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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 subset of Table 3-listed substances in Annex VI to the CLP Regulation (1272/2008/EC). The non-exhaustive list is based on: (1) the flammable content, and (2) flammable aerosol definitions in sections 1.8 and 1.9, and (3) the labelling requirements given in section 2.2, of the Annex to the Aerosol Dispensers Directive 75/324/EEC.

This list contains the Limit, Critical, Target and Long-term Values on ambient air for protection of human health and vegetation. It also contains the Alert, Information and Upper and Lower Assessment thresholds for sulphur dioxide, nitrogen dioxide, benzene, carbon monoxide, lead, PM2.5, PM10 and ozone.

This list contains the Annex I pollutants that European Union Member States (MS) must measure and report on as part of their national emission reporting requirements. Table A lists the required annual reporting requirements; Table B lists the optional annual reporting requirements; Table C lists required two- and four-year reporting requirements. The National Emission Ceilings Directive 2016/2284/EU establishes emission reduction commitments for all EU MS.

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 provides occupational exposure limit values (OELVs) for carcinogens, mutagens and reprotoxic substances pursuant to Annex III of Directive 2004/37/EC (CMRD). Employers are obligated to minimize worker exposure to these agents in so far as possible, and must arrange for medical surveillance of workers exposed to these substances.

This list contains a non-exhaustive inventory of substances based on Art. 2 carcinogen, mutagen and reprotoxin (CMR) definitions and Annex I of the Carcinogens, Mutagens and Reprotoxins Directive (CMRD). Category 1A and 1B CMRs are derived from the CLP Regulation's Table 3 of Annex VI (1272/2008/EC). Employers are obligated to minimize worker exposure to these agents as far as possible, and must arrange for medical surveillance of workers exposed to these substances.

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 substances which are banned from use in any cosmetic products marketed for sale or use in the European Union.

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 a non-exhaustive list of Carcinogens, Mutagens and Reproductive substances (CMRs) that are not allowed for use in components of active and intelligent materials and articles per Art. 5(2)(c)(i) of Regulation 450/2009/EC. The list is derived from a subset of substances on Table 3 of Annex VI to the CLP Regulation (1272/2008/EC).

This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.

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 the polluting substances for which emission limit values are assigned under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC). Member States must permit all qualifying facilities in order to ensure that they minimize impact on the environment. The permit issued must provide emission limit values for pollutants on this list.

This list contains emission limit values for polluting substances in waste gases and waste water, assigned according to facility type (i.e., combustion plants (Annex V), waste incineration/co-incineration plants (Annex VI), and installations producing titanium dioxide (Annex VIII)), under Directive 2010/75/EU on Industrial Emissions (Integrated Pollution Prevention and Control - IPPC). For this list, if a substance presents 2 values in the ''Average sampling duration'' field, these indicate minimum and maximum average sampling period.

This list contains the ADR Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive applies the European Agreements on the international transport of dangerous goods by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component are representative examples, but not exhaustive.

This list contains the RID Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive applies the European Agreements on the international transport of dangerous goods by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component are representative examples, but not exhaustive.

This list contains the ADN Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. This Directive establishes rules for the safe transport of dangerous goods between EU countries by road (ADR) and inland waterways (ADN), and the regulations concerning the international carriage of dangerous goods by rail (RID). Any specific CAS linked as members for substances where the list refers to finished material/article/compound/component are representative examples, but not exhaustive.

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 the indicative occupational exposure limit values (IOELVs) from Commission Directive 2017/164/EU. Member States are required to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, which establishes values for reference period of eight-hour time weighted average and for a short-term period of 15 minutes. The Directive adds limit values for 27 new chemical agents, and amends 6 existing ones established by earlier directives.

This list contains the maximum residue level (MRLs) entries as listed in the following annexes of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC: (1) Annex II: Maximum Residue Levels; (2) Annex III: Temporary MRLs; (3) Annex IV: Active Substances for Which No MRLs Are Required; and (4) Annex VII: Active Substance/Product Combinations.

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

This list contains a non-exhaustive inventory of hazardous substances based on Article 13(1)(a) of Directive 2014/68/EU, defining Group 1 fluids for purposes of classifying pressure equipment in accordance with the Directive. The list is derived from a subset of the substances with harmonised classifications, as listed on Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

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 biological and chemical agents, in accordance with Art. 7 and points 2 and 3 of the Annex to Directive 94/33/EC, to which young persons (under 18 years of age) may not be exposed at the workplace. The list is a non-exhaustive inventory of such substances based on: 1) agents of risk groups 3 and 4 under Directive 2000/54/EC; 2) Table 3 of Annex VI to the CLP Regulation; 3) and Annex I of Directive 2004/37/EC.

The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.

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.

This list contains hazardous substances based on Table 3 of Annex VI to the CLP Regulation 1272/2008/EC. According to the annexes to Directive 92/58/EEC, storage areas and containers containing chemical substances or mixtures that are classified as hazardous according to the CLP Regulation must be duly marked and/or labeled. Directive 92/58/EEC requires employers to ensure proper signage is posted in areas where hazards cannot be avoided or reduced.

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.