In the wake of global efforts to recall contaminated batches of infant formula, we examine what product withdrawals and recalls are, why one may be needed, and why having a procedure in place can help businesses to minimise financial and reputational damage when a withdrawal or recall is required.

No parent would give their child infant formula that was unsafe or toxic. Yet that was the risk many around the world faced, after traces of the toxin cereulide were found in numerous batches of infant formula, including well-known household brands such as SMA, Aptamil, and Cow & Gate.

Since December, businesses have had to recall contaminated products from the supermarket shelves of more than 60 countries. Consumers have also been urged to check the batch codes of infant formula sitting in cupboards at home and return items matching the codes listed in recall notices.

The impact of this crisis has been significant, both for consumers and for the businesses that supplied contaminated formula. In the UK, around 36 children were suspected of being affected by food poisoning linked to cereulide, a toxin that can cause nausea, vomiting and stomach cramps, and that is unlikely to be destroyed by cooking.

Across the channel, France has opened an investigation into the deaths of two infants who consumed contaminated formula, whilst the European Food Safety Authority (EFSA) has announced a new threshold for the amount of cereulide that a product can safely contain.

Danone and Nestlé, both of which are implicated, saw their share prices fall by around 13% and 4% respectively in the year to date. 

Both also faced calls from Food Standards Authority (FSA) chief executive Katie Pettifer to “explain what went wrong and provide assurances this will not happen again.”

  • What are product withdrawals and recalls?

    Product withdrawals and recalls are necessary when a food business has placed a product on the market that could be harmful or dangerous.

    Indeed, product recall is a requirement across all consumer goods, which are governed by the General Product Safety Regulations 2005 (‘the 2005 Regulations’). Some types of goods, such as toys and cosmetics, are also covered by specific legislation, as well as the 2005 Regulations. 

    In England and Wales, product withdrawals and recalls are captured under Article 19 of assimilated regulation 178/2002, (known as the ‘general food law’), which states that a food business must withdraw or recall a product if it “considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with food safety requirements.”

    Although they share similarities, the terms ‘withdrawal’ and ‘recall’ cannot be used interchangeably.

    Withdrawals require affected food to be removed from the market, including point-of-sale, where it has “left the immediate control of that initial food business operator.” 

    Product recalls are more drastic and require consumers to return or destroy affected products “when other measures are not sufficient to achieve a high level of health protection.”

    In either case, businesses will have to “inform the competent authorities” and “effectively and accurately inform the consumers of the reason for its withdrawal.”

  • Why should businesses have a withdrawal/ recall procedure?

    Withdrawing or recalling products from supermarkets is complex, time-consuming, expensive and reputationally damaging.

    In addition to identifying affected batches and ensuring they are removed from sale, businesses also need to manage stakeholders, such as customers and retailers, through careful and transparent communication.

    To reduce the number of people that consume a potentially harmful or contaminated product, time is usually of the essence, particularly where vulnerable consumers, such as babies, children or the elderly, are concerned.

    In addition to putting consumers at risk, failure to act in time could lead to regulatory investigation, legal action, or even criminal prosecution under the Food Safety Act 1990.

    Having a withdrawal/ recall procedure in place is an effective way of mitigating these risks, by ensuring businesses have the information they need to act swiftly, whilst meeting all the legal and regulatory requirements for conducting a withdrawal or recall.

  • What should a withdrawal/ recall procedure contain?

    A good withdrawal/ recall procedure should:

    • Identify who is responsible for carrying out any procedures. Having an individual or team in place that is responsible for leading on withdrawals or recalls means the process can begin immediately, whilst also providing a single point of contact for anyone in the business who has concerns.
    • Outline the process for initiating a withdrawal/ recall. This will include analysis of the incident and its extent, information which is required to enable a recall to be undertaken. It should also cover the process for notifying relevant stakeholders, such as the FSA, enforcement authorities, and individual and business customers.
    • Provide information to aid traceability. Under Article 18 of the general food law, businesses must be able to “identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed.” This includes having “systems and procedures which allow for this information to be made to the competent authorities on demand.” As such, a recall/ withdrawal procedure should provide a comprehensive map of a business’s supply chain, along with relevant contact details and guidance on where to find records of transactions or correspondence with third-party suppliers.
    • Provide details of any relevant insurance. Ideally, businesses will have some form of product recall insurance in place, which helps to cover the costs associated with product recalls, such as notifying customers, removing and destroying contaminated products, and managing reputational fallout. 
    • Be communicated to the business and updated regularly. Withdrawal/ recall procedures are only effective if they are tailored to the business and its customer base and understood by everyone that may be involved in a potential withdrawal/ recall. Businesses should include requirements for procedures to be reviewed at regular intervals and ensure that staff are regularly trained on procedures to avoid delays or mistakes.
  • What should I do if a recall/ withdrawal is required?

    Even where effective procedures are in place, recalls and withdrawals should be considered a last resort.

    As we have seen with the infant formula crisis, the need to recall or withdraw products is both expensive and reputationally damaging, particularly when required on a global scale. Nestlé and others are already facing legal complaints from a European consumer protection group, not to mention the prospect of losing a significant number of customers. As analyst Warren Ackerman said in an article for the Financial Times, “the loss of trust can outlast the recall itself.”

    Nevertheless, having in place an effective procedure for withdrawals and recalls is vital, ensuring that businesses can act quickly and efficiently to remove harmful products from the shelves and, most importantly, keep consumers safe. A well-executed recall, combined with a good communication strategy, has the greatest chance of success, both in terms of ensuring consumer safety and maintaining consumer trust. 

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Having legal advice from the outset of a product withdrawal or recall is vital to mitigating risk. If your business is facing a withdrawal or recall, please contact one of our legal specialists.

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