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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 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

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