Avis juridique important

|

31986L0354

Council Directive 86/354/EEC of 21 July 1986 amending Directive 74/63/EEC on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs, Directive 77/101/EEC on the marketing of straight feedingstuffs and Directive 79/373/EEC on the marketing of compound feedingstuffs

Official Journal L 212 , 02/08/1986 P. 0027 - 0032 Finnish special edition: Chapter 3 Volume 21 P. 0211  Swedish special edition: Chapter 3 Volume 21 P. 0211

*****COUNCIL  DIRECTIVE  of 21 July 1986  amending Directive 74/63/EEC on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs, Directive 77/101/EEC on the marketing of straight feedingstuffs and Directive 79/373/EEC on the marketing of compound feedingstuffs  (86/354/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the definitions of straight feedingstuffs and the various types of compound feedingstuffs in Directives 74/63/EEC (4), 77/101/EEC (5) and 79/373/EEC (6), as last amended by Directives 86/299/EEC (7), 83/87/EEC (8) and 82/957/EEC (9) respectively, should be aligned on the new definitions in Council Directive 84/587/EEC of 29 November 1984 amending Directive 70/524/EEC concerning additives in feedingstuffs (10); whereas 'milk replacer feeds' should also be defined;  Whereas it should be made clear that the provisions of Directives 74/63/EEC, 77/101/EEC and 79/373/EEC are without prejudice to the provisions of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (11);  Whereas Directive 74/63/EEC concerns undesirable substances and products in feedingstuffs; whereas, therefore, the maximum permitted levels laid down in the Annex to that Directive do not apply to the raw materials used for preparing compound feedingstuffs;  Whereas the fixing of maximum levels or the limiting of the presence of certain undesirable substances and products in raw materials is at the moment governed by divergent provisions in the Member States;  Whereas the consequences of the presence, above a certain level, of these substances or products are likely to prove harmful to human health and whereas it is therefore necessary to guarantee, in an appropriate and uniform manner,the safe use of these products and substances throughout the Community;  Whereas, moreover, the divergent provisions in the national legislation of Member States leads to substantial barriers in intra-Community trade and whereas it is desirable to adopt appropriate measures within the context of Directive 74/63/EEC;  Whereas, in addition, Directives 77/101/EEC and 79/373/EEC should be adopted to better facilitate the marketing of straight and compound feedingstuffs;  Whereas it is desirable to define the concept of raw materials in order to set clear limits to the scope of the measures relating to that class of products, which is also referred to by the term 'ingredients' in other Directives on animal feedingstuffs;  Whereas the provisions in question apply exclusively to raw materials intended for animal feed which are to be entered into circulation in the form of straight feedingstuffs or as carriers of premixtures of additives or, after being mixed with other products, as compound feedingstuffs;  Whereas, in order to ensure that certain particularly undesirable substances are not present in feedingstuffs, it is necessary not only to limit their presence in raw materials to an acceptable level but also to restrict the use of those raw materials to persons who have the requisite skill, apparatus and equipment for the diluting operations which ensure that the maximum levels laid down in the Directive for compound feedingstuffs are observed;  Whereas the minimum conditions laid down in Annex III to Council Directive 70/524/EEC for a person to be entered on a national list of manufacturers of compound feedingstuffs must also be applied to manufacturers of compound feedingstuffs using raw materials which contain a level of undesirable substances and products higher than that permitted in straight feedingstuffs; whereas it is desirable, however, that Member States should be able to confine the delivery of such highly contaminated raw materials to those manufacturers who produce compound feedingstuffs for sale where their inspection services are unable to monitor at farm level those manufacturers of compound feedingstuffs who are also livestock farmers and who use all or part of their production for their own requirements;  Whereas, for certain raw materials whose level of undesirable substances and products is not restricted in Annex II (A), provision should be made for the possibility of imposing appropriate labelling provisions if the quantity of the undesirable substance or product present in the raw materials exceeds the maximum level laid down for the corresponding straight feedingstuffs; whereas this measure is indispensable in order to ensure that such raw materials are not delivered to livestock farmers and to inform manufacturers of the nature and quantity of the undesirable substance or product present;  Whereas the Member States should provisionally be authorized to retain the national provisions which they have adopted concerning raw materials contaminated by aflatoxin other than those referred to in Annex II (A) or relating to undesirable substances or products other than aflatoxin affecting the quality of the raw materials; whereas a Community decision should be taken before 3 December 1990 so that by that date uniform Community rules exist regarding the presence of undesirable substances and products in raw materials used in the preparation of feedingstuffs;  Whereas, in order to guarantee the safety of feedingstuffs, rules should be laid down governing the presence of undesirable substances and products and processes sought for decontaminating raw materials; whereas, on the basis of the results obtained, the criteria should be laid down with which products subject to certain decontamination processes must comply;  Whereas the procedure introducing close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs should be applied in order to facilitate implementation of the measures proposed and to make, inter alia, amendments and additions concerning the fixing of maximum levels or labelling rules for raw materials contaminated by certain undesirable substances or products and the establishment of acceptability criteria for decontaminated raw materials;  Wheras an information procedure must be established for notifying Member States of cases of non-compliance with Community provisions in order to facilitate supervision of the application of Directive 74/63/EEC;  Whereas the experience gained in the implementation of Directive 79/373/EEC shows the need to improve or supplement the labelling of compound feedingstuffs in certain cases;  Whereas, in particular, an indication of the name or business name and address of the manufacturer must be stipulated where the latter is not responsible for the labelling particulars; whereas, however, account must be taken of the particular control systems in certain Member States and whereas such Member States should be authorized, for feedingstuffs produced and marketed in their territory, to replace these particulars by the official code number given to each manufacturer,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 74/63/EEC is hereby amended as follows:  1. The title of the Directive shall be replaced by the following: 'Council Directive on undesirable substances and products in animal nutrition.'  2. In Article 1:  (a) paragraph 1 shall be replaced by the following:  '1. This Directive deals with undesirable substances and products in animal nutrition.'  (b) The following point (e) shall be added to paragraph 2:  '(e) certain products used in animal nutrition.'  3. In Article 2:  (a) points (a), (b) and (h) shall be replaced by the following:  '(a) feedingstuffs: products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding; (b) straight feedingstuffs: the various vegetable or animal products in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and various organic or inorganic substances, whether or not containing additives, intended as such for oral animal feeding:  (h) compound feedingstuffs: mixtures of products of vegetable or animal origin in the natural state, fresh or preserved, and products derived from the industrial processing thereof, or of organic or inorganic substances, whether or not containing additives, for oral animal feeding in the form of complete feedingstuffs or complementary feedingstuffs;'  (b) the following point shall be added:  '(i) raw materials (ingredients); various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended to be entered for circulation as straight feedingstuffs or for the preparation of compound feedingstuffs or as carriers of premixtures;'  4. Article 3 shall be replaced by the following:  'Article 3  1. Member States shall prescribe that the substances and products listed in Annex I shall be tolerated in feedingstuffs only under the conditions therein set out.  2. Member States may authorize the maximum permitted levels provided for in Annex I in respect of feedingstuffs to be exceeded in the case of fodder which is produced and used in the same state on the same agricultural holding, where this is necessary for particular local reasons. The Member States concerned shall ensure that neither animal nor human health can suffer harm thereby.'  5. The following Articles shall be inserted:  'Article 3a  1. Member States shall prescribe that the raw materials listed in Annex II (A) may be marketed only if their content of the undesirable substance or product mentioned in column 1 of the said Annex does not exceed the maximum level laid down in column 3 of that Annex.  2. Where the content of the undesirable substance or product listed in column 1 of Annex II (A) exceeds the level laid down in column 3 of Annex I in respect of the straight feedingstuff, the raw material listed in column 2 of Annex II (A) may, without prejudice to paragraph 1, be marketed only if:  (a) it is intended for use by manufacturers of compound feedingstuffs entered on a national list as provided for in Article 13 (3) of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (1),  and  (b) it is accompanied by a document stating:  - that the raw material is intended for manufacturers of compound feedingstuffs who fulfil the conditions laid down in paragraph (a),  - that the raw material may not be fed unprocessed to livestock,  - the amount of the undesirable substance or product contained in the raw material.  