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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
Residues(petroleum), coker scrubber, Condensed-ring-arom.-contg.; Heavy Fuel oil [A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vaccum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt.% or more of 4-to 6-membered condensed rind aromatic hydrocarbons.]
A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
272-187-9
68783-13-1
Carc. 1B
Residues(petroleum), light vacuum; Heavy Fuel oil [A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C (446 °F).]
A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-984-6
68512-62-9
Carc. 1B
Residues, steam cracked, thermally treated; Heavy Fuel oil [A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).]
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
Residues,(petroleum), heavy coker gas oil and vacuum gas oil; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predomi nantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230 °C (446 °F).]
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-796-4
68478-17-1
Carc. 1B
Silicon carbide
206-991-8
409-21-2
Carc. 1B
Silicon carbide, fibrous
-
308076-74-6
Carc. 1B
Slack wax (petroleum), acid-treated; Slack wax [A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
292-659-8
90669-77-5
Carc. 1B
Slack wax (petroleum), carbon-treated; Slack wax [A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.]
A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.
309-723-9
100684-49-9
Carc. 1B
Slack wax (petroleum), clay-treated; Slack wax [A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predomi nantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
Slack wax (petroleum), hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
Slack wax (petroleum), low-melting, carbon-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
Slack wax (petroleum), low-melting, clay-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impur ities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
Slack wax (petroleum), low-melting, hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predomi nantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
Slack wax (petroleum), low-melting; Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
Slack wax (petroleum); Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
Tar, coal, high-temp., distn. and storage residues; Coal Tar Solids Residue [Coke-and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.]
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
Tar, coal, high-temp., high-solids; Coal Tar Solids Residue [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292 °F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Tar, coal, high-temp., residues; Coal Tar Solids Residue [Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.]
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Tar, coal, low-temp, distn. residues; Tar Oil, intermediate boiling [Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300 °C (572 °F). Composed primarily of aromatic compounds.]
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
Tar, coal, storage residues; Coal Tar Solids Residue [The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.]
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
trisodium [4'-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4''-(6-benzoylamino-3-sulfonato2-naphthylazo)-biphenyl 1,3',3'',1'''-tetraolato-O,O',O'',O''']copper(II)
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
urethane (INN); ethyl carbamate
200-123-1
51-79-6
Carc. 1B
Waste solids, coal-tar pitch coking; Coal Tar Solids Residue [The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.]
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
dimethylnitrosoamine; N-nitrosodimethylamine
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
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
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Beryllium phosphide (BeP2) EC / List no: - | CAS no: 1268721-56-7
Beryllium diboride EC / List no: 235-443-0 | CAS no: 12228-40-9
Octadecanoic acid, beryllium salt EC / List no: - | CAS no: 16687-38-0
Silicic acid, beryllium salt EC / List no: 261-293-0 | CAS no: 58500-38-2
Beryllium chloride EC / List no: 232-116-4 | CAS no: 7787-47-5
Beryllium EC / List no: 231-150-7 | CAS no: 7440-41-7
Beryllium sulphide EC / List no: 237-064-6 | CAS no: 13598-22-6
Beryllium diboride EC / List no: 235-694-6 | CAS no: 12536-51-5
Zinc beryllium silicate EC / List no: - | CAS no: 39413-47-3
Beryllium zinc silicate EC / List no: 247-151-0 | CAS no: 25638-88-4
Diethylberyllium EC / List no: 208-823-9 | CAS no: 542-63-2
Copper alloy, Cu 96, Be 2.2-2.8, Ni 1.1 (CDA 827) EC / List no: - | CAS no: 11108-64-8
Beryllium hexaboride EC / List no: 235-657-4 | CAS no: 12429-94-6
Beryllium dibromide EC / List no: 232-115-9 | CAS no: 7787-46-4
Aluminium alloy, Al,Be EC / List no: 603-236-8 | CAS no: 12770-50-2
Beryllium oxyfluoride EC / List no: - | CAS no: 63990-88-5
Bis(pentane-2,4-dionato-O,O')beryllium EC / List no: 233-513-5 | CAS no: 10210-64-7
Beryllium diiodide EC / List no: 232-119-0 | CAS no: 7787-53-3
Bertrandite (Be4(OH)2O(SiO3)2) EC / List no: 235-299-9 | CAS no: 12161-82-9
Beryllium selenide EC / List no: 235-450-9 | CAS no: 12232-25-6
Nitric acid, beryllium salt, tetrahydrate EC / List no: 690-699-4 | CAS no: 13510-48-0
Beryllium acetylide EC / List no: 208-050-7 | CAS no: 506-66-1
