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)
Resp. Sens. 1

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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
Amylase, α-, Aspergillus oryzae 232-588-1 9001-19-8 Expert judgement
Amylase, mixed with proteinase, Bacillus thuringiensis-fermented - 68909-36-4 Expert judgement
Amylase, gluco- 232-877-2 9032-08-0 Expert judgement
Amylase, fungal 232-742-8 9013-01-8 Expert judgement
Amylase, iso- 232-956-1 9067-73-6 Expert judgement
Amylase, mixture with proteinase 685-079-5 9001-11-0 Expert judgement
Amylase, α- 232-565-6 9000-90-2 Expert judgement
Bacteria, complex with amylase and proteinase - 68920-42-3 Expert judgement
Amylase, alpha-, Bacillus amyloliquefaciens - 152923-48-3 Expert judgement
Amylase, bacterial 232-560-9 9000-85-5 Expert judgement
Amylase, mixed with proteinase, Bacillus cereus-fermented - 68909-35-3 Expert judgement
Amylase 232-567-7 9000-92-4 Expert judgement
Amylase, gluco-, Rhizopus oryzae - 152923-55-2 Expert judgement
Amylase, β- 232-566-1 9000-91-3 Expert judgement