3. Member States shall prescribe that paragraph 2 (a) and (b) shall also apply to the raw materials and undesirable substances or products listed in Annex II (B) the maximum level of which is not restricted in Annex II (A), if the level of the undesirable substance or product present in the raw material exceeds that laid down in column 3 of Annex I for the corresponding straight feedingstuffs.  'Article 3b  Member States may restrict the application of Article 3a (2) (a) to those manufacturers of compound feedingstuffs who use the materials in question for the production and marketing of compound feedingstuffs.'  (1) OJ No L 270, 14. 12. 1970, p. 1.'  6. In Article 4, 'in this Directive' shall be replaced by 'in Annex I.'  7. In Article 5:  (a) the text of paragraph 1 shall be replaced by the following:  '1. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that a maximum content fixed in Annex I or II or a substance or product not listed therein constitutes a danger to animal or human health or the environment, that Member State may provisionally reduce that content, fix a maximum content or prohibit the presence of that substance or product in feedingstuffs or raw materials. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.'  (b) in paragraph 2, 'the Annex' shall be replaced by 'the Annexes'.  8. Article 6 shall be replaced by the following:  'Article 6  In accordance with the procedure laid down in Article 9 and in the light of developments in scientific and technical knowledge: (a) the amendments to be made to the Annexes shall be adopted;  (b) a consolidated version of the Annexes shall be drawn up periodically incorporating the successive amendments made pursuant to (a);  (c) criteria for the acceptability of raw materials which have undergone certain decontamination processes may be defined.'  9. The following Article shall be added:  'Article 6a  1. Until a Community decision is taken, Member States may retain measures governing the importation and entry for circulation within their territories of:  (a) raw materials contaminated by aflatoxin other than the raw materials referred to in Annex II (A), and  (b) raw materials contaminated by undesirable substances or products other than aflatoxin.  2. Not later than the 31 January 1987, Member States shall notify the Commission of the national provisions which they intend to retain by virtue of paragraph 1.  3. The amendments to be made to Annex II to remove discrepancies resulting from the application of paragraph 1 shall be adopted by 3 December 1990 at the latest.'  10. In Article 7, 'and raw materials' shall be inserted after 'feedingstuffs'.  11. In Article 8:  (a) paragraph 1 shall be replaced by the following:  '1. Member States shall take all necessary measures to ensure that feedingstuffs and raw materials are officially controlled, at least by random sampling, to verify whether the conditions laid down in this Directive are satisfied.'  (b) the following paragraph 3 shall be added:  '3. If a consignment of raw material is likely to be sent to a Member State after it has been judged not to comply with the provisions of this Directive on account of an excessive content of undesirable substances or products in another Member State, the latter Member State shall immediately give the other Member States and the Commission any useful information concerning that consignment of raw material.'  12. In Article 11, 'and raw materials' shall be inserted after 'feedingstuffs',  13. The Annex shall be amended as follows:  (a) 'I' shall be added after the word 'ANNEX';  (b) the three columns of Annex I shall be numbered 1, 2 and 3 respectively;  (c) in Annex I (B), the heading of column 3 shall be replaced by the following:  'Maximum content in mg/kg (ppm) of feedingstuffs referred to a moisture content of 12 %'.  14. The following shall be added as Annex II:  ANNEX II  A  1.2.3 //  //  //  // Substances, products  // Raw materials  // Maximum content in mg/kg (ppm) of raw material, referred a moisture content of 12 %   //    //   //   // (1)  // (2)  // (3)   //    //   //   // 1. Aflatoxin B1   // Groudnut, copra, palm-kernel, cotton seed, babassu, maize and products derived from the processing thereof   // 0,2   //    //   //  B  1.2 //  //  // Substances, products   // Raw materials   //  //   // (1)   // (2)'   //    //   //  //  //  //  15. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'.  Article 2  Directive 77/101/EEC is hereby amended as follows:  1. In Article 1 (2):  (a) point (b) shall be replaced by the following:  '(b) undesirable substances and products in animal nutrition;'  (b) the following point shall be added:  '(d) certain products used in animal nutrition.'  2. Article 2 shall be replaced by the following:  'Article 2  For the purposes of this Directive, straight feedingstuffs shall mean the various vegetable or animal products in their natural state, fresh or preserved, and products derived from the industrial processing thereof, as well as various organic or inorganic substances, whether or not containing additives, intended as such for oral animal feeding.'  3. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'.  Article 3  Directive 79/373/EEC is hereby amended as follows:  1. In Article 1 (2):  (a) point (c) shall be replaced by the following:  '(c) undesirable substances and products in animal nutrition;'  (b) the following point shall be added:  '(f) certain products used in animal nutrition.'  2. In Article 2:  (a) the text of points (a) and (b) shall be replaced by the following:  '(a) Feedingstuffs: products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding.  (b) Compound feedingstuffs: mixtures of products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, or of organic or inorganic substances, whether or not containing additives, for oral animal feeding in the form of complete feedingstuffs or complementary feedingstuffs.'  (b) the following points shall be added:  '(j) Milk replacer feeds: compound feedingstuffs administered in dry form or after dilution in a given quantity of liquid for feeding young animals as a supplement to, or substitute for, post-colostral milk or for feeding calves intended for slaughter.  (k) Ingredients (raw materials): various products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended to be entered for circulation as straight feedingstuffs or for the preparation of compound feedingstuffs or as carriers of premixtures.'  3. In Article 5:  (a) paragraph 1, point (a) shall be replaced by the following:  '(a) the description "complete feedingstuff", "complementary feedingstuff", "mineral feedingstuff", "molassed feedingstuff", "complete milk replacer feed", "complementary milk replacer feed", as appropriate;'  (b) in paragraph 4 the following point shall be added:  '(g) the name or business name and address or registered place of business of the producer, where the latter is not responsible for the labelling particulars;'  (c) the following paragraph shall be inserted:  '4a. Member States shall be authorized, for feedingstuffs produced and marketed in their territory, to prescribe instead of the particulars referred to in Article 5 (4) (g) indication of an official code number corresponding to the producers established in their territory.'  (d) in paragraph 5 the following point shall be added:  '(h) an indication of the physical condition of the feedingstuff or the specific processing it has undergone.'  (e) the following paragraph shall be inserted:  '7a. Paragraph 7 shall not apply where ingredients (raw materials) must be mentioned on the label of compount feedingstuffs pursuant to Directive 82/471/EEC.'  (f) paragraph 8 shall be supplemented by the following subparagraph:  'Such information  - may not mislead the purchaser in particular by attributing to the feedingstuff effects or properties that it does not possess or by suggesting that it possesses special characteristics when in fact all similar feedingstuffs possess such characteristics,  - must relate to objective or quantifiable factors which can be substantiated.' 4. The following Articles shall be inserted:  'Article 5a  In English, 'complementary feedingstuff' and 'complete feedingstuff' may be replaced, in the case of feedingstuff for pets, respectively by 'complementary pet food' and 'complete pet food'.  Article 5b  Without prejudice to the provisions of Article 5, Member States shall stipulate that the labelling of compound feedingstuffs for pet animals may draw particular attention to the presence or low content of one or more ingredients that are essential for the characteristics of the feedingstuff. In such case the minimum or maximum content, expressed in terms of the percentage by weight of the ingredient(s) incorporated, must be clearly indicated either opposite the statement drawing particular attention to it or them or in the list of ingredients or by mentioning it or them and the percentage(s) by weight concerned opposite the corresponding category of ingredients.'  5. 'Alimenti per animali' throughout the Directive in the Italian text shall be replaced by 'mangimi'.  Article 4  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 3 December 1988. They shall forthwith inform the Commission thereof.  Article 5  This Directive is addressed to the Member States.  Done at Brussels, 21 July 1986.  For the Council  The President  G. HOWE  (1) OJ No C 258, 26. 9. 1984, p. 7.  (2) OJ No C 175, 15. 7. 1985, p. 21.  (3) OJ No C 87, 9. 4. 1985, p. 4.  (4) OJ No L 38, 11. 2. 1974, p. 31.  (5) OJ No L 32, 3. 2. 1977, p. 1.  (6) OJ No L 86, 6. 4. 1979, p. 30.  (7) OJ No L 189, 11. 7. 1986, p. 40.  (8) OJ No L 56, 3. 3. 1983, p. 31.  (9) OJ No L 386, 31. 12. 1982, p. 42.  (10) OJ No L 319, 29. 11. 1984, p. 13.  (11) OJ No L 213, 21. 7. 1982, p. 8.


title: Commission Directive 2010/8/EU of 9 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto (Text with EEA relevance)

text:
               10.2.2010

               EN

               Official Journal of the European Union

               L 37/37

         COMMISSION DIRECTIVE 2010/8/EU
   of 9 February 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin sodium as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes warfarin sodium.

               (2)

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

               (3)

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

               (4)

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

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (11)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing warfarin sodium to ensure that they comply with Directive 98/8/EC.

               (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
   1.   Member States shall adopt and publish, by 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      The following entry for the substance warfarin sodium is added in Annex I to Directive 98/8/EC:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘33

                     Warfarin sodium

                     Sodium 2-oxo-3-(3-oxo-1-phenylbutyl)chromen-4-olate
                     EC No: 204-929-4
                     CAS No: 129-06-6

                     910 g/kg

                     1 February 2012

                     31 January 2014

                     31 January 2017

                     14

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

                                 1.

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

                                 2.

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

                                 3.

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

         (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


Avis juridique important

|

31995L0009

Commission Directive 95/9/EC of 7 April 1995 amending Directive 94/39/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (Text with EEA relevance)

Official Journal L 091 , 22/04/1995 P. 0035 - 0038

COMMISSION DIRECTIVE 95/9/EC of 7 April 1995 amending Directive 94/39/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes (1), and in particular Article 6 (c) thereof,Whereas Article 6 (c) of Directive 93/74/EEC provides that the measures adopted according to Article 6 (a) may be adjusted to developments in scientific and technical knowledge; whereas those measures have been adopted by Commission Directive 94/39/EC (2);Whereas certain nutritional purposes could not at first be included in the list of intended uses of animal feedingstuffs for particular nutritional purposes owing to the absence at the time of Community methods for calculating the energy value of pet foods;Whereas a method for calculating that energy value has now been adopted at Community level and the said nutritional purposes can therefore be included in the list;Whereas, furthermore, the list of particular nutritional purposes adopted for equines should be adapted and supplemented on the basis of available data;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The Annex to Directive 94/39/EC is amended in accordance with the Annex to this Directive.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 30 June 1995. They shall immediately inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall communicate to the Commission the text of the essential provisions of national law which they adopt in the field covered by this Directive.Article 3 This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 7 April 1995.For the CommissionFranz FISCHLERMember of the Commission(1) OJ No L 237, 22. 9. 1993, p. 23.(2) OJ No L 207, 10. 8. 1994, p. 20.ANNEX 1. In Part B, after the nutritional purpose 'Reduction of copper in the liver` for dogs and cats, the following nutritional purposes are inserted:>TABLE>2. In part B, the text of the particular nutritional purposes concerning equines is replaced by the following text:>TABLE>


Avis juridique important

|

31995L0022

Council Directive 95/22/EC of 22 June 1995 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products

