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Statutory Instruments

2015 No. 255

Agriculture, England

The Animal Feed (Composition, Marketing and Use) (England) Regulations 2015

Made

25th February 2015

Laid before Parliament

5th March 2015

Coming into force

6th April 2015

The Secretary of State makes the following Regulations in exercise of the powers conferred on him by sections 66(1), 68(1), 74A(1) and 84 of the Agriculture Act 1970(1), as read with regulation 14 of the Food Standards Act 1999 (Transitional and Consequential Provisions and Savings) (England and Wales) Regulations 2000(2).

In so far as these Regulations cannot be made under the powers in the Agriculture Act 1970 specified above, the Secretary of State makes these Regulations in exercise of his powers as a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to the common agricultural policy of the European Union(4), the control and regulation of genetically modified organisms(5), measures in the veterinary and phytosanitary fields for the protection of public health(6) and measures relating to feed produced for or fed to food-producing animals(7), as read with paragraph 1A of Schedule 2 to that Act.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State 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 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(8) or, in the case of provisions relating to feed for non food-producing animals, of section 84(1) of the Agriculture Act 1970.

PART 1E+WIntroductory and general

Modifications etc. (not altering text)

Title, application and commencementE+W

1.  These Regulations may be cited as the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015, apply in relation to England only and come into force on 6th April 2015.

Commencement Information

I1Reg. 1 in force at 6.4.2015, see reg. 1

Interpretation and scopeE+W

2.—(1) In these Regulations —

F1...

F2...

“Regulation 178/2002” means 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;

“Regulation 1829/2003” means Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed(9);

[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 as last amended by Commission Regulation (EU) 2015/2294 amending Regulation (EC) No. 1831/2003 of the European Parliament and of the Council as regards the establishment of a new functional group of feed additives];

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(10);

[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;]

“the Agency” means the Food Standards Agency;

“feed authority” means an authority identified in section 67(1) of the Agriculture Act 1970 as having the duty to enforce Part IV of that Act within its area or district as the case may be.

(2) Any expression used in these Regulations and in Regulation 178/2002, Regulation 1831/2003 [F6Regulation 767/2009 or Regulation 2020/354] has the meaning in these Regulations that it bears in the [F7retained] EU Regulation concerned.

[F8(3) Any reference to an F9... instrument defined in paragraph (1) is a reference to that F9... 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(11).

Textual Amendments

Commencement Information

I2Reg. 2 in force at 6.4.2015, see reg. 1

PART 2E+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.

Commencement Information

I3Reg. 3 in force at 6.4.2015, see reg. 1

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 they relate to feed business operators; and

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

Commencement Information

I4Reg. 4 in force at 6.4.2015, see reg. 1

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 or district; and

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

Commencement Information

I5Reg. 5 in force at 6.4.2015, see reg. 1

PART 3E+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.

Commencement Information

I6Reg. 6 in force at 6.4.2015, see reg. 1

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)(12) unless it is covered by an authorisation and satisfies relevant conditions), as read with Article 20(6) F10...;

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

(c)Article 21(3) F11...; and

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

Textual Amendments

Commencement Information

I7Reg. 7 in force at 6.4.2015, see reg. 1

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.

Commencement Information

I8Reg. 8 in force at 6.4.2015, see reg. 1

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.

Commencement Information

I9Reg. 9 in force at 6.4.2015, see reg. 1

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

10.—[F12(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 subparagraph (a) or (e) 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 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 [F13Food 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

Commencement Information

I10Reg. 10 in force at 6.4.2015, see reg. 1

PART 5E+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.

Commencement Information

I11Reg. 11 in force at 6.4.2015, see reg. 1

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

12.—(1) ) Subject to the transitional provisions contained in Article 32, a 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 [F14Schedule 3] may be indicated.

Textual Amendments

Commencement Information

I12Reg. 12 in force at 6.4.2015, see reg. 1

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

13.—(1) Each feed authority in its area or district 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 —

F15(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)Article 13(1)(b) as the competent authority that may submit to the [F16appropriate authority] doubts concerning the scientific substantiation of a claim.

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

Textual Amendments

Commencement Information

I13Reg. 13 in force at 6.4.2015, see reg. 1

PART 6E+W[F17Undesirable substances in products intended for animal feed]

Textual Amendments

Modifications etc. (not altering text)

Interpretation of this PartE+W

14.  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.

Textual Amendments

Commencement Information

I14Reg. 14 in force at 6.4.2015, see reg. 1

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 [F19a table in Schedule 4]; or

(b)uses any such feed,

commits 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) 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 [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) A 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 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 [F25a table in Schedule 4] shall be deemed not to be 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) 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; F27...

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

[F28(e)peat;

(f)leonardite.]

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

[F29(9) In order to reduce or eliminate sources of undesirable substances in products intended for animal feed, feed authorities 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 Schedule 5.

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

(11) Where the Secretary of State has grounds to believe that a level fixed in Schedule 4 or 5, or an undesirable substance not listed in Schedule 4 or 5, presents a danger to animal or human health, or to the environment, the Secretary of State—

(a)may, pending amendment of Schedule 4 or 5—

(i)change an existing level;

(ii)introduce a level; or

(iii)prohibit the presence,

of the undesirable substance concerned in products intended for animal feed by issuing a direction; and

(b)must decide whether to make an amendment to Schedule 4 or 5 that corresponds with the direction issued under sub-paragraph (a).

(12) A direction issued under paragraph (11)(a)—

(a)must be in writing;

(b)may specify a period of time during which it has effect;

(c)may be revoked by the Secretary of State at any time, by way of a written notice;

(d)irrespective of any period of time specified under sub-paragraph (b), ceases to have effect upon the entry into force of any corresponding amendment of Schedule 4 or 5 made pursuant to paragraph (11)(b).

(13) A direction issued under paragraph (11)(a) and a revocation notice under paragraph (12)(c) must be published by the Secretary of State without delay.]

Textual Amendments

Commencement Information

I15Reg. 15 in force at 6.4.2015, see reg. 1

[F30RegulationsE+W

15A.—(1) The Secretary of State may, by regulations, make provision to—

(a)add, amend or remove an entry in Schedule 4 or 5;

(b)amend the acceptability criteria for detoxification processes in Regulation (EU) 2015/786.

(2) Any power to make regulations under this Part is exercisable by statutory instrument.

(3) A statutory instrument containing regulations is subject to annulment in pursuance of a resolution of either House of Parliament.

(4) Regulations made under this regulation may—

(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking retained direct EU legislation);

(b)make different provision for different purposes.]

Textual Amendments

[F31PART 7E+WEnforcement of Regulation 2020/354

Textual Amendments

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.

Control of feed intended for particular nutritional purposesE+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 measures for feed labelled before 25 March 2022 in accordance with the rules applicable before 25 March 2020) commits an offence.]

PART 8E+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 [F3217] is liable on summary conviction to a term of imprisonment not exceeding 3 months or to a fine not exceeding level 5 on the standard scale, 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.

Textual Amendments

Commencement Information

I16Reg. 18 in force at 6.4.2015, see reg. 1

Duties to enforceE+W

19.  It is the duty of each feed authority within its area or district to execute and enforce Regulation 178/2002, Regulation [F331829/2003], Regulation 1831/2003, Regulation 767/2009, [F34Regulation 2020/354] and these Regulations.

Textual Amendments

Commencement Information

I17Reg. 19 in force at 6.4.2015, see reg. 1

PART 9E+WAmendment and revocation

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

20.—(1) The Official Feed and Food Controls (England) Regulations 2009(13) 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 expression “the Animal Feed (England) Regulations 2010” substitute “the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015”.

Commencement Information

I18Reg. 20 in force at 6.4.2015, see reg. 1

RevocationsE+W

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

Commencement Information

I19Reg. 21 in force at 6.4.2015, see reg. 1

Statutory reviewE+W

22.—(1) The Food Standards Agency must from time to time —

(a)carry out a review of the operation and effect of regulations 1 to 19;

(b)set out the conclusions of the review in a report; and

publish the report.

F35(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The report must in particular -

(a)set out the objectives intended to be achieved by the regulatory system established by these Regulations;

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if they do, the extent to which they could be achieved with a system that imposes less regulation.

(4) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Textual Amendments

Commencement Information

I20Reg. 22 in force at 6.4.2015, see reg. 1

Signed by authority of the Secretary of State for Health.

Jane Ellison

Parliamentary Under-Secretary of State

Department of Health

25th February 2015

Regulation 12

[F36SCHEDULE 1E+WSpecified Provisions of Regulation 767/2009

Textual Amendments

Table 1

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 Annex 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 Annex 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 Annex 2, 6 & 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 21

SCHEDULE 2E+WRevocations

Commencement Information

I21Sch. 2 in force at 6.4.2015, see reg. 1

RegulationsExtent
The Genetically Modified Animal Feed (England) Regulations 2004 (S.I. 2004/2334)The whole Regulations
The Feed (Corn Gluten Feed and Brewers Grains) (Emergency Control) (England) (Revocation) Regulations 2007 (S.I. 2007/3007)The whole Regulations
The Animal Feed (England) Regulations 2010 (S.I. 2010/2503)The whole Regulations other than regulations 1, 2 and 14.

Regulation 12(2)

[F37SCHEDULE 3E+WCategories of feed materials which may be indicated in place of individual feed materials

Textual Amendments

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 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]

Regulations 15 and 15A

[F37SCHEDULE 4E+WMaximum levels of undesirable substances

Modifications etc. (not altering text)

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 trihydroxide50
— 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 animals2
— 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 materials

with the exception of:

150
— 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 feed

with the exception of:

150
— 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)

Feed

with the exception of:

2.5
— canned pet food2.5 (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 oil0.3
— soybean and products derived from its processing, except crude soybean oil0.5
— crude vegetable oil1.0
— complete feed for fish except for Salmonids0.005
— complete feed for  Salmonids0.05
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 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; 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
Premixtures1.0
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 feedMaximum 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-products1.5
Feed materials of mineral origin1.0
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat2.0
— Other land animal products including milk and milk products and eggs and egg products1.25
— Fish oil20.0
— 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 % fat9.0
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 fish5.5
— 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 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 fat10
— Other land animal products including milk and milk products and eggs and egg products10
— Fish oil175
— 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 % fat50
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 fish40
— 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 feed3 000
— Datura sp.1 000
2. Crotalaria spp.Feed materials and compound feed100
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 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 curcas 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
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 seeds50

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 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 (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 materials0.4
Compound feed for
— laying birds and chickens reared for laying (> 16 weeks);0.4
— other animal species1.2
Premixtures for use in feed in which the use of decoquinate is not authorised.(2)
2. DiclazurilFeed materials0.01
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 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, 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.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 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.(2)

Regulations 15 and 15A

[F37SCHEDULE 5E+WAction thresholds triggering investigations: dioxins and PCBs

Modifications etc. (not altering text)

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 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; 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 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-products0.5(3)
Feed materials of mineral origin0.35(3)
Feed materials of animal origin:
— Animal fat, including milk fat and egg fat0.75(3)
— Other land animal products including milk and milk products and eggs and egg products0.35(3)
— Fish oil11.0(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 % fat5.0(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 fish2.5(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, which apply in relation to England only —E+W

(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;

(d)revoke or make consequential amendments to certain Regulations; and

(e)provide for periodic review of the operation and effect of these Regulations.

2.  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. L131, 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).E+W

3.  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.L268, 18.10.2003, p.1) (regulations 7 and 8).E+W

4.  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.L268, 18.10.2003, p.29) (regulation 10).E+W

5.  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. L229, 1.9.2009, p.1) (regulations 12 and 13 and Schedule 1).E+W

6.  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. L140, 30.5.2002, p.10) (regulations 14 and 15).E+W

7.  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. L62, 6.3.2008, p.9), (regulation 16 and 17).E+W

8.  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).E+W

9.  In Part 9 these Regulations make consequential amendments to the Official Feed and Food controls (England) Regulations 2009 (regulation 20), revoke wholly or partially certain instruments (regulation 21 and Schedule 2), and provide for review within 5 years of the way in which these Regulations enforce or implement the relevant EU legislation (regulation 22).E+W

10.  A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Animal Feed, TSEs and Animal By-products Branch of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH and is annexed to the Explanatory Memorandum which is available alongside the instrument on the National Archives website.E+W

(1)

1970 c.40. Section 66(1) contains definitions of the expressions “the Ministers”, “prescribed” and “regulations”. The definition of “the Ministers” was amended by the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272), Schedule 5, paragraph 1. Functions of “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 paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (2006 c.32). Those functions, so far as exercisable in relation to Scotland, were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46). By virtue of S.I. 1999/3141, functions of the Secretaries of State for Wales and Scotland previously exercisable in relation to England ceased to be so exercisable and were transferred to the Minister of Agriculture, Fisheries and Food. Functions of the Minister of Agriculture were transferred to the Secretary of State by the Ministry of Agriculture, Fisheries and Food (Dissolution) Order 2002 (S.I .2002/794). Section 74A was inserted by the European Communities Act 1972 (1972 c. 68), Schedule 4, paragraph 6. Sections 66(1) and 84 were amended by S.I. 2004/3254. Section 66(1) was also amended by S.I. 2010/2280.

(3)

1972 c.68. Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 (2006 c.51) and amended by Part 1 of Schedule 1 to the European Union (Amendment) Act 2008 (2008 c.7).

(4)

S.I. 1972/1811, amended by S.I. 2002/794.

(8)

OJ No. L31, 1.2.2002, p.1, as last amended by Regulation (EU) No. 652/2014 of the European Parliament and of the Council (OJ No. L189, 27.6.2014, p.1).

(9)

OJ No.L268, 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. L97, 9.4.2008, p.64).

(10)

OJ No. L229, 1.9.2009, p.1. This Regulation was last amended by Commission Regulation (EC) No. 939/2010 (OJ No. L277, 21.10.2010, p.4).

(11)

Categories (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.

(12)

The 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.