REACH: has the cloud of confusion cleared? - Pharmaceutical Technology

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PharmTech Europe

REACH: has the cloud of confusion cleared?
The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative. By seeking effective IT solutions and working in collaboration with its suppliers and importers, and perhaps a consultancy firm, communications, work planning, cost and administration can be effectively handled to ensure a smooth REACH registration process.


Pharmaceutical Technology Europe
Volume 22, Issue 5


(LEWIS MULATERO/GETTY IMAGES)
The Registration, Evaluation, Authorisation (and restriction) of Chemicals (REACH) initiative came into force on 1st June 2007. The aim of the directive is: to improve the safety of chemicals on the European market; to ensure that manufacturers and importers of chemicals are aware and responsible for managing risks associated with their use; to allow the free movement of substances throughout the EU market; to enhance innovation and competitiveness in the EU chemicals industry; and to promote the use of alternative methods of hazard assessment.

A major part of REACH was the requirement for manufacturers or importers of substances to preregister them with the central European Chemicals Agency (ECHA) before 1 December 2008 to obtain phase in status. The registration package is supported by a standard set of data on that substance where the amount of data required is proportionate to the amount of substance manufactured or supplied. If a substance was not registered, then the data on it will not be available and as a result, no one will no longer be able to manufacture or supply them legally, i.e., no data, no market!

Three years following on from its introduction and the picture is now much clearer about pharmaceutical companies' obligations under REACH. Challenges remain, however, to ensure that supply chains are not disrupted and brand value damaged through poor REACH plan execution and the inactivity of key participants in the REACH scheme.

Confusion over pharma's obligations

Initial signals in the media were confusing back in 2007/8. Pharmaceuticals were stated as being exempt from the main provisions of registration, evaluation, authorisation and downstream use of chemicals where they fell within the scope of Regulation 726/2004 (governing the centralised procedure), the Human Use Directive 2001/83 and the Veterinary Use Directive 2001/82. Closer examination, however, indicated that this did not cover chemicals used in the synthesis of drug actives (e.g. starting materials, reagents, solvents, catalysts, intermediates), ingredients in oral healthcare products and chemicals used in immediate and outer packaging.

Moreover, there was the other, as yet, unquantifiable risk at the time that substances with multiple uses beyond pharmaceutical excipient use in medicinal products may be affected by certain commercial considerations; i.e., the costs involved for a supplier registering a substance for its general use might far outweigh its commercial viability. Manufacturing or importing might therefore cease altogether, leaving the pharmaceutical company with no choice but to source elsewhere or substitute and reformulate its products with all the consequent costs involved.

Any substance that is used in applications in addition to those in the pharmaceuticals industry has had to go through the pre-registration process to achieve phase-in status of being fully registered between 2010 and 2018. As a manufacturer or importer, the pharmaceutical industry will be required to register any substances (> 1 tonne) that they manufacture or import directly into the EU. Furthermore, as a downstream user, the pharmaceutical industry needs to provide information on human and environmental exposure and emissions to the suppliers from whom they obtain the substances.

With this in mind, the pharmaceutical industry with its wealth and depth of experience and expertise in managing proscriptive regulation, set about developing their game plans.


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