Undesirable Substances in Animal Feeds Rules, 2005 (L.N. 81 of 2005)

L.N. 81 of 2005 VETERINARY SERVICES ACT (CAP. 437) Undesirable Substances in Animal Feeds Rules, 2005 IN exercise of the powers conferred by article 10 of the Veterinary Services Act, the Minister for Rural Affairs and the Environment has, after consultation with the Minister of Health, the Elderly and Community Care, made the following rules : B 987 1. ( 1) The title of these rules is the Undesirable Substances in Title, scope and Animal Feeds Rules, 2005. applicability. (2) These rules deal with undesirable substances in products intended for animal feed. (3) The scope of these rules is to implement the provisions found under Directive 2002/32 EC of the European Parliament and of the Council of the 7th May 2002 on undesirable substances in animal feeds. ( 4) These rules shall apply without prejudice to the prov1s1ons m: (a) Order (70/524) concerning additives in feedingstuffs; (b) Order (96/25)and Order (79/373) on the marketing of compound feedingstuffs; ( c) Orders relating to the fixing of maximum levels for pesticide residues, where these residues are not listed in Schedule I to this Order; (d) Veterinary legislation relating to public health and animal health; ( e) Order (82/ 4 71) concerning certain products used in animal nutrition; (f) Order (93/74)on feedingstuffs intended for particular nutritional purposes. B 988 Interpretation. 2. For the purposes of these rules: "additives" means additives as defined in Article 2(a) of Council Directive/Order (70/524)/EEC; "animals" 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 feedingstuffs; "the competent authority" means the competent authority as mentioned in Article 2 (f) of Order (95/53) fixing the principles governing the organisation of official inspections in the field of animal nutrition; "the Commission" means the Commission of the European Union; "complementary feedingstuffs" means mixtures of feedingstuff s 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; "complete feedingstuffs" means mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration; "compound feedingstuffs" means mixtures offeed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs; "the Council" means the Council of the European Union; "daily ration" means the average total quantity of feedingstuffs, 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; "feedingstuffs" means products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding; "feed materials" means various products of vegetable or animal origin, in their natural state, fresh or preserved, 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 feeding either directly as such or, after processing, in the preparation of compound feedingstuffs or as substrates for premixtures; "Member State" means a member state of the European Union; "premixtures" means mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs; "products intended for animal feed" means feed materials, pre mixtures, additives, feedingstuff s and all other products intended for use or used in animal feed; "putting into circulation" or "circulation" means the holding of products intended for animal feed for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale or other forms of transfer themselves; "undesirable substance" means any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. B 989 3. (1) Products intended for animal feed may enter for use in Animal feed Malta from third countries, be put into circulation and, or used in Malta prnducts. only if they are sound, genuine and of merchantable quality. When correctly used such products do not represent any danger to human health, animal health or to the environment or could adversely affect livestock production. (2) In particular, products intended for animal feed shall be deemed not to be in conformity with sub-rule (1) if the level of undesirable substances they contain does not comply with the maximum levels laid down in Schedule I. 4. (1) Undesirable substances listed in Schedule I may be Toleranceof undesirable tolerated in products intended for animal feed only subject to the substances. conditions laid down therein. (2) In order to reduce or eliminate sources of undesirable substances of products intended for animal feed, the competent authority, B 990 Products not to be mixed. Complementary feedingstuffs. New information. in co-operation with economic operators, shall carry out investigations to identify the sources of undesirable substances, in cases where the maximum levels are exceeded and in cases where increased levels of such substances are detected, taking into account background levels. For a uniform approach in cases of increased levels it may be necessary to set action thresholds to trigger such investigations. These may be laid down in Schedule IL (3) The competent authority shall transmit to the Commission and to the relevant international organisation and to the other Member States all relevant information and findings of the source and the measures taken to reduce the level or elimination of the undesirable substances. This information shall be transmitted in the frame of the annual report to be transmitted to the Commission and to the relevant international organisation according to the provisions of Article 22 of Directive (95/53)/EC except in those cases where the information is of immediate relevance for the other Member States. In this latter case, the information shall be transmitted immediately. 