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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
203-798-0
110-74-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
204-043-8
114-26-1
Acute Tox. 3
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
204-638-2
123-62-6
Skin Corr. 1B
201-176-3
79-09-4
Skin Corr. 1B
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
205-359-9
139-40-2
Carc. 2
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
211-914-6
709-98-8
Acute Tox. 4
200-827-9
74-98-6
Flam. Gas 1; Press. Gas
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-746-9
71-23-8
Flam. Liq. 2; Eye Dam. 1; STOT SE 3
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
220-113-0
2631-37-0
Acute Tox. 3
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
247-656-6
26399-36-0
Eye Irrit. 2
255-255-2
41198-08-7
Acute Tox. 4
425-740-5
-
Eye Dam. 1
BROWN JR 547
419-260-5
-
Eye Dam. 1
266-994-5
67747-09-5
Acute Tox. 4
-
-
B Bacteria and similar species
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
-
-
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.
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
425-830-4
-
Eye Dam. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
-
5787-96-2
Acute Tox. 3; STOT RE 2
253-390-1
37199-66-9
Skin Corr. 1B
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
223-393-2
3871-99-6
yes
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
234-329-8
11103-86-9
yes
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
232-151-5
7789-23-3
Acute Tox. 3
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
209-676-3
590-28-3
Acute Tox. 4
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
426-620-5
619297-89-1
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-300-5
-
Eye Dam. 1
233-002-7
10007-85-9
Eye Irrit. 2
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
266-578-3
67118-55-2
yes
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
246-376-1
24634-61-5
Eye Irrit. 2
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
-
299-45-6
Acute Tox. 2; Acute Tox. 1
-
-
B Bacteria and similar species
X4060
404-035-6
1379801-27-0
Skin Sens. 1
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
618-541-1
9036-19-5
yes
215-648-1
1336-36-3
STOT RE 2
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
-
-
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.
-
-
B Bacteria and similar species
432-400-1
10102-09-7
Skin Corr. 1A
-
-
P Parasites
-
-
P Parasites
263-072-4
61789-60-4
Carc. 1B
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B

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