EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

Last updated 14 May 2024. Database contains 4917 unique substances/entries.
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204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
Details
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
Details
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
Details
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
Details
206-052-2
298-02-2
Acute Tox. 1; Acute Tox. 2
Details
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
Details
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
Details
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
Details
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
Details
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
Details
-
5826-76-6
Acute Tox. 4
Details
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
Details
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
Details
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
Details
231-633-2
7664-38-2
Skin Corr. 1B
Details
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
Details
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
Details
215-236-1
1314-56-3
Skin Corr. 1A
Details
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
Details
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
Details
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
Details
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
Details
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
200-332-8
57-47-6
Acute Tox. 2
Details
604-030-0
137641-05-5
STOT RE 2
Details
202-128-4
92-13-7
Acute Tox. 2
Details
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
Details
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
Details
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
Details
200-076-7
51-03-6
STOT SE 3; Eye Irrit. 2
Details
607-329-4
24151-93-7
Acute Tox. 4
Details
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
Details
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
Details
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
Details
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
Details
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
Details
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
Details
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
Details

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