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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
220-630-1
2840-00-8
Acute Tox. 4
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
218-951-7
2300-66-5
Eye Irrit. 2
225-918-0
5146-66-7
Muta. 1B
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
427-370-1
164288-56-6
Eye Dam. 1
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1

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