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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 January 2022. Database contains 4812 unique substances/entries.
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AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
257-187-9
51414-25-6
Skin Sens. 1A
424-170-4
130603-71-3
Skin Sens. 1
402-540-6
105254-85-1
Skin Corr. 1B; Skin Sens. 1
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
620-041-3
907204-31-3
Lact.
401-950-2
31506-43-1
Eye Dam. 1
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
208-293-9
520-45-6
Acute Tox. 4
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
205-057-7
132-32-1
Carc. 1B
204-473-6
121-47-1
Acute Tox. 4
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
209-711-2
591-27-5
Acute Tox. 4
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-680-9
109-55-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
426-750-2
151860-15-0
Skin Sens. 1
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
203-582-6
108-43-0
Acute Tox. 4
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-580-5
108-41-8
Acute Tox. 4
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
213-923-0
1067-08-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
428-700-5
1873-90-1
Acute Tox. 4
413-910-1
95718-78-8
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1

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