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 24 lipnja 2024. Database contains 4917 unique substances/entries.
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215-235-6
1314-41-6
R Toxic for reproduction (article 57c)
Details
237-560-2
13840-56-7
Repr. 1B
R Toxic for reproduction (article 57c)
Details
235-067-7
12065-90-6
R Toxic for reproduction (article 57c)
Details
603-902-8
13517-20-9
R Toxic for reproduction (article 57c)
Details
600-611-8
10486-00-7
R Toxic for reproduction (article 57c)
Details
600-419-4
10332-33-9
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
234-390-0
11138-47-9;12040-72-1;37244-98-7
R Toxic for reproduction (article 57c)
Details
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Perfluoroheptanoic acid EC / List no: 206-798-9 | CAS no: 375-85-9
Ammonium perfluoroheptanoate EC / List no: 228-098-2 | CAS no: 6130-43-4
potassium perfluoroheptanoate EC / List no: - | CAS no: 21049-36-5
Sodium perfluoroheptanoate EC / List no: 243-518-4 | CAS no: 20109-59-5
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-
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
206-798-9
375-85-9
Repr. 1B; STOT RE 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
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-
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
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Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
799-972-3
-
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
-
-
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
-
57427-55-1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
701-468-5
21049-36-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
R Toxic for reproduction (article 57c)
Details
915-270-3
-
R Toxic for reproduction (article 57c)
Details
272-271-5
68784-75-8
R Toxic for reproduction (article 57c)
Details
234-363-3
11120-22-2
R Toxic for reproduction (article 57c)
Details
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
239-172-9
15120-21-5
R Toxic for reproduction (article 57c)
Details
243-518-4
20109-59-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
231-556-4
7632-04-4
R Toxic for reproduction (article 57c)
Details
263-467-1
62229-08-7
R Toxic for reproduction (article 57c)
Details
235-541-3
12267-73-1
Repr. 1B
R Toxic for reproduction (article 57c)
Details
201-075-4
78-00-2
R Toxic for reproduction (article 57c)
Details
235-380-9
12202-17-4
R Toxic for reproduction (article 57c)
Details
215-290-6
1319-46-6
R Toxic for reproduction (article 57c)
Details
235-252-2
12141-20-7
R Toxic for reproduction (article 57c)
Details
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
R Toxic for reproduction (article 57c)
Details
213-934-0
1067-53-4
Repr. 1B
R Toxic for reproduction (article 57c)
Details
238-253-6
14312-40-4
R Toxic for reproduction (article 57c)
Details
246-677-8
25155-23-1
Repr. 1B
R Toxic for reproduction (article 57c)
Details
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
204-650-8
123-77-3
Resp. Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
-
135821-03-3
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
135821-74-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
957070-06-3
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
253-692-3
37853-59-1
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-467-4
3910-35-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
228-846-8
6362-80-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
228-396-2
6258-73-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
255-584-1
41906-71-2
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
236-948-9
13560-89-9
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
250-325-9
30748-85-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
220-466-0
2772-45-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-383-8
3864-99-1
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
413-720-9
117933-89-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
413-720-9
117933-89-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
413-720-9
117933-89-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
221-573-5
3147-75-9
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
253-037-1
36437-37-3
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
209-968-0
599-64-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
-
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
269-511-6
68259-08-5
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
247-426-5
26040-51-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
201-247-9
80-07-9
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-445-4
3896-11-5
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
218-165-4
2058-94-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-803-4
376-06-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
201-329-4
81-15-2
Expl. 1.1; Carc. 2
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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Phenol, methylstyrenated EC / List no: 270-966-8 | CAS no: 68512-30-1
700-960-7
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
276-745-2
72629-94-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-587-1
355-46-4
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
201-581-5
85-01-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
270-966-8
68512-30-1
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-393-2
3871-99-6
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
473-390-7
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
-
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-203-2
307-55-1
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
274-462-9
70225-16-0
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
Details
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
Details
606-373-1
197706-50-6
Skin Sens. 1
Details
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
Details

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