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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Tar bases, coal, picoline fraction; Distillate Bases [Pyridine bases boiling in the range of approximately 125o C to 160o C (257oF 320oF) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.]
Pyridine bases boiling in the range of approximately 125°C to 160°C (257°F 320°F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.
295-548-2
92062-33-4
Carc. 1B; Muta. 1B
Tar bases, coal, toluidine fraction; Distillate Bases
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Tar oils, brown-coal; Light Oil [The distillate from lignite tar boiling in the range of approximately 80 °C to 250 °C (176°F to 482 °F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.]
The distillate from lignite tar boiling in the range of approximately 80°C to 250°C (176°F to 482°F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.
302-674-4
94114-40-6
Carc. 1B; Muta. 1B
Tar, coal, high-temp., distn. and storage residues; Coal Tar Solids Residue [Coke-and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.]
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
Tar, coal, storage residues; Coal Tar Solids Residue [The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.]
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
tetrakis(1,2,2,6,6-pentamethyl-4-piperidyl)-1,2,3,4-butanetetracarboxylate
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
tetramethylthiuram monosulphide
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
thioquinox(ISO); 2-thio-1,3-dithiolo(4,5,b)quinoxaline
202-272-8
93-75-4
Acute Tox. 4
trans-4-cyclohexyl-L-proline monohydrochloride
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
trans-4-phenyl-L-proline
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
trichloromethylstannane
213-608-8
993-16-8
Repr. 2
trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl (hydroxy) methylene]-3,5-dioxocyclohexanecarboxylate
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
trisodium bis(2-(5-chloro-4-nitro-2-oxidophenylazo)-5-sulphonato-1-naphtholato)chromate(1-)
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
trypsin
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
vanadium(IV) oxide hydrogen phosphate hemihydrate, lithium, zinc, molybdenum, iron and chlorine-doped
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
Waste solids, coal-tar pitch coking; Coal Tar Solids Residue [The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.]
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
α, α, α-trichlorotoluene; benzotrichloride
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α-trifluorotoluene; benzotrifluoride
202-635-0
98-08-8
Flam. Liq. 2
α, α-dichlorotoluene; benzylidene chloride; benzal chloride
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
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