# L_2012160EN.01002501.xml

| 21.6.2012 | EN | Official Journal of the European Union | L 160/25 |
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21.6.2012

EN

Official Journal of the European Union

L 160/25

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COMMISSION IMPLEMENTING DECISION

of 18 June 2012

approving restrictions of authorisations of biocidal products containing difethialone notified by Sweden in accordance with Article 4(4) of Directive 98/8/EC of the European Parliament and of the Council

(notified under document C(2012) 4027)

(Only the Swedish text is authentic)

(2012/318/EU)

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 Article 4(4) thereof,

Whereas:

| (1) | Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. The active substance difethialone was approved for inclusion in products belonging to product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC, by Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto (2). |
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(1)

Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. The active substance difethialone was approved for inclusion in products belonging to product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC, by Commission Directive 2007/69/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include difethialone as an active substance in Annex I thereto (2).

| (2) | Difethialone is an anticoagulant rodenticide known to pose risks of accidental incidents with children, as well as risks for animals and the environment. It has been identified as potentially persistent, liable to bioaccumulate and toxic (‘PBT’), or very persistent and very liable to bioaccumulate (‘vPvB’). |
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(2)

Difethialone is an anticoagulant rodenticide known to pose risks of accidental incidents with children, as well as risks for animals and the environment. It has been identified as potentially persistent, liable to bioaccumulate and toxic (‘PBT’), or very persistent and very liable to bioaccumulate (‘vPvB’).

| (3) | For reasons of public health and hygiene, it was nevertheless found to be justified to include difethialone and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise difethialone-based products. However, Directive 2007/69/EC obliges Member States to ensure, when granting authorisation of products containing difethialone, that primary as well as secondary exposure of humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures. |
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(3)

For reasons of public health and hygiene, it was nevertheless found to be justified to include difethialone and other anticoagulant rodenticides in Annex I to Directive 98/8/EC, thus allowing Member States to authorise difethialone-based products. However, Directive 2007/69/EC obliges Member States to ensure, when granting authorisation of products containing difethialone, that primary as well as secondary exposure of humans, non-target animals and the environment is minimised, by considering and applying all appropriate and available risk mitigation measures.

| (4) | The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that the most significant reductions in exposure to and risks posed by difethialone are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign in order to minimise the opportunity of primary or secondary exposure of non-target animals. The evaluation also concluded that only professional users are expected to follow such instructions. The risk mitigation measures mentioned in Directive 2007/69/EC therefore include restriction to professional use only. |
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(4)

The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that the most significant reductions in exposure to and risks posed by difethialone are achieved by restricting its use to treatment campaigns of limited duration, limiting access of non-target animals to the bait and removing unused bait and dead and moribund rodents during a baiting campaign in order to minimise the opportunity of primary or secondary exposure of non-target animals. The evaluation also concluded that only professional users are expected to follow such instructions. The risk mitigation measures mentioned in Directive 2007/69/EC therefore include restriction to professional use only.

| (5) | The company LiphaTech S.A.S. (‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of eight rodenticides containing difethialone (‘the products’). The products’ names and reference numbers in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision. |
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(5)

The company LiphaTech S.A.S. (‘the applicant’) has, in accordance with Article 8 of Directive 98/8/EC, submitted an application to the United Kingdom for authorisation of eight rodenticides containing difethialone (‘the products’). The products’ names and reference numbers in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision.

| (6) | The United Kingdom granted the authorisations on 20 April 2011 (Generation Pat’), on 26 April 2011 (Generation Block) and on 27 April 2011 (Generation Grain’Tech and Rodilon Trio) (‘the first authorisations’). The products were authorised with restrictions to ensure that the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom. Those restrictions did not include a restriction to trained professional users with a license. |
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(6)

