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).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Acute Tox. 2; Acute Tox. 1; STOT RE 2

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
2-chloro-4-nitroaniline 204-502-2 121-87-9 Expert judgement
5-chloro-2-nitroaniline 216-661-5 1635-61-6 Expert judgement
2-chloro-6-nitroaniline 212-204-9 769-11-9 Expert judgement
Benzenamine, 4-chloro-N-nitro- - 69732-97-4 Expert judgement
3-chloro-4-nitroaniline 642-644-0 825-41-2 Expert judgement
N-chloro-2-nitroaniline - 59483-60-2 Expert judgement
Benzenamine, 2-chloro-3-nitro- - 3970-41-0 Expert judgement
Benzenamine, chloronitro- - 41587-36-4 Expert judgement
4-chloro-3-nitroaniline 211-231-3 635-22-3 Expert judgement
Benzenamine, 3-chloro-5-nitro- - 5344-44-5 Expert judgement
3-chloro-2-nitroaniline 261-782-9 59483-54-4 Expert judgement
4-chloro-2-nitroaniline 201-925-4 89-63-4 Expert judgement
2-chloro-5-nitroaniline 228-498-7 6283-25-6 Expert judgement