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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 01 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
flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide
600-425-7
103361-09-7
Repr. 2
flumetralin (ISO); N-(2-chloro-6-fluorobenzyl)-N-ethyl-α, α,α-trifluoro-2,6-dinitro-p-toluidine
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
flufenoxuron (ISO); 1-(4-(2-cloro-α, α,α-p-trifluorotolyloxy)-2-fluorophenyl)-3-(2,6-difluorobenzolyl)urea
FLUFENOXURON
417-680-3
101463-69-8
Lact.
flufenacet (ISO);N-(4-fluorophenyl)-N-isopropyl-2-(5-trifluoromethyl-[1,3,4]thiadiazol-2-yloxy)acetamide
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
fluenetil (ISO); 2-fluoroethyl biphenyl-4-ylacetate
-
4301-50-2
Acute Tox. 1; Acute Tox. 2
flubenzimine (ISO);N-[3-phenyl-4,5-bis[(trifluoromethyl)imino]thiazolidin-2- ylidene]aniline
253-703-1
37893-02-0
Eye Irrit. 2
fluazinam (ISO); 3-chloro-N-[3- chloro-2,6-dinitro-4-(trifluor omethyl)phenyl]-5-(trifluoromethyl)pyridin-2-amine
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
fluazifop-P-butyl (ISO); butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
616-669-2
79241-46-6
Repr. 2
fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
274-125-6
69806-50-4
Repr. 1B
flonicamid (ISO); N-(cyanomethyl)-4-(trifluoromethyl)pyridine-3-carboxamide
605-127-0
158062-67-0
Acute Tox. 4
flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin; trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
Flexal 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.
Flavobacterium meningosepticum
-
-
B Bacteria and similar species
fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
ficin
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
ferbam (ISO); iron tris(dimethyldithiocarbamate)
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
fentin hydroxide (ISO); triphenyltin hydroxide
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
fentin acetate (ISO); triphenyltin acetate
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
fenthion (ISO); O, O-dimethyl-O-(4-methylthion-m-tolyl) phosphorothioate
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
fensulfothion (ISO); O,O-diethyl O-4-methylsulfinylphenyl phosphorothioate
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
fenson (ISO); 4-chlorophenyl benzenesulphonate
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
fenpyroximate (ISO); tert-butyl 4-[({(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene]amino}oxy)methyl]benzoate
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
fenpropimorph (ISO);cis-4-[3-(p-tert-butylphenyl)-2- methylpropyl]-2,6-dimethylmorpholine
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
fenpropathrin (ISO); α-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
fenoxycarb (ISO); ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
276-696-7
72490-01-8
Carc. 2
fenoxaprop-P-ethyl (ISO); ethyl (2R)-2-{4-[(6-chloro-1,3-benzoxazol-2-yl)oxy]phenoxy}propanoate
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
fenoprop (ISO); 2-(2,4,5-trichlorophenoxy)propionic acid
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
fenobucarb (ISO); 2-butylphenyl methylcarbamate
223-188-8
3766-81-2
Acute Tox. 4
fenitrothion (ISO); O, O-dimethyl O-4-nitro-m-tolyl phosphorothioate
204-524-2
122-14-5
Acute Tox. 4
fenchlorphos (ISO); O, O-dimethyl O-2,4,5-trichlorophenyl phosphorothioate
206-082-6
299-84-3
Acute Tox. 4
fenbutatin oxide (ISO); bis(tris(2-methyl-2-phenylpropyl)tin)oxide
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
fenazaquin (ISO);4-[2-[4-(1,1-dimethylethyl)phenyl]-ethoxy]quinazoline
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
fenazaflor (ISO); phenyl 5,6-dichloro-2-trifluor-omethylbenzimidazole-1-carboxylate
238-134-9
14255-88-0
Acute Tox. 4
fenarimol (ISO); 2,4'-dichloro-α-(pyrimidin-5-yl)benzhydryl alcohol
262-095-7
60168-88-9
Repr. 2; Lact.
fenamiphos (ISO); ethyl-4-methylthio-m-tolyl isopropyl phosphoramidate
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
fenaminosulf (ISO); sodium 4-dimethylaminobenzenediazosulphonate
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
fatty acids, tall-oil, reaction products with iminodiethanol and boric acid
294-785-9
91770-03-5
Skin Irrit. 2
fatty acids, C6-19-branched, nickel salts
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and tall oil
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Fatty acids, C16-18, lead salts
292-966-7
91031-62-8
yes
fatty acids, C 8-18 and C18-unsaturated, nickel salts
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Fasciolopsis buski
-
-
P Parasites
Fasciola hepatica
-
-
P Parasites
Fasciola gigantica
-
-
P Parasites
famoxadone (ISO); 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione
603-520-1
131807-57-3
STOT RE 2
Extracts, coal tar oil alk.; Alkaline Extract [he extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
266-017-2
65996-83-0
Carc. 1B; Muta. 1B
Extracts(petroleum), light paraffinic distillate solvent, acid-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predomi nantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
295-339-6
91995-76-5
Carc. 1B
Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent; Distillate aromaticextract (treated) [ complex combination of hydrocarbons obtained as the extractfrom the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.]
A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
272-180-0
68783-04-0
Carc. 1B
Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurized; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40 °C.]
A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-829-5
93763-11-2
Carc. 1B
Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.]
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
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