The BPR (Biocidal Products Regulation) was announced in 2012 and came into full force in 2013, its purpose to regulate not only the Biocidal Products we use but also any items that have been treated with a Biocidal Product in the EU, also known as ‘Treated Articles’. This one of many key differences between the BPR and its predecessor, the BPD (Biocidal Products Directive) which focused on active substances and biocidal products only.
This new extended scope, incorporating any product on the market that had utilized a Biocidal Product to impart a biocidal effect on an article, meant that the number of businesses affected would be much larger than ever before. But as we approach 7 years of enforcement, why are we still seeing so many non-compliant products on the market across the EU?
Well, for one thing there seems to be a grey area between a Biocidal Product (eg: mosquito spray) and a Treated Article (eg: a tent treated to deter mosquito which uses an active biocidal substance as an ingredient). In a 2016 a Swedish Chemical Agency (KEMI) survey asked 9 EU Member States to determine whether 10 borderline items were a Biocidal Product or a Treated article. The 9 Member States agreed on only one item’s status, so we can see that there are early issues with the BPR across the EU. But for the purpose of this article we’ll be looking at the various factors which could be resulting in ‘Treated Articles’ not yet being BPR compliant.
Do EU Manufacturers Know About The BRP?
Many manufacturers do have a regulatory professional within their team, or they consult an external regulatory expert from time to time. In addition, we know many relevant national federations and institutions, to which many manufacturers are a member, have sent out educational materials to members. For example, the National Bed Federation in the UK held educational seminars for their members.
It seems that if there are manufacturers in the EU who aren’t fully aware of the BPR they may be smaller manufacturers, or do not focus on antimicrobial products specifically. For these manufacturers the likelihood is they will face an inspection at some point and may need to change their suppliers, Biocidal Products used, or product claims.
A manufacturer or importer placing a treated article on the EU market is responsible for BPR compliance, even if they are selling to another manufacturer or retailer.
Do EU Importers Know About The BPR?
Typically, importers have less knowledge on regulatory matters to do with articles, they’re more focused on logistical regulations.
Importers may not realize that the BPR applies to articles imported into EU countries from non-EU countries. Within the BPR the responsibility for compliance sits with the company placing the articles onto the market for sale in the EU. So importers may not realize that if they’re selling B2B in the EU they could be responsible for placing non-compliant Treated Articles for sale.
Many of the Active Substances in Biocidal Products which have not gained approval under the BPR are commonly used elsewhere in the world. Any articles treated with active substances which have not been approved or have not been included on the under review list, may not be sold legally in the EU.
Do Retailers Know About The BPR?
Less likely to have a comprehensive understanding of the BPR are retailers. Again, the large national or multinational retailers likely have a regulatory capacity, but smaller retailers are less likely to.
The BPR is a technical document, perhaps easily understood by technical chemists and regulatory professionals, but certainly less accessible to retail businesses. So it’s easy to understand that retailers may be, unknown to them, selling non-compliant Treated Articles which have been imported from outside the EU or are supplied by smaller importers or manufacturers who aren’t compliant or are only partially compliant.
What Enforcement Measures Are In-Place?
EU Member States are responsible for enforcing the BPR in their area. And the enforcement action has been slow to get started possibly because the biocidal active substance review process is still on-going with many biocides still being assessed. Regardless, there are certainly plenty of commonly used biocidal Active Substances which are used in Treated Articles that have been labelled as ‘Not Approved’, so there is definitely a case for enforcement at this time.
EU member states individually have released information about their enforcement plans, with most opting to achieve compliance rather than to penalize. These enforcement plans include education, warnings, and notices before more serious legal action is taken.
Member States Due To Release Reports In 2020
One of the central measures within the BPR which is in-place to ensure consistency across the Member States of the EU is that each must submit a report every 5 years from 2015 onwards. This way progress can be measured and the details of the reports can help ensure that the BPR is having the desired effect. The first of these reports is due in 2020, and we may then be able to access data on Treated Article compliance across the EU.
Did You Know, Using The A Compliant Biocidal Product Isn’t All That’s Needed To Be BPR Compliant?
So here’s where many are brands are often accidentally non-compliant. The BPR requires specific points to be covered, simply using an approved Biocidal Product will not achieve compliance for a Treated Article. You must be able to demonstrate all of the following:
- You are using an approved biocidal Active Substance for your type of Treated Article
- Your biocidal claim is substantiated
- You have included a detailed BPR-compliant label on your Treated Article
- You have information freely available upon request that further details the biocide used
Are You Using The Correct Active Substance For The Correct Product Type?
While many will answer, ‘yes of course, the biocide we’re using works against the microbes we want to prevent’ this is only half of the answer. The BPR only approves certain Active Substances for certain types of end-product, or ‘Treated Article’ as they call it in the BPR documentation.
So for example, an Active Substance could be approved for use in textiles but not approved for use in construction materials, even though the biocide is effective against bacteria for both theoretical products. So you must not only check that your Active Substance is compliant, but that it is compliant for your intended end use. This is an easily overlooked aspect of BPR compliance. You can access the Product Type table and links to check that the Active Substance your using is compliant for your product in our free Guide To BPR Treated Articles here
What Are You Claiming, Exactly?
The BPR cares about your claims, if the Active Substance in your Biocidal Product is not approved as an antibacterial, then you can’t claim that the resulting Treated Article is antibacterial. You also must not claim things like ‘eucalyptus oil kills dust mites’ when in reality it deters dust mites. You must word your claim carefully to ensure it’s accurate, as you’ll be challenged on this point by an enforcement professional.
Similarly, if you are claiming a biocidal effect without having used an approved Biocidal Product to achieve this, you’ll need data to back up your claim, otherwise will have to remove or change your claim.
Are You Labelling Your Products Correctly?
Did you know, the BPR comes with labelling requirements? In addition, there are stipulations that you must provide additional information on the biocides used when asked by a member of the public (or another business). Again, this area of BPR compliance has been largely looked over by brands, and it requires a certain degree of education for marketing, customer service, retail and product owner teams within your business.
The Swedish Chemical Agency survey discovered that in 2016 82% of the Treated Articles in their survey did not have BPR compliant labelling. In the same survey, additional information on the biocides was requested from 45 Treated Article retailers, 64% of retailers replied but only 29% replied with the correct information.
Article 58 requires that your Treated Article is labelled as containing a Biocidal Product, you must name the Active Substance, any nano materials used. You can access a detailed example of compliant labelling in our free Guide To BPR Treated Articles ebook.
At this point, simply browsing the shelves of your local supermarket is the easiest way to spot that non-compliant products are still on sale. You’re likely to find products that do not provide the required labelling for BPR compliance, even if their biocidal Active Substances are all compliant.
While it’s understandable that some marketing and product teams are not happy to detail their biocidal ingredients on their packaging, there are ways to effectively use BPR as a USP. Read our blog ‘Using BPR Compliance As A USP For You Product’ to discover how.
Looking For More Information on BPR Treated Articles?
Our team of technical, regulatory and marketing professionals have published a free downloadable Guide To BPR for Treated Articles. You can access it by clicking this link. What makes this guide different is that it’s been written for those who do not have extensive technical chemistry or regulatory experience. It’s the easy to understand guide to BPR Treated Articles and should help you on your way towards compliance.
In our guide you will learn:
- About the BPR
- What a Treated Article is
- Why Article 58 is so important for manufacturers and retailers
- How to comply, including Biocidal Products for compliance
- Which types of Active Substances can be used for which purpose
- Examples of compliant labelling
Download The Guide to BPR Treated Articles Here