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FAQ

  1. Why is understanding FDA regulations vital for printers of direct food contact packaging?
  2. Most food companies today supply packaging specifications to their printing vendors so that they are ensured of regulatory compliance. Many people involved in the process are concerned and confused about the terminology, let alone the specifications themselves. Direct additives, indirect contact, minimal contact, incidental contact… what does it all mean?
  3. How does the FDA regulate Ink Color Additives and Coatings?
  4. What are the three Good Manufacturing Practices (GMPs) required by the FDA?
  5. How does the FDA enforce regulations?
  6. What is BPA, and why is it important to know that Roland & Associates does not use BPAs in any direct food coatings formulated and manufactured in their facilities?

Why is understanding FDA regulations vital for printers of direct food contact packaging?

Printers interested in producing food and Pharmaceutical packaging materials are faced with the responsibility of providing the food and drug company/packager with written guarantees of Food & Drug Administration (FDA) regulatory compliance. The food or drug company has the responsibility to comply with various regulations established by the FDA in Title 21 of the Code of Federal Regulations (21CFR). Typically, a list of regulations is provided by the food company. Printers rely on the information provided by their ink, coating, and substrate vendors. Since printers guarantee the finish product, and understanding of the regulations is prudent, especially for direct food contact.

Most food companies today supply packaging specifications to their printing vendors so that they are ensured of regulatory compliance. Many people involved in the process are concerned and confused about the terminology, let alone the specifications themselves. Direct additives, indirect contact, minimal contact, incidental contact… what does it all mean?

A “food additives,” as defined in the Act, is “…any substance the intended  use of which results or may reasonably be expected to result, directly or indirectly, in its becoming  a component or otherwise affecting the characteristics of any food ( including any substance intended for use in producing, manufacturing packing, processing, preparing, treating, food;…)

A strict interpretation of the food additive definition would make all substances that migrate, or may be expected to migrate, from food-contact materials into food, subject to premarket approval as food additives. FDA Agency personnel, in response to inquiries from manufactures of food-contact articles, have stated that certain specific uses of substances in food-contact materials do not require regulation under the food additive provisions. The Agency felt it necessary to formalize the system of premarket approval since historically, a number of companies have made their own determination that a particular substance effectively does not migrate to food and thus is not a food additive under its conditions of use. They have marketed the products without resources to the regulatory scheme of the 1993 proposed rule would prevent a company from making its own determination that a particular substance does not meet the definition of a food additive. However, as always, the company makes such a determination at its own risk. If the Agency learns of a substance use from, for example, a competitor and reaches a different conclusion than the company, the Agency may take regulatory action against the substance as an unsafe food additive or against the company that makes the substance for introducing any adulterated food into interstate commerce.

How does the FDA regulate Ink Color Additives and Coatings?

The only formal regulations that the FDA has regarding printing inks are those regulations for color additive diluents contained in 21CFR Part 73.  In general, substances listed in Section 73.1 for specific use in inks are colors additives listed for direct use in food; and substances that are generally recognized as safe (GRAS) for use in food are acceptable in ink formulations used on food or food packaging. In additions, substances regulated for use in food-contact materials may also be acceptable if the use in inks is encompassed by the permitted use in food packaging is a functional barrier to migration, the inks on the packaging exterior are not food additives and do not need to be regulated by the FDA. The category into which food packaging inks and coatings typically fit is Indirect Food Additives. Inks and coatings may have direct, indirect (commonly referred t as minimal), or incidental contact with the food. This means that they are not intended to become a part of food, but they may through some type of food contact.

What are the three Good Manufacturing Practices (GMPs) required by the FDA?

The FDA states that if there is a food-contact-approved functional barrier (e.g., resinous coating, protective film, transparent cover, etc.) separating printed material from the food, then such use of printing ink is not a food-additive situation, and the ingredients would not need to be approved for that use. However, even through a resinous coating is acceptable on the basis of its containing components approved under the food-additive regulations for their use, it must applied to form an effective functional barrier, that is, it must be of sufficient thickness and continuity that it prevents the ink from passing through the coatings and migrating to food. The manufacturer must employ good manufacturing practices to ensure that the coating has formed a continuous coating over the ink substrate so that no pin holing is present and/or the coating is of sufficient thickness to prevent ink migration. When these conditions are met, a functional barrier is formed. Most printers and converters will agree that a continuous coating, free of voids and pin holes, would be a difficult task to monitor and ultimately guarantee to an end-user company.
The FDA regulations require Good Manufacturing Practices (GMPs). There are three GMP general concepts that apply to inks and coatings:
(1) The quantity that is used is not more than is reasonably required to accomplish the intended physical or technical effect and does not exceed any limitations.
(2) The material must be of purity suitable for the intended use.
(3) The methodology for production and use should ensure compliance with the regulations.
Several 21CFR Sections reference quality assurance tests, which are described in sections of Parts 175 and 176. They are often confused with testing done to either get listed in the CFR or be accepted as GRAS for their intended use. Such tests are more rigorous than the quality assurance tests mentioned.

How does the FDA enforce regulations?

The FDA publishes regulations that explain the Act. However, manufactures sometimes violate the Act, accidentally or intentionally. In most cases, the FDA does not prosecute the producers if they voluntarily stop shipping an illegal product. If they have sold an illegal product, the manufacturer may be required to notify the people who bought it and arrange to make unsold stocks of the product off the market. Evidence of Act violations is gathered by FDA scientists and inspectors. The FDA employs scientist, including bacteriologists, chemists, and veterinarians who use hundreds of different laboratory tests to check the purity, safety, and usefulness of foods, drugs, and cosmetics. In addition, FDA inspectors supervise the enforcement of court rulings on violations. Three kinds of legal action can be taken if the FDA finds that producers have violated the federal food and drug laws: (1) A federal court may issue an injunction (court order) directing them to stop. (2) The court, acting on evidence from the FDA, may seize a product that is in violation. (3) A lawsuit of such violations can result in a fine or imprisonment, or both.

What is meant by the term FDA-approved product, especially as it applies to packaging materials for food and drug products? The concern and confusion in this industry are furthered by this term for both suppliers and packaging materials and their customers. It is also an area about which the FDA has been historically sensitive. If the term is used improperly, the FDA will issue a warning letter. In general, unless referring to a new drug or specific types of medical devises that require premarket FDA approval, people using this phraseology are either speaking loosely or simply know nothing about the FDA’s regulatory powers and scope of authority.
Other than the products mentioned above, there is no such thing as an FDA product approval. Just about every other product under the FDA’s jurisdiction is a regulated, if at all, on a generic basis, not on a product-specific basis. When the FDA has promulgated a regulation on a component of food packaging material, the proper way to let someone know that the product is satisfactory from a regulatory point of view is to state that it conforms with, or is in compliance with, the applicable food-additive regulations. One could even say that the FDA has approved the safe use of listed chemical substance for a specified use or that it is FDA acceptable. You risk incurring the Agency’s wrath if you use the phrase Approved by the FDA in connection with the marketing or labeling of a product that has been processed through the Food Additive Regulations, or otherwise imply that the FDA endorses or has approved a specific product when it has not done so.

What is BPA, and why is it important to know that Roland & Associates does not use BPAs in any direct food coatings formulated and manufactured in their facilities?

BPA stands for bisphenol A. BPA is an industrial, hormone-mimicking chemical compound that that has been used to make certain plastics and resins since the 1960s.

BPA is found in polycarbonate plastics and epoxy resins. Polycarbonate plastics are often used in containers that store food and beverages, such as water bottles. They may also be used in other consumer goods including clear plastic baby bottles and sippy cups, kitchen plastics such as measuring cups, drinkware and storage containers.

Epoxy resins are used to coat the inside of metal products, such as food cans, bottle tops and water supply lines. Some dental sealants and composites also may contain BPA.

Exposure to BPA, has been linked in animal studies to early puberty and other reproductive harms. There is concern that BPA may cause similar health problems in humans.  Some research has shown that BPA can seep into food or beverages from containers that are made with BPA. Additional concerns have shown possible health effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children. More than 90 percent of the general population has BPA in their bodies, at levels close to those which have been shown to cause harm in animal studies.
A number of canned foods and plastic bottle manufacturers have stopped using BPA, though because there is no labeling requirement, consumers do not know which products contain BPA and which don't.

However, the Food and Drug Administration (FDA) has said that BPA is safe at the very low levels that occur in some foods. This assessment is based on review of hundreds of studies.
The FDA is continuing its review of BPA, including supporting ongoing research.