L.S. 437.59 Regoli dwar Sustanzi mhux Mixtieqa fl-Ikel ta’ l-Annimali

(1)The title of these rules is the Undesirable Substances in Animal Feeds Rules. Title and scope.

(2)The scope of these rules is to transpose and implement Directive 2008/76/EC of the European Commission which amends the First Schedule to Directive 2002/32/EC of the European Parliament and Council regarding undesirable substances in animal feeds, and to prohibit the use of such substances in products intended for animal feeds, when the levels of such substances exceed the maximum levels set in the Schedule I. 2.

(1)Unless otherwise stated in these rules, the definitions prescribed in the Act shall apply. Interpretation.

(2)For the purpose of these rules and unless the context otherwise requires: "the Act" means the Veterinary Services Act; "additives" shall have the same meaning 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 and also animals living freely in the wild in cases where they are fed with feeding stuffs; "authorised provider" means a person authorised by the authority to import and, or wholesale or retail substances or products for animal feed according to the establishment of these rules; "background level" means a standard level taken into consideration to minimise or eliminate the sources of undesirable substances according to such level, as long as the maximum levels of such substances are exceeded and, or where added levels of the same substance are found in products intended for animal feed; "the Commission" means the Commission of the European Union; "the competent authority" m eans the Veterinary Services Authority as established by the Act; "complementary feeding stuffs" means mixtures of feeding stuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily portion only if used in combination with other feeding stuffs; "complete feeding stuffs" means mixtures of feeding stuffs which, by reason of their composition, are sufficient for a daily portion; Cap. 437. 1 2 [ S.L.437.59 UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS "compound feeding stuffs" means mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feeding stuffs; "the Council" means the Council of the European Union; "daily portion" means the average total quantity of feeding stuffs, 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; "feeding stuffs" means products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from t he ind ustrial pro cessing ther eo f, and organi c 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 feeding stuffs or as substrates for premixtures; "final consumer" means a person who buys particular nutritive products produced by animals for own personal use; "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 feeding stuffs; "products intended for animal feed" means feed materials, premixtures, additives, feeding stuffs 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. Applicability. 3.

(1)These rules shall apply without prejudice to the provisions in: (

1. a)Order 70/524 concerning additives in feeding stuffs; (
2. b)Order 96/25 and Order 79/373 on the marketing of compound feeding stuffs; (
3. c)Orders relating to the fixing of maximum levels for pesticide residues, where these residues are not listed in Schedule I; (
4. d)veterinary legislation relating to public health and UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS [ S.L.437.59 animal health; (
5. e)Order 82/471 concerning certain products used in animal nutrition; (
6. f)Order 93/74 on feeding stuffs intended for particular nutritional purposes.

(2)The competent authority shall establish and apply all such administrative measures required in terms of these rules in order to ensure that there is no breach of these rules and also to reduce the risk to final consumers and all other additional risk to animals and to the environment according to the establishment of the provisions mentioned in Schedule I. The measures established in these rules shall be in conformity with and according to the requirements of the Food Chain and Animal Health.

(3)These measures shall include the direct confiscation of the product, the suspension of activities carried out by the service provider when these are creating a risk to final consumers and to the environment and also the application of administrative fines. 4.

(1)Products intended for animal feed may enter for use in Malta from third countries, be put into circulation and, or used in Malta only if they are sound, genuine and of negotiable quality. When correctly used these products do not represent any danger to human health or animal health or to the environment and could not adversely affect livestock production. Putting into circulation of animal feed products.

(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. 5.

(1)Undesirable substances listed in Schedule I may be tolerated in products intended for animal feed only if they are subject to the conditions laid down therein.

(2)The competent authority shall, in co-operation with economic operators, 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, in order to reduce or eliminate sources of undesirable substances in products intended for animal feed. Maximum levels may be established so that cases of added levels are treated uniformally and if such m a x i m u m l ev e l s ar e e x c ee d e d s u ch i n v e s t i g a t i o n co u l d b e necessary. These may be laid down in Schedule II.

