Karen Cooksey, Principal Consultant, summarises the key rules and regulations covering the supply of hand sanitiser products.
There has been an unprecedented demand for biocidal hand sanitiser products during the COVID-19 pandemic. In the first months of the outbreak, shelves all over the world were empty, there were slim pickings online, and the few suppliers that had stock available were pricing at way over the odds. While the world’s population is being told to wash our hands and use hand sanitiser to avoid the spread of the virus, this demand for stock is likely to rise.
One of the reasons for the low supply of hand sanitiser is the availability of the active ingredient (ethanol, propan-1-ol or propan-2-ol), the part which kills the bacteria/virus. Many companies are struggling to get hold of the supplies, and the cost is rising every day. Efforts to increase the supply of the active substance and ultimately the amount of hand sanitiser on the market has seen breweries, distilleries and various chemical companies step up to the challenge and form new partnerships with local manufacturing companies, who while in a downtime have delved into this new product line. However, a new product brings with it a whole new set of rules and regulations when it is marketed for sale and subsequently sold, especially a biocidal product such as a hand sanitiser. There are mounting concerns that these new product manufacturers are not aware of their regulatory obligations; recently highlighted in the European Chemical Agency (ECHA) newsfeed.
So, what are the rules and regulations?
Let’s look initially at the Biocidal Product Regulation (BPR). The BPR (Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. A hand sanitiser falls into the definition of a biocidal product so is expected to comply with the BPR by receiving product authorisation before it is placed on the market.
However, due to the shortfall in supply of hand sanitiser, the majority of EU member states have the ability to implement a temporary relaxation of the BPR rules under Article 55, as COVID-19 poses a danger to public health which cannot be contained by other means. Here, we have concentrated on the UK, but the majority of member states have implemented similar measures. We recommend that you check the local legislation of individual EU member state for the most recent updates.
In the UK, the UK Health and Safety Executive (HSE) can apply a derogation under Article 55 (1) and is allowing manufacturers to sell propan-2-ol-based hand sanitisers without first obtaining product authorisation, but only once the HSE has been notified. But manufacturers must take care, as in the case of propan-2-ol, products must be formulated to the World Health Organisation (WHO) recommended formulation to apply for this speedier process.
For propan-1-ol and other formulations containing propan-2-ol, the HSE can still apply a derogation under Article 55 of the BPR, but these may take longer to issue, and manufacturers must provide more information on the efficacy and safety of these formulations.
In the case of ethanol, you do not need a product authorisation or any specific derogation from HSE to bring an ethanol-based hand sanitiser to the UK market as ethanol, the active substance, is currently under assessment in the BPR review programme. New alcohol manufacturers can breathe a sigh of relief as the HSE have also relaxed the rules for active substance suppliers. Previously, the BPR states that the active substance should only be purchased from companies listed on an approved list of suppliers, known as Article 95. However, in these unprecedented times, HSE would only expect manufacturers of hand sanitisers to take reasonable steps to source ingredients in such a way that they are compliant with Article 95 obligations.
Other regulations
Do the regulatory requirements end there? Unfortunately, they don’t. There are still further obligations imposed before the hand sanitiser can be placed on the market. These include:
- REACH, short for the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU)
REACH looks at the supply and management of chemicals to ensure a high level of protection to human health and the environment through its use. Generally, all chemicals manufactured in or imported into the EU, including the UK, in a quantity of one tonne per annum or more must be REACH registered. In terms of hand sanitiser, this means all the individual non-active substances/ingredients, or co-formulants present in the hand sanitiser and imported or manufactured in quantities of 1 tonne or more per year by a single legal entity need to be REACH registered. Suppliers may potentially cover the registration for that ingredient; however, this all needs to be checked and recorded to ensure your whole product formulation is compliant.
- Classification, Labelling and Packaging (CLP) (EU)
If you are supplying biocidal hand sanitiser products, the products’ packaging and labelling must comply with relevant legislation on Classification, Labelling and Packaging of substances and mixtures (CLP). These are the warnings we see on some consumer products such as detergents and weed killers.
- Advertising (UK)
Adverts for biocidal hand sanitiser products must not be misleading in respect of the risks from the product to human health, animal health or the environment, or in relation to its efficacy.
- Record keeping (UK)
Records of the quantity and safety of the biocidal hand sanitiser products supplied in the UK must be kept.
After the pandemic
Finally, if you wish to continue supplying the hand sanitiser product once the pandemic is over, then the ultimate question is what happens once the relaxation measures are removed by the HSE? It is uncertain whether a grace period will be announced to allow companies to ensure they are compliant. If not, and knowing how long supply chain discussions can take, it would be worthwhile for companies to start preparing to fulfil the BPR requirements now.
For UK companies, there is an added complication once they come to the end of the transition period of leaving the European Union (EU) on the 31st December 2020. Following this date, companies will need to ensure compliance with any equivalent scheme that the UK implements. Whether there will be any relationship between the UK and Europe with respect to REACH, CLP and BPR beyond this date is unknown, but in the absence of any agreement, the UK will implement similar regulations. With the uncertainty around the pandemic and the UK’s relationship with Europe, it is clear that the manufacturers and suppliers of hand sanitisers will need to keep up to date with the ever-changing regulatory world if they wish to continue to supply hand sanitiser products and remain compliant.
How Anthesis can help
Through their team of regulatory specialists, Anthesis has extensive experience of all matters relating to the BPR, CLP and REACH and can assist with any registration or compliance issues in these fields including the preparation of the required BPR and REACH dossiers. Anthesis is well-placed to support your compliance requirements in both the EU and the UK following its independence from the EU.
Contact our specialists for further details on assessing the regulatory requirements of your products.
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