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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 rujna 2024. Database contains 4821 unique substances/entries.
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215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
430-800-9
129228-21-3
Skin Irrit. 2
406-970-5
129228-11-1
Skin Irrit. 2
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
204-961-9
129-73-7
Carc. 2; Muta. 2
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
204-927-3
129-00-0
yes
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-825-9
127-18-4
Carc. 2
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
603-146-9
126535-15-7
Carc. 2
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
235-727-4
12626-81-2
yes
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
204-818-0
126-99-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-817-5
126-98-7
Flam. Liq. 2; Acute Tox. 3; Skin Sens. 1
204-811-2
126-91-0
Skin Sens. 1B
204-810-7
126-90-9
Skin Sens. 1B
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
425-860-8
125971-57-5
Skin Sens. 1
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
235-702-8
12578-12-0
yes
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1

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