The Indonesia National Agency of Drug and Food Control (NADFC) has issued the nation’s first official guidelines for food recall in the Head of NADFC Regulation No. 22 of 2017, which entered into force on November 28, 2017. The regulation establishes food recall procedures for manufacturers, importers, and distributors who are obligated to recall food products that are not in accordance with requirements set forth in prevailing laws and regulations.
Food recall is applicable to registered and unregistered processed food products, both local and imported. These include exported food products that have problems in the designated exporting country, and domestic processed food products registered with Indonesian municipal government authorities.
Mandatory food recall requires an order from the NADFC, and may occur if a distributed product poses risk of causing disease or injury, a product does not meet food safety laws or regulations, or the recall is deemed necessary to protect public health.
The NADFC may utilize information from the following sources to determine whether to order a mandatory product recall:
1. Balai Besar/Balai POM (i.e., provincial-level authority of NADFC);
2. Nongovernmental organizations;
3. Research institutions or universities;
4. Mass media;
6. Food business operators;
7. Overseas and international food safety organizations (e.g., International Food Safety Authorities Network, the European Union Rapid Alert System for Food and Fee, etc.); and
8. Other official sources.
A food business operator, such as a manufacturer, importer, distributor, or retailer, may use information from the following sources to determine whether to voluntarily recall a food product:
1. Test data;
3. Supplier of food ingredient used by a manufacturer;
4. Federal and provincial government agencies; and
5. Other sources.
The manufacturer, importer, or distributor must provide the following information to the NADFC in order to conduct a voluntary recall:
1. Identity of food product to be recalled;
2. Reason for recall;
3. Risk assessment of shortage of product supply in the market;
4. Quantity of food produced or being produced;
5. Quantity of food estimated to be in distribution;
6. Distribution information, including contact persons' details if necessary;
7. Records of communication related to the food recall;
8. Plan/strategy for food recall; and
9. Contact details of responsible persons at the company conducting the food recall.
The intent to recall a food product must be communicated to the NADFC through its 24-hour call center, and to buyers and consumers through letters, emails, or fax.
Based on information received, the NADFC will conduct a health risk assessment to determine the classification of the food recall, out of three possible classifications:
Class I recall. To qualify as a Class I recall, consumption of or exposure to the food product is presumed to cause serious health problems or even death. The timeline for a Class I Recall is as follows:
- Issuance of a public warning by the NADFC within 24 hours after determination of the classification of the recall;
- Recalled products are prohibited for sale or purchase and must be secured immediately after the public warning;
- Food products to be recalled must be cleared from markets within 14 calendar days after issuance of the NADFC’s recall order.
Class II recall. In a Class II recall, consumption of or exposure to the food product is presumed to cause temporary disruption to health, recoverable disruption to health, or a small possibility of serious disruption to health. This classification includes food that does not meet the mandatory Indonesian National Standard for quality, packaged food products that are distributed without a marketing permit, and food products that contain pork but fail to disclose this information on their food label. Food products to be recalled under Class II must be cleared from markets within 30 calendar days of issuance of the NADFC’s recall order.
Class III recall. In a Class III recall, consumption of or exposure to a food product is not detrimental to health, but there is a breach of regulation other than those mentioned under Class I and II recalls. Food products to be recalled under Class III must be cleared from markets within 60 calendar days of issuance of the NADFC’s recall order.
The process for a food recall in Indonesia consists of several steps. First, the NADFC will issue a recall order to the food manufacturer or importer after completing its health risk assessment. The NADFC will then issue a circular to all Balai Besar/Balai POM to instruct them to coordinate with local government agencies in the recall. In the case of a Class I recall, the circular will also include instructions to secure and destroy food products.
A public warning is subsequently issued by NADFC in a Class I recall, or by the relevant business operator in a voluntary recall. The recall is then executed within the provided timeline and recalled products are handled in accordance with official guidelines. If the recall has been effectively executed, the NADFC will issue an order letter to cease the recall; otherwise, a letter ordering a repeat of the recall will be issued.
The NADFC will determine the next course of action on the recalled products for products in mandatory recalls, while products in voluntary recalls may handled in the following ways as determined by the company: destroyed; used for other purposes besides human consumption (e.g., as animal feed); reprocessed to ensure food safety; relabeled; or returned to suppliers (in the case of imported food products).
All activities related to a food recall must be documented and reported to the NADFC by the manufacturer, importer, or distributor. There are two types of reports:
1. A progress report must be provided to confirm that the responsible party has identified all products to be recalled, and has communicated the recall to all related parties. The progress report must be provided within 10 working days from the start of a Class II or III recall. For a Class I recall, the NADFC will determine the timeline for providing a progress report.
2. A final report must be provided within 10 working days after the recall is completed. It will be used by the NADFC to assess the effectiveness of the recall process.
As part of food recall guidelines, business operators are required to perform a food recall and food traceability simulation exercise at least once a year, and document the exercise activities and results. This requirement is intended to measure the effectiveness of current food recall and food traceability systems.
The guidelines set forth in the Head of NADFC Regulation No. 22 of 2017 appear to provide a comprehensive framework for business operators to follow when a recall is deemed necessary. Although the guidelines are still relatively new, it is hoped that they will contribute to more effective food recalls and promote the confidence of food and beverage investors in Indonesia.