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BIOCIDES | PVC Regulating PVC biocides


Biocides, which are widely used in plasticised PVC products to extend life and appearance, are tightly regulated. We find out more about the European and US regulatory systems


Biocides—antimicrobial additives—are a near essential requirement in the formulation of flexible PVC materials for long term use applications due to the susceptibility to microbial attack of the plasticiser component, which can lead to unpleasant and unsightly issues such as staining, odour and mould growth. However, biocides contain active substances that have the potential to cause environmental and/or human harm, so their use is carefully regulated. A challenge for both producers and users is that the two main regulatory systems of the European Union and the US operate differently, can be complex, and continually—albeit slowly—evolve. In Europe, use of biocides is regulated through the Biocidal Products Regulation (BPR) via the Euro- pean Chemicals Agency (ECHA); in the US through the Federal Insecticide Fungicide Rodenticide Act (FIFRA) via the Environmental Protection Agency (EPA). Both have a similar objective—protection of consumers, workers and the environment—but their specific assessment processes and criteria lead to differences in the chemistries that can be used in each region. This can make selection a challenge for PVC formulators. Compounding World has spoken to experts


at two key players in the PVC biocides market — Helena Kim, Global Business Manager Plastics at Troy Corporation in the US, and Phil Clegg, Biocides Business Manager in the UK for Valtris Specialty Chemicals—to get a better understanding of how regulations shape, and continue to shape, biocide selection in the two regions. Troy is the world’s leading supplier of OBPA (oxybisphenox- arsine) antimicrobials for plastics and also produc- es DCOIT (dichlorooctylisothiazolinone) and OIT (octylisothiazolinone) antimicrobials; Valtris is a major player in DCOIT and OIT. These three


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biocides are currently mainstay products in the global market for flexible PVC protection.


EU approach to biocides The European Biocidal Products Regulation (BPR – Regulation EC No 528/2012) was adopted on 22 May 2012, replacing the earlier European Biocidal Product Directive (BPD). It took effect across the EU on 1 September 2013. Since that date, biocide suppliers can only market biocides, and users can only put on the EU market finished articles contain- ing biocides, supported under the BPR Review Programme. This involves submission of a full dossier containing a data package for the biocidal active substance relevant to the Product Type (plastics and textiles fall within Product Type 9) to ECHA. This dossier is then reviewed by the Biocidal Products Committee (BPC), which issues an


Main image: Biocides are widely used in plasticised PVC products to prevent mould and odour growth but regulation is complex and varies between the EU and US


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