Proposal for a directive of the European Parliament and of the Council on undesirable substances and products in animal nutrition
C 89 E/70 EN Official Journal of the European Communities 28. 3. 2000 Proposal for a Directive of the European Parliament and of the Council on undesirable substances and products in animal nutrition (2000/C 89 E/14) (Text with EEA relevance) COM(1999) 654 final - 1999/0259(COD) (Submitted by the Commission on 17 December 1999) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, content below the levels detectable by methods of analysis to be defined for the Community; Having regard to the Treaty establishing the European Economic Community, and in particular Article 152 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of Committee, the Economic and Social Having regard to the opinion of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty, Whereas: (1) Many amendments need to be made to Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition (1). In the interests of clarity and efficiency the said Directive should be recast; (2) Livestock production occupies a very important place in farming in the Community and satisfactory results depend to a large extent on the use of appropriate good-quality feedingstuffs; (3) Rules on feedingstuffs are needed to increase agricultural productivity; (4) It has been established that additives can be contaminated with undesirable substances and products. The scope of the Directive should therefore be extended to cover additives; (5) Feed materials, feedingstuffs and feed additives may contain undesirable substances or products which can endanger animal health or, because of their presence in livestock products, human health; (6) It is impossible to fully eliminate the presence of the substances and products in question but it is important that their content in feed materials and feed additives should be reduced in order to prevent undesirable and harmful effects. It is at present inappropriate to fix this (1) OJ L 115, 4. 5. 1999, p. 32. (7) Undesirable substances and products may be present in feedingstuffs and feed additives only in feed materials, accordance with the laid down in this conditions Directive and may not be used in any other way for the should purposes of therefore affecting other Community provisions on feedingstuffs, and particularly the rules applicable to compound feedingstuffs; animal apply without feeding. This Directive (8) This Directive must apply to feed materials, feedingstuffs and feed additives as soon as they enter the Community. It should therefore be stipulated that the maximum levels of undesirable substances or products that are set apply in general from the date on which the feed materials, feed- ingstuffs and feed additives are put into circulation, including all stages of marketing, and in particular as soon as they are imported; (9) Feed materials, feedingstuffs and feed additives must be sound, genuine and of merchantable quality. Using or putting into circulation feed materials, feedingstuffs or feed additives containing levels of undesirable substances or products that exceed the maximum levels laid down in Annex I to this Directive should therefore be prohibited; (10) The presence of certain undesirable products limited by fixing appropriate maximum levels; in complementary feedingstuffs substances or should be (11) While in certain cases a maximum level is fixed, taking account of background levels, continued effort is still needed to restrict the presence of some specific unde- sirable substances and products to the lowest possible levels in feed materials, feedingstuffs and feed additives so as to reduce their presence in the feed and food chain. this Directive, to lay down action thresholds well below the maximum levels fixed. Where such action thresholds are investigations must be carried out to identify exceeded, the sources of contamination and steps taken to reduce or eliminate such sources; should therefore be permitted, under It (12) Where animal or human health is endangered, Member States should still be allowed temporarily to reduce the fixed maximum permissible levels, to fix maximum levels for other substances or products or the presence of such substances or products in feedingstuffs. To ensure Member States do not abuse this power, any to prohibit 28. 3. 2000 EN Official Journal of the European Communities C 89 E/71 amendments to the Annex to this Directive should be decided on by emergency Community procedure, on the basis of supporting documents; This Directive shall apply without prejudice to the 2. provisions on: (13) Feed materials, feedingstuffs and feed additives that satisfy the requirements of this Directive should not be subject to restrictions on entry into circulation, as regards the level of undesirable substances and products they contain, other than those provided for in this Directive; (14) Member States should make control arrangements to ensure that the requirements regarding undesirable substances and products are met when feed materials, feedingstuffs and feed additives are circulated; appropriate (15) As part of the control the information system introduced by this Directive within departments, official Member States should also be informed by operators of cases where this Directive is not being complied with. In such cases, Member States are required to take all the necessary steps to ensure that undesirable substances cannot be used in animal nutrition. and products Member States are obliged, where applicable, to ensure that any batches of feed materials, feedingstuffs or feed additives are actually destroyed, if this course of action has been decided by their owner; (16) An appropriate Community procedure is needed for adapting the technical provisions in the Annex to this Directive in the light of developments in scientific and technical knowledge; (17) In order to facilitate implementation of the proposed measures, there should be a procedure for close coop- eration between the Member States and the Commission within the Standing Committee on Feedingstuffs set up by Decision 70/372/EEC (1); (18) Since the measures necessary for the implementation of this Directive are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (2), they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision; (19) This Directive should not affect the Member States’ obli- gation to comply with the deadlines set out in Part B of Annex of Directive III 1999/29/EC, transposition thereto for HAVE ADOPTED THIS DIRECTIVE: Article 1 This Directive deals with undesirable substances and 1. products in animal nutrition. (1) OJ L 170, 3. 8. 1970, p. 1. (2) OJ L 184, 17. 7. 1999, p. 23. (a) additives in feedingstuffs; (b) the putting into circulation of feedingstuffs; (c) the fixing of maximum permitted levels for pesticide residues in and on products intended for animal feeding, where these residues are not listed in Section B of Annex I to this Directive; (d) micro-organisms in feedingstuffs; (e) certain products used in animal nutrition; (f) feedingstuffs for particular nutritional purposes. Article 2 For the purposes of this Directive: (a) áfeedingstuffsí means products of vegetable or animal origin, fresh or preserved, and products and in for oral in their natural state, derived from the organic or mixtures, whether or not containing additives, animal feeding; industrial processing thereof, substances, used singly or inorganic (b) áfeed materialsí means various products of vegetable or in their natural state, fresh or preserved, animal origin, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended for use in oral animal such or, after processing, in the preparation of compound feedingstuffs or as substrates for premixtures; feeding either directly as (c) ácomplete feedingstuffsí means mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration; (d) ácomplementary feedingstuffsí means mixtures of feed- ingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if used in combination with other feedingstuffs; (e) ácompound feedingstuffsí means mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feed- ingstuffs; (f) ádaily rationí means the average total quantity of feed- ingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age class and yield, to satisfy all its needs; (g) áanimalsí means animals belonging to species normally fed and kept or consumed by man as well as animals living freely in the wild in cases where they are fed with feed- ingstuffs; (h) ápet animalsí means animals belonging to species normally fed and kept but not consumed by man, except animals bred for fur production. C 89 E/72 EN Official Journal of the European Communities 28. 3. 2000 (i) áadditivesí means additives as defined in Article 2 of Council Directive 70/524/EEE of 23 November 1970 on additives in feedingstuffs (1). Article 3 Feed materials, feedingstuffs and feed additives may be they are into circulation in the Community only if 1. put sound, genuine and of merchantable quality. In particular, feed materials, 2. feedingstuffs and feed additives shall be deemed not to be sound, genuine and of merchantable quality if the level of undesirable substances or products they contain is so high that they cannot comply with the maximum levels fixed for feed materials, feedingstuffs and feed additives in Annex I hereto. Article 4 1. Member States shall prescribe that the substances and products listed in Annex 1 hereto may be tolerated in feed materials, feedingstuffs and feed additives only subject to the conditions laid down therein. In order to minimise the presence of certain substances 2. and products inevitably found in feed materials, feedingstuffs and feed additives, the Member States shall require investi- gations to be carried out to identify and reduce or eliminate sources of contamination, not only in cases where the maximum levels are exceeded, but also where significant levels of are detected. If necessary, an action threshold may be laid down in Annex I hereto. such inevitable and products substances Article 5 shall prescribe that consignments of Member States feed materials, feedingstuffs or feed additives containing levels of an undesirable exceed the substance or product maximum level fixed in column 3 in Annex I hereto may not be mixed with other consignments of feed materials, feed- ingstuffs or feed additives. that Article 6 Insofar as there are no special provisions for complementary feedingstuffs, Member States shall prescribe that such feed- ingstuffs may not, allowing for the dilutions prescribed for their use, contain levels of the substances and products listed in Annex I hereto that exceed those fixed for complete feed- ingstuffs. Article 7 1. Where a Member State has detailed grounds, based on new information or a reassessment of existing information made since the provisions in question were adopted, demon- strating that a maximum level fixed in Annex I hereto or a (1) OJ L 270, 14. 12. 1970, p. 1. substance or product not listed therein constitutes a danger to animal or human health or the environment, that Member State may provisionally reduce the existing maximum level, that fix a maximum level or prohibit It substance or product shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision. in feedingstuffs or feed materials. the presence of An immediate decision shall be taken, in accordance with 2. the procedure laid down in Article 12, as to whether Annex I should be amended. So long as neither the Council nor the Commission has taken a decision, the Member State may maintain the measures it has implemented. Article 8 The procedure laid down in Article 11 shall be used, in the light of developments in scientific and technical knowledge: (a) to adopt amendments to be made to Annex I; (b) to draw up a consolidated version of Annex I periodically incorporating the successive amendments made under (a); (c) to define criteria for the acceptability of feed materials which have undergone certain decontamination processes. Article 9 Member States shall ensure that feed materials, feedingstuffs and feed additives which comply with this Directive are not subject to any other restrictions on circulation as regards the presence of undesirable substances and products. Article 10 1. Member States shall take all necessary measures to ensure that feedingstuffs, feed materials and feed additives are officially monitored, at least by random sampling, to verify whether the conditions laid down in this Directive are satisfied. 2. Member States shall inform the other Member States and the Commission of the names of the departments appointed to carry out this monitoring. 3. Member States shall prescribe that where operators (importers, producers, etc. ) or persons who, by virtue of their professional activities, are or have been in possession of, or have had direct contact with a consignment of feed materials, feedingstuffs or feed additives, become aware that: - a given consignment of feed materials is unsuitable for any use in animal nutrition either because it is contaminated with an undesirable substance or product listed in Annex I and therefore does not comply with Article 3(1) and consequently constitutes a serious risk for animal or public health, or because it is contaminated with an unde- 28. 3. 2000 EN Official Journal of the European Communities C 89 E/73 listed in Annex I but sirable substance or product not which potentially constitutes a serious risk for animal or public health, - a given consignment of feedingstuffs is unsuitable for any use in animal nutrition either because it is contaminated with an undesirable substance or product listed in Annex I comply with Annex I and and therefore does not consequently constitutes a serious risk for animal or public health, or because it is contaminated with an unde- sirable substance or product not listed in Annex I but which potentially constitutes a serious risk for animal or public health, - a given consignment of additives is unsuitable for any use in animal nutrition either because it is contaminated with an undesirable substance or product listed in Annex I and therefore does not comply with Annex I and consequently constitutes a serious risk for animal or public health, or because it is contaminated with an undesirable substance or product not listed in Annex I but which potentially constitutes a serious risk for animal or public health, such persons or operators shall immediately inform the official authorities, even if is the destruction of planned. the consignment After verifying the information received, Member States shall ensure that the necessary measures are taken to ensure that the contaminated consignment is not used in animal nutrition. Member States shall ensure that the final destination of the including possible destruction, contaminated consignment, cannot have harmful effects on public or animal health or on the environment. 4. If a consignment of feed materials, feedingstuffs or feed additives is likely to be sent to a Member State after it has been judged in another Member State not to comply with this Directive because it contains excessive levels of undesirable substances or products, shall immediately notify and the States information concerning that Commission of consignment. latter Member State the other Member any useful the Article 11 The Commission shall be assisted by the Standing instituted by Article 1 of 1. Committee Council Decision 70/372/EEC of 20 July 1970 (1). for Feedingstuffs, Article 12 The Commission shall be assisted by the Standing instituted by Article 1 of 1. Committee for Feedingstuffs, Council Decision 70/372/EEC. 2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply in compliance with Article 7 paragraph 3 and Article 8 thereof. The period provided for in Article 5(6) of Decision 3. 1999/468/EC shall be fifteen days. Article 13 The Member States shall apply at least the provisions of to third 1. this Directive to feedingstuffs intended for export countries. Paragraph 1 shall not affect the right of Member States to 2. allow consignments of feedingstuffs which do not fulfil the requirements of this Directive to be exported back to an exporting third country. Article 14 Directive 1999/29/EC is hereby 1. repealed, without prejudice to the obligations of the Member States to comply with the deadlines set out in Part B of Annex III thereto for the transposition of the Directives listed in Part A of that Annex. 2. References to Directive 1999/29/EC shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex II. Article 15 Member States shall bring into force and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 30 June 2000. They shall forthwith inform the Commission thereof. The measures adopted shall apply as from 1 July 2000. When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for making such reference shall be adopted by Member States. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive. Article 16 2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 paragraph 3 and Article 8 thereof. The period provided for in Article 5(6) of Decision 3. 1999/468/EC shall be three months. This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities. Article 17 The Directive is addressed to the Member States. (1) OJ L 170, 3. 8. 1970, p. 1. C 89 E/74 EN Official Journal of the European Communities 28. 3. 2000 Substances, products (1) A. Substances (ions or elements) ANNEX I Feedingstuffs (2) 1. Arsenic Feed materials with the exception of: - meal made from grass, from dried lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp - phosphates obtained processing of fish or other marine animals feedingstuffs and from the Complete feedingstuffs with the exception of: - complete feedingstuffs for fish Complementary feedingstuffs with the exception of: - mineral feedingstuffs 2. Lead Lead Feed materials with the exception of: 3. Fluorine - green fodder - phosphates - yeasts Complete feedingstuffs Complementary feedingstuffs with the exception of: - mineral feedingstuffs Feed materials with the exception of: - feedingstuffs of animal origin - phosphates Complete feedingstuffs with the exception of: - complete feedingstuffs for cattle, sheep and goats - in milk - other - complete feedingstuffs for pigs - complete feedingstuffs for poultry - complete feedingstuffs for chicks Mineral mixtures for cattle, sheep and goats Other complementary feedingstuffs 4. Mercury Feed materials with the exception of: - feedingstuffs produced by the processing of fish or other marine animals Complete feedingstuffs with the exception of: - complete feedingstuffs for dogs and cats Complementary feedingstuffs except: - complementary feedingstuffs for dogs and cats Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % (3) 2 4 10 2 4 4 12 10 40 30 5 5 10 30 150 500 2 000 150 30 50 100 350 250 2 000 (1) 125 (2) 0,1 0,5 0,1 0,4 0,2 28. 3. 2000 EN Official Journal of the European Communities C 89 E/75 (1) (2) 5. Nitrites Fish meal Complete feedingstuffs excluding: - feedingstuffs intended for pets except birds and aquarium fish 6. Cadmium Feed materials of vegetable origin Feed materials of animal origin, except: - feedingstuffs for pets Phosphates (3) 60 (expressed as sodium nitrite) 15 (expressed as sodium nitrite) 1 2 10 (3) B. Products 1. Aflaxotin B1 Complete feedingstuffs for cattle sheep and goats except: 1 - complete feedingstuffs for calves, lambs and kids Other complete feedingstuffs except: - feedingstuffs for pets Mineral feedingstuffs Other complementary feedingstuffs for cattle, sheep and goats Feed materials with the exception of: - groundnut, copra, palm-kernel, cotton seed, babassu, maize and products derived from the processing thereof Complete feedingstuffs for cattle, sheep and goats with the exception of: - dairy cattle - calves and lambs Complete feedingstuffs for pigs and poultry (except young animals) Other complete feedingstuffs Complementary feedingstuffs for cattle, sheep and goats (except complementary feedingstuffs for dairy animals, calves and lambs) Complementary feedingstuffs for pigs and poultry (except young animals) Other complementary feedingstuffs 0,5 5 (4) 0,5 0,05 0,02 0,05 0,005 0,01 0,02 0,01 0,05 0,03 0,005 C 89 E/76 EN Official Journal of the European Communities 28. 3. 2000 (1) (2) 2. Hydrocyanic acid Feed materials with the exception of: - linseed - linseed cakes - manioc products and almond cakes Complete feedingstuffs with the exception of: - complete feedingstuffs for chicks 3. Free gossypol Feed materials with the exception of: - cotton-seed cakes Complete feedingstuffs with the exception of: - complete feedingstuffs for cattle, sheep and goats - complete feedingstuffs for poultry (except laying hens) and calves - complete feedingstuffs for rabbits and pigs (except piglets) 4. Theobromine Complete feedingstuffs with the exception of: 5. Volatile mustard oil Feed materials with the exception of: - complete feedingstuffs for adult cattle - rapeseed cakes Complete feedingstuffs with the exception of: - complete feedingstuffs for cattle, sheep and goats (except young animals) - complete feedingstuffs for pigs (except piglets) and poultry 6. Vinyl thiooxazolidone (Vinyloxazolidine thione) Complete feedingstuffs for poultry with the exception of - complete feedingstuffs for laying hens 7. Rye ergot (Claviceps purpurea) All feedingstuffs containing unground cereals 8. Weed seeds and unground and uncrushed fruits toxic containing substances separately or in combination including glucosides or other alkaloids, All feedingstuffs (a) Lolium temulentum L. , (b) Lolium remotum Schrank, (c) Datura stramonium L. (3) 50 250 350 100 50 10 20 1 200 20 500 100 60 300 700 100 4 000 (expressed as allyl isothiocyanate) 150 (expressed as allyl isothiocyanate) 1 000 (expressed as allyl isothiocyanate) 500 (expressed as allyl isothiocyanate) 1 000 500 1 000 3 000 1 000 1 000 1 000 28. 3. 2000 EN Official Journal of the European Communities C 89 E/77 (1) (2) (3) 9. Castor oil plant - Ricinus communis L. All feedingstuffs 10 (expressed in terms of castor-oil plant husks) 10. Crotalaria spp. 11. Aldrin 12. Dieldrin 9 >= >; singly or dieldrin combined expressed as 9 >= >; All feedingstuffs All feedingstuffs with the exception of: - fats 9 >= >; 13. Camphechlor (toxaphene) All feedingstuffs 14. Chlordane (sum of cis- and trans-isomers and of All feedingstuffs with the exception of: oxychlordane, expressed as chlordane) - fats 15. DDT (sum of DDT-, TDE- and DDE-isomers, All feedingstuffs with the exception of: expressed as DDT) - fats 16. Endosulfan (sum of alpha- and beta-isomers and of All feedingstuffs with the exception of: endosulfansulphate expressed as endosulfan) - maize - oilseeds - complete feedingstuffs for fish 17. Endrin (sum of endrin and of delta-ketoi-endrin, All feedingstuffs with the exception of: expressed as endrin) - fats 18. Heptachlor (sum of heptachlor and of heptach- All feedingstuffs with the exception of: lorepoxide, expressed as heptachlor) - fats 19. Hexachlorobenzene (HCB) All feedingstuffs with the exception of: 20. Hexachlorocyclo-hexane (HCH) - fats 20. 1 alpha-isomers All feedingstufs with the exception of: - fats 20. 2 beta-isomers Compound feedingstuffs with the exception of: - feedingstuffs for dairy cattle Feed materials with the exception of: - fats 20. 3 gamma-isomers All feedingstuffs with the exception of: 21. Dioxin (sum of PCDD and PCDF), expressed in inter- Citrus pulp national toxic equivalent - fats 100 0,01 0,2 0,1 0,02 0,05 0,05 0,5 0,1 0,2 0,5 0,005 0,01 0,05 0,01 0,2 0,01 0,2 0,02 0,2 0,01 0,005 0,01 0,1 0,2 2,0 500 pg I-TEQ/kg (upper bound detection limit) (5) C 89 E/78 EN Official Journal of the European Communities 28. 3. 2000 (1) (2) (3) C. Botanical impurities 1. Apricots - Prunus armeniaca L. 2. Bitter almond - Prunus dulcis (Mill. ) D. A. Webb var. amara (DC. ) Focke (= Prunus amygdalus Batsch var. amara (DC. ) Focke) 3. Unhusked beech mast - Fagus silvatica L. 4. Camelina - Camelina sativa (L. ) Crantz 5. Mowrah, Bassia, Madhuca - Madhuca longifolia (L. ) (= Bassia longifolia L. = Illipe malabrorum indica Gmelin (= Bassia latifolia Macbr. Engl. ) Madhuca (Roxb. ) = Illipe latifolia (Roscb. ) F. Mueller) 6. Purghera - Jatropha curcas L. 7. Croton - Croton tiglium L. 8. Indian mustard - Brassica juncea (L. ) Czern. And Coss. ssp. integrifolia (West. ) Thell. 9. Sareptian mustard - Brassica juncea (L. ) Czern. And Coss. ssp. juncea 10. Chinese mustard - Brassica juncea (L. ) Czern. And Coss. ssp. juncea var. lutea Batalin 11. Black mustard - Brassica nigra (L. ) Koch 12. Ethiopian mustard - Brassica carinata A. Braun 9 8 >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>: >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>; All feedingstuffs 9 8 >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>: >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>; Seeds and fruit of the plant species listed opposite as well as their processed derivatives may only be present in feedingstuffs in trace amounts not quanti- tatively deter- minable (1) Member States may also prescribe a maximum fluorine content of 1,25 % of the phosphate content. (2) Fluorine content per 1% phosphorus. (3) Member States may also prescribe a maximum cadmium content of 0,5 mg per 1 % phosphorus. (4) Member States may also prescribe a maximum cadmium content of 0,75 mg per 1% phosphorus. (5) Upper bound concentrations are calculated assuming that all values of the different congeners less than the limit of detection are equal to the limit of detection. 28. 3. 2000 EN Official Journal of the European Communities C 89 E/79 ANNEX II CORRELATION TABLE Directive 1999/29 This Directive Article 1 Article 2(a) Article 2(b) Article 2(c) Article 2(d) Article 2(e) Article 2(f) Article 2(g) Article 2(h) - Article 3 Article 4(1) Article 4(2) - Article 5 Article 6 Article 7 Article 8 Article 9 Article 10 Article 11 Article 12 Article 13 Article 14 Article 15 Article 16 - - Article 17 Article 18 Annex I Annex II Annex III Annex IV Article 1 Article 2(a) Article 2(b) Article 2(c) Article 2(d) Article 2(e) Article 2(f) Article 2(g) Article 2(h) Article 2(i) Article 3 Article 4(1) - Article 4(2) - - Article 5 Article 6 Article 7 Article 8 Article 9 Article 10 Article 11 Article 12 Article 13 - Article 14 Article 15 Article 16 Article 17 Annex I - - Annex II