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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
phthalic anhydride
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
physostigmine
200-332-8
57-47-6
Acute Tox. 2
pilocarpine
202-128-4
92-13-7
Acute Tox. 2
pindone (ISO); 2-pivaloylindan-1,3-dione
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine dihydrochloride
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine hydrochloride
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine phosphate
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperidine
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
piperophos (ISO); S-2-methylpiperidinocarbonylmethyl-O, O-dipropyl phosphorodithioate
607-329-4
24151-93-7
Acute Tox. 4
pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
pirimiphos-ethyl (ISO); O, O-diethyl O-2-diethylamino-6-methylpyrimidin-4-yl phosphorothioate
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
pirimiphos-methyl (ISO); O-(2-diethylamino-6-methylpyrimidin-4-yl) O, O-dimethyl phosphorothioate
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
Pitch, coal tar, high-temp., heat-treated; Pitch [The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to180 °C (176 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
Pitch, coal tar, high-temp., secondary; Pitch Redistillate [The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140 °C to 170 °C (284 °F to 392 °F) according to DIN 52025. Composed primarily of tri-and polynuclear aromatic compounds which also contain heteroatoms.]
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
Pitch, coal tar, high-temp.; Pitch [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
Pitch, coal tar, low-temp., heat-treated; Pitch Residue, oxidised; Pitch Residue, heat-treated [A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50 °C to 140 °C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.]
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
Pitch, coal tar, low-temp., oxidized; Pitch Residue, oxidised [The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70 °C to 180 °C (158 °F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
Pitch, coal tar, low-temp; Pitch Residue [A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40 °C to 180 °C (104°F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
Pitch, coal tar-petroleum; Pitch Residues [The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (140°F to 356°F). Composed; primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
Pitch; Pitch
263-072-4
61789-60-4
Carc. 1B
Plasmodium falciparum
-
-
P Parasites
Plasmodium spp. (human and simian)
-
-
P Parasites
platinum(IV) nitrate/nitric acid solution
432-400-1
10102-09-7
Skin Corr. 1A
Plesiomonas shigelloides
-
-
B Bacteria and similar species
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.
poly(oxo(2-butoxyethyl-3-oxobutanoato-O'1,O'3)aluminium)
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
poly(oxypropylenecarbonyl-co-oxy(ethylethylene)carbonyl), containing 27 % hydroxyvalerate
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
poly-(methyl methacrylate)-co-(butylmethacrylate)-co-(4-acryloxybutyl-isopropenyl-α, α-dimethylbenzyl carbamate)-co-(maleicanhydride)
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
poly-[((4-((4-(ethyl-ethylene)amino)phenyl)-(4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)-3-methylcyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
poly-[((4-((4-ethyl-ethylene)amino)phenyl)-((4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)cyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
polychlorobiphenyls; PCB
215-648-1
1336-36-3
STOT RE 2
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5
618-541-1
9036-19-5
yes
polyhexamethylene biguanide hydrochloride; PHMB
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
polyhexamethylene biguanide hydrochloride; PHMB
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
polymer of allylamine hydrochloride
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
polymeric reaction product of bicyclo[2.2.1]hepta-2,5-diene, ethene, 1,4-hexadiene, 1-propene with N, N-di-2-propenylformamide
X4060
404-035-6
1379801-27-0
Skin Sens. 1
Porphyromonas spp.
-
-
B Bacteria and similar species
potasan; O, O-diethyl O-(4-methylcoumarin-7-yl) phosphorothioate
-
299-45-6
Acute Tox. 2; Acute Tox. 1
potassium
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
potassium (E,E)-hexa-2,4- dienoate
246-376-1
24634-61-5
Eye Irrit. 2
potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Skin Sens. 1
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate
266-578-3
67118-55-2
yes
potassium 2,5-dichlorobenzoate
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
potassium 2-(2,4-dichlorophenoxy)-(R)-propionate
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
potassium 2-amino-2-methylpropionate octahydrate
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
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