title: Commission Implementing Directive 2011/49/EU of 18 April 2011 amending Council Directive 91/414/EEC to include pencycuron as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               19.4.2011

               EN

               Official Journal of the European Union

               L 103/109

         COMMISSION IMPLEMENTING DIRECTIVE 2011/49/EU
   of 18 April 2011
   amending Council Directive 91/414/EEC to include pencycuron as active substance and amending Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included pencycuron.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of pencycuron.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to the Netherlands, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 4 December 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on pencycuron to the Commission on 24 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for pencycuron.

               (6)

               It has appeared from the various examinations made that plant protection products containing pencycuron may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include pencycuron in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit confirmatory information as regards the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron, the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron, the long-term risk to large omnivorous mammals.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing pencycuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               Decision 2008/934/EC provides for the non-inclusion of pencycuron and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning pencycuron in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning pencycuron in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   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.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing pencycuron as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to pencycuron are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing pencycuron as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning pencycuron. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing pencycuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing pencycuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 18 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance pencycuron. Summary: EFSA Journal 2010; 8(10):1828. [53 pp.]. doi:10.2903/j.efsa.2010.1828. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘354

                     Pencycuron
                     CAS No 66063-05-6
                     CIPAC No 402

                     1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea

                     ≥ 980 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pencycuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the protection of large omnivorous mammals.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (1)

                                 the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of pencycuron;

                                 (2)

                                 the fate and behaviour in natural surface water and sediment systems of the chlorophenyl and phenyl portions of pencycuron;

                                 (3)

                                 the long-term risk to large omnivorous mammals.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1), (2) and (3) by 31 May 2013.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Delegated Directive 2014/74/EU of 13 March 2014 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/82

         COMMISSION DELEGATED DIRECTIVE 2014/74/EU
   of 13 March 2014
   amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, (1) and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

               (2)

               Compliant pin connector systems are used in high speed digitizers, radiofrequency and wave signal sources, and wireless test equipment. Lead-free compliant pin connector systems are not yet used in industrial monitoring and control instruments (IMCIs). IMCIs have higher performance and reliability requirements than other electrical and electronic equipment, and the reliability of lead-free substitutes is not ensured under these conditions.

               (3)

               In order to allow manufacturers to make lead-free components technically practicable and to sufficiently demonstrate their reliability when used in IMCIs, the use of lead in other than C-press compliant pin connector systems for industrial monitoring and control instruments should therefore be exempted from the prohibition until 31 December 2020. In view of the innovation cycles for IMCIs this is a relatively short transition period which is unlikely to have adverse impacts on innovation.

               (4)

               In accordance with the repair-as-produced principle of Article 4(4) of Directive 2011/65/EU, which is meant to extend the lifetime of compliant products once placed on the market, spare parts shall benefit from this exemption past its end date without time limitations.

               (5)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2011/65/EU is amended as set out in 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 the last day of the sixth month after entry into force 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, 13 March 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 36 is added:

                     ‘36.

                     Lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments.
                     Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021.’


title: Commission Delegated Directive 2014/8/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/59

         COMMISSION DELEGATED DIRECTIVE 2014/8/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

               (2)

               The reliability of substitutes for lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards is not ensured.

               (3)

               Time is required for reliability testing and qualification of alternative solutions.

               (4)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2011/65/EU is amended as set out in 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 the last day of the sixth month after entry into force 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, 18 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 28 is added:

                  ‘28.

                  Lead in solders for mounting cadmium telluride and cadmium zinc telluride digital array detectors to printed circuit boards. Expires on 31 December 2017.’


title: Commission Delegated Directive 2014/15/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021 , provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/73

         COMMISSION DELEGATED DIRECTIVE 2014/15/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead, cadmium and hexavalent chromium in electrical and electronic equipment placed on the market.

               (2)

               The most commonly re-used medical parts are X-ray tubes, MRI coils, printed circuit boards from many different types of equipment, and detectors and components of detectors (e.g. radiation detectors). Some of these will contain small amounts of lead, cadmium and hexavalent chromium.

               (3)

               Comparing the environmental impacts of using refurbished parts in the above mentioned cases to those of substituting refurbished parts with new ones, demonstrates that the total negative environmental, health and consumer safety impacts of substitution would outweigh the total benefits thereof.

