ECHA examines safety of cobalt salts used in pharma manufacturing
pharmafile | March 19, 2013 | News story | Manufacturing and Production |Â Â ECHA, cobaltÂ
The European Chemicals Agency (ECHA) is looking into the safety of five cobalt salts that have applications in pharmaceutical manufacturing.
The salts – cobalt sulphate, cobalt dichloride, cobalt dinitrate, cobalt carbonate and cobalt diacetate – are used in culture media to make pharmaceuticals and for a range of chemical and biotech applications.
The probe will focus on whether there is a potential for workers to be exposed to these cobalt salts during their manufacturing, and if so whether that exposure could lead to harmful effects.
The European Commission asked the ECHA to carry out the investigation after it opted to postpone the decision on the inclusion of these substances in the Authorisation List (Annex XIV) of the REACH (Registration, Evaluation and Authorisation of Chemicals) legislation, which came into effect in 2008.
Under REACH, substances deemed sufficiently hazardous to require authorisation are listed in Annex IV, which introduces a deadline for their use to be prohibited unless sponsors provide evidence that they can be safely used in a specific application.
The ECHA said its investigation would be used by the Commission to determine whether the agency should draft use restrictions “if there are indications of a risk to human health which is not adequately controlled”.
The primary source of information for this inquiry will be the registration dossiers for the substances, said the ECHA, adding that it has already started to review the latest updates of these dossiers to assess the specific conditions of use in each sector.
Companies and associations for the various industrial sectors concerned have also been contacted to provide supplementary information, and the agency will hold a webinar this week to explain the procedure relating to the five cobalt salts, how the current preliminary study contributes to it, and the type of data sought.
Phil Taylor
