Politics in the United Kingdom (UK) suffered a little bit of turmoil during 2022. We had three Prime Ministers, four Chancellors of the Exchequer and three Secretaries of State at the Dept. for the Environment, Food & Rural Affairs (DEFRA) and the Dept. for Business, Energy & Industrial Strategy (BEIS). Not satisfied with months of Ministerial “musical chairs,” the current Prime Minster decided in February to break up BEIS in to three separate departments: one for Business & Trade (DBT), one for Energy Security & Net Zero (DESNZ) and a third for Science, Innovation & Technology (DSIT).
For aerosol regulation, or at least the primary piece of regulation aerosol dispensers must conform to, we now have a whole new department to deal with and another new Secretary of State.
While all of this has been going on, the business of Government has not stopped. Following our departure from the European Union (EU), all Government departments are being asked to look at the regulations that were copied over into UK law when we left [in 2020], and to see if they are fit for purpose—all 2,400 of them. This is called the Retained EU Law (Revocation & Reform) Bill 2022 (REUL).
The Aerosol Dispenser Regulations are law in the UK. Interestingly, they contain references to other pieces of EU legislation such as Classification, Labeling & Packaging (CLP), which is reviewed under REUL. All such references will need to be updated, assuming a Great Britain (GB) equivalent can be agreed upon. The ministerial department responsible for aerosol regulation, the Office for Product Safety & Standards (OPSS), is also carrying out a much wider Product Safety Review, and the Aerosol Dispenser Regulations will be part of this. SPRAY
Just over 35 years ago, I left my first job as an analytical chemist and started work in the customer service lab of a company called Aerosol Research & Development (ARD), an aerosol
valve manufacturer based just outside my home city of Portsmouth, on the south coast of England.
I had no idea at that time quite what I was getting involved with. I worked in a lab; this was just another job in a lab. I thought, I can do that.
ARD sort of still exists, having been bought out by Lindal in the late 1990s. One of the mainstays of its valve range was a powder valve called the CA39F. To the best of my knowledge, this valve is still in production today, a credit to the quality of its design from the 1980s. I am not sure that many products from the ‘80s have had the same longevity.
Certainly, the chlorofluorocarbon (CFC) propellants I used occasionally back then are long gone. At about the time Lindal was buying ARD, I left to take on the role of Technical Manager at Coster Aerosol, based in Babbage Road in Stevenage, a post-war “new town” built primarily in the 1960s and ’70s. There seems to be some sort of attraction for valve manufacturers in the UK to new towns. Coster was in Stevenage, Precision Valve is in Peterborough and Lindal is based in Leighton Buzzard, just outside the Daddy of all UK new towns, Milton Keynes.
Also based just outside Milton Keynes was my third (and final) valve company, Seaquist Perfect Dispensing, which was based in the home of the WWII code-breakers—Bletchley. At that time, Seaquist Perfect Dispensing was a brand within Aptar Group. Since then, Aptar has reorganized its business and the aerosol company I used to work for now sits in its Beauty + Home division.
After eight happy years at Seaquist Perfect, I joined Reckitt Benckiser as Aerosol Innovation Manager, based at its R&D facility in Hull, UK. I got to work on some of the biggest aerosol brands in the world including Air Wick, Lysol, Dettol, Veet, Mr. Sheen, Mortein and Olde English. I also got to see how aerosols, and the various components that make them, are produced in different regions, and got fantastic insights into how and why consumers buy products in aerosol dispensers.
This experience helped me enormously when I applied for the role I now enjoy, Chief Executive of the British Aerosol Manufacturers’ Association (BAMA), which, by a bizarre coincidence, is based in Babbage Road in Stevenage—a gentle stroll from the old Coster factory, which still has the customer service lab I helped set up in the car park.
What is the point of this wander down memory lane? Well, I have enjoyed 35 years in the aerosol industry, along with a happy marriage for almost the same length of time. It has provided me with a number of wonderful, diverse jobs and now—freed from the unending pressures of getting a delivery in to a customer on time, conducting lab tests or preparing samples for storage trials or consumer testing—I can take a step back and look at how others might enjoy a similarly happy and lengthy career.
There are plenty of potential issues facing us in the coming years. You only have to look at the impact of the war in Ukraine to realize that in our modern, interconnected world, what 50 years ago might have been seen as a “local” conflict now has global ramifications. Climate change, the push to net zero and the circular economy, whether you agree with the analysis or not, will all have an impact on our industry as policy makers look to control and reduce many of the materials we currently take for granted, certainly in Europe.
We can probably continue to do what we do, and the aerosol industry will carry on in its current guise for another 20 years. However, regulations will become more stringent. Raw materials will become scarcer and more expensive. The range of ingredients we can use will become smaller and smaller. New dispensing systems will, almost certainly, come on the market to challenge the products we make and probably, most significantly, consumer attitudes will change.
I have two children who are considered to be “Millennials” and I can promise you their attitudes and priorities are as different to mine as mine are to my parents. Should I be blessed with grandchildren, I suspect they will be similarly different to their parents.
The aerosol industry, in the time I have been involved with it, has constantly evolved and innovated. I believe now is the time for us to look at how more fundamental change might be embraced to allow us to continue to supply consumers with the safe, high-quality products we always have; however, how they are produced, distributed and used might radically differ from what we currently do.
We have the opportunity, with all the skills and knowledge contained within our industry, to act now and take the lead on what and how we might make aerosol dispensers for the second half of the 21st Century. SPRAY
In 2019, in conjunction with the French Aerosol Association (CFA), The British Aerosol Manufacturers’ Association (BAMA) embarked on a series of workshops to discuss the potential for refillable aerosols. This is, and continues to be, a difficult discussion for industry as we are obliged by regulation, for clear safety reasons, to make packaging that must be disposed of at end of life. Whether aerosols are “single use” is an ongoing conversation, as most are used multiple times during their lifetime; however, when empty, they do go into the waste stream.
There was some misunderstanding at the beginning, with the notion that we wanted to discuss how existing aerosol packaging could be refilled. This was never the ambition. We actually wanted to find out if it is possible to design a product that gives the same performance and efficacy as an existing aerosol dispenser, but that can be reused after being emptied, and how the consumer might get it refilled.
It became clear in our discussions that to move away from the linear make-use-dispose and-(hopefully)-recycle model is perfectly feasible. Similar technology is already on the market and the regulatory framework, albeit a little more complex than most aerosol regulations, exists for a variety of different products. In Europe, for example, there is the Transportable Pressure Equipment Directive that could easily be applied to consumer products but would add extra layers of inspection and testing on the part of manufacturers. We also have a category of products called “Chemicals under Pressure” in the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) that, at one time, were colloquially referred to as “giant aerosols,” many of which are collected, cleaned and reused.
However, the question of how consumers might take to these products hung in the air, so BAMA asked Paul Jenkins of The Pack Hub to carry out a survey on our behalf. Jenkins has been working in the refillable product area for many years and has access to various consumer panels to help understand their attitudes. He can also see through the fog of what consumers say they will do and what they will actually do.
The survey started very generally, looking at how many consumers already used refillable packaging, how they refilled it and what they thought were the positives and negatives. Many already used refillable drinks containers and most were aware of the option to have refillable food packaging that they then returned to the supermarket.
When the survey got into more detail on aerosols, many clearly understood the additional difficulties with refilling a pressurized package. They knew that there would be safety issues associated with the packaging and the refill system. However, most indicated that they would prefer a product that could be refilled at home rather than having to take it back to the store where it was purchased. If this was a route our industry looked to pursue, it would probably mean a move away from liquefied gases, particularly flammable ones. This isn’t impossible to imagine though; the Soda Stream system has been available on the market for many years and allows consumers to fill CO2 into a reusable container in relative safety.
What was clear was the need for any system to be simple, cost-effective and consumer-friendly.
The overriding message that came out of the survey, however, was that consumers didn’t know if they wanted refillable aerosols as they aren’t available on the market!
Where does this leave us? The make-use-dispose-recycle model has worked for our industry for many years, but pressure from Government to make more refillable and reusable products will grow as the push for a more circular economy develops. Perhaps there are some professional markets where refillable aerosol could be tried? The problem, as always, is that the cost of entry into a new market is high, with no guarantee of success.
