Documents Considered by the Committee on 22 October 2014 - European Scrutiny Committee Contents

2 Medicated animal feed

Committee's assessment Politically important
Committee's decisionNot cleared from scrutiny; further information awaited

Document detailsDraft Regulation on the manufacture, placing on the market and use of medicated feed
Legal baseArticles 43 and 168(4)(b) TFEU; co-decision; QMV
DepartmentEnvironment, Food and Rural Affairs
Document number(36338), 13196/14 + ADDs 1-3, COM(14) 556

Summary and Committee's conclusions

2.1 Medicated feeds are an important way of treating disease in farmed animals and domestic pets, and the EU conditions governing their manufacture, placing on the market and use are set out in Council Directive 90/167/EC. However, the Commission points out that this was adopted before the creation of the single market, that the freedom it provides Member States has given rise to a number of problems, and that many of its provisions are unclear. It has therefore now proposed that the Directive should be repealed, and replaced by this draft Regulation, which retains many of the previous provisions, whilst seeking to achieve greater clarity in a number of important areas.

2.2 Although this is a somewhat technical area, it is clear that the Government welcomes this proposal, and that, subject to a number of detailed points, it is broadly content with the approach suggested by the Commission. Having said that, the Government has indicated that it will be providing in due course a UK Impact assessment, and we think it prudent to await that before taking a definitive view. In the meantime, we are drawing the proposal to the attention of the House.

Full details of the documents: Draft Regulation on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EC (36338), 13196/14 + ADDs 1-3, COM(14) 556.


2.3 Medicated feeds containing antimicrobials and anti-parasites are an important way of treating disease in groups of farmed animals, especially pigs and poultry, as well as in domestic pets. The EU conditions governing their manufacture, placing on the market and use are set out in Council Directive 90/167/EC, which requires that production should take place on previously approved premises, that the feeding stuff should produce a "homogeneous and stable" mix, that there should be no undesirable interaction with other substances, that manufacturers should keep relevant records for at least three years, and that a feeding stuff should be supplied only on presentation of a prescription, valid for three months, issued by a registered veterinarian, who must be satisfied that the medication is justified.

2.4 However, the Commission points out that the measure was adopted before the creation of the single market, and that the freedom it provides Member States as regards national transposition has given rise to a number of problems. In addition, it observes that the Directive gives no indication of the standards to be applied in approving plants, of the acceptable techniques needed to produce medicated feed, or whether standards should be technology or results-based; that it provides no criteria for assessing the homogeneity of feed; that it does not deal with the issue of medicated feed being carried over between batches; and that it contains no specific labelling provisions.

The current document

2.5 Given these considerations, the economic importance of livestock farming and aquaculture within the EU, and the need to protect human health, the Commission has now proposed that Council Directive 90/167/EC should be repealed, and replaced by this draft Regulation. This retains many of the previous provisions, whilst seeking to achieve greater clarity, and would:

·  require medicated feed to be manufactured only in approved establishments with veterinary medicinal products authorised in accordance with Directive 2001/82/EC;

·  enable the Commission to establish criteria, such as target values, for the homogeneous incorporation of veterinary medicines into medicated feed;

·  establish maximum levels, related to the degree of risk involved, for the "carry over" of active substances between different types of feed manufactured on the same production line;

·  require that, in addition to the general provisions laid down in Regulation (EC) No. 767/2009, medicated feed should be subject as well to specific labelling requirements providing the user with information needed to administer it correctly;

·  require the supply and use of medicated feed to be subject to the issuing of a valid veterinary prescription issued by the person who has examined the animals to be treated (which would be valid for three weeks in the case of food-producing animals, and for six months for other animals);

·  prohibit the use of medicated feed containing microbials with the intention of preventing disease in food-producing animals, thus taking account of the severe public health risk posed by antibiotic resistance.

2.6 The proposal also includes five, essentially technical Annexes, which set out requirements for feed business operators, incorporation levels, labelling particulars, permitted tolerances and prescription form.

The Government's view

2.7 In his Explanatory Memorandum of 26 September 2014, the Parliamentary Under-Secretary of State at the Department for Environment, Food and Rural Affairs (George Eustice) says that the Government welcomes the proposed Regulation as it will harmonise the market for medicated feed and so give assurance that the UK industry is not at a competitive disadvantage compared with other Member States. He adds that the proposal should not adversely affect the UK's objective of securing the continuing availability of high quality, safe and effective medicated feeds, or give rise to a significant regulatory burden, and he is generally content with the changes aimed at reducing the risk of antibiotic resistance developing in the food chain.

2.8 At the same time, he says that there are some points of detail on which the Government will seek clarification:

·  broadly speaking, the UK industry already achieves low levels of carry over, but there are concerns whether commercial laboratories have the capability to analyse feed samples to the lower limits needed to confirm compliance for the more potent antibiotics, and achieving the level of detection required is likely to increase the cost of analysis;

·  shortening the validity period of a prescription for medicated feed, and reducing the amount of prescribed feed supplied at any one time, could conflict with optimum treatment times;

·  the Commission will be asked to clarify whether the proposed ban on the use of antibiotics in medicated feed to prevent disease extends to the treatment of healthy animals in contact with diseased animals, as this could have an impact on the spread of disease in groups of animals; and

·  it will be necessary to clarify the requirement that a prescribed medicated feed may be used only for animals "examined" by the person issuing the prescription and for a diagnosed disease, as this suggests that a veterinarian must carry out a physical examination, whereas the current requirement for a "clinical assessment" does not necessarily involve this.

2.9 Finally, the Minister says that the UK is content that the Commission should establish targets for the homogeneity of medicated feed by means of an implementing act (where it hopes that these will be set by scientific committees); that it will wish to ensure that Member States are consulted prior to the Commission suggesting amendments to the technical Annexes by means of Delegated Acts; and that, although the Regulation would apply 12 months from the date of adoption, this comparatively short length of time is unlikely to cause a problem, as most of the changes are comparatively minor in nature.

2.10 However, the Minister adds that, as this proposal forms part of a package including a much larger proposal on veterinary medicines,[9] negotiations are not expected to be completed before the end of 2016. In the meantime, an Impact Assessment for the UK is under preparation, and is likely to be submitted within the next six months (though the costs are highly dependent on the particular proposals, and could change significantly during the negotiations).

Previous Committee Reports


9   (36344), 13289/14: see Chapter 3 of this Report. Back

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