title: Commission Implementing Directive 2013/63/EU of 17 December 2013 amending Annexes I and II to Council Directive 2002/56/EC as regards minimum conditions to be satisfied by seed potatoes and lots of seed potatoes  Text with EEA relevance

text:
               18.12.2013

               EN

               Official Journal of the European Union

               L 341/52

         COMMISSION IMPLEMENTING DIRECTIVE 2013/63/EU
   of 17 December 2013
   amending Annexes I and II to Council Directive 2002/56/EC as regards minimum conditions to be satisfied by seed potatoes and lots of 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 24 thereof,
   Whereas:

               (1)

               Since the adoption of Directive 2002/56/EC new methods of potato breeding have been developed, diagnostic tools to identify harmful organisms and agronomic practices to fight the spread of harmful organisms have been improved.

               (2)

               Those technical developments permit the production of seed potatoes fulfilling stricter requirements than those laid down in Annexes I and II to Directive 2002/56/EC. At the same time knowledge about new disease agents has become available and knowledge about existing diseases has evolved showing that some diseases require stricter measures.

               (3)

               Against this background, the standard of United Nations Economic Commission for Europe (UNECE) concerning the marketing and commercial quality control of seed potatoes has been adapted in view of those technical and scientific developments (2).

               (4)

               Taking into account those developments, certain minimum conditions and tolerances, as set out in Annexes I and II to Directive 2002/56/EC, should be updated and restrictions concerning black scurf, powdery scab and seed potatoes, which have become excessively dehydrated and shrivelled, should be added in Annex II.

               (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. A maximum of seven generations for pre-basic and basic seed potatoes achieves a balance between the need to multiply sufficient numbers of seed potatoes for the production of certified seed potatoes, and the protection of their health status.

               (6)

               The requirements concerning the harmful organism Synchytrium endobioticum (Schilb.) Perc. should be removed from Annex I because its presence on seed potatoes is regulated by Council Directive 69/464/EEC (3). The requirements concerning the harmful organism Corynebacterium sepedonicum (Spieck. et Kotth.) Skapt. and Burkh., the name of which has been replaced by Clavibacter michiganensis subsp. sepedonicus (Spieck. et Kotth.) Davis et al., should be removed from Annexes I and II because its presence on seed potatoes is regulated by Council Directive 93/85/EEC (4). The requirements concerning the harmful organism Heterodera rostochiensis Woll., the name of which has been replaced by Globodera rostochiensis (Wollenweber) Behrens should be removed from Annex II because its presence on seed potatoes is regulated by Council Directive 2007/33/EC (5). The requirements concerning the harmful organism Pseudomonas solanacearum (Smith) Smith, the name of which has been replaced byRalstonia solanacearum (Smith) Yabuuchi et al., should be removed from Annex II because its presence on seed potatoes is regulated by Council Directive 98/57/EC (6).

               (7)

               Annexes I and II to Directive 2002/56/EC should therefore be amended accordingly.

               (8)

               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
   Amendments to Directive 2002/56/EC
   Annexes I and II to Directive 2002/56/EC are amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   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.
   Article 3
   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 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 17 December 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  UNECE STANDARD S-1 concerning the marketing and commercial quality control of seed potatoes, 2011 edition, New York.

      (3)  Council Directive 69/464/EEC of 8 December 1969 on control of Potato Wart Disease (OJ L 323, 24.12.1969, p. 1).

      (4)  Council Directive 93/85/EEC of 4 October 1993 on the control of potato ring rot (OJ L 259, 18.10.1993, p. 1).

      (5)  Council Directive 2007/33/EC of 11 June 2007 on the control of potato cyst nematodes and repealing Directive 69/465/EEC (OJ L 156, 16.6.2007, p. 12).

      (6)  Council Directive 98/57/EC of 20 July 1998 on the control of Ralstonia solanacearum (Smith) Yabuuchi et al., (OJ L 235, 21.8.1998, p. 1).

      ANNEX
      Annexes I and II to Directive 2002/56/EC are amended as follows:

                  (1)

                  Annex I is amended as follows:

                              (a)

                              Points 1 and 2 are replaced by the following:

                                          ‘1.

