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Scottish Statutory Instruments

2010 No. 373

Agriculture

The Animal Feed (Scotland) Regulations 2010

Made

27th October 2010

Laid before the Scottish Parliament

29th October 2010

Coming into force

23rd November 2010

The Scottish Ministers make the following Regulations in exercise of the powers conferred by sections 66(1), 68(1), 74A(1), (2) and (4) and 84 of the Agriculture Act 1970 M1 and section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 M2 and all other powers enabling them to do so.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Scottish Ministers that it is expedient for references to the Annexes to the EU instruments mentioned in regulation 2(3) to be construed as references to those Annexes as they may be amended from time to time.

There has been consultation as required by section 84(1) of the Agriculture Act 1970 with such persons or organisations appearing to represent the interests concerned and as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety M3.

Marginal Citations

M11970 c.40. Section 66(1) contains definitions of the expressions “the Ministers”, “prescribed” and “regulations” and was relevantly amended by S.I. 2004/3254 and S.S.I. 2010/354. Section 74A was inserted by paragraph 6 of Schedule 4 to the European Communities Act 1972 (c.68). Section 84 was amended by S.I. 2004/3254. Functions of the Secretary of State, in so far as exercisable within devolved competence, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (c.46). In so far as not so transferred and in so far as relating to animal feeding stuffs, which are not veterinary medicinal products or specified feed additives as defined in the Veterinary Medicines Regulations 2005 (S.I. 2005/2745), relevant functions were transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2006 (S.I. 2006/304).

M21972 c.68. Section 2(2) was amended by paragraph 15(3) of Schedule 8 to the Scotland Act 1998 (c.46), section 27(1) of the Legislative and Regulatory Reform Act 2006 (c.51) and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7). Paragraph 1A of Schedule 2 was inserted by section 28 of the 2006 Act and amended by Part 1 of the Schedule to the 2008 Act. The functions conferred on a Minister of the Crown under section 2(2) of the 1972 Act, in so far as exercisable within devolved competence, were transferred to the Scottish Ministers by section 53 of the 1998 Act. In so far as not so transferred and in so far as relating to animal feeding stuffs, which are not veterinary medicinal products or specified feed additives as defined in the Veterinary Medicines Regulations 2005 (S.I. 2005/2745), relevant functions were transferred to the Scottish Ministers by the Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2006 (S.I. 2006/304).

M3O.J. No. L 31, 1.2.2002, p.1, as last amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468 with regard to the regulatory procedure with scrutiny: Adaptation to the regulatory procedure with scrutiny – Part Four (O.J. No. L 188, 18.7.2009, p.14).

PART 1 SIntroductory and general

Citation, extent and commencementS

1.  These Regulations may be cited as the Animal Feed (Scotland) Regulations 2010, extend to Scotland only and come into force on 23rd November 2010.

Interpretation and scopeS

2.—(1) In these Regulations—

the Act” means the Agriculture Act 1970;

F1...

F2...

[F3“Regulation 1831/2003” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;]

F4...

Regulation 767/2009” means Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC M4;

[F5“Regulation 2020/354” means Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes and repealing Directive 2008/38/EC;]

F6...

[F7feed authority” means Food Standards Scotland].

(2) Any expression used in these Regulations and in Regulation 1831/2003 [F8, Regulation 767/2009 or Regulation 2020/354] has the meaning in these Regulations that it bears in the Regulation concerned.

[F9(3) Any reference to an Annex to F10... [F11Regulation 1831/2003,] [F12Regulation 2020/354] or Regulation 767/2009 is a reference to that Annex as it may be amended from time to time.]

(4) These Regulations do not apply to any feed additive in category (d) or (e) of Article 6(1) of Regulation 1831/2003, with the exception of those in the functional groups listed in paragraph 4(a), (b) and (c) of Annex 1 to that Regulation M5.

Textual Amendments

Marginal Citations

M4O.J. No. L 229, 1.9.2009, p.1. This Regulation was last amended by Commission Regulation (EC) No. 568/2010 (O.J. No. L 163, 30.6.2010, p.30).

M5Categories (d) and (e) of Article 6(1) comprise respectively zootechnical additives, and coccidiostats and histomonostats. Functional groups listed in paragraphs 4(a), (b) and (c) of Annex I comprise digestibility enhancers, gut flora stabilisers and substances incorporated with the intention of favourably affecting the environment.

PART 2 SMarketing and use of feed

Interpretation of this Part and Schedule 1S

3.  In this Part and in Schedule 1 any reference to a numbered Article or Annex is a reference to the Article or Annex so numbered in Regulation 767/2009.

Enforcement of requirements of Regulation 767/2009S

4.[F13(1) [F14A] person who—

(a)contravenes or fails to comply with the provisions of Regulation 767/2009 specified in Schedule 1; or

(b)places on the market or uses any feed that fails to comply with Article 6(1) or 8,

commits an offence.]

(2) Where, pursuant to Article 17(2)(c) (specific mandatory labelling requirements for compound feed), the name of a specific feed material may be replaced by the name of the category to which the feed material belongs, only the categories listed in [F15schedule 3] may be indicated.

[F16Competent authority for the purposes of Regulation 767/2009S

5.  The feed authority is the competent authority for the purposes of Regulation  767/2009]

PART 3 SFeed additives

Interpretation of this PartS

6.  In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 1831/2003.

Enforcement of requirements of Regulation 1831/2003S

7.[F17(1) A person commits an offence if that person contravenes or fails to comply with a provision specified in paragraph (2), as read, in the case of sub-paragraphs (a) and (c), with Article 2 (transitional provision) of Commission Regulation (EU) 2015/327 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards requirements for the placing on the market and conditions of use of additives consisting of preparations.]

(2) The provisions are—

(a)Article 3, paragraphs (1) to (4), (placing on the market, processing and use of feed additives), as read with Article 10 (status of existing products);

(b)Article 12 (post-authorisation monitoring); and

(c)Article 16, paragraphs (1) to (5) (labelling and packaging of additives and premixtures).

PART 4 SUndesirable substances in feed

Interpretation of this PartS

8.  In this Part—

F18(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)undesirable substance” means any substance or product, not being a pathogenic agent, which is present in or on a feed and—

(i)constitutes a potential danger to human or animal health or to the environment; or

(ii)could adversely affect livestock production.

