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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 travnja 2024. Database contains 4821 unique substances/entries.
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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.
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
200-104-8
51-55-8
Acute Tox. 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.
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
262-102-3
60207-31-0
Acute Tox. 4
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
252-626-0
35575-96-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 1; Skin Sens. 1
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-419-3
5834-96-8
Acute Tox. 4
207-802-1
495-48-7
Acute Tox. 4
603-524-3
131860-33-8
Acute Tox. 3
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P Parasites
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P Parasites
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B Bacteria and similar species
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B Bacteria and similar species
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P Parasites
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
208-167-3
513-77-9
Acute Tox. 4
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Acute Tox. 4
244-214-4
21109-95-5
Acute Tox. 4
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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
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
201-622-7
85-68-7
Repr. 1B
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.
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 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.
223-297-0
3813-05-6
Eye Irrit. 2; Skin Irrit. 2
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
207-807-9
495-73-8
Acute Tox. 3; Acute Tox. 4
212-010-4
741-58-2
Acute Tox. 4
605-769-1
17606-31-4
Acute Tox. 4
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
200-280-6
56-55-3
Carc. 1B
yes
205-911-9
205-99-2
Carc. 1B
202-860-4
100-52-7
Acute Tox. 4

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