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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 May 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
arsine
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
asbestos
-
132207-32-0
Carc. 1A; STOT RE 1
asbestos
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
asbestos
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
asbestos
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
asbestos
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
asbestos
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
asbestos
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
atrazine (ISO);2-chloro-4-ethylamine-6- isopropylamine-1,3,5-triazine
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
atropine
200-104-8
51-55-8
Acute Tox. 2
avermectin B1a (purity ≥ 80 %)
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
azaconazole (ISO);1-{[2-(2,4-dichlorophenyl)-1,3- dioxolan-2-yl]methyl}-1H-1,2.4- triazole
262-102-3
60207-31-0
Acute Tox. 4
azafenidin (ISO); 2-(2,4-dichloro-5-prop-2-ynyloxyphenyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyridine-3(2H)-one
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo [4,5-b]pyridin-3(2H)-yl) methyl] O,O-dimethyl thiophosphate
252-626-0
35575-96-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 1; Skin Sens. 1
azinphos-ethyl (ISO); O,O-diethyl 4-oxobenzotriazin-3-ylmethyl phosphorodithioate
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
azinphos-methyl (ISO); O,O-dimethyl-4-oxobenzotriazin-3-ylmethyl phosphorodithioate
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
azobenzene
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
azocyclotin (ISO); 1-(tricyclohexylstannyl)-1H-1,2,4-triazole
255-209-1
41083-11-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
azothoate (ISO); O-4-(4-chlorophenylazo)phenyl O,O-dimethyl phosphorothioate
227-419-3
5834-96-8
Acute Tox. 4
azoxybenzene
207-802-1
495-48-7
Acute Tox. 4
azoxystrobin (ISO); methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate
603-524-3
131860-33-8
Acute Tox. 3
barban (ISO); 4-chlorbut-2-ynyl N-(3-chlorophenyl)carbamate
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
barium calcium cesium lead samarium strontium bromide chloride fluoride iodide europium doped
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
barium carbonate
208-167-3
513-77-9
Acute Tox. 4
barium chlorate
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
barium chloride
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
barium perchlorate
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
barium peroxide
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
barium polysulphides
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
barium salts, with the exception of barium sulphate, salts of 1-azo-2-hydroxynaphthalenyl aryl sulphonic acid, and of salts specified elsewhere in this Annex
-
-
Acute Tox. 4
barium sulphide
244-214-4
21109-95-5
Acute Tox. 4
basic phenylmercury nitrate
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
Repr. 1B
yes
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
benazolin (ISO); 4-chloro-2,3-dihydro-2-oxo-1,3-benzothiazol-3-ylacetic acid
223-297-0
3813-05-6
Eye Irrit. 2; Skin Irrit. 2
bendiocarb (ISO); 2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
benfuracarb (ISO); ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-β-alaninate
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
benomyl (ISO);methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
benquinox (ISO); p-benzoquinone 1-benzoylhydrazone 4-oxime
207-807-9
495-73-8
Acute Tox. 3; Acute Tox. 4
bensulide (ISO); O, O-diisopropyl 2-phenylsulphonylaminoethyl phosphorodithioate
212-010-4
741-58-2
Acute Tox. 4
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane
605-769-1
17606-31-4
Acute Tox. 4
bentazone (ISO);3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
benz[a]anthracene
200-280-6
56-55-3
Carc. 1B
yes
benz[e]acephenanthrylene
205-911-9
205-99-2
Carc. 1B
benzaldehyde
202-860-4
100-52-7
Acute Tox. 4
benzene
200-753-7
71-43-2
Flam. Liq. 2; Carc. 1A; Muta. 1B; STOT RE 1; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2
benzene-1,2,4-tricarboxylic acid 1,2-anhydride; trimellitic anhydride
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
benzene-1,2:4,5-tetracarboxylic dianhydride; benzene-1,2:4,5-tetracarboxylic dianhydride; pyromellitic dianhydride
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
benzene-1,4-diamine dihydrochloride; p-phenylenediamine dihydrochloride
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
benzenesulfonic acid, 3,3'-(methylenebis((dihydroxyphenylene)azo)) bis-, potassium sodium salt; potassium sodium 3-[(E)-(6{3,4-dihydroxy-2-}(Z)-(3-sulfonatophenyl)diazenyl]benzyl}-2,3-dihydroxyphenyl)diazenyl]benzenesulfonate
HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
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