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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 March 2024. Database contains 4821 unique substances/entries.
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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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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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Nonyl (2,4-dichlorophenoxy)acetate EC / List no: 259-722-1 | CAS no: 55617-55-5
Isobutyl 2,4-dichlorophenoxyacetate EC / List no: 216-992-5 | CAS no: 1713-15-1
2,4-D crotyl ester EC / List no: - | CAS no: 14600-07-8
1,3-dimethylbutyl 2-(2,4-dichlorophenoxy)acetate EC / List no: 300-531-0 | CAS no: 93941-81-2
2-butoxyethyl 2,4-dichlorophenoxyacetate EC / List no: 217-680-1 | CAS no: 1929-73-3
Nitrilotri-2,1-ethanediyl tris[(2,4-dichlorophenoxy)acetate] EC / List no: 299-308-8 | CAS no: 93858-74-3
Ethyl 2,4-dichlorophenoxyacetate EC / List no: 208-558-9 | CAS no: 533-23-3
Acetic acid, (2,4-dichlorophenoxy)-, 2-hydroxyethyl ester EC / List no: - | CAS no: 38383-43-6
Acetic acid, (2,4-dichlorophenoxy)-, 4-pentylphenyl ester EC / List no: - | CAS no: 53640-17-8
Propyl 2,4-dichlorophenoxyacetate EC / List no: 217-677-5 | CAS no: 1928-61-6
Tetrahydrofurfuryl 2,4-dichlorophenoxyacetate EC / List no: 239-207-8 | CAS no: 15146-99-3
Hexyl 2,4-dichlorophenoxyacetate EC / List no: 217-633-5 | CAS no: 1917-95-9
Isopropyl 2,4-dichlorophenoxyacetate EC / List no: 202-305-6 | CAS no: 94-11-1
Acetic acid, (2,4-dichlorophenoxy)-, 2-propenyl ester EC / List no: - | CAS no: 58965-05-2
Butyl 2,4-dichlorophenoxyacetate EC / List no: 202-364-8 | CAS no: 94-80-4
2,4-D, 2-octyl ester EC / List no: - | CAS no: 1917-97-1
Acetic acid, (2,4-dichlorophenoxy)-, vinyl ester EC / List no: - | CAS no: 4280-66-4
2-ethylhexyl 2,4-dichlorophenoxyacetate EC / List no: 217-673-3 | CAS no: 1928-43-4
2-Butoxypropyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 10463-14-6
Acetic acid, (2,4-dichlorophenoxy)-, dodecyl ester EC / List no: - | CAS no: 62855-71-4
4-hydroxybutyl (2,4-dichlorophenoxy)acetate EC / List no: 252-929-8 | CAS no: 36227-43-7
Isooctyl (2,4-dichlorophenoxy)acetate EC / List no: 246-704-3 | CAS no: 25168-26-7
Octyl (2,4-dichlorophenoxy)acetate EC / List no: 217-674-9 | CAS no: 1928-44-5
1-butoxypropan-2-yl 2-(2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 3966-11-8
Trimethylsilyl (2,4-dichlorophenoxy)acetate EC / List no: - | CAS no: 34113-76-3
Heptyl 2,4-dichlorophenoxyacetate EC / List no: 217-634-0 | CAS no: 1917-96-0
2,4-D sec-butyl ester EC / List no: - | CAS no: 94-79-1
(2,4-Dichlorophenoxy)acetic acid 2-butoxy-2-oxoethyl ester EC / List no: - | CAS no: 52671-26-8
Pentyl (2,4-dichlorophenoxy)acetate EC / List no: 217-631-4 | CAS no: 1917-92-6
Methyl 2,4-dichlorophenoxyacetate EC / List no: 217-670-7 | CAS no: 1928-38-7
2,4-D 3-butoxypropyl ester EC / List no: - | CAS no: 1928-45-6
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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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