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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
605-037-1
156052-68-5
Skin Sens. 1
emamectin benzoate (ISO); (4''R)-4''-deoxy-4''-(methylamino) avermectin B1 benzoate
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
tepraloxydim (ISO); (RS)-(EZ)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one
604-715-4
149979-41-9
Carc. 2; Repr. 2
dimoxystrobin (ISO); (E)-2-(methoxyimino)-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
oxasulfuron (ISO); oxetan-3-yl 2-[(4,6-dimethylpyrimidin-2-yl)-carbamoylsulfamoyl]benzoate
604-430-5
144651-06-9
STOT RE 2
reaction mass of (S)-Indoxacarb and (R)-Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate [2]
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
26-(4-nonylphenoxy)-3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol
604-395-6
14409-72-4
yes
kresoxim-methyl (ISO); methyl (E)-2-methoxyimino-[2-(o-tolyloxymethyl)phenyl]acetate
604-351-6
143390-89-0
Carc. 2
cinidon ethyl (ISO); ethyl (Z)-2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
Aluminosilicate Refractory Ceramic Fibres
604-314-4
142844-00-6
yes
tritosulfuron (ISO) (containing ≤0,02 % AMTT); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0,02 % AMTT)
604-291-0
142469-14-5
Skin Sens. 1
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
trifloxystrobin (ISO); methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl) ethylideneaminooxy]-o-tolyl}acetate
604-237-6
141517-21-7
Lact.; Skin Sens. 1
isoxaflutole (ISO); 5-cyclopropyl-1,2-oxazol-4-yl α,α,α-trifluoro-2-mesyl-p-tolyl ketone
604-222-4
141112-29-0
Repr. 2
iprovalicarb (ISO); isopropyl [(2S)-3-methyl-1-{[1-(4-methylphenyl)ethyl]amino}-1-oxobutan-2-yl]carbamate
604-209-3
140923-17-7
Carc. 2
metaflumizone (ISO); (EZ)-2-[2-(4-cyanophe-nyl)-1-(a,a,a -trifluoro-m-tolyl)ethylidene]-[4-(tri-fluoromethoxy)phenyl] carbanilohydrazide [E-iso-mer > 90 %, Z-isomer <10 % relative content]; [1] (E)-2-[2-(4-cyanophenyl)-1-(a,a,a -trifluoro-m-tolyl) ethylidene]-[4-(trifluoro-methoxy)phenyl]carbani-lohydrazide [2]
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
profoxydim (ISO); 2-{(EZ)-1-[(2RS)-2-(4-chlorophenoxy)propoxyimino]butyl}-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
acetamiprid (ISO); (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine
603-921-1
135410-20-7
Acute Tox. 4
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
Gamma-hexabromocyclododecane
603-804-5
134237-52-8
yes
Beta-hexabromocyclododecane
603-802-4
134237-51-7
yes
Alpha-hexabromocyclododecane
603-801-9
134237-50-6
yes
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
azoxystrobin (ISO); methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate
603-524-3
131860-33-8
Acute Tox. 3
famoxadone (ISO); 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione
603-520-1
131807-57-3
STOT RE 2
disodium tetraborate decahydrate
603-411-9
1303-96-4
Repr. 1B
yes
silver zinc zeolite (Zeolite, LTA framework type, surface-modified with silver and zinc ions)
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
triflusulfuron-methyl; methyl 2-({[4-(dimethylamino)-6- (2,2,2-trifluoroethoxy)-1,3,5- triazin-2-yl]carbamoyl}sulfamoyl)-3-methylbenzoate
603-146-9
126535-15-7
Carc. 2
ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
metconazole (ISO); (1RS, 5RS;1RS, 5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
quinoxyfen (ISO);5,7-dichloro-4-(4-fluorophenoxy)quinoline
602-997-3
124495-18-7
Skin Sens. 1
1-hydroxybenzotriazole, monohydrated
602-929-2
123333-53-9
Expl. 1.3
pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one
602-927-1
123312-89-0
Carc. 2; Repr. 2
disodium octaborate tetrahydrate
602-894-3
12280-03-4
Repr. 1B
chlorfenapyr (ISO); 4-bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
white phosphorus
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
Disodium tetraborate pentahydrate
601-808-1
12179-04-3
Repr. 1B
yes
asbestos
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
cyprodinil (ISO); 4-cyclopropyl-6-methyl-N-phenylpyrimidin-2-amine
601-785-8
121552-61-2
Skin Sens. 1
asbestos
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
asbestos
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
tebufenpyrad (ISO); N-(4-tertbutylbenzyl)-4-chloro-3-ethyl-1-methyl-1H-pyrazole-5-carboxamide
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid
601-305-7
114311-32-9
Repr. 2
thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
pethoxamide (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1enyl)acetamide
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
clodinafop-propargyl (ISO)
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
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