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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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611-516-6
57369-32-1
Acute Tox. 4
610-007-6
422556-08-9
Skin Sens. 1
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
201-435-0
82-68-8
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
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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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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.
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
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
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
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
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
DESBIMID
401-970-1
-
Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 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
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ADINE CP 31
401-740-0
-
Acute Tox. 4
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; 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
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
BROWN JR 543
414-150-3
-
Skin Sens. 1
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
430-200-7
-
Eye Dam. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B
436-890-6
-
Eye Dam. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
MS6119
415-190-4
-
Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
429-860-9
86803-90-9
Skin Sens. 1
434-290-9
249630-78-2
Acute Tox. 4
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
433-640-8
-
Pyr. Sol. 1
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
427-040-5
-
Skin Corr. 1B
HFR-990
423-180-6
-
STOT RE 2
426-530-6
-
Skin Irrit. 2
430-690-2
52783-21-8
Skin Irrit. 2
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
434-330-5
-
Carc. 2; Skin Sens. 1
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
419-610-7
171866-24-3
STOT RE 2
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
429-710-2
-
Self-react. D; Acute Tox. 4
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
442-300-8
-
Skin Sens. 1
429-590-1
-
Skin Sens. 1
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
428-050-2
-
Skin Sens. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
419-000-0
-
Skin Sens. 1
EUGEWHITE
412-020-0
-
Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
442-800-6
-
Skin Irrit. 2
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
425-910-9
32480-08-3
Skin Irrit. 2
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
440-510-4
-
Eye Dam. 1; Skin Sens. 1
442-290-5
457624-86-1
Eye Dam. 1
435-440-6
-
Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
431-440-5
-
Eye Dam. 1
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
-
8069-76-9
Acute Tox. 4

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