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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 based on the list of substances with harmonised classification and labelling (i.e., Table 3 of Annex VI to the CLP Regulation 1272/2008/EC). While the harmonised list covers many hazardous substances, others not listed may also meet the classification criteria in accordance with the CLP Regulation.

This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. The basis of the list is Annex I(3) of the Construction Products Regulation 305/2011/EC, which stipulates that construction works must not have a high impact on human health or the environment as a result of: giving off toxic gas; emissions of dangerous substances, volatile organic compounds (VOC), greenhouse gases or dangerous particles into indoor or outdoor air; release of dangerous substances into drinking water, ground water, marine waters, surface waters or soil.

This list contains a non-exhaustive inventory of substances originating from: (1) Table 3 of Annex VI to CLP (i.e., the list of harmonised substances); (2) the Candidate List of Substances of Very High Concern (SVHCs); and REACH Annex XIV (Authorisation List). This list is compiled on the basis of Article 6(5) of Regulation 305/2011/EC on Marketing of Construction Products. This provision requires SDSs and information on hazardous substances (i.e., SVHCs) contained in construction products be provided with the declaration of performance.

This list contains coloring agents allowed for use in cosmetic products marketed in the European Union. The list indicates the approved fields for application, including whether or not the colorant is permitted for use in products applied near the eye or on mucous membranes, or in products intended to come in contact with the skin.

The Drinking Water Directive 2020/2184 concerns the quality of water intended for human consumption. Drinking water is wholesome and clean if it’s: (a) free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health; (b) meets the minimum requirements set out in Parts A, B and D of Annex I. Indicators parameters set out in Part C of Annex I shall also be monitored, as they can help to identify water treatment.

This list contains a non-exhaustive inventory of hazardous substances as defined by Article 2(11) of the End-of-Life Vehicles Directive 2000/53/EC. It is based on the relevant subset of substances with harmonised classification listed in Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

This list contains a non-exhaustive inventory of substances based on the list of hazardous substances with harmonised classification and labelling (i.e. Table 3 of Annex VI to the CLP Regulation), and the Candidate List of substances of very high concern (SVHCs). Pursuant to Article 6(6) of the EU Ecolabel Regulation, the ecolabel must not be awarded to goods containing substances or mixtures classified according to the CLP as toxic; hazardous to the environment; and carcinogenic, mutagenic, or toxic for reproduction (CMRs). Nor are products allowed the ecolabel award when they contain SVHCs (per Article 57 of REACH). While the CLP's harmonised list contains many such substances, other ones not listed in Table 3 may also meet the criteria specified for classification under the CLP.

This list contains Annex I fertiliser types according to their specific characteristics. Regulation 2003/2003/EC consolidates all European Union rules that apply to fertilisers, and ensures that the technical requirements it outlines are implemented uniformly. The Regulation only applies to mineral fertilisers consisting of one or more plant nutrients. Regulation 2003/2003/EC has been repealed with effect from 16 July 2022 by Regulation 2019/1009/EU.

The list contains labelling requirements for a given Product Function Category (PFC), and respective subcategories, related to the content of micronutrients boron (B), cobalt (Co), iron (Fe), manganese (Mn), molybdenum (Mo), Copper (Cu) and Zinc (Zn). The list is based on Annex III, Part II. The list is not exhaustive – for detailed labelling requirements please refer to the text of Regulation (EU) No 2019/1009.

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 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 the Annex II substances subject to general restrictions for use in plastic materials and articles intended to come into contact with food. Each listed substance includes specific migration limit that must not be exceeded.

This list contains the Annex I parameters from the Drinking Water Directive 98/83/EC, which concerns the quality of water intended for human consumption. Its objective is to protect human health from adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean.

This list contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class and category, hazard (H) statement, and/or concentration limits provided in Annex III of the Waste Framework Directive 2008/98/EC. The classifications of the substances listed in the list are based on their harmonised classifications per Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.