EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 19 lipnja 2024. Database contains 4821 unique substances/entries.
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KENODOX
404-300-6
116753-76-5
Org. Perox. C
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
UP 565
411-530-0
15024-10-9
Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
418-270-7
-
Skin Sens. 1
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
414-910-4
-
Eye Dam. 1; Skin Sens. 1
442-030-0
321912-47-4
Eye Dam. 1
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
432-400-1
10102-09-7
Skin Corr. 1A
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
X4060
404-035-6
1379801-27-0
Skin Sens. 1
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
426-300-5
-
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-620-5
619297-89-1
Eye Dam. 1
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
425-830-4
-
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
BROWN JR 547
419-260-5
-
Eye Dam. 1
425-740-5
-
Eye Dam. 1
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 1
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
DESBIMID
401-970-1
-
Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
403-410-1
114565-65-0
Skin Sens. 1
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ADINE CP 31
401-740-0
-
Acute Tox. 4
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
BROWN JR 543
414-150-3
-
Skin Sens. 1
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
430-200-7
-
Eye Dam. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B
436-890-6
-
Eye Dam. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
MS6119
415-190-4
-
Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
429-860-9
86803-90-9
Skin Sens. 1
434-290-9
249630-78-2
Acute Tox. 4
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
433-640-8
-
Pyr. Sol. 1
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1

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