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UPDATE ON REACH


Despite the financial woes currently plaguing the European Union, the EU is continuing to push forward with the implementation of its far-reaching chemical registration regulations, called REACH. Originally enacted in 2007, REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals), has the ultimate goal of reducing or eliminating harmful chemicals from the EU. Administered by the Helsinki-based European Chemicals Agency (ECHA), REACH places the onus on individual manufacturers to provide data on all chemicals that are manufactured or used in Europe.

Eventually, substances that are deemed to be highly hazardous (Substances of Very High Concern, or SVHCs) will need to be either eliminated or substituted with less hazardous alternatives.

REACH is huge in scope and ambition – as one of the EU’s largest pieces of legislation, it has and will have a significant impact on the worldwide chemical business and manufacturing. Not only do importers of chemicals and manufactured goods to Europe have to ensure that they adhere to the regulations, other countries – such as China and South Korea – are currently drafting new chemicals regulations that mirror REACH in many ways.

In late May, ECHA held its annual Stakeholders’ Day conference. Run in conjunction with the Helsinki Chemicals Forum, the conference discusses new developments in REACH.

Some of the early registration deadlines have now been passed, and ECHA says it has received some 26,000 registrations. The organization has now begun the process of conducting substance evaluations in order to form a list of the most hazardous chemicals. A total of 84 substances are already on a Candidate List of SVHCs – with companies encouraged to find and use safer substitutes.

To date, the registration deadlines have primarily affected large companies which produce or import very large amounts of chemicals. The upcoming registration deadlines, by contrast, will affect small- and medium-sized companies that manufacture or import smaller amounts of chemicals. The deadlines for registration of substances involving greater than 100 tonnes per annum and 1 tonne per annum are scheduled for June 1, 2013 and June 1, 2018, respectively. ECHA expects nearly 2,700 new substances to be registered in 2013, according to Kevin Pollard, the organization’s head of the dossier submission and dissemination unit.

Companies can now also apply for SVHCs to be placed on an Authorisation List to allow them to continue using the substance on a temporary or permanent basis. This process is just beginning, and ECHA will be conducting webinars about it in October.

Meantime, ECHA has now also started publishing information on consumer articles containing SVHCs. The data, available on ECHA’s website, describes some of the types and uses of articles where such hazardous substances may be found. The majority of the information published so far relates to four phthalates that are on the Candidate List due to their toxicity to reproduction.

This year’s Stakeholders’ Day also provided insight into other key issues such as the quality of information contained in registration dossiers provided by registrants. ECHA has stepped up its reviews of dossiers by doing random compliance checks, and has been targeting dossiers with poor quality information. According to George Cartlidge, senior scientific officer, evaluation, ECHA has found that only 7 percent of evaluated dossiers are closed without issue. The organization’s message to registrants was to keep the quality of data sufficient and up-to-date because a failed compliance check ends up creating much more work for the registrant.

To assist companies in developing or discovering alternatives and substitutions for hazardous chemicals, a non-government organization based in Sweden called ChemSec has launched a website called www.subsport.eu that provides information and case histories where companies can share data about substitutions.

For non-EU producers of substances governed by REACH who want to export their products to the EU, they have two choices: either to register directly or register through an Only Representative. The Canadian government maintains a web page (www.canadainternational.gc.ca/eu-ue/policies-politiques/reach_chemicals-chimiques.aspx?lang=eng&view=d) with information about how Canadian exporters are affected by REACH and how they can go about registering their substances or finding an Only Representative.

This article originally appeared in the June 2012 issue of Lab Product News.