Mixture Assessment Factor – Potential Impacts on Biocide Co-Formulants
At the Dublin Biocide Symposium presented by Kerona Scientific Ltd, which took place on the 28th and 29th of March 2023, Caroline Raine, Technical Associate Director of NCEC Ricardo Energy and Environment, gave a presentation on the debated topics related to the European green deal. Her presentation discussed the chemical strategy for sustainability and the associated changes in the legislation, particularly the changes in the Mixture Assessment Factor (MAF) and subsequent implications for the biocide industry.
The European green deal is a set of policy initiatives by the European Commission which aims to reduce greenhouse gases to 0% by 2050 and decouple economic growth from the use of resources. One of the implications of this policy is the chemical strategy for sustainability. The aims of the strategy include the banning of the most harmful chemicals in consumer products, the introduction of a one substance, one assessment process and accounting for the cocktail effect of chemicals.
The introduction of the chemical strategy for sustainability is a key driver of legislative change and has impacted the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging) Regulations. Examples of some of these changes include the expansion of the generic risk assessment, the expansion of the generic risk approach and the introduction of a new MAF.
The MAF, a mixture assessment factor, is a number that multiplies the endpoint obtained from laboratory test results, enabling us to simulate real-world conditions and eliminate some uncertainties. The RCR (Risk Characterisation Ratio) is used in risk assessment and is calculated by taking the exposure (in humans) or the predicted environmental concentration (environment) and dividing it by the derived/predicted no effect level. If the RCR is below 1, the level of risk is deemed acceptable. A stricter assessment is now being introduced, resulting in varying impacts depending on the RCRs and the MAFs of each substance. Substances that are already near the limit values or to which higher MAFs apply, will need to be adjusted to pass. ECHA has defined different potential actions to readjust the outcomes of the assessment such as, adjusting the RCR values, revising exposure scenarios and applying additional risk management measures.
Caroline ended her presentation with an update of the UK’s future plans regarding the MAF. The UK is developing plans to apply a MAF up to 5 for aquatic toxicity but does not consider it appropriate for human risk assessment.
If you would like a copy of the presentation, you can purchase the slides from the Biocide Symposium here:
Dublin Biocides Symposium 2023 – Speakers Presentations
Please don’t hesitate to contact the team at Kerona Scientific for regulatory support with REACH and risk assessments at firstname.lastname@example.org