How Responsive is the Chemical Industry to the REACH Regulation?

Thousands of chemicals have been placed in global markets for a long time, without sufficient if any information on their intrinsic properties to guarantee safe handling. The European Union, through its commission, clearly understood both potential and actual effects of chemical hazards on human health and the environment, leading to the commission passing a legislation in 2007 to regulate the production of chemicals placed in the EU market to ensure their safe use.

Since the EC Regulation on Registration, Evaluation and Authorization of Chemicals (REACH) came into effect four years ago, only a paltry 5, 012 chemical substances have been registered by the ECHA (as of August 18, 2011). This low number is partly attributed to the agency’s inability to cope with the high number of dossier submissions by the industry, as was reported on the 2011 agency’s report on the working of REACH and CLP.

The industry too can be apportioned blame in light of the recent ECHA call to the same substance multiple registrants. Both the agency and the industry must therefore step up their commitment to the full enforcement of the REACH regulation.

Since the REACH regulation places greater responsibility on the chemical industry to manage the risks associated with the chemicals substances, the industry ought to invest in appropriate information gathering infrastructure to achieve this end. This can be actualized with the help of professional compliance agencies should manufacturers find themselves unable to execute this internally.

With the first registration deadline (November 2010) gone for phase-in substances, Those produced in quantities from 1000 tonnes annually, carcinogenic, mutagenic, toxic to reproduction, and very toxic to aquatic organisms, it is important for the producers of the next deadline (May 2013) group of substances to expedite their process of compliance with the regulation.

Pre- registrants of phase-substances which are manufactured or imported in quantities above 100 tonnes annually should be at advanced stages of their Substance Information Exchange Forum discussions as provided for by the regulation to effectively share data and timely submit a joint registration dossier.

Manufacturers who can’t be part of a joint registration should make known their intentions in good time and pursue the opt-out possibilities captured in the Article 11(3) of the REACH regulation:

  • it would be disproportionately costly for him to submit this information jointly; or

  • submitting the information jointly would lead to disclosure of information which he considers to be commercially sensi tive and is likely to cause him substantial commercial detriment; or

  • he disagrees with the lead registrant on the selection of this information.

Much information is available to the industry; from the regulatory agency (ECHA) and third party compliance agencies to make the process of REACH compliance manageable. The ECHA guidance document on registration is instrumental in understanding the registration process. With that said, how much difference can we anticipate at the fall of the 2013 deadline?

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