Substance Regulatory Obligations

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

This list contains a non-exhaustive inventory of substances that fall within the European Union's hazardous substance definitions, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annexes XIV and XVII (Authorisation and Restriction lists). They can be considered hazardous for purposes of the General Product Safety Directive 2001/95/EC.

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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).

This list contains a non-exhaustive inventory of hazardous substances for purposes of the Marine Strategy Framework Directive, especially as it concerns Art. 3(8), and Annexes I and III. The listed substances meet the European Union's definitions as hazardous, as provided on: (1) Table 3 of Annex VI to the CLP Regulation (1272/2008/EC); (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annex XIV (Authorisation List).

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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).

This list contains a non-exhaustive inventory of substances to which pregnant workers and workers who have recently given birth or are breastfeeding may not be exposed. Employers are obligated to prevent the exposure of these workers to any agents that may have adverse health effects on either mother or child. The inventory originates from Table 3 of Annex VI to the CLP.

This list contains a non-exhaustive inventory of substances that fall within the scope of the European Union's definition of hazardous chemical and biological substances, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; and (2) Annex III of Directive 2000/54/EC (Biological Agents). The EU's Occupational Safety and Health (OSH) Framework Directive 89/391/EEC applies to risks arising from chemical, physical and biological agents at the workplace.