Executive Briefings

Cost of EU Chemical Regulation May Be Out of Reach for Some

The Registration, Evaluation, Authorization and Restriction of Chemicals regulation, or REACH, is a new European Union statute obligating manufacturers to demonstrate the safety of their chemicals as a condition of manufacture or sale in the EU.
The REACH "registration" regime became effective June 1, 2008. After that date, in order for a chemical to be manufactured or imported into the EU, it must be registered with the new European Chemicals Agency (EChA) in Helsinki, Finland. "Existing" chemicals, primarily those on the European Inventory of Existing Chemical Substances list, are eligible for extended registration deadlines from November 2010 through June 2018, depending on volume or hazards. However, manufacturers must "pre-register" during the six-month phase-in period from July 1 through November 30, 2008.
The registration regime applies to any manufacturer or importer meeting a threshold of one metric ton per year of a substance, whether on its own, in a preparation (mixture) or even in an article, where the substance is released during the normal and foreseeable conditions of the article's use (such as a pen, which releases ink as part of its function). Registrants must prepare a dossier of information on the impact of the substance on health and the environment, including toxicity studies, and registrants meeting the 10 metric ton threshold must include a chemical safety report, assessing the hazards, exposures and risks of each use of the substance during its life cycle.
REACH contains an authorization regime for the most hazardous chemicals, which are referred to as "substances of very high concern" (SVHC). While the European Commission has not yet proposed the specific list (this is scheduled to occur in 2009), the criteria for listing include substances that are carcinogenic, mutagenic or toxic to reproduction; persistent, bioaccumulative and toxic; or with very persistent and very bioaccumulative properties. REACH also requires the commission to determine whether substances with endocrine-disrupting properties should be classified as SVHCs. Authorizations are limited to particular uses, are limited in time (no more than five years) and must be renewed. Depending on the toxicity of an SVHC, its authorization may require a finding that there is no substitute, and that the socioeconomic benefits of the use outweigh the risks.
Manufacturers and importers of articles, even those not subject to registration requirements, are subject to requirements to notify EChA if their articles contain 0.1 percent or greater of an SVHC, if the substance meets the one metric ton per year volume threshold and if exposure to humans or the environment cannot be ruled out. In such cases, the manufacturer or importer would also need to provide the recipient with information sufficient to allow safe use of the article, including, at a minimum, the name of the substance.
The cost of REACH will be huge.
Source: Inside Supply Management, http://www.ism.ws

The Registration, Evaluation, Authorization and Restriction of Chemicals regulation, or REACH, is a new European Union statute obligating manufacturers to demonstrate the safety of their chemicals as a condition of manufacture or sale in the EU.
The REACH "registration" regime became effective June 1, 2008. After that date, in order for a chemical to be manufactured or imported into the EU, it must be registered with the new European Chemicals Agency (EChA) in Helsinki, Finland. "Existing" chemicals, primarily those on the European Inventory of Existing Chemical Substances list, are eligible for extended registration deadlines from November 2010 through June 2018, depending on volume or hazards. However, manufacturers must "pre-register" during the six-month phase-in period from July 1 through November 30, 2008.
The registration regime applies to any manufacturer or importer meeting a threshold of one metric ton per year of a substance, whether on its own, in a preparation (mixture) or even in an article, where the substance is released during the normal and foreseeable conditions of the article's use (such as a pen, which releases ink as part of its function). Registrants must prepare a dossier of information on the impact of the substance on health and the environment, including toxicity studies, and registrants meeting the 10 metric ton threshold must include a chemical safety report, assessing the hazards, exposures and risks of each use of the substance during its life cycle.
REACH contains an authorization regime for the most hazardous chemicals, which are referred to as "substances of very high concern" (SVHC). While the European Commission has not yet proposed the specific list (this is scheduled to occur in 2009), the criteria for listing include substances that are carcinogenic, mutagenic or toxic to reproduction; persistent, bioaccumulative and toxic; or with very persistent and very bioaccumulative properties. REACH also requires the commission to determine whether substances with endocrine-disrupting properties should be classified as SVHCs. Authorizations are limited to particular uses, are limited in time (no more than five years) and must be renewed. Depending on the toxicity of an SVHC, its authorization may require a finding that there is no substitute, and that the socioeconomic benefits of the use outweigh the risks.
Manufacturers and importers of articles, even those not subject to registration requirements, are subject to requirements to notify EChA if their articles contain 0.1 percent or greater of an SVHC, if the substance meets the one metric ton per year volume threshold and if exposure to humans or the environment cannot be ruled out. In such cases, the manufacturer or importer would also need to provide the recipient with information sufficient to allow safe use of the article, including, at a minimum, the name of the substance.
The cost of REACH will be huge.
Source: Inside Supply Management, http://www.ism.ws