Avis juridique important

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31995L0038

Council Directive 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels

Official Journal L 197 , 22/08/1995 P. 0014 - 0028

COUNCIL DIRECTIVE 95/38/EC of 17 July 1995 amending Annexes I and II to Directive  90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of  plant origin, including fruit and vegetables, and providing for the establishment of a list of  maximum levelsTHE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on maximum levels for pesticide  residues in and on certain products of plant origin, including fruit and vegetables  (1), and in  particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas the Commission has been instructed, within the framework of Directive 90/642/EEC, to  prepare a list of pesticide residues and their maximum levels for submission to the Council for  approval; Whereas pesticide residues may occur in products of plant origin, including fruit and vegetables,  as a result of agricultural practices; whereas it is necessary to take into account relevant data  for both authorized pesticide uses and supervised trials; Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it  is prudent to establish simultaneously, where appropriate, maximum residue levels for individual  pesticides in all major components of diet; whereas these levels represent the use of minimum  quantities of pesticide necessary to achieve adequate control, applied in such a manner that the  amount of residue is the smallest possible and is toxicologically acceptable; Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in  products of plant origin, namely methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl,  aldicarb, thiabendazole; whereas, however, it is not possible to do so for all pesticide residue  product combinations due to insufficient data; Whereas, in the case of thiabendazole, the available data are insufficient to establish, in  accordance with current rules, a maximum residue level for citrus fruit; whereas, however,  thiabendazole has been included in the list of substances included in Commission Regulation (EEC)  No 3600/92  (2) and is covered by the first stage of the work programme provided for in Article 8  (2) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on  the market  (3); whereas an important element of this programme will be the establishment of  maximum levels arising from use as plant protection products; Whereas certain pesticide residues may remain, in particular, in spices, which may need to be  controlled; whereas it is necessary to amend Annex I to Directive 90/642/EEC to include such spices  in the list of groups of product to which maximum residue levels apply; Whereas, it is only considered necessary to establish maximum pesticide residue levels in spices  for certain pesticides having regard to the toxicological nature of their residues and their use  pattern; Whereas, however, the available data are insufficient by current standards to establish maximum  pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases  a period of time not exceeding four years would seem reasonable for the generation of the necessary  data; whereas maximum levels should therefore be established on the basis of such data by 1 July  2000 at the latest; whereas failure to provide satisfactory data will result in the establishment  of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate  the necessary data must be given within one year of adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the  framework of the re-evaluation of active substances provided for in the work programme referred to  in Article 8 (2) of Directive 91/414/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 90/642/EEC is hereby amended as follows: 1. Annex I shall be supplemented by the addition of the following: >TABLE> 2. Annex II shall become Annex II, Part A, and shall be supplemented by the following: >TABLE> >TABLE> >TABLE> Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary  to comply with this Directive not later than 1 July 1996. 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. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 17 July 1995. For the Council The President L. ATIENZA SERNA


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31997L0071

Commission Directive 97/71/EC of 15 December 1997 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)

Official Journal L 347 , 18/12/1997 P. 0042 - 0044

COMMISSION DIRECTIVE 97/71/EC of 15 December 1997 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (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), as last amended by Directive 97/41/EC (2), 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 (3), as last amended by Directive 97/41/EC, 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 products of plant origin, including fruit and vegetables (4), as last amended by Directive 97/41/EC, and in particular Article 10 thereof,Whereas Directives 93/57/EEC (5), 94/29/EC (6), 95/39/EC (7) and 96/33/EC (8) amended the Annexes II of Directives 86/362/EEC and 86/363/EEC to establish maximum residue levels for lists of pesticides; whereas, however, certain positions were left open where available data were insufficient to establish maximum levels and interested parties were given the opportunity to generate the missing data within a specified timetable; whereas, if maximum levels are not adopted by the dates specified in footnotes to the lists added to the Annexes II of Directives 86/362/EEC and 86/363/EEC by Directives 93/57/EEC, 94/29/EC, 95/39/EC and 96/33/EC the appropriate lower limit of analytical determination will apply;Whereas Directives 93/58/EEC (9), 94/30/EC (10), 95/38/EC (11) and 96/32/EC (12) amended Annex II of Directive 90/642/EEC to establish maximum levels for lists of pesticides; whereas, however, certain positions were left open where available data were insufficient to establish maximum levels and interested parties were given the opportunity to generate the missing data within a specified timetable; whereas, if maximum levels are not adopted by the dates specified in footnotes to the lists added to the Annexes II of Directive 90/642/EEC by Directives 93/58/EEC, 94/30/EC, 95/38/EC and 96/32/EC the appropriate lower limit of analytical determination will apply;Whereas Member States may set national maximum residue levels where these are not fixed by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC; whereas Member States should set such national levels to reflect their national authorisations of plant protection products containing the relevant active substance and based on sufficient data to ensure that consumers are not exposed to unacceptable levels of pesticide residue;Whereas Member States' national maximum residue levels which have the effect to prohibit or restrict the putting into circulation of products originating in other Member States are subject to a conciliation procedure set out in Article 5a of Directives 86/362/EEC and 86/363/EEC and in Article 5b of Directive 90/642/EEC under which exceptional provisions apply, including where possible the establishment of a temporary maximum residue level;Whereas, for cereals and products of plant origin, maximum residue levels reflect the use of minimum quantities of pesticides to achieve adequate 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; whereas, for foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate;Whereas for the pesticides listed in Directives 93/57/EEC and 93/58/EEC undertakings were given by interested parties to generate missing data; whereas the data submitted are under examination by the Commission and the Member States' authorities with a view to preparing the necessary draft amending Commission Directives; whereas the date for closing the open positions in Directives 93/57/EEC and 93/58/EEC should be extended to 31 October 1998 to allow the necessary work and consultations to be finalized;Whereas all active substances of plant protection products already on the market two years after the date of notification of Directive 91/414/EEC concerning the placing of plant protection products on the market (13) are to be reviewed in the framework of the re-evaluations of existing active substances provided for in the programme of work set out in Article 8 (2) of the said Directive; whereas the first stage of the examination of the active substances and the plant protection products formulated with them is not yet completed; whereas these examinations and the consequential decisions to be taken are anticipated to have significant effects on authorized uses and thus on maximum residue levels which should be fixed for these pesticides; whereas therefore the deadlines specified in Directives 94/29/EC, 94/30/EC, 96/32/EC and 96/33/EC for the appropriate lower limits of analytical determination to apply where positions have been left open should be prolonged to the date of 1 July 2000, as provided by the Council in Directives 95/38/EC and 95/39/EC, in order to allow the consequences of the available re-evaluation of the authorizations of the pesticides concerned to be taken into account; whereas when the results of re-evaluations become available the Commission should amend the maximum levels fixed for those pesticides and should also fix or amend maximum levels for certain pesticides before 1 July 2000 where the necessary and sufficient information and studies are available and evaluated; whereas a programme of work, which will be communicated to the interested parties, should be established at the latest by 31 March 1998, setting out the deadlines within which such information and studies should be submitted by interested parties to the Commission and the Member States;Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1 In Annex II of Directive 86/362/EEC:1. the date '1 January 1998` in footnotes (a), (b) and (c) to the list of pesticide residues introduced by Directive 93/57/EEC should be amended to read '31 October 1998`;2. the date '30 June 1999` in footnotes (a), (b) and (c) to the list of pesticide residues introduced by Directive 94/29/EC should be amended to read 'at the latest 1 July 2000`;3. the date '30 April 2000` in footnotes (a) and (b) to the list of pesticide residues introduced by Directive 96/33/EC should be amended to read 'at the latest 1 July 2000`.Article 2 In Annex II of Directive 86/363/EEC:1. the date '1 January 1998` in footnote (a) to the list of pesticide residues introduced by Directive 93/57/EEC should be amended to read '31 October 1998`;2. the date '30 June 1999` in footnote (a) to the list of pesticide residues introduced by Directive 94/29/EC should be amended to read 'at the latest 1 July 2000`;3. the date '30 April 2000` in footnotes (a) and (b) in the list of pesticide residues introduced by Directive 96/33/EC should be amended to read 'at the latest 1 July 2000`.Article 3 In Annex II of Directive 90/642/EEC:1. the date '1 January 1998` in footnotes (a), (b), (c) and (d) to the list of pesticide residues introduced by Directive 93/58/EEC should be amended to read '31 October 1998`;2. the date '30 June 1999` in footnotes (a), (b) and (c) to the list of pesticide residues introduced by Directive 94/30/EC should be amended to read 'at the latest 1 July 2000`;3. the date '30 April 2000` in footnotes (a), (b), (c) and (d) to the list of pesticide residues introduced by Directive 96/32/EC should be amended to read 'at the latest 1 July 2000`.Article 4 Member States shall bring into force, not later than 31 December 1997, the laws, regulations or administrative provisions necessary to comply with this Directive.Article 5 This Directive is addressed to the Member States.Done at Brussels, 15 December 1997.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 221, 7. 8. 1986, p. 37.(2) OJ L 184, 12. 7. 1997, p. 33.(3) OJ L 221, 7. 8. 1986, p. 43.(4) OJ L 350, 14. 12. 1990, p. 71.(5) OJ L 211, 23. 8. 1993, p. 1.(6) OJ L 189, 23. 7. 1994, p. 67.(7) OJ L 197, 22. 8. 1995, p. 29.(8) OJ L 144, 18. 6. 1996, p. 35.(9) OJ L 211, 23. 8. 1993, p. 6.(10) OJ L 189, 23. 7. 1994, p. 70.(11) OJ L 197, 22. 8. 1995, p. 14.(12) OJ L 144, 18. 6. 1996, p. 12.(13) OJ L 230, 19. 8. 1991, p. 1.


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32002L0005

Commission Directive 2002/5/EC of 30 January 2002 amending Annex II to Council Directive 90/642/EEC as regards the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables

Official Journal L 034 , 05/02/2002 P. 0007 - 0012

Commission Directive 2002/5/ECof 30 January 2002amending Annex II to Council Directive 90/642/EEC as regards the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetablesTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(1), as last amended by Commission Directive 2001/57/EC(2), and in particular Article 7 thereof,Whereas:(1) For 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 both as low as practicable and toxicologically acceptable, having regard in particular to the protection of the environment and to the protection of the consumers notably in terms of the estimated dietary intake by consumers. Community maximum residue levels (MRLs) represent the upper limit to the amounts of such residues that might be found in commodities when good agricultural practices have been respected by producers.(2) MRLs for pesticides should be kept under review and may be changed to take account of new information and data. Maximum residue levels 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) Following publication of Commission Directive 2000/42/EC(3), the Commission received requests, supported by further data, to review the MRLs for lambda-cyhalothrin and amitraz on certain food commodities fixed by Directive 2000/42/EC. The applications and data were reviewed, and for some combinations, the data was sufficient to justify the fixing of an MRL above the lower limit of analytical determination. For other combinations the information available remains inadequate and it is appropriate to fix MRLs at the lower limit of analytical determination. For yet other combinations the information now available is sufficient to demonstrate that the setting of an MRL above the lower limit of analytical determination may give rise to an unacceptable acute or chronic exposure of the consumer to the residues. In such cases, the MRLs should remain fixed at the lower limit of analytical determination.(4) Information on new or changed uses of cypermetrin on asparagus, ethephon on pineapple, fenbutatinoxyde on peppers, metalaxyl on spring onions, acephate on peaches and chlorothalonil on celeriac has been notified to the Commission and evaluated. In the light of that information it is appropriate to modify the existing MRLs specified in the Annex to the Directive.(5) The lifetime exposure of consumers to each of the pesticides in this Directive via food products has been assessed and evaluated in accordance with the procedures and practices used within the European Union taking account of guidelines published by the World Health Organisation(4) and it is calculated that the MRLs fixed in this Directive will not lead to the acceptable daily intakes being exceeded.(6) Where relevant, the acute exposure of consumers to these pesticides 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 used within the European Union, taking account of guidelines published by the World Health Organisation. It is calculated that the maximum residue levels fixed in the present Directive do not cause acute toxic effects.(7) Through the World Trade Organisation, the Community's trading partners were consulted about the levels fixed in this Directive and their comments on these levels were taken into account.(8) The opinions of the Scientific Committee for Plants have been taken into account, in particular its advice and recommendations concerning the protection of consumers of food products treated with pesticides. The methodology described by the World Health Organisation, referred to above, as applied by rapporteur Member States, and monitored and evaluated by the Commission through the Standing Committee on Plant Health, is consistent with the guidance given by the Scientific Committee for Plants.(9) Directive 90/642/EEC should therefore be amended accordingly and should enter into force immediately.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1The maximum residue levels listed in the Annex to this Directive are to replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question.Article 2The maximum residue levels listed in Annex II to Directive 90/642/EEC are in respect of the pesticide commodity combinations referred to in this provision, to be replaced by the following: cypermetrin on asparagus: 0,1 mg/kg, ethephon on pineapples: 2 mg/kg, fenbutatinoxyde on peppers: 1 mg/kg, metalaxyl on spring onions: 0,2 mg/kg, metalaxyl on "scarole (broad-leaf endive)" and herbs: 1 mg/kg, chlorothalonil on "celeriac": 1 mg/kg, acephate on "Peaches": 0,2 mg/kg(5).Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 August 2002 at the latest. They shall forthwith inform the Commission thereof.They shall apply these measures as of 1 September 2002.2. 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 4This Directive shall enter into force on the first day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 30 January 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 350, 14.12.1990, p. 71.(2) OJ L 208, 1.8.2001, p. 36.(3) OJ L 158, 30.6.2000, p. 51.(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).(5) Pending trials for the second season, results to be submitted before 1 September 2002.ANNEX>TABLE>Note:For the convenience of the reader, MRLs are indicated in bold type character when they reflect changes relative to MRLs in Annexes of Directives earlier than Directive 2000/42/EC, when indicated in normal type characters, they are reiterations of existing MRLs.


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32002L0063

Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (Text with EEA relevance)

Official Journal L 187 , 16/07/2002 P. 0030 - 0043

Commission Directive 2002/63/ECof 11 July 2002establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/57/EC(2), and in particular Article 6 thereof,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(3), as last amended by Commission Directive 2002/42/EC(4), and in particular Article 8 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 products of animal origin(5), as last amended by Directive 2002/42/EC, and in particular Article 8 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(6), as last amended by Directive 2002/42/EC, and in particular Article 6 thereof,Whereas:(1) Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC provide for official checks and controls to ensure compliance with maximum levels for pesticide residues in and on products of plant and animal origin. They also provide that Community methods of sampling may be established by the Commission.(2) Methods of sampling for pesticides residues in fruit and vegetables were laid down by Commission Directive 79/700/EEC of 24 July 1979 establishing Community methods of sampling for the official control of pesticide residues in and on fruit and vegetables(7).(3) It is appropriate to update these methods to reflect technical progress and to establish methods of sampling for pesticides residues in products of animal origin as well as in other products of plant origin.(4) Methods of sampling for the determination of pesticides residues for compliance with maximum residue levels (MRLs) were developed and agreed by the Codex Alimentarius Commission(8). The Community supported and endorsed the recommended methods. It is appropriate to replace the existing sampling provisions with those developed and agreed by the Codex Alimentarius Commission.(5) Directive 79/700/EEC should therefore be repealed and replaced by this Directive.(6) 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 provisions laid down in this Directive apply to the sampling of products of plant and animal origin in order to determine the level of pesticide residues for the purposes of Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC and do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC(9) on measures to monitor certain substances and residues thereof in live animals and animal products.Article 2Member States shall require that sampling for the checks provided for in Article 6 of Directive 76/895/EEC, in Article 8 of Directive 86/362/EEC, in Article 8 of Directive 86/363/EEC and in Article 6 of Directive 90/642/EEC be carried out in accordance with the methods described in the Annex to this Directive.Article 3Directive 79/700/EEC is repealed.References to the repealed Directive shall be construed as references to this Directive.Article 41. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2003. They shall forthwith inform the Commission thereof.2. When Member States adopt these 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 5This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities.Done at Brussels, 11 July 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 244, 29.9.2000, p. 76.(3) OJ L 221, 7.8.1986, p. 37.(4) OJ L 134, 22.5.2002, p. 36.(5) OJ L 221, 7.8.1986, p. 43.(6) OJ L 350, 14.12.1990, p. 71.(7) OJ L 207, 15.8.1979, p. 26.(8) Document CAC/GL 33-1999 of the Codex Alimentarius Commission. FAO Rome. ftp://ftp.fao.org/codex/standard/volume2a/en/GL_033e.pdf(9) OJ L 125, 23.5.1996, p. 10.ANNEXMETHODS OF SAMPLING PRODUCTS OF PLANT AND ANIMAL ORIGIN FOR THE DETERMINATION OF PESTICIDE RESIDUES FOR CHECKING COMPLIANCE WITH MRLS1. OBJECTIVESamples intended for the official control of the levels of pesticide residues in and on fruit and vegetables and in products of animal origin shall be taken according to the methods described below.The objective of these sampling procedures is to enable a representative sample to be obtained from a lot for analysis to determine compliance with maximum residue levels (MRLs) for pesticides established in the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC and, in the absence of Community MRLs, with other MRLs such as those established by the Codex Alimentarius Commission. The methods and procedures laid down incorporate those recommended by the Codex Alimentarius Commission.2. PRINCIPLESCommunity MRLs are based on good agricultural practice data and raw commodities as well as foods derived from them that comply with the MRLs are intended to be toxicologically acceptable.A MRL for a plant, egg or dairy product takes into account the maximum level expected to occur in a composite sample, which has been derived from multiple units of the treated product and which is intended to represent the average residue level in a lot. A MRL for meat and poultry takes into account the maximum level expected to occur in the tissues of individual treated animals or birds.In consequence, MRLs for meat and poultry apply to a bulk sample derived from a single primary sample, whereas MRLs for plant products, eggs and dairy products apply to a composite bulk sample derived from one to ten primary samples.3. DEFINITION OF TERMSAnalytical portionA representative quantity of material removed from the analytical sample, of proper size for measurement of the residue concentration.Note:A sampling device may be used to withdraw the analytical portion.Analytical sampleThe material prepared for analysis from the laboratory sample, by separation of the portion of the product to be analysed(1)(2) and then by mixing, grinding, fine chopping, etc., for the removal of analytical portions with minimal sampling error.Note:Preparation of the analytical sample must reflect the procedure used in setting MRLs and thus the portion of the product to be analysed may include parts that are not normally consumed.Bulk sample/aggregate sampleFor products other than meat and poultry, the combined and well-mixed aggregate of the primary samples taken from a lot. For meat and poultry, the primary sample is considered to be equivalent to the bulk sample.Notes:a) The primary samples must contribute sufficient material to enable all laboratory samples to be withdrawn from the bulk sample.b) Where separate laboratory samples are prepared during collection of the primary sample(s), the bulk sample is the conceptual sum of the laboratory samples, at the time of taking the samples from the lot.Laboratory sampleThe sample sent to, or received by, the laboratory. A representative quantity of material removed from the bulk sample.Notes:a) The laboratory sample may be the whole or a part of the bulk sample.b) Units should not be cut or broken to produce the laboratory sample(s), except where subdivision of units is specified in Table 3.c) Replicate laboratory samples may be prepared.LotA quantity of a food material delivered at one time and known, or presumed, by the sampling officer to have uniform characteristics such as origin, producer, variety, packer, type of packing, markings, consignor, etc. A suspect lot is one which, for any reason, is suspected to contain an excessive residue. A non-suspect lot is one for which there is no reason to suspect that it may contain an excessive residue.Notes:a) Where a consignment is comprised of lots which can be identified as originating from different growers, etc., each lot should be considered separately.b) A consignment may consist of one or more lots.c) Where the size or boundary of each lot in a large consignment is not readily established, each one of a series of wagons, lorries, ships bays, etc., may be considered to be a separate lot.d) A lot may be mixed by grading or manufacturing processes, for example.Primary sample/incremental sampleOne or more units taken from one position in a lot.Notes:a) The position from which a primary sample is taken in the lot should preferably be chosen randomly but, where this is physically impractical, it should be from a random position in the accessible parts of the lot.b) The number of units required for a primary sample should be determined by the minimum size and number of laboratory samples required.c) For plant, egg and dairy products, where more than one primary sample is taken from a lot, each should contribute an approximately similar proportion to the bulk sample.d) Units may be allocated randomly to replicate laboratory samples at the time of collecting the primary sample(s), in cases where the units are of medium or large size and mixing the bulk sample would not make the laboratory sample(s) more representative, or where the units (e.g. eggs, soft fruit) could be damaged by mixing.e) Where primary samples are taken at intervals during loading or unloading of a lot, the sampling "position" is a point in time.f) Units should not be cut or broken to produce the primary sample(s), except where subdivision of units is specified in Table 3.SampleOne or more units selected from a population of units, or a portion of material selected from a larger quantity of material. For the purposes of these recommendations, a representative sample is intended to be representative of the lot, the bulk sample, the animal, etc., in respect of its pesticide residue content and not necessarily in respect of other attributes.SamplingThe procedure used to draw and constitute a sample.Sampling device(i) A tool such as a scoop, dipper, borer, knife or spear, used to remove a unit from bulk material, from packages (such as drums, large cheeses) or from units of meat or poultry which are too large to be taken as primary samples.(ii) A tool such as a riffle box, used to prepare a laboratory sample from a bulk sample, or to prepare an analytical portion from an analytical sample.Notes:a) Specific sampling devices are described by ISO(3)(4)(5) and IDF(6) standards.b) For materials such as loose leaves, the hand of the sampling officer may be considered to be a sampling device.Sampling officerA person trained in sampling procedures and, where required, authorised by the appropriate authorities to take samples.Note:The sampling officer is responsible for all procedures leading to and including preparation, packing and shipping of the laboratory sample(s). The officer must understand that consistent adherence to the specified sampling procedures is necessary, must provide complete documentation for samples, and should collaborate closely with the laboratory.Sample sizeThe number of units, or quantity of material, constituting the sample.UnitThe smallest discrete portion in a lot, which should be withdrawn to form the whole or part of a primary sample.Notes:Units should be identified as follows.a) Fresh fruit and vegetables. Each whole fruit, vegetable or natural bunch of them (e.g. grapes) should form a unit, except where these are small. Units of packaged small products may be identified as in (d). Where a sampling device may be used without damaging the material, units may be created by this means. Individual eggs, fresh fruit or vegetables must not be cut or broken to produce units.b) Large animals or parts or organs of them. A portion, or the whole, of a specified part or organ should form a unit. Parts or organs may be cut to form units.c) Small animals or parts or organs of them. Each whole animal or complete animal part or organ present may form a unit. Where packaged, units may be identified as in (d), below. Where a sampling device may be used without affecting residues, units may be created by this means.d) Packaged materials. The smallest discrete packages should be taken as units. Where the smallest packages are very large, they should be sampled as bulk, as in (e). Where the smallest packages are very small, a pack of packages may form the unit.e) Bulk materials and large packages (such as drums, cheeses, etc) which are individually too large to be taken as primary samples. The units are created with a sampling device.4. SAMPLING PROCEDURES(7)4.1. Precautions to be takenContamination and deterioration of samples must be prevented at all stages, because they may affect the analytical results. Each lot to be checked for compliance must be sampled separately.4.2. Collection of primary samplesThe minimum number of primary samples to be taken from a lot is determined from Table 1, or Table 2 in the case of a suspect lot of meat or poultry. Each primary sample should be taken from a randomly chosen position in the lot, as far as practicable. The primary samples must consist of sufficient material to provide the laboratory sample(s) required from the lot.Note:Sampling devices required for grain(8), pulses(9) and tea(10) are described in ISO recommendations and those required for dairy products(11) are described by the IDF.Table 1Minimum number of primary samples to be taken from a lot>TABLE>Table 2Number of randomly selected primary samples required for a given probability of finding at least one non-compliant sample in a lot of meat or poultry, for a given incidence of non-compliant residues in the lot>TABLE>Notes:a) The table assumes random sampling.b) Where the number of primary samples indicated in Table 2 is more than about 10 % of units in the total lot, the number of primary samples taken may be fewer and should be calculated as follows:>REFERENCE TO A GRAPHIC>wheren= minimum number of primary samples to be takenno= number of primary samples given in Table 2N= number of units, capable of yielding a primary sample, in the lot.c) Where a single primary sample is taken, the probability of detecting a non-compliance is similar to the incidence of non-compliant residues.d) For exact or alternative probabilities, or for a different incidence of non-compliance, the number of samples to be taken may be calculated from:>REFERENCE TO A GRAPHIC>where p is the probability and i is the incidence of non-compliant residues in the lot (both expressed as fractions, not percentages), and n is the number of samples.4.3. Preparation of the bulk sampleThe procedures for meat and poultry are described in Table 3. Each primary sample is considered to be a separate bulk sample.The procedures for plant products, eggs or dairy products are described in Tables 4 and 5. The primary samples should be combined and mixed well, if practicable, to form the bulk sample.Where mixing to form the bulk sample is inappropriate or impractical, the following alternative procedure may be followed. Where units may be damaged (and thus residues may be affected) by the processes of mixing or subdivision of the bulk sample, or where large units cannot be mixed to produce a more uniform residue distribution, the units should be allocated randomly to replicate laboratory samples at the time of taking the primary samples. In this case, the result to be used should be the mean of valid results obtained from the laboratory samples analysed.Table 3Meat and poultry: description of primary samples and minimum size of laboratory samples>TABLE>Table 4Plant products: description of primary samples and minimum size of laboratory samples>TABLE>Table 5Egg and dairy products: description of primary samples and minimum size of laboratory samples>TABLE>4.4. Preparation of the laboratory sampleWhere the bulk sample is larger than is required for a laboratory sample, it should be divided to provide a representative portion. A sampling device, quartering, or other appropriate size reduction process may be used but units of fresh plant products or whole eggs should not be cut or broken. Where required, replicate laboratory samples should be withdrawn at this stage or they may be prepared using the alternative procedure described above. The minimum sizes required for laboratory samples are given in Tables 3, 4 and 5.4.5. Sampling recordThe sampling officer must record the nature and origin of the lot; the owner, supplier or carrier of it; the date and place of sampling; and any other relevant information. Any departure from the recommended method of sampling must be recorded. A signed copy of the record must accompany each replicate laboratory sample and a copy should be retained by the sampling officer. A copy of the sampling record should be given to the owner of the lot, or a representative of the owner, whether or not they are to be provided with a laboratory sample. If sampling records are produced in computerised form, these should be distributed to the same recipients and a similar verifiable audit trail maintained.4.6. Packaging and transmission of the laboratory sampleThe laboratory sample must be placed in a clean, inert container which provides secure protection from contamination, damage and leakage. The container should be sealed, securely labelled and the sampling record must be attached. Where a bar code is utilised, it is recommended that alphanumeric information is also provided. The sample must be delivered to the laboratory as soon as practicable. Spoilage in transit must be avoided, e.g. fresh samples should be kept cool and frozen samples must remain frozen. Samples of meat and poultry should be frozen prior to despatch, unless transported to the laboratory before spoilage can occur.4.7. Preparation of the analytical sampleThe laboratory sample should be given a unique identifier which, together with the date of receipt and the sample size, should be added to the sample record. The part of the commodity to be analysed(12),(13), i.e. the analytical sample, should be separated as soon as practicable. Where the residue level must be calculated to include parts which are not analysed(14), the weights of the separated parts must be recorded.4.8. Preparation and storage of the analytical portionThe analytical sample should be comminuted, if appropriate, and mixed well, to enable representative analytical portions to be withdrawn. The size of the analytical portion should be determined by the analytical method and the efficiency of mixing. The methods for comminution and mixing should be recorded and should not affect the residues present in the analytical sample. Where appropriate, the analytical sample should be processed under special conditions, e.g. at sub-zero temperature, to minimise adverse effects. Where processing could affect residues and where practical alternative procedures are not available, the analytical portion may consist of whole units, or segments removed from whole units. If the analytical portion thus consists of few units or segments, it is unlikely to be representative of the analytical sample and sufficient replicate portions must be analysed, to indicate the uncertainty of the mean value. If analytical portions are to be stored before analysis, the method and length of time of storage should be such that they do not affect the level of residues present. Additional portions must be withdrawn for replicate and confirmatory analyses, as required.4.9. Schematic representationsSchematic representations of the sampling procedures described above are given in the document referred to in footnote 8 of page 30.5. CRITERIA FOR DETERMINING COMPLIANCEAnalytical results must be derived from one or more laboratory samples taken from the lot and received in a fit state for analysis. The results must be supported by acceptable quality control data(15). Where a residue is found to exceed a MRL, its identity should be confirmed and its concentration must be verified by analysis of one or more additional analytical portions derived from the original laboratory sample(s).The MRL applies to the bulk sample.The lot complies with a MRL where the MRL is not exceeded by the analytical result(s).Where results for the bulk sample exceed the MRL, a decision that the lot is non-compliant must take into account:(i) the results obtained from one or more laboratory samples, as applicable, and(ii) the accuracy and precision of analysis, as indicated by the supporting quality control data.(1) EC classification of foods: Annex I to Directive 86/362/EEC and Annex I to Directive 86/363/EEC, both as amended by Directive 93/57/EC (OJ L 211, 23.8.1993, p. 1) and Annex I to Directive 90/642/EEC, as amended by Directive 95/38/EC (OJ L 197, 22.8.1995, p. 14).(2) Part of products to which maximum limits apply: Annex I to Directive 90/642/EEC, as amended by Directive 93/58/EEC (OJ L 211, 23.8.1993, p. 6).(3) International Organisation for Standardisation, 1979. International standard ISO 950: Cereals - sampling (as grain).(4) International Organisation for Standardisation, 1979. International standard ISO 951: Pulses in bags - sampling.(5) International Organisation for Standardisation, 1980. International standard ISO 1839: Sampling - tea.(6) International Dairy Federation, 1995. International IDF standard 50C: Milk and milk products - methods of sampling.(7) ISO recommendations for sampling of grain (see footnote 3), or other commodities shipped in bulk may be adopted, if required.(8) International Organisation for Standardisation, 1979. International standard ISO 950: Cereals - sampling (as grain).(9) International Organisation for Standardisation, 1979. International standard ISO 951: Pulses in bags - sampling.(10) International Organisation for Standardisation, 1980. International Standard ISO 1839: Sampling - tea.(11) International Dairy Federation, 1995. International IDF standard 50C: Milk and milk products - methods of sampling.(12) EC classification of foods: Annex I to Directive 86/362/EEC and Annex I to Directive 86/363/EEC, both as amended by Directive 93/57/EC (OJ L 211, 23.8.1993, p. 1) and Annex I to Directive 90/642/EEC, as amended by Directive 95/38/EC (OJ L 197, 22.8.1995, p. 14).(13) Part of products to which maximum limits apply: Annex I to Directive 90/642/EEC, as amended by Directive 93/58/EEC (OJ L 211, 23.8.1993, p. 6).(14) For example, the stones of stone fruit are not analysed but the residue level is calculated assuming that they are included but contain no residue. See footnote 12.(15) Quality control procedures for pesticide residue analysis. Document SANCO/3103/2000; amendments will be found on the Commission's Internet site.


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32002L0079

Commission Directive 2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables (Text with EEA relevance.)

Official Journal L 291 , 28/10/2002 P. 0001 - 0019

Commission Directive 2002/79/ECof 2 October 2002amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2002/71/EC(2), and in particular Article 5 thereof,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(3), as last amended by Commission Directive 2002/76/EC(4), 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(5), as last amended by Directive 2002/71/EC, 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 products of plant origin, including fruit and vegetables(6), as last amended by Directive 2002/76/EC, and in particular Article 7 thereof,Whereas:(1) The Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC, consist of lists of pesticide residues and their maximum levels.(2) On re-examination of the available data it has been determined that sufficient information exists to permit maximum levels be fixed for certain pesticide residues, namely abamectin, azocyclotin, bioresmethrin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, cyhexatin, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin, tridemorph, triadimefon and triadimenol.(3) Pesticide residues may arise in food of animal origin as a result of agricultural practices. It is necessary to take into account relevant data obtained both from authorised pesticide use and from supervised trials and animal feeding studies.(4) The information available has been reviewed. For many pesticide/agricultural product combinations the data is sufficient to allow the calculation of a maximum residue level at which residues of the pesticide concerned may be considered safe for human health. Where this level exceeds the lower limit of analytical determination it is appropriate to fix the maximum residue level at the level calculated. For some combinations the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates that the setting of a maximum residue level above the lower limit of analytical determination may give rise to an unacceptable, acute or chronic exposure of the consumer to the residues. In such cases, it is appropriate to fix maximum residue levels at the lower limit of analytical determination.(5) The lifetime exposure and the acute exposure of consumers to these pesticides via food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the Community procedures and practices taking account of guidelines published by the World Health Organisation(7). For abamectin, maximum residue limits have been established in accordance with Council Regulation (EEC) No 2377/90(8), as last amended by Commission Regulation (EC) No 1752/2002(9) resulting from the use of veterinary medicinal products containing the same substance for the treatment of food-producing animal species (Commission Regulation (EC) No 3425/93(10). These uses and the evaluation of the acceptable daily intake provided by the Committee for Veterinary Medicinal Products on which these maximum residue limits were based were taken into account. It has been concluded that the maximum residue levels proposed in this Directive do not lead to the acceptable daily intakes being exceeded or to acute toxic effects.(6) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC.(7) Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.(8) The Community's trading partners have been consulted about the levels proposed in this Directive through the World Trade Organisation, and their comments on these levels have been considered.(9) The opinions of the Scientific Committee for Plants, and in particular advice and recommendations concerning the protection of consumers of food crops treated with plant protection products, have been taken into account(11).(10) 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 1In Annex II to Directive 76/895/EEC, the entry relating to "bromopropylate" is deleted.Article 2In part A of Annex II to Directive 86/362/EEC the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazole, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol listed in Annex I to the present Directive are added.Article 3Annex II to Directive 86/363/EEC is amended as follows:(a) in part A maximum pesticide residue levels for abamectin, bifenthrin, bitertanol, bromopropylate, cyromazine, flucytrinate, metacrifos, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex II to the present Directive are added;(b) in part B the maximum pesticide residue levels for azocyclotin and cyhexatin, fenpropimorph, clofentezine and myclobutanil, listed in Annex III to the present Directive are added.Article 4Annex II to Directive 90/642/EEC is amended as follows:(a) the maximum pesticide residue levels for abamectin, azocyclotin and cyhexatin, bifenthrin, bitertanol, bromopropylate, clofentezine, cyromazine, fenpropimorph, flucytrinate, hexaconazol, metacrifos, myclobutanil, penconazole, prochloraz, profenofos, resmethrin and bioresmethrin, tridemorph, triadimefon and triadimenol, listed in Annex IV to the present Directive are added;(b) the maximum pesticide residue level for ethion in tea is replaced by 3 mg/kg.Article 51. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 4(b) of the present Directive by 31 December 2002. They shall forthwith inform the Commission thereof.They shall apply these provisions with effect from 1 January 2003.2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with of Articles 1, 2 and 3 and Article 4(a) by 31 May 2003. They shall forthwith inform the Commission thereof.They shall apply these provisions with effect from 1 August 2003.3. When Member States adopt the provisions provided for in paragraphs 1 and 2, 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 6This Directive shall enter into force on the seventh day following that of its publication in the Official Journal of the European Communities.Article 7This Directive is addressed to the Member States.Done at Brussels, 2 October 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 225, 22.8.2002, p. 21.(3) OJ L 221, 7.8.1986, p. 37.(4) OJ L 240, 7.9.2002, p. 45.(5) OJ L 221, 7.8.1986, p. 43.(6) OJ L 350, 14.12.1990, p. 71.(7) 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).(8) OJ L 224, 18.8.1990, p. 1.(9) OJ L 264, 2.10.2002, p. 18.(10) OJ L 312, 15.12.1993, p. 12.(11) SCP/RESI/021; SCP/RESI/024ANNEX I>TABLE>ANNEX II>TABLE>ANNEX III>TABLE>ANNEX IVPESTICIDE RESIDUES AND MRLs (mg/kg)>TABLE>


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32000L0082

Commission Directive 2000/82/EC of 20 December 2000 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)

Official Journal L 003 , 06/01/2001 P. 0018 - 0026

Commission Directive 2000/82/ECof 20 December 2000amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2000/57/EC(2), and in particular Article 5 thereof,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(3), as last amended by Commission Directive 2000/81/EC(4) 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(5), as last amended by Directive 2000/81/EC, 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 products of plant origin, including fruit and vegetables(6), as last amended by Directive 2000/81/EC, and in particular Article 7 thereof,Whereas:(1) For cereals and products of plant origin including fruit and vegetables, residue levels should 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 the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake by consumers. For foodstuffs of animal origin, residue levels should reflect the consumption by animals of cereals and products of plant origin treated with pesticides as well as, where relevant, the direct consequences of the use of veterinary medicines.(2) Maximum residue levels for pesticides should be kept under review and the levels may be changed to take account of new information and data. Maximum residue levels (MRLs) should be 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 with such necessary data.(3) Commission Decisions have been taken not to include active substances in Annex I to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the marke(7), as last amended by Commission Directive 2000/80/CE(8), for azinphos-ethyl (Commission Decision 95/276/EC(9)), propham (Commission Decision 96/586/EC(10)), dinoterb (Commission Decision 98/269/EC(11)), DNOC (Commission Decision 1999/164/EC(12)), pyrazophos (Commission Decision 2000/233/EC(13)), monolinuron (Commission Decision 2000/234/EC(14)), and chlozolinate (Commission Decision 2000/626/EC(15)) and tecnazene (Commission Decision 2000/725/EC(16)). These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community. It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of their uses and to protect the consumer. In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission non-inclusion Decisions allowed a phasing-out period, and it is appropriate that MRLs premised on the notion that use of the substance concerned is not authorised in the Community should not apply until the end of the phasing-out period applying to that substance.(4) Maximum residue levels have been fixed in relation to azinphos-ethyl for some commodities in Annex II to Directive 76/895/EEC, as amended by Commission Directive 82/528/EEC(17), but Member States were permitted to establish higher MRLs. To establish harmonised maximum levels of pesticide residues for azinphos-ethyl in and on fruit and vegetables at Community level it is necessary to include these MRLs instead in Directive 90/642/EEC. Further, they should be amended following the withdrawal of authorisations at Community level.(5) Community maximum residue levels and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are no Codex maximum residue limits set for azinphos-ethyl, dinoterb, DNOC, monolinuron, propham and chlozolinate. There is a limited number of Codex maximum residue limits for pyrazophos and tecnazene and these have been considered in the setting of the maximum residue levels fixed in this Directive. The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data and of acceptable consumer intake assessments(18).(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1In Annex II to Directive 76/895/EEC the entries relating to azinphos-ethyl shall be deleted.Article 2In the table in Part A of Annex II to Directive 86/362/EEC entries in respect of the following pesticide residues shall be added:>TABLE>Article 3Annex II to Directive 86/363/EEC is hereby amended as follows:1. Entries in respect of the following pesticide residues shall be added to the table in part A:>TABLE>2. Entries in respect of the following pesticide residues shall be added to the table in The part B:>TABLE>Article 4In the table in Annex II to Directive 90/642/EEC, the entries for pesticide residues as set out in the Annex to this Directive shall be added.Article 51. This Directive shall enter into force 20 days after publication of this Directive.2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 1 July 2001. They shall immediately inform thereof the Commission.3. They shall apply these measures as from 1 July 2001 for azinphos-ethyl, propham, and dinoterb.4. They shall apply these measures as from 1 July 2002 for DNOC, pyrazophos, and monolinuron.5. They shall apply these measures as from 1 January 2003 for chlozolinate and tecnazene.6. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall adopt the procedure for such reference.Article 6This Directive is addressed to the Member States.Done at Brussels, 20 December 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 244, 29.9.2000, p. 76.(3) OJ L 221, 7.8.1986, p. 37.(4) OJ L 326, 22.12.2000, p. 56.(5) OJ L 221, 7.8.1986, p. 43.(6) OJ L 350, 14.12.1990, p. 71.(7) OJ L 230, 19.8.1991, p. 1.(8) OJ L 309, 9.12.2000, p. 14.(9) OJ L 170, 20.7.1995, p. 22.(10) OJ L 257, 10.10.1996, p. 41.(11) OJ L 117, 21.4.1998, p. 13.(12) OJ L 54, 2.3.1999, p. 21.(13) OJ L 73, 22.3.2000, p. 16.(14) OJ L 73, 22.3.2000, p. 18.(15) OJ L 263, 13.10.2000, p. 32.(16) OJ L 292, 21.11.2000, p. 30.(17) OJ L 234, 9.8.1982, p. 1.(18) Guidance notes on import tolerances - Document 7169/VI/99 rev. 1.ANNEX>TABLE>


title: Commission Directive 2005/83/EC of 23 November 2005 amending, for the purposes of their adaptation to technical progress, Annexes I, VI, VII, VIII, IX and X to Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles   (Text with EEA relevance)

text:
               24.11.2005

               EN

               Official Journal of the European Union

               L 305/32

      COMMISSION DIRECTIVE 2005/83/EC
   of 23 November 2005
   amending, for the purposes of their adaptation to technical progress, Annexes I, VI, VII, VIII, IX and X to Council Directive 72/245/EEC relating to the radio interference (electromagnetic compatibility) of vehicles
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof,
   Having regard to Council Directive 72/245/EEC of 20 June 1972 relating to the radio interference (electromagnetic compatibility) of vehicles (2), and in particular Article 4 thereof,
   Whereas:

               (1)

               Directive 72/245/EEC is one of the separate directives under the type-approval procedure established by Directive 70/156/EEC.

