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 26 april 2024. Database contains 4917 unique substances/entries.
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201-378-1
81-82-3
STOT RE 2
Details
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
Details
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
Details
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
Details
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572-48-5
Acute Tox. 3
Details
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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.
Details
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B Bacteria and similar species
Details
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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.
Details
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Details
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
Details
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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.
Details
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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.
Details
208-622-6
535-89-7
Acute Tox. 2
Details
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
231-720-5
7700-17-6
Acute Tox. 3
Details
206-083-1
299-86-5
Acute Tox. 4
Details
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F Fungi
Details
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F Fungi
Details
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P Parasites
Details
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P Parasites
Details
202-704-5
98-82-8
Flam. Liq. 3; Carc. 1B; Asp. Tox. 1; STOT SE 3
Details
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
Details
244-544-9
21725-46-2
Acute Tox. 4
Details
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
Details
220-130-3
2636-26-2
Acute Tox. 4
Details
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
Details
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
Details
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
Details
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
Details
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Details
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
Details
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
Details
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
Details
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
Details
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
Details
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
Details
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
Details
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
Details
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
Details
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
Details
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
Details
206-016-6
287-92-3
Flam. Liq. 2
Details
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
Details
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
Details
428-340-9
238088-70-5
Skin Irrit. 2
Details

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