FDA 21 CFR — US clearance for food-contact plastics
The US counterpart to EU 10/2011 — what you need for export into the US, and what we supply.
All plastic materials and products in the US that come into contact with food — relevant for export, US subsidiaries and international supply chains.
FDA 21 CFR is the part of the Code of Federal Regulations in which the US Food & Drug Administration governs food-contact materials. For plastics, Part 177 ("Indirect Food Additives: Polymers") is the main reference — it lists permitted polymers and additives with their respective use limits.
Unlike EU 10/2011 the FDA works more material- and use-specific: each polymer type has its own CFR paragraph (e.g. § 177.1520 for olefin polymers such as PE and PP).
Polymer compliance
The base polymer must fall under the specifications of the relevant CFR paragraph — for PE/PP typically 21 CFR § 177.1520.
GRAS or FCN-listed additives
All additives must either be classified as GRAS (Generally Recognized As Safe) or covered by a valid Food Contact Notification (FCN).
Conditions of use
CFR 21 defines conditions of use A–H, from frozen storage up to sterilisation temperature — each combination must be tested.
Extractables testing
Depending on the application, n-heptane, water and alcohol extraction tests at the relevant temperatures are mandatory.
FDA-compliant raw materials
We source FDA-compliant PE and PP pellets with documented 21-CFR specification and solid data sheets from the raw-material supplier.
Formulation review
Every additive (pigment, stabiliser, slip agent) is checked against GRAS/FCN lists and fixed in the project data sheet.
Extraction testing
On request we or an accredited lab run extraction tests matched to the intended service temperature and food type.
US compliance letter
We issue a "Letter of FDA Compliance" naming polymer, CFR paragraph, colorants and conditions of use — standard for US customers and customs.
Letter of FDA Compliance
Product-specific, referencing the 21 CFR paragraph(s) and permitted conditions of use.
Raw-material certificate from the pellet supplier
FDA specification and reference to the CFR paragraph of the polymer used.
Colorant / additive compliance evidence
GRAS or FCN references for every input material.
Extraction test report (optional)
On request, tailored to your conditions of use — n-heptane, water, ethanol.
Frequently asked questions
Is an EU 10/2011 DoC enough for the US market?
No. The FDA requires a separate 21 CFR statement. An EU DoC is a useful supporting document but does not replace an FDA compliance letter.
Does FDA 21 CFR also apply in Canada and Mexico?
Not directly — but both countries often accept FDA compliance as evidence in practice. Health Canada (Food Directorate) follows similar principles; Mexico refers to FDA and EU.
What if my process runs hotter than the FDA condition of use?
Then we need the actual temperature and exposure conditions — we size the tests accordingly. Many customers specifically have the "worst case" condition documented.
Need evidence for your audit?
We'll send the full compliance pack for your chosen product on request — often the same day.
More standards
Please note: All information on this page – in particular dimensions, technical data, material properties and application recommendations – is provided for general guidance only and is non-binding. The exact specifications tailored to your specific application are agreed on a binding basis as part of the quotation and order process.
Got a project?
Tell us about your requirement — we typically come back with a first assessment within 24 hours.