title: Commission Directive 2010/51/EU of 11 August 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl-meta-toluamide as an active substance in Annex I thereto  Text with EEA relevance

text:
               12.8.2010

               EN

               Official Journal of the European Union

               L 211/14

         COMMISSION DIRECTIVE 2010/51/EU
   of 11 August 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl-meta-toluamide 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 N,N-diethyl-meta-toluamide (hereinafter ‘DEET’).

               (2)

               Pursuant to Regulation (EC) No 1451/2007, DEET has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive.

               (3)

               Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 November 2007 in accordance with Article 14(4) and (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 11 March 2010, in an assessment report.

               (5)

               It appears from the examinations made that biocidal products used as repellents or attractants and containing DEET may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include DEET in Annex I to that Directive.

               (6)

               In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing DEET and used as repellents or attractants. Products intended for direct application to human skin should be labelled with instructions for use including amount and frequency of application in order to minimize primary exposure of humans. Concerns were identified during the risk assessment for human health, especially for children. Therefore, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI when used on children, products containing DEET should not be used on children less than two years old, and use should be restricted for children between two and twelve years old, except where motivated by the risk for human health through e.g. outbreaks of insect-borne diseases. Furthermore, products should contain deterrents for ingestion.

               (7)

               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 DEET and also to facilitate the proper operation of the biocidal products market in general.

               (8)

               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.

               (9)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (10)

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

               (11)

               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
   Transposition
   1.   Member States shall adopt and publish, by 31 July 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 August 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, 11 August 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry for the substance N,N-diethyl-meta-toluamide is added:

                     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)

                     ‘35

                     N,N-diethyl-meta-toluamide

                     N,N-diethyl-m-toluamide
                     EC No: 205-149-7
                     CAS No: 134-62-3

                     970 g/kg

                     1 August 2012

                     31 July 2014

                     31 July 2022

                     19

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

                                 1.

                                 primary exposure of humans shall be minimized by considering and applying appropriate risk mitigation measures, including, where applicable, instructions for the amount and frequency of application of the product on human skin;

                                 2.

                                 labels on products intended for application on human skin, hair or clothing shall indicate that the product is intended only for restricted use on children between two and twelve years old, and that it is not intended for use on children less than two years old, unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI without such measures;

                                 3.

                                 products must contain deterrents for ingestion.’

         (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


Important legal notice

|

32004L0071

Commission Directive 2004/71/EC of 28 April 2004 amending Council Directive 91/414/EEC to include Pseudomonas chlororaphis as active substance (Text with EEA relevance)

Official Journal L 127 , 29/04/2004 P. 0104 - 0106

Commission Directive 2004/71/ECof 28 April 2004amending Council Directive 91/414/EEC to include Pseudomonas chlororaphis as active substance(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC the Swedish authorities received on 15 December 1994 an application from Bio Agri AB, hereafter referred to as the applicant, for the inclusion of the active substance Pseudomonas chlororaphis in Annex I to the Directive. Decision 97/248/EC(2) of 25 March 1997 confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.(2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicants. The nominated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 7 April 1998.(3) The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 30 March 2004 in the format of the Commission review report for Pseudomonas chlororaphis.(4) The dossier and the information from the review were also submitted to the Scientific Committee for Plants. The Committee was asked to comment (a) on residue levels in food and feed; (b) on operator exposure; (c) whether with regard to possible hazard to humans a tiered approach should include repeated dosing as part of the primary data set; (d) on the toxicological safety of the antibiotic metabolites of the active substance; (e) on the necessity to monitor the health of workers; and (f) on a potential of Pseudomonas chlororaphis to cause wound infection or other pathogenic effects.In its opinion(3) the Committee concluded that (a) the issue of residues has been adequately addressed that there is no cause for concern; (b) operator exposure to Pseudomonas chlororaphis formulations has been adequately addressed; (c) in the specific case of Pseudomonas chlororaphis, and in the light of the results of the available studies, repeated dosing is not necessary to assess hazard to humans; (d) more studies would be needed for a more complete assessment of the mutagenicity potential of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR). However, the Committee considered the potential for human exposure to DDR as well as to other possible antibiotic metabolites so low that, even in the absence of further information, no major concern exists for consumer and operator safety; (e) a study based on the medical surveillance of workers should be conveniently carried out when introducing this agent in the field as a microbial pesticide; (f) there is no cause for concern for human safety with regard to wound infection.The recommendations of the Scientific Committee as well as further information by the notifier were taken into account during the further review and in this Directive and in the Review Report, where the need for monitoring of operators and worker based on medical surveillance to detect negative effects without delay as well as monitoring studies to quantify DDR contamination under practical conditions is stressed. The evaluation within the Standing Committee concluded that there would be no unacceptable risk for operators if appropriate risk mitigation measures are applied.(5) It has appeared from the various examinations made that plant protection products containing Pseudomonas chlororaphis may be expected to satisfy, in general, the requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC in the light of Article 5(3) thereof, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include this active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.(6) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing Pseudomonas chlororaphis and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(7) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 21. Member States shall adopt and publish by 31 March 2005 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 April 2005.2. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 31. Member States shall review the authorisation for each plant protection product containing Pseudomonas chlororaphis to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2005 at the latest.2. For each authorised plant protection product containing Pseudomonas chlororaphis as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2004 at the latest, Member States shall re-evaluate the product on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.Following that determination Member States shall:(a) in the case of a product containing Pseudomonas chlororaphis as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2006 at the latest; or(b) in the case of a product containing Pseudomonas chlororaphis as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2006 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.Article 4This Directive shall enter into force on 1 October 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 28 April 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/20/EC (OJ L 70, 9.3.2004, p. 32).(2) OJ L 98, 15.4.1997, p. 15.(3) Opinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of pseudomonas chlororaphis in the context of Council Directive 91/414/EEC scp/pseudom/002-final adpoted on 20 December 2001.ANNEXIn Annex I the following row is added at the end of the table.">TABLE>"


Avis juridique important

|

31999L0033

Directive 1999/33/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 67/548/EEC as regards the labelling of certain dangerous substances in Austria and Sweden

Official Journal L 199 , 30/07/1999 P. 0057 - 0058

DIRECTIVE 1999/33/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 10 May 1999amending Council Directive 67/548/EEC as regards the labelling of certain dangerous substances in Austria and SwedenTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),(1) Whereas Article 30 of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(4), provides that Member States may not prohibit, restrict or impede the placing on the market of substances which comply with that Directive;(2) Whereas Article 23(2)(c) of Directive 67/548/EEC thereof requires every package of a substance to show danger symbols, as laid down in Annex II; whereas Article 23(2)(e) of the said Directive requires every package of a substance to show specific S-phrases (safety phrases) relating to the safe use of the substance, and whereas the wording of those S-phrases is laid down in Annex IV to that Directive;(3) Whereas Article 69 of the 1994 Act of Accession and Annex VIII thereto provide that Article 30 in conjunction with Article 23(2) of Directive 67/548/EEC is not to apply to Austria before 1 January 1999, in that Austria may require the use of labels with additional symbols not included in Annex II and labels with additional S-phrases not listed in Annex IV to the said Directive regarding counter-measures in case of accident, and that those provisions are to be reviewed in accordance with EC procedures before 31 December 1998;(4) Whereas Article 23(2)(d) of Directive 67/548/EEC requires every package of a substance to show specific R-phrases (risk phrases) indicating the special risks arising from the dangers involved in using the substance, and whereas the wording of those R-phrases is laid down in Annex III to the said Directive;(5) Whereas Article 112 of the 1994 Treaty of Accession and Annex XII thereto provide that Article 30 in conjunction with Article 23(2)(d) of Directive 67/548/EEC is not to apply to Sweden before 1 January 1999, in that Sweden may require the use of the additional R-phrases "R-322" and "R-340" not listed in Annex III to the said Directive, and that those provisions are to be reviewed in accordance with Community procedures before 31 December 1998;(6) Whereas Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(5) provides for certain specific conditions for the application of the Directive as regards, inter alia, additional symbols, R-phrases and S-phrases for Austria and Sweden in order to take account of the level of their standards for the protection of health and the protection of the environment; whereas those specific conditions are limited to the two-year period running from 1 January 1999 to 31 December 2000; whereas during that period coherence of the marketing conditions of dangerous substances and preparations should be sought;(7) Whereas scientific and technical progress is foreseeable within the framework of international negotiations on the harmonisation of the classification of dangerous substances with regard to "R-322", and whereas, in the light of the ongoing international negotiations on the labelling of dangerous substances and taking account of the labelling survey launched by the Commission, Member State experts have agreed to consider the in-depth revision of existing Community legislation with regard to "R-340" an important priority;(8) Whereas Community legislation will have to be reviewed in the light of the outcome of the negotiations on the international harmonisation of the classification and labelling of dangerous substances, and whereas it can be expected that the outcome will lead to an approximation of standards in this respect throughout the Community;(9) Whereas the resolution of the Council and of the representatives of the Governments of the Member States, meeting within the Council, of 3 December 1990 on improving the prevention and treatment of acute human poisoning(6) calls for harmonisation of the procedures for collecting clinical toxicology data for all the poison centres in the Community in order to facilitate the development of a policy for toxic risk prevention; whereas to that end, the relevant competent authorities, in cooperation with the Commission, are to set up between the poison centres or, where appropriate, other competent services a Community system of information and collaboration concerning the availability of antidotes;(10) Whereas a symbol showing that residues of certain dangerous substances should be collected separately from other waste could reduce the potential release of dangerous substances to the environment by improving the use of special waste collection systems by the general public; whereas, owing to the lack of certain evidence, a certain amount of time is still required for considering the need for such a symbol within the Community;(11) Whereas the review of Community legislation on dangerous substances with regard to the provisions of the 1994 Act of Accession relating to Austria and Sweden could not be completed by 31 December 1998;(12) Whereas the provisions covered by this Directive should continue to be reviewed in accordance with Community procedures within the exemption period laid down; whereas, however, without prejudice to the outcome of that review, at the end of that period the acquis communautaire will apply to Austria and Sweden under the same conditions as it applies in the other Member States;(13) Whereas Community legislation can provide for derogations for limited periods for certain Member States in the light of their specific situations,HAVE ADOPTED THIS DIRECTIVE:Article 1The following paragraphs shall be added to Article 23 of Directive 67/548/EEC: "5. Austria may from 1 January 1999 until 31 December 2000 require the use of:- the additional symbol 'dustbin with a cross through it' concerning waste disposal, not included in Annex II, and- the additional S-phrase 'Antidote exists, medical staff contact Poisons Information Centre' regarding counter-measures in the case of accident, not listed in Annex IV.6. Sweden may from 1 January 1999 until 31 December 2000 require the use of the following additional R-phrases, not listed in Annex III:- 'R-322' for substances which present acute toxic effects not covered by criteria for classification of Annex VI (Swedish category 'moderately harmful'), and- 'R-340' for substances classified as carcinogenic, category 3, instead of R-phrase R40."Article 2The Republic of Austria and the Kingdom of Sweden shall adopt and publish the provisions necessary to comply with this Directive by 30 July 2000 at the latest. They shall forthwith inform the Commission thereof.When the Member States concerned adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.Article 3This Directive is addressed to the Member States.Done at Brussels, 10 May 1999.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentH. EICHEL(1) OJ C 374, 3.12.1998, p. 15.(2) OJ C 40, 15.2.1999, p. 43.(3) Opinion of the European Parliament of 16 December 1998 (OJ C 98, 9.4.1999, p. 151 ), Council Common Position of 8 February 1999 (OJ C 58, 1.3.1999, p. 26) and Decision of the European Parliament of 10 March 1999 (OJ C 175, 21.6.1999). Council Decision of 29 April 1999.(4) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 98/98/EC (OJ L 355, 30.12.1998, p. 1 ).(5) OJ L 200, 30.7.1999, p. 1.(6) OJ C 329, 31.12.1990, p. 6.


