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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
218-892-7
2275-14-1
Acute Tox. 3
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extracted from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils, upgraded shale oils and liquid coal fuels are not included in this definition.
232-298-5
8002-05-9
Carc. 1B
A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-750-6
68607-11-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons obtained in a hydrofiner-powerformer process and boiling in a range of approximately 27°C to 210°C (80°F to 410°F).
271-058-4
68514-79-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-704-2
68476-85-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-705-8
68476-86-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.
295-463-0
92045-80-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
232-373-2
8009-03-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B
A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.
265-206-7
64743-01-7
Carc. 1B
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
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
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
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
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
258-067-9
52645-53-1
Acute Tox. 4; Skin Sens. 1
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
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
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
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
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
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
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
-
-
B Bacteria and similar species
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
210-852-7
624-54-4
Flam. Liq. 3
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
211-047-3
628-63-7
Flam. Liq. 3
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
442-030-0
321912-47-4
Eye Dam. 1
414-910-4
-
Eye Dam. 1; Skin Sens. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
436-920-8
172399-10-9
Eye Dam. 1
301-312-2
93983-23-4
Eye Irrit. 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
418-270-7
-
Skin Sens. 1
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
426-590-3
187412-41-5
Skin Sens. 1
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-925-1
76-01-7
Carc. 2; STOT RE 1
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
-
-
F Fungi
254-938-2
40487-42-1
Skin Sens. 1
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
214-215-4
1114-71-2
Acute Tox. 4
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; 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.
-
-
P Parasites
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-176-5
64742-71-8
Carc. 1B
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-174-4
64742-70-7
Carc. 1B
-
-
F Fungi
200-397-2
58-74-2
Acute Tox. 4
232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
UP 565
411-530-0
15024-10-9
Skin Sens. 1
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-180-0
104-15-4
Skin Corr. 1B
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas

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