Control of animal feeds containing undesirable substancesS

9.—(1) Any person who—

(a)places on the market any [F19products intended for animal feed that are specified in column 2 of a table in schedule 4]; or

(b)uses any such feed,

is guilty of an offence if it contains any undesirable substance listed in column 1 of that [F20table] in excess of the relevant maximum content specified in column 3.

(2) Any person who places on the market or uses any complementary feed is guilty of an offence if—

(a)having regard to the quantity of it recommended for use in a daily ration, it contains any undesirable substance listed in column 1 of [F21a table in schedule 4] in excess of the maximum content specified for it in column 3 in relation to complete feeds; and

(b)there is no provision relating to any complementary feed in the corresponding entry in column 2 of that [F22table].

(3) Any person who for the purpose of dilution mixes any feed with a feed that is specified in column 2 of [F23a table in schedule 4] and which contains any undesirable substance listed in column 1 of that [F24table] in excess of the maximum content specified for it in column 3 is guilty of an offence.

(4) Any person who places on the market or uses any feed which is not sound and genuine and of merchantable quality is guilty of an offence.

(5) For the purposes of paragraph (4) a feed listed in column 2 of [F25a table in schedule 4] is not sound, genuine and of merchantable quality if it contains any undesirable substance specified in column 1 of that [F26table] in excess of the maximum content specified in relation to it in column 3.

(6) Any person who has, for the purpose of a trade or business, possession or control of any of the feeds specified in paragraph (7) shall, if required by an inspector, procure and produce to the inspector an analysis in order to demonstrate that the content of inorganic arsenic in the feed specified in that paragraph is less than 2 parts per million.

(7) The feeds are—

(a)palm kernel expeller;

(b)feeds obtained from the processing of fish and other marine animals;

(c)seaweed meal and feed materials derived from seaweed; F27...

(d)complete feeds for fish or for fur-producing animals[F28; and

(e)peat; leonardite].

(8) Any person who, without reasonable excuse, fails to comply with a requirement made under paragraph (6) is guilty of an offence.

[F29(9) In order to reduce or eliminate sources of undesirable substances in products intended for animal feed, the feed authority must, in cooperation with feed business 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; for the purpose of ensuring a uniform approach in cases of increased levels, action thresholds to trigger investigations are set out in table in schedule 5.]

Textual Amendments

[F30PART 5SEnforcement of Regulation 2020/354

Interpretation of this PartS

10.  In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 2020/354.

Offence of failing to comply with a specified provision of Regulation 2020/354S

11.  A person who contravenes or fails to comply with Article 1 (conditions on marketing) as read with Article 2 (derogation for feed which complies with the provisions of Directive 2008/38/EC) and Article 3 (derogation for feed labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020) commits an offence.]

PART 6SAdministration and enforcement

Penalties for offences under these RegulationsS

12.—(1) Any person found guilty of an offence under regulation 4(1), 7(1), 9(1) to (4) or [F3111] is liable—

(a)on summary conviction, to a term of imprisonment not exceeding three months or to a fine not exceeding the statutory maximum, or both; or

(b)on conviction on indictment, to a term of imprisonment not exceeding three months or to a fine, or both.

(2) Any person found guilty of an offence under regulation 9(8) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Duties to enforceS

13.  It is the duty of [F32the feed authority] to execute and enforce the provisions of these Regulations.

[F33Delegation by the feed authorityS

13A.(1) Where the feed authority may delegate any function under these Regulations, it may delegate the function to any person.

(2) Before delegating, the feed authority must consult the person to whom any delegation is to be made.

(3) Where the feed authority delegates any function, it must specify the function and the area within which that function is to be performed.

(4) Where the feed authority has delegated any of its functions, the feed authority may vary, suspend or cancel that delegation, in whole or in part.

(5) The feed authority must publish and maintain an up to date register containing the details and operative date of any delegation.]

PART 7 SAmendments and modifications to the Agriculture Act 1970

Amendments and modifications to the Agriculture Act 1970S

14.—(1) The Act is amended or modified, as the case may be, in accordance with paragraphs (2) to (9).

(2) In section 66 (interpretation of Part IV)—

(a)in subsection (1) M6, insert at the appropriate place the following definitions:—

Regulation (EC) No. 1831/2003” means Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;;

Regulation (EC) No. 767/2009” means Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC;; and

(b)for subsection (2) substitute—

(2) For the purposes of this Part of this Act material shall be treated as sold for use as a fertiliser or feeding stuff whether it is sold to be so used by itself or as an ingredient in something which is to be so used..

(3) In section 68 (duty of seller to give statutory statement)—

(a)after subsection (5) insert the following subsection:—

(5A) Nothing in subsections (1) to (5) applies to anyone to whom the requirements of Article 16 of Regulation (EC) No. 1831/2003 (labelling and packaging of feed additives and premixtures) or of Chapter 4 of Regulation (EC) No. 767/2009 (labelling, presentation and packaging) apply.; and

(b)after subsection (6) insert the following subsection:—

(7) Failure to comply with the labelling requirements of Article 16 of Regulation (EC) No. 1831/2003 or of Chapter 4 of Regulation (EC) No. 767/2009 shall not invalidate a contract of sale, but such labelling shall, regardless of any contract or notice to the contrary, have effect as a warranty by the person who gives it that the particulars contained in it are correct..

(4) In section 69(1) (marking of material prepared for sale) omit “or feeding stuff”.

(5) In section 70 (use of names or expressions with prescribed meanings)—

(a)subsection (1)(a) in so far as it applies in relation to feeding stuffs shall apply as if “under Regulation (EC) No. 767/2009” were substituted for “ ;by regulations made for the purposes of this section ”; and

(b)after subsection (5) insert the following subsection:—

(6) Nothing in subsections (2) to (4) of this section shall apply to anyone to whom the labelling requirements of Regulation (EC) No. 767/2009 apply..