title: Commission Directive 2013/7/EU of 21 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include Alkyl (C 12-16 ) dimethylbenzyl ammonium chloride as an active substance in Annex I thereto  Text with EEA relevance

text:
               22.2.2013

               EN

               Official Journal of the European Union

               L 49/66

         COMMISSION DIRECTIVE 2013/7/EU
   of 21 February 2013
   amending Directive 98/8/EC of the European Parliament and of the Council to include Alkyl (C12-16) dimethylbenzyl ammonium chloride 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 Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides, which is synonymous with Alkyl (C12-16) dimethylbenzyl ammonium chloride.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, Alkyl (C12-16) dimethylbenzyl ammonium chloride 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 that Directive.

               (3)

               Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 August 2007 in accordance with Article 10(5) and (7) of 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 (3).

               (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 21 September 2012, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as wood preservatives and containing Alkyl (C12-16) dimethylbenzyl ammonium chloride may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Alkyl (C12-16) dimethylbenzyl ammonium chloride for use in product type 8 in Annex I to that Directive.

               (6)

               Not all potential uses and exposure scenarios have been evaluated at Union level. For example, neither use by non-professionals, nor exposure of food or feeding stuff were assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, that products are used with appropriate personal protective equipment, and that products are not applied on wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

               (8)

               In view of the risks identified for the environment, it is appropriate to require that industrial or professional application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of products used as wood preservatives and containing Alkyl (C12-16) dimethylbenzyl ammonium chloride are collected for reuse or disposal.

