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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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

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Substance Name	EC No.	CAS No.	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4	229-851-8	6786-83-0		yes
Zirconia Aluminosilicate Refractory Ceramic Fibres	936-037-2	-		yes
Yersinia spp.	-	-	B Bacteria and similar species
Yersinia pseudotuberculosis	-	-	B Bacteria and similar species
Yersinia pestis	-	-	B Bacteria and similar species
Yersinia enterocolitica	-	-	B Bacteria and similar species
Yellow 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.
Yatapox 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.
Wuchereria bancrofti	-	-	P Parasites
Whitepox 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.
Western 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.
West Nile fever 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.
Wesselsbron 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.
Vibrio spp.	-	-	B Bacteria and similar species
Vibrio parahaemolyticus	-	-	B Bacteria and similar species
Vibrio cholerae (including El Tor)	-	-	B Bacteria and similar species
Vesicular stomatitis 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.
Venezuelan 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.
Variola (major and minor) 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.
Variant 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.
Vaccinia 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.
Trypanosoma cruzi	-	-	P Parasites
Trypanosoma brucei rhodesiense	-	-	P Parasites
Trypanosoma brucei gambiense	-	-	P Parasites
Trypanosoma brucei brucei	-	-	P Parasites
Trisodium orthoborate	238-253-6	14312-40-4		yes
Tris(4-nonylphenyl, branched) phosphite show/hide tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 \| CAS no: - Phenol, p-isononyl-, phosphite (3:1) EC / List no: - \| CAS no: 31631-13-7 Tris(nonylphenyl) phosphite EC / List no: 247-759-6 \| CAS no: 26523-78-4 Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 \| CAS no: 3050-88-2 Phenol, p-sec-nonyl-, phosphite EC / List no: - \| CAS no: 106599-06-8	799-976-5	-		yes
Trilead dioxide phosphonate	235-252-2	12141-20-7		yes
Trilead diarsenate	222-979-5	3687-31-8		yes
Trilead bis(carbonate)dihydroxide	215-290-6	1319-46-6		yes
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)	274-462-9	70225-16-0		yes
Tricosafluorododecanoic acid	206-203-2	307-55-1		yes
Trichuristrichiura	-	-	P Parasites
Trichophyton spp.	-	-	F Fungi
Trichophyton rubrum	-	-	F Fungi
Trichinella spiralis	-	-	P Parasites
Treponema spp.	-	-	B Bacteria and similar species
Treponema pertenue	-	-	B Bacteria and similar species
Treponema pallidum	-	-	B Bacteria and similar species
Treponema carateum	-	-	B Bacteria and similar species
Toxoplasma gondii	-	-	P Parasites
Toxocara canis	-	-	P Parasites
Toscana 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.
Toroviridae	-	-	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.
Tonate 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.
Tick-borne orthomyxoviridae: Dhori and Thogoto	-	-	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.
Tetralead trioxide sulphate	235-380-9	12202-17-4		yes
Tetraethyllead	201-075-4	78-00-2		yes
Tetradecane, chloro derivs.	-	198840-65-2		yes
Terphenyl, hydrogenated	262-967-7	61788-32-7		yes
Terphenyl, hydrogenated	262-967-7	61788-32-7		yes
Taenia solium	-	-	P Parasites
Taenia saginata	-	-	P Parasites
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate	626-360-4	15244-35-6		yes
Sulfurous acid, lead salt, dibasic	263-467-1	62229-08-7		yes
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)	616-572-5	7790-84-3		yes
Strongyloides stercoralis	-	-	P Parasites
Strongyloides spp.	-	-	P Parasites
Streptococcus suis	-	-	B Bacteria and similar species
Streptococcus spp.	-	-	B Bacteria and similar species
Streptococcus pyogenes	-	-	B Bacteria and similar species
Streptococcus pneumoniae	-	-	B Bacteria and similar species
Streptobacillus moniliformis	-	-	B Bacteria and similar species
Staphylococcusaureus	-	-	B Bacteria and similar species
St Louis 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.
Sporothrix schenckii	-	-	F Fungi
Sodium peroxometaborate;sodium peroxometaborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	231-556-4	7632-04-4		yes
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	239-172-9	15120-21-5		yes
Sodium dichromate	616-541-6	7789-12-0		yes
SIV	-	-	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.
Sindbis 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.
Sin Nombre	-	-	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.
Silicic acid, lead salt	234-363-3	11120-22-2		yes
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped	272-271-5	68784-75-8		yes
Shigella sonnei	-	-	B Bacteria and similar species
Shigella flexneri	-	-	B Bacteria and similar species
Shigella dysenteriae, other than Type 1	-	-	B Bacteria and similar species
Shigella dysenteriae (Type 1)	-	-	B Bacteria and similar species
Shigella boydii	-	-	B Bacteria and similar species
Severe acute respiratory syndrome coronavirus 2	-	-	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.
Serpulina spp.	-	-	B Bacteria and similar species
Seoul 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.
Semliki Forest 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.
Schistosoma mekongi	-	-	P Parasites
Schistosoma mansoni	-	-	P Parasites
Schistosoma japonicum	-	-	P Parasites
Schistosoma intercalatum	-	-	P Parasites
Schistosoma haematobium	-	-	P Parasites
Scedosporium prolificans (inflatum)	-	-	F Fungi
Scedosporium apiospermum	-	-	F Fungi
Sarcocystis suihominis	-	-	P Parasites
Sandfly 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.
Salts of Perfluorohexane-1-sulfonic acid show/hide 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt (1:1) EC / List no: - \| CAS no: 55120-77-9 Sulfonium, triphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 144116-10-9 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, neodymium(3+) salt (3:1) EC / List no: - \| CAS no: 41184-65-0 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, cesium salt (1:1) EC / List no: - \| CAS no: 92011-17-1 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, zinc salt EC / List no: - \| CAS no: 70136-72-0 Dibenzo[k,n][1,4,7,10,13]tetraoxathiacyclopentadecinium, 19-[4-(1,1-dimethylethyl)phenyl]-6,7,9,10,12,13-hexahydro-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 928049-42-7 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd.with 2-methyl-2-propanamine (1:1) EC / List no: - \| CAS no: 202189-84-2 Phosphonium, triphenyl(phenylmethyl)-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 1000597-52-3 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with N,N-diethylethanamine (1:1) EC / List no: - \| CAS no: 72033-41-1 Sulfonium, (thiodi-4,1-phenylene)bis[diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:2) EC / List no: - \| CAS no: 421555-73-9 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, yttrium(3+) salt (3:1) EC / List no: - \| CAS no: 41242-12-0 N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - \| CAS no: 108427-55-0 Beta-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - \| CAS no: 1329995-45-0 Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 \| CAS no: 68259-08-5 Iodonium, bis[(1,1-dimethylethyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) (9CI) EC / List no: - \| CAS no: 866621-50-3 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. With pyrrolidine (1:1) EC / List no: - \| CAS no: 1187817-57-7 Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1) EC / List no: 274-462-9 \| CAS no: 70225-16-0 Gamma-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - \| CAS no: 1329995-69-8 Iodonium, bis[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 213740-81-9 Perfluorohexane-1-sulphonic acid EC / List no: 206-587-1 \| CAS no: 355-46-4 Methanaminium, N,N,N-trimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) EC / List no: - \| CAS no: 189274-31-5 Sulfonium, [4-[(2-methyl-1-oxo-2-propenyl)oxy]phenyl]diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1), polymer with 2-ethyltricyclo[3.3.1.13,7]dec-2-yl 2-methyl-2-propenoate, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl 2-methyl-2-propenoate and tetrahydro-2-oxo-3-furanyl 2-methyl-2-propenoate EC / List no: - \| CAS no: 911027-69-5 Quinolinium, 1-(carboxymethyl)-4-[2-[4-[4-(2,2-diphenylethenyl)phenyl]-1,2,3,3a,4,8b-hexahydrocyclopent[b]indol-7-yl]ethenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 1462414-59-0 Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 1310480-27-3 Iodonium, bis[4-(1,1-dimethylpropyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic EC / List no: - \| CAS no: 421555-74-0 Sulfonium, tris[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 425670-70-8 Sulfonium, (4-methylphenyl)diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 910606-39-2 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, gallium salt (9CI) EC / List no: - \| CAS no: 341035-71-0 Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 \| CAS no: 3871-99-6 Iodonium, diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 153443-35-7 Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 1310480-24-0 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, sodium salt EC / List no: - \| CAS no: 82382-12-5 N,N,N-tributylbutan-1-aminium tridecafluorohexane-1-sulfonate EC / List no: - \| CAS no: 108427-54-9 Sulfonium, bis(4-methylphenyl)phenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 341548-85-4 Sulfonium, [4-[(2-methyl-1-oxo-2-propen-1-yl)oxy]phenyl]diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 911027-68-4 1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, scandium(3+) salt (3:1) EC / List no: - \| CAS no: 350836-93-0 Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(phenylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - \| CAS no: 1310480-28-4	-	-		yes
Salts of Perfluorobutane sulfonic acid	-	-		yes
Salts of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-		yes
Salmonella typhimurium	-	68583-35-7	B Bacteria and similar species
Salmonella typhi	-	-	B Bacteria and similar species
Salmonella paratyphi A, B, C	-	-	B Bacteria and similar species
Salmonella enteritidis	-	-	B Bacteria and similar species
Salmonella arizonae	-	-	B Bacteria and similar species
Salmonella (other serovars)	-	-	B Bacteria and similar species
Sabia 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.
S-(tricyclo(5.2.1.0'2,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate X4261	401-850-9	255881-94-8		yes
Russian spring-summer 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.
Rubivirus	-	-	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.
Ross River 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.
Rocio	-	-	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.
Rift Valley 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.
Rickettsia typhi	-	-	B Bacteria and similar species
Rickettsia tsutsugamushi	-	-	B Bacteria and similar species
Rickettsia spp.	-	-	B Bacteria and similar species
Rickettsia rickettsii	-	-	B Bacteria and similar species
Rickettsia prowazekii	-	-	B Bacteria and similar species
Rickettsia montana	-	-	B Bacteria and similar species
Rickettsia conorii	-	-	B Bacteria and similar species
Rickettsia canada	-	-	B Bacteria and similar species
Rickettsia akari	-	-	B Bacteria and similar species
Rhodococcusequi	-	-	B Bacteria and similar species
Rhinoviruses	-	-	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.
Reuviruses	-	-	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.
Respiratory syncytial 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.
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)	939-460-0	1471311-26-8		yes
Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.	-	-		yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane	413-720-9	117933-89-8		yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane	413-720-9	117933-89-8		yes
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	-		yes
Rabies 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.
Rabbitpox 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.
Pyrochlore, antimony lead yellow This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.	232-382-1	8012-00-8		yes
Pyrene	204-927-3	129-00-0		yes
Puumala 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.
Pseudomonas aeruginosa	-	68583-29-9	B Bacteria and similar species
Providencia spp.	-	-	B Bacteria and similar species
Providencia rettgeri	-	-	B Bacteria and similar species
Providencia alcalifaciens	-	-	B Bacteria and similar species
Proteus vulgaris	-	-	B Bacteria and similar species
Proteus penneri	-	-	B Bacteria and similar species
Proteus mirabilis	-	-	B Bacteria and similar species
Prospect Hill 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.
Prevotella spp.	-	-	B Bacteria and similar species
Powassan	-	-	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.
Potassium perfluorohexane-1-sulphonate	223-393-2	3871-99-6		yes
Potassium hydroxyoctaoxodizincatedichromate	234-329-8	11103-86-9		yes
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate	266-578-3	67118-55-2		yes
Porphyromonas spp.	-	-	B Bacteria and similar species
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5	618-541-1	9036-19-5		yes
Polioviruses	-	-	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.
Plesiomonas shigelloides	-	-	B Bacteria and similar species
Plasmodium spp. (human and simian)	-	-	P Parasites
Plasmodium falciparum	-	-	P Parasites
Phenol, tetrapropylene	-	57427-55-1		yes
Phenol, para alkylation products with C12-rich branched olefins from propene oligomerization	-	-		yes
Phenol, nonyl-, branched	291-844-0	90481-04-2		yes
Phenol, heptyl derivs.	276-743-1	72624-02-3		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) show/hide Phenol, tetrapropylene- EC / List no: - \| CAS no: 57427-55-1 Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 \| CAS no: 74499-35-7 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, 4-isododecyl- EC / List no: 608-055-8 \| CAS no: 27147-75-7	799-972-3	-		yes
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched	310-154-3	121158-58-5		yes
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched	310-154-3	121158-58-5		yes
Phenol, 4-nonyl-, phosphite (3:1)	608-492-4	3050-88-2		yes
Phenol with C12 alkylated branched olefin	-	-		yes
Phenanthrene	201-581-5	85-01-8		yes
Perfluorohexane-1-sulphonic acid	206-587-1	355-46-4		yes
Perfluorobutane sulfonic acid; PFBS	206-793-1	375-73-5		yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	234-390-0	11138-47-9;12040-72-1;37244-98-7		yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	234-390-0	11138-47-9;12040-72-1;37244-98-7		yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	234-390-0	11138-47-9;12040-72-1;37244-98-7		yes
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	600-419-4	10332-33-9		yes
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	600-611-8	10486-00-7		yes
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]	603-902-8	13517-20-9		yes
Peptostreptococcus anaerobius	-	-	B Bacteria and similar species
Pentazinc chromate octahydroxide	256-418-0	49663-84-5		yes
Pentalead tetraoxide sulphate	235-067-7	12065-90-6		yes
Pentacosafluorotridecanoic acid	276-745-2	72629-94-8		yes
Penicillium marneffei	-	-	F Fungi
Pasteurella spp.	-	-	B Bacteria and similar species
Pasteurella multocida	-	-	B Bacteria and similar species
Parainfluenza viruses types 1 to 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.
Paragonimus westermani	-	-	P Parasites
Paraffins (petroleum), normal C>10, chloro	307-202-0	97553-43-0		yes
Paraffin oils, chloro	287-196-3	85422-92-0		yes
Paracoccidioides brasiliensis	-	-	F Fungi
p-nonylphenol	203-199-4	104-40-5		yes
p-isononylphenol	247-770-6	26543-97-5		yes
p-(1-methyloctyl)phenol	241-427-4	17404-66-9		yes
p-(1,1-Dimethylpropyl)phenol	201-280-9	80-46-6		yes
p-(1,1-dimethylheptyl)phenol	250-339-5	30784-30-6		yes
Other Tacaribe complex 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.
Other LCM-Lassa complex 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.
Other known alphaviruses	-	-	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.
Other hantaviruses	-	-	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.
Other flaviviruses known to be pathogenic	-	-	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.
Other Caliciviridae	-	-	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.
Other bunyaviridae known to be pathogenic	-	-	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.
Oropouche 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.
Orf 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.
Orbiviruses	-	-	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.
Orange lead; lead tetroxide	215-235-6	1314-41-6		yes
Opisthorchis spp.	-	-	P Parasites
Opisthorchis felineus	-	-	P Parasites
Onchocerca volvulus	-	-	P Parasites
Omsk	-	-	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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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 26 srpnja 2024. Database contains 4821 unique substances/entries.

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