               (4)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2011/65/EU is amended as set out in 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 the last day of the sixth month after entry into force 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, 18 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 31 is added:

                  ‘31.

                  Lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021, provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer. Expires on 21 July 2021.’


title: Commission Delegated Directive 2014/4/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/51

         COMMISSION DELEGATED DIRECTIVE 2014/4/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

               (2)

               Lead is used in X-ray image intensifiers in order to enable vacuum tight connections between aluminium and steel.

               (3)

               The substitution of lead would lead to insufficiently reliable image intensifiers and must currently be considered as technically impracticable. In view of the health and safety of patients, the continued use of lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers is therefore still required.

               (4)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2011/65/EU is amended as set out in 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 the last day of the sixth month after entry into force 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, 18 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 24 is added:

                  ‘24.

                  Lead enabling vacuum tight connections between aluminium and steel in X-ray image intensifiers. Expires on 31 December 2019.’


title: Commission Implementing Directive 2014/20/EU of 6 February 2014 determining Union grades of basic and certified seed potatoes, and the conditions and designations applicable to such grades  Text with EEA relevance

text:
               7.2.2014

               EN

               Official Journal of the European Union

               L 38/32

      COMMISSION IMPLEMENTING DIRECTIVE 2014/20/EU
   of 6 February 2014
   determining Union grades of basic and certified seed potatoes, and the conditions and designations applicable to such grades
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (1), and in particular the first subparagraph of Article 3(3) thereof,
   Whereas:

               (1)

               Commission Directive 93/17/EEC (2) introduced rules concerning Union grades of basic seed potatoes.

               (2)

               Rapid technical and scientific developments in seed potato production systems and increased trade with seed potatoes in the internal market make it desirable that those rules are adapted. In view of the developments of the sector, such rules should also apply to certified seed potatoes.

               (3)

               Those rules should concern the designation of uniform Union grade names. They should also include conditions for the placing on the market of seed potatoes and lots of seed potatoes as any of the respective Union grades. Those conditions should concern, as appropriate, the presence of pests, potatoes belonging to other varieties, and potatoes with blemishes, shrivelling, soil or extraneous matter.

               (4)

               The requirement that the growing plant is raised in a production ground where three years have elapsed since potatoes were last grown, and that it is subject to a least two official inspections, is no longer necessary in view of the more stringent requirements for the Union grades set out in this Directive.

               (5)

               Since the adoption of Directive 2002/56/EC, scientific knowledge has developed concerning the link between the number of generations and the level of presence of pests of seed potatoes. Limiting the number of generations is a necessary way of mitigating the phytosanitary risk posed by pests in latent form. That limitation is necessary for the mitigation of that risk, and no other less stringent measures are available to replace it. Experience has shown that for the Union grades S, SE and E maximum numbers of generations should be allowed for each of those Union grades. In order to ensure compliance with the substantive requirements, those requirements should only be considered to be fulfilled on the basis of an official inspection.

               (6)

               Directive 93/17/EEC should therefore be repealed.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Union grades of basic seed potatoes
   1.   Member States shall ensure that basic seed potatoes may be marketed as ‘Union grade S’ if they fulfil the following conditions:

               (a)

               the potatoes have been found by official inspection to fulfil the conditions, as set out in point (1)(a) of Annex I; and

               (b)

               their lots have been found by official inspection to fulfil the conditions, as set out in point (1)(b) of that Annex.

         2.   Member States shall ensure that basic seed potatoes may be marketed as ‘Union grade SE’ if they fulfil the following conditions:

               (a)

               the potatoes have been found by official inspection to fulfil the conditions, as set out in point (2)(a) of Annex I; and

               (b)

               their lots have been found by official inspection to fulfil the conditions, as set out in point (2)(b) of that Annex.

         3.   Member States shall ensure that basic seed potatoes may be marketed as ‘Union grade E’ if they fulfil the following conditions:

               (a)

               the potatoes have been found by official inspection to fulfil the conditions, as set out in point 3(a) of Annex I; and

               (b)

               their lots have been found by official inspection to fulfil the conditions, as set out in point (3)(b) of that Annex.