               (9)

               Unacceptable risks for the environment were identified for situations where wood treated with Alkyl (C12-16) dimethylbenzyl ammonium chloride was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD (4)), was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (5)) or was in contact with fresh water (use class 4b as defined by OECD (6)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (10)

               The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 8 containing the active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               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 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.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

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

               (14)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (15)

               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 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2015.
   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 twentieth 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, 21 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      (3)  OJ L 307, 24.11.2003, p. 1.

      (4)  OECD Series on Emission Scenario Documents, Number 2, ‘Emission Scenario Document for Wood Preservatives, part 2’, p. 64.

      (5)  Ibid.

      (6)  Ibid.

      (7)  OJ C 369, 17.12.2011, p. 14.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum degree of purity of the active substance (1)

                     Date of inclusion

                     Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies (2)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (3)

                     ‘64

                     Alkyl (C12-16) dimethylbenzyl ammonium chloride;
                     C12-16-ADBAC

                     IUPAC name: Not applicable
                     EC No: 270-325-2
                     CAS No: 68424-85-1

                     Dry weight: 940 g/kg

                     1 February 2015

                     31 January 2017

                     31 January 2025

                     8

                     The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as use by non-professionals and exposure of food or feed, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 For industrial or professional users safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

                                 (2)

                                 Products shall not be used for treatment of wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

                                 (3)

                                 Labels and, where provided, safety data sheets of products authorised shall indicate that industrial or professional application shall be conducted within a contained area or on impermeable hard standing with bunding, and that freshly treated timber shall be stored after treatment on impermeable hard standing 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.

                                 (4)

                                 Products shall not be authorised for treatment of wood that will be in contact with fresh water or used for outdoor constructions near or above water, continually exposed to the weather or subject to frequentwetting, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.’

         (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 11. 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 substance.

         (2)  For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

         (3)  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


Avis juridique important

|

31996L0099

Council Directive 96/99/EC of 30 December 1996 amending Directive 92/12/EEC on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such products

