The Office for Product Safety & Standards has recently released updated guidance to businesses placing hand cleaning and sanitising products on the UK market.
Amid shortages of hand cleaning and sanitising products in the UK, many businesses have adapted their existing production lines to help produce the shortfall, including several producers of alcoholic beverages. Many have pledged to give the product away for free to those in need during the coronavirus crisis.
All hand cleaning and sanitising products have been regulated in the UK for some time. The recently updated guidance (now version 3) is intended for businesses that are new to the manufacture or import of hand cleaning and sanitising products.
Which regulations apply?
If you are manufacturing or importing hand cleaning or sanitising products you must comply with the regulations that apply to your product, to ensure they are safe to use and effective. Hand sanitising products generally fall into one of three categories:
1. Cosmetic products – products primarily used to clean, protect and condition the skin while providing a secondary antimicrobial effect, such as liquid soap, solid soap bars and moisturising hand creams. The Cosmetic Product Regulations apply to this product and are regulated by your local authority and Trading Standards. Specific guidance can be found here.
2. Biocide – products primarily claiming to kill germs, disinfect or sanitise using an active antimicrobial ingredient such as the hand sanitisers used in hospitals. Multiple regulations may apply to biocide products. They are regulated by the Health and Safety Executive. Specific guidance can be found here.
3. Medicines – products specifically used as surgical scrubs for use in operating theatres and products which make claims to treat and/or prevent infection associated with specifically named pathogens. If a product claims to prevent infection against specific viruses, such as COVID-19 or other named illnesses, it will be classed as a medicine. Medicines are regulated by the Medicines and Healthcare Products Regulatory Agency and guidance is available here.
There are also specifications for new suppliers or manufacturers of hand sanitiser to protect NHS health workers.
The Advertising Standards Authority is also currently focussing on advertisements that exploit health concerns during the current COVID-19 crisis. This was highlighted earlier this week when a former Apprentice contestant’s company has had three social media advertisements banned over misleading COVID-19 claims.
Other important considerations
Those new to the import or manufacture of hand sanitiser should also consider other important points, such as:
– Storage and transportation – many hand sanitisers contain highly flammable alcohol-based ingredients. You will need to consider the added risks of storing, processing and transporting these products, including a revised risk assessment covering these issues and ensuring your business is COVID-19 secure (see our previous update on this here)
– Business contracts – businesses selling such products should consider entering into carefully drafted contracts covering all commercial and contractual terms so all parties know where they stand, rather than relying on their standard terms and conditions or those of the other party which may not be suitable in this situation. Businesses donating products should consider providing a disclaimer with such products setting out the terms of the donation and any necessary information about the product and its manufacture or use.
The manner in which the manufacturing sector has rallied together to help with the hand sanitiser shortage is inspiring. However, it remains critical for you to understand exactly what is required to manufacture these products to protect your position and their safe and effective use. If you need to know more about any regulations which apply to particular products, revised risk assessments or your business arrangements with customers, please do get in touch.
Our manufacturing specialists provide focussed legal advice to multiple manufacturing businesses, both regionally and internationally. The combination of our industry knowledge and sector-specific legal insight means we can work as an integral part of our clients’ business swiftly getting to grips with the nuts and bolts of key issues.