Retail businesses across the world are repurposing their production lines in an effort to address the shortage of personal protective equipment (PPE) and hand sanitiser, which are crucial to the fight against COVID-19. French luxury group, LVMH, and Estée Lauder Companies have started making hydroalcholic gel in factories previously reserved for the production of luxury beauty products. Fashion giants, including H&M and Burberry, are also pivoting their supply chains to make PPE for front-line medical staff.
Whilst the speed of response from the retail sector has been extraordinary, companies should remain vigilant that any new products comply with regulatory requirements. To assist with this, the UK government, alongside regulatory bodies, have relaxed the regulatory regime for certain products needed to combat COVID-19. This article outlines the key requirements that companies producing PPE or hand sanitiser for the first time should be aware of.
Personal Protection Equipment
EU Regulation 2016/425 (PPE Regulation) sets out the essential requirements which must be met before PPE products can be placed on the UK market. The PPE Regulation requires that manufacturers must ensure all PPE has:
- been designed and manufactured in accordance with the applicable essential health and safety requirements. These are set out in Annex II of the Regulation;
- undergone a conformity assessment;
- is affixed with a CE mark which provides evidence of the product’s compliance with the regulatory requirements.
The UK government have introduced temporary derogations from the PPE Regulation which are set out in the Office for Product Safety and Standard Guidance. The guidance states that any PPE manufactured for purchase by government or NHS bodies does not require a CE mark provided that it meets the essential health and safety requirements. PPE manufactured for other corporate bodies can also be placed on the market without a CE mark, however the manufacturer must have started the conformity assessment.
Importantly, some products which appear similar to PPE may actually be classed as medical devices if their main purpose is to protect patients from the healthcare professional. Medical devices are regulated by the Medical Devices Regulations 2002 (MDR), which contain more stringent measures than the PPE Regulation. The Medical and Healthcare Products Agency (MHRA) is responsible for overseeing compliance with the MDR and has issued extensive guidance on producing medical supplies for COVID-19.
It can be difficult to determine whether certain COVID-19 products are medical devices or not, these are called 'borderline products.' The product may appear to straddle both the PPE and MDR regime and companies should give careful consideration as to which applies. The MHRA will assist businesses with determining whether their particular product is classed as a medical device. As a guide, we have set out the MHRA's standard position on face masks, gloves and gowns below.
General face masks which are designed to protect the wearer are governed by the PPE Regulation and manufacturers should comply with the requirements set out above.
Surgical or medical face masks which are designed to be worn by healthcare professionals in order to protect patients are Class I medical devices and therefore must meet the design and safety requirements of the MDR and be CE marked before they can be sold in the UK. The MHRA have introduced a derogation which allows manufacturers to apply for an exemption to the CE mark requirement. The information which should be included in the application is listed here. The MHRA have warned that they expect to receive a high volume of applications for derogations over the coming weeks and will prioritise these based on the needs of the healthcare providers.
Protective Gloves and Gowns
Gloves which are manufactured to protect the wearer (for example for use in laboratories) are considered PPE and must comply with the PPE Regulation.
Gloves which are intended to be used by healthcare professionals to protect the patient during an examination are considered to be Class I medical devices. A manufacturer may self-certify that the examination gloves meet the specifications under the MDR, rather than through a notified body.
However, a notified body must provide the certification if the gloves are supplied as "sterile". Surgical gloves are usually considered to be Class IIa medical devices and therefore the CE certificate must come from a notified body.
Similarly, gowns are usually considered to be medical devices, unless they are produced to protect the wearer.
Hand sanitisers fall into three regulatory groups:
- Cosmetics - products primarily used to clean and/or moisturise skin whilst providing a secondary antimicrobial effect;
- Biocides - products primarily claiming to kill germs, disinfect or sanitise or using an active antimicrobial ingredient such as the hand sanitisers used in hospitals; and
- Medicines - products specifically used as surgical scrubs for use in operating theatres and products which make claims to treat/prevent infection associated with specifically named pathogens.
Cosmetics are regulated by the EU Cosmetic Product Regulations (Regulation 1223/2009) which is enforced through local trading services, further guidance on cosmetics is available here. However, hand sanitisers specifically manufactured to tackle COVID-19 are more likely to be considered either a biocide or a medicine.
In the UK, biocides are regulated by the Health and Safety Executive (HSE) which enforces the EU Biocides Regulation (Regulation 528/2012). Usually biocides require product authorisation before they can be placed on the UK market. However, the HSE has published guidance on the manufacturing and supply of biocidal hand sanitiser during the COVID-19 outbreak which sets out the following exemptions:
- biocidal hand sanitiser containing Propan-2-ol will not be required to obtain a product authorisation if they meet the relevant WHO-Specified Formulation II. However, before placing the product on the market, businesses must obtain a derogation certification from the HSE;
- the same derogation applies to products containing Propan-1-ol. However, as there is no WHO formulation for hand sanitisers containing propanol-1-ol, the HSE will requires additional information on the product and may take longer to issue the derogation certificate;
- manufacturers do not require any form of product authorisations to place hand sanitiser containing ethanol on the UK Market.
A product is medicinal if it falls under either the presentation limb or functional limb of Article 1 of Directive 2001/83/EC. If the product is a medicine, then unless an exemption applies, it will be subject to the Human Medicines Regulations 2012 ("Regulations") which prohibit the advertising of medicine without a marketing authorisation. It is therefore crucial that businesses without a marketing authorisation do not make advertising claims that their hand sanitiser could prevent infection associated with specifically named pathogens (such as SARS-CoV-2) as this may bring the product within the remit of the Regulations.
Further Guidance on Hand Sanitiser Composition
The government has also published guidance on temporary changes to the use and supply of denatured alcohol and duty-free spirits for the manufacture of hand sanitiser.
Businesses producing or using denatured alcohol or duty-free spirit to make hand sanitiser for the first time must apply to HMRC for approval unless they are a licenced distiller or gin manufacturer. HMRC has confirmed manufacturers of hand sanitisers will have their applications for denatured alcohol fast-tracked. Specific derogations for businesses already producing hand sanitiser are set out in the guidance.
Don’t Get Caught Out
The speed with which the COVID-19 pandemic is progressing is putting pressure on businesses to make operational decisions quickly. Although there are a number of exemptions in place to reduce the regulatory burden on new entrants to the protective equipment market, it is important to ensure that all products comply with any safety requirements which are still required to be met.
Failure to meet the regulatory requirements can result in a criminal offence and penalties include unlimited fines, imprisonment for a term of up to three or six months (for individuals convicted of an offence), or both.
This is a rapidly changing area and it is expected that the government will publish further derogations to reduce red tape and tackle to shortage of PPE. Therefore it is vital that interested parties continue to monitor their compliance and are prepared to adapt swiftly, where necessary.
Last reviewed: 28 April 2020