National Agency of Drug and Food Control Regulation Number 11 of 2026 Strengthens Food Packaging Safety Standards

Introduction

On 23 June 2026, the National Agency of Drug and Food Control (“BPOM”) issued National Agency of Drug and Food Control Regulation Number 11 of 2026 on Food Packaging (“BPOM Regulation 11/2026”), which took effect on 30 June 2026.

BPOM Regulation 11/2026 establishes safety standards and specifications for food packaging materials that come into either direct or indirect contact with food consumed by the public.

Furthermore, BPOM Regulation 11/2026 was issued to protect public health from the risk of hazardous contaminants that may migrate from food packaging into food.

In addition, BPOM Regulation 11/2026 responds to the rapid advancement of science and technology in the field of food packaging materials. Accordingly, the governance framework for packaging safety has been updated to ensure that materials coming into contact with food do not release contaminants exceeding the safety thresholds for human health, while simultaneously replacing the previous regulation, which was considered no longer adequate to meet current needs.

Comparison

BPOM Regulation 11/2026 revokes and declares no longer effective National Agency of Drug and Food Control Regulation Number 20 of 2019 on Food Packaging (“BPOM Regulation 20/2019”). The comparison is set out below:

Key Provisions

Food Packaging Material Safety Requirements Based on Migration Testing

Pursuant to Article 3, every party producing packaged food is required to use Food Packaging Materials that do not endanger human health.

Furthermore, Article 4 provides that Food Packaging Materials include plastics, rubber and elastomers, paper and paperboard, ceramics, glass, metals and metal alloys, as well as multilayer materials.

Materials that come into direct contact with food are required to comply with migration limit requirements (the transfer of substances from packaging into food), including both overall migration limits and specific migration limits applicable to particular hazardous substances.

Migration testing is regulated under Annex II, while the maximum migration limits for each material are specified in detail under Annex I.

Permitted and Prohibited Food Contact Substances

Article 6 requires the use of Food Contact Substances (constituent substances that come into direct contact with food) that are safe and expressly permitted as listed in Annex III, which classifies such substances into those subject to migration limit requirements and those not subject to migration limit requirements.

Meanwhile, Article 7 prohibits any person from using packaging containing prohibited Food Contact Substances, including benzene, chloroform, and various types of colorants and heavy metals, as listed in Annex IV, because such substances present a risk of releasing contaminants that may endanger human health.

Reusable and Recycled Food Packaging

Article 8 requires businesses utilizing reusable packaging to ensure that such packaging continues to comply with the applicable migration limit requirements.

Furthermore, reusable plastic packaging must undergo a series of Migration Tests in accordance with the procedures prescribed under Annex V.

Meanwhile, Article 9 provides that Food Packaging manufactured from recycled materials may only be used where the production process complies with the applicable laws and regulations governing the manufacture of Food Packaging from recycled materials.

In addition, Article 10 emphasizes that Food Packaging produced from recycled materials must continue to satisfy the same safety requirements applicable to new packaging, including the requirements governing Food Packaging Materials and Food Contact Substances.

Safety Assessment Approval for New Materials

Pursuant to Article 11, businesses intending to use innovative Food Packaging Materials or Food Contact Substances that are not yet listed in the Annexes to BPOM Regulation 11/2026 are required to obtain prior approval through the Food Packaging Safety Assessment mechanism.

Such approval shall be granted in writing by the Head of BPOM based on an application submitted by the businesses together with supporting data and documents containing at least:

·      applicant information;

·      information regarding the Food Packaging Material and/or Food Contact Substance; and

·      Food Packaging test results.

The application form for the Food Packaging Safety Assessment is provided in Annex VI.

Administrative Sanctions

Pursuant to Article 12, any person violating the provisions relating to Food Packaging Materials, Food Contact Substances, Reusable Food Packaging, or Food Packaging manufactured from Recycled Materials shall be subject to administrative sanctions in accordance with the prevailing laws and regulations.

Transitional Provisions

Article 13 provides that all Food Packaging already circulating in the market at the time this Regulation was promulgated must complete the necessary operational adjustments to comply with the new requirements no later than 30 June 2027.

An exception to this transitional period applies to certain migration limit requirements that have been designated by BPOM for phased implementation based on the results of public health risk assessments.

Closing

BPOM Regulation 11/2026 strengthens food packaging safety standards by introducing a more comprehensive regulatory framework governing migration limit requirements, the use of Food Packaging Materials and Food Contact Substances, the utilization of reusable and recycled packaging, as well as the safety assessment mechanism for innovative materials. This policy is expected to enhance the protection of public health while providing greater legal certainty for the food industry.

In addition, businesses operating in the food sector, packaging manufacturers, importers, and other relevant stakeholders should ensure that packaging materials, manufacturing processes, and the use of Food Packaging comply with the prescribed requirements, including making the necessary adjustments to products already circulating in the market no later than 30 June 2027.

Compliance with these requirements constitutes an essential part of ensuring food safety, fulfilling regulatory obligations, and avoiding the imposition of administrative sanctions under the applicable laws and regulations.