title: Commission Implementing Directive 2014/83/EU of 25 June 2014 amending Annexes I, II, III, IV and V 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:
               26.6.2014

               EN

               Official Journal of the European Union

               L 186/64

         COMMISSION IMPLEMENTING DIRECTIVE 2014/83/EU
   of 25 June 2014
   amending Annexes I, II, III, IV and V 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 points (c) and (d) of the second paragraph of Article 14 thereof,
   After consulting the Member States concerned,
   Whereas:

               (1)

               Certain parts of the territory of Portugal were recognised as a protected zone with respect to Bemisia tabaci Genn. (European populations). Portugal has submitted information showing that Bemisia tabaci is now established in Madeira. The measures taken in 2013 with a view to the eradication of that harmful organism have proven to be ineffective. Madeira should therefore no longer be recognised as part of the protected zone of Portugal in respect of Bemisia tabaci. Parts B of Annexes I and IV to Directive 2000/29/EC should be amended accordingly.

               (2)

               Certain parts of the territory of Spain were recognised as a protected zone with respect to Erwinia amylovora (Burr.) Winsl. et al.. Spain has submitted information showing that Erwinia amylovora is now established in the autonomous communitiy of Aragón, the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana). The measures taken in 2013 with a view to the eradication of that harmful organism have proven to be ineffective. The autonomous community of Aragón, the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana) should therefore no longer be recognised as part of the protected zone of Spain in respect of Erwinia amylovora. Parts B of Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (3)

               The entire territory of Ireland was recognised as a protected zone with respect to Erwinia amylovora (Burr.) Winsl. et al.. Ireland has submitted information showing that Erwinia amylovora is now established in Galway city. The measures were taken between 2005 and 2013 with a view to the eradication of that harmful organism but have proven to be ineffective. The city of Galway should therefore no longer be recognised as part of the protected zone of Ireland in respect of Erwinia amylovora. Parts B of Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (4)

               The entire territory of Lithuania was recognised as a protected zone with respect to Erwinia amylovora (Burr.) Winsl. et al.. Lithuania has submitted information showing that Erwinia amylovora is now established in the municipalities of Kėdainiai and Babtai (region of Kaunas). The measures taken for a period of two successive years, 2012 and 2013, with a view to the eradication of that harmful organism have proven to be ineffective. The municipalities of Kėdainiai and Babtai (region of Kaunas) should therefore no longer be recognised as part of the protected zone of Lithuania in respect of Erwinia amylovora. Parts B of Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (5)

               Certain parts of the territory of Slovenia were recognised as a protected zone with respect to Erwinia amylovora (Burr.) Winsl. et al.. Slovenia has submitted information showing that Erwinia amylovora is now established in the communes of Renče-Vogrsko (south from the highway H4) and Lendava. The measures taken for a period of two successive years, 2012 and 2013, with a view to the eradication of that harmful organism have proven to be ineffective. The communes of Renče-Vogrsko (south from the highway H4) and Lendava should therefore no longer be recognised as part of the protected zone of Slovenia in respect of Erwinia amylovora. Parts B of Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (6)

               Certain parts of the territory of Slovakia were recognised as a protected zone with respect to Erwinia amylovora (Burr.) Winsl. et al.. Slovakia has submitted information showing that Erwinia amylovora is now established in the commune of Čenkovce (Dunajská Streda County). The measures taken for a period of two successive years, 2012 and 2013, with a view to the eradication of that harmful organism have proven to be ineffective. The commune of Čenkovce (Dunajská Streda County) should therefore no longer be recognised as part of the protected zone of Slovakia in respect of Erwinia amylovora. Parts B of Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (7)

               The scientific denomination of the harmful organism Ceratocystis fimbriata f. spp. platani Walter should be amended in line with the revised scientific denomination of the organism and should be referred to as Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. Annexes II and IV of Directive 2000/29/EC should be aligned.

               (8)

                  Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. is now known to occur in Switzerland. Section I of Part A of Annex IV and point I of Part B of Annex V to Directive 2000/29/EC should be amended accordingly.

               (9)

               In the light of developments in scientific knowledge, it is to be considered that, as regards wood of Platanus L., debarking does not obviate the pest risk associated with Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. Section I of Part A of Annex IV to Directive 2000/29/EC should be amended accordingly.

               (10)

               In view of the risk posed by Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr., it is technically justified, to include that harmful organism in Part B of Annex II to Directive 2000/29/EC in order to protect the production and trade of plants and plant products in certain endangered areas.

               (11)

               The United Kingdom has requested that its territory be recognised as a protected zone in respect of Ceratocystis platani (J.M. Walter) Engelbr. & T.C. Harr.. On the basis of surveys conducted between 2010 and 2013, the United Kingdom has submitted evidence that the harmful organism concerned does not occur in its territory, despite favourable conditions for that organism to establish itself there. It is, however, necessary that further surveys be carried out. Those surveys should be monitored by experts under the authority of the Commission. Therefore, the United Kingdom should be recognised as a protected zone in respect of Ceratocystis platani only until 30 April 2016. Parts B of Annexes II and IV to Directive 2000/29/EC should be therefore amended accordingly. Similarly, Part B of Annex IV and Part A.II of Annex V to Directive 2000/29/EC should be amended to introduce requirements for the movement of certain plants, plant products and other objects into the protected zones.

               (12)

               Annexes I, II, III, IV and V to Directive 2000/29/EC should therefore be amended accordingly.

