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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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450-010-8
-
Eye Dam. 1; Skin Sens. 1
432-100-9
-
Eye Dam. 1
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
COLUMBIADUNKELBLAU R
415-350-3
-
Eye Dam. 1
422-500-1
-
STOT RE 2
433-860-4
-
Eye Irrit. 2; Skin Sens. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
-
Skin Corr. 1B; Skin Sens. 1
TASP
411-250-9
-
Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
427-740-0
-
Eye Dam. 1; Skin Sens. 1
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 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
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-440-5
-
Eye Dam. 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
EBO
417-540-1
-
Eye Dam. 1
BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
404-986-7
74227-35-3
Eye Dam. 1
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
ARQUAD 3.16
405-620-9
-
Eye Dam. 1
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
428-260-4
-
Eye Dam. 1
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
428-400-4
-
Eye Dam. 1
444-050-5
-
Eye Dam. 1
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
-
Eye Dam. 1
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
GA161895; GLUCAMIDE
411-130-6
-
Eye Dam. 1
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
ORANGE LEP 2471
421-290-9
-
STOT RE 2
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
431-120-5
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
SHC 3000
401-530-9
-
Flam. Sol. 1; STOT SE 1; Acute Tox. 4
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
YELLOW MGI 1301
424-250-9
-
Eye Dam. 1
E-101
420-310-3
-
Acute Tox. 4
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
PES-SOLID
420-070-1
-
Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
424-510-1
-
Eye Dam. 1
PRODUKT 1245
420-980-7
-
Eye Dam. 1
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
428-630-5
-
Skin Sens. 1
426-860-0
191877-09-5
Eye Dam. 1
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
436-690-9
220727-26-4
Skin Sens. 1
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
X4261
401-850-9
255881-94-8
yes
425-210-3
169939-84-8
Skin Sens. 1
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
426-520-1
71420-85-4
Skin Sens. 1
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
422-100-7
102061-82-5
Eye Dam. 1; 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
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
430-890-1
81992-66-7
Skin Sens. 1
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
AF-390
407-720-8
155160-86-4
Skin Sens. 1
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
418-410-7
139122-78-4
Eye Irrit. 2
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; 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
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
LU20
405-450-5
66531-87-1
Skin Sens. 1

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