title: Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods (Text with EEA relevance)

text:
               6.10.2009

               EN

               Official Journal of the European Union

               L 262/40

      DIRECTIVE 2009/107/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 16 September 2009
   amending Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Article 16(1) of Directive 98/8/EC (3) provides for a transitional period of 10 years, commencing on 14 May 2000, the date of entry into force of that Directive, during which Member States may apply their national rules or practices for placing biocidal products on the market and, in particular, authorise the marketing of biocidal products containing active substances that are not yet included in the positive list set out in that Directive, that is Annexes I, IA or IB thereto.

               (2)

               Article 16(2) of Directive 98/8/EC establishes a 10-year work programme, also commencing on 14 May 2000, during which all the active substances contained in biocidal products that were present on the market before that date are to be systematically examined and, if found acceptable from the point of view of human and animal health and the environment, are to be included in the positive list set out in that Directive.

               (3)

               Paragraphs 1(c)(i) and 2(c)(i) of Article 12 of Directive 98/8/EC provide for the protection of all information submitted for the purposes of that Directive for a period of 10 years, also commencing on 14 May 2000, unless a shorter period of protection has been granted in a particular Member State, in which case that shorter period of protection will apply on its territory. That protection concerns only information submitted in support of the inclusion in the positive list set out in Directive 98/8/EC of active substances used in biocidal products that were present on the market before the date of entry into force of Directive 98/8/EC (the ‘existing’ active substances).

               (4)

               Once an existing active substance has been evaluated and included in the positive list set out in Directive 98/8/EC, its market is considered as harmonised, and the transitional rules for the placing on the market of products containing the active substance are replaced by the provisions of that Directive.

               (5)

               In accordance with Article 16(2) of Directive 98/8/EC, the Commission has submitted a report on the progress achieved with the 10-year work programme, two years before its completion. It is expected, based on the findings of that report, that the review of a significant number of active substances will not be finalised by 14 May 2010. Furthermore, even for the active substances for which a decision on their inclusion in the positive list set out in Directive 98/8/EC has been adopted by 14 May 2010, a sufficient time period is necessary for Member States to transpose the relevant acts and to grant, cancel or modify authorisations for the relevant products, in order to comply with the harmonised provisions of Directive 98/8/EC. There is a serious risk that, at the end of the transitional period on 14 May 2010, national rules will no longer apply, while the relevant harmonised rules will not yet have been adopted. An extension of the 10-year work programme is therefore considered necessary, to permit the finalisation of the review of all active substances notified for evaluation.

               (6)

               It is also necessary for the end of the review programme to coincide with that of the transitional period, in such a way that national systems or practices will regulate the placing of biocidal products on the market until they are ready to be replaced by harmonised provisions.

               (7)

               In addition, for reasons of consistency and in order to avoid the loss of data protection while certain active substances are still under evaluation, the period of protection of all data submitted for the purposes of Directive 98/8/EC should be extended in order to coincide with the end of the review programme.

               (8)

               The extension of the review programme proposed may not be enough to finalise the evaluation of a number of active substances. On the other hand, a significantly longer extension might work against intensifying the efforts to complete the review programme in a timely manner. Any extension of the review programme and the corresponding transitional period for any remaining active substances after 14 May 2014 should be limited to a maximum of two years and should take place only if there are clear indications that the legal act intended to replace Directive 98/8/EC will not enter into force before 14 May 2014.

               (9)

               The measures necessary for the implementation of Directive 98/8/EC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (4).

               (10)

               In particular, the Commission should be empowered to extend the review period and the corresponding transitional period for any remaining active substances for up to two years. Since those measures are of general scope and are designed to amend non-essential elements of Directive 98/8/EC, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (11)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (5), Member States are encouraged to draw up, for themselves and in the interests 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,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 98/8/EC is hereby amended as follows:

               1.

               Article 12 is amended as follows:

                           (a)

                           paragraph 1(c)(i) is replaced by the following:

                                       ‘(i)

                                       until 14 May 2014 for any information submitted for the purposes of this Directive, except where such information is already protected under existing national rules relating to biocidal products. In such cases, the information shall continue to be protected in that Member State until the expiry of any remaining period of data protection provided for under national rules, but not beyond 14 May 2014 or, if applicable, not beyond the date to which the transitional period referred to in Article 16(1) is extended in accordance with Article 16(2);’;

                           (b)

                           paragraph 2(c)(i) is replaced by the following:

                                       ‘(i)

                                       until 14 May 2014 for any information submitted for the purposes of this Directive, except in the case where data are already protected according to existing national rules relating to biocidal products, in which case such data shall be protected in that Member State until the expiry of any remaining period of data protection provided for under those national rules, but not beyond 14 May 2014 or, if applicable, not beyond the date to which the transitional period referred to in Article 16(1) is extended in accordance with Article 16(2);’;

               2.

               Article 16 is amended as follows:

                           (a)

                           paragraph 1 is replaced by the following:
                           ‘1.   By way of further derogating from Articles 3(1), 5(1), 8(2) and 8(4), and without prejudice to paragraphs 2 and 3 of this Article, a Member State may, until 14 May 2014, continue to apply its current system or practice of placing biocidal products on the market. If a decision to include an active substance in Annex I or IA sets a later date for compliance with Article 16(3) than 14 May 2014, this derogation shall continue to apply for products including that active substance until the date set in that decision. A Member State may, in particular, in accordance with its national rules, authorise the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I or IA for that product type. Such active substances must be on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d).’;

                           (b)

                           paragraph 2 is amended as follows:

                                       (i)

                                       the first subparagraph is replaced by the following:
                                       ‘2.   Following the adoption of this Directive, the Commission shall commence a 14-year work programme for the systematic examination of all active substances already on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). Regulations shall provide for the establishment and implementation of the programme, including the setting of priorities for the evaluation of the different active substances and a timetable. Those regulations, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4). Not later than two years before completion of the work programme, the Commission shall forward to the European Parliament and to the Council a report on progress achieved with the programme. Depending upon the conclusions of the report, it may be decided to extend the transitional period referred to in paragraph 1 and the 14-year period of the work programme for a period of no more than two years. That measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).’;

                                       (ii)

                                       in the second subparagraph the words ‘During that 10-year period’ are replaced by the words ‘During that 14-year period’.

         Article 2
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 May 2010. They shall forthwith inform the Commission thereof.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   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, 16 September 2009.

            For the European Parliament

            The President

         J. BUZEK

            For the Council

            The President

         C. MALMSTRÖM

      (1)  OJ C 182, 4.8.2009, p. 75.

      (2)  Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 27 July 2009.

      (3)  OJ L 123, 24.4.1998, p. 1.

      (4)  OJ L 184, 17.7.1999, p. 23.

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


title: Commission Directive 2010/72/EU of 4 November 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include spinosad as an active substance in Annex I thereto  Text with EEA relevance

text:
               5.11.2010

               EN

               Official Journal of the European Union

               L 288/20

         COMMISSION DIRECTIVE 2010/72/EU
   of 4 November 2010
   amending Directive 98/8/EC of the European Parliament and of the Council to include spinosad 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 spinosad.

               (2)

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

               (3)

               The Netherlands were designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 1 April 2008 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 27 May 2010, in an assessment report.

               (5)

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

               (6)

               Not all potential uses have been evaluated at EU 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 EU level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level. In particular, in the light of the identified adverse health effects for the unprotected professional user during application by spraying of biocidal products containing spinosad, it is appropriate to require at product authorisation level that products intended for professional use by spraying be used with appropriate personal protective equipment, unless it can be demonstrated that risks for industrial or professional users can be reduced by other means. Furthermore, in the light of the findings relating to possible indirect human exposure via consumption of food, it is appropriate to require, where relevant, verification of the need to set new or amended existing maximum residue levels (MRLs) and adoption of measures ensuring that the applicable MRLs are not exceeded.

               (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 spinosad 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.

               (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
   Transposition
   1.   Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 November 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, 4 November 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry for the substance spinosad 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)

                     ‘37

                     Spinosad

                     EC No: 434-300-1
                     CAS No: 168316-95-8
                     Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D.

                        Spinosyn A

                     (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-60-7

                        Spinosyn D

                     (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-63-0

                     850 g/kg

                     1 November 2012

                     31 October 2014

                     31 October 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 EU level risk assessment.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 —

                                 Authorisations shall be subject to appropriate risk mitigation measures. In particular, products authorised for professional use by spraying shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.

                                 —

                                 For products containing spinosad that may lead to residues in food or feed, Member States shall verify the need to set new and/or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 and/or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’

         (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 2009/1/EC of 7 January 2009 amending, for the purposes of its adaptation to technical progress, Directive 2005/64/EC of the European Parliament and of the Council on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability (Text with EEA relevance)

text:
               14.1.2009

               EN

               Official Journal of the European Union

               L 9/31

      COMMISSION DIRECTIVE 2009/1/EC
   of 7 January 2009
   amending, for the purposes of its adaptation to technical progress, Directive 2005/64/EC of the European Parliament and of the Council on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (1), and in particular the second subparagraph of Article 6(2) thereof,
   Whereas:

               (1)

               Directive 2005/64/EC is one of the separate Directives in the context of the EC type-approval procedure established under Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (2).

