Commission Implementing Regulation (EU) 2022/209 of 16 February 2022 establishing the format of the data to be collected and reported in order to determine the volume of sales and the use of antimicrobial medicinal products in animals in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

1 Data on the volume of sales of veterinary antimicrobial medicinal products shall be reported by the Member States to the Agency using the format specified in Annex I.

2 The Agency shall include the format of the data referred to in paragraph 1 in the protocols and templates it makes available to the Member States, as provided for in Article 8 of Delegated Regulation (EU) 2021/578. The terminology used in the Agency’s protocols and templates for reporting shall be based on controlled terms defined in existing catalogues of terms maintained by the Agency, as much as possible.

1 Data on the use of veterinary antimicrobial medicinal products shall be reported by the Member States to the Agency through the web interface referred to in Article 10 of Delegated Regulation (EU) 2021/578, using the format specified in Annex II.

2 The Agency shall include the format of the data referred to in paragraph 1 in the protocols and templates it makes available to the Member States, as provided for in Article 8 of Delegated Regulation (EU) 2021/578. The terminology used in the Agency’s protocols and templates for reporting shall be based on controlled terms defined in existing catalogues of terms maintained by the Agency, as much as possible.

When providing the information necessary for the purposes of calculating the volume of sales and of the use of antimicrobials and validating data, the Agency shall use the variables specified in Annex III.

1 Data identified by the Agency or reported by the Member States on the relevant animal populations, as specified in Article 16(5) of Delegated Regulation (EU) 2021/578, shall take into account animal species, categories and stages thereof as listed in Article 15 of Delegated Regulation (EU) 2021/578 according to the following format: (a) for terrestrial animals: the number of animals per year (living animals or slaughtered animals, depending on the animal species or categories concerned, as specified in the Agency’s protocols and templates for the reporting of data); (b) for farmed fish: the biomass produced per year (live weight at slaughter).

2 While identifying or reporting the data on the relevant animal populations, the Agency or the Member States, as specified in Article 16(5) of Delegated Regulation (EU) 2021/578, shall take into account the number of animals brought in from other Member States and sent to other Member States for fattening or slaughter, for the relevant animals species, categories and stages thereof, when appropriate, in accordance with the Agency’s protocols and templates referred to in Article 8 of Delegated Regulation (EU) 2021/578.

3 When Member States report the data on the relevant animal populations in their territories, they shall submit to the Agency a detailed description of the methodologies they used to generate the relevant animal population data.

1 The Agency shall adjust the data for the relevant animal populations referred to in Article 4 according to so-called denominators, which are calculated on the basis of a combination of the number of animals slaughtered and of the number of live animals present in a Member State during the data collection period, multiplied by standardised animal weights.

2 Depending on the data concerned, the most appropriate denominator to be used shall be indicated in the Agency’s protocols and templates referred to in Article 8 of Delegated Regulation (EU) 2021/578.

3 The data sources and the methodology for the calculation by the Agency of the different denominators shall be specified in the Agency’s protocols and templates referred to in Article 8 of Delegated Regulation (EU) 2021/578.

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.