# L_2015068EN.01003901.xml

| 13.3.2015 | EN | Official Journal of the European Union | L 68/39 |
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13.3.2015

EN

Official Journal of the European Union

L 68/39

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/419

of 12 March 2015

approving tolylfluanid as an active substance for use in biocidal products for product-type 21

(Text with EEA relevance)

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 products (1), and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes tolylfluanid. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes tolylfluanid.

| (2) | Tolylfluanid has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 21, antifouling products, as defined in Annex V to Regulation (EU) No 528/2012. |
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(2)

Tolylfluanid has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 21, antifouling products, as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Finland was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 18 September 2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (3). |
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(3)

Finland was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 18 September 2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (3).

| (4) | The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. |
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(4)

The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products used for product-type 21 and containing tolylfluanid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council (4) provided that certain specifications and conditions relating to its use are satisfied. |
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(5)

According to that opinion, biocidal products used for product-type 21 and containing tolylfluanid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council (4) provided that certain specifications and conditions relating to its use are satisfied.

| (6) | Nevertheless, the acceptability of the risks related to the use of antifouling products, as well as the suitability of the proposed risk mitigation measures, need to be further confirmed. In order to facilitate, at the time of the renewal of the approvals of existing antifouling active substances, the review and comparison of the risks and benefits of these substances as well as of the risk mitigation measures applied, the expiry date of approval of these substances should be the same. |
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(6)

Nevertheless, the acceptability of the risks related to the use of antifouling products, as well as the suitability of the proposed risk mitigation measures, need to be further confirmed. In order to facilitate, at the time of the renewal of the approvals of existing antifouling active substances, the review and comparison of the risks and benefits of these substances as well as of the risk mitigation measures applied, the expiry date of approval of these substances should be the same.

| (7) | It is therefore appropriate to approve tolylfluanid for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions. |
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(7)

It is therefore appropriate to approve tolylfluanid for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions.

| (8) | Since the evaluations did not address nanomaterials, the approval should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. |
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(8)

Since the evaluations did not address nanomaterials, the approval should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012.

| (9) | 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. |
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(9)

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.

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

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

Tolylfluanid shall be approved as an active substance for use in biocidal products for product-type 21, 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, 12 March 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 167, 27.6.2012, p. 1.

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).

2

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

3

(4)  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

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ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions (2) |
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| Tolylfluanid | IUPAC Name:
  N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-p-tolylsulfamide
  EC No: 211-986-9
  CAS No: 731-27-1 | 960 g/kg | 1 July 2016 | 31 December 2025 | 21 | 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.
  In the event that products containing tolylfluanid are subsequently authorised for use by non-professional users, persons making products containing tolylfluanid available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves.
  For biocidal products, authorisations are subject to the following conditions:






  (1) | Products containing tolylfluanid shall not be authorised or used to control the growth and settlement of fouling organisms on freshwater going vessels. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions (2)

Tolylfluanid

IUPAC Name:

N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-p-tolylsulfamide

EC No: 211-986-9

CAS No: 731-27-1

960 g/kg

1 July 2016

31 December 2025

21

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.

In the event that products containing tolylfluanid are subsequently authorised for use by non-professional users, persons making products containing tolylfluanid available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves.

For biocidal products, authorisations are subject to the following conditions:

(1)

Products containing tolylfluanid shall not be authorised or used to control the growth and settlement of fouling organisms on freshwater going vessels.

| (2) | For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. |
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(2)

For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.

| (3) | Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry. |
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(3)

Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.

| (4) | Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste containing tolylfluanid shall be collected for reuse or disposal. |
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(4)

Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste containing tolylfluanid shall be collected for reuse or disposal.

| (5) | 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 Council (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) 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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(5)

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 Council (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (4) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

For treated articles, the following condition applies:

where a treated article has been treated with or intentionally incorporates one or more biocidal products containing tolylfluanid, and where necessary due to the possibility of skin contact as well as the release of tolylfluanid under normal conditions of use of the treated article, the person responsible for placing the treated article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

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(1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

(2)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm

(3)  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).

(4)  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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