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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 srpnja 2024. Database contains 4821 unique substances/entries.
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BTAD
416-470-9
170292-97-4
Eye Irrit. 2
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
211-952-3
719-96-0
Skin Irrit. 2
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
UC-129
403-790-9
108673-51-4
Skin Sens. 1
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
423-840-3
14691-89-5
Acute Tox. 4
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
429-640-2
52870-46-9
Eye Irrit. 2
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
220-623-3
2836-04-6
Acute Tox. 3
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
205-319-0
138-24-9
Acute Tox. 3
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
202-959-2
101-61-1
Carc. 1B
yes
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
-
2810-74-4
Acute Tox. 4
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
Acute Tox. 4; Eye Irrit. 2
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
435-470-1
27366-72-9
Repr. 1B
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-831-6
100-22-1
Acute Tox. 4
CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904
403-340-1
164578-09-0
Eye Dam. 1
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
200-806-4
74-31-7
Skin Sens. 1
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
435-010-8
26157-73-3
Muta. 2
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
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B Bacteria and similar species
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B Bacteria and similar species
-
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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-
B Bacteria and similar species
-
-
B Bacteria and similar species
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
201-328-9
81-14-1
Carc. 2
248-505-7
27519-02-4
Skin Sens. 1B
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
205-628-0
144-41-2
Acute Tox. 3
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
-
-
B Bacteria and similar species
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
429-570-2
213990-58-0
Skin Sens. 1
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1

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