New EU rules on controls and enforcement of agri-food chain rules come into effect

On 14 December 2019, the provisions of Regulation (EU) No 2017/625 (‘Official Controls Regulation’) come into effect, repealing Regulations (EC) No 854/2004 and 882/2004. The Regulation lays down rules on official control and enforcement of agri-food chain rules, such as food and feed law, and animal and plant health regulations. This article will outline the main elements and changes in the new Regulation.

Expanding the scope

The scope of the Regulation is expanded to include official controls of food and feed law, animal health and welfare, plant health and protection, as well as animal by-products. With this change, the Regulation aims to harmonize controls and enforcement through the entire agri-food chain. The Regulation also applies to ‘other official controls’, such as controls on animal diseases or plant pests. Further, it is clarified that the regulation also applies to organics and plant protection products.

The Regulation also repeals several sector specific official control rules to ensure corresponding requirements. This applies to official control rules concerning, amongst others, animals, products of animal origin, animal by-products, animal welfare, plant health, GMOs for food/feed production, protected designations of origin and geographical indicators.

Risk-based approach

The Regulation maintains the risk-based approach, whereby the unannounced official controls should focus on those areas and activities where risks are higher. It is clarified that authorities must consider the risk to human-, animal- or plant- health and the environment; risk of misleading consumers; the operator’s history of compliance and reliability of the operator’s own checks when authorities plan such controls. New rules require authorities to also take into account the likelihood of fraudulent and deceptive behaviors when deciding on the frequency of controls. Official controls must furthermore be conducted in a manner that minimizes the burden on businesses.

Operators’ obligations and mandatory fees for controls

The Regulation clarifies that official controls may be carried out on all operators at all stages of production, processing, distribution and use of animals, goods, substances, materials or objects subject to by agri-food chain rules. Operators are therefore required to cooperate with authorities and give access to their equipment, means of transport, premises, computers, documents and other relevant information, and animals and goods under their control.

Moreover, authorities are required to keep a register of all operators subject to official controls. Operators must therefore provide authorities with information on their activities, including tele- and online sales and the places under their controls. However, in order to ease the administrative burden, authorities may instead use information from lists that already exist for other purposes, and certain operators can be exempted if registration would be disproportionate, considering the risk level of the operator’s activities.

Further, mandatory fees are imposed on operators for certain controls, including controls carried out in slaughterhouses, cutting plants, milk production, fishery and aquaculture; controls at border control posts; animals, animal products and plants; certain goods from third countries and controls to follow up on non-compliance. Depending on the particular type of control, fees may be a flat fee, the cost of the actual control(s) or set fees determined by the Regulation. In addition, new transparency rules require Member States to publish details on the methods and data used to calculate the fees, the fees for each category of operators and controls, as well as a breakdown of costs.

Delegation of official control activities

The Regulation provides that Member States may delegate official controls and other official activities to delegated bodies or a natural person. In order to do so, the delegation must be in writing and describe the delegated tasks; the delegated body must have the necessary expertise, equipment, and qualified and experienced staff; and the delegated body must be impartial, free from conflict of interests and accredited. Authorities are further required to carry out audits or inspections of the delegated body. The competence to take enforcement measures in case of non-compliance remains with the authorities and may therefore not be delegated.

Border controls on animals and goods entering the EU

The Regulation also establishes a common framework for import controls. Common rules will therefore apply to controls carried out at the borders on animals, products of animal origin, plants, and other products and goods that are subject to control when entering the EU. The import control system will furthermore be risk-based. Border Control Posts (BCPs) will replace the current Border Inspection Posts (BIPs) and Designated Point of Entries (DPEs). At the BCPs, all consignments subject to control will initially undergo a documentary check. The Regulation provides a list of animals and goods that are subject to those systematic checks. The frequency of identity- and physical tests will however be determined on the basis of the risks linked to the specific animals or goods. Although all controls will be carried out at the BCPs, the European Commission may adopt rules allowing for a derogation in certain cases and under certain conditions. This could for example be allowing onward transportation of animals or goods to the final destination pending results from physical checks at laboratories, or if the identity can be determined by an expert located outside the BCP. The new ‘Common Health Entry Document’ (CHED) will furthermore be used as a single standard document for prior notification of consignments.

Official certification

The Regulation introduces a uniform framework for official certification across Member States in all areas covered by the Regulation, and certification for exports to third countries. Under these rules, official certificates must be accurate, authentic and cannot be signed if they are incomplete or blank. The certificates confirm the results of official controls and must identify the person who has signed them. In cases where it is required that attestations are issued, this must be done by the operator or the relevant authority. There are furthermore rules requiring certifying officers to be impartial, free of conflicts of interest and properly trained.

Designated Laboratories and derogations from mandatory accreditation

There are also rules regarding laboratories designated by authorities to carry out analysis, tests or diagnosis of samples taken for official control. The laboratories’ EN ISO/IEC 17025 accreditation will remain a mandatory condition, but permanent derogation from this requirement is possible for laboratories with limited activities. Methods for analysis, tests and diagnosis may also be exempted from the mandatory accreditation on a temporary basis. This is possible for emergency situations or if a particular method is newly required by EU legislation.

Enforcement and penalties

The Regulation maintains the current enforcement requirements, whereby authorities must ensure that the operator remedies the non-compliance. Authorities must take into account the nature of the non-compliance and the operator’s history of compliance when deciding on enforcement actions. In addition, the non-exhaustive list for enforcement actions is extended due to the broader scope of the Regulation. The list now includes enforcement actions, such as; restriction or prohibition of movement of animals; slaughter of animals when most appropriate to protect public health, and animal health and welfare; and closing of the operator’s website. There are also more strict rules on financial penalties in order to deter fraudulent behavior and ensure fair competition. Penalties will reflect the economic advantage of the operator or a percentage of the operator’s turnover. New ‘whistleblower’ rules have also been included to encourage reporting of non-compliance. In this regard, Member States are now required to have procedures for receiving and following up on reports of non-compliance, appropriate protection of whistleblowers and data protection of the whistleblower.

The provisions of the Regulation become applicable on 14 December 2019. Companies in the agri-food chain should therefore consider the impact of these changes on their business and adjust as needed.

For more information on this please contact our experts in Food, Health and Safety

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