Das BVL lässt zu Source: BVL / Gloger

We authorise these products in Germany. In the procedure of authorisation, we decide whether and under what conditions a plant protection product or a veterinary medicine may be used. To this end, we evaluate the documents submitted by the applicants for a product authorisation: we examine recipes, the physical, chemical and technical properties of a product, the pharmaceutical quality, or the analytic methods used in testing the product. We are also responsible for the risk management. That means, we decide on approval and connect this decision with conditions and precautionary provisions of use, in order to minimise risks in use.

An authorisation decision of a plant protection product, for instance, includes minimum space definitions to adjacent lakes or rivers. Also, we define what protective clothes a farmer or hobby gardener must wear when using such product. Each plant protection product which is authorised is also classified as regards its poisonousness to bees. A product which is classified as “harmful to bees” must not be used on flowering plants or any plants approached by bees.

In the authorisation of veterinary drugs, efficacy and tolerability for animals and the environment are important criteria, besides pharmaceutical quality. Residues of pharmacological active substances such as antibiotics must not exceed fixed legal maximum levels. To this end, a waiting period – termed “withdrawal period” – is defined in the product authorisation decision. This is the minimum period of time to let pass between treatment of an animal and starting to use it for food production.

The Laender food control authorities routinely test residues to see whether legal provisions about plant protection products and veterinary medicines are observed. The BVL collects and publishes the test results in an annual report of the “National Residue Control Plan”. Samples of foodstuffs with illegal residues are very few. Topical warnings about foodstuffs are published by the competent authorities in the internet under the address www.lebensmittelwarnung.de

To explain it by an example...

Ministries, laws, maximum residue levels

When a farm or other business intends to grow genetically modified plants for scientific purposes (GMO field releases) in Germany, for instance, cereals, sugar beet, tobacco or potatoes, the BVL is the approval authority for that. In that procedure, we include other government authorities who contribute to the approval process according to a procedure which is prescribed by law. All applications to this end and approvals granted since 1991 are published on our website. Information published includes such on the applicants, new properties of the plant in question, and on the respective genetic modification. It shows, for instance, the microorganism which is original to a gene implanted in the genome of the modified plant.

In addition to that, the BVL’s GMO Site Register shows, by postal zip code, the places where genetically modified plants are grown, and the size of release trial fields. Germany does not commercially grow genetically modified crops for the time being. Approval of commercial growing of such crops must be obtained from the European Union.

We decide on authorisation, but...

…the authorisation procedure involves a number of government authorities with competencies in different technical fields. They contribute technical statements and health evaluations. Contributing authorities include the Robert Koch Institute (RKI), the Federal Institute for Risk Assessment (BfR), the Federal Environmental Agency (UBA), the Federal Institute for Drugs and Medical Devices (BfArm), Federal Agency for Nature Conservation (BfN), Julius Kühn Institute (JKI), Friedrich Löffler Institute (FLI), and Paul Ehrlich Institute (PEI).

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