No. 3 Regulatory at a Glance

No. 3 March 2021

MATERIALS IN DIRECT OR INDIRECT CONTACT WITH FOOD.

 

Food Contact Materials (FCMs) are materials intended to be brought into contact with food and beverages. They also include materials that can reasonably be expected to come into contact with food under normal or foreseeable conditions of use.

Molecules in materials can migrate into food during direct or indirect contact and alter the quality of the product.

Migration can occur at every stage of the supply chain, from production to serving, as a product can come into contact with packaging, machinery and containers.

Contact materials can include various substances e.g. plastic, rubber, aluminium, metal and paper.

Guide on the specific regulations for food contact materials in the following countries:

 

UNITED STATES OF AMERICA

In the United States, the Food and Drug Administration (FDA) is responsible for setting the rules and guidelines regarding the composition, properties and use of materials. The regulatory status of a FCM depends on the regulatory status of each individual component of this material. Individual components are regulated as indirect food additives, i.e. substances that could be transferred to food by its packaging or during processing, under the Food Drug and Cosmetics Act (FD&C Act) and Title 21 Code of Federal Regulations.

The FDA determines if each food contact substance is safe and then approves a food contact material only if all its constituents are given FDA clearance.

 

CANADA

In Canada, food contact materials are governed by Division 23 of the Food and Drug Act and Regulations.

Manufacturers and distributors do not have direct compliance responsibility, and are not required to submit a food contact notification or any test results.

In Canada, food contact materials are those that come into contact with food only during manufacturing and processing, and do not include items such as kitchen tools and utensils.

 

EUROPE

In Europe, the Commission Regulation (EC) 1935/2004 is the main reference for all food contact materials.

Article 3 states that materials and articles must be manufactured in compliance with the Good Manufacturing Practices (GMP) so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in concentrations that could endanger human health, or imply an unacceptable change in the composition of food products or involve a  deterioration in their organoleptic properties. Materials and articles in finished plastic must follow EU Regulation 10/2011.

Regulations can vary from one European country to another in the absence of specific EU measures.

 

MIFAST DISPERVYN VD is a Mifar product suitable for indirect food contact. It is a high-performance pigment dispersion in a high molecular weight vinyl-chloride and vinyl-acetate copolymer. It is particularly suitable for rigid and plasticised vinyl substrates, solvent-based aromatic polyurethane modified inks and coatings,  flexo and rotogravure inks for aluminium, vinyl and other substrates, as well as industrial coverings resistant to air drying.  This class of products is also suitable for printing plastic films, PVC coatings and for the production of finished synthetic materials in polyurethane. The technology used allows the pigment powder agglomerates to be separated into individual pigment particles and encapsulated individually within the resin. The extreme fineness of dispersion and coverage of the pigment surface, together with an accurate selection of the pigment, offers a high quality product.

 

The information herewith given is based on our present knowledge. Any conclusion and recommendation are made without liability on our part. Buyers and users are advised to make their own assessment under their own conditions and for their own requirements.