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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 21 lipnja 2024. Database contains 4821 unique substances/entries.
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603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
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B Bacteria and similar species
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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.
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
605-127-0
158062-67-0
Acute Tox. 4
274-125-6
69806-50-4
Repr. 1B
616-669-2
79241-46-6
Repr. 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
253-703-1
37893-02-0
Eye Irrit. 2
-
4301-50-2
Acute Tox. 1; Acute Tox. 2
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
600-425-7
103361-09-7
Repr. 2
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B Bacteria and similar species
231-954-8
7782-41-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1A
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-
Acute Tox. 2
205-631-7
144-49-0
Acute Tox. 2
240-898-3
16872-11-0
Skin Corr. 1B
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-
Acute Tox. 4
241-034-8
16961-83-4
Skin Corr. 1B
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
243-547-2
20153-50-8
Acute Tox. 4
243-546-7
20153-49-5
Acute Tox. 4
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
276-439-9
72178-02-0
Acute Tox. 4
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
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F Fungi
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F Fungi
A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-225-7
93924-31-3
Flam. Gas 1; Press. Gas; Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-226-2
93924-32-4
Flam. Gas 1; Press. Gas; Carc. 1B
295-394-6
92045-12-0
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
265-171-8
64742-67-2
Carc. 1B
614-346-0
68157-60-8
Carc. 2
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
294-145-9
91673-30-2
Skin Sens. 1
244-879-0
22259-30-9
Acute Tox. 2; Skin Sens. 1

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