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Welsh Statutory Instruments

2016 No. 386 (W. 120)

Agriculture, Wales

The Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016

Made

15 March 2016

Laid before the National Assembly for Wales

17 March 2016

Coming into force

12 May 2016

The Welsh Ministers make the following Regulations in exercise of the powers conferred on them by sections 66, 68, 74A 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.

The Welsh Ministers have been designated for the purposes of the control and regulation of the deliberate release, placing on the market and transboundary movements of genetically modified organisms M3, measures relating to feed produced for or fed to food-producing animals M4, measures in the veterinary and phytosanitary fields for the protection of public health M5 and measures in relation to the common agricultural policy of the European Union M6.

As set out above, these Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Welsh Ministers that it is expedient for references in these Regulations 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 open and transparent public consultation during the preparation of these Regulations in accordance with the requirements of 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 M7 or, in the case of provisions relating to feed for non food-producing animals, of section 84(1) of the Agriculture Act 1970.

Marginal Citations

M11970 c. 40. Functions formerly exercisable by “the Ministers”, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by S.I. 1999/672, and subsequently transferred to the Welsh Ministers by section 162 of, and paragraph 30 of Schedule 11 to, the Government of Wales Act 2006 (c. 32). 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.

M21972 c. 68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (c. 51) and amended by Part 1 of Schedule 1 to the European Union (Amendment) Act 2008 (c. 7).

M3S.I. 2003/2901. The functions conferred on the National Assembly for Wales by this designation are transferred to the Welsh Ministers by virtue of section 162 of, and paragraphs 28 and 30 of Schedule 11 to, the Government of Wales Act 2006.

M4S.I. 2005/1971. The functions conferred on the National Assembly for Wales by this designation are transferred to the Welsh Ministers by virtue of section 162 of, and paragraphs 28 and 30 of Schedule 11 to, the Government of Wales Act 2006. The designation does not extend to measures concerning feed containing medicinal products (including growth regulators) or medicinal products when destined for use in feed except provision concerning digestibility enhancers, gut flora stabilisers, or substances which favourably affect the environment.

M6S.I. 2010/2690. The designation does not extend to making provision in respect of feed that contains medicinal products destined for use in feed, except provision concerning substances that favourably affect the environment, digestibility enhancers, or gut flora stabilisers.

M7OJ No L 31, 1.2.2002, p 1, as last amended by Regulation (EU) No 652/2014 of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material (OJ No L 189, 27.6.2014, p 1).

PART 1 E+WIntroductory and general

Title, commencement and applicationE+W

1.—(1) The title of these Regulations is the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016.

(2) These Regulations come into force on 12 May 2016 and apply in relation to Wales.

Interpretation and scopeE+W

2.—(1) In these Regulations—

(2) Any expression used in these Regulations and in Regulation 178/2002, Regulation 1831/2003 or Regulation 767/2009 has the meaning in these Regulations that it bears in the [F5retained] EU Regulation concerned.

[F6(3) Any reference in these Regulations to an F7... instrument defined in paragraph (1) is a reference to that F7... instrument 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 M12.

Textual Amendments

Marginal Citations

M8OJ No L 31, 1.2.2002, p 1. This Regulation was last amended by Regulation (EU) No 652/2014 of the European Parliament and of the Council (OJ No L 189, 27.6.2014, p 1).

M9OJ No L 268, 18.10.2003, p 1. This Regulation was last amended by Regulation (EC) No 298/2008 of the European Parliament and of the Council (OJ No L 97, 9.4.2008, p 64).

M10OJ No L 268, 18.10.2003, p 29. This Regulation was last amended by Commission Regulation (EU) No 2015/2294 (OJ No L 324, 10.12.2015, p 3).

M11OJ No L 229, 1.9.2009, p 1. This Regulation was last amended by Commission Regulation (EC) No 939/2010 (OJ No L 277, 21.10.2010, p 4).

M12Categories (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 which favourably affect the environment.

PART 2 E+WEnforcement of Regulation 178/2002

Interpretation of this PartE+W

3.  In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 178/2002.

Offence of failing to comply with a specified provision of Regulation 178/2002E+W

4.—(1) A person who contravenes or fails to comply with a provision specified in paragraph (2) commits an offence.

(2) The specified provisions are—

(a)Article 12, in so far as it relates to feed (conditions on export or re-export to third countries);

(b)Article 15(1) (prohibition on the placing on the market or feeding to any animal of unsafe feed);

(c)Article 16, in so far as it relates to feed (prohibition on misleading labelling, advertising or presentation);

(d)Article 18(2) and (3) (requirements that operators must have traceability information and make such information available to competent authorities) in so far as it relates to feed business operators; and

(e)Article 20 (responsibilities of feed business operators regarding feed that does not satisfy feed safety requirements).

Competent authorities for the purposes of Regulation 178/2002E+W

5.  The competent authority—

(a)for the purposes of Articles 15 and 18 is the feed authority in its area; and

(b)for the purposes of Article 20 is the feed authority in its area or the Agency.

PART 3 E+WEnforcement of Regulation 1829/2003

Interpretation of this PartE+W

6.  In this Part any reference to a numbered Article is a reference to the Article so numbered in Regulation 1829/2003.

Offence of failing to comply with a specified provision of Regulation 1829/2003E+W

7.—(1) A person who contravenes or fails to comply with a provision specified in paragraph (2) commits an offence.

(2) The specified provisions are—

(a)Article 16(2) (prohibition on placing on the market, using or processing a product referred to in Article 15(1) M13 unless it is covered by an authorisation and satisfies relevant conditions) F8...;

(b)Article 21(1) (requirement that the authorisation holder and the parties concerned must comply with conditions imposed on an authorisation for that product, and that the authorisation holder must comply with post-market monitoring requirements);

(c)Article 21(3) (requirement that an authorisation holder inform the [F9Food Safety Authority] of any new scientific or technical information about a product which might affect the evaluation of the safety of its use in feed, or of any prohibition or restriction on the feed in a third country); and

(d)Article 25 (requirement for certain labelling indications).

Textual Amendments

Marginal Citations

M13The products referred to in Article 15(1) are genetically modified organisms (“GMOs”) for feed use, feed containing or consisting of GMOs and feed produced from GMOs.

Competent authority for the purposes of Regulation 1829/2003E+W

8.  The national competent authority for the purposes of Chapter III of Regulation 1829/2003 is the Agency.

PART 4E+WEnforcement of Regulation 1831/2003

Interpretation of this PartE+W

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

Offence of failing to comply with a specified provision of Regulation 1831/2003E+W

10.—(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-paragraph (a) or (e) with Article 2 (transitional provision) of Commission Regulation (EU) No 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 M14.

(2) The specified provisions are—

(a)Article 3(1) (prohibition on placing on the market, processing or using a feed additive unless it is covered by an authorisation and satisfies relevant conditions), as read with paragraph (2) (national authorisation for scientific experimental purposes), paragraph (4) (conditions on mixing of additives) and Article 10 (status of existing products);

(b)Article 3(3) (restriction on the persons who may first place on the market certain additives);

(c)Article 12(1) (requirement that any person using or placing on the market an additive, or a feed into which it has been incorporated, or any other interested party, must ensure that any conditions which have been imposed are respected);

(d)Article 12(2) (requirement on the holder of an authorisation to observe monitoring obligations where they have been imposed, to inform the [F10Food Safety Authority] of any new information about a product which might affect the evaluation of the safety of its use in feed, or of any prohibition or restriction on the feed imposed by the competent authority in a third country);

(e)Article 16(1), (3) and (4) (prohibition on the placing on the market of feed additives or premixtures unless labelled in the specified manner and with prescribed information), as read with paragraph (2) (derogation for certain flavouring compounds); and

(f)Article 16(5) (requirement that additives and premixtures must be marketed only in closed packages or containers which must be closed in such a way that the fastener is damaged on opening and cannot be re-used).

Textual Amendments

Marginal Citations

M14OJ No L 58, 3.3.2015, p 46.

[F11Transitional provision: withdrawal from the EUE+W

10A.  For the purpose of regulation 10(1), as read with regulation 10(2)(e), a person is not considered to have contravened or failed to comply with Article 16(1)(b) of Regulation 1831/2003 if—

(a)the alleged contravention would relate to a product that was placed on the market on or after the day on which the Food, Animal Feed and Seeds (Miscellaneous Amendments and Transitional Provisions) (Wales) (EU Exit) Regulations 2021 came into force and before the end of 30 September 2022; and

(b)the matter constituting the alleged contravention or failure to comply would not have constituted a contravention of, or failure to comply with, that Article as it had effect immediately before IP completion day.]