5. Products intended for animal feed containing levels of an undesirable substance that exceed the maximum level fixed in Schedule I may not be mixed for dilution purposes with the same, or other, products intended for animal feed. 6. In so far as there are no special provisions for complementary feedingstuffs, complementary feedingstuffs may not, taking into account the proportion prescribed for their use in a daily ration, contain levels of the undesirable substances listed in Schedule I that exceed those fixed for complete feedingstuffs. 7. (1) Where the competent authority has grounds, based on new information or a reassessment of existing information made since the provisions in question were adopted, demonstrating that a maximum level fixed in Schedule I, or an undesirable substance not listed therein, present a danger to animal or human health or to the environment, it may provisionally reduce the existing maximum level, fix a maximum level or prohibit the presence of that undesirable substance in products intended for animal feed. It shall immediately inform the other Member States and the Commission and to the relevant international organisation thereof, stating the grounds for its decision. (2) An immediate decision shall be taken, whether to amend Schedules I and IL (3) Insofar as neither the Council nor the Commission and the relevant international organisation has taken a decision, the competent authority may maintain the measures it has implemented. The competent authority must ensure that the decision taken is made public. B 991 8. (1) In consideration of developments in scientific and Adaptation of technical knowledge, Schedules I and II shall be adapted in agreement Schedules. with decisions adopted by the relevant international organisation. (2) Furthermore, in accordance with the procedure laid down in Article 24, the competent authority: (a) shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to sub-rule (l); (b) may define acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes may be defined. (3) Measures shall be taken to guarantee the correct application of any acceptable processes pursuant to sub-rule (2) and the conformity of the detoxified products intended for animal feed with the provisions of Schedule I. 9. Products intended for animal feed which comply with these rules shall not be subject to any other restrictions on circulation as regards the presence of undesirable substances other than those provided for in these rules and Directive (95/53)/EC. 10. Provisions that may have an effect upon public or animal health or on the environment shall be adopted after consultation with the relevant international organisation. No other restrictions applicable. Provisions that may be adopted. B 992 Undesirable substances (1) 1. Arsenic 2. Lead SCHEDULE I Maximum content in mg/kg Products intended for animal (ppm) relative to a feedingstuff feed with a moisture content of 12 % (2) (3) Feed materials with the 2 exception of: meal made from grass, from 4 dried luceme and from dried clover, and dried sugar beet pulp and dried molasses sugar 10 beet pulp phosphates and feedingstuffs obtained from the processing 2 of fish or other marine animals Complete feedingstuffs with 4 the exception of: 4 complete feedingstuffs for fish 12 Complementary feedingstuffs with the exception of: mineral feedingstuff s Feed materials with the 10 exception of: 40 green fodder 3 0 phosphates 5 yeasts 5 Complete feedingstuffs 10 Complementary feedingstuffs with the exception of: 30 mineral feedingstuff s 3. Fluorine 4. Mercury 5. Nitrites Feed materials with the 150 exception of: 500 feedingstuff s of animal origin 2 000 phosphates 150 Complete feedingstuffs with the exception of: complete feedingstuffs for cattle, sheep and goats 30 in milk 50 other complete pigs complete poultry complete chicks 100 feedingstuffs for 350 250 feedingstuff s for 2 000 ( 1) feedingstuffs for 125 (2) Mineral mixtures for cattle, sheep and goats Other complementary feedingstuff s Feed materials with the 0, 1 exception of: 0,5 feedingstuff s produced by the processmg of fish or other marine animals 0, 1 Complete feedingstuffs with the exception of: 0,4 complete feedingstuffs for dogs and cats 0,2 Complementary feedingstuffs except: complementary feedingstuffs for dogs and cats Fish meal 60 B 993 Complete feedingstuffs ( expressed as sodium nitrite) excluding: 15 feedingstuffs intended for ( expressed as sodiumnitrite) pets except birds and aquarium fish B 994 6. Cadmium 7. Aflatoxin B1 Feed materials of vegetable 1 ongm Feed materials of animal origin except: feedingstuff s for pets Phosphates Complete feedingstuffs for cattle, sheep and goats except: 2 10 (3) complete feedingstuffs for 1 calves, lambs and kids 0,5 Other complete feedingstuffs except: feedingstuff s for pets Mineral feedingstuff s Other complementary feedingstuffs for cattle, sheep and goats 5 (4) 0,5 Feed materials with the 0,05 exception of: 0,02 groundnut, copra, palm kemel, 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 0,05 0,005 0,01 0,02 pigs and poultry (except young 