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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 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;	-	-

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.

[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.

[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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ECHA Consults on Recommending 5 Substances for REACH Authorisation