On 15 March 2017 the Official Controls Regulation on the food supply chain was adopted by the EU Parliament and Commission in Regulation 2017/625 on .
The news didn’t make too many waves in the industry, perhaps because – at least for the immediate future – there will be no significant changes in food safety standards and rules for official controls inside the EU and on imported goods. There are, however, important changes to other aspects.
In this first article of a two-part series, we’ll give an overview of Regulation 2017/625, the Official Controls Regulation, and summarise the changes for public stakeholders. In the second article we will look at how business operators will be affected by the changes.
The new law Official Controls Regulation at a glance
There are several reasons why Regulation 2017/625 is an important milestone for food safety in the EU:
- It simplifies and reduces legal fragmentation. The Regulation repeals 854/2004 on official controls on products of animal origin intended for human consumption, plus nine more acts of legislation (Regulations, Commission Directives and Decisions), and amends several others. Previously, official controls in each segment of the supply chain (e.g. animal welfare, pesticide residues, controls on products of animal origin, etc) were regulated separately, while now they are under one legal roof.
- It strengthens the basic principles of previous laws. Although the new Regulation doesn’t change important principles like transparency of controls and cooperation between Member States, it brings more clarity to existing provisions by using more precise verbiage.
- It improves harmonization of procedures and standards. One example is the creation of a single information management system for official controls (IMSOC), which integrates existing systems (like RASFF and Traces) and facilitates the exchange of information between Member States.
- It creates the legal basis for future, more radical changes. A recurring sentence in the regulation is “The Commission shall adopt delegated acts in accordance with Article 144 to amend this Regulation.” The reference is to the article that gives the Commission power to adopt delegated acts. It is an important novelty, that creates the legal basis for more sweeping changes in the future.
Wider scope Official Controls Regulation
Regulation 2017/625 establishes the rules for the performance of official controls and other related aspects such as:
- the financing of official controls
- the administrative assistance and cooperation between Member States
- the controls by the Commission in Member States and in non-EU countries
- the requirements for importing animals and goods into the Union
- the establishment of IMSOC
In this respect there are no significant changes. However, there’s an important difference is in the areas where the rules are applied. The scope of the new legislation is much wider than before and includes official controls on:
- food and feed law
- animal health and animal welfare rules
- plant health (including organics and plant protection products)
- veterinary and zootechnical checks
- live animals and products of animal origin intended for human consumption
- release into the environment of GMO’s
Food fraud is now a risk element
The new Regulation maintains the risk-based principle of official controls, adding two provisions:
- food fraud is now an element of risk and part of the risk assessment
- the obligation of competent authorities to limit or minimise the burden on operators while performing official controls
Greater transparency and accountability of competent authorities
Regulation 2017/625 increases the level of accountability and transparency of competent authorities at all levels.
All official controls performed by Member States are based on a multi-annual national control plan (MANCP). A new provision introduces a single body in charge of coordinating the preparation of the MANCP and collect the information about its implementation
The content of the plan remains the same, although the new regulation provides more details. The MANCP will include:
- the objectives
- how risk is categorised in official controls
- delegated bodies, if any
- the general organisation and management of official controls at national, regional and local level
- contingency plans in case of non-compliance and how competent authorities in different Member States will cooperate and assist each other
The MANCP must be published and can be amended while still in progress, if new hazards arise.
Annual report by Member States to the Commission. Every year by the 31st of August, each Member State must publish a report on the implementation of the MANCP. Reporting is not a new requirement, but Regulation 2017/625 adds important details. For example, it specifies that any amendments to the MANCP and the type and number of cases of non-compliance must be included in the report. Another novelty is the possibility, for those operators that are found to be non-compliant, to add their own comments.
Further information that must be published. Other than the information included in the report, Member States must publish at least once a year “relevant information concerning the organisation and the performance of official controls.”
In addition to that, they must also “ensure the regular and timely publication” (or include it in the report, if appropriate) of further details about official controls, such as what measures were taken in cases of non-compliance, as well as the type and number of imposed penalties.
A new provision encourages Member States to establish a rating scheme for individual operators. Although it’s not a requirement, if a rating scheme is adopted it must be based on principles of fairness and transparency.
Commission controls and reports. The Commission may conduct Union-wide checks to verify compliance with the laws covered by the Official Controls Regulation. It also has the authority to carry out audits in each Member State in order to verify the implementation of the MANCP and the functioning of the food safety system in general. Although these checks are not new, Regulation 2017/625 includes further details and expands the scope of action of the Commission.
The results of these audits and checks must be made available to the public. The Commission must publish an annual report based on submitted MANCPs, with a summary of the results and recommendations, if necessary. The new regulation specifies the deadline of 31st of January for its submission regarding the previous calendar year.
More possibilities to delegate control tasks to third parties
The new law introduces the possibility of delegating official controls to a natural person in addition to delegated bodies. The conditions for delegation haven’t changed:
- the delegation must be in writing and include an accurate description of which tasks are being delegated
- the delegated body must be competent, experienced and impartial
- only control tasks can be delegated. In case of non-compliance, only competent authorities can take action
More flexibility for official laboratories
Official laboratories are delegated by Member States to collect samples and do analyses, tests and diagnoses. In addition to the general delegation requirements, they must be certified with standard EN ISO/IEC 17025 by a national accreditation body.
However, Regulation 2017/625 acknowledges that accreditation is “a complex and costly process,” which may even be impractical in some cases. For example, in certain particularly simple types of analysis (like the detection of Trichinella in meat) an accreditation wouldn’t be necessary. By contrast, for new methods an accreditation may not be available yet.
For these reasons, Regulation 2017/625 introduces some degree of flexibility, allowing labs to carry out analysis before they have obtained the relevant accreditation. These derogations are described in detail in articles 40, 41 and 42, and are one of the examples where the Commission is empowered to adopt delegated acts.
More clarity on the methods for sampling, analysis, tests and diagnosis
All sampling, analysis, tests and diagnosis carried out by laboratories must follow a specific cascade of methods, which is a series of rules and protocols to be applied in order of priority. Whenever a rule doesn’t exist for a specific case, then the next one in the hierarchy will apply and so on. The new cascade of methods follows this order:
- European Union rules
- internationally recognised rules or protocols, or methods developed and recommended by EURL
- relevant national rules
- methods developed or recommended by national reference laboratories, or validated with intra-laboratory methods, provided that they are validated in accordance with internationally accepted scientific protocols
Noteworthy changes in this case are a more detailed hierarchy and the inclusion of relevant national rules in the cascade.
A new structure for reference laboratories and centres
Regulation 2017/625 maintains national reference laboratories but replaces Community reference laboratories with EU Reference Laboratories (EURLs). They have the important task of coordinating national reference laboratories and providing them with common practices for methods of analysis, scientific and technical assistance and training for official labs.
EURLs will be designated by the Commission through delegated acts “in those sectors where there is a recognised need to promote uniform practices and reliability of methods of analysis, tests and diagnosis.” Designation will be valid for a minimum of five years and subject to review by the Commission. Examples of EURLs that are already established are on food contact materials, feed additives, and on genetically modified food & feed.
In addition to EURLs, the new Regulation includes a provision for establishing the new EU Reference Centres for animal welfare, with the task of providing assistance to Member States in the field of animal welfare. This assistance is provided in many ways such as: carrying out scientific and technical studies, conducting training courses and making research findings available and technical innovations, providing scientific and technical advice.
Another provision includes the possibility of establishing EU Reference Centres for the authenticity and integrity of the agri-food chain, whose task will be to provide knowledge in detecting fraudulent or deceptive practices.
Administrative Assistance and Cooperation
An important principle that was maintained is the requirement of Member States to facilitate transmission of information through liaison bodies between competent authorities. However, Regulation 2017/625 also requires Member States to facilitate transmission of information coming from law enforcement authorities, public prosecutors and judicial authorities, regarding cases of non-compliance which may pose a health risk or fraud. The Commission is committed to finding a common format for the transmission of this information.
