Investments and innovation are needed to further explore microbial control solutions that target specific microorganisms, leaving other organisms unharmed. The development of such technologies is hugely beneficial for humans and the environment. However, investing in new and more effective microbial control solutions can be challenging for substances like biocides, due to rapidly evolving and complex legislative requirements, the incurrence of costs up-front and the size of the market, relatively small if compared to other sectors where chemicals are used.
New and existing microbial control technologies are rightfully subject to stringent research and testing. However, compliance with the demands of the Biocidal Product Regulation (BPR), the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the Classification, Labelling and Packaging (CLP) Regulation means that it can take many years before a new microbial control solution is accepted to market, due to complexities in the regulatory framework.
Companies therefore run the risk of entering into a lengthy and expensive innovation process without any guarantee that their new biocidal product will be approved. Furthermore, as evaluations have been concluded for only one third of existing biocides on the market, according to the latest Commission Report published in July 2021, there remains considerable uncertainty as new regulatory precedents continue to be set. This represents a significant risk of non-approval for new substances as companies are unable to gauge what testing methodology and regulatory approaches, including parameters for safety and efficacy, are likely to apply in ten years’ time.
Hazard vs Risk
In recent years, a debate over whether to apply a predominantly ‘hazard’ or ‘risk-based’ approach to the regulation of chemicals has emerged. A hazard represents the potential of a chemical substance to cause harm, whereas a risk is the possibility of harm arising from a particular exposure to a chemical substance, under specific conditions.
The regulatory framework for biocides currently includes both hazard-based and risk-based assessments as part of individual substance evaluations. It allows for the identification of a substance’s hazardous properties, as well as an assessment of exposure to see whether risk management measures can be applied to manage the potential for harm. An example of a risk management measure is limiting the concentration of a hazardous substance in a final product formula to level where it does not represent a risk to the user or to the environment. A risk-based framework also allows assessment of the potential net benefit brought by an intrinsically hazardous substance to society.
However, several stakeholders have been increasingly campaigning for a predominantly hazard-based approach, at the expense of a risk-based one, to chemicals regulation, with the idea to bring benefits to human health and the environment.
If a hazard-based approach is applied to biocides, this would lead to non-approval decisions based purely on the intrinsic properties of these chemicals and without taking the negligible risk for humans or the environment into account. Few, if any, biocidal active substances would achieve approval, as they are designed on purpose to eliminate microbes. The resulting real-world effect would manifest in a lower level of protection within our societies against very potent pathogens, as well as the accelerated deterioration of materials and products due to unrestricted microbial action. This could have significant and serious impacts on public health and the environment as society struggles to control germs and waste.
Lack of a holistic regulatory approach
A combination of active substances and non-active substances – known as co-formulants – is required within microbial control technologies. An active substance is the substance with biocidal properties that contributes to the product’s efficacy for its intended use – i.e., it neutralises the unwanted organism and pathogen. Co-formulants are nonetheless essential to its overall chemical formulation, for example its colour, smell and viscosity.
Biocidal active substances are subject primarily to the BPR as well as the CLP. Instead, a co-formulant is not regulated under the BPR, but under REACH, CLP, and potentially other legislations.
The different regulations that apply to the individual substances found in a single biocidal product creates complexity as different substances undergo assessment at different times and to different timescales. The lack of a holistic regulatory approach to a final biocidal product means that the various individual substances in product formulas may face prohibitions or restrictions that are considered and applied independently of their final uses.
MCEC regularly informs policymakers, industry players and the scientific community of the importance of antimicrobial technologies for society. Many people are unaware of the wide ranging benefits such solutions offer, for disease and infection control, marine shipping, paints and coatings, wastewater management, and oil and gas recovery. While society came to recognise the importance of hand and surface disinfectants during the Covid-19 pandemic, fewer people are aware of their essential nature beyond a public health crisis. Antimicrobial technologies are part of the solution to the development of a sustainable and greener economy. They help manage energy costs, reduce waste by increasing the durability of products, and keep European citizens safe.
MCEC believes that an overall understanding of the importance of biocides and the subsequent benefits brought to our everyday lives, needs to be taken into consideration in the regulation of antimicrobial technologies. For biocides to fulfil their essential purpose, of microbial control, it is essential that they are regulated under a risk-based approach and in a proportionate manner. We must find a way to counterbalance the hazards from which biocides protect us, while harnessing their very intrinsic properties that make them effective for their role in microbial control.
MCEC encourages policymakers to take a holistic approach to regulating biocides and welcomes an open discussion with authorities about the challenges ahead.