As part of its 'Smart Regulation' policy, the Commission has initiated a Regulatory Fitness and Performance Programme (REFIT). This is a continuous process, affecting the whole policy cycle – from the design of a piece of legislation to implementation, enforcement, evaluation and, where justified, revision.
Under the first stages of this programme, the Commission has reviewed the entire stock of Union legislation and decided on follow-up actions, including 'Fitness Checks' involving comprehensive policy evaluations aimed at assessing whether the regulatory framework for a particular policy sector is 'fit for purpose'. Fitness Checks provide an evidence-based critical analysis of whether Union actions are proportionate to their objectives and delivering as expected.
On 15 January 2018 the Commission completed the Fitness Check on the General Food Law Regulation (Regulation (EC) No 178/2002), which was launched in 2014. Scroll down for all important documents related to this publishing.
It is a comprehensive policy evaluation assessing whether the legislative framework introduced by the General Food Law Regulation for the entire food and feed sector is 'fit for purpose' and whether it captures and reflects policy trends of today. It contributes to the political agenda defined by President Juncker, giving priority to modernisation and simplification of existing legislation.
The Fitness Check focuses on the General Food Law Regulation, which is the foundation of all legal measures at EU and national level in the area of food law. However, given its nature as framework legislation, this evaluation has also assessed the implementation of the common definitions, objectives, general principles and requirements set out in the General Food Law Regulation in other EU sectorial food and feed legislation. This allowed the Commission to assess the cumulative effects and potential overlaps or inconsistencies that may have been created by the overall legislative framework.
The Fitness Check covers the period 2002-2013 in the EU 28 Member States; where significant, more recent data available has also been taken into account.
The mandate for the Fitness Check on the General Food Law Regulation, published in 2014, defines the overall scope and aim of the exercise and sets out the key questions to be addressed in relation to the Fitness Check criteria:
- Effectiveness (Have the objectives been met?)
- Efficiency (What are the costs and benefits involved?)
- Coherence (Does the policy complement other actions or are there contradictions?)
- Relevance (Is EU action still relevant?)
- EU added value (Can or could similar changes have been achieved at national/regional level, or did EU action provide clear added value?)
The collection of evidence, data and information constituted a critical part of this Fitness Check. To support the evidence-base of the Fitness Check, the Commission procured two external studies:
- External study on the general part of General Food Law Regulation (Articles 1-21)
- External study on the RASFF and the management of emergencies/crises (Articles 50 to 57)
These studies were launched in September 2014 and were completed in December 2015.
With respect to the European Food Safety Authority (EFSA) and for the purposes of this Fitness Check, the Commission produced an internal intermediary report, which updates the latest external evaluation of EFSA (2012) in order to cover the period up to 2013-2014.
Ensuring that all interested parties were able to provide input and make their views known was crucial to the process. Broad stakeholder consultations (MS, stakeholders, SMEs, etc.) have been performed during the whole Fitness Check exercise to collect the views of relevant actors in the food chain and to gather information and evidence.
- The General Food Law Regulation is still relevant today with respect to the current trends: growth and competitiveness and increased globalisation. Nevertheless, it is less adequate to address new challenges like food sustainability in general, and more specifically, food waste;
- Overall, the General Food Law Regulation has achieved its core objectives, namely high protection of human health and consumers' interests and the smooth functioning of the internal market;
- No systemic failures have been identified;
- Current food safety levels are more favourable than before the adoption of the General Food Law Regulation (e.g. food largely free of pesticide residues and of veterinary medicinal product residues or below the EU legal limits, re-evaluation programmes of existing authorised substances in place etc.);
- The systematic implementation of the risk analysis principle in EU food law has overall raised the level of protection of public health;
- The creation of EFSA has improved the scientific basis of EU measures. Major improvements in increasing EFSA's scientific capacity of expertise, the quality of its scientific outputs, its collection of scientific data and in the development and harmonisation of risk assessment methodologies have taken place;
- Better traceability of food and feed in the entire agri-food chain;
- Better transparency of the EU decision-making cycle;
- EU emergency measures and existing crisis management arrangements have overall achieved consumer health protection and the efficient management and containment of food safety incidents. Nevertheless, the 2011 E.coli outbreak in sprouts in Germany has high-lightened the need to continuously re-evaluate the management of food crises;
- The General Food Law Regulation has contributed to the effective functioning of the internal market by creating a level playing field for all feed and food business operators in the EU market and reducing disruptions of trade where problems have occurred. The value of the EU internal trade in the food and drink sector has increased by 72% over the past decade. It has also contributed to the EU product safety recognition worldwide and to an improved quality perception for EU products in non-EU markets. The EU food and drink industry has achieved a more globally competitive position since 2003 vis-à-vis the main trading partners.
Nevertheless, certain shortcomings have been identified:
- There are still national differences in the implementation and enforcement of the EU legislative framework; however, these are not systematic but occur rather on a case-by-case basis;
- Despite overall considerable progress, transparency of risk analysis remains an important issue in terms of perception:
- As regards risk assessment in the context of authorisation dossiers, EFSA is bound by strict confidentiality rules and by the legal requirement to primarily base its assessment on industry studies, laid down in the GFL Regulation and in the multiple authorisation procedures in specific EU food legislation. These elements lead civil society to perceive a certain lack of transparency and independence, having a negative impact on the acceptability of EFSA's scientific work by the general public. There is therefore a need to address these issues in order to protect the reputation of EFSA's work;
- Risk communication has not always been effective with a negative impact on consumers' trust and on the acceptability of risk management decisions;
- A number of negative signals have been identified on the capacity of EFSA to maintain a high level of scientific expertise and to fully engage all MS in scientific cooperation;
- Lengthy authorisation procedures in some sectors (e.g. feed additives, plant protection products, food improvement agents, novel foods, health claims) slow down the market entry process.
Currently ongoing or planned evaluations on nutrition and health claims, plant protection products, food contact materials, food irradiation and feed additives will allow, amongst others, a more in-depth assessment of the way the GFL principles and requirements are translated into sectorial rules.
In parallel, a more detailed analysis of EFSA's operation and governance structure will be undertaken in the context of EFSA's external evaluation launched in 2017, building upon the findings of this Fitness Check and the specific issues of concern to EFSA.
The possibility of strengthening the transparency, reliability and independence of studies underpinning EFSA's assessments, while protecting legitimate confidential business information should be further explored.
- Executive summary - Fitness Check of the General Food law (Regulation (EC) No 178/2002)
- Commission Staff Working Document - Refit Evaluation of the General Food law (Regulation (EC) No 178/2002)
- List of Appendices to the Commission Staff Working Document:
- Appendices 1 to 4, plus 7 (EFSA intermediary evaluation report) and 8
- Appendix 5 - External study on the general part of General Food Law Regulation (Articles 1-21) and relevant annexes:
- Annex 1 - Terms of Reference REFIT General Food Law Task specifications
- Annex 2a - Mapping of EQs
- Annex 2b - EQs judgement criteria and indicators
- Annex 3 - Consolidated survey results (MS CAs and FBOs)
- Annex 4 - Analysis of SME Panel results
- Annex 5a - Online survey GFL evaluation Stakeholders
- Annex 5b - Online survey GFL evaluation MS CAs
- Annex 5c - Final questionnaire for the SME panel
- Annex 5d - FCEC working document Advisory Group 19.12.14
- Annex 5e - FCEC working document MS Expert Group 16.01.15
- Annex 5f - Interview guide for TCs
- Appendix 6 - External study on the RASFF and the management of emergencies/crisis (Articles 50 to 57) and relevant annexes
- List of Appendices to the Commission Staff Working Document: