Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilShow full title

ANNEX I U.K. ADDITIVE GROUPS

1. In the category ‘technological additives’, the following functional groups are included: U.K.

(a)

preservatives: substances or, when applicable, micro-organisms which protect feed against deterioration caused by micro-organisms or their metabolites;

(b)

antioxidants: substances prolonging the storage life of feedingstuffs and feed materials by protecting them against deterioration caused by oxidation;

(c)

emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more immiscible phases in feedingstuffs;

(d)

stabilisers: substances which make it possible to maintain the physico-chemical state of feedingstuffs;

(e)

thickeners: substances which increase the viscosity of feedingstuffs;

(f)

gelling agents: substances which give a feedingstuff texture through the formation of a gel;

(g)

binders: substances which increase the tendency of particles of feedingstuffs to adhere;

(h)

substances for control of radionucleide contamination: substances that suppress absorption of radionucleides or promote their excretion;

(i)

anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere;

(j)

acidity regulators: substances which adjust the pH of feedingstuffs;

(k)

silage additives: substances, including enzymes or micro-organisms, intended to be incorporated into feed to improve the production of silage;

(l)

denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identification of the origin of specific food or feed materials;

(m)

[F1 substances for reduction of the contamination of feed by mycotoxins: substances that can suppress or reduce the absorption, promote the excretion of mycotoxins or modify their mode of action [F2 ;] ]

(n)

[F3 hygiene condition enhancers: substances or, when applicable, microorganisms which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination [F4 ;] ]

(o)

[F5 other technological additives: substances or, when applicable, microorganisms added to feed for a technological purpose and which favourably affect the characteristics of the feed.]

Textual Amendments

F1 Inserted by Commission Regulation (EC) No 386/2009 of 12 May 2009 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 (Text with EEA relevance).

F2 Substituted by Commission Regulation (EU) 2015/2294 of 9 December 2015 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 (Text with EEA relevance).

F3 Inserted by Commission Regulation (EU) 2015/2294 of 9 December 2015 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 (Text with EEA relevance).

F4 Substituted by Commission Regulation (EU) 2019/962 of 12 June 2019 amending Annex I to Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of two new functional groups of feed additives (Text with EEA relevance).

F5 Inserted by Commission Regulation (EU) 2019/962 of 12 June 2019 amending Annex I to Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the establishment of two new functional groups of feed additives (Text with EEA relevance).

2. In the category ‘sensory additives’, the following functional groups are included: U.K.

(a)

colourants:

(i)

substances that add or restore colour in feedingstuffs;

(ii)

substances which, when fed to animals, add colours to food of animal origin;

(iii)

substances which favourably affect the colour of ornamental fish or birds;

(b)

flavouring compounds: substances the inclusion of which in feedingstuffs increases feed smell or palatability.

3. In the category ‘nutritional additives’, the following functional groups are included: U.K.

(a)

vitamins, pro-vitamins and chemically well-defined substances having similar effect;

(b)

compounds of trace elements;

(c)

amino acids, their salts and analogues;

(d)

urea and its derivatives.

4. In the category ‘zootechnical additives’, the following functional groups are included: U.K.

(a)

digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through action on target feed materials;

(b)

gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora;

(c)

substances which favourably affect the environment;

(d)

other zootechnical additives[F4 ;]

(e)

[F5 physiological condition stabilisers: substances or, when applicable microorganisms, which, when fed to animals in good health, favourably affect their physiological condition, including their resilience to stress factors.]

ANNEX II U.K. DUTIES AND TASKS OF THE F6 ... REFERENCE LABORATORY

Textual Amendments

F6 Word in Annex 2 heading omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(a); 2020 c. 1, Sch. 5 para. 1(1)

1. F7 ... U.K.

Textual Amendments

F7 Annex 2 point 1 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(b); 2020 c. 1, Sch. 5 para. 1(1)

[F8 1A. The reference laboratory may be assisted by scientific experts or official laboratories with the performance of the duties and tasks set out in this Annex.] U.K.

Textual Amendments

F8 Annex 2 point 1A inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(10)(a)

[F9 2. F10 ... U.K.

The [F11 reference laboratory] shall be responsible for:

Textual Amendments

F11 Words in Annex 2 point 2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

2.1.

the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);

2.2.

evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official control in accordance with the requirements of the implementing rules referred to in Article 7(4) [F12 , (6), and (7)] and the guidance of the [F13 Food Safety Authority] referred to in Article [F14 7(8)];

2.3.

submitting a full evaluation report to the [F15 Food Safety Authority] on the results of the duties and tasks referred to in this Annex;

2.4.

where necessary, the testing of the method(s) of analysis.

Textual Amendments

F12 Words in Annex 2 point 2.2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Annex 2 point 2.2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in Annex 2 point 2.2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(d)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Annex 2 point 2.3 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(e); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F9 Substituted by Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (Text with EEA relevance).

F10 Words in Annex 2 point 2 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

3. The [F16 reference laboratory is] responsible for coordination of the validation of the method(s) of analysis of the additive, in accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005 (1). This task may involve the preparation of food or feed test material. U.K.

Textual Amendments

F16 Words in Annex 2 point 3 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(f); 2020 c. 1, Sch. 5 para. 1(1)

4. The [F17 reference laboratory must] provide scientific and technical assistance to the [F18 appropriate authority], especially in cases where [F19 there are reasonable grounds to] contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role defined for it under [F20 Regulation (EU) 2017/625]. U.K.

Textual Amendments

F17 Words in Annex 2 point 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(g)(i); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Annex 2 point 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(g)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Annex 2 point 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(g)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F20 Words in Annex 2 point 4 substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(10)(b)

5. On request by the [F21 appropriate authority], the [F22 reference laboratory] may also be responsible for conducting special analytical or other related studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for existing products notified under Article 10 and included in the Register and for the period until an application for authorisation under Article 10(2) is submitted in accordance with Article 10(2). U.K.

Textual Amendments

F21 Words in Annex 2 point 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(h)(i); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Annex 2 point 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(h)(ii); 2020 c. 1, Sch. 5 para. 1(1)

[F23 6. The reference laboratory shall: U.K.

(a)

be responsible for the overall coordination of scientific experts or official laboratories; and

(b)

ensure that the relevant data concerning the applications are made available to the scientific experts or official laboratories.]

Textual Amendments

F23 Annex 2 point 6 inserted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(10)(c)

7. Without prejudice to the responsibilities of the [F24 reference laboratory] laid down in [F25 Regulation (EU) 2017/625], the [F26 reference laboratory] may create and maintain a database of methods of analysis available for control of feed additives and make it available to F27 ... other interested parties.] U.K.

Textual Amendments

F24 Words in Annex 2 point 7 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(j)(i); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Annex 2 point 7 substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(10)(d)

F26 Words in Annex 2 point 7 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(j)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F27 Words in Annex 2 point 7 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 33(j)(iii); 2020 c. 1, Sch. 5 para. 1(1)

[F28 ANNEX III U.K.

Textual Amendments

F28 Substituted by Commission Regulation (EU) 2015/327 of 2 March 2015 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 (Text with EEA relevance).

1. SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN ADDITIVES AND FOR PREMIXTURES. U.K.

(a)

Zootechnical additives, coccidiostats and histomonostats:

• the expiry date of the guarantee or the storage life from the date of manufacture,

• the directions for use, and

• the concentration.

(b)

Enzymes, in addition to the abovementioned indications:

• the specific name of the active component or components in accordance with their enzyme activities, in conformity with the authorisation given,

• the International Union of Biochemistry identification number, and

• instead of concentration: units of activity (units of activity per gram or units of activity per millilitre).

(c)

Micro-organisms:

• the expiry date of the guarantee or the storage life from the date of manufacture,

• the directions for use,

• the strain identification number, and

• the number of colony-forming units per gram.

(d)

Nutritional additives:

• the active-substance level, and

• the expiry date of the guarantee of that level or storage life from the date of manufacture.

(e)

Technological and sensory additives with the exception of flavouring compounds:

• the active substance level.

(f)

Flavouring compounds:

• the incorporation rate in premixtures.

2. ADDITIONAL LABELLING AND INFORMATION REQUIREMENTS FOR CERTAIN ADDITIVES CONSISTING OF PREPARATIONS AND PREMIXTURES CONTAINING SUCH PREPARATIONS. U.K.

(a)

Additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:

(i)

the indication on the packaging or container of the specific name, the identification number and the level of any technological additive contained in the preparation for which maximum levels are set in the corresponding authorisation;

(ii)

the following information via any written medium or accompanying the preparation:

• the specific name and the identification number of any technological additive contained in the preparation, and

• the name of any other substance or product contained in the preparation, indicated in descending order by weight.

(b)

Premixtures containing additives belonging to the categories referred to in Article 6(1)(a), (b) and (c) and consisting of preparations:

(i)

if appropriate, the indication on the packaging or container that the premixture contains technological additives included in additive preparations, for which maximum levels are set in the corresponding authorisation;

(ii)

upon request from the purchaser or the user, information on the specific name, the identification number and an indication of the level of technological additives referred to in point (i) of this paragraph included in the additive preparations.]

ANNEX IV U.K. GENERAL CONDITIONS OF USE

1. The quantity of additives that also exists in the natural state in certain feed materials shall be calculated so that the total of the elements added and the elements present naturally does not exceed the maximum level provided for in the authorisation Regulation. U.K.

2. Mixing of additives shall be permitted only in premixtures and feedingstuffs where there is physico-chemical and biological compatibility between the components of the mixture in relation to the effects desired. U.K.

3. Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for [F29 complete feed]. U.K.

Textual Amendments

F29 Words in Annex 4 point 3 substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 8(11)

4. In the case of premixtures containing silage additives the words ‘of silage additives’ must clearly be added on the label after ‘PREMIXTURE’. U.K.

[F30 5. Technological additives or other substances or products contained in additives consisting of preparations shall only modify the physico-chemical characteristics of the active substance of the preparation and shall be used in accordance with their conditions of authorisation where such provisions are provided for. U.K.

Physico-chemical and biological compatibility between the components of the preparation shall be ensured in relation to the effects desired.]

Textual Amendments

F30 Inserted by Commission Regulation (EU) 2015/327 of 2 March 2015 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 (Text with EEA relevance).

(1)

[F9 OJ L 59, 5.3.2005, p. 8 .]

Textual Amendments

F9 Substituted by Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (Text with EEA relevance).