The European Commission has put forward to the Standing Committee on Foodstuffs and the Standing Committee for Feedingstuffs proposals to limit the presence of dioxin in food and feed. The Commission proposes a sound strategy which as a first step would set strict but feasible maximum limits to take effect from January 2002 onwards. Any food or feed exceeding these maximum limits would be considered unsuitable for consumption. In addition to the establishment of maximum limits, target and action levels would be set: Target levels in food and feed would set the ultimate goal of achieving a human exposure below the tolerable weekly intake of 14 programmes dioxins. Action levels would act as a tool of "early warning" of higher than desirable levels of dioxin in food and feed, that would trigger investigations to identify and reduce/eliminate the source of contamination. These action levels would lie between the maximum limits and the target levels. The action levels would be laid down in a Commission Recommendation as a package with the legislation establishing maximum limits respectively in food and feed. The target levels would be set as soon as more scientific data becomes available. If the proposed measures are supported by the Member States, the entire package will be formally adopted in autumn by the Commission.

"Our dioxin strategy is a sound response to a complicated cycle of contamination. Our ultimate goal must be to reduce the release of dioxins into the environment. At the same time we need to decrease the presence of dioxins in feedingstuffs and consequently in foodstuffs in order to achieve the target levels whereby human dioxin exposure falls below the Tolerable Weekly Intake recommended by scientists", said David Byrne, Commissioner responsible for Health and Consumer Protection.

The maximum limits for dioxin in food will be set by amending Commission Regulation EC/466/2001 on maximum levels for certain contaminants in foodstuffs. Maximum limits in feed will be fixed by amending Council Directive 1999/29/EC on the undesirable substances and products in animal nutrition. Both proposals have to be agreed by qualified majority by the Standing Committee on Foodstuffs for the food-related proposal and by the Standing Committee on Feedingstuffs for the feed-related proposal. If there is not a qualified majority in favour of the proposals, they will be referred to the Council. The action and the objective of setting target levels will be laid down in two Commission Recommendations to be adopted together with the amended Regulation on food and Directive for feed in the autumn.

The proposed measures

It is proposed to establish protective measures at the level of the food and feed chain to limit the presence of dioxins in food and feed with a view to protecting public health.

These proposed legislative measures concerning feedingstuffs and foodstuffs consist of threeparts :

• the establishment of maximum levels at a strict but feasible level in food and feed (see annex for exact limits) In order to ensure that all operators in the food and feed chain continue to make efforts and to take all necessary measures to reduce the presence of dioxins in feed and food, a revision clause is foreseen with the aim of setting lower levels by the year 2006.
• the establishment of action levels as a tool for "early warning" of higher than desirable levels of dioxin in food or feed (see annex for exact limits). The action levels are designed to trigger a proactive approach from competent authorities and operators to identify sources and pathways of contamination and to take measures to eliminate them. These action levels lie between the maximum limits and the target levels.
• the establishment of target levels, to bring, over time, food and feed within the limits recommended by the Scientific Committees (see annex for exact limits). These would be the levels to be achieved in order to bring human exposure below the tolerable weekly intake of 14 pg dioxins.

Target levels would act as the driving force for measures which are necessary to further reduce emissions into the environment.

With a decline of emissions, contamination levels for the different food groups would decrease and (slowly) come closer to the target levels. However, for the time being it is difficult to foresee accurately the impact of environmental measures on dioxin levels in different feed materials and in the different foodstuffs of animal origin. Accordingly, no numerical target levels can yet be set with reasonable scientific certainty.

On the basis of current data, it is possible to propose measures only for dioxins. Ultimately, dioxin-like PCBs will need to be covered by the same requirements as currently envisaged for dioxins.

Scientific opinions

Today's proposals are based on the opinions of the Scientific Committee for Food (SCF) and the Scientific Committee for Animal Nutrition (SCAN) who have been requested by the Commission to assess the risks for public health arising from the presence of dioxins and PCBs in food and feed.

The Scientific Committee on Animal Nutrition (SCAN) adopted its final opinion in November 2000. The main conclusion of the SCAN is that fish oil and fishmeal of European origin are the most heavily contaminated feed materials. These materials are used for fish feed and also incorporated in the diet of other food producing animals. Emphasis should be put on reducing the impact of the most contaminated feed materials (fish meal and fish oil).

This is achievable by substituting the most contaminated by lesser-contaminated sources, by reducing their intrinsic contamination or by using non (or less) contaminated alternatives. Reducing the intrinsic contamination can be done by decontamination and/or purification of e.g fish oil with active carbon.

The Scientific Committee on Food (SCF) adopted its opinion in November 2000 and updated its opinion on 30 May 2001.The Committee established a tolerable weekly intake (TWI) for dioxins and dioxin-like PCBs of 14 pg/kg body weight. This evaluation concurs with the evaluation made by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its meeting of beginning of June 2001 (70 pg WHO-TEQ/kg bodyweight/month). Toxicity is not only the result of daily intake but also of lifetime accumulation in the body. From the exposure estimates provided by the Member States, a considerable part of the European population has dietary intakes higher than the tolerable intake. Dixoxins have a broad series of toxic and biochemical effects and some of them are classified as known human carcinogens. In laboratory animals they have been linked to endometriosis (severe effects on the uterus), developmental and neurobehavorial effects (learning disabilities), developmental reproductive effects (low sperm count, genital malformations) and immunotoxic effects. These effects occur at much lower levels of exposure than carcinogenic effects.

Although the SCF has concluded that a considerable part of the European population is exceeding the tolerable intake, the Committee also states that this does not necessarily mean that there is an appreciable risk to the health of individuals, because the TWI includes a safety factor. However, exceeding the TWI leads to erosion of the protection embedded in the safety factor.

It is important to state that the dietary intake of individuals varies widely among Europe due to food from different sources and different eating habits.

Background (see also MEMO/01/270: Facts on dioxins in food and feed)

• Food contributes to more than 80 % of the daily dioxin intake. With the average consumption habits, food of animal origin contributes to about 80 % of this daily intake. The dioxin level in food originating from farmed animals is widely the result of the dioxin in feed. Thus the control of dioxin level in feed is a decisive tool to reduce the human dioxin intake.
• Based on an EU-wide survey, the average human intake corresponds to an average exposure of 1.2 3.0 pg TEQ/kg bw/day. The main sources of dietary exposure are fish (with a wide variability depending on geographical origin), milk/milk products and meat. Groups particularly at risk include people with particular diets resulting in high exposure (high fish consumption) and sensitive groups like women of child bearing age.
• There is a downward trend in human exposure to dioxin and PCB, halving the exposure over the last 10-15 years. However, a considerable part of the European population still has an intake exceeding the Tolerable Weekly Intake.
• Source directed measures are of major importance in order to reduce exposure. The establishment of maximum limits is an effective measure to avoid that unacceptably contaminated feed materials, feedingstuffs and foodstuffs enter the food and feed chain, but maximum limits alone cannot solve the problem of contamination and are therefore not sufficient to minimise exposure. An overall strategy, including environmental measures, is necessary to reduce exposure to dioxins and PCBs to levels below 14 picogramme per kilogram bodyweight a week for a large majority of the EU population.