INTRODUCTION In a series of seven articles published on the Arpal Group blog between July and September 2014, we provided best practice advice to our customers and partners covering the new CLP Regulations for classifying and labelling hazardous chemicals, including most cleaning chemicals currently used in the workplace. All seven articles were then reproduced as a free to download e-book. An equally important piece of legislation is the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). Introduced in 2012, it represented one of the most seismic pieces of legislation to affect the chemicals industry in decades. In a five-part technical series published on the Arpal Group blog between October and November 2017, we examined the key aspects of the legislation, where it originated from and the impact it has had on the industry, at source and downstream. BPR covers the supply, marketing and use of biocidal products used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria/viruses by the action of Active Substances (ingredients) contained in the biocidal product mixture. The regulation aims to improve the way biocidal products are managed and marketed in the EU, while also ensuring a high level of protection for humans and the environment. The blog series covered the following topics: Part 1: History and legal framework Part 2: From directive to regulation Part 3: The regulation starts to bite Part 4: Authorisation of biocidal products Part 5: Implications for customers We hope that our customers, distributors and end-users will find the advice provided in this e-book reprint to be useful in ensuring proper compliance with the new regulations. Please do not hesitate to Contact Us immediately if you require further clarification on any of the points raised in the series of articles. We will be only too happy to share our experience and expertise in this area. Arpal Group www.thearpalgroupblog.com 2
Biocidal Products Regulation Introduction 1. History and Legal Framework 2. From Directive to Regulation 3. The Regulation Starts to Bite 4. Authorisation of Biocidal Products 5. Implications for Customers 3
1. History & Legal Framework The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) is one of the most seismic pieces of legislation to affect the chemical industry in decades. In this five-part technical series, we examine key aspects of the legislation, where it originated from and its impact on the industry. BPR aimed at improving the marketing and use of biocidal products used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria/viruses by the action of Active Substances (ingredients) contained in the biocidal product mixture; ensuring a high level of protection for humans and the environment. Regulatory History & Intentions A system intended to create a level playing field for the supply of disinfectant products across the EU came into effect 20 years ago with the grand title Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. This was quickly shortened to the Biocidal Products Directive (BPD) with the original aims of the legislation being considered reasonable by most observers. BPD sought to create a regulatory structure that allowed biocidal products (and the active ingredients within the products) to be assessed to show that they were effective whilst offering a high level of protection to people using the products and to the environment. 4
Prior to BPD being introduced, there was strong political and consumer pressure to control the use and supply of biocidal products. Each member state had its own set of national rules for the supply of biocidal products ranging from simple notification schemes with few restrictions to more heavily regulated systems as used in the Netherlands for example. There was growing evidence that some of the biocidal products on the market had unintended side-effects on the health of end-users and the environment. The patchwork of different regulatory systems across EU member countries acted as an impediment to free trade. One EU state could outlaw the import of biocidal products from another because the products did not comply with local regulations. BBD: The Application of Common Rules BPD sought to create a common set of rules that could be applied to all biocidal products sold in the EU, restricting use of the most dangerous biocides, outlawing the very worst. It was argued that a common set of rules, applied to all countries, would be fair, prevent trade restrictions between member states and curb uncontrolled pollution. So BPD was initiated with good intentions; introducing controls, forcing suppliers of biocidal products to take responsibility for their products and encouraging manufacturers to create safer disinfectants in a way that allowed free trade across the EU. As with much legislation, however, the devil is in the detail. Some aspects of BPD soon became unworkable. As a result, BPD morphed into BPR (Biocidal Products Regulations) in 2012 but concerns remain within the industry that some of the original aims of BPD have been lost along the way with the process taking much longer than intended, imposing a compliance cost burden which restricts new product development and ultimately consumer choice. Part of the problem arose from how a biocide was defined in the legislation and the sheer number of different product types that fell within the scope of BPD. 5
