EN Official Journal of the European Union C 242/54

Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC’

(COM(2014) 556 final — 2014/0255 (COD))

and the ‘Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products’

(COM(2014) 558 final — 2014/0257 (COD))

(2015/C 242/10)

Rapporteur:

Mr José María ESPUNY MOYANO

On 24 September, 20 October and 23 October 2014, the European Parliament and the Council decided to consult the European Economic and Social Committee, under Articles 43, 114, 168(4)(b) and 304 of the Treaty on the Functioning of the European Union, on the

Proposal for a Regulation of the European Parliament and of the Council on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC

COM(2014) 556 final — 2014/0255 (COD),

and the

Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products

COM(2014) 558 final — 2014/0257 (COD).

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 8 January 2015.

At its 504th plenary session, held on 21 and 22 January 2015 (meeting of 21 January 2015), the European Economic and Social Committee adopted the following opinion by 208 votes to 4 with 16 abstentions.

1. Conclusions and recommendations

1.1. Medicated feed

1.1.1. The EESC believes it is necessary and appropriate to update European legislation on medicated feed so as to ensure uniform conditions for manufacturing, placing on the market and using medicated feed, while protecting the health and welfare of animals and the expectations of consumers.

1.1.2. The EESC supports the use of medicated feed as a tool to ensure the production of healthy animals and to improve public health.

1.1.3. The EESC welcomes the fact that the regulation includes the manufacture, placing on the market and use of medicated feed for animals not earmarked for food production as an alternative form of administration for the treatment of diseases, especially chronic conditions.

1.1.4. The EESC urges that minor species and aquaculture, where the availability of veterinary medicinal products is a problem, should have access to medicated feed and that barriers preventing manufacturing and distribution from running smoothly be lowered. At the same time, the EESC welcomes the introduction of anticipated production in order to better plan manufacturing and minimise potential carry-overs. This means that there will never be an inadequate stock because medicinal products have gone out of date.

1.1.5. The EESC calls for the regulation to attach greater value to the role of the vet or the skilled qualified professional, who is familiar with existing rules and has the capacity to diagnose and prescribe the right treatment to ensure wellbeing, welfare and public health.

1.1.6. The EESC believes that vets or qualified skilled professionals, in performing their duties, are the only people who can determine the timeframe needed for treatment, and that this cannot be determined by rigid rules alone, given the differences among species, their physiological condition, the conditions under which medicinal products are administered, the severity of disease, etc.

1.1.7. The EESC realises that there will be carry-overs to non-target feed of the active substances contained in medicated feed, although these carry-overs must take place in accordance with the ALARA principle (As Low As Reasonably Achievable).

1.1.8. The EESC highlights the different production systems that exist and believes it is essential for the carry-overs to take account of existing technologies in the industry and for them to be established in such a way that they do not run the risk of generating bacterial resistance.

1.1.9. The EESC believes that a system for the overall management of unused or expired products should be put in place in order to control any risk that might arise with regard to the protection of animal health, human health or the environment.

1.1.10. The EESC also underlines the need to establish criteria, such as target values, to ensure the appropriate homogeneity of medicated feed.

1.1.11. The Committee believes that trade within the Community could be undermined by the proposed legislation and considers that it should be made more flexible so as to make the sector more competitive.

1.1.12. The Committee notes that vets or skilled qualified professionals must comply with their duty not to carry out routine preventative treatments using antimicrobials, although there are cases where such treatment is needed (as in the case of human medicine) to ensure the health and wellbeing of animals and ultimately, public health.

1.1.13. The EESC believes that identification of preventive treatments using antimicrobials should be examined in each Member State, taking account of the specific features and characteristics of the production systems, animal species, health situation, availability of medicinal products, etc. in each country.

1.1.14. The EESC believes that the legislative proposal should list the individual protection equipment needed by workers so as to prevent them from being exposed to chemical products through the dust generated during the manufacturing process and to the ensuing risk of inhalation.

1.1.15. The EESC recommends that the Member States introduce specific training programmes for workers exposed to chemical agents.

1.1.16. The EESC believes that the regulation should leave a possibility for Member States to produce implementing acts meant to avoid administrative burdens and red tape for small farmers producing for their own use, without compromising specific regulations on safety and hygiene of medicated feed.

1.2. Veterinary medicinal products

1.2.1. Animal health has a strategic importance given its impact on animal wellbeing and welfare, public health and food safety, the environment and the rural economy. Therefore, the availability of authorised veterinary medicinal products is crucial so that vets or skilled qualified professionals have at their disposal sufficient tools to control, prevent and treat animal diseases.

1.2.2. Like other veterinary medicinal products, antibiotics are needed to combat bacterial infections in animals. The EESC considers that access to safe and effective antibiotics is a key element of the tools that vets rely on to maintain and restore animal health and welfare, as well as public health.

1.2.3. The EESC therefore welcomes the objective of the legislative proposal to develop an updated and proportionate body of legislation and the availability of veterinary medicinal products with a view to safeguarding animal health, public health, food safety and the environment — a principle which should also be followed to ensure the availability of antibiotics in veterinary medicine.

1.2.4. The market for veterinary medicinal products has some particularities and specific features which differ from the human medicines market and therefore the EESC considers it highly appropriate that this legislative proposal is focussed purely on veterinary medicinal products. In this respect, while the principles must be consistent, the way in which they are applied must be fully adapted to the conditions of the sector.

1.2.5. The EESC believes that the current legislation entails significant red tape for industry, which has a negative impact on the innovation that is needed; it therefore welcomes the introduction of streamlined rules to be applied during the authorisation procedures as well as during the subsequent oversight, the changes to the marketing authorisations, etc. which are aimed at reducing these administrative constraints, though there is room for improvement in the proposal.

2. Gist of the proposals

2.1. Medicated feed

2.1.1. The proposal lays down the requirements for the manufacturing, placing on the market and use of medicated feed in the European Union.

2.1.2. To this end, the proposals provide definitions which must be used, in particular: — ‘medicated feed’: a mixture of one or more veterinary medicinal products or intermediate products with one or more feeds which is ready to be directly fed to animals without further processing; — ‘intermediate product’: a mixture of one or more veterinary medicinal products with one or more feeds, intended to be used for the manufacture of medicated feed; — ‘a feed business operator’: any natural or legal person responsible for ensuring that the requirements of this regulation are met within the feed business under their control; — ‘mobile mixer’: a feed business operator with a feed establishment consisting of a specifically equipped lorry for the manufacture of medicated feed.

2.1.3. The Committee welcomes the classification of medicated feed as a compound feed under Regulation (EC) No 767/2009 and Regulation (EC) No 183/2005 on compound feed.

2.1.4. The scope of medicated feed is broadened to include all animal species not earmarked for food production as well as pets.

2.1.5. The proposed legislation endorses the use of medicated feed as a valid and very useful tool for dealing with animal and public health. According to the proposal, it is also valuable for production systems which are very competitive within Europe.

2.1.6. Livestock farming in the European Union, as well as the different systems of production in the various Member States, have a relevant role to play and they should therefore be equipped with tools, such as medicated feed, to make this sector more competitive.

2.1.7. The appendices to this regulation set out all the requirements needed for factories to produce safe and homogeneous medicated feed and ensure that cross-contamination is kept to a minimum.

2.1.8. This legislative proposal considers that medicated feeds imported by the European Union should comply with the same legislative requirements set out in this regulation.

2.1.9. The future regulation points out that medicated feed needs to be manufactured using authorised veterinary medicinal products and that all compounds used must be compatible so as to ensure that products are safe and effective.

2.2. Veterinary medicinal products

2.2.1. This legislative proposal covers both the data requirements and the authorisation procedures for placing veterinary medicinal products on the market. It also covers packaging and labelling, distribution and supervision of safety in the market (pharmacovigilance) and matters relating to the monitoring and use of veterinary medicinal products.

2.2.2. A new feature introduced by the proposal is the broadening of the centralised authorisation procedure in such a way that authorisation requests can be made for any veterinary medicinal product. At the same time, in order to avoid unnecessary administrative and financial burdens, the authorisation request will need to be assessed once only.

2.2.3. The proposal introduces a major simplification of the rules by reducing the information required on labelling and packaging and offering the possibility of using harmonised pictograms and abbreviations.

2.2.4. It also regulates the protection period applying to technical documentation submitted to obtain or amend a marketing authorisation, and extends the protection period in the case of limited markets and new antibiotics.

2.2.5. The European Commission is authorised to lay down requirements for prohibiting or restricting certain antibiotics in veterinary medicine.

2.2.6. Veterinary medicinal products must be authorised before being placed on the market, as is the case with medicines for human use. To this end, data must be provided to test the quality of production, safety (for animals, users and the environment) as well as clinical effectiveness. In addition, data guaranteeing consumer safety must be provided for treatments of production animals.

2.2.7. The four procedures for obtaining authorisation to place a veterinary medicinal product on the market (centralised procedure, decentralised procedure, mutual recognition procedure and national procedure) are maintained with some changes. The regulation also establishes a system for varying the terms of marketing authorisations that takes account of the level of risk involved. At the same time, it introduces a pharmacovigilance approach based on risk and establishes a procedure for harmonising summaries of product characteristics.

2.2.8. The regulation covers requirements for homeopathic veterinary medicinal products, as well as questions relating to manufacture, distribution and use, among other things.

3. General comments

3.1. Medicated feed

3.1.1. The EESC supports the proposed regulation as well as the Commission’s plan to harmonise the requirements for medicated feed across the Member States.

3.1.2. The EESC feels that manufacturing requirements must not be so high that the feed industry has difficulty in meeting them. Cross-contamination is a reality in the sector and it would be wrong to impose technically unattainable standards which are not proportionate to the actual animal health risk.

3.1.3. The Committee believes that livestock farming occupies an important place in EU agriculture and for this reason it is essential to compile appropriate tools for livestock farmers and feed manufacturers with a view to a high level of market competitiveness. Regulation of the use and manufacture of medicated feed is necessary but, at the same time, it must be adapted to the technology which exists in the sector today.

3.1.4. According to the Commission’s impact analysis, legislation on medicated feed should have a significant positive impact on the cost efficiency and economic growth of the medicated feed manufacturing sector, not least given the innovative applications of veterinary medicinal products.

Animal and public health can be expected to be improved both in Member States with currently lax standards for medicated feed and those with prohibitive standards.

3.1.5. It is important to establish carry-over levels for medicated feed on the basis of Commission expertise and in accordance with the ALARA principle and technical manufacturing improvements in the sector.

3.1.6. The EESC considers that certain forms of production included in the legislation, such as mobile mixers, must comply with the principles of food safety and homogeneity of medicated feed in order to avoid high carry-over levels and exercise greater control over these levels.

3.1.7. The Committee believes it is right that intra-Community trade should not be hampered by the requirements of this regulation. This kind of trade should therefore be made more flexible.

3.1.8. The EESC points out that there are minor species in the various Member States for which currently few therapeutic options exist and that, for this reason, it is essential not to add to this problem by introducing additional burdens associated with the anticipated production of medicated feed for these species.

3.2. Veterinary medicinal products

3.2.1. The EESC believes that the procedures for authorising veterinary medicinal products must be established in such a way that they avoid unnecessary delays in actually placing products on the market in the various Member States seeking to authorise these medicinal products, and facilitate the swift resolution of disagreements among the competent authorities.

3.2.2. The EESC believes that the legislative framework must promote research, technological development and innovation in the field of veterinary medicinal products in order to respond to the health needs and challenges facing the various species and production models in Europe.

3.2.3. Historically, there has been a problem of a lack of availability of veterinary medicinal products for some species of animal, known as minor species, and of specific indications in other species (minor uses), which are particularly important in Europe from a socioeconomic perspective.

3.2.4. In the light of this, there is a need for a European policy to promote the genuine availability of veterinary medicinal products for minor species and uses, guaranteeing their quality, safety and effectiveness while at the same time ensuring that their development is economically viable for businesses in the animal health industry.

3.2.5. The Committee welcomes measures to reduce administrative burdens through steps to simplify labelling requirements, veterinary pharmacovigilance, changes to the authorisation conditions and the granting of marketing authorisations for an unlimited period.

3.2.6. The EESC agrees with the introduction of an electronic system for submitting requests, and with the idea of a European central database to promote the exchange of information between industry and agencies and which will have a positive impact on reducing administrative burdens.

3.2.7. The measures to improve the way in which the veterinary pharmacovigilance system works will also have a positive effect on reducing administrative burdens, while at the same time guaranteeing the safety of medicinal products. The risk-based approach is thus considered to be highly appropriate.

3.2.8. One of the objectives of the revised legislation is to improve the way in which the single market functions. This must be achieved without jeopardising other objectives such as reducing the administrative burden and increasing the availability of medicinal products. In order to meet these objectives, the procedure for harmonising summaries of product characteristics should be efficient and comply with the principles of proportionality and mutual recognition.

3.2.9. The new regulatory framework should encourage innovation and the development of new medicinal products, especially antibiotics, for which a legislative framework is required ensuring predictability and based on science while always taking account of the ‘precautionary principle’.

3.2.10. The proposed legislation should promote the use of veterinary medicinal products registered in the EU when there is a therapeutic gap, rather than those authorised for human use. Veterinary medicinal products have been proved through practice to be safe and effective. This option represents a considerable advantage as opposed to the use of medicinal products for human use which have not been proven safe and effective for use in animals. In addition, this is of particular importance in connection with antimicrobial resistance, since the current proposal permits the use of antibiotics for human use as a first option when there is a therapeutic gap.

