title: Commission Directive 2012/42/EU of 26 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include hydrogen cyanide as an active substance in Annex I thereto  Text with EEA relevance

text:
               27.11.2012

               EN

               Official Journal of the European Union

               L 327/31

         COMMISSION DIRECTIVE 2012/42/EU
   of 26 November 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include hydrogen cyanide 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 hydrogen cyanide.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, hydrogen cyanide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in the following product types, as defined in Annex V to that Directive: product type 8, wood preservatives, product type 14, rodenticides, and product type 18, insecticides, acaricides and products to control other arthropods.

               (3)

               The Czech Republic was designated as Rapporteur Member State and submitted three competent authority reports, including recommendations, to the Commission on 24 January 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority reports were 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 25 May 2012, in three assessment reports.

               (5)

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

               (6)

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

               (7)

               In view of the highly toxic and flammable properties of the active substance and the assumptions made during the risk assessment, it is appropriate to require that products are only authorised for use by professionals adequately trained to use them and that safe operational procedures during fumigation and venting are established for operators and bystanders, including the following requirements: products shall be used with adequate personal protective equipment including, where appropriate, self-contained breathing apparatus and gas-tight clothing; re-entry into fumigated spaces shall be prohibited until the air concentration has reached safe levels for operators and bystanders by ventilation; exposure during and after ventilation shall be prevented from exceeding safe levels for operators and bystanders by the establishment of a supervised exclusion zone; prior to fumigation, any food and any porous material with a potential to absorb the active substance, except wood intended to be treated, shall either be removed from the space to be fumigated or protected from absorption by adequate means, and the space to be fumigated shall be protected against accidental ignition.

               (8)

               The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product types 8, 14 and 18 containing the active substance hydrogen cyanide 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 to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (10)

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

               (11)

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

               (12)

               In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011 (3), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (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 30 September 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 October 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 26 November 2012.

            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 C 369, 17.12.2011, p. 14.

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

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum 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)

                     ‘60

                     hydrogen cyanide

                     hydrogen cyanide
                     EC No: 200-821-6
                     CAS No: 74-90-8

                     976 g/kg

                     1 October 2014

                     30 September 2016

                     30 September 2024

                     8, 14 and 18

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Member States shall ensure that authorisations of products for use as a fumigant are subject to the following conditions:

                                 (1)

                                 product shall only be supplied to and used by professionals adequately trained to use them;

                                 (2)

                                 safe operational procedures during fumigation and venting shall be established for operators and bystanders;

                                 (3)

                                 products shall be used with adequate personal protective equipment including, where appropriate, self-contained breathing apparatus and gas-tight clothing;

                                 (4)

                                 re-entry into fumigated spaces shall be prohibited until the air concentration has reached safe levels for operators and bystanders by ventilation;

                                 (5)

                                 exposure during and after ventilation shall be prevented from exceeding safe levels for operators and bystanders by the establishment of a supervised exclusion zone;

                                 (6)

                                 prior to fumigation, any food and any porous material with a potential to absorb the active substance, except wood intended to be treated, shall either be removed from the space to be fumigated or protected from absorption by adequate means, and the space to be fumigated shall be protected against accidental ignition.’

         (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

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31989L0520

Commission Directive 89/520/EEC of 6 September 1989 amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition

Official Journal L 270 , 19/09/1989 P. 0013 - 0014 Finnish special edition: Chapter 3 Volume 30 P. 0135  Swedish special edition: Chapter 3 Volume 30 P. 0135

