Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and the Council on additives for use in animal nutrition"

(COM(2002) 153 final - 2002/0073 (COD))

(2003/C 61/08)

On 10 April 2002, the Council of the European Union decided to consult the Economic and Social Committee, under Articles 37 and 152(4)(b) 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 29 August 2002. The rapporteur was Mr Scully.

At its 393rd Plenary Session on 18 and 19 September 2002 (meeting of 18 September) the Economic and Social Committee adopted the following opinion by 129 votes to one, with five abstentions.

1. Background

1.1. Anti-microbials have been used as growth promoters, especially in pig and poultry farming for more than four decades. The use of growth promoters leads to 4 - 5 % more body weight for animals receiving them. Much larger amounts of antibiotics are used in this manner than in medical applications: in Denmark in 1994, 24 kg of the glycopeptide vancomycin were used for human therapy, whereas 24000 kg of a similar glycopeptide avoparcin were used in animal feed.

1.1.1. The use of antibiotics, in various states of purity, as feed additives has increasingly come under regulation, first nationally and then, with the adoption of Council Directive 70/524/EEC(1) and 96/51/EC(2), on an EU-wide basis.

1.2. In 1999, the Scientific Steering Committee (SSC) expressed great concern about increasing health threats due to anti-microbial resistance and recommended immediately to reduce the inappropriate use of anti-microbials. The core strategy of reducing anti-microbial use should apply equally across each of the areas of human medicine, veterinary medicine, animal production and plant protection.

1.3. Emergence of anti-microbial resistance is a multifactoral problem and thus requires a multifaceted solution and it has therefore been subject of debate at various national and international bodies such as the World Health Organisation(3), the World Organisation for Animal Health (OIE), the "Copenhagen" conference(4), the EU Consumer Committee(5) etc. The Economic and Social Committee produced an own initiative opinion(6), that was explicitly welcomed by the June 1999 EU Health Council Resolution, that followed most of its recommendations.

1.4. Since the 1970s the European Commission has banned the use of more than 20 antibiotics for use in animal husbandry. In addition, the Council of Ministers by its Regulation (EC) 2821/98(7) of 17 December 1998 accepted the European Commission's proposal to ban four antibiotics used as animal growth-promoters (bacitracin zinc, virginiamicyn, thylosine phosphate and spiramycin) entering into force since 1 July 1999.

1.5. In June 2001, the European Commission published a Communication on a Community Strategy against anti-microbial resistance(8). The strategy details priority actions in four key areas: surveillance, prevention, research and product development, and international cooperation. It also included a recommendation on the prudent use of antibiotics in human medicine, which has been adopted by the EU Health Council on 15 November 2001.

1.6. The Commission has now proposed to phase out by January 2006 the four remaining antibiotics (monensin sodium, salinomycin sodium, avilamycin and flavophospholipol) currently authorised for use as growth-promoters in feed. The proposal(9) represents a major streamlining and simplification of the existing rules on the safety evaluation and marketing authorisation of feed additives. The proposal concerns additives intended for use in feedingstuffs and in drinking water for animals.

1.7. The Commission proposes in the draft regulation on additives for use in animal nutrition the following improvements of the status quo:

- new authorisations for feed additives to be granted for a ten-year period only;

- the re-evaluation of feed additives authorised under existing legislation within the next seven years;

- an obligation on companies to demonstrate the efficiency of the product and the absence of a risk for human health, animal health and the environment;

- evaluations by the European Food Safety Authority;

- maximum residue limits for some feed additives, to be controlled through a post-monitoring system;

- a clear and transparent authorisation procedure;

- stricter measures in the case of coccidiostats, if they were of antibiotic origin; a new dossier for re-evaluation to be presented by the applicant within a four-year period.

2. General comments

2.1. The debate whether animal husbandry can do without antibacterial growth promoters continues. Sweden has demonstrated that procedural modifications can decrease the use of antibiotics as feed additives; the antibacterials are prohibited as growth promoters since 1986(10). Learning from the Swedish experience, agricultural science should define conditions for animal rearing without use of antibacterial growth promoters and without sacrificing productivity.

2.2. The Committee welcomed the White Paper on Food Safety(11) aims in respect of upgrading food safety in Europe (applying the farm to fork approach), consequently recognising the importance of feedingstuffs for the safety of food and any possible threat to human health linked to food consumption.

2.2.1. In this respect, the Committee particularly welcomes that the European Commission has chosen in this occasion as legal instrument a regulation (instead of a directive), which has clear enforcement advantages.

2.3. The EESC supports the Commission proposal aiming to streamline the authorisation procedure for feed additives and to phase out the remaining four antibiotics used for growth promotion. While for some Member States the delay in phasing out the remaining antibiotics for growth promotion might not be acceptable, for other countries this might be of major concern since comparable, effective alternatives might not be available or not developed yet. The Committee thinks that the European Commission offers an acceptable compromise. In no case, however, would any further delay be acceptable.

2.4. The Committee particularly welcomes the safeguard clause foreseen in the legislation with respect to the renewal of authorisation.

2.5. The current procedure for authorising new additives or new uses of additives is upon request of the applicant company or, if the applicant is located in a third country, of a selected Member State acting as rapporteur. This evaluation will now be transferred to the EFSA. The EESC is in favour of a centralised procedure and supports indeed the linkage between feedingstuffs, food safety and human health as expressed in the EESC opinion on the White Paper on Food Safety(12). The Commission proposal correctly centralises the authorisation procedure.

2.6. In addition to the measures proposed, the Committee suggests the introduction of symbols/logos to clarify the target use of such substances either as feed additives or as medicinal products.

2.7. Use and licensing of animal additives or veterinary medicines varies tremendously worldwide. In developing countries, which are responsible for about 25 % of the world-meat production, policies regulating veterinary use of antibiotics are poorly developed or absent. In Southeast Asia, use of anti-microbials in shrimp farming is hardly regulated. The problems caused by inappropriate use of antibiotics reach beyond the country of origin. Meat products are traded worldwide, and bacterial populations evolve independently of geographical boundaries.

2.7.1. The EESC is therefore concerned that this proposal does not sufficiently identify the obligations of applicants from third countries and not least multinational companies acting from outside Europe but of EU origin. The EESC suggests to include more precise provisions in this proposal covering such areas of ambiguity.

2.8. The EESC agrees that action by the Community relating to human health, animal health and the environment should be based on the 'precautionary principle'. The Committee assumes that the authorisation procedure is strictly following this principle already and consequently any subsequent action should be based on new emerging evidence on risks to human or animal health or the environment. The Committee would prefer further detailed consideration in this draft legislation with regard to the application of the precautionary principle, in order to avoid improper use.

2.9. The general objectives of this draft regulation set out that the European Food Safety Authority (EFSA) will have the competence and responsibility to provide a single address for dossier evaluation for all feed additives, bringing clarity, efficiency and transparency to the process. The adoption of an assessment report and a public consultation process have been mentioned. It is also recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision would be based, and that other factors relevant to the matter under consideration should legitimately be taken into account, such as ethical factors, feasibility of controls and the benefits for the animals or for the consumer of animal products. It is therefore suggested, that the authorisation of an additive should be granted by the European Commission.

2.9.1. The EESC is concerned that the text provides no information how this scheme should function in practice. The process of public consultation, which might actually bring other legitimate factors to the attention of the stakeholders and politicians involved, has not been further considered. The European Commission should therefore further explain the actual implementation process of this draft regulation.

2.10. Veterinary medicinal products as defined in Directive 2001/82/EC(13) could be considered to include coccidiostats. The latter are in-feed agents administered throughout the life of a broiler chicken, for example, to prevent the disease of coccidiosis. The Directive defines a Veterinary Medicinal Product as: "Any substance or combination of substances presented for treating or preventing disease in animals."

2.10.1. The Committee considers that all agents used for disease treatment and/or prevention should be licensed as veterinary medicines in accordance with the definitions provided in Directive 2001/82/EC. The Committee is aware that several widely used coccidiostats, none of which have application in human medicine, are produced wholly by fermentation processes and are considered of non-human pharmaceutical quality (so called "feed grade").

2.10.2. The Committee recognises that as a consequence of the latter, the classification of coccidiostats as veterinary medicines may at present pose bureaucratic difficulties in the EU. Nevertheless, the Committee wishes to encourage the European Commission to look again into this subject and to propose any necessary changes required, in the EU Veterinary Medicines legislation and/or in Pharmacopoeia, which would be necessary to accommodate the coccidiostats, including those based on feed grade antibiotics.

2.10.3. The Committee also favours the approach of dealing with the coccidiostats within the scope of Directive 2001/82/EC in agreement with the Federation of European veterinarians (FVE) which believes that these products must be maintained on the market but it would recommend subjecting their use to a veterinary control through a veterinary prescription. This would follow the recommendations from many international bodies such as the OIE or the WHO and would offer additional guarantees for a rational and prudent use of these substances, along the lines of the principles developed by the FVE in its guidelines on "The prudent use of antibiotics in veterinary medicine" communicated in 1999.

