Injection molding

In the injection molding industry, you often hear requirements like this: "Our products are exported to Europe and the United States, so they must pass food-grade certification."

When it comes to the US and EU markets, what exactly is food-grade certification for plastic parts?

I. US market: FDA certification

Products exported to the United States usually need to comply with the regulatory requirements of the US Food and Drug Administration (FDA) (mainly referring to 21 CFR Part 177). FDA testing focuses on the chemical composition safety of materials.

• Core testing: mainly migration testing. Laboratories use solvents that simulate food (such as aqueous, acidic, and oily simulants) to soak plastic parts and detect how many chemical substances have migrated into the food.

• Proof of compliance: usually based on an FDA compliance test report issued by a third-party laboratory, or an FDA Letter of Guaranty provided by the upstream raw material supplier.

II. European/German market: LFGB and EU 10/2011

EU regulatory requirements are very strict. Among them, the most famous and most widely recognized is Germany's LFGB certification (the Food, Tobacco Products, Cosmetics and Other Commodities Management Act), and it must also comply with the EU framework regulation EU 10/2011.

In addition to testing chemical migration, LFGB's toughest point is the introduction of subjective testing:

• Sensory test: Professional testers use smell and taste to judge whether plastic parts, after contacting food, will cause the food to develop off-odors or change color. As long as there is a slight off-odor, it directly fails.

• Overall migration and specific migration: It is also necessary to test the release amount of specific harmful substances such as heavy metals (lead, cadmium), primary aromatic amines, and formaldehyde.

• Peroxide value test: For plastics that contact oily foods, test whether the oils and fats have been oxidized and deteriorated.

III. Why can finished products still fail even if the raw materials are compliant?

This is a pitfall that many foreign trade customers have stepped into. After obtaining food-grade raw materials, if the injection molding factory's process control is not in place, the finished products will still fail FDA or LFGB:

Non-compliant masterbatch and additives: The plastic pellets are food-grade, but in order to make the color look good, non-food-grade masterbatch is added, or toner containing heavy metals is used, directly causing excessive heavy metal migration.

Contamination from mold release agents: To make demolding easier during injection molding, workers spray ordinary industrial mold release agents. These chemicals remain on the product surface, and the test will definitely fail.

Excessive regrind (recycled material): To reduce costs, non-food-grade regrind is blended in, or the blending ratio is too high, damaging the material's original stability.

Release from mold materials: If the mold cavity rusts, or non-compliant polishing paste is used, it will also cause contamination on the product surface.

Injection Molding Materials - hainamould Mould Company Limted