               (2)

               It is necessary to establish the detailed rules enabling to verify, in the framework of the preliminary assessment of the manufacturer referred to in Article 6 of Directive 2005/64/EC, whether the materials used for the construction of a vehicle type comply with the provisions of Article 4(2)(a) of Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (3).

               (3)

               In particular, it is appropriate to ensure that competent authorities are able to verify for the purpose of reusability, recyclability and recoverability the existence of contractual arrangements between the vehicle manufacturer concerned and his suppliers and that the requirements for this purpose contained in such arrangements are properly communicated.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress — Motor Vehicles,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2005/64/EC is amended by inserting a new paragraph 4 as follows:

                  ‘4.1.

                  For the purposes of preliminary assessment under Article 6 of Directive 2005/64/EC, the vehicle manufacturer shall be required to demonstrate that, through contractual arrangements with his suppliers, compliance with Article 4(2)(a) of Directive 2000/53/EC is ensured.

                  4.2.

                  For the purposes of preliminary assessment under Article 6 of Directive 2005/64/EC, the vehicle manufacturer shall be required to establish procedures for the following purposes:

                              (a)

                              to communicate the applicable requirements to his staff and to all of his suppliers;

                              (b)

                              to monitor and ensure that suppliers act in accordance with those requirements;

                              (c)

                              to collect the relevant data through the full supply chain;

                              (d)

                              to check and verify the information received from suppliers;

                              (e)

                              to react adequately where the data received from the suppliers indicate non-compliance with the requirements under Article 4(2)(a) of Directive 2000/53/EC.

                  4.3.

                  For the purposes of paragraph 4.1 and 4.2, the vehicle manufacturer shall be required to use, in agreement with the competent body, ISO 9000/14000 or other standardised quality assurance programme.’

   Article 2
   With effect from 1 January 2012, if the requirements laid down in Directive 2005/64/EC as amended by this Directive are not complied with, Member States, on grounds related to the reusability, recyclability and recoverability of motor vehicles, shall refuse to grant EC type-approval or national type-approval for new types of vehicles.
   Article 3
   1.   Member States shall adopt and publish, by 3 February 2010, 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.
   They shall apply those provisions from 4 February 2010.
   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 4
   This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 7 January 2009.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 310, 25.11.2005, p. 10.

      (2)  OJ L 42, 23.2.1970, p. 1.

      (3)  OJ L 269, 21.10.2000, p. 34.


Avis juridique important

|

31986L0081

Council Directive 86/81/EEC of 25 February 1986 amending, on account of the accession of Spain and Portugal, Directive 72/280/EEC on the statistical surveys to be carried out by Member States on milk and milk products

Official Journal L 077 , 22/03/1986 P. 0029 - 0029 Finnish special edition: Chapter 3 Volume 20 P. 0163  Swedish special edition: Chapter 3 Volume 20 P. 0163

*****COUNCIL  DIRECTIVE  of 25 February 1986  amending, on account of the accession of Spain and Portugal, Directive 72/280/EEC on the statistical surveys to be carried out by Member States on milk and milk products  (86/81/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to the Act of Accession of Spain and Portugal, and in particular Article 396 thereof,  Having regard to the proposal from the Commission,  Whereas Directive 72/280/EEC (1) as last amended by Regulation (EEC) No 3768/85 (2) has provided for surveys to be carried out by the Member States on milk production and milk products;  Whereas it is necessary to make certain technical amendments to the said Directive and in particular to define the Community's financial contribution to the expenses incurred by the new Member States for the surveys to be carried out in 1986, 1987 and 1988,  HAS ADOPTED THIS DIRECTIVE:  Article 1  With effect from 1 March 1986, Directive 72/280/EEC shall be amended as follows:  1. the following shall be added to Article 4 (3) (a):  'Spain: Comunidades autonomas  Portugal: Regiões';  2. the following subparagraph shall be added to Article 8:  'The expenses incurred by the Kingdom of Spain and the Portuguese Republic in carrying out the survey provided for by this Directive in 1986, 1987 and 1988 shall be charged as a fixed sum to the budget of the European Communities.'  Article 2  This Directive is addressed to the Member States.  Done at Brussels, 25 February 1986.  For the Council  The President  G. BRAKS  (1) OJ No L 179, 7. 8. 1972, p. 2.  (2) OJ No L 362, 31. 12. 1985, p. 8.