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ADDITIVES | ANTIMICROBIALS


allowed, some are not allowed, and some may have their status change once their review is completed. In general, users must check if an active substance is allowed in plastics by referenc- ing the BPR Article 95 list. “Silver antimicrobials work by creating very small


Above: Hospital


surfaces and equipment is a key application area for antimicrobial additives


products supplier Microban. “Once these microbes take hold, the microbial contamination is usually persistent and poses a hygiene issue,” he says. “A few years ago, GE released a line of washers that incorporate active post-wash venting of the wash cavity and intelligent application of antimicrobial-treated parts (supplied by Microban Products Company). This is an outstanding example of intelligent rethinking and redesign of a device to enhance longevity and cleanliness.”


Regulation matters Within the EU, antimicrobials and biocides are regulated under the Biocidal Products Regulation (BPR) and must be registered for use for a particu- lar product type (such as plastics) through a dossier submitted by a company. There is concern from some that the range of available chemistries in the EU is narrowing and will continue to do so. For example, zinc pyrithione (ZnPT), which has long been used as an active ingredient in medicated shampoos as well as an antimicrobial in plastics, was reclassified as a 1B reproductive toxin and its prohibition from use in cosmetics in the EU took effect 1 March 2022. Currently, ZnPT is not restricted in plastics


applications in the EU and may be used as an antimicrobial. However, there is concern that it could face restrictions in the future, or that users may in the meantime “deselect” it and seek alternatives. In the US, biocides for use in plastics (and other “treated articles”) are regulated by the Environmental Protection Agency under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); no restrictions to ZnPT are expected in the US at this time. In Europe, silver-based antimicrobials should be viewed on a case-by-case basis, as some are


18 COMPOUNDING WORLD | July 2023


concentrations of silver cations on the surface of the products in which they are meant to protect. These small amounts of these cations are enough to be highly effective against microbes,” Ong explains. “There are many designs and structures in silver-based antimicrobials that will result in the controlled release of silver cations. Sophisticated designs are not purely silver or simple silver salts but use a design where an inert substrate can host a reservoir of these silver cations in a stable and long-lasting manner. All these antimicrobial constructions are regarded as unique entities and evaluated and regulated separately by regulatory bodies.”


Ong believes that industry is losing some of its


traditional broad-spectrum biocides and suggests that increasingly complex regulatory review processes, together with tightening restrictions, are real barriers to industry investment in synthesising new materials, as it takes time to identify alterna- tives. “This should be a call to action for universities and others to look at natural antimicrobials, to repurpose some of these naturally occurring molecules and identify methods, such as grafting or carrier materials, to obtain chemical stability and thermal processing stability,” he says.


Active developments According to Julie Simmons, Regulatory Affairs Manager at Wells Plastics in the UK, the EU BPR (and the UK’s developing GB BPR system resulting from its decision to leave the EU regulatory framework) are developing and changing subtly all the time. “In our opinion, it seems likely active substances will be reviewed earlier under EU BPR as the UK HSE focusses attention and resources on UK REACH,” she says. “It is unclear what will happen if active substanc-


es are approved or non-approved in the EU but are still in the review programme in the UK. As both the UK government and the HSE have made clear, divergence is possible (and has already been seen with the different per- and polyfluoroalkyl substanc- es (PFAS) proposals), therefore there may be EU non-approved additives that will still be able to be used in the UK as they have not been reviewed yet. There is also the possibility that the EU and UK will make different decisions on the approval/non- approval of actives,” Simmons says.


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IMAGE: SHUTTERSTOCK


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