as placed on the market | Date of inclusion | Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) | Expiry date of inclusion | Product type | Specific provisions (*1) |
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| ‘2 | dichlofluanid | N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide
  EC No: 214-118-7
  CAS No: 1085-98-9 | > 96 % w/w | 1 March 2009 | 28 February 2011 | 28 February 2019 | 8 | Member States shall ensure that authorisations are subject to the following conditions:






  (1) | Products authorised for industrial and/or professional use must be used with appropriate personal protective equipment. |

No

Common name

IUPAC name

Identification numbers

Minimum purity of the active substance in the biocidal product as placed on the market

Date of inclusion

Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

Expiry date of inclusion

Product type

Specific provisions (*1)

‘2

dichlofluanid

N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide

EC No: 214-118-7

CAS No: 1085-98-9

> 96 % w/w

1 March 2009

28 February 2011

28 February 2019

8

Member States shall ensure that authorisations are subject to the following conditions:

(1)

Products authorised for industrial and/or professional use must be used with appropriate personal protective equipment.

| (2) | In view of the risks identified for the soil compartment appropriate risk mitigation measures must be taken to protect that compartment. |
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(2)

In view of the risks identified for the soil compartment appropriate risk mitigation measures must be taken to protect that compartment.

| (3) | Labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for re-use or disposal. |
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(3)

Labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for re-use or disposal.

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(*1)  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’

*1

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