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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 November 2021. Database contains 4812 unique substances/entries.
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227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
418-570-8
25383-07-7
Repr. 2
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
421-830-3
49805-30-3
Acute Tox. 4; Skin Sens. 1
431-210-4
50905-10-7
Eye Dam. 1
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
420-610-4
36394-75-9
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
411-150-5
29617-66-1
Acute Tox. 4; Skin Corr. 1A
434-990-4
7331-52-4
Skin Sens. 1
430-900-2
192725-50-1
Eye Dam. 1
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
-
-
Acute Tox. 4; Skin Sens. 1
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
412-470-8
73246-45-4
Flam. Liq. 3; STOT RE 2; Eye Irrit. 2
414-600-9
149182-72-9
Acute Tox. 4
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
601-696-4
120298-38-6
Skin Sens. 1
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL
404-670-9
89797-01-3
Skin Sens. 1
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
410-780-8
-
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
426-210-6
120086-58-0
Skin Corr. 1B
430-100-3
86978-24-7
Acute Tox. 4
227-633-7
5912-86-7
Skin Sens. 1A
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
209-673-7
590-18-1
Flam. Gas 1; Press. Gas
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
600-853-4
107898-54-4
Skin Irrit. 2
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
430-730-9
-
Eye Dam. 1
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1
Acute Tox. 4; Skin Sens. 1
-
99095-19-9
Acute Tox. 4; Skin Sens. 1
419-600-2
99199-90-3
Skin Sens. 1
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3

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