When it comes to food contact compliance in plastic for solvent dyes, it is essential to ensure that the materials and dyes used are safe for contact with food and comply with relevant regulations. While we are providing a general overview, it is important to note that specific regulations apply to different countries and regions.

In many regions, including the United States and the European Union, the regulatory framework for food contact materials is based on risk assessment principles. The materials and additives used in plastic products intended for food contact must undergo safety evaluations to minimize risks for human health.

Solvent dyes are often used in the coloring of plastics, including those used in food packaging and containers. To ensure compliance with food contact regulations, it is necessary to consider the following aspects:

Authorized Substances

Check if the solvent dyes you intend to use are compliant with food contact applications, regarding the general regulatory framework of the region. Regulatory agencies provide lists of authorized substances that can be used in contact with food. For example, in the United States, the Food and Drug Administration (FDA) maintains a list of substances called the “Generally Recognized as Safe” (GRAS) list. In the EU, compliance with the European Food Contact Materials Regulation (EC) No. 1935/2004 is required.

Migration Control

One key condition for food contact approval is migration control. Migration refers to the transfer of substances from the materials in contact with food into the foodstuff itself. Solvent dyes used in food contact applications must undergo through a rigorous testing to assess their potential migration into food and ensure that they do not have risk to human health. This testing typically involves simulating food contact conditions and measuring the amount of dye transferred into the food simulants.

Food Contact Regulatory Compliance

It is final producer responsibility to ensure that the plastic and solvent dyes used meet the specific regulations and standards for food contact materials in the corresponding jurisdiction. Some examples are, FDA regulation in the United States (21 CFR), or European Union regulation EU 10/2011, among many others in the different countries and regions.

Dyes and pigments have to meet purity criteria. These criteria are set out in Resolution AP(89) 1, which is voluntary, since EU 10/2011 does not apply directly to pigments and colorants.

Supplier’s Declaration of Conformity must indicate compliance with the following Purity Criteria:  maximum allowable concentrations (ppm) of heavy metals Pb, As, Hg, Se, Ba, Cr, Cd and Sb, primary aromatic amines, etc.

Compliance with these purity criteria is essential for manufacturers and suppliers of plastic materials used in food contact applications to demonstrate that their products meet the necessary safety requirements. 

In addition, adherence to 2023/2006 (Good Manufacturing Practices) is crucial for ensuring food contact compliance. GMP involves implementing processes and controls that ensure safe and hygienic production of materials intended for food contact. All raw materials used, as well as solvent dyes, must follow appropriate manufacturing practices, including proper handling, storage, labeling, and traceability, to minimize risk of contamination.

Solvent Dyes Regulatory Compliance

Manufacturers and suppliers of solvent dyes used for food contact applications must provide comprehensive documentation to demonstrate compliance with relevant regulations. This dossier typically includes information about the presence of certain impurities and/or substances of concern, migration compliance and any other relevant information. The more detailed and comprehensive documentation package, the lower risk for plastic manufacturers when developing final products with the corresponding regulatory standards. 

However, note that compliance requirements can vary depending on each application, the intended duration of food contact, and the type of plastic being used, etc. Therefore, as already stated, it is the final producer of the final product to ensure compliance with legislative requirements in the corresponding commercialization region around the globe.

For WAXOLINE® , there is a comprehensive regulatory dossier available with most recent regulation updates including food contact compliance.

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