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ADDITIVES | ANTIMICROBIALS


nanomaterials playing a part in the development of “circular” bio-based antimicrobial products. “Considerable interest has…been shown in different application sectors in the shift away from common additives such as metal ions and oxides of silver, copper and titanium, which are under scrutiny due to their possible toxicity and disposal issues,” they say.


Antibacterial CNTs The Aimplas researchers say carbon-based nanomaterials have recently been found to display strong bactericidal properties. “Their antibacterial mechanism is complex and depends on factors such as composition and surface concentration, but they appear to be able to act on cell membranes


and destroy them and/or cause oxidative stress, as in the case of silver-based nanomaterials. Because these materials can act on contact without releas- ing substances, they are suitable for medical applications such as prostheses and implants in constant contact with the body,” they say. Natural antibacterial agents derived from


extracts from animals, plants and microorganisms are generally considered safe and environmentally friendly. However, natural antimicrobial peptides such as nisin, natamycin, leucocin, enterocin and pediocin — which are already used to prevent food spoilage — are sensitive to high temperatures, making them difficult to use in thermoplastic compounds. “However, they can be encapsulated in porous inorganic or heterostructure (inorganic/


Biocides and the EU Green Deal


The European Union’s Green Deal initiative aims to see the development of manufactured products that are more durable, have longer lifetimes, and avoid waste. The Microbial Control Executive Council (MCEC), an initiative of leading companies developing and supplying microbial control technology and solutions, believes its members’ products support these policy objectives. In a recent presentation, the MCEC said the overarching aim of EU chemicals legislation is to better protect people and planet and boost innovation towards the production and use of safe and sustainable chemi- cals. It said that the focus of innovation in microbial control technologies is on solutions where only the unwanted microorganisms are targeted, and humans and environment remain unharmed. However, whereas regula- tion aims to boost innovation in general, the MCEC said for biocides lengthy and repetitive approval and reapproval procedures can form a hurdle for for R&D investment MCEC said its members are calling for a supportive EU policy framework that promotes coherence across the different instruments of chemicals management. Clarity on which legislation prevails over another for the active and non-active substances


24 COMPOUNDING WORLD | July 2022


Above: European antimicrobial producers see regulatory inconsistencies in the EU’s Green Deal strategy


that a biocidal product is composed of, is essential, according to MCEC Chairman José Mosquera. In the EU, biocides and biocidal


applications are mainly regulated by the Biocidal Products Regulation (BPR). Under the Chemicals Strategy for Sustainability (CSS), published in October 2020, new legislation and criteria are on the horizon. The MCEC says the BPR is not mentioned, but this may not mean the CSS will not have an impact on biocides. Major changes will be introduced in the overarching chemical regulations that apply to all chemicals, including to components of biocidal products, through REACH and the Classification, Labelling and Packaging regulation, CLP. The proposed changes raise questions, according to Mosquera. These include the introduction of new


hazard categories for Endocrine Disruptors (EDs), Persistent Bioaccu- mulative and Toxic (PBT) chemicals, and Persistent Mobile and Toxic (PMT) chemicals under CLP. Active and non-active substances alike fall under the CLP and more hazard classes will apply to them. it is unclear whether the categorisation, proposed by EU policymakers, to manage EDs will differ from that of the BPR. The MCEC also highlighted additional data requirements under REACH to better identify the possible properties of substances. Increased data requirements could impact the availability of co-formulants, it said. In its definition of Safe and Sustain- able-by-Design (SSbD) and essential use, the EC has a vision that chemicals “are produced/used in a way that maximises their benefits to society while avoiding harm to planet and people”. This approach is intended to foster the development of chemicals that are safe and deliver environmen- tal, societal, and/or economical value through their applications but Mos- quera asks what will be considered “safe”. He says this is a key question for biocides, which have a certain degree of controlled toxicity as an intrinsic property. Similarly, Mosquera asks how “essential use” will be defined. � www.microbial-control.com


www.compoundingworld.com


IMAGE: SHUTTERSTOCK


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