SEAC adopts restriction proposals on four phthalates and TDFAs in sprays used by the public
The Committee for Socio-Economic Analysis (SEAC) adopted their opinions on two restriction proposals on four phthalates (DEHP, DBP, DIBP and BBP) in articles and on TDFAs in sprays used by the general public. The committee also agreed on 14 draft opinions on 10 applications for authorisation and adopted one final opinion.
Helsinki, 20 June 2017 –
Applications for authorisation
SEAC continued its work on 10 applications for authorisation. The committee agreed in total on 14 draft opinions on specific uses of chromium (VI) substances, bis(2-methoxyethyl) ether (diglyme) (EC 203-924-4; CAS 111-96-6) and 2,2’-dichloro-4,4’-methylenedianiline (MOCA) (EC 202-918-9; CAS 101-14-4).
The committee also finalised its work on one further application for authorisation by adopting the opinion on the use of diglyme as a process solvent in the manufacture of an intermediate for an active pharmaceutical ingredient.
SEAC adopted its final opinion, in support of the proposal to restrict the four phthalates (DEHP (EC 204-211-0; CAS 117-81-7), DBP (EC 201-557-4; CAS 84-74-2, 93952-11-5), DIBP (EC 201-553-2; CAS 84-69-5) and BBP (EC 201-622-7; CAS 85-68-7)) in articles.
The restriction was proposed by ECHA and Denmark and is an example of two authorities collaborating on the development of a restriction proposal.
The recommendation is to restrict phthalates in articles, such as flooring, coated fabrics and paper, recreational gear and equipment, mattresses, footwear, office supplies and equipment, and other articles moulded or coated with plastic, that cause exposure through the skin or by inhalation.
SEAC reconfirmed that the proposed restriction is the most appropriate EU-wide measure to address the identified risks in terms of the proportionality of its socio-economic benefits to its costs.
Having considered the 13 comments received during the public consultation on the draft opinion agreed in March 2017, SEAC proposed additional derogations (for certain parts, products or appliances of aircraft and for certain articles for automotive vehicles) and made minor adjustments in the justification for its opinion.
The proposed restriction will apply three years after the amendment of the REACH Annex XVII comes into force.
TDFAs in sprays used by the general public
The committee also supported the proposal by Denmark to restrict the placing on the market of sprays used by the general public containing TDFAs (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silanetriol and any of its mono-, di- or tri-O-(alkyl) derivatives.
Having considered the two comments received during the public consultation on the draft opinion agreed in March 2017, SEAC made no changes to its opinion but made minor changes to the justification.
SEAC reconfirmed that the proposed restriction is the most appropriate EU-wide measure to address the identified risks in terms of the proportionality of its socio-economic benefits to its socio-economic costs.
The measure requires that sprays should not be placed on the market if they contain TDFAs in a concentration equal to or greater than two parts per billion by weight in a mixture with organic solvents. Spray products comprise aerosol dispensers, pump and trigger sprays and mixtures marketed for spray applications.
The proposed restriction will apply 18 months after the amendment of the REACH Annex XVII comes into force. There are no uses that are proposed to be derogated (excluded) from the scope of the restriction.
Role of SEAC in EU regulatory processes
SEAC is responsible for preparing the opinion of the Agency on applications for authorisation and proposals for restrictions. SEAC also prepares opinions on specific questions relating to socio-economic issues and on any other aspects concerning the safety of substances on their own, in preparations or in articles at the Executive Director's request. The final decision for proposals for restrictions as well as on applications for authorisation will be taken by the European Commission through a committee procedure. Further information about SEAC is available on the ECHA website at the link below: