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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 April 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
(1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
95342-41-9
yes
(1R,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-21-0
yes
(1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
741687-98-9
yes
(1S,2S,5R,6R,9S,10S,13R,14R)-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
-
135821-03-3
yes
(1S,2S,5S,6S,9R,10R,13R,14R)-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
-
135821-74-8
yes
(1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-30-1
yes
(1S,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-25-4
yes
(2R)-3-(4-tert-Butylphenyl)-2-methylpropanal
-
75166-31-3
yes
(2S)-3-(4-tert-Butylphenyl)-2-methylpropanal
-
75166-30-2
yes
(R)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (0-20 %)
-
178961-20-1
Skin Sens. 1
1,1-dimethyl-3-phenyluronium trichloroacetate; fenuron-TCA
-
4482-55-7
Skin Irrit. 2
1,2,3,4-tetranitrocarbazole
-
6202-15-9
Expl. 1.1; Acute Tox. 4
1,2-dimethylhydrazine
-
540-73-8
Carc. 1B; Acute Tox. 3
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
1-(3,4-dichlorophenylimino); thiosemicarbazide
-
5836-73-7
Acute Tox. 2
2,2-dichlorovinyl 2-ethylsulphinylethyl methyl phosphate
-
7076-53-1
Acute Tox. 3
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin
-
1065124-65-3
Acute Tox. 4; STOT SE 2
2,3-epoxypropyl-2-ethylcyclohexyl ether; ethylcyclohexylglycidyl ether
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,4,5-trimethylaniline hydrochloride
-
21436-97-5
Carc. 1B; Acute Tox. 3
2,7-naphthalenedisulfonic acid, nickel(II) salt
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
3-chloro-6-cyano-bicyclo(2,2,1)heptan-2-one-O-(N-methylcarbamoyl)oxime; triamid
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
3-methylpyrazol-5-yl-dimethylcarbamate; monometilan
-
2532-43-6
Acute Tox. 3
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
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