How To Seek Approval for Chemicals Everywhere
It’s a jungle of chemical regulations out there. Here are some options for companies seeking global registration for their chemical product.
These days you can find a specialist for almost any problem—including getting your company’s industrial chemicals approved in multiple countries.
“Registering your compound globally may be daunting at first,” says Anniek van den Broek, part of Charles River’s Regulatory Affairs. “Some companies have this goal from the beginning, whereas others wish to register one country at a time. The latter may cause duplicate studies or dossier work, so even if the intention is not to go global immediately, it is always wise to at least look at the possibilities in advance and set up your testing scheme accordingly.”
[Check out Charles River’s Industrial Chemical E-Guide: Global Registrations]
One demanding aspect of this process is keeping up with changes to chemical registration laws. You may think you have sound knowledge of a country’s regulations, but legal changes come frequently and must be adopted (sometimes) immediately. Regulatory Affairs must keep abreast of any changes and be nimble enough to implement them right away.
“The trickiest may perhaps be the fact that chemicals can be a different ‘type’ of chemical under each legislation,” van den Broek said. “A substance of ‘Unknown, or Variable composition, Complex reaction product or Biological materials,’ or in short a UVCB, is a typical description used under EU (REACH) chemical law. However, this chemical may be called something different under another legislation.” In addition, for example polymers are handled differently under different chemical regulations.
Although the EU is the only market where a block of countries can be registered in one fell swoop, there are other overlaps that can save time and testing for clients. For example, van den Broek says that the Philippines will accept an abbreviated chemical dossier if you can show that the chemical was approved elsewhere, like in the US or South Korea. Also, though she says that all regions will accept data from tests performed under OECD guidelines, some require special modifications to standard tests, such as Japan which requires a recovery group as well as the standard repeat-dose study, and China, which requires some locally-performed ecotoxicity testing.
One of the biggest news stories of the decade may also soon have ripple effects on chemical regulations. It is not yet clear what effect Great Britain’s withdrawal from the EU will have on their testing requirements, but it is likely there will be modifications. While the rest of the EU will continue with their REACH regulation (Registration, Evaluation, Authorisation and restriction of Chemicals), Great Britain might go their own way.
“A major hurdle for the chemical industry may perhaps be the fact that each country has its own focus points,” she said. “Some legislations are focused on human health whereas in others the environmental effects weigh heavier. The second major obstacle is finding local representatives to assist companies with submitting the correct information to the authorities. Most countries require submissions in the local language and sometimes even require pre-submission discussion meetings with the authorities. Often companies have to rely on their local importers to act as submitter, which also means they need to share sensitive data on the chemical with that importer which is not the ideal route to keeping your intellectual property confidential.”
Therefore chemical manufacturers often partner with laboratories, such as Charles River, that have the global expertise to understand the complex web of regulations, the local connections to perform the necessary studies, and the authority to achieve registration in multiple markets.
The benefit of submitting your dossier to an authority in a country is, of course, a much broader market. However, the cost associated with this type of global registration could be prohibitive, unless it is performed as efficiently as possible. Therefore, also careful consideration should be given to buying Letters of Access (LoAs), which often specifies that the data are only allowed to be used for one specific country or region.
“In the end, whether it is navigating through the reform of the Toxic Substances Control Act (TSCA) in the US, future changes to British regulations, or updates on data requirements in China, CRL’s expertise on the required data, together with their expert knowledge on regulations, can help steer chemical companies through the jungle of country-specific regulations, taking global registration into account, data requirements and all administrative work associated with it,” says van den Broek.