4. Specific comments

4.1. Medicated feed

4.1.1. Article 2 on ‘definitions’ should clarify the following terms used in the document: ‘active substance’, ‘non-target feed’, ‘mobile mixer’ and ‘on-farm mixer’: these terms are relevant for the development of the legislation. At the same time, care should also be taken to ensure that the terminology is sufficiently precise so as not to contradict existing terms contained in national legislation.

4.1.2. A more reasonable deadline should be set for veterinary prescriptions so that treatment can be carried out without compromising animal safety. It would therefore be a good idea to extend the deadline from three weeks to a suitable period of time.

4.1.3. Vets or skilled qualified professionals must, while carrying out their duties, indicate the duration of the treatment to be provided, how much treatment is appropriate, waiting times, etc., using as a basis the information indicated in the summary of the product characteristics. These instructions shall form part of the prescription of the medicated feed, issued by the official veterinarian. The livestock farmer must follow the prescription, verifying the consistency of these instructions with the information set out in the summary of the product characteristics. In case of discrepancy, the producer will be exempt from liability. The treatment of animals is the responsibility of the veterinarian, who is familiar with and responsible for the situation of the litter. Obliging the livestock farmer to adhere strictly to the information in the product characteristic summary would actually mean that the farmer takes on the obligations and responsibilities of the veterinarian.

4.1.4. It is appropriate to permit the preventative use of antimicrobials, although this should be limited to cases where this is strictly necessary and justified. Under no circumstances must routine preventative use be permitted and good hygiene and use practices must be promoted.

4.1.5. The EESC calls for the regulation to indicate the legislation on which water quality requirements and those for conduit material are based. As regards the tolerances permitted in the labelling, no distinction should be made between products since all of these products have to undergo the same process of authorisation, with the same requirements and without making any distinction.

4.1.6. If there is an inconsistency in the labelling, this is due to a technical or analytical error (measurement uncertainty due to analytical method and type and content of active substance) and this can happen whether or not the feed contains antimicrobials. In addition, the degree of error in the analytical methods used to determine the presence of antimicrobials in feed is greater than for other substances, which means that there is less reproducibility and that such a low tolerance is therefore unjustified.

4.1.7. Furthermore, the EESC welcomes the fact that the tests carried out to authorise products also guarantee their homogeneity.

4.1.8. The requirement that medicated feed containing the daily dose of veterinary medicinal product must be mixed in to at least 50 % of the daily feed ration is cumbersome in practice and should be expanded as follows: ‘Medicated feed containing the daily dose of veterinary medicinal product must correspond to at least 50 % of the daily feed ration of complete feed or complementary feed (dry weight)’.

4.2. Veterinary medicinal products

4.2.1. The need to wait six months between a national procedure and the submission of a request for mutual recognition could cause problems if a serious situation arises in animal or public health. In exceptional circumstances therefore, it should be possible to obtain an exemption from this minimum six-month period. At the same time, in order to avoid any procedural delays, a date should be set for concluding the decentralised procedures and mutual recognition by the reference Member State.

4.2.2. Development of veterinary medicinal products should be promoted for all animal species by extending the investment and innovation protection not only in the case of minor species but all species. It would therefore be a good idea to extend the data protection period for all species, including in cases of the extension of authorisation to cover more than one species.

4.2.3. The various species of animals and various diseases require different forms of administration and this requires different pharmaceutical dosage forms (for example, liquids, solids, gels, injectables, etc.). A change in the pharmaceutical dosage form requires the product to be almost fully developed. This investment should therefore be protected.

4.2.4. The labelling requirements for immediate and outer packaging need to be made more flexible so as to include other optional information which might be of interest to users, in addition to mandatory information.

4.2.5. The benefits of using electronic media will only be realised when there is a single harmonised procedure throughout the Member States, which uses the same format and is applicable to all procedures.

4.2.6. The procedure for harmonising the summary of product characteristics must be purely administrative, avoiding the need to re-evaluate products proven to be safe and effective in the market over many years, thus preventing an unnecessary workload.

4.2.7. The proposed legislation could have a negative impact on the development of new antibiotics in veterinary medicine by not ensuring the existence of a predictable, stable and transparent market providing an incentive for companies.

4.2.8. It would be a good idea to establish a classification system for when medicinal products are used because of a therapeutic gap, giving priority to the use of veterinary medicinal products registered in the EU and limiting the use of medicinal products for human use to cases where there are no veterinary alternatives.