The United Kingdom granted the authorisations on 20 April 2011 (Generation Pat’), on 26 April 2011 (Generation Block) and on 27 April 2011 (Generation Grain’Tech and Rodilon Trio) (‘the first authorisations’). The products were authorised with restrictions to ensure that the conditions of Article 5 of Directive 98/8/EC were met in the United Kingdom. Those restrictions did not include a restriction to trained professional users with a license.

| (7) | On 9 June 2011, the applicant submitted a complete application to Sweden for mutual recognition of the first authorisations of the products. For the products with the Swedish product names Rodilon Block, Rodilon Trio and Rodilon Paste, the applications were restricted to authorisation for professional use only. |
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(7)

On 9 June 2011, the applicant submitted a complete application to Sweden for mutual recognition of the first authorisations of the products. For the products with the Swedish product names Rodilon Block, Rodilon Trio and Rodilon Paste, the applications were restricted to authorisation for professional use only.

| (8) | On 11 October 2011, Sweden notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisations in accordance with Article 4(4) of Directive 98/8/EC. Sweden proposed to impose a restriction on the products to use by trained professionals with a license. |
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(8)

On 11 October 2011, Sweden notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisations in accordance with Article 4(4) of Directive 98/8/EC. Sweden proposed to impose a restriction on the products to use by trained professionals with a license.

| (9) | The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Only the applicant submitted comments within that deadline. The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products, and the applicant in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 6-7 December 2011 and in the meeting of the Competent Authorities for Biocidal Products of 29 February to 2 March 2012. |
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(9)

The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Only the applicant submitted comments within that deadline. The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products, and the applicant in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 6-7 December 2011 and in the meeting of the Competent Authorities for Biocidal Products of 29 February to 2 March 2012.

| (10) | The applicant has argued that the restriction to use by trained professionals with a license is unjustified and should not be accepted, since its products are also suitable for rodent control by non-trained professionals and non-professionals. Furthermore, the applicant has put forward the arguments that the products are ready-to-use products; that the active ingredient content in the products is low; that an antidote exists; that the products can easily be kept out of the reach of children and non-target animals; that non-professional users are likely to remove dead rodents; that non-professional users can be trained and that the proposed restriction to use by trained professionals is likely to increases the cost of householder’s insurances in Sweden in the long term. |
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(10)

The applicant has argued that the restriction to use by trained professionals with a license is unjustified and should not be accepted, since its products are also suitable for rodent control by non-trained professionals and non-professionals. Furthermore, the applicant has put forward the arguments that the products are ready-to-use products; that the active ingredient content in the products is low; that an antidote exists; that the products can easily be kept out of the reach of children and non-target animals; that non-professional users are likely to remove dead rodents; that non-professional users can be trained and that the proposed restriction to use by trained professionals is likely to increases the cost of householder’s insurances in Sweden in the long term.

| (11) | The Commission notes that, in accordance with Directive 2007/69/EC, authorisations of biocidal products containing difethialone are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only. The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that only professional users could be expected to follow the instructions leading to the most significant reductions in exposure and risk. A restriction to professional users should therefore in principle be considered as an appropriate risk mitigation measure. The arguments put forward by the applicant do not undermine that conclusion. |
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(11)

The Commission notes that, in accordance with Directive 2007/69/EC, authorisations of biocidal products containing difethialone are to be subject to all appropriate and available risk mitigation measures, including the restriction to professional use only. The scientific evaluation leading to the adoption of Directive 2007/69/EC concluded that only professional users could be expected to follow the instructions leading to the most significant reductions in exposure and risk. A restriction to professional users should therefore in principle be considered as an appropriate risk mitigation measure. The arguments put forward by the applicant do not undermine that conclusion.

| (12) | In the absence of any indication to the contrary, the Commission therefore considers that restriction to professional users is an appropriate and available risk mitigation measure for the authorisation of products containing difethialone in Sweden. The fact that the United Kingdom did not consider such a restriction to be appropriate and available for authorisation in its territory is immaterial for that conclusion. The decision of the United Kingdom to authorise non-professional use was based in particular on the risk of a delay in treatment of household infestations due to the costs involved in hiring trained professionals, and the associated risks to public hygiene. Sweden, however, has explained that that risk is less prevalent in Sweden thanks to the Swedish insurance system, in which householder insurances typically cover the cost of professional pest control in case of an infestation. |
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(12)

In the absence of any indication to the contrary, the Commission therefore considers that restriction to professional users is an appropriate and available risk mitigation measure for the authorisation of products containing difethialone in Sweden. The fact that the United Kingdom did not consider such a restriction to be appropriate and available for authorisation in its territory is immaterial for that conclusion. The decision of the United Kingdom to authorise non-professional use was based in particular on the risk of a delay in treatment of household infestations due to the costs involved in hiring trained professionals, and the associated risks to public hygiene. Sweden, however, has explained that that risk is less prevalent in Sweden thanks to the Swedish insurance system, in which householder insurances typically cover the cost of professional pest control in case of an infestation.

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

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

Sweden may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC for the products mentioned in the Annex to this Decision to use by trained professionals with a license.

Article 2

This Decision is addressed to the Kingdom of Sweden.

Done at Brussels, 18 June 2012.

For the Commission

Janez POTOČNIK

Member of the Commission

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

1

(2)  
  OJ L 312, 30.11.2007, p. 23.

2

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ANNEX

Products for which Sweden may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC to use by trained professionals with a license

| Product name in the United Kingdom | United Kingdom application reference number in R4BP | Product name in Sweden | Swedish application reference number in R4BP |
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| Rodilon Trio | 2009/4329/3930/UK/AA/4792 | Radar mus och råtta korn | 2009/4329/3930/SE/MA/5034 |
| Generation Pat’ | 2009/4329/3926/UK/AA/4788 | Rodilon Paste | 2009/4329/3926/SE/MA/5036 |
| Generation Pat’ | 2009/4329/3926/UK/AA/4788 | Radar mus och råtta pasta | 2009/4329/3926/SE/MA/5037 |
| Generation Grain’Tech | 2009/4329/3929/UK/AA/4785 | Generation Grain’Tech | 2009/4329/3929/SE/MA/5038 |
| Generation Pat’ | 2009/4329/3926/UK/AA/4788 | Generation Pat’ | 2009/4329/3926/SE/MA/5039 |
| Rodilon Trio | 2009/4329/3930/UK/AA/4792 | Rodilon Trio | 2009/4329/3930/SE/MA/5040 |
| Generation Block | 2009/4329/3928/UK/AA/4786 | Rodilon Block | 2009/4329/3928/SE/MA/5041 |
| Generation Block | 2009/4329/3928/UK/AA/4786 | Generation Block | 2009/4329/3928/SE/MA/5042 |

Product name in the United Kingdom

United Kingdom application reference number in R4BP

Product name in Sweden

Swedish application reference number in R4BP

Rodilon Trio

2009/4329/3930/UK/AA/4792

Radar mus och råtta korn

2009/4329/3930/SE/MA/5034

Generation Pat’

2009/4329/3926/UK/AA/4788

Rodilon Paste

2009/4329/3926/SE/MA/5036

Generation Pat’

2009/4329/3926/UK/AA/4788

Radar mus och råtta pasta

2009/4329/3926/SE/MA/5037

Generation Grain’Tech

2009/4329/3929/UK/AA/4785

Generation Grain’Tech

2009/4329/3929/SE/MA/5038

Generation Pat’

2009/4329/3926/UK/AA/4788

Generation Pat’

2009/4329/3926/SE/MA/5039

Rodilon Trio

2009/4329/3930/UK/AA/4792

Rodilon Trio

2009/4329/3930/SE/MA/5040

Generation Block

2009/4329/3928/UK/AA/4786

Rodilon Block

2009/4329/3928/SE/MA/5041

Generation Block

2009/4329/3928/UK/AA/4786

Generation Block

2009/4329/3928/SE/MA/5042

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