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).

EU CLP (1272/2008)
Carc. 1B

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Group members
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Name EC / List no. CAS no. Association
Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 200-786-7 72-57-1 Expert judgement
Disodium 3,3'-((3,3'-dimethyl(1,1'-biphenyl)-4,4'-diyl)bis(azo)bis(4-aminonaphthalene-1-sulphonate) 213-594-3 992-59-6 Expert judgement
Benzamide, 3,3'-((3,3'-dimethyl(1,1'-biphenyl)-4,4'-diyl)bis(imino(1-acetyl-2-oxo-2,1-ethanediyl)-2,1-diazenediyl))bis(4-methyl- - 64441-14-1 Expert judgement
3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bis[bis(3-aminopropyl)(p-methoxybenzyl)methylammonium] dichloride 255-154-3 40948-42-3 Expert judgement
2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide] 228-789-9 6358-88-9 Expert judgement
2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] 268-048-7 67990-27-6 Expert judgement
Tetrasodium 6,6'-((3,3'-dimethyl-(1,1'-biphenyl-4,4'diyl)bis(azo)bis(4-amino-5-hydroxy-1,3-naphthalenedisulphonate) 206-242-5 314-13-6 Expert judgement
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(3-hydroxynaphthalene-2-carboxamide) 223-007-2 3692-05-5 Expert judgement
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide] 227-783-3 5979-28-2 Expert judgement
Disodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-diamino-5-methylbenzenesulphonate] 229-024-1 6405-94-3 Expert judgement
Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydroxynaphthalene-2,7-disulphonate] 218-432-5 2150-54-1 Expert judgement
2,2'-[(3,3'-dimethyl-4,4'-biphenylylene)bis(azo)]bis[4-(1,1,3,3-tetramethylbutyl)phenol] 230-616-7 7218-82-8 Expert judgement
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide], disodium salt 271-328-1 68540-94-3 Expert judgement
N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide) 202-111-1 91-96-3 Expert judgement