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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 April 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
tetraammonium 5-(4-(7-amino-1-hydroxy-3-sulfonato-2-naphthylazo)-6-sulfonato-1-naphthylazo)isophthalate
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
tetrabutylammonium butyltriphenylborate
P3B
418-080-4
120307-06-4
Skin Sens. 1
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate
432-770-2
139189-30-3
Skin Sens. 1
tetralithium 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
tetrapotassium 2-(4-(5-(1-(2,5- disulfonatophenyl)-3-ethoxycar bonyl-5-hydroxypyrazol-4- yl)penta-2,4-dienylidene)-3- ethoxycarbonyl-5-oxo-2-pyra zolin-1-yl)benzene-1,4- disulfonate
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
tetrasodium 1,2-bis(4-fluoro-6- [5-(1-amino-2-sulfonatoanthra chinon-4-ylamino)-2,4,6- trimethyl-3-sulfonatopheny lamino]-1,3,5-triazin-2- ylamino)ethane
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
tetrasodium 3,3'-(piperazine-1,4-diylbis((6-chloro-1,3,5-triazine-2,4-diyl)imino(2-acetamido)-4,1-phenyleneazo))bis(naphthalene-1,5-disulphonate)
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
tetrasodium 4-amino-5-hydroxy-6-(4-(2-(2-(sulfonatooxy)ethylsulfonyl)ethylcarbamoyl)phenylazo)-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
tetrasodium [7-(2,5-dihydroxy-KO2-7-sulfonato-6-[4-(2,5,6-trichloro-pyrimidin-4-ylamino)phenylazo]-(N1,N7-N)1-naphthylazo)-8-hydroxy-KO8-naphthalene-1,3,5-trisulfonato(6)]cuprate(II)
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl)-O,O-dimethyl thiophosphate
260-515-3
57018-04-9
Skin Sens. 1
trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
trans—N-methyl-2-styryl-[4'- aminomethine-(1-acetyl-1-(2- methoxyphenyl)acetamido)]py ridinium acetate
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
trifloxystrobin (ISO); (E, E)-α-methoxyimino-2-[[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]benzeneacetic acid methyl ester
604-237-6
141517-21-7
Skin Sens. 1
tris(2-(2-hydroxyethoxy)ethyl)ammonium 3-acetoacetamido-4-methoxybenzenesulfonate
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
tris(nonylphenyl) phosphite
247-759-6
26523-78-4
Skin Sens. 1
yes
trisodium 3-amino-6,13-dichloro-10-((3-((4-chloro-6-(2-sulfophenylamino)-1,3,5-triazin-2-yl)amino)propyl) amino)-4,11-triphenoxydioxazinedisulfonate
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate
430-280-3
844491-96-9
Skin Sens. 1
trisodium 7-(4-(6-fluoro-4-(2-(2-vinylsulphonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulphonate
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
trisodium bis[(3'-nitro-5'-sulfonato(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
RED JB 747
418-220-4
-
Skin Sens. 1
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
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
α-[3-(1-oxoprop-2-enyl)l-1-oxypropyl]dimethoxysilyloxy-ω-[3(1-oxoprop-2-enyl)-1-oxypropyl]dimethoxysilyl poly(dimethylsiloxane)
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
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
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
(Z)-2-methoxy-4-(prop-1-enyl)phenol
227-633-7
5912-86-7
Skin Sens. 1A
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
250-863-4
31906-04-4
Skin Sens. 1A
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
isoeugenol
202-590-7
97-54-1
Skin Sens. 1A
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
coriandrol; (S)-3,7-dimethyl-1,6-octadien-3-ol; d-linalool
204-810-7
126-90-9
Skin Sens. 1B
licareol; (R)-3,7-dimethyl-1,6-octadien-3-ol; l-linalool
204-811-2
126-91-0
Skin Sens. 1B
linalool; 3,7-dimethyl-1,6-octadien-3-ol; dl-linalool
201-134-4
78-70-6
Skin Sens. 1B
muscalure; cis-tricos-9-ene
248-505-7
27519-02-4
Skin Sens. 1B
trimethoxyvinylsilane; trimethoxy(vinyl)silane
220-449-8
2768-02-7
Skin Sens. 1B
metazachlor (ISO); 2-chloro-N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)-acetamide
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
ethyl nitrate
210-903-3
625-58-1
Unst. Expl.
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]
239-924-6
15825-70-4
Unst. Expl.
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Unst. Expl.
ethylene dinitrate; ethylene glycol dinitrate
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
glycerol trinitrate; nitroglycerine;glycerol trinitrate; nitroglycerine [>40 % phlegmatiser]
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate;oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate [>25 % phlegmatiser]
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
salts of picric acid
-
-
Unst. Expl.; Acute Tox. 3
mercury difulminate; mercuric fulminate; fulminate of mercury;mercury difulminate; mercuric fulminate; fulminate of mercury [≥ 20 % phlegmatiser]
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
dichloroacetylene
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
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