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Pharmaceutical Manufacturing and Packing Sourcer

Supervising Substances

Since its conception in 2006, the Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) regulation has had a significant impact on the chemical industry in the EU. The primary purpose of this legislation is to gain more knowledge about chemical substances so that companies can better protect their employees and the environment and inform the public about potential substance hazards.

While the intentions of REACH are clear and simple, in reality, this legislation is complicated and difficult to implement for many companies. The European Chemicals Agency (ECHA) has tried to help by publishing several detailed guidelines, but sometimes the explanations and examples caused more confusion. Substances that have to be registered by the 2018 deadline lie in the 1-100 tonne tonnages. Companies have to prepare registration dossiers for each substance, which contain substance information, such as toxicological and ecotoxicological tests, physicochemical properties, guidance for safe use and more. This is a big problem that manufacturers or importers have to face, as many of them have minimum information about their substances, and, because of REACH, they have to spend large sums of money on obtaining this information.

However, most pharmaceutical companies have the opportunity to register their substances as transported or isolated intermediates. According to REACH, on on-site isolated intermediate is defined as a substance, which is used for the manufacture of another substance, and takes place on the same site, whereas a transported isolated intermediate is moved between or supplied to other sites. Registering as an intermediate is a big advantage because the amount of information needed for the registration dossier and associated costs are significantly decreased. To be able to register these substances as intermediates, they have to be handled under strictly controlled conditions, which must be well-founded and documented. In the end, the simplified registration is not as simple as expected.

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Jana Osičková works as an officer in the department of Ecology and Emergency Prevention at Farmak – a traditional European generic API manufacturer in the Czech Republic. She graduated from Brno University of Technology, Czech Republic, with a master’s degree in food science and biotechnology. She is a specialist in REACH legislation and SCCs and is currently working on registering substances used and manufactured in Farmak. 
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