SSbD Knowledge Sharing Portal
SSbD and the link to EU legislation
- Introduction
The current legal frameworks for assessing and managing chemicals in the European Union (EU) have evolved over several decades. Starting with the directive on dangerous substances ↗ in 1967, there are today over 40 individual pieces of legislation ↗ dedicated to ensuring overarching chemical safety, e.g. the Regulation on Classification, Labelling and Packaging (CLP ↗) or the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH ↗) Regulation as well as the safety of various substance groups in their applications (for e.g. cosmetics, biocidal products). In addition, there are numerous regulations and directives addressing various aspects of sustainability concerning chemical substances, processes, and products at different stages of their life cycle. The EC SSbD Framework ↗ shares many of the overall aims of the existing legal frameworks. Among these are the reduction of the impacts of chemical or material life cycles on human health and the environment, the transition to a more circular economy, and fostering innovation and competitiveness of the European industry. Thus, there is a high degree of commonality between the EC SSbD Framework’s safety and sustainability criteria, indicators, and elements on one side, and provisions included under various pieces of EU legislation on the other side. With that in mind, information gained during an SSbD assessment helps to identify and prepare to meet the legal requirements that a substance or product under consideration must comply with once it enters the European market. Assessing a substance or its application within the EU SSbD Framework may also help to identify legal issues at an early stage of innovation. Conversely, many of these pieces of legislation can be used in the context of the SSbD Framework as information sources to retrieve data on marketed substances for the purpose of e.g. a general analysis of a substance’s life cycle, re-design of products or for comparison and benchmarking with new chemicals and materials.
The full resource of information presented on this page is published here ↗.
- Pieces of EU legislation related to safety and sustainability
The following table provides an overview of provisions from some of the most prominent EU legislation related to safety and sustainability, highlighting links to criteria, indicators, and elements of the SSbD assessment, as well as information and methodologies from EU legislation that can support SSbD assessments (adapted from Schwirn et al., 2025 ↗).
Piece of EU legislation Provisions in pieces of EU legislation that have links to criteria, indicators, and elements of SSbD assessment Information and methodologies coming from pieces of EU legislation that can assist SSbD assessment Regulation (EC) 1272/2008 (CLP) ↗ identification of hazardous substances; hazard information C&L inventory ↗ Regulation (EC) 1907/2006 (REACH) ↗
under revision
hazard, exposure, and risk assessment along substance’s life cycle; identification, restriction, and authorisation of SVHC list of restricted substances, list of substances subject to authorisation; REACH data base ↗; guidance for hazard, exposure, and risk assessment ↗; (Extended) Safety Data Sheet, exposure scenarios, use maps; guidance for socioeconomic analysis ↗ Regulation (EU) 2019/1021 (POP) ↗ prohibition and restriction of production and use of POP list of prohibited and restricted substances Upcoming regulation establishing a common data platform on chemicals ↗ hazard information, exposure related information, environmental sustainability related information substance specific FAIR data related to safety and environmental sustainability Regulation (EU) 2024/590 (ozone layer depleting substances) ↗ prohibition of production and use of ozone-depleting substances list of prohibited substances Regulation (EU) 2024/573 (fluorinated greenhouse gases) ↗ regulation of production and use of fluorinated greenhouse gases and of alternative substances not fluorinated list of substances, products and equipment whose import and export needs a licence Directive (EC) 98/24 (Chemical agents) ↗ identification of hazardous agents at workplace; prohibition of chemical agents at workplace; determination of occupational exposure, occupational risk assessment as well as risk mitigation measures list of prohibited chemical agents; general principles for management of risks and specific protection and prevention measures Directive (EC) 2000/39 ↗ occupational exposure limits list of indicative occupational exposure limit values identification of CMR substances at workplace; determination, prevention, and reduction of exposure at workplace; exposure limit values list of occupational exposure limit values of CMR substances inventory of hazardous substances; risk assessment, exposure reduction, and prevention measures; improvement of environmental performance BAT reference documents upcoming information from plant permits and from the environmental management system to be published Regulation (EU) 2023/988 (General Product Safety) ↗ product safety assessment Regulation (EU) 2024/1781 (ESPR) ↗ identification of substances of concern; eco-design; improvement on product aspects related to safety, sustainability and end of life processes upcoming EC web portal for data in the digital product passport Regulation (EC) 66/2010 (EU Ecolabel) ↗ prohibition and restriction of hazardous substances depending on product group; environmental life cycle impacts EC website on product groups and criteria ↗ Regulation (EC) 1107/2009 (Plant protection products) ↗ identification of active substances that shall be approved for PPP, of substances that shall not be considered of low risk, and of candidates for substitution; exposure and risk assessment during use guidance for assessment; Assessment Reports Regulation (EU) 540/2011 ↗ substances approved for PPP list of substances approved active substances for PPP Directive (EC) 2009/128 Sustainable Use of Pesticides ↗ reduction of the risks and impacts from the use of pesticides to human end environment; integrated pest management; alternative approaches or techniques information on the sustainable use of pesticides via a web portal ↗ Regulation (EU) 528/2012 (Biocidal products) ↗
under evaluation
identification of active substances that shall not approved for biocidal products; exposure and risk assessment during use; consideration of disproportionate negative societal impact of not-authorisation guidance on e.g. hazard, exposure, and risk assessment; Assessment Reports; Database on approved active substances ↗ Regulation (EC) 1223/2009 (Cosmetic Products) ↗
under revision
prohibition and restriction of hazardous substance in cosmetic products; product safety assessment list of substances prohibited in cosmetic products; List of substances restricted in cosmetic products, List of allowed colorants, preservatives, and UV-filters; SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation ↗ prohibition and restriction of hazardous substance in toys; hazard, exposure, and product safety assessment guidance of the EC and the Expert Group on Toy Safety ↗ Regulation (EU) 2024/3110 (Construction Product Regulation) ↗ safety for worker and user; environmental sustainability performance Regulation (EU) 2023/1542 (battery/battery waste) ↗ restriction of hazardous substances in batteries; carbon footprint declaration, recycling content; performance, durability; removability, replaceability, and safety parameters; battery due diligence upcoming guidance on battery due diligence identification of hazardous waste; waste hierarchy; waste management; prevention and reducing adverse impacts design to facilitating re-use, dismantling and recovery of WEEE, its components, and materials restriction of hazardous substances in electrical and electronic equipment list of restricted substance under revision
restriction of hazardous substances in vehicles; design and production to facilitate the dismantling, reuse and recovery, in particular the recycling of ELV, their components, and materials; use of recycled vehicles and products list of restricted substances Directive (EU) 2022/2464 (CSRD) ↗
under revision
environmental, social and governance performance of a company’s activity Directive (EU) 2024/1760 (CSDD) ↗
under revision
integration of sustainable due diligence into company policies and risk management systems Regulation (EU) 2020/852 (sustainable investment) ↗ determination whether an economic activity qualifies as environmentally sustainable Regulation (EU) 2024/1252 (critical raw materials) ↗ fostering efficiency and circularity; mitigate supply risk list of strategic and of critical raw materials in the EU - Hazard assessment of the chemical/material
The hazard assessment within the EC SSbD Framework follows the life cycle of a chemical or material under consideration, starting with the intrinsic properties. Hazard-based SSbD criteria as defined in the EC SSbD Framework are based on several hazard categories which are laid down in the Regulation on Classification, Labelling and Packaging (CLP ↗). These criteria align with hazard criteria in further chemicals legislation. For instance, the EU SSbD framework lists criteria for substances that primarily mirror those in the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH ↗) Regulation to identify so-called “Substances of very high concern” (SVHC). Other criteria of the EC SSbD Framework include parts of criteria according to the Ecodesign for Sustainable Products Regulation (ESPR ↗) while the remaining hazard categories according to CLP are summarised as further set of criteria in the EC SSbD Framework. This highlights the interconnection of SSbD hazard criteria and existing legal specification, establishing a foundation for safety considerations.
However, the link between safety assessment as considered in the EC SSbD framework and EU legislation is much broader. Much product-oriented EU legislation, the workplace safety legislation, and the legislation for environmental protection and on waste often refer to CLP, REACH, Persistent Organic Pollutants (POP) Regulation ↗, and their substance criteria. The goal of setting these references is to identify hazards and risks of substances, to enable a sound risk management for a safe handling, use, and disposal by controlling their production, marketing, use, and disposal.
Several pieces of legislation specifically restrict the use of certain hazardous substances in products and waste, including:
- the Regulation on batteries and waste batteries ↗,
- the Directive on Restriction of Hazardous Substances in Electrical and Electronic Equipment (ROHS) ↗ or
- the Directive on End-of-Life-Vehicles (ELV) ↗ which is currently under revision ↗.
Other legislative frameworks generally prohibit or regulate substances and mixtures in products or waste, particularly those classified according to CLP as: (i) carcinogenic, mutagenic, or reprotoxic (CMR), (ii) endocrine disruptors (ED), (iii) persistent, bioaccumulative and toxic (PBT), (iv) very persistent and very bioaccumulative (vPvB), or substances identified as POP. Examples include:
- the Toy Safety Directive ↗ (currently under revision ↗),
- the Cosmetic Product Regulation ↗ (currently under evaluation ↗),
- the Plant Protection Product Regulation (PPPR) ↗,
- the Biocidal Product Regulation (BPR) ↗ (currently under evaluation ↗),
- the Regulation on EU Ecolabel ↗, or
- the Waste Framework Directive (WFD) ↗ (currently under revision ↗).
Also, REACH regulates the uses of certain substances via the restriction and authorisation of so-called Substances of Very High Concern (SVHC). Interconnection can also be found in legislation to other life cycle stages of a chemical substance. Several worker safety directives regulate the handling of hazardous substances at the workplace, including:
- the Directive on the protection of the health and safety of workers from the risks related to chemical agents at work (Chemicals Agents Directive, CAD) ↗ or
- the Directive on the protection of workers from the risks related to exposure to Carcinogens, Mutagens, and Reprotoxic substances at work (CMRD) ↗.
The recently revised Directive on Industrial Emissions (IED) ↗ establishes rules to prevent and reduce the use and emissions of hazardous substances. It mandates an environmental management system with an inventory of hazardous substances, and an analysis of the possibilities for substituting them by safer alternatives or reducing their use or emissions. In particular, this relates to substances that fulfil the criteria of Article 57 of REACH (i.e. so-called SVHC) or that are listed as restricted substances according to REACH Annex XVII.
The ESPR ↗ requires the improvement of products in relation to various aspects including transparency about the presence of substances of concern. The regulation enables the EC to set information requirements e.g. to realise the tracking of the substances of concern throughout the life cycle for specific products via delegated acts.
- Safety assessment considering the whole life cycle
The EC SSbD Framework comprises the assessment of risks of a chemical or material in the workplace in any occupational setting, throughout its entire life cycle, and of the risks to consumers and the environment during the final application, respectively. This assessment requires the combination of hazard results with exposure information about the involved life cycle steps. The exposure potential will depend on many factors including the production processes, foreseen uses, and end of life processes.
This assessment intends to enable stakeholders to implement measures to mitigate risks, and ensure the safe use and handling of the material or chemical. Moreover, the information gathered and generated may guide and support later compliance with both process- and product-related legal requirements. Information generated to address safety issues in an SSbD assessment can contribute to chemical risk assessments required under REACH ↗, including the definition of exposure scenarios. In addition, the revised IED ↗ includes obligations to assess risks, reduce emissions, and apply prevention measures for hazardous substances when used in production processes. The CAD ↗ obliges the employer to perform a risk assessment for the hazardous chemical agent at the workplace, including the type and duration of exposure, work conditions, and the effectiveness of prevention measures. Additionally, the CMRD ↗ obliges the employer to assess and manage the risks associated with CMRD substances. It stipulates prevention and protection measures as well as exposure limits. The General Product Safety Regulation ↗ lays down that only safe products shall be marketed in the EU, and therefore, sets out general safety requirements for non-food consumer products while complementing sector-specific legislation. Specific obligations for assessing the risk of a product are defined for example in the PPPR ↗, BPR ↗ or the Cosmetic Products Regulation ↗.
- Environmental sustainability assessment
The EC SSbD Framework addresses the environmental sustainability impacts of a chemical or material along their entire life cycle.
Assessing impacts of chemicals, materials, products, and processes on environmental sustainability is not a blank sheet in European legislation, and it has become more prominent recently. Thus, the EC SSbD Framework can support preparedness for current and upcoming related requirements and reporting obligations. While it is acknowledged that existing legislation covers a range of aspects and features approaches different from what is considered in the environmental sustainability assessment of SSbD, the LCA as proposed in the EC SSbD Framework provides an opportunity to identify hotspots, track impacts, and manage data in a harmonised way for auditing.
In this way, the EC SSbD framework may help to improve the environmental sustainability performance along the life cycle of chemicals, materials, and products in view of the legislation addressing circular economy and improvement of energy and resource demand. Examples are:
- The ESPR ↗ sets ambitious ecodesign requirements for specific product groups, aiming to significantly improve their circularity, energy efficiency, and other environmental sustainability aspects. Ecodesign requirements relate to product durability, reusability, upgradability and reparability, presence of substances of concern, energy and resource efficiency, recycled content in a product, remanufacturing and recycling, carbon and environmental footprints, and expected waste generation.
- The Regulation concerning batteries and waste batteries ↗ prescribes performance and durability requirements, carbon footprint declaration, and recycling content depending on the battery type. Furthermore, from late summer 2027, economic operators have to identify, assess, and manage environmental risk categories along the supply chain ↗.
- The EU Corporate Sustainability Reporting Directive (CSRD) ↗ , which is under revision ↗, requires large companies and listed small- and medium-sized companies, as well as parent companies of large groups, to include in a dedicated section of their management report the information necessary to understand i) the company’s performance on sustainability matters, and ii) how sustainability matters affect the company’s development and positioning. This information should provide financial market players with the necessary basis for measuring the sustainability performance of their portfolios and making sustainability-driven investment decisions. Environmental sustainability reporting obligations include aspects such as information on climate protection and adaptation, water and marine resources consumption, resource protection and circular economy, environmental pollution, biodiversity and ecosystems protection.
- The Corporate Sustainability Due Diligence Directive (CSDD) ↗ (under revision ↗) outlines the mandatory due diligence that companies must implement regarding human rights and environmental impacts along their supply chains. The CSRD is the main framework through which companies must report on their relevant sustainability activities.
- In order to be able to advertise sustainable financing, companies must report according to the EU Taxonomy Regulation ↗ whose criteria and objectives correspond to those of the EC SSbD Framework.
- The Directive on Waste from Electrical and Electronic Equipment (WEEE) ↗ lays down measures to protect the environment and human health by preventing or reducing the adverse impacts caused by WEEE, ensuring good management practices, reducing overall impacts of resource use, and improving the efficiency of such use
- The Construction Product Regulation (CPR) ↗ defines harmonised rules on how to express environmental and safety performance of construction products as well as environmental, functionality, and safety performance requirements for these products. In doing so, it also lists predetermined environmental essential characteristics in its Annex II.
- The proposed draft regulation to replace the ELV Directive ↗ aims for long-term energy savings at the manufacturing stage, reduced dependency on imported raw materials, and the promotion of sustainable and circular business models.
- In 2023, the Commission made a proposal for a targeted revision of the WFD ↗ which focuses on two resource-intensive sectors: textiles and food. Its objectives are to reduce environmental and climate impacts, increase environmental quality, and improve public health associated with textile waste management. For the food sector, the aim is to reduce the environmental and climate impacts of food waste generation.
- The revised IED ↗ includes new obligations for operators to improve energy and resource efficiency, apply circular economy practices, use safer chemicals, and to establish an environmental management system that fulfils given minimum requirements. Besides measures on safety, the revised IED requires continuous improvement of the environmental performance of the installation, indicative ranges of environmental performance indicators (“benchmarks”), inclusion of an energy audit or implementation of an energy management system. It also obliges establishing a plan for the transformation of an installation during the 2030-2050 period to contribute to the emergence of a sustainable, clean, circular, and climate-neutral economy by 2050 ↗.
- Socio-economic sustainability assessment
The socio-economic assessment as proposed in the EC SSbD Framework provides synergies with obligations of the Regulation concerning batteries and waste batteries ↗, and reporting requirements of CSRD ↗ and CSDD ↗. For example, reporting obligations of the CSRD include social affairs and human rights as well as governance. This includes the factors i) equality and equal opportunities, ii) working conditions, and iii) respecting human rights for social affairs, for business ethics, for business culture, iv) lobbying and v) fair business relations for the area of governance.
According to the Regulation concerning batteries and waste batteries, economic operators must include considerations on critical raw materials use and social risk categories along the supply chain into their corporate strategy, starting from late summer 2027. The CSDD aims to foster sustainable and responsible corporate behaviour across global value chains. Large companies will be required to identify and, where necessary, prevent, end or mitigate adverse impacts of their activities on human rights (e.g. child labour, and exploitation of workers). To comply with the corporate risk-based due diligence duty, these companies need to integrate due diligence into their policies. They are obliged to take appropriate measures to identify, prevent, and mitigate potential adverse impacts while identified actual adverse impacts must be eliminated, minimised or remediated. Additionally, they must establish and maintain a notification mechanism and a complaints procedure, monitor the effectiveness of the due diligence policy and measures, and publicly communicate on their due diligence efforts.
The socio-economic analysis (SEA) under REACH ↗ is a further link of SSbD assessment to legislation, and it is especially relevant to substances. The SEA serves as an information source and decision-support tool in the restriction and authorisation processes for SVHCs under REACH. A typical SEA according to REACH Annex XVI includes key elements such as the economic consequences of a restriction or authorisation for industry, impacts on consumers, benefits for human health and the environment, social implications, effects on trade, competition, and economic development, as well as information on the availability, technical feasibility, and economic reliability of alternative substances and techniques. The EC SSbD Framework can contribute to socio-economic analysis by furthering a systematic collection of socio-economic implications of the substance under consideration, considering also possibilities for re-design, substitution or other alternative approaches.