BAKGRUNN (fra kommisjonsforordningen)

(1) Regulation (EU) 2019/4 lays down specific provisions regarding medicated feed and intermediate products. Cross-contamination of non-target feed with antimicrobials has been identified as a core issue of the Union in the context of protecting animal health, human health and the environment, and should be avoided or kept as low as possible.
(2) In accordance with Article 7(3) of Regulation (EU) 2019/4, the Commission must adopt delegated acts to supplement that Regulation by establishing, as regards the 24 antimicrobial active substances listed in Annex II thereto (‘the 24 antimicrobial active substances’), specific maximum levels of cross-contamination for the antimicrobial active substances in non-target feed and methods of analysis for the antimicrobial active substances in feed. Pursuant to Article 7(3) of that Regulation, those delegated acts which establish maximum levels of cross-contamination must be based on a scientific risk assessment carried out by the European Food Safety Authority (‘EFSA’).
(3) At the Commission’s request, EFSA assessed, in cooperation with the European Medicines Agency (‘EMA’), the specific concentrations of the 24 antimicrobial active substances resulting from cross-contamination in non-target feed for food-producing animals, below which there would be no effect on the emergence of, and/or selection for, resistance in antimicrobial active substances relevant for human and animal health (‘antimicrobial resistance’, ‘AMR’).
(4) EFSA was also requested by the Commission to assess the levels of the 24 antimicrobial active substances which could have a growth promotion or increased yield effect, taking into account that the use of antibiotics as feed additives, other than coccidiostats or histomonostats, has been phased out since 1 January 2006 in accordance with Article 11(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council. The specific maximum level of each antimicrobial active substance in non-target feed should be below the level that causes a growth promotion or increased yield effect.
(5) In addition, the Commission requested the Reference Laboratory, set up pursuant to Regulation (EC) No 1831/2003 (‘the Reference Laboratory’), to recommend methods of analysis for the 24 antimicrobial active substances in feed.
(6) In its 13 Opinions of 15 September 2021 on maximum levels of cross‐contamination for the 24 antimicrobial active substances in non‐target feed (‘Opinions of 15 September 2021’), EFSA could only establish specific concentrations concerning AMR for six of the 24 antimicrobial active substances and not for all relevant animal species, due to a lack of data. In addition, EFSA only identified levels causing effects on growth promotion or increased yield for 14 of the 24 antimicrobial active substances and not for all relevant animal species, again due to an absence of relevant data.
(7) In April 2022 and February 2023, the Reference Laboratory issued two reports on the methods of analysis and minimum achievable limits of quantification (‘LOQ’) in feed for the 24 antimicrobial active substances (‘Reports of April 2022 and February 2023’).
(8) The specific concentrations concerning AMR established by EFSA for six antimicrobial active substances, in the Opinions of 15 September 2021, are significantly lower than the minimum LOQs established by the Reference Laboratory in the Reports of April 2022 and February 2023. This means, in practice, that the specific concentrations are not measurable and would, therefore, not be enforceable by the Member States in accordance with Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council.
(9) The lowest levels of the 14 antimicrobial active substances, for which EFSA could indicate in its Opinions of 15 September 2021 as causing a growth promotion or increased yield effect, are significantly higher than the LOQ for the same substance and are therefore measurable and enforceable by the Member States in accordance with Article 17(2) of Regulation (EC) No 178/2002. To avoid a growth promotion or increased yield effect, the maximum levels of cross-contamination for the antimicrobial active substances in non-target feed should be below the lowest levels causing a growth promotion or increased yield effect.
(10) High economic investment and increased logistical costs to comply with the maximum levels of cross-contamination in non-target feed if such levels are very low is likely to result in a reduction of the production of medicated feed. In addition, the EMA Advice of 28 August 2020 on implementing measures under Article 106(6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via routes other than medicated feed, concludes that it may also result in an increased recourse to methods of oral administration of antimicrobial active substances other than medicated feed, such as the administration on the surface of solid feed, that may increase the risk of AMR and the inability to treat certain bacterial infections in certain species due to the absence of other appropriate routes of administration, for example, in aquaculture. The maximum levels of cross-contamination should, therefore, not be detrimental to the production of medicated feed, in particular, by small and medium size feed manufacturing plants, excluding them in practice from the production of medicated feed, which would result in possible issues for public health, and animal health and welfare. It is, therefore, appropriate to establish a maximum level of cross-contamination that is strict but also feasible to achieve by applying good practices to minimise cross-contamination. In addition to the Opinions of 15 September 2021, the experience gained in the Member States in applying national law indicates that a cross-contamination level in the non-target feed of 1% of the active substance in the medicated feed, represents a good balance between feasibility and AMR control. Intermediate products contain higher concentrations of active substances than medicated feed. Therefore, where non-target feed is manufactured, processed, stored or transported after the manufacturing, processing storage or transport of intermediate products, a cross-contamination level of 1% of the substance to be contained in the derived medicated feed, should apply.
(11) The maximum levels of cross-contamination for some antimicrobial active substances in non-target feed should be reviewed if new scientific evidence becomes available, allowing to further control antimicrobial resistance in the non-target feed with enforceable maximum levels which are achievable by applying good practices to minimise cross-contamination.
(12) Medicated feed or intermediate products intended for fish often contains substantially higher doses of antimicrobial active substances than medicated feed or intermediate products intended for food-producing animals other than fish. In addition, no levels of antimicrobial active substances creating a growth promotion or increased yield effect in fish, have been identified in the Opinions of 15 September 2021. Stricter specific maximum levels of cross-contamination in non-target feed intended for food-producing animals other than fish therefore are needed where the cross-contamination originates from medicated feed or intermediate products intended for fish, in order to avoid a growth promotion or increased yield effect in food-producing animals other than fish. Since these stricter specific maximum levels of cross-contamination in non-target feed intended for food-producing animals other than fish should be measurable and enforceable by the Member States, they should be set at the LOQ.
(13) It should be ensured that food derived from animals fed with the non-target feed complies with the maximum residue limits laid down in Table 1 set out in the Annex to Commission Regulation (EU) 37/2010. Stricter specific maximum levels of cross-contamination for antimicrobial active substances in non-target feed should, therefore, be laid down in this Regulation, in particular for milk- or egg-producing animals and for animals close to the date of slaughter. Since these stricter specific maximum levels of cross-contamination in non-target feed should be measurable and enforceable by the Member States, they should be set at the LOQ.
(14) The methods of analysis recommended by the Reference Laboratory in the Reports of April 2022 and February 2023 should be used as reference methods for the analysis of the 24 antimicrobial active substances in feed. Alternative methods of analysis should only be allowed when validated and considered as equivalent by the competent authorities of the Member States.
(15) It is appropriate to provide official laboratories carrying out the methods of analysis for antimicrobial active substances in feed with sufficient time to adapt to the LOQs and prove their competence for carrying out such methods of analysis by generally accepted means, such as by accreditation, sound in-house validation or proficiency test data targeting a timely accreditation. Therefore, this Regulation should apply 12 months after the date of its entry into force,