title: Commission Delegated Directive 2012/51/EU of 10 October 2012 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for applications containing cadmium  Text with EEA relevance

text:
               18.12.2012

               EN

               Official Journal of the European Union

               L 348/18

         COMMISSION DELEGATED DIRECTIVE 2012/51/EU
   of 10 October 2012
   amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for applications containing cadmium
   (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 cadmium in electrical and electronic equipment placed on the market.

               (2)

               The substitution of cadmium in photoresistors for analogue optocouplers applied in professional audio equipment is still technically impracticable. The use of cadmium in those photoresistors should therefore be exempted from the prohibition. However, that exemption should be limited in time as the research for cadmium free technology is in progress and substitutes could become available by the end of 2013.

               (3)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III 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 2 January 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 10 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex III to Directive 2011/65/EU the following point 40 is added:

                     ‘40

                     Cadmium in photoresistors for analogue optocouplers applied in professional audio equipment

                     Expires on 31 December 2013’


title: Commission Delegated Directive 2014/13/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 in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/69

         COMMISSION DELEGATED DIRECTIVE 2014/13/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 in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators
   (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)

               Mobile medical devices are medical devices which are designed and approved by a notified body according to Council Directive 93/42/EEC (2) to be hand carried, or to be transported on own wheels, on a cart or trolley or in a vehicle, aircraft or vessel during and/or between operations.

               (3)

               Substitution or elimination of lead in the populated printed circuit boards of mobile medical devices is currently technically impracticable. A temporary exemption to allow the continued use of lead solders is needed until further research has been carried out to identify alloys that are reliable for the normal life of mobile medical devices.

               (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.

      (2)  OJ L 169, 12.7.1993, p. 1.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 33 is added:

                  ‘33.

                  Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb.’


title: Commission Delegated Directive 2012/50/EU of 10 October 2012 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for applications containing lead  Text with EEA relevance

text:
               18.12.2012

               EN

               Official Journal of the European Union

               L 348/16

         COMMISSION DELEGATED DIRECTIVE 2012/50/EU
   of 10 October 2012
   amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for applications containing lead
   (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 substitution of lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors is still technically impracticable. The use of lead in those materials should therefore be exempted from the prohibition.

               (3)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III 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 2 January 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 10 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex III to Directive 2011/65/EU the following point 7(c)-IV is inserted:

                     ‘7(c)-IV

                     Lead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductors

                     Expires on 21 July 2016’


title: Commission Implementing Directive 2012/8/EU of 2 March 2012 amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species  Text with EEA relevance

text:
               3.3.2012

               EN

               Official Journal of the European Union

               L 64/9

         COMMISSION IMPLEMENTING DIRECTIVE 2012/8/EU
   of 2 March 2012
   amending Directive 2003/90/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2) (a) and (b) thereof,
   Whereas:

               (1)

               Commission Directive 2003/90/EC (2) was adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties this Directive provides that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply.

               (2)

               The CPVO has since established further guidelines for a number of other species, and has updated existing ones.

               (3)

               Directive 2003/90/EC should therefore be amended accordingly.

               (4)

               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
   Annexes I and II to Directive 2003/90/EC are replaced by the text in the Annex to this Directive.
   Article 2
   For examinations started before 1 October 2012 Member States may apply Directive 2003/90/EC in the version applying before its amendment by this Directive.
   Article 3
   Member States shall adopt and publish, by 30 September 2012 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 October 2012.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 2 March 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 193, 20.7.2002, p. 1.

      (2)  OJ L 254, 8.10.2003, p. 7.

      ANNEX
      ‘
            ANNEX I

               List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Festuca filiformis Pourr.

                        Fine-leaved sheep's fescue

                        TP 67/1 of 23.6.2011

                           Festuca ovina L.

                        Sheep's fescue

                        TP 67/1 of 23.6.2011

                           Festuca rubra L.

                        Red fescue

                        TP 67/1 of 23.6.2011

                           Festuca trachyphylla (Hack.) Krajina

                        Hard fescue

                        TP 67/1 of 23.6.2011

                           Lolium multiflorum Lam.

                        Italian ryegrass

                        TP 4/1 of 23.6.2011

                           Lolium perenne L.

                        Perennial ryegrass

                        TP 4/1 of 23.6.2011

                           Lolium x boucheanum Kunth

                        Hybrid ryegrass

                        TP 4/1 of 23.6.2011

                           Pisum sativum L.

                        Field pea

                        TP 7/2 of 11.3.2010

                           Brassica napus L.

                        Swede rape

                        TP 36/2 of 16.11.2011

                           Helianthus annuus L.

                        Sunflower

                        TP 81/1 of 31.10.2002

                           Linum usitatissimum L.

                        Flax/Linseed

                        TP 57/1 of 21.3.2007

                           Avena nuda L.

                        Small naked oat, Hulless oat

                        TP 20/1 of 6.11.2003

                           Avena sativa L. (includes A. byzantina K. Koch)

                        Oats and Red oat

                        TP 20/1 of 6.11.2003

                           Hordeum vulgare L.

                        Barley

                        TP 19/2rev. of 11.3.2010

                           Oryza sativa L.

                        Rice

                        TP 16/1 of 18.11.2004

                           Secale cereale L.

                        Rye

                        TP 58/1 of 31.10.2002

                           xTriticosecale Wittm. ex A. Camus

                        Hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale

                        TP 121/2 rev. 1 of 16.2.2011

                           Triticum aestivum L.

                        Wheat

                        TP 3/4 rev. 2 of 16.2.2011

                           Triticum durum Desf.

                        Durum wheat

                        TP 120/2 of 6.11.2003

                           Zea mays L.

                        Maize

                        TP 2/3 of 11.3.2010

                           Solanum tuberosum L.

                        Potato

                        TP 23/2 of 1.12.2005

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II

               List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Fodder beet

                        TG/150/3 of 4.11.1994

                           Agrostis canina L.

                        Velvet bent

                        TG/30/6 of 12.10.1990

                           Agrostis gigantea Roth.

                        Red top

                        TG/30/6 of 12.10.1990

                           Agrostis stolonifera L.

                        Creeping bent

                        TG/30/6 of 12.10.1990

                           Agrostis capillaris L.

                        Brown top

                        TG/30/6 of 12.10.1990

                           Bromus catharticus Vahl

                        Rescue grass

                        TG/180/3 of 4.4.2001

                           Bromus sitchensis Trin.

                        Alaska brome grass

                        TG/180/3 of 4.4.2001

                           Dactylis glomerata L.

                        Cocksfoot

                        TG/31/8 of 17.4.2002

                           Festuca arundinacea Schreber

                        Tall fescue

                        TG/39/8 of 17.4.2002

                           Festuca pratensis Huds.

                        Meadow fescue

                        TG/39/8 of 17.4.2002

                           xFestulolium Asch. et Graebn.

                        Hybrids resulting from the crossing of a species fo the genus Festuca with a species of the genus Lolium

                        TG/243/1 of 9.4.2008

                           Phleum nodosum L.

                        Small timothy

                        TG/34/6 of 7.11.1984

                           Phleum pratense L.

                        Timothy

                        TG/34/6 of 7.11.1984

                           Poa pratensis L.

                        Smooth-stalked meadow grass

                        TG/33/6 of 12.10.1990

                           Lupinus albus L.

                        White lupin

                        TG/66/4 of 31.3.2004

                           Lupinus angustifolius L.

                        Narrow-leaved lupin

                        TG/66/4 of 31.3.2004

                           Lupinus luteus L.

                        Yellow lupin

                        TG/66/4 of 31.3.2004

                           Medicago sativa L.

                        Lucerne

                        TG/6/5 of 6.4.2005

                           Medicago x varia T. Martyn

                        Sand lucerne

                        TG/6/5 of 6.4.2005

                           Trifolium pratense L.

                        Red clover

                        TG/5/7 of 4.4.2001

                           Trifolium repens L.

                        White clover

                        TG/38/7 of 9.4.2003

                           Vicia faba L.

                        Field bean

                        TG/8/6 of 17.4.2002

                           Vicia sativa L.

                        Common vetch

                        TG/32/6 of 21.10.1988

                           Brassica napus L. var. napobrassica (L.) Rchb.

                        Swede

                        TG/89/6rev. of 4.4.2001 + 1.4.2009

                           Raphanus sativus L. var. oleiformis Pers.

                        Fodder radish

                        TG/178/3 of 4.4.2001

                           Arachis hypogea L.

                        Groundnut/Peanut

                        TG/93/3 of 13.11.1985

                           Brassica rapa L. var. silvestris (Lam.) Briggs

                        Turnip rape

                        TG/185/3 of 17.4.2002

                           Carthamus tinctorius L.

                        Safflower

                        TG/134/3 of 12.10.1990

                           Gossypium spp.

                        Cotton

                        TG/88/6 of 4.4.2001

                           Papaver somniferum L.

                        Poppy

                        TG/166/3 of 24.3.1999

                           Sinapis alba L.

                        White mustard

                        TG/179/3 of 4.4.2001

                           Glycine max (L.) Merrill

                        Soya bean

                        TG/80/6 of 1.4.1998

                           Sorghum bicolor (L.) Moench

                        Sorghum

                        TG/122/3 of 6.10.1989

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’


title: Commission Implementing Directive 2013/45/EU of 7 August 2013 amending Council Directives 2002/55/EC and 2008/72/EC and Commission Directive 2009/145/EC as regards the botanical name of tomato  Text with EEA relevance

text:
               8.8.2013

               EN

               Official Journal of the European Union

               L 213/20

         COMMISSION IMPLEMENTING DIRECTIVE 2013/45/EU
   of 7 August 2013
   amending Council Directives 2002/55/EC and 2008/72/EC and Commission Directive 2009/145/EC as regards the botanical name of tomato
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (1), and in particular Articles 2(2), 44(2), Article 45 and Article 48(1)(b) thereof,
   Having regard to Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material, other than seed (2), and in particular Article 1(3) thereof,
   Whereas:

               (1)

               In the light of the development of scientific knowledge, the International Code of Botanical Nomenclature (ICBN) has been revised, in particular with respect to the botanical name of the species tomato.

               (2)

               In order to reflect that development, Directives 2002/55/EC, 2008/72/EC and Commission Directive 2009/145/EC of 26 November 2009 providing for certain derogations, for acceptance of vegetable landraces and varieties which have been traditionally grown in particular localities and regions and are threatened by genetic erosion and of vegetable varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions and for marketing of seed of those landraces and varieties (3) should therefore be amended accordingly.

               (3)

               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 2002/55/EC
   Directive 2002/55/EC is amended as follows:

               (1)

               in Article 2(1)(b) the words ‘Lycopersicon esculentum Mill.’ are replaced by the words ‘Solanum lycopersicum L.’;

               (2)

               in the table in point 3(a) of Annex II, the words ‘Lycopersicon esculentum’ are replaced by the words ‘Solanum lycopersicum L.’;

               (3)

               in the table in point 2 of Annex III, the words ‘Lycopersicon esculentum’ are replaced by the words ‘Solanum lycopersicum L.’.

         Article 2
   Amendments to Directive 2008/72/EC
   In the table in Annex II to Directive 2008/72/EC, the words ‘Lycopersicon esculentum Mill.’ are replaced by the words ‘Solanum lycopersicum L.’.
   Article 3
   Amendments to Directive 2009/145/EC
   Directive 2009/145/EC is amended as follows:

               (1)

               in the table in Annex I, the words ‘Lycopersicon esculentum Mill.’ are replaced by ‘Solanum lycopersicum L.’;

               (2)

               in the table in Annex II, the words ‘Lycopersicon esculentum Mill.’ are replaced by ‘Solanum lycopersicum L.’.

         Article 4
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2014 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 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, 7 August 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 193, 20.7.2002, p. 33.

      (2)  OJ L 205, 1.8.2008, p. 28.

      (3)  OJ L 312, 27.11.2009, p. 44.


title: Commission Implementing Directive 2014/19/EU of 6 February 2014 amending Annex I to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

text:
               7.2.2014

               EN

               Official Journal of the European Union

               L 38/30

      COMMISSION IMPLEMENTING DIRECTIVE 2014/19/EU
   of 6 February 2014
   amending Annex I to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof,
   Whereas:

               (1)

               From information supplied by the Member States it has become apparent that Diabrotica virgifera virgifera Le Conte has already spread and established in a large part of the Union territory. From an impact assessment carried out by the European Commission it was concluded that no measures are feasible to eradicate it or to effectively prevent its further spread.

               (2)

               In addition, effective and sustainable means of control minimizing the impact of this organism on maize yield exist, in particular the implementation of a crop rotation scheme.

               (3)

               Therefore no further protective measures should be set out under Directive 2000/29/EC with respect to Diabrotica virgifera virgifera Le Conte. Consequently that organism should no more be listed as a harmful organism under that Directive.

               (4)

               Annex I to Directive 2000/29/EC should therefore be amended accordingly.

               (5)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 2000/29/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish, by 31 May 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 1 June 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the third 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, 6 February 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 169, 10.7.2000, p. 1.

      ANNEX
      Annex I to Directive 2000/29/EC is amended as follows:
      In heading (a) of Section II of Part A, point 0.1 is deleted.


title: Commission Implementing Directive 2011/50/EU of 19 April 2011 amending Council Directive 91/414/EEC to include carbetamide as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               20.4.2011

               EN

               Official Journal of the European Union

               L 104/41

         COMMISSION IMPLEMENTING DIRECTIVE 2011/50/EU
   of 19 April 2011
   amending Council Directive 91/414/EEC to include carbetamide 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 second and third stages 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 carbetamide.

               (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 carbetamide.

               (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 France, 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)

               France 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 12 February 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 carbetamide to the Commission on 22 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 carbetamide.

               (6)

               It has appeared from the various examinations made that plant protection products containing carbetamide 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 carbetamide 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)

               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.

               (8)

               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 carbetamide 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.

               (9)

               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.

               (10)

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

               (11)

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

               (12)

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

               (13)

               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 carbetamide 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 carbetamide 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 carbetamide 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 carbetamide 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 carbetamide. 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 carbetamide 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 carbetamide 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, 19 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 carbetamide. EFSA Journal 2010; 8(12):1913. [57 pp.]. doi:10.2903/j.efsa.2010.1913. 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

                     ‘356

                     Carbetamide
                     CAS No: 16118-49-3
                     CIPAC No: 95

                     (R)-1-(Ethylcarbamoyl)ethyl carbanilate

                     ≥ 950 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI the conclusions of the review report on carbetamide, 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:

                                 (a)

                                 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 (b)

                                 the risk to non-target plants;

                                 (c)

                                 the risk to aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.’

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


title: Commission Delegated Directive 2014/6/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 in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/55

         COMMISSION DELEGATED DIRECTIVE 2014/6/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 in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions
   (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)

               There are no technically viable substitutes available for the application of lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions.

               (3)

               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 25 is added:

                  ‘25.

                  Lead in the surface coatings of pin connector systems requiring nonmagnetic connectors which are used durably at a temperature below – 20 °C under normal operating and storage conditions. Expires on 30 June 2021.’


title: Commission Implementing Directive (EU) 2016/317 of 3 March 2016 amending Council Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC as regards the official label of seed packages (Text with EEA relevance)

text:
               5.3.2016

               EN

               Official Journal of the European Union

               L 60/72

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2016/317
   of 3 March 2016
   amending Council Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC as regards the official label of seed packages
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), and in particular Article 21a thereof,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (2), and in particular Article 21a thereof,
   Having regard to Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (3), and in particular Article 27 thereof,
   Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (4), and in particular Article 45 thereof,
   Having regard to Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (5), and in particular Article 24 thereof,
   Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (6), and in particular Article 24 thereof,
   Whereas:

               (1)

               Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC lay down rules as regards the official labelling of seed packages.

               (2)

               In recent years some cases of fraudulent use of official labels have been detected. The security of the official labels should therefore be improved, in line with the currently available technical knowledge, to ensure that such fraudulent practices are avoided. In this view, and in order to allow the competent authorities to better record and control the printing, distribution and use of individual official labels by operators, and to track seed lots, the security of the official labels should be improved by introducing an officially assigned serial number in the official labels of basic seed, certified seed, commercial seed and mixtures of seed, and also in the label and document provided in the case of seed not certified, harvested in another Member State.

               (3)

               Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 66/401/EEC
   Directive 66/401/EEC is amended as follows:

               (1)

               Annex IV is amended as follows:

                           (a)

                           in Section (A)(I)(a), the following point 2a is inserted:

                                       ‘2a.

                                       Officially assigned serial number.’;

                           (b)

                           in Section (A)(I)(b), the following point 3a is inserted:

                                       ‘3a.

                                       Officially assigned serial number.’;

                           (c)

                           in Section (A)(I)(c), the following point 2a is inserted:

                                       ‘2a.

                                       Officially assigned serial number.’;

               (2)

               Annex V is amended as follows:

                           (a)

                           in Section (A), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’;

                           (b)

                           in Section (C), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’.

         Article 2
   Amendments to Directive 66/402/EEC
   Directive 66/402/EEC is amended as follows:

               (1)

               Annex IV is amended as follows:

                           (a)

                           in Section (A)(a), the following point 2a is inserted:

                                       ‘2a.

                                       Officially assigned serial number.’;

                           (b)

                           in Section (A)(b), the following point 2a is inserted:

                                       ‘2a.

                                       Officially assigned serial number.’;

               (2)

               Annex V is amended as follows:

                           (a)

                           in Section (A), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’;

                           (b)

                           in Section (C), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’.

         Article 3
   Amendments to Directive 2002/54/EC
   Directive 2002/54/EC is amended as follows:

               (1)

               Annex III is amended as follows:
               In Section (A)(I), the following point 2a is inserted:

                           ‘2a.

                           Officially assigned serial number.’;

               (2)

               Annex IV is amended as follows:

                           (a)

                           in Section (A), the following indent is added after the first indent:

                                       ‘—

                                       officially assigned serial number,’;

                           (b)

                           in Section (C), the following indent is added after the first indent:

                                       ‘—

                                       officially assigned serial number,’.

         Article 4
   Amendments to Directive 2002/55/EC
   Directive 2002/55/EC is amended as follows:

               (1)

               Annex IV is amended as follows:
               In Section (A)(I), the following point 2a is inserted:

                           ‘2a.

                           Officially assigned serial number.’;

               (2)

               Annex V is amended as follows:

                           (a)

                           in Section (A), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’;

                           (b)

                           in Section (C), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’.

         Article 5
   Amendment to Directive 2002/56/EC
   In Section (A) of Annex III to Directive 2002/56/EC, the following point 2a is inserted:

                  ‘2a.

                  Officially assigned serial number’.

   Article 6
   Amendments to Directive 2002/57/EC
   Directive 2002/57/EC is amended as follows:

               (1)

               Annex IV is amended as follows:

                           (a)

                           in Section (A)(a), the following point 2a is inserted:

                                       ‘2a.

                                       Officially assigned serial number.’;

                           (b)

                           in Section (A)(b), the following point 3a is inserted:

                                       ‘3a.

                                       Officially assigned serial number.’;

               (2)

               Annex V is amended as follows:

                           (a)

                           in Section (A), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’;

                           (b)

                           in Section (C), the following indent is inserted after the first indent:

                                       ‘—

                                       officially assigned serial number,’.

         Article 7
   Transposition
   1.   Member States shall adopt and publish, by 31 March 2017 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 April 2017.
   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 8
   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 9
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 3 March 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ 125, 11.7.1966, p. 2298/66.

      (2)  OJ 125, 11.7.1966, p. 2309/66.

      (3)  OJ L 193, 20.7.2002, p. 12.

      (4)  OJ L 193, 20.7.2002, p. 33.

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

      (6)  OJ L 193, 20.7.2002, p. 74.


title: Commission Implementing Directive 2011/55/EU of 26 April 2011 amending Council Directive 91/414/EEC to include paclobutrazol as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               27.4.2011

               EN

               Official Journal of the European Union

               L 106/5

         COMMISSION IMPLEMENTING DIRECTIVE 2011/55/EU
   of 26 April 2011
   amending Council Directive 91/414/EEC to include paclobutrazol 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 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 paclobutrazol.

               (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 two 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 paclobutrazol.

               (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 United Kingdom, 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 United Kingdom 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 20 November 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 paclobutrazol to the Commission on 4 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 paclobutrazol.

               (6)

               It has appeared from the various examinations made that plant protection products containing paclobutrazol 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 paclobutrazol 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 confirmatory information as regards the specification of the technical material, as commercially manufactured, the analytical methods in soil and surface water for the metabolite NOA457654, the risk assessment for aquatic organisms, the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin, and the potential endocrine disrupting properties. Paclobutrazol and its metabolite CGA 149907 is a mixture of several optical structures of the same molecule. Depending of the environmental conditions, these structures may break down differently in the environmental compartments soil, water and air. Further information should be submitted by the applicant as regards the potential effect of this phenomenon under realistic conditions of use.

               (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 six months after inclusion to review existing authorisations of plant protection products containing paclobutrazol 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 paclobutrazol and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning paclobutrazol 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 paclobutrazol 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 paclobutrazol 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 paclobutrazol 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 paclobutrazol 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 paclobutrazol. 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 paclobutrazol 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 paclobutrazol 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, 26 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 paclobutrazol. EFSA Journal 2010;8(11):1876. [60 pp.] doi:10.2903/j.efsa.2010.1876. Available online: www.efsa.europa.eu/efsajournal.htm

      (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

                     ‘353

                     Paclobutrazol
                     CAS No: 76738-62-0
                     CIPAC No: 445

                     (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol

                     ≥ 930 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on paclobutrazol, 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 risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (1)

                                 the specification of the technical material, as commercially manufactured;

                                 (2)

                                 the analytical methods in soil and surface water for the metabolite NOA457654;

                                 (3)

                                 the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

                                 (4)

                                 the potential endocrine disrupting properties of paclobutrazol;

                                 (5)

                                 the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.’

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


title: Commission Delegated Directive 2014/16/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 as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi 2 O 5 :Pb) phosphors  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/75

         COMMISSION DELEGATED DIRECTIVE 2014/16/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 as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors
   (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 as an activator in the fluorescent powder of discharge lamps that are used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. A scientifically and technically practicable possibility for substitution or elimination of lead in this application is currently not available.

               (3)

               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 34 is added:

                  ‘34.

                  Lead as an activator in the fluorescent powder of discharge lamps when used for extracorporeal photopheresis lamps containing BSP (BaSi2O5:Pb) phosphors. Expires on 22 July 2021.’


title: Commission Implementing Directive 2014/97/EU of 15 October 2014 implementing Council Directive 2008/90/EC as regards the registration of suppliers and of varieties and the common list of varieties

text:
               16.10.2014

               EN

               Official Journal of the European Union

               L 298/16

         COMMISSION IMPLEMENTING DIRECTIVE 2014/97/EU
   of 15 October 2014
   implementing Council Directive 2008/90/EC as regards the registration of suppliers and of varieties and the common list of varieties
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), and in particular Article 5(3) and Article 7(5) and (6) thereof,
   Whereas:

               (1)

               It is necessary to set out provisions concerning the register of suppliers provided for in Directive 2008/90/EC and the notification obligations of suppliers.

               (2)

               For the purpose of transparency, Member States should make available that register, where appropriate. The decision whether that register, or parts of it are to be published is left to the Member States.

               (3)

               A variety register should be provided for. That register should include varieties registered under Council Directive 92/34/EEC (2) in addition to those registered under Directive 2008/90/EC. That register should indicate whether varieties have an official description or an officially recognised description.

               (4)

               Genetically modified varieties should be registered only if the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC of the European Parliament and of the Council (3) or Regulation (EC) No 1829/2003 of the European Parliament and of the Council (4).

               (5)

               The conditions under which varieties are to be registered as varieties with an official description and the procedure for their registration should be provided for. Member States may, as provided for in Directive 2008/90/EC, lay down conditions concerning the registration of a variety with an officially recognised description.

               (6)

               In order to register a variety as a variety with an official description, the responsible official body should establish such a description.

               (7)

               The period of validity of registration, the renewal of registration and the removal of a variety from the variety register should be provided for.

               (8)

               Member States should notify to each other and to the Commission certain information concerning registered varieties and applications for registration of varieties. Based on that information the Commission should publish a common list of varieties to create a transparent and easily consultable database to increase the confidence on the market.

               (9)

               It is appropriate to repeal Commission Directive 93/79/EEC (5).

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plants of Fruit Genera and Species,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Register of suppliers
   1.   Member States shall keep and update a register of suppliers, as provided for in Article 5(1) of Directive 2008/90/EC. That register shall be referred to hereinafter as ‘the register of suppliers’.
   In addition to suppliers registered in accordance with this Directive, that register shall include suppliers accredited in accordance with national provisions transposing Article 6(1) of Directive 92/34/EEC.
   Where appropriate, Member States shall make available the register of suppliers.
   2.   The register of suppliers shall include the following information:

               (a)

               name, address and contact details of the supplier;

               (b)

               activities within the meaning of Article 2(9) of Directive 2008/90/EC that are exercised by the supplier in the Member State concerned, the address of the premises involved and the main genera or species concerned; and

               (c)

               registration number or code.

         3.   Member States shall ensure that the responsible official body removes a natural or legal person from the register of suppliers, if it is established that that person no longer exercises any activity within the meaning of Article 2(9) of Directive 2008/90/EC.
   Article 2
   Notification obligation of suppliers
   1.   Member States shall ensure that suppliers notify the information referred to in Article 1(2)(a) and (b).
   No notification shall, however, be required from suppliers accredited in accordance with Article 6(1) of Directive 92/34/EEC.
   2.   Member States shall ensure that suppliers notify any change in their situation concerning the information referred to in Article 1(2)(a) and (b).
   3.   Member States shall ensure that suppliers are informed of their registration and of any modifications thereto within a time period to be laid down by national legislation.
   Article 3
   Variety register
   1.   Member States shall keep, update and publish a register of varieties (hereinafter ‘variety register’).
   In addition to varieties registered in accordance with this Directive, the variety register shall include varieties registered before 30 September 2012 in accordance with Article 9(3) of Directive 92/34/EEC and varieties registered in accordance with the second sentence of the first subparagraph of Article 7(4) of Directive 2008/90/EC.
   2.   The variety register shall include the following information:

               (a)

               denomination of the variety and synonyms;

               (b)

               species the variety belongs to;

               (c)

               the indication ‘official description’ or ‘officially recognised description’, as appropriate;

               (d)

               date of registration, or, where applicable, of renewal of registration;

               (e)

               end of validity of registration.

         3.   Member States shall keep a file for each variety they register. That file shall contain a description of the variety and a summary of all the facts relevant to the registration of the variety.
   Article 4
   Conditions for registration of varieties
   1.   Member States shall ensure that a variety is registered as a variety with an official description if it fulfils the following requirements:

               (a)

               it is distinct, uniform and stable within the meaning of paragraph 2;

               (b)

               a sample of the variety is available; and

               (c)

               as regards genetically modified varieties, the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.

         2.   A variety shall be considered as:

               (a)

               ‘distinct’ where it is clearly distinguishable, by reference to the expression of the characteristics that result from a particular genotype or combination of genotypes, from any other variety commonly known at the date of the application referred to in Article 5;

               (b)

               ‘uniform’ where, subject to the variation that may be expected from the particular features of its propagation, it is sufficiently uniform in the expression of those characteristics which are included in the examination for distinctness, as well as any other characteristics used for the variety description;

               (c)

               ‘stable’ where the expression of the characteristics which are included in the examination for distinctness, as well as any other characteristics used for the variety description, remain unchanged after repeated propagation or, in the case of micropropagation at the end of each cycle.

         Article 5
   Application for registration of a variety
   1.   For registration of a variety as a variety with an official description, Member States shall require that a written application be submitted to the responsible official body of the Member State concerned.
   2.   The application shall be accompanied by the following:

               (a)

               the information required by the technical questionnaires set out at the time of application:

                           (i)

                           in Annex II to the ‘Protocols for distinctness, uniformity and stability tests’ of the Administrative Council of the Community Plant Variety Office (CPVO) for the relevant species for which such a protocol has been published; or, where no such protocols have been published;

                           (ii)

                           in Section X of the ‘Test guidelines for the conduct of tests for distinctness, uniformity and stability’ of the International Union for the Protection of new Varieties of Plants (UPOV) and the Annex to the Test guideline concerned for the relevant species for which such guidelines have been published; or where no such guidelines have been published;

                           (iii)

                           in national provisions;

               (b)

               information on whether the variety is officially registered in another Member State, or is the subject of an application for such a registration in another Member State;

               (c)

               a proposed denomination;

               (d)

               in the case of a genetically modified variety, evidence that the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.

         3.   The applicant may submit any of the following with its application:

               (a)

               an official description established, in accordance with Article 6(5), by a responsible official body of another Member State;

               (b)

               any other relevant information.

         Article 6
   Examination of applications
   1.   Member States shall ensure that, where a responsible official body receives an application for registration of a variety as a variety with an official description, an examination of that variety is performed in accordance with paragraphs 2, 3 and 4.
   2.   Growing trials shall be carried out to establish an official description of the variety.
   Where the applicant submits information in accordance with Article 5(3)(a) and the responsible official body considers that this information shows that the conditions for registration provided for in Article 4 are fulfilled, no growing trials shall, however, be carried out.
   Where growing trials are to be carried out, the responsible official body shall request a sample of the material of the variety.
   3.   The growing trials referred to in paragraph 2 shall be performed by:

               (a)

               the responsible official body receiving the application; or

               (b)

               the responsible official body of another Member State having agreed to perform those trials; or

               (c)

               any legal person, in accordance with Article 13(2) of Directive 2008/90/EC.

