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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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201-990-9
90-41-5
Carc. 2; Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
201-956-3
89-98-5
Skin Corr. 1B
201-944-8
89-83-8
Acute Tox. 4; Skin Corr. 1B
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
201-622-7
85-68-7
Repr. 1B
yes
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
201-599-3
85-34-7
Acute Tox. 4
201-581-5
85-01-8
yes
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
201-559-5
84-75-3
Repr. 1B
yes
201-557-4
84-74-2
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
201-549-0
84-65-1
Carc. 1B
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
201-435-0
82-68-8
Skin Sens. 1
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
201-378-1
81-82-3
STOT RE 2
201-377-6
81-81-2
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
201-328-9
81-14-1
Carc. 2
201-297-1
80-62-6
Flam. Liq. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
201-289-8
80-54-6
Repr. 1B
yes
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
201-280-9
80-46-6
yes
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
201-248-4
80-08-0
Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-207-0
79-43-6
Skin Corr. 1A
201-204-4
79-41-4
Acute Tox. 4; Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
201-196-2
79-33-4
Skin Corr. 1C; Eye Dam. 1
201-195-7
79-31-2
Acute Tox. 4
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
201-187-3
79-22-1
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
201-185-2
79-20-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
201-182-6
79-16-3
Repr. 1B
yes
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
201-176-3
79-09-4
Skin Corr. 1B
201-175-8
79-08-3
Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
201-162-7
78-96-6
Skin Corr. 1B
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
201-134-4
78-70-6
Skin Sens. 1B
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-123-4
78-57-9
Acute Tox. 4
201-114-5
78-40-0
Acute Tox. 4
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-075-4
78-00-2
yes
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
201-025-1
77-40-7
yes
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
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
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
200-927-2
76-03-9
Skin Corr. 1A
200-925-1
76-01-7
Carc. 2; STOT RE 1
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
200-915-7
75-91-2
Muta. 2
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-898-6
75-75-2
Skin Corr. 1B
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
200-857-2
75-28-5
Flam. Gas 1; Press. Gas
200-857-2
75-28-5
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
200-854-6
75-25-2
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-849-9
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
200-848-3
75-20-7
Water-react. 1
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-842-0
75-12-7
Repr. 1B
yes
200-838-9
75-09-2
Carc. 2
200-837-3
75-08-1
Flam. Liq. 2; Acute Tox. 4
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
200-825-8
74-96-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4
200-824-2
74-95-3
Acute Tox. 4
200-822-1
74-93-1
Flam. Gas 1; Press. Gas; Acute Tox. 3
200-821-6
74-90-8
Acute Tox. 2; Acute Tox. 1
200-821-6
74-90-8
Flam. Liq. 1; Acute Tox. 2
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
200-819-5
74-88-4
Carc. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 3; Skin Irrit. 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
200-815-3
74-85-1
Flam. Gas 1; Press. Gas; STOT SE 3
200-814-8
74-84-0
Flam. Gas 1; Press. Gas
200-813-2
74-83-9
Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-812-7
74-82-8
Flam. Gas 1; Press. Gas
200-806-4
74-31-7
Skin Sens. 1
200-775-7
72-20-8
Acute Tox. 2; Acute Tox. 3
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
200-756-3
71-55-6
Acute Tox. 4
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
200-753-7
71-43-2
Flam. Liq. 2; Carc. 1A; Muta. 1B; STOT RE 1; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-751-6
71-36-3
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
200-733-8
70-30-4
Acute Tox. 3
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-659-6
67-56-1
Flam. Liq. 2; Acute Tox. 3; STOT SE 1
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
200-629-2
66-71-7
Acute Tox. 3
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-590-1
64-69-7
Acute Tox. 3; Skin Corr. 1A
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
200-579-1
64-18-6
Skin Corr. 1A
200-578-6
64-17-5
Flam. Liq. 2
200-573-9
64-02-8
Acute Tox. 4; Eye Dam. 1
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1

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