Defining the Term Biocide Even in the early days of BPD, problems were anticipated with implementation of the legislation. There were difficulties arising from the way in which a biocide was defined. Issues also arose with the regulatory hierarchy with some products falling into several different product categories, each with its own set of regulations. For example, should a liquid soap used to sanitise (clean & disinfect) your hands be governed by BPD or by Cosmetic Regulations as the product is used on skin? Depending on why the soap is being used, it could even be considered a medicinal product. 6
We examine this quandary later in the series, but for now, let s start by looking at how a biocide is defined. BPD Article 2.1 defined a biocide as: Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. The above sentence is unlikely to win awards from the organisers of the Plain English Campaign but let s take a moment to examine some of the key wording. substances and preparations containing one or more active substances This means that BPD applied to both biocidal products supplied to customers, such as disinfectants and sanitisers, and the individual ingredients within the mixture that provide biocidal properties. intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism This is an important phrase as it raises two keys issues: 1. A biocidal product does not need to totally eradicate nasty bugs. If it merely deters bacterial growth or inhibits the multiplication or impact of harmful organisms, the product was considered to be within the scope of BPD. 2. An important feature of the legislation is the intention of the person placing the product on the market. If the product does not make any claims to have an impact on harmful organisms, then by implication it is not a biocidal product as defined by BPD. An example of this is alcohol. Alcohol has long been known to kill bacteria, but a bottle of whisky, containing 40% alcohol, is sold as a drink and is not intended to be used as a disinfectant. There are hundreds of products in everyday use that inhibit the spread of harmful organisms, but these products would only be subject to biocidal product legislation if there is a specific or implied claim of biocidal activity on the product labelling or in related marketing or advertising of the product. by chemical or biological means Essentially excludes products that kill harmful organisms by physical or mechanical action, and only by chemical or biological means. So a chemical product used in the manufacture of bait for killing mice falls within the scope of the biocide legislation, whereas the mouse trap would not. The Resulting Categorisation: Product Types (PTs) 7
When BPD came into force on the 13th May 2000, 23 different types of biocide were described across four main groups. We will examine this in more detail in Post 3, but biocidal products supplied by the cleaning industry fall mainly into Group 1 Disinfectants & General Biocidal Products including human hygiene; private area and public health; food, feed and drinking water disinfectants. But the legislation extends to some more esoteric products, including: PT9: Fibre, leather, rubber and polymerised materials preservatives. PT15: Products used for the control of birds, by means other than repulsion or attraction. PT22: Embalming or taxidermist fluids. So faced with so many diverse chemicals to assess and control, across a growing number of EU member states, it may have been predictable that the timescale envisaged to fully adopt the legislation would start to slide and the primary legislation itself would have to be revisited. 8
2. Moving from Directive to Regulation In Part 1, we examined the Biocidal Products Directive 98/8/EC (1998) which established a common set of rules for all biocidal products sold in the EU, restricting use of the more dangerous biocides, outlawing the very worst. As a Directive, the regulators granted a two year period, until May 14 2000, so that EU member states could incorporate BPD into their own national legislation. At this point, it is worth noting the difference in EU law between a Directive and a Regulation. A Directive is a legal act of the European Union requiring member states to achieve a particular result without dictating the means by which this result is achieved. A Regulation, on the other hand, is self-executing; it does not require any implementing measures. Under BPD, there was a degree of variation across EU member states in how the Directive was implemented. This added to the complexity of administering the legislation, with different rules for different countries. Inevitably, timelines and targets were missed. BPD (and subsequently BPR) adopted a two-step approach when authorising (approving) the use of biocides approval of an Active Substance followed by the approval process for Biocidal Products containing these active substances. Key timelines are listed below: BPD comes into force May14th, 1998. Implementation of BPD in national law in all EU countries by May 14th, 2000. Deadline for all existing Active Substances on the market to be notified to EU regulators, March 28th, 2002. 9
