The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007.
The EU has changed history and set the pace for future productrelated legislation with its Registration, Evaluation and Authorization of Chemicals (REACH) Regulation no. 1907/2006, which came into effect in June 2007. REACH is a major reform of all previous chemical legislation and affects every company that manufactures or trades products containing chemical substances in the EU. The requirements have set unprecedented standards for the regulation of chemical substances, bringing both requisites for information on intrinsic properties, as well as the possibility to restrict dangerous substances to the highest level on a global scale.
The basic underlying principle, which marks a fundamental shift in EU policy, is the transfer of responsibilities with respect to the safety of chemicals: REACH places the responsibility on the supplier, manufacturer or importer of chemicals. This is most prominently marked by the 'No Data – No Market' principle; they fully carry the duty to register all substances produced or imported in quantities above 1 tonne per company per year. If you don't register, you won't sell.
Another example of the new requirements for industrial chemicals is the notification and disclosure requirements regarding chemical Substances of Very High Concern (SVHC) listed on the Candidate List. SVHCs are substances characterized as having potentially significant adverse effects on health or the environment. A first Candidate List was published by the European Chemicals Agency on 28 October 2008 and currently contains 15 SVHCs, but this will grow continuously during the coming years. All companies supplying products, such as typical consumer goods, packaging material or other types of equipment (so-called 'articles' in the REACH regulation) have to inform their customers of the presence of SVHCs in concentrations above 0.1% w/w.
For the SVHC requirements, the real effect will only gradually show in the relationship between suppliers and customers, and industry is now struggling to adapt their product-specifications to the new requirements. Some have already applied a zero tolerance policy for SVHCs by banning them from their products. Regardless of the specific implementation used, failure to disclose the content of SVHCs and provide the necessary instructions for safe use could result in loss of revenues and obsolete inventory.
The pharmaceutical industry is not unaffected by REACH; the legislation has implications for raw materials used in pharmaceutical production, chemicals and products used to create the final packaged form, or chemicals that are used in applications other than APIs. Thus, REACH requirements are present, for example, for solvents, intermediates and packaging materials. Additionally, even though the specific uses of chemical substances for most pharmaceutical products are exempt from the registration duty, any substance that is used as a pharmaceutical intermediate and any substance that is used in other applications as well as pharmaceuticals (e.g., salicylic acid used in cosmetic products) has to be registered with respect to the use outside the pharmaceutical application. For substances that have been pre-registered, the dossier for full registration as applicable has to be submitted when the deadlines for registration are reached, starting in 2010.
As a downstream user, the pharmaceutical industry will eventually need to ensure that supply chains are not disrupted because of any postREACH market restructuring. Also, companies will need to address issues relating to SVHCs in items such as packaging materials, products to introduce pharmaceuticals into the human body, medical devices and certain types of test kits.
The pharmaceutical industry will first of all have to adapt to the possible market adjustments resulting from the complicated and expensive registration process that will affect most suppliers of chemicals. The effect may range from reduced numbers of suppliers to rising supply costs, and increasing demands for cost-sharing related to additional testing and documentation. In addition, the SVHC issue will leave the industry with strategic decisions about whether to accept SVHCs in pharmaceuticals or related products and, if so, how to inform customers according to the information requirements. In this respect, it should be noted carefully that, in practical terms, the effects of the SVHC requirements are likely to go beyond the 15 substances directly affected by the requirements because of increasing debate and public attention on SVHCs in general, which may prompt companies (i.e., retailers) to require phase-out of such substances to protect their brand.
Torben Nörlem, Intertek Health and Environmental Chief Counsel