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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 April 2024. Database contains 4821 unique substances/entries.
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253-855-9
38260-54-7
Acute Tox. 4
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
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
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
219-732-9
2514-53-6
Skin Irrit. 2
200-815-3
74-85-1
Flam. Gas 1; Press. Gas; STOT SE 3
209-940-8
598-56-1
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
MCDPAE
406-580-5
52460-86-3
Skin Irrit. 2
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
203-291-4
105-37-3
Flam. Liq. 2
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
210-903-3
625-58-1
Unst. Expl.
434-630-6
60372-77-2
Eye Dam. 1
244-845-5
22212-55-1
Acute Tox. 4
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
208-778-5
541-41-3
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-294-0
105-39-5
Acute Tox. 3
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
422-360-1
100491-29-0
Skin Sens. 1
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
LUPEROX 533
403-320-2
67567-23-1
Org. Perox. D; Flam. Liq. 3
ECPA
427-630-2
99469-99-5
Eye Dam. 1
230-391-5
7085-85-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
266-362-9
66441-23-4
Skin Sens. 1
EPSI
410-220-2
77375-79-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
429-220-9
132584-17-9
Skin Sens. 1
3-NITROBENZYLIDENETHYLESTER
404-490-0
39562-16-8
Eye Dam. 1; Skin Sens. 1
414-920-9
60658-04-0
Acute Tox. 3; STOT RE 1; Skin Sens. 1

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