(6) In section 71 (particulars to be given of certain attributes if claimed to be present)—

(a)subsection (4) in so far as it applies in relation to feeding stuffs shall apply as if—

(i)“the requirements of Article 13 (claims) of Regulation (EC) No. 767/2009” were substituted for “ ;subsection (1) of this section ”; and

(ii)“that Article” were substituted for “ ;that subsection ”; and

(b)after subsection (5) insert the following subsection:—

(6) Nothing in subsections (1) to (3) of this section shall apply to anyone to whom Article 13 (claims) of Regulation (EC) No. 767/2009 applies..

(7) Omit sections 73 (deleterious ingredients in feeding stuff) and 73A.

(8) In section 74 (limits of variation) after subsection (2) insert the following subsection:—

(3) Nothing in subsection (2) shall apply to anyone to whom Article 11.5 and Annex IV (permitted tolerances) of Regulation (EC) No. 767/2009 applies..

(9) Section 74A(3) does not apply to regulations concerning feed.

Marginal Citations

M6Section 66(1) was relevantly amended by S.I. 2004/3254 and S.S.I. 2010/354.

PART 8SAmendments to Regulations

Amendment of the Feed (Hygiene and Enforcement) (Scotland) Regulations 2005S

15.—(1) The Feed (Hygiene and Enforcement) (Scotland) Regulations 2005 M7 are amended in accordance with paragraphs (2) to (6).

(2) In regulation 2(1) (interpretation)—

(a)after the definition of “agricultural analyst” insert the definition—

the Animal Feed Regulations” means the Animal Feed (Scotland) Regulations  2010;; and

(b)after the definition of “Regulation 183/2005” insert the definition—

Regulation 767/2009” means Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC;.

(3) In regulation 15(2)(b) (offences, penalties and enforcement) omit “food-producing”.

(4) For regulation 24(13) (powers of entry for authorised officers) substitute—

(13) In this regulation—

(a)“compound feeding stuff” bears the same meaning as “compound feed” as defined in Article 3(2)(h) of Regulation 767/2009;

(b)“feeding stuff which is intended for a particular nutritional purpose” bears the same meaning as “feed intended for particular nutritional purposes” as defined in Article 3(2)(o) of that Regulation; and

(c)prescribed manner” means prescribed by any provision referred to in regulation 29..

(5) In each of regulations 34(1) and (2) (defences of fault of another person, mistake etc and export), 35(1) and (3) (defences by corporate bodies or Scottish partnerships) and 36(1) (time limit for prosecutions) after “these Regulations” insert “ ;or the Animal Feed Regulations ”.

(6) In Schedule 1 (specified feed law)—

(a)omit “The Feeding Stuffs (Scotland) Regulations 2000”;

(b)for “The Feeding Stuffs (Scotland) Regulations 2005 (as modified by the Feeding Stuffs (Application to Zootechnical Additives etc.) (Scotland) Regulations 2005)” substitute “ ;The Animal Feed (Scotland) Regulations 2010 ”; and

(c)insert at the end—

Regulation 767/2009.

Marginal Citations

M7S.S.I. 2005/608, as amended by S.S.I. 2005/616, 2006/578, 2008/201, 2009/263 and 446, and 2010/354.

Amendment of the Official Feed and Food Controls (Scotland) Regulations 2009S

16.—(1) The Official Feed and Food Controls (Scotland) Regulations 2009 M8 are amended in accordance with paragraph (2).

(2) In paragraph (f) of Schedule 2 (definition of relevant feed law), for “the Feeding Stuffs (Scotland) Regulations 2005” substitute “ ;the Animal Feed (Scotland) Regulations 2010 ”.

Marginal Citations

M8S.S.I. 2009/446, as amended by S.S.I. 2010/5, 177 and 354.

RevocationsS

17.  The enactments listed in Schedule 2 are revoked.

[F34Transitional provisionsS

18.(1) The validity, effect or consequences of anything done under these Regulations as they had effect immediately before the Food Standards Scotland becomes the feed authority is not affected by the Food Standards Scotland becoming the feed authority.

(2) Any inspection, investigation or legal proceedings commenced prior to the Food Standards Scotland becoming the feed authority is not affected by the Food Standards Scotland becoming the feed authority.

(3) Any inspection, investigation or legal proceeding commenced prior to the Food Standards Scotland becoming the feed authority may be continued after that date as if the amendments to these Regulations coming into force on that day had not been made.

(4) Any liability to a penalty for an offence committed before the Food Standards Scotland becoming the feed authority is not affected by the Food Standards Scotland becoming the feed authority.

(5) Despite Food Standards Scotland becoming the feed authority, these Regulations as they had effect before that day continue to have effect for the purposes of investigating any offence referred in paragraph (4).]

RICHARD LOCHHEAD

A member of the Scottish Executive

St Andrew's House,

Edinburgh

Regulation 4(1)

[F35SCHEDULE 1SSPECIFIED PROVISIONS OF REGULATION 767/2009

Specified provision

Subject matter

Article 4(1) & (2), as read with Article 4(3) and Annex IGeneral safety and other requirements to be met when feed is placed on the market or used
Article 5(1)Extension of requirements in relation to feed for food-producing animals in other legislation to apply to feed for non food-producing animals
Article 5(2), as read with Article 12(1), (2) & (3)Obligation on person responsible for labelling to make information available to competent authority
Article 9Controls on the marketing of feeds for particular nutritional purposes
Article 11, as read with Article 12(1), (2) & (3), Annexes II & IV and the Catalogue of feed materialsRules and principles governing the labelling and presentation of feed
Article 12(4) & (5)Designation of the person responsible for labelling and the obligations and responsibilities of that person
Article 13(1), as read with Article 12(1), (2) & (3)General conditions on making a claim about the characteristics or functions of a feed on the labelling or presentation of it
Article 13(2) & (3), as read with Article 12(1), (2) & (3)Special conditions applying to claims concerning optimisation of the nutrition and support or protection of the physiological conditions
Article 14(1) & (2), as read with Article 12(1), (2) & (3)Requirements for the presentation of the mandatory labelling particulars
Article 15, as read with Article 12(1), (2) & (3), Annex VI and VII and Article 21General mandatory labelling requirements for feed materials and compound feeds
Article 16, as read with Articles 12(1), (2) & (3) and 21, Annex II and V and the Catalogue of feed materialsSpecific labelling requirements for feed materials
Article 17(1) & (2), as read with Articles 12(1), (2) & (3) and 21 and Annex II, VI & VIISpecific labelling requirements for compound feeds
Article 18, as read with Article 12(1), (2) & (3)Additional labelling requirements for feed for particular nutritional purposes (dietetic feeds)
Article 19, as read with Article 12(1), (2) & (3)Additional labelling requirements for pet food
Article 20(1), as read with Article 12(1), (2) & (3) and Annex VIIIAdditional requirements for labelling of non-compliant feed, such as that containing contaminated materials
Article 23Requirements relating to the packaging and sealing of feed materials and compound feeds for placing on the market
Article 24(5)Requirement that if the name of a feed material listed in the Catalogue of feed materials is used, all relevant provisions of the Catalogue must be complied with.
Article 24(6)Obligation on a person who first places on the market a feed material not listed in the Catalogue of feed materials to notify its use
F36. . .F36. . .]

Regulation 17

SCHEDULE 2SREVOCATIONS

1.  The Feeding Stuffs (Scotland) Regulations 2005 M9.S

Marginal Citations

2.  The Feeding Stuffs (Scotland) Amendment and the Feeding Stuffs (Sampling and Analysis) Amendment (Scotland) Regulations 2006 M10.S

Marginal Citations

3.  The Feeding Stuffs (Scotland) Amendment Regulations 2006 M11.S

Marginal Citations

4.  Regulation 2 of and the Schedules to the Feeding Stuffs (Scotland) and the Feed (Hygiene and Enforcement) (Scotland) Amendment Regulations 2006 M12.S

Marginal Citations

5.  The Feed (Specified Undesirable Substances) (Scotland) Regulations 2007 M13.S

Marginal Citations

6.  The Feeding Stuffs (Scotland) Amendment Regulations 2008 M14.S

Marginal Citations

7.  The Feeding Stuffs (Scotland) Amendment Regulations 2009 M15.S

Marginal Citations

8.  The Feed (Specified Undesirable Substances) (Scotland) Regulations 2009 M16.S

Marginal Citations

9.  Regulations 11, 14, 15 and 25 of, and Schedule 2 to, the Feed (Sampling and Analysis and Specified Undesirable Substances) (Scotland) Regulations 2010 M17.S

Marginal Citations

Regulation 4(2)

[F37SCHEDULE 3SCategories of feed materials which may be indicated in place of individual feed materials on the packaging, container or label of compound feedingstuffs for pet animals

Description of the categoryDefinition
1. Meat and animal derivativesAll the fleshy parts of slaughtered warm-blooded land animals, fresh or preserved by appropriate treatment, and all  products  and  derivatives of the processing of the carcase or parts of the carcase of warm-blooded land animals
2. Milk and milk derivativesAll milk products, fresh or preserved by appropriate treatment, and derivatives from their processing
3. Eggs and egg derivativesAll egg products fresh or preserved by appropriate treatment and derivatives from their processing
4. Oils and fatsAll animal and vegetable oils and fats
5. YeastsAll yeasts, the cells of which have been killed and dried
6. Fish and fish derivativesFish or parts of fish, fresh or preserved by appropriate treatment, and derivatives from their processing
7. CerealsAll types of cereal, regardless of their presentation, or products made from the starchy endosperm
8. VegetablesAll types of vegetables and legumes, fresh or preserved by appropriate treatment
9. Derivatives of vegetable originDerivatives resulting from the treatment of vegetable products, in particular cereals, vegetables, legumes and oil seeds
10. Vegetable protein extractsAll products of vegetable origin in which the proteins have been concentrated by an adequate process to contain at least 50% crude protein, as related to the dry matter, and which may be restructured (textured)
11. MineralsAll inorganic substances suitable for animal feed
12. Various sugarsAll types of sugar
13. FruitAll types of fruit, fresh or preserved by appropriate treatment
14. NutsAll kernels from shells
15. SeedsAll types of seeds as such or roughly crushed
16. AlgaeAlgae, fresh or preserved by appropriate treatment
17. Molluscs and crustaceansAll types of molluscs, crustaceans, shellfish, fresh or preserved by appropriate treatment, and their processing derivatives
18. InsectsAll types of insects and their stages of development
19. Bakery productsAll bread, cakes, biscuits and pasta products]

Regulation 9

[F37SCHEDULE 4SMaximum levels of undesirable substances

Table 1: INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS

Undesirable substanceProducts intended for animal feedMaximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
(1)

The maximum levels refer to total arsenic.

(2)

Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 68/2013 on the Catalogue of feed materials.

(3)

The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use of the premixture are in accordance with the maximum levels for complementary and complete feed.

(4)

The % of phosphorus is relative to a feed with a moisture content of 12%.

(5)

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.

(6)

For the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5% w/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 an equal extraction efficiency.

(7)

Forage includes products intended for animal feed such as hay, silage, fresh grass, etc.

(8)

The maximum levels refer to total mercury.

(9)

The maximum level is applicable on wet weight basis.

(10)

The maximum levels are expressed as sodium nitrite.

(11)

The maximum level refers to melamine only. The inclusion of the structurally related compounds cyanuric acid, ammeline and ammelide in the maximum level will be considered at a later stage.

(12)

The maximum level is applicable to canned pet food as sold.

1. Arsenic (1)Feed materials2
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,4
— palm kernel expeller,4
— peat; leonardite,5
— phosphates, calcareous marine algae,10
— calcium carbonate; calcium and magnesium carbonate (2); calcareous marine shells, 15
— magnesium oxide; magnesium carbonate,20
— fish, other aquatic animals and products derived from them,25
— seaweed meal and feed materials derived from seaweed.40
Iron particles used as tracer.50
Feed additives belonging to the functional group of compounds of trace elements30
with the exception of:
— cupric sulphate pentahydrate; cupric carbonate; dicopper chloride trihydroxide; ferrous carbonate; dimanganese chloride trihydroxide,50
— zinc oxide; manganous oxide; cupric oxide.100
Complementary feed4
with the exception of:
— mineral feed,12
— complementary feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed,10
— long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed,30
Complete feed2
with the exception of:
— complete feed for fish and fur animals,10
— complete feed for pet animals containing fish, other aquatic animals and products derived from them and/or seaweed meal and feed materials derived from seaweed.10
2. CadmiumFeed materials of vegetable origin.1
Feed materials of animal origin.2
Feed materials of mineral origin2
with the exception of:
— phosphates.10
Feed additives belonging to the functional group of compounds of trace elements10
with the exception of:
— cupric oxide, manganous oxide, zinc oxide and manganous sulphate monohydrate.30
Feed additives belonging to the functional groups of binders and anti-caking agents.2
Premixtures.(3)15
Complementary feed0.5
with the exception of:
— mineral feed
– – containing < 7% phosphorus(4)5
– – containing ≥ 7% phosphorus(4)0.75 per 1% phosphorus (4), with a maximum of 7.5
— complementary feed for pet animals,2
— long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.15
Complete feed0.5
with the exception of:
— complete feed for cattle (except calves), sheep (except lambs), goats (except kids) and fish,1
— complete feed for pet animals.2
3. Fluorine (5)Feed materials150
with the exception of:
— feed materials of animal origin except marine crustaceans such as marine krill; calcareous marine shells,500
— marine crustaceans such as marine krill,3 000
— phosphates,2 000
— calcium carbonate, calcium and magnesium carbonate,(2)350
— magnesium oxide,600
— calcareous marine algae.1 250
Vermiculite (E 561).3 000
Complementary feed:
— containing ≤ 4% phosphorus(4),500
— containing > 4% phosphorus(4).125 per 1% phosphorus(4)
Complete feed150
with the exception of:
— complete feed for pigs,100
— complete feed for poultry (except chicks) and fish,350
— complete feed for chicks,250
— complete feed for cattle, sheep and goats
– – in lactation,30
– – other.50
4. Lead(6)Feed materials10
with the exception of:
— forage(7),30
— phosphates, calcareous marine algae and calcareous marine shells,15
— calcium carbonate, calcium and magnesium carbonate(2),20
— yeasts.5
Feed additives belonging to the functional group of compounds of trace elements100
with the exception of:
— zinc oxide,400
— manganous oxide, ferrous carbonate, cupric carbonate, copper (I) oxide.200
Feed additives belonging to the functional groups of binders and anti-caking agents30
with the exception of:
— clinoptilolite of volcanic origin; natrolite-phonolite.60
Premixtures.(3)200
Complementary feed10
with the exception of:
— mineral feed,15
— long-term supply formulations of feed for particular nutritional purposes with a concentration of trace elements higher than 100 times the established maximum content in complete feed.60
Complete feed.5
5. Mercury(8)Feed materials0.1
with the exception of:
— fish, other aquatic animals and products derived from them intended for the production of compound feed for food producing animals,0.5
— fish, other aquatic animals and products derived from them intended for the production of compound feed for dogs, cats, ornamental fish and fur animals,1.0(9)
— fish, other aquatic animals and products derived from them as canned wet feed material for direct feeding of dogs and cats,0.3
— calcium carbonate, calcium and magnesium carbonate(2).0.3
Compound feed0.1
with the exception of:
— mineral feed,0.2
— compound feed for fish,0.2
— compound feed for dogs, cats, ornamental fish and fur animals.0.3
6. Nitrite(10)Feed materials15
with the exception of:
— fishmeal,30
— silage,
— products and by-products from sugar beet and sugarcane and from starch and alcoholic drink production.
Complete feed15
with the exception of:
— complete feed for dogs and cats with a moisture content exceeding 20%.
7. Melamine(11)Feed2.5
with the exception of:
— canned pet food,2.5(12)
— the following feed additives:
— guanidino acetic acid (GAA),20
— urea,
— biuret.

Table 2: MYCOTOXINS

Undesirable substanceProducts intended for animal feedMaximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
1. Aflatoxin B1Feed materials0.02
Complementary and complete feed0.01
with the exception of:
— compound feed for dairy cattle and calves, dairy sheep and lambs, dairy goats and kids, piglets and young poultry animals,0.005
— compound feed for cattle (except dairy cattle and calves), sheep (except dairy sheep and lambs), goats (except dairy goats and kids), pigs (except piglets) and poultry (except young animals).0.02
2. Rye ergot (Claviceps purpurea)Feed materials and compound feed containing unground cereals.1 000

Table 3: INHERENT PLANT TOXINS

Undesirable substanceProducts intended for animal feedMaximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
(1)

The maximum levels are expressed as allyl isothiocyanate.

(2)

Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of total glucosinolates is lower than 30 mmol/kg. The method of analysis of reference is EN-ISO 9167:2019 (Rapeseed and rapeseed meals — Determination of glucosinolates content — Method using high-performance liquid chromatography); published by the International Organization for Standardization in May 2019, edition 1. Available from the ISO website https://www.iso.org.

1. Free gossypolFeed materials20
with the exception of:
— cottonseed,6 000
— cottonseed cakes and cottonseed meal.1 200
Complete feed20
with the exception of:
— complete feed for cattle (except calves),500
— complete feed for sheep (except lambs) and goats (except kids),300
— complete feed for poultry (except laying hens) and calves,100
— complete feed for rabbits, lambs, kids and pigs (except piglets).60
2. Hydrocyanic acidFeed materials50
with the exception of:
— linseed,250
— linseed cakes,350
— manioc products and almond cakes.100
Complete feed50
with the exception of:
— complete feed for young chickens (< 6 weeks).10
3. TheobromineComplete feed300
with the exception of:
— complete feed for pigs,200
— complete feed for dogs, rabbits, horses and fur animals.50
4. vinyl thiooxazolidone (5-vinyloxazolidine-2-thione)Complete feed for poultry1 000
with the exception of:
— complete feed for laying hens.500
5. Volatile mustard oil(1)Feed materials100
with the exception of:
— Camelina seed and products derived from it(2), products derived from mustard seed(2), rape seed and products derived from them.4 000
Complete feed150
with the exception of:
— complete feed for cattle (except calves), sheep (except lambs) and goats (except kids),1 000
— complete feed for pigs (except piglets) and poultry.500

Table 4: ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs)

Undesirable substanceProducts intended for animal feedMaximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
(1)

Singly or combined expressed as dieldrin.

