Explanatory Memorandum to COM(2014)556 - Regulation on the manufacture, placing on the market and use of medicated feed - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)556 - Regulation on the manufacture, placing on the market and use of medicated feed. |
|---|---|
| source | COM(2014)556  |
| date | 10-09-2014 |
Farmed animals in the EU are fed with roughage, feed materials and compound feed (mixture of feed materials). If animals are sick and need a treatment, veterinary medicinal products may be administered on the basis of a veterinary prescription. The vast majority of medicated feed for farmed animals contains antimicrobials or anti-parasites.
As regards the oral administration of medicines to animals, the animal holders can either add medicines themselves to the animal feed or drinking water or use medicated feed into which the medicine is incorporated by themselves or by another approved manufacturer.
Medicated feed is generally used to treat animal diseases in large groups of animals, in particular pigs and poultry. There is a clear correlation between the level of manufacture standards and the quality of the treatment via medicated feed. High standards mean good homogenous distribution of the medicine in the feed, good compatibility of the medicine with the feed and as a result good dosage and efficient treatment of the animal and low carry-over of the medicine into non-target animal feed.
There are 13.7 million animal holdings in the EU. The value of livestock farming output in the EU is €157 billion. The value of the EU`s aquaculture which includes production of crustaceans, molluscs, and finfish is estimated to be €3.3 billion. Pet animals represent the second largest type of animals kept in the EU. There are around 64 million cats, 60 million dogs, 40 million pet birds, 25 million small mammals and many millions of ornamental fishes. All these farmed animals, aquaculture species and pets, depending on their health condition, may need medication.
The aim of the review of the medicated feed rules is to harmonise at a high safety level the manufacture, marketing and use of medicated feed and intermediate products in the EU and to reflect technical progress in this field. The draft proposal updates the current legislation on medicated feed by repealing Directive 90/167/EEC which sets out the conditions under which medicated animal feed may be manufactured, placed on the market and used within the EU. The Directive has been established before the creation of the internal market and it has never been adapted in substance. The national transposition of this legal instrument has given freedom to Member States regarding interpretation and implementation of the legal provisions, but this flexibility has contributed to some problems. The Directive gives no indication on what standards to apply in approving plants or the acceptable techniques to produce medicated feed, whether standards should be technology-based or results-based, it does not provide for homogeneity criteria, it is totally silent on the concept of carry-over of medicated feed between batches, on the specific labelling of medicated feed and on medicated feed for pets and it is vague on whether feed may be prepared in advance of prescription in the feed mill, allowing Member States to arrive with different interpretations.
Furthermore, the existing legislation is likely to perpetuate existing discrepancies in its implementation between the Member States. This creates an uneven playing field for professional operators on the single market. There is a need to harmonise implementation of the legislation, reduce financial and administrative burdens and support innovation.
The draft proposal will allow the anticipated medicated feed production, mobile and on-farm mixing, while simultaneously establishing the parameters for these schemes. The provisions include measures for disposal of not used medicated feed on farm. EU wide limits will be set for the carry-over of veterinary medicines in feed that should be adapted based on an assessment of the risk for the animals and the humans with regard to the different types of active substances.
Contents
The impact assessment builds on the results of an external study entitled "Evaluation of the EU Legislative Framework in the Field of Medicated Feed” carried out in 2009/2010 by the Food Chain Evaluation Consortium (FCEC).
It is furthermore based on a wide stakeholders’ consultation in the context of the evaluation conducted in 2009/2010, following which internal consultations and discussion with the Member States took place. In addition, during the whole process consultations with the stakeholders were done in the margins of the Advisory Group on the Food Chain and Animal and Plant Health, the Animal Health Advisory Committee and the Advisory Committee on Fisheries and Aquaculture working group on aquaculture. Furthermore, targeted consultations of the International Federation for Animal Health Europe, the European Feed Manufacturers` Federation, the Federation of Veterinarians in Europe and the EU Farmers and Agri-Cooperatives were undertaken.
Following the stakeholders' consultation in the margins of the FCEC evaluation, a new web-based stakeholders' survey was organised from 30 March to 31 May 2011, using an Interactive Policy Making questionnaire to collect comments on the policy options.
