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ECHA Inashauriana Kuhusu Kupendekeza Dawa 5 kwa Uidhinishaji wa REACH

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 Mei 2024

Maelezo ni kama ifuatavyo:

Name of substanceCAS NoSVHC-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
Bariamu diboroni tetraoksidi13701-59-2Toxic 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):

SubstanceIntrinsic property(ies) referred to in Article 57Mipango ya mpitoExempted usesReview periods
Tarehe ya mwisho ya kutuma maombiSunset date
Phthalate ya Dibutyl
(DBP)
C
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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