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31998L0001

Commission Directive 98/1/EC of 8 January 1998 amending certain Annexes to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Official Journal L 015 , 21/01/1998 P. 0026 - 0033

COMMISSION DIRECTIVE 98/1/EC of 8 January 1998 amending certain Annexes to Council Directive 77/93/EEC 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 COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 77/93/EEC of 21 December 1976 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), as last amended by Commission Directive 97/14/EC (2), and in particular Article 13, second paragraph, third and fourth indents, thereof,Whereas measures should be taken to protect the Community against Diabrotica barberi Smith & Lawrence, Diabrotica undecimpunctata howardi Barber, Diabrotica undecimpunctata undecimpuctata Mannerheim and Diabrotica virgifera Le Conte, harmful organisms which have not hitherto been known to occur in the Community;Whereas measures should be taken against the introduction into and spread within the Community of Meloidogyne chitwoodi Golden et al. (all populations) and M. fallax Karssen and Tomato yellow leaf curl virus;Whereas the provisions on protective measures against Enarmonia prunivora Walsh and Ditylenchus dipsaci (Kühn) Filipjev, organisms listed in the Annexes to the said Directive, should be improved, and in particular the list of host plants should be extended;Whereas it is no longer appropriate to maintain the current provisions on protective measures against Tomato spotted wilt virus;Whereas certain measures against Gymnosporangium asiaticum Miyabe ex Yamada, in particular in respect of plants of Photinia Ldl., should be modified because it has been determined that the said organism is only present in some third countries;Whereas improved measures should be taken to protect the Community against the introduction of harmful organisms affecting hybrids of Solanum L., other than those intended for planting, and aquarium plants;Whereas certain provisions concerning organisms affecting naturally or artificially dwarfed plants for planting, other than seeds, originating in non-European countries should be improved;Whereas certain provisions concerning organisms affecting isolated bark of Castanea Mill. should be amended and, in particular, adapted to the present distribution of organisms such as non-European Pissodes spp. and Scolytidae spp.;Whereas certain provisions concerning Monilinia fructicola (Winter) Honey, should be amended because it has been determined that only Prunus fruits from non-European countries should be subjected to phystosanitary control in the high-risk period from 15 February to 30 September;Whereas since it has been determined that the risk of spreading Xanthomonas campestris pv. pruni by intra-Community trade in P. laurocerasus L. and P. lusitanica L., is minimal, the relevant measures should be modified;Whereas since it has become apparent that there is no risk of transmitting Bemisia tabaci Genn with seeds, tubers and corms of Begonia L., the relevant measures should be modified;Whereas certain measures against Clavibacter michiganensis spp. insidiosus Davis et al. should be modified in order to take account of the area of origin of the seeds and the presence of the disease in that area;Whereas in order to take into account the phytosanitary risk involved with the import of parts of certain plants, other than fruits and seeds, certain measures should be modified;Whereas these amendments are in accordance with the requests of the Member States concerned;Whereas, therefore, the relevant Annexes to Directive 77/93/EEC should be amended accordingly;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Comittee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1 Annexes I to V to Directive 77/93/EEC are hereby amended as indicated in the Annex to this Directive.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 May 1998. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall immediately communicate to the Commission the main provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.Article 3 This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 8 January 1998.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 26, 31. 1. 1977, p. 20.(2) OJ L 87, 2. 4. 1997, p. 17.ANNEX 1. In Annex I, Part A, Section I(a), the following points are inserted after point 10:'10.1. Diabrotica barberi Smith & Lawrence10.2. Diabrotica undecimpunctata howardi Barber10.3. Diabrotica undecimpunctata undecimpunctata Mannerheim10.4. Diabrotica virgifera Le Conte`.2. In Annex I, Part A, Section I(a), the following point is inserted after point 11:'11.1. Hirschmanniella spp., other than Hirschmanniella gracilis (de Man) Luc & Goodey`.3. In Annex I, Part A, Section II(a), the following points are inserted after point 6:'6.1. Meloidogyne chitwoodi Golden et al. (all populations)6.2. Meloidogyne fallax Karssen`.4. In Annex I, Part A, Section II(a), the following point is inserted after point 8:'8.1. Rhizoecus hibisci Kawai & Takagi`.5. In Annex II, Part A, Section I(a), point 12, the text in the right-hand column is replaced by the following:'Plants of Crataegus L., Malus Mill., Photinia Ldl., Prunus L. and Rosa L., intended for planting, other than seeds, and fruit of Malus Mill. and Prunus L., originating in non-European countries`.6. In Annex II, Part A, Section II(d), point 15, the right-hand column, the following words are added:'other than seeds`.7. In Annex II, Part A, Section II(d), the following point is added:>TABLE>.8. In Annex III, Part A, point 9 is replaced by the following:>TABLE>9. In Annex III, Part A, point 12, the text in the left-hand column is replaced by the following:'Tubers of species of Solanum L. and their hybrids, other than those specified in points 10 and 11`.10. In Annex IV, Part A, Section I, point 16, the text in the left-hand column is replaced by the following:'From 15 February to 30 September, fruits of Prunus L., originating in non-European countries`.11. In Annex IV, Part A, Section I, point 25.4, right-hand column, the following is added:'and(cc) either, the tubers originate in areas in which Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen are known not to occur; or(dd) in areas where Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen are known to occur,- either the tubers originate from a place of production which has been found free from Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen based on an annual survey of host crops by visual inspection of host plants at appropriate times and by visual inspection both externally and by cutting of tubers after harvest from potato crops grown at the place of production, or- the tubers after harvest have been randomly sampled and, either checked for the presence of symptoms after an appropriate method to induce symptoms, or laboratory tested, as well as inspected visually both externally and by cutting the tubers, at appropriate times and in all cases at the time of closing of the packages or containers before marketing according to the provisions on closing in Council Directive 66/403/EEC (*), and no symptoms of Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen have been found.(*) OJ 125, 11. 7. 1966, p. 2320/66.`12. In Annex IV, Part A, Section I, point 43 is replaced by the following:>TABLE>13. In Annex IV, Part A, Section I, the following point is inserted after point 45:>TABLE>14. In Annex IV, Part A, Section I, point 46, right-hand column 'and (45.1)` is inserted after '(45)`.15. In Annex IV, Part A, Section II, point 19.1, right-hand column, the following is added:'and(e) either, the tubers originate in areas in which Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen are known not to occur; or in areas where Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen are known to occur,- either the tubers originate from a place of production which has been found free from Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen based on an annual survey of host crops by visual inspection of host plants at appropriate times and by visual inspection both externally and by cutting of tubers after harvest from potato crops grown at the place of production, or- the tubers after harvest have been randomly sampled and, either checked for the presence of symptoms after an appropriate method to induce symptoms or laboratory tested, as well as inspected visually both externally and by cutting the tubers, at appropriate times and in all cases at the time of closing of the packages or containers before marketing according to the provisions on closing in Council Directive 66/403/EEC, and no symptoms of Meloidogyne chitwoodi Golden et al. (all populations) and Meloidogyne fallax Karssen have been found.`16. In Annex IV, Part A, Section II, the following point is inserted after point 27:>TABLE>17. In Annex IV, Part A, Section II, point 29.2, right-hand column, the word 'or` is inserted between (a) and (b).18. In Annex IV, Part B, point 24, the text in the left-hand column is replaced by the following:'Plants of Begonia L., intended for planting other than seeds, tubers and corms, and plants of Euphorbia pulcherrima Willd., intended for planting, other than seeds, other than those for which there shall be evidence by their packaging or their flower (or bract) development or by other means that they are intended for sale to final consumers not involved in professional plant production.`19. In Annex V, Part A(I), point 1.1, the word 'Prunus L.` is replaced by 'Prunus L., other than Prunus laurocerasus L. and Prunus lusitanica L.`.20. In Annex V, Part A(I), point 2.1, the words 'Prunus laurocerasus L., Prunus lusitanica L.` are inserted between 'Populus L.` and 'Pseudotsuga Carr.`.21. In Annex V, Part A(II), point 2.1 is replaced by the following:'Plants of Begonia L., intended for planting other than seeds, tubers and corms, and plants of Euphorbia pulcherrima Willd, intended for planting, other than seeds`.22. In Annex V, Part B(I), point 1, the words 'or aquarium plants` are deleted.23. In Annex V, Part B(I), point 1, the words 'Allium ascalonicum L.` are inserted after 'Zea mais L.`.24. In Annex V, Part B(I), point 2 is replaced by the following:'2. Parts of plants, other than fruits and seeds, of- Castanea Mill., Dendranthema (DC) Des. Moul., Dianthus L., Pelargonium l'Herit ex Ait, Phoenix spp., Populus L., Quercus L.,- conifers (Coniferales),- Acer saccharum Marsh., originating in North American countries,- Prunus L., originating in non-European countries.`25. In Annex V, Part B(I), point 5, second indent, the words 'Castanea Mill.` are deleted.


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31998L0086

Commission Directive 98/86/EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)

Official Journal L 334 , 09/12/1998 P. 0001 - 0063

COMMISSION DIRECTIVE 98/86/EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), as amended by European Parliament and Council Directive 94/34/EC (2) and in particular Article 3(3)(a) thereof;After consulting the Scientific Committee for Food;Whereas, it is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (3), as last amended by Directive 98/72/EC (4);Whereas, it is necessary to replace the purity criteria set out in Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity for emulsifiers, stabilisers, thickeners and gelling agents which may be used in foodstuffs intended for human consumption (5), as last amended by Commission Directive 92/4/EEC (6);Whereas Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (7) set out a first list of purity criteria for a number of food additives; whereas this list should now be complemented with the newly established purity criteria for other additives;Whereas it is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA);Whereas food additives, if prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria;Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 96/77/EC shall be amended as follows:1. Article 2 is replaced by the following:'Article 2The purity criteria referred to in Article 1 replace the purity criteria set out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.`2. In the Annex, the text of the Annex to this Directive shall be added.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1999. They shall immediately inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.Article 3This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 4This Directive is addressed to the Member States.Done at Brussels, 11 November 1998.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 40, 11.2.1989, p. 27.(2) OJ L 237, 10.9.1994, p. 1.(3) OJ L 61, 18.3.1995, p. 1.(4) OJ L 295, 4.11.1998, p. 18.(5) OJ L 223, 14.8.1978, p. 7.(6) OJ L 55, 29.2.1992, p. 96.(7) OJ L 339, 30.12.1996, p. 1.ANNEX 'Ethylene oxide may not be used for sterilising purposes in food additives>TABLE>`


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31994L0014

Commission Directive 94/14/EC of 29 March 1994 amending Seventh Directive 76/372/EEC establishing Community methods of analysis for the official control of feedingstuffs

Official Journal L 094 , 13/04/1994 P. 0030 - 0031

COMMISSION DIRECTIVE 94/14/EC of 29 March 1994 amending Seventh Directive 76/372/EEC establishing Community methods of analysis for the official control of feedingstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Community,  Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article  2 thereof,  Whereas the Seventh Commission Directive 76/372/EEC (3), as last amended by Directive 92/95/EEC (4), prescribes the methods to be used for the determination of aflatoxin B1;  Whereas it is necessary to revise once more the dosage method used at present, in order to state precisely the operating procedure for preparing the sample and to define the rules for the expression of the results;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:   Article 1  The Annex to Directive 76/372/EEC is amended as shown in the Annex.   Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive, not later than one year after its entry into force. They shall immediately inform the  Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.   Article 3  This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.   Article 4  This Directive is addressed to the Member States.  Done at Brussels, 29 March 1994.  For the Commission René STEICHEN Member of the Commission  (1) OJ No L 170, 3. 8. 1970, p. 2.  (2) OJ No L 362, 31. 12. 1985, p. 8.  (3) OJ No L 102, 15. 4. 1976, p. 8.  (4) OJ No L 327, 13. 11. 1992, p. 54.     ANNEX  Part C of the Annex to Directive 76/372/EEC is replaced by the following:  'C. Observations concerning Methods A and B 1. Defatting Samples containing more than 5 % fats must be defatted with light petroleum (bp 40 to 60 °C) after the preparations indicated in 5.1.  In such cases, the analytical results must be expressed in terms of the weight of the non-defatted sample.  2. Reproducibility of the results for Method A The reproducibility of the results, i.e. the variation between the results obtained by two or more laboratories on the same sample has been estimated at:  ± 50 % of the mean value for mean values of aflatoxin B, from 10 and up to 20 mg/kg;  ± 10 mg/kg on the mean value for mean values greater than 20 and up to 50 mg/kg;  ± 20 % of the mean value for mean values above 50 mg/kg.'


title: Commission Directive 2010/39/EU of 22 June 2010 amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to the active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen  (Text with EEA relevance )

text:
               23.6.2010

               EN

               Official Journal of the European Union

               L 156/7

         COMMISSION DIRECTIVE 2010/39/EU
   of 22 June 2010
   amending Annex I to Council Directive 91/414/EEC as regards the specific provisions relating to the active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen
   (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)

               The active substances clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen were included in Annex I to Directive 91/414/EEC by Commission Directive 2008/69/EC (2) in accordance with the procedure provided for in Article 11b of Commission Regulation (EC) No 1490/2002 (3).

               (2)

               In accordance with Article 12a of Regulation (EC) No 1490/2002 EFSA presented to the Commission the conclusions on the peer review for clofentezine (4) on 4 June 2009, for diflubenzuron (5) on 16 July 2009, for lenacil (6) on 25 September 2009, for oxadiazon (7) and picloram (8) on 26 November 2009 and for pyriproxyfen (9) on 21 July 2009. These conclusions were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 May 2010 in the format of the Commission review reports for clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen.

               (3)

               Taking into account the EFSA conclusions, it is confirmed that plant protection products containing clofentezine, diflubenzuron, lenacil, oxadiazon, picloram or pyriproxyfen 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 were examined and detailed in the Commission review report.

               (4)

               For certain substances it is necessary to include specific provisions requiring Member States, when authorising those substances, to pay particular attention to certain points or to ensure that appropriate risk mitigation measures are taken.

               (5)

               Without prejudice to the conclusions referred to in recital 3, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I to that Directive may be subject to conditions. It is appropriate as regards clofentezine, to require that the notifier carry out a monitoring programme to assess the potential of that substance for long-range atmospheric transport and related environmental risks. Moreover, the notifier shall also submit confirmatory studies in respect of toxicological and environmental risks of clofentezine metabolites.

               (6)

               It is appropriate as regards diflubenzuron, to require that the notifier submit confirmatory data in respect of the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA).

               (7)

               It is appropriate as regards lenacil, to require that the notifier submit further information on certain soil metabolites which occurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. If a decision on the classification of lenacil under Council Directive 67/548/EEC (10) identifies the need for further information on the relevance of certain metabolites, the Member States concerned should request the submission of such information.

               (8)

               It is appropriate as regards oxadiazon, to require that the notifier submit further information on the potential toxicological relevance of an impurity in the proposed technical specification and on the occurrence of a metabolite in primary crops and rotational crops. In addition, the notifier should be required to submit a metabolism study on ruminants and information on further trials on rotational crops and information on the risk to earthworm-eating birds and mammals and on the long-term risk to fish.

               (9)

               It is appropriate as regards picloram, to require that the notifier submit confirmatory information in respect of the monitoring analytical method applied in residue trials and a soil photolysis study to confirm the evaluation of picloram degradation.

               (10)

               It is appropriate as regards pyriproxifen, to require that the notifier submit information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators.

               (11)

               Directive 91/414/EEC should therefore be amended accordingly.

               (12)

               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 in accordance with the Annex to this Directive.
   Article 2
   Member States shall adopt and publish, by 31 December 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 January 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 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 22 June 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 172, 2.7.2008, p. 9.

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

      (4)  EFSA Scientific Report (2009) 269, Conclusion on pesticide peer review regarding the risk assessment of the active substance clofentezine (finalised: 4 June 2009).

      (5)  EFSA Scientific Report (2009) 332, Conclusion on pesticide peer review regarding the risk assessment of the active substance diflubenzuron (finalised: 16 July 2009).

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance lenacil on request from the European Commission. EFSA Journal 2009; 7(9):1326. [83 pp.]. doi:10.2903/j.efsa.2009.1326. Available online: www.efsa.europa.eu (finalised: 25 September 2009).

      (7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance oxadiazon on request of EFSA. EFSA Journal 2009; 7(12): [92 pp.]. doi:10.2903/j.efsa.2009.1389. Available online: www.efsa.europa.eu (finalised: 25 November 2009).

      (8)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance picloram. EFSA Journal 2009; 7(12):1390. [78 pp.]. doi:10.2903/j.efsa.2009.1390. Available online: www.efsa.europa.eu (finalised: 25 November 2009).

      (9)  EFSA Scientific Report (2009) 336, Conclusion on pesticide peer review regarding the risk assessment of the active substance pyriproxyfen (finalised: 21 July 2009).

      (10)  OJ 196, 16.8.1967, p. 1.

      ANNEX
      Annex I to Directive 91/414/EEC is amended as follows:

                  1.

                  In row 177 relating to clofentezine, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clofentezine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

                              —

                              the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

                              —

                              the potential for long range transport via air;

                              —

                              the risk to non target organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate.

                        The Member States concerned shall ensure that the notifier presents to the Commission a monitoring programme to assess the potential for long-range atmospheric transport of clofentezine and the related environmental risks by 31 July 2011. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State and to the Commission by 31 July 2013.
                  The Member States concerned shall ensure that the notifier submits to the Commission confirmatory studies on clofentezine metabolites relating to their toxicological and environmental risk assessment by 30 June 2012.’

                  2.

                  In row 180 relating to diflubenzuron, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diflubenzuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

                              —

                              the protection of aquatic organisms;

                              —

                              the protection of terrestrial organisms;

                              —

                              the protection of non-target arthropods including bees.

                        Conditions of use shall include adequate risk mitigation measures, where appropriate.
                  The Member States concerned shall ensure that the notifier submits to the Commission further studies to address the potential toxicological relevance of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.’

                  3.

                  In row 182 relating to lenacil, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on lenacil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;

                              —

                              the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

                        The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 which occurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.
                  If a decision on the classification of lenacil under Directive 67/548/EEC identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.’

                  4.

                  In row 183 relating to oxadiazon, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on oxadiazon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In this overall assessment Member States must pay particular attention to:

                              —

                              the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against this specification of the technical material;

                              —

                              the potential for ground water contamination by the metabolite AE0608022 where the active substance is applied in situations for which prolonged anaerobic conditions may be expected to occur or in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.

                        The Member States concerned shall ensure that the notifier submits to the Commission:

                              —

                              further studies to address the potential toxicological relevance of an impurity in the proposed technical specification;

                              —

                              information to further clarify the occurrence of metabolite AE0608033 in primary crops and rotational crops;

                              —

                              further trials on rotational crops (namely root crops and cereals) and a metabolism study on ruminants to confirm the consumer risk assessment;

                              —

                              information to further address the risk to earthworm-eating birds and mammals, and the long-term risk to fish.

                        They shall ensure that the notifier provides such information to the Commission by 30 June 2012.’

                  5.

                  In row 184 relating to picloram, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In the overall assessment Member States must pay particular attention to:

                              —

                              the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate;

                        The Member States concerned shall ensure that the notifier submits to the Commission:

                              —

                              further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates;

                              —

                              a soil photolysis study to confirm the evaluation of picloram degradation.

                        They shall ensure that the notifier provides such information to the Commission by 30 June 2012.’

                  6.

                  In row 185 relating to pyriproxyfen, in the column ‘Specific provisions’, Part B is replaced by the following:
                  ‘PART B
                  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyriproxyfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
                  In the overall assessment Member States must pay particular attention to:

                              —

                              the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, where appropriate;

                              —

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

                        The Member States concerned shall ensure that the notifier submits to the Commission further information confirming the risk assessment in respect of two points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite DPH-pyr and the risk posed by pyriproxfen to pollinators. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.’


