ECHA Consults on Recommending 5 Substances for REACH Authorisation
Published: Author: Visits: 260

The European Chemicals Agency (ECHA) is considering recommending five substances for the REACH Authorisation List.

EU,REACH,Authorisation,Chemical,SVHC,Substance

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 substanceCAS No.SVHC-relevant intrinsic propertyVolume range in scope of authorisation (t/y)

Examples of uses in the

scope of authorisation

Melamine108-78-1Equivalent 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/yUse 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/yUse 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)255881-94-8PBT (Article 57d)100 -<1,000 t/yUse in lubricants and greases e.g. in vehicles or machinery
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide75980-60-8Toxic for reproduction (Article 57 c)1,000 -<10,000 t/yUse as photoinitiator in UV curable inks, coatings and adhesives
Barium diboron tetraoxide13701-59-2Toxic for reproduction (Article 57c)100 -<1,000 t/yUse 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 arrangementsExempted usesReview periods
Last application dateSunset 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;

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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.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.

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