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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
Balantidium coli
-
-
P Parasites
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
Bartonella (Rochalinea) spp.
-
-
B Bacteria and similar species
Bartonella bacillifonnis
-
-
B Bacteria and similar species
Bartonella quintana
-
-
B Bacteria and similar species
basic phenylmercury nitrate
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
Bebaru virus
-
-
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.
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
Belgrade
-
-
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.
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[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-1,2:4,5-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
benzidine based azo dyes; 4,4'-diarylazobiphenyl dyes, with the exception of those specified elsewhere in this Annex
-
-
Carc. 1B
benzidine; 1,1'-biphenyl-4,4'-diamine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamine
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
benzo[e]pyrene
205-892-7
192-97-2
Carc. 1B
benzo[j]fluoranthene
205-910-3
205-82-3
Carc. 1B
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
benzoic acid
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide
431-600-4
112226-61-6
Skin Sens. 1
Benzol forerunnings (coal); Light Oil Redistillate, low boiling [The distillate from coke oven light oil having an approximate distillation range below 100 o C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
benzonitrile
202-855-7
100-47-0
Acute Tox. 4
benzophenone-3,3',4,4'-tetracarboxylic dianhydride; 4,4'-carbonyldi(phthalic anhydride)
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
benzothiazole-2-thiol
205-736-8
149-30-4
Skin Sens. 1
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
691-719-4
1072957-71-1
Acute Tox. 3
benzoyl chloride
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
benzthiazuron (ISO); 1-benzothiazol-2-yl-3-methylurea
217-685-9
1929-88-0
Acute Tox. 4
benzyl 2,4-dibromobutanoate
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
benzyl [hydroxy-(4-phenylbutyl)phosphinyl] acetate
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
benzyl alcohol
202-859-9
100-51-6
Acute Tox. 4
benzyl benzoate
204-402-9
120-51-4
Acute Tox. 4
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