Health and food safety

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Official controls on the agri-food chain

Overall state of play:

Commission proposal adopted on 6 May 2013, COM(2013)265
Legal act adopted: Regulation No 2017/625, 15 March 2017
Date of effect: 27 April 2018
Main application date: 14 December 2019

State of play, main conclusions, outlook

The Regulation aligns existing rules on official controls along the agri-food chain by eliminating regulatory overlaps. It applies the risk-based approach to all areas of the food chain and thus broadens the scope of the current rules, introducing an integrated comprehensive system which reduces unnecessary administrative burden caused by duplication of efforts. Hence the new regulation provides the prerequisites for a more targeted, rationalised and efficient response to non-compliances.

Estimated savings and benefits

More efficient controls and higher rates of compliance with agri-food chain requirements are expected to result in savings for competent authorities and for law abiding businesses. The integration of the system of official controls at borders will generate cost savings as a result of a more efficient use of resources.

Due to the limited availability of data, the savings have not been quantified.

REFIT Platform

In the REFIT Platform opinion on monitoring residues of veterinary medicines in foodstuffs of animal origin, a majority of the members of the Government group and some members of the Stakeholder group recommend that the Commission adopts general rules for Member States on risk-based control plans for residues of pharmacologically active substances. Both groups agree that the recommendation should not be seen as undermining policy objectives.

The Commission followed up on this opinion on veterinary medicinal residues in foodstuffs through new tertiary legislation.

State of Play:

Adopted: COM(2013)265, adopted by the Commission on 6 May 2013

Which objective(s) does the Commission pursue?

The initiative will:

• Create a single framework for all official controls along the entire agri-food chain (1 Regulation replacing 7 Directives, 2 Regulations and 1 Decision);

• Modernise, harmonise, simplify and clarify the system;

• Strengthen enforcement tools;

• Improve efficiency of controls;

• Tackle food fraud;

• Ensure appropriate resources for control authorities;

• Improve transparency on official controls and their financing.

More specifically, in terms of regulatory fitness, it will allow:

• Better allocation and use of resources collected through fees. The generalisation of risk based official controls across the entire agri-food chain will allow cross sector risk assessments and prioritisations of controls. In addition, full transparency on the calculation and use of fees and arrangements on their efficient use will increase the accountability of competent authorities;

• Obligation for competent authorities to perform official controls as much as possible in a manner that minimises the burden on enterprises;

• Exemption of microenterprises from mandatory official control fees;

• Mandatory consultation of operators by competent authorities on the method of calculation of fees;

• Creation of a common set of integrated, harmonised and modernised rules and tools for official controls of animals and goods at their entry into the Union.

Estimated savings and benefits

Due to the limited availability of data, the estimated savings were not quantified during the impact assessment process. No significant additional costs are expected to be generated by the new act which will produce a range of benefits linked to better enforcement of agri-food law (for example: reduction of fraud, more targeted controls, easier and more efficient enforcement cooperation across borders).

State of Play:

Adopted on 15 March 2017, Regulation (EU) 2017/625; Date of effect on 27 April 2018

Outcome of Legislative Procedure

The benefits intended by the Commission with its proposal from 2013 have largely been retained.

A more risk-based approach provides for better allocation and use of control resources. Efficiency will improve also by the streamlining of the legislative framework and strengthened provisions on administrative assistance and cooperation across borders. Coordination and cooperation is supported by an integrated computerised information system.

Member States are required to be fully transparent on the calculation of fees collected from operators. Food operators will have to be consulted on the method of calculation. A harmonised set of criteria, on which the calculation of fees should be based, contribute to a level playing field.

Systematic border controls of food containing products of animal origin, and post mortem inspections in slaughter houses, will be performed by appropriately trained professionals, not necessarily by official veterinarians. This should contribute to a more efficient use of available resources.

On residues of veterinary medicines:

The Delegated Regulation with specific provisions on the follow-up on non-compliances to the use or residues of veterinary medicinal products was adopted in June 2019 (Regulation 2019/2090). A delegated act (Regulation 2022/2292) on import conditions related to the use and residues of veterinary medicinal products was adopted in September 2022.

A delegated act (Regulation2022/1644) and an implementing act (Regulation 2022/1646) concerning control plans for monitoring of residues of veterinary medicinal products were adopted on 07 July 2022 and 23 September respectively covering risk-based control plan for production in the Member States, surveillance plan for production in the Member States and risk-based control plan for third country imports. This is addressing the REFIT platform opinion by introducing general rules on control plans that allow for more cost-effective residue monitoring.

On other official controls related aspects

A considerable number of delegated and implementing acts have been adopted by 14 December 2019, covering in particular the simplified and coherent system of checks at the external border of the EU, the Information Management System for Official Controls, an IT tool for the more efficient recording and follow-up to official controls and the designation of European Reference Laboratories and European Reference Centres which support the consistent implementation of the EU agri-food chain legislation covered by the Official Controls Regulation. A full list of all acts adopted is available at:

https://food.ec.europa.eu/document/download/9afe4839-7526-4b18-aa87-e70713b5641f_en?filename=oc_qa_ocregulation_20191212_delegated_implemented_acts_en.pdf

In terms of reduction of burden, particularly a delegated act¹ specified the cases and conditions under which competent authorities may designate laboratories as official laboratories where they have not been accredited for all the methods they use. Furthermore, an implementing act² introduced more risk-proportionate baseline frequencies for the performance of identity checks and physical checks on composite products at entry into the Union. Regarding the rules on border checks on organic products, particularly a delegated act³ exempting commodities not subject to sanitary and phytosanitary checks from organic checks at border control posts, should contribute to the reduction of burden.

¹ Commission Delegated Regulation (EU) 2021/1353 of 17 May 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to the cases and conditions under which competent authorities may designate official laboratories which do not fulfil the conditions in relation to all the methods they use for official controls or other official activities (OJ L 121, 13.8.2021, p.20).

² Commission Implementing Regulation (EU) 2021/2141 of 3 December 2021 amending Implementing Regulation (EU) 2019/2129 as regards the frequency rates of physical checks on certain composite products entering the Union (OJ L 433, 6.12.2021, p. 5).

³ Commission Delegated Regulation (EU) 2022/2305 of 21 October 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with rules on the cases where and conditions under which organic products and in-conversion products are exempted from official controls at border control posts, the place of official controls for such products and amending Commission Delegated Regulations (EU) 2019/2123 and (EU) 2019/2124 (OJ L 461, 27.12.2021, p. 5).