Avis juridique important

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31995L0023

Council Directive 95/23/EC of 22 June 1995 amending Directive 64/433/EEC on conditions for the production and marketing of fresh meat

Official Journal L 243 , 11/10/1995 P. 0007 - 0013

COUNCIL DIRECTIVE 95/23/ECof 22 June  1995amending Directive 64/433/EEC on conditions for the production and marketing of fresh  meatTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 43  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 64/433/EEC (4) regulates the production and marketing of fresh meat of bovine  animals, swine, sheep and goats and domestic solipeds; Whereas the regulations for low-capacity establishments eligible for approval under simplified  structure and infrastructure criteria should be simplified, to take account of particular  circumstances and of the principle of subsidiarity; Whereas hygiene requirements should be defined for the production and marketing of sliced offal; Whereas the regulations on accompanying documents can be simplified; Whereas meat from low-capacity establishments should comply only with general hygiene requirements  for meat production and marketing and for this reason may be not marked with the Community stamp  and be the subject of trade; Whereas the maximum handling limits for low-capacity slaughterhouses and cutting plants should be  aligned on those laid down in Council Directive 92/120/EEC of 17 December 1992 on the conditions  for granting temporary and limited derogations from specific Community health rules on the  production and marketing of certain products of animal origin (5); Whereas, however, account should be taken of certain specific situations in applying these limits; Whereas experience has shown the need to amend the Directive 64/433/EEC on a number of technical  points which have caused problems of practical application, HAS ADOPTED THIS DIRECTIVE: Article 1Directive 64/433/EEC is hereby amended as follows: (1) The following point shall be added to Article 2: '(o) "repackaging centre" means a workshop or depot where wrapped meet intended for placing on the  market is reassembled and/or repackaged.'(2) Article 3 (1) shall be amended as follows: (a) Section A (a) shall be replaced by the following: '(a) have been obtained in a slaughterhouse meeting the conditions laid down in Chapters I and II  of Annex I and approved and supervised in accordance with Article 10;'(b) in Section A (f): (ba) subdivision (ii) shall be replaced by the following: '(ii) an accompanying commercial document which must: - be drawn up by the dispatching establishment, - in addition to the particulars provided for in point 50 of Chapter X of Annex I, bear the  veterinary approval number of the approved establishment and in the case of frozen meat, the month  and year of freezing in clear, - for meat intended for Finland and Sweden, bear one of the indications provided for in the third  indent of Part IV of Annex IV, - be kept by the consignee so that it can be produced at the request of the competent authority.  Computer data must be printed at the request of the aforesaid authority'; (bb) the last subparagraph shall be replaced by the following: 'At the request of the competent authority in the Member State of destination, a health attestation  must be supplied where meat is intended for export to a third country after processing. The costs  incurred in such attestation shall be borne by operators;'(c) in Section B: - the introductory phrase shall be replaced by the following: 'B. cuts or pieces smaller than those referred to in Section A, or boned meat whether or not  wrapped:'; - in points (a) and (b), the words 'or wrapped' shall be inserted each time after 'cut'; (d) in Section C: - in the first subparagraph the second sentence shall be replaced by the following: 'Uncut offal must comply with the requirements of Sections A and B.', - in the last sentence of the first subparagraph 'sliced' shall be deleted, - the second subparagraph shall be deleted; (e) the following sentence shall be added to Section D (b): 'In this case the veterinary approval number of the cold store must be given on the accompanying  commercial document.'; (f) the following section shall be added: 'F. fresh meat from which the packaging has been removed and which is to be re-packaged in an  establishment other than that in which it was first wrapped: (a) must meat the requirements of Sections A, B, C and D; (b) must be removed from its packaging and repackaged in a repackaging centre which satisfies the  requirements of Chapter I of Annex I and is approved and supervised in accordance with Article  10.'(3) Article 4 shall be replaced by the following: 'Article 4A. As from 1 January 1995, Member States may, by way of derogation from Article 3, allow  meat from slaughterhouses which do not satisfy the requirements of Chapters I and II of Annex I to  be placed on the market for marketing in their national territory, provided the following  conditions are met: (a) the slaughterhouses in question must: (i) handle not more than 20 livestock units per week with a maximum of 1 000 livestock units per  year; (ii) satisfy the requirements of Annex I, Chapters V and VII, point 66 first, second and fourth  paragraphs and point 67 of Chapter XIV and point 69 of Chapter XV, with the exception of the  requirements relating to imported fresh meat, and points 71, 72 and 73; (iii) fulfil the requirements of Annex II; (iv) notify the veterinary service in advance of the time of slaughter and the number and the  origin of the animals to allow it to carry out the ante mortem inspection in accordance with  Chapter VI of Annex I, either on the farm or at the slaughterhouse. (b) the operator of the slaughterhouse, the owner or his agent must keep a register of: - animals entering the establishment and slaughter products leaving it, - the checks carried out, - the results of those checks. This information shall be communicated to the competent authority at its request; (c) the official veterinarian or an auxiliary must carry out the post-mortem inspection of the meat  in accordance with Annex I, Chapter VIII, in compliance with the requirements of Annex I, Chapter  VII, point 32. Where the meat has lesions or appears to have deteriorated, the post-mortem  inspection must be carried out by the official veterinarian. The official veterinarian or the  auxiliary under his responsibility must regularly monitor compliance with the hygiene rules laid  down in Chapters V and VII of Annex I. When applying this Article, Member States shall use the following conversion rates: (i) beef and veal- adult bovine animals within the meaning of Regulation (EEC) No 805/68 and  solipeds: 1 livestock unit- other bovines: 0,50 livestock unit(ii) pigmeat- pigs with a live  weight of over 100 kg: 0,20 livestock unit- other pigs (a): 0,15 livestock unit(iii) other meat-  sheep and goats: 0,10 livestock unit- lambs, kids and piglets of less than 15 kg live weight: 0,05  livestock unit. B. Within the limit of 1 000 livestock units referred to in Section A, first subparagraph,  subdivision (a) (i), Member States may derogate from the weekly limit laid down therein to take  account of the need to slaughter lambs and kids in the period leading up to religious festivals,  provided that the official veterinarian is present at the time of slaughter, that the hygiene  requirements are complied with and that the meat has not been frozen before being placed on the  market. C. The maximum amounts provided for in Section A, first subparagraph, subdivision (a) (i) may be  applied to individual operators slaughtering on their own account at quite separate times in the  week in an establishment which satisfies the following requirements: (a) the owner of the establishment or any other person using this establishment has received  specific training, recognized by the competent authority, in production hygiene; (b) the animals to be slaughtered are the property of the owner of the establishment, or of a  self-employed butcher or have been purchased by them to meet the requirements referred to in point  (d); (c) the meat is produced in premises which meet the requirements of Annex II; (d) production must be confined to supplying establishments belonging to the butchers referred to  in (b) and to sale on the spot to the consumer or to local bodies. Where several individual slaughter quantities are added up, the maximum amounts provided for in  Section A, first subparagraph, subdivision (a) (i) may be raised to 30 livestock units per week and  1 500 livestock units per year for the slaughterhouse meeting the conditions set out in the first  subparagraph. Member States availing themselves of this possibility shall forward the list of  establishments benefiting from these provisions to the Commission. D. Under the procedures provided for in Article 16, Member States may, at their request, be  authorized to apply the requirements of Section A to slaughterhouses situated in regions suffering  from special geographical constraints or affected by supply difficulties which handle not more than  2 000 livestock units per year. E. Derogations may be granted by the competent authority in accordance with Annex II in the case of  cutting plants which are not situated in an approved establishment and which produce not more than  five tonnes of boned meat per week or the equivalent of bone-in meat. The provisions of Annex I, Chapter V, Chapter VII, point 38, Chapter IX - with the exception of the  requirement for the temperature of the cutting room laid down in the second sentence of point 46  (c) - and point 48 of Chapter X shall apply to cutting and storage operations in the establishments  referred to in the first subparagraph. F. Meat that comes from the establishments referred to in this Article and that has been judged fit  for human consumption, bearing in mind the hygiene and health requirements laid down by this  Directive, must be marked with a national stamp which cannot be confused with the Community stamp  and may in particular not be oval. However, this stamp shall not be necessary for cuts which have  not been packaged. G. Member States may also allow derogations from the minimum requirements of Chapter I of Annex I  for low-capacity cold stores in which only packaged meat and other foodstuffs are stored. Sweden  may, until 20 June 1997, authorize packaged meat and non-packaged meat to be stored in one and the  same cold store by means of an appropriate separation. H. Slaughterhouses benefiting from the derogations provided for in this Article shall be subject to  the Community inspection required for approved establishments. (a) Game animals being treated in the same way as the respective species for the purposes of  applying the conversion rates.'; (4) The following Article shall be inserted: 'Article 4a1. Member States shall communicate, by 31 December 1995, the list of the establishments  referred to in Article 1 of Directive 91/498/EEC (*) and the list of the establishments for which  the time limits are set pursuant to this Article. 2. The competent authorities may allow a slaughterhouse which qualifies for a derogation in  accordance with Article 2 of Directive 91/498/EEC (*) and which can show, to the satisfaction of  the competent authority, that it has begun to bring itself into compliance with the requirements of  this Directive but which cannot, for reasons not attributable to it, meet the time limits  originally laid down, the additional time essential in order for it to comply with them. 3. Where an establishment registered in accordance with Article 4 is undergoing alterations on the  basis of a restructuring plan approved by the competent authority with the aim of obtaining  authorization in accordance with Article 10, that authority may determine the quantities marketed  by the establishment in question in line with the progress of the work. 4. In transposing the provisions of this Directive into their national legislation, Member States  shall specify the manner in which the penalties provided for in Article 10 and in Article 2 (2) of  Directive 91/498/EEC are to apply in the event of failure by an establishment referred to in this  Article to honour the commitments entered into upon being granted a temporary derogation, so that  those penalties can be applied by 31 December 1995 and, as regards Sweden, by 31 December 1996 and,  as regards Austria and Finland, by 31 December 1997. (*) Council Directive 91/498/EEC of 29 July 1991 on the conditions for granting temporary and  limited derogations from specific Community health rules on the production and marketing of fresh  meat (OJ No L 268, 24. 9. 1991, p. 105). Directive as last amended by the 1994 Act of  Accession.'(5) In Article 5 in 1 (a) (iii), 'macroscopically visible' shall be added before  'sarcocystosis'. (6) Article 6 shall be amended as follows: - in the fifth indent of subparagraph (e) of paragraph 1, the words 'the correct conduct of  bleeding' shall be deleted; - in paragraph 1, subparagraph (h) shall be replaced by the following: '(h) meat must be marked with a national stamp which cannot be confused with the Community samp and  in particular is not oval.'(7) In (iii) of the first subparagraph of Article 9, the words 'and in  an approved packaging centre' shall be inserted after 'cold-store'. (8) The following shall be added at the end of the fourth and fifth subparagraphs of Article 10  (1): 'with regard to part of the activity in question or the whole establishment'. (9) In Article 12: (a) paragraph 1 shall be replaced by the following: '1. Veterinary experts from the Commission may, in so far as is necessary to ensure uniform  application of this Directive and in cooperation with the competent authorities in the Member  States, make on-site checks. By checking a representative number of establishments, they may also  verify whether the competent authorities are checking on compliance with this Directive by  establishments. The Member State on whose territory the checks are being carried out shall provide  the experts with all necessary assistance to fulfil their mission. The Commission shall inform the  Member State concerned of the results of the checks carried out.'(b) the following paragraph shall  be added: '3. Provisions for the implementation of this Article, in particular those to cover the  arrangements for cooperating with the national authorities, shall be adopted in accordance with the  procedure laid down in Article 16'. (10) Article 13 (1) shall be deleted. (11) Annex I shall be amended as follows: (a) the following shall be added to point 14 (c) (i) of Chapter II: '. . . if such operations are carried out in the slaughterhouse. In addition, where swine are  concerned, this provision shall apply to the extent necessary to prevent contamination of fresh  meat and offal'; (b) in point 17 (a) of Chapter IV, the reference to 'the fourth paragraph of point 66 of Chapter  XIV' shall be replaced by 'the eighth paragraph of point 66 of Chapter XIV'; (c) the first paragraph of point 25 of Chapter VI shall be replaced by the following: 'Animals must undergo ante-mortem inspection within a period which is less than 24 hours after  their arrival in the slaughterhouse and less than 24 hours before slaughter. In addition, the  official veterinarian may require inspection at any other time'; (d) in point 33 of Chapter VII, the following sentence shall be added: 'Mechanical insufflation for the flaying of lambs and kids of a live weight of less than 15 kg may  be approved by the competent authorities in compliance with the hygiene requirements.'; (e) in point 43 of Chapter IX, the word 'slicing' shall be replaced by 'cutting' and the words 'of  animals of the bovine species' shall be deleted; (f) in Chapter XI: - point 49 shall be replaced by the following: 'Health marking must be carried out under the responsibility of the official veterinarian. For this  purpose, he shall supervise(a) the health mark; (b) the marks and wrapping material when marked as provided for in this Chapter.'; - in point 50 (b), the following subparagraph shall be added: 'The dimensions and characters of the mark may be reduced for health marking of lamb, kids and  piglets.'; - in point 51: (i) the following shall be inserted as second indent: '- lamb, kid and piglet carcases must bear at least two stamps, one on each side of the carcase, on  the shoulder or on the external surface of the thighs,'; (ii) the following shall be inserted as second subparagraph: 'However, in the case of lamb, kid and piglet carcases, health marking may take the form of a label  or tag but it must be possible to use them only once.'; - points 52 to 56 shall be replaced by the following: '52. The livers of bovine animals, swine and solipeds must be hot-branded in accordance with point  50 if they are intended for another Member State or for an EEA country. 53. All other subproducts of slaughtering fit for human consumption must be marked immediately in  accordance with point 50, either directly on the product or on the wrapping or packaging. The mark  in accordance with point 50 must be applied to a label fixed to the wrapping or packaging or  printed on the packaging. If wrapping or packaging takes place in a slaughterhouse, the mark must  include the approval number of the establishment. 54. Packaging must always be marked in accordance with point 55. 55. Packaged cut meat and packaged offal referred to in point 52 and point 53 must bear a health  mark in accordance with point 50. The mark must include the veterinary approval number of the  cutting plant instead of that of the slaughterhouse. The mark must be applied to a label fixed to  the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging  is opened. Non-destruction of the mark must be tolerated only when the packaging is destroyed by  being opered. However, when cut meat or offal is wrapped in accordance with point 62 of Chapter XII, the label  referred to above may be affixed to the wrapping. In the case of offal packaged in a  slaughterhouse, the number included in the mark must be the veterinary approval number of the  slaughterhouse concerned. This requirement also applies where stackable meat transport containers  (Euro-boxes) satisfying the requirements of point 59 (b) are used. 56. Where fresh meat is wrapped in commercial portions intended for direct sale to the consumer,  points 53 and 55 shall apply. The dimension requirements of point 50 need not apply to the mark  required under this point. If meat is re-packaged in a plant other than that in which it was first wrapped, the wrapping must  bear the health mark of the cutting plant where it was first wrapped, and the packaging must bear  the health mark of the packaging centre.'; - point 58 shall be replaced by the following: '58. The colours used for health marking must be those listed in Article 2 (8) of Directive  94/36/EC (OJ No L 237, 10. 9. 1994, p. 13).'(g) in Chapter XII, - the following subparagraph shall be added to point 59 (a): 'Wood may not be used except in the case of lamb and kid carcases, provided that all precautions  are taken to prevent contact between the meat and the packaging in the event of a tear in the  wrapping.', - the fourth subparagraph of point 60 shall be replaced by the following: 'Where livers, kidneys or hearts are the subject of trade or are imported, each wrapping may  contain only a complete organ.', - point 62 shall be replaced by the following: 'However, when wrapping fulfils all the protective conditions of packaging, it need not be  transparent and colourless. Euro-boxes may also be used as a second container, provided that the  other conditions of point 59 are fulfilled.', - the following subparagraph shall be added to point 63: 'Fresh meat may also be packed in a cutting room, provided that Euro-boxes, which must meet the  requirements of point 59 (b) have been cleaned and disinfected prior to being brought into the  cutting room.', - the following phrase shall be added to point 64: 'except in the case of commercial portions intended for direct sale to the consumer', (h) in point 66 of Chapter XIV, the second paragraph shall be replaced by the following: 'Derogations from this requirement may, for technical reasons relating to maturation of the meat,  be granted by the competent authority on a case-by-case basis for the transportation of meat to  cutting plants or butcher shops in the immediate vicinity of the slaughterhouse, provided that such  transportation takes not more than two hours.'(12) In Annex II, Chapter II: (i) in point 10: - in point (c), the words 'distinctly separated areas' shall be replaced by the words 'a distinctly  separated area', - point (f) shall be replaced by the following: '(f) a refrigerating room of sufficient capacity in relation to the size and type of animals  slaughtered, with a separate area intended for storing confiscated carcases, except in cases where  confiscated carcases are immediately dispatched, under official control, to a specialist  establishment for additional examinations.'; (ii) in point 11: - the words 'or clean' shall be deleted, - the following sentence shall be added: 'In the slaughter room, stomachs and intestines may be cleaned at times when no slaughtering is  taking place.'; (ii) the following point shall be added: '(15) Slaughterhouses must have a room with a lockable cupboard at the disposal of the inspection  service through its work.'Article 21. Member States shall bring into force the laws,  regulations and administrative provisions including any penalties, necessary to comply with this  Directive by 1 July 1995. They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall  be accompanied by such reference on the occasion of their official publication. The methods of  making such reference shall be laid down by Member States. 2. Member States shall communicate to the Commission the text of the main provisions of domestic  law which they adopt in the field governed by this Directive. 3. Pending the application of this Directive, the relevant national rules shall apply, in  compliance with the general rules of the Treaty. Article 3This Directive shall enter into force on the day of its publication in the Official  Journal of the European Communities. It shall apply from 1 July 1995. Article 4This Directive is addressed to the Member States. Done at Brussels, 22 June 1995. For the CouncilThe PresidentPh. VASSEUR(1) OJ No C 224, 12. 8. 1994, p. 15. (2) OJ No C 109, 1. 5. 1995. (3) OJ No C 397, 31. 12. 1994, p. 18. (4) OJ No 121, 29. 7. 1994, p. 2012/64. Directive as updated by Directive 91/497/EEC (OJ No L 268,  24. 9. 1991, p. 69) and as last amended by the 1994 Act of Accession. (5) OJ No L 62, 15. 3. 1993, p. 86.


Avis juridique important

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32002L0008

Commission Directive 2002/8/EC of 6 February 2002 amending Directives 72/168/EEC and 72/180/EEC concerning the characteristics and minimum conditions for examining vegetable and agricultural varieties respectively

Official Journal L 037 , 07/02/2002 P. 0007 - 0008

Commission Directive 2002/8/ECof 6 February 2002amending Directives 72/168/EEC and 72/180/EEC concerning the characteristics and minimum conditions for examining vegetable and agricultural varieties respectivelyTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species(1), as last amended by Directive 98/96/EC(2), and in particular Article 7(2) thereof,Having regard to Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed(3), as last amended by Directive 98/96/EC, and in particular Article 7(2) thereof,Whereas:(1) Commission Directives 72/168/EEC of 14 April 1972 on determining the characteristics and minimum conditions for inspecting vegetable varieties(4) and 72/180/EEC of 14 April 1972 determining the characteristics and minimum conditions for examining agricultural varieties(5) have established, with a view to official acceptance of the varieties in the Member States' catalogues, the characteristics to be covered as a minimum by the examinations of the various species, as well as the minimum requirements for carrying out the examinations.(2) Test guidelines relating to the examinations have recently been issued by the Administrative Council of the Community Plant Variety Office established by Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights(6), as amended by Regulation (EC) No 2506/95(7), in respect of certain species.(3) It is necessary to establish consistency between the test guidelines, on the one hand, and the determination of the characteristics to be covered as a minimum by the examination of the species and also the minimum requirements for carrying out those examinations, on the other.(4) Directives 72/168/EEC and 72/180/EEC should therefore be amended accordingly.(5) The new provisions should also apply to the varieties which have not been accepted by 31 March 2002 for inclusion in the common catalogues.(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 72/168/EEC is hereby amended as follows:1. Article 1 is replaced by the following: "Article 11. Member States shall provide that the official examinations carried out for the acceptance of varieties shall cover at least the following characteristics:(a) for tomato (Lycopersicon lycopersicum L. Karsten ex. Farw.), leek (Allium porrum L.), French beans (Phaseolus vulgaris L.), cabbage (Brassica oleracea L. convar. Capitata (L.) Alef.), cauliflower (Brassica oleracea L. convar. Botrytis (L.) Alef. Var. botrytis L.) and lettuce (Lactuca sativa L.), those characteristics listed in the respective test guidelines entitled 'Protocol for Distinctness, Uniformity and Stability Tests', issued by the Administrative Council of the Community Plant Variety Office pursuant to Article 56 of Council Regulation (EC) No 2100/94(8), and published in the Official Gazette of the Community Plant Variety Office.All the characteristics shall be referred to, providing that observation of a characteristic is not rendered impossible by the expression of any other characteristic, and providing that the expression of a characteristic is not prevented by the environmental conditions under which the test is conducted. This provision is without prejudice to the application of provisions governing vegetable varieties.(b) for other vegetable species, those characteristics listed in Annex I.2. Member States shall ensure that:(a) in respect of the vegetable species listed in point (a) of paragraph 1, the minimum requirements for carrying out the examinations in respect of trial design and growing conditions, as laid down in the test guideline referred to in paragraph 1, point (a), are fulfilled at the time of the examinations;(b) in respect of other vegetable species, the minimum requirements for carrying out the examinations, as listed in Annex II, are fulfilled at the time of the examinations."2. In Annex I, points 2, 9, 12, 13, 14, 26, 29 and 33 are deleted.3. In Annex II, Part A, points 2, 9, 12, 13, 14, 26, 29 and 33 are deleted.Article 2Directive 72/180/EEC is hereby amended as follows.1. Article 1 is replaced by the following: "Article 11. Member States shall provide that the official examinations carried out for the acceptance of varieties shall cover at least the following characteristics:(a) in respect of the characteristics as regards the examination of distinctness, stability and uniformity:(i) for wheat (Triticum aestivum L.) and maize (Zea mays L.), those characteristics listed in the respective test guidelines entitled 'Protocol for Distinctness, Uniformity and Stability Tests', issued by the Administrative Council of the Community Plant Variety Office pursuant to Article 56 of Council Regulation (EC) No 2100/94(9), and published in the Official Gazette of the Community Plant Variety Office.All the characteristics shall be referred to, providing that observation of a characteristic is not rendered impossible by the expression of any other characteristic, and providing that the expression of a characteristic is not prevented by the environmental conditions under which the test is conducted. This provision is without prejudice to the application of provisions governing agricultural varieties.(ii) for other agricultural plant species, those characteristics listed in Annex I, Part A;(b) in respect of the characteristics as regards the examination of the value for cultivation and use, those listed in Annex I, Part B.2. Member States shall ensure that:(a) in respect of wheat (Triticum aestivum L.) and maize (Zea mays L.), the minimum requirements for carrying out the examinations in respect of trial design and growing conditions, as laid down in the test guidelines referred to in paragraph 1, point (a), under (i), are fulfilled at the time of the examinations;(b) in respect of other agricultural plant species, the minimum requirements for carrying out the examinations, as listed in Annex II, are fulfilled at the time of the examinations."2. In Annex I, Part A:(a) the words "Soft whea" and "Triticum aestivum L." under point 39 are deleted;(b) point 41 is deleted.3. In Annex II:(a) the words "3.1 Autogamous species" are replaced by the words "3.1 Self-pollinating species other than wheat";(b) point 3.3 is deleted.Article 31. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 31 March 2002 at the latest. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. This Directive shall apply to all varieties which have not been accepted by 31 March 2002 for inclusion in the common catalogue of varieties of vegetable species or in the common catalogue of varieties of agricultural plant species respectively.Where the official examinations carried out for the acceptance of the varieties have started prior to that date, either wholly or partially in accordance with the original provisions of Directives 72/168/EEC or 72/180/EEC, the varieties concerned shall not be required to undergo new examination to demonstrate compliance with the new provisions.3. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive.Article 4This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 6 February 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 225, 12.10.1970, p. 1.(2) OJ L 25, 1.2.1999, p. 27.(3) OJ L 225, 12.10.1970, p. 7.(4) OJ L 103, 2.5.1972, p. 6.(5) OJ L 108, 8.5.1972, p. 8.(6) OJ L 227, 1.9.1994, p. 1.(7) OJ L 258, 28.10.1995, p. 3.(8) OJ L 227, 1.9.1994, p. 1.(9) OJ L 227, 1.9.1994, p. 1.


title: Commission Directive 2007/73/EC of 13 December 2007 amending certain Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards maximum residue levels for acetamiprid, atrazine, deltamethrin, imazalil, indoxacarb, pendimethalin, pymetrozine, pyraclostrobin, thiacloprid and trifloxystrobin (Text with EEA relevance)

text:
               14.12.2007

               EN

               Official Journal of the European Union

               L 329/40

      COMMISSION DIRECTIVE 2007/73/EC
   of 13 December 2007
   amending certain Annexes to Council Directives 86/362/EEC and 90/642/EEC as regards maximum residue levels for acetamiprid, atrazine, deltamethrin, imazalil, indoxacarb, pendimethalin, pymetrozine, pyraclostrobin, thiacloprid and trifloxystrobin
   (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 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 (2), and in particular Article 7 thereof,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3), and in particular Article 4(1)(f) thereof,
   Whereas:

               (1)

               In accordance with Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations have to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops.

