Division 4 Hazardous Substances and Biological Agents

Division 4 is responsible for improving the protection of employees who work with hazardous substances and biological agents (pathogens). To this end, it describes the health hazards posed by substances, assesses them, and proposes protective measures that will reduce employees' risks to a socially acceptable level. Its assessments also constitute the basis for the safe use of chemicals, work equipment, and products. The evidence-based advice it provides is rooted in the results from research and development (R&D) projects, but also many years of experience performing statutory tasks and delivering policy advice for ministries and other occupational safety and health (OSH) stakeholders.

In order to perform its diverse tasks efficiently, the division is divided into two sections, Hazardous Substances, Chemical Safety (Section 4.I) and Biological Agents, Biocides (Section 4.II). Section 4.I covers the protection of employees from the perspective of chemical safety, the associated requirements for the placing of substances on the market in the EU, and the manufacture and use of hazardous substances at work. Section 4.II concentrates on the health risks posed by biological agents at work and the safe use of biocidal products, which have inherently hazardous properties due to their effect profile. 

Both sections work closely together, particularly on issues relating to exposure, toxicology, and biomonitoring.

The research and development projects undertaken within the division are geared towards policy advice and issues arising from the Federal Institute’s statutory tasks. Their results inform authorisation decisions, the development of legislation, and the technical regulations on occupational safety and health. Such projects are pursued at BAuA's modern, in-house laboratories or by conducting field studies in companies and, where necessary, receive support from external research services.

At the national level, Division 4 advises the Federal Ministry of Labour and Social Affairs (Bundesministerium für Arbeit und Soziales, BMAS) on the further development and implementation of the Hazardous Substances Ordinance (Gefahrstoffverordnung, GefStoffV), the Biological Agents Ordinance (Biostoffverordnung, BioStoffV), and the Ordinance on Preventive Occupational Health Care (Verordnung zur Arbeitsmedizinischen Vorsorge, ArbMedVV).

At the European level, the division's focus is on shaping of European directives on occupational safety and health in relation to chemical and biological substances and on the legal tasks relating to chemical safety in the EU. One priority here is to establish links between the requirements for the safe placing of hazardous substances on the market and the operational level in order to generate synergies for occupational safety and health.

While this interface has been the division’s focus for some time, new controversies are currently developing between the EU Chemicals Strategy for Sustainability with its goal of a "toxic-free" environment, on the one hand, and, on the other, the EU Critical Raw Materials strategy, which aims to keep relevant substances in material cycles for as long as possible by means of recycling. This aim has implications in particular for metals that are essential for certain applications such as batteries, but are also carcinogenic. Division 4 sees it as its duty to support the far-reaching changes in the working environment resulting from this regarding the protection of employees at both the legal and practical level. 

Division 4's activities make key contributions to all the fields of action described by BAuA's current Work and Research Programme (A-E, with priorities in B1, B2, and C2). In this respect, research and development studies supply the foundations for the division’s evidence-based contributions to policy advice, regulation, and knowledge transfer. 

Section 4.I "Hazardous substances, chemical safety"

The safe design of activities involving hazardous substances in the workplace is the central concern of the Hazardous Substances, Chemical Safety Section and a priority for safety in use. Hazardous substances may be produced and used as chemicals at workplaces or generated by work processes (e.g. welding fumes). 

The legal framework for Section 4.I is laid down by German and European OSH legislation and the EU regulations on chemical safety. Typical examples of legislation in the field of occupational safety and health are the European directives on hazardous substances in general and on carcinogenic hazardous substances in particular, which are transposed in Germany by the Hazardous Substances Ordinance. The main pieces of European chemical safety legislation are the CLP and REACH regulations. They serve to harmonise the classification and labelling of chemical substances and mixtures and specify procedures for companies regarding the registration, evaluation, and authorisation of chemical substances in the EU. 

One important overarching topic is the Chemicals Strategy for Sustainability, as part of the European Commission's Green Deal. The Chemicals Strategy brings about changes to many legal provisions and thus the priorities set for safe activities involving hazardous substances. Another driver of far-reaching changes to material flows is the European Commission's goal to increasingly keep strategic raw materials, many of which also have hazardous properties, in substance cycles in order to make the EU more resilient against external influences. The section is actively monitoring these changes regarding emerging occupational safety and health issues.

Section 4.I's functions are to provide policy advice on the further development of hazardous substances legislation and technical regulations, perform statutory tasks under the CLP and REACH regulations as the REACH Assessment Unit OSH, and promote the transfer of knowledge to support practical occupational safety and health action with a focus on SMEs. One topical issue for the further development of chemical safety is the regulation of fibrous materials that release respirable fibrous dusts.

