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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 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
nonadecafluorodecanoic acid
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
sodium nonadecafluorodecanoate
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
Ammonium salts of perfluorononan-1-oic-acid
-
4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
ammoniumpentadeca-fluorooctanoate
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorononan-1-oic acid
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorononan-1-oic acid sodium salts
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorooctanoic acid
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
ammonium perfluorooctanesulfonate; ammonium heptadecafluorooctanesulfonate
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
diethanolamine perfluorooctane sulfonate
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
perfluorooctane sulfonic acid; heptadecafluorooctane-1-sulfonic acid
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
(E)-3-[1-[4-[2-(dimethylamino)ethoxy]phenyl]-2-phenylbut-1-enyl]phenol
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
vinclozolin (ISO); N-3,5-dichlorophenyl-5-methyl-5-vinyl-1,3-oxazolidine-2,4-dione
256-599-6
50471-44-8
Carc. 2; Repr. 1B; Skin Sens. 1
chlorotoluron (ISO); 3-(3-chloro-p-tolyl)-1,1-dimethylurea
239-592-2
15545-48-9
Carc. 2; Repr. 2
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
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
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
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
chloroform; trichloromethane
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
cyanamide; carbanonitril
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
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
thiourea; thiocarbamide
200-543-5
62-56-6
Carc. 2; Repr. 2; Acute Tox. 4
quizalofop-P-tefuryl (ISO); (±) tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
molinate (ISO);S-ethyl 1-perhydroazepinecarbothioate; S-ethyl perhydroazepine-1-carbothioate
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
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
clorofene; chlorophene; 2-benzyl-4-chlorophenol
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
dodecachloropentacyclo[5.2.1.02,6.03,9.05,8]decane; mirex
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
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
pentachloroethane
200-925-1
76-01-7
Carc. 2; STOT RE 1
2-ethylphenylhydrazine hydrochloride
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
nickel;nickel powder [particle diameter < 1mm]
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
nickel;nickel powder [particle diameter < 1mm]
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
chlorpropham (ISO); isopropyl 3-chlorocarbanilate
202-925-7
101-21-3
Carc. 2; STOT RE 2
isoproturon (ISO); 3-(4-isopropylphenyl)-1,1-dimethylurea
251-835-4
34123-59-6
Carc. 2; STOT RE 2
metosulam (ISO); N-(2,6-dichloro-3-methylphenyl)-5,7-dimethoxy[1,2,4]triazolo[1,5-a] pyrimidine-2-sulfonamide
410-240-1
139528-85-1
Carc. 2; STOT RE 2
2,2'-((3,3', 5,5'-tetramethyl-(1,1'-biphenyl)-4,4'-diyl)-bis(oxymethylene))-bis-oxirane
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
4-[4-(1,3-dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone
ANTHRACHINON BLAU 27 HD
406-057-1
114565-66-1
Carc. 2; Skin Sens. 1
C.I. Disperse Yellow 3; N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]acetamide
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
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
reaction mass of: 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)]-3-oxo-butanamide; 2-[[3,3'-dichloro-4'-[[1[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'biphenyl]-4-yl]azo]-N-(2-methylphenyl)-3-oxo-butanamide; 2-[[3,3'-dichloro-4'-[[1[[(2,4-dimethylphenyl)amino]carbonyl]-2-oxopropyl]azo][1,1'-biphenyl]-4-yl]azo]-N-(2-carboxylphenyl)-3-oxo-butanamide
434-330-5
-
Carc. 2; Skin Sens. 1
trifluralin (ISO) (containing <0.5 ppm NPDA); α, α, α-trifluoro-2,6-dinitro-N, N-dipropyl-p-toluidine (containing; < 0,5 ppm NPDA); 2,6-dinitro-N, N-dipropyl-4-trifluoromethylaniline (containing < 0,5 ppm NPDA); N, N-dipropyl-2,6-dinitro-4-trifluoromethylaniline (containing < 0.5 ppm NPDA)
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
aclonifen (ISO); 2-chloro-6-nitro-3-phenoxyaniline
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate
255-391-2
41483-43-6
Carc. 2; Skin Sens. 1B
calcium iodoxybenzoate
-
-
Expl.
iodoxybenzene
-
696-33-3
Expl.
cellulose nitrate; nitrocellulose
618-392-2
9004-70-0
Expl. 1.1
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]
239-924-6
15825-70-4
Expl. 1.1
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Expl. 1.1
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