Finally, focussed interviews with experts from the industry and competent authorities were undertaken mainly to collect data for the assessment of the different options.
In June 2009 a questionnaire was sent to the Member States plus Norway and Switzerland to gather information from the competent authorities on the status quo in the field of medicated feed.
In addition, the Commission has consulted and reported regularly to the working party of Chief Veterinary Officers, the Standing Committee on the Food Chain and Animal Health (Section Animal Nutrition) and the Veterinary Pharmaceutical Committee.
The purpose of the impact assessment was to support the changes proposed to the medicated feed legislation (Directive 90/167/EEC) in line with the principles set out in the Commission's Work programme. This is related to similar on-going work in the field of veterinary medical products. The Health and Consumers Directorate-General has taken the initiative to revise Directive 90/167/EEC at the same time as the revision of the veterinary medicinal products legislation.
Member States and the different stakeholders involved in this field have on several times indicated the importance of ensuring that the revision of the medicated feed legislation takes the specificities of the sector into account. This can only be done by an independent approach which builds on the links with the feed legislation and the veterinary medicinal products legislation.
The impact assessment identified the following main axes along which the system has to change in order to answer the stakeholders concerns: residues of veterinary medicines in feed, imprecise dosage of veterinary medicines, impossible market access to medicated feed for pets and barriers to intra EU trade of medicated feed.
The impact assessment concluded that an EU Regulation with detailed rules would have the most positive impacts and would provide for the best way forward to achieve the objectives for the EU. It should have a significant positive impact on cost efficiency and economic growth of the medicated feed manufacturing sector, also considering innovative applications of veterinary medicines. 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. Safe tolerance levels for the unavoidable carry-over of veterinary medicines in feed would lead to a pragmatic and solid level playing field for the industry and the control authorities.
The aim of this proposal is to repeal Directive 90/167/EEC by the proposed Regulation.
The scope of the proposed Regulation covers the manufacture, placing on the market and use of medicated feed for use in pets and in food-producing animals within the Union. It does not apply to veterinary medicinal products used as the medicinal component of medicated feed (previously called 'medicated premixes'), which are dealt with under the veterinary medicinal products legislation.
The Regulation lays down rules for the manufacture, composition, placing on the market and use of medicated feed. The general manufacture requirements laid down in Regulation (EC) No 183/2005 apply. Furthermore, medicated feed may only be manufactured from veterinary medicinal products authorised under the veterinary medicinal products legislation. It also sets rules for the approval of feed business operators and rules they need to comply with in order to manufacture medicated feed. The Regulation lays down rules for the homogenous incorporation of the veterinary medicinal products into the medicated feed and requirements in order to avoid carry-over of active substances from veterinary medicinal products into non target feed.
With respect to labelling, the general provisions laid down in Regulation (EC) No 767/2009 apply. Specific rules for the prescription, the validity of the prescription, the use of medicated feed containing antimicrobials in food-producing animals and the quantities required for the treatment of animals with medicated feed are laid down. Manufacturers, distributors and users of medicated feed must keep daily records for the effective tracing of medicated feed. For veterinary medicinal products authorised at national level, the Regulation sets Intra-Union rules for trade of medicated feed in order to prevent distortions in competition.
Rules for the adoption of delegated acts and of implementing acts on the basis of the Regulation are laid down in the proposal.
Articles 43 and 168(4)(b) of the TFEU provide for the legal basis of the proposal.
Directive 90/167/EEC was based on Article 43 of the Treaty establishing the European Economic Community (now Article 43 of the TFEU), implementing the Common Agricultural Policy. The objectives of that policy are to increase agricultural productivity, to ensure a fair standard of living for the agricultural community, to stabilise markets, to assure the availability of supplies and to ensure that supplies reach consumers at reasonable prices. To aim for harmonised and adequate production conditions for the EU livestock farmers can be also derived from this Article.
Article 168(4)(b) of the TFEU covers measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health.
The proposal takes the form of a Regulation of the European Parliament and of the Council. Other means would not be appropriate because the objectives of the measure can be achieved most efficiently by fully harmonised requirements throughout the Union.