(2)

Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin.

(3)

Numbering system according to Parlar, prefixed by either CHB or ‘Parlar’:

CHB 26: 2-endo,3-exo,5-endo,6-exo,8,8,10,10-octochlorobornane,
CHB 50: 2-endo,3-exo,5-endo,6-exo,8,8,9,10,10-nonachlorobornane,
CHB 62: 2,2,5,5,8,9,9,10,10-nonachlorobornane.
1. Aldrin(1)Feed materials and compound feed0.01(2)
with the exception of:
— fats and oils,0.1(2)
— compound feed for fish.0.02(2)
2. Dieldrin(1)Feed materials and compound feed0.01(2)
with the exception of:
— fats and oils,0.1 (2)
— compound feed for fish.0.02 (2)
3. Camphechlor (toxaphene) – sum of indicator congeners CHB 26, 50 and 62(3)Fish, other aquatic animals and products derived from them0.02
with the exception of:
— fish oil.0.2
Complete feed for fish.0.05
4. Chlordane (sum of cis- and trans-isomers and of oxychlordane, expressed as chlordane)Feed materials and compound feed0.02
with the exception of:
— fats and oils.0.05
5. DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT)Feed materials and compound feed0.05
with the exception of:
— fats and oils.0.5
6. Endosulfan (sum of alpha- and beta-isomers and of endosulfansulphate expressed as endosulfan)Feed materials and compound feed0.1
with the exception of:
— cotton seed and products derived from its processing, except crude cotton seed oil,0.3
— soybean and products derived from its processing, except crude soybean oil,0.5
— crude vegetable oil,1.0
— complete feed for fish except for Salmonids,0.005
— complete feed for Salmonids.0.05
7. Endrin (sum of endrin and of delta-ketoi-endrin, expressed as endrin)Feed materials and compound feed0.01
with the exception of:
— fats and oils.0.05
8. Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor)Feed materials and compound feed0.01
with the exception of:
— fats and oils.0.2
9. Hexachlorobenzene (HCB)Feed materials and compound feed0.01
with the exception of:
— fats and oils.0.2
10. Hexachlorocyclo-hexane  (HCH)
— alpha-isomersFeed materials and compound feed0.02
with the exception of:
— fats and oils.0.2
— beta-isomersFeed materials0.01
with the exception of:
— fats and oils.0.1
Compound feed0.01
with the exception of:
— compound feed for dairy cattle.0.005
— gamma-isomersFeed materials and compound feed0.2
with the exception of:
— fats and oils.2.0

Table 5 (Part 1): DIOXINS AND PCBs

Undesirable substanceProducts intended for animal feedMaximum content in ng WHO-PCDD/F-TEQ/kg (ppt)(1) relative to a feed with a moisture content of 12%
(1)

Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

(2)

Table 5 (Part 2): Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006)).

(3)

Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3.5 ng WHO-PCDD/F-TEQ/kg product and 6.5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20.0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

(4)

The maximum level is also applicable to the feed additives belonging to the functional groups of substances for the control of radionuclide contamination and substances for reduction of the contamination of feed by mycotoxins which also belong to the functional groups of binders and anti-caking agents.

(5)

Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.

1. Dioxins (sum of polychlorinated dibenzo- para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)(2))Feed materials of plant origin0.75
with the exception of:
— vegetable oils and their by-products.0.75
Feed materials of mineral origin.0.75
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat,1.50
— Other land animal products including milk and milk products and eggs and egg products,0.75
— Fish oil,5.0
— Fish, other aquatic animals, and products derived from them with the exception of fish oil, hydrolysed fish protein containing more than 20% fat (3) and crustacea meal,1.25
— Hydrolysed fish protein containing more than 20% fat; crustacea meal.1.75
Feed additives belonging to the functional groups of binders and anti-caking agents.(4)0.75
Feed additives belonging to the functional group of compounds of trace elements.1.0
Premixtures.1.0
Compound feed0.75
with the exception of:
— compound feed for pet animals and fish,1.75
— compound feed for fur animals.
Undesirable substanceProducts intended for animal feed.Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt)(1) relative to a feed with a moisture content of 12%.
2. Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors), 2005(2))Feed materials of plant origin1.25
with the exception of:
— vegetable oils and their by-products.1.5
Feed materials of mineral origin.1.0
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat,2.0
— Other land animal products including milk and milk products and eggs and egg products,1.25
— Fish oil,20.0
— Fish, other aquatic animals, and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat,(3)4.0
— Fish protein, hydrolysed, containing more than 20% fat.9.0
Feed additives belonging to the functional groups of binders and anti-caking agents. (4)1.5
Feed additives belonging to the functional group of compounds of trace elements.1.5
Premixtures.1.5
Compound feed1.5
with the exception of:
— compound feed for pet animals and fish,5.5
— compound feed for fur animals.
Undesirable substanceProducts intended for animal feed.Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12%.(1)
3. Non-dioxin-like PCBs (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6)(1))Feed materials of plant origin.10
Feed materials of mineral origin.10
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat,10
— Other land animal products including milk and milk products and eggs and egg products,10
— Fish oil,175
— Fish, other aquatic animals and products derived from them with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat,(5)30
— Fish protein, hydrolysed, containing more than 20% fat.50
Feed additives belonging to the functional groups of binders and anti-caking agents.(4)10
Feed additives belonging to the functional group of compounds of trace elements.10
Premixtures.10
Compound feed10
with the exception of:
— compound feed for pet animals and fish,40
— compound feed for fur animals.

Table 5 (Part 2): Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs

CongenerTEF value
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs)
2,3,7,8-TCDD1
1,2,3,7,8-PeCDD1
1,2,3,4,7,8-HxCDD0.1
1,2,3,6,7,8-HxCDD0.1
1,2,3,7,8,9-HxCDD0.1
1,2,3,4,6,7,8-HpCDD0.01
OCDD0.0003
2,3,7,8-TCDF0.1
1,2,3,7,8-PeCDF0.03
2,3,4,7,8-PeCDF0.3
1,2,3,4,7,8-HxCDF0.1
1,2,3,6,7,8-HxCDF0.1
1,2,3,7,8,9-HxCDF0.1
2,3,4,6,7,8-HxCDF0.1
1,2,3,4,6,7,8-HpCDF0.01
1,2,3,4,7,8,9-HpCDF0.01
OCDF0.0003
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs
Non-ortho PCBs
PCB 770.0001
PCB 810.0003
PCB 1260.1
PCB 1690.03
Mono-ortho PCBs
PCB 1050.00003
PCB 1140.00003
PCB 1180.00003
PCB 1230.00003
PCB 1560.00003
PCB 1570.00003
PCB 1670.00003
PCB 1890.00003
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl.

