EU 10/2011 Declaration of Conformity for PP Containers
The three regulations that apply together
| Regulation | What it controls |
|---|---|
| (EC) 1935/2004 | Framework — no transfer that endangers health, changes composition or impairs taste; traceability required |
| (EU) 10/2011 | Plastics — the Union list of authorised substances, OML and SML limits, DoC requirements |
| (EC) 2023/2006 | Good Manufacturing Practice for food-contact materials |
A DoC that cites only 10/2011 is incomplete. Regulators expect the framework regulation to be referenced too.
What the DoC must contain (Annex IV)
- Issuer — name and address of the company issuing the declaration
- Manufacturer or importer — name and address
- Product identity — article type, material, reference, enough to identify it unambiguously
- Date of the declaration
- Statement of compliance with 10/2011 and 1935/2004
- Restricted substances — information on substances with specific migration limits
- Dual-use substances — additives that are also food additives
- Conditions of use — food types, contact time and temperature, surface-to-volume ratio used in testing
- Functional barrier confirmation, if a multilayer structure relies on one
The numbers behind it
| Parameter | Limit |
|---|---|
| Overall migration (OML) | 10 mg/dm² of contact surface |
| Overall migration, small articles | 60 mg/kg of food |
| Specific migration (SML) | per substance, Annex I |
| Standard test ratio for containers <500 ml or >10 L | 6 dm² per kg food |
The three questions buyers actually ask
"Is your DoC for this specific SKU or a general one?" A general document covering "PP containers" is weak. Annex IV requires identification of the product. If the DoC does not name your article, customs or the customer's auditor can reject it.
"What conditions of use does it state?" If it says "for dry food, 10 days at 40°C" and your customer fills hot soup, the DoC does not cover the real use. The conditions must match the application.
"Can you support it with test reports?" The DoC is a claim; the supporting file is the evidence. That file does not travel down the supply chain but must be available to authorities on request.
Where suppliers commonly fall short
- DoC issued in the factory's name only, while the customer sells under its own brand — the importer of record has no document in its own name
- Conditions of use copied from a template, unrelated to the actual product
- Test report from a non-accredited lab
- DoC older than the last recipe or resin change
FAQ
Who issues the DoC? The business operator placing the article on the market at that stage — in practice the manufacturer, and for private label, often the importer.
How often should it be renewed? When composition, process or legislation changes, or when new data appears. In practice, review annually.
Does a DoC cover the lid? Only if the lid is identified. Film lids and gaskets are separate materials and need their own coverage.
Next step
Tell us the destination market and the intended use (food type, temperature, contact time). We will confirm the DoC scope needed and what testing it requires.
Related reading
- EU Regulation (EC) 1935/2004 & (EU) 10/2011 Explained for Plastic Food Containers
- How to Read a Migration Test Report
- FDA 21 CFR 177.1520: What Your Supplier Must Provide
Models covered on this site: 470 ml PF-520 · 750 ml PF-GG750 · 950 ml PF-GG950 · see all models in this category.
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