         Article 2
   Union grades of certified seed potatoes
   1.   Member States shall ensure that certified seed potatoes may be marketed as ‘Union grade A’ if they fulfil the following conditions:

               (a)

               the potatoes have been found by official inspection to fulfil the conditions, as set out in point (1)(a) of Annex II; and

               (b)

               their lots have been found by official inspection to fulfil the conditions, as set out in point (1)(b) of that Annex.

         2.   Member States shall ensure that certified seed potatoes may be marketed as ‘Union grade B’ if they fulfil the following conditions:

               (a)

               the potatoes have been found by official inspection to fulfil the conditions, as set out in point (2)(a) of Annex II; and

               (b)

               their lots have been found by official inspection to fulfil the conditions, as set out in point (2)(b) of that Annex.

         Article 3
   Information to the Commission
   Member States shall inform the Commission of the extent to which they apply the respective Union grades in certifying their own production.
   Article 4
   Transposition
   1.   Member States shall adopt and publish, by 31 December 2015 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 1 January 2016.
   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 5
   Repeal
   Directive 93/17/EEC is repealed with effect from 1 January 2016.
   Article 6
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 7
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 6 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 193, 20.7.2002, p. 60.

      (2)  Commission Directive 93/17/EEC of 30 March 1993 determining Community grades of basic seed potatoes, together with the conditions and designations applicable to such grades (OJ L 106, 30.4.1993, p. 7).

      ANNEX I

         Conditions for basic seed potatoes

                  (1)

                  The conditions for basic seed potatoes of ‘Union grade S’ shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of plants not breeding true to the variety and the number of plants of a different variety shall, together, not exceed 0,1 %;

                                          (ii)

                                          the number of growing plants affected by blackleg shall not exceed 0,1 %;

                                          (iii)

                                          in the direct progeny, the number of plants with symptoms of virus infection shall not exceed 1,0 %;

                                          (iv)

                                          the number of growing plants with mosaic symptoms and the number of plants with symptoms caused by leaf roll virus shall, together, not exceed 0,2 %;

                                          (v)

                                          the number of generations, including pre-basic in the field and basic generations, shall be restricted to five;

                                          (vi)

                                          if the generation is not indicated on the official label, the potatoes concerned shall be considered as belonging to the fifth generation;

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,5 % by mass, of which seed potatoes affected by wet rot shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10 % of their surface shall not exceed 5,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10 % of their surface shall not exceed 3,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf shall not exceed 1,0 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          presence of earth and extraneous matter shall not exceed 1,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 6,0 % by mass.

                  (2)

                  The conditions for basic seed potatoes of ‘Union grade SE’ shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of plants not breeding true to the variety and the number of plants of a different variety shall, together, not exceed 0,1 %;

                                          (ii)

                                          the number of growing plants affected by blackleg shall not exceed 0,5 %;

                                          (iii)

                                          in the direct progeny the number of plants with symptoms of virus infection shall not exceed 2,0 %;

                                          (iv)

                                          the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 0,5 %;

                                          (v)

                                          the number of generations, including pre-basic in the field and basic generations, shall be restricted to six;

                                          (vi)

                                          if the generation is not indicated on the official label, the potatoes concerned shall be considered as belonging to the sixth generation;

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,5 % by mass, of which seed potatoes affected by wet rot shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10 % of their surface shall not exceed 5,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10 % of their surface shall not exceed 3,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf shall not exceed 1,0 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          presence of earth and extraneous matter shall not exceed 1,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 6,0 % by mass.

                  (3)

                  The conditions for basic seed potatoes of ‘Union grade E’ shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of growing plants not breeding true to the variety and the number of plants of a different variety shall, together, not exceed 0,1 %;

                                          (ii)

                                          the number of growing plants affected by blackleg shall not exceed 1,0 %;

                                          (iii)

                                          in the direct progeny the number of plants with symptoms of virus infection shall not exceed 4,0 %;

                                          (iv)

                                          the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 0,8 %;

                                          (v)

                                          the number of generations, including pre-basic in the field and basic generations, shall be restricted to seven;

                                          (vi)

                                          if the generation is not indicated on the official label, the potatoes concerned shall be considered as belonging to the seventh generation;

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,5 % by mass, of which seed potatoes affected by wet rot shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10 % of their surface shall not exceed 5,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10 % of their surface shall not exceed 3,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf shall not exceed 1,0 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          presence of earth and extraneous matter shall not exceed 1,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 6,0 % by mass.

