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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 January 2022. Database contains 4812 unique substances/entries.
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400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
204-455-8
121-21-1
Acute Tox. 4
204-462-6
121-29-9
Acute Tox. 4
402-770-7
92585-24-5
Skin Sens. 1
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
444-970-7
-
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
210-843-8
624-41-9
Flam. Liq. 3
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-449-0
2438-20-2
Flam. Liq. 3
209-512-0
583-59-5
Acute Tox. 4
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
211-765-7
693-98-1
Repr. 1B
yes
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
210-256-7
611-15-4
Acute Tox. 4
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
205-182-7
135-19-3
Acute Tox. 4
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
209-474-5
581-89-5
Carc. 1B
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
411-810-2
1570-95-2
Eye Dam. 1
423-460-8
3508-98-3
Acute Tox. 4
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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