Division IV | Umweltbundesamt

Chemical Safety

Chemical safety in Germany and Europe

Chemical safety in Germany is mainly governed by the following legislation:

• the Chemikaliengesetz (Chemicals Act), which also applies to biocides
• the EU biocides regulation
• the Pflanzenschutzgesetz (Plant Protection Products Act) and the EU Plant Protection Products Regulation
• the Wasch- und Reinigungsmittelgesetz (Detergent and Cleaning Agent Act) and the EU Detergent Regulation
• the Arzneimittelgesetz (Pharmaceutical Drug Act)
• the REACH and CLP regulations
• the Infektionsschutzgesetz (Infectious Diseases Act)
• Article 62 of the Wasserhaushaltsgesetz (Federal Water Act)

The tenor of Germany’s chemical safety regulations is mainly determined by EU law. This also applies to the methods used for assessments, whose results under EU legislation are reported to and implemented from Brussels.

Division IV activities

European experts benefit from Division IV’s experience and expertise via initiatives such as the following: Division IV recommendations concerning the EU biocides and plant protection products  regulations; the guidelines for environmental risk assessment of pharmaceutical drugs; technical issues concerning the EU detergent regulation and the REACH chemical regulation.

Division IV (a) assesses the environmental risk entailed by chemicals; and (b) is involved in authorizing biocides, drugs and pesticides according to the Biocide part of the Chemikaliengesetz (Chemicals Act), the Pflanzenschutzgesetz (Plant Protection Products Act), the Arzneimittelgesetz (Pharmaceutical Drug Act) and the Infektionsschutzgesetz (Protection against Infection Act). Its approval regarding environmental risk assessment and risk reduction measures is necessary for authorization of chemical products. The work is carried out in collaboration with the Federal Institute for Occupational Safety and Health (BAuA), the Federal Institute for Risk Assessment (BfR), the Federal Office of Consumer Protection and Food Safety (BVL), and the Federal Institute for Drugs and Medical Devices (BfArM).

Chemicals

The main European chemical law is the REACH regulation, which stipulates that although industrial chemicals are subject to an approval procedure in exceptional cases only, a registration dossier is nonetheless to be submitted to the European Chemicals Agency (ECHA). It falls to the member states (in Germany via the UBA) to evaluate such dossiers and identify particularly hazardous chemicals (substances of very high concern), insofar as environmental risk comes into play.

Pesticides and biocides

Plant protection products  are subject to government approval before use. As they are released directly into the environment and contain chemicals that are designated to be toxic for certain pests, especially close scrutiny as to whether they are compatible with the natural environment and safe for groundwater is necessary.

Biocides, which kill or ward off pests in non-agricultural settings, are likewise subject to government approval, which is based on a thorough environmental assessment. Biocides are used to fight organisms that are potential vectors of diseases or to protect materials against corrosion by fungi and other organisms.

From a public health standpoint, it is crucial to have a sufficient variety of effective products and procedures on hand to prevent the spread of diseases brought on by cockroaches, ticks and other pests. We test the efficacy of pest control products and procedures as prescribed by law ruling out at the same time the possibility of any unacceptable environmental impact.

Pharmaceutical drugs

Pharmaceutical drugs are intended to keep humans and animals healthy. However, as they are highly bioactive substances, their residues can potentially have undesirable effects on the environment. In the context of the approval process, we determine the nature of such effects and promulgate environmental protection rules.

Detergents and cleaning agents

Because they are so widely used and can potentially be incorporated into the water cycle, detergents and cleaning agents are governed by a specific set of regulations and must meet particularly high biodegradability standards for water bodies and sewage treatment plants.

Substances hazardous to water

It is essential that safety precautions in technical installations be taken for substances that are hazardous to water so as to rule out any possibility that they could be harmful to our water resources. The risk classes that we define for these products constitute an additional safety measure in this regard.

International chemical safety

We also participate in the drafting of chemical safety rules and measures at the international level. Particularly noteworthy in this regard are persistent organic pollutants (POPs), whose manufacture and use are banned or highly restricted by international conventions. We also work with international organizations such as the World Health Organization (WHO) and the United Nations Environmental Program (UNEP). The OECD plays a particularly important role in the field of chemical safety, in that it works to promote safety of nanomaterials and elaborates internationally harmonized substance testing standards, among other things.

Chemical research

Division IV also focuses on optimization of the scientific basis for assessments of ecotoxicological effects, biodegradability, chemical bioaccumulation in organisms and the food chain, and environmental exposure to chemicals. This aspect of our work also includes investigations of specific mechanisms of action such as the effect of endocrinic disruption. To this end, we contribute to the development and improvement of suitable environmental risk testing methods and provide experimental support in this sphere. We also elaborate assessment methods for nanoparticles in various applications and propose how to implement nanomaterial regulations in various chemical substance laws. This implementation process is based on extensive proprietary databases.

Databases

We provide support for the Joint Substance Data Pool of the German Federal Government and the German Federal States (GSBL), which now contains more than 309,000 datasets for querying purposes. Part of this database is known as the Gefahrstoffschnellauskunft (GSA) which is widely used by first responders and end users.

The Federation / Länder Dioxin Database, which we operate in collaboration with two other government agencies, has proven to be a highly effective instrument for documentation of the success of measures aimed at reducing dioxin, furan and PCB impacts. We document and assess contamination with such substances detected in environmental samples, biota, animal feed, and food for human consumption, and recommend measures aimed at reducing such inputs.

Artificial stream and pond system (FSA) and lab

Our Artificial stream and pond system (FSA) in Berlin-Marienfelde is a highly sophisticated and large scale testing facility comprising man-made streams, rivers, ponds, lakes and lake-like lowland rivers that are stocked with the aquatic biota normally found in such water bodies. The FSA, which counts among the largest model ecosystems (mesocosms), enables invaluable connections to be made between field studies and simplified and readily controlled lab tests. The FSA is connected with an analytical chemical lab and a GLP certified lab for ecotoxicological testing, where we carry out activities such as investigating the environmental impact of pharmaceutical drugs and developing assay methods for environmental chemicals.