The amendment to the Genetic Engineering Act (GenTG) of December 1993 provides for shorter deadlines for registration and approval procedures for genetic engineering plants and genetic engineering work.

The shortening is to be achieved in that the genetic engineering work of security level 1 no longer requires a statement by the Central Commission for Biosafety and the ZKBS is not involved in genetic engineering work of security level 2 if the genetic engineering work to be assessed is already carried out by the ZKBS classified genetic engineering work is comparable. In these cases, a safety assessment of the genetic engineering work is carried out by the licensing authority in the respective federal state.

However, the question arose as to which properties make genetic engineering work comparable with other genetic engineering work, i.e. which criteria are decisive for comparability. As a new task for the ZKBS, the creation and publication of general statements of frequently performed genetic engineering work with the underlying criteria of comparability was added.

Based on these statements, it should be possible for the state authorities to evaluate comparable genetic engineering work without consulting the expert ZKBS on a case-by-case basis.

Legal basis

Section 12 (4) GenTG:

"In the case of security level 2, the competent authority obtains an opinion from the committee according to § 5 on the safety-related classification of the planned genetic engineering work and the necessary safety-related measures via the competent higher federal authority, if the genetic engineering work does not correspond to a genetic engineering work already classified by the commission is comparable. The committee according to § 5 gives its opinion immediately. The opinion must be taken into account when making the decision. If the competent authority deviates from the opinion on a decision, it must present the reasons for this in writing. "

Section 1, Paragraph 2, Clause 2 of the ZKBS Ordinance:

"The Commission publishes general statements on frequently performed genetic engineering work with the respective underlying criteria of comparability in the Federal Gazette and regularly publishes newly recognized biological security measures in the Federal Gazette in accordance with Section 6 of the Genetic Engineering Safety Ordinance."