German Federal Agency for Nature Conservation (BfN)


Experimental Release and Placement on the Market

In regulating the handling of GMOs, a distinction must be made between work done in contained environments (which is not covered by the BfN's mandate) and handling GMOs outside such environments. The latter is then subdivided into two areas. Firstly, following trials in the greenhouse, experimental release of GMOs into the open environment serves testing of their agronomical traits. This can include the safety research needed to prove that the GMOs are safe for placement on the market. Deliberate (experimental) release can support basic research or be used to test market maturity of the new crops. If the deliberate (experimental) release produces positive results, an application for marketing approval is submitted. This approval covers the GMO's placement on the market for specifically stated purposes: the GMO may then be placed on the free market within the scope of the approval received.

Authorisation of Deliberate Release

The approval of deliberate (experimental) release is subject to the procedure set out in Article 14 ff of Germany's Genetic Engineering Act in conjunction with Part B of Directive 2001/18/EC. In Germany, the experimental release procedure begins with notification being submitted to the Federal Office of Consumer Protection and Food Safety (BVL), which examines the notification for completeness before initiating public announcement of certain sections of the application. The other EU Member States are notified using the Summary Notification Information Format (SNIF), which briefly summarises the deliberate release notification. The BfN, the Robert Koch Institute (RKI) and the Federal Institute for Risk Assessment (BfR) must all be consulted during the notification examination process. The authorities draw up a risk assessment based on the data supplied by notifiers. Account is also taken of the statements put forward by the Central Commission for Biological Safety (CCBS)* , public objections, statements of the various federal states and government agencies from other EU Member States. Finally, the BVL decides on whether to approve the deliberate release – again in consultation with BfN, RKI and BfR, and having considered the statements of other agencies. In its approval document, the BVL has the authority to place notifiers under obligation to comply with specific safety requirements.

A notification of deliberate release usually contains a detailed description of the release location. For certain GMOs with sufficiently well-known constructs, the Commission has left it to the Member States to decide whether they wish to introduce a different, simplified procedure.

Procedural Framework for Deliberate Release (PDF) (in German)

Approval for Placement of GMOs on the Market

There are now two different procedures that can be used to approve the placement of GMOs on the market:

  • Placing on the Market under Directive 2001/18/EC

    One of the procedures used is governed by Article 14 ff of Germany's Genetic Engineering Act (GenTG) read in conjunction with Part C of Directive 2001/18/EC. Notifiers may submit an application for market placement approval to a Member State of their choice. The Member State's competent authority (or authorities) conducts an initial assessment and then writes an assessment report on which the other Member States may comment. The decision on whether to reject the notification may be made by the Member State conducting the initial assessment. By way of contrast, the decision to accept the notification may only be made when no other Member State raises an objection or when any objections raised do not hold up after further investigation. Where objections do hold up, the decision on whether to reject or accept the notification can only be made through the "Regulatory Committee Procedure". The BVL and, for example, the BfN may be called upon for advice when preparing for Regulatory Committee meetings or those of the Council of Ministers.

    Procedural Framework for Market Placement under Directive 2001/18/EC (PDF) (in German)
  • Placement on the Market under Regulation (EC) No. 1829/2003

    The second procedure is that governing market placement approval under Regulation (EC) No. 1829/2003 read in conjunction with the German law implementing the EC genetic engineering legislation (EGGenTDurchfG) and is far more standardised; the Member States are restricted to making statements and their decisions in the Council. This procedure applies for genetically modified food and feed. The European Food Safety Authority (EFSA) oversees the entire procedure and in cooperation with the competent Member State authorities, produces a statement to assist the Commission in drafting its proposal for a decision, which then passes through the Regulatory Committee Procedure where the final decision is made.
    The role of the German authorities is restricted in this instance to examining applications for the placement on the market of products made from or containing GMOs and submitting a reasoned statement on their suitability for approval. The BVL again calls upon the BfN (in its consultative capacity) to assist in drafting the statement. This allows BfN to present its views on issues such as the impact of GMO use on the environment.
    In this way, the EFSA may entrust a Member State's competent authority to conduct either a food and feed safety assessment or a GMO environmental risk assessment on its behalf. In cases where the EFSA entrusts the BVL with the GMO environmental risk assessment, the BfN is again involved in its capacity as the consultant authority.

    Procedural Framework for Placement on the Market under Regulation (EC) No. 1829/2003 (PDF) (in German)

Unless the availability of new information requires an approval document to be amended after the fact or withdrawn, the approval is valid for a period of ten years and may be extended for further periods of ten years.

* The CCBS is a voluntary body of experts which assesses genetically modified organisms (GMOs) for potential harm to humans, animals and the environment. It publishes statements to announce its findings. The CCBS secretariat is hosted by the Federal Office of Consumer Protection and Food Safety (BVL).

Last Change: 06/07/2006