At some point we will, as an industry, have to “take the plunge” and put something onto the market to see how it fairs. I look forward to seeing such a trial take place and BAMA will be happy to help in any small way it can when this happens. SPRAY
The British Aerosol Manufacturers’ Association (BAMA) hosted its first Aerosol Discussion Evening of 2022 in February and invited Tom Giddings, GM of the Aluminum Packaging Recycling Organization (Alupro), to be one of the three speakers at the event.
Alupro operates under the umbrella of Metal Matters and both organizations have been actively supported by BAMA for several years. Their successful campaigns have made it possible for empty aerosol containers to be accepted by 96% of the UK local authorities in their general curbside recycling collections.
Part of Gidding’s presentation covered Scotland’s Deposit Return Scheme (DRS) for beverage containers. Scotland will be the first of the UK nations to implement such an initiative, and Economy Minister Lorna Slater has announced that the Scottish DRS will now go live on Aug. 16, 2023. An independent review had found that, because of the COVID-19 pandemic, the previous go-live date of July 2022 was no longer practical.
However, DRS infrastructure, such as reverse vending machines, will start rolling out from Summer 2022 and, where possible, the Scottish Government will work with retailers to enable use of this infrastructure on a voluntary basis from November 2022.
The Minister confirmed that the design of the scheme remains unchanged and that the target of achieving 90% collection rates by 2024 will be maintained.
This can have significant consequences for aerosol cans. As things stand, the percentage of aerosol cans in an average cubit meter of metal packaging collected for recycling is below 5% in the UK. Should beverage cans disappear from general curbside collection, only food tins and aerosol cans would be left, resulting in a possible hazardous waste percentage that exceeds the safety threshold.
BAMA has been exploring a variety of options to overcome this issue, including refillable containers, inclusion of aerosols in the DRS and non-flammable propellants. We don’t expect to find a one-size-fits-all solution, but would rather produce a range of options for manufacturers to choose from. The alternative is a significant increase in waste collection and disposal costs that would have to be passed on to price-conscious consumers.
On the positive side, the Waste & Resources Action Program (WRAP) reported that, in early February, some major UK retailers—including Marks & Spencer, Morrisons, Ocado Group and Waitrose & Partners—came together as the “Refill Coalition.”
This coalition plans to look at co-designing a new, innovative refill solution with the potential to test it in-store later this year. If successful, BAMA hopes that a similar group will look at how aerosol products could be refilled in-store, as well.
The refillable option will help reduce the increased waste disposal costs that the Extended Producer Responsibility (EPR) expects manufacturers to cover. It could also give consumers another reason to visit physical brick-and-mortar stores to drop off the empties, collect the refills and so reduce the impact of transport emissions per unit of products. It might not be the best or only solution for several products, but it seems worth exploring further. SPRAY
The UK has completed its first year outside the European Union (EU) and its Government appears intent in pursuing its sovereignty as far as regulation is concerned. Although the official “transition period” has ended, things are far from settled for manufacturers and marketers, with new policies being drafted and existing ones amended.
GB CLP
With its exit from the EU finalized, the UK proceeded to create a Great Britain (GB) version of CLP (Classification, Labeling & Packaging of Chemicals). GB CLP is based on the UN Globally Harmonized System, as it was implemented by EU CLP on Jan. 1, 2021, but the UK has indicated that, in the future, it will reflect more changes to the GHS than to the EU CLP. The Mandatory Classification List (MCL) is now up and running, and companies placing aerosols on the GB market that are covered by CLP must use its classifications.
The UK Health & Safety Executive (HSE) will update the MCL as data on hazard classifications becomes available, but said that while parallel discussions in the EU will be taken into account, it will not guarantee the adoption of the same classifications as the EU if the evidence doesn’t support them.
For GB, the need to submit information to the European Chemical Agency (ECHA) Poison Center remains voluntary, but the British Aerosol Manufacturers’ Association (BAMA) continues to recommend that companies do so. Submitting information is mandatory in Northern Ireland and must be done by submitting information directly to the UK National Poisons Information Service (NPIS), as it has no access to information stored on the ECHA Poison Center Notification (PCN) Portal.