2.11. The Committee thinks however that alternative substances to replace cocciodiostats should be considered and dealt with in this proposal; in particular, emphasis should be granted on research on the irreversibility of resistance among protozoa. The Committee endorses the FVE recommendation to the European Commission to give priority to research projects into alternatives to coccidiostats (through its 5th and 6th Research Programme), as coordinated efforts between European scientists could be decisive for a long-term solution to this problem.

2.12. Additives that are either genetically modified or produced from a GMO should first comply with the requirements of and be evaluated according to the Regulation on genetically modified food and feed, prior to undergoing the authorisation procedure under this proposed Regulation. GMOs, which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment, should not be released into the environment. This position is affirmed in the past by the EESC: "As a precautionary measure to protect the environment and health, the ESC is of the view that no antibiotic-resistant marker genes should be used when genetically modified organisms are deliberately released into the environment"(14).

2.13. The Commission acknowledges that detailed labelling of the product should be required since it enables the final user to make a choice in full knowledge of the facts. Particular rules for the labelling of feed additives are laid down in this draft legislation. The Committee is concerned that no explicit links are made to other important labelling requirements, such as for the labelling of additives consisting or being produced from GMOs.

2.13.1. The EESC finds it important that based on meaningful feed additive information, properly indicated, the farmers would be able to perform their duties as regards to the appropriate use of such substances in order to avoid inducing any harmful effects to public health. The latter requires adequate labelling measures.

2.14. For certain categories of additives the proposal foresees a post-marketing monitoring program. It is not clear who is going to decide whether such monitoring will be necessary. The EESC supports full transparency regarding any monitoring requirements. The results of monitoring should be made available to the public.

2.14.1. The Committee, in agreement with FEDESA (European Federation of Animal Health), believes that a post-marketing surveillance system, as laid down in the relevant EU legislation, should be used for in-use monitoring of any adverse effects of these products after the marketing authorisation has been granted.

2.15. A proposal for the establishment of MRLs in the relevant foodstuffs of animal origin is foreseen as part of the authorisation procedure. The Committee strongly believes that the risk assessor, the EFSA, should not decide whether or not to establish an MRL. This should be a decision to be made by the risk manager, in this case the European Commission, reacting on the advice of the risk assessor.

2.16. There are indications that the therapeutic usage of antibiotics has increased recently, since the ban on the use of some antibiotics as growth-promoters. Some of these antibiotics, such as amoxicillin, are also used in human medicine. At a WHO meeting with experts in this field, in October 1997, the group of experts considered that attention must be given to the risks associated with the widespread use of fluoroquinolones as medicines for animals, especially as these drugs are an important group of antibiotics in human medicine.

2.16.1. In this respect, the EESC demands that the monitoring of anti-microbial consumption should not be limited to human medicine but extended to veterinary medicine and agricultural use together with strict control of the therapeutic use of antibiotics. This is in order to ensure that existing legislation is strictly respected and not undermined by increased and uncontrolled use of antibiotics that should only be used to cure sick animals.

2.16.2. The Committee finds it important to keep a close link to the monitoring and control of zoonoses and zoonotic agents with regard to the recognition of antibiotic resistance.

2.17. Proper enforcement of the legislation is crucial. The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are fully implemented. These penalties should be harmonised and laid down in the appropriate EU Regulation. The EESC wishes to stress the importance of controls carried out by qualified inspectors and strongly believes that the strict application of penalties in case of non-compliance is the key for effective implementation of the legislation. The EESC wishes to have a strong link made with the legislation proposed by the European Commission on "Official Food and Feed veterinary controls"(15).

2.18. The EESC expresses its concerns regarding the rising costs of livestock production due to this European Commission proposal, tackling compensation measures if necessary, as EU livestock production would become less competitive on the world market.

2.19. The provisions on imported meat from animals must fully comply with EU-rules in order to avoid distortion of competition and assure the EU consumers' protection. The EU should make a serious effort to get the latter endorsed by the WTO. In fact this point relates also to animal welfare conditions and the use of growth hormones and additives in general.

2.20. The EESC would like to note that in addition to coccidiostats other medicinal substances authorised today as feed additives should be moved under the EU legislation covering veterinary medicinal products.

