C 126/2
EN
Official Journal of the European Union
21.3.2022
Part II of Annex II to Regulation (EU) 2018/848 sets livestock production rules.
Point 1.5.2.5 of Part II of Annex II to Regulation (EU) 2018/848 states that ‘the withdrawal period between the last administration to an animal 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 shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC (4), and shall be at least 48 hours.’
Points 1.5.1.2 and 1.5.1.3 of Part II of Annex II to Regulation (EU) 2018/848 state respectively the following in relation to disease prevention for livestock: ‘immunological veterinary medicinal products may be used’, and ‘chemically synthetised allopathic veterinary medicinal products , including antibiotics and boluses of synthetised allopathic molecules, shall not be used for preventive treatments’.
This establishes an implicit distinction between immunological veterinary medicinal products and chemically synthetised allopathic veterinary medicinal products.
Vaccines are immunological veterinary medicinal products and point 1.5.2.5 of Part II of Annex II to Regulation (EU) 2018/848 is not relevant for their use.
Question 2: 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, 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?
Answer:
Regulation (EU) 2018/848 applies from 1 January 2022, as established in Article 61 thereof.
Recital (43) of Regulation (EU) 2018/848, describes the intention of the legislator regarding the withdrawal period for animals and states that ‘animal health management should mainly be based on the prevention of disease. [...] The preventive use of chemically synthetised allopathic medicinal products, including antibiotics, should not be permitted in organic production.
In the event of sickness or injury of an animal requiring immediate treatment, the use of such products should be limited to the minimum necessary to re-establish the well-being of the animal.
In such cases, in order to guarantee the integrity of organic production for consumers, the official withdrawal period after use of such medicinal products as specified in the relevant Union legislation should be double the normal withdrawal period and have a minimum duration of 48 hours.’
Part II of Annex II to Regulation (EU) 2018/848 sets livestock production rules; livestock production is defined in Article 3, point (27), as meaning the production of domestic or domesticated terrestrial animals, including insects.
Point 1.5.2.5 of Part II of Annex II to Regulation (EU) 2018/848 applies.
This provision states that ‘the withdrawal period between the last administration to an animal 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 shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC (5), and shall be at least 48 hours.’
The cross-reference to Article 11 of Directive 2001/82/EC in Regulation (EU) 2018/848 refers in particular to the second indent of paragraph 2 of that article, which states that ‘[...] unless the medicinal product used indicates a withdrawal period for the species concerned, the specified withdrawal period shall not be less than: — 7 days for eggs, — 7 days for milk, — 28 days for meat from poultry and mammals including fat and offal’ and should be interpreted as a reference to withdrawal periods of veterinary medicinal products used within or outside the terms of the marketing authorisation.
(4) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1 which will be repealed by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 4).
(5) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1 which will be repealed by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 4).