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EUROPEAN COMMISSION

Brussels, XXX SANTE/10501/2018

(POOL/E4/10501/2018/10501-EN.doc) […](2018) XXX draft

COMMISSION IMPLEMENTING DECISION (EU) …/…

of XXX

postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8

(Text with EEA relevance)

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postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products¹, and in particular Article 14(5) thereof,

After consulting the Standing Committee on Biocidal Products, Whereas:

(1) The active substance sulfuryl fluoride was included into Annex I to Directive 98/8/EC of the European Parliament and of the Council² for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

(2) The approval of sulfuryl fluoride for use in biocidal products of product-type 8 will expire on 31 December 2018. In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application has been submitted for the renewal of the approval of this active substance on 28 June 2017.

(3) The evaluating competent authority of Sweden has informed the Commission services on 14 February 2018 on its decision pursuant to Article 14(2) of Regulation (EU) No 528/2012 that a full evaluation will have to be performed. A 365-day period is allowed to perform a full evaluation pursuant to Article 8(1) of that Regulation.

During the evaluation, the evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

(4) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency ('the Agency') is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(5) Consequently, for reasons beyond the control of the applicant, the approval of sulfuryl fluoride for use in biocidal products of product-type 8 is likely to expire before a

1 OJ L 167, 27.6.2012, p. 1.

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

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decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application.

Considering the periods of time allowed for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 30 June 2021.

(6) Except for the expiry date of the approval, sulfuryl fluoride should remain approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 is postponed to 30 June 2021.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels,

For the Commission

The President

Jean-Claude JUNCKER

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EUROPEAN COMMISSION

COMMISSION IMPLEMENTING DECISION of XXX

on the terms and conditions of the authorisation of a biocidal product family containing deltamethrin referred by Sweden in accordance with Article 36 of Regulation (EU)

No 528/2012 of the European Parliament and of the Council

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COMMISSION IMPLEMENTING DECISION of XXX

on the terms and conditions of the authorisation of a biocidal product family containing deltamethrin referred by Sweden in accordance with Article 36 of Regulation (EU)

No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Whereas:

(1) On 29 August 2013, the company Bayer CropScience Deutschland GmbH (‘the applicant’) submitted an application to Germany (‘the Member State concerned’) for the mutual recognition of an insecticide biocidal product family containing the active substance deltamethrin (‘the contested product family’). Applications for mutual recognition of the contested product family were also submitted to a number of other Member States. The competent authority of Sweden acted as the Member State responsible for the evaluation of the application referred to in Article 34(1) of Regulation (EU) No 528/2012 (“the reference Member State”).

(2) Pursuant to Article 35(2) of Regulation (EU) No 528/2012, Germany referred an objection to the coordination group on 23 February 2017, indicating that the contested product family does not meet the conditions laid down in Article 19(1)(c) of that Regulation.

(3) Germany considers that the determination of the quantity of active substance in the contested product family made by the reference Member State, and indicated in the draft summary of the product characteristics established pursuant to Article 22(2)(e) of Regulation (EU) No 528/2012, is not correct. Germany argues that excluding the impurities of the active substance when expressing the quantitative composition in terms of the main constituent of that substance, is inconsistent with the definition of an active substance laid down in Article 3(1)(c) of that Regulation, which in turn refers to the definition of a substance laid down in Article 3(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council². Since the definition of a substance in Article 3(1) of Regulation (EC) 1907/2006 refers to a chemical element

1 OJ L 167, 27.6.2012, p. 1.

2 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

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and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, the quantitative composition should, according to the objection referred by Germany, not refer only to the content of the active substance without impurities.

(4) The coordination group secretariat invited the other Member States and the applicant to submit written comments about the referral. Austria, Belgium, Denmark, France, the Member State concerned, Hungary, Norway, the reference Member State, the United Kingdom and the applicant submitted comments. The referral was also discussed in the coordination group's meetings of 14 March 2017 and 10 May 2017.

(5) As no agreement was reached in the coordination group, the reference Member State referred the unresolved objection to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 18 May 2017. It hereby provided the Commission with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement. A copy of that statement was forwarded to the Member States concerned and the applicant.

(6) The reference Member State, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Latvia, Luxembourg, Norway, Slovenia and Switzerland authorised the contested product family in the period from 29 June 2017 to 19 December 2017 pursuant to Article 34(7) of Regulation (EU) No 528/2012.

