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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 26 April 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
Parainfluenza viruses types 1 to 4
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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.
Pasteurella multocida
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B Bacteria and similar species
Pasteurella spp.
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B Bacteria and similar species
Penicillium marneffei
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F Fungi
pentapotassium 2-(4-(5-[1-(2,5-disulfonatophenyl)-4,5-dihydro-3-methylcarbamoyl-5-oxopyrazol-4-ylidene]-3-methyl-1,3-pentadienyl)-3-methylcarbamoyl-5-oxidopyrazol-1yl)benzene-1,4-disulfonate
418-270-7
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Skin Sens. 1
pentasodium monohydrogen 6-chloro-3,10-bis[2-[4-chloro-6-(2,4-disulfophenylamino)-1,3,5-triazin-2-yl-amino]ethylamino]-13-ethylbenzo[5.6][1.4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
414-910-4
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Eye Dam. 1; Skin Sens. 1
Peptostreptococcus anaerobius
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B Bacteria and similar species
Phenol with C12 alkylated branched olefin
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yes
Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)
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Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
799-972-3
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yes
Phenol, para alkylation products with C12-rich branched olefins from propene oligomerization
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yes
Plasmodium falciparum
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P Parasites
Plasmodium spp. (human and simian)
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P Parasites
Plesiomonas shigelloides
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B Bacteria and similar species
Polioviruses
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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.
poly-(methyl methacrylate)-co-(butylmethacrylate)-co-(4-acryloxybutyl-isopropenyl-α, α-dimethylbenzyl carbamate)-co-(maleicanhydride)
RX-33
419-590-1
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Flam. Sol. 1; Skin Sens. 1
Porphyromonas spp.
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B Bacteria and similar species
potassium 3-iodo-6-methylbenzenesulfonate
426-300-5
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Eye Dam. 1
potassium sodium 4-(4-chloro-6-(3,6-disulfonato-7-(5,8-disulfonato-naphthalen-2-ylazo)-8-hydroxy-naphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-(2-sulfatoethanesulfonyl)-phenylazo)-naphthalene-1,7-disulfonate
REAKTIVROT 2713
412-490-7
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Skin Sens. 1
potassium sodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulphonato-6-(2-sulphonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-ylamino) phenyl-N-methyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulphonatophenylazo)naphthalene-2,7-disulphonat
C.I. REACTIVE RED 231
402-150-6
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Eye Irrit. 2; Skin Sens. 1
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)
425-830-4
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Eye Dam. 1
Powassan
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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.
Prevotella spp.
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B Bacteria and similar species
product by process iron complex of azo dyestuffs obtained by coupling a mixture of diazotized 2-amino-1-hydroxybenzene-4-sulfanilide and 2-amino-1-hydroxybenzene-4-sulfonamide with resorcin, the obtained mixture being subsequently submitted to a second coupling reaction with a mixture of diazotized 3-aminobenzene-1-sulfonic acid (metanilic acid) and 4'-amino-4-nitro-1,1'-diphenylamine-2-sulfonic acid and metallization with ferric chloride, sodium salt
BROWN JR 547
419-260-5
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Eye Dam. 1
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride
425-740-5
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Eye Dam. 1
Prospect Hill virus
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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.
Proteus mirabilis
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B Bacteria and similar species
Proteus penneri
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B Bacteria and similar species
Proteus vulgaris
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B Bacteria and similar species
Providencia alcalifaciens
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B Bacteria and similar species
Providencia rettgeri
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B Bacteria and similar species
Providencia spp.
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B Bacteria and similar species
Puumala virus
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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.
pyrethrins including cinerins, with the exception of those specified elsewhere in this Annex
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Acute Tox. 4
Rabbitpox virus
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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.
Rabies virus
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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.
reaction mass of 1,1'-((dihydroxyphenylene)bis(azo-3,1-phenylenazo(1-(3-dimethylaminopropyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))dipyridinium dichloride dihydrochloride, mixed isomers and 1-(1-(3-dimethylaminopropyl)-5-(3-((4-(1-(3-dimethylaminopropyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo)phenylazo)-2,4(or 2,6 or 3,5)-dihydroxyphenylazo)phenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium dichloride
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
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Skin Sens. 1
reaction mass of 1,1'-(methylenebis(4,1-phenylene))dipyrrole-2,5-dione and N-(4-(4-(2,5-dioxopyrrol-1-yl)benzyl)phenyl)acetamide and 1-(4-(4-(5- oxo-2H-2-furylide namino)benzyl)phenyl)pyrrole-2,5-dione
DESBIMID
401-970-1
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Skin Sens. 1
reaction mass of 2-acryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate and 2-methacryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate
KAYARAD R-825
405-360-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of 2-chloroethyl chloropropyl 2-chloroethylphosphonate, reaction mass of isomers and 2-chloroethyl chloropropyl 2-chloropropylphosphonate, reaction mass of isomers
ADINE CP 31
401-740-0
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Acute Tox. 4
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE
915-270-3
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yes
reaction mass of 5-heptyl-1,2,4- triazol-3-ylamine and 5-nonyl-1,2,4-triazol-3-ylamine
PK 323
401-940-8
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Acute Tox. 4; Eye Irrit. 2
reaction mass of C12-14-tert-alkylammonium diphenyl phosphorothioate and dinonyl sulphide (or disulphide)
X 3761
400-930-0
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of iron complexes of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-(5-amino-sulfonyl-2-hydroxyphenylazo)benzene; and: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-2-sulfophenylamino)phenylazo]benzene (n=2,5,6)
BROWN JR 543
414-150-3
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Skin Sens. 1
reaction mass of isomers of: sodium [(2-hydroxyethylsulfamoyl){][}2-(2-piperazin-1-ylethylamino)ethylsulfamoyl][2-(4-aminoethylpiperazine-1-yl)ethylsulfamoyl{](sulfamoyl)[}(sulfonatophthalocyaninato)]copper(II)
SUBSTANCE S166075
424-270-8
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Eye Dam. 1
reaction mass of isomers of: sodium phenethylnaphthalenesulfonate; sodium naphthylethylbenzenesulfonate
UNISOL S
405-760-0
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Eye Dam. 1; Skin Sens. 1
reaction mass of isomers of: α-((dimethyl)biphenyl)-ω-hydroxypoly(oxyethylene)
EMULGATOR SWA; EMULVIN SWA
406-325-8
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Acute Tox. 4
reaction mass of mono to tetra(lithium and/or sodium)3-amino-10-[4-(4-amino-3-sulfonatoanilino)-6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to tetra(lithium and/or sodium)3-amino-10-[4,6-bis(4-amino-3-sulfonatoanilino)-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to penta(lithium and/or sodium)10,10'-diamino-6,6',13,13'-tetrachloro-3,3'-[6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10-amino-6,6', 13,13'-tetrachloro-10'[4-(4-amino-3-sulfonatoanilino)-[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10,10'-diamino-6,6',3,3'[(2-sulfonato)-1,4-phenylenediiminobis[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate
430-200-7
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Eye Dam. 1
reaction mass of n-octadecylaminodiethyl bis(hydrogen maleate); n-octadecylaminodiethyl hydrogen maleate hydrogenphthalate
ETHOXYLATED POLYESTER RESIN
405-960-8
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Skin Sens. 1
reaction mass of trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate
436-890-6
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Eye Dam. 1
reaction mass of α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene) and α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1
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