Commission Regulation (EC) No 490/2004 of 16 March 2004 concerning the provisional authorization of a new use of an additive already authorized in feedingstuffs (Saccharomyces cerevisiae)

Before 1 January 1997, a ruling will be given in accordance with the procedure laid down in Article 24 of Directive 70/524/EEC on the dossiers referred to in Article 3 (b) concerning the authorization of additives in animal nutrition.

concerning the provisional authorization of a new use of an additive already authorized in feedingstuffs ( Saccharomyces cerevisiae )

whereas at the moment no criteria exist for the examination of requests for authorization for use as additives of this new generation of products;

This Directive shall apply without prejudice to Directive 70/524/EEC and particularly to the provisions concerning the authorization of enzymes, micro-organisms and their preparations for use as additives.

Before the two-year period stipulated in paragraph 1 (a) has expired the Member State may request the Commission to include in the list adopted in accordance with Article 3 the additive which had been the subject of national authorization pursuant to paragraph 1 of this Article.

'PROCEDURE FOR THE AUTHORIZATION OF ADDITIVES

Whereas experience has shown that the authorization of additives by means of directives causes considerable delays;

Community authorization of additives referred to in Article 2 (aaa) shall be valid for 10 years from the date on which final authorization takes effect and shall be renewable for 10-year periods.

Whereas, in order to put an end to the differences between Member States regarding the arrangements for admitting the additives in Annex II onto their territory, the provisional authorization of additives meeting a minimum number of conditions should be extended throughout the Community;

ARRANGEMENTS APPLICABLE TO AUTHORIZATION OF OTHER ADDITIVES

Community authorization of an additive shall be given only if:

A regulation shall be adopted to withdraw the authorization of an additive:

Whereas rules for harmonization in the field of additives should not affect the application of provisions of Member States existing on 1 January 1992, which prohibit the use of certain additives in certain specific foodstuffs which are considered as traditional and are produced on their territory, provided that those provisions do not cover a whole series of foodstuffs including foodstuffs which do not come under this Directive but regarding which Community provisions provide for authorization of additives;

Presentation of an application for assessment of a food additive prior to its authorization.

specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs on authorization of the additive;

specific name given to the additive upon authorization, and active substance level, provided that a maximum level is fixed for complete feedingstuffs upon authorization of the additive;

specific name given to the additive upon authorization, and level of the various elements insofar as a maximum level is fixed for complete feedingstuffs upon authorization of the additive;

Whereas pursuant to the provisions of Council Directive 93/114/EC (4) it is necessary to include in the Community procedure for the authorization of additives the requirements of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (5), as amended by Commission Directive 94/15/EC (6) for a specific environmental-risk evaluation, in order that they may be applicable to all additives containing or consisting of genetically modified organisms;

if any of the conditions for the authorization of the additive referred to in Article 3a are no longer met,

use of the words "with antioxidant" followed by the specific name given to the additive upon authorization,

the specific name of the additive in accordance with the authorization given and level of the various elements;

'This information must be in accordance with the conditions of use prescribed upon authorization of the additive.`.

In accordance with the procedure laid down in Article 23, authorizations of the additives referred to in Article 1:

to ascertain whether the additive put into circulation actually corresponds to the additive described in the dossier on the basis of which the Community authorization was granted.

use of the words "colourant" or "coloured with" followed by the specific name given to the additive upon authorization,

Unless the mixture concerned is the subject of a specific authorization as an additive, Member States shall require that:

The additives referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization;

use of the words "preservative" or "preserved with" followed by the specific name given to the additive upon authorization,

The additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization;

In accordance with the procedure laid down in Article 23, provisional authorizations of the additives referred to in paragraph 1:

list of other additives authorized on a provisional basis for no longer than four years or five years in the case of additives which have been the subject of provisional authorization before 1 April 1998.`

the specific name given to the additive upon authorization, the EC registration number of the additive and, in the case of an additive within the meaning of Article 2 (aaa), the trade name and the registration number given to the person responsible for putting it into circulation;

The provisions of paragraph 3 shall also apply to the use of data from a dossier concerning an additive which has been the subject of withdrawal of authorization at the request of the holder of that authorization.

whereas such authorizations become definitive for certain additives or are valid for a period of 10 years for other additives when all the conditions for authorization are fulfilled, although that may occur no later than the date of expiry of the period of provisional authorization;

Where, for reasons beyond the control of the authorization holder, no decision may be taken on the renewal application before the expiry date of the authorization, the period of authorization of the additive shall be automatically extended until the Commission takes a decision.

additives not subject to authorization linked to the person responsible for putting them into circulation and referred to in Part II of Annex C;`

Any application for authorization of an additive or a new usage for an additive shall be supported by a dossier which should include detailed reports presented in the order and with the numbering proposed in these guidelines.

The period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above.

the period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above.

Additives as referred to in Article 2 (aaa) included in Annex II before 1 April 1998 may continue to be the subject of national provisional authorizations;

Additives as referred to in Article 2 (aaa), included in Annex II before 1 April 1998, may continue to be the subject of national provisional authorizations;

Whereas the investigation of various additives currently listed in Annex II and therefore capable of authorization at national level has not yet been completed;

With a view to their re-evaluation, the additives as referred to in paragraph 1 must, before 1 October 1998, be the subject of new applications for authorization;

specific name given to the additive upon authorization, alpha-tocopherol level and expiry date of the guarantee of that level or storage life from the date of manufacture;

specific name given to the additive upon authorization, active substance level and expiry date of the guarantee of that level or storage life from the date of manufacture;

from the date on which the first authorization by means of regulation takes effect for the additives referred to in Article 9g (1), Article 9h (1) and Article 9i (1), or