Food-Grade FIBC: The EU Declaration of Compliance Explained

A company producing food in the European Union must be able to document that the big bag carrying its ingredients is suitable for food contact. That document is the Declaration of Compliance (DoC).

It is one of the first documents requested in audits, and if it is missing, the non-conformity falls not only on the packaging supplier but on the food manufacturer as well.

This article explains the legislation behind the declaration, the information it must contain and what to check when you receive it from your supplier.

1. Which legislation applies?

Three regulations apply together:

• Framework Regulation (EC) 1935/2004: The basic rule for all food-contact materials. A material must not transfer substances to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food, or impair its taste and odour. It also makes traceability mandatory.
• Plastics Regulation (EU) 10/2011: Detailed rules for plastic materials. Big bag fabric (polypropylene) and liners (polyethylene and other polymers) are subject to it. This is also the regulation that requires a written declaration of compliance.
• Good Manufacturing Practice Regulation (EC) 2023/2006: Requires food-contact materials to be manufactured under a quality assurance and quality control system.

2. The basic limits: migration

“Migration” is the transfer of substances from the packaging into the food. The Plastics Regulation sets two kinds of limit:

• Overall migration limit: The total of all substances migrating from the packaging into the food must not exceed 10 mg per square decimetre (10 mg/dm²) of contact surface.
• Specific migration limits: Lower limits set individually for certain substances.

In addition, only monomers and additives on the regulation’s list of authorised substances may be used to manufacture the plastic.

3. How is a migration test carried out?

Instead of real food, the test uses “food simulants” that mimic the behaviour of food. Which simulant is used depends on the type of food to be packed: there are different simulants for aqueous, acidic, alcoholic, fatty and dry foods.

Most products carried in big bags (flour, sugar, starch, milk powder) are dry foods. For dry foods the regulation defines food simulant E, a porous polymer known by the trade name Tenax.

The test conditions (time and temperature) must reflect the actual use of the product. For big bags this is usually long-term storage at room temperature; the standard overall migration test condition defined in the regulation for this use is 10 days at 40 °C.

4. What must the declaration of compliance contain?

Annex IV of Regulation (EU) 10/2011 sets out the content of the declaration. The declaration you receive from your supplier should include:

1. The name and address of the company issuing the declaration
2. The name and address of the manufacturer (or importer)
3. The identity of the product (big bag type, liner, material)
4. The date of the declaration
5. Confirmation that the product complies with (EU) 10/2011 and (EC) 1935/2004
6. Adequate information on substances subject to restrictions (substances with a specific migration limit)
7. Information on substances that are also used as additives in food (“dual-use” substances)
8. Conditions of use: the food types it may come into contact with, for how long and at what temperature; and the surface-to-volume ratio used in testing
9. For multi-layer materials, confirmation regarding any functional barrier used

Behind the declaration there must be supporting documents (test reports, raw material declarations) that can be presented to the competent authorities on request.

5. What to check when you receive the declaration

• Date: Is the declaration up to date? It should be renewed when raw materials, the production process or legislation change.
• Scope: Does it cover the product you are buying (that liner, that fabric), or is it a general document?
• Conditions of use: Does the food type in the declaration match your product? A declaration issued for dry food may not be valid for a fatty product.
• Contact layer: In a big bag with a liner, the surface in contact with the food is the liner; the declaration must explicitly cover the liner.
• Test report: Is it from an accredited laboratory, and what is its date?

6. A new addition: PPWR and PFAS

The EU Packaging and Packaging Waste Regulation (PPWR), which has applied since 12 August 2026, introduced separate limits for PFAS (“forever chemicals”) in food-contact packaging. In addition to the food-contact declaration of compliance, a PPWR declaration of conformity may also be requested.

Read more: PPWR and FIBC Big Bags

7. At Karaca Ambalaj

For the food-grade big bags manufactured in its BRC IoP AA certified facility in Turkey, Karaca Ambalaj provides its customers with a declaration of compliance with (EC) 1935/2004 and (EU) 10/2011.

Contact us about the documents required for your product.

Related articles: Choosing Big Bags for Food Manufacturers · BRC IoP Certification: Why It Matters for Food Packaging

This article is for general information only and does not constitute legal advice. The binding texts are the current versions of the regulations as published on EUR-Lex.