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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 lipnja 2024. Database contains 4821 unique substances/entries.
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205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
209-090-8
555-31-7
Flam. Sol. 1
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
231-768-7
7723-14-0
Flam. Sol. 1
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
BONTRON E-84; E-84
403-360-0
42405-40-3
Flam. Sol. 1; Acute Tox. 4
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
CGI 784
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
SHC 3000
401-530-9
-
Flam. Sol. 1; STOT SE 1; Acute Tox. 4
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
202-905-8
100-97-0
Flam. Sol. 2; Skin Sens. 1
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
620-041-3
907204-31-3
Lact.
287-477-0
85535-85-9
Lact.
yes
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
FLUFENOXURON
417-680-3
101463-69-8
Lact.
604-237-6
141517-21-7
Lact.; Skin Sens. 1
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
225-918-0
5146-66-7
Muta. 1B
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
234-232-0
10605-21-7
Muta. 1B; Repr. 1B; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
MEM
418-250-8
65756-41-4
Muta. 2
MEP
418-200-5
69227-51-6
Muta. 2
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
435-010-8
26157-73-3
Muta. 2
200-915-7
75-91-2
Muta. 2
219-014-5
2314-97-8
Muta. 2
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
208-601-1
534-52-1
Muta. 2; Acute Tox. 2; Acute Tox. 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
AMINAZA TOLFAMATATE
418-350-1
-
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-545-8
532-82-1
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1

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