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A hand gel or hand sanitiser can be classed as a cosmetic, biocide or medicine. The classification depends on the primary function of the product, the claims made and the overall presentation. The product classification then requires full compliance with the relevant regulatory framework. For more detailed information, please visit the CTPA website and you may also find useful consulting Appendix 5 of the Guidance Note 8 from the Medicines and Healthcare products Regulatory Agency (MHRA).
It is important to note that compliance doesn’t only cover formulation requirements, there are other significant safety and efficacy standards that must also be met. Therefore, it’s important that businesses switching their usual operations to start making hand sanitisers know the full regulatory framework they must comply with before making the product available on the UK market. Please note that only cosmetic hand gels fall under the remit of CTPA. The Health and Safety Executive (HSE) should be contacted for more information about biocidal hand sanitisers, and contact the MHRA to know more about medicinal hand sanitisers.
In addition to the legal status of a hand sanitiser and ensuring compliance with the right regulatory framework, it is important to also consider that any claims made on the product must be substantiated according to the product’s classification but also considering the understanding of the averagely well-informed consumer. If the claims made are not substantiated, the consumer could be misled into thinking that the product will protect against or prevent from the spread of infections when in fact it may not be the case. While the provision of these products is a commendable action given the current health emergency, it is critical that they are safe and effective to use.
Derogations for biocides in EU Member States
CTPA is aware that other EU Member States are issuing derogations to the usual process for placing a biocide on the EU market under the EU Biocidal Products Regulation, in order to make more hand sanitisers available for consumers and health professionals. While biocides are outside of CTPA’s remit, we are in discussion with the relevant UK Government departments to understand what the UK position will be. However, until a derogation is officially issued by the UK Government, companies must comply with the current requirements.
Even though temporary measures are in place in some countries for biocidal hand sanitisers, specific formulations (usually according to World Health Organisation guidelines) and controls on manufacturing premises must be met to ensure the safety of the finished product. These derogations are only applicable to hand sanitisers marketed as biocides and only cover the process for placing on the market; all other requirements under the Biocidal Products Regulation must be met.
Using alcohol for manufacturing hand gels and hand sanitisers
Both denatured and undenatured alcohol can be used to make hand sanitisers. The use of undenatured alcohol will imply the payment of an excise duty. The rules for the EU are established under Directive 92/83/EEC, which is then implemented in all Member States. Companies can find useful information on the EU Commission website and Q&A on this topic.
For the UK specifically, companies may find useful consulting this page; however, CTPA suggests to contact directly Her Majesty Revenue and Customs (HMRC) for more detailed information on the duty to pay on the alcohol as raw material and the alcohol used in the finished product.
Production of denatured alcohol in the UK must also be authorised by the HMRC and there are specific requirements related to applying for a licence to produce denatured alcohol, receiving alcohol to be denatured, making production premises safe, running manufacturing operations and specific formulations to be used for the denaturation process. Excise Notice 473 provides all this relevant information.