Table 6: HARMFUL BOTANICAL IMPURITIES

Undesirable substanceProducts intended for animal feedMaximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
(1)

Insofar as determinable by analytical microscopy.

(2)

Includes also seed husk fragments.

(3)

Where unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing non-compliant levels of seeds of Ambrosia spp. before milling or crushing on the condition that:

—the consignment is transported as a whole to the milling or crushing plant, and the milling or crushing plant is informed in advance of the presence of high levels of Ambrosia spp. seeds in order to take additional prevention measures to avoid dissemination into the environment,
—solid evidence is provided that prevention measures are taken to avoid dissemination of Ambrosia spp. seeds into the environment during transport to the crushing or milling plant, and
—the competent authority agrees to the transport, after having ensured that the abovementioned conditions are fulfilled.
In case these conditions are not fulfilled, the consignment must be cleared before any transport into the country and the screenings must be appropriately destroyed.
1. Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination includingFeed materials and compound feed.3 000
Datura sp.1 000
2. Crotalaria spp.Feed materials and compound feed.100
3. Seeds and husks from Ricinus communis L., Croton tiglium L. and Abrus precatorius L. as well as their processed derivatives(1), separately or in combination Feed materials and compound feed.10(2)
4. Unhusked beech mast — Fagus sylvatica L.Feed materials and compound feed.Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
5. Purghera — Jatropha curcas L.Feed materials and compound feed.Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
6. Seeds from Ambrosia spp.Feed materials(3)50
with the exception of:
– Millet (grains of Panicum miliaceum L.) and sorghum (grains of Sorghum bicolor (L) Moench s.l.) not directly fed to animals.(3)200
Compound feed containing unground grains and seeds.50

7. Seeds from

— Indian mustard — Brassica juncea (L.) Czern. and Coss. ssp. integrifolia (West.) Thell.

— Sareptian mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea

— Chinese mustard — Brassica juncea (L.) Czern. and Coss. ssp. juncea var. lutea Batalin

— Black mustard — Brassica nigra (L.) Koch

— Ethiopian mustard — Brassica carinata A. Braun

Feed materials and compound feed.Seeds may only be present in feed in trace amounts not quantitatively determinable.

Table 7: AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER

CoccidiostatProducts intended for animal feed(1)Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12%
(1)

Without prejudice to the authorised levels pursuant to Regulation (EC) No 1831/2003.

(2)

The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50% of the maximum levels established in the feed when the instructions for use of the premixture are followed.]

1. DecoquinateFeed materials.0.4
Compound feed for:
— laying birds and chickens reared for laying (> 16 weeks),0.4
— other animal species.1.2
Premixtures for use in feed in which the use of decoquinate is not authorised.(2)
2. DiclazurilFeed materials.0.01
Compound feed for:
— laying birds and chickens reared for laying (> 16 weeks),0.01
— rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed),0.01
— other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening.0.03
Premixtures for use in feed in which the use of diclazuril is not authorised.(2)
3. Halofuginone hydrobromideFeed materials.0.03
Compound feed for:
— laying birds, chickens reared for laying and turkeys (> 12 weeks),0.03
— chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed),0.03
— other animal species.0.09
Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised.(2)
4. Lasalocid A sodiumFeed materials.1.25
Compound feed for:
— dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 16 weeks) and chickens reared for laying (> 16 weeks),1.25
— chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed),1.25
— pheasants, guinea fowl, quails and partridges (except laying birds) for the period before slaughter in which the use of lasalocid A sodium is prohibited (withdrawal feed),1.25
— other animal species.3.75
Premixtures for use in feed in which the use of lasalocid A sodium is not authorised.(2)
5. Maduramicin ammonium alphaFeed materials.0.05
Compound feed for:
— equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks),0.05
— chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed),0.05
— other animal species.0.15
Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.(2)
6. Monensin sodiumFeed materials.1.25
Compound feed for:
— equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks),1.25
— chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed),1.25
— other animal species.3.75
Premixtures for use in feed in which the use of monensin sodium is not authorised.(2)
7. NarasinFeed materials.0.7
Compound feed for:
— turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks),0.7
— other animal species.2.1
Premixtures for use in feed in which the use of narasin is not authorised.(2)
8. NicarbazinFeed materials.1.25
Compound feed for:
— equine species, laying birds and chickens reared for laying (> 16 weeks),1.25
— other animal species.3.75
Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised.(2)
9. Robenidine hydrochlorideFeed materials.0.7
Compound feed for:
— laying birds and chickens reared for laying (> 16 weeks),0.7
— chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed),0.7
— other animal species.2.1
Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.(2)
10. Salinomycin sodiumFeed materials.0.7
Compound feed for:
— equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks),0.7
— chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed),0.7
— other animal species.2.1
Premixtures for use in feed in which the use of salinomycin sodium is not authorised.(2)
11. Semduramicin sodiumFeed materials.0.25
Compound feed for:
— laying birds and chickens reared for laying (> 16 weeks),0.25
— chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed),0.25
— other animal species.0.75
Premixtures for use in feed in which the use of semduramicin sodium is not authorised.(2)(2)

Regulation 9(9)

[F37SCHEDULE 5SAction thresholds triggering investigations: dioxins and PCBs

Table 1: DIOXINS AND PCBS

Undesirable substancesProducts intended for animal feedAction threshold in ng WHO-PCDD/F TEQ/kg (ppt)(2) relative to a feedingstuff with a moisture content of 12%Comments and additional information (e.g. nature of investigations to be performed)
(1)

Table 2: Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006)).

(2)

Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

(3)

Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

(4)

In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

1. Dioxins (sum of polychlorinated dibenzo- para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)(1))Feed materials of plant origin0.5(3)
with the exception of:
— vegetable oils and their by-products.0.5(3)
Feed materials of mineral origin.0.5(3)
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat,0.75(3)
— Other land animal products including milk and milk products and eggs and egg products,0.5(3)
— Fish oil,4.0(4)
— Fish, other aquatic animals and products derived from them, with the exception of fish oil, hydrolysed fish protein containing more than 20% fat and crustacea meal,0.75(4)
— Hydrolysed fish protein containing more than 20% fat, crustacea meal.1.25(4)
Feed additives belonging to the functional groups of binders and anti-caking agents.0.5(3)
Feed additives belonging to the functional group of compounds of trace elements.0.5(3)
Premixtures.0.5(3)
Compound feed0.5(3)
with the exception of:
— compound feed for pet animals and fish,1.25(4)
— compound feed for fur animals.
2. Dioxin-like PCBs (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005)(1))Feed materials of plant origin0.35(3)
with the exception of:
— vegetable oils and their by-products.0.5(3)
Feed materials of mineral origin.0.35(3)
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat,0.75(3)
— Other land animal products including milk and milk products and eggs and egg products,0.35(3)
— Fish oil,11.0(4)
— Fish, other aquatic animals and products derived from them, with the exception of fish oil and fish protein, hydrolysed, containing more than 20% fat,(3)2.0(4)
— Fish protein, hydrolysed, containing more than 20% fat.5.0(4)
Feed additives belonging to the functional groups of binders and anti-caking agents.0.5(3)
Feed additives belonging to the functional group of compounds of trace elements.0.35(3)
Premixtures.0.35(3)
Compound feed0.5(3)
with the exception of:
— compound feed for pet animals and fish,(4)2.5(4)
— compound feed for fur animals.

Table 2: Table of TEF (toxic equivalency factors) for dioxins, furans and dioxin-like PCBs

CongenerTEF value
Dibenzo-para-dioxins (‘PCDDs’) and Dibenzo-para-furans (PCDFs)
2,3,7,8-TCDD1
1,2,3,7,8-PeCDD1
1,2,3,4,7,8-HxCDD0.1
1,2,3,6,7,8-HxCDD0.1
1,2,3,7,8,9-HxCDD0.1
1,2,3,4,6,7,8-HpCDD0.01
OCDD0.0003
2,3,7,8-TCDF0.1
1,2,3,7,8-PeCDF0.03
2,3,4,7,8-PeCDF0.3
1,2,3,4,7,8-HxCDF0.1
1,2,3,6,7,8-HxCDF0.1
1,2,3,7,8,9-HxCDF0.1
2,3,4,6,7,8-HxCDF0.1
1,2,3,4,6,7,8-HpCDF0.01
1,2,3,4,7,8,9-HpCDF0.01
OCDF0.0003
‘Dioxin-like’ PCBs: Non-ortho PCBs + Mono-ortho PCBs
Non-ortho PCBs
PCB 770.0001
PCB 810.0003
PCB 1260.1
PCB 1690.03
Mono-ortho PCBs
PCB 1050.00003
PCB 1140.00003
PCB 1180.00003
PCB 1230.00003
PCB 1560.00003
PCB 1570.00003
PCB 1670.00003
PCB 1890.00003
Abbreviations used: ‘T’ = tetra; ‘Pe’ = penta; ‘Hx’ = hexa; ‘Hp’ = hepta; ‘O’ = octa; ‘CDD’ = chlorodibenzodioxin; ‘CDF’ = chlorodibenzofuran; ‘CB’ = chlorobiphenyl.]

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations—S

(a)revoke the Feeding Stuffs (Scotland) Regulations 2005 as amended and re-enact certain of their provisions;

(b)provide for the execution and enforcement of the comprehensive new EU Regulation on the marketing and use of feed detailed in paragraph 2, and for the continuing enforcement of the EU Regulation on feed additives mentioned in paragraph 3;

(c)maintain the implementation of EU Directives concerning dietetic feeds and contaminants in feed;

(d)prescribe offences and penalties for breaches of these Regulations;

(e)make amendments and modifications to Part IV of the Agriculture Act 1970; and

(f)amend certain other Regulations.

2.  In Part 2, these Regulations provide for the execution of Regulation (EC) No. 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No. 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (O.J. No. L 229, 1.9.2009, p.1) (regulations 3 to 5 and Schedule 1). References in regulation 4(2) to the Annex to Directive 82/475 and in Schedule 1 to the Annex to Regulation 242/2010 or the Annexes to Regulation 767/2009 are references to those Annexes as they may be amended from time to time (regulation 2(3)).S

3.  In Part 3, the Regulations provide for the continuing enforcement of Regulation (EC) No. 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (O.J. No. L 268, 18.10.2003, p.29) (regulations 6 and 7).S

4.  In Part 4, the Regulations implement Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (O.J. No. L 140, 30.5.2002, p.10) (regulations 8 and 9). Directive 2002/32 has already been amended a number of times, and any reference to an Annex to this Directive is a reference to that Annex as it may be amended from time to time (regulation 2(3)).S

5.  In Part 5, the Regulations implement Commission Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (O.J. No. L 62, 6.3.2008, p.9) (regulations 10 and 11). Any reference to an Annex to this Directive is a reference to that Annex as it may be amended from time to time (regulation 2(3)).S

6.  Part 6 of these Regulations makes provision for a breach of specified requirements to constitute an offence, sets out the maximum penalty applicable on conviction for such an offence and provides feed authorities with the duty to enforce these Regulations and the EU Regulations mentioned above (regulations 12 and 13).S

7.  In Part 7, the Regulations make amendments or modifications to the Agriculture Act 1970 where the relevant sections of the Act would otherwise duplicate, gloss or be incompatible with provisions of Regulation 767/2009 (regulation 14).S

8.  In Part 8, the Regulations make consequential amendments to the Food (Hygiene and Enforcement) (Scotland) Regulations 2005 and the Official Feed and Food Controls (Scotland) Regulations 2009 (regulations 15 and 16).S

9.  A Business and Regulatory Impact Assessment has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency (Scotland), 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ and online at www.legislation.gov.uk.S

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