Food Grade Masterbatch FAQ: FDA, EU 10/2011, and Compliance

Food Contact Compliance Questions

Coloring plastics for food and beverage contact requires strict regulatory compliance. This FAQ answers the most common questions about food-grade masterbatch, covering FDA, EU 10/2011, migration testing, and documentation.

What makes masterbatch food-grade?

Food-grade masterbatch uses pigments and carrier resins approved for food contact, with migration of substances below regulatory limits. Compliance is verified through migration testing under simulated use conditions.

What regulations apply to food-contact masterbatch?

The main regulations are FDA 21 CFR (US), EU 10/2011 (EU), and GB 9685 (China). Each specifies approved substances and migration limits for food-contact plastics.

What is migration testing?

Migration testing measures how much of a substance transfers from the plastic into food. It uses food simulants (water, acetic acid, ethanol, oil) under standardized time and temperature conditions, then compares results to specific migration limits (SML).

What pigments are approved for food contact?

Common approved pigments include titanium dioxide, iron oxides, carbon black (with purity requirements), ultramarine blue, and selected phthalocyanine pigments. Each must meet specific purity and migration requirements.

Do I need to test my finished product?

Yes. While the masterbatch supplier provides compliance documentation, the finished article manufacturer is ultimately responsible for compliance. Testing should be done on the final product at the maximum intended loading ratio.

What documentation should I receive?

You should receive a declaration of compliance (DoC), migration test reports, heavy metal analysis, and — where applicable — FDA or EU 10/2011 conformity statements.

Is the carrier resin part of food-contact compliance?

Yes. The carrier resin must also be food-contact approved. Using a non-approved carrier in an otherwise compliant masterbatch can cause the whole formulation to fail compliance.

Does TiO2 in food contact have restrictions?

The EFSA 2022 opinion on TiO2 as a food additive (E171) does not affect TiO2 in food-contact plastic. However, market uncertainty exists, and some brands are moving to TiO2-reduced formulations — discuss this with your supplier.

Conclusion

Food-grade masterbatch requires approved pigments, compliant carriers, migration testing, and complete documentation. MHK Color provides FDA/EU 10/2011/GB 9685 compliant masterbatch with full compliance documentation. Contact our regulatory team for your food-contact requirements.