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Unit Safety of Chemicals

The unit is responsible for the assessment of chemicals with regard to properties that are hazardous to human health. The focus lies on the assessment of chemical substances that fall under European chemical legislation (REACH Regulation (EC) 1907/2006), and comprises toxicological assessment and risk assessment for consumers. The unit therefore performs an essential part of the role assigned to the BfR in the German Chemicals Act as the "assessment unit for health and consumer protection" in the implementation of the REACH Regulation.

Particular importance is given to the carcinogenic, mutagenic and reprotoxic properties of substances as well as properties that result in the sensitisation of the respiratory tract.

The assessment of chemicals also comprises the toxicokinetics and metabolism of chemicals, further toxic effects like neurotoxicity or specific organ toxicity, the mode of actions underlying the toxicity of substances and findings observed in humans. Assessment covers as well information on structure-activity relationships and the use of computer-supported aids for the modeling of toxicity and physico-chemical properties. By submitting substance dossiers to the European Chemicals Agency (ECHA), the BfR proposes classification and labelling or restrictions on the production or use of substances with hazardous properties, and identifies substances of very high concern (SVHC) for the authorisation process under REACH.

The unit develops proposals for the improvement of toxicological assessment concepts, testing strategies and test methods for chemicals, and participates in national and international bodies (EU, OECD, WHO/IPCS).

In addition, the unit is also involved in the assessment of substances that are of particular interest or risk assessments which are subject of international discussion (e.g. acrylamide, bisphenol A, formaldehyde, nanomaterials, perfluoro compounds).

The unit cooperates closely with the Federal Environment Agency (UBA) and the Federal Institute for Occupational Safety and Health (BAuA), which houses the "Federal Chemicals Office" as the national coordination centre on questions of chemicals safety.

Main fields of activity:

• Toxicological assessment of chemicals
• Risk assessment of chemicals for consumers (together with Unit 34)
• REACH coordination in the BfR
• Identification of substances of very high concern (SVHC) under REACH
• Proposals for the harmonised classification and labelling of dangerous substances on the EU level within the context of the CLP Regulation (EC No. 1272/2008)
• Proposals for restriction measures for the production and use of substances under REACH
• Dossier and Substance Evaluation as well as evaluation of Testing Proposals for substance registrations under REACH
• Toxicological assessment of nanomaterials (REACH, OECD WPMN)
• Support for German members of the Committees for Risk Assessment and Socioeconomic Analysis as well as in the Member State committee at ECHA
• Support for the national REACH-CLP Helpdesk at the Federal Institute for Occupational Safety and Health (BAuA)
• Further development of EU chemical legislation (REACH, CLP, REACH Test Method Regulation (EC No 440/2008), including their annexes and guidance documents)
• Participation in international bodies (EU, OECD, WHO/IPCS) for the (further) development of test methods, testing strategies and toxicological assessment concepts
• Supervision of research activities  in relation to improved risk assessment of chemicals

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