In September, Regulation (EU) 2019/1381 came into force, with major implications for the transparency of scientific data used to evaluate pesticides and food additives.

The new regulation was prompted by an evaluation of the EU general food law (Regulation EC 178/2002), which concluded that risk communication was not effective enough overall. This affects consumer confidence in the outcome of the risk assessment process. The regulation’s key concerns are to ensure the quality and reliability of scientific studies and the transparency of the risk assessment conducted at EU level. Accordingly, it amends the general food law as well as the texts of several other regulations that deal with genetically modified organisms, materials in contact with food, plant protection products, and food additives, enzymes and flavourings.

The amendments mean that, from 27 March 2021:

  • there will be a standard data format for dossiers;
  • the entire dossier will be made publicly available, including supplementary information provided by the applicant;
  •  the European Food Safety Authority (EFSA) will now have a say in whether the applicant’s requests for confidentiality of data will be granted;
  • applicants must notify studies to an EFSA database when commissioning them;
  • EFSA will be able, under exceptional circumstances, to commission studies in order to verify evidence used in the risk assessment process.

The complete text of the regulation is available at EUR-Lex.

If you would like to know more about how this regulation could affect your business, contact the Kerona team via or +353 1 849 5284.