2.21. The EESC wishes to ask the European Commission to anticipate the phasing out date (2006) foreseen in Article 12 of this proposal, serving so the interest of all parties involved.

3. Specific comments

3.1. The proposal defines various technical terms or expressions used in the text.

3.1.1. The Committee is concerned that the proposal fails to define coccidiostats.

3.2. As the MBMs' ban is temporary, the EESC believes that this proposal should clearly indicate the risk involved by the use of additives of animal origin and should foresee comprehensive policy measures.

3.3. The EESC misses more detailed information on how to guarantee transparency of the authorisation procedure as the Committee considers it insufficient just to publish the opinion of the EFSA. The process of establishing the opinion is crucial with regard to the transparency of the system and therefore at least the summary of a dossier (after deletion of any information identified as confidential) should be available to the public for a defined period of time to allow for comments.

3.4. The establishment of MRLs should be an integral part of the authorisation procedure. The suggestion of the EFSA for the non-application of MRLs should not prevent the European Commission from requesting further research into the area with the aim to establish MRLs. In any case the MRLs should be fixed before an authorisation is granted.

3.5. The risk assessment procedure will be carried out by the EFSA. The Committee finds it important that the risk assessment procedure should follow a codified modus operandi, which should be publicly accessible.

3.6. The status of existing products needs to be checked and therefore notification and accompanying particulars as explained in this proposal need to be supplied to the EFSA. The proposal refers to a Regulation that needs to be applied in case of non-notification or incorrect submission of particulars to the EFSA. The Committee is concerned that no further details are given as to the content and timeframe for adoption of such legislation.

3.6.1. Moreover the Committee is concerned that the timeframe for the withdrawal of products, not notified in time or for which the dossier was considered deficient, has not been defined.

3.7. For carrying out controls on the authorisation of animal feedingstuffs the draft legislation makes certain provisions. The EESC believes that these provisions are insufficient to carry out effectively such controls.

3.7.1. The Committee therefore suggests properly defined assignment of duties undertaken by the national Control authorities.

3.7.2. The Committee is also in favour of the establishment of a clear reporting procedure from the MS to the European Commission referring to incidents of non-compliance.

3.8. This draft legislation explains the tasks of the Community reference laboratories. The Committee finds it important to spell out the need for the establishment and publication of validated test methods in order to perform necessary substances testing as it is a precondition for any efficient controls.

3.9. The Committee regrets that the proposal fails to include special labelling requirements resulting from special legislation dealing with GMOs and asks for appropriate amendment of the proposal.

3.10. The Committee urges the EU Commission to seek for an agreement on internationally accepted rules, regarding the application of the precautionary principle, under the umbrella of Codex Alimentarius.

Brussels, 18 September 2002.

The President

of the Economic and Social Committee

Göke Frerichs

(1) OJ L 270, 14.12.1970, p. 1-17.

(2) OJ L 235, 17.9.1996, p. 39-58.

(3) WHO Global Principles for the Containment of Anti-microbial Resistance, Report of a WHO consultation with the participation of the Food and Agriculture Organization of the United Nations and the Office International des Epizooties Geneva, Switzerland, 5-9 June 2000.

(4) The Copenhagen Recommendations. Report from the Invitational EU Conference on The Microbial Threat. Copenhagen Denmark, 9-10 September 1998, http://www.sum.dk/publika/micro98/ ws_2.htm

(5) Opinion of the Consumer Committee adopted on 1 March 1999 on "Resistance to antibiotics - a threat to public health" http://europa.eu.int/comm/ consumers/policy/committee/ cc08_en.html

(6) Resistance to antibiotics as a threat to public health CES 1118/98, OJ C 407, 28.12.1998 and Council Resolution, OJ C 195, 13.7.1999, p. 1-3.

(7) Council Regulation (EC) No 2821/98, OJ L 351, 29.12.1998, p. 4-8.

(8) COM(2001) 333 final.

(9) Proposal for a Regulation of the European Parliament and the Council on additives for use in animal nutrition COM(2002) 153 final.

(10) Weirup M. 1998. Preventive methods replace antibiotic growth promoters: ten years experience from Sweden.

APUA Newsletter 16(2):1-4.

(11) COM(1999) 719 final.

(12) Opinion CES 585/2000, OJ C 204, 18.7.2000.

(13) OJ L 311, 28.11.2001, p. 1.

(14) See point 2.8.1 of the Opinion CES 1117/98, OJ C 407, 28.12.1998.

(15) COM(2002) 377 final.