April 20, 2023

European Agency Prioritizes Lead, Other Substances Under REACH

Earlier this month, the European Chemicals Agency recommended that the European Commission add lead and seven other substances to the Authorization List under REACH, the EU’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. According to ECHA, six of the recommended substances, including lead, are toxic for reproduction. The other two substances are identified as respiratory sensitizers. The European Commission decides which substances will be included in the Authorization List and the conditions that will apply for each substance, ECHA’s press release explains. Companies must apply for authorization to continue using substances once they’ve been added to the list.

ECHA’s recommendation regarding lead accounts for the many comments it received during a three-month consultation period as well as the opinion of the agency’s Member State Committee, which discussed concerns related to timing, other ongoing or planned regulatory activities, and expectations for industry and authorities.

“This recommendation brings lead metal to the same regulatory stage as other lead compounds with similar uses already recommended for inclusion to the [Authorization] List,” said Ofelia Bercaru, director for prioritization and integration at ECHA. “We are aware of the challenges and considered that balancing the risks posed by lead to workers and the environment with its continued use requires a policy decision by the Commission and EU Member States.”

The other substances named in ECHA’s recommendation include ethylenediamine, which the agency says is used as a processing agent in refinery streams; 2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers, used as fragrance in washing and cleaning products; and glutaral, which is used in leather tanning and as an X-ray film developer and corrosion inhibitor. Two more substances—2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one and 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone—are used as photoinitiators in UV-curable coatings, inks, and adhesives. The last two substances recommended by ECHA have no registered uses, but “could potentially replace structurally similar substances that have already been recommended or are included in the [Authorization] List,” the agency says. Thus, adding diisohexyl phthalate and orthoboric acid, sodium salt to the list may help “avoid regrettable substitution[s].”

The list of the substances included in ECHA’s latest recommendation is available on the agency’s website (PDF). Further details are available in ECHA’s press release.