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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-900-2
192725-50-1
Eye Dam. 1
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
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
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
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
POLYSANTOL
411-580-3
107898-54-4
Skin Irrit. 2
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
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
204-528-4
122-20-3
Eye Irrit. 2
COMPIMIDE™ 121
405-840-5
110866-35-8
Skin Sens. 1
203-820-9
110-97-4
Eye Irrit. 2
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
413-740-8
1132-95-2
Skin Corr. 1B
442-850-9
114772-40-6
Skin Sens. 1
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
203-977-3
112-49-2
Repr. 1B
yes
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
412-180-1
10221-57-5
Flam. Liq. 2
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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