Product recall requirementsRecall criteria
What criteria apply for determining when a matter requires a product recall or other corrective actions?
The GPSR provide that a producer of consumer goods must be prepared to take ‘appropriate action’ to deal with unsafe products including, where necessary to avoid risks, withdrawal from the supply chain, warnings to consumers or (as a last resort) recall from consumers. No legal criteria are laid down in these regulations for determining what action is appropriate in any given circumstances. Published codes of practice for recall will be relevant, including the Consumer Safety in Europe Corrective Action Guide (2012). The GPSR incorporate the ‘precautionary principle’ (see EU COM (2001) 1), which may justify the action even where the risk cannot be determined with sufficient certainty.
PAS 7100 highlights that - as per the RAPEX risk assessment methodology referred to above - risk can be classified into one of four basic levels: serious, high, medium and low. ‘Serious risk’ normally requires immediate action, ‘high risk’ normally requires rapid action and ‘medium risk’ normally requires some action, while ‘low risk’ does not generally require action for products on the market but it may require changes to the design of the product, or to manufacturing or quality control processes.
For commercial products, the duty in section 6 of the HSWA may comprise taking reasonably practicable steps to recall or modify products if this is necessary to prevent risks of injury. Again, there are no specific legal criteria to determine thresholds of risk requiring such precautions.
The common law of negligence is also relevant as it may comprise a duty to take reasonable steps to warn users or to prevent use of consumer or commercial products until they can be modified or replaced. This duty may apply even where the risk arises only where the product is incorrectly maintained or used.
Food and drink
The criteria for recall or other action are contained in article 19 of Regulation (EC) 178/2002 on General Food Law. Article 19 requires the withdrawal of foodstuffs from the supply chain if there is any non-compliance with the food safety requirements, to inform consumers of the reason for the withdrawal, and recall from consumers ‘if necessary . . . when other measures are not sufficient to achieve a high level of health protection’.
The MHRA’s Guide to Defective Medicinal Products (2014) refers to article 117 of Directive 2001/83/EC, which specifies under what circumstances a recall may be required. A medicinal product should be withdrawn if:
- it is harmful under normal conditions of use;
- it lacks therapeutic efficacy;
- qualitative and quantitative composition of the product is not as declared; or
- the controls on the product or the ingredients have not been carried out or some other obligation relating to the granting of the market authorisation is not fulfilled.
The MHRA uses an international classification system for medicine recalls:
- class 1: the defect presents a life threatening or serious risk to health;
- class 2: the defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious; and
- class 3: the defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification.
‘Class 4 drug alerts’ also exist where there is no threat to patients or no serious defect likely to impair product use or efficacy. These usually cover minor defects, for example, in packaging or printed materials. The extent and urgency of the recall will generally be discussed and agreed with the MHRA using these criteria.
The MHRA adopts the EU term ‘field safety corrective action’ (FSCA) to embrace recall and related warnings. Guidance on determining the need for a recall is contained in the MHRA’s Directives Bulletin No. 3 - Guidance on the Operation of the EU Vigilance System in the UK (2008), which refers to risk assessments being carried out in accordance with the international standard BS EN ISO 14971. The European Commission’s MEDDEV 2.12/1 Rev 8, sets out guidance on the medical device vigilance system, including field safety corrective action.Consumer warnings
What are the legal requirements to publish warnings or other information to product users or to suppliers regarding product defects and associated hazards, or to recall defective products from the market?
Under the GPSR, it is primarily for the manufacturer of a consumer product to determine whether a product is unsafe (and thus requires notification to the enforcement authorities) and what corrective action is appropriate in the particular circumstances (eg, warnings, withdrawal or recall). The authorities in the UK largely rely upon manufacturers voluntarily taking the appropriate corrective action. Should an enforcing authority not be satisfied with the approach taken by a manufacturer or other responsible party, it is likely to voice its concerns and informally request that additional corrective action be taken. The GPSR require the authorities to act in a manner proportionate to the seriousness of the risk and to encourage and promote voluntary action by manufacturers and distributors. The authorities nevertheless have powers to impose requirements (see question 19).Recall notices
Are there requirements or guidelines for the content of recall notices?
UK legislation does not generally set out specific requirements or guidelines for the content of recall notices. However, PAS 7100 identifies the following elements that a corrective action announcement should always contain:
- a clear heading that draws attention to the announcement containing the words ‘Important Safety Warning’ and a description of the corrective action - for example, product recall;
- a clear description of the hazard and associated or potential safety risk;
- product identification details such as brand, bar code, colour, size (and where possible model, batch or serial number);
- a photograph of the product;
- details of when and where the product was available for sale;
- a description of the action required by the consumer;
- details of arrangements for any proposed exchange, refund or repair; and
- a website address and freephone number for further information.
PAS 7100 also states that, if possible, additional information to ensure consumer safety (eg, ‘Stop using immediately’, ‘Unplug and do not use’) should also be included.
In addition, recall notices should be clear, concise, factual and easily understandable. Graphics should be used where possible as English may not be the first language of some of the target audience. PAS 7100 suggests that a ‘checker tool’ in online messages and web pages to assist consumers can also be useful.
Annex G of PAS 7100 contains visual examples of product recall notices, with recommended content and display features. Figure G3 sets out a notification using social media.
Some bodies (such as the British Retail Consortium) have also drawn up product recall guidelines, which outline the key elements that should be included in notices to suppliers, notices for the trade press or the general public. Examples of notices can also be found in Product Safety in Europe: A Guide to Corrective Action Including Recalls (Prosafe, etc).
For medical devices, there is a template for ‘Field Safety Notices’ - see MEDDEV 2.12/1 Rev 8 (Annex 5).Media
What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?
There is no prescriptive list of the media that must be used to publish or communicate warnings or recalls to suppliers or users, albeit that PAS 7100 contains a list of example communication channels that could be used. The method selected should relate to the assessed levels of risk, the mechanisms available, the affected product type and the target group of consumers likely to be affected. Producers can convey messages, for example, by local or national newspapers or advertisement in specialist magazines, letters to suppliers and end users (eg, using warranty records), web-postings, email or text messages, use of social media, posters at the point of sale, communications to installers or maintainers, store loyalty schemes or a mixture of each of these or other approaches.
A plan of the proposed action has to be submitted to the relevant regulatory authority as part of the notification process. If the enforcing authority does not consider the approach to communication of information to users and others to be adequate, additional or alternative forms of corrective action can be requested.
In some sectors, there will be involvement by the regulator in the chain of communication. For vehicle recalls, the DVLA can address and send letters directly to registered vehicle owners. The FSA (for food) and the MHRA (for medicinal products and medical devices) can also publish their own alerts.Time frame
Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?
There are no set targets or time periods at which a recall is deemed to have been successfully completed - albeit a recall can never be completely closed unless 100 per cent of products are accounted for. Enforcing authorities are likely to request update reports as to the success rate of any corrective action that is taken. The enforcing authority may require additional measures to be adopted, including repeat recall notices if they consider the response to corrective action to have been unsatisfactory.
The government has previously published success rates of recalls for different types of product based on the percentage retrieved of the overall numbers sold. See Product Recall Research (DTI, 2000). In 2014, Electrical Safety First produced a report, Consumer Voices on Product Recall, suggesting that the ‘success rate of recalls is rarely more than 10 per cent to 20 per cent’. However, it is questionable whether some of the data accurately represents typical outcomes of recalls in practice. For example, because of the ability to trace vehicle owners directly through the DVLA, vehicle recalls often have much higher success rates in recall than other product sectors.Repair and replacement
Must a producer or other supplier repair or replace recalled products, or offer other compensation?
There is no positive obligation on a producer conducting a recall to offer to repair, replace or pay compensation as part of its corrective action programme. Practices vary but, unless the items in question are of low value or perishable, manufacturers generally tend to offer repair or replacement products.
Rights of recovery for any loss or damage relating to the product simply ceasing to be usable will largely be against the seller from whom the consumer directly purchased the products (unless he or she has suffered injury or property damage when a claim in that regard against the manufacturer or importer into the EU may be made). Whether or not the seller can obtain recourse for the costs of repair or replacement and such like, from the manufacturer or others in the supply chain is an issue that will be determined by reference to the terms of the relevant supply contracts.
In accordance with the Consumer Rights Act 2015, a consumer will have a ‘short-term’ right to reject the goods, after which the consumer will have a right to repair or replacement. The right to a price reduction or final right to reject is also available.
Subject to the express or implied terms governing quality in the contract of sale, the owner of a commercial product that has been recalled may be able to reject the product, if not already accepted, and reclaim the purchase price as well as additional losses incurred. More usually though the owner will be deemed to have accepted a product already in use, and the owner’s rights will consist of a claim for damages for breach of warranty against the immediate seller. The damages would comprise the loss to the owner flowing directly and naturally resulting in the ordinary course of events from the breach of warranty.
In the event of the immediate seller being liable to the owner, the seller may, depending on the relevant contractual terms, be able to recover the losses from others in the supply chain.Penalties
What are the penalties for failure to undertake a recall or other corrective actions?
See question 3.