Last year, the European Commission brokered an agreement of the National CLP Competent Authorities (CARACAL) to exclude propellant when using a calculation method to classify aerosols for health and environmental effect. BAMA asked the HSE if this interpretation will also apply to GB CLP. The response received contains a degree of ambiguity and states, “EU guidance on the classification of propellants has no automatic applicability on UK/GB suppliers.” However, it was then added that if challenged by an enforcing authority, duty holders must ensure they can justify the decisions they made. It is understood that HSE plans to produce its regulatory guidance for GB CLP, but this is likely to take some time.
UK REACH
UK Registration, Evaluation, Authorization & Restriction of Chemicals (REACH) was created to regulate chemicals following the UK’s exit from the EU. The key principles, aims and processes of EU REACH (i.e., registration, evaluation, authorization and restriction) have been retained in UK REACH, but the two systems now operate independently from each other. UK REACH applies to chemicals manufactured, imported into and used in Great Britain, but as long as the Northern Ireland Protocol lasts, chemicals in Northern Ireland will continue to be regulated by EU REACH. UK REACH is administered by the HSE and applies to substances manufactured or imported into GB in quantities greater than one tonne per year and works in the same way as the EU version, but has four duty holders:
1. Manufacturers: Companies that produce substances in GB
2. Importers: Companies that import chemicals into GB from anywhere in the world
3. Importers under UK REACH: Those who were considered Downstream Users before EU Exit
4. Downstream Users: Companies that use chemicals in GB but are not the registered manufacturer or importer of the chemicals
Downstream Users have the obligation to use only UK REACH-registered substances in GB. Manufacturers and importers into GB must register substances they supply in quantities greater than one tonne per year. GB-based manufacturers or importers who held EU REACH registrations had a grace period to copy across their registrations from EU REACH to UK REACH. This is known as “grandfathering” and a database of over 4,000 substances has recently been published by the Dept. for Environment, Food & Rural Affairs. The advantage of following that route is that companies holding the registration have up to six years (depending on the tonnage) to provide HSE with full registration information.
Importers of finished aerosols manufactured in the EU, or companies importing EU REACH registered chemicals to fill into aerosols in GB, now fall within Group Three— Importers under UK REACH who, before EU Exit, were Downstream Users. These companies had until Oct. 27, 2021 to complete a Downstream User Import Notification, which then allowed them the same time extensions as for the previous two categories.
Chemicals that are neither in the grandfather list nor subject to the above Notification must be fully registered. On the positive side, the UK has developed an IT system to further help companies using chemicals to comply with REACH chemical regulations and to support the submission of dossiers and information to the HSE. SPRAY
The Engineering Employer’s Federation, to which The British Aerosol Manufacturers’ Association (BAMA) is an affiliate partner, has published a report on the first six months of trading for UK manufacturers since the country exited the European Union (EU) at the end of 2020. Following is an extract of some of its key content.
At the beginning of 2021, manufacturers saw the greatest single change in how they trade and do business in the EU and internationally in over 40 years. Businesses were little prepared for the change and the majority experienced significant disruption.
The report does not look at the overall trade volumes, because the overlapping impact of the COVID-19 pandemic would skew the results. It looks mainly at the impact of the changes post-Brexit—the critical disrupting factors, what has improved and what obstacles remain for manufacturers.
The report shows that 96% of manufacturers experienced challenges within the new trading environment. Initially, the struggle was compliance with new customs paperwork and procedures, but this has eased as companies’ familiarity with and understanding of the new processes improved with time.
UK Government statistics for international trade indicate that:
• Total exports of goods increased by £1.3 billion ($1.79 billion) (4.9%) in May 2021, driven by a £1 billion ($1.38 billion) (8%) increase in exports to EU countries.
• Total imports of goods fell by 1.4% in May 2021 because of a 3.4% fall in imports from non-EU countries.
• Monthly goods imports from non-EU countries continue to be higher than those from the EU for the fifth consecutive month, but the gap is narrowing.
While there are reasons for optimism, as some of the processes are becoming routine, some issues still remain. We saw European trade carrying on, after some initial hiccups, but at a higher cost and with longer delivery times. Complying with Rules of Origin requirements to benefit from a tariff-free exchange of goods has proved to be particularly difficult.
