EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Carc. 1B

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:2:2) - 75659-73-3 Expert judgement
3,3'-(3,3'-dimethoxy-4,4'-biphenylene)bis(2,5-diphenyl-2H-tetrazolium) chloride 217-488-8 1871-22-3 Expert judgement
Butanamide, 2,2'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(N-(chlorophenyl)-3-oxo- - 72845-99-9 Expert judgement
3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)diazo]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, sodium salt, compound with 2,2'-iminodiethanol 273-433-8 68966-43-8 Expert judgement
Tetrasodium 4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxynaphthalene-2,7-disulphonate] 265-533-5 65151-33-9 Expert judgement
Tetralithium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 275-603-7 71550-22-6 Expert judgement
3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)diazo]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, sodium salt 273-439-0 68966-50-7 Expert judgement
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one] 229-986-2 6883-91-6 Expert judgement
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxy-N-phenylnaphthalene-2-carboxamide] 233-354-1 10127-03-4 Expert judgement
5,5'-diphenyl-3,3'-bis(4-nitrophenyl)-2,2'-(3,3'-dimethoxybiphenyl-4,4'-ylene)ditetrazolium dichloride 206-067-4 298-83-9 Expert judgement
3,3'-dihydroxy-N,N'-(3,3'-dimethoxybiphenyl-4,4'-diyl)di-2-naphthamide 202-108-5 91-92-9 Expert judgement
Tetrasodium 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[azo(2-amino-5-hydroxy-7-sulphonato-6,1-naphthylene)azo]]bis[5-nitrobenzoate] 274-429-9 70210-33-2 Expert judgement
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide] 229-388-1 6505-28-8 Expert judgement
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chlorophenyl)-3-oxobutyramide] 241-469-3 17453-73-5 Expert judgement
Disodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis(4-hydroxynaphthalene-1-sulphonate) 219-382-7 2429-71-2 Expert judgement
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:1:3) - 75659-72-2 Expert judgement
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:3:1) - 75752-17-9 Expert judgement
6,6'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-5-hydroxynaphthalene-1,3-disulphonic] acid 223-333-5 3841-14-3 Expert judgement
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-(acetylamino)-4-hydroxynaphthalene-2,7-disulphonate] 267-711-8 67906-44-9 Expert judgement
2-Naphthalenecarboxamide, N,N'-(3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(3-hydroxy-, disodium salt - 52735-88-3 Expert judgement
5,5'-(3,3'-Dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(1-(4-nitrophenyl)-3-phenylformazan) - 63469-14-7 Expert judgement
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide] 226-614-0 5437-88-7 Expert judgement
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydroxynaphthalene-2,7-disulphonate] 224-091-3 4198-19-0 Expert judgement
3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[5-[4-(aminothioxomethyl)phenyl]-2-(p-nitrophenyl)-2H-tetrazolium] dichloride 253-257-8 36889-43-7 Expert judgement
1-Naphthalenesulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(4-hydroxy-, lithium sodium salt (1:1:1) - 75673-35-7 Expert judgement
1-Naphthalenesulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(4-hydroxy-, lithium salt (1:2) - 75673-34-6 Expert judgement
Tetrasodium 6,6'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-5-hydroxynaphthalene-1,3-disulphonate] 220-026-8 2610-05-1 Expert judgement
Disodium 2,2'-[(3,3'-dimethoxy-4,4'-biphenylylene)bis[azo(methylimino)]]di(ethanesulphonate) 241-085-6 17011-51-7 Expert judgement
Disodium 4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[iminocarbonyl(2-hydroxy-4,1-phenylene)azo]]bis(3-hydroxynaphthalene-1-sulphonate) 274-498-5 70247-69-7 Expert judgement
Benzoic acid, 4,4'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl(2-acetyl-1-oxo-2,1-ethanediyl)imino))bis-, 1,1'-dibutyl ester - 820212-95-1 Expert judgement
3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[2,5-bis(p-nitrophenyl)-2H-tetrazolium] dichloride 214-665-1 1184-43-6 Expert judgement
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one] 229-389-7 6505-29-9 Expert judgement
Copper, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-2,7-naphthalenedisulfonate) morpholine ammonium lithium sodium complexes - 96591-22-9 Expert judgement
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] 229-920-2 6837-37-2 Expert judgement
N,N'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide] 223-873-1 4104-12-5 Expert judgement
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide] 230-458-9 7147-42-4 Expert judgement
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 219-385-3 2429-74-5 Expert judgement