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Are Your Food Scanner X-ray Curtains Approved by the FDA?

Posted by Jared Carver on

 Are Your Food Scanner X-ray Curtains Approved for Food Contact

Are Your Food Scanner X-ray Curtains Approved for Food Contact?

Maintaining FDA compliance in the food industry has always been crucial. With the recent increase in focus on sanitation procedures, it is important to review the elements of the regulations we follow.

The term “FDA approved” is often misused to describe food-safe materials that have not been tested directly by the FDA.  The correct terminology for x-ray curtains and similar food handling components is FDA Compliant.  

The “FDA is responsible for protecting public health by regulating human drugs and biologic, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.” However, only select products undergo pre-market approval by the FDA.[i]

Food Manufacturers look at two primary factors when determining whether an x-ray curtain is safe to use in their food manufacturing facilities.

1. Are the Curtains on the X-Ray Scanning Machine Compliant with the ROHS ‘Lead-Free’ Directive?

The word “lead-free” is commonly used in reference to plumbing fixtures, paint, solder, ceramics, and food additives.  Lead-free can also apply to food inspection equipment. The FDA requires that food manufactures evaluate food packaging material in order to uncover defects like loose particles, unpleasant odors, absorption of lead from equipment, and more.[ii]

With food x-ray scanners, lead-free most often refers to the material used to ‘block’ or attenuate x-rays in the curtain shields which cover the conveyor tunnels.  A lead-free curtain would usually contain heavy metals, which could include tungsten, tin, antimony, bismuth and barium.

When considering the x-ray curtains used on food inspection equipment, the Restriction of Hazardous Substances (ROHS) Directive addresses ‘lead-free’ compliance limiting the lead content to 0.1% by weight.  XrayCurtains.com has been manufacturing lead-free curtains since 2004 and provides a Declaration of Conformity with the ROHS Directive for lead-free curtain shields.

2. Are the X-ray Curtains “Food Contact Compliant” ?

Most x-ray curtains are made from polymers for flexibility. When in the food inspection x-ray curtains will be in direct contact with food, the materials used must be compliant with the FDA Code of Federal Regulations addressed in 21 CFR Part 177- Indirect Food Additives: Polymers under Sub part C—Substances for Use Only as Components of Articles Intended for Repeated Use.[iii]

XrayCurtains.com offers Food Contact x-ray curtain shields made from rubber.  This requires compliance with article 177.2600 “Rubber articles intended for repeated use”.  In order to certify compliance, the material must meet rigorous testing standards for contact with both aqueous and fatty foods. 

Our food contact x-ray curtain shields have been tested at certified laboratories to allow us to issue Certificates of Compliance with US FDA and European regulations for direct food contact.

Ensure compliance with regulations by asking your supplier for these two forms:

1) Certificate of Conformance with the ROHS ‘lead-free’ Directive 2011/65/EU

2) Certificate of Compliance with US FDA Article 177 or EC Directive 1935/2004 for Food Contact Articles

 

For answers to food compliance questions for your facility, reach out to us at +1 (832) 519-8787 or at sales@leadfreeshields.com

View our inventory of lead-free curtains at www.xraycurtains.com/food-scanner

 Download a PDF of this Article

 

[i] https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

[ii] https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/miscellaneous-food-products-vol2

[iii] https://www.law.cornell.edu/cfr/text/21/part-177


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