Opinion of the Economic and Social Committee on the "Proposal for a Directive of the European Parliament and Council on undesirable substances and products in animal nutrition"

(2000/C 140/04)

On 23 March 2000, the Council of the European Union decided to consult the Economic and Social Committee, under Article 152 of the Treaty establishing the European Community on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 15 March 2000. The rapporteur was Mr Nielsen.

At its 371st plenary session (meeting of 29 of March 2000) the Economic and Social Committee adopted the following opinion by 81 votes to two, with one abstention.

1. Background

1.1. During the dioxin crisis in June/July 1999 the Commission put forward an ambitious work programme, which was unanimously approved by the Council. The current proposal, which forms part of this work programme, substantially tightens up the rules governing undesirable substances and products in feedingstuffs. These rules date back to 1974(1) and, following a large number of amendments, were consolidated in Directive 1999/29/EC(2).

1.2. In addition, the proposal should be seen in the light of the subsequent White Paper on Food Safety(3), which describes the general principles of food safety and outlines the set of proposals the Commission intends to present in the near future with a view to coordinated action at all stages in the food chain, from "farm to table". The overview includes several proposals concerning feedingstuffs; the current proposal too is mentioned in this connection.

1.3. The purpose of Directive 1999/29/EC was to reduce the content of undesirable substances and products potentially dangerous to animal and human health in feedingstuffs. The Directive's preamble states that it is impossible to fully eliminate the presence of such substances and products and that it is inappropriate to fix this content below the maximum levels detectable by the methods of analysis to be defined. Feed materials and feedingstuffs may not be put into circulation in the EU unless they are "sound, genuine and of merchantable quality" and comply with specified maximum levels for undesirable materials(4).

1.4. Annex I to the above Directive, which is regularly updated by the Commission, assisted by the Standing Committee on Feedingstuffs, to keep pace with scientific and technical progress, currently covers maximum levels for six chemical substances (arsenic, lead, fluorine, mercury, nitrites and cadmium), 21 different products (including aflatoxin, dieldrin and dioxin) and 12 botanical impurities (various types of mustardseed, etc.) These ceilings apply to specified feed materials and feedingstuffs. As the annex does not set any maximum levels for the content of undesirable substances in additives(5). In some cases these are covered by the general requirement regarding "sound, genuine and of merchantable quality".

1.5. The Commission proposes the following improvements on the status quo:

- extension of the Directive's scope to cover feed additives;

- introduction of a ban on dilution where the maximum permitted level is exceeded(6);

- removal of the option allowing a derogation for particular local reasons;

- an option of fixing an action threshold considerably lower than the specified maximum level so that an investigation can be launched at an early stage to identify the source of contamination and take steps to reduce or eliminate it;

- adjustment of the regulatory procedure provisions concerning the Standing Committee on Feedingstuffs(7).

2. General comments

2.1. The Committee supports the White Paper's aims and general priorities in respect of upgrading food safety in the EU through coordinated action at all stages of the food chain. The Committee is composed of representatives from all the relevant interest categories and is therefore a natural and highly appropriate forum for discussion of both the broader aspects and specific proposals relating to future EU food safety. Hence the Committee is eager, in both these areas, to make a constructive and realistic contribution towards securing sustainable food safety in the EU.

2.2. Here the ESC also welcomes the Commission's work programme to curb dioxin. After the June 1999 crisis, attention was subsequently focused on the more persistent problem presented by dioxin. The ESC recognises the existence of this environmental problem, which varies in gravity from one Member State to another, depending on incineration technology.

2.3. In the ESC's view, the dioxin problem - like other environmental problems in the EU - primarily needs to be tackled at source, partly by sorting and recovering/removing waste materials generating dioxin when incinerated, and partly through the use of smoke filters at the incineration plant to capture the remaining dioxin. Despite the decrease in dioxin emissions these past few years, it will take several years before the dioxin content in affected fish stocks and rural areas drops substantially. Realistic maximum levels therefore need to be set and the most heavily polluted fishery and agricultural products will have to be removed from the food chain. Here it is important to align the maximum levels for products for human consumption with those applicable to dioxins in oils and fats used in feed, which in the latter case are subject to the committee procedure referred to above.

2.4. The dioxin problem therefore illustrates the close link between food safety and environment protection. Throughout the food production chain, plant and animal foodstuffs are subject to environmental influences in the shape of various chemical interactions. As in the case of dioxin, these must primarily be tackled at source. The desired improvement in food safety will therefore in future need to be accompanied by more energetic EU action in the environmental sphere. However, steps must also be taken to prevent EU measures in this sphere being undermined by imports from non-EU countries.

2.5. In connection with the specific proposals regarding undesirable substances in feedingstuffs, increased attention and more active measures need to be focused on reducing the total content of undesirable substances and products in feedingstuff production, and by extension in the food chain. In addition to the aspects relating to the White Paper referred to above, that would be consistent with the precautionary principle. The content of undesirable substances and products in feedingstuffs must under no circumstances endanger human or animal health. The specific maximum levels must therefore be established on the basis of the latest findings and available scientific data, applying an adequate safety factor which takes account of the inadequacy of expertise in this field and the potential synergies between different risk factors.

2.6. With this in mind, the ESC supports the introduction of specific maximum levels for the content of undesirable substances in additives and the future ban on dilution, despite the fact that these proposals are very far-reaching and represent a shift in approach. More stringent rules will provide a greater incentive for the operators involved to take preventive measures (checking the quality of raw materials; introducing additional requirements in contracts with suppliers; taking action at source). However, it is necessary to clarify what is to be done with raw materials (e.g. grain) which exceed the maximum level, when the producer is not to blame for the pollution. Other things being equal, adoption of the proposed directive will push up the costs of EU feedingstuffs production; the Commission should therefore present a cost/benefit impact assessment in connection with adoption of the proposal.

2.7. The ESC supports the future control measures outlined in the White Paper, including coordination between EU and Member State control authorities. In this connection, both EU and Member State control systems should in future provide every encouragement for operators in the feedingstuff industry, raw material producers etc. to minimise the content of undesirable substances. This should be achieved through continued promotion of mandatory, approved internal checks in undertakings which can detect sources of pollution more speedily and effectively than national authorities are able to do. Much greater emphasis should be placed on the HACCP principle in connection with the approval or certification of operators' internal checks as well as quality guarantees and registration of data for the individual consignments so as to facilitate the detection of sources of pollution more effectively and at an earlier stage. For this purpose it will be necessary to develop and introduce technical equipment and IT systems, as well as to step up education and training measures.

2.8. At the same time care must be taken to ensure that checks are sufficiently effective and implemented uniformly in the Member States. The cost of removing consignments in which the content of undesirable substances exceeds maximum levels can encourage operators to "turn a blind eye" to breaches at one stage in the production chain. In addition, it is difficult to ascertain whether consignments imported into the EU from third countries have been mixed, or whether rejected consignments "make their way back" after being mixed. The same applies to the production of feed compounds on the holding. The ESC would expect future internal checks, registration, quality guarantees etc. by operators combined with more incisive action by the authorities, the introduction of contractual obligations in the case of imports from third countries, and so on, to help to alleviate the scale of these problems.

2.9. Maximum levels, in application of the above principles, should be set so as to be practicable. On the other hand, the individual maximum levels must also take full account of the practical, technological, economic, competition-related and other aspects that come into play in connection with the relevant undesirable substances or products in combination with the feedingstuffs, feed materials and feed additives in question. In particular, when determining maximum levels for undesirable substances and ingredients in feed additives account must be taken of the limited concentrations in compound preparations.

2.10. Higher EU standards in this and other relevant sectors presupposes ongoing adjustment to international trade rules, which is vital for the EU animal feed industry to be able to compete internationally. As the White Paper points out, the situation has changed significantly. The ESC calls for a substantial effort on the part of the EU to foster greater international understanding for these aspects in future, in tandem with a greater scientific effort in this sphere.

2.11. Under the proposal, the Member States are required to demand an investigation of contamination with a view to identifying, reducing or eliminating the source of contamination if a significant level of certain undesirable substances or products is detected. With this in mind, the Commission, assisted by the Standing Committee on Feedingstuffs, may set action thresholds in the annex for the relevant substances and products which are "well below the maximum levels fixed". The ESC can support this proposal, on condition that the introduction of action thresholds does not call into question the scientific premises. Further, application of action thresholds must not make unreasonable demands on the operators concerned, e.g. in the form of publicity and possible misunderstandings regarding interpretation of the actual situation.

2.12. No practical use has been made of the existing option of granting a derogation for particular local reasons, in the case of feed produced and used on an agricultural holding without subsequent processing, e.g. in connection with the development of toxins in grain as a result of climatic conditions. The ESC can therefore approve the abolition of this derogation. However, in this connection it should be pointed out that reducing the use of pesticides increases the risk of fungous infections, and hence the development of toxins.

3. Specific comments

3.1. The Danish version's definitions of "feedingstuffs" and "feed materials" (Article 2) vary slightly in their references to the same elements and concepts, and should be harmonised. In addition, some of the proposal's provisions are worded ambiguously and should preferably be clarified (e.g. Article 10(3) relating to the obligation to notify the authorities in the event of awareness of a breach of maximum levels, and Articles 11 and 12 concerning the regulatory procedure involving the Standing Committee on Feedingstuffs).

3.2. Adoption of the proposed amendments will necessitate corresponding changes in the annex. It is not clear whether the Commission envisages specific or uniform maximum levels for feedingstuffs, feed materials and feed additives in respect of the individual undesirable substances. There is also the matter of whether differentiated maximum levels for the content of undesirable substances in feed additives can be justified in certain cases.

3.3. The proposal does not take a stand on decontamination. In the ESC's view, decontamination should be permitted if this can be done without detriment to the feedingstuffs, feed materials and feed additives concerned.

3.4. Concern was expressed in some quarters that feeding animals with, for instance, genetically modified maize or soya protein containing antibiotic marker genes could aggravate antibiotics-resistance. The ESC assumes that the approval procedure and the future rules on "novel feed" will address this risk.

3.5. Nickel is used as a catalyst in hardening fat. Normally it is removed at the end of processing but significant concentrations can be found in consignments of feed fats. Nickel is environmentally unfriendly and involves allergy risks. The annex to Directive 96/25/EC(8) specifies that "feed materials must, as far as good manufacturing practices allow, be free from chemical impurities resulting from their manufacturing process and from technical auxiliaries ...". This clause has proved inadequate; the annex to the current directive should therefore set a maximum level for nickel.

Brussels, 29 March 2000.

The President

of the Economic and Social Committee

Beatrice Rangoni Machiavelli

(1) Directive 74/63/EEC, OJ L 38, 11.2.1974, p. 31.

(2) OJ L 115, 4.5.1999, p. 32.

(3) COM(1999) 719 of 12.1.2000.

(4) Feed materials are primarily products used in the preparation of compound feedingstuffs.

(5) Additives are substances, preparations or micro-organisms added to feedingstuffs with a view to achieving a positive effect in connection with use of the feed concerned.

(6) Apart from individual undesirable substances, it has hitherto been possible for operators to dilute the concentration of undesirable substances and products in a consignment of feed materials or feedingstuffs.

(7) Council Decision 1999/468/EC, OJ L 184, 17.7.1999, p. 23.

(8) As indicated in the amendment to Commission Directive 98/67/EC, OJ L 261, 24.9.1998, p. 13.