Avis juridique important

|

32003L0078

Commission Directive 2003/78/EC of 11 August 2003 laying down the sampling methods and the methods of analysis for the official control of the levels of patulin in foodstuffs (Text with EEA relevance)

Official Journal L 203 , 12/08/2003 P. 0040 - 0044

Commission Directive 2003/78/ECof 11 August 2003laying down the sampling methods and the methods of analysis for the official control of the levels of patulin in foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1), and in particular Article 1 thereof,Whereas:(1) Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs(2), as last amended by Commission Regulation (EC) No 1425/2003(3) fixes maximum limits for patulin in certain foodstuffs.(2) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(4) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs.(3) It seems necessary to fix general criteria, which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance. It is also of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach across the European Union. These interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply.(4) The provisions for the sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge.(5) 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 1The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of patulin in foodstuffs is carried out in accordance with the methods described in Annex I to this Directive.Article 2The Member States shall take all measures necessary to ensure that sample preparation and methods of analysis used for the official control of the levels of patulin in foodstuffs comply with the criteria described in Annex II to this Directive.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2004 at the latest. They shall forthwith inform the Commission thereof.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 texts of the provisions of national law which they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 5This Directive is addressed to the Member States.Done at Brussels, 11 August 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 372, 31.12.1985, p. 50.(2) OJ L 77, 16.3.2001, p. 1.(3) See page 1 of this Official Journal.(4) OJ L 290, 24.11.1993, p. 14.ANNEX IMETHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF PATULIN IN CERTAIN FOODSTUFFS1. Purpose and scopeSamples intended for official checking of the levels of patulin in foodstuffs shall be taken according to the methods described below. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum levels laid down in Commission Regulation (EC) No 466/2001 shall be established on the basis of the levels determined in the laboratory samples.2. Definitions>TABLE>3. General provisions3.1. PersonnelSampling shall be performed by an authorised person as specified by the Member States.3.2. Material to be sampledEach lot which is to be examined must be sampled separately.3.3. Precautions to be takenIn the course of sampling and preparation of the samples precautions must be taken to avoid any changes, which would affect the patulin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.3.4. Incremental samplesAs far as possible incremental samples should be taken at various places distributed throughout the lot or sublot. Departure from this procedure must be recorded in the record.3.5. Preparation of the aggregate sampleThe aggregate sample is made up by uniting the incremental samples. It shall be at least 1 kg unless not practical e.g. when a single package has been sampled.3.6. Replicate samplesReplicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised aggregate sample unless this conflicts with Member States' rules on sampling.3.7. Packaging and transmission of samplesEach sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage.3.8. Sealing and labelling of samplesEach sample taken for official use shall be sealed at the place of sampling and identified following the Member State's regulations.A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.4. Sampling plansThe sampling method applied shall ensure that the aggregate sample is representative for the lot that is to be controlled.Number of incremental samplesThe aggregate sample shall be at least 1 kg (see point 3.5), except where it is not possible e.g. when sampling a single package.The minimum number of incremental samples to be taken from the lot shall be as given in Table 1. In the case of liquid products the lot shall be thoroughly mixed insofar as possible by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of patulin can be assumed within a given lot. It is therefore sufficient to take three incremental samples from a lot to form the aggregate sample.The incremental samples shall be of similar weight. The weight of an incremental sample should be at least 100 grams, resulting in an aggregate sample of at least 1 kg. Departure from this procedure must be recorded in the record provided for under 3.8.Table 1 Minimum number of incremental samples to be taken from the lot>TABLE>If the lot consists of individual packages, then the number of packages, which shall be taken to form the aggregate sample, is given in Table 2.Table 2 Number of packages (incremental samples) which shall be taken to form the aggregate sample if the lot consists of individual packages>TABLE>5. Compliance of the lot or sublot with the specificationThe control laboratory shall analyse the laboratory sample for enforcement in duplicate analysis in case the obtained result of the first analysis is less than 20 % below or above the maximum level, and calculate the mean of the results.The lot is accepted if the result of the first analysis is more than 20 % below the maximum level or, where duplicate analysis is necessary, if the mean does not exceed the respective maximum level as laid down in Regulation (EC) No 466/2001 taking into account the measurement uncertainty and correction for recovery.The lot is non-compliant with the maximum level as laid down in Regulation (EC) No 466/2001, if the mean, corrected for recovery exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty.ANNEX IISAMPLE PREPARATION AND CRITERIA FOR METHODS OF ANALYSIS USED IN OFFICIAL CHECKING OF THE LEVELS OF PATULIN IN CERTAIN FOODSTUFFS1. PrecautionsAs the distribution of patulin in certain foodstuffs could be non-homogeneous, samples should be prepared - and especially homogenised - with extreme care.All the material received by the laboratory is to be used for the preparation of test material.2. Treatment of the sample as received in the laboratoryFinely grind (insofar relevant) and mix thoroughly the complete aggregate sample using a process that has been demonstrated to achieve complete homogenisation.3. Subdivision of samples for enforcement and defence purposesThe replicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised material unless this conflicts with Member States' rules on sampling.4. Method of analysis to be used by the laboratory and laboratory control requirements4.1. DefinitionsA number of the most commonly used definitions that the laboratory will be required to use are given below.The most commonly quoted precision parameters are repeatability and reproducibility.r= Repeatability, the value below which the absolute difference between two single test results obtained under repeatability conditions (i.e. same sample, same operator, same apparatus, same laboratory, and short interval of time) may be expected to lie within a specific probability (typically 95 %) and hence r = 2,8 x sr.sr= Standard deviation, calculated from results generated under repeatability conditions.RSDr= Relative standard deviation, calculated from results generated under repeatability conditions>REFERENCE TO A GRAPHIC>, where>REFERENCE TO A GRAPHIC>is the average of results over all laboratories and samples.R= Reproducibility, the value below which the absolute difference between single test results obtained under reproducibility conditions (i.e. on identical material obtained by operators in different laboratories, using the standardised test method) may be expected to lie within a certain probability (typically 95 %); R = 2,8 x sR.sR= Standard deviation, calculated from results under reproducibility conditions.RSDR= Relative standard deviation calculated from results generated under reproducibility conditions>REFERENCE TO A GRAPHIC>.4.2. General requirementsMethods of analysis used for food control purposes must comply with the provisions of items 1 and 2 of the Annex to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption(1).4.3. Specific requirementsWhere no specific methods for the determination of patulin in foodstuffs are prescribed at Community level, laboratories may select any method provided the selected method meets the following criteria:Performance characteristics for patulin>TABLE>The detection limits of the methods used are not stated as the precision values are given at the concentrations of interest.The precision values are calculated from the Horwitz equation:>REFERENCE TO A GRAPHIC>where:- RSDR is the relative standard deviation calculated from results generated under reproducibility conditions>REFERENCE TO A GRAPHIC>.- C is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1,000 mg/kg)This is a generalised precision equation, which has been found to be independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.4.4. Recovery calculation and reporting of resultsThe analytical result is to be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported. The analytical result corrected for recovery is used for checking compliance (see Annex I, point 5).The analytical result has to be reported as x+/- U whereby x is the analytical result and U is the measurement uncertainty.4.5. Laboratory quality standardsLaboratories must comply with Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs.(1) OJ L 372, 31.12.1985, p. 50.


title: Commission Directive 2006/30/EC of  13 March 2006  amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for the benomyl group   (Text with EEA relevance)

text:
               14.3.2006

               EN

               Official Journal of the European Union

               L 75/7

      COMMISSION DIRECTIVE 2006/30/EC
   of 13 March 2006
   amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for the benomyl group
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 10 thereof,
   Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2), and in particular Article 10 thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3), and in particular Article 7 thereof,
   Whereas:

               (1)

               In the case of cereals and products of plant origin including fruit and vegetables, residue levels reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is as low as is practicable and toxicologically acceptable, having regard, in particular to the protection of the environment and the estimated dietary intake of consumers. In the case of foodstuffs of animal origin, residue levels reflect the consumption by animals of cereals and products of plant origin treated with pesticides, and where relevant, the direct consequences of the use of veterinary medicines. Community maximum residue levels (MRLs) represent the upper limit of the amount of such residues that might be expected to be found in commodities when good agricultural practices have been respected.

               (2)

               MRLs for pesticides are kept under review and changed to take account of new information and data. MRLs are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported by the necessary data.

               (3)

               Several Member States informed the Commission of their desire to revise national MRLs in accordance with Article 8 of Directive 90/642/EEC, in the light of concerns about consumer intake. Proposals for the review of Community MRLs were submitted to the Commission.

               (4)

               The lifetime and short-term exposure of consumers to the pesticides referred to in this Directive via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (4). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

               (5)

               The acute exposure of consumers to those pesticides via each of the food products that may contain residues has been assessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation. It is concluded that the presence of pesticide residues at or below the new MRLs will not cause acute toxic effects.

               (6)

               Through the World Trade Organisation, the Community’s trading partners have been consulted about the new MRLs and their comments on these levels have been taken into account.

               (7)

               The Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

               (8)

               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 REGULATION:
   Article 1
   In Annex I to Directive 90/642/EEC in category ‘2. Vegetables, fresh or uncooked, frozen or dry, (iii) Fruiting vegetables, (a) Solanacea’, the entry ‘okra’ is added between the entries ‘aubergine’ and ‘others’.
   Article 2
   Part A of Annex II to Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 3
   Part B of Annex II to Directive 86/363/EEC is amended in accordance with Annex II to this Directive.
   Article 4
   Part A of Annex II to Directive 90/642/EEC is amended in accordance with Annex III to this Directive.
   Article 5
   1.   Member States shall adopt and publish, by 14 September 2006 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 15 September 2006.
   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 6
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 7
   This Directive is addressed to the Member States.

      Done at Brussels, 13 March 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2006/4/EC (OJ L 23, 27.1.2006, p. 69).

      (2)  OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2005/70/EC (OJ L 276, 21.10.2005, p. 35).

      (3)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2006/9/EC (OJ L 22, 26.1.2006, p. 24).

      (4)  Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).

      ANNEX I
      In part A of Annex II to Directive 86/362/EEC the lines for benomyl, carbendazim and thiophanate-methyl are replaced by the following:

                     Pesticide residue

                     Maximum level in mg/kg

                     ‘Benomyl and carbendazim, expressed as carbendazim

                                 2

                                 Barley

                                 2

                                 Oats

                                 0,1

                                 Rye

                                 0,1

                                 Triticale

                                 0,1

                                 Wheat

                                 0,01 (1)

                                 Cereal others

                     Thiophanate-methyl

                                 0,3

                                 Barley

                                 0,3

                                 Oats

                                 0,05

                                 Rye

                                 0,05

                                 Triticale

                                 0,05

                                 Wheat

                                 0,01 (1)

                                 Cereal others

         (1)  Indicates lower limit of analytical determination.’

      ANNEX II
      In part B of Annex II to Directive 86/363/EEC the rows for benomyl, carbendazim and thiophanate–methyl are replaced by the following:

                     Pesticide residue

                     Maximum level (mg/kg)

                     Of meat, including fat, preparations of meat, offal and animal fats as listed in Annex I within CN codes 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602

                     For milk and milk products listed in Annex I within CN codes 0401, 0402, 0405 00 and 0406

                     Of shelled fresh eggs, for bird’s eggs and egg yolks listed in Annex I within CN codes 0407 00 and 0408

                     ‘Carbendazim and thiophanate-methyl, expressed as carbendazim

                     0,05 (1)

                     0,05 (1)

                     0,05 (1)

         (1)  Indicates lower limit of analytical determination.’

      ANNEX III
      In part A of Annex II to Directive 90/642/EEC, the column for the benomyl group is replaced by the following:

                     Pesticide residue and maximum residue level

                     Groups and examples of individual products to which the MRLs would apply

                     Sum of benomyl and carbendazim, expressed as carbendazim

                     Thiophanate-methyl

               ‘1.   Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar; nuts

                                 (i)

                                 CITRUS FRUIT

                     0,1 (1)

                     0,1 (1)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,1 (1)

                     0,2

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     Others

                                 (iii)

                                 POME FRUIT

                     0,2

                     0,5

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     Apricots

                     0,2

                     2

                     Cherries

                     0,5

                     0,3

                     Peaches (including nectarines and similar hybrids)

                     0,2

                     2

                     Plums

                     0,5

                     0,3

                     Others

                     0,1 (1)

                     0,1 (1)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     Table grapes

                     0,3

                     0,1 (1)

                     Wine grapes

                     0,5

                     3

                                 (b)

                                 Strawberries (other than wild)

                     0,1 (1)

                     0,1 (1)

                                 (c)

                                 Cane fruit (other than wild)

                     0,1 (1)

                     0,1 (1)

                     Blackberries

                     Dewberries

                     Loganberries

                     Raspberries

                     Others

                                 (d)

                                 Other small fruit and berries (other than wild)

                     0,1 (1)

                     0,1 (1)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     Gooseberries

                     Others

                                 (e)

                                 Wild berries and wild fruit

                     0,1 (1)

                     0,1 (1)

                                 (vi)

                                 MISCELLANEOUS

                     0,1 (1)

                     0,1 (1)

                     Avocados

                     Bananas

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     Olives

                     Papaya

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

               2.   Vegetables, fresh or uncooked, frozen or dry

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,1 (1)

                     0,1 (1)

                     Beetroot

                     Carrots

                     Cassava

                     Celeriac

                     Horseradish

                     Jerusalem artichokes

                     Parsnips

                     Parsley root

                     Radishes

                     Salsify

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                                 (ii)

                                 BULB VEGETABLES

                     0,1 (1)

                     0,1 (1)

                     Garlic

                     Onions

                     Shallots

                     Spring onions

                     Others

                                 (iii)

                                 FRUITING VEGETABLES

                                 (a)

                                 Solanacea

                     Tomatoes

                     0,5

                     2

                     Peppers

                     Aubergines

                     0,5

                     2

                     Okra

                     2

                     1

                     Others

                     0,1 (1)

                     0,1 (1)

                                 (b)

                                 Cucurbits — edible peel

                     0,1 (1)

                     0,1 (1)

                     Cucumbers

                     Gherkins

                     Courgettes

                     Others

                                 (c)

                                 Cucurbits — inedible peel

                     0,1 (1)

                     0,3

                     Melons

                     Squashes

                     Watermelons

                     Others

                                 (d)

                                 Sweetcorn

                     0,1 (1)

                     0,1 (1)

                                 (iv)

                                 BRASSICA VEGETABLES

                                 (a)

                                 Flowering brassica

                     0,1 (1)

                     0,1 (1)

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     0,5

                     1

                     Head cabbage

                     Others

                     0,1 (1)

                     0,1 (1)

                                 (c)

                                 Leafy brassica

                     0,1 (1)

                     0,1 (1)

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                     0,1 (1)

                     0,1 (1)

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,1 (1)

                     0,1 (1)

                                 (a)

                                 Lettuce and similar

                     Cress

                     Lamb's lettuce

                     Lettuce

                     Scarole (broadleaf endive)

                     Others

                                 (b)

                                 Spinach and similar

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Watercress

                                 (d)

                                 Witloof

                                 (e)

                                 Herbs

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     Beans (with pods)

                     0,2

                     0,1 (1)

                     Beans (without pods)

                     Peas (with pods)

                     0,2

                     0,1 (1)

                     Peas (without pods)

                     Others

                     0,1 (1)

                     0,1 (1)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,1 (1)

                     0,1 (1)

                     Asparagus

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     Leek

                     Rhubarb

                     Others

                                 (viii)

                                 FUNGI

                     0,1 (1)

                     0,1 (1)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,1 (1)

                     0,1 (1)

                     Beans

                     Lentils

                     Peas

                     Others

               4.   Oil seeds

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rape seed

                     Soya bean

                     0,2

                     0,3

                     Mustard seed

                     Cotton seed

                     Others

                     0,1 (1)

                     0,1 (1)

                                 5.