Beryllium hydroxide EC / List no: 236-368-6 | CAS no: 13327-32-7
Beryllium nitrate EC / List no: 237-062-5 | CAS no: 13597-99-4
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
Beryllium phosphide EC / List no: 261-137-1 | CAS no: 58127-61-0
Beryllium nitrate trihydrate EC / List no: - | CAS no: 7787-55-5
Beryllium carbonate EC / List no: 236-030-8 | CAS no: 13106-47-3
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
Hexakis[μ-(acetato-O:O')]-μ4-oxotetraberyllium EC / List no: 242-785-4 | CAS no: 19049-40-2
Beryllium sulfate tetrahydrate EC / List no: 629-461-1 | CAS no: 7787-56-6
Disodium tetrafluoroberyllate EC / List no: 237-630-2 | CAS no: 13871-27-7
Beryllium telluride EC / List no: 235-451-4 | CAS no: 12232-27-8
Phosphoric acid, beryllium salt EC / List no: 252-356-3 | CAS no: 35089-00-0
Beryllium, bis(carbonato(2-))dihydroxytri- EC / List no: - | CAS no: 66104-24-3
Beryllium diammonium tetrafluoride EC / List no: 238-948-4 | CAS no: 14874-86-3
Tetraberyllium boride EC / List no: 235-695-1 | CAS no: 12536-52-6
Beryllium di(acetate) EC / List no: 208-850-6 | CAS no: 543-81-7
Beryllium fluoride EC / List no: 232-118-5 | CAS no: 7787-49-7
Beryllium sulphate EC / List no: 236-842-2 | CAS no: 13510-49-1
Triberyllium nitride EC / List no: 215-132-6 | CAS no: 1304-54-7
-
-
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
1,4-dichlorobut-2-ene
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
dimethylsulfamoylchloride
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
3-propanolide;1,3-propiolactone
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
1,2-dimethylhydrazine
-
540-73-8
Carc. 1B; Acute Tox. 3
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
2,4,5-trimethylaniline hydrochloride
-
21436-97-5
Carc. 1B; Acute Tox. 3
1,3-dichloro-2-propanol
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
dimethylcarbamoyl chloride
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
toluene-2,4-diammonium sulphate; 4-methyl-m-phenylenediamine sulfate
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
α-chlorotoluene; benzyl chloride
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α-trichlorotoluene; benzotrichloride
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
o-toluidine; 2-aminotoluene
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
1,2-dibromoethane
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-chloroaniline
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
salts of hydrazine
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1,2,4-triazolidine-3,5-dione, compound with hydrazine (1:1) EC / List no: 264-246-2 | CAS no: 63467-96-9
Hydrazinium dihydrogen phosphate EC / List no: 239-919-9 | CAS no: 15823-35-5
Hydrazine Acetate EC / List no: 629-465-3 | CAS no: 13255-48-6
Hydrazine, phosphate (2:1) EC / List no: - | CAS no: 59779-45-2
Dihydrazinium sulphate EC / List no: 236-688-6 | CAS no: 13464-80-7
Hydrazine, sulfate (2:1), monohydrate EC / List no: - | CAS no: 66375-32-4
Hydrazine, sulfate EC / List no: - | CAS no: 1184-66-3
Thiocyanic acid, compd. with hydrazine (1:1) EC / List no: - | CAS no: 24786-78-5
Hydrazinium sulphamate EC / List no: 254-708-1 | CAS no: 39935-03-0
Dithiocarbazic acid, compound with hydrazine (1:1) EC / List no: 243-844-7 | CAS no: 20469-71-0
Hydrazine, hydriodide (3:2) EC / List no: - | CAS no: 10034-92-1
Hydrazine, monohydriodide EC / List no: - | CAS no: 10039-55-1
Hydrazine, monohydrofluoride EC / List no: - | CAS no: 18220-64-9
Hydrazinium acetate EC / List no: 230-845-2 | CAS no: 7335-65-1
Compound of carbonic acid with hydrazine(1:2) EC / List no: - | CAS no: 112077-84-6
Hydrazine, phosphate EC / List no: - | CAS no: 23488-13-3
Hydrazinium nitrate EC / List no: 236-690-7 | CAS no: 13464-97-6
Hydrazine, nitrate EC / List no: - | CAS no: 37836-27-4
Hydrazinium(2+) sulphate EC / List no: 233-110-4 | CAS no: 10034-93-2
Hydrazine, hydrochloride EC / List no: - | CAS no: 14011-37-1
Hydrazine difluoride EC / List no: - | CAS no: 13537-45-6
Nitroformic acid, compound with hydrazine (1:1) EC / List no: 244-023-6 | CAS no: 20773-28-8
Hydrazine perchlorate EC / List no: - | CAS no: 27978-54-7
Hydrazine, diperchlorate, dihydrate EC / List no: - | CAS no: 73497-82-2
Hydrazine dihydrochloride EC / List no: 226-283-2 | CAS no: 5341-61-7
Hydrazine, dinitrate EC / List no: - | CAS no: 13464-98-7
Hydrazine, dihydrobromide, dihydrate EC / List no: - | CAS no: 40849-90-9
Hydrazine selenate EC / List no: - | CAS no: 73506-32-8
Hydrazinium chloride EC / List no: 220-154-4 | CAS no: 2644-70-4
Hydrazinium bromide EC / List no: 237-412-7 | CAS no: 13775-80-9
Hydrazine dihydrobromide EC / List no: 245-543-6 | CAS no: 23268-00-0
Hydrazine, diperchlorate EC / List no: - | CAS no: 13812-39-0
Hydrazine tartrate EC / List no: 211-211-4 | CAS no: 634-62-8
-
-
Carc. 1B; Acute Tox. 3; Skin Sens. 1
1,3-propanesultone; 1,2-oxathiolane 2,2-dioxide
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis(2-chloroaniline)
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
2-nitroanisole
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
3,3'-dimethoxybenzidine; o-dianisidine
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
4,4'-bi-o-toluidine
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
4,4'-thiodianiline and its salts
-
-
Carc. 1B; Acute Tox. 4
4,4'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
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