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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 March 2024. Database contains 4821 unique substances/entries.
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201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
822-682-6
1417782-03-6
Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
428-230-0
79568-06-2
STOT RE 2
222-048-3
3327-22-8
Carc. 2
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
444-350-6
133413-70-4
Eye Irrit. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
692-456-8
688046-61-9
Carc. 2
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
433-490-3
6563-83-3
Skin Sens. 1
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(2-BENZOTHIAZOLYLTHIO)BERNSTEINSÄURE; BTTBS; HALOX 650; IRGACOR 252
401-450-4
95154-01-1
Skin Sens. 1
OA 8523
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
616-221-6
7541-49-3
Skin Irrit. 2
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-678-2
5932-68-3
Skin Sens. 1A
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
429-900-5
82356-51-2
Skin Sens. 1
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
NCC ETHER
406-100-4
94097-88-8
Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
MEXORYL SX; SX 32
410-960-6
92761-26-7
Eye Dam. 1
TFA-4713
418-960-8
-
Skin Corr. 1B; Skin Sens. 1
AOC 1020X
402-370-2
149057-70-5
Flam. Liq. 3; Eye Dam. 1
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
TICA 118
422-200-0
178277-55-9
Skin Corr. 1B; Acute Tox. 4
ETILEFRONE. HCL
401-840-4
55845-90-4
Eye Dam. 1

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