RAC and SEAC agree on restriction and authorisation proposals


The restriction proposal for nonylphenol/nonylphenol ethoxylates and one further authorisation application for phthalates were agreed by both RAC and SEAC.

Helsinki, 17 June 2014 - During the plenary meetings in June 2014, the Committee for Risk Assessment (RAC) adopted opinions on two restriction proposals: the first on nonylphenol and nonylphenol ethoxylates, and the second on 1-methyl-2-pyrrolidone, whereas the Committee for Socio-economic Analysis (SEAC) has found an agreement on the restriction proposal on nonylphenol. The Committees have also both agreed on draft opinions for applications for authorisation.

Restriction proposal on nonylphenol and nonylphenol ethoxylates in textiles

RAC and SEAC agreed their opinions on the Swedish proposal to restrict nonylphenols /nonylphenol ethoxylates in textile articles, or textile parts of articles, that can be washed in water, if the total concentration of these substances is equal to or higher than 0.01% by weight. The suggested transitional period is five years after the entry into force of the restriction.

RAC concluded that the proposed restriction, with modified scope and conditions, is the most appropriate EU-wide measure to reduce aquatic risks from nonylphenol ethoxylates and their degradation products. SEAC concluded that the restriction is justified and proportionate. Both Committees supported the restriction of the main components, i.e. nonylphenol ethoxylates in textile articles or textile parts of articles that can be washed in water, but did not find sufficient evidence to support a restriction of nonylphenol in the same textile articles.

The 60-day public consultation on the SEAC draft opinion will be launched in June. SEAC plans to adopt its final opinion in September 2014.

Restriction proposal on 1-methyl-2-pyrrolidone (NMP)

RAC adopted its opinion on the Dutch proposal to restrict the manufacturing and use of NMP. RAC modified the conditions of the proposed restriction and concluded that it is the most effective EU-wide measure in terms of reducing the risks. According to the opinion of RAC, manufacturers, importers and downstream users of NMP on its own or in mixtures in a concentration equal or greater than 0.3% shall use a long-term Derived No Effect Level (DNEL) of 10 mg/m³ for inhalation and 4.8 mg/kg/day for dermal exposure in their chemical safety assessments and safety data sheets for workers.

SEAC plans to agree on its draft opinion in September 2014 as the deadline for the SEAC opinion has been postponed based on Article 71(3) of the REACH Regulation.

Applications for authorisation for phthalates, lead chromate pigments and diarsenic trioxide

RAC and SEAC discussed 28 uses of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), lead chromate pigments and diarsenic trioxide proposed in 10 applications for authorisation.

RAC agreed on draft opinions for one use of DBP. SEAC agreed on draft opinions for two uses of DBP and one use of DEHP. As a result, the draft opinions on all uses of one application were now finalised.  

SEAC agreed in all three applications for diarsenic trioxide, with a reservation to possibly re-open the cases pending the outcome of the RAC opinion on these applications.

The draft opinions on the applications for authorisation agreed by RAC and SEAC will be sent to the applicants for their comments.