Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (Text with EEA relevance)

Article 1

Content and format of the information necessary to apply Articles 112(4) and 115(5) of Regulation (EU) 2019/6

The content and format of the information necessary to apply Articles 112(4) and 115(5) of Regulation (EU) 2019/6 and to be contained in the single lifetime identification document shall comply with the requirements set out in Annexes I and II to this Regulation.

Article 2

Transitional measures

By way of derogation from Article 1, the following shall be deemed to meet the content and format requirements of information referred to in Article 1:

• (a) the content and format of the information in ‘Section IX Medicinal Treatment’ of the identification document set out in the Annex to Decision 93/623/EEC and issued in accordance with Article 43(1)(a) of Implementing Regulation (EU) 2015/262;

• (b) the content and format of the information in ‘Section IX Administration of veterinary medicinal products’ of the identification document as set out in Annex I to Implementing Regulation (EC) No 504/2008 and issued in accordance with Article 43(1)(b) and (c) of Implementing Regulation (EU) 2015/262;

• (c) the content and format of the information in ‘Section II Administration of veterinary medicinal products’ of the identification document set out in Part 1 of Annex I to Implementing Regulation (EU) 2015/262 issued in accordance with Article 9 or 14 of that Regulation.

Article 3

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 28 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

• 1.The content of the information necessary to apply Article 112(4) of Regulation (EU) 2019/6 shall be the following:

• (a) contact details of the signing veterinarian responsible who treated the equine animal concerned with a veterinary medicinal product authorised under the exemption provided for in Article 8(4) of Regulation (EU) 2019/6 or a medicinal product administered in accordance with Article 112(4) of that Regulation;

• (b) the declaration for the equine animal concerned that it is not intended for slaughter for human consumption to be done by the veterinarian responsible in consent with the owner or operator of the equine animal.

• 2.The content of the information necessary to apply Article 115(5) of Regulation (EU) 2019/6 shall be the following:

• (a) contact details of the signing veterinarian responsible who administered a medicinal product containing a substance included in the list established in accordance with Article 115(5) of Regulation (EU) 2019/6;

• (b) date and place of the last administration of the medicinal product referred to in point (a) to the equine animal concerned;

• (c) details of the substance referred to in point (a).

ANNEX II

• 1.The information necessary to apply Articles 112(4) and 115(5) of Regulation (EU) 2019/6 shall be included in a dedicated section that:

• (a) shall be indivisibly integrated in the single lifetime identification document;

• (b) shall contain titled form fields to be completed in accordance with detailed instructions; those titled form fields and the instructions for their completion shall be displayed in French, English and the official language of the Member State in which the single lifetime identification document is issued;

• (c) shall consist of at least two parts providing form fields for the entry of information necessary:
• (i) to declare the equine animal as not intended for slaughter for human consumption in order to apply Article 112(4);
• (ii) to document the date of last administration of a medicinal product containing a substance included in the list established in accordance with Article 115(5) of Regulation (EU) 2019/6, and details of that substance.

• 2.The format of the information necessary to apply Article 112(4) of Regulation (EU) 2019/6 shall meet the following additional criteria:

• (a) the format of the dedicated section referred to in paragraph 1 shall ensure that at least the declaration on the exclusion from slaughter for human consumption can be protected from fraudulent alterations;

• (b) the format of the declaration referred to in point (a) shall be compatible with a corresponding entry in the database referred to in Article 109(1)(d) of Regulation (EU) 2016/429.