Enforcement of product safety lawsRegulators
Who enforces the product safety laws in your jurisdiction? If there are multiple regulators, how do their activities intersect and to what extent do they cooperate?
The principal enforcers of GPSR 2005, SI 2005/1803 in England and Wales are local authorities primarily through the appropriate trading standards department. The Office for Product Safety and Standards (OPSS) is also an overseeing regulator that works in liaison with Trading Standards. This type of hierarchy in general consumer product safety regulators in a unique feature of the UK system within Europe and can mean that market trends and systemic safety issues can be detected and scrutinised more thoroughly than in other parts of Europe.
There are also product-specific regulators in the UK also, as below.
Medical devices, pharmaceuticals, medical apps, medical instruments, healthcare wearables
The MHRA is granted enforcement powers in respect of medicines and medical devices through provisions contained in the Human Medicines Regulations 2012, the Consumer Protection Act 1987 and the Medical Devices Regulations 2002. It has similar investigatory powers for both medicines and devices, to collect evidence and interview witnesses under the Human Medicines Regulations 2012 for medicines, the Consumer Rights Act 2015 for devices and the Police and Criminal Evidence Act 1984 for both medicines and devices.
The MHRA also enforces regulations in respect of blood products.
The Health and Safety Executive (HSE) is the primary regulatory authority for enforcement of product safety laws relating to biocides. However, if an incident or concern involves animals, the environment rail networks, retail sales and or advertisement, laws are also enforced by various wildlife and environment agencies, Trading Standards offices in Great Britain or Consumerline in Northern Ireland.
The authorities work together by:
- sharing information, for example HSE can provide other authorities with:
- advice on the GB Biocidal Products Regulation (GB BPR) and the Control of Pesticides Regulation (COPR), and on how individual products are affected by it;
- details of the approval/authorisation status of individual products and the conditions placed on them; and
- copies of the approval/authorisation documents;
- supporting prosecutions, for example, by providing witness statements.
The responsibilities of the different authorities described above come from general health and safety law working in combination with more specific enforcement laws for COPR and GB BPR.
Personal protective equipment
Regulatory enforcement of laws applicable to PPE is dependent on the type of PPE:
- surgical (medical) face and transparent face masks:
- as above, the MHRA is granted enforcement powers in respect of medicines and medical devices;
- face masks intended to protect the wearer:
- enforcement of these the PPE supply regulations is now split between HSE and trading standards services. HSE leads for PPE intended for use at work in scope of the new regulations and placed on the market under the new regulations; and
- face coverings intended for use by the general public:
- face coverings for the general public are not PPE or medical devices but must meet comply with the General Product Safety Regulations 2005 (GPSR). The principal enforcers of GPSR 2005, SI 2005/1803 in England and Wales are local authorities primarily through the appropriate trading standards department. In some cases, action can be taken by the Secretary of State via the Office of Product Safety and Standards. See above regarding powers of these regulators.
The Office for Product Safety and Standards (OPSS) is the competent authority for cosmetic products in the UK. Cosmetics are also supervised by the BEIS and the UK Trading Standards for enforcement and market surveillance. See above for powers of these regulators.
Food and nutrition supplements
Food and nutrition supplements are regulated by the Food Standards Agency (FSA). The Department of Health and Social Care has responsibility for national and EU legislation on food supplements within England. The responsibility for the policy area of food supplements legislation in Wales rests with the Welsh Assembly. The Food Standards Agency Devolved Administrations of Scotland, and Northern Ireland are responsible for national legislation in their own administrations where separate but similar Regulations apply. The legislation is enforced through local Trading Standards Offices and Port Health Authorities.
The Care Quality Commission (CQC) is the regulator for healthcare providers in England (with Northern Ireland, Scotland, and Wales each having its own regulator). The CQC requires all service providers to register to perform remote medical advice. Providers must satisfy the CQC that the care and treatment they provide will meet the requirements of the Health and Social Care Act 2008 and associated regulations. Digital providers of medical advice are regulated by the same regime as non-digital providers.
