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Biocides, antimicrobials and pesticides must surely be one of the most paradoxical groups of substances. They are the great life savers of the 20th and 21st centuries (antibiotics, disinfectants), as well as substances with some of the worst environmental records. We need biocides because, well, the experiences of the past couple of years have taught us that! On the other hand, we also worry about them because they are known for leaching into soils and water sources and are sometimes toxic to humans and other organisms.

Biocidal (or antimicrobial, or pesticidal) new substance registrations can take years to approve–indeed, it is not uncommon for them to take over a decade. Depending on their use, they may also require registrations with multiple authorities within the same country (for example, at the US state level). In the EU, the Biocidal Product Regulation (BPR) process is always two-step, with the active substances registered at the European level and the products authorised for use in each relevant member state. From a business standpoint, it is important to remember that even when you have successfully registered a biocide or antimicrobial with the relevant authority, several other requirements must be met, such as Poison Centre Notifications and Hazard Communication labelling requirements. All told the cost of a new registration may be prohibitive for all but those with the deepest pockets.

High-profile media or NGO campaigns and lawsuits involving these substances are also of concern to regulators, investors, and manufacturers. Indeed, these are helping to shape regulatory policy, as we’ve previously pointed out in the case of other types of substances (PFAS, in particular). These campaigns and lawsuits tend to follow similar patterns and often focus on what are considered safe levels of exposure, the types of people who are exposed (who may not have been considered in original exposure models), and claims of failure to warn (labelling). Since new scientific studies can shift our understanding of biocides, or as society's risk tolerance changes, there is a need for sound strategies and substitutions to phase out the use of hazardous substances in favour of more sustainable alternatives.

An OECD paper on the sustainable use of biocides sets out the principles of prevention, substitution, optimisation, regulation, education, monitoring and enforcement. In particular, we highlight what Joel Tickner et al. (2015) call ‘functional substitution’. That is, finding substitutes that retain the efficacy and functionality of other options.

The assessment of alternatives is lately moving beyond ‘safer’ to ‘sustainable’ across the full lifecycle of a substance or product, including such considerations as recyclability and environmental justice. Policy and regulatory initiatives are driving this issue forward: Article 18 of the BPR, the EU's Chemicals Strategy for Sustainability, the US Sustainable Chemistries and Research Act, various Executive Orders, and TSCA Section 8. These initiatives often concern reporting obligations to increase transparency or the sustainable use of biocides following the OECD principles above.

Yordas has extensive experience in advising companies on substitution strategies. When examining possible alternatives, we can consider a broad range of factors, including:

• Regulatory authoritative lists, such as Conventions and Protocols, toxic substances lists, candidate lists and low-risk lists, such as US FIFRA 24b and BPR Annex 1 ;

• NGO watch lists, such as ChemWatch’s SINLIST, the ZDHC’s DSL, IAEG’s AD-DSL, or the GADSL

• GHS Classification and toxicological data

• Understanding and advising on whether and how an alternative will work as part of a formulation

• Uncertainties or gaps in hazard and risk data

• New Alternatives Methods for assessment

• Efficacy testing

• Life Cycle Assessments

A client who produces garden supplies wanted to find a safe and sustainable fungicide to add to their mulch products. They approached us for advice on ‘greener’ alternatives to more hazardous substances. After reviewing an extensive list of possibilities, we advised a mixture of citric acid and garlic oil. Not only did this substitution result in a product that could retain its ‘green’ credentials, but it also simplified the regulatory burden as the substances are eligible for FIFRAs 24(b) program.

Another client wanted to import and market a treated article on the EU market. However, as the active substance was novel, it required a new active substance application. Until the evaluation was complete and product authorisation sought, the client could not put their product on the market. Yordas advised active substance substitution to shorten the length of time and cost to market. We then supported the client in identifying an alternative active substance already on the BPR Annex 1 list.

From a regulatory perspective, there are other strategies companies can use to ease the regulatory burden, including:

• In the EU, ensuring you have a number of suppliers with registrations of the same active substance under BPR Article 95 can mitigate supply chain issues. This solution is best when part of a broader chemicals management plan that integrates supplier sustainability and transparency.

• Utilising active substances in the EU and GB Review Programme: Products containing active substances in these programmes can benefit from the transitional measures of BPR Article 89 and be marketed according to national legislation. Depending on the country, this should lead to shorter timelines for necessary regulatory steps whilst authorities evaluate these active substances. Once evaluated and approved, product authorisation is still necessary.

In addition, knowledge is key. An early warning about how the regulatory landscape will change allow you to identify new market opportunities and make substitutions as soon as possible. Tracking these changes is critical to understanding current market impacts and ensuring future business opportunities and continuity. For example, Health Canada is consolidating and updating regulations concerning surface sanitisers and disinfectants under a new Biocidal Regulation. This regulation will include a new pathway to acceptance of products on the market using Use of Foreign Decisions (UFD), beginning with US EPA biocide product reviews. As a result, registration and market-entry strategies that biocide manufacturers take in the region may change.

To find out how our team can help you address your substitution strategy challenges, contact our team today. To stay up-to-date about upcoming regulatory changes or to learn more about our Biocides services, visit our website.

Get to know our team

Rosalinda Gioia, Principal: Science

Rosalinda is an internationally recognised chemical environmental fate researcher. She is a respected ecotoxicologist and is highly experienced in understanding chemical regulations. A previous holder of a prestigious Marie Curie Fellowship with the Spanish National Research Council where she investigated the biodegradation of pollutants in river catchments, Linda came to Yordas after several years leading the Chemical Assessment team at the UK Centre for Environment, Fisheries and Aquaculture (CEFAS).

Linda has led projects on Trace Organic Monitoring Pollutants (TOMPs) for the UK Department of Environment, Food and Rural Affairs (DEFRA) and provided expert scientific advice and policy support to government regulators on chemical risk assessments relating to Persistent Organic Pollutants (POPs) for the oil & gas industry, for which she has authored technical bulletins and papers to the annual meeting of OSPAR’s Offshore Industry Committee (OIC). Rosalinda currently project manages REACH Lead Registrations and Biocides active substance approval and product authorisation dossiers. She also provides technical leadership and advice relating to the environmental fate of chemicals, persistence, bioaccumulation and toxicity (PBT) and risk assessments in aquatic environments.

Hayley Lewis, Senior Regulatory Consultant

Hayley is a senior regulatory consultant focusing on BPR with more than 9 years of experience as a development chemist and quality manager within the fine and speciality chemical sectors. She brings expertise in regulatory audits against various ISO standards and how these apply to the realities of chemical manufacturers. Hayley holds a PhD in Molecular and Cellular Physiology from Liverpool University.