PART 5 E+WEnforcement of Regulation 767/2009

Interpretation of this Part and Schedule 1E+W

11.  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.

Offence of failing to comply with a specified provision of Regulation 767/2009E+W

12.—(1) [F12A] person who—

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

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

commits an offence.

(2) Where, pursuant to Article 17(2)(c), 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 [F13Schedule 1A] may be indicated.

Competent authorities for the purposes of Regulation 767/2009E+W

13.—(1) Each feed authority in its area is the competent authority for the purposes of—

(a)Article 5(3), 13(1)(a) and 17(3) and Annex VII, Chapter 1, paragraph 8; and

(b)Article 13(1)(b) as the competent authority that may request scientific substantiation of a claim and to whose attention purchasers have the right to bring doubts regarding the truthfulness of a claim.

(2) The Agency is the competent authority for the purposes of—

F14(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)Article 13(1)(b) as the competent authority that may submit to the [F15Welsh Ministers] doubts concerning the scientific substantiation of a claim.

(3) The Agency and each feed authority in its area is a competent authority for the purposes of Article 5(2).

PART 6E+W[F16Undesirable substances in products intended for animal feed]

Interpretation of this PartE+W

14.  In this Part—

F17(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)undesirable substance” (“sylwedd annymunol”) 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 substancesE+W

15.—(1) A person who—

(a)places on the market any feed that is specified in column 2 of [F18a table in Schedule 1B]; or

(b)uses any such feed,

commits an offence if it contains any undesirable substance listed in column 1 of that [F19table] in excess of the relevant maximum content specified in column 3.

(2) A person who places on the market or uses any complementary feed commits 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 [F20a table in Schedule 1B] 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 [F21table].

(3) A person who for the purpose of dilution mixes any feed with a feed that is specified in column 2 of [F22a table in Schedule 1B] and which contains any undesirable substance listed in column 1 of that [F23table] in excess of the maximum content specified for it in column 3 commits an offence.

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

(5) For the purposes of paragraph (4) a feed listed in column 2 of [F24a table in Schedule 1B] shall be deemed not to be sound, genuine and of merchantable quality if it contains any undesirable substance specified in column 1 of that [F25table] in excess of the maximum content specified in relation to it in column 3.

(6) A person who has, for the purpose of a trade or business, possession or control of any of the feeds specified in paragraph (7) must, 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; F26...

(d)complete feeds for fish or for fur-producing animals.

[F27(e)peat;

(f)leonardite.]

(8) A person who, without reasonable excuse, fails to comply with a requirement made under paragraph (6) commits an offence.

[F28(9) In order to reduce or eliminate sources of undesirable substances in products intended for animal feed, feed authorities must 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.

(10) In cases of increased levels of undesirable substances listed in Schedule 1C, action thresholds to trigger investigations are set out in that Schedule.

(11) Feed authorities must send to the Agency all relevant information and findings of the source and the measures taken to reduce the level of, or eliminate, undesirable substances.]

Textual Amendments

[F29Regulations amending Schedules 1B and 1CE+W

15A.(1) Where paragraph (2) applies, the Welsh Ministers may, by regulations, make provision to amend, add, or remove an entry in Schedule 1B or 1C.

(2) This paragraph applies where—

(a)the Welsh Ministers consider that the presence in feed of an undesirable substance not listed in Schedule 1B, or at a level permitted in accordance with Schedule 1B, presents, or would present, a danger to animal or human health or to the environment, or

(b)the Welsh Ministers consider it necessary in order to adapt to scientific and technical developments.

(3) The Welsh Ministers may, by regulations, define acceptability criteria for detoxification processes through which an undesirable substance listed in Schedule 1B is on purpose removed from feed.

(4) A power to make regulations under this regulation—

(a)is exercisable by statutory instrument;

(b)includes the power to make different provision for different purposes;

(c)includes the power to make incidental, supplementary, consequential, transitional, transitory or saving provision (including provision amending, repealing or revoking enactments or retained direct EU legislation).

(5) A statutory instrument that contains regulations under this regulation is subject to annulment in pursuance of a resolution of Senedd Cymru.]