*****COMMISSION  DIRECTIVE  of 6 September 1989  amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition  (89/520/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (1), as last amended by Directive 88/485/EEC (2), and in particular Article 6 thereof,  Whereas Directive 82/471/EEC provides for regular amendment of the Annex thereto as a result of developments in scientific or technical knowledge;  Whereas the study of a new product belonging to the amino acids group has shown that this product satisfies the requirements of Directive 82/471/EEC; whereas the use of this product in animal nutrition should, therefore, be permitted under certain conditions;  Whereas it has been found necessary to alter the composition characteristics and special provisions laid down in the Annex for 'Hydroxyanalogues of amino acids';  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 Anex to Directive 82/471/EEC is amended as set out in the Annex hereto.  Article 2  The Member State shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1990.  The provisions adopted pursuant to the first paragraph shall make express reference to this Directive.  They shall immediately inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 6 September 1989.  For the Commission  Ray MAC SHARRY  Member of the Commission  (1) OJ No L 213, 21. 7. 1982, p. 8.  (2) OJ No L 239, 30. 8. 1988, p. 36.  ANNEX  1. Under group 3.1. 'Methionine' the following product is added:  1.2.3.4.5.6.7 //  //  //  //  //  //  //  // 1   // 2   // 3  // 4   // 5   // 6   // 7   //    //   //   //   //   //   //  // Name of product group   // Name of product   // Designation of nuritive principle or identity of micro-organism  // Culture substrate (specifications, if any)   // Composition characteristics of product   // Animal species   // Special provisions   //    //   //   //   //   //   //   //  // '3.1.4. Concentrated liquid sodium DL-methionine technically pure  // (CH3 S(CH2)2-CH (NH2)-COO) Na   // -  // DL-methionine: minimum 40,0 % Sodium: minimum 6,2 %  // All animal species   // Declarations to be made on the label or packaging of the product: - the name 'concentrated liquid sodium-DL-methionine' - DL-Methionine content - moisture content'   //    //   //   //   //   //   //  2. Point 4 'hydroxyanologues of amino acids' is replaced by the following:  1.2.3.4.5.6.7 //  //  //  //  //  //  //  // 1   // 2   // 3  // 4   // 5   // 6   // 7   //    //   //   //   //   //   //  // Name of product group   // Name of product   // Designation of nuritive principle or identity of micro-organism  // Culture substrate (specifications, if any)   // Composition characteristics of product   // Animal species   // Special provisions   //    //   //   //   //   //   //   // '4. Hydroxy-analogues of amino acids  //  //  //  //  //  //  // 4.1. Hydroxy-analogue of methionine and its salts  //  //  //  //  //  //  //  // 4.1.1. DL-2-hydroxy-4- methylmercapto- butyric acid  // CH3-S-(CH2)2- CH(OH)-COOH   // -  // Total acids: minimum 85 % Monomer acid: minimum 65 %   //   //   //   // 4.1.2. Calcium salt of DL-2-hydroxy-4- methylmercapto- butyric acid  // (CH3-S-(CH2)2- CH(OH)-COO)2Ca   // -  // Monomer acid: minimum 83 % Calcium: minimum 12 %   //   //   //   //   //   //   //   // All animal species except ruminants   // Declarations to be made on the label or packaging of the product: - name (column 2) - monomer and total acids content in the case of 4.1.1, monomer content in the case of 4.1.2 - moisture content - animal species or categories Declarations to be made on the label or packaging of compound feedingstuffs: - name (column 2) - monomer and total acids content in the case of 4.1.1, monomer content in the case of 4.1.2 - the amount of the product contained in the feedingstuff'   //    //   //   //   //   //   //   //


title: Directive 2009/123/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2005/35/EC on ship-source pollution and on the introduction of penalties for infringements (Text with EEA relevance)

text:
               27.10.2009

               EN

               Official Journal of the European Union

               L 280/52

      DIRECTIVE 2009/123/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 21 October 2009
   amending Directive 2005/35/EC on ship-source pollution and on the introduction of penalties for infringements
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               The purpose of Directive 2005/35/EC (3) and of this Directive is to approximate the definition of ship-source pollution offences committed by natural or legal persons, the scope of their liability and the criminal nature of penalties that can be imposed for such criminal offences by natural persons.

               (2)

               On 23 October 2007 the Court of Justice of the European Communities annulled (4) Council Framework Decision 2005/667/JHA of 12 July 2005 to strengthen the criminal-law framework for the enforcement of the law against ship-source pollution (5), which had supplemented Directive 2005/35/EC with criminal-law measures. This Directive should fill the legal vacuum following the judgment.

               (3)

               Criminal penalties, which demonstrate social disapproval of a different nature than administrative sanctions, strengthen compliance with the legislation on ship-source pollution in force and should be sufficiently severe to dissuade all potential polluters from any violation thereof.

               (4)

               A consistent set of legislative measures has already been adopted at EU level to reinforce maritime safety and help prevent ship-source pollution. The legislation in question is addressed to flag States, ship owners and charterers, classification societies, port States and coastal States. The existing system of sanctions for illicit ship-source discharges of polluting substances, supplementing that legislation, needs to be further strengthened by the introduction of criminal penalties.

               (5)

               Common rules on criminal penalties make it possible to use more effective methods of investigation and effective cooperation within and between Member States.

               (6)

               The Member States should also apply effective, proportionate and dissuasive penalties to legal persons throughout the Community because frequently ship-source pollution offences are committed in the interest of legal persons or for their benefit.

               (7)

               The applicability of Directive 2005/35/EC should not be subject to exceptions other than those set out in this Directive. Therefore, certain categories of natural and legal persons, such as cargo owners or classification societies should be included in the scope of that Directive.

               (8)

               This Directive should oblige Member States to provide in their national legislation for criminal penalties in respect of those discharges of polluting substances to which this Directive applies. This Directive should not create obligations regarding the application of such penalties or any other available system of law enforcement, to individual cases.

               (9)

               Under this Directive, illicit ship-source discharges of polluting substances should be regarded as a criminal offence as long as they have been committed with intent, recklessly or with serious negligence and result in deterioration in the quality of water. Less serious cases of illicit ship-source discharges of polluting substances that do not cause deterioration in the quality of water need not be regarded as criminal offences. Under this Directive such discharges should be referred to as minor cases.

               (10)

               Given the need to ensure a high level of safety and protection of the environment in the maritime transport sector, as well as the need to ensure the effectiveness of the principle whereby the polluting party pays for the damage caused to the environment, repeated minor cases, which do not individually but in conjunction result in deterioration in the quality of water, should be regarded as a criminal offence.

               (11)

               This Directive is without prejudice to other liability systems for damage caused by ship-source pollution under Community, national or international law.

               (12)

               Jurisdiction with regard to criminal offences should be established in accordance with the national law of Member States and in accordance with their obligations under international law.

               (13)

               Member States should provide information to the Commission on the implementation of this Directive, in order to enable the Commission to evaluate its effect.

               (14)

               Since the objectives of this Directive cannot be sufficiently achieved by the Member States acting alone, by reason of the cross-border damage which may be caused by the behaviour concerned, and, by reason of scale and effects of the proposed action, can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

               (15)

               This Directive respects fundamental rights and complies with the principles recognised by Article 6 of the Treaty on European Union and reflected in the Charter of Fundamental Rights of the European Union.

               (16)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (6), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables, illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (17)

               Directive 2005/35/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 2005/35/EC
   Directive 2005/35/EC is hereby amended as follows:

               1.

               the title is replaced by the following:

               2.

               Article 1(1) is replaced by the following:
               ‘1.   The purpose of this Directive is to incorporate international standards for ship-source pollution into Community law and to ensure that persons responsible for discharges of polluting substances are subject to adequate penalties, including criminal penalties, in order to improve maritime safety and to enhance protection of the marine environment from pollution by ships.’;

               3.

               the following point is added to Article 2:

                           ‘5.

                           “Legal person” shall mean any legal entity in possession of such status under applicable national law, other than States themselves or public bodies in the exercise of State authority or public international organisations.’;

               4.

               Articles 4 and 5 are replaced by the following:
               ‘Article 4
               Infringements
               1.   Member States shall ensure that ship-source discharges of polluting substances, including minor cases of such discharges, into any of the areas referred to in Article 3(1) are regarded as infringements if committed with intent, recklessly or with serious negligence.
               2.   Each Member State shall take the necessary measures to ensure that any natural or legal person having committed an infringement within the meaning of paragraph 1 can be held liable therefor.
               Article 5
               Exceptions
               1.   A discharge of polluting substances into any of the areas referred to in Article 3(1) shall not be regarded as an infringement, if it satisfies the conditions set out in Annex I, Regulations 15, 34, 4,1 or 4,3 or in Annex II, Regulations 13, 3.1.1 or 3.1.3 of Marpol 73/78.
               2.   A discharge of polluting substances into the areas referred to in Article 3(1)(c), (d) and (e) shall not be regarded as an infringement for the owner, the master or the crew, if it satisfies the conditions set out in Annex I, Regulation 4,2 or in Annex II, Regulation 3.1.2 of Marpol 73/78.’;

               5.

               after Article 5 the following Articles are inserted:
               ‘Article 5a
               Criminal offences
               1.   Member States shall ensure that infringements within the meaning of Articles 4 and 5 are regarded as criminal offences.
               2.   Paragraph 1 shall not apply to minor cases, where the act committed does not cause deterioration in the quality of water.
               3.   Repeated minor cases that do not individually but in conjunction result in deterioration in the quality of water shall be regarded as a criminal offence, if committed with intent, recklessly or with serious negligence.
               Article 5b
               Inciting, aiding and abetting
               Member States shall ensure that any act of inciting, or aiding and abetting an offence committed with intent and referred to in Article 5a(1) and (3), is punishable as a criminal offence.’;

               6.

