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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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34492-97-2
Carc. 1A; 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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B Bacteria and similar species
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B Bacteria and similar species
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Acute Tox. 4
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yes
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Expl.
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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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B Bacteria and similar species
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B Bacteria and similar species
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F Fungi
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F Fungi
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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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Resp. 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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B Bacteria and similar species
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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
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Acute Tox. 3; STOT RE 2
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Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
3-chloro-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
2-chloro-6-nitroaniline EC / List no: 212-204-9 | CAS no: 769-11-9
2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
2-chloro-5-nitroaniline EC / List no: 228-498-7 | CAS no: 6283-25-6
Benzenamine, chloronitro- EC / List no: - | CAS no: 41587-36-4
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
Benzenamine, 4-chloro-N-nitro- EC / List no: - | CAS no: 69732-97-4
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Acute Tox. 2; Acute Tox. 1; STOT RE 2
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Carc. 1B; Skin Sens. 1
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F Fungi
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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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B Bacteria and similar species
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B Bacteria and similar species
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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.
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
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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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B Bacteria and similar species
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B Bacteria and similar species
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68583-16-4
B Bacteria and similar species
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B Bacteria and similar species
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572-48-5
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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B Bacteria and similar species
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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
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P Parasites
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P Parasites
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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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1563-67-3
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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74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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Acute Tox. 4
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63919-26-6
Acute Tox. 4
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P Parasites
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19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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P Parasites
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83-59-0
Acute Tox. 3; Acute Tox. 4
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P Parasites
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Carc. 1B
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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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P Parasites
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P Parasites
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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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B Bacteria and similar species
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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
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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
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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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B Bacteria and similar species
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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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136-25-4
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
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2,4-D 3-butoxypropyl ester EC / List no: - | CAS no: 1928-45-6
Acetic acid, (2,4-dichlorophenoxy)-, dodecyl ester EC / List no: - | CAS no: 62855-71-4
2,4-D, 2-octyl ester EC / List no: - | CAS no: 1917-97-1
4-hydroxybutyl (2,4-dichlorophenoxy)acetate EC / List no: 252-929-8 | CAS no: 36227-43-7
2-ethylhexyl 2,4-dichlorophenoxyacetate EC / List no: 217-673-3 | CAS no: 1928-43-4
Nitrilotri-2,1-ethanediyl tris[(2,4-dichlorophenoxy)acetate] EC / List no: 299-308-8 | CAS no: 93858-74-3
(2,4-Dichlorophenoxy)acetic acid 2-butoxy-2-oxoethyl ester EC / List no: - | CAS no: 52671-26-8
1,3-dimethylbutyl 2-(2,4-dichlorophenoxy)acetate EC / List no: 300-531-0 | CAS no: 93941-81-2
Isopropyl 2,4-dichlorophenoxyacetate EC / List no: 202-305-6 | CAS no: 94-11-1
1-butoxypropan-2-yl 2-(2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 3966-11-8
Acetic acid, (2,4-dichlorophenoxy)-, 4-pentylphenyl ester EC / List no: - | CAS no: 53640-17-8
Pentyl (2,4-dichlorophenoxy)acetate EC / List no: 217-631-4 | CAS no: 1917-92-6
Nonyl (2,4-dichlorophenoxy)acetate EC / List no: 259-722-1 | CAS no: 55617-55-5
Trimethylsilyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 34113-76-3
Acetic acid, (2,4-dichlorophenoxy)-, 2-propenyl ester EC / List no: - | CAS no: 58965-05-2
Tetrahydrofurfuryl 2,4-dichlorophenoxyacetate EC / List no: 239-207-8 | CAS no: 15146-99-3
2,4-D sec-butyl ester EC / List no: - | CAS no: 94-79-1
Isobutyl 2,4-dichlorophenoxyacetate EC / List no: 216-992-5 | CAS no: 1713-15-1
Octyl (2,4-dichlorophenoxy)acetate EC / List no: 217-674-9 | CAS no: 1928-44-5
Acetic acid, (2,4-dichlorophenoxy)-, 2-hydroxyethyl ester EC / List no: - | CAS no: 38383-43-6
Hexyl 2,4-dichlorophenoxyacetate EC / List no: 217-633-5 | CAS no: 1917-95-9
Propyl 2,4-dichlorophenoxyacetate EC / List no: 217-677-5 | CAS no: 1928-61-6
2,4-D crotyl ester EC / List no: - | CAS no: 14600-07-8
Ethyl 2,4-dichlorophenoxyacetate EC / List no: 208-558-9 | CAS no: 533-23-3
Butyl 2,4-dichlorophenoxyacetate EC / List no: 202-364-8 | CAS no: 94-80-4
2-butoxyethyl 2,4-dichlorophenoxyacetate EC / List no: 217-680-1 | CAS no: 1929-73-3
Isooctyl (2,4-dichlorophenoxy)acetate EC / List no: 246-704-3 | CAS no: 25168-26-7
Methyl 2,4-dichlorophenoxyacetate EC / List no: 217-670-7 | CAS no: 1928-38-7
Heptyl 2,4-dichlorophenoxyacetate EC / List no: 217-634-0 | CAS no: 1917-96-0
Acetic acid, (2,4-dichlorophenoxy)-, vinyl ester EC / List no: - | CAS no: 4280-66-4
2-Butoxypropyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 10463-14-6
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Acute Tox. 4; Skin Sens. 1
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Acute Tox. 4; Skin Sens. 1
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Acute Tox. 4; 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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P Parasites
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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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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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4301-50-2
Acute Tox. 1; Acute Tox. 2
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B Bacteria and similar species
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Acute Tox. 2

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