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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 April 2024. Database contains 4821 unique substances/entries.
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425-370-4
93957-50-7
Skin Sens. 1
426-750-2
151860-15-0
Skin Sens. 1
DMA
407-500-1
21983-80-2
Skin Sens. 1
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
DD-63
404-590-4
90884-29-0
Skin Sens. 1
423-860-2
56309-94-5
Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
420-220-4
92771-56-7
Skin Sens. 1
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
401-130-4
71526-07-3
Skin Sens. 1
438-670-5
87199-17-5
Skin Sens. 1
430-840-7
202483-63-4
Skin Sens. 1
425-860-8
125971-57-5
Skin Sens. 1
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
410-530-8
107815-88-3
Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
416-360-0
162221-28-5
Skin Sens. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
431-600-4
112226-61-6
Skin Sens. 1
205-736-8
149-30-4
Skin Sens. 1
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
430-700-5
10138-36-0
Skin Sens. 1
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
404-420-9
71786-70-4
Skin Sens. 1
418-370-0
143925-92-2
Skin Sens. 1
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
202-759-5
99-49-0
Skin Sens. 1
216-920-2
1698-60-8
Skin Sens. 1
227-011-5
5598-13-0
Skin Sens. 1
215-273-3
1317-42-6
Skin Sens. 1
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
601-785-8
121552-61-2
Skin Sens. 1
218-827-2
2244-16-8
Skin Sens. 1
204-424-9
120-78-5
Skin Sens. 1
IRB
418-070-1
141714-54-7
Skin Sens. 1
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
432-860-1
255387-46-3
Skin Sens. 1
CYRACURE (R) PHOTOINITIATOR UVI-6974; CYRACURE PHOTOINITIATOR UVI-6976
403-500-0
159120-95-3
Skin Sens. 1
PRODUKT 1096
414-230-8
-
Skin Sens. 1
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
DURALINK (R) HTS; ERP-390
401-320-7
5719-73-3
Skin Sens. 1
214-620-6
1166-52-5
Skin Sens. 1
428-020-9
6195-20-6
Skin Sens. 1
250-010-6
30043-49-3
Skin Sens. 1
429-680-0
122665-86-5
Skin Sens. 1
DM-8
405-880-3
100501-62-0
Skin Sens. 1
429-220-9
132584-17-9
Skin Sens. 1
266-362-9
66441-23-4
Skin Sens. 1
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
422-360-1
100491-29-0
Skin Sens. 1
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
294-145-9
91673-30-2
Skin Sens. 1
203-377-1
106-24-1
Skin Sens. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
229-352-5
6485-40-1
Skin Sens. 1
427-850-9
202667-43-4
Skin Sens. 1
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
CGA 184699
410-690-9
103055-07-8
Skin Sens. 1
BLACK JR 578
419-230-1
-
Skin Sens. 1
445-990-9
376588-17-9
Skin Sens. 1
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
442-860-3
87333-22-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
JE 127
421-220-7
144740-59-0
Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
429-570-2
213990-58-0
Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
200-806-4
74-31-7
Skin Sens. 1
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
UC-129
403-790-9
108673-51-4
Skin Sens. 1
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
425-300-2
186450-73-7
Skin Sens. 1
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
202-411-2
95-33-0
Skin Sens. 1
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1
426-150-0
121246-28-4
Skin Sens. 1
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
Skin Sens. 1
UP 565
411-530-0
15024-10-9
Skin Sens. 1
254-938-2
40487-42-1
Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
418-270-7
-
Skin Sens. 1
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
X4060
404-035-6
1379801-27-0
Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
610-007-6
422556-08-9
Skin Sens. 1
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
201-435-0
82-68-8
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
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
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
BROWN JR 543
414-150-3
-
Skin Sens. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
MS6119
415-190-4
-
Skin Sens. 1
429-860-9
86803-90-9
Skin Sens. 1
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
442-300-8
-
Skin Sens. 1
429-590-1
-
Skin Sens. 1
428-050-2
-
Skin Sens. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
419-000-0
-
Skin Sens. 1
EUGEWHITE
412-020-0
-
Skin Sens. 1
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
MDI
406-550-1
-
Skin Sens. 1
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
PRICARE
411-860-5
-
Skin Sens. 1
427-090-8
116044-44-1
Skin Sens. 1
435-450-0
5460-63-9
Skin Sens. 1
424-290-7
188070-47-5
Skin Sens. 1
434-240-6
-
Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
430-050-2
-
Skin Sens. 1
TASP
411-250-9
-
Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
ITC 288/S
410-800-5
-
Skin Sens. 1
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
428-630-5
-
Skin Sens. 1
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
277-299-1
73138-82-6
Skin Sens. 1
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
Skin Sens. 1
436-690-9
220727-26-4
Skin Sens. 1
618-004-1
87392-12-9
Skin Sens. 1
425-210-3
169939-84-8
Skin Sens. 1
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
426-520-1
71420-85-4
Skin Sens. 1
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
430-890-1
81992-66-7
Skin Sens. 1
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
AF-390
407-720-8
155160-86-4
Skin Sens. 1
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
LU20
405-450-5
66531-87-1
Skin Sens. 1
218-953-8
2302-17-2
Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
P3B
418-080-4
120307-06-4
Skin Sens. 1
429-270-1
136210-30-5
Skin Sens. 1
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
RED JB 747
418-220-4
-
Skin Sens. 1
604-291-0
142469-14-5
Skin Sens. 1
605-037-1
156052-68-5
Skin Sens. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
227-678-2
5932-68-3
Skin Sens. 1A
227-633-7
5912-86-7
Skin Sens. 1A

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