(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 such level or to eliminate the undesirable substances. This information shall be transmitted in the form of an annual report to be transmitted to the Commission and t o t h e r e l e v an t i n t e r n a t i on a l o rg a n i sa t i o n ac c o r d i n g t o t h e provisions of Article 22 of Directive 95/53/EC except in those cases where the information is of immediate relevance for the other Tolerance for undesirable substances. 3 4 [ S.L.437.59 UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Member States. In this latter case, the information shall be transmitted immediately. Products which shall not be mixed.

1. Products intended for animal feed containing levels of undesirable substances that exceed the maximum level fixed in Schedule I shall not be mixed for dilution purposes with the same, or other products intended for animal feed. Levels of undesirable substances for complimentary feeding stuffs.
2. In so far as there are no special provisions for complementary feeding stuffs, taking into account the portion prescribed for their use in a daily portion, such shall not contain levels of undesirable substances listed in Schedule I that exceed those fixed for complete feeding stuffs. New information. 8.

(1)The competent authority may, on grounds based on new information or a reassessment of existing information made after the relevant provisions were adopted, provisionally reduce the existing maximum level and fix a maximum level or prohibit the presence of such undesirable substance in products intended for animal feed, when such information indicates that a maximum level laid down in Schedule I, or an undesirable substance not listed therein, may present a danger to animal or human health or to the environment.

(2)In such case, the competent authority shall immediately inform the other Member States, the Commission and the relevant international organisation, and it shall state the grounds for its decision.

(3)Insofar as neither the Council nor the Commission or the relevant international organisation has taken a decision, the competent authority may maintain the measures it has implemented. The competent authority shall ensure that the decision taken is made public. Adaptation of Schedules. 9.

(1)Schedules I and II shall be adapted in terms of scientific developments and technical knowledge according to the decisions adopted by the relevant international organisation.

(2)The competent authority in accordance with the procedure laid down in article 24 of the Act: (a) shall periodically adopt consolidated versions of Schedules I and II inserting any adaptations made pursuant to sub-rule

(1); (b) may define acceptable criteria for detoxification processes which shall complement the criteria provided for products intended for animal feed which have undergone such processes.

(3)The competent authority shall take all such appropriate measures which guarantee the correct application of any acceptable processes pursuant to sub-rule

(2)and also the conformity of the detoxified products intended for animal feed with the provisions of the Schedule I. UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS [ S.L.437.59

1. 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 in Directive 95/53/EC. Animal feed products not subject to restrictions.
2. Provisions that may have an effect on public health or an im al h e al th o r o n th e e nv i r on m e nt m ay be ad op t ed af t er consultation with the relevant international organisation. Provisions that may be adopted. 5 [ S.L.437.59 6 Substituted by: L.N. 358 of
3. UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS SCHEDULE I (Regulations 1

(2), 3

(2), 4

(2), 5

(1), 6, 7, 8

(1)and 9) Undesirable substances 1. Arsenic (*)(**) (*) Products intended for animal feed 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 - pulp kernel expeller, - phosphates and calcerous marine algae - calcium carbonate, - magnesium oxide, - feeding stuffs obtained from the processing of fish or other marine animals, including fish, - seaweed meal and feed materials derived from seaweed, Iron particles used as tracer. Additives belonging to the functional group of compounds of trace - copper sulphate pentahydrate and copper carbonate, - zinc, oxide, manganese oxide and copper oxide, Complete feedingstuffs with the exception of: - complete feedingstuffs for fish and complete feedingstuffs for fur animals, Complementary feedingstuffs with the exception of: - mineral feedingstuffs, Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 2 4 4 (***) 10 15 20 25 (***) 40 (***) 50 30 50 100 2 10 (***) 4 12 The maximum levels refer to total arsenic. (**) Maximum levels refer to an analytical determination of arsenic, whereby extraction is performed in nitric acid (5% w/

