Regulation (EU) 2019/1381: transparency of EU risk analysis

Context: the General Food Law and EFSA

Regulation (EC) No 178/2002 lays down the general principles and requirements of food law, establishes the European Food Safety Authority and sets out procedures in the field of food safety. It is the framework law to which the whole of Union food law is anchored, including the Hygiene Package of which Regulation (EC) 852/2004 is part. EFSA, established by that regulation Article 22 of Regulation (EC) No 178/2002, provides the independent scientific advice on which the Commission and Member States base risk-management decisions; its tasks are set out in the following articles Article 23 of Regulation (EC) No 178/2002.

What Regulation (EU) 2019/1381 provides

The regulation — known as the Transparency Regulation — amends Regulation (EC) No 178/2002 and certain sectoral acts to make the Union's risk analysis more transparent and reliable Article 1 of Regulation (EU) 2019/1381. In short, it provides for public access to the studies and scientific data submitted in support of authorisation applications, a register of commissioned studies, rules on risk communication, and tools to strengthen confidence in the scientific basis of decisions. The intervention acts on how the Union produces and communicates science upstream of the rules, not on the operational requirements of food businesses.

What changes for operators

For food business operators subject to Regulation (EC) 852/2004 no new direct obligation arises. Regulation (EU) 2019/1381 touches neither self-checks based on HACCP principles, nor registration of the establishment, nor the general hygiene requirements. It should be read as an improvement to the institutional framework: it makes the science underpinning the rules that operators already apply more robust and verifiable. In our view it is worth knowing in order to understand the origin and reliability of the technical requirements, but it calls for no business change.

Coordination with Regulation (EC) 852/2004

Regulation (EC) 852/2004 governs the hygiene of foodstuffs and presupposes the principles of the General Food Law: traceability, the risk-based approach and operator responsibility all derive from that framework. By strengthening the transparency of risk assessment at Union level, Regulation (EU) 2019/1381 consolidates the scientific foundations of the system without changing its operational obligations. For an overview of regulatory developments see the updates section.