Address https://gelex.eu/eli/EU/act/oj/L/2022/2510@2022-12-08/en

Contents

1. Preamble
2. ANNEX
3. ANNEX Framework for the future definition of safe and sustainable by design criteria and the procedure for assessing chemicals and materials
4. 2.
5. 3. Table 1 Non-exhaustive list of guiding design principles, associated definitions, and examples of actions at the (re)design stage
6. 3.
7. 4.
8. Step 1 Hazard assessment (intrinsic properties)
9. Step 2 Human health and safety aspects of production and processing
10. Step 3 Human health and environmental aspects in the final application phase
11. Step 4 Environmental sustainability assessment
12. 4.1. Table 2 List of aspects (hazardous properties) relevant for Step 1
13. 4.1.
14. 4.2. Table 3 Examples of aspects and indicators relevant for Step 2 adapted from the German Hazardous Substances Column Model.
15. 4.4. Table 5 Aspects, indicators and methods for the environmental footprint method for Step 4
16. 5.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,

Whereas:

(1) The European Green Deal sets out four interlinked policy goals for the transition to a sustainable economy and society: climate neutrality, biodiversity protection, circular economy and a zero pollution ambition for a toxic-free environment.

(2) The EU sustainable finance strategy aims to support the financing of the transition to a sustainable economy.

(3) The Taxonomy Regulation sets out four conditions that an economic activity has to fulfil in order to qualify as environmentally sustainable. It also sets out six environmental objectives, including the transition to a circular economy and pollution prevention and control.

(4) In the Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment (the Chemicals Strategy), the Commission announced that it would develop safe and sustainable by design criteria’ for chemicals and materials. The Commission will also incentivise Member States, industry and other stakeholders to prioritise innovation for substituting, as far as possible, substances of concern across sectors, as for example textiles, food contact materials, information and communications technologies, construction materials, low-carbon mobility, batteries or renewable energy sources.

(5) The European Parliament has adopted a resolution on the Chemicals Strategy, stressing the need to develop safe and sustainable by design criteria to help prevent and control pollution, improve the tracing of hazardous chemicals in products, and promote their substitution by safer and more sustainable alternatives. The Council conclusions on the Chemicals Strategy of 15 March 2021 also call on the Commission to promptly develop, in cooperation with the Member States and in consultation with stakeholders, harmonised, clear and precise definitions and, where adequate, criteria or principles for the concepts that are crucial for the effective implementation of the Chemicals Strategy, such as safe and sustainable by design chemicals.

(6) The Circular Economy Action Plan states that the Commission will support the substitution and elimination of hazardous substances through research and innovation.

(7) The EU Action Plan Towards Zero Pollution for Air, Water and Soil and the Proposal for a Regulation on establishing a framework for setting ecodesign requirements for sustainable products, emphasise the commitment to ensure that chemicals and materials are as safe and sustainable as possible by design and during their life cycle, so that material cycles are non-toxic.

(8) A first sector-specific reference to safety and sustainability by design can be found in the EU Strategy for Sustainable and Circular Textiles. The strategy highlights the importance of developing safe and sustainable by design criteria for chemicals and materials to support industry to substitute or, if not possible, minimise substances of concern in textile products.

(9) European citizens also see the need to act. A 2020 Eurobarometer survey shows that 84 % of Europeans are worried about the impact on their health of chemicals present in everyday products, and 90 % are worried about chemicals’ impact on the environment.

(10) Several hundred substances have already been identified as substances of very high concern under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006, and many more could fall under the definition of substances of concern in the Proposal for a Regulation on establishing a framework for setting ecodesign requirements for sustainable products.

(11) The transition to chemicals and materials that are safe and sustainable by design requires a common understanding of safety and sustainability aspects to be successful. It is therefore necessary to develop a European assessment framework for safe and sustainable by design chemicals and materials, that can assist in the definition of safety and sustainability criteria, to guarantee coherence between actors, sectors and value chains.

(12) The envisaged framework should make it possible to comprehensively assess the safety and sustainability of chemicals and materials throughout their life cycle and support the design, development, production and use of chemicals and materials that provide a desirable function or service while being safe and sustainable. The application of the framework will make possible the definition of safe and sustainable by design criteria which should help set high standards for the safety and sustainability of chemicals and materials.

(13) The review of safety and sustainability dimensions, aspects, methods, indicators and tools, that is the root of the Annex to this Recommendation, although referring to a number of additional socioeconomic sustainability aspects, focuses mainly on chemical safety and environmental sustainability. Assessments of socioeconomic aspects, beyond those considered already, may be necessary in order to provide additional information and enable more informed decisions, in particular when promoting substitution. Such considerations can be taken into account in the application of the framework, whenever relevant.

(14) The aim of the envisaged safe and sustainable by design framework is to be at the forefront of research and innovation, and to promote use of the latest scientific knowledge to meet the highest levels of ambition for safety and sustainability in innovation.

(15) The framework should aim to become a global reference for innovation in pursuit of the green industrial transition; for substituting as much as possible the production and use of substances of concern; for promoting the use of sustainable resources and feedstock for the production of chemicals and materials; for minimising the impact of the production and use of chemicals and materials, throughout their life cycle, on the climate, on the environment, and on human health; and for driving industry’s and public authorities’ R&I investments in the right direction.

(16) This Recommendation proposes a European safe and sustainable by design framework as a point of reference for Member States, industry, academia, research and technology organisations (RTOs) and bodies providing benchmarks for safe and sustainable chemicals and materials.

(17) This Recommendation sets a testing period for the framework with a voluntary reporting mechanism for Member States and stakeholders during this testing period. A revision process of the framework will be launched at the latest by the end of the testing period. Based on feedback collected during the testing period, the Commission will consider including in the assessment additional safety and environmental aspects, as well as economic and social sustainability aspects as an additional facet when relevant.

(18) As stressed in the Chemicals Strategy, greater public and private investments in providing safe and sustainable chemicals, and a greater capacity to innovate on the part of the chemicals industry, will be vital for developing new solutions and supporting both the green and digital transitions. The vision for 2030 that lies behind this Recommendation should therefore ensure that future European, national and international initiatives for safe and sustainable chemicals and materials are grounded in the proposed framework. The Commission will promote this Recommendation in international fora.

(19) To provide incentives for testing the framework and, in particular, address substances of concern, the Commission will support the testing period. This will be done in particular through actions in the Horizon Europe framework programme for the development of safe and sustainable by design chemicals and materials, and the development and improvement of testing methods and assessment tools to expand the assessment possibilities the framework has to offer.

(20) The Commission has also developed a Strategic Research and Innovation Plan for safe and sustainable chemicals and materials, identifying key research and innovation areas in the life cycle (design, production, use and disposal/recycling/remediation) of chemicals and materials to facilitate and support at European and national level the industrial transition towards safe and sustainable chemicals and materials.

(21) The Commission, aware of the data needed to implement the envisaged framework, will continue promoting findable, accessible, interoperable and reusable (FAIR) data. The Commission is also developing an EU common data platform on chemicals to facilitate the sharing, access and re-use to existing data used in Union legal acts related to chemicals.

(22) This Recommendation respects the principle of subsidiarity as the envisaged safe and sustainable by design framework serves the needs of the European Research Area and the single market for chemicals and materials, where there is a need for common understanding at European level of safety and sustainability for chemicals and materials. It also respects the principle of proportionality as it combines the establishment of the framework with a period of testing by non-legally binding means, without detracting from any existing or future (Union) legislation on chemicals and materials,

HAS ADOPTED THIS RECOMMENDATION: PURPOSE AND SCOPE This Recommendation proposes that a European framework for safe and sustainable by design chemicals and materials be established for R&I activities. The details of the testing period and the framework, based on technical reports from the Commission’s Joint Research Centre,, are set out in the Annex to this Recommendation. The envisaged framework consists of methods for assessing the safety and sustainability aspects of a chemical or material. The results obtained from applying the framework will make it possible to define safe and sustainable by design criteria, including scoring systems and thresholds developed based on the results obtained. The process of criteria definition will be launched in parallel with the revision of the framework. The purpose of this Recommendation is to launch the testing of the assessment framework and get feedback to be able to improve relevance, reliability and operability. This Recommendation is addressed to Member States, industry, including small and medium-sized enterprises (SMEs), academia and research and technology organisations (RTOs) that contribute to or work on the development of chemicals and materials. It invites them to use the framework in their R&I programmes and activities related to chemicals or materials. They are also encouraged to refer to the framework in relevant policy or strategy documents. Member States, industry, academia and RTOs should also ensure that the methods, models and data produced and used when applying the framework tally with the findable, accessible, interoperable and reusable (FAIR) guiding principles. USES BY MEMBER STATES Member States are encouraged to: Promote the framework in their national R&I programmes, thereby supporting the testing period with applications and use cases. Increase the availability of high-quality FAIR data for assessing safety and sustainability by incorporating this aspect into their national R&I programmes and into related policies when relevant. Support the improvement of assessment methods, models and tools, and make new ones available, to integrate into the framework in order to improve the assessment of safety and sustainability. Support the development of educational curricula to ensure that the skills required to implement the framework are taught. USES BY INDUSTRY, ACADEMIA and RTOs: Industry (including SMEs), academia and RTOs are encouraged to: Use the framework in their R&I processes for developing chemicals or materials, thereby supporting the testing period. Make available high-quality FAIR data for assessing safety and sustainability, without flouting intellectual property rights and, if relevant, security considerations. Support the development and making available of new assessment methods, models and tools that can be integrated into the framework to improve the assessment of safety and sustainability. Support the development of professional training and educational curricula to ensure the teaching of the skills required to implement the framework. REPORTING ON THE IMPLEMENTATION OF THE RECOMMENDATION: Member States, industry, academia and RTOs are encouraged to report to the Commission on the implementation of this Recommendation during the testing period. To facilitate their reporting, the Commission will make a reporting template available. The information transmitted should include the following.

How Member States, industry, universities and RTOs use the framework in their R&I programmes, activities and elsewhere.

Initiatives and use cases for testing the framework.

Initiatives for the development of new methods, models and tools for assessing safety and sustainability and how their outcomes can be accessed and used.

Initiatives for the development of safe and sustainable by design chemicals and materials.

Assessment reports presenting the results obtained from testing the framework.

Problems and bottlenecks identified with the use of the framework

Information on the establishment of scoring systems and thresholds that can support setting of safe and sustainable by design criteria in a revised framework.

Done at Brussels, 8 December 2022. For the Commission Mariya Gabriel Member of the Commission

ANNEX

ANNEX Framework for the future definition of safe and sustainable by design criteria and the procedure for assessing chemicals and materials

1. Principles underpinning the safe and sustainabile by design framework A set of principles has been defined for the development of the new safe and sustainable by design (SSbD) framework.

Define a hierarchy that puts safety first, to avoid regrettable substitutions.

Define cut-off criteria for the design of chemicals and materials to stimulate sustainable research and innovation (R&I), based not only on data referred to in the requirements of EU legislation on chemicals, but also on data that are outside the scope of those requirements.

Focus on iteratively minimising environmental pressures, using dynamic boundaries and cut-offs, so that the framework becomes a tool for managing improvements along the innovation process.

Ensure optimal use of available data on adverse effects. Every (new) chemical or material should be compared to the full spectrum of structurally or functionally similar substances to assess the expected potential to cause negative impact on human health or the environment.

Communicate SSbD actions taken throughout the supply chain; make all relevant and non-confidential data available in a findable, accessible, interoperable and reusable (FAIR) format, for greater transparency and accountability and to better discharge the duty of care.

Promote the use of a coherent framework by the various stakeholders, including industry and policymakers.

2. Framework features and structure The SSbD framework proposed is a general approach to assessing and defining safety and sustainability criteria for chemicals and materials, throughout the innovation process. It can be applied to the development of new chemicals and materials or to the re-assessment of existing ones. In the case of existing chemicals and materials, the framework can be used: i) to support the redesign of their production processes to make them safer and more sustainable by evaluating alternative processes, or ii) to compare them using the SSbD criteria (e.g., for innovation by substitution with better performing chemicals or materials or for selection in downstream applications). The framework consists of a (re)design stage and a safety and sustainability assessment across the different steps in the life cycle of a chemical or material, considering functionality and end-use(s). Although the framework does not assess the safety and sustainability of products, it does address how the chemicals or materials are used in products. The SSbD framework comprises the following two components: The SSbD framework can help with the various stages of the innovation process (design, planning, experimental testing and prototyping) where decisions are taken to proceed with, abandon or tweak the innovation approach. The safety and sustainability assessment should start as early as possible in the innovation process to ensure that SSbD principles are being applied to a chemical’s or material’s design. After that, the assessment should be done iteratively, at the subsequent stages of development, as more information gradually becomes available. The framework should allow for flexibility in its implementation, to ensure alignment with horizontal or product specific legislations or with regulatory exemptions. The proposed safety and sustainability assessment follows a hierarchical approach in which safety aspects are considered first, before moving on to sustainability aspects. The first step is to ensure safety by considering chemicals or materials with certain (human health as well as environmental) hazardous properties as non-sustainable by design, even if their design follows recommended design principles or they have a relatively low environmental impact. If the chemical or material in question fulfils the minimum safety criteria, the assessment can proceed to environmental sustainability aspects. In future applications of the framework, socioeconomic sustainability aspects can also be evaluated as a complementary assessment. This stage-based approach is intended to reduce the burden of the assessment as the initial steps propose to identify prohibitive issues. For example, if the assessment of a chemical or material identifies safety concerns, an LCA would only be done after these had been addressed, e.g., by determining if risk management measures can address the safety concerns. Nevertheless, depending on each organisation’s working methods, the different steps could be conducted simultaneously.

2.

1. a (re)design stage at which guiding design principles are proposed to support the safe and sustainable design of chemicals and materials;

2. a safety and sustainability assessment stage at which the safety and sustainability of the chemical or material in question are assessed.

3. Table 1 Non-exhaustive list of guiding design principles, associated definitions, and examples of actions at the (re)design stage

Stage 1: Guiding (re)design principles The SSbD framework covers three levels of the term by design: The purpose of this stage is to provide guidance on the principles to be considered at the (re)design stage to maximise the possibilities of a successful safety and sustainability assessment outcome. At this stage, the goal, scope and system boundaries, which will determine the parameters of the assessment of the chemical or material in question, should be defined. This includes choices such as assessing a mixture as a single element or as components of mixtures. Adhering to those principles does not necessarily make it possible to draw conclusions about the safety and sustainability performance of the chemicals and materials in question. This requires an assessment of safety and sustainability in the next stage. The design principles are summarised in Table 1 (a non-exhaustive list). They are derived from existing best practices, e.g. Green Chemistry Principles, Green Engineering Principles, Sustainability Chemistry Criteria, German Environment Agency (UBA) Golden Rules, Circularity Chemistry Principles. Other principles from those best practices can also be considered. Design principle Definition Examples of actions Material efficiency Incorporating all the chemicals or materials used in a process into the final product or fully recovering them inside the process, thereby using fewer raw materials and generating less waste. Maximise yield during reaction to reduce chemical or material consumption. Recover more unreacted chemicals or materials. Select materials and processes that minimise the generation of waste. Identify the occurrence of the use of critical raw materials, in order to minimise or substitute them. Minimise the use of hazardous chemicals or materials Preserving the functionality of products while reducing or completely avoiding the use of hazardous chemicals or materials where possible. Using the best technology to avoid exposure at all stages of the life cycle of a chemical or material. Reduce and/or eliminate hazardous chemicals or materials in production processes. Redesign production processes to minimise the use of hazardous chemicals/materials. Eliminate hazardous chemicals or materials in final products. Design for energy efficiency Minimising the energy used to produce and use a chemical or material in the production process and/or in the supply chain. Select or develop (production) processes that: Use renewable sources Conserving resources, by means of resource-closed loops or by using renewable material and energy sources. Promote the use of feedstocks that: or processes that: Prevent and avoid hazardous emissions Applying technologies to minimise or avoid hazardous emissions or the release of pollutants into the environment. Select materials or processes that: Design for end of life Design chemicals and materials so that, once they have served their purpose, they break down into chemicals that do not pose any risk to the environment or to humans. Design chemicals and materials in a way that makes them fit for re-use, waste collection, sorting and recycling/upcycling. Avoid using chemicals or materials that impede end-of-life processes such as recycling. Select materials that are: Consider the whole life cycle Applying the design principles to the entire life cycle, from the raw materials supply chain to the final product’s end of life. Consider:

3.

(1) molecular design, to design new chemicals and materials based on their chemical structure;

(2) process design, to make the production process safer and more sustainable, both for chemicals and materials being developed and for existing chemicals and materials;

(3) product design, where the results of the SSbD assessment support the selection of the chemicals or materials to meet the functional demands of the final product in which they are used.

3. Table 1 Non-exhaustive list of guiding design principles, associated definitions, and examples of actions at the (re)design stage a.

involve alternative and less energy-intensive production/separation techniques

b.

maximise energy re-use (e.g. integration of heat networks and cogeneration)

c.

have fewer production steps

d.

use catalysts, including enzymes

e.

reduce inefficiencies and exploit available residual energy in the process or select lower temperature reaction pathways

a.

are renewable

b.

are circular

c.

do not create land competition

d.

do not negatively affect biodiversity

a.

use renewable energy resources with low-carbon emissions and without adverse effects on biodiversity

minimise the generation of hazardous waste and hazardous by-products

b.

minimise the generation of emissions (e.g. volatile organic compounds, total organic carbon, acidifying and eutrophication pollutants, and heavy metals)

a.

more durable (longer life and less maintenance)

b.

easy to separate and sort

c.

valuable even after being used (commercial afterlife)

d.

fully biodegradable for uses that unavoidably lead to release into the environment or wastewater

a.

using reusable packaging for the chemical or material being assessed and for chemicals or materials in its supply chain

b.

energy-efficient logistics (e.g., reducing transported quantities, changing the means of transport)

c.

reducing transport distances in the supply chain

4. Stage 2: Safety and sustainability assessment Once the design principles have been listed, the next stage is the safety and sustainability assessment composed of four steps. The first three steps mainly cover different aspects of the safety of chemicals or materials. These three steps build on knowledge generated with existing EU chemicals legislation like Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006, Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 or occupational safety and health (OSH) Directive 89/391/EEC, which is adapted to the R&I application of SSbD. The fourth step covers the environmental aspect of sustainability. Depending on how the SSbD framework is applied, it may also be worthwhile assessing socioeconomic aspects of sustainability – for instance, as an additional element to complement the main safety and sustainability assessment in the framework’s future application. The four steps, although presented sequentially, can be performed in parallel, as information becomes available at various points of the life cycle of the chemical or material in question and depending on whether a new or existing chemical or material is being assessed. Each step consists of aspects that can be measured using indicators. The indicators are assessed with the methods proposed in the framework. For the purposes of the framework a criterion can be formed by an aspect with an assessment method and a minimum threshold or target values (on which a decision about the safety or sustainability of a chemical or material may be based). At this stage thresholds for Step 1 are available as they have been set in EU legislations on chemicals (CLP and REACH). At this stage the SSbD framework has applicability only in the innovation stage of chemicals and materials development, as explained in stage 1; it does not interfere with Union legal obligations for chemicals and materials.

4.

Step 1 Hazard assessment (intrinsic properties)

This step looks at the intrinsic properties of the chemical or material in order to understand its hazard profile (human health, environment and physical hazards), before assessing the safety during its production, processing and use.

Step 2 Human health and safety aspects of production and processing

This step assesses the human health and safety aspects of the production and processing of the chemical or material in question. Production means the production process from raw material extraction to production of the chemical or material including recycling or waste management. The goal is to assess whether the production and processing of the chemical or material in question poses any risk to workers, in line with, or beyond, EU Occupational Health and Safety directives.

Step 3 Human health and environmental aspects in the final application phase

This step assesses the hazards and risks of the final application of the material or chemical in question. It covers use-specific exposure to the chemical or material and the associated risks. The goal is to assess whether the use of a chemical or material in its final application poses any risk to human health or the environment.

Step 4 Environmental sustainability assessment

In the fourth step environmental sustainability impacts along the entire chemical/material life cycle are considered by means of an LCA, assessing several impact categories such as climate change and resource use. Toxicity and ecotoxicity are also considered in this step, referring to impacts due to life cycle emissions to humans and the environment via environmental compartments (e.g., soil, water, air), including mobility between compartments and not via direct exposure (covered in Step 3). Figure 2: Illustration of the safety and sustainability aspects of the chemical or material covered by the safety and sustainability assessment. Coloured boxes indicate which life cycle stage is covered. The red dot refers to the chemical or material being assessed, while the yellow and grey dots refer to all the other substances emitted during its life cycle (e.g., other toxic chemicals emitted during the extraction of raw material or as a result of the energy used in the production process).

(1) Hazardous properties of the chemical or material in question

(2) Human health and safety aspects of production and processing

(3) Hazards and risks of the final application of the chemical or material in question

(4) Environmental impacts throughout the life cycle of the chemical or material in question

4.1. Table 2 List of aspects (hazardous properties) relevant for Step 1

Hazard assessment (Step 1) In EU legislation on chemicals (REACH and CLP), chemical hazards are divided in human health hazards, environmental hazards and physical hazards. These hazards are further divided into hazard classes and categories, which are included in the assessment. The aim is to establish a set of SSbD criteria for the intrinsic properties of chemicals and materials that can have adverse effects on humans or the environment. It is based on the hazard classes and categories established in the CLP Regulation. The SSbD assessment is voluntary and linked to R&I activities. Its scope may therefore be broader than the data these Regulations cover. The three main hazard categories are: The SSbD classification of the hazardous properties is closely linked to relevant EC initiatives, such as the Chemicals Strategy for Sustainability, the proposal for a regulation regarding sustainable products or the EU sustainable finance. The classification criteria for substances and mixtures established by the CLP Regulation need to be consulted for any detailed information on the assessment methods. The test methods Regulation lays down the test methods to use for generating data for hazard assessment, and the methods are to a large extent based on the OECD Guidelines for the Testing of Chemicals, which are one of the main tools for globally assessing the potential adverse effects of chemicals on human health and the environment. Additionally, methods recommended for assessing the hazardous properties are included in the ECHA’s Guidance on the Application of the CLP Criteria, which supports the CLP criteria for hazard properties. Further support on assessment methods is available in the European Chemical Agency’s (ECHA’s) Guidance on Information Requirements and Chemical Safety Assessment, that describes the information requirements and how to fulfil them in accordance with the REACH Regulation. Classification for SSbD assessment can already consider further hazard classes like: persistent, bioaccumulative and toxic (PBT), very persistent very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent very mobile (vPvM), endocrine disruption. Even if those hazard classes are not yet in place under CLP, draft criteria under development could already be applied. For the assessment of aspects in Table 2, a tiered approach is proposed depending on the data availability. As the information available for new developed chemicals or materials could be limited at the beginning of the process, a tiered approach is beneficial to be able to characterise hazards as early as possible at the innovation stage (i.e. during the design of the chemical or material) by using, for example, new approach methodologies (NAMs) to generate data and knowledge. A tiered approach makes it possible to identify suspected hazardous chemicals or materials early on the innovation process, and take informed decisions (e.g., further assess the hazard, screen out the substance, request more data through the life cycle of the chemical or material in question). High-throughput screening, computer-based models, read-across and other alternative approaches should initially be used so that only the most promising candidates (less hazardous chemicals or materials) are tested at higher tiers in accordance with the regulatory requirements for chemicals to be placed on the market. If the assessment is performed on an existing chemical (e.g., already on the market), NAMs could be used to fill-in any data gaps needed to fulfil the information requirements for the aspects mentioned in Table 2. A screening of available academic data should also be done before deciding on the need for additional studies, in particular those involving laboratory animals. Group definition Human health hazards Environmental hazards Physical hazards Group A: Includes the most harmful substances (according to the Chemicals Strategy for Sustainability), including substances of very high concern (SVHC) (i.e., substances meeting the criteria laid down in REACH Art. 57(a-f) and identified in accordance with REACH Art. 59(1), Group B: Includes substances of concern, as described in the Chemicals Strategy for Sustainability and defined in Article 2(28) of the ecodesign proposal for sustainable products, but not included in Group A Group C: Includes the other hazard classes not in Groups A or B

4.1.

1. intrinsic hazardous properties relevant to human health (human health hazards)

2. intrinsic hazardous properties relevant to the environment (environmental hazards)

3. hazard physical properties (physical hazards).

Carcinogenicity Cat. 1A and 1B

Germ cell mutagenicity Cat. 1A and 1B

Reproductive/developmental toxicity Cat. 1A and 1B

Endocrine disruption Cat. 1 (human health)

Respiratory sensitisation Cat. 1

Specific target organ toxicity – repeated exposure (STOT-RE) Cat. 1, including immunotoxicity and neurotoxicity

Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB)

Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM)

Endocrine disruption Cat. 1 (environment)

Skin sensitisation Cat 1

Carcinogenicity Cat. 2

Germ cell mutagenicity Cat. 2

Reproductive/developmental toxicity Cat. 2

Specific target organ toxicity – repeated exposure (STOT-RE) Cat. 2

Specific target organ toxicity – single exposure (STOT-SE) Cat. 1 and 2

Endocrine disruption Cat. 2 (human health)

Hazardous for the ozone layer

Chronic environmental toxicity (chronic aquatic toxicity)

Endocrine disruption Cat. 2 (environment)

Acute toxicity

Skin corrosion

Skin irritation

Serious eye damage/eye irritation

Aspiration hazard (Cat. 1)

Specific target organ toxicity – single exposure (STOT-SE) Cat. 3

Acute environmental toxicity (acute aquatic toxicity)

Explosives

Flammable gases, liquids and solids

Oxidising gases, liquids, solids

Gases under pressure

Self-reactive

Pyrophoric liquids, solids

Self-heating

In contact with water emits flammable gas

Organic peroxides

Corrosivity

Desensitised explosives

4.2. Table 3 Examples of aspects and indicators relevant for Step 2 adapted from the German Hazardous Substances Column Model.

Human health and safety aspects of production and processing (Step 2) The aspects included in this step are related to occupational health and safety during the production and processing of a chemical or material. The risk should be estimated as a combination of the chemical or material hazards, exposure during the different processes and the risk management measures in place. For this part of the assessment, it is important to identify all the production and processing steps, the substances used in each of them (e.g., raw chemicals or materials, processing aids), the substances that may be produced during the processes (volatile organic compounds, by-products, etc.), and identify their hazards and risks for workers. The operational conditions (how the substance is used in the process, whether its processing is closed/open, its concentration in a preparation) together with the release potential (volatility, dustiness, fugacity, temperature, pressure), and the risk management measures in place (e.g., local exhaust ventilation) will determine the likelihood of workers’ exposure and the potential exposure route (inhalation, dermal, oral ingestion). As in Step 1, a tiered approach can be applied, depending on data availability. There are various qualitative/simplified models available (also known as control-banding models) for assessing safety and managing risks at the workplace. These models are designed to characterise risk at the workplace using a tier 1 approach, when the whole set of data required to perform a quantitative assessment is not available. The models are based on assigning scores or levels to some of the following variables to be considered during the characterisation of risk: There are two types of models: models that estimate the potential risk of exposure (they do not include the preventive measures taken as an input variable) and models that estimate the expected risk of exposure (they estimate the final risk, considering the preventive measures implemented, if any). The result is a categorisation into different risk levels, to determine if the risk is acceptable and, if needed, the types of preventive measures to be applied. Among the recommended assessment tools for Step 2 is the tiered targeted risk assessment (TRA) tool developed by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). ECETOC TRA, developed to facilitate the registration of chemicals in accordance with the REACH Regulation, and widely used by industry and known by small and medium-sized enterprises. To use this tool, it is recommended to apply ECHA guidance (Chapter R12 Use description) to define the use of the chemical or material in question at the different stages, since the tool uses this guidance as a reference. Other models and tools are also available, e.g., Chesar (also relevant for Step 3 where more details are provided), the International Labour Organization (ILO) model, the German Hazardous Substances Column Model, supported by the Easy-to-use Workplace Control Scheme for Hazardous Substances (EMKG) tool, the INRS model; the Dutch Stoffenmanager model, or the Belgian REGETOX model. Examples of relevant aspects and indicators to be assessed in Step 2 are listed in Table 3. They are adapted from the German Hazardous Substances Column Model developed by the Institute for Occupational Safety and Health of the German Social Accident Insurance Body. For the case of chronic human health hazards, they are linked to the grouping of hazard classes in Step 1. The Column Model has been developed primarily to support the substitution assessment of hazardous substances, but the approach could be adapted for other purposes and by using the same information. Aspect Sub-aspects and indicators Acute human health hazards Chronic human health hazards Physical properties Hazards from release behaviour Processing-related risk contribution Very-high-risk process High-risk process Medium-risk process Low-risk process Negligible risk Substances of no concern regarding intrinsic hazardous properties, according to Step 1 (i.e., not classified in groups A, B or C)

hazards of chemicals

frequency and duration of exposure

amount of the chemical or material in question that is used or present

physical properties of the chemical or material in question, such as volatility or dustiness

operational conditions

type of risk management measures in place

Acutely toxic substances or mixtures, Cat. 1 or 2 (H300, H310, H330)

Substances or mixtures that, in contact with acids, liberate highly toxic gases (EUH032)

Human hazards similar to Group A of Step 1

Unstable explosive substances or mixtures (H200)

Explosive substances, mixtures or articles, divisions 1.1 (H201), 1.2 (H202), 1.3 (H203), 1.4 (H204), 1.5 (H205) and 1.6 (without H-phrase)

Flammable gases, Cat. 1A (H220, H230, H231, H232) and Cat. 1B and 2 (H221)

Pyrophoric gases (H232)

Flammable liquids, Cat. 1 (H224)

Self-reactive substances or mixtures, Types A (H240) and B (H241)

Organic peroxides, Types A (H240) and B (H241)

Pyrophoric liquids or solids, Cat. 1 (H250)

Substances or mixtures that, in contact with water, emit flammable gases, Cat. 1 (H260)

Oxidising liquids or solids, Cat. 1 (H271)

Gases

Liquids with a vapour pressure > 250 hPa (mbar)

Dust-generating solids

Open processing

Possibility of direct skin contact

Large-area application

Open design or partially open design, natural ventilation

Acutely toxic substances or mixtures, Cat. 3 (H301, H311, H331)

Substances or mixtures that are toxic in contact with the eyes (EUH070)

Substances or mixtures that, in contact with water or acids, liberate toxic gases (EUH029, EUH031)

Substances or mixtures with specific target organ toxicity (single exposure), Cat. 1: Organ damage (H370)

Skin-sensitising substances or mixtures (H317, Sh)

Substances or mixtures that sensitise the respiratory organs (H334, Sa)

Substances or mixtures corrosive to the skin, Cat. 1, 1A (H314)

Human hazards similar to Group B of Step 1

Aerosols, Cat. 1 (H222 and H229)

Flammable liquids, Cat. 2 (H225)

Flammable solids, Cat. 1 (H228)

Self-reactive substances or mixtures, Types C and D (H242)

Organic peroxides, Types C and D (H242)

Self-heating substances or mixtures Cat. 1 (H251)

Substances or mixtures that, in contact with water, emit flammable gases, Cat. 2 (H261)

Oxidising gases, Cat. 1 (H270)

Oxidising liquids or solids, Cat. 2 (H272)

Desensitised explosives, Cat. 1 (H206) and Cat. 2 (H207)

Substances or mixtures with certain properties (EUH001, EUH014, EUH018, EUH019, EUH044)

Liquids with a vapour pressure of 50–250 hPa (mbar)

Partially open design, processing-related opening with simple extraction, open with simple extraction

Acutely toxic substances or mixtures, Cat. 4 (H302, H312, H332)

Substances or mixtures with specific target organ toxicity (single exposure), Cat. 2: Possible organ damage (H371)

Substances or mixtures corrosive to the skin, Cat. 1B, 1C (H314)

Eye-damaging substances or mixtures (H318)

Substances or mixtures that have a corrosive effect on respiratory organs (EUH071)

Non-toxic gases that can cause suffocation by displacing air (e.g. nitrogen)

Human hazards similar to Group C of Step 1, except those listed under acute human health hazards (left column).

Aerosols, Cat. 2 (H223 and H229)

Flammable liquids, Cat. 3 (H226)

Flammable solids, Cat. 2 (H228)

Self-reactive substances or mixtures, Types E and F (H242)

Organic peroxides, Types E and F (H242)

Self-heating substances or mixtures, Cat. 2 (H252)

Substances or mixtures that, in contact with water, emit flammable gases, Cat. 3 (H261)

Oxidising liquids or solids, Cat. 3 (H272)

Gases under pressure (H280, H281)

Corrosive to metals (H290)

Desensitised explosives, Cat. 3 (H207) and Cat. 4 (H208)

Liquids with a vapour pressure of 10–50 hPa (mbar), with the exception of water

Closed processing with possibilities of exposure, e.g. during filling, sampling or cleaning

Closed design, tightness not ensured, partially open design with effective extraction

Skin-irritant substances or mixtures (H315)

Eye-irritant substances or mixtures (H319)

Skin damage when working in moisture

Substances or mixtures with a risk of aspiration (H304)

Skin-damaging substances or mixtures (EUH066)

Substances or mixtures with specific target organ toxicity (single exposure), Cat. 3: irritation of the respiratory organs (H335)

Substances or mixtures with specific target organ toxicity (single exposure), Cat. 3: drowsiness, dizziness (H336)

Substances chronically harmful in other ways (no H-phrase)*

Aerosols, Cat. 3 (H229 without H222, H223)

Not readily flammable substances or mixtures (flash point > 60 ... 100 °C, no H-phrase)

Self-reactive substances/mixtures, Type G (no H-phrase)

Organic peroxides, Type G (no H-phrase)

Liquids with a vapour pressure 2–10 hPa (mbar)

Closed design, tightness ensured, partially closed design with integrated extraction, partially open design with highly effective extraction

Liquids with a vapour pressure < 2 hPa (mbar)

Non-dust-generating solids

4.3. Human health and environmental aspects of the final application (Step 3) This step assesses the human health and environmental impacts of the application of the chemical or material in question. As in Step 2, the conditions of use will determine the likelihood of exposure to the chemical or material as well as the potential exposure routes (all relevant pathways) and the related toxicity impacts on human health, including service-life exposure, and the environment (e.g., from wash-off uses, such as shampoo ending up in wastewater treatment plant effluents). The risk is characterised as a combination of the chemical or material hazards and the assessment of the estimated exposure of human health and the environment to the hazards during the application of the chemical or material in question. Information on the chemical’s or the material’s intrinsic properties are necessary for the safety assessment, and mainly covers the same hazard properties as considered in Step 1: physical hazards, environmental hazards and human health hazards. Information about other physico-chemical properties is also needed to identify the fate of the chemical or material in question, estimate the exposure and identify the exposure pathway(s) and characterise risk (e.g., properties such as the chemical’s or material’s physical form and vapour pressure relevant for human health, or water solubility and the octanol water partition coefficient (Log Kow) relevant for the environment). To estimate exposure, it is particularly important to identify/describe the application of the chemical or material in question and define the use conditions by providing information on frequency and duration of exposure, the amount of the chemical or material used or present in the application, the conditions of use of the chemical or material and the instructions for its use. If the chemical or material has several possible uses, ideally the different exposure routes should be considered. As in previous steps, the approach might be optimised depending on whether a new or existing chemical or material is being assessed, and on what data are available. As in Step 2, it is recommended to apply ECHA guidance (Chapter R12 Use description21) as a starting point to define the use of the chemical or material in question in this step. R12 guidance provides lists of product categories and article categories and many available exposure estimation tools, such as ECETOC TRA20, use these description categories as input for assessing exposure and safety. The chemical safety assessment and reporting tool (Chesar)22 is another tool recommended for the safety assessment of the chemical/material. The tool was developed by ECHA for assisting companies in producing chemical safety reports (CSR) and exposure scenarios (ES) in a structured, harmonised, transparent and efficient way. This includes reporting the substance-related data (relevant phys-chem, fate and hazard data), describing the uses of the substance, carrying out exposure assessment including identifying conditions of safe use, related exposure estimates and demonstrating control of risks. For carrying out the exposure assessment, a number of exposure estimation tools are included in Chesar: the ECETOC TRA tool for workers’ and for consumers’ exposure estimation, as well as EUSES for environmental exposure estimation. Those tools require as input the expected conditions of use. Use maps, developed by industry sectors, collect information on the uses and the conditions of use of chemicals in their sector in a harmonised and structured way. They contain the input parameters for workers’ exposure assessment (SWEDs), for consumers’ exposure assessment (SCEDs) and for environmental exposure assessment (SPERCs). The existing use maps are available in Chesar format at https://www.echa.europa.eu/csr-es-roadmap/use-maps/use-maps-library. It is also possible to document in Chesar the exposure estimates obtained from other tools or measured exposure data. Some tools, such as ConsExpo29, can directly export their outputs to Chesar. As in Step 2, tools from higher tiers (e.g., ConsExpo) or sector specific tools developed by industry for assessing specific product types and articles, can also be used if the data are available to do so.

4.4. Table 5 Aspects, indicators and methods for the environmental footprint method for Step 4

Environmental sustainability assessment (Step 4) This step covers the assessment of the environmental sustainability aspects of the chemical or material in question, focusing on its environmental impacts throughout the value chain. To assess the environmental sustainability of the chemical or material in question, a function-based LCA, covering the entire life cycle, must be done. If the new chemical or material has several possible uses, or if it can be produced by means of several production routes, different LCAs must be done considering each production, use and its end of life. Ideally, the LCA studies of the different uses of the chemical or material should be conducted following the same modelling principles to ensure harmonisation and allow comparison of results. It is therefore recommended, whenever possible, to use the product environmental footprint method30 as a guiding document for doing the LCA. The environmental footprint impact assessment method is recommended to be used to assess the life cycle environmental performance of products. It consists of a minimum set of impacts to assess. Other aspects, not yet fully covered by current LCA practices, might need to be assessed on a case-by-case basis using possible indicators that could be developed for the purpose. Given that existing environmental impacts go beyond those the environmental footprint method covers, there could be the possibility of adding other impacts in the future. The underlying models and characterisation factors for the environmental footprint method, available at https://eplca.jrc.ec.europa.eu/LCDN/developerEF.xhtml, should be applied in accordance with the latest environmental footprint package available. The aspects taken into consideration, the indicators and methods in place at the date of the publication of this recommendation are listed in Table 5, which should be regarded solely as an example, given that recommended methods are constantly evolving. LCA assessment level/aspects Sub-aspect Indicator and unit Recommended default LCIA method Toxicity Human toxicity, cancer effects Comparative Toxic Unit for humans (CTUh) based on USEtox2.1 model (Fantke et al., 2017) adapted as in (Saouter et al., 2018) Human toxicity, non- cancer effects Comparative Toxic Unit for humans (CTUh) Based on USEtox2.1 model (Fantke et al., 2017), adapted as in Saouter et al., 2018 Ecotoxicity freshwater Comparative Toxic Unit for ecosystems (CTUe) Based on USEtox2.1 model (Fantke et al., 2017), adapted as in Saouter et al., 2018 Climate change Climate change Global warming potential (GWP100, kg CO2 eq) Bern model – Global warming potential (GWP) over a 100-year time horizon (based on IPCC, 2013) Pollution Ozone depletion Ozone depletion potential (ODP) (kg CFC-11eq) EDIP model based on the ODPs of the World Meteorological Organization (WMO) over an infinite time horizon (WMO, 2014+ integrations) Particulate matter/respiratory inorganics Human health effects associated with exposure to PM2.5 (Disease incidences) PM model (Fantke et al., 2016) in UNEP, 2016 Ionising radiation, human health Human exposure to U235 (kBq U235) Human health effect model as developed by Dreicer et al., 1995 (Frischknecht et al, 2000) Photochemical ozone formation Tropospheric ozone concentration increase (kg NMVOC eq) LOTOS-EUROS (Van Zelm et al., 2008) as applied in ReCiPe 2008 Acidification Accumulated exceedance (mol H+ eq) Accumulated exceedance (Posch et al., 2008; Seppälä et al., 2006) Eutrophication, terrestrial Accumulated exceedance (mol N eq) Accumulated exceedance (Seppälä et al., 2006, Posch et al., 2008) Eutrophication, aquatic freshwater Fraction of nutrients reaching freshwater end compartment (P, kg P eq) EUTREND model (Struijs, et al. 2009) as implemented in ReCiPe 2008 Eutrophication, aquatic marine Fraction of nutrients reaching marine end compartment (N, kg N eq) EUTREND model (Struijs et al., 2009) as implemented in ReCiPe 2008 Resources Land use Soil quality index (Biotic production, erosion resistance, mechanical filtration and groundwater replenishment), dimensionless Soil quality index based on the LANCA model (De Laurentiis et al., 2019) and on the LANCA CF version 2.5 (Horn & Maier, 2018) Water use User deprivation potential (deprivation-weighted water consumption, m3 water eq. of deprived water) Available WAter REmaining (AWARE) model (Boulay et al., 2018; UNEP, 2016) Resource use, minerals and metals Abiotic resource depletion (ADP ultimate reserves, kg Sb eq) CML (Guinée et al., 2002) and (Van Oers et al. 2002) Resource use, energy carriers Abiotic resource depletion – fossil fuels (ADP-fossil, MJ) CML (Guinée et al., 2002) and (Van Oers et al., 2002)

5. Assessment procedure and reporting The application of the SSbD framework to a chemical or material will provide three outputs: Not all current aspects and indicators have thresholds associated (these are mainly in place for regulatory safety aspects). This means that, for aspects and indicators without thresholds, the criteria are not complete. In such cases, a pragmatic approach in the testing is to compare the chemical/material under assessment with the chemical(s) or material(s) that might be replaced, in line with what is currently done using alternative assessment methods. In case of new chemicals or materials the comparison should be based on functionality. This approach will lead to relative improvements, based on the performance of the chemical(s) or material(s) compared. Templates for presenting the results will be made available online by the Commission, including a proposal for their graphic visualisation. For Step 1 of the safety and sustainability assessment, four assessment levels are envisaged. The aspects listed in groups A, B and C (Table 2) are hierarchical, meaning that they need to be assessed one after the other, and the next aspect-related criterion will only be assessed if the previous one has been fulfilled. If there is evidence that the chemical or material in question possesses one of the hazardous properties included in the group of hazardous properties being assessed, there is, for the SSbD assessment, no need to gather information on the other properties in the same group. This aims to simplify the assessment and make it easier to gather data and to eliminate problematic chemicals or materials faster, early in the research and development process. However, to proceed to assessing the next criterion, evidence on all aspects of the same set of criteria needs to be provided. For Steps 2, 3 and 4 of the safety and sustainability assessment it is recommended to report the complete assessment for the case analysed, indicating what methods have been used. It is also recommended to benchmark the results of the steps with the chemical or material that is being replaced, to see if there is an improvement (comparative assessment). The final SSbD report should include an analysis of the results obtained in Steps 2, 3 and 4 and identify the aspects and indicators with the highest impact on safety and sustainability. Criteria for Steps 2, 3 and 4 are to be defined case-by-case on the basis of the results obtained, as not all chemicals and materials will require the same safety and sustainability measures.

5.

1. adherence to SSbD principles during the (re)design stage;

2. a safety and sustainability assessment;

3. the dashboard summarising the results.

Level 0 – chemicals or materials in criteria group A (e.g., considered most harmful substances, including SVHC).

Level 1 – chemicals or materials in criteria group B (e.g., having chronic human health or environmental effects, substances of concern not included in group A).

Level 2 – chemicals or materials in criteria group C (e.g., having other hazardous properties).

Level 3 – chemicals or materials not in any of the hazard categories listed in the previous criteria groups. For these, it should be borne in mind that the chemical or material in question could still be harmful in certain applications from a risk perspective that goes beyond generic hazard criteria and involves the consideration of application-specific exposure settings.

6. Overview of data sources to support the safety and sustainability assessment As a starting point and in addition to the tools mentioned in the description of Steps 1-4, sources such as the ECHA’s Information on Chemicals (including C&L Inventory and EUCLEF), the European Food Safety Authority’s (EFSA’s) Chemical Hazards Database (OpenFoodTox), the Organisation for Economic Cooperation and Development’s (OECD’s) eChemPortal, the United States of America Environmental Protection Agency’s (EPA’s) CompTox, can be screened first, especially for information on the hazardous properties of existing chemicals. For the environmental footprint, Life Cycle Inventory (LCI) datasets are available on the European Platform for Life Cycle Assessment, created and managed by the Commission. If available, environmental footprint-compliant datasets should be used. A large platform for searching for data across different databases is the Global LCA Data Access Network. It also provides tools for harmonising datasets from different sources. For modelling the end-of-life scenario, the variety of data needed depending on the chemical or material being assessed makes it difficult to pinpoint specific data sources. A recommended source for general end-of-life statistics is the Eurostat database, which provides data on waste management in Europe. Additional useful information is published by trade associations of producers that often release studies and statistics on their own sector’s sustainability.

Versions

1. 2022-12-08