               (2)

               The Electromagnetic Compatibility requirements and test provisions for electrical and electronic equipment have been constantly updated through the standardisation work of the International Special Committee on Radio Interference (CISPR) and the International Organisation for Standardisation (ISO). Therefore Commission Directive 2004/104/EC (3), which amended Directive 72/245/EEC, introduced references to the test procedures outlined in the recent editions of the relevant standards.

               (3)

               Since the entry into force of Directive 2004/104/EC, several standards have been replaced by more recent versions adapting them to technical progress. It is therefore necessary to update the references to those standards in Directive 72/245/EEC.

               (4)

               In addition, some editorial corrections need to be introduced.

               (5)

               Directive 72/245/EEC should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I, VI, VII, VIII, IX and X to Directive 72/245/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 30 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 1 October 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 texts of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 23 November 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 42, 23.2.1970, p. 1. Directive as last amended by Commission Directive 2005/49/EC (OJ L 194, 26.7.2005, p. 12).

      (2)  OJ L 152, 6.7.1972, p. 15. Directive as last amended by Directive 2005/49/EC.

      (3)  OJ L 337, 13.11.2004, p. 13.

      ANNEX
      Directive 72/245/EEC is amended as follows:

                  1.

                  Annex I is amended as follows:

                              (a)

                              In point 2.1.12 (a), the words ‘by degradation or change in engine, gear, brake, suspension, active steering, speed limitation devices, for example’ are replaced by the words ‘by degradation or change in: e.g. engine, gear, brake, suspension, active steering, speed limitation devices’.

                              (b)

                              In point 6.8.1, the words ‘ISO 7637-2:DIS2002’ are replaced by the words ‘ISO 7637-2: 2nd edition 2004’.

                              (c)

                              In point 6.9.1, the words ‘ISO 7637-2: DIS2002’ are replaced by the words ‘ISO 7637-2: 2nd edition 2004’.

                              (d)

                              Point 7. of Appendix 1 is replaced by the following:

                                          ‘7.

                                          ISO 11451 ‘Road vehicles — Electrical disturbances by narrowband radiated electromagnetic energy — Vehicle test methods’

                                                      Part 1:

                                                      General and definitions

                                                      (ISO 11451-1: 3rd edition 2005)

                                                      Part 2:

                                                      Off vehicle radiation source

                                                      (ISO 11451-2: 3rd edition 2005)

                                                      Part 4:

                                                      Bulk current injection (BCI)

                                                      (ISO 11451-4: 1st edition 1995)’.

                              (e)

                              Point 8 of Appendix 1 is replaced by the following:

                                          ‘8.

                                          ISO 11452 ‘Road vehicles — Electrical disturbances by narrowband radiated electromagnetic energy — Component test methods’

                                                      Part 1:

                                                      General and definitions

                                                      (ISO 11452-1: 3rd edition 2005)

                                                      Part 2:

                                                      Absorber lined chamber

                                                      (ISO 11452-2: 2nd edition 2004)

                                                      Part 3:

                                                      Transverse electromagnetic mode (TEM) cell

                                                      (ISO 11452-3: 2nd edition 2001)

                                                      Part 4:

                                                      Bulk current injection (BCI)

                                                      (ISO 11452-4: 3rd edition 2005)

                                                      Part 5:

                                                      Strip line

                                                      (ISO 11452-5: 2nd edition 2002)’.

                  2.

                  Annex VI is amended as follows:

                              (a)

                              In point 1.2, the words ‘ISO DIS 11451-2: 2003’ are replaced by the words ‘ISO 11451-2: 3rd edition 2005’.

                              (b)

                              In points 3.1, 3.1.1 and 4.1.1, the words ‘ISO DIS 11451-1: 2003’ are replaced by the words ‘ISO 11451-1: 3rd edition 2005’.

                  3.

                  Point 3.1 of Annex VII is replaced by the following:

                              ‘3.1.

                              The test shall be performed according to CISPR 25 (2nd edition 2002) clause 6.4 — ALSE method’.

                  4.

                  Point 3.1 of Annex VIII is replaced by the following:

                              ‘3.1.

                              The test shall be performed according to CISPR 25 (2nd edition 2002) clause 6.4 — ALSE method’.

                  5.

                  Annex IX is amended as follows:

                              (a)

                              Point 1.2.1, is replaced by the following:

                                          ‘1.2.1.

                                          ESAs may comply with the requirements of any combination of the following test methods at the manufacturer's discretion provided that this results in the full frequency range specified in paragraph 3.1 of this Annex being covered.

                                                      —

                                                      Absorber Chamber test: according to ISO 11452-2: 2nd edition 2004

                                                      —

                                                      TEM cell testing: according to ISO 11452-3: 2nd edition 2001

                                                      —

                                                      Bulk current injection testing: according to ISO 11452-4: 3rd edition 2005

                                                      —

                                                      Stripline testing: according to ISO 11452-5: 2nd edition 2002

                                                      —

                                                      800 mm Stripline: according to clause 4.5 of this Annex.

                                                Frequency range and general test conditions shall be based on ISO 11452-1: 3rd edition 2005.’

                              (b)

                              Point 2.1 is replaced by the following:

                                          ‘2.1.

                                          The test conditions shall be according to ISO 11452-1: 3rd edition 2005’.

                              (c)

                              Point 3.1 is replaced by the following:
                              ‘3.1.   Frequency range, dwell times
                              Measurements shall be made in the 20 to 2 000 MHz frequency range with frequency steps according to ISO 11452-1: 3rd edition 2005.
                              The test signal modulation shall be:

                                          —

                                          AM, with 1 kHz modulation and 80 % modulation depth in the 20-800 MHz frequency range,

                                          —

                                          PM, t on 577 μs, period 4 600 μs in the 800-2 000 MHz frequency range,

                                    if not otherwise agreed between technical service and ESA manufacturer.
                              Frequency step size and dwell time shall be chosen according to ISO 11452-1: 3rd edition 2005.’

                              (d)

                              Point 3.2 is replaced by the following:

                                          ‘3.2.

                                          The technical service shall perform the test at the intervals specified in ISO 11452-1: 3rd edition 2005 throughout the frequency range 20 to 2 000 MHz.
                                          Alternatively, if the manufacturer provides measurement to data for the whole frequency band from a test laboratory accredited to the applicable parts of ISO 17025: 1st edition 1999 and recognised by the Approval Authority, the Technical Service may choose a reduced number of spot frequencies in the range, e.g. 27, 45, 65, 90, 120, 150, 190, 230, 280, 380, 450, 600, 750, 900, 1 300, and 1 800 MHz to confirm that the ESA meets the requirements of this Annex’.

                              (e)

                              Point 4.1.2 is replaced by the following:
                              ‘4.1.2.   Test methodology
                              The “substitution method” shall be used to establish the test field conditions according to ISO 11452-2: 2nd edition 2004.
                              The test shall be performed with vertical polarisation’.

