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Position paper: Proposal for a Regulation on the manufacture, placing on the market and use of medicated feed (COM 2014/556)

The purpose of the Regulation on medicated feed is to harmonise the manufacturing, marketing and use of medicated feed. IFAH-­Europe welcomes the proposed Regulation, which is a step in the right direction for much-­needed harmonisation across the EU. However, there is a need for improving the Regulation’s provisions.

Executive Summary

Medicated feed is one of the ways a farmer or a pet owner can administer a veterinary medicine to animals. All administration routes are valuable, but sometimes medicated feed can be the best, if not the only, option. It is particularly useful for pigs, poultry and fish, as well as for companion animals.
Only veterinary medicines approved and licensed for this particular use may be used to make medicated feed. These veterinary medicines are incorporated in feeds by specially licensed facilities and can only be delivered after obtaining a veterinary prescription (or in the UK, by appropriately designated persons), indicating the correct dosage and duration of the treatment.

The manufacture and use of medicated feed can be best described by the three 3Cs:
• Control: medicated feed is manufactured under internationally recognised quality standards known as Hazard Analysis at Critical Control Point (HACCP). This minimizes the risk of incorrect dosing due to human error.
• Compliance: this method of administration ensures full conformity with the prescription in terms of dosing and duration of treatment.
• Care: administrating medicines through feed reduces the stress and risk of injury for the animal and persons involved. This is important for companion animals suffering from a chronic disease.

The purpose of the Regulation is to harmonise the manufacturing, marketing and use of medicated feed. IFAH-Europe welcomes the proposed Regulation, which is a step in the right direction for much-needed harmonisation across the EU. However, there is a need for improving the Regulation’s provisions with regard to the areas listed below.

Route of supply
The majority of medicated feed is supplied directly from the feed manufacturer to the farm, under veterinary prescription. However, medicated feed for companion animals is normally supplied via veterinarians and pharmacists. Under the proposed regulation, to be able to continue to supply, veterinarians and pharmacists will have to register as feed business operators. This presents an unnecessary and significant administrative burden and would discourage vets and pharmacists from making medicated feed available for companion animals. Therefore, there needs to be an exception under article 3 for this specific route of supply.

As feed is mixed with the pharmaceutical ingredient, traces of medicated feed may remain in the production line and small amounts may be transferred into the next batch of feed. This is called “carry-over”. The proposal sets a 1% carry-over limit for feed that includes antimicrobials and 3% carry-over limit for all other medicated feed.
The lower limit for antimicrobials reflects a concern that this carry-over may contribute to the development of anti-microbial resistance. However, a 2012 study found that the risk of antimicrobial resistance selection remains low, even in a worst case level of 10% carry-over. Moreover, the proposal states that the provisions should be governed by the ALARA (As Low As Reasonably Achievable) principle, which for European feed manufacturers is considered to be 3%. Article 7.2 should thus be amended to set the limit at 3% as the general and only rule for carry-over.

Preventive use
The proposed regulation does not take into account a situation that farmers and veterinarians can at times face: disease outbreaks can affect all animals in a group, hereby necessitating treatment of the entire group. Some of the animals will show symptoms and will clearly be ill, others may be infected but lack symptoms, while others again may not yet be infected. This is an example of an instance where medicated feed can be prescribed to benefit a group of animals and prevent the further spread of disease.

IFAH-Europe agrees that unjustified preventive treatment with antibiotics is unacceptable. It also underlines that it in such justified instances as the above, the regulation must not remove the opportunity for veterinarians to help animals through the use of medicines that have been approved for this specific purpose and are best administered through feed, according to their terms of approval set by the regulatory authority. Acknowledging the need for a treatment for the benefit of a group of animals in exceptional cases and in accordance to the terms of approval set by the regulatory authority is essential in order to clarify article 16.2 and align it with the proposed regulation on veterinary medicines, where no such prohibition exists.

Duration of treatment containing antimicrobials
The proposed regulation states that medicated feed for food producing animals containing antimicrobials can only be supplied for two weeks of treatment. Antimicrobials should be used responsibly and according to the veterinary prescription, including recommendations given on medicine use. As per the regulators’ approvals and the data gathered during clinical trials, different antimicrobial products may require different treatment durations, some exceeding the proposed two week limit.
In order to promote responsible use and adherence to the veterinary prescription of antimicrobials, the proposed article 16.b should be amended to allow the supply of a quantity of medicated feed sufficient to complete the prescribed treatment regime in accordance with the licensed approval.

Tolerance levels
As feed and a pharmaceutical ingredient are mixed, it is recognised that some variability will always be present, regardless of the accuracy of the mixing process. The proposed regulation sets “tolerance levels”, i.e. the allowed variability of the content of the active principle against the label in the feed. This covers both technical (i.e. the homogeneity of the mix) and analytical tolerance (i.e. the variability in the analytical methods used among different laboratories).
Given the differences that may appear according to the different analytical methods used, the proposed 10% tolerance limit is insufficient and not in accordance with the ALARA principle. Therefore we would propose that the tolerances set in Annex IV are limited to the technical deviations.


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