Financing of Official Controls Regulation and Other Official Activities
With the new Regulation, Member States can still impose fees on operators to recover costs of certain official controls, following the same principle of transparency of calculation.
However, while the previous law simply stated that “Member States shall make public the method of calculation of fees and communicate it to the Commission”, the new Regulation gives more relevance to this principle, by including it in the opening premises. Also, it increases the amount of information that competent authorities must provide regarding costs, how they were calculated and who collected the fees.
Official controls subject to fees are those:
- on animals, products and by-products of animal origin, plants and plant products, whether at the production plants (slaughterhouses, cutting plants, etc) or border control points
- on goods coming from non-EU countries depending on risk
- on goods subject to emergency measures
- necessary to obtain approval of feed production plants
- necessary to follow-up non-compliance
The calculation method of fees depends on the type of control. For the first type on the list, authorities can choose between a flat rate, the cost of each individual control, or the fees specified in the related annex. In the previous Regulation, these were the minimum applicable fees but now they are one of the possible options.
For all the other types of controls, fees will be based on actual costs. Article 81 provides details of what is actually included in the costs. The new Regulation also gives Member States the authority to collect fees or charges for other activities, unless they’re already prohibited by existing laws.
Timeline of application Official Controls Regulation
For the most part, the new regulation will be applied on 14 December 2019. However, a few parts will follow a different timeline.
28 April 2017
Rules concerning the financing of EURLs and the accreditation of national reference laboratories for plant health.
29 April 2018
Articles from 92 to 100 about the establishment of EURLs and reference centres.
29 April 2022
- protective measures against pests of plants
- the cascade of methods for sampling and testing
- accreditation of official laboratories to standard EN ISO/IEC 17025
14 December 2022 or earlier
Several parts of the law will become effective only after the Commission has adopted implementing acts to define specific aspects.
Imported food and animals
For official controls on imported animals, products of animal origin, germinal products and animal by-products at EU borders, the Commission will define:
- the official list of animals and goods subject to OC
- the appropriate frequency and method for those checks
- The rules for animals and goods exempt from official controls, especially those
- intended for scientific purposes
- intended for consumption by the crew and passengers on board of international trips
- goods which are part of passengers’ personal luggage and are intended for personal use
- the authorisation to continue transportation to the final destination for those animals and goods that are pending results of physical checks
- identity and physical checks that may be performed at control points other than border control posts, or by customs authorities or other public authorities.
- Format, time requirements and specific rules for the use of the Common Health Entry Document (CHED)
Until then, Directives 91/496/EEC and 97/78/EC will remain in place.
Residues in live animals and animal products
The official controls on certain substances and residues in live animals and animal products will continue to be performed following the previous regulation (Directive 96/23/EC) until the Commission has established a date when the new rules will come into effect.
Some parts of (EC) No 1/2005 on animal transportation will remain in place until the Commission has established a date when the new rules will be effective.
Some parts of (EC) No 396/2005 on pesticide levels on food and feed will remain in place until the Commission has established a date when the new rules will be effective.
The following regulations are repealed as a result of the Official Controls Regulation:
- Regulation (EC) No 854/2004 on official controls on products of animal origin intended for human consumption.
- Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.
- Council Directive 89/608/EEC on mutual assistance application of legislation on veterinary and zootechnical matters.
- Council Directive 89/662/EEC on checks in intra-Community trade with a view to the completion of the internal market.
- Council Directive 90/425/EEC concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals.
- Council Directive 91/496/EEC on the organization of veterinary checks on animals entering the Community.
- Commission Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products.
- Commission Directive 96/93/EC on certification of animals and animal products.
- Commission Directive 97/78/EC on organisation of veterinary checks on products entering.
- Commission Decision 92/438/EEC on computerization of veterinary import procedures.
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