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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 March 2023. 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
A mixture of: trilithium 4-amino-3-((4-((4-((2-amino-4-hydroxyphenyl)azo)phenyl)amino)-3-sulfophenyl)azo)-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulfonate; trilithium 4-amino-3-((4-((4-((4-amino-2-hydroxyphenyl)azo)phenyl)amino)-3-sulfophenyl)azo)-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulfonate
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
A mixture of: Trisodium 4-benzoylamino-6-(6-ethenesulfonyl-1-sulfato-naphthalen-2-ylazo)-5-hydroxynaphthalene-2,7-disulfonate; 5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphtyl)azo)naphthalene-2,7-disulfonic acid sodium salt; 5-(benzoylamino)-4-hydroxy-3-((1-sulfo-6-((2-(sulfooxy)ethyl)sulfonyl)-2-naphtyl)azo)naphthalene-2,7-disulfonic acid
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
A mixture of: trisodium 5-{4-chloro-6-[2-(2,6-dichloro-5-cyanopyrimidin-4-ylamino)-propylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalene-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(2,6-dichloro-5-cyanopyrimidin-4-ylamino)-1-methyl-ethylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalene-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-propylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-1-methyl-ethylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
A mixture of: α-[3-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyl]-ω-[3-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyloxy]-poly-(oxyethylene-co-oxypropylene); 1,2-(or 1,3-)bis[α-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyl)-ω-oxy-poly(oxyethylene-co-oxypropylene)]-3-(or 2-)propanol; 1,2,3-tris[α-(3-mercaptopropanoxycarbonyl-amino)methylphenylaminocarbonyl)-ω-oxy-poly-(oxyethylene-co-oxypropylene)]propane]
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
A reaction mass of: (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium 4-toluenesulfonate; (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium bromide
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
abamectin (combination of avermectin B1a and avermectin B1b) (ISO)
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
Absettarov
-
-
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.
Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction; Wash Oil Redistillate [A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260 °C to 290 °C (500°F to 554°F).]
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
Acanthamoeba castellani
-
-
P Parasites
acephate (ISO); O, S-dimethyl acetylphosphoramidothioate
250-241-2
30560-19-1
Acute Tox. 4
acequinocyl (ISO); 3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl acetate
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
acetaldehyde; ethanal
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
acetamide
200-473-5
60-35-5
Carc. 2
acetamiprid (ISO); (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine
603-921-1
135410-20-7
Acute Tox. 4
acetic acid ... %
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
Acetic acid, lead salt, basic
257-175-3
51404-69-4
yes
acetic anhydride
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
acetochlor (ISO); 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
acetone; propan-2-one; propanone
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
acetonitrile; cyanomethane
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
acetophenone
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
acetyl chloride
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
acetylene; ethyne
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
acibenzolar-S-methyl; benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
acifluorfen (ISO); 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
aclonifen (ISO); 2-chloro-6-nitro-3-phenoxyaniline
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
aconitine
206-121-7
302-27-2
Acute Tox. 2
acrolein; prop-2-enal; acrylaldehyde
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
acrylamide; prop-2-enamide
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
acrylic acid, 3-(trimethoxysilyl)propyl ester
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
acrylic acid, monoester with propane-1,2-diol
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
acrylic acid; prop-2-enoic acid
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
acrylonitrile
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Actinomadura madurae
-
-
B Bacteria and similar species
Actinomadura pelletieri
-
-
B Bacteria and similar species
Actinomyces gerencseriae
-
-
B Bacteria and similar species
Actinomyces israelii
-
-
B Bacteria and similar species
Actinomyces pyogenes
-
-
B Bacteria and similar species
Actinomyces spp.
-
-
B Bacteria and similar species
Acute haemorrhagic conjunctivitis 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.
Acyl Halides of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid
-
-
yes
Adenoviridae
-
-
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.
Adinobacillus actinomycetemcomitans
-
-
B Bacteria and similar species
adipic acid
204-673-3
124-04-9
Eye Irrit. 2
alachlor (ISO); 2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
aldicarb (ISO); 2-methyl-2-(methylthio)propanal-O-(N-methylcarbamoyl)oxime
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
aldrin (ISO)
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
alkali fluorosilicates(K)
240-896-2
16871-90-2
Acute Tox. 3
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