Key insights into the upcoming regulatory changes from SETAC Copenhagen 2022

Key insights into the upcoming regulatory changes from SETAC Copenhagen 2022
19 August 2022

In May 2022, NCEC’s Environmental Chemistry and Toxicology (ECT) team and Ricardo’s Life Cycle Assessment (LCA) team attended the 32nd SETAC Europe annual conference in Copenhagen, Denmark. Read more on SETAC here.

The team presented, co-chaired and attended discussions and are now sharing some key insights which we think are going to have the most impact on the chemical industry in the coming year.

EU Green Deal / Chemicals Strategy for Sustainability

A key theme this year was the European Green Deal and the European Commission’s Chemicals Strategy for Sustainability (CSS): Towards a Toxic-Free Environment. The CSS was launched in October 2020, setting the ambition and future strategic direction for chemicals policy in the European Union. The CSS aims to better protect human health and the environment by moving towards a toxic-free environment and boost innovation for safe and sustainable use of chemicals. It is a key element of the EU Green Deal

The CSS proposes ambitious changes to the current regulatory regime for chemicals in the EU through a series of actions including a phase out on all uses of per and polyfluoroalkylated substances (PFAS) in the EU, action to assess the risks to the environment and human health from chemical mixtures and the introduction of new hazard classes for endocrine disruptors and persistent, mobile and toxic (PMT) substances. 

If you trade in the EU, it is very likely that you and your customers will be affected by the CSS as well-known regulations such as REACH and the Classification, Labelling and Packaging (CLP) will be changing. Preparing for some of the changes that the CSS will bring, we created a horizon scanning and compliance reporting tool. The tool enables you to check and plan for changes that will impact your product portfolio by performing a substance inventory check, identifying whether your substances appear on any global regulatory lists and provides the results in a clear, easy-to-read report. The impact of the CSS is continually evolving, we share advice, videos and guidance on what this means for your organisation. Make sure you don’t miss out by signing up to regulatory newsletter (sign up here if you haven’t already!). 

Persistence/ PMT initiatives and complex substances

Over the past few years, the topic of persistence and biodegradability has gained momentum and is receiving increasing attention from the scientific community and environmental regulators, with the number of attendees spilling out of the room at the ‘Persistent, Mobile and Toxic (PMT/vPvM) substances: New Perspectives and Developments in their Assessment, Management and Regulation’ session. 

This session included presentations and discussions about the various aspects of persistence assessment, including the challenges faced in identifying and analysing PMT substances and the proposed introduction of mobility criteria within the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.

Chris Hughes, Associate Director – Regulatory at NCEC, presented our work on the CEFIC-LRI ECO52 project, ‘Challenging substance properties and improvement of the use of weight of evidence in persistence assessment’ (download session poster here) and co-chaired the topical discussion ‘Moving persistence assessment into the 21st Century’, an interactive session providing a very useful snapshot of the state of opinion on persistence assessment. 

Chris also co-chaired a busy session on ‘New developments in the characterisation, testing and assessment of complex substances (MCS, UVCBs & MOCs)1’. It was the first session on these substances at SETAC. Approaches to characterising these substances (e.g. reaction masses, essential oils, petroleum substances and resins), their fate, exposure, hazards and risks were discussed, including novel testing methods (i.e., analytical methods) and non-testing methods (i.e., QSARs and grouping approaches). 

We presented our work with Concawe on the development of relevance and reliability criteria for hydrocarbon degradation half-lives in soils and sediments for use in regulatory persistence assessments. It is hoped that this work will support the degradation and persistence assessment of complex UVCB substances, such as petroleum substances, and the development of data quality evaluation schemes for persistence.

Our team can support organisations with their significant expertise in persistence assessment and biodegradation testing, and have recognised capability with complex and difficult substances such as UVCBs. 

Below are some recent projects related to persistence and PMT initiatives our team has been working on: 

  • Project focused on the parameters and discretionary options of the OECD 309 test (aerobic mineralisation in surface water), which can impact test results hence influencing conclusions of persistence (more information on how you can get involved can be found here).
  • Development of a Persistence Assessment Tool (PAT), to provide support to practitioners in the evaluation of persistence under regulatory frameworks.
  • Evaluation of risk to drinking water sources by PMT substances and organophosphorus flame retardants (OPFR) to help governments understand the risks from emerging contaminants and inform future policy and guidance. Posters with more information can be found here.
  • Systematic, retrospective analysis of PBT/vPvB2 decisions to understand established data quality, relevance criteria and implementation of regulatory guidance in decision making (read more here). 

EU and UK REACH 

Following the UK’s departure from the EU and the adoption of UK-REACH in Great Britain (GB), many organisations have faced challenges concerning registration of their substance(s) and their compliance to EU and UK regulations. The Health and Safety executive (HSE) has set up various short-deadline processes to ensure the continued registration of substances manufactured or imported into GB under UK REACH, creating an increased workload for registrants. Recently, there has been an increase in requirements surrounding REACH (EU and UK) dossier quality and the information to be provided on them, which has added additional time and cost pressure for EU and UK REACH registrants. 

Further to our insightful conversations with other attendees at SETAC and with changes anticipated due to the CSS as well as consultations underway for UK REACH changes, it is clear that the demand for regulatory support with the assessment and registration of chemical substances under EU and UK REACH is also growing.

We are already supporting organisations across the world to manage their ongoing obligations under EU and UK REACH from our legal entities in the UK and across Europe, and look forward to supporting more businesses with the complexities that are still to come while reducing the costs of compliance. 

Per and polyfluoroalkyl substances (PFAS)

PFAS are a large group of man-made chemical compounds, that have attracted increasing public attention owing to their emerging concern to environmental health. This is attributed to their high environmental persistence and hazardous properties including mobility, toxicity, and bioaccumulation potential. In response to these issues, the European Commission outlined a set of actions to ensure the use of PFAS is phased out of the EU (more info about PFAS and the European Commission here).

There was an array of presentations at SETAC describing the analysis of PFAS in the environment, highlighting the range and extent of PFAS precursors present in the environment as result of both historic and current use of PFAS containing products. These results illustrate the need to search for a broad range of PFAS to adequately characterise the scale and nature of environmental contamination. The major challenge that remains is the question of how to interpret the analytical data – the ‘so what’ in terms of risk to human health and the environment, within the regulatory context and the strategic development of policy.

Our team has extensive experience assessing the environmental risks from emerging contaminants such as PFAS and OPFRs. Emma Pemberton, Principal Environmental Chemist at NCEC, was the evidence acquisition lead for the Environment Agency’s PFAS working group before joining us. She developed a cross-business evidence plan for PFAS that identified and prioritised evidence gaps and research needs. Currently, she is involved in a variety of projects including evaluation of risks to drinking water from PMT chemicals and OPFRs, gap analysis of pesticide legislation and evaluation of data used for PBT/vPvB assessment under REACH. She is analysing the impact CSS will have on PFAS and will soon be releasing more information on it to help the chemical industry. If you would like to receive updates on this, please sign up to our regulatory newsletter here.

Mixtures and the implementation of a mixture assessment factor (MAF)

Among the measures outlined by the CSS, the application of a generic mixture assessment factor (MAF) has been suggested for inclusion to existing and future risk assessments. This aims to account for the effects of unintentional mixtures present in the environment that have not previously been considered and may pose a greater risk to the environment. At SETAC, the session ‘Mixtures matter – from science to regulation and management’ addressed the current shortcomings in regulatory approaches and the operationalisation of the MAF. Methods for identifying and characterising observed mixtures, such as principal component analysis (PCA), were also deliberated. 

When a MAF is applied to existing risk assessments, this may lead to the risk assessment no longer demonstrating safe use. Therefore, introduction of a MAF under REACH is likely to lead to substantial impacts to chemical safety reports (CSRs). 

Our poster presentation demonstrating our work with CEFIC on the MAF module of an impact assessment of the CSS gained lots of interest, emphasising the mounting attention in this area, and can be found here. This work considered the impact and potential mitigation options for the risk characterisation ratios (RCRs) of selected chemical safety reports to remain below the threshold following the introduction of a MAF. To understand more about what this means for your organisation, make sure to sign up to the regulatory newsletter here as we will provide updates on this topic.

Life Cycle Assessment (LCA)

LCA was a strong theme at SETAC. Presentations covered novel LCA approaches, such as characterising the fates of microplastics by type through the water column and separate methodologies for characterising these impacts on marine life. There were some excellent presentations on potential inconsistencies in the application of the ISO 14044 requirements for LCA, with very interesting debates on attributional and consequential LCA and the need for a unified approach. 

It is encouraging to see the LCA field so active in scrutinising, developing and improving LCA methodologies for assessing the impacts of new materials, substances and processes. However, wider moves such as the CSS and the Green Deal discussed above point towards policy requiring a unified approach. LCA academics should always test and suggest new approaches, but organisations will benefit from a unified methodology such as the Commission’s Product Environmental Footprint method which will enable products to be compared on an even footing. This method currently has some obstacles, but the direction of travel is clear, and organisations should be gearing up to provide multi criteria LCAs, not simply product carbon footprints. 

We showcased Ricardo’s enviable experience supporting clients with LCA’s in the chemicals sector and presented a poster on supporting Domino in its multi-criteria assessment of its inks and printers. The work provided a cradle to grave assessment of Domino’s products, identifying the different hotspots across multiple environmental issues to avoid the problem of burden shifting. 

If you would like to know more about our contributions at SETAC or how we can support you with the upcoming changes, please follow the links below or contact us through the form on this page. 

Written by –

Chesney Swansborough and Eléonore Delouvrier
ECT Team, NCEC


More about SETAC

The Society of Environmental Toxicology and Chemistry (SETAC) is a non-profit global professional society, established in 1979, that provides a forum for individuals and institutions engaged in environmental toxicology and chemistry. This year, more than 2,000 people attended the conference in-person, with a further 389 attending virtually from 65 countries across the world. 



 



1. Multi-Constituent Substances (MCS), substances of Unknown or Variable Composition, Complex Reaction Products, and Biological Materials (UVCBs), and More-than-one-constituent substances (MOCS))
2. Persistent, bioaccumulative and Toxic (PBT)/very Persistent and very Bioaccumulative (vPvB)