                                          Basic seed potatoes shall satisfy the following minimum conditions:

                                                      (a)

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

                                                      (b)

                                                      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 % and in the direct progeny, shall, together, not exceed 0,25 %;

                                                      (c)

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

                                                      (d)

                                                      on official inspections of the growing plants, the number of plants with mosaic symptoms and the number of plants with symptoms caused by leaf roll virus shall, together, not exceed 0,8 %.

                                          2.

                                          Certified seed potatoes shall satisfy the following minimum conditions:

                                                      (a)

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

                                                      (b)

                                                      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 % and in the direct progeny, shall, together, not exceed 0,5 %;

                                                      (c)

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

                                                      (d)

                                                      on official inspections of the growing plants, the number of plants with mosaic symptoms and the number of plants with symptoms caused by leaf roll virus shall, together, not exceed 6,0 %.’

                              (b)

                              Point 3 is deleted.

                              (c)

                              Point 4 is replaced by the following:

                                          ‘4.

                                          The tolerances allowed under points (1)(c) and (d), and points 2(c) and (d), shall only be applicable where the virus diseases are caused by viruses that are prevalent in Europe.’

                              (d)

                              Points 5 and 6 are deleted.

                              (e)

                              The following point is added:

                                          ‘7.

                                          The maximum number of generations of basic potatoes shall be four, and the combined generations of pre-basic potatoes in the field and basic potatoes shall be seven.
                                          The maximum number of generations of certified seed potatoes shall be two.
                                          If the generation is not indicated on the official label, the potatoes concerned shall be considered as belonging to the maximum generation that is permitted within the respective category.’

                  (2)

                  Annex II is replaced by the following:

                     ‘ANNEX II

                        MINIMUM QUALITY CONDITIONS FOR LOTS OF SEED POTATOES

                     Tolerances for the following impurities, blemishes and diseases allowed for seed potatoes:

                                 (1)

                                 presence of earth and extraneous matter: 1,0 % by mass for basic seed potatoes and 2,0 % by mass for certified seed potatoes;

                                 (2)

                                 dry and wet rot combined, except if caused by Synchytrium endobioticum, Clavibacter michiganensis subsp. sepedonicus or Ralstonia solanacearum: 0,5 % by mass, of which wet rot 0,2 % by mass;

                                 (3)

                                 external blemishes, e.g. misshapen or damaged tubers: 3,0 % by mass;

                                 (4)

                                 common scab affecting tubers over more than one third of their surface: 5,0 % by mass;

                                 (5)

                                 black scurf affecting tubers over more than 10,0 % of their surface: 5,0 % by mass;

                                 (6)

                                 powdery scab affecting tubers over more than 10,0 % of their surface: 3,0 % by mass;

                                 (7)

                                 shrivelled tubers due to excessive dehydration or dehydration caused by silver scurf: 1,0 % by mass.

                           Total tolerance for items 2 to 7: 6,0 % by mass for basic seed potatoes, and 8,0 % by mass for certified seed potatoes.’


title: Commission Delegated Directive (EU) 2015/574 of 30 January 2015 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 mercury in intravascular ultrasound imaging systems  Text with EEA relevance

text:
               10.4.2015

               EN

               Official Journal of the European Union

               L 94/6

         COMMISSION DELEGATED DIRECTIVE (EU) 2015/574
   of 30 January 2015
   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 mercury in intravascular ultrasound imaging systems
   (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 mercury in electrical and electronic equipment placed on the market.

               (2)

               Mercury is used in electric rotating connectors in medical devices for intravascular ultrasound imaging. Substitution of mercury or of the specific component would shorten product life or impair performance significantly.

               (3)

               Both the substitution of mercury in the connector and the elimination of mercury via substitution of the connector or the device are technically impracticable or have negative overall impacts due to an impact on patients' health.

               (4)

               The use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency modes of operation (> 50 MHz) should therefore be exempted until 30 June 2019. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.

               (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 ninth 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, 30 January 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU, the following point 42 is added:

                     ‘42.

                     Mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.
                     Expires on 30 June 2019.’