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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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JKY-120
405-730-7
51601-57-1
STOT RE 2
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
444-860-9
474510-57-1
STOT RE 2
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
434-820-9
106461-41-0
STOT RE 2
421-080-7
161462-35-7
STOT RE 2
428-230-0
79568-06-2
STOT RE 2
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
SP 807
420-150-4
80498-15-3
Resp. Sens. 1
232-589-7
9001-22-3
Resp. Sens. 1
-
-
Resp. Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
253-465-9
37329-65-0
Resp. Sens. 1
204-650-8
123-77-3
Resp. Sens. 1
yes
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Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
-
-
Resp. Sens. 1
232-565-6
9000-90-2
Resp. Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1

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