The scientific basis for these tasks is provided by application-oriented research and development work on the topics discussed above.

The section’s current R&D priorities include among others:

  • Model development and data generation to improve the assessment and evaluation of exposures during activities with hazardous substances
  • Better integration of exposure and use-related data into chemical safety assessment procedures
  • Methods for the risk assessment of fibrous materials and fibrous particulate hazardous substances in the workplace
  • Standardisation of OSH-relevant testing, measurement, and assessment methods
  • Further development of the Easy-to-use Workplace Control Scheme for Hazardous Substances (EMKG) for risk assessment

The Committee on Hazardous Substances (Ausschuss für Gefahrstoffe, AGS), whose office is based within Section 4.I, is the most important body in Germany working to flesh out occupational safety and health provisions. In addition to managing the committee's business, the section is involved in the development of technical regulations in order to support state-of-the-art occupational safety and health action. The section is also responsible for Division 4's contributions to the work of the Committee on Maternity Protection (Ausschuss für Mutterschutz, AfMu), helping ensure issues around hazardous substances can be regulated coherently across two distinct areas of law - occupational safety and health and maternity protection. The division also takes part in the deliberations of the Committee on Safety and Health at Work (Ausschuss für Sicherheit und Gesundheit bei der Arbeit, ASGA) about overarching OSH topics.

Section 4.II "Biological Agents, Biocides"

Section 4.II concentrates on dealing with key issues relating to occupational safety and health for individuals who work with biological agents and biocides. In Germany, several million employees carry out activities in which they directly handle biological agents (pathogenic microorganisms) such as bacteria, fungi, or viruses (e.g. in laboratories) or are exposed to them on account of the work they do (e.g. in the healthcare sector). Bioaerosols pose a particular challenge here, as their composition and the associated hazards are highly complex in some workplaces.

The legal basis for the protection of employees from biological agents is formed by the European Biological Agents Directive and the Biological Agents Ordinance, which transposes the directive into German law. Disinfectants are one way of controlling exposure to biological agents in the workplace. They comprise an important group of biocides that are used to combat harmful organisms. As part of its statutory duties under the European Biocidal Products Regulation as the Biocides Assessment Unit OSH, Section 4.II ensures that all necessary expertise is pooled and marketing requirements prevent either biocidal active substances or biocidal products from posing unacceptable risks to employees when they are in use.

Biomonitoring has a special role to play in this area. It involves investigating the absorption of substances into the body. Biomonitoring based on the analysis of blood, urine, or exhaled air samples allows the assessment of individual health risks and provides input for exposure assessments. In many cases, biomonitoring is also an integral part of preventive occupational health care.

The basis for the performance of Section 4.II's tasks is application-oriented research and development work on the topics discussed above.

The section’s current R&D priorities include among others:

  • Research questions about infection control in the working environment investigated in collaboration with all divisions on the topics of protective measures, epidemiology, the availability of effective disinfectants, and the organisation of occupational safety and health provision for crises
  • Development of methods for the risk assessment of biological substances in the workplace
  • Field studies and laboratory investigations into the release of and exposure to bioaerosols using state-of-the-art OMICS methods
  • Field and laboratory studies on biomonitoring based on the analysis of blood, urine, or exhaled air samples
  • The collection and modelling of exposure data for authorisation procedures

The Committee on Biological Agents (Ausschuss für Biologische Arbeitsstoffe, ABAS), whose office is hosted by Section 4.II, is the most important body working to flesh out occupational safety and health provisions for activities with biological agents in Germany. In addition to managing the committee's business, the section is involved in drawing up technical regulations that support state-of-the-art occupational safety and health action. Furthermore, section 4.II contributes to the Occupational Medical Rules developed by the Occupational Medicine Committee (Ausschuss für Arbeitsmedizin, AfAMed) and supports the work of the Committee on Hazardous Substances (Ausschuss für Gefahrstoffe, AGS) concerned with the technical rules that govern biocides.

Further Information

Contact

Prof. Dr Thomas Kuhlbusch

Head of
Division 4 Hazardous Substances and Biological Agents

sekfb4@baua.bund.de

Dr Wendel Wohlleben

Scientific Management
Division 4 Hazardous Substances and Biological Agents

sekfb4@baua.bund.de

WissD'in Dr Michaela Clever

Head of
Section 4.I Hazardous Substances, Chemical Safety

info-zentrum@baua.bund.de

PD Dr Udo Jäckel

Head of
Section 4.II Biological Agents, Biocides

info-zentrum@baua.bund.de

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