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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
lead sulfochromate yellow; C.I. Pigment Yellow 34 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
Lead titanium trioxide
235-038-9
12060-00-3
yes
Lead titanium zirconium oxide
235-727-4
12626-81-2
yes
lead(II) methanesulphonate
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
Legionella pneumophila
-
-
B Bacteria and similar species
Legionella spp.
-
-
B Bacteria and similar species
Leishmania brasiliensis
-
-
P Parasites
Leishmania donovani
-
-
P Parasites
Leishmania ethiopica
-
-
P Parasites
Leishmania major
-
-
P Parasites
Leishmania mexicana
-
-
P Parasites
Leishmania peruviana
-
-
P Parasites
Leishmania spp.
-
-
P Parasites
Leishmania tropica
-
-
P Parasites
lenacil (ISO); 3-cyclohexyl-6,7- dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione
218-499-0
2164-08-1
Carc. 2
leptophos (ISO); O-4-bromo-2,5-dichlorophenyl O-methyl phenylphosphorothioate
244-472-8
21609-90-5
Acute Tox. 3; STOT SE 1; Acute Tox. 4
Leptospira interrogans (all serovars)
-
-
B Bacteria and similar species
leucomalachite green; N, N,N',N'-tetramethyl-4,4'-benzylidenedianiline
204-961-9
129-73-7
Carc. 2; Muta. 2
licareol; (R)-3,7-dimethyl-1,6-octadien-3-ol; l-linalool
204-811-2
126-91-0
Skin Sens. 1B
Light oil (coal), coke-oven; Crude benzole [he volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700 °C (1 292 °F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.]
The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.
266-012-5
65996-78-3
Carc. 1B; Muta. 1B
Light oil (coal), semi-coking process; Fresh oil [he volatile organic liquid condensed from the gasevolved in the low-temperature (less than 700 °C (1 292 °F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.]
The volatile organic liquid condensed from the gas evolved in the low-temperature (less than 700°C (1292°F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.
292-635-7
90641-11-5
Carc. 1B; Muta. 1B
Ligroine; Low boiling point naphtha [ complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20 °C to 135 °C (58°F to 275°F).]
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
linalool; 3,7-dimethyl-1,6-octadien-3-ol; dl-linalool
201-134-4
78-70-6
Skin Sens. 1B
lindane (ISO); γ-HCH or γ-BHC; γ-1,2,3,4,5,6-hexachlorocyclohexane
200-401-2
58-89-9
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Lact.
linuron (ISO); 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea
206-356-5
330-55-2
Repr. 1B; Carc. 2; Acute Tox. 4; STOT RE 2
Listeria ivanovii
-
-
B Bacteria and similar species
Listeria monocytogenes
-
-
B Bacteria and similar species
lithium
231-102-5
7439-93-2
Water-react. 1; Skin Corr. 1B
lithium 1-amino-4-(4-tert-butylanilino)anthraquinone-2-sulfonate
BLUE 14 52 200
411-140-0
125328-86-1
Eye Dam. 1; Skin Sens. 1
lithium 3-oxo-1,2(2H)-benzisothiazol-2-ide
LI-BIT
411-690-1
111337-53-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
lithium bis(trifluoromethylsulfonyl)imide
BIS TRIFLUOROMETHANE SULFONIMIDE LITHIUM; FLUORAD BRAND LITHIUM TRIFLUOROMETHANESULPHONIMIDE HQ-115
415-300-0
90076-65-6
Acute Tox. 3; STOT RE 2; Skin Corr. 1B
lithium methanolate; lithium methoxide
212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
lithium nickel dioxide
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
lithium potassium sodium N,N''-bis{6-[7-[4-(4-chloro-1,3,5-triazin-2-yl)amino-4-(2-ureidophenylazo)]naphthalene-1,3,6-trisulfonato}-N'-(2-aminoethyl)piperazine
427-850-9
202667-43-4
Skin Sens. 1
lithium sodium (4-((5-chloro-2-hydroxyphenyl)azo)-2,4-dihydro-5-methyl-3H-pyrazol-3-onato(2-))(3-((4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl)azo)-4-hydroxy-5-nitrobenzenesulfonato(3-)) chromate(2-)
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
lithium sodium 4,4', 4''-(nitrilotris(ethane-2,1-diylimino(6-chloro-1,3,5-triazine-4,2-diyl)imino))tris(5-hydroxy-6-(1-sulfonaphthalene-2-ylazo)-2,7-naphthalene)disulfonate
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulphonatophenylazo)-5-hydroxy-3-(4-(2-(sulphonatooxy)ethylsulphonyl)phenylazo)naphthalene-2,7-disulphonate
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
Loa loa
-
-
P Parasites
Louping ill
-
-
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.
Lubricating greases; Grease [A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.]
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.
278-011-7
74869-21-9
Carc. 1B
Lubricating oils (petroleum), base oils, paraffinic; Baseoil — unspecified [ complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100 °F (23cSt at 40 °C).]
A complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100°F (23cSt at 40°C).
297-474-6
93572-43-1
Carc. 1B
Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40 °C. It contains a relatively large proportion of saturated hydrocabons.]
A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-737-9
72623-86-0
Carc. 1B
Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C32 and produced a finished oil with a viscosity in the order of 17cSt to 23cSt at 40 °C (104 °F.]
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C32 and produces a finished oil with a viscosity in the order of 17cSt to 23cSt at 40°C (104°F).
309-875-6
101316-70-5
Carc. 1B
Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated; Baseoil — unspecified
295-423-2
92045-42-6
Carc. 1B
Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed; Baseoil — unspecified
307-034-8
97488-95-4
Carc. 1B
Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550 °C (698 °F to 1022°F).]
A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-594-8
94733-15-0
Carc. 1B
Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370 °C to 550 °C (698 °F to 1022 °F).]
A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-595-3
94733-16-1
Carc. 1B
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