Expanding into Covid-19 safety goods: Loosening of the regulatory framework
In the midst of the ongoing Covid-19 pandemic, many businesses in the United Kingdom have taken up the challenge to manufacture and supply essential medical equipment and personal protective equipment (PPE). This article provides an overview of the distinct yet stringent regulatory frameworks that these manufacturers must adhere to, focusing on hand sanitiser, ventilators, and PPE.
Hand Sanitiser
Manufacturers producing hand sanitiser in the UK must ensure their products comply with UK cosmetic regulations. This includes proper classification as cosmetics, safety assessments, and the compilation of a Product Information File (PIF) containing safety reports and Good Manufacturing Practice (GMP) compliance as per ISO 22716:2007.
A UK-based Responsible Person (RP) must be appointed to ensure compliance, maintain files, and provide a contact point on labelling. Labels must include specific mandatory information such as the RP name and address, country of origin (for imports), and net content, following Schedule 34 of UK Product Safety and Metrology regulations.
Given the heightened regulatory scrutiny, manufacturers must take extra precautions to prevent contamination with harmful substances like methanol and combat counterfeit products, as observed in similar FDA enforcement trends in other markets.
Ventilators
While specific ventilator regulations are not detailed in these guidelines, manufacturers typically must comply with the UK Medical Devices Regulations, which require conformity assessment to assure safety and performance. Post-pandemic inquiry reports emphasise the importance of safety in ventilation systems in healthcare facilities, underscoring ongoing concerns about design, maintenance, and infection control even beyond production.
Personal Protective Equipment (PPE)
UK PPE regulations require products to meet safety and performance standards, usually aligned with EU-based standards retained post-Brexit but now governed by UK authorities. There is an emphasis on sustainability considerations, with healthcare experts recommending reusable PPE (such as cloth isolation gowns) to reduce environmental impact and supply chain vulnerabilities demonstrated during the pandemic.
Innovation in biodegradable and recyclable PPE is an active area, but products must still undergo robust efficacy and safety validation before approval.
Key Regulatory Considerations
- Accurate product classification (cosmetic vs biocidal vs medical device).
- Appointment of a UK Responsible Person accountable for compliance.
- Strict adherence to labeling, safety assessment, and documentation (PIF for sanitizers).
- Compliance with GMP standards.
- Vigilance against contamination and counterfeit risks, especially for hand sanitiser.
- Meeting UK medical device regulations (likely for ventilators).
- Conformance to PPE safety standards and growing sustainability practices.
- Awareness of supply chain disruptions affecting raw materials and component availability.
These expectations reflect an evolved regulatory environment shaped by lessons from the Covid-19 pandemic and ongoing efforts to assure product quality and safety for public health in the UK.
Hand sanitiser can fall under three regulatory regimes: cosmetic, biocidal, or medical. Hand sanitisers containing Propan-2-ol can be marketed without a product authorisation if they meet the relevant World Health Organisation (WHO)-specified formulation II, but manufacturers must contact the Health & Safety Executive (HSE) to obtain a derogation certificate. The regulatory framework for PPE equipment, such as non-surgical face masks and gloves, is EU Regulation 2016/425.
[1] ISO 22716:2007 - Cosmetics - Good Manufacturing Practice Guidelines [2] Sustainable PPE: A Guide for Healthcare Professionals [3] FDA Enforcement Trends Regarding Hand Sanitiser During the Covid-19 Pandemic [4] Post-Pandemic Inquiry Report: Safety in Ventilation Systems in Healthcare Facilities [5] UK Product Safety and Metrology Regulations 2019 (SI 2019/1261)
In the realm of health-and-wellness, manufacturers producing hand sanitiser in the UK are required to follow UK cosmetic regulations, ensuring proper classification, safety assessments, and GMP compliance. Medical-conditions, such as contamination with harmful substances like methanol, must be addressed to prevent them, as observed during the Covid-19 pandemic.
In the context of health-and-wellness, Personal Protective Equipment (PPE) in the UK must meet safety and performance standards, which are often EU-based standards retained post-Brexit but now governed by UK authorities. Additionally, sustainability considerations are emphasised, particularly for reusable PPE, as a means to reduce environmental impact and supply chain vulnerabilities.
