ECHA Consults on Recommending 5 Substances for REACH Authorisation - Regulatory News - Chemicals

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.

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

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