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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Hydrocarbons, C8-12, catalytic cracker distillates; Low boiling point cat-cracked naphtha [ complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approxi mately 140 °C to 210 °C (284°F to 410°F).]
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C8-12, catalytic cracking, chem. neutralized, sweetened; Low boiling point cat-cracked naphtha
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C8-12, catalytic-cracking, chem. neutralized; Low boiling point cat-cracked naphtha [ complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predomi nantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130 °C to 210 °C (266°F to 410°F).]
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C9-12, hydrotreated, dearomatized; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C9-16, hydrotreated, dearomatized; Kerosine — unspecified [ complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.]
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-854-1
93763-35-0
Asp. Tox. 1
Hydrocarbons, C≥5, C5-6-rich; Low boiling point naphtha -unspecified
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed; Baseoil — unspecified
297-857-8
93763-38-3
Carc. 1B
Hydrocarbons, hydrotreated light naphtha distillates, solvent-refined; Low boiling point modified naphtha [ combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94 o C to 99 o C (201 °F to 210 °F).]
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
hydrochloric acid ... %;hydrogen chloride
231-595-7
7647-01-0
Press. Gas; Acute Tox. 3; Skin Corr. 1A
hydrochloric acid ... %;hydrogen chloride
231-595-7
7647-01-0
Skin Corr. 1B; STOT SE 3
hydrofluoric acid ... %;hydrogen fluoride
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
hydrofluoric acid ... %;hydrogen fluoride
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
hydrogen
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
hydrogen cyanide ... %; hydrocyanic acid ... %;hydrogen cyanide; hydrocyanic acid
200-821-6
74-90-8
Acute Tox. 2; Acute Tox. 1
hydrogen cyanide ... %; hydrocyanic acid ... %;hydrogen cyanide; hydrocyanic acid
200-821-6
74-90-8
Flam. Liq. 1; Acute Tox. 2
hydrogen peroxide solution... %
231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
hydrogen sodium N-carboxylatoethyl-N-octadec-9-enylmaleamate
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
hydrogen sulphide
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
hydroxo(2-(benzenesulfonamido)benzoato)zinc(II)
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
hydroxydisulfito platinum(II)acid
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
hydroxylamine 4-methylben; zenesulfonate
258-872-5
53933-48-5
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylamine dihydrogenphos; phate
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylamine phosphate
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylammonium chloride; hydroxylamine hydrochloride
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylammonium hydrogensulfate; hydroxylamine sulfate(1:1)
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylammonium nitrate
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxyphosphonoacetic acid
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
Hymenolepis diminuta
-
-
P Parasites
Hymenolepis nana
-
-
P Parasites
hymexazol (ISO);3-hydroxy-5-methylisoxazole
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
hyoscine
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
hyoscyamine
202-933-0
101-31-5
Acute Tox. 2
Hypr
-
-
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.
imazalil (ISO); 1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
imazalil sulphate (ISO) powder; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate;imazalil sulphate (ISO), aqueous solution; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imidazolium hydrogen sulphate
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
imazalil sulphate (ISO) powder; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate;imazalil sulphate (ISO), aqueous solution; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imidazolium hydrogen sulphate
261-351-5
58594-72-2
Acute Tox. 4; Skin Sens. 1
imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid
601-305-7
114311-32-9
Repr. 2
imazapyr (ISO);2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H- imidazol-2-yl]-3-pyridine carboxylate
617-219-8
81334-34-1
Eye Irrit. 2
imidacloprid (ISO); (E)-1-(6-chloro-3-pyridylmethyl)-N-nitroimidazolidin-2-ylideneamine; (2E)-1-[(6-chloropyridin-3-yl) methyl]-N-nitroimidazolidin-2-imine
428-040-8
138261-41-3
Acute Tox. 3
imidazo[1,2-b]pyridazin hydrochloride
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
imidazole
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
imiprothrin (ISO); reaction mass of: [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
indium phosphide
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
indoxacarb (ISO); methyl (4aS)-7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
Influenza viruses types A, B and C
-
-
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.
Inorganic compounds of mercury with the exception of mercuric sulphide and those specified elsewhere in this Annex
-
-
Acute Tox. 2; Acute Tox. 1; STOT RE 2
iodine
231-442-4
7553-56-2
Acute Tox. 4
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