Regulations and Updates on Food Contact Packaging: What Manufacturers Need to Know

When a packaging (or conveyor belt, coating, rubber, etc.) comes into direct or indirect contact with food, it’s not just a technical matter: it’s a public health issue, legal responsibility, and customer trust. Therefore, companies in the sector must ensure their materials comply with strict regulations to avoid unsafe migrations of chemical substances, undesirable odors, flavors, or risks to consumers.

The document you shared—a declaration of conformity for a rubber food belt, mentioning compliance with FDA, Regulation (EC) 1935/2004, Regulation (EU) 10/2011, REACH, phthalate ban, etc.—is a good example of the type of certifications customers may require to ensure product traceability and safety.

In this article, I will review the European legal fundamentals, practical obligations for manufacturers, and some recent regulatory updates to watch out for.

European Regulatory Framework: The “General Framework” and Specific Standards

Regulation (EC) 1935/2004: Basic Principles and Scope

This regulation is the cornerstone for all materials and objects intended to come into contact with food in the EU.

Its basic principles are:

• Materials must be manufactured according to good manufacturing practices (GMP) so that, under normal or foreseeable conditions of use, they do not transfer their components to food in quantities that:
  • Pose a danger to human health, or
  • Cause an unacceptable change in the food’s composition, or
  • Alter organoleptic characteristics (odor, taste, texture).
• Adequate technical documentation, traceability, declaration of conformity, labeling, and user information must exist.
• In practice, this regulation serves as the basis for specific materials (plastics, ceramics, active/intelligent, etc.) to have their own specific regulations.

Regulation (EC) 2023/2006: Good Manufacturing Practices (GMP)

Complementing the general framework, this regulation defines how internal manufacturing procedures, controls, verification, traceability, etc., should be organized to ensure consistency in the quality and safety of food contact materials.

Specific Regulation for Plastics: Regulation (EU) 10/2011

For materials based (wholly or partially) on plastics, there is specific legislation containing:

• Positive lists of permitted monomers, additives, migration limits, and purity requirements.
• Specific testing rules with food simulants, surface/volume ratio formulas, etc.
• Scope including plastic films, multilayers, plastic coatings, adhesives in plastic layers, etc.

Thus, we mention in our certificate that the food belt complies with Regulation (EU) 10/2011 for plastic components, which is key to demonstrating that those controllable parts have been evaluated to the highest standards.

Other Relevant Regulations: REACH, 450/2009, 2024/3190 (BPA), etc.

• REACH (Regulation (EC) 1907/2006): Regulates chemicals in general in the EU. In the context of food packaging, it’s important that components are not subject to restrictions or are authorized for food contact use.
• Regulation (EC) 450/2009 on active and intelligent materials: Applies when packaging has additional functions (oxygen absorption, compound release, sensors, etc.). In those cases, active components must be specifically authorized, considered ingredients, clearly indicate their function, etc.
• Recent regulation on BPA and bisphenols: In January 2025, the EU adopted Regulation (EU) 2024/3190, which reviews the use of BPA and other bisphenols in food contact materials, amending Regulation 10/2011, and setting market deadlines for articles containing them.
  • Single-use articles made with BPA that were compliant before January 20, 2025, may be marketed until July 20, 2026, and remain on the market until January 20, 2029.
  • The list of substances under 10/2011 is modified to remove BPA, BPS, and other declared hazardous bisphenols.

This reform is particularly significant for those designing packaging or coatings with polymers that might incorporate such compounds.

What a Declaration of Conformity Should Contain and What Controls to Perform

For customers to trust your food product (packaging, rubber belts, coatings, etc.), the required documentation includes:

1. Written declaration of conformity: Specify which regulations are met (e.g., 1935/2004, 10/2011, REACH, etc.), migration analyses (water, hexane, or other simulants), lab reports, batch number, traceability, statement that no hazardous substances are released.
2. Supporting technical documentation: Material description, composition, production process, testing methods, total and specific migration results, purity, residual limits, etc.
3. Analytical tests: Overall migration, specific migration, tests under more demanding temperature/time conditions, according to intended use.
4. Traceability: Identify raw materials, suppliers, production phases, final batch, distribution.
5. Adequate labeling: Indicate “suitable for food contact” or symbol (glass and fork), usage instructions, temperature limits, warnings if necessary, manufacturer identity, etc.
6. Review on changes: If you change formulation, supplier, process, you must reassess conformity.

Many of these elements—analyses in water and hexane, compliance with national regulations (RD 847/2011 in Spain), phthalate-free, REACH compliance, and polycyclic aromatic hydrocarbons regulations (EU Regulation 835/2011)—demonstrate alignment with the highest technical standards.

What Risks Arise from Non-Compliance?

• Migration of toxic substances to food (lead, phthalates, unreacted monomers, unauthorized additives).
• Alteration of food taste, odor, or color, affecting sensory quality and consumer perception.
• Market withdrawals, legal sanctions, liability to consumers or health authorities.
• Loss of trust from customers or distribution chains, due to lack of traceability or compliance demonstration.

Key Regulatory Updates to Watch (2025 Onward)

• The BPA and other bisphenols restriction mentioned above, with its transition schedule, requires reviewing polymer and resin formulations used in food contact.
• Possible future modifications to Regulation 10/2011 or other specific standards, as knowledge of emerging risks advances (nanoparticles, unknown substances, etc.).
• Increased regulatory pressure on recycled materials in food contact: In some cases, they must meet additional requirements (like Royal Decree 846/2011 in Spain) for recycled plastics in food contact.
• Harmonized monitoring of mineral oil hydrocarbons (MOH) in food and food contact materials (EU Recommendation 2017/84).
• Greater emphasis by customers and institutions on independent certifications (third-party audits and tests) to validate real compliance.

Practical Advice for Manufacturers of Food Contact Packaging or Belts

1. From the design phase, choose raw materials with a history of food contact use and positive lists (or previously authorized substances).
2. Conduct migration studies (overall and specific) with accredited labs before launching the product or whenever something relevant changes.
3. Maintain rigorous internal controls, quality protocols, records (traceability), and documented change management.
4. Accompany products with a clear declaration of conformity, with applicable standards, testing method, and usage warnings if applicable.
5. Stay informed on regulatory updates (like the BPA reform) to anticipate and adapt formulations.
6. In composite materials (e.g., rubber over metal, rubber with coatings), ensure each part complies with its specific regulation or technical agreement.
7. Verify compatibility with intended uses: temperature, cleaning, prolonged contact, food types (fatty, acidic, alcoholic), etc.

Conclusion

This type of documentation detailing compliance with European standards, migration tests, absence of phthalates, traceability, and certifications is exactly what is expected today as a quality standard in the international food contact products market.

For customers (food manufacturers, distributors, packaging industries), communicating that conveyor belts, packaging, or components have passed those controls and comply with the strictest standards provides peace of mind, reduces risks, and gives a competitive edge over uncertified products.