Official Journal L 243 , 11/10/1995 P. 0001 - 0006

COUNCIL DIRECTIVE 95/22/ECof 22 June 1995amending Directive 91/67/EEC concerning the  animal health conditions governing the placing on the market of aquaculture animals and  productsTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/67/EEC of 28 January 1991 concerning the animal health  conditions governing the placing on the market of aquaculture animals and products (1), and in  particular Article 25 (2) thereof, Having regard to the proposal from the Commission, Whereas due weight should be given to certain scientific and technical developments in respect of  the approval of zones with regard to infectious haematopoietic necrosis (IHN) and viral  haemorrhagic septicaemia (VHS); Whereas the criteria for granting approved status to these zones should be adjusted in  consequence; Whereas in the light of experience the administrative procedures for granting approved status to  zones or parts of zones and for the suspension, restoration and withdrawal of approval of these  zones or parts of zones should also be adjusted; Whereas farms, although situated in a non-approved zone with regard to IHN and VHS, may in  accordance with the requirements laid down in Annex CIA to Directive 91/67/EEC obtain approved  status with regard to the said diseases; Whereas it appears necessary, in order to ensure better protection against the introduction of IHN  and VHS, to define more precisely the criteria which must be applied for granting approved status  to fish farms; Whereas these criteria must include details on the water supply of the farms, on the level of  testing carried out prior to approval of the farm, and on protective measures against the possible  introduction of disease, HAS ADOPTED THIS DIRECTIVE: Article 1Directive 91/67/EEC is hereby amended as follows: A. In Annex B: (a) point I.B.2. shall be replaced by the following: '(2) All farms in the continental zone are placed under the supervision of the official services.  Two health inspections per year for four years must have been carried out. The health inspections must have been carried out at the times of the year when the water  temperature favours the development of these diseases. The health inspection must at least consist  of: - an inspection of fish showing abnormalities, - the taking of samples in accordance with a programme established under the procedure provided for  in Article 15, which are to be sent as quickly as possible to an approved laboratory to be tested  for the pathogens in question. However, zones having a historical record of absence of the diseases referred to in Annex A, column  1, list II, may obtain approved status if: (a) their geographical situation does not permit easy introduction of disease; (b) an official disease control system has been in place for an extended period of time of at least  ten years, during which: - there has been regular monitoring of all farms, - a disease notification system has been applied, - no case of disease has been reported, - under the rules in force, only fish eggs or gametes from non-infected zones or farms, subject to  official checks and presenting equivalent health guarantees, were able to be introduced into the  zone. The period of 10 years referred to in the first subparagraph may be reduced to five years as a  result of the testing carried out by the official service of the requesting Member State, provided  that, in addition to the requirements referred to in the first subparagraph, the regular monitoring  of all farms referred to above has included at least two health inspections per year involving at  least: - an inspection of fish showing abnormalities, - a taking of samples of at least 30 fish at each visit. Member States wishing to benefit from the provisions relating to historical records must submit  their request no later than 31 December 1996.'; (b) under I.B, the following point shall be added: '(5) Where a Member State has requested approval for a water catchment area or part of a water  catchment area originating in a neighbouring Member State, or common to two Member States, the  following provisions shall apply: - the two Member States concerned should simultaneously submit a request for approval in accordance  with the procedures laid down in Articles 5 or 10, - the Commission, in accordance with the procedure laid down in Article 26, after examining and  checking the requests and evaluating the health situation, shall, if need be, lay down any other  provisions necessary for granting such approval. The Member States, in accordance with Directive 89/608/EEC (1), shall grant each other mutual  assistance for the application of this Directive, and in particular of this paragraph; (1) OJ No L 351, 2. 12. 1989, p. 34.'; (c) point I.D.1., the last sentence shall be replaced by the following: 'The latter shall immediately suspend approval of the zone or of part of the zone, provided that  the part of the zone which still has approved status continues to meet the definition in point  A.'; (d) point I.D.5. shall be replaced by the following: '(5) Where the results are positive, the official service shall withdraw approval of the zone, part  of the zone referred to in point 1.'; (e) the introductory sentence of point I.D.6. shall be replaced by the following: '(6) Restoration of approval of a zone or part of a zone referred to in point 1 is subject to the  following requirements:'; (f) point I.D.7. shall be replaced by the following: '(7) The central competent authority shall inform the Commission and the other Member States  regarding the suspension, restoration or withdrawal of approval of zones, or parts of zones  referred to in point 1.'; (g) point II.A shall be replaced by the following: 'A. A coastal zone consists of a part of the coast or sea water or an estuary with a precise  geographical delimitation which consists of a homogeneous hydrological system or a series of such  systems. If necessary, a coastal zone may be deemed to consist of a part of the coast or sea water  or an estuary situated between the mouths of two watercourses or of a part of the coast or sea  water or an estuary where there are one or more farms, provided that provision is made for a buffer  zone on both sides of the farm or farms, the extent of which shall be set by the Commission on a  case-by-case basis in accordance with the procedure laid down in Article 26.'; (h) point II.D shall be replaced by the following: 'D. Suspension, restoration and withdrawal of approval. The rules are identical to those set out in point I.D; however, where the zone is composed of a  series of hydrological systems, suspension, restoration and withdrawal of approval may relate to a  part of this series where this part has a precise geographical delimitation and consists of a  homogeneous hydrological system, provided that the part which still has approved status continues  to meet the definition in point A.'; (i) the last sentence of point III.D.1. shall be replaced by the following: 'The latter shall immediately suspend approval of the zone or, if the zone is composed of a series  of hydrological systems, of part of that series where such part has a precise geographical  delimitation and consists of a homogeneous hydrological system, provided that the part which still  has approved status continues to meet the definition in point A.'; (j) point III.D.5. shall be replaced by the following: '(5) Where the results are positive, the official service shall withdraw approval of the zone or  part of the zone as referred to in point 1.'; (k) the introductory sentence of point III.D.6. shall be replaced by the following: '(6) Restoration of approval of a zone or part of a zone as referred to in point 1 is subject to  the following requirements:'; (l) point III.D.7. shall be replaced by the following: '(7) The central competent authority shall inform the Commission and the other Member States  regarding suspension, restoration or withdrawal of approval of zones or parts of zones referred to  in point 1.'; B. In Annex C: (a) point I.A. shall be replaced by the following: 'A. Grant of approvalIn order to be approved a farm must meet the following requirements: (1) water must be supplied by a well, a borehole or a spring. Where such water supply is situated  at a distance from the farm, the water must be supplied directly to the farm, and be channelled  through a pipe or, with the agreement of the official service, via an open channel or a natural  conduit, provided that this does not constitute a source of infection for the farm and does not  allow the introduction of wild fish. The water channel must be under the control of the farm or, in  cases where this is not possible, the official service; (2) there must be a natural or artificial barrier situated downstream which prevents fish from  entering the said farm; (3) if necessary, it must be protected against flooding and infiltration of water; (4) it must comply, mutatis mutandis, with the requirements set out in Annex B.I.B. Furthermore,  where approval is requested on the basis of a historical record with an official control system for  a 10-year period, it must meet the following additional requirements: - it must have been submitted, at least once per year, to a clinical inspection and the taking of  samples to be tested for the pathogens in question in an approved laboratory; (5) it may be the subject of additional measures imposed by the official service, when considered  necessary to prevent the introduction of diseases. Such measures may include the establishment of a  buffer zone around the farm in which a monitoring programme is carried out, and the establishment  of protection against the intrusion of possible pathogen carriers or vectors; (6) However: (a) a new farm which meets the requirements referred to in 1, 2, 3 and 5, but which commences its  activities with fish, eggs or gametes from an approved zone or an approved farm situated in a  non-approved zone may obtain approval without undergoing the sampling required for the grant of  approval; (b) a farm which meets the requirements referred to in 1, 2, 3 and 5, which recommences its  activities after a break with fish, eggs or gametes from an approved zone or an approved farm  situated in a non-approved zone may obtain approval without undergoing the sampling required for  the grant of approval provided that: - the health history of the farm over the last four years of its operation is known to the official  service; however, if the farm concerned has been in operation for less than four years, the actual  period in which it has been in operation shall be taken into account, - the farm has not been subject to animal-health measures in respect of the diseases listed in list  II of Annex A and there have been no antecedents of those diseases on the farm, - prior to the introduction of the fish, eggs or gametes, the farm is cleaned and disinfected,  followed by depopulation for a minimum period of 15 days under official supervision.'; (b) point II.A.1. shall be replaced by the following: '1. it must be supplied with water by means of a system which includes equipment for the  destruction of the agents of the diseases referred to in Annex A, column 1, list II; the criteria  required for the uniform application of these provisions and in particular those relating to the  proper functioning of the system shall be laid down in accordance with the procedure provided for  in Article 26;'; (c) the following point shall be added to point II.A: '3. However: (a) a new farm which meets the requirements referred to in 1 and 2, but which commences its  activities with fish, eggs or gametes from an approved zone or an approved farm situated in a  non-approved zone may obtain approval without undergoing the sampling required for the grant of  approval; (b) a farm which meets the requirements referred to in 1 and 2, which recommences its activities  after a break with fish, eggs or gametes from an approved zone or an approved farm situated in a  non-approved zone may obtain approval without undergoing the sampling required for the grant of  approval provided that: - the health history of the farm over the last four years of its operation is known to the official  service; however, if the farm concerned has been in operation for less than four years, the actual  period in which it has been in operation shall be taken into account, - the farm has not been subject to animal-health measures in respect of the diseases listed in list  II of Annex A and there have been no antecedents of those diseases on the farm, - prior to introduction of the fish, eggs or gametes, the farm is cleaned and disinfected, followed  by depopulation for a minimum period of 15 days under official supervision.'; (d) point III.A.1. shall be replaced by the following: '(1) it must be supplied with water by means of a system which includes equipment for the  destruction of the agent of the diseases referred to in Annex A, column 1, list II; the criteria  required for the uniform application of these provisions and in particular those relating to the  proper functioning of the system shall be laid down in accordance with the procedure provided for  in Article 26.'; (e) the following point shall be added to point III.A: '(3) However: (a) a new farm which meets the requirements referred to in 1 and 2, but which commences its  activities with molluscs from an approved zone or an approved farm situated in a non-approved zone  may obtain approval without undergoing the sampling required for the grant of approval; (b) a farm which meets the requirements referred to in 1 and 2, which recommences its activities  after a break with molluscs from an approved zone or an approved farm situated in a non-approved  zone may obtain approval without undergoing the sampling required for the grant of approval  provided that: - the health history of the farm over the last two years of its operation is known to the official  service, - the farm has not been subject to animal-health measures in respect of the diseases listed in list  II of Annex A and there have been no antecedents of those diseases on the farm, - prior to the introduction of the molluscs, the farm is cleaned and disinfected, followed by  depopulation for a minimum period of 15 days under official supervision.'Article 21. Member  States shall bring into force the laws, regulations and administrative provisions necessary to  comply with this Directive before 1 July 1996. They shall forthwith notify 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 text of the main provisions of national  law which they adopt in the field governed by this Directive. Article 3This Directive shall enter into force on the 20th day after that of its publication in  the Official Journal of the European Communities. Article 4This Directive is addressed to the Member States. Done at Brussels, 22 June 1995. For the CouncilThe PresidentPh. VASSEUR(1) OJ No L 46, 19. 2. 1991, p. 1.  Directive as last amended by Directive 93/54/EEC (OJ No L 175, 19. 7. 1993, p. 34).


title: Commission Directive 2010/5/EU of 8 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include acrolein as an active substance in Annex I thereto (Text with EEA relevance)

text:
               9.2.2010

               EN

               Official Journal of the European Union

               L 36/24

         COMMISSION DIRECTIVE 2010/5/EU
   of 8 February 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include acrolein 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 Article 11(4) thereof,
   Whereas:

               (1)

               The United Kingdom has received on 18 August 2006 an application from Baker Petrolite, in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance acrolein in its Annex I for use in product-type 12, slimicides, as defined in Annex V to Directive 98/8/EC. Acrolein was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product.

               (2)

               After carrying out an evaluation, the United Kingdom submitted its report, together with a recommendation, to the Commission on 16 March 2009.

               (3)

               The report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 17 September 2009, and the findings of the review were incorporated in an assessment report.

               (4)

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

               (5)

               Not all potential uses have been evaluated at the Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to compartments and populations 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.

               (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 acrolein used as slimicides.

               (7)

               In particular, it is appropriate to require that products intended for industrial or professional use be used with appropriate personal protective equipment and that safe operational procedures are established such as the use of air monitoring and exclusion zones, unless it can be demonstrated that risks for industrial or professional users can be reduced by other means.

               (8)

               Appropriate measures should be taken to limit the risks to the marine environment, since unacceptable risks to this compartment have been identified during the evaluation. To this end, certain conditions should be imposed by the competent authorities when authorising the biocidal product, such as ensuring that waste water is monitored and, if necessary, treated before discharge, unless it can be demonstrated that risks for the environment can be reduced by other means.

               (9)

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

               (10)

               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
   1.   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2010 at the latest.
   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, 8 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      ANNEX
      The following entry for the substance acrolein is added in Annex I to Directive 98/8/EC:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘30

                     Acrolein

                     Acrylaldehyde
                     EC No: 203-453-4
                     CAS No: 107-02-8

                     913 g/kg

                     1 September 2010

                     Not applicable

                     31 August 2020

                     12

                     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, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Union level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 1.

                                 Waste waters containing acrolein shall be monitored prior to discharge, unless it can be demonstrated that risks for the environment can be reduced by other means. Where necessary in view of the risks to marine environment, waste waters shall be held in suitable tanks or reservoirs or appropriately treated before discharge.

                                 2.

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

         (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 2007/40/EC of 28 June 2007 amending Directive 2001/32/EC recognising protected zones exposed to particular plant health risks in the Community

text:
               29.6.2007

               EN

               Official Journal of the European Union

               L 169/49

      COMMISSION DIRECTIVE 2007/40/EC
   of 28 June 2007
   amending Directive 2001/32/EC recognising protected zones exposed to particular plant health risks in the Community
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the first subparagraph of Article 2(1)(h) thereof,
   Having regard to the requests made by the Czech Republic, Denmark, France and Italy,
   After consulting the Member States concerned,
   Whereas:

               (1)

               By Commission Directive 2001/32/EC (2), certain Member States or certain areas in Member States were recognised as protected zones in respect of certain harmful organisms.

               (2)

               Denmark was recognised as a protected zone with respect to Cryphonectria parasitica (Murrill) Barr. Following the results of the relevant surveys carried out in Denmark, Denmark has submitted information showing that an adequate phytosanitary protection of Denmark against Cryphonectria parasitica (Murrill) Barr does not require maintaining the status of Denmark as a protected zone against that organism and requested its protected zone status against Cryphonectria parasitica (Murrill) Barr be withdrawn. Denmark should therefore no longer be recognised as a protected zone in respect of that harmful organism.