[F30Part 7E+WEnforcement of Regulation 2020/354

Interpretation of this PartE+W

16.  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 Article 1 of Regulation 2020/354E+W

17.  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 (transitional provision for feed labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020) commits an offence.]

PART 8 E+WAdministration and enforcement

Penalties for offences under these RegulationsE+W

18.—(1) A person found guilty of an offence under regulation 4(1), 7(1), 10(1), 12(1), 15(1), (2), (3) or (4) or [F3117] is liable on summary conviction to a term of imprisonment not exceeding six months or to a fine, or both.

(2) A person found guilty of an offence under regulation 15(8) is liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Duties to enforceE+W

19.  It is the duty of each feed authority within its area to execute and enforce Regulation 178/2002, Regulation 1829/2003, Regulation 1831/2003, Regulation 767/2009 [F32, Regulation 2020/354] and these Regulations.

PART 9 E+WAmendment and revocation

Amendment of the Official Feed and Food Controls (Wales) Regulations 2009E+W

20.—(1) The Official Feed and Food Controls (Wales) Regulations 2009 M15 are amended in accordance with paragraph (2).

(2) In Schedule 2 (definition of relevant feed law)—

(a)omit paragraph (c); and

(b)in paragraph (f), for “the Animal Feed (Wales) Regulations 2010” substitute “ the Animal Feed (Composition, Marketing and Use) (Wales) Regulations 2016 ”.

Marginal Citations

RevocationsE+W

21.  The Regulations listed in the first column of Schedule 2 are revoked to the extent specified in the second column.

Vaughan Gething

Deputy Minister for Health, one of the Welsh Ministers

Regulation 12

[F33SCHEDULE 1E+WSpecified Provisions of Regulation 767/2009

Specified provisionSubject matter
Article 4(1) and (2), as read with Article 4(3) and Annex 1General 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) and (3)Obligation on person responsible for labelling to make information available to competent authority.
Article 6(1), as read with Annex 3Prohibition or restriction on the marketing or use of certain materials for animal nutritional purposes.
Article 8Controls on the levels of additives in feeds.
Article 9Controls on the marketing of feeds for particular nutritional purposes.
Article 11, as read with Article 12(1), (2) and (3), Annexes 2 and 4 and the Catalogue of feed materialsRules and principles governing the labelling and presentation of feed.
Article 12(4) and (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) and (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) and (3), as read with Article 12(1), (2) and (3)Special conditions applying to claims concerning optimisation of the nutrition and support or protection of the physiological conditions.
Article 14(1) and (2), as read with Article 12(1), (2) and (3)Requirements for the presentation of the mandatory labelling particulars.
Article 15, as read with Articles 12(1), (2) and (3) and 21 and with Annexes 6 and 7General mandatory labelling requirements for feed materials and compound feeds.
Article 16, as read with Article 12(1), (2) and (3) and 21 and with Annexes 2 and 5 and the Catalogue of feed materialsSpecific labelling requirements for feed materials.
Article 17(1) and (2) as read with Articles 12(1), (2) and (3) and 21 and with Annexes 2, 6 and 7Specific labelling requirements for compound feeds.
Article 18, as read with Article 12(1), (2) and (3)Additional labelling requirements for feed for particular nutritional purposes (dietetic feeds).
Article 19, as read with Article 12(1), (2) and (3)Additional labelling requirements for pet food.
Article 20(1) as read with Article 12(1), (2) and (3) and with Annex 8Additional 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(2)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(3)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.]

Regulation 12(2)

[F34SCHEDULE 1AE+WCategories of feed materials which may be indicated in place of individual feed materials

Description of the categoryDefinition
1. Meat and animal derivatives

— All 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 the processing of those products.
3. Eggs and egg derivativesAll egg products, fresh or preserved by appropriate treatment, and derivatives from the processing of those products.
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 the processing of those products.
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.

Regulations 15 and 15A

SCHEDULE 1BE+WMaximum 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 1831/2003, 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 1N 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 tracer50
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 origin1
Feed materials of animal origin2
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 agents2
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
–otherwise.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 feed5
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 cereals1000

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 BS EN ISO 9167:2019 “Rapeseed and rapeseed meals. Determination of glucosinolates content. Method using high-performance liquid chromatography”. Published by the British Standards Institution on 30 June 2019 (ISBN 978 0 539 07739 1). Available from the British Standards Institution https://knowledge.bsigroup.com.

