Draft Administrative Measures for Recall of Health Food Products under Consultation

10 August 2011

Ai-Leen Lim

Food safety has become one of the highest non-economic national priorities in China. From melamine-contaminated milk to artificial eggs made of chemicals, the issue of tainted food calls for urgent attention.

According to Article 53 of the Food Safety Law of the PRC, the State will establish a food recall system for food found to fall below the safety standards. The Implementing Rules on the Food Safety Law of the PRC provides for treatment of recalled foods.

The PRC’s State Food and Drug Administration (“SFDA”) recently issued draft Administrative Measures for the Recall of Health Food Products according to the Food Safety Law and the Implementing Rules (the “Draft Measures”). The Draft Measures were released on 11 July 2011 for consultation. The food and drug administrative departments of provinces, autonomous regions and municipalities may submit their comments on or before 10 August 2011.

The Draft Measures apply to the recall of health food products sold in mainland China. Health food producers are required to recall their products with potential safety hazards according to the prescribed procedures. Such products are defined as health food products which harm or may harm human health, as prove by evidence. It should be noted that the definition of health food producers include the agents of such imported foods.
The Draft Measures provide for two kinds of recall: (i) a self-initiated recall; and (ii) a recall under an official order.

(i) Self-initated Recall
When health food producers discover any safety hazards in their products, they should submit to the food and drug administrative department of their county a recall plan within 3 days after the discovery. The plan should include the implementing unit, scope and time frame of the recall measures etc. Within 10 days after the end of the recall period, the producers should submit a report on the recall to the relevant departments. The result of the recall would be evaluated by the provincial food and drug administrative departments. The health food producers are then required to dispose of the recalled foods in an appropriate manner and record the process in detail. Even if the producers have performed harmless tests on the recalled foods, they are not allowed to sell the treated foods or reuse them in health foods production. However, when the reason of recall is that the food labels or instructions are not consistent with the requirements, producers can sell the foods again after taking effective remedial measures.

(ii) Recall under Order
Besides self-initiated recall by producers, food and drug administrative departments at county level or above can order the producers to recall the health food products and cease production and sale if they find potential hazards. The producers should follow the same steps as in a self-initiated recall. The said government departments are required to send a notification of such order to the producers.

The Draft Measures also provide for steps to be taken in the investigation and evaluation of food safety hazards. Health food producers are required to investigate and evaluate any potential safety hazards of their products, and report to the relevant departments if any hazards are found. Traders in the health food business should cooperate with the producers and the departments in the investigation.

The Draft Measures impose responsibilities on health foods producers, traders and agents of imported health foods. They are expected to take a more active role in food safety incidents. By requiring the producers to investigate into any food safety hazards and come up with a recall plan where appropriate, the regulators are seeking to have the burden of ensuring food safety shared between the Government and the producers, traders and agents of imported health foods. The detailed draft Measures, when it comes into force, would guide health foods producers, traders and agents as to where they stand and what their duties are in relation to the Government departments in tainted food cases. The food industry in China will no doubt wait with bated breath for the finalization of the above Measures, in order to bring China's food safety standards closer to those of its trading partners.