The new EU chemical legislation poses
enormous demands not only to chemical industries –
pharmaceutical enterprises are also
affected to a great extent.

REACH is coming...

…come along!

One of the most ambitious legislative projects in the history of the European Union will come into force in June 2007: the complete realignment of the EU chemical legislation. A regulation termed REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is set out to enhance the protection of human health and the environment while at the same time promoting innovation.

With the adoption of REACH all substances produced in or imported to the EU have to be registered before being marketed. The central idea of registration consists of a comprehensive analysis of the hazard, i.e. the potentially hazardous properties of the substance, and of the risk for human health and the environment posed by exposure to the substance. At first glance the pharmaceutical industries appear not to be concerned as substances contained in medicinal products for human or veterinary use are exempted from the duty of registration.

On closer inspection it becomes apparent that pharmaceutical businesses are also severely affected by REACH. All substances for synthesis or processing are entirely subject to REACH. The furthermore introduced liability of the downstream user to pass on safety relevant information “upstream” to his supplier additionally complicates the situation. Even if you neither manufacture nor import you might be directly affected by REACH, because every use of a chemical substance – e.g. as starting material in drug synthesis – has to be specified in the registration dossier. Do you know if your supplier registers the substance for your own use?

Especially the pharmaceutical industry takes REACH more and more seriously, because without registration manufacturing and marketing of many pharmaceutical products within the EU may cause problems. PharmaLex helps you to keep track of REACH. We can show you if and how you are affected and what has to be done to comply with all aspects of the new regulation. Gain the crucial competitive advantage now and secure your company’s success – acting in time enables you to benefit from all advantages REACH has to offer.