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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
203-572-1
108-32-7
Eye Irrit. 2
606-168-7
189278-12-4
Carc. 2
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
602-927-1
123312-89-0
Carc. 2; Repr. 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
236-656-1
13457-18-6
Acute Tox. 4
-
108-34-9
Acute Tox. 2; Acute Tox. 1
204-927-3
129-00-0
yes
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
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
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; 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
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
419-610-7
171866-24-3
STOT RE 2
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
417-050-8
151006-58-5
Acute Tox. 4
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
427-090-8
116044-44-1
Skin Sens. 1
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
424-290-7
188070-47-5
Skin Sens. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 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
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
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
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
939-460-0
1471311-26-8
yes
426-860-0
191877-09-5
Eye Dam. 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
A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.
309-710-8
100684-37-5
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.
309-711-3
100684-38-6
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40°C (104°F).
310-057-6
102110-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
233-940-7
10453-86-8
Acute Tox. 4
203-585-2
108-46-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
243-193-9
19622-19-6
Acute Tox. 4
425-210-3
169939-84-8
Skin Sens. 1
205-801-0
152-16-9
Acute Tox. 1; Acute Tox. 2
203-300-1
105-46-4
Flam. Liq. 2
237-732-7
13952-84-6
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
234-363-3
11120-22-2
yes
233-054-0
10026-04-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
605-752-9
175217-20-6
STOT RE 2
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
204-535-2
122-34-9
Carc. 2
213-801-7
1014-70-6
Acute Tox. 4
A complex combination of hydrocarbons obtained by treatment of petroleum slack wax with activated charcoal for the removal of trace polar constituents and impurities.
309-723-9
100684-49-9
Carc. 1B
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
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
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
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

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