Major legislative changes are poised to impact food and beverage companies across the EU. To modernize and simplify existing rules, and more effectively enforce compliance with health and safety standards, the EU adopted a single regulation covering each of three sections: animal health, plant health and official controls. These three regulations replace almost 70 previous pieces of legislation.
The new laws originated in May 2013, when the European Commission (EC) set out its proposals for legislative reforms. Proposed changes to rules on plant reproductive material, also introduced at that time, were subsequently abandoned.
The Animal Health Regulation (Regulation 2016/429 on transmissible animal diseases), also known as the “Animal Health Law,” introduces a single and simplified framework for animal health based on the principle that “prevention is better than cure.” The regulation sets out the responsibilities of all relevant actors and creates a framework for an improved early detection and control system. The regulation will apply EU-wide from 21 April 2021.
The Plant Health Regulation (Regulation 2016/2031 on protective measures against pests of plants) likewise creates a single framework outlining rules governing the main pest situations. This regulation will apply EU-wide from 14 December 2019, following a transition period of three years, during which the EU will adopt necessary secondary legislation supporting the regulation.
The Official Controls Regulation (Regulation 2017/625 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), in contrast to the sector-specific Animal Health and Plant Health Regulations, is of general relevance across the EU agri-food chain. It enforces compliance with a range of EU legislation, including the Animal and Plant Health Regulations.
This regulation sets out the means to verify compliance with EU food and feed law, animal health and welfare rules, plant health and animal byproduct rules, and other sector-specific rules. It covers organics and plant protection products (but not basic agricultural products, which remain covered by other rules). It also establishes a common integrated system of official controls at EU border control posts for animals and goods. Controls may be carried out at all stages of production, processing, distribution and use of animals, goods, substances, materials or objects governed by agri-food chain rules.
In addition to providing national enforcers and the EC with necessary enforcement powers, the regulation facilitates regulatory cooperation across national borders in the EU. Further, the regulation requires operators to assist and cooperate with regulatory staff during inspections, and provides the EC with audit and control powers in the EU and third countries, plus the power to take action at the EU level.
Broadly, the regulation maintains the risk-based approach to control of operators. Thus, factors such as the type of activities under the operator’s control, the location of these activities, and the use of products, processes, materials or substances will determine the frequency of official controls performed by competent authorities. The regulation also requires competent authorities, in their official control frequency assessments, to take into account the likelihood that consumers might be misled regarding food properties. However, the regulation explicitly provides that the burden for operators should be limited to what is necessary for the performance of efficient and effective official controls.
The new regulation will increase transparency by requiring publication of the results of controls and encouraging member states to use rating schemes. There will be national registers of operators subject to official controls, and operators will need to provide regulators with details about their operations.
The regulation also introduces more stringent financial penalties for noncompliance with EU agri-food rules, and new protection of whistleblowers intends to encourage and facilitate reporting of noncompliance.
Adopted on 15 March 2017, the regulation entered into force on 27 April 2017. There is a transitional period, with the main application date being 14 December 2019. Some provisions will apply only from 29 April 2022 onward.
Companies need to understand and prepare for the impact of these new regulations, particularly the cross-sector official controls rules. Food and beverage operators in the EU face greater risk and will need to update their compliance programmes.