COMMISSION DELEGATED REGULATION (EU) 2022/2292
of 6 September 2022
supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/625 of the European Parliament and the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 126(1) thereof,
Whereas:
| (1) | Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States, in particular to ensure compliance, by consignments of animals and goods from third countries or regions thereof intended for human consumption, upon entry into the Union, with Union legislation on food and feed safety. |
| (2) | Regulation (EU) 2017/625 empowers the Commission to adopt delegated acts to supplement the conditions laid down in that Regulation for the entry into Union of food-producing animals and certain goods. Those conditions may include additional requirements, namely the possibility of allowing the entry of animals and goods only from third countries that appear on lists drawn up by the Commission for that purpose. These additional requirements include guarantees of compliance with:
| — | measures to monitor substances and groups of residues in animals and goods intended for human consumption, in accordance with Council Directives 96/23/EC (2) and 96/22/EC (3), |
| — | the rules for the prevention, control and eradication of transmissible spongiform encephalopathies in live animals and products of animal origin, in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (4), |
| — | the general principles and requirements governing food in general and food safety in particular at Union and national level, in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council (5), |
| — | the general rules for food business operators on the hygiene of foodstuffs, in accordance with Regulation (EC) No 852/2004 of the European Parliament and of the Council (6), |
| — | the specific rules on the hygiene of food of animal origin for food business operators, in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council (7), | |
| (4) | At present, third countries from which animals and products of animal origin are authorised for the entry into the Union as regards the Union rules on public health are included and kept on lists drawn on the basis of various requirements, including the existence of a control plan for pharmacologically active substances, pesticides and contaminants setting out guarantees on the monitoring of certain groups of substances and their residues and contaminants, in accordance with the requirements of Directive 96/23/EC. |
| (6) | The introduction of additional requirements to ensure compliance with the measures for monitoring substances and groups of residues in animals and goods intended for human consumption laid down in Directive 96/23/EC should be combined with the additional requirements already laid down in Delegated Regulation (EU) 2019/625. |
| (7) | It is thus appropriate to lay down all these additional requirements in one single Delegated Regulation, thereby simplifying their interpretation and application and enhancing transparency for third countries. |
| (8) | Regulation (EC) No 853/2004 lays down requirements for food business operators entering products of animal origin into the Union. Accordingly, the additional requirements laid down in this Regulation for official controls should be consistent with those already laid down in Regulation (EC) No 853/2004. |
| (9) | When laying down requirements for the entry into the Union of consignments of certain animals and good intended for human consumption, reference should be made to the Combined Nomenclature codes set out in Council Regulation (EEC) No 2658/87 (11), to identify these goods and animals clearly. |
| (10) | Consignments of certain animals and goods intended for human consumption should only be allowed to enter the Union, based on a risk analysis, where the third countries or regions thereof from which these animals and goods originate can ensure compliance with the requirements on the safety of those animals and goods and those third countries or regions thereof are included, in accordance with Article 127(2) of Regulation (EU) 2017/625, in the lists laid down in Commission Implementing Regulation (EU) 2021/405 (12). |
| (12) | Under Article 127(3) of Regulation (EU) 2017/625, the Commission may subject the decision to include third countries in lists laid down in Implementing Regulation (EU) 2021/405 to the provision, by those third countries, of appropriate evidence and guarantees of compliance with the Union requirements on the use of pharmacologically active substances in food-producing animals and of the compliance of consignments of products of animal origin and composite products intended to enter into the Union with the maximum residue limits of pharmacologically active substances, maximum residue levels of pesticides and maximum levels of contaminants established in Union legislation. This ensures that those food-producing animals, products of animal origin and composite products offer the same level of health protection as the one provided for by Union legislation on food and food safety. |
| (13) | To ensure that same level of health protection, evidence and guarantees should be provided by submitting a pharmacological substance, pesticide and contaminant control plan that meets certain requirements provided for in this Regulation. To ensure continuous compliance with those requirements, updated control plans should be submitted to the Commission on a yearly basis. |
| (14) | Third countries may also be included in the list laid down in Annex -I to Implementing Regulation (EU) 2021/405 if they provide appropriate evidence and guarantees that the food-producing animals and products of animal origin, including those used in composite products entering the Union, originate in a Member State or a third country included in a list of third countries with approved control plan for pharmacologically active substances, pesticides and contaminants for those food-producing animals and products of animal origin, including those used in composite products. Information on the procedures in place to ensure the traceability of the concerned food-producing animals and products of animal origin and to guarantee the origin of those animals and products should be provided to benefit from that listing. |
| (15) | Union legislation lays down rules on the use of pharmacologically active substances and establishes limits for their residues in products of animal origin arising from such use. Food-producing animals and products of animal origin including those used in composite products should only enter the Union from third countries ensuring that controls on the use of |
...
