FDA 21 CFR: American compliance for components in contact with food

You export technopolymer components to the USA and your customer asks for FDA compliance. The European certification you already have (EU Reg. 10/2011) isn't enough: the American system works differently, and understanding the differences lets you respond precisely instead of deferring the matter to the material supplier.

Structure of 21 CFR

The Code of Federal Regulations Title 21 (21 CFR) is the collection of American federal regulations on food, drugs and medical devices, issued by the FDA (Food and Drug Administration). For plastic materials in contact with food, the main sections are Part 177 (Indirect Food Additives: Polymers) and Part 178 (Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers).

The logic is different from the European one. The 21 CFR lists, for each type of polymer, the permitted conditions of use: type of food, maximum temperature, conditions of use. You don't find a single centralized positive list as in the EU, but a series of sheets per material.

Differences with the European regulation

When you go from EU to USA, you aren't only changing the regulatory label: the system logic changes.

The 21 CFR doesn't impose systematic migration tests. It specifies instead the permitted composition and the conditions of use. EU Reg. 10/2011, on the contrary, requires migration tests and a formal declaration of conformity. The 21 CFR is more prescriptive on the material composition; the EU regulation is more up to date on previously unregulated substances, thanks to the recent amendments.

Self-affirmation: the American mechanism

Not everything you use is explicitly listed in the 21 CFR. For substances not covered, the FDA recognizes two alternative paths: GRAS (Generally Recognized As Safe, substances recognized as safe on the basis of scientific consensus) and FCN (Food Contact Notification, a formal notification to the FDA).

Many technopolymer manufacturers for food use have chosen the self-affirmation route: they document internally the complete toxicological assessment of the material under the foreseen conditions of use and make this documentation available on request. If your supplier has taken this road, you can market the component as food-contact compliant even when the specific formulation doesn't appear in the 21 CFR.

What to ask the material supplier

For a component intended for the American market, request from the supplier:

1. The 21 CFR section applicable to the specific material in the marketed formulation
2. Any usage limitations: temperature, type of food, conditions of use
3. The self-affirmation document or the GRAS notification, if available

Always ask that the compliance letter refer to the exact commercial formulation, not to the generic base polymer.

Colorants and additives: the critical point

The base polymer (POM, PA, PEEK) in the natural formulation, that is, the raw white or ivory, is generally compliant with the applicable 21 CFR sections. The problems arise when colorants, functional additives (fillers, internal lubricants, UV stabilizers) and composite materials such as glass-fiber reinforced PA or POM with graphite come into play.