Introduction

• This publication is to provide a guidance for carrying out food recalls. It explains what should be done when food products have to be removed from supply or use by consumers for public health and safety reasons. Recall of food product is in the common interest of the industry, the government and in particular, the consumer.
• A recall is defined as an action to remove from sale, distribution and consumption, foods which may pose a safety hazard to consumers.

Legislation

There is no specific legislation governing the recall of food. Under the Public Health & Municipal Services Ordinance, food on sale for human consumption must be wholesome, unadulterated, uncontaminated, properly labelled and fit for human consumption. Violations of the provisions may lead to prosecution against the manufacturer, the importer or the distributor of the food. Specifically, under Section 59 of the Ordinance an authorised officer may examine or seize any food which he considers to be unfit for human consumption. In actual cases, most recalls of foods are carried out voluntarily by the supplier.

Role of the Government

• The Government's main role in a recall is to monitor the progress of the recall and assess the adequacy of a company's action. After a recall is completed, the Food and Environmental Hygiene Department will make sure that the product is destroyed or suitably improved. Where the recall is related to serious defects in the manufacturing process locally, the Food and Environmental Hygiene Department will consider if it is necessary to tighten up the licensing requirements.
• The Food and Environmental Hygiene Department will make publicity about a recall when it considers that the public need to be alerted about a health hazard or that clarification of the situation needs to be made to allay public worries.
• In cases of public health emergencies, the Food and Environmental Hygiene Department may, depending on the available evidence, alert the public before a decision on recall has been reached.

Role of the Company

• Companies supplying products to Hong Kong carry the prime responsibility of implementing the recall, and for ensuring compliance with the recall procedure at its various stages including follow-up checks to ensure that recalls are successful and that subsequent batches of the food products are safe for human consumption. A recall should be undertaken in consultation with the Food and Environmental Hygiene Department and preferably with prior agreement on the recall strategy. During the recall process, company personnel should keep all relevant parties informed of the latest developments.
• If the recall involves products exported overseas, the company concerned should notify, as soon as practicable, overseas recipients of recalled stocks.

Initiation of a Recall

• A recall may be initiated as a result of reports/complaints referred to the company from a variety of sources. The reports may be referred by manufacturers, wholesalers, retailers, medical practitioners, government agencies and consumers. A recall of goods manufactured overseas may also be initiated by reports appearing in overseas bulletins and similar publications of health authorities, or from information received directly from such authorities.
• To minimize the risk that may arise, recalls are usually carried out in the shortest time practicable. Companies are encouraged to develop its own recall procedure so that it can respond promptly to any emerging situation. The procedure should be able to achieve the purposes of stopping distribution and sale of an affected item, notifying the public and the Food and Environmental Hygiene Department of the problem, and effectively and efficiently retrieve from the market any product which is potentially unsafe.

Notification to the Food and Environmental Hygiene Department

Safety-related recalls referred to in this document involve the risk of death, illness or injury to the public. In view of the increasing aspiration of the consumer and to avoid possible confusion in the event of a food recall, the company should notify the Food and Environmental Hygiene Department immediately after the recall exercise has been initiated. While the information on the recall together with any opinions on the risk to public health and safety and the action proposed by the company should be forwarded to the Food and Environmental Hygiene Department in writing within two days of initiating the recall using the 'Food Recall Notification Form' as provided at Appendix A, such information should be provided to the Department by telephone (tel. no. 2867 5527) or by fax (fax no. 2521 4784) immediately after the recall has been initiated. Any enquiries about recall procedures or actual cases of recall should be directed to the Senior Superintendent (Centre for Food Safety)2 of the Food and Environmental Hygiene Department at the above tel. no. 2867 5527.

Informing the Consumer

Depending on the extent of the recall, the company concerned should inform the consumer of the recall at the earliest possible moment. Information dissemination may take the form of a press release, letter to the concerned parties or paid advertisement in the media. Sufficient telephone hotline service should be made available to deal with enquiries.

Assessment of the Recall

• Depending on the imminent risk that may be involved, there are two classes of recall:

(a) Class one recall-emergency situation
This arises when there is a reasonable probability that the use or consumption of the product would cause adverse health consequences or death.

(b) Class two recall-concern situation
The product may have serious defects which represent a potential health risk.

• This classification is to be determined by the Food and Environmental Hygiene Department in consultation with the company concerned. To expedite the classification, the company should provide all information on the 'Food Recall Notification Form'. Other relevant details may include:

(a) availability for investigation of suspect sample or other samples;
(b) assessment of risk; and
(c) proposed recall classification.

• Since some of the above information may be of a commercially sensitive or private nature, the Department will, upon request by the company concerned, maintain confidentiality on selected information as and when necessary.
• The party initiating the recall should, in consultation with the Food and Environmental Hygiene Department, work out the extent of the recall. In determining the recall level, the principal factors to be considered are the significance of the risk, the channels by which the goods have been distributed and the level to which distribution has taken place.

Product Recovery

Products may be recovered by return to supermarkets, return via distribution chains or direct return from consumers. The product is to be recovered to a central site, or in the case of widely distributed product, to major recovery sites. The recovered product must be stored in an area which is separated from any other food product. Accurate records are to be kept of the amount of recovered product and the batch codes of the product recovered. After recovery, products may be corrected or reprocessed before release to the market if it is fit for human consumption. Otherwise the product is to be destroyed.

Follow-up Action

• Post-recall reporting
  The party initiating the recall should provide the Department with an interim report as soon as a recall is completed, in any case not later than one month after the announcement of a recall. A final report should be ready within two months of the recall. The reports should contain essential information such as:

(a)	the circumstances leading to the recall;
(b)	the action taken by the company including details of any publicity;
(c)	the extent of distribution of the relevant batch in Hong Kong and overseas;
(d)	the result of the recall (quantity of stock returned, corrected, outstanding, etc.);
(e)	the proposed method of disposal or otherwise of recalled stock with record of destruction; and
(f)	the action proposed to be implemented in future to prevent a recurrence of the problem.

The report helps to establish the effectiveness of the recall. Unless satisfactory reports are received, the Department may consider taking further action, e.g. stepped-up inspection, against the company concerned.

• Effectiveness of Recall Action

To be effective, recall notification must reach as far as the product has been distributed. The effectiveness of the recall is assessed upon the amount of product returned as a percentage of the amount of product which left the manufacturer while taking into account the retail turnover of that product.

Conclusion

Worldwide, cooperation between the company and the regulatory authority has proven over the years to be the quickest and most reliable method to remove potentially dangerous products from the market. These guidelines outline the procedures which would enhance efficiency and transparency in the recall of food products. The implementation of such guidelines will hopefully minimize the loss inflicted on the company and the community at large.

A flow chart summarizing the procedures to be followed in a food recall.