The 5 substances of the Annex XIV inclusion project
The European Commission has recently published a draft amendment to Annex XIV of the REACH Regulation, which lists substances subject to authorisation. Thus, 5 new entries could be added. The substances concerned are the following:
- Tetraethyllead, toxic for reproduction (1a), used as an additive in aircraft fuels
- 4,4'-bis(dimethylamino)-4''- (methylamino)trityl alcohol (with ≥ 0,1% of Michler's ketone (EC No 202-027-5) or Michler's base (EC No 202-959-2)), carcinogenic (1b), used in printing inks
- Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl), endocrine disruptors with environmental effects, used in lubricants and greases
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia4-stannatetradecanoate (DOTE), reprotoxic properties used as stabiliser in polymers
- Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE et MOTE), reprotoxic properties, used as stabiliser in polymers.
These 5 substances of very high concern (SVHC) will be subject to authorisation once the decision has been formally adopted by the Member States, the European Parliament and the Council of Ministers. If these substances are indeed added to the authorisation list, the Latest Application Date should be 18 months after the entry into force of the decision, and the sunset date 36 months after the entry into force.
Consequences for the industry
If these substances are banned in Europe, companies using them will either have to find alternatives to these substances that can perform the same function but do not pose a danger to the environment or human health, or submit an authorisation dossier.
A permit application should be prepared well in advance to ensure that it is well done and maximises the chances of it being accepted by the relevant authorities.
Other decisions were postponed by the European Commission. A further 13 chemicals had been recommended by ECHA for inclusion in Annex XIV. These include the controversial BPA (endocrine disruptor) and dechlorane plus (very persistent and very bioaccumulative), which the Commission says were not retained because they will be subject to other regulatory restrictions.
EcoMundo's experts support you in the audits of your sites, in the design of your authorisation dossiers (analysis of alternatives, socio-economic analysis, chemical safety report) as well as in the implementation of your post-authorisation compliance.
Our teams have a 100% success rate in the dossiers they have submitted, and the requested authorisation durations have always been obtained, including for long periods (12 years)!
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