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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 lipnja 2024. Database contains 4821 unique substances/entries.
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210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
202-433-2
95-57-8
Acute Tox. 4
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
202-424-3
95-49-8
Acute Tox. 4
423-740-1
10461-98-0
Acute Tox. 4
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
431-400-7
57374-49-9
Skin Sens. 1
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-542-8
108-01-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
202-621-4
97-95-0
Acute Tox. 4
202-377-9
94-96-2
Eye Dam. 1
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
205-743-6
149-57-5
Repr. 2
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
260-828-5
57583-34-3
Repr. 2
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
231-057-1
7425-14-1
Repr. 2
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
444-860-9
474510-57-1
STOT RE 2
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
430-800-9
129228-21-3
Skin Irrit. 2

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