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Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (Text with EEA relevance)

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Changes and effects yet to be applied to :

  • Regulation applied (with modifications) by S.I. 2023/959 reg. 4(a) Sch. 1
  • Art. 7 para. 2 Point (c) replacement by EUR 2019/1381 Regulation (This amendment by the EU not applied to legislation.gov.uk because it is brought into force after IP completion day.)
  • Art. 7 para. 1 replacement by EUR 2019/1381 Regulation (This amendment by the EU not applied to legislation.gov.uk because it is brought into force after IP completion day.)
  • Art. 16(1) words substituted by S.I. 2019/654 reg. 24(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 24(a)(i) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 12(4))
  • Art. 18 replacement by EUR 2019/1381 Regulation (This amendment by the EU not applied to legislation.gov.uk because it is brought into force after IP completion day.)

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  • Art. 2(2)(o)-(t) inserted by S.I. 2019/654 reg. 10(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 10(a)(ii) substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 12(3))
  • Art. 18A(4)(d) words substituted by S.I. 2019/1013 reg. 32 (This amendment not applied to legislation.gov.uk. S.I. 2019/1013 revoked immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 21(e))

ANNEX IU.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)

[F1substances 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)

[F3hygiene condition enhancers: substances or, when applicable, microorganisms which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination [F4;] ]

(o)

[F5other 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

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)

[F5physiological 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 IIU.K.DUTIES AND TASKS OF THE F6... REFERENCE LABORATORY

Textual Amendments

1.F7...U.K.

Textual Amendments

[F81A.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

[F92. F10...U.K.

The [F11reference laboratory] shall be responsible for:

Textual Amendments

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 [F13Food Safety Authority] referred to in Article [F147(8)];

2.3.

submitting a full evaluation report to the [F15Food 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

Textual Amendments

3. The [F16reference 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

4. The [F17reference laboratory must] provide scientific and technical assistance to the [F18appropriate authority], especially in cases where [F19there 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 [F20Regulation (EU) 2017/625]. U.K.

Textual Amendments

5. On request by the [F21appropriate authority], the [F22reference 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

[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

7. Without prejudice to the responsibilities of the [F24reference laboratory] laid down in [F25Regulation (EU) 2017/625], the [F26reference 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

[F28ANNEX III U.K.

Textual Amendments

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 IVU.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 [F29complete feed].U.K.

Textual Amendments

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.

[F305. 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

Textual Amendments

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