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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 srpnja 2024. Database contains 4821 unique substances/entries.
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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.
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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.
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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.
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F Fungi
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F Fungi
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
247-143-7
25637-27-8
Acute Tox. 4
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
203-852-3
111-27-3
Acute Tox. 4
211-653-8
680-31-9
Carc. 1B; Muta. 1B
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
AMINAZA TOLFAMATATE
418-350-1
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
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Hexachloroplatinate(2-) EC / List no: - | CAS no: 16871-54-8
Hexachloroplatinic acid EC / List no: 241-010-7 | CAS no: 16941-12-1
Dicesium hexachloroplatinate EC / List no: 240-945-8 | CAS no: 16902-25-3
Disodium hexachloroplatinate EC / List no: 240-983-5 | CAS no: 16923-58-3
Chloroplatinic acid hexahydrate EC / List no: 629-612-1 | CAS no: 18497-13-7
Sodium hexachloroplatinate(IV) hexahydrate EC / List no: 626-326-9 | CAS no: 19583-77-8
Dipotassium hexachloroplatinate EC / List no: 240-979-3 | CAS no: 16921-30-5
Diammonium hexachloroplatinate EC / List no: 240-973-0 | CAS no: 16919-58-7
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) EC / List no: 255-585-7 | CAS no: 41909-89-1
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
204-273-9
118-74-1
Carc. 1B; STOT RE 1
204-129-5
116-16-5
Acute Tox. 4
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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.
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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.
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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.
245-737-0
23560-59-0
Acute Tox. 3
203-838-7
111-14-8
Skin Corr. 1B
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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B Bacteria and similar species
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12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
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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.
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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.
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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.
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
Acute Tox. 4
600-130-3
100784-20-1
Repr. 1B
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
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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.
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
219-468-4
2439-99-8
Eye Dam. 1
617-243-9
81591-81-3
Acute Tox. 4
213-997-4
1071-83-6
Eye Dam. 1
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
232-589-7
9001-22-3
Resp. Sens. 1
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Carc. 2
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P Parasites
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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.
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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.
203-377-1
106-24-1
Skin Sens. 1
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated from the gases from vapor recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 196°C(-4°F to 384°F).
271-025-4
68514-15-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36.1°C to 193.3°C (97°F to 380°F).
271-727-0
68606-11-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C (68°F to 392°F).
302-639-3
94114-03-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.
271-726-5
68606-10-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.
302-691-7
94114-55-3
Carc. 1B
A complex high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45°C to 185°C (113°F to 365°F).
297-458-9
93572-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
270-769-7
68477-87-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.
272-893-7
68919-20-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.
273-265-5
68955-28-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.
272-885-3
68919-12-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulfide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-789-6
68478-05-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-884-8
68919-11-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-883-2
68919-10-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.
272-882-7
68919-09-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
273-270-2
68955-34-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately minus 70°C to 0°C (minus 94°F to 32°F).
295-404-9
92045-22-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-269-7
68955-33-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidized catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
271-625-6
68602-84-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B

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