When the Biocidal Products Regulation came into being in September 2013, BioCote welcomed its introduction.  Robust legislation that introduces clear guidelines regarding the use, sale and marketing of biocides throughout Europe was long in the making and much overdue. The BPR, as we know it, impacts all companies involved in the supply and/or use of biocides. Not only does this include companies like BioCote, but also for the first time those companies that manufacture products that contain our additives to introduce a secondary, antimicrobial function. Previously unregulated, these products are now known as ‘Treated Articles’.

The regulation of any chemical substance is important. Why? Just like any other chemical, the inappropriate use of an antimicrobial additive can have damaging consequences. Instances like British consumers suffering horrific burns after relaxing on leather sofas in their own homes are well documented. The cause? Manufacturers using an unsuitable biocide intended to protect the leather. This is exactly the sort of scenario that the Biocidal Products Regulation was introduced to prevent and at the heart of the legislation is an intention to protect humans, animals and the environment. Prior to the introduction of the BPR, BioCote felt so strongly about this issue that we campaigned for its introduction and actively collaborated with the UK Government.  Our intention, to positively shape the legislation now in place, not just in the UK but across the EU.

As a result, we now have legislation in place in the European Union that quite rightly differentiates between biocidal products and treated articles and introduces measures to control routes to market: the BPR. The EU is not unique in this regard; legislation that covers treated articles, how they are classified and marketed is already in place in the USA. In fact it has been so, in various forms, since 1910. What may come as a surprise is that whilst the sale of biocides themselves is controlled around the world, the EU and the US are the only regions in which treated articles are currently regulated.

So, the regulation of biocides and products containing them is a positive step, but does the Biocidal Products Regulation do enough? Could it be further improved? When conducting a review of the legislation, a good place to start is with treated articles.

The definition of ‘Treated Article’ is a product that incorporates a biocidal ingredient but is not a biocide itself. For example, a pair of socks that are treated with an antimicrobial ingredient to inhibit the growth of microbes that may cause foul odour. The primary purpose of the sock is to keep your feet warm, any antimicrobial treatment and the effect it has are secondary and do not change the purpose of the sock.

This is clear enough, however if you market your treated article inappropriately you run the risk of inadvertently changing the primary purpose of the product and subsequently promoting an unregistered biocidal product. In short, your product changes function and becomes a biocidal product because you market it as such. For companies that do not have the support of an organisation like BioCote, it is easy to get this wrong and the consequences could be seriously damaging to a company’s brand and reputation. This opinion is not unique to BioCote. In December of 2016, the Swedish Chemicals Agency (Kemi) produced a report highlighting similar concerns. It begs the question of how can a company take a treated article to market throughout the EU with confidence if the member states that spent many years determining the governing legislation cannot agree on its implementation and interpretation?

BioCote think this requires greater clarity. Perhaps some straightforward common sense should prevail, but in its absence how about: Can the product, whatever that product is, be sold for the same use and purpose with or without the biocide included? If the answer is yes, then the product is a treated article. If no, it is a biocidal product.

Confusion may be too strong a word, but if the unification of regulation across the EU was an intention of the Biocidal Products Regulation, you may question its success. Varying interpretation of the legislation from member state to member state presents its own challenges. Local legislation that was intended to be replaced or superseded by the BPR, but remains in place is positively awkward. But what does this mean to a company looking to supply a product into the European Union? Well a company who may have thought they now had easier access to the EU can face further registration and costs in certain countries. A further condition of the BPR, when supplying a treated article into the EU, is that it contains a registered biocidal ingredient or one notified (pre-registration) for the intended purpose. Local regulations that then contradict this undermine the primary intention of the BPR: to harmonise the sale and use of biocides and products containing them. This clearly is another area of the legislation that would benefit from further clarity.

As mentioned previously, a key intention of the Biocidal Products Regulation was to protect consumers. In the case of labelling, the BPR seeks to enable consumers to make an informed decision about the products they are buying. This is especially important when the product in question contains an otherwise invisible ingredient. This was the intention of labelling requirements for treated articles introduced in September 2013, but do they really help?

Currently a company placing a treated article on the market within the EU is required to label that product accordingly. The label should contain information about what the antimicrobial ingredient is, and the reason for its inclusion. Does this help? Let’s revisit the socks. If you were to pick up a pair of socks with antimicrobial properties from a high street retailer, and check the label to find an unpronounceable chemical contained in those socks for antimicrobial purposes, will it help you as a consumer make an informed buying decision? Unless you are a chemist, probably not. Do you feel informed, or just confused? How about if the socks were labelled with something much more straightforward. ‘This product is protected with an ingredient to prevent foot odour’. Whilst more meaningful, this statement would currently be considered non-compliant. Worse still, what if the product is not labelled at all? An alarming number of treated articles currently on the market contain no labelling information. Is this a further example of a lack of clarity in the legislation itself, or a lack of enforcement from the relevant competent authorities? Labelling appropriately is imperative to the protection of consumers. Is it doing this? We would have to say the jury is out.

BioCote offers our partner companies guidance on how to label and market their products appropriately, as well as advice on their other commitments as a responsible supplier of treated articles. This includes, for example, complying with rules on consumers’ right to information upon request. Any manufacturer putting a treated article on the market upon request and by law is required to provide information regarding their treated article within a pre-agreed timeframe. Here is the rub: who knows this? Whilst ignorance is not a defence, on the part of the manufacturer how many of them know they should be labelling, how to structure that label and where the label should be displayed? Regarding the rights to information upon request, this is, in theory, a great idea but is impractical to implement in a meaningful way.

There is an argument that a lack of clarity subverts the intention of the Biocidal Products Regulation to harmonise legislation regarding biocides and their use to protect people, animals and the environment. However, its highly interpretive nature also allows for flexibility for manufacturers of treated articles to better express their reasons for choosing an antimicrobial function for their products. The same cannot be said for companies marketing products under the treated article exemption in the USA where real reasons for including antimicrobial ingredients are sometimes denied by a very prescriptive legislation that allows absolutely no room for interpretation. Further clarity for the Biocidal Products Regulation is going to come from either the legislation becoming more definitive in its instruction or by enforcement and legal precedent. We at BioCote are monitoring this closely and supporting our partners in every way we can.