1. This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
2. It shall apply from 12 months after the date of publication of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 September 2003.
For the European Parliament
The President
P. COX
For the Council
The President
R. BUTTIGLIONE
(1) OJ C 203 E, 27.8.2002, p. 10.
(2) OJ C 61, 14.3.2003, p. 43.
(3) Opinion of the European Parliament of 21 November 2002 (not yet published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 1), Decision of the European Parliament of 19 June 2003 (not yet published in the Official Journal) and Council Decision of 22 July 2003.
(4) OJ L 31, 1.2.2002, p. 1.
(5) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).
(6) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
(7) OJ L 40, 11.2.1989, p. 27. Directive amended by Directive 94/34/EC of the European Parliament and of the Council (OJ L 237, 10.9.1994, p. 1).
(8) See page 1 of this Official Journal.
(9) OJ L 184, 17.7.1999, p. 23.
(10) OJ L 86, 6.4.1979, p. 30. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
(11) OJ L 64, 7.3.1987, p. 19. Directive as last amended by Commission Directive 2001/79/EC (OJ L 267, 6.10.2001, p. 1).
(12) OJ L 311, 28.11.2001, p. 1.
(13) OJ L 125, 23.5.1996, p. 35. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(14) OJ L 115, 4.5.1999, p. 32. Directive as last amended by Regulation (EC) No 806/2003.
(15) OJ L 126, 13.5.1983, p. 23.
(16) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive as last amended by Regulation (EC) No 806/2003.
(17) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1490/2003 (OJ L 214, 26.8.2003, p. 3).
(18) See page 24 of this Official Journal.
(19) OJ L 125, 23.5.1996, p. 10.
(20) OJ L 145, 31.5.2001, p. 43.
ANNEX I
ADDITIVE GROUPS
1.
In the category ‘technological additives’, the following functional groups are included:
(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.
2.
In the category ‘sensory additives’, the following functional groups are included:
(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:
(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:
(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.
ANNEX II
DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY
1.
The Community reference laboratory referred to in Article 21 is the Joint Research Centre of the Commission (JRC).
2.
For the tasks outlined in this Annex, the JRC may be assisted by a consortium of national reference laboratories.
The JRC shall be notably responsible for:
—
the reception, preparation, storage and maintenance of the reference samples;
—
the testing and evaluation or validation of the method for detection;
—
evaluating the data provided by the applicant for authorisation to place the feed additive on the market, for the purpose of testing and evaluation or validation of the method for detection;
—
submitting full evaluation reports to the Authority.
3.
The Community reference laboratory shall play a role in dispute settlements between Member States concerning the results of the tasks outlined in this Annex.
ANNEX III
SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND FOR PREMIXTURES
(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.
ANNEX IV
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.
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.
3.
Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for complete feedingstuffs.
4.
In the case of premixtures containing silage additives the words ‘of silage additives’ must clearly be added on the label after ‘PREMIXTURE’.