PVC | BIOCIDES
Above: The US and EU have different regulatory approaches to biocides and different review processes
within the EU is through a particular biocide’s inclusion in the BPR, other aspects of the BPR could also have potential to influence biocidal selection. She cites the labelling element as an example. Within the BPR, antimicrobial treated articles (which would include PVC products) require labelling either where the seller makes a claim of antimicro- bial performance or where any conditions associ- ated with the approval of the biocide require it. Back in November 2018, ECHA’s Risk Assess-
ment Committee (RAC) issued an opinion that labelling under the EU’s Classification, Labelling and Packaging (CLP) Regulation EC No 1272/2008 should be required for mixtures where OIT is present at above 15ppm, indicating that the mixture may cause allergic skin reactions. The definition of hazardous mixtures in the CLP (which is separate to the BPR) extends to paints and coatings containing OIT. The RAC has since proposed a similar CLP labelling limit for DCOIT in mixtures. It should be noted that a requirement to label under CLP is not intended as a restriction on use but a means of ensuring safe handling. While CLP review may result in more stringent labelling of some mixtures containing biocides for some products, Clegg says it should not be assumed that a limit applied to a liquid paint would also be applied to a plastics article “where the biocide is entrapped and potential for bioavailabil- ity is low.” He says it is necessary to distinguish
between labelling requirements for liquid paints and coatings, which are considered as hazardous mixtures and are regulated by the CLP regulation, and treated articles which are regulated by the BPR. In any event, any potential labelling changes for biocide-treated articles would only come into force on completion of an assessment of the active substances in the BPR, which is not expected before early 2022, and any requirement to label would not, in itself, be a restriction on use. How- ever, if labelling was to be required for articles treated with OIT or DCOIT it could encourage users to consider alternatives, according to Kim. “There has been a shift away from these types of chemis- tries in markets outside of PVC in order to avoid the labelling,” she says.
The US approach Biocides are regulated in the US by the EPA through the Federal Insecticide Fungicide Rodenti- cide Act (FIFRA). As part of this regulatory scheme, the EPA operates a registration review programme. This asks suppliers to substantiate the effectiveness of their biocide product, provide updated occupa- tional and exposure information, and provide latest information on environmental effects every 15 years. This is achieved through the issue of a Data Call-In (DCI) to all participating suppliers. The EPA issued a DCI for OBPA in 2011 and DCIs for DCOIT and OIT in 2015. “The financial burden to participate in the DCIs for
each chemistry can be in the millions of dollars, taking several years on average to complete,” says Kim. “If there are multiple suppliers for the chemistry, the cost to generate data can be shared. With OBPA, however, Troy is the sole EPA supporter of this chemistry and is taking on the full financial responsi- bility to maintain this chemistry in the market.” Troy is nearing completion of the data package for its OBPA DCI and expects to submit the final pieces of requested data to the EPA in the second half of this year, Kim says. The DCI for DCOIT and OIT was issued later so no timeframe for submis- sion is yet available.
Learning more about biocide regulation
Global regulation covering the use of biocides is constantly being reviewed to minimise the risk of harm to humans and the environment. As a consequence, options available to end users is becoming more restrict- ed. OBPA, DCOIT and OIT all provide
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good performance in flexible PVC applications. OBPA is not authorised for use as a biocide in plastics in the EU; DCOIT and OIT both are. All three are authorised for use in plastics in the US; all are currently going through the EPA’s regular registration review
COMPOUNDING WORLD | September 2020
process with a decision on OBPA expected soonest. Learn more about the EU Biocidal
Products Regulation HERE Find out more about the US
Federal Insecticide Fungicide Roden- ticide Act HERE
www.compoundingworld.com
IMAGE: SHUTTERSTOCK
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