Food-Contact Compliance Documentation: FDA Letter of Guarantee & EU Declaration

Overview #

When a brand partner ships packaging into the US or EU market, customs authorities and retail buyers increasingly ask for written proof that the packaging materials are safe for food contact — not just a verbal assurance, but a formal document with specific regulatory backing. This article covers the two most common compliance documents we issue for food-contact packaging: the FDA Letter of Guarantee (LOG) under 21 CFR, and the EU Declaration of Compliance (DoC) under EU Regulation No. 10/2011 for plastic materials, or EU Framework Regulation 1935/2004 for all food-contact materials. The brands that benefit most are those selling food, beverage, confectionery, nutraceuticals, or any product where the inner packaging surface contacts or is in close proximity to the consumable. The key technical insight: a compliant document is only as valid as the underlying material traceability chain — if your supplier cannot provide a full migration test report and substance declaration back to the raw material level, the document is not worth the paper it is printed on.

Regulatory Frameworks: FDA vs. EU — What Each Document Actually Requires #

The FDA Letter of Guarantee is a supplier-issued document, not a government-issued certificate. Under 21 CFR Part 174–186 (indirect food additives) and 21 CFR Part 176–177 (paper, paperboard, and polymers), the manufacturer guarantees in writing that the materials used comply with the applicable FDA regulations. There is no mandatory format, but the LOG must identify the specific CFR sections applicable to each material component, the intended food-contact use condition (e.g., single-use, aqueous food, fatty food, dry food), and the name and address of the guarantor — which is us, as the OEM manufacturer.

The EU Declaration of Compliance under EU 10/2011 is more prescriptive. It must include: the identity of the food-contact material or article, the date of declaration, the name and address of the business operator issuing it, the identity of the substance or material, the applicable EU regulation, and — critically — the results of migration testing or a calculation demonstrating compliance with the Overall Migration Limit (OML) of 10 mg/dm² and the Specific Migration Limit (SML) for any listed substance. For paper and board, the relevant standard is EN 645 (cold water extract) and EN 647 (hot water extract), and we reference these in every paper-based food-contact DoC we issue.

Material-Level Traceability: What We Require from Our Substrate and Ink Suppliers #

A compliance document is only as strong as the traceability chain behind it. When we onboard a new substrate or ink for food-contact applications, we require the following from every tier-1 supplier before we will issue any LOG or DoC to a brand partner:

• A full substance declaration listing all intentionally added substances (IAS) and, where known, non-intentionally added substances (NIAS) above 0.01 mg/kg
• Migration test reports conducted under EN 1186 (overall migration) or EN 13130 (specific migration), using food simulants A (10% ethanol, aqueous), B (3% acetic acid), C (20% ethanol), D1 (50% ethanol), D2 (vegetable oil), and E (dry simulant Tenax), as applicable to the intended food type
• For inks and coatings: confirmation that all colorants and photoinitiators comply with EuPIA (European Printing Ink Association) Exclusion List and, for UV-cured inks, that photoinitiator migration is below 0.01 mg/kg in the food simulant — the threshold below which no specific migration limit applies under EU 10/2011 Annex I

On our production floor, we maintain a live supplier compliance register updated quarterly. Any substrate or ink supplier that cannot provide updated migration data within 30 days of a formulation change is suspended from food-contact jobs until documentation is reinstated. We currently hold active compliance documentation for 14 paper and board grades and 9 ink systems approved for food-contact use.

For paperboard specifically, we specify virgin-fibre board (SBS — Solid Bleached Sulphate or FBB — Folding Box Board) for all direct food-contact applications. Recycled-fibre board is not used for direct food contact in our facility due to the risk of mineral oil aromatic hydrocarbons (MOAH) and mineral oil saturated hydrocarbons (MOSH) migration — a risk flagged in EFSA’s 2012 scientific opinion and still unresolved in EU legislation as of 2024. Our standard SBS grade for food-contact folding cartons is 270–350 gsm with a moisture content of 7–9% and a Cobb60 value below 25 g/m² on the food-contact side.

