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CEMAS services to support registration of substances within the EU
Under the new EU system of Registration, Evaluation, Authorisation and Restriction of CHemicals (REACH), enterprises that manufacture or import more than one tonne of a chemical substance per year are required to register it with the new European Chemicals Agency. Each registration submission consists of a Technical Dossier and, for substances above 10 tonnes, a Chemical Safety Report (CSR). Failure to register will mean that the substance cannot be manufactured or imported. The REACH legislation means that approximately 30,000 existing substances will need to be registered by 2018.
CEMAS can help meet the regulatory requirements of the REACH programme, offering a wide range of tests, conducted to EU standardised testing methods in accordance with Good Laboratory Practice (GLP), and providing information to aid preparation and submission of the required technical dossier.
CEMAS can carry out all necessary analytical studies to meet the requirements of REACH including:
CEMAS sees continual investment in state-of-the-art instrumentation as crucial to our success. Spark-HollandTM Pharma technology has been acquired to complement our LC/MS/MS (Sciex API 4000 and 5000) systems. CEMAS has both ambient and environmentally controlled storage for accelerated and long-term storage stability studies.
CEMAS conducts studies required by REACH to determine the short-term effects of chemicals on algae, invertebrates and fish in the aquatic environment for substances produced or imported at quantities between 1-10 tonnes per annum.
CEMAS conducts the necessary longer-term studies on invertebrates and fish required for higher volume substances (>100 tonnes per annum) or for substances that trigger higher tier studies according to the REACH testing guidelines.
CEMAS also carries out activated sludge inhibition and biodegradability studies required for chemicals produced or imported at quantities > 10 tonnes per annum.
CEMAS also carries out studies to evaluate the terrestrial ecotoxicological effects of substances, including:
Laboratory studies are conducted within environmentally controlled chambers in the CEMAS Ecotoxicology Unit. Semi-field and field trials are carried out at other suitable locations as required.
Study design, protocol and reporting are tailored to satisfy regulatory requirements using both CEMAS standard procedures and specific customer requirements.
