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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 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
benzyltributylammonium 4-hydroxynaphthalene-1-sulphonate
BONTRON P-51
402-240-5
102561-46-6
Acute Tox. 4
beryllium
231-150-7
7440-41-7
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
beryllium compounds with the exception of aluminium beryllium silicates, and with those specified elsewhere in this Annex
show/hide
Beryllium chloride EC / List no: 232-116-4 | CAS no: 7787-47-5
Beryllium phosphide (BeP2) EC / List no: - | CAS no: 1268721-56-7
Triberyllium nitride EC / List no: 215-132-6 | CAS no: 1304-54-7
Beryllium fluoride EC / List no: 232-118-5 | CAS no: 7787-49-7
Phosphoric acid, beryllium salt (2:3) EC / List no: - | CAS no: 13598-26-0
Steel manufacture, chemicals
This category includes the chemical substances which are manufactured as part of steel and alloy steels. The following list identifies those elements which may exist in steel or which may comprise compounds present in steel or alloy steels. Aluminum, beryllium, boron, calcium, carbon, cerium, chromium, cobalt, copper, hafnium, iron, lanthanum, lead, magnesium, manganese, molybdenum, nickel, niobium, nitrogen, oxygen, phosphorus, selenium, silicon, sulfur, tantalum, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium.
EC / List no: 266-048-1 | CAS no: 65997-19-5
Copper alloy, Cu 96, Be 2.2-2.8, Ni 1.1 (CDA 827) EC / List no: - | CAS no: 11108-64-8
Tetraberyllium boride EC / List no: 235-695-1 | CAS no: 12536-52-6
Beryllium diiodide EC / List no: 232-119-0 | CAS no: 7787-53-3
Beryllium carbonate EC / List no: 236-030-8 | CAS no: 13106-47-3
Phosphoric acid, beryllium salt EC / List no: 252-356-3 | CAS no: 35089-00-0
Nitric acid, beryllium salt, tetrahydrate EC / List no: 690-699-4 | CAS no: 13510-48-0
Octadecanoic acid, beryllium salt EC / List no: - | CAS no: 16687-38-0
Beryllium zinc silicate EC / List no: 247-151-0 | CAS no: 25638-88-4
Beryllium diboride EC / List no: 235-443-0 | CAS no: 12228-40-9
Beryllium nitrate EC / List no: 237-062-5 | CAS no: 13597-99-4
Beryllium selenide EC / List no: 235-450-9 | CAS no: 12232-25-6
Beryllium, bis(carbonato(2-))dihydroxytri- EC / List no: - | CAS no: 66104-24-3
Beryllium hexaboride EC / List no: 235-657-4 | CAS no: 12429-94-6
Beryllium sulphide EC / List no: 237-064-6 | CAS no: 13598-22-6
Beryllium EC / List no: 231-150-7 | CAS no: 7440-41-7
Silicic acid, beryllium salt EC / List no: 261-293-0 | CAS no: 58500-38-2
Beryllium nitrate trihydrate EC / List no: - | CAS no: 7787-55-5
Beryllium hydrogen phosphate (1:1) EC / List no: - | CAS no: 13598-15-7
Beryllium orthosilicate EC / List no: 239-251-8 | CAS no: 15191-85-2
Beryllium diammonium tetrafluoride EC / List no: 238-948-4 | CAS no: 14874-86-3
Bis(pentane-2,4-dionato-O,O')beryllium EC / List no: 233-513-5 | CAS no: 10210-64-7
Aluminium alloy, Al,Be EC / List no: 603-236-8 | CAS no: 12770-50-2
Beryllium telluride EC / List no: 235-451-4 | CAS no: 12232-27-8
Hexakis[μ-(acetato-O:O')]-μ4-oxotetraberyllium EC / List no: 242-785-4 | CAS no: 19049-40-2
Beryllium diboride EC / List no: 235-694-6 | CAS no: 12536-51-5
Beryllium acetylide EC / List no: 208-050-7 | CAS no: 506-66-1
Beryllium sulfate tetrahydrate EC / List no: 629-461-1 | CAS no: 7787-56-6
Beryllium oxyfluoride EC / List no: - | CAS no: 63990-88-5
Bertrandite (Be4(OH)2O(SiO3)2) EC / List no: 235-299-9 | CAS no: 12161-82-9
Disodium tetrafluoroberyllate EC / List no: 237-630-2 | CAS no: 13871-27-7
Beryllium hydroxide EC / List no: 236-368-6 | CAS no: 13327-32-7
Beryllium dibromide EC / List no: 232-115-9 | CAS no: 7787-46-4
Beryllium phosphide EC / List no: 261-137-1 | CAS no: 58127-61-0
Beryllium sulphate EC / List no: 236-842-2 | CAS no: 13510-49-1
Diethylberyllium EC / List no: 208-823-9 | CAS no: 542-63-2
Zinc beryllium silicate EC / List no: - | CAS no: 39413-47-3
Beryllium di(acetate) EC / List no: 208-850-6 | CAS no: 543-81-7
-
-
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
beryllium oxide
215-133-1
1304-56-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Beta-hexabromocyclododecane
603-802-4
134237-51-7
yes
Bhanja
-
-
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.
