Materials are ‘food grade’ if they are suitable for food contact or production, taking into account their intended use, and if they do not migrate into the food, contaminate the food or taint it.
A food grade declaration states that only substances are used which are mentioned in authorised lists such as the Union List in Regulation (EU) 10/2011 for plastic food contact materials.
Purpose
The declaration should confirm that the raw materials used for manufacturing plastic food contact materials and articles comply with Regulation (EU) 10/2011 and its amendments. It is essential to ensure that only authorised substances (monomers, additives, and starting aids) are used, and that all relevant restrictions are clearly stated.
Without the help of such a declaration, a test protocol cannot be composed for the manufactured food contact material or article. Subsequently, without this test protocol, it is impossible to draw up a valid Declaration of Compliance for the manufactured food contact material or article.
Mandatory
Article 17 of Framework Regulation (EC) 1935/2004 requires traceability of materials intended for food contact to ensure compliance and safety throughout the supply chain. Regulation (EU) 10/2011 provides specific rules for plastic materials, including the so-called Union List of authorised substances and applicable restrictions (e.g., migration limits or concentration). To comply, businesses must maintain technical specifications of raw materials (e.g., granulate or resin) and provide a food-grade declaration referencing to the Union List, detailing any substances with migration limits or other restrictions, ensuring the material’s suitability for food contact applications.
Key elements
The key elements of a food grade declaration are:
- Identification of substances
Authorised monomers and additives:
Only substances listed in the Union List, Annex I of Regulation (EU) 10/2011, should be used.
These include:
- Monomers (starting substances used in plastic production);
- Additives (such as stabilisers, plasticisers, and antioxidants);
- Starting aids (substances assisting in the polymerisation process but not remaining in the final material).
- Compliance with restrictions
If any of the substances are subject to specific migration limits (SML), or any other restriction (such as specific food types or use conditions), they must be explicitly mentioned.
Example wording:
“This material contains [substance name], which is subject to a specific migration limit (SML) of [X mg/kg]. The material complies with these limits under the specified conditions of use.”
- Dual use additives
These are additives that are authorised for use in both food contact materials and food additives (or flavourings). It is critical to declare if any dual-use substances are present.
Example wording:
“The material contains the following dual-use substances: [substance name(s)], which comply with the restrictions and safety assessments under both (EU) No 10/2011 and applicable food regulations.”
- Test protocol considerations
This declaration is essential for enabling downstream users (manufacturers of the final articles) to perform migration testing on the finished product. The declaration must provide adequate details on:
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Migration conditions: Indicate the food types, time, and temperature conditions under which compliance has been verified.
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Specific Restrictions: Include the specific restrictions of substances that are subject to testing in the final article.
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Intended Use Conditions: Clarify any limits or conditions of use for the material (e.g., for contact with aqueous, fatty, or acidic foods).
- Conclusion and signature
The declaration should be signed by a responsible person, along with the date and company information, confirming that all relevant aspects of the regulation have been adhered to.