               Article 8 is replaced by the following:
               ‘Article 8
               Penalties
               Each Member State shall take the necessary measures to ensure that infringements within the meaning of Articles 4 and 5 are punishable by effective, proportionate and dissuasive penalties.’;

               7.

               after Article 8 the following Articles are inserted:
               ‘Article 8a
               Penalties against natural persons
               Each Member State shall take the necessary measures to ensure that the offences referred to in Article 5a(1), and (3) and Article 5b are punishable by effective, proportionate and dissuasive criminal penalties.
               Article 8b
               Liability of legal persons
               1.   Each Member State shall take the necessary measures to ensure that legal persons can be held liable for the criminal offences referred to in Article 5a(1) and (3) and Article 5b, committed for their benefit by any natural person acting either individually or as part of an organ of the legal person, and who has a leading position within the structure of the legal person, based on:

                           (a)

                           a power of representation of the legal person;

                           (b)

                           authority to take decisions on behalf of the legal person; or

                           (c)

                           authority to exercise control within the legal person.

                     2.   Each Member State shall also ensure that a legal person can be held liable where lack of supervision or control by a natural person referred to in paragraph 1 has made the commission of a criminal offence referred to in Article 5a(1) and (3) and Article 5b possible for the benefit of that legal person by a natural person under its authority.
               3.   The liability of a legal person under paragraphs 1 and 2 shall not exclude criminal proceedings against natural persons involved as perpetrators, inciters or accessories in the criminal offences referred to in Article 5a(1) and (3) and Article 5b.
               Article 8c
               Penalties against legal persons
               Each Member State shall take the necessary measures to ensure that a legal person held liable pursuant to Article 8b is punishable by effective, proportionate and dissuasive penalties.’.

         Article 2
   Transposition
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 16 November 2010. They shall forthwith communicate to the Commission the text of those measures.
   When they are adopted by Member States, those measures 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 Member States.
   Article 3
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 21 October 2009.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         C. MALMSTRÖM

      (1)  OJ C 77, 31.3.2009, p. 69.

      (2)  Opinion of the European Parliament of 5 May 2009 (not yet published in the Official Journal) and Council Decision of 14 September 2009.

      (3)  OJ L 255, 30.9.2005, p. 11.

      (4)  Case C-440/05 Commission v Council, ECR [2007] I-9097.

      (5)  OJ L 255, 30.9.2005, p. 164.

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


title: Commission Directive 2012/40/EU of 26 November 2012 correcting Annex I to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market  Text with EEA relevance

text:
               27.11.2012

               EN

               Official Journal of the European Union

               L 327/26

         COMMISSION DIRECTIVE 2012/40/EU
   of 26 November 2012
   correcting Annex I to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
   (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 Directive 2009/91/EC of 31 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include disodium tetraborate as an active substance in Annex I thereto (2) defines disodium tetraborate by three CAS numbers for three different forms of the substance. The CAS numbers are based on a report submitted to the Commission by the Netherlands on 7 July 2006 and endorsed by the Standing Committee on Biocidal Products on 20 February 2009.

               (2)

               The Netherlands have informed the Commission that the CAS number for the pentahydrate form in the original report was incorrect, and submitted a revised report to the Commission according to which the correct CAS number for this form is 12179-04-3. The revised report was endorsed by the Standing Committee on Biocidal Products on 25 May 2012.

               (3)

               Annex I to Directive 98/8/EC should therefore be corrected accordingly.

               (4)

               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 bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 26 November 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 201, 1.8.2009, p. 39.

      ANNEX
      In Annex I to Directive 98/8/EC, the third column of entry No 24 is replaced by the following:
      IUPAC name
      Identification numbers

         ‘disodium tetraborate
         EC No: 215-540-4
         CAS No (anhydrous): 1330-43-4
         CAS No (pentahydrate): 12179-04-3
         CAS No (decahydrate): 1303-96-4’


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31995L0070

Council Directive 95/70/EC of 22 December 1995 introducing minimum Community measures for the control of certain diseases affecting bivalve molluscs

Official Journal L 332 , 30/12/1995 P. 0033 - 0039

COUNCIL DIRECTIVE  95/70/ECof 22 December 1995introducing minimum Community measures for the control of certain  diseases affecting bivalve molluscsTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 43  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Whereas molluscs are listed in Annex II to the Treaty; whereas the marketing of molluscs  constitutes an important source of revenue for the aquaculture sector; Whereas the mollusc diseases referred to in Annex A, list II, 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 (3), have a very serious effect on the shellfish industry; whereas  other diseases having a similar effect occur in third countries, whereas a list of such diseases  should be drawn up and the Commission should be given the ability to adjust that list in the light  of developments in the animal-health field; Whereas an outbreak of such diseases can quickly take on epizootic proportions, causing mortality  and disturbances on a scale liable considerably to reduce the profitability of shellfish-farming; Whereas it is therefore necessary to establish at Community level the measures to be taken in the  event of outbreaks of disease, in order to ensure rational development of shellfish-farming and to  contribute to the protection of animal health in the Community; Whereas Member States should report to the Commission and the other Member States all cases of  abnormal mortality observed in bivalve molluscs; Whereas, in such an event, measures must be taken aimed at preventing the spread of the disease, in  particular with regard to the removal of live bivalve molluscs from the farms or zones concerned; Whereas a thorough epidemiological investigation is essential to determine the origin of the  disease and to prevent further spread; Whereas, in order to ensure an effective system of control, diagnosis of the diseases must be  harmonized and carried out under the auspices of responsible laboratories, the coordination of  which may be ensured by a reference laboratory designated by the Community; Whereas, in order to ensure uniform implementation of this Directive, a Community inspection  procedure should be established; Whereas common measures for the control of diseases form a minimum basis for maintaining a uniform  standard of animal health; Whereas the Commission should be entrusted with the task of adopting the necessary implementing  measures, HAS ADOPTED THIS DIRECTIVE: Article 1 This Directive establishes minimum Community measures for the control  of the diseases affecting bivalve molluscs referred to in this Directive. Article 2 1. For the purposes of this Directive, the definitions laid down in Article 2 of  Directive 91/67/EEC and Article 2 of Directive 91/492/EEC (4) shall apply as necessary. 2. In addition, 'observed abnormal mortality' shall mean sudden mortality affecting approximately  15 % of stocks and occurring over a short period between two inspections (confirmed within 15  days). In hatchery a mortality shall be considered abnormal when the farmer cannot obtain larvae  during a period which included successive spawns from different broodstocks. In nursery a mortality  shall be considered abnormal when a sudden sizeable mortality occurs in a short time on a number of  tubes. Article 3 Member States shall ensure that all farms rearing bivalve molluscs: 1. are registered by the official service; this registration must be kept constantly up to date; 2. keep a record of: (a) live bivalve molluscs entering the farm, containing all information relating to their delivery,  their number or weight, their size and their origin; (b) bivalve molluscs leaving the farm for reimmersion, containing all information relating to their  dispatch, their number or weight, their size and destination; (c) observed abnormal mortality. This record, which shall be open to scrutiny by the official service at all times, on demand, shall  be updated regularly and kept for four years. Article 4 1. Member States shall ensure that a monitoring and sampling programme is applied in  bivalve mollusc farms, farming areas and harvested natural beds in order to observe whether there  is an abnormal mortality and keep track of the health situation of stocks. In addition, the official service may apply the above programme to purification centres and storage  tanks which discharge water into the sea. If, during application of this programme, any abnormal mortality is observed, or if the official  service has information giving it reason to suspect the presence of diseases, the following  measures shall be taken: - a list shall be drawn up of the sites where the diseases referred to in Annex A, list II to  Directive 91/67/EEC are present, provided that such diseases are not the subject of a programme  approved pursuant to the aforementioned Directive, - a list shall be drawn up of the sites at which abnormal mortality has been observed as a result  of the presence of the diseases referred to in Annex D, or on which the official service has  information giving it reason to suspect the presence of diseases, - monitoring of the evolution and geographical spread of the diseases referred to in the first and  second indents. 2. The detailed rules for implementing this Article, and inter alia the rules to be applied for  establishing the programme referred to in paragraph 1, particularly as regards the frequency and  timetable of monitoring, procedures for taking samples (statistically representative volume) and  methods of diagnosis, shall be adopted in accordance with the procedure provided for in Article  10. Article 5 1. Member States shall ensure that the suspected presence of any diseases referred to  in Article 4 and any abnormal mortality rate observed in bivalve molluscs in farms, in farming  areas or in harvested natural beds or in purification centres or storage tanks which discharge  water into the sea is notified as soon as possible to the official service by the shellfish-farmers  or any other person who has made such observations. 2. In the case referred to in paragraph 1, the official service in the Member States shall ensure  that: (a) samples are taken for examination in an approved laboratory; (b) pending the result of the examination referred to in (a), no molluscs leave the affected farm,  farming area or harvested natural beds or purification centres or storage tanks which discharge  water into the sea for relaying or reimmersion in another farm or in the aquatic environment,  unless authorized by the official service. 3. If the examination referred to in paragraph 2 (a) fails to demonstrate the presence of a  pathogen, the restrictions referred to in paragraph 2 (b) shall be lifted. 4. If the examination referred to in paragraph 2 shows the presence of a pathogen causing the  observed abnormal mortality capable of being the cause of that mortality, or of a pathogen of one  of the diseases referred to in Article 4, an epizootic investigation must be carried out by the  official service in order to determine the possible means of contamination and to investigate  whether molluscs have left the farm, the farming area or the harvested natural beds for relaying or  reimmersion elsewhere during the period preceding observation of the abnormal mortality. If the epizootic investigation shows that the disease has been introduced into one or more farms,  farming areas or harvested natural beds as a result inter alia of molluscs being moved, the  provisions of paragraph 2 shall apply. However, by way of derogation from Article 3 (1) (c) of Directive 91/67/EEC, the official service  may, within its territory, authorize the movement of live bivalve molluscs to other farms, farming  areas or harvested natural beds which are infected with the same disease. If necessary, further appropriate measures may be decided on in accordance with the procedure in  Article 10. 5. The official service shall ensure that the Commission and the other Member States are  immediately informed, in accordance with the current Community procedures, of any cases of abnormal  mortality rates observed involving a pathogen, of any measures taken to analyse and control the  situation and of the cause of the mortality. Article 6 1. Sampling and laboratory testing for the determination of the cause of abnormal  mortality of bivalve molluscs shall be carried out using the methods established in accordance with  the procedure laid down in Article 10. 2. Member States shall ensure that in each Member State a national reference laboratory is  designated, with facilities and expert personnel enabling it to carry out the testing referred to  in paragraph 1. 3. By way of derogation from paragraph 2, Member States which do not have a national laboratory  competent in the matter may use the services of a national laboratory with competence in the matter  in another Member State. 4. The list of national reference laboratories for diseases of bivalve molluscs is set out in Annex  C. 5. National reference laboratories shall cooperate with the Community reference laboratory referred  to in Article 7. Article 7 1. The Community reference laboratory for diseases of bivalve molluscs is indicated in  Annex A. 2. Without prejudice to Decision 90/424/EEC of 26 June 1990 (1) on expenditure in the veterinary  field and in particular Article 28 thereof, the functions and duties of the laboratory referred to  in paragraph 1 shall be those laid down in Annex B. Article 8 1. Commission experts may, to the extent necessary to ensure uniform application of  this Directive, carry out on-the-spot checks. In so doing, they may carry out random,  non-discriminatory checks to ensure that the competent authority is monitoring compliance with the  requirements of this Directive. The Commission shall inform the Member States of the results of these checks. 2. The checks referred to in paragraph 1 shall be carried out in collaboration with the competent  authority. 3. The Member State in whose territory the inspections are carried out shall provide the experts  with any assistance they require to accomplish their task. 4. Detailed rules for the application of this Article shall be adopted in accordance with the  procedure laid down in Article 10. Article 9 Annex A shall be amended as necessary by the Council, acting by a qualified majority on  a proposal from the Commission. Annexes B, C and D may be amended as necessary in accordance with the procedure laid down in  Article 10. Article 10 1. Where the procedure laid down in this Article is to be followed, matters shall be  referred without delay to the Standing Veterinary Committee, (hereinafter referred to as 'the  Committee'), set up by decision 68/361/EEC (2), by its Chairman, either on his own initiative or at  the request of a Member State. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be  taken. The Committee shall deliver its opinion on the draft within the time limit which the  Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the  majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is  required to adopt on a proposal from the Commission. The votes of the representatives of the Member  States within the Committee shall be weighted in the manner set out in that Article. The Chairman  shall not vote. 3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion  of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no  opinion is delivered, the Commission shall, without delay, submit to the Council a proposal  relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months, from the date of referral to the Council, the  Council has not acted, the proposed measures shall be adopted by the Commission, save where the  Council has decided against the said measures by a simple majority. Article 11 By 31 December 1999 at the latest, the Commission shall submit a report to the Council  which has been drawn up, if necessary after consulting the Scientific and veterinary Committee,  taking account of experience acquired in applying this Directive and of technical and scientific  developments, accompanied where appropriate by any proposals for amendments. The Council shall act by a qualified majority on any such proposals. Article 12 1. Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive before 1 June 1997. They shall forthwith inform  the Commission thereof. When Member States adopt these provisions, 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 Member States. 2. However, from the date laid down in paragraph 1, Member States may, subject to the general rules  of the Treaty, maintain or apply for their production stricter provisions than those laid down by  this Directive. They shall notify the Commission of any such measure. 3. Member States shall communicate to the Commission the main provisions of national law which they  adopt in the field governed by this Directive. Article 13 This Directive shall enter into force on the 20th day following that of its  publication in the Official Journal of the European Communities. Article 14 This Directive is addressed to the Member States. Done at Brussels, 22 December 1995. For the CouncilThe PresidentL. ATIENZA SERNA(1) OJ No C 285, 13. 10. 1994,  p. 9. (2) OJ No C 109, 1. 5. 1995, p. 2. (3) OJ No L 46, 19. 2. 1991, p. 1. Directive as last amended by Directive 95/22/EC (OJ No L 243,  11. 10. 1995, p. 1). (4) Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the  production and the placing on the market of live bivalve molluscs (OJ No L 268, 24. 9. 1991, p. 1).  Directive as amended by the 1994 Act of Accession. (1) OJ No L 224, 18. 8. 1990, p. 19. Decision last amended by Decision 94/370/EC (OJ No L 168, 2.  7. 1994, p. 31). (2) OJ No L 255, 18. 10. 1968, p. 23.  ANNEX A COMMMUNITY REFERENCE LABORATORY FOR DISEASES OF BIVALVE MOLLUSCS IFREMERBoîte  Postale 13317390 La TrembladeFrance ANNEX B FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORATORY FOR DISEASES OF  BIVALVE MOLLUSCS The function and duties of the Community reference laboratory shall be: 1. to coordinate, in consultation with the Commission, the methods employed in Member States for  diagnosing diseases of bivalve molluscs, specifically by: (a) building up and retaining a collection of histological slides, strains or isolates of the  relevant pathogens and making these available to approved laboratories in the Member States; (b) organizing periodic comparative tests of diagnostic procedures at Community level; (c) collecting and collating data and information on the methods of diagnosis used and the results  of tests carried out in the Community; (d) characterizing isolates of pathogens by the most up-to-date and appropriate methods to allow  greater understanding of the epizootiology of the disease; (e) keeping abreast of developments in the surveillance, epizootiology and prevention of the  relevant diseases throughout the world; (f) retaining expertise on relevant disease pathogens to enable rapid differential diagnosis; 2. to assist actively in the diagnosis of disease outbreaks in Member States by receiving pathogen  isolates for confirmatory diagnosis, characterization and epizootic studies; 3. to facilitate the training or retraining of experts in laboratory diagnosis with a view to the  harmonization of diagnostic techniques throughout the Community; 4. to collaborate as regards methods of diagnosing exotic diseases, with the competent laboratories  in third countries where those diseases are prevalent.  ANNEX C NATIONAL REFERENCE LABORATORIES FOR DISEASES OF BIVALVE MOLLUSCS >TABLE  POSITION> ANNEX D >TABLE>