# L_2010037EN.01003701.xml

| 10.2.2010 | EN | Official Journal of the European Union | L 37/37 |
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10.2.2010

EN

Official Journal of the European Union

L 37/37

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COMMISSION DIRECTIVE 2010/8/EU

of 9 February 2010

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 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 (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 warfarin sodium. |
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(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 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 (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 warfarin sodium.

| (2) | Pursuant to Regulation (EC) No 1451/2007, warfarin sodium has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC. |
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(2)

Pursuant to Regulation (EC) No 1451/2007, warfarin sodium has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

| (3) | Ireland was designated as Rapporteur Member State and submitted its report, together with a recommendation, to the Commission on 3 October 2005 in accordance with Article 14(4) and 14(6) of Regulation (EC) No 1451/2007. |
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(3)

Ireland was designated as Rapporteur Member State and submitted its report, together with a recommendation, to the Commission on 3 October 2005 in accordance with Article 14(4) and 14(6) of Regulation (EC) No 1451/2007.

| (4) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 17 September 2009, in an assessment report. |
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(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 17 September 2009, in an assessment report.

| (5) | It appears from the examinations made that biocidal products used as rodenticides and containing warfarin sodium may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals. However, warfarin sodium is for the time being considered essential for reasons of public health and hygiene. It is therefore appropriate to include warfarin sodium in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing warfarin sodium can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC. |
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(5)

It appears from the examinations made that biocidal products used as rodenticides and containing warfarin sodium may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals. However, warfarin sodium is for the time being considered essential for reasons of public health and hygiene. It is therefore appropriate to include warfarin sodium in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing warfarin sodium can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

| (6) | In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing warfarin sodium and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals. To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed for all rodenticides containing warfarin sodium, while other conditions should be imposed by the Member States on a case by case basis. |
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(6)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing warfarin sodium and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals. To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed for all rodenticides containing warfarin sodium, while other conditions should be imposed by the Member States on a case by case basis.

| (7) | In view of the identified risks, warfarin sodium should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed. |
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(7)

In view of the identified risks, warfarin sodium should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

| (8) | It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance warfarin sodium and to facilitate the proper operation of the biocidal products market in general. |
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(8)

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

| (9) | A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. |
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(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.

| (10) | A reasonable period should be allowed to elapse before an active substance is included in Annex I 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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(10)

A reasonable period should be allowed to elapse before an active substance is included in Annex I 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.

| (11) | 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 14 containing warfarin sodium to ensure that they comply with Directive 98/8/EC. |
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(11)

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 14 containing warfarin sodium to ensure that they comply with Directive 98/8/EC.

| (12) | Directive 98/8/EC should therefore be amended accordingly. |
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(12)

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

| (13) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(13)

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 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall apply those provisions from 1 February 2012.

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 its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 9 February 2010.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

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ANNEX

The following entry for the substance warfarin sodium is added 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) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘33 | Warfarin sodium | Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate
  EC No: 204-929-4
  CAS No: 129-06-6 | 910 g/kg | 1 February 2012 | 31 January 2014 | 31 January 2017 | 14 | The active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
  Member States shall ensure that authorisations are subject to the following conditions:






  1. | the nominal concentration of the active substance shall not exceed 790 mg/kg and only ready-for-use products shall be authorised; |

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)

‘33

Warfarin sodium

Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate

EC No: 204-929-4

CAS No: 129-06-6

910 g/kg

1 February 2012

31 January 2014

31 January 2017

14

The active substance shall be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.

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

1.

the nominal concentration of the active substance shall not exceed 790 mg/kg and only ready-for-use products shall be authorised;

| 2. | products shall contain an aversive agent and, where appropriate, a dye; |
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2.

products shall contain an aversive agent and, where appropriate, a dye;

| 3. | primary and secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the possibility of restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’ |
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3.

primary and secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the possibility of restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.’

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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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