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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 lipnja 2024. Database contains 4821 unique substances/entries.
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435-350-7
141250-43-3
Eye Dam. 1
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
1,1-DIMETHYLETHOXY-CARBONYL-METHYLEN-TRIPHENYLPHOSPHORAN; DMY; PHOSPHORANE
412-880-7
35000-38-5
Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
TERTIARYBUTYLARSINE; TERTIÄRBUTYLARSIN
423-320-6
4262-43-5
Pyr. Liq. 1; Acute Tox. 2
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
426-730-3
123439-82-7
Acute Tox. 4; Eye Dam. 1
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
444-440-5
220689-12-3
Acute Tox. 4
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
P3B
418-080-4
120307-06-4
Skin Sens. 1
TETRACONAZOLE
407-760-6
112281-77-3
Acute Tox. 4
KAYASET BLACK T-2
405-110-6
88377-66-6
STOT RE 2
429-270-1
136210-30-5
Skin Sens. 1
CIS/TRANS-TIMO; FLOROL; FLOROSA
405-040-6
63500-71-0
Eye Irrit. 2
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
440-460-3
252579-81-0
Eye Irrit. 2
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
430-390-1
845730-14-5
Acute Tox. 4
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
BRILLANTGREEN K-RWA 6083; BRILLIANT GREEN K-RWA 6083
410-160-7
148732-74-5
Eye Irrit. 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
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
432-550-6
243858-01-7
Eye Dam. 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
429-230-3
371921-41-4
Eye Dam. 1
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; 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
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
REACTIVE RED SR 6947; ROUGE REACTIF SR 6947
411-540-5
130201-57-9
Eye Dam. 1; Skin Sens. 1
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
RED ULK 1640
420-350-1
172277-97-3
Eye Dam. 1
428-650-4
153719-23-4
Repr. 2; Acute Tox. 4
RT 1766A
404-820-3
164637-97-2
Skin Irrit. 2; Skin Sens. 1
STANNOUS METHANE SULPHONAT; STANNOUS METHANE SULPHONATE; TIN (II) METHANE SULPHONATE; TIN METHANE SULPHONATE; TIN METHANESULFONATE; TIN SALT FS; ZINN(II) METHANESULFONATE; ZINN(II)-METHANSULFONAT
401-640-7
53408-94-9
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
FC4010
417-290-3
147086-81-5
Acute Tox. 4
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
443-150-6
101226-85-1
Flam. Liq. 3
405-060-5
118712-89-3
Skin Irrit. 2
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
432-270-4
221354-37-6
Repr. 2; STOT RE 2
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
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
440-480-2
341026-59-3
Eye Dam. 1; 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
423-100-1
-
Eye Dam. 1
TURQUOISE 10 40 518
411-430-7
-
Eye Dam. 1; Skin Sens. 1
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
RED JB 747
418-220-4
-
Skin Sens. 1
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
422-090-4
172737-80-3
Eye Dam. 1
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
BTN; VPO CATALYST
406-260-5
58834-75-6
Eye Irrit. 2; Skin Sens. 1
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2

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