Consumable CBD products are regulated by the Food Standards Agency (FSA), cosmetic CBD products are governed by UK Cosmetics Regulation (as above), vape products are regulated under the General Product Safety Regulations, and medicinal CBD is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).Enforcement actions and penalties
What enforcement actions are available to the regulatory authorities? What penalties may they impose for non-compliance with product safety laws?
In enforcing product safety regulations Trading Standards offices have a broad range of powers, including:
- to enter premises to observe the carrying on of a business, to inspect goods or documents, to test weighing or measuring equipment or to make a test purchase. Refusal of entry could be viewed as obstructing an officer, which is a criminal offence;
- to enter your home, or any other premises used solely or mainly as a dwelling, but only with a warrant issued by a court;
- seize goods and documents;
- or to issue any of the following:
- simple caution;
- enforcement order;
- compliance notice; and
- administrative penalties.
OPSS also has a unique set of enforcement powers in respect of product safety. OPSS and BEIS powers include the possibility to:
- carry out inspections;
- test products and notify the results to the manufacturers (or their representative);
- carry out documentary review and investigations;
- supervise market surveillance;
- agree sanctions with manufacturers;
- issue statutory notices;
- impose a financial penalty;
- institute criminal proceedings;
- refer a matter to another enforcement body for investigation or action; and
- publish enforcement actions taken against manufacturers.
Product-specific regulators also have unique powers.
Medical devices, pharmaceuticals, medical apps, medical instruments, healthcare wearables, telemedicine
The MHRA’s powers include:
- rights of entry;
- inspection of premises and articles;
- seizure of articles, substances and documents;
- right to take samples; and
- rights to open containers and packaging.
The MHRA’s powers also include the launch of criminal proceedings in appropriate circumstances.
HSE’s powers allow them to:
- enter premises;
- seize evidence – including taking measurements, photographs, recordings and samples;
- serve notices – for example, improvement notices and prohibition notices; and
- prosecute offenders.
Where HSE determines it is appropriate to prosecute a person for an offence, they may be tried:
- summarily – for example, in the Magistrates' Courts in England and Wales or by summary complaint in the Sheriff Court in Scotland; or
- on indictment – for example, in the Crown Courts in England and Wales or by solemn proceedings in the Sheriff Court in Scotland.
Personal protective equipment
Dependent on the type of PPE:
- for surgical (medical) face and transparent face masks, see MHRA’s enforcement powers above;
- for face masks intended to protect the wearer, see HSE’s powers above; and
- for face coverings intended for use by the general public, see TS and OPSS/BEIS powers above.
See TS/OPSS/BEIS enforcement powers above.
Food and nutrition supplements
The FSA has multiple enforcement powers to:
- bring prosecutions by application of the Food Standards Act of 1999;
- cooperate with local authorities like the Trading Standards to investigation and prosecute offenders;
- carry out inspections;
- issue an improvement notice; and
- enter, search and seize.
For consumables, the FSA has multiple enforcement powers as above.
For medicinal CBD, the MHRA’s power are applicable, namely, notices, warnings and formal cautions before proceeding with criminal prosecution.Enforcement process and procedures
What is the typical process for enforcement actions and what procedures are involved? What rules govern enforcement actions?
Generally, enforcement actions taken by UK regulators are required to be proportionate and dissuasive. While the regulators available to them, they generally escalate the actions taken based on the seriousness of the offence or the lack of responsiveness of the company against whom they are enforcing against.Enforcement trends
How prevalent is enforcement action under the product safety laws? Have there been any notable recent examples of enforcement actions?
Given regulatory enforcement has historically been a weak link in an otherwise strong system for the EU, and UK by implication, and the fact that regulators generally adopt informal approaches, the need for formal enforcement action is limited in the UK.
As an example, the OPSS published its enforcement actions since 1 April 2020 to 31 March 2021, and only four actions were taken – largely issuing of mandatory recall notices that require companies to take recall action.