Rules of Origin was a condition of the Trade & Cooperation Agreement that emerged only in the final stages, with firms having a limited time to understand the implications for their business operations. This challenge has been significant and will continue to be so, as the increased administration to provide proof of origin becomes a new compliance issue.
Over one-third of UK firms (primarily small- and medium-sized enterprises [SMEs]) are still reporting ongoing challenges with customs. Overall, it has been a mixed experience for the manufacturing sector in the first half of 2021.
The beginning of 2021 also saw new arrangements for UK visitors traveling to the EU on work-related matters. The UK is now a “third country” from an EU point of view and UK employers have to navigate individual EU member state rules for their mobile workforce. Whether a business traveler will need to apply for a visa or not depends on the nature of the business visit and what the traveler will be undertaking in each country. If travelers are considered to be working by undertaking commercial or customer-facing activity, they may need both a visa and a work permit. However, attendance to conferences and symposiums, either as an audience member or as speaker, should be exempt.
The impact of these changes on business travel has yet to be tested, and the true impact will only be appreciated once the COVID-19 restrictions to international movement are fully lifted. With the UK taking back full regulatory autonomy, manufacturers face many new rules that apply to the UK market. In recent years, much of the UK regulatory environment for manufacturers in areas including employment regulation, environmental and climate controls and product legislation had been developed at EU levels with the UK contributing to its design. With the UK’s exit from the EU, these powers have now returned to the British Government and in some cases to the UK devolved administrations (Scotland, Northern Ireland and Wales). The Government will need to decide how it will exercise this sovereignty to the benefit of businesses and consumers in the UK.
There are calls on the Government to help ease ongoing difficulties and work with the EU to seek mutually beneficial improvements to the trading relationship. The new trading environment has ramped up costs, caused import and export delays and is hampering smooth trade as companies struggle to recover from the COVID-19 pandemic.
Key findings of the report include:
• Ninety-six percent of UK companies have struggled to adapt to the new trading environment since the start of the year
• Forty-seven percent had difficulty with customs processes initially; this has improved as companies come to a better understanding of the new rules
• Still, 36% are still struggling with the new customs procedures and paperwork
• Twenty-nine percent say that providing evidence of the origin of their products proves challenging
• There is high uncertainty surrounds business travel, as international travel is only now reopening for business; companies haven’t had the chance to test their understanding of business travel rules for the various EU countries
• Eighty-six percent of manufacturers want Government to work with the EU to ease the difficulties around export processes and customs formalities
• Regulation critical to manufacturers is now solely in the control of UK legislators. The UK Government will decide how this sovereignty is used to benefit manufacturers in the UK. However, many manufacturers favor cooperation or alignment with the EU.
BAMA restarts face-to-face events
On Aug. 19, BAMA resumed its first in-person event after 18 months of COVID-19 restrictions on travelling and gatherings, holding its regional Discussion Evening & Dinner at The Tower Hotel in London.
Based on a combination of business networking and learning, the Discussion Evenings provide a welcome opportunity for the supply chain to meet in a convivial environment, said BAMA. The small scale (25–35 attendees) helps create meaningful interactions and stronger interpersonal relationships, while three after-dinner presentations stimulate discussion and foster new collaborations.
BAMA felt it was impossible to replicate the successful events online once venues shut down and people went into lock-down. The pandemic situation gradually improved with the rollout of the UK vaccination program, but most companies still apply a safety protocol that forbids non-essential travel, even at the domestic level.
Therefore, when BAMA announced that registration to its August 2021 Discussion Evening was open, it did so with a shade of apprehension, fearing not many would show. As it turned out, the request to present an NHS COVID Pass (which lets the holder share COVID-19 vaccination records or test status in a secure way) didn’t stop people from attending.
Joe Tyrrell of LINDAL Group gave a practical demonstration of the 3D Aerosol Configurator, which quickly and easily transforms traditional aerosol packaging decorative processes into sophisticated 3D designs. The tool allows customers to select any of LINDAL’s standard actuators and overcaps with the most commonly used aerosol cans to build more than 5,000 unique aerosol packages. Each 3D model is fully color customizable, allowing branded artwork to be added to the can, to save customers both time and money. Confidential designs are stored on LINDAL’s secure platform.
