ADDITIVES | ANTIMICROBIAL
biocides is reducing the number of available active substances, with some applications having only one or two viable options remaining. This is creating a genuine market need for alternatives. Demand for new, effective and compliant active substances is increasing, even though the pathway to bring them to market has become more difficult.” In response to these recognised challenges, the
European Commission is currently evaluating the BPR. A public consultation period ended in March, and the evaluation is expected to conclude mid-2027, which could be followed by an impact assessment for potential revisions. “While the outcome of the review remains
Above: The microbiological laboratory at Sanitized once again received accreditation from the International Antimicrobial Council in December
“As the use of recycled content continues to
grow, manufacturers are increasingly focused on maintaining the performance, aesthetics, and service life of finished products,” said Sanitized. “As part of a broader performance-enhancement package, antimicrobial technologies can help support the value, durability, and usability of recycled-content materials across a range of applications.” Antimicrobials can support sustainability goals
by extending product lifetime and improving durability, added Sanitized. Aligning with regula- tory requirements for different regions is also important. The EU’s Biocidal Products Regulation (BPR), which came into effect in 2013, aimed to strength- en safety, but had the effect of introducing barriers that limit innovation in markets such as thermoplas- tics, suggested Julie Simmons, Regulatory Affairs Manager at UK-headquartered Wells Performance Materials. The requirement for approval of new active substances that requires a comprehensive analysis with extensive data even for small volumes has been a barrier to developers, particularly for smaller companies and specialised applications. “Unlike Reach, the BPR has no volume banding; the same data requirements apply whether a sub- stance is used at a few tonnes or at scale,” ex- plained Simmons. Additional regulatory require- ments for endocrine disruption and persistent, bioaccumulative and toxic properties add more cost and uncertainty for new substances, she said. “The ability to generate early-stage commercial and technical data has effectively been removed, slowing down innovation and limiting the number of new active substances entering the market,” she said. “At the same time, the BPR is reshaping the market in ways that create new opportunities. Reclassification and non-approval of legacy
18 COMPOUNDING WORLD | July 2026
uncertain, there is cautious optimism that a more proportionate regulatory approach may emerge – one that introduces simpler, lower-cost pathways and better aligns data requirements with actual exposure risks,” said Simmons. “Achieving this balance is essential to enabling companies to generate real-world insights without the burden of full upfront approval, thereby supporting innova- tion rather than constraining it.”
New technologies She noted that in addition to Wells’ established Bactiglas range of antimicrobial masterbatches and powders, the company is investigating technolo- gies with novel mechanisms of activation that may have fewer regulatory constraints. Lanxess added that while the requirements for active substance approval and product authorisa- tion remain complex and resource-intensive, with scrutiny of existing active substances, the current BPR review may refine requirements. Long-term regulatory investment is important, the company noted.
Glass Technologies, which was founded by long-time antimicrobial industry expert Kenn Vest, recently acquired a copper-glass antimicrobial technology developed by Corning. The Guardiant antimicrobial technology is an inorganic additive registered with both the US EPA and the Canadian PMRA that enables customers to successfully pass the US EPA Dry Quick Kill test method, said Vest. It can be compounded into a masterbatch for plastics applications, including higher temperature plastics. It can also be used in coating applications. The company is currently in discussion with potential distribution partners. In the US, under the Federal Insecticide, Fungi- cide and Rodenticide Act (FIFRA), all antimicrobial products must be registered with the US Environ- mental Protection Agency unless they qualify for exemption from registration under FIFRA’s treated
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IMAGE: SANITIZED
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