         Where point (c) applies and trials are carried out on the premises of private enterprises, the responsible official body shall ensure that no measures are applied that might interfere with the official examination.
   4.   The growing trials shall be performed in accordance with the following provisions as regards trial design, growing conditions and characteristics of the variety to be covered as a minimum:

               (a)

               the ‘Protocols for distinctness, uniformity and stability tests’ of the Administrative Council of the Community Plant Variety Office (CPVO) applicable at the beginning of the technical examination; or, where no protocols have been published for the relevant species;

               (b)

               the ‘Test guidelines for the conduct of tests for distinctness, uniformity and stability’ of the International Union for the Protection of New Varieties of Plants (UPOV) applicable at the beginning of the technical examination; or, where no guidelines have been published for the relevant species;

               (c)

               national provisions.

         5.   If based on the examination referred to in paragraph 1, the responsible official body concludes that the variety concerned fulfils the conditions of Article 5 it shall establish an official description and include that variety in the variety register.
   Article 7
   Period of validity of variety registration
   The maximum period of validity of the registration of a variety shall be 30 years.
   In the case of genetically modified varieties, the validity of the registration shall be limited to the period for which the genetically modified organism of which the variety consists is authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003.
   Article 8
   Renewal of variety registration
   1.   Member States shall ensure that the registration of a variety may be renewed for further maximum periods of 30 years, provided that material of that variety is still available.
   In the case of a genetically modified variety, renewal shall, in addition, be subject to the condition that the respective genetically modified organism continues to be authorised for cultivation pursuant to Directive 2001/18/EC or Regulation (EC) No 1829/2003. The renewal period shall be limited to the period of authorisation of the genetically modified organism concerned.
   2.   For renewal of the registration, Member States shall require that a written application be submitted to the responsible official body of the Member State concerned. The application shall be accompanied by evidence showing that the conditions set out in paragraph 1 are fulfilled.
   A Member State may, however, renew the registration of a variety for which no written application has been submitted, where it considers that renewal serves to preserve genetic diversity and sustainable production or serves another general interest.
   Article 9
   Removal of a variety from the variety register
   Member States shall ensure that a variety is removed from the variety register if:

               (a)

               the conditions for registration, as set out in Article 4, are no longer fulfilled;

               (b)

               at the time of the application for registration or during examination, false or fraudulent particulars had been supplied concerning the facts on the basis of which the variety was registered.

         Article 10
   Notifications
   1.   Each Member State shall notify to the responsible official bodies of the other Member States and the Commission the information required to access the variety register of the Member State concerned.
   Each Member State shall notify the Commission as soon as possible of the inclusion of a variety in its variety register, and any other amendment to its variety register.
   2.   Each Member State shall, on request, make available to another Member State or the Commission:

               (a)

               the official or officially recognised description of varieties registered in the variety register of the Member State concerned;

               (b)

               the results of examinations of applications for registration of varieties performed by the Member State concerned pursuant to Article 6;

               (c)

               any other information available in respect of varieties included in the variety register of the Member State concerned or removed from that register;

               (d)

               the list of varieties for which applications for registration are pending in the Member State concerned.

         Article 11
   Common list
   The Commission shall, on the basis of the information received pursuant to subparagraph 2 of Article 10(1), establish, regularly update and publish in an electronic format a common list of the varieties included in the variety registers of the Member States.
   Article 12
   Transposition
   1.   Member States shall adopt and publish, by 31 December 2016 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 January 2017.
   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 13
   Repeal
   Directive 93/79/EEC is repealed with effect from 1 January 2017.
   Article 14
   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 15
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 15 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 267, 8.10.2008, p. 8.

      (2)  Council Directive 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (OJ L 157, 10.6.1992, p. 10).

      (3)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

      (4)  Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).

      (5)  Commission Directive 93/79/EEC of 21 September 1993 setting out additional implementing provisions for lists of varieties of fruit plant propagating material and fruit plants, as kept by suppliers under Council Directive 92/34/EEC (OJ L 256, 14.10.1993, p. 25).