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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 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
diniconazole (ISO);(E)-β-[(2,4-dichlorophenyl)methylene]-α-(1,1-dimethylethyl)-1H—1,2,4-triazol-1- ethanol;(E)-(RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2-(1H—1,2,4- triazol-1-yl)pent-1-en-3-ol
617-485-5
76714-88-0
Acute Tox. 4
bifenthrin (ISO); (2-methylbiphenyl-3-yl)methylrel-(1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
benfuracarb (ISO); ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-β-alaninate
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
clomazone (ISO); 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one
617-258-0
81777-89-1
Acute Tox. 4
glyphosate-trimesium; glyphosate-trimethylsulfonium
617-243-9
81591-81-3
Acute Tox. 4
imazapyr (ISO);2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H- imidazol-2-yl]-3-pyridine carboxylate
617-219-8
81334-34-1
Eye Irrit. 2
sabadilla (ISO);veratrine
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
bordeaux mixture; reaction products of copper sulphate with calcium dihydroxide
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
fluazinam (ISO); 3-chloro-N-[3- chloro-2,6-dinitro-4-(trifluor omethyl)phenyl]-5-(trifluoromethyl)pyridin-2-amine
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
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