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A fundamental requirement for food-grade thermoplastic machining companies is to produce food-grade plastics that meet the stringent requirements of the U.S. Food and Drug Administration (FDA) regulations and European regulations for products intended to come into contact with food. (FDA) and European regulations for products intended to come into contact with food. Ensinger has the solution: In addition to our portfolio of standard engineering thermoplastics, we also offer a special portfolio of food contact plastics that meet the specific safety and performance demands of the food industry.
Ensinger attaches to its materials a specific certificate that the product is suitable for food contact certifying that the raw materials are FDA-approved and that Regulation (EC) No. 1935/2004, (EU) No. 10/2011 (migration testing for semi-finished plastic products) and (EC) No. 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with foodstuffs are complied with.
How do I know if a product is fda approved?
This means that the Post Consumer Recycled Polyethylene Terephthalate (PCR-PET) produced by Alcamare is suitable for use at levels of up to 100% recycled content in the manufacture of single-layer packaging and containers that come into contact with food, packaged at room temperature or below, i.e. under Conditions of Use (COU) E to G described in Table 2, which can be accessed from the Internet in the Packaging and Food Contact Substances section under the Food topic at www.fda.gov.
The Mexican company provided the U.S. agency with a complete description of the recycling process used, which includes sorting, shredding, washing and drying stages.
The raw material comes from different collection centers of the same group. Different types of PET (polyethylene terephthalate) beverage bottles are used, duly classified by color and type, excluding those used in juices and sports drinks, as well as containers made with multilayer structures.
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The market currently requires Food and Drug Administration (FDA) approval for food contact materials. In the United States, materials and articles intended for food contact are regulated by the FDA: they are included in the Indirect Food Additives.
Therefore, even packaging is a food additive and is regulated by Title 21 U.S. Code of Federal Regulations (21 CFR), which includes adhesives, coatings, paper and paperboard, polymers and production process adjuvants.
Mérieux NutriSciences has also developed innovative screening tests through customized analytical protocols (volatile, semi-volatile, non-volatile substances and quantification of residue content) based on the Migration Test Protocol included in the “Guidance for Industry: Preparation of premarket submission for food contact substances: chemistry recommendations”. The document lists FDA recommendations that can be used when applying for the compliance process, such as Food Contact Notification (FCN) or the Food Additive Petition (FAP) for food contact substances.
Plastic materials fda
This Technical Regulation applies to synthetic kerosenes, petroleum waxes (paraffin waxes and microcrystalline waxes) and polyethylene waxes and to products made from them used in the coating of containers and articles intended to come into contact with food and for the coating of cheese.
2.2. The products referred to in this regulation must be manufactured with the substances mentioned in the Positive List of Substances contained in Point 3, complying with the restrictions and specifications established therein.
The residue of the chloroform soluble portion of the aqueous extract obtained from the extraction of the coating, done for 48 hours at 21°C with demineralized water, must not exceed 8 mg/dm2 of surface in contact with food.
2.7. The Positive List of Components for the manufacture of paraffin-based coatings may be updated for the inclusion and exclusion of substances, as well as for the modification of restrictions and specifications, at the request of the States Parties, when new technical-scientific knowledge justifies it.