Publication of active substance dossier

As a result of amendments to the General Food Law, applications and dossiers for the approval of active substances (or the renewal of such approval) will be made public. This applies to applications and dossiers submitted from 27 March 2021.

Regulation (EU) No 2019/1381 stipulates amendments to the General Food Law (Regulation (EC) No 178/2002) and to the Plant Protection Regulation (EC) No 1107/2009. The changes apply to two main components of applications and corresponding dossiers submitted from 27 March 2021:

  • the assessment of the confidentiality of the data and its public disclosure;
  • the use of standardised data formats, which EFSA makes available on its website.

Assessment of requests for confidentiality and public disclosure

This means that applications for the approval/renewal of active substances and the corresponding dossiers that fall under plant protection legislation will be actively disclosed. This applies to both the summary and the complete dossier.

An applicant can request that parts of the application and/or the dossier be kept confidential. The rapporteur Member State assesses this request for confidentiality, in consultation with EFSA. After consulting EFSA, the rapporteur Member State decides which information in applications for approval of an active substance and changes in the terms of approval should remain confidential. The confidentiality of applications for renewal of approval is assessed by EFSA.

The importance of confidentiality must be demonstrated by the applicant. For assessing and granting the request for confidentiality, the following conditions apply:

  • confidentiality can be granted only for some exhaustively described data;
  • information can still be made public by:
  1. Member States when it is necessary to take immediate action due to health risks for humans, animals and the environment;
  2. EFSA when it assesses risks on scientific grounds if these risks have an expected impact on human, animal and environmental health;

This information can also be made public if it falls under the provisions of Directive 2003/4/EC (freedom of access to information) or Regulation (EC) No 1367/2006.

Use of standardised data formats

An application for the approval of an active substance or for a change in the terms of an approval shall be submitted by the producer of the active substance to a Member State, together with a summary and a complete dossier. This application is submitted in standardised data formats, which are made available by EFSA.

In these standardised data formats, documents can be submitted, searched, copied and printed in compliance with European Union regulations.

EFSA provides training and instruction sessions to guide users in the use of these standardised data formats. For more information, see the EFSA website.