“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. Furthermore, 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.