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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 May 2024. Database contains 4821 unique substances/entries.

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Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
cellulases with the exception of those specified elsewhere in this Annex	-	-	Resp. Sens. 1
Central European tick-borne encephalitis virus	-	-		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.
Chikungunya virus	-	-		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.
Chlamydia pneumoniae	-	-		B Bacteria and similar species
Chlamydia psittaci (avian strains)	-	-		B Bacteria and similar species
Chlamydia psittaci (other strains)	-	-		B Bacteria and similar species
Chlamydia trachomatis	-	-		B Bacteria and similar species
chloroanilines (with exception of those specified elsewhere in this Annex)	-	-	Acute Tox. 3; STOT RE 2
chloronitroanilines with the exception of those specified elsewhere in this Annex show/hide 4-chloro-2-nitroaniline EC / List no: 201-925-4 \| CAS no: 89-63-4 Benzenamine, chloronitro- EC / List no: - \| CAS no: 41587-36-4 5-chloro-2-nitroaniline EC / List no: 216-661-5 \| CAS no: 1635-61-6 2-chloro-6-nitroaniline EC / List no: 212-204-9 \| CAS no: 769-11-9 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 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 Benzenamine, 2-chloro-3-nitro- EC / List no: - \| CAS no: 3970-41-0 3-chloro-2-nitroaniline EC / List no: 261-782-9 \| CAS no: 59483-54-4 2-chloro-5-nitroaniline EC / List no: 228-498-7 \| CAS no: 6283-25-6 Benzenamine, 4-chloro-N-nitro- EC / List no: - \| CAS no: 69732-97-4 3-chloro-4-nitroaniline EC / List no: 642-644-0 \| CAS no: 825-41-2	-	-	Acute Tox. 2; Acute Tox. 1; STOT RE 2
chromium (VI) compounds, with the exception of barium chromate and of compounds specified elsewhere in this Annex	-	-	Carc. 1B; Skin Sens. 1
Cladophialophora bantiana	-	-		F Fungi
Clonorchis sinensis	-	-		P Parasites
Clonorchisviverrini	-	-		P Parasites
Clostridium botulinum	-	-		B Bacteria and similar species
Clostridium perfringens	-	-		B Bacteria and similar species
Clostridium spp.	-	-		B Bacteria and similar species
Clostridium tetani	-	-		B Bacteria and similar species
Coccidioides inunitis	-	-		F Fungi
Coltivirus	-	-		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.
complex of cobalt(III)-bis(N-phenyl-4-(5-ethylsulfonyl-2-hydroxyphenylazo)-3-hydroxynaphthylamide), hydrated(n H2O,2 SUBSTANCE S171393	427-390-9	-	Skin Sens. 1
condensation product of: 3-(7-carboxyhept-1-yl)-6-hexyl-4-cyclohexene-1,2-dicarboxylic acid with polyamines (primarily; amino-ethyl-piperazine and triethylenetetramine) INDULIN MQK-1M	413-770-1	-	Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Confidential or not yet assessed substance Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.	-	-	STOT RE 2
Coronaviridae	-	-		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.
Corynebacterium diphtheriae	-	-		B Bacteria and similar species
Corynebacterium minutissimum	-	-		B Bacteria and similar species
Corynebacterium spp.	-	-		B Bacteria and similar species
Cowpox virus	-	-		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.
Coxiella burnetii	-	-		B Bacteria and similar species
Coxsackie viruses	-	-		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.
Creutzfeldt-Jakob disease	-	-		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.
Crimean-Congo haemorrhagic fever	-	-		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.
Cryptococcus neoformans var. gattii	-	-		F Fungi
Cryptococcus neoformans var. neofonnans	-	-		F Fungi
Cryptosporidium parvum	-	-		P Parasites
Cryptosporidium spp.	-	-		P Parasites
Cyclospora cayetanensis	-	-		P Parasites
Cytomegalovirus	-	-		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.
Dengue virus type 1-4	-	-		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.
Di-, tri- and tetrachlorotetradecane	950-299-5	-			yes
diethanolamine salt of 4-CPA	-	-	Acute Tox. 4
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety show/hide dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: - \| CAS no: - 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	-			yes
Dipetalonema streptocerca	-	-		P Parasites
Diphyllobothrium latum	-	-		P Parasites
disodium 2-[[4-(2-chloroethylsulfonyl)phenyl]-[(2-hydroxy-5-sulfo-3-[3-[2-(2-(sulfooxy)ethylsulfonyl)ethylazo]-4-sulfobenzoato(3-)cuprate(1-) PRODUKT 1096	414-230-8	-	Skin Sens. 1
disodium 3,3'-[iminobis[sulfonyl-4,1-phenylene-(5-hydroxy-3-methylpyrazole-1,4-diyl)azo-4,1-phenylenesulfonylimino-(4-amino-6-hydroxypyrimidine-2,5-diyl)azo-4,1-phenylenesulfonylimino(4-amino-6-hydroxypyrimidine-2,5-diyl)azo]bis(benzenesulfonate)] YELLOW JB 1238	423-110-4	-	Eye Dam. 1
Dracunculusmedinensis	-	-		P Parasites
e-glass microfibres of representative composition [Calcium-aluminium-silicate fibres with random orientation with the following representative composition (% given by weight): SiO2 50,0-56,0 %, Al2O3 13,0-16,0 %, B2O3 5,8-10,0 %, Na2O < 0,6 %, K2O < 0,4 %, CaO 15,0-24,0 %, MgO < 5,5 %, Fe2O3 < 0,5 %, F2 < 1,0 %. Process: typically produced by flame attenuation and rotary process. (Additional individual elements may be present at low levels; the process list does not preclude innovation).]	-	-	Carc. 1B
Eastern equine encephalomyelitis	-	-		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.
Ebola virus	-	-		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.
Echinococcus granulosus	-	-		P Parasites

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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

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Last updated 13 May 2024. Database contains 4821 unique substances/entries.

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