Chemicals and regulation

Industry is facing increasing pressure to comply with the requirements of chemicals legislation and to provide products that are safe for users. These requirements are not limited to the EU REACH Regulation but also apply to a wide range of other markets, such as South Korea, China and Türkiye, which are introducing chemicals legislation inspired by REACH.

As a company, it is essential to:

• understand the consequences of non-compliance with legal requirements
• stay up to date with changes in legislation
• meet technical requirements with comprehensive and well-documented data

We can help you address regulatory challenges in the global market. We have a strong international network and extensive contacts with local authorities, with whom we cooperate on registrations and approvals.

In South Korea, we work with a recognised partner, Prof. Dr. Sanghun Kim, formerly of KIST Europe, to meet the requirements of South Korea’s K-REACH legislation. In China, we work with our local office and can act as your Only Representative or provide assistance with notifications.

Our specialists include toxicologists and ecotoxicologists with internationally recognised expertise, ensuring high-quality services tailored to your needs.

We can support you on an ad hoc basis or provide ongoing assistance.

REACH-registrations

We have been involved in numerous lead registrations under REACH and have extensive knowledge of the legislative requirements and the toxicological documentation required for registration.

A significant part of the cost of registration can be associated with testing. We have therefore specialised in the use of alternative testing methods to meet the required documentation requirements.

Among other things, we offer:

• read-across to analogous substances
• QSAR modelling to support missing data
• documentation based on a weight-of-evidence approach
• advice on regulatory strategy
• advice on selecting the appropriate approach for meeting data requirements and testing chemical substances

We combine these methods with our extensive toxicological expertise and searches of the scientific literature.

REACH-registrering for Rockwool International

For Rockwool International, we managed a consortium for the registration of the high-tonnage substances Man-Made Vitreous Fibers (MMVF) and E-Glass. The work included drafting the consortium agreement with all participating parties, chairing meetings, handling confidential matters, and providing secretariat services for the consortium.

REACH-registration of nickel

On behalf of the Nickel Institute and Nickel Consortia, we developed more than 100 exposure scenarios covering all identified uses of nickel and nickel compounds 100 exposure scenarios covering all identified uses of nickel and nickel compounds.

The work also included the identification and assessment of alternatives to nickel coatings in applications such as automotive, aerospace and electronics.

Cases: Substances Subject to Authorisation

In collaboration with our partners RPA Ltd., EPPA and Fobig, we have prepared applications for authorisation for the continued use of substances included on the REACH Authorisation List. The applications included mapping, data collection, and assessment of technical and economic data, including:

• preparing or updating chemical safety reports
• assessing alternatives (partly via a partner)
• conducting socio-economic analyses (via a partner)

Key elements of a successful application include the identification and assessment of technical alternatives to the current use. Among other things, it was important to consider existing alternatives, including those offered by competitors, even if these could not immediately provide the same functions and benefits.

In the chemical safety reports, we quantified all potential exposures throughout the life cycle of the substances used, including exposure among downstream users. This covered workers in industry, the environment, and people exposed indirectly via the environment.

It was essential that the risk assessments were quantitative unless the substance had no threshold value, and that data from both the workplace and the environment were available to support the exposure assessments.