In-Depth Guide to Food-Grade Packaging Safety Standards: Understanding FDA and EU Approval Requirements

May 19, 2025 • Sorbar

Food Packaging Technology Series

In the highly competitive world of food and beverage packaging, ensuring safety and compliance is critical. Brands targeting the European and North American markets must comply with stringent standards set by regulatory bodies such as the FDA (US Food and Drug Administration) and the EU (European Union). This article explores these standards, highlighting what they mean for packaging and the impact they have on brands.

Understanding FDA Approval

The FDA is responsible for regulating food contact substances in the U.S. to ensure they are safe for use. The following are key considerations:

1.  Food Contact Substance (FCS) Definition
The FDA considers any material that comes into contact with food to be a food contact substance. This includes packaging materials such as plastic films, coatings, adhesives, and even colorants.

2. Compliance with Title 21 of the Code of Federal Regulations
Title 21 of the Code of Federal Regulations outlines requirements for packaging materials. Compliance ensures that materials do not transfer hazardous substances into food that could affect the safety or quality of the food.

3.  Submission of a Food Contact Notification (FCN)
Companies must submit an FCN to the FDA for any new food contact substance. This involves rigorous testing to demonstrate safety under intended conditions of use.

4.  GRAS (Generally Recognized As Safe) Substances
Some materials may be considered GRAS, which means that experts believe they are safe under the intended conditions of use. These substances do not need to be submitted to the FCN, but must still comply with FDA regulations.

Navigating EU Certification

The European Union (EU) has its own set of regulations designed to safeguard consumer safety and has established comprehensive guidelines for food packaging materials.

1.  European Union Framework Regulation (EC) No. 1935/2004
This overarching regulation ensures that materials do not release harmful ingredients into food. It requires packaging materials to be produced using Good Manufacturing Practice (GMP).

2.  Specific measures for different materials
The EU has specific measures for different materials such as plastics, ceramics and recycled materials. For example, plastics must meet the requirements outlined in Regulation (EU) No. 10/2011.

3.  Declaration of Conformity (DoC)
Companies must provide a declaration of conformity for materials intended to come into contact with food, stating compliance with applicable regulations and providing traceability details.

4.  General and Specific Migration Limit
Testing Packaging materials must be tested to ensure that any substances that may migrate into food do not exceed established safety limits.

Addressing customer pain points

For our customers, especially those in the mid-sized food and beverage industry, these regulations can be daunting. Here’s how we can help:

1.  Expert Guidance and Consultation
With more than a decade of experience, our team can provide expert consultation to ensure your packaging complies with all FDA and EU requirements, helping you save time and resources.

2. Customized Solutions
We provide tailor-made packaging solutions, such as stand-up pouches with customized printing, which not only comply with regulatory standards, but also increase brand awareness and product freshness.

3. QUALITY ASSURANCE
Our state-of-the-art facilities and dual printing capabilities ensure that every project meets the highest quality standards from conception to delivery.

4. Flexibility and Efficiency
We understand the importance of competitive pricing and minimum order quantity flexibility, and therefore do not have minimum order quantities to meet your unique needs.

Conclusion
In the ever-evolving packaging industry, compliance with FDA and EU safety standards is critical to market success. At www.sorbar.com, we offer more than compliance; we offer a partnership that helps your brand confidently navigate these complexities through innovative, effective and safe packaging solutions. Trust our expertise and let us help you achieve excellence.

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