Official Journal L 008 , 11/01/1997 P. 0012 - 0013

COUNCIL DIRECTIVE 96/99/EC of 30 December 1996 amending Directive 92/12/EEC on the general arrangements for products subject to excise duty and on the holding, movement and monitoring of such productsTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 99 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Parliament (1),Whereas the Economic and Social Committee, having been consulted on the Commission proposal, did not deliver its opinion within the time limit set by the Council pursuant to Article 198 of the Treaty; whereas it is appropriate to disregard the fact that the said Committee delivered no opinion;Whereas Directive 92/12/EEC (2) lays down the general arrangements for the holding, movement and monitoring of products subject to excise duty;Whereas Article 26 of that Directive provides a derogation permitting Denmark to apply excise duty to alcoholic drinks and tobacco products exceeding certain quantities when they are brought into its territory by private individuals who import them for their own use;Whereas the 1994 Act of Accession provides, also by reference to Article 26 of Directive 92/12/EEC, that Sweden and Finland may apply excise duty to a more extensive list of alcohol drinks and tobacco products under the same conditions;Whereas the derogations so provided for were accorded because in a Europe without frontiers where excise rates vary widely, an immediate total removal of excise limitations would have caused an unacceptable diversion of trade and revenue and distortion of competition in the Member States concerned, which have traditionally applied high excise duties to the products concerned both as an important source of revenue and for health and social reasons;Whereas the derogations were granted until 31 December 1996 and subject to a review mechanism similar to that laid down in Article 28l of Directive 77/388/EEC (3);Whereas, however, on 31 December 1996, minimum rates of excise duty applied throughout the Community will be lower than was expected when the derogations were accorded, so that their abolition on that date will cause greater problems than had been envisaged;Whereas, therefore, it is appropriate to provide further time for adjustment in Denmark, Finland and Sweden by extending the date laid down in Article 26 of Directive 92/12/EEC;Whereas, however, the provisions of Article 26 represent a derogation from a fundamental principle of the internal market, namely the right of its citizens to transport goods purchased for their own use throughout the Community without incurring liability to new duty charges, so that it is necessary to limit its effects as far as possible;Whereas it is therefore appropriate, in the case of Denmark and Finland, to provide, on the one hand, for the gradual liberalization of the quantitative restrictions which may be applied prior to their complete removal on 31 December 2003 and, on the other hand, to reduce from 36 hours to 24 hours the qualifying period which requires a minimum stay outside the territory of the Member State concerned before residents may benefit from any allowance;Whereas, the Member States concerned may decide upon the precise details of the liberalization process in the light of all relevant factors;Whereas, however, the process should be subject to monitoring not later than 30 June 2000;Whereas, in the case of Sweden, it is appropriate to authorize the continuation of the present restrictions until 30 June 2000 and subject to a review mechanism similar to that laid down in Article 28l of Directive 77/388/EEC;Whereas Article 1 (2) of Council Regulation (EEC) No 3925/91 of 19 December 1991 concerning the elimination of controls and formalities applicable to the cabin and hold baggage of persons taking an intra-Community flight and the baggage of persons making an intra-Community sea-crossing (4) states that its enforcement is without prejudice to checks linked to prohibitions or restrictions laid down by the Member States, provided that they are compatible with the three Treaties establishing the European Communities; whereas, in that context, the verifications necessary for the enforcement of the quantitative restrictions referred to in Article 26 of Directive 92/12/EEC must be considered to be such controls and, as such, to be compatible with Community legislation,HAS ADOPTED THIS DIRECTIVE:Article 1 Article 26 of Directive 92/12/EEC shall be replaced by the following:'Article 261. Without prejudice to Article 8, until 31 December 2003, Denmark and Finland shall be authorized to apply the specific arrangements laid down in the second and third subparagraphs to certain alcoholic drinks and tobacco products brought into their territory by private individuals for their own use.From 1 January 1997, Denmark and Finland shall be authorized to continue to apply the same restrictions on the quantity of goods which may be brought into their territories without further excise duty payment as they applied on 31 December 1996. Those restrictions shall be progressively removed by these Member States.Where such goods are imported by persons resident within their territories, Denmark and Finland shall be authorized to restrict the grant of admission without payment of duty to persons who have been absent from their territory for a period of more than 24 hours.2. Before 30 June 2000, the Commission shall report to the European Parliament and the Council on the operation of paragraph 1.3. Without prejudice to Article 8, from 1 January 1997 to 30 June 2000, and subject to a review mechanism similar to that laid down in Article 28l of Directive 77/388/EEC, Sweden shall be authorized to continue to apply the same restrictions as it applied on 31 December 1996 on the quantity of alcoholic drinks and tobacco products which may be brought into Swedish territory without further excise duty payment by private individuals for their own use.4. Denmark, Finland and Sweden may collect excise duties and carry out the necessary checks with respect to the products covered by this Article.`Article 2 1. Member States shall bring into force the laws regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1997. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the texts 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 1 January 1997.Article 4 This Directive is addressed to the Member States.Done at Brussels, 30 December 1996.For the CouncilThe PresidentS. BARRETT(1) Opinion delivered on 13 December 1996 (not yet published in the Official Journal)(2) OJ No L 76, 23. 3. 1992, p. 1. Directive as last amended by Directive 94/74/EC (OJ No L 365, 31. 12. 1994, p. 46).(3) OJ No L 145, 13. 6. 1977, p. 1. Directive as last amended by Directive 95/7/EC (OJ No L 102, 9. 5. 1995, p. 18).(4) OJ No L 374, 31. 12. 1991, p. 4.


title: Commission Directive 2013/3/EU of 14 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance thiamethoxam to product-type 18  Text with EEA relevance

text:
               15.2.2013

               EN

               Official Journal of the European Union

               L 44/6

         COMMISSION DIRECTIVE 2013/3/EU
   of 14 February 2013
   amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance thiamethoxam to product-type 18
   (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 thiamethoxam.

               (2)

               Commission Directive 2008/77/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiamethoxam as an active substance in Annex I thereto (3) included thiamethoxam as an active substance in Annex I to Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.

               (3)

               Pursuant to Regulation (EC) No 1451/2007, thiamethoxam has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

               (4)

               Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (5)

               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 21 September 2012, in an assessment report.

               (6)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing thiamethoxam may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to extend the inclusion of thiamethoxam in Annex I to that Directive to product-type 18.

               (7)

               Not all potential uses have been evaluated at Union level. For example, neither outdoor use, nor use by non-professional users were assessed. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (8)

               In the light of the unacceptable risks identified for professional users in the brushing application scenario, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (9)

               In the light of the risks identified for the aquatic and terrestrial ecosystems when products were emitted via a sewage treatment plant or directly to surface water, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (10)

               In the light of the risks identified in several scenarios of use without personal protective equipment, it is appropriate to require that products authorised for professional use be used with such equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by other means.

               (11)

               In the light of the possible indirect human exposure via consumption of food as a result of those uses presented in the assessment report, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with 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 (4) or with 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 (5). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

               (12)

               In view of the risks identified for the environment, it is appropriate to require that product authorisations are subject to appropriate risk mitigation measures for the protection of honey bees.

               (13)

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

               (14)

               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 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.

               (15)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (16)

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

               (17)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (18)

               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 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2015.
   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 twentieth 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, 14 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      (3)  OJ L 198, 26.7.2008, p. 41.

      (4)  OJ L 152, 16.6.2009, p. 11.

      (5)  OJ L 70, 16.3.2005, p. 1.

      (6)  OJ C 369, 17.12.2011, p. 14.

      ANNEX
      In Annex I to Directive 98/8/EC, the following is added to entry No 14:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum degree of purity of the active substance (1)

                     Date of inclusion

                     Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies (2)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (3)

                     ‘980 g/kg

                     1 February 2015

                     31 January 2017

                     31 January 2025

                     18

                     The Union level risk assessment did not address all potential uses; certain uses, such as outdoor application and use by non-professionals, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Products shall not be authorised for application by brushing, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
                     For products containing thiamethoxam that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.
                     Products applied in such a way that emission via a sewage treatment plant or directly to surface water cannot be prevented shall not be authorised, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 Products authorised for professional use shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by other means.

                                 (2)

                                 Where appropriate, measures shall be taken to protect honey bees.’

         (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 11. 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 substance.

         (2)  For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

         (3)  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


title: Commission Directive 2011/67/EU of 1 July 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin as an active substance in Annex I thereto  Text with EEA relevance

text:
               2.7.2011

               EN

               Official Journal of the European Union

               L 175/13

         COMMISSION DIRECTIVE 2011/67/EU
   of 1 July 2011
   amending Directive 98/8/EC of the European Parliament and of the Council to include abamectin 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 abamectin.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, abamectin has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

               (3)

               The Netherlands was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 19 June 2009 in accordance with Article 14(4) and (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 18 February 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing abamectin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include abamectin in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In the light of the risks identified for sediment when products are used with a certain application rate and emitted to a sewage treatment plant, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (8)

               In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the possible risks for infants and children, appropriate risk mitigation measures should be taken to minimise the potential exposure of infants and children.

               (9)

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

               (10)

               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 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.

               (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,

         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
   Transposition
   1.   Member States shall adopt and publish, by 30 June 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 July 2013.
   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, 1 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     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)

                     ‘43

                     Abamectin

                     Abamectin is a mixture of avermectin B1a and avermectin B1b

                                    Abamectin:

                                             IUPAC name: n.a.

                                             EC No: n.a.

                                             CAS No: 71751-41-2

                                    Avermectin B1a:

                                             IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-6'-[(S)-secbutyl]-21,24-dihydroxy-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

                                             EC No: 265-610-3

                                             CAS No: 65195-55-3

                                    Avermectin B1b:

                                             IUPAC name: (10E,14E,16E,22Z)-(1R,4S,5'S,6S,6'R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6'-isopropyl-5',11,13,22-tetramethyl-2-oxo-3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene-6-spiro-2'-(5',6'-dihydro-2'H-pyran)-12-yl2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabinohexopyranoside

                                             EC No: 265-611-9

                                             CAS No: 65195-56-4

                     The active substance shall comply with all the following purities:

                                    Abamectin:

                                 minimum 900 g/kg

                                    Avermectin B1a:

                                 minimum 830 g/kg

                                    Avermectin B1b:

                                 maximum 80 g/kg

                     1 July 2013

                     30 June 2015

                     30 June 2023

                     18

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Products applied in such a way that emission to a sewage treatment plant cannot be prevented shall not be authorised for those application rates for which the Union level risk assessment showed unacceptable risks, unless data are submitted demonstrating that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
                     Authorisations shall be subject to appropriate risk mitigation measures. In particular, appropriate risk mitigation measures shall be taken to minimise the potential exposure of infants and children.’

         (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


title: Commission Directive 2013/4/EU of 14 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include Didecyldimethylammonium Chloride as an active substance in Annex I thereto  Text with EEA relevance

text:
               15.2.2013

               EN

               Official Journal of the European Union

               L 44/10

         COMMISSION DIRECTIVE 2013/4/EU
   of 14 February 2013
   amending Directive 98/8/EC of the European Parliament and of the Council to include Didecyldimethylammonium Chloride 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 Didecyldimethylammonium Chloride.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, Didecyldimethylammonium Chloride 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 that Directive.

               (3)

               Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 August 2007 in accordance with Article 10(5) and (7) 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 21 September 2012, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as wood preservatives and containing Didecyldimethylammonium Chloride may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Didecyldimethylammonium Chloride for use in product type 8 in Annex I to that Directive.

               (6)

               Not all potential uses and exposure scenarios have been evaluated at Union level. For example, neither use by non-professionals, nor exposure of food or feeding stuff was assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, that products are used with appropriate personal protective equipment, and that products are not applied on wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

               (8)

               In view of the risks identified for the environment, it is appropriate to require that industrial or professional application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of products used as wood preservatives and containing Didecyldimethylammonium Chloride are collected for reuse or disposal.

               (9)

               Unacceptable risks for the environment were identified for situations where wood treated with Didecyldimethylammonium Chloride was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD (3)), was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (4)) or was in contact with fresh water (use class 4b as defined by OECD (5)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

               (10)

               The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 8 containing the active substance Didecyldimethylammonium Chloride and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               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 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.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

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

               (14)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (15)

               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 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2015.
   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 twentieth 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, 14 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      (3)  OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.

      (4)  Ibid.

      (5)  Ibid.

      (6)  OJ C 369, 17.12.2011, p. 14.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum degree of purity of the active substance (1)

                     Date of inclusion

                     Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies (2)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (3)

                     ‘61

                     Didecyldimethylammonium Chloride;
                     DDAC

                     N,N-Didecyl-N,N-dimethylammonium Chloride
                     EC No: 230-525-2
                     CAS No: 7173-51-5

                     Dry weight: 870 g/kg

                     1 February 2015

                     31 January 2017

                     31 January 2025

                     8

                     The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as use by non-professionals and exposure of food or feed, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 For industrial or professional users safe operational procedures shall be established, and products shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

                                 (2)

                                 Products shall not be used for treatment of wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

                                 (3)

                                 Labels and, where provided, safety data sheets of products authorised shall indicate that industrial or professional application shall be conducted within a contained area or on impermeable hard standing with bunding, and that freshly treated timber shall be stored after treatment on impermeable hard standing 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.

                                 (4)

                                 Products shall not be authorised for treatment of wood that will be in contact with fresh water or used for outdoor constructions near or above water, continually exposed to the weather or subject to frequent wetting, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures.’

         (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 11. 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 substance.

         (2)  For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

         (3)  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


title: Directive 2005/88/EC of the European Parliament and of the Council of  14 December 2005  amending Directive 2000/14/EC on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors   (Text with EEA relevance)

text:
               27.12.2005

               EN

               Official Journal of the European Union

               L 344/44

      DIRECTIVE 2005/88/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 14 December 2005
   amending Directive 2000/14/EC on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Directive 2000/14/EC of the European Parliament and of the Council (3) has been the subject of a review by the Working Group on Outdoor Equipment, set up by the Commission.

               (2)

               In its report dated 8 July 2004, this Working Group concluded that a number of the stage II limits due to be mandatorily applied as from 3 January 2006 were not technically feasible. However, the intention was never to restrict the placing on the market or putting into service of equipment solely based on technical feasibility.

               (3)

               It is therefore necessary to provide that certain types of equipment listed in Article 12 of Directive 2000/14/EC, which would not be able to meet the stage II limits by 3 January 2006 solely for technical reasons, can still be placed on the market and/or put into service as from that date.

               (4)

               The experience of the first five years of application of Directive 2000/14/EC has demonstrated that more time is needed to fulfil the provisions under Articles 16 and 20 thereof and highlighted the need to review that Directive with a view to its possible amendment, in particular with respect to the stage II limits referred to therein. It is therefore necessary to extend by two years the deadline for submission of the report to the European Parliament and to the Council on the Commission’s experience in implementing and administering Directive 2000/14/EC as referred to in Article 20(1) of that Directive.

               (5)

               Article 20(3) of Directive 2000/14/EC provides for the submission, by the Commission, of a report to the European Parliament and to the Council on whether, and to what extent, technical progress allows a reduction of limit values for lawnmowers and lawn trimmers/lawn-edge trimmers. In view of the fact that the obligations contained in Article 20(1) of that Directive are more prescriptive than those in Article 20(3), and in order to avoid duplication of effort, it is appropriate to include these types of equipment in the general report provided for in Article 20(1) of that Directive. Consequently, the separate reporting obligation in Article 20(3) of that Directive should be deleted.

               (6)

               Since the objective of this Directive, namely, to ensure the ongoing functioning of the internal market by requiring equipment used outdoors to comply with harmonised environmental noise provisions, cannot be sufficiently achieved by Member States and can therefore, by reason of the scale and effects of the proposed action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective, in that its scope is confined to those types of equipment for which compliance with the stage II limits is presently impossible for technical reasons.

               (7)

               In accordance with point 34 of the Interinstitutional agreement on better law making (4), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (8)

               Directive 2000/14/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2000/14/EC is hereby amended as follows:

               1.

