ROHS Compliance

Recently, the Philippine Food and Drug Administration (FDA) issued for public consultation a draft titled “General Guidelines for Compliance of Food Contact Materials for Pre-Packaged Processed Food.”  

Legal Basis 

The draft Guidelines are issued pursuant to the Food Safety Act of 2013 and its Implementing Rules and Regulations, in line with the FDA’s mandate to ensure food safety, protect public health, and prevent consumer exposure to hazardous products. 

While current laws do not explicitly define adulteration caused by food contact materials (FCMs), such risks fall within the broader interpretation of adulteration. The concept of “migration,” as clarified under FDA Circular No. 2022-011, together with established international scientific research, provides the regulatory and scientific foundation for these Guidelines. 

Objectives 

The draft aims to: 

  • Establish clear compliance requirements for Food Business Operators (FBOs) using food contact materials for pre-packaged processed foods 

  • Prevent food adulteration caused by chemical migration 

  • Strengthen regulatory oversight and monitoring of FCMs 

Scope of Application 

The Circular applies to all locally manufactured and imported finished food contact materials intended for food packaging, including: 

  1. Direct Food Contact Materials (Primary Packaging) 

Materials such as: 

  • Metals, glass, ceramics, enamels 

  • Various synthetic resins (e.g., phenolic, melamine, urea, formaldehyde-based resins) 

  • Plastics including PVC, PE, PP, PS, PVDC, PET, PMMA, nylon, PMP, PC, PVOH 

  • Rubber 

  • Paper and paperboard 

  1. Active Packaging 

Packaging designed to release or absorb substances under normal conditions, including: 

  • Oxygen absorbers 

  • Carbon dioxide absorbers/emitters 

  • Ethylene absorbers 

  • Antimicrobial packaging 

  • Ethanol emitters 

  • Moisture absorbers 

  • Flavor/odor adsorbers 

  • Self-heating and self-cooling packaging 

  • Gas-permeability control materials 

  1. Intelligent Packaging 

Examples include: 

  • RFID tags 

  • Time-temperature indicators 

  • Freshness indicators 

  • Biosensors 

  • Gas sensors 

The Circular also covers: 

  • Reprocessed/recycled packaging materials 

  • Other existing or innovative materials intended for food contact 

Exclusions 

Not covered are: 

  • Naturally occurring, untreated materials (e.g., banana leaves, bamboo, mollusk shells) 

  • Edible coverings (e.g., sausage casings) 

  • Fixed water supply systems 

  • Materials not intended for food packaging 

General Compliance Requirements 

  • Migration levels must not exceed applicable limits. 

  • Direct-contact materials, including recycled materials, must comply with FDA regulations or Philippine National Standards (PNS). 

  • In the absence of PNS, ASEAN or other internationally recognized standards may be applied. 

  • FBOs must provide a Certificate of Suitability (or equivalent documentation) during inspections. 

  • Compliance will also be verified through post-market surveillance. 

Key Responsibilities of Food Business Operators 

FBOs placing pre-packaged processed food on the market must: 

  • Select appropriate packaging based on food type, contact duration, and storage/processing conditions 

  • Ensure packaging materials are properly labeled and supported by supplier declarations of compliance 

  • Obtain valid Certificates of Suitability from suppliers 

  • Maintain traceability systems for food contact materials 

  • Ensure proper storage and handling of packaging prior to use 

  • Guarantee the safety of active, intelligent, and innovative packaging 

  • Clearly label inedible components (e.g., “DO NOT EAT”) 

After the transition period, Certificates of Suitability will become mandatory for all applicable packaging materials. 

Transition Period 

Products already on the market before the regulation takes effect will be granted a 12-month transition period. During this time, existing stocks may continue to be used, provided they do not pose safety risks or violate applicable laws. Full compliance will be required after the transition period. 

Monitoring and Review 

The FDA’s Center for Regulatory Research and Development will review the Circular three years after implementation to assess its effectiveness and impact. 

 

Violations and Penalties 

Non-compliance may result in administrative sanctions under applicable laws, including: 

  • The Food Safety Act of 2013 

  • The Food and Drug Administration Act 

  • The Philippine Consumer Act 

Prohibited acts include the manufacture, sale, or importation of non-compliant or adulterated food and consumer products. 

Effectivity 

The Circular will take effect 15 days after publication in the Official Gazette or a newspaper of general circulation and upon filing with the Office of the National Administrative Register, University of the Philippines Law Center.