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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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236-675-5
13463-67-7
Carc. 2
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
FC4010
417-290-3
147086-81-5
Acute Tox. 4
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
443-150-6
101226-85-1
Flam. Liq. 3
405-060-5
118712-89-3
Skin Irrit. 2
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
215-548-8
1330-78-5
Acute Tox. 4
215-548-8
1330-78-5
STOT SE 1
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
215-812-2
1420-06-0
Acute Tox. 4
604-237-6
141517-21-7
Lact.; Skin Sens. 1
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
603-146-9
126535-15-7
Carc. 2
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-290-6
1319-46-6
yes
235-252-2
12141-20-7
yes
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
213-934-0
1067-53-4
Repr. 1B
yes
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
237-159-2
13674-87-8
Carc. 2
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
422-090-4
172737-80-3
Eye Dam. 1
238-253-6
14312-40-4
yes
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
-
138182-18-0
Repr. 2; STOT RE 2
604-291-0
142469-14-5
Skin Sens. 1
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
203-677-2
109-52-4
Skin Corr. 1B
217-681-7
1929-77-7
Acute Tox. 4
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
417-130-2
1379689-21-0
Eye Dam. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
605-037-1
156052-68-5
Skin Sens. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
427-580-1
211299-54-6
Skin Irrit. 2
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; 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
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
L-2-CHLOROPROPIONIC ACID; L-2-CHLORPROPIONSÄURE
411-150-5
29617-66-1
Acute Tox. 4; Skin Corr. 1A
433-010-2
2135910-74-4
Acute Tox. 4; Skin Sens. 1
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
246-147-6
24307-26-4
Acute Tox. 4
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
206-022-9
288-88-0
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1

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