(7) According to the definition laid down in Article 3(1)(c) of Regulation (EU) No 528/2012, an active substance means a substance that has an action on or against harmful organisms. Pursuant to Article 3(2) of that Regulation, the definition in Article 3(1) of Regulation (EC) No 1907/2006 is to apply for the term “substance”.

According to that definition, a substance also includes any additive necessary to preserve its stability and any impurity deriving from the process used. The risk assessment and the efficacy assessment carried out for the approval of deltamethrin as an active substance in accordance with Article 4 of Regulation (EU) No 528/2012 were based on the active substance including its impurities, and the approval itself sets a minimum degree of purity to be observed by any source of that active substance.

(8) Therefore, a reference to the content of the active substance in the contested product family should not relate to the concentration of the main constituent of the active substance on its own without impurities.

(9) On 30 April 2018, the Commission provided the applicant with the opportunity to provide written comments in accordance with Article 36(2) of Regulation (EU) No 528/2012. The Commission took into account the comments provided by the applicant.

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

Article 1

This Decision applies to the biocidal product family identified by the asset number SE- 0017809-0000 in the Register for Biocidal Products.

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Article 2

The minimum and maximum percentage for the concentration of the active substance in the biocidal product family referred to in Article 1, as referred to in Article 22(2)(e) of Regulation (EU) No 528/2012, shall be expressed by considering the active substance as it was approved, which includes the main constituent of the active substance and any additives or impurities.

Under the terms and conditions set out in paragraph 1, the biocidal product family referred to in Article 1 meets the conditions laid down in Article 19(1)(c) of Regulation (EU) No 528/2012.

Article 3 This Decision is addressed to the Member States.

Done at Brussels,

Vytenis ANDRIUKAITIS

Member of the Commission

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EUROPEAN COMMISSION

COMMISSION IMPLEMENTING REGULATION (EU) …/...

of XXX

approving penflufen as an active substance for use in biocidal products of product- type 8

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approving penflufen as an active substance for use in biocidal products of product- type 8

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products¹, and in particular Article 9(1)(a) thereof,

Whereas:

(1) The evaluating competent authority of the United Kingdom received on 7 July 2015 an application for the approval of the active substance penflufen for use in biocidal products of product-type 8, wood preservatives, as described in Annex V to Regulation (EU) No 528/2012.

(2) The evaluating competent authority of the United Kingdom submitted the assessment report together with its recommendations on 28 February 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.

(3) The opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority².

(4) According to that opinion, biocidal products of product-type 8 containing penflufen may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(5) It is therefore appropriate to approve penflufen for use in biocidal products of product- type 8, subject to compliance with certain specifications and conditions.

(6) Since the opinion of the European Chemical Agency concludes that penflufen meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council³, treated articles

1 OJ L 167, 27.6.2012, p. 1.

2 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Penflufen, Product type: 8, ECHA/BPC/184/2017, Adopted on 14 December 2017.

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treated with or incorporating penflufen should be labelled appropriately when placed on the market.

(7) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

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

HAS ADOPTED THIS REGULATION:

Article 1

Penflufen is approved as an active substance for use in biocidal products of product-type 8, subject to the specifications and conditions set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

The President

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EUROPEAN COMMISSION

Brussels, XXX

SANTE/12067/2017 ANNEX (POOL/E4/2017/12067/12067-EN ANNEX.doc)

[…](2018) XXX draft ANNEX

ANNEX to the

COMMISSION IMPLEMENTING REGULATION (EU) .../...

approving penflufen as an active substance for use in biocidal products of product-type 8

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ANNEX

Common Name IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance¹

Date of approval

Expiry date of approval

Product

type Specific conditions

Penflufen IUPAC Name:

5-fluoro-1,3-dimethyl-N-{2- [(2RS)-4-methylpentan-2- yl]phenyl}-1H-pyrazole-4- carboxamide

EC No: not available CAS No: 494793-67-8

980g/kg (1:1 ratio (R:S) ratio of enantiomers)

1 January

2019 31

December 2028

8 The authorisations of biocidal products are subject to the following conditions:

1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

2) In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

a) industrial and professional users;

b) soil and groundwater for wood in service that will be exposed to frequent weathering.

3) In view of the risks identified for soil, labels, and, where provided, safety data sheets of product authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

The placing on the market of treated articles is subject to the following condition:

The person responsible for the placing on the market of a treated article treated with or incorporating penflufen shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3)

1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

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of Regulation (EU) No 528/2012.

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EUROPEAN COMMISSION

of XXX

approving cypermethrin as an existing active substance for use in biocidal products of product-type 18

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Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products¹, and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014² establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes cypermethrin.

(2) Cypermethrin has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

(3) Belgium was designated as a rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 15 April 2015.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 5 May 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority³.

(5) According to that opinion, biocidal products of product-type 18 containing cypermethrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(6) It is therefore appropriate to approve cypermethrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(7) Furthermore, a need to further investigate the endocrine disrupting potential of cypermethrin has been identified in a screening study carried out in preparation of the

1 OJ L 167, 27.6.2012, p. 1.

2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cypermethrin, Product type: PT 18, ECHA/BPC/153/2017, Adopted on 5 May 2017

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impact assessment conducted by the Commission on various options to set criteria to identify endocrine disruptors⁴. An assessment of the potential endocrine disrupting properties of cypermethrin will also be conducted in the context of Regulation (EC) No 1107/2009 of the European Parliament and of the Council⁵, and the conclusions thereof are expected before the end of 2018. Depending on the outcome of that assessment, the Commission will consider the need to review the approval of cypermethrin as active substance for use in biocidal products in accordance with Article 15 of Regulation (EU) No 528/2012.

(8) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

Article 1

Cypermethrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.

Article 2

Done at Brussels,

The President

4 COM (2016) 350 final.

5 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

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Brussels, XXX

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ANNEX

Date of

approval Expiry date of

approval Product

Cypermethrin IUPAC Name:

Cypermethrin cis:trans 40:60;

(RS)-α-cyano-3 phenoxybenzyl-(1RS)- cis,trans-3-(2,2- dichlorovinyl)-2,2- dimethylcyclopropane carboxylate

EC No: 257-842-9 CAS No: 52315-07-8

≥ 92% w/w Isomeric ratio:

cis:trans 40:60

1June

2020 31 May 2030 18 The authorisations of biocidal products are subject to the following conditions:

1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

a) professional users;

b) secondary exposure of infants and toddlers;

c) surface water for:

i) surface application indoors; and

ii) outdoor wall and perimeter applications in urban areas;

d) soil for:

i) surface application indoors;

ii) outdoor wall applications in urban and rural areas; and

iii) outdoor perimeter applications in rural areas;

e) sediment for:

i) surface application and chemical barrier and crack and crevice treatment indoors; and ii) outdoor wall and perimeter applications in

urban areas;

f) groundwater for outdoor wall and perimeter applications in urban areas.

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3) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council² or Regulation (EC) No 396/2005 of the European Parliament and of the Council³ shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

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EUROPEAN COMMISSION

of XXX

approving acetamiprid as an existing active substance for use in biocidal products of product-type 18

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Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014² establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes acetamiprid.

(2) Acetamiprid has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

(3) Belgium was designated as rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 27 July 2015.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority³.

(5) According to that opinion, biocidal products of product-type 18 containing acetamiprid may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(6) It is therefore appropriate to approve acetamiprid for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(7) The opinion of the European Chemicals Agency concludes that acetamiprid meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with

1 OJ L 167, 27.6.2012, p. 1.

3 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Acetamiprid, Product type: 18, ECHA/BPC/185/2017, Adopted on 14 December 2017.

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Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council⁴. Acetamiprid therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.

(8) Pursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding seven years.

(9) Since acetamiprid meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating acetamiprid should be appropriately labelled when placed on the market.

(10) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

Article 1

Acetamiprid is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.

Article 2

Done at Brussels,

The President

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EUROPEAN COMMISSION

Brussels, XXX

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ANNEX

Product

Acetamiprid IUPAC Name:

(E)-N1-[(6-chloro-

3pyridyl)methyl]-N2-cyano- N1-methylacetamide EC No: None

CAS No: 135410-20-7

99,0% w/w 1 January

2020 31

December 2026

18 Acetamiprid is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following conditions:

1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

b) infants and toddlers following secondary exposure when the product is sprayed by professionals;

c) surface water, sediment, soil, groundwater for products applied by spray or brush in stables;

d) surface water, sediment, soil, groundwater for products applied by spray outdoors.

3) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council² or Regulation (EC) No 396/2005 of the

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European Parliament and of the Council³ shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

The placing on the market of treated articles is subject to the following condition:

The person responsible for the placing on the market of a treated article treated with or incorporating acetamiprid shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

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EUROPEAN COMMISSION

of XXX

approving cyphenothrin as an existing active substance for use in biocidal products of product-type 18

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Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014² establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes cyphenothrin.

(2) Cyphenothrin has been evaluated for use in biocidal products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council³, which corresponds to product-type 18 as described in Annex V to Regulation (EU) No 528/2012.

(3) Greece was designated as a rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 11 April 2013.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority⁴.

(5) It can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States' evaluation has been completed by 1 September 2013 should be evaluated while taking into account the conditions set out in Article 5 of Directive 98/8/EC. Following the opinion of the European Chemicals Agency, biocidal products of product-type 18 containing cyphenothrin may be expected to

1 OJ L 167, 27.6.2012, p. 1.

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

4 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cyphenothrin, Product type: 18, ECHA/BPC/183/2017, Adopted on 14 December 2017.

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satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

(6) It is therefore appropriate to approve cyphenothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(7) The opinion of the European Chemicals Agency concludes that cyphenothrin meets the criteria for being a persistent (P) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council⁵.

(8) For the purposes of Regulation (EU) No 528/2012, cyphenothrin meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be therefore considered a candidate for substitution. The receiving competent authority or, in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority, should perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing cyphenothrin.

(9) Since it can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved under the terms of Directive 98/8/EC, the period of approval should be 10 years, in accordance with the practice established under that Directive.

(10) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

Article 1

Cyphenothrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.

Article 2

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Done at Brussels,

The President

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EUROPEAN COMMISSION

Brussels, XXX

SANTE/12069/2017 ANNEX (POOL/E4/201712069/12069-EN ANNEX.doc)

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ANNEX

Product

Cyphenothrin IUPAC Name:

(RS)-α-cyano-3- phenoxybenzyl

(1RS,3RS;1RS,3SR)-2,2- dimethyl-3-(2-methylprop-1- enyl)cyclopropanecarboxylate EC No: 254-484-5

CAS No: 39515-40-7

92% w/w (total

isomers) 1 January

2020 31

December 2029

18 Cyphenothrin is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following conditions:

1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

b) toddlers;

c) surface water, sediment, soil and groundwater, following indoor surface treatment;

d) earthworm-eating mammals and fish-eating mammals due to secondary poisoning, following indoor surface treatment.

3) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council² or Regulation (EC) No 396/2005 of the

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European Parliament and of the Council³ shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

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EUROPEAN COMMISSION

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not approving empenthrin as an existing active substance for use in biocidal products of product-type 18

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not approving empenthrin as an existing active substance for use in biocidal products of product-type 18

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014² establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes empenthrin (EC No: n.a., CAS No: 54406-48-3).

(2) Empenthrin has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

(3) Belgium was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 24 June 2016.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 13 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority³.

(5) According to that opinion, biocidal products used for product-type 18 containing empenthrin may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012.

(6) In particular, according to Article 6(2) of Regulation (EU) No 528/2012, sufficient data is to be provided by the applicant in order to make it possible to determine whether an active substance meets the exclusion criteria referred to in Article 5(1) of that Regulation. The applicant has been requested on several occasions by the evaluating competent authority to provide data on carcinogenicity to perform this assessment, and failed to provide sufficient data in due time, making it impossible to assess the exclusion criterion set out in Article 5(1)(a) of that Regulation.

1 OJ L 167, 27.6.2012, p. 1.

3 Biocidal Products Committee (BPC), Opinion on the application for approval of the active substance Empenthrin, Product type: 18, ECHA/BPC/182/2017, Adopted on 13 December 2017.

(35)

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²

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(7) In addition, the scenarios evaluated in the human health and environmental risk assessments identified unacceptable risks and no safe use could be identified.

(8) It is therefore not appropriate to approve empenthrin for use in biocidal products of product-type 18.

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

Article 1

Empenthrin (EC No: n.a., CAS No: 54406-48-3) is not approved as an active substance for use in biocidal products of product-type 18.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels,

The President