Key points and timelines for the amendment of the Deliberate Release Directive (Directive 2001/18/EC) for the opt-out procedure

1. First of all, contrary to the drafts published so far, the amended directive does not contain a uniform implementation deadline for the opt-out procedure. Although the directive is addressed to the Member States, it enters into force on the 20th day after its publication in the Official Journal. This, in turn, means that, since the directive was published in the Official Journal on March 13, 2015, the directive also enters into force for Germany on April 2, 2015.

2. A total of three articles have been added or newly introduced to the Deliberate Release Directive. All three articles set different deadlines. The changes relate to the following aspects:

– The newly inserted Article 26a (1a) of Directive 2001/18/EC concerns measures in border areas of Member States; deadline for regulation is 3 April 2017

– The new Article 26b of Directive 2001/18/EC regulates the procedure for new applications for the authorisation of GMOs or for the renewal of a consent/authorisation of GMOs; the deadline for Member States to request a restriction of the geographical scope is 45 days after the forwarding of the assessment report/opinion.

– Article 26c of Directive 2001/18/EC regulates transitional measures for ongoing procedures. These initially concern the important deadlines which Member States must now observe as a matter of urgency. According to this, Member States may request that the geographical scope of a notification, application or authorisation be adjusted in ongoing procedures between April 2, 2015 – the date of entry into force – and October 3, 2015. The Commission will transmit this request to the applicant and the other Member States. The applicant then has a 30-day period from the date of transmission in which they must confirm their original application. If they do not confirm the scope of their original application, the geographical scope of the application will be adjusted. The authorisation or decision will then be granted only on the basis of the adjusted geographical scope. Especially with regard to pending applications, urgency is now required, as applications for adjustment of the geographical scope must be submitted by October 3, 2015. This could prove problematic given the current debate in Germany over whether the geographical scope should be limited by declarations from the federal government, which has reserved responsibility for release issues since 1990, or by declarations from the states. Given the narrow timeframe until October 3, 2015, the window for enacting a federal law transferring powers to the states, which would then be required to enact state-level regulations, appears extraordinarily tight.

This publication can also be found on the website of the law firm Dr. Kauch .