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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
Clostridium tetani
-
-
B Bacteria and similar species
clothianidin (ISO); 3-[(2-chloro-1,3-thiazol-5-yl)methyl]-2-methyl-1-nitroguanidine
433-460-1
210880-92-5
Acute Tox. 4
Coal liquids, liq. solvent extn. [The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.]
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Coal liquids, liq. solvent extn. soln. [The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydro-genated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.]
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
cobalt
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
cobalt carbonate
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt di(acetate)
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dichloride
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dimolybdenum nickel octaoxide
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt dinitrate
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
cobalt nickel dioxide
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt nickel gray periclase; C.I. Pigment Black 25; C.I. 77332
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt nickel oxide
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt oxide
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
cobalt sulfate
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt sulfide
215-273-3
1317-42-6
Skin Sens. 1
Coccidioides inunitis
-
-
F Fungi
colchicine
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
colecalciferol; cholecalciferol; Vitamin D3
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
Coltivirus
-
-
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.
complex of cobalt(III)-bis(N-phenyl-4-(5-ethylsulfonyl-2-hydroxyphenylazo)-3-hydroxynaphthylamide), hydrated(n H2O,2
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
condensation product of: 3-(7-carboxyhept-1-yl)-6-hexyl-4-cyclohexene-1,2-dicarboxylic acid with polyamines (primarily; amino-ethyl-piperazine and triethylenetetramine)
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Confidential or not yet assessed substance
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
STOT RE 2
constitutional isomers of penta-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hexa-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hepta-O-allyl-β-D-fructofuransoyl-α-D-glucopyranoside
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
copper chloride; copper (I) chloride; cuprous chloride
231-842-9
7758-89-6
Acute Tox. 4
copper dihydroxide; copper(II) hydroxide
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
copper flakes (coated with aliphatic acid)
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
copper sulphate
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
copper sulphate pentahydrate
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
copper(II) carbonate-copper(II) hydroxide (1:1)
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
copper(II) methanesulfonate
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
coriandrol; (S)-3,7-dimethyl-1,6-octadien-3-ol; d-linalool
204-810-7
126-90-9
Skin Sens. 1B
Coronaviridae
-
-
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.
Corynebacterium diphtheriae
-
-
B Bacteria and similar species
Corynebacterium minutissimum
-
-
B Bacteria and similar species
Corynebacterium pseudotuberculosis
-
68583-16-4
B Bacteria and similar species
Corynebacterium spp.
-
-
B Bacteria and similar species
coumachlor (ISO); 3-[1-(4-chlorophenyl)-3-oxobutyl]-4-hydroxycoumarin
201-378-1
81-82-3
STOT RE 2
coumafuryl (ISO); fumarin; (RS)-3-(1-(2-furyl)-3-oxobutyl)4-hydroxycoumarin; 4-hydroxy-3-[3-oxo-1-(2-furyl)butyl]coumarin
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
coumaphos (ISO); O-3-chloro-4-methylcoumarin-7-yl O,O-diethyl phosphorothioate
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
coumatetralyl; 4-hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl)coumarin
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
coumithoate (ISO); O,O-diethyl O-7,8,9,10-tetrahydro-6-oxo-benzo(c)chromen-3-yl phosphorothioate
-
572-48-5
Acute Tox. 3
Cowpox 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.
Coxiella burnetii
-
-
B Bacteria and similar species
Coxsackie 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.
Creosote [The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.]
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Creosote oil [ complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200 °C to 325 °C (392°F to 617°F).]
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
Creosote oil, acenaphthene fraction, acenaphthene-free; Wash Oil Redistillate [The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.]
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Creosote oil, acenaphthene fraction; Wash Oil [ complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240 o C to 280 o C (464°F to 536 °F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.]
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
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