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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 lipnja 2024. Database contains 4821 unique substances/entries.
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601-785-8
121552-61-2
Skin Sens. 1
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
-
-
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.
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
218-827-2
2244-16-8
Skin Sens. 1
432-960-5
124655-09-0
Acute Tox. 4
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
201-248-4
80-08-0
Acute Tox. 4
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
208-764-9
541-02-6
yes
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
-
1563-67-3
Acute Tox. 3
258-256-6
52918-63-5
Acute Tox. 3
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
213-052-6
919-86-8
Acute Tox. 3
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
-
-
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.
237-198-5
13684-56-5
Repr. 2
213-800-1
1014-69-3
Acute Tox. 4
204-424-9
120-78-5
Skin Sens. 1
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
950-299-5
-
yes
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
205-017-9
131-18-0
Repr. 1B
yes
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
205-016-3
131-17-9
Acute Tox. 4
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
206-373-8
333-41-5
Acute Tox. 4
206-382-7
334-88-3
Carc. 1B
200-181-8
53-70-3
Carc. 1B
205-878-0
189-64-0
Carc. 1B; Muta. 2
205-886-4
191-30-0
Carc. 1B; Muta. 2
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
215-125-8
1303-86-2
Repr. 1B
yes
200-824-2
74-95-3
Acute Tox. 4
201-557-4
84-74-2
Repr. 1B
yes
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
214-787-5
1194-65-6
Acute Tox. 4
202-564-5
97-17-6
Acute Tox. 4
214-118-7
1085-98-9
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-207-0
79-43-6
Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
200-838-9
75-09-2
Carc. 2
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
D-2,4-DP; DICHLORPROP-P; DUPLOSAN DP-ACID
403-980-1
15165-67-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
236-881-5
13530-68-2
yes
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
620-436-0
75736-33-3
Eye Irrit. 2
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
221-515-9
3129-91-7
Acute Tox. 4
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1

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