Quality Control and Document Issuance Process #

We do not issue compliance documents as a formality. Every LOG or DoC we produce goes through a three-stage internal review before it reaches the brand partner:

1. Material verification: The QC manager cross-checks the job’s bill of materials against our approved food-contact supplier register. Any unapproved material triggers a hold.
2. Document drafting: Our compliance team drafts the LOG or DoC referencing the specific CFR sections or EU regulation articles applicable to each material component. For EU DoCs, we complete all 14 mandatory fields per EU 10/2011 Article 15.
3. Sign-off: Thomas Wu (OEM Production Manager) reviews and countersigns. Documents are issued on company letterhead with batch number, production date range, and the specific job reference number.

Our standard turnaround for issuing a LOG or DoC alongside a production order is 5–7 working days from the date the final material batch is confirmed. For new material combinations not previously tested, we require 15–20 working days to obtain third-party migration test reports from our accredited laboratory partners (ISO/IEC 17025 accredited).

We also conduct annual internal audits against GB/T 4806.8-2016 (China’s national standard for paper and board in food contact) for any orders destined for the Chinese domestic market, ensuring our documentation covers all three major regulatory jurisdictions simultaneously where required.

Specification Notes for Brand Partners #

When you brief us on a food-contact packaging project, the first thing we need is the intended food type and contact conditions: is the packaging in direct contact with the food, or is there an inner liner or bag? Is the food aqueous, fatty, dry, or alcoholic? These answers determine which EU food simulants apply and which CFR sections we reference in the LOG. A common mistake we see is brands specifying “food-safe” without defining the contact scenario — a box that holds a dry biscuit in a sealed inner bag has a very different compliance requirement than a tray that directly contacts a fatty cheese.

Once we have the contact scenario confirmed, our process is: digital proof of the compliance document template in 3–5 working days, physical sample with accompanying draft LOG or DoC in 10–15 working days, and full production with final signed compliance documents issued within 5–7 working days of production completion. If your market requires third-party laboratory migration testing (common for EU retail buyers and some US grocery chains), add 15–20 working days for test report turnaround. We recommend building compliance documentation into your project timeline from day one, not as an afterthought at shipment.

Frequently Asked Questions #

Q1: What is the Overall Migration Limit that EU food-contact packaging must comply with, and how do you verify it?
A: The EU Overall Migration Limit under EU Regulation No. 10/2011 is 10 mg/dm². We verify compliance through migration test reports conducted by ISO/IEC 17025 accredited laboratories using the EN 1186 test method with the applicable food simulants. For paper and board, we additionally reference EN 645 and EN 647 cold and hot water extract tests.

Q2: What is your lead time for issuing a food-contact compliance document, and does it cost extra?
A: For materials already on our approved food-contact register, we issue the LOG or DoC within 5–7 working days of production completion at no additional charge — it is part of our standard OEM service for food-contact orders. If the project requires new third-party migration testing, the additional lead time is 15–20 working days and we will quote the testing cost separately.

Q3: Do you use recycled-fibre board for food-contact packaging?
A: No. We do not use recycled-fibre board for direct food-contact applications in our facility. The risk of MOSH and MOAH contamination — flagged in EFSA’s 2012 scientific opinion — means we specify virgin-fibre SBS or FBB board at 270–350 gsm for all direct food-contact folding carton jobs. This is a firm production policy, not a case-by-case decision.

Q4: Can you issue compliance documentation that covers both the US FDA and EU markets simultaneously?
A: Yes. We routinely issue a combined package: an FDA Letter of Guarantee referencing the applicable 21 CFR sections alongside an EU Declaration of Compliance covering EU 10/2011 and EU 1935/2004. For orders also destined for China, we add a GB/T 4806.8-2016 compliance statement. The three-jurisdiction document set is our standard offering for international food brand partners.

Q5: What happens if a UV ink photoinitiator is detected above the safe threshold in migration testing?
A: The threshold we work to is 0.01 mg/kg in the food simulant — below this level, no specific migration limit applies under EU 10/2011 Annex I. If a photoinitiator migrates above this level, we do not release the job. We reformulate with a compliant ink system from our approved register, retest, and only proceed once the result is below threshold. This has occurred twice in the past three years; both cases were resolved by switching to a low-migration UV ink system within 10 working days.

Planning a food-contact packaging project? Contact our team to request a complimentary specification review and sample quote.