How the latest regulatory changes on food contact materials in the EU and Spain affect the food industry, and what kind of solutions are being adopted in the food industry to comply with current legislation.
New European Union (EU) and Spanish regulations on food contact materials (FCM) are profoundly transforming the food industry. These regulations seek to ensure consumer safety, foster sustainability and promote innovation in materials used for food packaging and storage.
Key changes in European and Spanish regulations
The EU has implemented a number of regulations that directly affect CSFs:
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Regulation (EU) 2025/351: Entered into force in March 2025 and amends previous rules such as Regulation (EU) 10/2011. It introduces stricter requirements on the purity of substances used in plastics, especially recycled plastics, and reinforces good manufacturing practices.
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Ban on Bisphenol A (BPA)From January 2025, the use of BPA and its derivatives in food contact materials is banned due to its health risks.
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Regulation (EU) 2022/1616: Establishes conditions for the safe use of recycled plastics in contact with food, including traceability and quality control requirements.
In Spain, the Spanish Agency for Food Safety and Nutrition(AESAN) supervises the implementation of these regulations, ensuring that materials do not transfer harmful substances to food or alter their properties.
Solutions adopted by the food industry
To comply with these regulations, the food industry has adopted various strategies:
1. Reformulation of materials
Companies are eliminating banned substances such as BPA and looking for safe, EU-approved alternatives. This involves reviewing and modifying the compositions of materials used in packaging and utensils.
2. Implementation of good manufacturing practices (GMPs)
More stringent GMP protocols are being adopted to ensure that production processes minimize contamination risks and meet food safety standards.
3. Use of safe recycled materials
With the drive for a circular economy, companies are incorporating recycled plastics into their products, provided they meet the purity and traceability requirements established by regulations.
4. Innovation in sustainable materials
New biodegradable and compostable materials are being developed and used, such as bioplastics derived from renewable sources, which comply with regulations and respond to the demand for sustainability.
5. Conformity assessment and certification
Companies perform migration tests and other analyses to ensure that their products comply with regulatory limits. In addition, they obtain certifications that endorse the safety of their food contact materials.
Regulations and official sources for consultation
These are some of the resources to be used to go deeper into the subject and ensure compliance with current legislation, in addition to those indicated in the first section:
Legislation in force
Yes, the regulations you mention are still in force in 2025, although some have been modified or supplemented by new provisions. Below, I detail the current status of each one:
1- Regulation (EC) No. 1935/2004
This regulation establishes the general principles for all materials and articles intended to come into contact with food. It remains the legal basis in the European Union for ensuring that these materials do not transfer components to food in quantities that may be harmful to human health.
2- Regulation (EU) no. 10/2011
This specific regulation for plastic food contact materials and articles details the permitted substances and migration limits. It has been amended by Regulation (EU) 2025/351, which introduces stricter requirements on the purity of substances used in plastics, especially recycled plastics, and reinforces good manufacturing practices.
This regulation regulates the use of recycled plastics in contact with food, establishing requirements to ensure their safety. It has been amended by Regulation (EU) 2025/351 to update the conditions for the safe use of recycled plastics, including traceability and quality control requirements.
4-Regulation(EC) No. 2023/2006
This regulation defines good manufacturing practice for materials and articles intended to come into contact with food is still in force. It has been amended by Regulation (EU) 2025/351 to strengthen the requirements related to the quality control and manufacture of plastic materials and articles intended to come into contact with food.
This royal decree establishes the positive list of substances permitted for the manufacture of polymeric materials intended to come into contact with foodstuffs in Spain. It is still in force, but it is expected to be modified to adapt to new European regulations and scientific advances.
6- Royal Decree 846/2011
This royal decree regulated the conditions to be met by raw materials based on recycled polymeric materials for use in contact with foodstuffs in Spain. It has been repealed by Regulation (EU) 2025/351.
Institutional agencies and resources for consultation
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Spanish Agency for Food Safety and Nutrition (AESAN): Provides detailed information on the regulations applicable in Spain and related technical documents.
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European Food Safety Authority (EFSA): Provides scientific assessments and advice on food contact materials.
What should food industries consider when purchasing packaging or food contact materials?
To ensure regulatory compliance and food safety, industries should consider the following key aspects when selecting suppliers of food contact materials:
Declaration of Conformity (DoC)
All material must be accompanied by a written statement certifying that it complies with applicable legislation, such as Regulations (EU) 1935/2004, 10/2011, and 2023/2006. This must include:
- Manufacturer and product identification
- List of materials used
- Confirmation of compliance with migration limits
- Intended conditions of use (temperature, time, type of food)
2. Migration tests
Suppliers must provide analysis results demonstrating that the containers comply with the overall and specific migration limits under the intended conditions of use.
3. Certification and traceability
It is essential that materials have documented traceability from manufacture to delivery. Traceability facilitates rapid product recall in the event of an incident.
4. Audits and quality controls
Evaluate if the supplier implements Good Manufacturing Practices (GMP) according to Regulation (EC) 2023/2006. It is also advisable to periodically audit their production processes.
5. Food compatibility
The type of material must be suitable for the specific food with which it will be in contact (acidic, fatty, aqueous, etc.) and for the process (freezing, cooking, microwave).
6. Sustainability and environmental compliance
Verify whether the materials also comply with environmental criteria and waste regulations, such as the use of recycled plastics certified under Regulation (EU) 2022/1616.
These precautions not only ensure legal compliance, but also strengthen consumer safety and the company’s reputation in the marketplace.
Conclusion
In 2025, the food industry faces a more demanding and dynamic regulatory environment than ever before. With the entry into force of new regulations, companies must review and adapt all processes related to packaging and utensils that are in contact with food.
It is therefore essential to work with suppliers that guarantee regulatory compliance, traceability and food safety, backed by up-to-date technical documentation. And with machinery manufacturers that are up to date in the manufacture of machinery and components.
At MarCoPack we manufacture filling, capping and labeling machinery that adapts to the latest legal requirements. If you are looking for equipment that complies with current regulations, we can help you, contact us.
Jose Martínez
Director Oficina Técnica MARCOPACK
