EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 01 May 2024. Database contains 4753 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
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; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate; sodium peroxoborate hexahydrate [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; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate; sodium peroxoborate hexahydrate [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; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate; sodium peroxoborate hexahydrate [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; borax 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
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
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [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 (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [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; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [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
difethialone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
mesotrione(ISO); 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione
600-533-4
104206-82-8
Repr. 2; STOT RE 2
flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione
600-425-7
103361-09-7
Repr. 1B
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, 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
yes
tau-fluvalinate (ISO); cyano-(3-phenoxyphenyl)methyl N-[2-chloro-4-(trifluoromethyl)phenyl]-D-valinate
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate
600-130-3
100784-20-1
Repr. 1B
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
Formaldehyde, oligomeric reaction products with aniline
500-036-1
25214-70-4
yes
reaction product: bisphenol-A-(epichlorhydrin); epoxy resin (number average molecular weight ≤ 700)
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Nonylphenol, ethoxylated
500-024-6
9016-45-9
yes
reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium; 4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium
451-440-9
586372-44-3
Eye Dam. 1
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