0,01 animals) 0,05 Other complete feedingstuffs Complementary feedingstuffs for cattle, sheep and goats (except complementary 0,03 feedingstuffs for dairy animals, calves and lambs) Complementary feedingstuffs 0,005 for pigs and poultry ( except young animals) Other complementary feedingstuff s 8. Hydrocyanic acid 9. Free gossypol 10. Theobromine 11. Volatile mustard oil 12. Vinyl thiooxazolidone (Vinyloxazolidine thione) 13. Rye ergot (Claviceps purpurea) Feed materials with the 50 exception of: linseed 250 linseed cakes 350 manioc products and almond 100 cakes 50 Complete feedingstuffs with 10 the exception of: complete feedingstuffs for chicks Feed materials with the 20 exception of: 1 200 cotton-seed cakes Complete feedingstuffs with the exception of: complete feedingstuffs for cattle, sheep and goats 20 500 100 complete feedingstuffs for poultry (except laying hens) 60 and calves complete feedingstuffs for rabbits and pigs ( except piglets) Complete feedingstuffs with 300 the exception of: complete feedingstuffs for 700 adult cattle B 995 Feed materials with the 100 exception of: 4 000 ( expressed as isothiocyanate) - rape-seed 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 150 ( expressed allylisothiocyanate) 1 000( expressed as isothiocyanate) 500 ( expressed allylisothiocyanate) Complete feedingstuffs for 1 000 poultry with the exception of: complete feedingstuffs for 500 laying hens All feedingstuff s containing 1 000 unground cereals allyl as allyl as B 996 14. Weed seeds and unground All feedingstuff s 3 000 and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including (a) Lolium temulentum L., 1 000 (b) Loli um remotum Schrank 1 000 (c) Datura stramonium L. 1 000 15. Castor oil plant - Ricinus All feedingstuff s 10 (expressed m terms of communis L. castor-oil plant husks) 16. Crotalaria spp. All feedingstuff s 100 17. Aldrin} s· 1 h. d } All feedingstuff s with the r mg y or com me expressed as dieldrin xcept10n 18. Dieldri of: ,2 fats 19. Camphechlor (toxaphene) All feedingstuff s 0,1 20. Chlordane (sum of cis- and All feedingstuff s with the 0,02 trans-isomers and of exception of: oxychlordane, expressed as - fats 0,05 chlordane) 21. DDT (sum of DDT-, TDE- All feedingstuff s with the 0,05 and DDEisomers, expressed as exception of: DDT) - fats 0,5 22. Endosulfan (sum of alpha- All feedingstuff s with the 0,1 and betaisomers and of exception of: endosulfansulphate expressed - maize 0,2 as endo-sulfan) - oilseeds 0,5 complete feedingstuff s for 0,005 fish 23. Endrin ( sum of endrin and All feedingstuff s with the 0,01 of delta-ketoiendrin, expressed exception of: as endrin) - fats 0,05 24. Heptachlor (sum of All feedingstuff s with the 0,01 heptachlor and of hepta- exception of: chlorepoxide, expressed as - fats 0,2 heptachlor) 25. Hexachlorobenzene (HCB) All feedingstuff s with the 0,01 exception of: fats 0,2 26. Hexachlorocyclo-hexane (HCH) 26.1. alpha-isomers 20.2. beta-isomers 26.3. gamma-isomers 27. Dioxin (sum of PCDD and PCDF), expressed m international toxic equivalents 28. Apricots - Prunus , armeniaca L. 29. Bitter almond - Prunus dulcis (Mill.) D.A.m Webb var. amara (DC.) Focke (= Prunus amygdalus Batsch var. amara (DC.) Focke) 30. Unhusked beech mast Fagus silvatica L. 31. Camelina - Camelina sativa (L.) Crantz 32. Mowrah, Bassia, Madhuca Madhuca longifolia (L.) Macbr. ( = Bassia longifolia L. = Illipe malabrorum Engl.) Madhuca indica Gmelin (= Bassi a latifolia Roxb.) = Illipe latifolia (Roscb.) F. Mueller) 33. Purghera - Jatropha curcas L. 34. Croton - Croton tiglium L. 3 5. Indian mustard - Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell. 36. Sareptian mustard Brassica juncea (L.) Czern. i and Coss. ssp. juncea 3 7. Chinese mustard - Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin B 997 All feedingstuffs with the 0,02 exception of: fats 0,2 Compound feedingstuffs with 0,01 the exception of: feedingstuffs for dairy cattle Feed materials with the exception of: fats All feedingstuffs with the exception of: fats 0,005 0,01 0,1 0,2 2,0 500 pg I-TEQ/kg Citrus pulp AMENDED 2003/57/EC BY DIR (upper bound detection limit) I All feedingstuff s I : •eeds and fruit of the plant pec1es listed m the first 1 olumn hereof, as well as their rocessed derivatives may only e present in feedingstuff s in ace amounts not quantitavely 1 eterminable B 998 38. Black mustard - Brassica nigra (L.) Koch 39. Ethiopian mustard Brassica carinata A. Braun (1) The competent authority may also prescribe a maximum fluorine content of 1,25 % of the phosphate content. (2) Fluorine content per 1 % phosphorus. (3) The competent authority may also prescribe a maximum cadmium content of 0,5 mg per 1 % phosphorus. (4) Member States Competent authority 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. Undesirable substances B 999 SCHEDULE II Action threshold m mg/kg Comments and addition! Products (ppm) relative to a product information ( e.g. the nature of intended for intended for animal feed with a the investigation to be animal feed moisture content of 12 % performed) Ippubblikat mid-Dipartiment ta' 1-lnformazzjoni (doi.gov.mt) Valletta - Published by the Department of Information - (doi.gov.mt) - Valletta Mitbugh fl-Istamperija tal-Gvem - Printed at the Government Printing Press Prezz 48c - Price 48c