               (13)

               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
   Annexes I, II, III, IV and V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish, by 30 September 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 October 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   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, 25 June 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 169, 10.7.2000, p. 1.

      ANNEX

                  (1)

                  Annex I, in heading (a) of Part B, point 1 is replaced by the following:

                                          ‘1.

                                             Bemisia tabaci Genn. (European populations)

                              IRL, P (Azores, Beira Interior, Beira Litoral, Entre Douro e Minho, Ribatejo e Oeste (communes of Alcobaça, Alenquer, Bombarral, Cadaval, Caldas da Rainha, Lourinhã, Nazaré, Obidos, Peniche and Torres Vedras) and Trás-os-Montes), UK, S, FI’

                  (2)

                  Annex II is amended as follows:

                              (a)

                              In heading (c) of Section II of Part A, point 1 is replaced by the following:

                                                      ‘1.

                                                         Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr.

                                          Plants of Platanus L., intended for planting, other than seeds, and wood of Platanus L., including wood which has not kept its natural round surface’

                              (b)

                              In point 2 of heading (b) of Part B, the text in the third column, protected zone(s), is replaced by the following:
                              ‘E (except the autonomous communities of Aragon, Castilla la Mancha, Castilla y León, Extremadura, Murcia, Navarra and La Rioja, and the province of Guipuzcoa (Basque Country), the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana)), EE, F (Corsica), IRL (except Galway city), I (Abruzzo, Apulia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Lazio, Liguria, Lombardy (except the provinces of Mantua and Sondrio), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Barbona, Boara Pisani, Castelbaldo, Masi, Piacenza d'Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT (except the municipalities of Babtai and Kėdainiai (region of Kaunas)), P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska, and the communes of Lendava and Renče-Vogrsko (south from the highway H4)), SK (except the communes of Blahová, Čenkovce, Horné Mýto, Okoč, Topoľníky and Trhová Hradská (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Dvory nad Žitavou (Nové Zámky County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                              (c)

                              In heading (c) of Part B, the following point is inserted before point 0.1:

                                                      ‘0.0.1.

                                                         Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr.

                                          Plants of Platanus L., intended for planting, other than seeds, and wood of Platanus L., including wood which has not kept its natural round surface

                                          UK’

                  (3)

                  Annex III is amended as follows:

                              (a)

                              In point 1 of part B, the text in the second column, protected zone(s), is replaced by the following:
                              ‘E (except the autonomous communities of Aragon, Castilla la Mancha, Castilla y León, Extremadura, Murcia, Navarra and La Rioja, and the province of Guipuzcoa (Basque Country), the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana)), EE, F (Corsica), IRL (except Galway city), I (Abruzzo, Apulia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Lazio, Liguria, Lombardy (except the provinces of Mantua and Sondrio), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Barbona, Boara Pisani, Castelbaldo, Masi, Piacenza d'Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT (except the municipalities of Babtai and Kėdainiai (region of Kaunas)), P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska, and the communes of Lendava and Renče-Vogrsko (south from the highway H4)), SK (except the communes of Blahová, Čenkovce, Horné Mýto, Okoč, Topoľníky and Trhová Hradská (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Dvory nad Žitavou (Nové Zámky County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                              (b)

                              In point 2 of part B, the text in the second column, protected zone(s), is replaced by the following:
                              ‘E (except the autonomous communities of Aragon, Castilla la Mancha, Castilla y León, Extremadura, Murcia, Navarra and La Rioja, and the province of Guipuzcoa (Basque Country), the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana)), EE, F (Corsica), IRL (except Galway city), I (Abruzzo, Apulia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Lazio, Liguria, Lombardy (except the provinces of Mantua and Sondrio), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Barbona, Boara Pisani, Castelbaldo, Masi, Piacenza d'Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT (except the municipalities of Babtai and Kėdainiai (region of Kaunas)), P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska, and the communes of Lendava and Renče-Vogrsko (south from the highway H4)), SK (except the communes of Blahová, Čenkovce, Horné Mýto, Okoč, Topoľníky and Trhová Hradská (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Dvory nad Žitavou (Nové Zámky County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                  (4)

                  Annex IV is amended as follows:

                              (a)

                              Section I of Part A is amended as follows:

                                          (i)

                                          Point 5 is replaced by the following:

                                                                  ‘5.

                                                                  Wood of Platanus L., except that in the form of chips, particles, sawdust, shavings, wood waste and scrap, but including wood which has not kept its natural round surface, originating in Armenia, Switzerland or the USA.

                                                      Official statement that the wood has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, achieved through an appropriate time/temperature schedule. There shall be evidence thereof by a mark “kiln-dried” or “KD” or another internationally recognised mark, put on the wood or on any wrapping in accordance with current usage.’

                                          (ii)

                                          Point 7.1 is replaced by the following new points 7.1.1 and 7.1.2:

                                                                  ‘7.1.1.

                                                                  Whether or not listed among the CN-codes in Annex V, Part B, wood in the form of chips, particles, sawdust, shavings, wood waste and scrap and obtained in whole or in part from:

                                                                              —

                                                                                Acer saccharum Marsh., originating in the USA and Canada,

                                                                              —

                                                                                Populus L., originating in the American continent.

                                                      Official statement that the wood:

                                                                  (a)

                                                                  has been produced from debarked round wood,
                                                                  or

                                                                  (b)

                                                                  has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter achieved through an appropriate time/temperature schedule,
                                                                  or

                                                                  (c)

                                                                  has undergone an appropriate fumigation to a specification approved in accordance with the procedure referred to in Article 18(2). There shall be evidence of the fumigation by indicating on the certificates referred to in Article 13(1)(ii), the active ingredient, the minimum wood temperature, the rate (g/m3) and the exposure time (h),
                                                                  or

                                                                  (d)

                                                                  has undergone an appropriate heat treatment to achieve a minimum temperature of 56 °C for a minimum duration of 30 continuous minutes throughout the entire profile of the wood (including at its core), the latter to be indicated on the certificates referred to in Article 13.1.(ii).

                                                                  7.1.2.

                                                                  Whether or not listed among the CN-codes in Annex V, Part B, wood in the form of chips, particles, sawdust, shavings, wood waste and scrap and obtained in whole or in part from:

                                                                              —

                                                                                Platanus L. originating in Armenia, Switzerland or the USA.

                                                      Official statement that the wood:

                                                                  (a)

                                                                  has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter achieved through an appropriate time/temperature schedule,
                                                                  or

                                                                  (b)

                                                                  has undergone an appropriate fumigation to a specification approved in accordance with the procedure referred to in Article 18(2) There shall be evidence of the fumigation by indicating on the certificates referred to in Article 13(1)(ii), the active ingredient, the minimum wood temperature, the rate (g/m3) and the exposure time (h),
                                                                  or

                                                                  (c)

                                                                  has undergone an appropriate heat treatment to achieve a minimum temperature of 56 °C for a minimum duration of 30 continuous minutes throughout the entire profile of the wood (including at its core), the latter to be indicated on the certificates referred to in Article 13(1)(ii).’

                                          (iii)

                                          Point 12 is replaced by the following:

                                                                  ‘12.

                                                                  Plants of Platanus L., intended for planting, other than seeds, originating in Armenia, Switzerland or the USA.

                                                      Official statement that no symptoms of Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. have been observed at the place of production or in its immediate vicinity since the beginning of the last complete cycle of vegetation.’

                              (b)

                              Section II of Part A is amended as follows:

                                          (i)

                                          Point 2 is replaced by the following:

                                                                  ‘2.

                                                                  Wood of Platanus L., including wood which has not kept its natural round surface.

                                                      Official statement that:

                                                                  (a)

                                                                  the wood originates in areas known to be free from Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr.,
                                                                  or

                                                                  (b)

                                                                  there shall be evidence by a mark “kiln-dried”, “KD” or another internationally recognised mark, put on the wood or on its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule.’

                                          (ii)

                                          Point 8 is replaced by the following:

                                                                  ‘8.

                                                                  Plants of Platanus L., intended for planting, other than seeds

                                                      Official statement that:

                                                                  (a)

                                                                  the plants originate in an area known to be free from Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr.,
                                                                  or

                                                                  (b)

                                                                  no symptoms of Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr. have been observed at the place of production or in its immediate vicinity since the beginning of the last complete cycle of vegetation.’

                              (c)

                              Part B is amended as follows:

                                          (i)

                                          The following point is inserted after point 6.3:

                                                                  ‘6.4.

                                                                  Wood of Platanus L., including wood which has not kept its natural round surface, originating in the Union, or in Armenia, Switzerland or the USA

                                                      Without prejudice to the provisions applicable to the wood listed in Annex IVA(I)5 and 7.1.2, and IVA(II)2, where appropriate, official statement that:

                                                                  (a)

                                                                  the wood originates in an area free from Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr., established in accordance with relevant International Standards for Phytosanitary Measures, or

                                                                  (b)

                                                                  there shall be evidence by a mark “kiln-dried”, “KD” or another internationally recognised mark, put on the wood or on its packaging in accordance with current commercial usage, that it has undergone kiln-drying to below 20 % moisture content, expressed as a percentage of dry matter, at time of manufacture, achieved through an appropriate time/temperature schedule, or

                                                                  (c)

                                                                  the wood originates from a protected zone listed in the right hand column

                                                      UK’

                                          (ii)

                                          The following point is inserted after point 12:

                                                                  ‘12.1.

                                                                  Plants of Platanus L., intended for planting, other than seeds, originating in the Union, or in Armenia, Switzerland or the USA

                                                      Without prejudice to the provisions applicable to the plants listed in Annex IVA(I)12 and IVA(II)8, where appropriate, official statement that:

                                                                  (a)

                                                                  the plants have been grown throughout their life in an area free from Ceratocystis platani (J. M. Walter) Engelbr. & T. C. Harr., established in accordance with relevant International Standard for Phytosanitary Measures, or

                                                                  (b)

                                                                  the plants have been grown throughout their life in a protected zone listed in the right hand column.

                                                      UK’

                                          (iii)

                                          In point 21, the text in the third column, protected zone(s), is replaced by the following:
                                          ‘E (except the autonomous communities of Aragon, Castilla la Mancha, Castilla y León, Extremadura, Murcia, Navarra and La Rioja, and the province of Guipuzcoa (Basque Country), the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana)), EE, F (Corsica), IRL (except Galway city), I (Abruzzo, Apulia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Lazio, Liguria, Lombardy (except the provinces of Mantua and Sondrio), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Barbona, Boara Pisani, Castelbaldo, Masi, Piacenza d'Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT (except the municipalities of Babtai and Kėdainiai (region of Kaunas)), P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska, and the communes of Lendava and Renče-Vogrsko (south from the highway H4)), SK (except the communes of Blahová, Čenkovce, Horné Mýto, Okoč, Topoľníky and Trhová Hradská (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Dvory nad Žitavou (Nové Zámky County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                                          (iv)

                                          In point 21.3, the text in the third column, protected zone(s), is replaced by the following:
                                          ‘E (except the autonomous communities of Aragon, Castilla la Mancha, Castilla y León, Extremadura, Murcia, Navarra and La Rioja, and the province of Guipuzcoa (Basque Country), the Comarcas de L'Alt Vinalopó and El Vinalopó Mitjà in the province of Alicante and the municipalities of Alborache and Turís in the province of Valencia (Comunidad Valenciana)), EE, F (Corsica), IRL (except Galway city), I (Abruzzo, Apulia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Lazio, Liguria, Lombardy (except the provinces of Mantua and Sondrio), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the provinces of Rovigo and Venice, the communes Barbona, Boara Pisani, Castelbaldo, Masi, Piacenza d'Adige, S. Urbano, Vescovana in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT (except the municipalities of Babtai and Kėdainiai (region of Kaunas)), P, SI (except the regions Gorenjska, Koroška, Maribor and Notranjska, and the communes of Lendava and Renče-Vogrsko (south from the highway H4)), SK (except the communes of Blahová, Čenkovce, Horné Mýto, Okoč, Topoľníky and Trhová Hradská (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Dvory nad Žitavou (Nové Zámky County), Málinec (Poltár County), Hrhov (Rožňava County), Veľké Ripňany (Topoľčany County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                                          (v)

                                          In point 24.1, the text in the third column, protected zone(s), is replaced by the following:
                                          ‘IRL, P (Azores, Beira Interior, Beira Litoral, Entre Douro e Minho, Ribatejo e Oeste (communes of Alcobaça, Alenquer, Bombarral, Cadaval, Caldas da Rainha, Lourinhã, Nazaré, Obidos, Peniche and Torres Vedras) and Trás-os-Montes), FI, S, UK’.

                                          (vi)

                                          In point 24.2, the text in the third column, protected zone(s), is replaced by the following:
                                          ‘IRL, P (Azores, Beira Interior, Beira Litoral, Entre Douro e Minho, Ribatejo e Oeste (communes of Alcobaça, Alenquer, Bombarral, Cadaval, Caldas da Rainha, Lourinhã, Nazaré, Obidos, Peniche and Torres Vedras) and Trás-os-Montes), FI, S, UK’.

                                          (vii)

                                          In point 24.3, the text in the third column, protected zone(s), is replaced by the following:
                                          ‘IRL, P (Azores, Beira Interior, Beira Litoral, Entre Douro e Minho, Ribatejo e Oeste (communes of Alcobaça, Alenquer, Bombarral, Cadaval, Caldas da Rainha, Lourinhã, Nazaré, Obidos, Peniche and Torres Vedras) and Trás-os-Montes), FI, S, UK’.

                  (5)

                  Annex V is amended as follows:

                              (a)

                              Section II of Part A is amended as follows:

                                          (i)

                                          Point 1.2 is replaced by the following:

                                                      ‘1.2.

                                                      Plants, intended for planting, other than seeds, of Platanus L., Populus L. and Beta vulgaris L.’

                                          (ii)

                                          In point 1.10 point (a) is replaced by the following:

                                                      ‘(a)

                                                      has been obtained in whole or part from conifers (Coniferales), excluding wood which is bark-free,

                                                         Castanea Mill., excluding wood which is bark-free,

                                                         Platanus L., including wood which has not kept its natural round surface;
                                                      and’

                              (b)

                              In point 6(a) of Section I of Part B, the second indent is replaced by the following:

                                          ‘—

                                             Platanus L., including wood which has not kept its natural round surface, originating in Armenia, Switzerland or the USA,’.


title: Commission Implementing Directive 2011/46/EU of 14 April 2011 amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               15.4.2011

               EN

               Official Journal of the European Union

               L 101/20

         COMMISSION IMPLEMENTING DIRECTIVE 2011/46/EU
   of 14 April 2011
   amending Council Directive 91/414/EEC to include hexythiazox as active substance and amending Commission Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

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

               (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 hexythiazox.

               (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 Finland, 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)

               Finland 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 October 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 hexythiazox to the Commission on 7 September 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for hexythiazox.

               (6)

               It has appeared from the various examinations made that plant protection products containing hexythiazox 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 hexythiazox in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit information confirming the risk assessment for the toxicological relevance and the potential occurrence of the metabolite PT-1-3 (7) in processed commodities, the potential adverse effects of hexythiazox on bee brood and the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

               (8)

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

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing hexythiazox 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 (8) 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 hexythiazox and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning hexythiazox 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 hexythiazox 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 hexythiazox 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 hexythiazox 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 hexythiazox 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 hexythiazox. 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 hexythiazox 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 hexythiazox 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, 14 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 hexythiazox. EFSA Journal 2010; 8(9):1722. [78 pp.]. doi:10.2903/j.efsa.2010.1722. Available online: www.efsa.europa.eu

      (7)  (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl- 1,3-thiazolidin-2-one.

      (8)  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

                     ‘343

                     Hexythiazox
                     CAS No 78587-05-0
                     CIPAC No 439

                        (4RS,5RS)-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-1,3-thiazolidine-3-carboxamide

                     ≥ 976 g/kg
                     (1:1 mixture of (4R, 5R) and (4S, 5S))

                     1 June 2011

                     31 May 2021

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

                                 —

                                 the protection of aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate,

                                 —

                                 the operators and workers safety. Conditions of use shall include protective measures, where appropriate.

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

                                 (a)

                                 the toxicological relevance of the metabolite PT-1-3 (2);

                                 (b)

                                 the potential occurrence of the metabolite PT-1-3 in processed commodities;

                                 (c)

                                 the potential adverse effects of hexythiazox on bee brood;

                                 (d)

                                 the possible impact of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) 2 years after the adoption of specific guidance.’

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

         (2)  (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.


title: Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation  Text with EEA relevance

text:
               10.10.2012

               EN

               Official Journal of the European Union

               L 275/27

         COMMISSION IMPLEMENTING DIRECTIVE 2012/25/EU
   of 9 October 2012
   laying down information procedures for the exchange, between Member States, of human organs intended for transplantation
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2010/53/EU of the European Parliament and of the Council, of 7 July 2010, on standards of quality and safety of human organs intended for transplantation (1), and in particular to Article 29 thereof,
   Whereas:

               (1)

               In order to ensure a high level of public health the exchange of human organs between Member States requires a detailed set of uniform procedural rules for the transmission of information on organs and donor characterisation, for the traceability of organs and for the reporting of serious adverse events and reactions.

               (2)

               A variety of stakeholders in the Member States may be involved, as senders or as addressees, in the transmission of information for the exchange of human organs, such as competent authorities, delegated bodies including European organ exchange organisations, procurement organisations and transplantation centres. Where such bodies send or receive information for the exchange of human organs, they should act in accordance with the common procedures laid down in this Directive. These procedures should not preclude additional verbal contacts, in particular in case of urgencies.

               (3)

               In the implementation of this Directive, Member States are to ensure that the processing of donors’ and recipients’ personal data complies with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (2). In order to enhance awareness of the persons processing information transmitted pursuant to this Directive, it is appropriate to include a reminder in the written communications pursuant to this Directive.

               (4)

               In order to allow for rapid responses in case of alerts, and in order to facilitate the implementation of the obligation, provided for in Article 10(3)(b) of Directive 2010/53/EU, to keep data needed to ensure full traceability for a minimum of 30 years after donation, and without prejudice to the obligations of other bodies in that respect, it is appropriate that competent authorities or delegated bodies handle and record that information. Procurement organisations and transplantation centres should therefore ensure that their respective competent authorities or delegated bodies receive a copy of the information on organ and donor characterisation exchanged pursuant to this Directive, where applicable.

               (5)

               Given the current variety of practices between Member States, it is not appropriate at this stage to provide for a standard form for the transmission of information on organ and donor characterisation in this Directive. However, in order to facilitate mutual understanding of the information transmitted, such a standard form should be developed in the future, in cooperation with the Member States.

               (6)

               A serious adverse event or reaction may be detected in a Member State of origin or destination and may be of concern for the quality and safety of the donated organs and as a consequence for the health of recipients, and in case of living donation also for the health of the donor. When organs are exchanged between Member States, such concerns may occur in different Member States. Moreover, organs from one donor might be transplanted into recipients in different Member States so that, if a serious adverse event or reaction is first detected in one Member State of destination, the competent authorities or delegated bodies in the Member State of origin and in the other Member States of destination have to be informed. It is essential to ensure that all competent authorities or delegated bodies of all the Member States concerned are informed without undue delay. In order to reach this objective, Member States should ensure that all relevant information is disseminated among all Member States concerned through a set of written reports. Initial reports should be updated if additional relevant information becomes available.

               (7)

               The transmission of information is very often a matter of urgency. It is essential that the senders of information are able to identify and inform rapidly the relevant addressees. The competent authorities or delegated bodies of a Member State should, where appropriate in accordance with the repartition of competence in the Member State concerned, transfer the information received pursuant to this Directive to the appropriate recipient. A list of national contact points, including their contact details, should be made available at Union level and be constantly kept up to date.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Committee on organ transplantation, established under Article 30 of Directive 2010/53/EU,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Scope
   This Directive shall apply to the cross-border exchange of human organs intended for transplantation within the European Union.
   Article 2
   Subject matter
   In line with Article 29 of Directive 2010/53/EU, this Directive sets out:

               (a)

               procedures for the transmission of information on organ and donor characterisation;

               (b)

               procedures for the transmission of the necessary information to ensure the traceability of organs;

               (c)

               procedures for ensuring the reporting of serious adverse events and reactions.

         Article 3
   Definitions
   For the purpose of this Directive, the following definitions shall apply:

               (a)

               ‘Member State of origin’ means the Member State where the organ is procured with the purpose of transplantation;

               (b)

               ‘Member State of destination’ means the Member State to which the organ is sent for the purpose of transplantation;

               (c)

               ‘National donor/recipient identification number’ means the identification code attributed to a donor or a recipient in accordance with the identification system established at national level pursuant to Article 10(2) of Directive 2010/53/EU;

               (d)

               ‘Specification of the organ’ means (1) the anatomical description of an organ including: its type (e.g. heart, liver); (2) where applicable, its position (left or right) in the body; and (3) whether it is a whole organ or a part of an organ, mentioning the lobe or segment of the organ;

               (e)

               ‘a delegated body’ means a body to which tasks have been delegated in accordance with Article 17(1) of Directive 2010/53/EU or a European organ exchange organisation to which tasks have been delegated in accordance with Article 21 of Directive 2010/53/EU.

         Article 4
   Common procedural rules
   1.   Member States shall ensure that the information transmitted pursuant to this Directive between competent authorities or delegated bodies, procurement organisations and/or transplantation centres:

               (a)

               is transmitted in writing either electronically or by fax;

               (b)

               is written in a language mutually understood by the sender and the addressee or, in absence thereof, in a mutually agreed language, or, in absence thereof, in English;

               (c)

               is transmitted without undue delay;

               (d)

               is recorded and can be made available upon request;

               (e)

               indicates the date and time of the transmission;

               (f)

               includes the contact details of the person responsible for the transmission;

               (g)

               contains the following reminder:
               ‘Contains personal data. To be protected against unauthorised disclosure or access.’.

         2.   In case of urgencies, the information can be exchanged in a verbal form, in particular for exchanges pursuant to Articles 5 and 7. These verbal contacts must be followed by a transmission in writing in accordance with those Articles.
   3.   The Member States of destination or origin shall ensure that the receipt of the information transmitted in accordance with this Directive is confirmed to the sender, in accordance with the requirements set out in paragraph 1.
   4.   Member States shall ensure that designated personnel in competent authorities or delegated bodies:

               (a)

               are available 24 hours a day and 7 days a week, for urgent situations;

               (b)

               are able to receive and transmit information pursuant to this Directive without undue delay.

         Article 5
   Information on organ and donor characterisation
   1.   Member States shall ensure that, where organs are envisaged for exchange between Member States, prior to exchanging the organ, the competent authority or delegated body of the Member State of origin transmits the information collected to characterise the procured organs and the donor, as specified in Article 7 and in the Annex to Directive 2010/53/EU, to the competent authorities or delegated bodies of the potential Member States of destination.
   2.   Member States shall ensure that, where some of the information to be transmitted in accordance with paragraph 1 is not available at the time of the initial transmission and becomes available later, it is transmitted in due time to allow for medical decisions:

               (a)

               by the competent authority or delegated body of the Member State of origin to the competent authority or delegated body of the Member State of destination; or

               (b)

               directly by the procurement organisation to the transplantation centre.

         3.   Member States shall take appropriate measures to ensure that procurement organisations and transplantation centres transmit to their respective competent authorities or delegated bodies a copy of the information pursuant to this Article.
   Article 6
   Information to ensure the traceability of organs
   1.   Member States shall ensure that the competent authority or delegated body of the Member State of origin inform the competent authority or delegated body of the Member State of destination of:

               (a)

               the specification of the organ;

               (b)

               the national donor identification number;

               (c)

               the date of procurement;

               (d)

               name and contact details of the procurement centre.

         2.   Member States shall ensure that the competent authority or delegated body of the Member State of destination inform the competent authority or delegated body of the Member State of origin of:

               (a)

               the national recipient identification number or, if the organ was not transplanted, of its final use;

               (b)

               the date of transplantation, if applicable;

               (c)

               name and contact details of the transplantation centre.

         Article 7
   Reporting of serious adverse events and reactions
   Member States shall ensure that the following procedure is implemented by their competent authorities or delegated bodies:

               (a)

               Whenever the competent authority or delegated body of the Member State of destination is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another Member State, it shall immediately inform the competent authority or delegated body of the Member State of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in Annex I, in so far as this information is available.

               (b)

               The competent authority or delegated body of the Member State of origin shall immediately inform the competent authorities or delegated bodies of each concerned Member State of destination and transmit them each an initial report containing the information set out in Annex I, whenever it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States.

               (c)

               When additional information becomes available following the initial report, it shall be transmitted without undue delay.

               (d)

               The competent authority or delegated body of the Member State of origin shall, as a rule within three months of the initial report transmitted pursuant to point (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in Annex II. The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely manner to the competent authority or delegated body of the Member State of origin. The final report shall be drawn up after collecting relevant information from all Member States involved.

         Article 8
   Interconnection between Member States
   1.   Member States shall communicate to the Commission the contact details of the competent authority or delegated bodies to which the relevant information shall be transmitted for the purpose of, on the one hand, Article 5, and, on the other hand, Articles 6 and 7. These contact details include at least the following data: the organisation’s name, telephone number, e-mail address, fax number and postal address.
   2.   Where a Member State has several competent authorities or delegated bodies, it shall ensure that the information received by one of them pursuant to Article 5, 6 or 7 is forwarded to the appropriate competent authority or delegated body at national level, in accordance with the repartition of competences in that Member State.
   3.   The Commission shall make available to the Member States a list of all competent authorities and delegated bodies designated by Member States in accordance with paragraph 1. The Member States shall keep the information in that list up to date. The Commission may entrust the establishment and maintenance of this list to a third party.
   Article 9
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 April 2014 at the latest.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 10
   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.

      Done at Brussels, 9 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 207, 6.8.2010, p. 14, corrected by OJ L 243, 16.9.2010, p. 68.

      (2)  OJ L 281, 23.11.1995, p. 31.
   ANNEX I

      Initial Report for suspected serious adverse events or reactions

               1.

               Reporting Member State

               2.

               Report identification number: country (ISO)/national number

               3.

               Contact details of the reporter (competent authority or delegated body in the reporting Member State): telephone, e-mail and, when available, fax

               4.

               Reporting centre/organisation

               5.

               Contact details of coordinator/contact person (transplant/procurement centre in the reporting Member State): telephone, e-mail and, when available, fax

               6.

               Reporting date and time (yyyy/mm/dd/hh/mm)

               7.

               Member State of origin

               8.

               National donor identification number, as communicated under Article 6

               9.

               All Member States of destination (if known)

               10.

               National recipient identification number(s), as communicated under Article 6

               11.

               Onset date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)

               12.

               Detection date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm)

               13.

               Description of serious adverse event or reaction

               14.

               Immediate measures taken/proposed

         ANNEX II

      Final Report of serious adverse events or reactions

               1.

               Reporting Member State

               2.

               Report identification number: country (ISO)/national number

               3.

               Contact details of the reporter: telephone, e-mail and, when available, fax

               4.

               Reporting date and time (yyyy/mm/dd/hh/mm)

               5.

               Identification number(s) of initial report(s) (Annex I)

               6.

               Description of case

               7.

               Involved Member States

               8.

               Outcome of the investigation and final conclusion

               9.

               Preventive and corrective actions taken

               10.

               Conclusion/Follow-up, if required


title: Commission Implementing Directive 2014/58/EU of 16 April 2014 setting up, pursuant to Directive 2007/23/EC of the European Parliament and of the Council, a system for the traceability of pyrotechnic articles (Text with EEA relevance)

text:
               17.4.2014

               EN

               Official Journal of the European Union

               L 115/28

         COMMISSION IMPLEMENTING DIRECTIVE 2014/58/EU
   of 16 April 2014
   setting up, pursuant to Directive 2007/23/EC of the European Parliament and of the Council, a system for the traceability of pyrotechnic articles
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2007/23/EC of the European Parliament and of the Council of 23 May 2007 on the placing on the market of pyrotechnic articles (1), and in particular Article 18(2)(a) thereof,
   Whereas:

               (1)

               Directive 2007/23/EC lays down rules for the safety of pyrotechnic articles on the Union market and provides for the setting up of a traceability system at Union level.

               (2)

               In order to ensure traceability of pyrotechnic articles they should be labelled with a registration number based on a uniform numbering system. Notified bodies should maintain a register with the registration numbers they assign when carrying out the conformity assessment. Such a system would guarantee identification of pyrotechnic articles and their manufacturers throughout all stages of the supply chain. Manufacturers and importers should maintain records of the registration numbers of the pyrotechnic articles made available on the market and make that information available to the relevant authorities upon request.

               (3)

               The uniform numbering system is based on elements already applied in accordance with existing harmonised standards and will therefore create little additional burden on economic operators.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established by Directive 2007/23/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Registration number
   1.   Pyrotechnic articles shall be labelled with a registration number comprising the following:

               (a)

               the four-digit identification number of the notified body that has issued EC type-examination certificate in accordance with the conformity assessment procedure referred to in Article 9(a) of Directive 2007/23/EC (Module B), or certificate of conformity in accordance with the conformity assessments procedure referred to in Article 9(b) of Directive 2007/23/EC (Module G) or quality system approval in accordance with the conformity assessment procedure referred to in Article 9(c) of Directive 2007/23/EC (Module H);

               (b)

               the category of the pyrotechnic article for which conformity is certified in abbreviated format, in upper case:

                           —

                           F1, F2, F3 or F4 for fireworks of category 1, 2, 3 and 4 respectively,

                           —

                           T1 or T2 for theatrical pyrotechnic articles of category T1 and T2 respectively,

                           —

                           P1 or P2 for other pyrotechnic articles of category P1 and P2 respectively;

               (c)

               the processing number used by the notified body for the pyrotechnic article.

         2.   The registration number shall be structured as follows: ‘XXXX — YY — ZZZZ…’, where XXXX refers to point (a) of paragraph 1, YY refers to point (b) of paragraph 1 and ZZZZ… refers to point (c) of paragraph 1.
   Article 2
   Obligations of notified bodies
   1.   Notified bodies carrying out conformity assessment procedures pursuant to Article 9 of Directive 2007/23/EC shall maintain a register of pyrotechnic articles, for which they have issued EC type-examination certificates in accordance with the conformity assessment procedure referred to in Article 9(a) of Directive 2007/23/EC (Module B), or certificates of conformity in accordance with the conformity assessment procedure referred to in Article 9(b) of Directive 2007/23/EC (Module G) or quality system approvals in accordance with the conformity assessment procedure referred to in Article 9(c) of Directive 2007/23/EC (Module H); in the format set out in the Annex to this Directive.
   The register of pyrotechnic articles shall contain at least the information on the items set out in the Annex. That information shall be kept for at least 10 years from the date on which the notified bodies have issued certificates or approvals referred to in the first subparagraph.
   Notified bodies shall regularly update the register and make it publicly available on the internet.
   2.   Where the notification of a conformity assessment body is withdrawn, that body shall transfer the register to another notified body or the competent authority of the Member State concerned.
   Article 3
   Obligations of manufacturers and importers
   Manufacturers and importers of pyrotechnic articles shall:

               (a)

               keep a record of all registration numbers of pyrotechnic articles manufactured or imported by them together with their trade name, generic type and subtype, if applicable, and the site of manufacture for at least 10 years after the article has been placed on the market;

               (b)

               transfer the record to the competent authorities in case the manufacturer or importer is ceasing its activity;

               (c)

               provide the competent authorities and market surveillance authorities of all Member States, upon their reasoned request, with the information referred to in point (a).

