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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
442-860-3
87333-22-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
JE 127
421-220-7
144740-59-0
Skin Sens. 1
LUGALVAN ES 9571
420-940-9
15768-07-7
Eye Irrit. 2; Skin Irrit. 2
443-120-2
393509-79-0
Eye Dam. 1
MEFAT
404-130-2
105560-93-8
Eye Dam. 1; Skin Sens. 1
620-362-9
1918-18-9
Acute Tox. 4
G 18-1108
403-270-1
6386-39-6
Acute Tox. 4
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
250-366-2
30864-28-9
Acute Tox. 4; Skin Sens. 1
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
425-190-6
119916-05-1
STOT RE 2
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
BROMBENZOAT; BROMOBENZOATE
410-310-1
70264-94-7
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
201-185-2
79-20-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-299-8
105-45-3
Eye Irrit. 2
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
202-500-6
96-33-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-501-1
96-34-4
Flam. Liq. 3; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-187-3
79-22-1
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-481-7
107-31-3
Flam. Liq. 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-819-5
74-88-4
Carc. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 3; Skin Irrit. 2
210-866-3
624-83-9
Flam. Liq. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; Resp. Sens. 1; Skin Sens. 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
209-132-5
556-61-6
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
201-297-1
80-62-6
Flam. Liq. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
414-460-9
105726-67-8
Acute Tox. 4
209-060-4
554-12-1
Flam. Liq. 2; Acute Tox. 4
204-317-7
119-36-8
Repr. 2; Acute Tox. 4; Skin Sens. 1B
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
203-475-4
107-25-5
Flam. Gas 1; Press. Gas
F5384
401-340-6
83055-99-6
Skin Sens. 1
236-035-5
13108-52-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N 5297
419-010-5
112941-26-1
Acute Tox. 4; Eye Irrit. 2
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
209-765-7
592-62-1
Carc. 1B; Repr. 1B
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
203-624-3
108-87-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
228-652-3
6317-18-6
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
200-471-4
60-34-4
Carc. 1B
204-064-2
115-09-3
Carc. 2; Repr. 1A; Lact.; Acute Tox. 2; STOT RE 1

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