FSA Consultation Letter, 14 February 2003

ANIMAL FEED/CONTAMINANTS - New EC Proposals for Maximum Levels of Dioxins

Background

There is a wide range of EC rules that apply to the composition and marketing of animal feeds. These include a list of authorised feed additives, rules on the labelling of the content of manufactured feeds and controls on undesirable substances (contaminants).

Directive 1999/29 provides rules on undesirable substances in feeds and its Annexes sets various MPLs for such substances (e.g. lead, arsenic). These Annexes were amended last year (by way of Directive 2001/102/EC) to introduce MPLs for dioxins in a range of compound (manufactured) feeds and feed materials (used as ingredients or fed singly to animals).

A number of the general controls on undesirable substances in feeds have also been recently revised and strengthened and these are set out in Council Directive 2002/32/EC. This comes into force on 1st August 2003 and replaces Directive 1999/29/EC and we will consult you shortly on its implementation into national legislation.

New Commission Proposal

A copy of the proposed draft Commission amending Directive is available on the FSA web site (SANCO/1014/2002 rev1). This has three main purposes:

• when Directive 2002/32/EC was adopted, it did not contain the dioxin MPLs set out in 2001/102/EC. To ensure continuing application of these MPLs, the amending Directive links the levels to 2002/32/EC;
  
• revised MPLs for certain binders and new MPLs for trace elements. Previous measures, consolidated in Directive 2001/102/EC set provisional MPLs for kaolinitic clays and some other additives authorised for use as binders, anti-caking agents and coagulants. It is proposed that these levels be revised from 0.5 ng (nanograms) WHO-PCDD/F-TEQ/kg to 1.0ng WHO-PCDD/F-TEQ/kg. In addition new MPLs for trace elements authorised for use in animal feeds (iron, iodine, cobalt, copper, manganese, zinc and molybdenum) are proposed at 1.0 ng/kg;
  
• a new MPL of 0.75 ng/kg is introduced for all premixtures (premixtures are mixtures of additives, often with a carrier, for incorporation into compound feeds).

Discussion

The FSA have carried out some estimates of the implications of the proposed MPL of 1 ng/kg for trace elements, to ensure that it is sufficient to protect feed and food safety and to assess its consistency with the existing MPLs for compound (manufactured) feeds. The calculations assumed that the range of authorised trace elements is used in a feed at the maximum levels permitted for these additives and that each additive had a dioxin content at the MPL of 1 ng/kg. This usage would only contribute about 0.002 ng/kg to the level of dioxins in the final feed (assuming there is no other dioxin contamination from other sources). This is a very small fraction of the MPL for compound feeds of 0.75 ng/kg.

The existing MPL for binders etc., (of 0.5 ng/kg) was set at about the level of determination (i.e. the lowest level that it was possible to measure reliably the levels of dioxins in such material) rather than on any assessment of risk. Again we have carried out some calculations on the implications of the proposed increase of the MPL to 1 ng/kg. The calculations assume that feed binders are typically incorporated in compound feeds at 2% and have a dioxin content at the MPL of 1 ng/kg. This usage would contribute 0.02 ng/kg to the level of dioxins in the final feed. This again is well below the MPL for compound feeds.

Therefore premixtures and binders complying with the proposed new MPLs are unlikely to have a significant impact on feed and food safety.

However, it is not clear on what basis the Commission has set the proposed MPLs and whether it has undertaken its risk assessment to justify the limits. We will raise this point in further discussions. This is particularly relevant to the new MPL for premixtures which is set at the same level as that for compound feeds.

Comments

This proposal largely places responsibilities on businesses that manufacture, market or use certain feed additives. However it is designed to strengthen feed and food safety and ultimately affects consumers of animal products. The FSA would therefore be grateful to receive comments from a wide range of organisations which may have an interest.

The proposed Directive may be discussed and possibly voted upon at the Standing Committee on Animal Feeds meeting scheduled for 19-20 March.