What the declaration is for
A declaration of compliance, often shortened to DoC, is a written statement from a business in the supply chain that a material or article meets the food contact rules of a market, for stated conditions of use. In the European Union, Regulation (EU) 10/2011 requires a written declaration for plastic materials and articles at each marketing stage other than retail, and Regulation (EC) 1935/2004 sets the framework. In the United States, there is no single required form, but a supplier declaration referencing 21 CFR, for PP usually 21 CFR 177.1520, is the standard way of showing compliance, because FDA does not approve finished containers.
The declaration matters because it is the document a retailer, an importer or a market authority asks for first. If it is vague, everything that rests on it, from the label to the listing, is exposed.
Resin declaration or article declaration
The most common document a buyer receives is the resin producer's declaration: a well formatted statement that a PP grade complies with EU 10/2011, GB 4806.7-2023 or 21 CFR 177.1520. It is real and useful, but it is an intermediate document. It covers the resin as it left the producer. The partner plant then adds masterbatch, sometimes recycled content, processing heat and, for some items, printing on the outside. The finished container needs its own declaration from the partner plant, which can rely on the resin declaration as part of its evidence.
A quick test: if the declaration names a resin grade and not your item, it is a resin declaration. Ask for the article declaration as well.
What a complete declaration contains
| Element | What it should say | Common gap |
|---|---|---|
| Issuer | Name and address of the partner plant issuing it | Trading company named instead of the plant |
| Item | Model, size, colour; for example 750 ml box, 170x115x51 mm, clear | Generic product family only |
| Parts and materials | Base, lid and inserts, each with its material | Lid not mentioned |
| Regulations | EU 1935/2004 and 10/2011, 21 CFR 177.1520, GB 4806.7-2023 as relevant | One market only, or a regulation that does not apply |
| Conditions of use | Food types, maximum temperature and time, microwave or freezer use, single or repeated use | Missing entirely |
| Evidence | Reference to migration test reports and resin declarations | No report reference |
| Substances with limits | Substances with specific migration limits or dual-use additives, where relevant | Omitted |
| Date and signature | Date of issue and an authorised signature | Undated or unsigned |
The conditions of use line deserves the most attention. In US terms it is often expressed as conditions of use from 21 CFR 176.170(c), graded A to H. In EU terms it is a description of food types, contact time and temperature, and for articles, the ratio of surface to volume the compliance was checked at. A declaration without conditions of use cannot be matched to your program.
Matching the declaration to the item
Once the declaration arrives, the desk checks it against the item in four steps:
- The model, size and colour on the declaration match the cut sheet and the approved sample.
- Every part that touches food is covered, including a lid of a different material.
- The conditions of use cover the program: hot fill, freezer, microwave or repeated use.
- The test reports referenced exist, match the item and cover the simulants and conditions; see migration testing explained.
When a step fails, the fix is usually straightforward: a revised declaration from the partner plant, an added lid, or a fresh test for a new colour. The fix is cheaper at the sample stage than after shipment.
Change control
A declaration is valid for the item as described. If the partner plant changes the resin grade, the masterbatch supplier, the recycled content or the lid material, the basis of the declaration changes too. The order specification should state that changes to any food contact part are notified in writing before production, and the declaration is reissued where needed. This clause matters most on repeat orders, months after the first approval, when a substitution can happen quietly. The desk records resin grade and lot against each production batch for this reason; see quality control.
Language, format and multi-market files
Declarations from Chinese partner plants are often issued in Chinese against GB 4806 and translated for export. That is fine, provided each market gets a declaration that names its own rules. A single document that lists GB 4806.7-2023, EU 10/2011 and 21 CFR 177.1520 together can work, but only if the evidence behind it covers all three, and each regulation has different test logic. For a program shipping to the US and the EU, the desk usually asks for one article declaration per market, in English, on the plant's letterhead, with the same item description and the same reference to the approved sample. Keeping the item description identical across documents is what lets an importer match them in seconds.
Paper and fibre items
Paper boxes need their own file. In China GB 4806.8 covers paper and board for food contact. For the United States, the question that comes up most often for paper and plant fibre is PFAS: California AB 1200 has banned intentionally added PFAS in plant fibre food packaging since 1 January 2023, with a screening line of 100 ppm total organic fluorine, and at least 13 states restrict PFAS in food packaging in some form. A statement on intentionally added PFAS from the partner plant belongs in the same file as the declaration. Windows in PET or PVC on a bakery box are covered as non-heated parts.
Who issues what
Declarations and test reports are issued to partner plants or to your brand per project. Lidwell does not issue declarations in its own name and does not hold certificates. The desk requests the documents, checks them against the item and the market, and keeps them in the program file so repeat orders start from a verified set. Where your brand is the business placing the item on the market, your own declaration may be needed; confirm the requirements with your test lab or counsel. The compliance guide lists the documents by market, and compliance and certifications explains how the file is kept.
To start a program with the document file planned in, send the items and target markets through the quote form.