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Registrants should get ready to comment substance evaluation draft decisions

ECHA/NA/14/15

Draft decisions on requests for further information about those substances evaluated under the Community rolling action plan (CoRAP) in 2013 will be sent to the registrants for comments at the end of April. 

Helsinki, 3 April 2014 – In 2013, Member States have been evaluating 47 registered substances under the substance evaluation process and they have also prepared a draft decision in case further information is needed in order to assess the safety of the substance. The deadline for submitting a draft decision to ECHA was on 20 March 2014. ECHA has now received draft decisions on 37 substances, and the registrants should get ready to give their consolidated comments on the draft decisions addressed to them. ECHA plans to send out the draft decisions to the relevant registrants in week 18, 28 April – 2 May 2014. As foreseen by REACH, registrants of these substances will have 30 days to consider and submit their joint or individual comments. A notification letter will contain the deadline by when the comments must be submitted. This deadline will include an extra seven-day period as addressed in the latest update of point 9(d) of the Terms and Conditions of REACH-IT.

The registrants receiving a draft decision on substance evaluation will be those with active registrations on a substance on the date when the draft for the decision is first sent. However, two categories of registrants will be excluded, i.e. registrants who exclusively use the substance as an on-site isolated intermediate and under strictly controlled conditions, and those who have ceased or will still cease manufacture/import of the substance in accordance with Article 50(3) of REACH before the decision is adopted by ECHA.

The 37 substances and the evaluating Member States are listed below.

For one substance, 1,4-benzenediamine, N,N'-mixed phenyl and tolyl derivs. (EC 273-227-8) examined by Germany, which was exceptionally added to the CoRAP on 1 July 2013, the Member State's deadline for submitting a draft decision to ECHA is 1 July 2014 and this draft decision is not yet available to ECHA. Registrants of that substance will be informed directly by ECHA.

For nine substances there are no draft decisions. In such cases the evaluating Member State has been asked to submit a conclusion document according to Article 48 of REACH normally within four months from the end of the evaluation period. When available and cleared for confidential information the documents will be published.

 

TABLE 1
Substances evaluated in 2013 with a draft decision.

#

  

Member State

EC number

CAS number

Substance name

Draft decision

1

AT

203-570-0

108-30-5

succinic anhydride

yes

2

BE

700-403-8

Not available

ammonium salts of mono- and bis[3,3,4,4,5,5,6,6,7,7,
8,8,8-tridecafluorooctyl and/or poly (substituted alkene)] phosphate

yes

3

BE

700-427-9

Not available

mono- and/or di- and/or tri(1-phenylethyl)-m-cresol and p-cresol

yes

4

DK

204-337-6

119-61-9

benzophenone

yes

5

DK

249-204-3

28768-32-3

4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline] 

yes

6

DK

'500-097-4

'37353-75-6

'4,4'-Propane-2,2-diyldiphenol, polymer with 2-methyloxirane

yes

7

EE

202-966-0

101-68-8

4,4'-methylenediphenyl diisocyanate

yes

8

FI

203-624-3

108-87-2

methylcyclohexane

yes

9

FR

200-843-6

75-15-0

carbon disulphide

yes

10

FR

201-126-0

78-59-1

3,5,5-trimethylcyclohex-2-enone

yes

11

FR

202-112-7

91-97-4

3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate

yes

12

FR

204-077-3

115-27-5

1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride

yes

13

FR

247-759-6

26523-78-4

tris(nonylphenyl)phosphite

yes

14

FR/NL

200-001-8

50-00-0

formaldehyde

yes

15

DE

203-726-8

109-99-9

tetrahydrofuran

yes

16

DE

'225-625-8

'4979-32-2

'N,N-dicyclohexylbenzothiazole-2-sulphenamide

yes

17

DE

253-781-7

38103-06-9

4,4'-[(isopropylidene)bis (p-phenyleneoxy)]diphthalic dianhydride

yes

18

HU

202-425-9

95-50-1

1,2-dichlorobenzene

yes

19

IE

'219-207-4

'2386-87-0

'7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo [4.1.0]heptane-3-carboxylate

yes

20

IT

210-382-2

614-45-9

tert-butyl perbenzoate

yes

21

IT

217-421-2

1843-05-6

octabenzone

yes

22

IT

249-044-4

28472-97-1

diisodecyl azelate

yes

23

PL

202-626-1

98-00-0

furfuryl alcohol

yes

24

PT

202-163-5

92-52-4

biphenyl

yes

25

SK

448-020-2

not available

mixture of two components: 1. N-(1,3- dimethylbutyl)-N´- phenyl-p-phenylenediamine 2. N1-(1,3-dimethylbutyl)- N4-(4-(1-methyl-1- phenylethyl)phenyl)ben zene-1,4-diamine

yes

26

ES

205-016-3

131-17-9

diallyl phthalate

yes

27

ES

247-660-8

26401-35-4

diisotridecyl adipate

yes

28

SE

205-480-7

141-32-2

butyl acrylate

yes

29

SE

214-685-0

1185-55-3

trimethoxy(methyl)silane

yes

30

SE

'220-449-8

'2768-02-7

'trimethoxyvinylsilane

yes

31

SE

254-052-6

38640-62-9

bis(isopropyl)naphthalene

yes

32

NL

272-234-3 

68784-26-9

phenol, dodecyl-, sulfurized, carbonates, calcium salts, overbased      

yes

33

NL

700-161-3

not available

Reaction mass of mixed (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphates, ammonium salt

yes

34

UK

200-889-7

75-65-0

2-methylpropan-2-ol

yes

35

UK

'202-908-4

'101-02-0

'triphenyl phosphite

yes

36

UK

203-312-7

105-59-9

2,2'-methyliminodiethanol

yes

37

UK

203-492-7

107-46-0

hexamethyldisiloxane

yes

 

DE

273-227-8

68953-84-4

1,4-Benzenediamine, N,N'-mixed phenyl and tolyl derivs.

Not yet known

 

TABLE 2
Substances evaluated in 2013 without a draft decision

#

  

Member State

EC number

CAS number

Substance name

Draft decision

1

AT

203-571-6

108-31-6

maleic anhydride

no

2

CZ

'203-820-9

'110-97-4

'1,1'-iminodipropan-2-ol

no

3

DE

202-496-6

96-29-7

butanone oxime

no

4

DE

205-736-8

149-30-4

benzothiazole-2-thiol

no

5

DE

231-150-7 

7440-41-7

beryllium

no

6

LV

204-825-9

127-18-4

Tetrachloroethylene

no

7

PL

203-812-5

110-88-3

1,3,5-trioxane

no

8

RO

231-944-3

7779-90-0 

trizinc bis(orthophosphate) 

no

9

SI

'931-384-6 

'NS

'Reaction products of bis(4-methylpentan-2-yl)
dithiophosphoric acid with phosphorus oxide, propylene oxide and amines, C12-14-alkyl (branched)

no