EN
21.3.2022
Official Journal of the European Union
C 126/3
Hence, when an organic terrestrial food-producing species of animal is treated with a veterinary medicinal product used in accordance with the terms of the marketing authorisation for that species, the withdrawal period that applies to the production of organically produced foodstuffs from that animal is twice the withdrawal period set for that species of terrestrial food producing animal in the summary of the characteristics of the marketing authorisation of such a veterinary medicinal product and at least 48 hours.
In the particular case where the withdrawal period for a species of terrestrial food-producing animal laid down in the summary of the characteristics of the marketing authorisation of a veterinary medicinal product is zero days, it should be 48 hours in organic production.
From 28 January 2022, Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC will apply in combination with the specific provisions related to organic production of Regulation (EU) 2018/848 and the situation will remain the same as described above.
Question 3: When an organic terrestrial food-producing animal belonging to a certain species is treated with a veterinary medicinal product used outside the terms of the marketing authorisation for that species, which withdrawal period should be applied between the last administration of a chemically synthetised allopathic veterinary medicinal product, including of an antibiotic, under normal conditions of use, and the production of organically produced foodstuffs from that animal?
In case an organic terrestrial food-producing animal belonging to a certain species is treated with a veterinary medicinal product used outside the terms of the marketing authorisation for that species, between 1 January 2022 and 27 January 2022, the specified withdrawal period shall not be less than: — 14 days for eggs, — 14 days for milk, — 56 days for meat from poultry and mammals including fat and offal, which correspond to not less than twice the withdrawal periods set for conventional food producing animal species in Article 11 of Directive 2001/82/EC.
From 28 January 2022, Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC will apply in combination with the specific provisions related to organic production of Regulation (EU) 2018/848.
Articles 113 and 115 of Regulation (EU) 2019/6 set respectively the rules applying for the use of medicinal products outside the terms of the marketing authorisation in food-producing terrestrial animal species, and for the withdrawal period for medicinal products used outside the terms of the marketing authorisation in food producing animal species.
In particular, Article 115 states that:
‘unless a medicinal product used has a withdrawal period provided in its summary of the product characteristics for the animal species in question, a withdrawal period shall be set by the veterinarian in accordance with the following criteria: (a) for meat and offal from food-producing mammals and poultry and farmed game birds the withdrawal period shall not be less than: (i)
the longest withdrawal period provided in its summary of the product characteristics for meat and offal multiplied by factor 1,5;
(ii) 28 days if the medicinal product is not authorised for food-producing animals; (iii) one day, if the medicinal product has a zero withdrawal period and is used in a different taxonomic family than the target species authorised; (b) for milk from animals producing milk for human consumption the withdrawal period shall not be less than: (i)
the longest withdrawal period for milk provided in the summary of the product characteristics for any animal species multiplied by factor 1,5;