Cross-contamination of antimicrobial substances in non-target feed
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EU proposes maximum levels of cross-contamination of antimicrobial active substances in non-target feed, and methods of analysis
Draft Delegated Regulation supplementing Regulation (EU) 2019/4 of the European Parliament and of the Council by establishing specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed and methods of analysis for these substances in feed
Annex to the Commission Delegated Regulation
The proposed Regulation will supplement the Medicated Feed Regulation (EU) 2019/4. It will establish maximum acceptable levels of cross-contamination for 24 antimicrobial active substances in “non-target feed”. (The EU defines non-target feed as feed that is not intended to contain a specific substance.)
The maximum level for non-target feed will be 1% of the amount of active substance that is allowed in medicated feed. This maximum level should also apply in non-target feed that is used for flushing to remove left-overs after production of medicated feed.
However, stricter restrictions are needed to avoid:
- cross-contamination between medicated feed produced for fish and feed for other food-producing animals
- residues in milk or eggs
- residues in animals close to the date of slaughter.
The draft Regulation also provides reference analysis methods for these 24 antimicrobial substances.
feed for food-producing animals
What is changing?
The proposed new rules apply to the 24 active substances listed in Annex II of Regulation 2019/4. In cases where a feed is processed, stored, or transported in the same equipment that was used for a medicated feed containing one of these 24 antimicrobial substances, the European Commission proposes to establish a harmonised acceptable level for cross-contamination. Enforceable maximum levels should be at 1% of the active substance in the medicated feed.
Maximum levels of cross-contamination in non-target feed for milk- or egg-producing animals, and for animals close to the date of slaughter, should apply at the limit of quantification (LOQ, the lowest concentration of a substance that can be measured with certainty using standard tests).
Where the cross-contamination originates from medicated feed intended for fish, the LOQ will apply in non-target feed for all food-producing animals other than fish.
Feed materials used to remove left-overs (flushing) from medicated feed in manufacturing, processing, storage, or transport facilities can be reused in the production of non-target feed if the end product complies either with the maximum of 1% of the active substance in the medicated feed, or with the LOQ if the end product is intended as feed for milk- or egg-producing animals or for animals close to the date of slaughter.
Methods of analysis for the antimicrobial active substances are also proposed.
The new permitted level represents a good balance between the control of antimicrobial resistance and levels that have effects on growth promotion or increased yield, feasibility for the feed industry, and enforceability by competent authorities.
Medicated feed intended for fish often contains substantially higher doses of antimicrobial active substances than medicated feed intended for food-producing animals other than fish. To avoid growth promotion or increased yield in these animals, maximum levels should apply at the LOQ.
Feed materials from flushing can be used in non-target feed, provided that such feed complies with the maximum permitted levels, in order to avoid feed waste.
Both the EU and the World Trade Organization (WTO) are seeking feedback on this new legislation:
- EU: feedback open until 9 November 2023
- WTO: feedback open until 5 December 2023.
Commission publication is planned for the first quarter of 2024.
Entry into force: 20 days after publication.
Entry into application: 6 months after entry into force.
Manufacturers, and processing, storage, and transport facilities handling feed for export to the EU should assess and minimise risks of cross-contamination with antimicrobial active substances in non-target feed, if they also handle medicated feed in the same facilities. Cross-contamination should be avoided or kept as low as possible by applying good practices to prevent antimicrobial resistance.
Exporting countries are recommended to use the methods of analysis for antimicrobial active substances referred to in the Annex to this new Regulation. Alternative analytical methods may be used if they are validated in accordance with internationally accepted scientific protocols, and only if the LOQ is the same as, or lower than, that referred to in the Annex.
It is also recommended to use official, accredited laboratories with proven competence for such analysis.
Comments or concerns about potential impacts can be submitted in two ways:
- on the EU Have your say portal until 9 November 2023
- via the National SPS notification authority of the country concerned to the EU SPS Enquiry Point until 5 December 2023.
Regulation (EU) 2019/4 lays down rules for medicated feed. The use of antibiotics (other than coccidiostats or histomonostats) as feed additives has been phased out from 1 January 2006 in accordance with Regulation (EC) 1831/2003.
The European Food Safety Authority (EFSA 2021), in cooperation with the European Medicines Agency, carried out a scientific risk assessment of the growth promotion or increased yield effect that these substances may cause when present in non-target feed.
EFSA (2021) Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 1: Methodology, general data gaps and uncertainties. EFSA Journal, 19(10): 6852.
Regulation (EU) 2019/4 Medicated Feed Regulation
Regulation (EC) 1831/2003 on additives for use in animal nutrition
Draft Delegated Regulation establishing specific maximum levels of cross-contamination of antimicrobial active substances in non-target feed and methods of analysis for these substances in feed
Annex to the Regulation
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