Biocidal Products containing Active Substances that were not notified must be withdrawn from the EU market, December 14th, 2003. For Biocidal Products containing Active Substances that had been notified, a transitional period was allowed where products could continue to be sold awaiting a decision on the Active Substances, May 14th, 2010. A 10 year period, from the date of implementation into national legislation, was allowed for the BPD process to be completed for all notified Active Substances and Biocidal Products containing these substances. It quickly became apparent that this timetable was not going to be achievable. Consider some of the challenges: 23 different product types used in different applications by different types of enduser. By 2006 there were already 25 Member States in the EU (15 in 1995), each with their own national legislation to implement. Other new members were to follow. The cost associated with collating the data required to authorise an Active Substance is very high; with the time taken to accumulate long term human health and environmental data also being significant, lasting years in some cases. The type of testing required to establish product efficacy is complex and expensive to carry out. Some of the data required to demonstrate the safety of Active Substances involved vertebrate testing, raising ethical concerns in the wider community. This became 10
more controversial when repeat testing was required to validate historical test data that had been established using different test protocols. The biocidal claims made for products that were already on the market were inconsistent. One product might claim a 99.9% kill against a particular organism, whereas another product might claim a 99.99% kill against a different bug. The EU sought to standardise biocidal claims so that business consumers could make an informed choice when buying a biocidal product. Different countries had different disinfection standards. These were not always comparable. How to handle products containing multiple Active Substances, going through different authorisation programmes? What about Active Substances that are used in several different Product Type applications? These, and other problems, resulted in the 2010 target being met for only a few product types. In 2009, BPD was amended to extend the transitional period to May 2014! By this point, there were strong industry voices asking for the BPD project to be abandoned. With so many missed deadlines and only a small fraction of available biocidal products having completed the authorisation process, arguably the project had lost its way. From BPD to BPR The response from EU regulators was to repeal BPD replacing it with BPR (Regulation (EU) 528/2012) from Sept 1 st 2013. BPR was aimed at streamlining the authorisation process, making it faster and less expensive to register Active Substances and Biocidal Products. 11
Although BPR retained many of the features of BPD, as a regulation it was enforceable across all EU countries from a central authority, allowing limited scope for local variations. It was agreed quite quickly, however, that the deadline of May 2014 was unachievable. A new target for completing the authorisation of all Active Substances was set for the end of 2024. An amendment was also passed to make the 2024 deadline legally enforceable. Should this deadline be missed like the others before, it will be interesting to see how the EU goes about prosecuting its own regulatory body and Member States. BPR retained the two-step approach to authorising biocidal Active Substances and related Biocidal Products, amending the number of product types from 23 to 22, excluding Preservatives for Food and Feedstocks. Introducing several measures to simplify the process, BPR also widened the range of products that fall under the control of the Regulation. As the project was shape shifting, there were some positive steps allowed by BPR: Vertebrate Testing BPR forced organisations registering Active Substances to share data on vertebrate testing. This was a sensible move as it attempted to avoid the need for duplicate animal testing being carried out by several different organisations. However, the mechanism (and compensation) for sharing data between competitors was not made clear. Union Authorisation BPR introduced this concept for most product types, allowing companies that operate in many EU countries to sell their biocidal products in all Member States without having to register in each individual country. Mutual Recognition Provided a mechanism allowing companies with a product authorised in one EU country to extend this authorisation to other Member States in an efficient way. Biocidal Product Families This allowed a number of formulations containing the same Active Substances, used for similar purposes, to be registered together as a family of products. This helps to reduce registration expense by sharing costs over a range of different products. Same Biocidal Product This allows fast track authorisation for a new biocidal product identical to a product already authorised or complying with an existing Biocidal Product Family authorisation. This allows new biocidal products to be brought to market without the 2-3 year wait required for a standard authorisation. Reductions in Registration Fees were offered to SMEs and small businesses. Although undoubtedly helpful, for many small companies the cost of compiling the vast amount of product data needed for registration is much higher than the 12
