9th a recommendation Annex XIV REACH October 2019: ECHA proposes 18 substances for authorisation
ECHA/PR/19/14
18 substances of very high concern (SVHCs) are recommended to be added to the REACH Authorisation List.
Helsinki, 1 October 2019 – ECHA's ninth recommendation to the European Commission to prioritise substances of very high concern for authorisation includes 18 substances. Thirteen of these substances are toxic for reproduction, of which one has also endocrine disrupting properties. The other substances are an endocrine disruptor, a carcinogen, a very persistent and very bioaccumulative (vPvB) substance and two respiratory sensitisers.
The substances have been prioritised from the Candidate List because of their intrinsic properties in combination with high volume and widespread uses, which may pose a threat to human health or the environment. Some of these substances are currently not used in the EU but could replace other substances recommended for the Authorisation List (Annex XIV). Their inclusion should avoid regrettable substitution.
ECHA organised a public consultation on the draft recommendation between September and December 2018. The Member State Committee (MSC) considered the comments received and adopted its opinion on 26 June 2019.
ECHA took into account the comments and registration updates as well as the MSC's opinion when deciding on the substances now recommended to be added to the REACH Authorisation List and for proposing the related latest application and sunset dates. All substances that underwent public consultation are included in the final recommendation.
The final decision on the inclusion of the substances in the Authorisation List and on the dates by which companies will need to apply for authorisation to ECHA will be taken by the European Commission in collaboration with the Member States and the European Parliament.
List of substances included in the ninth recommendation, including examples of their uses in the scope of authorisation
|
# |
Substance name |
SVHC-relevant intrinsic property |
Examples of uses in the scope of authorisation |
|
1 |
4,4'-isopropylidenediphenol (Bisphenol A; BPA) |
Toxic for reproduction, Endocrine disrupting properties - human health and environment |
Epoxy resin hardeners |
|
2 |
1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca- 7,15-diene (“Dechlorane Plus”™) |
vPvB |
Flame retardant in adhesives and polymers |
|
3 |
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 disrupting properties - environment |
Lubricants and greases |
|
4 |
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5- dithia-4-stannatetradecanoate (DOTE) |
Toxic for reproduction |
Stabiliser in polymers |
|
5 |
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 and MOTE) |
Toxic for reproduction |
Stabiliser in polymers |
|
6 |
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 |
Printing inks |
|
7 |
Dioxobis(stearato)trilead |
Toxic for reproduction |
Stabiliser in PVC |
|
8 |
Fatty acids, C16-18, lead salts |
Toxic for reproduction |
Stabiliser in PVC |
|
9 |
Trilead dioxide phosphonate |
Toxic for reproduction |
Stabiliser in PVC; rubber production; mirror backing |
|
10 |
Sulfurous acid, lead salt, dibasic |
Toxic for reproduction |
1) |
|
11 |
[Phthalato(2-)]dioxotrilead |
Toxic for reproduction |
1) |
|
12 |
Trilead bis(carbonate) dihydroxide |
Toxic for reproduction |
Artists’ paints |
|
13 |
Lead oxide sulfate |
Toxic for reproduction |
Mirror backing |
|
14 |
Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] (HHPA) |
Respiratory sensitising properties |
Epoxy resin hardeners |
|
15 |
Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] (MHHPA) |
Respiratory sensitising properties |
Epoxy resin hardeners |
|
16 |
Tetraethyllead |
Toxic for reproduction |
Additive in aviation fuel |
|
17 |
2-methoxyethanol |
Toxic for reproduction |
Solvent |
|
18 |
2-ethoxyethanol |
Toxic for reproduction |
Solvent |
1) The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilisers in some of their uses. This is to avoid regrettable substitution.
Collegati