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 09 maj 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated microcrystalline and liquid hydrocarbons having carbon numbers predominantly greater than C20.
295-459-9
92045-77-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-149-6
97862-97-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
Details
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
Details
258-067-9
52645-53-1
Acute Tox. 4; Skin Sens. 1
Details
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
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21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
206-587-1
355-46-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-798-9
375-85-9
Repr. 1B; STOT RE 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
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Perfluoroheptanoic acid EC / List no: 206-798-9 | CAS no: 375-85-9
Ammonium perfluoroheptanoate EC / List no: 228-098-2 | CAS no: 6130-43-4
Sodium perfluoroheptanoate EC / List no: 243-518-4 | CAS no: 20109-59-5
potassium perfluoroheptanoate EC / List no: - | CAS no: 21049-36-5
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R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
206-793-1
375-73-5
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
Details
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
600-419-4
10332-33-9
R Toxic for reproduction (article 57c)
Details
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
600-611-8
10486-00-7
R Toxic for reproduction (article 57c)
Details
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
603-902-8
13517-20-9
R Toxic for reproduction (article 57c)
Details
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
Details
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B Bacteria and similar species
Details
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
210-852-7
624-54-4
Flam. Liq. 3
Details
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
Details
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
211-047-3
628-63-7
Flam. Liq. 3
Details
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
256-418-0
49663-84-5
C Carcinogenic (article 57a)
Details
442-030-0
321912-47-4
Eye Dam. 1
Details
414-910-4
-
Eye Dam. 1; Skin Sens. 1
Details
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
Details
436-920-8
172399-10-9
Eye Dam. 1
Details
301-312-2
93983-23-4
Eye Irrit. 2
Details
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
Details
205-391-3
140-01-2
Repr. 1B; Acute Tox. 4; STOT RE 2
Details

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