Packaging described as food safe, food-grade or suitable for food contact is intended for use in contact with food under specified conditions. Such materials must meet the applicable legal requirements to ensure that they do not compromise food safety or adversely affect the quality of the packaged product.
Food-contact suitability is particularly important for plastic packaging, including polyethylene (PE) films, bags and other flexible packaging materials. These materials may come into direct contact with food during filling, storage, transportation and distribution.
A suitable food-contact material must not release its constituents into food in quantities that could endanger human health. It must also not cause unacceptable changes to the composition of the food or adversely affect its taste or smell.
However, the terms food safe, food-grade and suitable for food contact are not, by themselves, proof that a particular material is suitable for every food or every application. Suitability depends on the material's composition, the type of food, the contact time, the temperature and the intended conditions of use.
Are There Legal Regulations for Food-Safe Packaging?
Yes. Food-contact materials placed on the European Union market are subject to specific legal requirements. The principal framework legislation is Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. It establishes the general safety requirements for materials that may come into direct or indirect contact with food.
Under this regulation, materials must be manufactured so that, under normal or foreseeable conditions of use, they do not transfer their constituents into food in quantities that could:
- Endanger human health.
- Cause an unacceptable change in the composition of the food.
- Deteriorate the organoleptic characteristics of the food, including its taste and smell.
These requirements apply to food-contact materials across a range of material groups, including plastics, paper, cardboard, glass and metals, subject to the applicable rules for each material.
In addition to the general framework regulation, food-contact materials must comply with other applicable requirements, including the rules on good manufacturing practice under Commission Regulation (EC) No 2023/2006.
Official EU information is available from the European Commission's Food Contact Materials overview.
What Is Migration in Food Packaging?
Migration is the transfer of substances from a packaging material into the food it contacts. These substances may originate from the raw materials, additives or other components used during manufacturing.
Migration is an important factor in assessing the safety of food-contact materials. Its extent depends on several factors, including the chemical properties of the substances, the composition of the packaging material, the type of food, the contact time and the temperature.
For example, a packaging material intended for short-term contact with a dry food at room temperature may require a different assessment from a material intended for prolonged contact with fatty foods or for use at elevated temperatures.
To demonstrate compliance, migration testing may be carried out using food simulants. These are test media designed to represent particular food types and their interaction with packaging materials. The selected test conditions must reflect the intended or foreseeable conditions of use.
Migration testing helps establish whether the material complies with the applicable overall and specific migration limits. The results, together with other relevant technical documentation, support the assessment of food-contact suitability.
Which Regulations Apply to Plastic Food Packaging?
For plastic materials and articles intended to come into contact with food, Commission Regulation (EU) No 10/2011 is a key piece of specific legislation alongside Regulation (EC) No 1935/2004.
The plastics regulation establishes requirements concerning the substances used in plastic materials, applicable migration limits, testing procedures and documentation. It also specifies requirements for a written Declaration of Compliance (DoC) at the relevant stages of the supply chain.
Manufacturers and other responsible business operators must ensure that their materials comply with the applicable requirements for their intended use. This includes assessing the material composition and providing the necessary supporting documentation.
Compliance is not established solely by identifying a particular plastic type. For example, polyethylene is widely used in food packaging, but the suitability of a specific PE film depends on the complete formulation, including any additives, pigments and processing aids, as well as the intended conditions of contact.
Further information is available in the official text of Commission Regulation (EU) No 10/2011.
Which Plastics Are Suitable for Food Contact?
Several types of plastic can be used in food-contact applications when the specific material and its intended use comply with the relevant legal requirements.
Polyethylene (PE) is widely used for food packaging because of its useful combination of flexibility, moisture barrier properties, chemical resistance and processability. Depending on the grade and formulation, PE can be used to manufacture films, bags, liners and other packaging products.
However, not every polyethylene formulation is automatically suitable for food contact. The suitability of the finished material depends on the substances used, their permitted uses and restrictions, the manufacturing process and the conditions under which the material will contact food.
Other plastics, such as polypropylene (PP) and polyethylene terephthalate (PET), are also used in food packaging. Their suitability likewise depends on compliance with the relevant requirements and the intended application.
When selecting a plastic packaging material, it is therefore important to verify the compliance of the specific product rather than relying solely on the name of the polymer.
What Is a Declaration of Compliance (DoC)?
A Declaration of Compliance is a formal document used to confirm that a food-contact material or article meets the applicable legal requirements.
For plastic materials covered by Regulation (EU) No 10/2011, a written Declaration of Compliance must be available at the relevant stages of the supply chain, as specified by the regulation. The document identifies the material or article and confirms compliance with the applicable requirements.
Depending on the product and the information required, the declaration includes details that allow downstream users to assess whether the material is suitable for their intended application. This can include the types of food for which the material is intended, relevant time and temperature conditions, and other restrictions on use.
The declaration is supported by appropriate technical documentation. Such documentation may include migration test results, calculations, compositional information and other evidence demonstrating compliance.
A Declaration of Compliance is therefore an important part of the technical documentation for food-contact packaging. It should relate to the specific material or product and its intended conditions of use.
Are FDA-Approved Raw Materials Automatically Food Safe in Europe?
Not automatically. FDA compliance or authorisation under applicable United States requirements and compliance with European Union food-contact legislation are separate regulatory assessments.
A raw material that is permitted for a particular food-contact application in the United States is not necessarily sufficient to demonstrate that the finished packaging material complies with all applicable EU requirements.
For the European market, the relevant requirements of Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 where applicable, and other applicable legislation must be considered.
Similarly, the use of compliant raw materials alone does not automatically demonstrate that the finished packaging product is compliant. The complete formulation, manufacturing process, migration behaviour and intended conditions of use must be taken into account.
Where both European and US markets are served, the applicable requirements for each market should be assessed separately and supported by appropriate documentation.
How Can You Identify Food-Safe PE Film?
When choosing polyethylene film for food packaging, it is important to verify that the specific product is intended for the proposed application and that the relevant compliance documentation is available.
The following points should be considered:
- Material composition: The polymer, additives, pigments and other constituents must be suitable for the intended food-contact application.
- Migration compliance: The material must meet the applicable overall and specific migration limits.
- Intended food type: The suitability assessment must cover the relevant food categories, such as aqueous, acidic, alcoholic or fatty foods, as applicable.
- Contact time and temperature: The material must be suitable for the expected storage, processing and use conditions.
- Technical documentation: A relevant Declaration of Compliance and supporting documentation should be available where required.
- Manufacturing controls: Applicable good manufacturing practice requirements must be observed.
These considerations help ensure that the packaging material is appropriate for its intended use and provides reliable performance throughout the relevant food-contact conditions.
Our Approach to Food-Contact Packaging
The suitability of packaging for food contact depends on the materials used, the manufacturing process and the intended conditions of application. For this reason, food-contact compliance should be assessed for the specific product rather than assumed from the polymer type alone.
Our raw materials are selected with applicable food-contact requirements in mind. Where supported by the relevant product documentation, information about raw-material compliance, migration testing and suitability for the intended application can be provided to help customers evaluate their packaging requirements.
For applications requiring direct contact with food, we recommend confirming the intended food type, contact time, temperature and relevant market requirements before selecting a particular film.
This approach helps ensure that the chosen polyethylene packaging is appropriate for the application and that the necessary technical documentation is available to support its use.
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