Steve Clarke, CEO of Cryptocycle, presented an App that uses blockchain technology to track consumer products as they get recycled and provide a reward to the consumer for each item. Users can download the App on their mobile phone and scan the code on their recycling bin before proceeding to scan the items to be disposed. Beyond the incentive for post-consumer recycling, the software can provide detailed geographical data on recycling rates as well as the category of products and frequency of consumption. Users are required to sign in, so data is shared voluntarily and anonymously. Each product code is unique, as with many products in the pharmaceutical industry, so AI prevents consumers going to a store and scanning a whole shelf of codes. The App uses a number of security measures such as geo-location, time lock and till activation.
Bhavina Bharkhada, Head of Policy & Campaigns at MAKE UK, discussed Diversity, Equality & Inclusion in UK Manufacturing. Bharkhada’s presentation noted that diversity of different ethnic origins, physical and mental abilities, gender, sexual orientation, religion, etc. is a key element in creating a welcoming, open environment where people feel they belong. This results in improved effectiveness, less sick leave and overall improved business performance. SPRAY
They say every cloud has a silver lining: the 2020 thunderstorm bestowed a little of this on the aerosol industry, as The British Aerosol Manufacturers’ Association’s (BAMA) annual filling survey demonstrated the strength and versatility of this sector, despite the challenges of the COVID-19 pandemic.
National lockdowns and closure of non-essential activities impacted everyone. The aerosol sector was quick to adjust to the changing circumstances and respond to new market needs, with overall production still in excess of 1.5 billion units, down just 1.3% from 2019.
There have been variations by product category. Hard surface cleaners grew 255%, from 14 million in 2019 to exceeding 50 million units in 2020, while Household product filling saw a general increase, with the exception of shoe polish. Veterinary products also saw a surge in production by 170%. Both of these shifts seem to come as direct consequence of the pandemic, with homes and public places looking to improve hygiene standards, and restrictions on social interaction leading to a peak in pet adoptions and pet care.
The unusually warm Spring of 2020 pushed up demand for insecticides; working from home meant that the presence of insects was more noticeable and possibly more annoying. This product’s fillings grew by 40%.
Unsurprisingly, with few opportunities to go out-of-doors, hair spray sales were down by nearly 5% and other personal care/cosmetic products, such as suntan and bronzing sprays, declined by two-thirds. There was an even bigger reduction for novelty products, including party strings and glitter sprays, which reduced to one quarter of the previous year’s output.
The stalwart of UK aerosol production for many years has been antiperspirants; these saw a decrease of nearly 16% in 2020. Body sprays partially compensated by gaining 7.6% and reaching a total output of 353 million units. Sales of shaving preparations continue to show a gentle decline, with a loss of 6.5% from the 157 million of 2019.
Sales in other aerosol categories kept fairly stable. BAMA figures show some ups and down across the years in different sectors; this is often affected by the data received and where the product filling has been distributed by those contributing.
Export volume from UK aerosol manufacturers continues to be very strong, both to the EU and around the world. BAMA looks forward to seeing this continuous growth in the coming years, following new trade deals by the UK government.
“I was relieved to see that the overall UK aerosol production held up remarkably well, despite most of us spending 2020 in lockdown,” observed Patrick Heskins, BAMA Chief Executive. He continued: “The figures BAMA put together showed only a minimal drop compared to 2019, with some sectors, such as disinfectant sprays and hard surface cleaners, seeing significant growth.
None of us should underestimate the importance that these products played during the pandemic and the response of our industry, across the supply chain, deserves praise for a job well done.
For the first time since we started our Annual Filling Survey, member companies were asked to provide some detail on their UK sales versus export. The figures kindly provided show the importance of the UK aerosol industry as an exporter—29% of the aerosols filled are sold to the internal market, 55% exported to EU countries and 16% to the rest of the world.
