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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 May 2024. Database contains 4821 unique substances/entries.

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Showing 4,201 - 4,400 of 4,821 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde	257-187-9	51414-25-6	Skin Sens. 1A
4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde	250-863-4	31906-04-4	Skin Sens. 1A
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde	641-410-5	130066-44-3	Skin Sens. 1A
isoeugenol	202-590-7	97-54-1	Skin Sens. 1A
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide CGI 819	423-340-5	162881-26-7	Skin Sens. 1A
benzyl salicylate	204-262-9	118-58-1	Skin Sens. 1B
coriandrol; (S)-3,7-dimethyl-1,6-octadien-3-ol; d-linalool	204-810-7	126-90-9	Skin Sens. 1B
licareol; (R)-3,7-dimethyl-1,6-octadien-3-ol; l-linalool	204-811-2	126-91-0	Skin Sens. 1B
linalool; 3,7-dimethyl-1,6-octadien-3-ol; dl-linalool	201-134-4	78-70-6	Skin Sens. 1B
muscalure; cis-tricos-9-ene	248-505-7	27519-02-4	Skin Sens. 1B
tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl)-O,O-dimethyl thiophosphate	260-515-3	57018-04-9	Skin Sens. 1B
trimethoxyvinylsilane; trimethoxy(vinyl)silane	220-449-8	2768-02-7	Skin Sens. 1B
metazachlor (ISO); 2-chloro-N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)-acetamide	266-583-0	67129-08-2	Skin Sens. 1B; Carc. 2
ethyl nitrate	210-903-3	625-58-1	Unst. Expl.
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]	239-924-6	15825-70-4	Unst. Expl.
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]	201-084-3	78-11-5	Unst. Expl.
ethylene dinitrate; ethylene glycol dinitrate	211-063-0	628-96-6	Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
glycerol trinitrate; nitroglycerine;glycerol trinitrate; nitroglycerine [>40 % phlegmatiser]	200-240-8	55-63-0	Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate;oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate [>25 % phlegmatiser]	211-745-8	693-21-0	Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
salts of picric acid	-	-	Unst. Expl.; Acute Tox. 3
mercury difulminate; mercuric fulminate; fulminate of mercury;mercury difulminate; mercuric fulminate; fulminate of mercury [≥ 20 % phlegmatiser]	211-057-8	628-86-4	Unst. Expl.; Acute Tox. 3; STOT RE 2
dichloroacetylene	620-404-6	7572-29-4	Unst. Expl.; Carc. 2; STOT RE 2
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]	232-259-2	7803-49-8	Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]	236-542-1	13424-46-9	Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)	239-290-0	15245-44-0	Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
calcium carbide	200-848-3	75-20-7	Water-react. 1
calcium hydride	232-189-2	7789-78-8	Water-react. 1
sodium hydride	231-587-3	7646-69-7	Water-react. 1
trizinc diphosphide; zinc phosphide	215-244-5	1314-84-7	Water-react. 1; Acute Tox. 2
aluminium phosphide	244-088-0	20859-73-8	Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
magnesium phosphide; trimagnesium diphosphide	235-023-7	12057-74-8	Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
calcium phosphide; tricalcium diphosphide	215-142-0	1305-99-3	Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
diethyl(ethyldimethylsilanolato) aluminium CS 100; SILOXAL	401-160-8	55426-95-4	Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A
(2-methylpropyl)lithium; isobutyllithium	440-620-2	920-36-5	Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
magnesium powder (pyrophoric);magnesium, powder or turnings	231-104-6	7439-95-4	Water-react. 1; Pyr. Sol. 1
zinc powder — zinc dust (pyrophoric)	231-175-3	7440-66-6	Water-react. 1; Pyr. Sol. 1
zirconium powder (pyrophoric);zirconium powder, dry (non pyrophoric)	231-176-9	7440-67-7	Water-react. 1; Pyr. Sol. 1
n-hexyllithium N-HEXYLLITHIUM	404-950-0	21369-64-2	Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
aluminium lithium hydride	240-877-9	16853-85-3	Water-react. 1; Skin Corr. 1A
ethyl propoxy aluminium chloride EAPOXC	421-790-7	13014-29-4	Water-react. 1; Skin Corr. 1A
lithium	231-102-5	7439-93-2	Water-react. 1; Skin Corr. 1B
potassium	231-119-8	7440-09-7	Water-react. 1; Skin Corr. 1B
sodium	231-132-9	7440-23-5	Water-react. 1; Skin Corr. 1B
calcium	231-179-5	7440-70-2	Water-react. 2
aluminium powder (pyrophoric);aluminium powder (stabilised)	231-072-3	7429-90-5	Water-react. 2; Flam. Sol. 1
aluminium powder (pyrophoric);aluminium powder (stabilised)	231-072-3	7429-90-5	Water-react. 2; Pyr. Sol. 1
(1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	95342-41-9			yes
(1R,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-21-0			yes
(1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	741687-98-9			yes
(1S,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-03-3			yes
(1S,2S,5S,6S,9R,10R,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene	-	135821-74-8			yes
(1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-30-1			yes
(1S,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one	-	852541-25-4			yes
(2R)-3-(4-tert-Butylphenyl)-2-methylpropanal	-	75166-31-3			yes
(2S)-3-(4-tert-Butylphenyl)-2-methylpropanal	-	75166-30-2			yes
(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one	701-394-3	1782069-81-1			yes
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one	253-242-6	36861-47-9			yes
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters	271-094-0	68515-51-5			yes
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters	272-013-1	68648-93-1			yes
1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene	236-948-9	13560-89-9			yes
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof	-	-			yes
1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; 3-Benzylidene camphor	239-139-9	15087-24-8			yes
2,2-dimethylpropan-1-ol, tribromo derivative (TBNPA)	253-057-0	36483-57-5			yes
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid	236-236-8	13252-13-6			yes
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride	218-173-8	2062-98-8			yes
2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol; UV-327	223-383-8	3864-99-1			yes
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol; UV-328	247-384-8	25973-55-1			yes
2-(2H-Benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol; UV-350	253-037-1	36437-37-3			yes
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers show/hide 2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 \| CAS no: 80-54-6 (2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - \| CAS no: 75166-30-2 (2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - \| CAS no: 75166-31-3	799-970-2	-			yes
2-[2-(4-nonylphenoxy)ethoxy]ethanol	243-816-4	20427-84-3			yes
2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol	230-770-5	7311-27-5			yes
2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol	618-344-0	9002-93-1			yes
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol	687-832-3	1119449-37-4			yes
2-Benzotriazol-2-yl-4,6-di-tert-butylphenol; UV-320	223-346-6	3846-71-7			yes
2-{2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethoxy}ethanol	687-833-9	1119449-38-5			yes
20-(4-nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol	248-743-1	27942-27-4			yes
20-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-3,6,9,12,15,18-hexaoxaicosan-1-ol	219-682-8	2497-59-8			yes
26-(4-nonylphenoxy)-3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol	604-395-6	14409-72-4			yes
26-(nonylphenoxy)-3,6,9,12,15,18,21,24-octaoxahexacosan-1-ol	247-816-5	26571-11-9			yes
3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)	622-370-8	1522-92-5			yes
4,4'-(1-Methylpropylidene)bisphenol	201-025-1	77-40-7			yes
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol	209-218-2	561-41-1			yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated	-	-			yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated	621-341-7	2315-61-9			yes
4-(1-ethyl-1-methylhexyl)phenol	257-907-1	52427-13-1			yes
4-(2,6-dimethylheptan-2-yl)phenol	635-388-6	521947-27-3			yes
4-(3,4,5,6-tetramethyloctan-2-yl)phenol	-	-			yes
4-(3,4,5-trimethylheptyl)phenol	272-233-8	68784-25-8			yes
4-(3,5-dimethylheptan-3-yl)phenol	635-389-1	186825-36-5			yes
4-(3,6-dimethylheptan-3-yl)phenol	635-391-2	142731-63-3			yes
4-(3-ethylheptan-2-yl)phenol	635-696-0	186825-39-8			yes
4-Heptylphenol	217-862-0	1987-50-4			yes
4-Heptylphenol, branched and linear	-	-			yes
4-Isododecylphenol;Phenol, 4-isododecyl	608-055-8	27147-75-7;27459-10-5			yes
4-Isododecylphenol;Phenol, 4-isododecyl	608-055-8	27147-75-7;27459-10-5			yes
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine	202-453-1	95-80-7			yes
4-Nonylphenol, branched and linear	-	-			yes
4-Nonylphenol, branched and linear, ethoxylated	-	-			yes
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated) 1 - 2.5 moles ethoxylated	500-315-8	127087-87-0			yes
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated) 1 - 2.5 moles ethoxylated	500-045-0	26027-38-3			yes
4-tert-Octylphenol monoethoxylate	621-345-9	2315-67-5			yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]	-	-			yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-			yes
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride; C.I. Basic Blue 26	219-943-6	2580-56-5			yes
[Phthalato(2-)]dioxotrilead	273-688-5	69011-06-9			yes
Absettarov	-	-		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.
Acanthamoeba castellani	-	-		P Parasites
Acetic acid, lead salt, basic	257-175-3	51404-69-4			yes
Actinomadura madurae	-	-		B Bacteria and similar species
Actinomadura pelletieri	-	-		B Bacteria and similar species
Actinomyces gerencseriae	-	-		B Bacteria and similar species
Actinomyces israelii	-	-		B Bacteria and similar species
Actinomyces pyogenes	-	-		B Bacteria and similar species
Actinomyces spp.	-	-		B Bacteria and similar species
Acute haemorrhagic conjunctivitis 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.
Acyl Halides of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-			yes
Adenoviridae	-	-		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.
Adinobacillus actinomycetemcomitans	-	-		B Bacteria and similar species