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bifenthrin (ISO); (2-methylbiphenyl-3-yl)methylrel-(1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate
207-612-9
485-31-4
Repr. 1B; Acute Tox. 4
biphenyl-2-ylamine
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
biphenyl-3,3', 4,4'-tetrayltetraamine; diaminobenzidine
202-110-6
91-95-2
Carc. 1B; Muta. 2
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
biphenyl; diphenyl
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bis(1,1-dimethyl-2-propynyloxy)dimethylsilane
PLR-22; XC95-A0638
414-960-7
53863-99-3
Acute Tox. 4
bis(1,2,3-trithiacyclohexyldimethylammonium) oxalate; thiocyclam-oxalate
250-859-2
31895-22-4
Acute Tox. 4
bis(1-methylethyl)-dimethoxysilane
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,2,6,6-tetramethyl-4-piperidyl) succinate
TINUVIN 780
402-940-0
62782-03-0
Eye Irrit. 2
bis(2,4,4-trimethylpentyl)dithiophosphonic acid
420-160-9
107667-02-7
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2,4,6-trinitrophenyl)amine; hexyl
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphinoxide
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
bis(2-chloroethyl) ether
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
bis(2-dimethylaminoethyl)(methyl)amine
221-201-1
3030-47-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2-ethylhexyl) dithiodiacetate
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
bis(2-ethylhexyl)-4,5-epoxycyclohexane-1,2-dicarboxylate
430-700-5
10138-36-0
Skin Sens. 1
bis(2-methoxyethyl) ether
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
bis(2-methoxyethyl) phthalate
204-212-6
117-82-8
Repr. 1B
yes
bis(3,5-di-tert-butylsalicylato-O1,O2)zinc
BONTRON E-84; E-84
403-360-0
42405-40-3
Flam. Sol. 1; Acute Tox. 4
bis(3-(trimethoxysilyl)propyl)amine
280-084-5
82985-35-1
Eye Dam. 1
bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
bis(4-dodecylphenyl)iodonium hexafluoroantimonate
404-420-9
71786-70-4
Skin Sens. 1
bis(4-fluorophenyl)-methyl-(1,2,4-triazol-4-ylmethyl)silane hydrochloride
U 9649
401-380-4
89066-61-5
Eye Irrit. 2
bis(4-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(4-methylbenzoyl)peroxide
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
bis(8-hydroxyquinolinium) sulphate
205-137-1
134-31-6
Acute Tox. 4
bis(chloromethyl) ether; oxybis(chloromethane)
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
bis(d-gluconato-O1,O2)nickel
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
Z-27
421-660-1
-
Eye Dam. 1; Skin Sens. 1
bis(hydrogenated tallow C16-18-alkyl)hydroxylamine
418-370-0
143925-92-2
Skin Sens. 1
bis(hydroxylammonium) sulfate; hydroxylamine sulfate (2:1)
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
bis(N-methyl-N-phenylhydrazine)sulfate
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE
214-604-9
1163-19-5
yes
bis(piperidinothiocarbonyl) disulphide
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Bis(tributyltin)oxide; TBTO
200-268-0
56-35-9
yes
bis(α,α-dimethylbenzyl) peroxide
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
bis(η5-cyclopentadienyl)-bis(2,6-difluoro-3-[pyrrol-1-yl]-phenyl)titanium
CGI 784
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
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