registration fee itself. We examine the data mountain required in Part Four of this series. Most stakeholders in the BPR process welcomed the above changes, but the Regulations also introduced some new categories of product that had not been recognised previously in biocidal product legislation. 13
3. Starting to Bite The first two parts of this series examined the journey from BPD to BPR, the many challenges faced by regulators, industry and other stakeholders when attempting to comply with the legislation. In Part 3, we look at the way in which the new legislation has provided greater clarity in areas that were previously contentious. Clarity on the Hierarchy of Legislation When products fall between different regulations it is not always obvious which regulation should take precedence. In an earlier article, we spoke about how antibacterial hand soaps could be defined as products that makes specific biocidal claims and therefore should meet the criteria to be governed by BPR. But they are also cosmetics as they are used on the skin, so they would also fall under the scope of the Cosmetic Regulations (EU Cosmetics Regulation ((EC) No. 1223/2009). Although there are a set of rules and restrictions that apply to placing a cosmetic product on the market, it is considerably easier and cheaper to register liquid hand soaps as a cosmetic rather than face the costs associated with authorising it as a biocidal product. Faced with this type of dilemma, the EU regulator has deemed that the primary purpose of the product determines the legislation that applies. This, in turn, is determined by how the product is marketed and labelled. So a soap that is primarily used to prevent cross-contamination from the hands in a food or medical environment is required to be authorised as a biocidal product. We examine 14
the credibility of current biocidal hand soaps and washing up liquids and the future of cleaning and disinfection in Part 5 of this series. Clarity on Products Containing More Than One Biocidal Active Substance BPR operates a two-tier approach. Biocidal products are called for authorisation soon after the Active Substance in the product has been authorised. So if a disinfectant contains two or more Active Substances, the product does not need to be authorised until the final biocidal Active Substance has been approved. The Introduction of Article 95 For manufacturers and formulators of Biocidal Products (sanitisers and disinfectants), such as RP Adam Ltd, BPR was effectively a bureaucratic monster that was trundling along, with timelines that seemed to extend far into the future, with no end in sight, making future strategic planning almost impossible. As a company that sells millions of pounds worth of these types of products each year, we needed clarity, as did our competitors in the industry. For manufacturers and importers of Active Substances, the situation was very different as they had spent years heavily involved in the process, spending huge sums in compiling the data required for authorisation. Manufacturers were also concerned that while they were engaged in compliance, products from outside the EU continued to flood into the market with little control. So the European Chemicals Agency (ECHA) took steps to close this loophole by enforcing Article 95 of BPR on 1 September 2015. 15
A list was created detailing all Active Substances that were being supported through the BPR process. The list named the active biocide, the organisations supporting the authorisation and the specific applications (Product Types) where the active substance was intended to be used. After 1 September 2015, Article 95 stated that formulators of existing biocidal products, such as RP Adam Ltd, had to meet specific conditions to remain in the market. There are three main criteria to adhere to: 1. Biocidal products must only contain Active Substances or ingredients named in the Article 95 list. 2. Active Substances used as ingredients in Biocidal Products or formulations must only be supplied by companies engaged in the BPR process and these companies must be listed on the ECHA website. 3. If an Active Substance is being supported for a specific application, it does not mean that the same substance can be used in products intended for other areas of use. For example, an Active Substance that is being registered solely for use in PT3 Veterinary Hygiene products cannot be used in a disinfectant product where the application is PT4 Food & Feed Area disinfection. The full list of the Product Types (PTs) is provided below: MAIN GROUP 1: Disinfectants and General Biocidal Products Product Type 1: Human hygiene biocidal products Product Type 2: Private area and public health area disinfectants and other biocidal products 16
Product Type 3: Veterinary hygiene biocidal products Product Type 4: Food and feed area disinfectants Product Type 5: Drinking water disinfectants MAIN GROUP 2: Preservatives Product Type 6: In-can preservatives Product Type 7: Film preservatives Product Type 8: Wood preservatives Product Type 9: Fibre, leather, rubber preservatives Product Type 10: Masonry preservatives Product Type 11: Preservatives for liquid-cooling Product-type 12: Slimicides Product Type 13: Metalworking-fluid preservatives MAIN GROUP 3: Pest Control Product Type 14: Rodenticides Product Type 15: Avicides Product Type 16: Molluscicides Product Type 17: Piscicides Product Type 18: Insecticides, acaricides and products to control other arthropods Product Type 19: Repellents and attractants MAIN GROUP 4: Other Biocidal Products Product Type 20: Anti-fouling products Product Type 21: Embalming and taxidermist fluids Product Type 22: Control of other vertebrates BPR Now Restricts Vague Biocidal Claims Any product label or marketing material that suggests that the product kills or reduces the danger from harmful organisms is deemed to be a biocide by definition in BPR. Product effectiveness is considered to be the ability of a biocidal product to fulfill the label claims made on the product label. Meaningful efficacy has to be proven in a far more robust way than previously. We examine this issue in more detail in the final article in this series. Reputable manufacturers prove that their biocidal products do exactly what they say on the tin. This usually means undertaking recognisable and comparable test protocols, killing specific bugs over detailed contact times at precise dilutions, in clean or dirty conditions. Whilst these robust claims add credibility to the products offering, under BPR these will not suffice for registration in many cases, with new additional tests having to be carried out under more stringent conditions. 17
In essence, the days of making unsubstantiated claims will become a thing of the past including: Kills bugs fast Inhibits bacterial growth Helps prevent the spread of germs Powerful anti-bacterial action Germ fighting Prevents growth of a wide range of bacteria Kills and prevents bacteria Neutralises the ability of bacteria to function, grow and spread Actively works with the skin to help control bacteria Products featuring phrases on the label or in advertising will be defined as biocides and subject to full BPR registration requirements, or will be forced to withdraw from the market. Biocidal Products will have to be classified, packaged and labelled in accordance with CLP, but they will also have to show: The identity of every Active Substance The Authorisation Number The uses and instructions for use Dilution rate, time needed for effect First aid measures, adverse effects, precautions during treatment and in treated areas Product disposal including packaging Batch number and expiry date Article 95 was probably the first indication for product formulators that BPR had some teeth as it effectively outlawed the cheap import of biocidal ingredients and created restrictions in the supply of products that had been sold for generations. It is worth noting that Article 95 only applies to products that are placed on the market in the EU, meaning that products made in the UK, but intended to supply to customers outside the EU, can continue to be made and sold as before irrespective of BPR and Article 95. 18
4. Authorisation of a Biocidal Product We stated, at the start of this series, that the aim of the Biocidal Products Regulation was to create a regulatory framework that allowed biocidal products to be assessed for effectiveness while offering a high level of protection to product users and the environment. So why has a process started in 1998 taken so long to complete? Current estimates indicate that the process may continue until 2024 or even 2026. The delay is a result of process complexity and the numerous complications when trying to comply with BPR. Official EU guidance continues to be tweaked and amended adding to the significant cost and administrative burden faced by industry in attempting to meet legislation requirements. The Registration Process & Biocidal Product Dossiers The process involved in authorising a biocidal product or product family is complex. To ensure compliance with all regulatory requirements requires a high level of supplier expertise. Many SMEs have engaged a regulatory consultant to help them steer through the bureaucratic minefield; failure to tick all the boxes can be costly. A Product Dossier is required to support an application for biocidal product authorisation. Compiling this document can be a very time consuming, difficult and expensive process. The deadline for submitting the Product Dossier may be unknown. 19
In addition to efficacy tests showing that the product actually does what it says on the label, further tests are required to measure the physical and chemical characteristics of the product. This work can only be done by an accredited laboratory. Tests, including stability testing, can take two years or more to complete. The Biocidal Product Dossier: Outline Summary of Data Required Letter of Access (LoA) explicit permission must be sought from the manufacturers of Active Substances used in the product expressed in a LoA. This allows the regulator access to confidential data compiled for the Active Substance. Without the LoA, it is virtually impossible to register a biocidal product. This normally leads to a commercial agreement between the manufacturer of the Active Substance and the manufacturer of Biocidal Products in exchange for the LoA. Clearly, this then binds the manufacturers together in a long term commercial agreement and restricts choice but there is no other way of progressing. Full Formulation Disclosure (or formulation concentration bands for Product Families). Phys-Chem Studies relating to finished product formulations. The number and type of tests is extensive and include ph, acid/alkalinity measurements, foaming characteristics, dispersion, freeze/thaw tests, surface tension, viscosity, stability, auto-ignition tests and more. Some of these tests are relatively simple to carry out, but BPR stipulates that an accredited laboratory must be used i.e. one holding BS EN ISO 17025 certification. Most manufacturers of disinfectant products will not hold this accreditation so test costs could run into tens of thousands of pounds per formulation. 20
Storage Stability Testing this is particularly challenging. If a product is declared as having a 2 year shelf-life, then it has to be stored for 2 years in packaging that is used when the product is placed on the market. An accelerated test can be carried out over a period of 8 to 12 weeks providing a good indication of product stability. The dossier, however, must have data from the full term storage test before the product can be authorised. Biocidal Efficacy Testing data showing performance against harmful organisms at the dilution and contact times stated on the product label. The type of testing is determined by the Product Type and the type of biocidal claim made. Different tests are needed to prove bactericidal, virucidal, fungicidal activity. Unlike Phys- Chem tests, testing against harmful organisms does not need to be done by an accredited laboratory. We examine the tests required in the final post of this series. Product Risk Assessments detailed risk assessments required to show that the product is safe for people to use and to the environment. Risk assessment takes into account how the product is used and diluted and the type of person expected to be using it. Hazardous products supplied to the general public may require a more rigorous risk assessment than products intended for use by trained staff in industry. Significant Costs or Investment for the Future? 21
When the regulator reviews the Product Dossier, recognition is taken of the confidential information held for the Active Substances. If there are information gaps, the regulator may ask for additional studies to be carried out before approval is given. Carrying out additional studies can cost tens or even hundreds of thousands of pounds, so engaging well qualified expertise in carrying out risk assessments is essential, although expensive. The costs involved in compiling a Product Dossier depend upon the complexity of the formulation, but reliable estimates are in the region of 75,000 to 125,000. This could double if your Biocidal Product has more than one Active Substance. In addition, there are Registration Fees to allow product sales in different countries. The ROI decision whether these huge sums are worth investing needs to be made early in the process. Supply chains will be significantly affected by BPR. Timelines for Authorisation It is not possible to state with accuracy when the deadline for authorisation will fall for some biocidal products. What is known, however, is that if the deadline is missed the biocidal product will be given short notice to withdraw from the market. As BPR operates on a two-tier system, the process to authorise a biocidal product can only begin when the Active Substances contained within the product have themselves been approved. Some biocidal products, for example PT8 Wood Preservatives, have been through the process and this gives us a good indication of the timelines for products in other Product Types. At this point it is worth noting that an active substance may have been authorised for one type of application (Product Type) but is still awaiting approval in another. 22
Firing The Starting Gun: The Race is About to Begin It is likely that the starting gun will be fired for products containing propanol (alcohol), lactic acid and chlorine in powder or tablet form, in late 2017/early 2018. Later in 2018, we estimate quaternary ammonium compounds (QUATS), used widely in surface sanitisers will be called, along with ethanol and hydrogen peroxide. Once the start date has been announced, manufacturers of Biodical Products have two years to register each product. A tall order given that the storage stability tests themselves can take two years to complete. Without this data the Product Dossier will not be authorised. During this time, no new products (containing the Active Substance) can be supplied; only those that are already on the market. When the registration process is completed, all nonregistered brands must be withdrawn from the market. The Market Will Change So the pressure is very much on for manufacturers of Biocidal Products. The costs and time taken to gain Product Authorisation mean that it will simply not be commercially viable to maintain some existing product ranges in the future. With compliance costs running into six figures per product, many products will not survive the BPR process and inevitably both the manufacturer and end user will lose out. Customers can expect product costs to increase as regulatory costs are passed on and there will be a restricted choice of authorised products available. 23
