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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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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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3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
2-chloro-6-nitroaniline EC / List no: 212-204-9 | CAS no: 769-11-9
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
Benzenamine, 4-chloro-N-nitro- EC / List no: - | CAS no: 69732-97-4
Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
3-chloro-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
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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 S171393
427-390-9
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Skin Sens. 1
INDULIN MQK-1M
413-770-1
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Acute Tox. 4; Skin Corr. 1B; 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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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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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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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.
950-299-5
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yes
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Acute Tox. 4
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Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
799-973-9
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yes
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P Parasites
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P Parasites
PRODUKT 1096
414-230-8
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Skin Sens. 1
YELLOW JB 1238
423-110-4
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Eye Dam. 1
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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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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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Octyl (2,4-dichlorophenoxy)acetate EC / List no: 217-674-9 | CAS no: 1928-44-5
Butyl 2,4-dichlorophenoxyacetate EC / List no: 202-364-8 | CAS no: 94-80-4
Nitrilotri-2,1-ethanediyl tris[(2,4-dichlorophenoxy)acetate] EC / List no: 299-308-8 | CAS no: 93858-74-3
Nonyl (2,4-dichlorophenoxy)acetate EC / List no: 259-722-1 | CAS no: 55617-55-5
2,4-D crotyl ester EC / List no: - | CAS no: 14600-07-8
2-Butoxypropyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 10463-14-6
2,4-D, 2-octyl ester EC / List no: - | CAS no: 1917-97-1
2,4-D 3-butoxypropyl ester EC / List no: - | CAS no: 1928-45-6
2-ethylhexyl 2,4-dichlorophenoxyacetate EC / List no: 217-673-3 | CAS no: 1928-43-4
Heptyl 2,4-dichlorophenoxyacetate EC / List no: 217-634-0 | CAS no: 1917-96-0
Trimethylsilyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 34113-76-3
Ethyl 2,4-dichlorophenoxyacetate EC / List no: 208-558-9 | CAS no: 533-23-3
Isopropyl 2,4-dichlorophenoxyacetate EC / List no: 202-305-6 | CAS no: 94-11-1
Propyl 2,4-dichlorophenoxyacetate EC / List no: 217-677-5 | CAS no: 1928-61-6
Acetic acid, (2,4-dichlorophenoxy)-, 2-propenyl ester EC / List no: - | CAS no: 58965-05-2
1-butoxypropan-2-yl 2-(2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 3966-11-8
(2,4-Dichlorophenoxy)acetic acid 2-butoxy-2-oxoethyl ester EC / List no: - | CAS no: 52671-26-8
Acetic acid, (2,4-dichlorophenoxy)-, dodecyl ester EC / List no: - | CAS no: 62855-71-4
Acetic acid, (2,4-dichlorophenoxy)-, vinyl ester EC / List no: - | CAS no: 4280-66-4
Isooctyl (2,4-dichlorophenoxy)acetate EC / List no: 246-704-3 | CAS no: 25168-26-7
Hexyl 2,4-dichlorophenoxyacetate EC / List no: 217-633-5 | CAS no: 1917-95-9
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
Acetic acid, (2,4-dichlorophenoxy)-, 2-hydroxyethyl ester EC / List no: - | CAS no: 38383-43-6
Pentyl (2,4-dichlorophenoxy)acetate EC / List no: 217-631-4 | CAS no: 1917-92-6
Acetic acid, (2,4-dichlorophenoxy)-, 4-pentylphenyl ester EC / List no: - | CAS no: 53640-17-8
1,3-dimethylbutyl 2-(2,4-dichlorophenoxy)acetate EC / List no: 300-531-0 | CAS no: 93941-81-2
4-hydroxybutyl (2,4-dichlorophenoxy)acetate EC / List no: 252-929-8 | CAS no: 36227-43-7
Methyl 2,4-dichlorophenoxyacetate EC / List no: 217-670-7 | CAS no: 1928-38-7
2-butoxyethyl 2,4-dichlorophenoxyacetate EC / List no: 217-680-1 | CAS no: 1929-73-3
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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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B Bacteria and similar species
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Acute Tox. 2
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Acute Tox. 4
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F Fungi
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F Fungi
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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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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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Carc. 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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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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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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