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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
Filter the list

445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
432-100-9
-
Eye Dam. 1
450-010-8
-
Eye Dam. 1; Skin Sens. 1
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
423-010-0
-
Eye Dam. 1
423-580-0
-
STOT RE 2
COMPLEXING AGENT BN
410-650-0
-
Eye Dam. 1; Skin Sens. 1
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
430-050-2
-
Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
434-240-6
-
Skin Sens. 1
424-290-7
188070-47-5
Skin Sens. 1
435-450-0
5460-63-9
Skin Sens. 1
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
-
Skin Corr. 1B
FRUITATE
407-520-0
80657-64-3
Skin Irrit. 2
427-090-8
116044-44-1
Skin Sens. 1
434-420-4
-
Skin Irrit. 2; Eye Dam. 1
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
PRICARE
411-860-5
-
Skin Sens. 1
PRIAZUL LAUROYL LACTYLATE; PRICARE LAURYL LACTYLATE (1:1.5)
412-590-0
58856-63-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
426-840-1
-
Eye Dam. 1
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
DYE K
402-660-9
-
Repr. 1B
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
427-140-9
-
Carc. 2
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
MUGETANOL
407-640-3
63767-86-2
Eye Irrit. 2; Skin Irrit. 2
NEWLON AM-92I
407-490-9
-
Acute Tox. 4; Skin Corr. 1B
422-260-8
20701-68-2
Eye Dam. 1
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
429-990-6
-
Eye Dam. 1; Skin Sens. 1
SP 7077
430-180-1
-
Skin Irrit. 2
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
417-050-8
151006-58-5
Acute Tox. 4
422-920-5
-
STOT RE 2
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
MDI
406-550-1
-
Skin Sens. 1
MCP 455
406-240-6
-
Flam. Liq. 3; Skin Corr. 1B
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
DP 15
410-640-6
-
Skin Irrit. 2; Eye Dam. 1
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
MONO 442
412-260-6
52658-19-2
Eye Irrit. 2; Skin Sens. 1
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
427-730-6
202420-04-0
Skin Corr. 1B
451-440-9
586372-44-3
Eye Dam. 1
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
R 7623 TECHNICAL
403-250-2
-
Carc. 2; Repr. 1B; Acute Tox. 4
423-750-4
-
Eye Irrit. 2
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
-
8069-76-9
Acute Tox. 4
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
431-440-5
-
Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
435-440-6
-
Eye Dam. 1
442-290-5
457624-86-1
Eye Dam. 1
440-510-4
-
Eye Dam. 1; Skin Sens. 1
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
425-910-9
32480-08-3
Skin Irrit. 2
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
442-800-6
-
Skin Irrit. 2
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
EUGEWHITE
412-020-0
-
Skin Sens. 1
419-000-0
-
Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
428-050-2
-
Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
429-590-1
-
Skin Sens. 1
442-300-8
-
Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
429-710-2
-
Self-react. D; Acute Tox. 4
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
419-610-7
171866-24-3
STOT RE 2
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
434-330-5
-
Carc. 2; Skin Sens. 1
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
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.
-
-
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.
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
201-435-0
82-68-8
Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
610-007-6
422556-08-9
Skin Sens. 1
611-516-6
57369-32-1
Acute Tox. 4
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
-
-
Acute Tox. 4
204-927-3
129-00-0
yes
-
108-34-9
Acute Tox. 2; Acute Tox. 1
236-656-1
13457-18-6
Acute Tox. 4
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
602-927-1
123312-89-0
Carc. 2; Repr. 2
-
-
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.
-
68583-29-9
B Bacteria and similar species
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
show/hide
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
619-000-2
94125-34-5
Acute Tox. 4
PROSULFOCARB
401-730-6
52888-80-9
Acute Tox. 4; Skin Sens. 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.
606-168-7
189278-12-4
Carc. 2
245-951-4
23950-58-5
Carc. 2
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
203-572-1
108-32-7
Eye Irrit. 2

Export search results to: