SDA Calls EU REACH Program Unworkable

Major portions of Europe’s proposed chemical management policy are unworkable and would place significant burdens on business and government with “negligible” improvements to human health and the environment, according to The Soap and Detergent Association (SDA). In extensive comments filed with the European Commission on its proposed REACH (Registration, Evaluation, and Authorization of Chemicals) policy, SDA said it agrees with the regulations’ stated health and environmental improvement goals, but expresses real doubts about the ability of the proposed regulation to achieve those objectives.

“The proposed regulation contains important gaps and vague text and raises concerns that it would be interpreted and applied inconsistently,” said SDA in its written comments.

One of SDA’s chief concerns is REACH’s proposed definition of what chemical “substances” would have to be registered with European authorities.

“The proposed definition of ‘substance’ includes impurities and additives, effectively making them part of a chemical’s identity,” wrote SDA. “This definition would severely challenge the workability of the regulation. Further, including impurities as part of the chemical identity puts the EU out of step with virtually every other major chemical management system in the world, since substances are typically not differentiated by their impurities.

“As drafted, the inclusion of impurities in the proposed definition of ‘substance’ would require separate registrations for substances that differ only in the degree of purity or types of impurities present in the substance. This would place a significant burden on the system with negligible enhanced improvement in the environment and human health, challenging its workability.”

SDA also said that the proposed language would hinder cooperative industry efforts to gather or generate new data on chemicals –potentially leading to an increase in unnecessary animal testing.

“For example, without disclosing to competitors the entire impurity profile of a substance of interest, which could disclose a proprietary production process for making it, potential consortia members may not be able to assure themselves that they could work together on the same ‘substance.’ As a result, each manufacturer would engage in its own testing for registration,” said SDA.

Other key concerns and recommendation expressed by SDA include:

• Overlaps in the scopes of coverage between REACH and other European Union health, environment or product legislation should be avoided. REACH should not apply to chemical substances and preparations that are regulated under other regulatory schemes and to substances for which data have been reported to Competent Authorities under other regulatory schemes.

• The regulation fails to provide uniform criteria addressing what shall be considered confidential, imposes no requirements on governments to adequately protect confidential business information (CBI), and imposes no sanctions for wrongful disclosures of such information. The proposed regulation should be revised to address these elements.

• Too much responsibility is placed on national competent authorities, which may be limited in resources that they can apply, inviting inconsistent decisions. SDA urged a much larger role for a new central agency.

• Risk-based hazard communication should be adopted and classification should be de-linked from other downstream legislation.

• Allowances should be made for industry to be much more involved in the different stages of the Restriction process in order to improve the workability of the regulation.

• The proposed regulation should be modified to incorporate a mechanism for companies to appeal a decision by a regulatory authority.

• The concept of “unacceptable risk” should be defined, and should be scientifically sound.

To make the system workable, SDA urges that:

• The work done under REACH be prioritized and that the scope of registration focus on those substances which are potentially dangerous for humans and the environment based on their hazard and exposure;

• Polymers be kept out of the scope of registration; and

• The scope of substances exempted from Registration be extended to impurities, inorganic catalysts, homogenous and heterogeneous alloys, by-products formed incidentally by chemical interaction between components in a preparation and articles.

A copy of SDA’s comments is available on its website at www.cleaning101.com/about/issues.html.