      ANNEX II

         Minimum Conditions for certified seed potatoes

                  (1)

                  The conditions for certified seed potatoes of ‘Union grade A’ shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of plants not breeding true to the variety and the number of plants of a different variety shall, together, not exceed 0,2 %;

                                          (ii)

                                          the number of growing plants affected by blackleg shall not exceed 2,0 %;

                                          (iii)

                                          in the direct progeny the number of plants with symptoms of virus infection shall not exceed 8,0 %;

                                          (iv)

                                          the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 2,0 %;

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,5 % by mass, of which seed potatoes affected by wet rot shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10 % of their surface shall not exceed 5,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10 % of their surface shall not exceed 3,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf shall not exceed 1,0 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          presence of earth and extraneous matter shall not exceed 2,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 8,0 % by mass.

                  (2)

                  The conditions for certified seed potatoes of ‘Union grade B’ shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of plants not breeding true to the variety and the number of plants of a different variety shall, together, not exceed 0,5 %;

                                          (ii)

                                          the number of growing plants affected by blackleg shall not exceed 4,0 %;

                                          (iii)

                                          in the direct progeny the number of plants with symptoms of virus infection shall not exceed 10,0 %;

                                          (iv)

                                          the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 6,0 %;

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,5 % by mass, of which seed potatoes affected by wet rot shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10 % of their surface shall not exceed 5,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10 % of their surface shall not exceed 3,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf shall not exceed 1,0 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          presence of earth and extraneous matter shall not exceed 2,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 8,0 % by mass.


title: Commission Implementing Directive 2014/22/EU of 13 February 2014 amending Annex IV to Council Directive 2006/88/EC as regards infectious salmon anaemia (ISA)  Text with EEA relevance

text:
               14.2.2014

               EN

               Official Journal of the European Union

               L 44/45

      COMMISSION IMPLEMENTING DIRECTIVE 2014/22/EU
   of 13 February 2014
   amending Annex IV to Council Directive 2006/88/EC as regards infectious salmon anaemia (ISA)
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (1), and in particular Article 61(2) thereof,
   Whereas:

               (1)

               Directive 2006/88/EC lays down, inter alia, certain animal health rules applicable to aquaculture animals and products thereof, including specific provisions concerning the exotic and non-exotic diseases and species susceptible thereto, listed in Part II of Annex IV to that Directive.

               (2)

               Section B of Part I of Annex IV to Directive 2006/88/EC sets out the criteria to be fulfilled in order for a disease to be listed as a non-exotic disease in Part II of that Annex. Infectious salmon anaemia (ISA) is currently included in that list.

               (3)

               In May 2013 the World Organisation for Animal Health (OIE) amended Chapter 10.5. of the Aquatic Animal Health Code (OIE Aquatic Code) as regards ISA. According to the revised OIE Aquatic Code (16th Edition 2013), ISA is defined as an infection with genotype HPR-deleted or genotype HPR0 (non-deleted highly polymorphic region) of the genus Isavirus (ISAV) of the family Orthomyxoviridae. Furthermore, both genotypes are now notifiable in accordance with Article 1.3.1. and 10.5.1 of the OIE Aquatic Code. Before that revision no distinction was made between the two genotypes of ISAV.

               (4)

               Only infections with genotype HPR-deleted of the genus ISAV fulfil the criteria set out in Section B of Part I of Annex IV to Directive 2006/88/EC. Consequently, only infections with genotype HPR-deleted of the genus ISAV should be listed in Part II of Annex IV to Directive 2006/88/EC. For the purpose of Directive 2006/88/EC, infectious salmon anaemia (ISA) should therefore be defined as an infection with genotype HPR-deleted of the genus ISAV.

               (5)

               Part II of Annex IV to Directive 2006/88/EC should therefore be amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2006/88/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 15 November 2014 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 16 November 2014 at 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 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, 13 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 328, 24.11.2006, p. 14.

      ANNEX
      In Annex IV to Directive 2006/88/EC, Part II is replaced by the following:

         ‘PART II

            Listed diseases

                     Exotic diseases

                     Disease

                     Susceptible species

                     Fish

                     Epizootic haematopoietic necrosis

                     Rainbow trout (Oncorhynchus mykis) and redfin perch (Percha fluviatilis)

                     Molluscs

                     Infection with Bonamia exitiosa

                     Australian mud oyster (Ostrea angasi) and Chilean flat oyster (O. chilensis)

                     Infection with Perkinsus marinus

                     Pacific oyster (Crassostrea gigas) and Eastern oyster (C. virginica)

                     Infection with Microcytos mackini

                     Pacific oyster (Crassostrea gigas), Eastern oyster (C. virginica), Olympia flat oyster (Ostrea conchaphila) and European flat oyster (O. edulis)

                     Crustaceans

                     Taura syndrome

                     Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (P. styrlirostris), and Pacific white shrimp (P. vannamei)

                     Yellowhead disease

                     Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (P. duoranum), Kuruma prawn (P. japonicas), black tiger shrimp (P. monodon), Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (P. styrlirostris), and Pacific white shrimp (P. vannamei)

                     Non-exotic diseases

                     Fish

                     Viral haemorrhagic septicaemia (VHS)

                     Herring (Cupea spp.), whitefish (Coregonus sp.), pike (Esox Lucius), haddock (Gadus aeglefinus), Pacific cod (G. macrocephalus), Atlantic cod (G. morhua), Pacific salmon (Onchorhynchus spp.), rainbow trout (O. mykiss), rockling (Onos mustelus), brown trout (Salmo trutta), turbot (Schophtalmus maximus), sprat (Sprattus sprattus), grayling (Thymallus thymallus) and olive flounder (Paralichthys olivaceus)

                     Infectious haematopoetic necrosis (IHN)

                     Chum salmon (Oncorchynchus keta), coho salmon (O. kisutch), Masou salmon (O. masou), rainbow or steelhead trout (O. mykiss), sockeye salmon (O. nerka), pink salmon (O. rhodurus), Chinook salmon (O. tshawytscha), and Atlantic salmon (Salmo salar)

                     Koi herpes virus (KHV) disease

                     Common carp and koi carp (Cyprinus carpio)

                     Infectious salmon anaemia (ISA): infection with genotype HPR-deleted of the genus Isavirus (ISAV)

                     Rainbow trout (Oncorhynchus mykiss), Atlantic salmon (Salmo salar), and brown and sea trout (Salmo trutta)

                     Molluscs

                     Infection with Marteilia refringens

                     Australian mud oyster (Ostrea angsi), Chilean flat oyster (O. chilensis), European flat oyster (O. edulis), Argentinian oyster (O. pelchana), blue mussel (Mytilus edulis) and Mediterranean mussel (M. galloprovincialis)

                     Infection with Bonamia ostrea

                     Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), Olympia flat oyster (O. conchaphila), Asiatic oyster (O. denselammellosa), European flat oyster (O. edulis) and Argentinian oyster (O. puelchana)

                     Crustaceans

                     White spot disease

                     All decapod crustaceans (order Decapoda)’


title: Commission Implementing Directive 2014/21/EU of 6 February 2014 determining minimum conditions and Union grades for pre-basic seed potatoes  Text with EEA relevance

text:
               7.2.2014

               EN

               Official Journal of the European Union

               L 38/39

      COMMISSION IMPLEMENTING DIRECTIVE 2014/21/EU
   of 6 February 2014
   determining minimum conditions and Union grades for pre-basic seed potatoes
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (1), and in particular Article 18(c) thereof,
   Whereas:

               (1)

               Seed potatoes progressively accumulate diseases with each cycle of multiplication. Properly functioning seed potato production systems thus require healthy starting material that is multiplied with a minimal rate of degeneration.

               (2)

               Different national standards on the production of pre-basic seed potatoes have obstructed the marketing of those potatoes throughout the Union, and have impeded the functioning of the internal market. Therefore it is appropriate to establish minimum conditions under which pre-basic seed potatoes may be marketed throughout the Union. Those conditions should concern diseases, symptoms, defects and production requirements for pre-basic seed potatoes, and lots of those potatoes, to ensure the production and marketing of healthy and high quality pre-basic seed potatoes.

               (3)

               Those conditions should take into account the standard of United Nations Economic Commission for Europe (UNECE), concerning the marketing and commercial quality control of seed potatoes, as well as the relevant standards of the International Plant Protection Convention (IPPC) and the European and Mediterranean Plant Protection Organization (EPPO), in view of technical and scientific developments. Those standards aim at helping facilitate international trade, encouraging high quality production, improving profitability and protecting consumer interests.

               (4)

               In view of the production practices of suppliers, and the demand of the users of pre-basic seed potatoes, it is appropriate that the minimum conditions for pre-basic seed potatoes also include the possibility for marketing them as Union grades. Two Union grades should apply for pre-basic seed potatoes (‘Union grade PBTC’ and ‘Union grade PB’), in line with the existing production practices concerning pre-basic seed potatoes of grade PBTC, and pre-basic seed potatoes of grade PB. Different conditions per grade should thus be adopted concerning diseases, symptoms, defects, production requirements and generations for those grades.

               (5)

               In order to be effective, those rules should also set out provisions concerning official testing and official field inspections.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (1)

               ‘mother plant’ means an identified plant from which material is taken for propagation;

               (2)

               ‘micro-propagation’ means the practice of rapidly multiplying plant material to produce a large number of plants, using culture in vitro of differentiated vegetative buds or meristem taken from a plant.

         Article 2
   Minimum conditions for pre-basic seed potatoes
   1.   Member States shall ensure that pre-basic seed potatoes satisfy the following minimum conditions:

               (a)

               they derive from mother plants which are free from the following harmful organisms: Pectobacterium spp., Dickeya spp., Potato leaf roll virus, Potato virus A, Potato virus M, Potato virus S, Potato virus X, and Potato virus Y;

               (b)

               they are free from symptoms of blackleg;

               (c)

               the number of growing plants not breeding true to the variety and the number of plants of a different variety together, shall not exceed 0,01 %;

               (d)

               in the direct progeny, the number of plants showing symptoms of virus infection shall not exceed 0,5 %;

               (e)

               the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 0,1 %;

               (f)

               the maximum number of field generations shall be four.

         2.   Member States shall provide that pre-basic seed potatoes may be marketed as ‘Union grades PBTC’ and ‘Union grade PB’, in accordance with the conditions set out in the Annex.
   3.   Compliance with the requirements of paragraph 1(b), (c) and (e) shall be established through official field inspections. In case of doubt, those inspections shall be supplemented by official tests on leaves.
   Where methods of micro-propagation are used, compliance with point 1(a) shall be established by official testing, or testing under official supervision, of the mother plant.
   Where methods of clonal selection are used, compliance with point 1(a) shall be established by official testing, or testing under official supervision, of the clonal stock.
   Article 3
   Minimum conditions for lots of pre-basic seed potatoes
   Member States shall provide that lots of pre-basic seed potatoes shall satisfy the following minimum conditions:

               (a)

               presence of earth and extraneous matter shall not exceed 1,0 % by mass;

               (b)

               the number of potatoes affected by rots, other than ring rot or brown rot, shall not be present in a quantity exceeding 0,2 % by mass;

               (c)

               the number of potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

               (d)

               the number of potatoes affected by common scab over more than one third of their surface, shall not exceed 5,0 % by mass;

               (e)

               the number of potatoes affected by black scurf over more than 10,0 % of their surface, shall not exceed 1,0 % by mass;

               (f)

               the number of potatoes affected by powdery scab over more than 10,0 % of their surface, shall not exceed 1,0 % by mass;

               (g)

               shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf, shall not exceed 0,5 % by mass;

               (h)

               the total number of potatoes, as referred to in points (b) to (g), shall not exceed 6,0 % by mass.

         Article 4
   Transposition
   1.   Member States shall adopt and publish, by 31 December 2015 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 1 January 2016.
   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 5
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 6
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 6 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 193, 20.7.2002, p. 60.

      ANNEX

         Conditions for placing on the market of pre-basic seed potatoes as Union grades PBTC and PB

                  (1)

                  The conditions for pre-basic seed potatoes of Union grade PBTC shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          plants not breeding true to the variety, or plants of a different variety, shall not be present in the crop;

                                          (ii)

                                          plants affected by blackleg shall not be present in the crop;

                                          (iii)

                                          in the direct progeny, virus infection shall not be present in the crop;

                                          (iv)

                                          plants with mosaic symptoms or symptoms caused by leaf roll virus shall not be present in the crop;

                                          (v)

                                          the plants, including tubers, are produced through micro-propagation;

                                          (vi)

                                          the plants, including tubers, are produced in a protected facility and in a growing medium which is free from pests;

                                          (vii)

                                          tubers shall not be multiplied beyond the first generation.

                              (b)

                              lots shall be free from seed potatoes falling under any of the following points:

                                          (i)

                                          they are affected by rots;

                                          (ii)

                                          they are affected by black scurf;

                                          (iii)

                                          they are affected by common scab;

                                          (iv)

                                          they are affected by powdery scab;

                                          (v)

                                          they have become excessively shrivelled due to dehydration;

                                          (vi)

                                          they have external blemishes, including misshapen or damaged tubers.

                  (2)

                  The conditions for pre-basic seed potatoes of Union grade PB shall be as follows:

                              (a)

                              conditions concerning seed potatoes:

                                          (i)

                                          the number of plants not breeding true to the variety and the number of plants of a different variety together, shall not exceed 0,01 %;

                                          (ii)

                                          plants shall be free from symptoms of blackleg;

                                          (iii)

                                          the number of growing plants with mosaic symptoms or symptoms caused by leaf roll virus shall not exceed 0,1 %;

                                          (iv)

                                          in the direct progeny, the number of plants with symptoms caused by any virus, shall not exceed 0,5 %.

                              (b)

                              tolerances applicable to lots, as regards the following impurities, blemishes and diseases:

                                          (i)

                                          seed potatoes affected by rots, other than ring rot or brown rot, shall not exceed 0,2 % by mass;

                                          (ii)

                                          seed potatoes affected by black scurf over more than 10,0 % of their surface, shall not exceed 1,0 % by mass;

                                          (iii)

                                          seed potatoes affected by common scab over more than one third of their surface, shall not exceed 5,0 % by mass;

                                          (iv)

                                          seed potatoes affected by powdery scab over more than 10,0 % of their surface, shall not exceed 1,0 % by mass;

                                          (v)

                                          shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf, shall not exceed 0,5 % by mass;

                                          (vi)

                                          seed potatoes with external blemishes, including misshapen or damaged tubers, shall not exceed 3,0 % by mass;

                                          (vii)

                                          the presence of earth and extraneous matter shall not exceed 1,0 % by mass;

                                          (viii)

                                          the total percentage of seed potatoes covered by tolerances, as referred to in points (i) to (vi), shall not exceed 6,0 % by mass.


title: Commission Implementing Directive 2011/41/EU of 11 April 2011 amending Council Directive 91/414/EEC to include dithianon as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               12.4.2011

               EN

               Official Journal of the European Union

               L 97/38

         COMMISSION IMPLEMENTING DIRECTIVE 2011/41/EU
   of 11 April 2011
   amending Council Directive 91/414/EEC to include dithianon as active substance and amending Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included dithianon.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of dithianon.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to Greece, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Greece evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 27 January 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on dithianon to the Commission on 15 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for dithianon.

               (6)

               It has appeared from the various examinations made that plant protection products containing dithianon may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include dithianon in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit information confirming the storage stability and the nature of residues in processed products, the aquatic and groundwater exposure assessment for phthalic acid and the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing dithianon to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               Decision 2008/934/EC provides for the non-inclusion of dithianon and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning dithianon in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning dithianon in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   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.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing dithianon as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to dithianon are met, with the exception of those identified in Part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing dithianon as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account Part B of the entry in Annex I to that Directive concerning dithianon. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing dithianon as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing dithianon as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 11 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance dithianon. EFSA Journal 2010; 8(11):1904. [121 pp.]. doi:10.2903/j.efsa.2010.1904. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘344

                     Dithianon
                     CAS No: 3347-22-6
                     CIPAC No: 153

                     5,10-dihydro-5,10-dioxonaphtho[2,3-b]-1,4-dithiine-2,3-dicarbonitrile

                     ≥ 930 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall:

                                 (a)

                                 pay particular attention to the protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate;

                                 (b)

                                 pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate;

                                 (c)

                                 pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate.

                           The Member States concerned shall request the submission of confirmatory information as regards:

                                 (a)

                                 the storage stability and the nature of residues in processed products;

                                 (b)

                                 the aquatic and groundwater exposure assessment for phthalic acid;

                                 (c)

                                 the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.

                           The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.’

         (1)  Further details on identity and specification of active substance are provided in the review report.