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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
yes
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
yes
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
yes
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
peracetic acid . . . %
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
Peptostreptococcus anaerobius
-
-
B Bacteria and similar species
pepsin A
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
pentyl propionate
210-852-7
624-54-4
Flam. Liq. 3
pentyl nitrite
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
pentyl formate
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
pentyl acetate
211-047-3
628-63-7
Flam. Liq. 3
penthachloronaphthalene
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Pentazinc chromate octahydroxide
256-418-0
49663-84-5
yes
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
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 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 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 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 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 (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
205-391-3
140-01-2
Acute Tox. 4; STOT RE 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
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
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
pentane-2,4-dione; acetylacetone
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
pentane
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
pentan-3-one; diethyl ketone
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
Pentalead tetraoxide sulphate
235-067-7
12065-90-6
yes
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
pentaerythritol triacrylate
222-540-8
3524-68-3
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 tetraacrylate
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Pentacosafluorotridecanoic acid
276-745-2
72629-94-8
yes
pentachlorophenol
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
pentachloroethane
200-925-1
76-01-7
Carc. 2; STOT RE 1
pentachlorobenzene
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
Penicillium marneffei
-
-
F Fungi
pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidine
254-938-2
40487-42-1
Skin Sens. 1
penconazole (ISO); 1-[2-(2,4-dichlorophenyl)pentyl]-1H-1,2,4-triazole
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
pebulate (ISO); N-butyl-N-ethyl-S-propylthiocarbamate
214-215-4
1114-71-2
Acute Tox. 4
Pasteurella spp.
-
-
B Bacteria and similar species
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