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Authorisation procedure

GMO releases may be carried out only if authorisation to do so has been granted (§ 14 Para. 1 of the Genetic Engineering Act (GenTG)). Authorisation decisions are individual decisions and refer to concrete, specific GMOs, specific locations and a limited period The following prerequisites are connected to authorisation of a release (§ 16 para. 1 in conjunction with § 13 Para. 1 No. 1 and 2); authorisation will be granted on the following conditions:

  1. it is ensured that all of the safety precautions deemed necessary in the light of scientific and technical knowledge are being implemented and that, according to scientific knowledge, no unwarrantable damaging effects for the legally protected interests referred to in § 1 No. 1 are anticipated;
  2. there are no facts from which concerns regarding the reliability of the operator or the persons responsible for management and supervision could arise;
  3. it is guaranteed that the project leader and the commissaries for biological safety both possess the expert knowledge required to carry out their tasks and are able to fulfil their obligations.

The existence of the authorisation requirements must be checked in the process of the authorisation procedure. The applicant must present documentation for this purpose. If the operator is a legal entity, e.g. a company or a higher education institution, a legal representative will act on its behalf in external relations. For instance, if an application for the authorisation of a release has been submitted by a university, this will usually be signed by chancellor acting as the operator’s representative. Applications for the authorisation of release projects must be submitted to the BVL with the required information. The BVL will then check the application for completeness and involve the following entities as part of a further procedure:

  • the Central Committee on Biological Safety (established on the legal basis of the GenTG);
  • the Robert Koch Institute (RKI), the Federal Agency for Nature Conservation (BfN) and the Federal Institute for Risk Assessment (BfR) as advisory authorities;
  • the Julius Kühn Institute (JKI) for the purpose of obtaining an opinion, along with the Friedrich Loeffler Institute (FLI) for cases concerning genetically modified vertebrates or genetically modified microorganisms to be applied to vertebrates;
  • the federal state in which the release is to be executed according to the application, and
  • the other EU Member States via the EU Commission.

The authorities and establishments involved are issued with complete information and information is provided for other EU Member States in a summary referred to as the SNIF (Summary Notification Information Format). Using the application documents, the BVL checks whether or not the prerequisites for authorisation are present. The operator requesting the release must include a risk assessment for the project and provide information in its application with regard to the safety precautions it has planned. The assessment carried out by the operator is checked by the BVL in its inspection of the contents of the project’s safety assessment, taking into account the planned safety precautions. At the same time, the public are given the opportunity to participate in a written consultation process.

The BVL must reach a decision on the application within 3 months. Periods in which the BVL

  1. is awaiting further documents from the operator
  2. and public participation is taking place are not taken into account when calculating this deadline.

In addition to its own assessment, the BVL also considers the following when making a decision on the application:

  • the scientific opinion provided by the ZKBS;
  • opinions of the advisory authorities and the JKI, along with opinions from the FLI where appropriate;
  • the opinion of the competent federal state authority and
  • comments and suggestions from other EU Member States.

The opinions given by the ZKBS with regard to releases of GMOs are usually prepared by two memebers of the ZKBS as rapporteurs and finalised in the ZKBS plenary session. The BVL Genetic Engineering Department also functions as the ZKBS administrative office. The opinion delivered by the ZKBS is a recommendation; the BVL is not bound by this opinion. The decision-making practice of the BVL has, however, been largely informed by the scientific opinion of the ZKBS with regard to release projects. Advisory authority opinions concentrate mainly on the safety conditions to be satisfied in the event of a release. These are listed as ancillary provisions in the notification of authorisation. The approval authority (BVL) and the advisory authorities (RKI, BfN, BfR) do not need to reach an agreement with regard to the decision which has been earmarked for the application and ancillary provisions. The BVL considers the opinion of the federal state concerned when making its decisions. Detailed comments from other EU Member States are checked and taken into account where appropriate.

If the requirements for authorisation have been satisfied, authorisation is granted by the BVL in a written notification of authorisation, which is delivered to the applicant and passed on to the competent federal state authority to enable it to carry out its compulsory monitoring tasks. If new information on the safety assessment or any of the other prerequisites for authorisation comes to light whilst the release project is being carried out, the BVL may attach additional conditions for the continuation of the release or revoke its authorisation.

A graphical representation of the stages of the procedure can be found here.

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