EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 19 dubna 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
(+/-)-(R*,R*)-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran; 6-fluoro-2-(2-oxiranyl)chromane
419-620-1
-
Skin Sens. 1
(2R*, 3S*)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (1R)-10-camphorsulfonate
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(C16 or C18-n-alkyl)(C16 or C18-n-alkyl)ammonium 2-((C16 or C18-n-alkyl)(C16 or C18-n-alkyl)carbamoyl)benzenesulphonate
OA 8523
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
(ethyl-1,2-ethanediyl)[-2-[[[(2-hydroxyethyl)methylamino]acetyl]-propyl]ω-(nonylphenoxy)poly]oxy-(methyl-1,2-ethanediyl)
TFA-4713
418-960-8
-
Skin Corr. 1B; Skin Sens. 1
(R)-1-cyclohexa-1,4-dienyl-1-methoxycarbonyl-methylammoniumchloride
444-320-2
-
Acute Tox. 4
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)3-(hydroxymethyl)benzonitrile hemisulfate
430-790-6
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(±)-4-(3-chlorophenyl)-6-[(4-chlorophenyl)hydroxy(1-methyl-1H-imidazol-5-yl)methyl]-1-methyl-2(1H)-quinolin
430-730-9
-
Eye Dam. 1
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof
-
-
yes
2,2-dialkyl-4-hydroxymethyl1,3-dioxolane; reaction products with ethylene oxide (alkyl is C1-12 and the sum to C13, average degree of ethoxylation is 3,5)
430-580-4
-
Skin Irrit. 2
2,5-dioxopyrrolidin-1-yl N-{[methyl[[2-(1-methylethyl)-4-thiazoly]methyl]amino]carbonyl}-L-Valinate
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers
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(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
799-970-2
-
yes
2-alkoyloxyethyl hydrogen maleate, where alkoyl represents (by weight 70 to 85 % unsaturated octadecoyl, 0.5 to 10 % saturated octadecoyl, and 2 to 18 % saturated hexadecoyl
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
4,4'-oxydianiline and its salts; p-aminophenyl ether
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-thiodianiline and its salts
-
-
Carc. 1B; Acute Tox. 4
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
-
-
yes
4-(3,4,5,6-tetramethyloctan-2-yl)phenol
-
-
yes
4-Heptylphenol, branched and linear
-
-
yes
4-Nonylphenol, branched and linear
-
-
yes
4-Nonylphenol, branched and linear, ethoxylated
-
-
yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
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]
-
-
yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
Absettarov
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Acanthamoeba castellani
-
-
P Parasites
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