               The table in Article 12 shall be replaced by the following:

                           ‘Type of equipment

                           Net installed power P (in kW)
                           Electric power P
                              el
                               (5) in kW
                           Mass of appliance m in kg
                           Cutting width L in cm

                           Permissible sound power level in dB/1 pW

                           Stage I as from 3 January 2002

                           Stage II as from 3 January 2006

                           Compaction machines (vibrating rollers, vibratory plates, vibratory rammers)

                              P ≤ 8

                           108

                           105 (6)

                           8 < P ≤ 70

                           109

                           106 (6)

                              P > 70

                           89 + 11 lg P

                           86 + 11 lg P
                               (6)

                           Tracked dozers, tracked loaders, tracked excavator-loaders

                              P ≤ 55

                           106

                           103 (6)

                              P > 55

                           87 + 11 lg P

                           84 + 11 lg P
                               (6)

                           Wheeled dozers, wheeled loaders, wheeled excavator-loaders, dumpers, graders, loader-type landfill compactors, combustion-engine driven counterbalanced lift trucks, mobile cranes, compaction machines (non-vibrating rollers), paver-finishers, hydraulic power packs

                              P ≤ 55

                           104

                           101 (6)
                               (7)

                              P > 55

                           85 + 11 lg P

                           82 + 11 lg P
                               (6)
                               (7)

                           Excavators, builders’ hoists for the transport of goods, construction winches, motor hoes

                              P ≤ 15

                           96

                           93

                              P > 15

                           83 + 11 lg P

                           80 + 11 lg P

                           Hand-held concrete-breakers and picks

                              m ≤ 15

                           107

                           105

                           15 < m < 30

                           94 + 11 lg m

                           92 + 11 lg m
                               (6)

                              m ≥ 30

                           96 + 11 lg m

                           94 + 11 lg m

                           Tower cranes

                           98 + lg P

                           96 + lg P

                           Welding and power generators

                              P
                              el ≤ 2

                           97 + lg P
                              el

                           95 + lg P
                              el

                           2 < P
                              el ≤ 10

                           98 + lg P
                              el

                           96 + lg P
                              el

                           10 > P
                              el

                           97 + lg P
                              el

                           95 + lg P
                              el

                           Compressors

                              P ≤ 15

                           99

                           97

                              P > 15

                           97 + 2 lg P

                           95 + 2 lg P

                           Lawnmowers, lawn trimmers/lawn-edge trimmers

                              L ≤50

                           96

                           94 (6)

                           50 < L ≤ 70

                           100

                           98

                           70 < L ≤ 120

                           100

                           98 (6)

                              L > 120

                           105

                           103 (6)

                           The permissible sound power level shall be rounded up or down to the nearest integer number (less than 0,5, use lower number; greater than or equal to 0,5, use higher number)’

               2.

               Article 20 shall be amended as follows:

                           (a)

                           In the first sentence of paragraph 1, the words ‘Not later than 3 January 2005’ shall be replaced by ‘Not later than 3 January 2007’;

                           (b)

                           Paragraph 3 shall be deleted.

         Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2005 at the latest. They shall forthwith inform the Commission thereof.
   They shall apply those measures from 3 January 2006.
   When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   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 day of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 14 December 2005.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         C. CLARKE

      (1)  Opinion delivered on 27 October 2005 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 26 October 2005 (not yet published in the Official Journal) and Council Decision of 8 December 2005.

      (3)  OJ L 162, 3.7.2000, p. 1.

      (4)  OJ C 321, 31.12.2003, p. 1.

      (5)  P
      el for welding generators: conventional welding current multiplied by the conventional load voltage for the lowest value of the duty factor given by the manufacturer.

      P
      el for power generators: prime power according to ISO 8528-1:1993, clause 13.3.2

      (6)  The figures for stage II are merely indicative for the following types of equipment:

               —

               walk-behind vibrating rollers;

               —

               vibratory plates (> 3kW);

               —

               vibratory rammers;

               —

               dozers (steel tracked);

               —

               loaders (steel tracked > 55 kW);

               —

               combustion-engine driven counterbalanced lift trucks;

               —

               compacting screed paver-finishers;

               —

               hand-held internal combustion-engine concrete-breakers and picks (15<m<30)

               —

               lawnmowers, lawn trimmers/lawn-edge trimmers.

         Definitive figures will depend on amendment of the Directive following the report required in Article 20(1). In the absence of any such amendment, the figures for stage I will continue to apply for stage II.

      (7)  For single-engine mobile cranes, the figures for stage I shall continue to apply until 3 January 2008. After that date, stage II figures shall apply.
   The permissible sound power level shall be rounded up or down to the nearest integer number (less than 0,5, use lower number; greater than or equal to 0,5, use higher number)’