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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 10 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
pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
1,3-diphenylguanidine
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
myclobutanil(ISO);2-(4-chlorophenyl)-2-(1H-1,2,4- triazol-1-ylmethyl)hexanenitrile
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
1,2,4-triazole
206-022-9
288-88-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
fluazinam (ISO); 3-chloro-N-[3- chloro-2,6-dinitro-4-(trifluor omethyl)phenyl]-5-(trifluoromethyl)pyridin-2-amine
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
hymexazol (ISO);3-hydroxy-5-methylisoxazole
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one; dimethyl propyleneurea
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
salicylic acid
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
malachite green oxalate
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
malachite green hydrochloride
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)methyl] O,O-dimethyl phosphorodithioate; O, O-dimethyl phthalimidomethyl S-phosphorodithioate
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
tebuconazole (ISO); 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
propylenethiourea
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
penconazole (ISO); 1-[2-(2,4-dichlorophenyl)pentyl]-1H-1,2,4-triazole
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
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
2-chloracetamide
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
diammonium 1-hydroxy-2-(4-(4-carboxyphenylazo)-2,5-dimethoxyphenylazo)-7-amino-3-naphthalenesulfonate
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
ioxynil octanoate (ISO); 4-cyano-2,6-diiodophenyl octanoate
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate
216-885-3
1689-99-2
Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
salts of ioxynil with the exception of those specified elsewhere in this Annex
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Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 | CAS no: 2961-62-8
3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - | CAS no: 2961-61-7
-
-
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
ioxynil (ISO) 4-hydroxy-3,5-diiodobenzonitrile
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
benfuracarb (ISO); ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-β-alaninate
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
salts of bromoxynil with the exception of those specified elsewhere in this Annex
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Potassium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-998-3 | CAS no: 2961-68-4
Sodium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-997-8 | CAS no: 2961-67-3
-
-
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol
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2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 | CAS no: 1689-99-2
3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 | CAS no: 1689-84-5
2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 | CAS no: 56634-95-8
2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 | CAS no: 3861-41-4
216-882-7
1689-84-5
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
dimethyltin dichloride
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
avermectin B1a (purity ≥ 80 %)
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 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
trichloromethylstannane
213-608-8
993-16-8
Repr. 2
octamethylcyclotetrasiloxane; [D4]
209-136-7
556-67-2
Repr. 2
yes
isoxaflutole (ISO); 5-cyclopropyl-1,2-oxazol-4-yl α,α,α-trifluoro-2-mesyl-p-tolyl ketone
604-222-4
141112-29-0
Repr. 2
fluazifop-P-butyl (ISO); butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
616-669-2
79241-46-6
Repr. 2
diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
278-355-8
75980-60-8
Repr. 2
cycloxydim (ISO); 2-(N-ethoxybutanimidoyl)-3-hydroxy-5-(tetrahydro-2H-thiopyran-3-yl)cyclohex-2-en-1-one
405-230-9
101205-02-1
Repr. 2
androsta-1,4,9(11)-triene-3,17-dione
433-560-3
15375-21-0
Repr. 2
5,6,12,13-tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
3-oxoandrost-4-ene-17-β-carboxylic acid
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
2-ethylhexyl-2-ethylhexanoate
231-057-1
7425-14-1
Repr. 2
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-828-5
57583-34-3
Repr. 2
2-ethylhexanoic acid
205-743-6
149-57-5
Repr. 2
2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether
203-906-6
111-77-3
Repr. 2
1-cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
dicyclohexyl phthalate
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
2-ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]thio]acetate
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
phenol, dodecyl-, branched
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 4-dodecyl-, branched
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 3-dodecyl-, branched
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 2-dodecyl-, branched
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
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