A food package goes through three questions before reaching the shelf: what it is made of, how it was produced, and how it protects the product along the supply chain. Each question has its own standards, which change from market to market and are updated frequently. For R&D, Quality and Regulatory teams, keeping up with these changes prevents rework and delays in launches and exports.
In this article, you will learn about the three layers of requirements that support the sanitary safety of packaging, the main references in Brazil, the United States and the European Union, and a practical way to organize monitoring. The content is informative and does not replace consulting the current version of each standard or regulatory consulting.
The three layers of requirements
- Materials and substances: what the material may release into the food. Includes lists of authorized substances and migration limits.
- Good manufacturing practices: how the package is produced. Includes production hygiene, process control and batch traceability.
- Sanitary performance: how the package behaves along the supply chain. Includes protection against contamination, food shelf life and the tests that prove performance.
Main references by market
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The current version of each standard, with the most recent amendments, must be checked at the official source before each project.
Why monitor continuously
Lists of authorized substances are updated periodically. In Brazil, RDC 963/2025, of February 20, 2025, amended RDC 326/2019 and added new substances to the positive list of additives, among them one with use restricted to antimicrobial agent, as reproduced by LegisWeb. In export markets, regulatory requirements follow the same logic of periodic revision. The article on European Union regulations on single-use plastics shows how a European regulatory topic changes the packaging of a product.
How to organize monitoring
- Map markets and categories: list the destination countries and the types of food each package holds.
- Keep a compliance matrix: relate each material and additive to the lists and limits of each market.
- Request documentation from suppliers: declaration of compliance, migration reports and batch traceability.
- Define owners: one person or team monitors the updates from the agencies of each market.
- Review the portfolio at each update: the result feeds R&D and purchasing planning.
Where antimicrobial technology fits
When a package receives antimicrobial technology, the project documentation brings together efficacy and migration data, and the regulatory framework of the destination market.
Frequently asked questions
Do packaging biosafety and food contact standards have the same scope?
Packaging biosafety brings together sanitary safety requirements across the whole supply chain. Food contact standards make up the part that deals with the substances in the material and with migration limits.
Does each country require different documentation?
Each market has its own lists, limits and declaration formats. For this reason, the survey by destination takes place at the start of the project.
How often do the standards change?
The lists of substances are updated periodically, as RDC 963/2025 shows in Brazil. Continuous monitoring keeps the company prepared for changes.
Next steps for your company
The starting point is the compliance matrix, with the destination markets, materials and additives of each package. From it, the team identifies where documentation is missing and which regulatory changes affect the portfolio. To see how this topic connects to the tests that prove performance, read the article on antimicrobial efficacy tests.
