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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 travnja 2024. Database contains 4821 unique substances/entries.
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430-690-2
52783-21-8
Skin Irrit. 2
426-530-6
-
Skin Irrit. 2
HFR-990
423-180-6
-
STOT RE 2
427-040-5
-
Skin Corr. 1B
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
433-640-8
-
Pyr. Sol. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
434-290-9
249630-78-2
Acute Tox. 4
429-860-9
86803-90-9
Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
MS6119
415-190-4
-
Skin Sens. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
436-890-6
-
Eye Dam. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
430-200-7
-
Eye Dam. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
BROWN JR 543
414-150-3
-
Skin Sens. 1
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
915-270-3
-
yes
ADINE CP 31
401-740-0
-
Acute Tox. 4
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 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
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
DESBIMID
401-970-1
-
Skin Sens. 1
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.

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