               (2)

               Maximum residue levels (MRLs) reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in terms of estimated dietary intake.

               (3)

               For atrazine temporary MRLs have been set in Directive 86/362/EEC by Commission Directive 2007/7/EC (4), pending submission of data by the applicant. Upon further examination, it appeared that more time should be allowed for the generation of residue trials data. It is therefore appropriate to prolong the validity of temporary MRLs for atrazine.

               (4)

               MRLs for pesticides covered by Directive 90/642/EEC are to be kept under review and may be modified to take account of new or changed uses. Information about new or changed uses has been communicated to the Commission which should lead to changes in the residue levels of acetamiprid, deltamethrin, indoxacarb, pendimethalin, pymetrozine, pyraclostrobin, thiacloprid and trifloxystrobin.

               (5)

               For imazalil a Member State informed the Commission of its 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.

               (6)

               The lifetime exposure of consumers to the pesticides referred to in this Directive via food products that may contain residues of those pesticides has been assessed and evaluated in accordance with the procedures and practices used within the Community, taking account of guidelines published by the World Health Organisation (5). Based on those assessments and evaluations, the MRLs for those pesticides should be set so as to ensure that the acceptable daily intake is not exceeded.

               (7)

               An acute reference dose (ARfD) has been set for acetamiprid, deltamethrin, imazalil, indoxacarb, pymetrozine, pyraclostrobin and thiacloprid. The acute exposure of consumers via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the Community, taking account of guidelines published by the World Health Organisation. The opinions of the Scientific Committee on Plants (SCP), in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides (6), have been taken into account. Based on the dietary intake assessment, the MRLs for those pesticides should be fixed so as to ensure that the ARfD will not be exceeded. In the case of the other substances, an assessment of the available information has shown that no ARfD is required and that therefore a short term assessment is not needed.

               (8)

               Where authorised uses of plant protection products do not result in detectable levels of pesticide residues 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 with such necessary data, MRLs should be fixed at the lower limit of analytical determination.

               (9)

               The setting or modification at Community level of provisional MRLs does not prevent the Member States from establishing provisional MRLs for acetamiprid, indoxacarb, pyraclostrobin, thiacloprid and trifloxystrobin in accordance with Article 4(1)(f) of Directive 91/414/EEC and Annex VI to that Directive. It is considered that a period of four years is sufficient to permit further uses of these substances. The provisional Community MRLs should then become definitive.

               (10)

               It is therefore necessary to modify the MRLs set in Directives 86/362/EEC and 90/642/EEC, to allow proper surveillance and control of the uses of the plant protection products concerned and to protect the consumer. Where MRLs have already been defined in the Annexes to those Directives, it is appropriate to amend them. Where MRLs have not yet been defined, it is appropriate to set them for the first time.

               (11)

               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.

               (12)

               Directives 86/362/EEC and 90/642/EEC should therefore be amended 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
   Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 2
   Directive 90/642/EEC is amended in accordance with Annex II to this Directive.
   Article 3
   Member States shall adopt and publish, by 14 June 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive, except for deltamethrin and atrazine, for which they shall adopt and publish these by 18 December 2007 and for imazalil, for which they shall adopt and publish these by 14 September 2008. 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 June 2008, except for deltamethrin and atrazine for which they shall be applied from 19 December 2007 and for imazalil, for which they shall be applied from by 15 September 2008.
   When Member States adopt those provisions they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 13 December 2007.

            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 2007/62/EC (OJ L 260, 5.10.2007, p. 4).

      (2)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2007/62/EC.

      (3)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

      (4)  OJ L 43, 15.2.2007, p. 19.

      (5)  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).

      (6)  Opinion regarding questions relating to amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC (Opinion expressed by the SCP on 14 July 1998); Opinion regarding variable pesticide residues in fruit and vegetables (Opinion expressed by the SCP on 14 July 1998) http://europa.eu.int/comm/food/fs/sc/scp/outcome_ppp_en.html).

      ANNEX I
      In Part A of Annex II to Directive 86/362/EEC, the line for ‘Atrazine’ is replaced by the following:

                     Pesticide residues

                     Maximum levels in mg/kg

                     ‘Atrazine

                     0,1 (1) CEREALS

         (1)  Temporary MRLs valid until 1 June 2009, pending submission of residue data by the applicant.’

      ANNEX II
      In Part A of Annex II to Directive 90/642/EEC, the columns for acetamiprid, deltamethrin, imazalil, indoxacarb, pendimethalin, pymetrozine, pyraclostrobin, thiacloprid and trifloxystrobin are replaced by the following:

                     Pesticide residue and maximum residue level (mg/kg)

                     Groups and examples of individual products to which the MRLs apply

                     ‘Acetamiprid

                     Deltamethrin
                     (cis-deltamethrin) (2)

                     Imazalil

                     Indoxacarb as sum of the isomers S and R

                     Pendimethalin

                     Pymetrozine

                     Pyraclostrobin

                     Thiacloprid

                     Trifloxystrobin

                                 1.

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

                     0,05 (1)

                                 (i)

                                 CITRUS FRUIT

                     1 (3)

                     0,05 (1)

                     5

                     0,02 (1)
                         (3)

                     0,3

                     1 (3)

                     0,02 (1)
                         (3)

                     0,3 (3)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,05 (1)

                     0,05 (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     1 (3)

                     Walnuts

                     Others

                     0,02 (1)
                         (3)

                                 (iii)

                                 POME FRUIT

                     1 (3)

                        2

                     0,02 (1)

                     0,3 (3)

                     0,3 (3)

                     0,5 (3)

                     Apples

                     0,2

                     0,5 (3)

                     Pears

                     Quinces

                     Others

                     0,1

                     0,3 (3)

                                 (iv)

                                 STONE FRUIT

                     0,05 (1)

                     Apricots

                     0,1 (3)

                     0,3 (3)

                     0,05

                     0,2 (3)

                     0,3 (3)

                     1 (3)

                     Cherries

                     0,2 (3)

                     0,2

                     0,3 (3)

                        0,3
                         (3)

                     1 (3)

                     Peaches (including nectarines and similar hybrids)

                     0,1 (3)

                     0,3 (3)

                     0,05

                     0,2 (3)

                     0,3 (3)

                     1 (3)

                     Plums

                     0,02 (3)

                     0,1 (3)

                     0,1 (3)

                     0,2 (3)

                     Others

                     0,01 (1)
                         (3)

                     0,1

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (v)

                                 BERRIES AND SMALL FRUIT

                     0,01 (1)
                         (3)

                     0,05 (1)

                                 (a)

                                 Table and wine grapes

                     0,2

                     2 (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     5 (3)

                     Table grapes

                     1 (3)

                     Wine grapes

                     2 (3)

                                 (b)

                                 Strawberries (other than wild)

                     0,2

                     0,02 (1)
                         (3)

                     0,5

                     0,5 (3)

                     0,5 (3)

                     0,5 (3)

                                 (c)

                                 Cane fruit (other than wild)

                     0,02 (1)
                         (3)

                     1 (3)

                     0,02 (1)
                         (3)

                     Blackberries

                     0,5

                     3

                        1
                         (3)

                     Dewberries

                     Loganberries

                     Raspberries

                        0,5

                     3

                        1
                         (3)

                     Others

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                                 (d)

                                 Other small fruit and berries (other than wild)

                     1 (3)

                     Bilberries

                     Cranberries

                     Currants (red, black and white)

                     0,5

                     1 (3)

                        0,5

                        2
                         (3)

                     1 (3)

                     Gooseberries

                     0,2

                     1 (3)

                        0,5

                     1 (3)

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                        0,5
                         (3)

                     0,02 (1)
                         (3)

                                 (e)

                                 Wild berries and wild fruit

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (vi)

                                 MISCELLANEOUS

                     0,01 (1)
                         (3)

                     0,02 (1)

                     Avocados

                     Bananas

                     2

                        0,2
                         (3)

                     0,05 (3)

                     Dates

                     Figs

                     Kiwi

                     0,2

                     Kumquats

                     Litchis

                     Mangoes

                     0,05 (3)

                        0,5
                         (3)

                     Olives (table consumption)

                     1

                     Olives (oil extraction)

                     1

                     Papaya

                     0,05 (3)

                        0,5
                         (3)

                     1 (3)

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

                     0,05 (1)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

               2.   Vegetables, fresh or uncooked, frozen or dry

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     Beetroot

                     Carrots

                     0,2

                     0,1 (3)

                     0,05 (3)

                     Cassava

                     Celeriac

                        0,1

                     Horseradish

                     0,2

                     0,3 (3)

                     Jerusalem artichokes

                     Parsnips

                     0,2

                     0,3 (3)

                     Parsley root

                     0,2

                        0,1
                         (3)

                     Radishes

                        0,2
                         (3)

                     Salsify

                        0,1
                         (3)

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                     0,02 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (ii)

                                 BULB VEGETABLES

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Garlic

                     0,1

                     0,2 (3)

                     Onions

                     0,1

                     0,2 (3)

                     Shallots

                     0,1

                     0,2 (3)

                     Spring onions

                     0,1

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (iii)

                                 FRUITING VEGETABLES

                     0,05 (1)

                                 (a)

                                 Solanacea

                     Tomatoes

                     0,1 (3)

                     0,3

                     0,5

                     0,5 (3)

                     0,5

                     0,2 (3)

                     0,5 (3)

                     0,5 (3)

                     Peppers

                     0,3 (3)

                     0,3 (3)

                     1

                     0,5 (3)

                     1 (3)

                        0,3
                         (3)

                     Aubergines

                     0,1 (3)

                     0,3

                     0,5 (3)

                     0,5

                     0,2 (3)

                     0,5 (3)

                     Okra

                     0,3

                     Others

                     0,01 (1)
                         (3)

                     0,2

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (b)

                                 Cucurbits — edible peel

                     0,3 (3)

                     0,2

                     0,2

                     0,2 (3)

                     0,5

                     0,02 (1)
                         (3)

                     0,3 (3)

                     0,2 (3)

                     Cucumbers

                     Gherkins

                     Courgettes

                     Others

                                 (c)

                                 Cucurbits — inedible peel

                     0,01 (1)
                         (3)

                     0,2

                     0,1 (3)

                     0,2

                     0,02 (1)
                         (3)

                     Melons

                     2

                     0,2 (3)

                     0,3 (3)

                     Squashes

                     Watermelons

                     0,2 (3)

                     0,2

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (d)

                                 Sweet corn

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,05 (1)

                                 (a)

                                 Flowering brassica

                     0,1

                     0,3 (3)

                     0,02 (1)

                     0,1 (3)

                     0,02 (1)
                         (3)

                     Broccoli (including Calabrese)

                        0,05
                         (3)

                     Cauliflower

                        0,05
                         (3)

                     Others

                     0,02 (1)
                         (3)

                                 (b)

                                 Head brassica

                     0,1

                     0,02 (1)
                         (3)

                        0,2
                         (3)

                     Brussels sprouts

                     0,2 (3)

                     Head cabbage

                     3 (3)

                     0,05

                     0,2 (3)

                     Others

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                                 (c)

                                 Leafy brassica

                     0,5

                     0,2

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     Chinese cabbage

                     0,2 (3)

                     Kale

                     0,2 (3)

                     Others

                     0,02 (1)
                         (3)

                                 (d)

                                 Kohlrabi

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,05 (1)

                     0,05 (1)

                     0,02 (1)
                         (3)

                                 (a)

                                 Lettuce and similar

                     0,5

                     2

                     2 (3)

                     Cress

                     Lamb's lettuce

                     5 (3)

                        1
                         (3)

                        10
                         (3)

                     Lettuce

                     5 (3)

                     2 (3)

                     Scarole (broad-leaf endive)

                        5
                         (3)

                     2 (3)

                     Ruccola

                     Leaves and stems of brassica, including turnip greens

                     Others

                     0,01 (1)
                         (3)

                     0,02 (1)
                         (3)

                     2 (3)

                                 (b)

                                 Spinach and similar

                     0,01 (1)
                         (3)

                     0,5

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Spinach

                        2

                     Beet leaves (chard)

                     Others

                     0,02 (1)
                         (3)

                                 (c)

                                 Watercress

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (d)

                                 Witloof

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (e)

                                 Herbs

                     0,5

                     2 (3)

                     1

                     2 (3)

                     3 (3)

                     Chervil

                     Chives

                     Parsley

                        5
                         (3)

                     Celery leaves

                     Others

                     0,01 (1)
                         (3)

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,01 (1)
                         (3)

                     0,2

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,2

                     1

                     0,02 (1)
                         (3)

                     Beans (with pods)

                     1 (3)

                     0,5 (3)

                     Beans (without pods)

                     Peas (with pods)

                     Peas (without pods)

                     Others

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     Asparagus

                     Cardoons

                     Celery

                        0,1

                     Fennel

                     Globe artichokes

                     0,1

                     0,1 (3)

                     Leek

                     0,2

                     0,5 (3)

                        0,2
                         (3)

                     Rhubarb

                     Others

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (viii)

                                 FUNGI

                     0,01 (1)
                         (3)

                     0,05

                     0,05 (1)

                     0,02 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,01 (1)
                         (3)

                     1

                     0,05 (1)

                     0,02 (1)
                         (3)

                        0,2

                     0,02 (1)

                     0,3 (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

                                 4.

