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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 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
mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt
616-995-5
8018-01-7
Repr. 2; Skin Sens. 1
4,4'-(1,3-phenylene-bis(1-methylethylidene))bis-phenol
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
reaction mass of: 4,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 4,8-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 5,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
benzyl 2,4-dibromobutanoate
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
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
4-tert-butylphenol
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
spirotetramat (ISO); (5s,8s)-3- (2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4,5]dec- 3-en-4-yl ethyl carbonate
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
sulcotrione (ISO); 2-[2-chloro-4-(methylsulfonyl)benzoyl]cyclohexane-1,3-dione
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
tembotrione (ISO); 2-{2- chloro-4-(methylsulfonyl)-3- [(2,2,2-trifluoroethoxy)methyl] benzoyl}cyclohexane-1,3-dione
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
(S)-2,3-dihydro-1H-indole-2-carboxylic acid
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
dodemorph acetate; 4-cyclododecyl-2,6-dimethylmorpholin- 4-ium acetate
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
dodemorph (ISO); 4-cyclododecyl-2,6-dimethylmorpholine
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
(R, S)-2-amino-3,3-dimethylbutane amide
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
triammonium 4-[4-[7-(4-carboxylatoanilino)-1-hydroxy3-sulfonato-2-naphthylazo]-2,5-dimethoxyphenylazo]benzoate
432-270-4
221354-37-6
Repr. 2; STOT RE 2
oxadiargyl (ISO); 3-[2,4-dichloro-5-(2-propynyloxy)phenyl]-5-(1,1-dimethylethyl)-1,3,4-oxadiazol-2(3H)-one
254-637-6
39807-15-3
Repr. 2; STOT RE 2
mesotrione(ISO); 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione
600-533-4
104206-82-8
Repr. 2; STOT RE 2
amitrole (ISO);1,2,4-triazol-3-ylamine
200-521-5
61-82-5
Repr. 2; STOT RE 2
(R)-5-bromo-3-(1-methyl-2-pyrrolidinyl methyl)-1H-indole
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
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]
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 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
hexabromocyclododecane
show/hide
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
247-148-4
25637-99-4
Repr. 2; Lact.
yes
fenarimol (ISO); 2,4'-dichloro-α-(pyrimidin-5-yl)benzhydryl alcohol
262-095-7
60168-88-9
Repr. 2; Lact.
1,2,5,6,9,10-hexabromocyclododecane
221-695-9
3194-55-6
Repr. 2; Lact.
yes
valinamide
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
piperazine phosphate
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine hydrochloride
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine dihydrochloride
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
phoxim (ISO); α-(diethoxyphosphinothioylimino) phenylacetonitrile
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
bromoxynil heptanoate (ISO); 2,6-dibromo-4-cyanophenyl heptanoate
260-300-4
56634-95-8
Repr. 2; Acute Tox. 4; Skin Sens. 1
5-chloro-1,3-dihydro-2H-indol-2-one
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
trans-4-cyclohexyl-L-proline monohydrochloride
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
fenpropimorph (ISO);cis-4-[3-(p-tert-butylphenyl)-2- methylpropyl]-2,6-dimethylmorpholine
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
butroxydim (ISO); 5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
4-[(3-chlorophenyl)(1H-imidazol-1-yl)methyl]-1,2-benzenediamine dihydrochloride
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
nonylphenol
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
4-nonylphenol, branched
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
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
quinomethionate; chinomethionat (ISO); 6-methyl-1,3-dithiolo(4,5-b)quinoxalin-2-one
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
O, O'-(ethenylmethylsilylene)di[(4-methylpentan-2-one)oxime]
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
maneb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric)
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
3-(piperazin-1-yl)-benzo[d]isothiazole hydrochloride
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
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