Publication of active substance dossier

The transparency Regulation amending the General Food Law has consequences for the procedures for active substance applications and applications for MRL’s. The new requirements are  applicable to all applications submitted from 27 March 2021.

Amendments according to the Transparency Regulation

De amendments as a result of the Transparency regulation are (a.o.):

  • Obligation to submit information in advance of applying for (renewal of) approval of an active substance and for MRL applications, about studies to be conducted.
  • Applications and their dossiers have to be submitted to EFSA using a standardised (IUCLID) data format;
  • a new procedure for the decision making on the confidentiality claims for application dossiers;
  • publication of a non-confidential version of all information about an application
  • public consultation in the submitted application dossiers

Some of the amendments are briefly explained.

In the annex background Transparency Regulation information can be found about the goal of the transparency regulation and reference is made to some relevant documents.

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: