Chemicals and REACH
Overview
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
REACH applies to all chemical substances manufactured or imported above 1 tons per year in the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
How does REACH impact your business?
What are the consequences of such submission? On the best scenario, the submitted dossier had to be reviewed in a few months, on the worst the principle “no registration, no market” is applied!!
How LKC can help you:
Provides independent expert opinion and helps its customers to develop innovative regulatory strategies tailored to the specific situation. Develops a robust strategy based on tonnage bands, intrinsic properties of the compound and appropriate risk assessment which finds a compromise between economics and registration requirements to allow fast registration and a smooth entrance into the market at an affordable cost.
Provides Registration Project Management. It brings economic and scientific advantages when the same team is in charge of all the registrations related to a same compound.
To represent clients in SIEFs or act as 3rd Party or Only Representative. LKC has legal entity in UK and can support EU and Non EU manufacturers and importers.
Provide inventory and data check and suggest the best option to fill the gap: testing proposal or read across, waiver preparation and (Q)SAR approaches. LKC can provide expert statements or in silico methods to save expenses and reduce testing efforts.
Has the technical competences to prepare the IUCLID 5 registration dossier. Literature data search, data evaluation (Klimisch scoring) and data gap analysis, preparation of (robust) study summary, DNEL and PNEC calculation, PBT, vPvB assessment, classification and labeling.
Selects laboratories with experience and certified compliance with OECD and national Good Laboratory Practice regulations.
Contracts and monitors studies carried out in contract facilities. LKC team of experts (toxicologists, ecotoxicologist, chemists…) has considerable experience study monitoring to maintain close observation on the study procedures for a variety of chemicals.
Has the experience in conducting detailed risk assessments and summarizing the results in registration format. LKC experts can provide the human and environmental risk assessment (EUSES, Chesar, ECETOC TRA), evaluate its results and suggest either higher tier assessment or the best operational conditions and/or risk management measure to control the risk. These conditions will then be summarized in the exposure scenarios which is an essential part of the CSR.
Prepares registration dossiers, complete or in part, including all risk assessments in print and in electronic format. Has proven experience with the successful submission of regulatory dossiers and IUCLID formats for specialized chemicals in the EU.
If you are looking for support to register your specialized chemicals in Europe, please contact us