1. w)for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has equal extraction efficiency. (***) Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of inorganic arsenic is lower than 2ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme. UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Undesirable substances 2. Lead 3. Fluorine (*) [ S.L.437.59 Products intended for animal feed Feed materials with the exception of: - green fodder - phosphates - yeasts Complete feeding stuffs C o m p l e m e n t a r y f e e d i n g s t u ff s w i t h t h e exception of: mineral feeding stuffs Feed materials with the exception of: - feeding stuffs of animal origin with the exception of marine crustaceans such as marine krill - marine crustaceans such as marine krill - phosphates - calcium carbonate - magnesium oxide - calcareaous marine algae Vermiculite (E 561) Complementary feeding stuffs - containing 4% or less phosphorus - containing more than 4% phosphorus Complete feeding stuffs with the exception of: - complete feeding stuffs for cattle, sheep and goats - in lactation - other - complete feeding stuffs for pigs - complete feeding stuffs for poultry - complete feedingstuffs for chicks - complete feedingstuffs for fish 7 Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 10 40 30 5 5 10 30 150 500 3 000 2 000 350 600 1 000 3 000 (**) 500 125 per 1% phosphorus 150 30 50 100 350 250 350 (*) Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency. (**) The levels shall be reviewed by 31st December 2008 with the aim of reducing the maximum levels. [ S.L.437.59 8 Undesirable substances 4. Mercury (*) (**) (*) UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Products intended for animal feed Feed materials with the exception of: - feeding stuffs produced from fish or by the processing of fish or other aquatic animals, - calcium carbonate. Compound (complementary and complete) feeding stuffs with the exception of: - mineral feed, - compound feedingstuffs for fish - compound feedingstuffs for dogs, cats and fur animals. Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 0,1 0,5 0,3 0,1 0,2 0,2 0,3 The maximum levels refer to total mercury. (**) Maximum levels refer to an analytical determination of mercury, whereby extraction is performed in nitric acid (5% w/
2. w)for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has equal extraction efficiency. 5. Nitrites Feed materials with the exception of: - fishmeal, - silage. Complete feedingstuffs with the exception of: 6. Cadmium - complete feedingstuffs for dogs and cats with a moisture content exceeding 20% Feed materials of vegetable origin Feed materials of animal origin except: feeding stuffs for pets Phosphates Complete feeding stuffs for cattle, sheep and goats except: - complete feeding stuffs for calves, lambs and kids Other complete feeding stuffs except: - feeding stuffs for pets Mineral feeding stuffs Oth er co mpl emen tar y fe edi ng stu ff s f or cattle, sheep and goats 15 (expressed as sodium nitrate) 30 (expressed as sodium nitrate) 15 (expressed as sodium nitrate) 1 2 10

(1)1 0.5 5

(2)0.5

(1)Member States may also prescribe a maximum cadmium content of 0.5 per 1% phosphorus.

(2)Member States may also prescribe a maximum cadmium content of 0.75 per 1% phosphorus. UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Undesirable substances

1. Aflatoxin B1
2. Hydrocyanic acid
3. Free gossypol
4. Theobromine [ S.L.437.59 Products intended for animal feed Feed materials with the exception of: - ground nut, copra, palm-kernel, cotton seed, babassu, maize and products derived from the processing thereof Complete feeding stuffs for cattle, sheep and goats with the exception of: - dairy cattle - calves and lambs Complete feeding stuffs for pigs and poultry (except young animals) Other complete feeding stuffs Complementary feeding stuffs for cattle, sh eep and g oat s (ex cep t co mp lemen tar y feeding stuffs for dairy animals, calves and lambs) Complementary feeding stuffs for pigs and poultry (except young animals) Other complementary feeding stuffs Feed materials with the exception of: - linseed - linseed cakes - manioc products and almond cakes Complete feeding stuffs with the exception of: - complete feeding stuffs for chicks Feed materials with the exception of: - cottonseed - cottonseed cakes and cottonseed meal Complete feeding stuffs with the exception of: - complete feeding stuffs for adult cattle, - complete feeding stuffs for sheep (except lambs) and goats (except kids), - complete feeding stuffs for poultry (except laying hens) and calves - complete feeding stuffs for rabbits, lambs, kids and pigs (except piglets). Complete feeding stuffs with the exception of: - complete feedingstuffs for pigs, - complete feedingstuffs for dogs, rabbits, horses and for animals. 9 Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 0,05 0,02 0,05 0,005 0,01 0,02 0,01 0,05 0,03 0,005 50 250 350 100 50 10 20 5 000 1 2000 20 500 300 100 60 300 200 50 10 [ S.L.437.59 Undesirable substances
5. Volatile mustard oil UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Products intended for animal feed Feed materials with the exception of: - rape-seed cakes Complete feeding stuffs with the exception of: - complete feeding stuffs for cattle, sheep and goats (except young animals) - complete feeding stuffs for pigs (except piglets) and poultry
6. Vinyl thiooxazolidone ( Vi n y l o x a z o l i d i n e thione)
7. Rye ergot (Claviceps purpurea)
8. Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including Datura sp.
9. Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivates (****), separately or in combination. Complete feeding stuffs for poultry with the exception of: - complete feedingstuffs for laying hens Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 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 A l l f e e d i n g s t u ff s c o n t a i n i n g u n g r o u n d cereals All feedingstuffs 1 000 3 000 All feedingstuffs 1 000 10 (****) In so far determinable by analytical microscopy.
10. Crotalaria spp.
11. Aldrin Singly or combined expressed as
12. Dieldrin
13. Camphechlor (toxaphene)
14. Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane) All feedingstuffs All feeding stuffs with the exception of: - fats 100 0,01 0,2 All feeding stuffs 0.1 All feeding stuffs with the exception of: - fats 0.02 0.05 UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS [ S.L.437.59 11 Undesirable substances Products intended for animal feed
15. DDT (sum of DDT-, DD D- , ( o r TD E- ) a n d DDEisomers, expressed as DDT)
16. Endosulfan (sum of alpha- and betaisomers and of endosulfansulphate expressed as endosulfan)
17. Endrin (sum of endrin and of deltaketoiendrin, expressed as endrin
18. Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor)
19. Hexachlorobenzene (HCB) All feeding stuffs with the exception of: - fats and oils Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% 0.05 0.5 All feeding stuffs with the exception of: - maize - oilseeds - complete feeding stuffs for fish 0.1 0.2 0.5 0.005 All feeding stuffs with the exception of: - fats 0.01 0.05 All feeding stuffs with the exception of: - fats 0.01 0.2 All feeding stuffs with the exception of: - fats All feeding stuffs with the exception of: 0.01 0.2 0.02 - fats Compound feeding stuffs with the exception of: - feeding stuffs for dairy cattle Feed materials with the exception of: - fats All feeding stuffs with the exception of: - fats Citrus pulp 0.2 0.01
20. Hexachlorocyclohexane (HCH) 26.1 alpha-isomer 26.2 beta-isomers 26.
21. gamma-isomers
22. Dioxin (sum of PCDD and PCDF) expressed in international toxic equivalent 0.005 0.01 0.1 0.2 2.0 500pg I-TEQ/ kg (upper bound detection limit)

(3)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. 12 [ S.L.437.59 Undesirable substances

1. Unhusked beech mast - Fagus silvatica L.
2. Purghera - Jatropha curcas L.
3. Indian mustard Brassica juncea (L.) Czern. and Coss. ssp. i n t e g r i f o l i a ( We s t . ) Thell.
4. Sareptian mustard Brassica juncea (L.) Czern. and Coss. ssp. juncea
5. Chinese mustard Brassica juncea (L.) Czern. and Coss. ssp. j u n c e a v a r. l u t e a Batalin
6. Black mustard Brassica nigra (L.) Koch
7. Ethiopian mustard Brassica carin ata A. Braun UNDESIRABLE SUBSTANCES IN ANIMAL FEEDS Products intended for animal feed All feedingstuffs Maximum content in mg/ kg (ppm) relative to a feedingstuff with a moisture content of 12% Seeds and fruit of the plant species listed opposite as well as their processed derivatives may only be present in feeding stuffs in trace amounts not q u a n t i ta t i v e l y determinable SCHEDULE II Undesirable substances Products intended Action threshold Comments and additional for animal feed relative to a information (e.g. the feedingstuff with nature of the investigation a moisture to be performed) content of 12%