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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 svibnja 2024. Database contains 4821 unique substances/entries.
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Carc. 2
232-589-7
9001-22-3
Resp. Sens. 1
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
yes
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
213-997-4
1071-83-6
Eye Dam. 1
617-243-9
81591-81-3
Acute Tox. 4
219-468-4
2439-99-8
Eye Dam. 1
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 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.
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 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
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
600-130-3
100784-20-1
Repr. 1B
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
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.
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12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
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B Bacteria and similar species
218-165-4
2058-94-8
yes
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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.
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
206-803-4
376-06-7
yes
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-838-7
111-14-8
Skin Corr. 1B
245-737-0
23560-59-0
Acute Tox. 3
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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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beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
247-148-4
25637-99-4
Repr. 2; Lact.
yes
204-129-5
116-16-5
Acute Tox. 4
204-273-9
118-74-1
Carc. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
show/hide
Dicesium hexachloroplatinate EC / List no: 240-945-8 | CAS no: 16902-25-3
Bis(benzyltrimethylammonium) hexachloroplatinate(2-) EC / List no: 255-585-7 | CAS no: 41909-89-1
Chloroplatinic acid hexahydrate EC / List no: 629-612-1 | CAS no: 18497-13-7
Disodium hexachloroplatinate EC / List no: 240-983-5 | CAS no: 16923-58-3
Dipotassium hexachloroplatinate EC / List no: 240-979-3 | CAS no: 16921-30-5
Natriumchloroplatinat EC / List no: 626-326-9 | CAS no: 19583-77-8
Diammonium hexachloroplatinate EC / List no: 240-973-0 | CAS no: 16919-58-7
Hexachloroplatinate(2-) EC / List no: - | CAS no: 16871-54-8
Hexachloroplatinic acid EC / List no: 241-010-7 | CAS no: 16941-12-1
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
AMINAZA TOLFAMATATE
418-350-1
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
211-653-8
680-31-9
Carc. 1B; Muta. 1B
203-852-3
111-27-3
Acute Tox. 4
209-731-1
591-78-6
Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
247-143-7
25637-27-8
Acute Tox. 4
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 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
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
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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F Fungi
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F Fungi
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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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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.
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
616-584-0
7803-57-8
yes
HNF; HYDRAZINIUM NITROFORMATE
414-850-9
4682-01-3
Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
233-109-9
10034-85-2
Skin Corr. 1B
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
309-745-9
100801-63-6
Carc. 1B; Muta. 1B
The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F).
309-748-5
100801-65-8
Carc. 1B; Muta. 1B

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