Chemicals and regulation

Industry is facing increasing pressure to comply with chemical regulations and to supply products that are safe for users. These requirements extend beyond the EU’s REACH regulation to encompass a wide range of other markets—such as South Korea, China, and Turkey—that are introducing chemical legislation modeled on REACH.

For any company, it is crucial to

• understand the consequences of non-compliance with legal requirements
• stay updated on legislative changes
• meet technical requirements with comprehensive, documented data

We can help you navigate the regulatory challenges of the global market. We possess a strong international network and maintain extensive contacts with local authorities, with whom we collaborate on registrations and approvals.

In South Korea, we partner with a recognized expert, Prof. Dr. Sanghun Kim (formerly of KIST Europe), to ensure compliance with South Korea’s K-REACH legislation. In China, we work through our local office and can act as your Only Representative or assist with notifications.

Our team includes internationally recognized toxicologists and ecotoxicologists, ensuring high-quality services tailored to your specific needs.

We handle assignments on either an ad hoc or an ongoing basis.

REACH-registrations

We have participated in numerous lead registrations under REACH and possess extensive knowledge of the regulatory requirements and the toxicological documentation required for registration.

Testing costs can represent a significant portion of registration expenses. We have therefore specialized in using alternative testing methods to generate the required documentation.

We offer, among other things:

• read-across for analogous substances
• QSAR-modeling to address data gaps
• documentation bases on ”weight of evidence”
• advice on regulatory strategy
• advice on selecting approaches to meet data reuirements and testing of chemical substances

We apply these methods in combination with our extensive toxicological expertise and searing literature.

REACH registration for Rockwool International

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

REACH-registrations for the PARAD Consortium

We have worked closely with KIST Europe to develop testing strategies and programs for the PARAD Consortium regarding the registration of acrylate substances under REACH.

One of the consortium members was the South Korean company Miwon, a market leader in the field.

REACH-registration of nickel

On behalf of Nickel Institute and Nickel Consortia, we developed more than 100 exsposure scenarios for all identified uses of nickel and nickel components for the REACH-registration.

The task also included identifying and assessing alternatives to nickel coatings in, for example, cars, aeroplanes, and electronics.

Cases: Substances subject to authorization

In collaboration with our partners RPA Ltd., EPPA, and Fobig, we prepared applications for the authorization of continued use of substances included in the REACH Authorization List. The application process involved mapping, data collection, and the 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 specific use in question. It was particularly important to consider existing alternatives - including those from competitors - even if they did not immediately offer the same functions and benefits.

In the chemical safety reports, we quantified all potential exposures throughout the life cycle of the substances in question, including at the downstream user stage. Exposure assessments covered industrial workers, the environment, and individuals exposed via the environment. It was crucial that the risk assessments were quantitative - unless the substance was a non-threshold substance - and that data from both the occupational and environmental contexts were available to support the exposure assessments.