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Background Transparency Regulation

In 2019 the Transparency Regulation (EU) 2019/1381 has been published by the EU Commission. The reason for this regulation lies in the REFIT program of the General Food Law (EC) nr. 178/2002 and an European citizen initiative about glyphosate and pesticides. The regulation preserves the framework for the food chain, by:

  • improving the transparency of the risk assessment in the food chain;
  • reinforcing the reliability, objectivity and independency of the submitted scientific studies.

More concrete this means that risk communication will have an important position side by side to the risk assessment and the risk management. Third parties will have a more prominent role in the process.

Relevante documents

To implement the Transparency Regulation in de General Food Law, The Plant protection products regulation and the residue regulation the EU commission and EFSA have adopted several Regulations and guidances. These have been published recently. It concerns:

  • Implementing Regulation (EU 2021 / 428) adopting a standard data format for the submission of applications for the approval of an active substance or amendment to the conditions of an approval as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market.

  • Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (Text with EEA relevance.)

  • Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (Text with EEA relevance)

EFSA has written a few “Practical Arrangements” (PA’s). In these PA’s EFSA describes how the rules on transparency and confidentiality will be applied. The PA’s contain practical guidelines about the procedures to follow. The PA’s can be found here:

Cooperation between the applicants, EFSA and the EU member states is developed in the EFSA administrative Guidance. This Guidance has been amended to reflect the abovementioned regulation. Both version – before and on/after 27-03-2021 – are available on the EFSA website (the applicability is defined by the date of submission of the application):