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EU REACH: WTO Draft on amendment of Authorisation List

FEBRUARY 2019 - Relevant for: Electrical and electronics, hardlines, softlines, toys and children's products

On 16 February 2019, the European Commission (EC) submitted a draft text1,2 to the World Trade Organization (WTO) to amend the Authorisation List (Annex XIV) of the REACH Regulation. There is a total of 12 substances of very high concern (SVHCs) to be included in the 6th update of Annex XIV. The total number of SVHCs listed in Annex XIV may increase from 43 to 55.

 

According to REACH Regulation Article (56), the substances which are listed in Annex XIV cannot be used or placed in the market unless the authorisation is granted. The European Chemicals Agency (ECHA) makes recommendation of priority substances to be included in Annex XIV3 about every two years. These priority substances are chosen from the SVHC Candidate List.

 

On 14 November 2016 and 5 February 2018, the ECHA submitted the 7th and the 8th recommendation of Annex XIV to the EC respectively. There were a total of 16 SVHCs included in both recommendations (i.e. 9 SVHCs in the 7th recommendation and 7 SVHCs in the 8th recommendation). From the WTO draft text, only 11 SVHCs which are listed in 7th and 8th recommendation were proposed by the EC to be included into Annex XIV. Another proposed SVHC was recommended by ECHA in the 5th recommendation which was submitted on 10 February 2014. Hence, there is a total of 12 SVHCs proposed to be included in the next update of Annex XIV.

 

Please see Table 1 below for the 12 proposed substances.

 

Table 1. The list of 12 SVHCs to be added into Annex XIV:

Entry #

Substance

CAS Number

Intrinsic Property(ies) referred to Article 57

Latest application date

Sunset date

44

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear

68515-50-4

Toxic for reproduction (category 1B)

Date of entry into force +18 months

Date of entry into force +36 months

45

Dihexyl phthalate

84-75-3 

Toxic for reproduction (category 1B)

Date of entry into force +18 months

Date of entry into force +39 months

46

1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)

68515-51-5; 68648-93-1

Toxic for reproduction (category 1B)

Date of entry into force +18 months

Date of entry into force +39 months

47

Trixylyl phosphate

25155-23-1

Toxic for reproduction (category 1B)

Date of entry into force +21 months

Date of entry into force +39 months

48

Sodium perborate; perboric acid, sodium salt

 -

Toxic for reproduction (category 1B)

Date of entry into force +21 months

Date of entry into force +39 months

59

Sodium peroxometaborate

7632-04-4

Toxic for reproduction (category 1B)

Date of entry into force +21 months

Date of entry into force +39 months

50

5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]

 -

vPvB

Date of entry into force +24 months

Date of entry into force +42 months

51

2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)

25973-55-1

PBT, vPvB

Date of entry into force +27 months

Date of entry into force +45 months

52

2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)

3864-99-1

vPvB

Date of entry into force +27 months

Date of entry into force +45 months

53

2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)

36437-37-3

vPvB

Date of entry into force +27 months

Date of entry into force +45 months

54

2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)

3846-71-7

PBT, vPvB

Date of entry into force +27 months

Date of entry into force +45 months

55

Diazene-1,2-dicarboxamide  (C,C'-azodi(formamide)) (ADCA)

123-77-3

Respiratory sensitising properties (Article 57(f) - human health)

Date of entry into force +36 months

Date of entry into force +54 months

Remark:

 

vPvB: very persistent and very bioaccumulative
PBT: persistent, bioaccumulative and toxic

 

[1] WTO draft text for amendment of REACH Authorisation List (Annex XIV) (Part 1)

[2] WTO draft text for amendment of REACH Authorisation List (Annex XIV) (Part 2)

[3] Dedicated webpage on the recommendation of Authoristaion List

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