Unexpected things often happen...

The Deliberate Release Directive (Directive 2001/18/EC) of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2001/18/EC) was amended by Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 (OJ L 231, p. 1, 26). The background to this amendment is an adjustment of risk analysis and risk communication in the authorisation of food in the European Union as an essential component of the risk analysis process, which was deemed insufficiently effective based on an evaluation. Against this background, all EU regulations applicable in the food chain had to be adapted accordingly. These are the following for genetic engineering law:

• the release directive,
• Regulation (EC) No 1829/2003 on genetically modified food and feed and
• the Novel Food Regulation (EC) 1831/2003. The amendments to the Deliberate Release Directive concern only releases and placing on the market. They are of a more formal and data protection nature, based on EU standards. Three key points should be highlighted:

1. Firstly, notifications for releases and placing on the market must be submitted in accordance with the standard data formats, where provided for in Union law (Articles 6 and 13(2a) of the Release Directive),
2. In addition, the notifier may request confidentiality of his information upon application, stating verifiable reasons (Article 25 of the Release Directive). This applies in particular to DNA sequence information, except for sequences used for the detection, identification, and quantification of the transformation event, and breeding profiles and breeding strategies.
3. Ultimately, when the Scientific Committee is consulted within the framework of the notifications (Article 28 of the Release Directive), the information must be made public – to the extent permitted.