COMMISSION REGULATION (EC) No 2439/1999
of 17 November 1999
on the conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(1), as last amended by Commission Regulation (EC) No 1636/1999(2), and in particular Article 11 thereof,
Whereas:
(1) kaolinitic clays originating from certain mines situated in the Federal Republic of Germany have been found to contain extremely high levels of dioxins. According to available information, this could be a contamination of geological origin;
(2) under Article 11 of Directive 70/524/EEC, a Member State which, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, finds that the use of one of the additives listed in the Directive constitutes a danger to animal or human health or the environment may temporarily suspend the authorisation to use that additive;
(3) several Member States have prohibited the use of contaminated kaolinitic clays in pre-mixtures and feedingstuffs;
(4) under Article 3a(b) of Directive 70/524/EEC, authorisation of an additive is to be given only if, taking account of the conditions of use, it does not adversely affect human or animal health or the environment;
(5) the use of feedingstuffs contaminated with dioxins may contaminate foodstuffs of animal origin. Dioxins are classified as a human carcinogen by recognised international organisations. These organisations recommend that measures are taken to reduce the ingestion of dioxins through food as much as possible;
(6) contaminated additives should be avoided as much as possible;
(7) a complete risk assessment cannot be carried out for lack of adequate scientific data. In view of the need for urgent measures to prevent an unacceptable degree of contamination of feedingstuffs and pending the results of the monitoring programme on clays and the risk assessment, the acceptable level of dioxins in kaolinitic clays should be restricted by way of precaution to the analytical limit of determination. This limit may be reviewed in the light of the results of any investigations carried out and of the monitoring programme;
(8) the contamination of kaolin found in Germany could in fact also concern other additives authorised for use as binders, anti-caking agents and coagulants under Directive 70/524/EEC, as indicated by the fact that ball clay, sedimentary clays containing other minerals besides kaolin, originating from a mine in the United States has also been shown to be heavily naturally contaminated by dioxins of geological origin. It is appropriate to examine in the frame of the monitoring programme the possible presence of dioxins in all these authorised additives. It is foreseen for the time being to apply a provisional maximum limit only for the kaolinitic clays, the analytical limit of determination will apply as the maximum limit after a well-defined period of time for the additives other than the kaolinitic clays in the absence of the establishment, if required, of a specific maximum limit based on sufficient data concerning the presence of dioxins;
(9) the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,
The conditions for the authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" referred to in the Annex to this Regulation are hereby replaced by those set out in the Annex hereto in accordance with Directive 70/524/EEC.
The Commission shall re-examine the provisions of this Regulation before 1 March 2000 in the light of any investigations carried out and of the results of the monitoring programme.
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.