With the commencement of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), the new European regulation of registration and authorisation of chemical substances, will have different consequences for the chemical and pharmaceutical industry. Chemicals with a production or import volume >1 metric ton per year must be registered. Without registration during defined timelines, these chemicals are not allowed to be sold anymore within the EU. Some chemicals are identified as "substances of very high concern" (svhc), e.g. carcinogenic, mutagenic or toxic to reproduction etc. They need a marketing authorization. Within defined timelines, the manufacturers and importers must pre-register their chemicals that are already on the EU market, to benefit from transitional arrangement and register at a later stage. Therefore they must submit considerable technical dossiers. Failure to register means that the substance cannot longer be manufactured and imported.
The timeline for pre-registration ends on 1 December 2008.
Detailed information about REACH you will find here.
If a manufacturer or importer failed registration or did not register, some chemical substances will not longer be available on the European market. If such a substance is an ingredient of a disinfectant, the disinfectant manufacturer will have to discontinue the production or change the ingredients as a consequence. In both cases a new validation would be required by the pharmaceutical company which used the disinfectant as a part of their hygienic programme. Against the background of the necessary timeframe which will be needed for a new validation, the pharmaceutical manufacturers should contact their suppliers of cleaning agents and disinfectants precociously for information about potential changes.
A current report of the svhc for open comments you will find here.
Axel H Schroeder
On behalf of the European Compliance Agency (ECA)