Statistics show that less than half of the active substances that were available on the EU market at the beginning of the regulatory process will be supported through to authorisation. A significant number of products will not meet the safety criteria envisaged when BPD was introduced. There will be many others where the cost of authorisation will simply outweigh the sales value of the product. For those involved in the authorisation of Active Substances, costs can be 10-15 times higher than authorising a Biocidal Product. And worse, the authorisation is only valid for 10 years when presumably, the process starts all over again. It is difficult to be optimistic about the world of biocidal products post-bpr. It seems likely that the laudable aim of having biocides that are safer for the end user and the environment may in part be achieved by eliminating the worst offenders, but this has to be balanced by the cost of reducing choice and the potential impact of crushing product innovation. Imagine a start-up life sciences company who discover a highly effective and environmentally friendly new biocide. To be able to market their product in the EU will require upfront cost of around 5m to compile a BPR dossier for the new Active Substance. Additional costs are needed to gain Union Authorisation. It may take 4-5 years before there is any return on investment. Only manufacturers with deep pockets will become involved in biocide product development. 24
5. Implications for Business Customers Previous sections have discussed the onerous requirements of BPR compliance from the perspective of the Active Substance manufacturer. In this post, we examine the wide-ranging implications for companies who buy or supply disinfectants and sanitisers, including RP Adam s valuable customers and distributors. BPR is changing the landscape. Common practices and perceptions, understood for decades, may no longer apply. The rules of today are not going to be the same as the rules of yesterday. BPR will stifle disinfectant product R&D. Unless a product is on the market at the time of the Active Substance Product Dossier Submission, it must be withdrawn from sale with no new biocidal products using that Active Substance being allowed on the market for at least two years. Changes to Surface Disinfection Procedures for Food Business Operators Take a commonly used professional grade kitchen surface sanitiser as an example. From the users perspective, the product seems to work well at removing grease and grime from kitchen surfaces and front of house table tops. Because no-one can see germs, the customer takes it for granted that the product supplier has conducted independent tests to prove it kills food poisoning bacteria to a safe level. This is not always the case. Under BPR, suppliers will no longer be able to make vague efficacy claims about their products unless they comply with the full registration process. A registration number on 25
the product label will confirm that the product is biocidal and has met all test and validation requirements under BPR. Currently, the most common test is BS EN 1276 which tests a product against four prescribed bacteria at a stated dilution rate over a specified period of time in clean or dirty conditions. If the solution kills the bacteria with a five log reduction it passes the test and qualifies as a BS EN 1276 approved product. This efficacy is usually backed up with a test certificate issued by an independent laboratory. Companies like RP Adam Ltd will state this information on the product label. As a result of BPR, however, this will no longer be required. A registration number on the label will be sufficient to validate that the product is biocidal, that all BPR tests and validation requirements have been met. Under BPR there are a number of efficacy tests that need to be undertaken for surface sanitisers and disinfectants. These depend on the claim made about the product. For example, in the food, industrial and institutional areas, a surface sanitiser has to pass specified tests to claim that it is bactericidal, but additional testing is required to say your product is bactericidal and fungicidal. These include: Bactericidal EN 1276 and EN 13697 Yeasticidal EN 1650 and EN 13697 Fungicidal EN 1650 and EN 13697 Virucidal EN 14476 Although some of the (EN) test methods listed above have the same description, the test organisms used in the tests are different depending on the biocidal claim being made. 26
For Food Areas (PT4): BS EN 1276 is a bactericidal suspension test to kill 99.999% of the following bugs: Pseudomonas aeruginosa Escherichia coli Staphylococcus aureas Enterococcus hirae BS EN 13697 is a surface test to kill 99.99% of the following bugs: Pseudomonas aeruginosa Escherichia coli Staphylococcus aureas Enterococcus hirae Although the BS EN 13697 test only requires a 4-log reduction kill rate and four bugs in the test, compared to a 5-log reduction and six bugs in the 1276 test, it is a harder test to pass. To achieve BPR conformity, the level of active biocides like QUATS within the product will need to increase. Compared to the pre-2015 position when the test protocol used for BS EN 13697 was altered, the pseudomonas organisms used are generated in a different way so that it now more difficult to kill and contains an interfering substance that inhibits biocidal action. Results from the previous version of EN 13697 (2002), which was easier to pass, will not be accepted when products are evaluated under BPR. 27
There is a cleaning performance trade-off between ability and increasing disinfection efficacy i.e. the more active biocide in the product to kill germs, the cleaning performance starts to fall off. So consumers who have bought a brand for years because of its dual action cleaning and disinfection properties are likely to see an increase in cost of the product and a decrease in the cleaning performance. This is what manufacturers are grappling with at the moment. Companies who have been peddling mediocre quality at cheap prices will see their costs go up and product performance dip dramatically. Customers will begin to look for better alternatives with manufacturers de-listing long-standing products because sales have plummeted or registration costs have made the product uneconomic. We predict that food businesses will need to operate a two-stage cleaning and disinfect process (which is recommended by the Food Standards Agency anyway). BPR will inevitably force the FBO to buy two products instead of one; a good quality detergent to clean and a surface disinfectant registered under BPR with full validation data. The all singing, all dancing one product does all era is coming to an end as manufacturers try and juggle with the legislative requirements of BPR and the expectations of the customer. Biocidal hand soaps and washing up liquids are two product categories of products that have been hanging on to historical biocidal claims for far too long. Even today (pre-bpr), it is stretching the truth to call them effective biocidal products. Post-BPR, there will be very different types of hand soaps available and these will cost much more. Bactericidal Washing Up Liquids There is no credible bactericidal washing-up liquid currently available on the market. A typical washing-up liquid is a high foaming, relatively safe, neutral ph detergent that can be used at a high dilution so: 1. Maintaining these characteristics whilst achieving a meaningful BS EN disinfectant standard would require such a high concentration of active biocide that the product would be classified as hazardous to the user. It might also trigger an environmental hazard classification. 2. Alternatively, reducing the active biocide content to avoid a hazard classification would mean that the volume of washing-up liquid required would render the product uneconomic. Neither approach would be acceptable to the typical end-user because of safety concerns or associated costs of a product generally accepted as a relatively low cost, high volume commodity item. 28
If a washing up liquid is used only in the initial cleaning stage of a 2-stage process, there is no requirement for the washing up liquid to have any bactericidal action or comply with any BPR disinfection standards. Bactericidal Hand Soaps The BPR tests required for biocidal hand soaps depend upon the area of use. Medical and veterinary areas have different standards to meet compared to food areas. In the latter, the soaps must pass BS EN 1276 and BS EN 1499, as well as possible requirements to show yeasticidal activity. The FSA go to great pains to emphasise that proper hand washing methods are adhered to that biocidal formulations are never seen as a substitute for good hand washing techniques using liquid soap. In essence physical removal of bacteria from hands is the preferred method, well illustrated in the following video issued FSA Scotland. The FSA mentions the BS EN 1499 standard as offering extra protection against harmful bacteria but there is no legal obligation that such soap must be used. Depending on the FBO, the driver in terms of hand hygiene products will probably be their individual HACCP system and whether the FBO thinks that extra protection is needed in terms of using a hand disinfectant or alcohol rinse as part of a two stage process. We anticipate that, in the future, FSA recommendations will align with BPR. And Finally: What About BPR Enforcement? There is no doubt that some companies will try to flout BPR, continuing to sell products that are not registered. 29
The Health & Safety Executive has advised that enforcement almost always originates from a complaint made by an aggrieved party (a competitor) stating unfair competition i.e. that they have paid huge fees for registration and/or were forced to change the formulation, while the offending company continues to sell products with no intention of complying with BPR. Normally the HSE would then ask Trading Standards to visit the offending company and find out whether the claims are legitimate. The decision to prosecute would depend on whether the HSE think the law has been broken; also, if they have a chance of winning costs by going to court. Where there is clear case, but no obvious fraud or malicious intent, Trading Standards would probably request an immediate product withdrawal and cessation of manufacture. So unless the HSE want to actively pursue companies, it probably relies on companies like RP Adam to report rogue competitors. It seems self-policing to us. Reputable manufacturers, distributors and customers need to be vigilant. Trade bodies, such as the Cleaning & Hygiene Suppliers Association, should also rigorously apply the new standards covering approved biocidal chemicals. 30