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Regulatory Information

North American Food Contact Regulations

FDA Regulations for Traditional Nonstick Coatings

The regulation properly known as 21 CFR 175.300, "Resinous and Polymeric Coatings", is the umbrella regulation covering most coating formulations that have any food contact. There are additional regulations numbering in the dozens that cover specific polymers, additives, pigments. They tend to cover single specific resins or additives.

The FDA does not allow heavy metals to be used in coatings for food contact. Heavy metals (lead, chrome, cadmium, and others) are often introduced when high- temperature pigments are used that contain these complexes. Bright colors, especially in the red, orange, yellow spectrum should be viewed with extreme caution as they tend to include the metals mentioned above.

It must be pointed out that the FDA does not have approval authority related to coatings. There is no such thing as an "FDA Approved Coating". Coatings are considered FDA-compliant, when they meet four criteria:

  1. The coating manufacturer can confirm in writing that it uses materials that conform to the FDA regulations (such as §175.300) and follow good manufacturing practice in the formulation and manufacture of the coatings, AND
  2. The coating is applied in a continuous film over the substrate, AND
  3. The finished product, e.g. cookware, etc., passes the extraction tests covered in §175.300 Tables 1 and 2 to prove conformance to the FDA Regulations, AND
  4. The finished product is thoroughly cleaned prior to use.

All four criteria, not one or the other, must be met for the finished product, and the coating, to be considered FDA-compliant.

FDA Regulations for Sol-gel Coatings

Sol-gel coatings do not meet the definition for “Resinous and Polymeric Coating,” nor do they fall under any other specific regulation for food additives. Instead, since all nonstick coatings are considered food additives, the cured sol-gel must meet the safety standards in §170 Subpart B-Food Additive Safety. To meet these requirements, migration of substances from the coating must be < 0.5 parts per billion and not have other impacts on food or the environment. (1 part per billion is the equivalent of 1 second in 32 years). In addition, as with traditional nonstick coatings, all of the other components of the formulation, e.g. polymers, additives, pigments, etc. must still comply with their respective regulations.

Health Canada

Health Canada is the agency responsible for the health and well-being of Canadian citizens. Within Health Canada’s structure is the Bureau of Chemical Safety, comparable to the USA’s Food and Drug Administration.

One of the Bureau’s sections is the Food Packaging Materials and Incidental Additives, responsible for ensuring that chemicals do not enter food (from any source, including housewares) at levels that pose an unacceptable risk to health. Like the U.S. FDA, this section will review coating formulae upon request and, if the submission complies with Canada’s Food and Drug Act and Regulations, issue a Letter of No Objection to the petitioner. If it is suspected that food is being adulterated by housewares, Canada’s Consumer Product Safety Bureau is empowered to conduct investigations, inspections, seizures, recalls, and prosecutions.

Consumer Product Safety Commission (CPSC)

In 2008, the Consumer Product Safety Commission published a certification rule requiring manufacturers and importers (including private label) to certify that their products comply with all CPSC product safety rules, bans, standards and limitations administered by the CPSC.

The question was raised as to whether this ruling applied to the coatings applied to cookware, bakeware and small appliances and/or other basic housewares items.

With regard to the CPSC rule, nonstick coatings are regulated by the Food and Drug Administration (FDA), not the CPSC. The FDA has jurisdiction over food-contact surfaces when there is a risk of migration of harmful substances, whereas the CPSC has jurisdiction over mechanical failures, such as breaking glass, handles falling off, or delamination multi-ply steel bodies.

Generally, the FDA is the predominant authority over cookware, bakeware and small- appliance products used in food-service applications. Their regulations are always the first place to look. After some research, to our knowledge, there are no CPSC regulations or requirements (other than obviously fitness of purpose and general safety) that involve cookware or bakeware. The CPSC has authority over product safety, particularly as it affects product performance, design and fitness for use.

The CPSC rule does not impact products as far as the nonstick coating is concerned.

Standards Setting Bodies – NSF (USA, Asia)/UL (USA)

The National Sanitation Foundation International is an independent, third-party standards organization. NSF certification is a valuable marketing tool and a necessity for companies that sell equipment for food processing and potable water applications. Many companies that sell housewares products at retail also seek NSF certification. NSF certifies entire articles, not just the coatings (except as components of the article).

Like the NSF, Underwriters Laboratories (UL) is an independent, third-party standards organization.  Known primarily for its certification of electrical appliances rather than food and water standards, UL now conducts tests and issues certifications for NSF and ANSI standards (much as the NSF does).

 

 
 
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