         Article 4
   Transposition
   1.   Member States shall adopt and publish, by 30 April 2015 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 17 October 2016.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 5
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 16 April 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 154, 14.6.2007, p. 1.

      ANNEX

         Register format referred to in Article 2(1)

                  Registration number

                  Date of issue of EC type-examination certificate (Module B), certificate of conformity (Module G) or quality system approval (Module H) and date of expiry where applicable

                  Manufacturer

                  Type of product (generic) and subtype if applicable

                  Production phase conformity module (1)

                  Notified body undertaking production phase conformity assessment (1)

                  Additional information

         (1)  Always has to be filled in if under responsibility of the notified body carrying out conformity assessment procedure referred to in Article 9(a) of Directive 2007/23/EC (Module B). Not required for conformity assessment procedures referred to in Article 9(b) and (c) (Modules G and H). Information shall be given (where known) if another notified body is involved.


title: Commission Implementing Directive 2011/47/EU of 15 April 2011 amending Council Directive 91/414/EEC to include aluminium sulphate as active substance and amending Commission Decision 2008/941/EC  Text with EEA relevance

text:
               16.4.2011

               EN

               Official Journal of the European Union

               L 102/24

         COMMISSION IMPLEMENTING DIRECTIVE 2011/47/EU
   of 15 April 2011
   amending Council Directive 91/414/EEC to include aluminium sulphate as active substance and amending Commission Decision 2008/941/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 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth 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 aluminium sulphate.

               (2)

               In accordance with Article 24e of Regulation (EC) No 2229/2004 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 2008/941/EC of 8 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 aluminium sulphate.

               (3)

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

               (4)

               The application was submitted to the Netherlands, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004. 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 2008/941/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 9 March 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 aluminium sulphate to the Commission on 28 October 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 aluminium sulphate.

               (6)

               It has appeared from the various examinations made that plant protection products containing aluminium sulphate 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 aluminium sulphate 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, in the form of appropriate analytical data.

               (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 aluminium sulphate 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 2008/941/EC provides for the non-inclusion of aluminium sulphate and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning aluminium sulphate in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/941/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 aluminium sulphate in the Annex to Decision 2008/941/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 aluminium sulphate 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 aluminium sulphate 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 aluminium sulphate 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 aluminium sulphate. 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 aluminium sulphate 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 aluminium sulphate 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, 15 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 168, 27.6.2002, p. 14.

      (3)  OJ L 379, 24.12.2004, p. 13.

      (4)  OJ L 335, 13.12.2008, p. 91.

      (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 aluminium sulfate. EFSA Journal 2010;8(11):1889. [32 pp.] doi:10.2903/j.efsa.2010.1889. 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

                     ‘351

                     Aluminium sulphate
                     CAS No: 10043-01-3
                     CIPAC not available

                        Aluminium sulphate

                     970 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only indoor uses as post-harvest bactericide for ornamental plants may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium sulphate, 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.
                     The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.
                     The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 December 2011.’

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


title: Commission Delegated Directive (EU) 2016/585 of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes (Text with EEA relevance)

text:
               16.4.2016

               EN

               Official Journal of the European Union

               L 101/12

         COMMISSION DELEGATED DIRECTIVE (EU) 2016/585
   of 12 February 2016
   amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment placed on the market.

               (2)

               Refurbishment practices exists for imaging equipment such as magnetic resonance imaging devices, computer tomography devices, in vitro diagnostic devices, patient monitoring devices, and electron microscopes. Some of the recovered spare parts reused for refurbishment will contain small amounts of lead, cadmium, hexavalent chromium, or PBDE.

               (3)

               The exemption set out in point 31 of Annex IV to Directive 2011/65/EU does not allow for the use of spare parts recovered from used equipment which was not already placed on the Union market thus limiting the availability of recovered spare parts.

               (4)

               A comparison of the environmental impacts of using refurbished parts in such cases with the environmental impacts of substituting refurbished parts with new ones demonstrates that the total negative environmental, health and consumer safety impacts of substitution would outweigh the total benefits thereof.

               (5)

               Considering that the substance restriction will start to apply to the different equipment concerned on different dates as provided for in Article 4(3) of Directive 2011/65/EU, a different expiry date for the exemption should be set for each type of equipment.

               (6)

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

               (7)

               In order to ensure a smooth transition for market operators from the existing provisions to those specified in this Directive and to prevent single market disruptions, it is appropriate to set a date for the simultaneous application by the Member States of their national provisions which also provides a reasonable period of time after the date of transposition,

         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 adopt and publish, by 28 February 2017, 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 6 November 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 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, 12 February 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      Annex IV to Directive 2011/65/EU is amended as follows:

                  (1)

                  point 31 is deleted;

                  (2)

                  the following point 31a is added:

                              ‘31a.

                              Lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, or electron microscopes and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer.
                              Expires on:

                                          (a)

                                          21 July 2021 for the use in medical devices other than in vitro diagnostic medical devices;

                                          (b)

                                          21 July 2023 for the use in in vitro diagnostic medical devices;

                                          (c)

                                          21 July 2024 for the use in electron microscopes and their accessories.’