Transport of GMOs

The difficulty in determining the permissible conditions for the internal or external transport of GMOs lies in the definition of the term "placing on the market" in the Genetic Engineering Act. According to Section 3 No. 6 GenTG, placing on the market means the supply of products to third parties, including making them available to third parties, and bringing them into the scope of the law, provided the products are not intended for genetic engineering work in genetic engineering facilities or for authorized release. The only exceptions to the term "placing on the market" are transit traffic under customs supervision and supply for the purpose of an authorized clinical trial. Since the term "placing on the market" is therefore relatively broadly defined, it is questionable whether this directly constitutes placing on the market whenever a third party is involved in the transport of GMOs. If the answer to this question is affirmative, a marketing authorization would then have to be applied for in accordance with Section 14 Paragraph 1 GenTG. This is suggested, for example, by the BVL website, which states that GMOs and products can be transported within Germany "because a comprehensive risk assessment was previously carried out during the respective approval procedures." The BVL somewhat imprecisely states that for GMOs intended for genetic engineering work, e.g., in laboratories, animal stables, or greenhouses, the work is assigned to a risk group, and notifications, registrations, or even approvals are required accordingly. Furthermore, special conditions for the transport and subsequent handling of these GMOs are based on this risk group. The question remains whether the stricter provisions of Section 14 of the Genetic Engineering Act (GenTG) should nevertheless be applied to delivery to a transport company, since the product is first delivered to a third party and not transported directly from one facility to the next. This could be due to the fact that the legislature intended to comprehensively cover all handling of GMOs in the Genetic Engineering Act. Ultimately, such a marketing authorization will likely not be required because the product is intended for genetic engineering work in genetic engineering facilities – at least after transport has been completed. According to the wording of the law, the destination of the transport – namely a genetic engineering facility – is sufficient.

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