                                 Oilseeds

                     0,05 (1)

                     0,1 (1)

                     0,02 (1)
                         (3)

                     0,05 (1)
                         (3)

                     Linseed

                     Peanuts

                     Poppy seed

                     Sesame seed

                     Sunflower seed

                     Rape seed

                     0,1

                     0,3 (3)

                     Soya bean

                     0,5 (3)

                     Mustard seed

                     0,1

                        0,2
                         (3)

                     Cotton seed

                     0,02 (3)

                     0,05

                     Hemp seed

                     Pumpkin seed

                     Others

                     0,01 (1)
                         (3)

                     0,05 (1)

                     0,05 (1)
                         (3)

                     0,02 (1)

                     0,05 (1)
                         (3)

                                 5.

                                 Potatoes

                     0,01 (1)
                         (3)

                     0,05 (1)

                        3

                     0,02 (1)
                         (3)

                     0,05 (1)

                     0,02 (1)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     0,02 (1)
                         (3)

                     Early potatoes

                     Ware potatoes

                                 6.

                                 Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis)

                     0,1 (1)
                         (3)

                     5

                     0,1 (1)

                     0,05 (1)
                         (3)

                     0,1 (1)

                     0,1 (1)

                     0,05 (1)
                         (3)

                     0,05 (1)
                         (3)

                     0,05 (1)
                         (3)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     0,1 (1)
                         (3)

                     5

                     0,1 (1)

                     0,05 (1)
                         (3)

                     0,1 (1)

                     15

                     10 (3)

                     0,05 (1)
                         (3)

                     30 (3)

         (1)  Indicates lower limit of analytical determination.

         (2)  Temporary MRLs valid until 1 November 2008, pending review of the Annex III dossier under Directive 91/414/EEC and re-registration of deltamethrin formulations at Member State level.

         (3)  Indicates that the maximum residue level has been established provisionally in accordance with Article 4(1)(f) of Directive 91/414/EEC.’


Avis juridique important

|

31990L0119

Council Directive 90/119/EEC of 5 March 1990 of hybrid breeding pigs for breeding

Official Journal L 071 , 17/03/1990 P. 0036 - 0036 Finnish special edition: Chapter 3 Volume 32 P. 0084  Swedish special edition: Chapter 3 Volume 32 P. 0084

*****COUNCIL  DIRECTIVE  of 5 March 1990  of hybrid breeding pigs for breeding  (90/119/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species (1) and in particular Article 8 thereof,  Having regard to the proposal from the Commission,  Whereas Directive 88/661/EEC was particularly intended gradually to liberalize intra-Community trade in hybrid breeding pigs; whereas, for this purpose, additional harmonization with regard to the acceptance of such animals, for breeding purposes, is necessary;  Whereas the provisions concerning acceptance for breeding relate both to animals as well as their semen, ova and embryos;  Whereas, in this respect, it is necessary to prevent national provisions relating to the acceptance for breeding purposes of hybrid breeding pigs and their semen, ova and embryos from constituting a prohibition or restriction of intra-Community trade or an obstacle thereto whether in the case of natural service, artificial insemination or the taking of ova or embryos;  Whereas female and male hybrid breeding pigs, their semen, ova and embryos should be subject to no prohibition, restriction or obstacle in connection with breeding;  Whereas the provision that semen, ova and embryos must be manipulated by officially approved staff is capable of providing the guarantees necessary for attaining the desired end;  Whereas in the light of particular conditions currently existing in Spain and Portugal it is necessary to provide for a longer period for the implementation of this Directive in those Member States,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall ensure that, without prejudice to animal health rules there is no prohibition or restriction of or obstacle to:  - the acceptance of hybrid breeding female pigs for breeding,  - the acceptance of hybrid breeding male pigs for natural service,  - the acceptance for artificial insemination of hybrid breeding male pigs whose line has been tested for monitoring performance and assessing its genetic value,  - the use of the semen of the animal referred to in the third indent,  - the acceptance, for official testing, of hybrid breeding male pigs or the use of the semen of such pigs within quantitative limits necessary for the tests for monitoring their performance and assessing their genetic value to be carried out,  - the use of ova and embryos from hybrid breeding female pigs.  Article 2  Member States shall ensure that, without prejudice to animal health rules, for marketing, the semen, ova and embryos are collected, treated and stored by an officially approved centre or officially approved staff.  Article 3  Member States shall bring into force the laws, regulations and administrative provisionns necessary to comply with this Directive by not later than 1 January 1991. They shall forthwith inform the Commission thereof.  However, the Kingdom of Spain and the Portuguese Republic shall have an additional period of time of two years within which to comply with this Directive.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 5 March 1990.  For the Council  The President  J. WALSH  (1) OJ No L 382, 31. 12. 1988, p. 36.


title: Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance)

text:
               30.4.2009

               EN

               Official Journal of the European Union

               L 109/10

      DIRECTIVE 2009/35/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 23 April 2009
   on the colouring matters which may be added to medicinal products
   (recast)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               The primary purpose of any laws concerning medicinal products must be to safeguard public health. However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

               (3)

               Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (5) established a single list of colouring matters authorised for use in foodstuffs, but disparities between the laws of Member States concerning the colouring of medicinal products still exist.

               (4)

               Those disparities tend to hinder trade in medicinal products within the Community and trade in colouring matters which may be added to those products. Such disparities therefore directly affect the functioning of the internal market.

               (5)

               Experience has shown that there is no reason, on health grounds, why the colouring matters authorised for use in foodstuffs should not also be authorised for use in medicinal products. Consequently, Annex I to Directive 94/36/EC as well as the Annex to Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs (6) should also apply for medicinal products.

               (6)

               However, when the use of a colouring matter in foodstuffs and medicinal products is prohibited in order to safeguard public health, technological and economic disturbances should be avoided as far as is possible. To this end a procedure should be provided for which establishes close cooperation between the Member States and the Commission within a committee for the adjustment to technical progress of the Directives on the elimination of technical barriers to trade in the sector of colouring matters which may be added to medicinal products.

               (7)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

               (8)

               In particular, the Commission should be empowered to amend the limited period of use of medicinal products. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (9)

               The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

               (10)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Member States shall not authorise, for the colouring of medicinal products for human and veterinary use as defined in Article 1 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (8) and in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (9), any colouring matters other than those covered by Annex I to Directive 94/36/EC.
   Article 2
   Member States shall take all measures necessary to ensure that the colouring matters covered by Annex I to Directive 94/36/EC satisfy the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in the Annex to Directive 95/45/EC.
   Article 3
   The methods of analysis needed to verify that the general and specific criteria of purity adopted pursuant to the First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity (10) are satisfied shall also apply for the purpose of this Directive.
   Article 4
   Where a colouring matter is deleted from Annex I to Directive 94/36/EC but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this provision shall also apply to medicinal products.
   This limited period of use may however be amended by the Commission as regards medicinal products.
   Those measures designed to amend non-essential elements of this Directive, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 5(2).
   Article 5
   1.   The Commission shall be assisted by a committee.
   2.   Where reference is made to this paragraph, Articles 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   Article 6
   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 7
   Directive 78/25/EEC, as amended by the acts listed in Annex I, Part A is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
   Article 8
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 9
   This Directive is addressed to the Member States.

      Done at Strasbourg, 23 April 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         P. NEČAS

      (1)  OJ C 162, 25.6.2008, p. 41.

      (2)  Opinion of the European Parliament of 23 September 2008 (not yet published in the Official Journal) and Council Decision of 23 March 2009.

      (3)  OJ L 11, 14.1.1978, p. 18.

      (4)  See Annex I, Part A.

      (5)  OJ L 237, 10.9.1994, p. 13. Directive repealed prospectively by Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16.).

      (6)  OJ L 226, 22.9.1995, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008.

      (7)  OJ L 184, 17.7.1999, p. 23.

      (8)  OJ L 311, 28.11.2001, p. 1.

      (9)  OJ L 311, 28.11.2001, p. 67.

      (10)  OJ L 257, 10.9.1981, p. 1. Directive repealed prospectively by Regulation (EC) No 1333/2008.

      ANNEX I
      PART A

         Repealed Directive with list of its successive amendments

         (referred to in Article 7)

                  Council Directive 78/25/EEC
                  (OJ L 11, 14.1.1978, p. 18)

                  1979 Act of Accession, Annex I, Section X, point D
                  (OJ L 291, 19.11.1979, p. 108)

                  Council Directive 81/464/EEC
                  (OJ L 183, 4.7.1981, p. 33)

                  1985 Act of Accession, Annex I, Section IX, point C
                  (OJ L 302, 15.11.1985, p. 217)

                  Council Regulation (EC) No 807/2003
                  (OJ L 122, 16.5.2003, p. 36)

                  Annex III, point 25 only

            PART B

         List of time-limits for transposition into national law

         (referred to in Article 7)

                  Directive

                  Time-limit for transposition

                  78/25/EEC

                  15 June 1979 (1)

                  81/464/EEC

                  30 September 1981

         (1)  Pursuant to Article 7(2) of Directive 78/25/EEC: ‘2. However, any Member State may permit, on its own territory, until the end of a period of four years from the notification of this Directive, the marketing of medicinal products containing colouring matters which do not comply with the requirements of this Directive so long as these colouring matters were authorised in that Member State before the adoption of the Directive.’

      ANNEX II

         Correlation table

                  Directive 78/25/EEC

                  This Directive

                  Article 1, first paragraph

                  Article 1

                  Article 1, second paragraph

                  —

                  Articles 2 and 3

                  Articles 2 and 3

                  Article 4, first sentence

                  Article 4, first paragraph

                  Article 4, second sentence, first part

                  Article 4, second paragraph

                  Article 4, second sentence, second part

                  Article 4, third paragraph

                  Articles 5(1) and 6(1) and (2)

                  Article 5

                  Article 6(3)

                  —

                  Article 7(1), (2) and (3)

                  —

                  Article 7(4)

                  Article 6

                  —

                  Article 7

                  —

                  Article 8

                  Article 8

                  Article 9

                  —

                  Annex I

                  —

                  Annex II


title: Commission Directive 2008/85/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiabendazole as an active substance in Annex I thereto (Text with EEA relevance)

text:
               6.9.2008

               EN

               Official Journal of the European Union

               L 239/6

      COMMISSION DIRECTIVE 2008/85/EC
   of 5 September 2008
   amending Directive 98/8/EC of the European Parliament and of the Council to include thiabendazole as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes thiabendazole.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, thiabendazole has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.

               (3)

               Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 9 May 2006 in accordance with 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 February 2008, in an assessment report.

               (5)

               It appears from the examinations made that biocidal products used as wood preservatives and containing thiabendazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include thiabendazole in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as wood preservatives and containing thiabendazole can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

               (6)

               However, unacceptable risks were identified for the in situ treatment of wood outdoors and for treated wood exposed to weathering. Therefore, authorisations for these uses should not be granted unless data have been submitted in order to demonstrate that the products can be used without unacceptable risks to the environment.

               (7)

               In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing thiabendazole and used as wood preservatives to ensure that risks are reduced to an acceptable level in accordance with Article 5 of Directive 98/8/EC and Annex VI thereto. In particular, appropriate measures should be taken to protect the soil and aquatic compartments since unacceptable risks in these compartments have been identified during the evaluation and products intended for industrial and/or professional use should be used with appropriate protective equipment if the risk identified for industrial and/or professional users cannot be reduced by other means.

               (8)

               It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance thiabendazole and also to facilitate the proper operation of the biocidal products market in general.

               (9)

               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 entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (10)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 8 containing thiabendazole to ensure that they comply with Directive 98/8/EC.

               (11)

               Directive 98/8/EC should therefore be amended accordingly.

               (12)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 30 June 2009 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 July 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 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, 5 September 2008.

            For the Commission

         Stavros DIMAS

            Member of the Commission

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      ANNEX
      The following entry ‘No 13’ is inserted in Annex I to Directive 98/8/EC:

                     No

                     Common name

                     IUPAC name
                     Identification numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘13

                     Thiabendazole

                     2-thiazol-4-yl-1H-benzoimidazole
                     EC No: 205-725-8
                     CAS No: 148-79-8

                     985 g/kg

                     1 July 2010

                     30 June 2012

                     30 June 2020

                     8

                     Member States shall ensure that authorisations are subject to the following conditions:

                                 in view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, with respect to the double-vacuum and dipping application tasks, must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by others means.

                                 In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

                                 Products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm