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The ECHA has developed a common screening approach to evaluate substances in the EU
The biggest piece of legislation to have gone through the European Chemicals Agency (ECHA) is now in full effect, and companies around the world are feeling its impact. ECHA is the driving force among regulatory authorities in implementing the EU’s chemical legislation, helping companies comply with regulations. One piece of legislation on everyone’s mind right now is Reach.
The EU regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, or Reach, was first introduced in June 2007 to improve the protection of human health and the environment from the risks that can be posed by chemicals. It applies to all chemical substances and places the burden of proof for safety on companies that produce or use chemicals.
To comply, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. If this sounds like a tall order, it is. The regulation has an impact on most companies in the EU, as well as many companies outside it.
Operating outside the EU does not exclude a company from feeling the weight of Reach. Its impact is global, and it touches manufacturers, importers and even downstream users. If you make, buy or use chemicals, and do business within the EU, you are likely to have felt the impact of Reach. The impact may take the form of a delay and information exchange along the supply chain.
Delays in production are inevitable when legislation requires that components of a product go through rigorous testing and authorisation in order to be used in products sold in the EU. These delays and associated costs can be ameliorated by clear communications between suppliers and customers regarding compositions, Reach registration status, and the presence, or not, of any substances of very high concern in the products being sold.
Companies can also expect positive impacts from Reach. Once the implementation of the regulation runs its course, companies will have access to toxicity profiles of every single substance used in the EU. Having that kind of information at your fingertips will help in the future, when we expect to see similar regulations being implemented in other countries. The earlier companies get involved in the Reach process, the more prepared they will be to answer any questions or address any regulations in the future.
COMMON SCREENING APPROACH
Through Reach, the ECHA has already identified more than 160 substances of very high concern for authorisation. And it anticipates it has hundreds more to identify. ECHA has developed a common screening approach to systematically evaluate the long list of substances that are being used in the EU. Through the screening, ECHA searches for available information on substances in order to identify appropriate Reach processes and next steps. The efforts put into the regulation reflect how serious the ECHA and EU are about its impact to limit or prohibit the use of hazardous substances in products.
The ultimate goal of limiting or prohibiting hazardous substances in products will take time to achieve. The laborious task of collecting and assessing information on the properties of substances used in products is time-consuming – not to mention that we are talking about any product made within or imported to a whole continent. Spanning more than a decade, Reach was introduced in June of 2007 and the final registration deadline is in 2018. Beyond May 2018, it will be against the law to continue to manufacture or import any unregistered substances.
Currently in Reach’s spotlight are plasticizers, especially ortho-phthalates, included as some of the first substances to go through the authorisation process and some of the most affected substances under the regulation because of their popularity. Of the 163 substances already identified for authorisation by the EU, 13 are ortho-phthalates, a family of chemicals used to soften and increase flexibility of plastic and vinyl.
HISTORY OF REGULATION
Plasticizers and phthalates are no strangers to scrutiny. For more than 20 years now, manufacturers have felt the pressure of regulations, with Europe leading the charge. In the past, reports on the safety of ortho-phthalate plasticizers, traditionally the most dominant of plasticizers, have resulted in restrictions on their use in some sensitive applications, such as children’s toys. EU Directive 2005/84/EC, later replaced by Reach regulation, took effect in January of 2007 and set limits on phthalates in toys and childcare products.
Phthalates are among the most widely researched of all chemical substances because of their popularity in products like toys, food packaging materials, medical applications, shoes and apparel.
For the last five years, the industry has actually witnessed the shift in purchasing to non-phthalates. The transition began with companies wanting to avoid the hassle associated with continued use of phthalates. Non-phthalate plasticizers account for the highest growth market because of these kinds of restrictions. We expect to see a continued rise in the use of non-phthalate plasticizers. Because of this, Eastman has prepared our teams to assist customers in the transition to a new material. An educated and experienced team can more easily attain compliance in an often complicated industry.
This is especially important considering the potential for other continents or countries to take on similar legislation. The US Environmental Protection Agency (EPA) has the Toxic Substances Control Act (TSCA), allowing a regulatory framework to collect data on chemicals in order to evaluate, assess, mitigate and control risks posed by their manufacturing, processing and use. TSCA is not nearly as developed as Reach quite yet, but it has the potential to be similar in scope and impact, with an update likely coming in the next year.
Overall, Reach is a very comprehensive, yet still very new, piece of legislature. Its impact is broad, reaching companies all over the world. Thus far, it has prompted companies to work together to find solutions, build data sets and share costs. Ultimately, it means companies are more strictly measuring, tracking and managing the chemicals in their products and supply chains. We do not have all of the answers yet and we are experiencing growing pains with the process, but Reach is driving supply chain transparency and end-user safety, which is a good thing.
Located in Wiltshire, England, Martin Stimpson is the global market development manager in the Adhesives and Plasticizers Business unit for Eastman Chemical Company (UK) Ltd. Stimpson’s focus is on new product and new market development for plasticizers and formulation additives. He has 20 years’ experience in the European plasticizer markets. He received a Bachelor of Science degree in chemistry from North East London Polytechnic and a doctorate in chemistry from City University London.