EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 25 lipnja 2024. Database contains 4917 unique substances/entries.
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BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
Details
441-550-5
-
Self-react. C; Carc. 2
Details
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
239-732-2
15662-33-6
Acute Tox. 4
Details
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
Details
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
Details
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
Details
701-118-1
2156592-54-8
Repr. 1B; Eye Irrit. 2
Details
701-162-1
-
Repr. 1B
Details
701-271-4
-
Repr. 1B; Eye Irrit. 2
Details
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
Details
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
Details
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
Details
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
Details
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
Details
202-095-6
91-76-9
Acute Tox. 4
Details
276-957-5
72869-86-4
Skin Sens. 1B
Details
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
Details
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
Details
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
Details
424-850-0
189702-72-5
Eye Dam. 1
Details
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
Details
429-400-7
199327-61-2
Repr. 1B
Details
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
Details
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
Details
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
Details
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
Details
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
Details
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
Details
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
Details
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
Details
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
Details
213-584-9
989-38-8
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
Details
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
421-940-1
28698-31-9
Eye Dam. 1
Details
416-360-0
162221-28-5
Skin Sens. 1
Details
M1
422-060-0
137390-08-0
Acute Tox. 2
Details
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
426-890-4
77341-67-4
Eye Dam. 1
Details
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
Details
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
Details
419-270-1
123599-82-6
Eye Irrit. 2
Details
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
Details
425-520-9
197179-61-6
Eye Dam. 1
Details
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
Details
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
Details
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
Details
BROWN JR 543
414-150-3
-
Skin Sens. 1
Details
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
Details
MS6119
415-190-4
-
Skin Sens. 1
Details
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
Details
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
Details
HFR-990
423-180-6
-
STOT RE 2
Details
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
Details
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
Details
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
Details
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
Details
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
Details
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
Details
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
Details
SP 7077
430-180-1
-
Skin Irrit. 2
Details
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
Details
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
Details
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
Details
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
Details
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
Details
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
Details
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
Details
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
Details
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
Details
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
Details
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
Details
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
Details
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
Details
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
Details
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
Details
-
-
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.
Details
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
Details
-
-
P Parasites
Details
250-241-2
30560-19-1
Acute Tox. 4
Details
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
Details
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
Details
200-473-5
60-35-5
Carc. 2
Details
603-921-1
135410-20-7
Repr. 2; Acute Tox. 3
Details
682-791-8
160430-64-8
Repr. 2; Acute Tox. 3
Details
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
Details
209-030-0
553-00-4
Carc. 1A; Acute Tox. 4
Details
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
Details
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
Details
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
Details
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
Details
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
Details
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
Details
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
Details
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
Details
206-121-7
302-27-2
Acute Tox. 2
Details
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
Details
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
Details
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
Details
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
-
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.
Details
-
-
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.
Details
-
-
B Bacteria and similar species
Details
204-673-3
124-04-9
Eye Irrit. 2
Details
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
Details
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
Details
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
Details
240-896-2
16871-90-2
Acute Tox. 3
Details
240-934-8
16893-85-9
Acute Tox. 3
Details
240-968-3
16919-19-0
Acute Tox. 3
Details
-
-
Acute Tox. 4
Details
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
292-454-3
90622-53-0
Carc. 1B
Details
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
Details
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
Details
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
Details
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
Details
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
Details
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
Details
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Details
231-208-1
7446-70-0
Skin Corr. 1B
Details
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
Details
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
Details
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
Details
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
Details
209-090-8
555-31-7
Flam. Sol. 1
Details
212-634-7
834-12-8
Acute Tox. 4
Details
-
919-76-6
Acute Tox. 4
Details
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
Details
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
Details
217-990-7
2032-59-9
Acute Tox. 3
Details
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
Details
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
200-521-5
61-82-5
Repr. 2; STOT RE 2
Details
215-647-6
1336-21-6
Skin Corr. 1B
Details
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
Details
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
Details
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
Details
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
Details
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
Details
235-183-8
12124-97-9
Repr. 1B; Lact.; STOT SE 3; STOT RE 1; Eye Irrit. 2
Details
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
Details
235-185-9
12125-01-8
Acute Tox. 3
Details
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
Details
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
232-989-1
9080-17-5
Skin Corr. 1B
Details
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
232-565-6
9000-90-2
Resp. Sens. 1
Details
show/hide
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
-
-
Resp. Sens. 1
Details
-
-
P Parasites
Details
433-560-3
15375-21-0
Repr. 2
Details
-
-
P Parasites
Details
-
-
P Parasites
Details
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
Details
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
Details
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
Details
201-549-0
84-65-1
Carc. 1B
Details
-
-
Acute Tox. 4
Details
231-601-8
7647-18-9
Skin Corr. 1B
Details
233-047-2
10025-91-9
Skin Corr. 1B
Details
232-009-2
7783-56-4
Acute Tox. 3
Details
215-175-0
1309-64-4
Carc. 2
Details
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
Details
-
-
B Bacteria and similar species
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
Details
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
Details
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Details

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