Regulation explainer
Common Mistakes Importers Make Under EU Regulation 10/2011
small importers and resellers shipping to European Union. Drafted with AI assistance from the regulation dataset and approved by a person before publication; see the editorial policy.
Guide
Shipping plastic food contact items into the EU without understanding EU Regulation 10/2011 is one of the easiest ways to get goods held at the border. Here are the mistakes small importers and resellers make most often, and what to do instead.
**Mistake 1: Accepting "food safe" as proof of compliance**
A supplier telling you a product is "food safe" is not documentation. EU Regulation 10/2011 requires a formal Declaration of Compliance (DoC) that states the product meets the regulation's requirements. Without a DoC, you have no paper trail if customs or a market authority asks for one. Ask your supplier for the DoC before you place the order, not after the shipment arrives.
**Mistake 2: Treating overall migration and specific migration as the same thing**
Some importers assume one test covers everything. It doesn't. Overall Migration (OM) testing checks the total amount of material that can transfer into food, capped at 10mg/dm². Specific Migration Limits (SML) are separate limits for individual substances. You need both a Migration Test Report (using methods like EN 1186 or EN 13130) and confirmation that individual SMLs have been checked, not just the overall figure.
**Mistake 3: Ignoring substance-specific limits**
EU Regulation 10/2011 sets tight limits on specific substances, including BPA (0.05 mg/kg food), styrene (0.1 mg/kg food), formaldehyde (15 mg/kg food), lead (0.01 mg/kg food), and cadmium (0.01 mg/kg food). Assuming your material is "probably fine" because it looks like previous shipments is not a substitute for testing. Get the SML results for each substance relevant to your product's material and colourants.
**Mistake 4: Skipping traceability records**
Under EU Regulation 10/2011, you need to be able to trace materials back through the supply chain. Importers who don't keep traceability records have no way to identify which batch or supplier a problem came from if an issue is raised later. Keep records for every batch, not just a general file for the product line.
**Mistake 5: Not asking for a Material Safety Data Sheet**
An MSDS gives details on the material composition and handling. Some importers only collect it if asked by a customer, which is too late if a regulator requests it first. Request the MSDS alongside the DoC and test reports as a standard part of onboarding any new supplier.
The common thread is the same: documentation needs to be collected before goods move, not chased down after a query arrives. If you want help keeping [EU Regulation 10/2011](/regulations/eu-10-2011) documents and [supplier compliance](/supplier-compliance) records organised, take a look at how Complyra can help.
Complyra checks product and supplier information against regulatory requirements to support procurement decisions. It does not issue certifications or guarantee legal compliance; final responsibility for compliance remains with the buyer and supplier.
Related
Regulation reference
- EU Regulation 10/2011 — Plastic Food Contact Materials — scope, documents and limits from the dataset