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Technical Note 131:
Compliance with FDA and European Food Contact Regulations

The purpose of this Technical Note is to communicate the food contact status of CROHMIQ® Static Protective Type D FIBC fabrics used to produce FIBC for bulk storage or transport of dry food under US FDA Title 21 CFR, parts 177.1520, 177.1630 and 178.2010, for food contact applications and the EU Materials and Articles in Contact with Food Regulations.

The basic requirements of a food contact container are that it shall:

• provide a functional barrier against adulteration of contents by outside agents, and
• prevent any constituent part of the container from becoming a component of the food.

FDA regulations are based on permissible levels of potentially harmful substances and a list of “generally recognised as safe” (GRAS) substances.

EU regulations are based on a “positive list” of substances, i.e. a list of substances that cannot be used in food contact containers.

Independent analysis of the component materials used in the construction of CROHMIQ fabric has concluded that the extruded coating of CROHMIQ fabric provides a functional food contact barrier against adulteration from outside agents and that under FDA regulations the component materials of the CROHMIQ extruded coating and base fabric are either GRAS or within the relevant specifications.

FIBC made from CROHMIQ Static Protective Type D FIBC fabrics have an extruded olefin coating on the interior face of the container that provides a functional food contact barrier. The extruded coating complies with Commission Regulation (EU) No 10/2011 and the General Provisions stated in Annex I of Commission Regulation (EC) No 1935/2004.

The fabric base supporting the extruded coating does come into contact with food where seams are formed for construction of the container. The fabric also complies with Commission Regulation (EU) No 10/2011 and the General Provisions stated in Annex I of Commission Regulation (EC) No 1935/2004.

Independent analysis has confirmed that under EU regulations, none of the component materials used in the construction of CROHMIQ fabric (including the extruded coating) is on the positive list – i.e. all component materials are permitted for food contact.

FIBC constructed from CROHMIQ fabric are suitable for food contact applications provided that:

• The extruded coating is on the inside of the FIBC, i.e. in contact with the food.
• The sewing materials, sift-proof barriers, etc. used in seams are approved for food contact.
• Any liner used is approved for food contact.
• No unapproved materials are added to the fabric (e.g. printing) or placed inside the FIBC (e.g. baffles).