                                 Potatoes

                     0,1 (1)

                     0,1 (1)

                     Early potatoes

                     Ware potatoes

                                 6.

                                    Tea (dried leaves and stalks, fermented or other-wise, Camellia sinensis)

                     0,1 (1)

                     0,1 (1)

                                 7.

                                    Hops (dried), including hop pellets and unconcentrated powder

                     0,1 (1)

                     0,1 (1)

         (1)  Indicates lower limit of analytical determination.’


title: Commission Directive 2010/85/EU of 2 December 2010 amending Council Directive 91/414/EEC to include zinc phosphide as active substance and amending Decision 2008/941/EC  Text with EEA relevance

text:
               3.12.2010

               EN

               Official Journal of the European Union

               L 317/32

         COMMISSION DIRECTIVE 2010/85/EU
   of 2 December 2010
   amending Council Directive 91/414/EEC to include zinc phosphide as active substance and amending 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 zinc phosphide.

               (2)

               In accordance with Article 24e of Regulation (EC) No 2229/2004 the applicant 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 2008/941/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 zinc phosphide.

               (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 Germany, 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)

               Germany 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 July 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 zinc phosphide to the Commission on 2 July 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 28 October 2010 in the format of the Commission review report for zinc phosphide.

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

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

               (11)

               Decision 2008/941/EC concerning the non-inclusion of certain active substances in Annex I to Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances provides for the non-inclusion of zinc phosphide and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning zinc phosphide in the Annex to that Decision.

               (12)

               It is therefore appropriate to amend Decision 2008/941/EC accordingly.

               (13)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning zinc phosphide in the Annex to Decision 2008/941/EC is deleted.
   Article 3
   Member States shall adopt and publish by 31 October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall 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 November 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 zinc phosphide as an active substance by 1 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to zinc phosphide 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 zinc phosphide 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 30 April 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 zinc phosphide. 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 zinc phosphide as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or

               (b)

               in the case of a product containing zinc phosphide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 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 May 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 2 December 2010.

            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 zinc phosphide. EFSA Journal 2010; 8(7):1671. [48pp].doi:10.2903/j.efsa.2010.1671. Available online: www.efsa.europa.eu

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

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

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘319

                     Zinc phosphide
                     CAS No: 1314-84-7
                     CIPAC No: 69

                        Trizinc diphosphide

                     ≥ 800 g/kg

                     1 May 2011

                     30 April 2021

                     PART A
                     Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.
                     In this overall assessment Member States should pay particular attention to:

                                 —

                                 the protection of non-target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.’

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


title: Commission Directive 2010/90/EU of 7 December 2010 amending Council Directive 91/414/EEC to include pyridaben as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               8.12.2010

               EN

               Official Journal of the European Union

               L 322/38

         COMMISSION DIRECTIVE 2010/90/EU
   of 7 December 2010
   amending Council Directive 91/414/EEC to include pyridaben as active substance and amending 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 pyridaben.

               (2)

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

               (3)

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

               (4)

               The application was submitted to the Netherlands, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 15 June 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 pyridaben to the Commission on 28 May 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 28 October 2010 in the format of the Commission review report for pyridaben.

               (6)

               It has appeared from the various examinations made that plant protection products containing pyridaben 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 pyridaben 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 further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the exposure to the aqueous photolysis metabolites W-1 and B-3, the long term risk for mammals, the assessment of fat soluble residues.

               (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 pyridaben to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

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

               (11)

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

               (12)

               Decision 2008/934/EC provides for the non-inclusion of pyridaben and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning pyridaben 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 pyridaben in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 31 October 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall 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 November 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 pyridaben as an active substance by 1 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to pyridaben 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 pyridaben 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 30 April 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 pyridaben. 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 pyridaben as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or

               (b)

               in the case of a product containing pyridaben as one of several active substances, where necessary, amend or withdraw the authorisation by 30 April 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 May 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 7 December 2010.

            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 pyridaben. EFSA Journal 2010; 8(6):1632. [70 pp.]. doi:10.2903/j.efsa.2010.1632. Available online: www.efsa.europa.eu

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

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

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘318

                     Pyridaben
                     CAS No: 96489-71-3

                     CIPAC No: 583

                     2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyrididazin-3(2H)-one

                     > 980 g/kg

                     1 May 2011

                     30 April 2021

                     PART A
                     Only uses as insecticide and acaricide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

                                 —

                                 the risk to aquatic organisms and mammals,

                                 —

                                 the risk to non target arthropods including honeybees.

                           Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 —

                                 the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,

                                 —

                                 the potential long term risk for mammals,

                                 —

                                 the assessment of fat soluble residues.

                           They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.’

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