The European Commission has announced the addition of six substances—including dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), and di-(2-ethylhexyl) phthalate (DEHP)—to the authorization list (Annex XIV) of REACH (Registration, Evaluation, Authorization and Restriction of Chemicals). As a result of this announcement, use of these three phthalates after February 2015 will require authorization by the European Chemicals Agency (ECHA).
European manufacturers have previously indicated their intent to seek authorization for continued use of DEHP in medical and other applications beyond 2015. The information required for authorization will be submitted to ECHA once the Agency has finalized the details of the authorization process. All three of the substances have been previously registered with ECHA under REACH. Registration requires the submission of complete health and safety information, including assessments and safety determination for each registered use.
A number of other phthalates also have been registered with ECHA, including benzyl isononyl (B74P), B84P, dimethyl (DMP), diethyl (DEP), dipropylheptyl (DPHP), di-isononyl (DINP), di-isodecyl (DIDP), and diundecyl phthalate (DUP). No additional authorization is required for the continued use of these substances.
DBP, BBP, and DEHP currently are prohibited from use in toys and child care articles in the United States and Europe and are also restricted from cosmetics in Europe. These three substances continue to be used safely in many other applications, however, and the results of biomonitoring studies in the United States and Europe indicate that exposure to the general public is very low. As a result, the European Chemicals Bureau concluded after a thorough risk assessment that there is “at present no need for further information and/or testing and no need for risk reduction measures” in consumer applications beyond those that already are being applied for these three substances.
View related ACC statement: Manufacturers Will Seek REACH Authorization for Important Phthalate Applications.