Prosecutions are even more rare occurrences on the above basis. There are very few examples in the UK, and any prosecutions are usually the result of prolonged failed attempts by the regulators to get engagement from the company in question. In 2019, Memon Imports Ltd and its director were fined over £35,000 for supplying unsafe toys, including one toy that contained toxic chemicals. Memon Imports and the director had failed on several occasions to provide technical documents for the toys in question, one of which contained excessive levels of a CMR chemical. In addition to having inadequate systems in place to test any imports against European Standards, a test certificate was forged during the course of trading standard’s investigation.Challenging enforcement actions
What mechanisms are available to companies to challenge the imposition of enforcement actions?
There are a range of actions available to review decisions taken by regulatory bodies, which are largely administrative decisions.
- judicial review;
- inquests; and
- public inquiries.
All bodies exercising functions of a public law nature or regulatory are also susceptible to challenge by judicial review if the internal regulatory review process has been concluded.
Specific procedures may be available for certain regulator’s actions, as below.
Compliance notices from trading standards requiring a business to take action or stop doing something can be appealed.
The MHRA’s decision to issue the notices/notifications through the Chartered Institute of Arbitrators (CIArb) can be appealed in relation to the following:
- prohibition notice (Consumer Protection Act, schedule 2, part 1);
- notice to warn (Consumer Protection Act, schedule 2, part 2);
- recall notice (General Product Safety Regulations, Regulations 15 & 17);
- clinical investigation notifications (UK MDR 2002, Regulations 16 & 29);
- notified body or UK approved body designations (UK MDR 2002, Regulation 45); and
- applications for exceptional use of non-complying devices (UK MDR 2002, Regulations 12, 26 & 39)
The MHRA will explain each regulatory decision to the manufacturer when they issue the decision, including their right to appeal.
Appeals can be made on a similar basis against any decision issued by the HSE or FSA.
If regulatory action is taken by the OPSS and BEIS or if a regulatory decision has been made in relation to a business or product, there is a legal right to appeal. If a regulatory decision has been made in relation to a business or product but there is no legal right to appeal, the OPSS/BEIS advance can still be challenged if this is believed to be wrong.
Notification requirementsNotification time limits
What are the time limits for notification?
The GPSR requires producers and distributors to notify the relevant authorities ‘forthwith’ but does not provide a specific time limit.
In a recent guidance document (January 2021) on the application of the GPSR post-Brexit, given the non-applicability of previous European Commission guidance on the topic, the Office for Product Safety and Standards (OPSS) indicated that producers and distributors must notify the relevant authorities ‘immediately’.
Further, according to the BSI Code of Practice on Consumer Product Safety Related Recalls and other Corrective Actions (known as PAS7100:2018), to the extent all information is not available at the time of initial notification, producers and distributors should notify the relevant authorities and the additional information should be provided at a later stage as it becomes available, rather than delaying notification.
Separate time frames apply to product/regulator-specific reporting requirements, as above.Form and content of notification
What form should notification take? What product information and other data should be provided in the notification to the competent authority?
Under the GPSR, the notification is required to take the following form and contain the following aspects:
- in writing;
- include detail of the action taken by the producer or supplier to prevent risks to the consumers; and
- include the relevant state or states in which the product is or has been placed or supplied, if the product is placed or supplied to consumers outside of Northern Ireland.
The scope of the information to be provided with the notification widens in case the risk posed by the product is a serious one, and the following must be included in the notification (according to the GPSR and PAS 7100:2018):
- information enabling a precise identification of the product or the batch in question;
- a description of the risks presented by the product;
- all available and relevant information to enable tracing of the product; and
- the detail of the action taken to prevent risks to the consumers.
Regulators may request notification in a specific preferred format (including forms) or with specific details above and beyond the above.
Again, product or regulator specific notifications entail their own requirements. For example, notifications to the Driver and Vehicle Standards Agency should include (if possible) the following information (2019 vehicle safety defects and recalls: code of practice):
- the effect of the safety defect;
- a description of the defect and an estimation of the number of units affected; and
- the model and make of the products (including detail of any third-party components).
- This must take place as soon as the safety defect has been confirmed.