This means UK aerosol manufacturers meet about 65% of UK demand and produce 17% of all aerosols sold in the EU. We are still the largest manufacturer in Europe and the importance of the EU as a market must be reflected in our ongoing strategy. However, as the UK Government signs new trade deals around the world, we should look at making the best of the opportunities offered by new opening markets.” SPRAY
In many parts of the world, concerns are being raised about the inhalation of volatile chemicals and fine particles. Spray products, and aerosols in particular, are susceptible to these concerns because they both use volatile chemicals and put fine particles into the air. However, in many countries, the regulatory frameworks that exist to place aerosols on the market have already addressed these concerns. For example, in Europe, aerosol dispenser regulations require the marketer of an aerosol to conduct hazard assessments that include consideration of the risk from inhalation of a spray.
In 2013, the British Aerosol Manufacturers’ Association (BAMA), working with sister associations in the EU for aerosols, cosmetics and detergents, and with the help of the Research Institute for Fragrance Materials (RIFM), produced a guide on safety assessment. It was published the following year in the journal Toxicology Letters as an article titled “Principle Considerations for the Risk Assessment of Sprayed Consumer Products” (Toxicology Letters 227 (2014) 41-49).
On Feb. 24, 2021, at the invitation of the Household & Consumer Products Association (HCPA), I presented to HCPA and National Aerosol Association (NAA) members, via webinar, the five-step methodology that BAMA has developed from these principles to enable aerosol marketers to assess product inhalation risk during consumer use. The BAMA Methodology is represented in Figure 1.
The BAMA Methodology uses guidance that has been published to support EU regulations on the use of chemicals and cosmetic products, but is tailored to be accessible to small- and medium-sized aerosol companies. Key to the Methodology is to only complete those stages needed to show that the aerosol is safe to use.
To explain how to do this, BAMA has developed a detailed guidance, summarized as follows:
Step 1: Collect Toxicology Data
The ingredients used in the aerosol formulation will have safety data sheets (SDS) if they have any hazardous properties. If the ingredients used are not hazardous, then the aerosol spray is unlikely to be hazardous, and the risk assessment is complete.
Step 2: Assess the Hazards Present
This consists of three tasks: identifying the hazards, identifying the concentration that does not present a hazard to the user and checking if the ingredients are used at lower concentrations. Step 2 may rule out the use of some ingredients.
Step 3: Assess the Exposure When Using the Aerosol
This requires a tiered approach that involves answering the questions How is the aerosol dispensed? and What would be the exposure to the person using the product? For Step 3, there is the opportunity to model or measure the exposure from using the aerosols. Modeling is easier but, depending on the sophistication of the models, will need varying amounts of input information and the output exposures will usually be an overestimate of the real exposure. Models range from the relatively simple and easy-to-use BAMA Indoor Air Model to some quite sophisticated models based on computational fluid dynamics that give more accurate exposure estimates but require expertise to use. Measurement can be the most accurate way to estimate exposure, but it is expensive and needs expertise to ensure that the data measured is relevant to the use of the aerosol.
Step 4: Characterize the Risk of Using the Aerosol
Once the exposure during aerosol use has been estimated, modeled or measured, the next step is to assess the risk to human health of that particular level of exposure compared to the regulatory limits. In Europe, for aerosols used in industrial or household settings, this is done by calculating the risk characterization ratio (RCR), while for cosmetic products, it is done by calculating the margin of safety (MoS). Both are similar approaches but come up with slightly different numbers.
Step 5: Check the Correct Risk Management Measures are in Place
Step 5 should be very familiar because it is the process that most companies undertake prior to placing a product on the market. Be sure to check that the aerosol has the correct labeling and safety features.
As mentioned above, the key to BAMA’s Methodology for Inhalation Risk Assessment is to only do the steps necessary to show that the aerosol is safe to use. Sometimes this may mean that certain ingredients cannot be used; in other cases it may mean that changes to the valve or propellant are needed in order to increase the particle size. However, aerosol products, when formulated correctly and with the exposure risk properly assessed, do not present any greater hazard to users than any other product. This is probably why over 15 billion aerosols are sold around the world each year.
For more information on BAMA’s Methodology for Inhalation Risk Assessment, please contact the BAMA office at enquiries@bama.co.uk. SPRAY
