Transparency and sustainability of the EU risk assessment in the food chain

About the Regulation

Following the approval by the European Parliament on 17 April 2019, the Council formally adopted, on 13 June 2019, a new Regulation on the transparency and sustainability of the EU risk assessment in the food chain. This new Regulation is based on a European Commission's proposal tabled in April 2018 and mainly amends the General Food Law Regulation.

• It aims at increasing the transparency of the EU risk assessment in the food chain, on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and revisiting the governance of EFSA in order to ensure its long-term sustainability.
• It is a direct response to a successful European Citizens' Initiative "Stop Glyphosate" and builds upon the findings of the fitness check of the General Food Law Regulation, a comprehensive evaluation, completed in January 2018.

The new Transparency Regulation was published in the Official Journal on 6 September 2019. It entered into force 20 days after publication and became applicable on 27 March 2021.

The Commission and EFSA are working closely to ensure the proper implementation of the new Regulation. More details on the implementation work are available here.

The main elements of the Regulation aim at:

• Increasing the independence of studies: Potential applicants are required to notify all studies they undertake for authorisation purposes, when commissioned, to the European Food Safety Authority; this provision provides additional guarantees that companies applying for authorisations submit all relevant information and do not hold back unfavourable studies. 

  The Authority also provides general advice to applicants, in particular SMEs, prior to the submission of the dossier, upon request. The Commission also has the possibility in exceptional circumstances of serious controversies or conflicting results to ask the Authority to commission additional studies for verification purposes. Finally the Commission will be performing a series of fact-finding missions to assess the compliance of laboratories/studies with standards until March 2025.

• Strengthening the governance and the scientific cooperation: As of 1 July 2022, Member States, the European Parliament, the Commission as well as food chain and civil society interests are involved in the governance of the Authority by being duly represented in its Management Board. Member States are expected to foster the Authority's scientific capacity and engage the best independent experts into its work
• Developing comprehensive risk communication: A general plan for risk communication will be adopted so as to ensure a coherent risk communication strategy throughout the risk analysis process, combined with open dialogue amongst all interested parties.

For further information, please check:

• Q&A
• Factsheet
• Press Release

Background Information

• Official Proposal
• Consultation
• Roadmap
• Context

Official Proposal

In April 2018 the European Commission officially proposed a targeted revision of the General Food Law Regulation (see summary of the public consultation).

• 2018: Press Release
• 2018: Q&A

Commission responded this way to the concerns expressed by citizens in a successful European Citizens' Initiative, with a proposal to improve the transparency of scientific studies in the food safety area.

The proposal, drawing also on the Commission's Fitness Check of the General Food Law, which dates back from 2002, will:

Give citizens greater access to information submitted to the European Food Safety Authority (EFSA) on approvals concerning the agri-food chain, provide the possibility for additional studies to be requested by the Commission and will involve the EU countries' scientists more closely in approval procedures.

The Commission is proposing a targeted revision of the General Food Law Regulation coupled with the revision of eight pieces of sectoral legislation, to bring them in line with the general rules and strengthen transparency in the area of GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

Consultation

Between January and March 2018, there was a public consultation on the transparency and sustainability of the EU risk assessment in the food chain.

More information on the consultation:

• Consultation strategy
• Working Group meeting of the Advisory Group on the food chain, animal and plant health
• Meeting of EFSA's Advisory Forum and Scientific Committee
• Meeting of the Expert Group on the General Food Law

Roadmap

On 20 December 2017, the Commission published on a Roadmap on the transparency and sustainability of the EU risk assessment in the food chain. This roadmap is a first step in the legislative process and outlines the purpose, content and scope of the initiative.

Feedback received during the first four weeks after publication of the roadmap will be considered in the design of the initiative. Whether feedback received after that period can be taken into account will depend on the type of feedback and the status of the legislative process at the time of receipt.

View the feedback received.

Context

Since the adoption of the General Food Law Regulation in 2002 the political, economic and societal context has evolved, affecting consumers' perception and expectations in relation to the food chain.

Regarding the European Food Safety Authority's (EFSA) work, citizens have started to question the risk assessments based on studies provided by the industry and, in particular, where the industry seeks an authorisation (e.g. for pesticides, GMOs, etc.).

This initiative on the 'Transparency and sustainability of the EU risk assessment in the food chain' follows the findings of the Fitness Check of the General Food Law and the Commission Communication on the European Citizens' Initiative (ECI) "Ban glyphosate and protect people and the environment from toxic pesticides".

In the context of this ECI, the Commission committed to come forward with a legislative proposal covering the transparency and independence of the scientific studies that are the basis of the EU risk assessment of regulated products and substances carried out by EFSA, as well as other aspects, such as the governance of EFSA.

Contact

Directorate E (Food safety, sustainability, and innovation), Unit E1: Farm to fork strategy

SANTE-CONSULT-E1ec [dot] europa [dot] eu (SANTE-CONSULT-E1[at]ec[dot]europa[dot]eu)