               (3)

               From information supplied by the Czech Republic, France and Italy, the Czech Republic, the regions of Champagne-Ardenne, Lorraine and Alsace in France and the region of Basilicata in Italy should be recognised as protected zones in respect of Grapevine flavescence dorée MLO, because this pathogen is not present there.

               (4)

               Directive 2001/32/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   The Annex to Directive 2001/32/EC is amended as follows:

               1.

               in point (c)(01) ‘Denmark’ is deleted.

               2.

               the following point (d)(4) is added:

                                       ‘4.

                                       Grapevine flavescence dorée MLO

                           Czech Republic (until 31 March 2009), regions of Champagne-Ardenne, Lorraine and Alsace in France (until 31 March 2009), region of Basilicata in Italy (until 31 March 2009)’

         Article 2
   Member States shall adopt and publish by 31 October 2007 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 the Directive.
   They shall apply those provisions from 1 November 2007.
   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 a reference is to be made.
   Article 3
   This Directive shall enter into force on the 20th 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, 28 June 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2006/35/EC (OJ L 88, 25.3.2006, p. 9).

      (2)  OJ L 127, 9.5.2001, p. 38. Directive as last amended by Directive 2006/36/EC (OJ L 88, 25.3.2006, p. 13).


title: Commission Directive 2010/10/EU of 9 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include brodifacoum as an active substance in Annex I thereto (Text with EEA relevance)

text:
               10.2.2010

               EN

               Official Journal of the European Union

               L 37/44

         COMMISSION DIRECTIVE 2010/10/EU
   of 9 February 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include brodifacoum 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 brodifacoum.

               (2)

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

               (3)

               Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 5 June 2005 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 17 September 2009, in an assessment report.

               (5)

               It appears from the examinations made that biocidal products used as rodenticides and containing brodifacoum may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals and the environment. However, the target rodents are vermin and thus constitute a danger to public health. Moreover, it has not yet been established that adequate alternatives to brodifacoum exist, which are both equally effective and less damaging to the environment. It is therefore justified to include brodifacoum in Annex I for a limited period, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing brodifacoum can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

               (6)

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

               (7)

               Because of the identified risks and its characteristics, which render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, brodifacoum should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

               (8)

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

               (9)

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

               (10)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing brodifacoum to ensure that they comply with Directive 98/8/EC.

               (11)

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

               (12)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      The following entry for the substance brodifacoum is inserted in Annex I to Directive 98/8/EC:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘16

                     brodifacoum

                     3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydro-1-napthyl]-4-hydroxycoumarin
                     EC No: 259-980-5
                     CAS No: 56073-10-0

                     950 g/kg

                     1 February 2012

                     31 January 2014

                     31 January 2017

                     14

                     In view of the fact that the active substance characteristics render it potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance is to be subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in this Annex is renewed.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 1.

                                 The nominal concentration of the active substance in the products shall not exceed 50 mg/kg and only ready-for-use products shall be authorised.

                                 2.

                                 Products shall contain an aversive agent and, where appropriate, a dye.

                                 3.

                                 Products shall not be used as tracking powder.

                                 4.

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

         (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


Avis juridique important

|

31993L0069

Commission Directive 93/69/EEC of 23 July 1993 adapting to technical progress Council Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilizers

Official Journal L 185 , 28/07/1993 P. 0030 - 0042 Finnish special edition: Chapter 13 Volume 29 P. 0003  Swedish special edition: Chapter 13 Volume 29 P. 0003

COMMISSION DIRECTIVE 93/69/EEC of 23 July 1993 adapting to technical progress Council Directive 76/116/EEC on the approximation of the laws of the Member States relating to fertilizersTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Directive 89/530/EEC (2), and in particular Article 9 (1) thereof,  Whereas Article 8a of the Treaty envisages an area without internal frontiers in which the free circulation of goods, persons, services and capital is assured;  Whereas Directive 76/116/EEC laid down rules for the marketing of EEC fertilizers;  Whereas new fertilizers need to be added to Annex I to Directive 76/116/EEC to enable them to be designated as 'EEC fertilizer'; whereas Council Directives 89/284/EEC (3) and 89/530/EEC supplementing and amending Directive 76/116/EEC both have specific  Annexes which have not been incorporated into Annex I to Directive 76/116/EEC; whereas, therefore, it is necessary to restructure Annex I to Directive 76/116/EEC to make it clearer and easier to read and understand;  Whereas, in view of the scope and effects of the proposed action, the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the stated objectives; whereas those objectives cannot be achieved  by Member States individually, and furthermore their attainment at Community level is already provided for by Directive 76/116/EEC;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Fertilizers,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annex I to Directive 76/116/EEC shall be amended as follows:  (a) the straight nitrogenous fertilizers listed in Annex I to this Directive shall be added to point 1 of Part A;  (b) the compound fertilizers listed in Annex II to this Directive shall be added to Part B;  (c) the fluid fertilizer listed in Annex III to this Directive shall be added to point 1 of Part C.  Article 2  1. Annex I to Directive 89/284/EEC shall become Part D of Annex I to Directive 76/116/EEC and shall be entitled 'Secondary nutrient fertilizers'.  2. The fertilizer listed in Annex IV to this Directive shall be added to Part D of Annex I to Directive 76/116/EEC.  Article 3  1. The Annex to Directive 89/530/EEC shall become Part E of Annex I to Directive 76/116/EEC and shall be entitled 'Trace element fertilizers'.  2. Chapter A in Part E of Annex I to Directive 76/116/EEC shall be replaced by Annex V to this Directive.  Article 4  1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 April 1994. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  2. Member States shall apply these provisions with effect from 1 May 1994.  Article 5  This Directive is addressed to the Member States.  Done at Brussels, 23 July 1993.  For the Commission Martin BANGEMANN Vice-President (1) OJ No L 24, 30. 1. 1976, p. 21.  (2) OJ No L 281, 30. 9. 1989, p. 116.  (3) OJ No L 111, 22. 4. 1989, p. 34.    ANNEX I  ANNEX I   A. STRAIGHT FERTILIZERS   1. NITROGENOUS FERTILIZERS    /* Tables: see OJ */      (1) Technical information as complete as possible must be provided with each package or bulk consignment by the person responsible for marketing. This information must in particular enable the user to determine the rates and timing of  application in relation to the crop being grown.    ANNEX II  ANNEX I   B. LIST OF COMPOUND FERTILIZER TYPES   1. NPK FERTILIZERS    /* Tables: see OJ */      2. NP FERTILIZERS    /* Tables: see OJ */      3. NK FERTILIZERS    /* Tables: see OJ */       ANNEX III  ANNEX I   C. FLUID FERTILIZERS   1. STRAIGHT FLUID FERTILIZERS    /* Tables: see OJ */       ANNEX IV  ANNEX I   D. SECONDARY NUTRIENT FERTILIZERS    /* Tables: see OJ */       ANNEX V  ANNEX I   E  Explanatory note: The following notes are applicable to the whole of part E.  Note 1: A chelating agent may be designated by means of its initials as set out in Chapter E.  Note 2: If the product leaves no solid residue after being dissolved in water it may be described as 'for dissolution'.  Note 3: Where a trace element is present in a chelated form, the pH range guaranteeing acceptable stability of the chelated fraction shall be stated.  CHAPTER A   FERTILIZERS CONTAINING ONLY ONE TRACE ELEMENT    /* Tables: see OJ */


title: Commission Directive 2010/9/EU of 9 February 2010 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 aluminium phosphide releasing phosphine to product type 18 as defined in Annex V thereto (Text with EEA relevance)

text:
               10.2.2010

               EN

               Official Journal of the European Union

               L 37/40

         COMMISSION DIRECTIVE 2010/9/EU
   of 9 February 2010
   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 aluminium phosphide releasing phosphine to product type 18 as defined in Annex V 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 aluminium phosphide.

               (2)

               Commission Directive 2009/95/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include aluminium phosphide releasing phosphine as an active substance in Annex I thereto (3) included aluminium phosphide as an active substance in Annex I to Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

               (3)

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

               (4)

               Germany was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 26 October 2007 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 17 September 2009, in an assessment report.

               (6)

               It appears from the examinations made that biocidal products used as insecticides and containing aluminium phosphide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include aluminium phosphide in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as insecticides and containing aluminium phosphide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

               (7)

               Not all potential uses have been evaluated at the Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations 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. In particular, where relevant, Member States should assess outdoor use, which has not been addressed in the Union level risk assessment.

               (8)

               In the light of the conclusions of the assessment report, it is appropriate to require that products containing aluminium phosphide and used as insecticides be authorised only for use by trained professionals in accordance with Article 10(2)(i)(e) of Directive 98/8/EC, and that specific risk mitigation measures are applied at product authorisation level to such products. Such measures should be aimed at limiting the risk of exposure of users to aluminium phosphide to an acceptable level.

               (9)

               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 (4) establishes maximum limits for aluminium phosphide residues which are present in or on food and feed. Pursuant to Article 3(2)(c) of Regulation (EC) No 396/2005, the maximum residue limits apply to any pesticide residues, including those which may arise as a result of use as a biocide. Member States should ensure that adequate residue trials are provided at product authorisation to allow consumer risk assessment. Furthermore, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005.

               (10)

               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 aluminium phosphide 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 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.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 18 containing aluminium phosphide to ensure that they comply with Directive 98/8/EC.

               (13)

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

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      (3)  OJ L 201, 1.8.2009, p. 54.

      (4)  OJ L 70, 16.3.2005, p. 1.

      ANNEX
      The following is added to entry ‘No 20’ in Annex I to Directive 98/8/EC:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘830 g/kg

                     1 February 2012

                     31 January 2014

                     31 January 2022

                     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 compartments and populations that have not been representatively addressed in the Union level risk assessment. In particular, where relevant, Member States shall assess outdoor use.
                     When granting product authorisation, Member States shall ensure that adequate residue trials are provided to allow consumer risk assessment and that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 1.

                                 Products shall only be supplied to and used by specifically trained professionals in the form of ready-for-use products.

                                 2.

                                 In view of the risks identified for operators, appropriate risk mitigation measures must be applied. Those include, amongst others, the use of appropriate personal and respiratory protective equipment, the use of applicators and the presentation of the product in a form designed to reduce the exposure of operators to an acceptable level. For indoor use, those include also the protection of operators and workers during fumigation, the protection of workers at re-entry (after fumigation period) and the protection of bystanders against leaking of gas.

                                 3.

                                 For products containing aluminium phosphide that may lead to residues in food or feed, labels and/or safety data sheets for authorised products must contain instructions for use, such as the adherence to waiting periods, which ensure compliance with the provisions laid down in Article 18 of Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 70, 16.3.2005, p. 1).’

         (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 2010/11/EU of 9 February 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin as an active substance in Annex I thereto (Text with EEA relevance)

text:
               10.2.2010

               EN

               Official Journal of the European Union

               L 37/47

         COMMISSION DIRECTIVE 2010/11/EU
   of 9 February 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include warfarin as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes warfarin.

               (2)

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

               (3)

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

               (4)

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

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (11)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing warfarin to ensure that they comply with 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
   1.   Member States shall adopt and publish, by 31 January 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 9 February 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      The following entry for the substance warfarin is added in Annex I to Directive 98/8/EC:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘32

                     Warfarin

                     (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin
                     EC No: 201-377-6
                     CAS No: 81-81-2

                     990 g/kg

                     1 February 2012

                     31 January 2014

                     31 January 2017

                     14

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

                                 1.

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

                                 2.

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

                                 3.

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

         (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