Biocidal active substances and biocidal products are defined in the Biocidal Products Regulation (BPR) as products that exert a controlling effect on harmful organisms. The aim of these biocidal substances is to exterminate, render harmless, or prevent the spread of harmful organisms. As such, they have potent properties. Because of this, biocides are heavily regulated in the EU by a stringent regulatory framework which ensures their effective use while also protecting the environment and human health.
The Biocidal Product Regulation
The BPR is the main legislation that regulates biocidal substances and products and, therefore, microbial control technologies. It takes a two-step approach to regulation: first, biocidal active ingredients must undergo an approval process; and second, biocidal products containing approved active substances are submitted to an authorisation process. The substance approval process consists of a peer review/risk assessment that, when completed and approved, signals to the European Commission that the substance in question is sufficiently safe and effective and can be placed on the EU market. The procedure for biocidal product authorisation requires products to be approved by either the EU or by a Member State Competent Authority in which the product will be used.
The Chemicals Strategy for Sustainability
The BPR provides the necessary safety requirements for human health and the preservation of the environment. However, under the Chemicals Strategy for Sustainability, a European Commission’s Communication published in October 2020, new legislation and criteria that may have an impact on microbial control technologies are on the horizon . Among these, discussions are ongoing regarding their definition and implementation. Some of them are of particular interest for microbial control technologies:
- Essential Use: the objective of the European Commission is to develop a definition of “essential use” to complement existing legislation, according to which substances may be used, provided an initial assessment proving their essentiality for society. The development of such a definition will become key for biocidal active substances and biocidal products.
- One Substance, One Assessment: the European Commission has proposed the One Substance, One Assessment (OSOA) principle to streamline the work among agencies (e.g., ECHA, EFSA) dealing with chemicals legislation and to make decision-making on chemicals faster, more consistent and predictable. This new approach is also expected to be reflected in the chemical legislative framework, including BPR, REACH and CLP.
- Safe and Sustainable-by-Design: the European Commission has a vision that chemicals “are produced/used in a way that maximises their benefits to society while avoiding harm to planet & people”. The approach is intended to foster the development of chemicals that are safe and deliver environmental, societal, and/or economical value through their applications. The definition of what can be considered as “safe” is of particular interest for the microbial control industry, as biocides are expected to have a certain degree of controlled toxicity as intrinsic property to make products safe.
Registration, Evaluation, Authorisation and Restriction of Chemicals
Under the EU regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), companies have to demonstrate to the European Chemicals Agency (ECHA) how their substance can be safely used, with subsequently agreed risk management measures appropriately communicated to users. REACH applies to all chemical substances. Therefore, the regulation has an impact on most companies across the EU, including members of MCEC who produce microbial control technologies for products like paints, detergents and furniture.
Because biocidal active substances are first and foremost regulated under the BPR, they are only subject to REACH’s registration and restriction provisions, and not its clauses regulating evaluation and authorisation. It is therefore possible that a substance with biocidal properties is not authorised under REACH, yet is permitted under the BPR and may be used in a biocidal product.
However, REACH is the core regulation for the co-formulants in biocidal products. Co-formulants do not contribute to a product’s biocidal effects, but are nonetheless essential to the overall chemical formulation – for example its colour, smell and viscosity. The microbial control industry relies very much on the availability of co-formulants for the manufacture of effective biocidal products.
The Classification, Labelling and Packaging (CLP) Regulation
The Classification, Labelling and Packaging (CLP) Regulation requires companies to classify, label and package their hazardous chemicals – or products containing hazardous chemicals – appropriately before placing them on the market. While some products, such as cosmetics, are exempt from the CLP’s requirements, biocidal products are not. In practice, this means that biocidal active substances and biocidal products must be labelled with statements and pictograms identifying relevant hazards, alongside information on how to manage the associated risks.
How a biocidal substance is classified under CLP will also impact its treatment under the BPR. For example, classification as a carcinogen, mutagen and reprotoxic substance of category 1A or 1B under the CLP would meet the BPR’s exclusion criteria, meaning that it could not be approved as a biocidal active substance, unless it also matched further criteria under the BPR that allows for an exemption to this rule. Exemptions may be granted to substances that are needed on the grounds of public health or of public interest when no alternatives are available.
Both REACH and CLP Regulation are expected to be reviewed under the Chemicals Strategy for Sustainability. Discussions are currently ongoing at technical level and the publication of legislative proposals is expected in the coming months.
The aim of the chemical regulatory framework is to provide an unrivalled degree of protection for humans and the environment. This is aligned with MCEC’s commitment to health and safety.
Microbial control substances are necessarily potent because they aim to protect us from falling ill and protect products and infrastructure from deterioration. MCEC members take all necessary precautions for the appropriate development, technological advancement, and sustainable use of microbial control technologies. This includes educating customers as to how they should use their products without causing harm to themselves, the environment or wildlife, and conducting extensive research to find microbial control solutions that only target the implicated microorganism, while leaving humans and the environment unharmed.