EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.

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Prikazano 1 - 200 od 4.917 rezultata.

Substance Name	EC No.	CAS No.	EU REACH: List of SVHC	EU_BA Directive 2000/54/EC
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4	229-851-8	6786-83-0	C Carcinogenic (article 57a)		Details
Zirconia Aluminosilicate Refractory Ceramic Fibres	936-037-2	-	C Carcinogenic (article 57a)		Details
Yersinia spp.	-	-		B Bacteria and similar species	Details
Yersinia pseudotuberculosis	-	-		B Bacteria and similar species	Details
Yersinia pestis	-	-		B Bacteria and similar species	Details
Yersinia enterocolitica	-	-		B Bacteria and similar species	Details
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.	Details
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.	Details
Wuchereria bancrofti	-	-		P Parasites	Details
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.	Details
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.	Details
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.	Details
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.	Details
Vibrio spp.	-	-		B Bacteria and similar species	Details
Vibrio parahaemolyticus	-	-		B Bacteria and similar species	Details
Vibrio cholerae (including El Tor)	-	-		B Bacteria and similar species	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
Trypanosoma cruzi	-	-		P Parasites	Details
Trypanosoma brucei rhodesiense	-	-		P Parasites	Details
Trypanosoma brucei gambiense	-	-		P Parasites	Details
Trypanosoma brucei brucei	-	-		P Parasites	Details
Trisodium orthoborate	238-253-6	14312-40-4	R Toxic for reproduction (article 57c)		Details
Tris(4-nonylphenyl, branched) phosphite show/hide Phenol, p-sec-nonyl-, phosphite EC / List no: - \| CAS no: 106599-06-8 Phenol, p-isononyl-, phosphite (3:1) EC / List no: - \| CAS no: 31631-13-7 tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 \| CAS no: - 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	799-976-5	-	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
Trilead dioxide phosphonate	235-252-2	12141-20-7	R Toxic for reproduction (article 57c)		Details
Trilead diarsenate	222-979-5	3687-31-8	C Carcinogenic (article 57a) R Toxic for reproduction (article 57c)		Details
Trilead bis(carbonate)dihydroxide	215-290-6	1319-46-6	R Toxic for reproduction (article 57c)		Details
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)	274-462-9	70225-16-0	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Tricosafluorododecanoic acid	206-203-2	307-55-1	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Trichuristrichiura	-	-		P Parasites	Details
Trichophyton spp.	-	-		F Fungi	Details
Trichophyton rubrum	-	-		F Fungi	Details
Trichinella spiralis	-	-		P Parasites	Details
Treponema spp.	-	-		B Bacteria and similar species	Details
Treponema pertenue	-	-		B Bacteria and similar species	Details
Treponema pallidum	-	-		B Bacteria and similar species	Details
Treponema carateum	-	-		B Bacteria and similar species	Details
Toxoplasma gondii	-	-		P Parasites	Details
Toxocara canis	-	-		P Parasites	Details
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.	Details
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.	Details
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.	Details
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.	Details
Tetralead trioxide sulphate	235-380-9	12202-17-4	R Toxic for reproduction (article 57c)		Details
Tetraethyllead	201-075-4	78-00-2	R Toxic for reproduction (article 57c)		Details
Tetradecane, chloro derivs.	-	198840-65-2	PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Terphenyl, hydrogenated	262-967-7	61788-32-7	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Terphenyl, hydrogenated	262-967-7	61788-32-7	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Taenia solium	-	-		P Parasites	Details
Taenia saginata	-	-		P Parasites	Details
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate	626-360-4	15244-35-6	C Carcinogenic (article 57a) M Mutagen (article 57b) R Toxic for reproduction (article 57c) HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)		Details
Sulfurous acid, lead salt, dibasic	263-467-1	62229-08-7	R Toxic for reproduction (article 57c)		Details
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)	616-572-5	7790-84-3	C Carcinogenic (article 57a) M Mutagen (article 57b) R Toxic for reproduction (article 57c) HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)		Details
Strongyloides stercoralis	-	-		P Parasites	Details
Strongyloides spp.	-	-		P Parasites	Details
Streptococcus suis	-	-		B Bacteria and similar species	Details
Streptococcus spp.	-	-		B Bacteria and similar species	Details
Streptococcus pyogenes	-	-		B Bacteria and similar species	Details
Streptococcus pneumoniae	-	-		B Bacteria and similar species	Details
Streptobacillus moniliformis	-	-		B Bacteria and similar species	Details
Staphylococcusaureus	-	-		B Bacteria and similar species	Details
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.	Details
Sporothrix schenckii	-	-		F Fungi	Details
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	R Toxic for reproduction (article 57c)		Details
Sodium perfluoroheptanoate	243-518-4	20109-59-5	R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)		Details
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	R Toxic for reproduction (article 57c)		Details
Sodium dichromate	616-541-6	7789-12-0	C Carcinogenic (article 57a) M Mutagen (article 57b) R Toxic for reproduction (article 57c)		Details
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.	Details
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.	Details
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.	Details
Silicic acid, lead salt	234-363-3	11120-22-2	R Toxic for reproduction (article 57c)		Details
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped	272-271-5	68784-75-8	R Toxic for reproduction (article 57c)		Details
Shigella sonnei	-	-		B Bacteria and similar species	Details
Shigella flexneri	-	-		B Bacteria and similar species	Details
Shigella dysenteriae, other than Type 1	-	-		B Bacteria and similar species	Details
Shigella dysenteriae (Type 1)	-	-		B Bacteria and similar species	Details
Shigella boydii	-	-		B Bacteria and similar species	Details
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.	Details
Serpulina spp.	-	-		B Bacteria and similar species	Details
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.	Details
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.	Details
Schistosoma mekongi	-	-		P Parasites	Details
Schistosoma mansoni	-	-		P Parasites	Details
Schistosoma japonicum	-	-		P Parasites	Details
Schistosoma intercalatum	-	-		P Parasites	Details
Schistosoma haematobium	-	-		P Parasites	Details
Scedosporium prolificans (inflatum)	-	-		F Fungi	Details
Scedosporium apiospermum	-	-		F Fungi	Details
Sarcocystis suihominis	-	-		P Parasites	Details
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.	Details
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-, scandium(3+) salt (3:1) EC / List no: - \| CAS no: 350836-93-0 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 Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 \| CAS no: 68259-08-5 N,N,N-tributylbutan-1-aminium tridecafluorohexane-1-sulfonate EC / List no: - \| CAS no: 108427-54-9 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-, zinc salt EC / List no: - \| CAS no: 70136-72-0 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 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 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 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 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-, gallium salt (9CI) EC / List no: - \| CAS no: 341035-71-0 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 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 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 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 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 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 Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1) EC / List no: 274-462-9 \| CAS no: 70225-16-0 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 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 Perfluorohexane-1-sulphonic acid EC / List no: 206-587-1 \| CAS no: 355-46-4 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 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 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 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 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 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 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-, sodium salt EC / List no: - \| CAS no: 82382-12-5 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 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 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 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 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 N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - \| CAS no: 108427-55-0 Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 \| CAS no: 3871-99-6	-	-	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Salts of Perfluorobutane sulfonic acid	-	-	HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)		Details
Salts of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid	-	-	E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)		Details
Salt of 4,4'-Oxydianiline	-	-	C Carcinogenic (article 57a) M Mutagen (article 57b)		Details
Salmonella typhimurium	-	68583-35-7		B Bacteria and similar species	Details
Salmonella typhi	-	-		B Bacteria and similar species	Details
Salmonella paratyphi A, B, C	-	-		B Bacteria and similar species	Details
Salmonella enteritidis	-	-		B Bacteria and similar species	Details
Salmonella arizonae	-	-		B Bacteria and similar species	Details
Salmonella (other serovars)	-	-		B Bacteria and similar species	Details
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.	Details
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	PBT Persistent, Bioaccumulative and Toxic (article 57d)		Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
Rickettsia typhi	-	-		B Bacteria and similar species	Details
Rickettsia tsutsugamushi	-	-		B Bacteria and similar species	Details
Rickettsia spp.	-	-		B Bacteria and similar species	Details
Rickettsia rickettsii	-	-		B Bacteria and similar species	Details
Rickettsia prowazekii	-	-		B Bacteria and similar species	Details
Rickettsia montana	-	-		B Bacteria and similar species	Details
Rickettsia conorii	-	-		B Bacteria and similar species	Details
Rickettsia canada	-	-		B Bacteria and similar species	Details
Rickettsia akari	-	-		B Bacteria and similar species	Details
Rhodococcusequi	-	-		B Bacteria and similar species	Details
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.	Details
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.	Details
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.	Details
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	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
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	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
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	-	R Toxic for reproduction (article 57c)		Details
Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine	473-390-7	-	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
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.	Details
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.	Details
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	R Toxic for reproduction (article 57c)		Details
Pyrene	204-927-3	129-00-0	PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e)		Details
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.	Details
Pseudomonas aeruginosa	-	68583-29-9		B Bacteria and similar species	Details
Providencia spp.	-	-		B Bacteria and similar species	Details
Providencia rettgeri	-	-		B Bacteria and similar species	Details
Providencia alcalifaciens	-	-		B Bacteria and similar species	Details
Proteus vulgaris	-	-		B Bacteria and similar species	Details
Proteus penneri	-	-		B Bacteria and similar species	Details
Proteus mirabilis	-	-		B Bacteria and similar species	Details
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.	Details
Prevotella spp.	-	-		B Bacteria and similar species	Details
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.	Details
Potassium perfluorohexane-1-sulphonate	223-393-2	3871-99-6	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Potassium perfluoroheptanoate	701-468-5	21049-36-5	R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)		Details
Potassium hydroxyoctaoxodizincatedichromate	-	-	C Carcinogenic (article 57a)		Details
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate	266-578-3	67118-55-2	E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)		Details
Porphyromonas spp.	-	-		B Bacteria and similar species	Details
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5	618-541-1	9036-19-5	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
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.	Details
Plesiomonas shigelloides	-	-		B Bacteria and similar species	Details
Plasmodium spp. (human and simian)	-	-		P Parasites	Details
Plasmodium falciparum	-	-		P Parasites	Details
Phenol, tetrapropylene	-	57427-55-1	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenol, para alkylation products with C12-rich branched olefins from propene oligomerization	-	-	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenol, nonyl-, branched	291-844-0	90481-04-2	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
Phenol, methylstyrenated	270-966-8	68512-30-1	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Phenol, heptyl derivs.	276-743-1	72624-02-3	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
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, 4-isododecyl- EC / List no: 608-055-8 \| CAS no: 27147-75-7 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 Phenol, tetrapropylene- EC / List no: - \| CAS no: 57427-55-1 Phenol, dodecyl-, branched EC / List no: 310-154-3 \| CAS no: 121158-58-5 [No public or meaningful name is available] EC / List no: - \| CAS no: 27459-10-5	799-972-3	-	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched	310-154-3	121158-58-5	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched	310-154-3	121158-58-5	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenol, 4-nonyl-, phosphite (3:1)	608-492-4	3050-88-2	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
Phenol with C12 alkylated branched olefin	-	-	R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
Phenanthrene	201-581-5	85-01-8	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Perfluorohexane-1-sulphonic acid	206-587-1	355-46-4	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Perfluoroheptanoic acid and its salts show/hide potassium perfluoroheptanoate EC / List no: - \| CAS no: 21049-36-5 Sodium perfluoroheptanoate EC / List no: 243-518-4 \| CAS no: 20109-59-5 Ammonium perfluoroheptanoate EC / List no: 228-098-2 \| CAS no: 6130-43-4 Perfluoroheptanoic acid EC / List no: 206-798-9 \| CAS no: 375-85-9	-	-	R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)		Details
Perfluorobutane sulfonic acid; PFBS	206-793-1	375-73-5	HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)		Details
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	R Toxic for reproduction (article 57c)		Details
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	R Toxic for reproduction (article 57c)		Details
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	R Toxic for reproduction (article 57c)		Details
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	R Toxic for reproduction (article 57c)		Details
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	R Toxic for reproduction (article 57c)		Details
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	R Toxic for reproduction (article 57c)		Details
Peptostreptococcus anaerobius	-	-		B Bacteria and similar species	Details
Pentazinc chromate octahydroxide	256-418-0	49663-84-5	C Carcinogenic (article 57a)		Details
Pentalead tetraoxide sulphate	235-067-7	12065-90-6	R Toxic for reproduction (article 57c)		Details
Pentacosafluorotridecanoic acid	276-745-2	72629-94-8	VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Penicillium marneffei	-	-		F Fungi	Details
Pasteurella spp.	-	-		B Bacteria and similar species	Details
Pasteurella multocida	-	-		B Bacteria and similar species	Details
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.	Details
Paragonimus westermani	-	-		P Parasites	Details
Paraffins (petroleum), normal C>10, chloro	307-202-0	97553-43-0	PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Paraffin oils, chloro	287-196-3	85422-92-0	PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e)		Details
Paracoccidioides brasiliensis	-	-		F Fungi	Details
p-nonylphenol	203-199-4	104-40-5	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
p-isononylphenol	247-770-6	26543-97-5	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
p-(1-methyloctyl)phenol	241-427-4	17404-66-9	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
p-(1,1-Dimethylpropyl)phenol	201-280-9	80-46-6	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
p-(1,1-dimethylheptyl)phenol	250-339-5	30784-30-6	ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
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.	Details
Orange lead; lead tetroxide	215-235-6	1314-41-6	R Toxic for reproduction (article 57c)		Details

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EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

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Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.

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