                              (f)

                              Point 4.2.2 is replaced by the following:
                              ‘4.2.2.   Test methodology
                              The test shall be performed according to ISO 11452-3: 2nd edition 2001.
                              Depending on the ESA to be tested the technical service shall choose the method of maximum field coupling to the ESA or to the wiring harness inside the TEM-cell.’

                              (g)

                              Point 4.3.2 is replaced by the following:
                              ‘4.3.2.   Test methodology
                              The test shall be performed according to ISO 11452-4: 3rd edition 2005 on a test bench.
                              As an alternative the ESA may be tested while installed in the vehicle according to ISO 11451-4: 1st edition 1995.

                                          —

                                          The injection probe shall be positioned at a distance of 150 mm from the ESA to be tested.

                                          —

                                          The reference method shall be used to calculate injected currents from forward power.

                                          —

                                          The frequency range of the method is limited by the injection probe specification.’

                  6.

                  In points 2 and 3 of Annex X, ‘ISO 7637-2: 2002’ is replaced by ‘ISO 7637-2: 2004’.


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32000L0057

Commission Directive 2000/57/EC of 22 September 2000 amending the Annexes to Council Directives 76/895/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)

Official Journal L 244 , 29/09/2000 P. 0076 - 0077

Commission Directive 2000/57/ECof 22 September 2000amending the Annexes to Council Directives 76/895/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables and certain products of plant origin, including fruit and vegetables respectively(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 76/895/EEC of 23 November 1976 on the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2000/24/EC(2), and in particular Article 5 thereof,Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in certain products of plant origin, including fruit and vegetables(3), as last amended by Directive 2000/42/EC(4),Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market(5), as last amended by Commission Directive 2000/10/EC(6), and in particular Article 7 thereof,Whereas:(1) In accordance with the provisions of Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations are required 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) For products of plant origin, including fruit and vegetables, maximum residue levels generally 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 view of the protection of the environment and in terms of estimated dietary intake.(3) Maximum residue levels 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 with such necessary data.(4) Maximum residue levels for pesticides should be kept under review. The levels may be changed to take account of new uses, new information and data and, in particular, should be urgently reconsidered with a view to reduction if concerns about dietary exposure of consumers, based on new or reviewed information, are brought to the attention of the Commission, in particular in implementation of Article 4 of Directive 76/895 and Article 8 of Directive 90/642/EEC.(5) Information on new or changed uses of the pesticides covered by this Directive have been notified to the Commission. The information supporting these uses has been evaluated and it is appropriate to modify the existing maximum residue limits in the Annexes of the Directives.(6) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides, has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organistion(7) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of the acceptable daily intakes.(7) Where appropriate, the acute exposure of consumers to these pesticides 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 European Community, taking account of recommendations published by the World Health Organisation, and no acute intake concerns have been identified.(8) Article 4 of Commission Directive 98/82/EC(8), on the setting of maximum residue levels, fixed temporary maximum residue levels for vinclozolin for some commodities in advance of the adoption for all agricultural products of reviewed maximum residue levels on the basis of the evaluation works under the provisions of Article 8(2) of Directive 91/414/EEC. This evaluation is not yet complete. It is nonetheless appropriate to reduce the exposure of consumers to residues of vinclozolin by reducing the maximum residue levels of vinclozolin for certain commodities. It is also appropriate that these revised levels be fixed on a temporary basis pending the completion of the said evaluation work.(9) All of the pesticides for which maximum residue limits are being fixed by this Directive need to be evaluated in the framework of Directive 91/414/EEC. The maximum residue limits fixed by this Directive for each pesticide will need to be reviewed case by case on the basis of eventual Commission decisions following the evaluation work carried out under Article 8(2) of Directive 91/414/EEC.(10) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.(11) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.(12) This Directive is in accordance with the opinion of the Standing Committee on Plant Health;HAS ADOPTED THIS DIRECTIVE:Article 1In Annex II of Directive 76/895/EEC the entry of "3" for folpet in wine grapes is replaced by "10".Article 2Annex II of Directive 90/642/EEC is modified as follows:1. the entry of "1" for maleic hydrazide in carrots and in parsnips is replaced by "30";2. the entry of "0,1" for glyphosate in cottonseed is replaced by "10";3. the entries of "0,05" for the dithiocarbamates maneb, mancozeb, metiram, propineb and zineb in olives are replaced by "5";4. a new entry is made for the pesticide residue diphenylamine with the following maximum residue limits:>TABLE>5. The entries for vinclozolin of "3" and "2" for tomatoes and peaches are replaced by "0,05*" and "0,05*" respectively. These revised values are fixed on a temporary basis.Article 3This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.They shall apply these provisions as of 1 April 2001.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 4This Directive is addressed to the Member States.Done at Brussels, 22 September 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 340, 9.12.1976, p. 26.(2) OJ L 107, 4.5.2000, p. 28.(3) OJ L 350, 14.12.1990, p. 71.(4) OJ L 158, 30.6.2000, p. 51.(5) OJ L 230, 19.8.1991, p. 1.(6) OJ L 57, 2.3.2000, p. 28.(7) "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).(8) OJ L 290, 29.10.1998, p. 25.


Avis juridique important

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31981L0036

Council Directive 81/36/EEC of 9 February 1981 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables

Official Journal L 046 , 19/02/1981 P. 0033 - 0034 Finnish special edition: Chapter 3 Volume 13 P. 0012  Spanish special edition: Chapter 03 Volume 21 P. 0038  Swedish special edition: Chapter 3 Volume 13 P. 0012  Portuguese special edition Chapter 03 Volume 21 P. 0038

COUNCIL DIRECTIVE of 9 February 1981 amending Annex II to Directive 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (81/36/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), as last amended by Directive 80/428/EEC (2) and in particular Articles 4 and 8 thereof,  Having regard to the proposal from the Commission,  Whereas Article 4 of Directive 76/895/EEC provides that where a Member State considers that a maximum level fixed in Annex II might endanger the health of humans or of animals other than harmful organisms, that Member State may temporarily reduce that level in its own territory;  Whereas the Kingdom of the Netherlands has invoked the provisions of the aforesaid Article in respect of the maximum levels fixed for dimethoate, omethoate and fenchlorphos;  Whereas fenchlorphos was the subject of the amendments provided for in Directive 80/428/EEC ; whereas the Commission has now completed its further studies on the other two pesticides;  Whereas, on the basis of new scientific data, the maximum level laid down for omethoate in Annex II must be amended;  Whereas it is also desirable to separate completely the maximum levels fixed for dimethoate and omethoate and to make a consequential adjustment to the maximum level laid down for dimethoate;  Whereas, in the absence of a favourable opinion of the Standing Committee on Plant Health, the Commission has not been able, in accordance with the procedure provided for in Article 8 of Directive 76/895/EEC, to adopt the measures it envisaged,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Annex II to Directive 76/895/EEC shall be amended as follows:   (1) OJ No L 340, 9.12.1976, p. 26.  (2) OJ No L 102, 19.4.1980, p. 26.     1. The provisions concerning dimethoate and omethoate shall be replaced by the following: >PIC FILE= "T0020163">        2. Footnote (3) shall be deleted.         Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1982. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 9 February 1981.  For the Council  The President  G. BRAKS