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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
papain
232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
papaverine
200-397-2
58-74-2
Acute Tox. 4
Paracoccidioides brasiliensis
-
-
F Fungi
Paraffin oils (petroleum), catalytic dewaxed heavy; Baseoil — unspecified [ complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-174-4
64742-70-7
Carc. 1B
Paraffin oils (petroleum), catalytic dewaxed light; Baseoil — unspecified [ complex combination of hydrocarbons obtained from a catalytic dewxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained from a catalytic dewaxing process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-176-5
64742-71-8
Carc. 1B
Paraffin oils (petroleum), solvent-refined dewaxed heavy; Baseoil — unspecified [ complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50 °C.]
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
Paraffin oils, chloro
287-196-3
85422-92-0
yes
Paraffin waxes (coal), brown-coal high-temp tar, clay-treated; Coal Tar Extract [A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated; Coal Tar Extract [A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated; Coal Tar Extract [A complex combination of hydrocarbons obtained by the treatment of lignite carbon ization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
Paraffin waxes (coal), brown-coal-high-temp. tar, hydrotreated; Coal Tar Extract [A complex combination of hydrocarbons obtained from lignite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predomi nantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process treated with hydrogen in the presence of a catalyst. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-455-7
92045-72-2
Carc. 1B
Paraffin waxes (coal), brown-coal-high-temp. tar; Coal Tar Extract [A complex combination of hydrocarbons obtained from lignite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained from liqnite carbonization tar by solvent crystallisation (solvent deoiling), by sweating or an adducting process. It consists predominantly of straight and branched chain saturated hydrocarbons having carbon numbers predominantly greater than C12.
295-454-1
92045-71-1
Carc. 1B
Paraffins (petroleum), normal C>10, chloro
307-202-0
97553-43-0
yes
Paragonimus westermani
-
-
P Parasites
Parainfluenza viruses types 1 to 4
-
-
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.
paraquat dichloride;1,1-dimethyl-4,4'-bipyridinium dichloride
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
paraquat dimethylsulfate;1,1-dimethyl-4,4'-bipyridinium dimethyl sulphate
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
parathion (ISO); O,O-diethyl O-4-nitrophenyl phosphorothioate
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
parathion — methyl (ISO); O,O-dimethyl O-4-nitrophenyl phosphorothioate
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
Pasteurella multocida
-
-
B Bacteria and similar species
Pasteurella spp.
-
-
B Bacteria and similar species
pebulate (ISO); N-butyl-N-ethyl-S-propylthiocarbamate
214-215-4
1114-71-2
Acute Tox. 4
penconazole (ISO); 1-[2-(2,4-dichlorophenyl)pentyl]-1H-1,2,4-triazole
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidine
254-938-2
40487-42-1
Skin Sens. 1
Penicillium marneffei
-
-
F Fungi
pentachlorobenzene
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
pentachloroethane
200-925-1
76-01-7
Carc. 2; STOT RE 1
pentachlorophenol
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Pentacosafluorotridecanoic acid
276-745-2
72629-94-8
yes
pentaerythritol tetraacrylate
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Unst. Expl.
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Expl. 1.1
pentaerythritol triacrylate
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
pentaerythritol, dipentaerythritol, fatty acids, C6-10, mixed esters with adipic acid, heptanoic acid and isostearic acid
426-590-3
187412-41-5
Skin Sens. 1
Pentalead tetraoxide sulphate
235-067-7
12065-90-6
yes
pentan-3-one; diethyl ketone
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
pentane
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
pentane-2,4-dione; acetylacetone
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
pentanol isomers, with the exception of those specified elsewhere in this Annex
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
pentapotassium 2,2',2'',2''',2''''-(ethane-1,2-diylnitrilo)pentaacetate
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
pentapotassium 2-(4-(5-[1-(2,5-disulfonatophenyl)-4,5-dihydro-3-methylcarbamoyl-5-oxopyrazol-4-ylidene]-3-methyl-1,3-pentadienyl)-3-methylcarbamoyl-5-oxidopyrazol-1yl)benzene-1,4-disulfonate
418-270-7
-
Skin Sens. 1
pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
pentasodium 4-amino-6-(5-(4-(2-ethyl-phenylamino)-6-(2-sulfatoethanesulfonyl)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
pentasodium 5-anilino-3-(4-(4-(6-chloro-4-(3-sulphonatoanilino)-1,3,5-triazin-2-ylamino)-2,5-dimethylphenylazo)-2,5-disulphonatophenylazo)-4-hydroxynaphthalene-2,7-disulphonate
301-312-2
93983-23-4
Eye Irrit. 2
pentasodium 7-(4-(4-(3-(2-sulfatoethanesulfonyl)phenylamino)-6-(4-(2-sulfatoethanesulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
436-920-8
172399-10-9
Eye Dam. 1
pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
pentasodium monohydrogen 6-chloro-3,10-bis[2-[4-chloro-6-(2,4-disulfophenylamino)-1,3,5-triazin-2-yl-amino]ethylamino]-13-ethylbenzo[5.6][1.4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
414-910-4
-
Eye Dam. 1; Skin Sens. 1
pentasodium N-[5-[[4-[[3-[(aminocarbonyl)amino]-4-[(3,6,8-trisulfonatonaphthalen-2-yl)azo]phenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-2-sulfonato-4-[[4-[[-2-(oxysulfonato)ethyl] sulfonyl]phenyl]azo]phenyl]-3-aminopropanoic acid
442-030-0
321912-47-4
Eye Dam. 1
Pentazinc chromate octahydroxide
256-418-0
49663-84-5
yes
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