Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain

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Publication Date 06/09/2019
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Regulation of the European Parliament and of the Council of 20 June 2019 revising some aspects of Regulation (EC) No 178/2002 (General Food Law Regulation), as well as a number of legislative acts dealing with specific sectors in the food chain.

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In 2002, the General Food Law Regulation (Regulation (EC) No 178/2002) established the risk analysis principle as a general principle in EU food law. It created an EU food safety system in which responsibility for risk assessment (science) and for risk management (policy) are kept separate. The European Food Safety Authority (EFSA) was established as an independent EU agency responsible for scientific advice on risks associated with the agri-food chain.

The results of a Fitness Check to the Regulation published earlier in 2018 showed that, while the legislation met its core objectives of ensuring a high level of protection for human health and the smooth functioning of the internal market, concerns remained over the transparency of scientific studies and the risk assessment process in the agri-food chain. At the same time, a European Citizen's Initiative (ECI) on glyphosate was submitted to the European Commission in October 2017. One of its requests was to improve the transparency of scientific studies submitted to the European Food Safety Authority, and to enhance the commissioning of studies by public authorities. A public consultation, run between January and March 2018, showed that citizens and stakeholders acknowledged the importance of improving the public access to the industry studies used by EFSA in its risk assessments, as a significant element to ensure trust in the EU food safety risk assessment.

This Regulation responds to the Fitness Check, to the ECI and to the public consultation. It amends the General Food Law Regulation as well as eight legislative acts dealing with specific sectors in the food chain: GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods. It aims at improving public access to industry studies used by the EFSA in its risk assessments. It seeks to safeguard EFSA's ability to recruit scientific experts, reinforce the co-operation between EFSA and national scientific bodies and to increase Member States' involvement in EFSA's operations. Risk communication is also to be improved.

The draft law was presented by the Commission on 11 April 2018. The European Parliament's plenary session adopted a negotiating position on 11 December, and the Council of the European Union adopted its general approach on 17 December. An informal agreement between the co-legislators was reached on 11 February 2019, following three rounds of trilogue meetings. The Parliament formally endorsed it on 17 April, followed by the Council on 13 June.

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Commentary and Analysis
Corporate Europe Observatory, 17/04/2019: Massive transparency win as MEPs pass EU General Food Law revision
Arnold&Porter: BlioSlice Blog, 12/09/2019: Strengthened Transparency in the EU General Food Law Regulation
EPRS: Briefing, September 2019: Reconsidering the General Food Law

EurActiv, 11/04/2018: Commission efforts to build trust in food safety receives mixed reviews
Politico, 11/04/2018: EU Commission wants new powers to vet product safety
EurActiv, 19/10/2018: New food transparency rules risk falling victim to EU institution spat
EurActiv, 12/02/2019: Food safety: Midnight deal for revised General Food Law

EUR-Lex: COM(2018)179: Proposal for a Regulation on the transparency and sustainability of the EU risk assessment in the food chain
EUR-Lex: SWD(2018)97: Staff Working Document accompanying the Proposal - Synopsis report
European Parliament: Legislative Observatory: Procedure File for Proposal on transparency and sustainability of the EU risk assessment in the food chain (2018/0088(COD))
European Parliament: Legislative Train Schedule: Transparency and sustainability of the EU risk assessment in the food chain
European Commission: Fact Sheet, 14/03/2018: Commission's proposal on transparency and sustainability of the EU risk assessment model in the food chain [Q&A]
Council of the European Union: Press Release, 12/02/2019: Safe and transparent food chain: provisional agreement on availability and independence of scientific studies
Council of the European Union: Press Release, 13/06/2019: Transparency and sustainability of EU scientific assessment of food safety: General Food Law adopted
UK Parliament: Lords Select Committee: Transparency of food chain risk assessments
European Commission: General Food Law: Implementation of the Transparency Regulation
European Commission: Press Release, 25/03/2021: Reinforcing trust in scientific studies on food products: new rules for more transparency and independence

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