Alkanes, C10-21, chloro	281-985-6	84082-38-2			yes
Alkanes, C10-26, chloro	307-451-5	97659-46-6			yes
Alkanes, C10-32, chloro	283-930-1	84776-06-7			yes
Alkanes, C12-14, chloro	287-504-6	85536-22-7			yes
Alkanes, C14-16, chloro	701-376-5	1372804-76-6			yes
Alkanes, C16-27, chloro	283-931-7	84776-07-8			yes
Alkanes, C16-35, chloro	285-195-2	85049-26-9			yes
Alkanes, C6-18, chloro	272-924-4	68920-70-7			yes
Alkanes, chloro	263-004-3	61788-76-9			yes
Alpha-hexabromocyclododecane	603-801-9	134237-50-6			yes
Aluminosilicate Refractory Ceramic Fibres	604-314-4	142844-00-6			yes
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate	700-242-3	62037-80-3			yes
Ammonium perfluorohexane-1-sulphonate	269-511-6	68259-08-5			yes
Ancylostoma duodenale	-	-		P Parasites
Angiostrongylus cantonensis	-	-		P Parasites
Angiostrongylus costaricensis	-	-		P Parasites
Anthracene	204-371-1	120-12-7			yes
Arcanobacterium haemolyticum	-	-		B Bacteria and similar species
Ascaris lumbricoides	-	-		P Parasites
Ascaris suum	-	-		P Parasites
Aspergillus fumigatus	-	-		F Fungi
Astroviridae	-	-		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.
Australia encephalitis	-	-		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.
Babesia divergens	-	-		P Parasites
Babesia microti	-	-		P Parasites
Bacillus anthracis	-	-		B Bacteria and similar species
Bacteroides fragilis	-	-		B Bacteria and similar species
Balantidium coli	-	-		P Parasites
Bartonella (Rochalinea) spp.	-	-		B Bacteria and similar species
Bartonella bacillifonnis	-	-		B Bacteria and similar species
Bartonella quintana	-	-		B Bacteria and similar species
Bebaru 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.
Belgrade	-	-		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.
Benzo[ghi]perylene	205-883-8	191-24-2			yes
Beta-hexabromocyclododecane	603-802-4	134237-51-7			yes
Bhanja	-	-		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.
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE	214-604-9	1163-19-5			yes
Bis(tributyltin)oxide; TBTO	200-268-0	56-35-9			yes
BK and JC 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.
Blastomyces dermatitidis	-	-		F Fungi
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium (1:2)	-	90568-23-3			yes
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium, hydrate (1:2:6)	-	125022-34-6			yes
Bordetella bronchiseptica	-	-		B Bacteria and similar species
Bordetella parapertussis	-	-		B Bacteria and similar species
Bordetella pertussis	-	-		B Bacteria and similar species
Boric acid (H3BO3), disodium salt	-	22454-04-2			yes
Boric acid (H3BO3), sodium salt (1:1)	-	14890-53-0			yes
Boric acid (H3BO3), sodium salt, hydrate	-	25747-83-5			yes
Boric acid, sodium salt	215-604-1	1333-73-9			yes
Borrelia burgdorferi	-	-		B Bacteria and similar species
Borrelia duttonii	-	-		B Bacteria and similar species
Borrelia recurrentis	-	-		B Bacteria and similar species
Borrelia spp.	-	-		B Bacteria and similar species
Bovine spongiform encephalopathy (BSE) and other related animal TSEs	-	-		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.
Brucella abortus	-	-		B Bacteria and similar species
Brucella canis	-	-		B Bacteria and similar species
Brucella melitensis	-	-		B Bacteria and similar species
Brucella suis	-	-		B Bacteria and similar species
Brugia malayi	-	-		P Parasites
Brugia pahangi	-	-		P Parasites
Buffalopox 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.
Bunyamwera 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.
Burkholderia mallei	-	-		B Bacteria and similar species
Burkholderia pseudomallei	-	-		B Bacteria and similar species
Butyl 4-hydroxybenzoate	202-318-7	94-26-8			yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3	208-953-6	548-62-9			yes
Cadmium chloride, hydrate (2:5)	640-998-0	7790-78-5			yes
Cadmium nitrate	-	-			yes
Cadmium sulphate;cadmium sulphate show/hide Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 \| CAS no: 15244-35-6 Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 \| CAS no: 7790-84-3	233-331-6	10124-36-4;31119-53-6			yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)	231-152-8	7440-43-9			yes
Calcium arsenate	231-904-5	7778-44-1			yes
California 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.
Campylobacter fetus	-	-		B Bacteria and similar species
Campylobacter jejuni	-	-		B Bacteria and similar species
Campylobacter spp.	-	-		B Bacteria and similar species
Candida albicans	-	-		F Fungi
Candida tropicalis	-	-		F Fungi
Capillaria philippinensis	-	-		P Parasites
Capillaria spp.	-	-		P Parasites
Cardiobacterium hominis	-	-		B Bacteria and similar species
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.

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EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

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

RELEVANT LEGISLATION

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Last updated 14 May 2024. Database contains 4821 unique substances/entries.

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