the european chemicals agency (echa) is considering recommending five substances for the reach authorisation list.
these five substances cover:
- melamine;
- bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (tbph);
- s-(tricyclo[5.2.1.0 2,6]deca-3-en-8(or 9)-yl) o-(isopropyl or isobutyl or 2-ethylhexyl) o-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate;
- diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; and
- barium diboron tetraoxide.
moreover, echa is also inviting comments regarding the implications of adding a new hazard to dibutyl phthalate (dbp) which is already on the authorisation list.
the consultations are open until 7 may 2024.
details are as follows:
| name of substance | cas no. | svhc-relevant intrinsic property | volume range in scope of authorisation (t/y) | examples of uses in the scope of authorisation |
|---|---|---|---|---|
| melamine | 108-78-1 | equivalent level of concern having probable serious effects to human health (article 57(f) - human health). equivalent level of concern having probable serious effects to the environment (article 57(f) - environment) | ＞10,000 t/y | use as additive in foams and coatings, use in resins |
| bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (tbph) | - | vpvb (article 57e) | 100 -1,000 t/y | use in the production of rubber articles, in plastics, in adhesives and sealants, in foam |
| bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (tbph) | 255881-94-8 | pbt (article 57d) | 100 -＜1,000 t/y | use in lubricants and greases e.g. in vehicles or machinery |
| diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | 75980-60-8 | toxic for reproduction (article 57 c) | 1,000 -＜10,000 t/y | use as photoinitiator in uv curable inks, coatings and adhesives |
| barium diboron tetraoxide | 13701-59-2 | toxic for reproduction (article 57c) | 100 -＜1,000 t/y | use in coatings and paints, thinners, paint removers |
a new hazard added to dibutyl phthalate (dbp) (cas: 84-74-2):
| substance | intrinsic property(ies) referred to in article 57 | transitional arrangements | exempted uses | review periods | |
|---|---|---|---|---|---|
| last application date | sunset date | ||||
| dibutyl phthalate (dbp) cas: 84-74-2 ec: 201-557-4 | toxic for reproduction (category 1b) endocrine disrupting properties (article 57(f) - human health) endocrine disrupting properties (article 57(f) - environment) | (a) 21 august 2013 (*) (b) by way of derogation from point (a): 14 june 2023 for uses in: — immediate packaging of medicinal products covered under regulation (ec) no 726/2004, directive 2001/82/ec, and/or directive 2001/83/ec; — mixtures containing dbp at or above 0,1 % and below 0,3% weight by weight. (c) by way of derogation from points (a) and (b): [18 months after entry into force] for uses in: − food contact materials within the scope of regulation (ec) no 1935/2004 ; − medical devices regulated by directive 90/385/eec*, directive 93/42/eec* or directive 98/79/ec** or regulation 2017/745 and regulation 746/746; | (a) 21 february 2015 (**) (b) by derogation of point (a): 14 december 2024 for uses in: — immediate packaging of medicinal products covered under regulation (ec) no 726/2004, directive 2001/82/ec, and/or directive 2001/83/ec; — mixtures containing dbp at or above 0,1 % and below 0,3 % weight by weight. (c) by derogation of points (a) and (b): [36 months after entry into force] for uses in: − food contact materials within the scope of regulation (ec) no 1935/2004; − medical devices regulated by directive 90/385/eec*, directive 93/42/eec* or directive - 2 98/79/ec** or regulation 2017/745 and regulation 746/746; | - | - |
note: changes under consideration are written in red.
cirs warmly reminds that if a substance is included in the authorisation list, it cannot be placed on the market or used after a given date unless an authorisation is granted for a specific use. companies that are using, manufacturing or importing these substances can apply for authorisation.
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