Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designates antimicrobials and groups of antimicrobials that are reserved for the treatment of certain infections in humans. Applicable since 9 February 2023, it draws a hard line: the listed substances shall not be used in veterinary medicinal products or in medicated feed, and using human medicinal products containing them in animals is prohibited.
A prohibition, not a restriction
This is worth stating plainly because it is often softened in internal summaries. The regulation does not make these substances harder to use in animals or subject to additional conditions. It removes them from veterinary use entirely. The list, set out in the Annex, covers eighteen antimicrobials or groups, spanning antibiotics, antivirals and antiprotozoals. The purpose is to preserve the efficacy of substances used to treat infections in humans, particularly those regarded as treatments of last resort.
What it touches in practice
- Veterinary medicinal products. No authorised veterinary product may contain a listed substance.
- Medicated feed. The prohibition extends to medicated feed manufactured under Regulation (EU) 2019/4.
- Use of human products in animals. The cascade does not provide a route around the list. Administering a human medicinal product containing a listed substance to an animal is prohibited.
- Development pipelines. Any veterinary development programme built around a listed substance has no route to authorisation in the Union.
The import dimension
The Union has extended the logic beyond its own borders. Commission Delegated Regulation (EU) 2023/905 supplements Regulation (EU) 2019/6 in relation to the prohibition on the use of certain antimicrobial medicinal products in animals, or in products of animal origin, exported from third countries into the Union. Commission Implementing Regulation (EU) 2026/1189, adopted on 4 June 2026, amends Implementing Regulation (EU) 2021/405 as regards the application of those restrictions and repeals Implementing Regulation (EU) 2024/2598, with its main provision applying from 3 September 2026. For companies importing products of animal origin, or supplying into supply chains that do, this is now an active compliance question rather than a future one.
What companies should check
Three checks cover most of the exposure. First, confirm that no product in your veterinary portfolio, current or in development, relies on a listed substance. Second, confirm that your medicated feed arrangements and any contract manufacturing reflect the prohibition. Third, if you sit anywhere in an animal-origin import chain, confirm that your suppliers understand the third-country requirements and that you have documentary assurance rather than an assumption.
How PQRA helps
PQRA reviews veterinary portfolios and development programmes against the reserved antimicrobials framework, advises on medicated feed and contract manufacturing implications, and supports companies assessing exposure under the third-country import provisions. We translate the legal text into a clear position on what you can market, where, and on what evidence.
To assess your antimicrobial exposure, contact PQRA.
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