UK Law and Practice Contributed by: Lisa Lunt and Sarah Samuel, Fletchers Solicitors
Sector-specific regulators In addition to the general product safety regime, a number of sector-specific regulators have responsibil - ity for particular product categories. The Food Standards Agency (FSA) is responsible for food safety and hygiene across England, Wales and Northern Ireland. It oversees food recalls, conducts risk assessments, sets enforcement policy and works with local authorities that carry out inspections and enforcement at a local level. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components. It has powers to authorise products, monitor safety through post-market surveil - lance, and require corrective action, including with - drawals and recalls. Given the technical complexity and potential risks involved, MHRA oversight is highly developed and enforcement activity is closely linked to regulatory compliance. The Driver and Vehicle Standards Agency (DVSA) is responsible for vehicle safety standards. It oversees safety recalls and investigates vehicle-related defects, with powers to require manufacturers to remedy safety issues and to co-ordinate large-scale recall exercises. The Health and Safety Executive (HSE) enforces prod - uct safety obligations in relation to workplace equip - ment and certain industrial products under the Health and Safety at Work etc Act 1974. Its remit includes products used at work, machinery and industrial equipment, with powers to issue improvement and prohibition notices and to bring criminal prosecutions where risks to health and safety arise. Scope of regulatory powers Across these bodies, regulatory powers typically include market surveillance, inspection and testing of products, requirements to provide warnings or correc - tive action, seizure and destruction of unsafe goods, and civil and criminal enforcement. The system is designed to allow regulators to inter - vene proportionately, with criminal prosecution gener - ally reserved for serious or persistent breaches, and
an increasing emphasis placed on recalls, corrective action and compliance-led outcomes. 1.3 Obligations to Commence Corrective Action UK law imposes clear obligations on producers and distributors to take corrective action where a product presents a risk to health or safety. These obligations arise both proactively, once a risk is identified, and reactively, in response to regulatory intervention. Duty to Notify and Take Action Under the GPSR, producers and distributors are required to notify the relevant enforcement authority where they know, or ought reasonably to know, that a product they have placed on the market poses a risk to consumers (Regulation 9). This notification duty is coupled with an expectation that appropriate corrective action is taken, which may include issuing warnings, withdrawing the product from the supply chain or organising a recall, depend - ing on the severity and nature of the risk. Corrective action is expected even where no incident has yet occurred, and the adequacy of voluntary measures is taken into account when regulators con - sider whether formal enforcement action is required. Corrective Action Required by Enforcement Authorities Regulators have wide statutory powers to require cor - rective action through formal notices issued under the GPSR, the CPA and the HSWA. These powers are graduated and enable proportionate intervention based on the level of risk. Measures Restricting Supply Enforcement authorities may take steps to restrict or suspend the supply of products, including: • prohibition notices (Section 13, CPA), which prevent the supply of a product except on terms approved by the authority; • suspension notices (Regulation 11, GPSR; Sec - tion 14, CPA), which temporarily prohibit placing a product on the market pending investigation; and
292 CHAMBERS.COM
Powered by FlippingBook