1. Free gossypolFeed materials20
with the exception of:
— cottonseed;6000
— cottonseed cakes and cottonseed meal.1200
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 poultry1000
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 it.4000
Complete feed150
with the exception of:
— complete feed for cattle (except calves), sheep (except lambs) and goats (except kids);1000
— complete feed for pigs (except piglets) and poultry.500

Table 4

Organochlorine compounds (except dioxins and polychlorinated biphenyls (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 fish0.05
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 the processing of it, except crude cotton seed oil;0.3
— soybean and products derived from the processing of it, 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. Hexachlorocyclohexane (HCH)

— alpha-isomers

Feed 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 polychlorinated biphenyls (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)

See Table 5 (Part 2) for TEFs (= toxic equivalency factors) for dioxins, furans and dioxin-like polychlorinated biphenyls (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 3.5ng WHO-PCDD/F-TEQ/kg product and 6.5ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20.0ng 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 75μg/kg product are applicable to fresh fish and 200μg/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 origin0.75
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 and crustacea meal.1.75
Feed additives belonging to the functional groups of binders and anti-cakingagents(4)0.75
Feed additives belonging to the functional group of compounds of trace elements1.0
Premixtures1.0
Compound feed0.75
with the exception of:
— compound feed for pet animals and fish;1.75
— compound feed for fur animals.
2. Sum of dioxins and dioxin-like polychlorinated biphenyls (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 origin1.0
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 hydrolysed fish protein containing more than 20% fat(3);4.0
— Hydrolysed fish protein 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 elements1.5
Premixtures1.5
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 feedMaximum content in μg/kg (ppb) relative to a feed with a moisture content of 12%(1)
3. Non-dioxin-like polychlorinated biphenyls (PCBs) (sum of PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180 (ICES – 6) (1))Feed materials of plant origin10
Feed materials of mineral origin10
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 hydrolysed fish protein containing more than 20% fat(5);30
— Hydrolysed fish protein 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 elements10
Premixtures10
Compound feed10
with the exception of:
— compound feed for pet animals and fish;40
— compound feed for fur animals.

Table 5 (Part 2)

TEFs (= toxic equivalency factors) for dioxins, furans and dioxin-like polychlorinated biphenyls (PCBs), for the purposes of Table 5.1 footnote (2)

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’ polychlorinated biphenyls (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 clean the grains and seeds containing non-compliant levels of Ambrosia spp. seeds 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 level of Ambrosia spp. seeds in order to take additional prevention measures to avoid dissemination into the environment, and
-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.
Where these conditions are not fulfilled, the consignment must be cleaned before it is transported into Wales 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 including:Feed materials and compound feed3000
Datura sp.1000
2. Crotalariaspp.Feed materials and compound feed100
3. Seeds and husks from Ricinus communis L.,Croton tiglium L. andAbrus precatoriusL. as well as their processed derivatives(1), separately or in combinationFeed materials and compound feed10(2)
4. Unhusked beech mast —Fagus sylvatica L.Feed materials and compound feedSeeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
5. Purghera — Jatropha curcasL.Feed materials and compound feedSeeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable.
6. Seeds fromAmbrosiaspp.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.junceavar.luteaBatalin

—Black mustard —Brassica nigra(L.) Koch

—Ethiopian mustard —Brassica carinataA. Braun

Feed materials and compound feedSeeds 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 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 materials0.4
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 materials0.03
Compound feed for:
— laying birds and chickens reared for laying (> 16 weeks);0.03
— rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed);0.03
— other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening, guinea fowl and turkeys for fattening.0.09
Premixtures for use in feed in which the use of diclazuril is not authorised(2)
3. Halofuginone hydrobromideFeed materials0.03
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 materials1.25
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 materials0.05
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 materials1.25
Compound feed for:
— equine species, dogs, small ruminants (sheep and goat), ducks, bovine species, 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 materials0.7
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 materials1.25
Compound feed for:
— equine species, laying birds and chickens reared for laying (> 16 weeks);1.25
— other animal species.1.25
Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised(2)
9. Robenidine hydrochlorideFeed materials0.7
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 materials0.7
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 materials0.25
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

Regulations 15 and 15A

SCHEDULE 1CE+WAction thresholds triggering investigations

Table 1 (part 1)

Dioxins and polychlorinated biphenyls (PCBs)

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

See Table 1 (part 2) for TEFs (= toxic equivalency factors) for dioxins, furans and dioxin-like polychlorinated biphenyls (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)

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., must 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)(2))Feed materials of plant origin0.5(3)
with the exception of:
— vegetable oils and their by-products.0.5(3)
Feed materials of mineral origin0.5(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 and crustacea meal.1.25(4)
Feed additives belonging to the functional groups of binders and anti-caking agents0.5(3)
Feed additives belonging to the functional group of compounds of trace elements0.5(3)
Premixtures0.5(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 polychlorinated biphenyls (PCBs) (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 2005) (2))Feed materials of plant origin0.35(3)
with the exception of:
— vegetable oils and their by-products.0.5(3)
Feed materials of mineral origin0.35(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 hydrolysed fish protein containing more than 20% fat(3);2.0(4)
— Hydrolysed fish protein containing more than 20% fat.5.0(4)
Feed additives belonging to the functional groups of binders and anti-caking agents0.5(3)
Feed additives belonging to the functional group of compounds of trace elements0.35(3)
Premixtures0.35(3)
Compound feed0.5(3)
with the exception of:
— compound feed for pet animals and fish;2.5(4)
— compound feed for fur animals.

Table 1 (Part 2)

TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like polychlorinated biphenyls (PCBs), for the purposes of Table 1 (Part 1) footnote (2)

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’ polychlorinated biphenyls (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.]

Regulation 21

SCHEDULE 2E+WRevocations

RegulationsExtent
The Genetically Modified Animal Feed (Wales) Regulations 2004 (S.I. 2004/3221) (W. 277)The whole Regulations
The Feed (Corn Gluten Feed and Brewers Grains) (Emergency Control) (Wales) (Revocation) Regulations 2007 (S.I. 2007/3173) (W. 278)The whole Regulations
The Animal Feed (Wales) Regulations 2010 (S.I. 2010/2652) (W. 220)The whole Regulations other than regulations 1, 2 and 14.

Explanatory Note

(This note is not part of the Regulations)

These Regulations, which apply in relation to Wales only —

(a)

provide for the continuing enforcement or implementation of EU Regulations and Directives on feed safety, genetically modified feed, feed additives, the marketing and use of feed, undesirable substances (contaminants) in feed and feed for particular nutritional purposes;

(b)

provide for ambulatory references to the EU instruments specified in regulation 2(3);

(c)

prescribe offences and penalties for failure to comply with the Regulations; and

(d)

revoke or make consequential amendments to certain Regulations.

In Part 2 these Regulations provide for the enforcement of specified provisions 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 (OJ No L 31, 1.2.2002, p 1) by making it an offence to contravene those provisions (regulation 4) and by designating the competent authorities for the purposes of that EU instrument (regulation 5).

In Part 3 these Regulations provide for the enforcement of specified provisions of Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ No L 268, 18.10.2003, p 1) (regulations 7 and 8).

In Part 4 these Regulations provide for the enforcement of specified provisions of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (OJ No L 268, 18.10.2003, p 29) (regulation 10).

In Part 5 these Regulations provide for the enforcement 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 (OJ No L 229, 1.9.2009, p 1) (regulations 12 and 13 and Schedule 1).

In Part 6 these Regulations implement Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed (OJ No L 140, 30.5.2002, p 10) (regulations 14 and 15).

In Part 7 these Regulations implement Commission Directive 2008/38/EC establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes (OJ No L 62, 6.3.2008, p 9), (regulation 16 and 17).

In Part 8 these Regulations prescribe the maximum penalties that a court may impose on conviction for an offence under these Regulations (regulation 18) and designate local feed authorities as having the duty to enforce (regulation 19).

In Part 9 these Regulations make consequential amendments to the Official Feed and Food controls (Wales) Regulations 2009 (regulation 20) and revoke wholly or partially certain instruments (regulation 21 and Schedule 2).

The Welsh Ministers' Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, a regulatory impact assessment has been prepared as to the likely costs and benefits of complying with these Regulations. A copy can be obtained from the Food Standards Agency at Food Standards Agency Wales, 11th Floor, Southgate House, Wood Street, Cardiff, CF10 1EW or from the Agency's website at www.food.gov.uk/wales.