Foodlaw-Reading Dr David Jukes, The University of Reading, UK
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Food Law News - EU - 2017

Commission Consultation, 20 December 2017

GENERAL FOOD LAW - Draft Commission Roadmap: Transparency and sustainability of the EU risk assessment model in the food chain

The Commission has prepared a draft roadmap. The following are the introductory sections from the document. The consultation closes on the 17 January 2018.

Note that the full title is given as: Commission Proposal for a Regulation on transparency and sustainability of the EU food and feed safety risk assessment model amending Regulation (EC) No 178/2002 Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; and Directive 2001/18/EC on the deliberate release into the environment of GMOs, Regulation (EC) No 1829/2003 on GM food and feed, Regulation (EC) No 1831/2003 on feed additives, Regulation (EC) No 2065/2003 on smoke flavourings, Regulation (EC) No 1935/2004 on food contact materials, Regulation (EC) No 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings, Regulation (EC) No 1107/2009 on plant protection products and Regulation (EU) No 2015/2283 on novel foods.

Draft Commission Roadmap: Transparency and sustainability of the EU risk assessment model in the food chain A copy of the document is available on this site (click on image).

For more details, see: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773_en

Context

The General Food Law Regulation was adopted in 2002 setting out a comprehensive harmonised legal framework, addressed to EU institutions and Member States as well as to food business operators. It covers the entire food chain, i.e. all stages of production, processing and distribution of food and feed, including import ('farm to fork' approach). It follows a framework approach providing the basis for developing both EU and national food law. The General Food Law Regulation established the European Food Safety Authority (EFSA) as the EU risk assessment body for food and feed safety.

This initiative follows from the findings of the Fitness Check of the General Food Law [see Note 1 below] and the Commission Communication on the European Citizens' Initiative (ECI) "Ban glyphosate and protect people and the environment from toxic pesticides" [see Note 2 below].

One of the ECI petitioners' requests was to modify the EU pesticide approval procedure to tackle the transparency and independence of the scientific studies used to support authorisation dossiers.

In the Communication, the Commission acknowledged that "transparency in scientific assessments and decision-making is vital to ensuring trust in the regulatory system. It also attaches continued importance to the quality and independence of the scientific studies that are the basis of the EU risk assessment carried out by EFSA". The Commission therefore committed to come forward with a legislative proposal by May 2018 covering these and other aspects such as the governance of EFSA, drawing on the results of the Fitness check of the General Food Law and after a public consultation to be launched shortly. Problem the initiative aims to tackle

The Fitness Check of the General Food Law and recent public debates surrounding specific substances (e.g. the renewal of the authorisation of glyphosate, also subject of the ECI mentioned above) have shown some aspects in the current legislative framework that need to be addressed. In particular:

• Citizens perceive the risk assessment process (and the decision-making based on it) as opaque and demand more transparency; trust in the process itself is adversely affected as a result of the perceived insufficient transparency. In addition, a variety of transparency and confidentiality rules is applicable to the risk assessment and decision-making process depending on the sub-area concerned. Similar (but not uniform) rules on confidentiality exist in the multiple authorisation procedures laid down in EU sectorial legislation, in the General Food Law Regulation and in Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.
• Negative perceptions are also the result of EFSA's evaluations of authorisation dossiers being essentially based on studies, data and information generated (and paid for) by the applicant for authorisation. Current procedures are based on the principle that it is for the applicant for an authorisation to provide the scientific evidence supporting it, and that public money should not be used to commission costly studies (several thousand to several million Euros) that will eventually help industry put a product on the market. While this principle remains valid, recent debates have raised concerns regarding the transparency and independence of industry-generated studies and data.
• Risk communication is, overall, considered not to be effective enough, especially in light of the difficulty of communicating science-based risk assessment decisions in an environment characterised by increasing scepticism about the objectivity of scientific findings.
• EFSA's high level of scientific expertise is linked to its capacity to pool expertise from Member States. This capacity is adversely impacted by a number of factors:
  • difficulties encountered to attract new experts due to, among other: insufficient recognition for the scientists’ career, financial compensation for the experts and their employers considering the amount of time required for their contribution to EFSA's work;
  • the fact that more than two thirds of EFSA's Scientific Panels' experts (69%) originate from six Member States only and the difficulties encountered by EFSA in receiving sufficient support from many Member States to its scientific work (e.g. via studies, provision of data) clearly point to future challenges in ensuring a long term sufficient expertise and in fully engaging all Member States in scientific cooperation.
• In contrast with other EU Agencies, Member States are not represented in EFSA's Management Board and its governance has not been aligned with the Common Approach on EU decentralised agencies [see Note 3 below].

Notes:

1. The results of the Fitness Check of the General Food Law will be available on the following website by 12 January 2018: https://ec.europa.eu/food/safety/general_food_law/fitness_check_en.
2. Communication from the Commission on the European Citizens' Initiative "Ban glyphosate and protect people and the environment from toxic pesticides", dated 12.12.2017, C(2017)8414, to be found at: https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf. Ref. Ares(2017)6265773 - 20/12/2017
3. https://europa.eu/european-union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf