EU Regulation (EU) 2019/1381 - Transparency and Sustainability of the EU Risk Assessment in the Food Chain

What it says

This Regulation amends the General Food Law and other food-chain legislation to increase transparency of EU risk assessment. It makes the studies and information submitted in support of applications to EFSA publicly available, requires notification of planned studies, provides for pre-submission advice, and strengthens governance and risk communication.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Companies applying for authorizations, such as for novel foods or additives, need to notify studies they commission.
• Confidentiality may be requested for certain information, but the default is openness.
• General pre-submission advice from EFSA can help applicants prepare complete dossiers.

What inspectors look for

• Whether applications and studies were notified as required.
• Whether confidentiality requests are justified.
• Whether the dossier is complete.

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