USA Reach Regulation for Various Sectors

In the USA, Food Contact Materials (FCM) is regulated under the Federal Food, Drug and Cosmetic Act (FFDCA), Title 21 of the Code of Federal Regulations (CFR), where a revised Title 21 is issued on approximately April 1^st of each year and is usually available several months later.

The regulation is jointly produced by the National Archives and Records Administration's (NARA) Office of the Federal Register (OFR), and the Government Publishing Office (GPO) to provide the public with access to authentic government information.

Food Contact Materials (FCMs) refer to substances that can be applied as a potential component directly or indirectly affecting food characteristics. It also includes substances intended for food processes such as producing, manufacturing, packaging, processing, storing, transporting, and holding, which also involves any source of radiation within its production.

There are two exception categories under FCM, USA: substances categorized as “Generally Recognized as Safe (GRAS)”, and substances sanctioned prior to 1958. For example, under 21 CFR 175.300, “Resinous and Polymeric Coatings, epoxy resins derived from BPA and epichlorohydrin” are as well prohibited in use for powdered and liquid infant formula packaging.

The FDAMA changed the Food, Drug, and Cosmetic Act (FD&C Act) to make the FDA's operations more efficient. A notification method for food-contact substances was one of the new procedures designed to achieve this goal. A food-contact substance is defined as "any compound intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or keeping food if such use is not intended to have a technical effect in such food" under the modified FD&C Act (United States, 1998a).

Act: The Federal Food, Drug and Cosmetic Act (FFDCA)

NEPA:FDA urges the federal agencies to take the environmental considerations into account in the planning and making their decisions. NEPA is basically a declaration of the nation’s environmental policy and goals. It intensifies the FDA’s command under FFDCA and various public health laws. It does not require FDA decisions to favour environmental protection over other considerations mandated by other laws.

FFDCA:US Congress granted the authority to the FDA to regulate the food additives in the 1958 Food Additives Amendment to the FFDCA. As per the Section 201(s) of FFDCA a food additive is described as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in it becoming a component or otherwise affecting the characteristics of any food. A food additive is judged dangerous unless it complies with an exemption (for investigational use), a regulatory listing, or, as indicated below, an effective food contact notification, according to the FFDCA.

The general and specific regulations for all food ingredients and packaging materials as per 21 CFR 170-189. It is observed that the time required in order to put a regulation in force is both lengthy and the process itself is resource intensive. As a result of which two additional processes have superseded the petition process, the Threshold of Regulation (TOR) exemption method and the FCN process are both used for pre-market approval of components in food contact items.

Table listing the general and specific regulations. Title 21 of the Code of Federal Regulations.

Comprehensive Summary: The rationale for the notifier's conclusion that the usage of the FCS is safe should be summarised and discussed in detail in an FCN. While addressing all safety data given in the warning, the summary should describe cumulative dietary exposure to the FCS and any possible impurities, the findings of toxicity tests, and any ADI generated from those studies. Any data or information that appears to contradict the conclusion that the use of the FCS is safe should be discussed by the notifier.

Chemical Identity: Identity being the name, structure, molecular formula, CAS Number as well as the data from which each substance can be identified. Manufacturing processes' details, purity percentages, safety. These must be shown to estimate the safety measures taken.

Intended Conditions of Use: FCN submitters must describe the conditions under which an additive will come into contact with food and include data on the quantity of any material that is likely to become a component of food under the intended conditions of use, according to the FDA.

The concentration of the food contact substance in the final food contact material, the temperature of use, the types of food contacted, the duration of contact, and whether the food contact material is intended for repeated or single-use application should all be included in the information on the intended use conditions.

The planned conditions of use requirement is likely the single most critical aspect in determining the expense and complexity of achieving a suitable regulatory status for a chemical, as it determines the expected exposure

Intended Technical Effects: We have to show the data that proves that the Food Contact Substance will achieve its intended use without changing the organoleptic properties of the food particles present; but will have effect on the food article.

Estimated Dietary Intake: FDA estimates the probable exposure to the substance by combining migration data with information regarding the typical uses of Food Contact Articles that may contain the substance. Using this the daily intake is estimated i.e. EDI (product of concentration and total food intake). CEDI i.e. Cumulative estimated daily intake is also required. It is estimated by looking at all the sources of exposure, rather than just the EDI. These calculations are based on the assumption that the substance will migrate at its full extent and that FCM of a given type will be made using the subject substance.

Toxicity info: The type of toxicological data will depend on the nature of the material and the CEDI for the substance.

For substances with CEDI < 0.5 ppb; No data required.

0.5 ppb

50 ppb

If it exceeds 1 ppm then FDA recommends filing the food additive petition instead of FCN.

Environmental info: FCN must include an environmental assessment or a claim for categorical exclusion from the requirement for an environmental assessment. Exclusions from the EA requirement are provided by FDA regulations for substances used only in coatings, substances used only in repeated use food contact applications, and substances that make up less than 5% of the finished food packaging material and remain in the packaging material after the consumer has used it.

Due to the introduction of the Food Contact Notification the number of Food Additive Petitions has reduced substantially. Nevertheless, the FDCA states that the FCN process will be used for food contact substances authorizations except where FDA declares that FAP is necessary for safety assurance. The regulations when an FAP is required:-

Use of FCM will increase the CEDI of the substance from both food and food contact uses to a level equal to or greater than 1 ppm,assuming the substance is not a biocide.

For a substance that is biocide if the CEDI is increased to a level greater than 200 ppb.

When existing data for the substance include one or more bioassays that FDA has not reviewed and are not clearly negative for carcinogenicity.

The things to be included in the FAP:-

• Composition, specification and method of manufacturing;
• Its intended conditions of use;
• The quantity and identity of substances likely to become components of foods under intended use conditions;
• An estimate of concentration of the additive in the daily diet;
• Toxicology data demonstration the safety of this intake level;
• Proposed tolerance;
• Either an EA or a claim for categorical exclusion from the need to provide the EA

Once FDA receives a FAP it is assigned to the Consumer Safety Officer (CSO).

The CSO sends the pertinent elements of the petition to specialists for review, who then write reports on the food contact substance's exposure and safety. If the FAP is accepted, the FDA issues a final regulation in the Federal Register that allows food additives to be used immediately. The benefit of a FAP is that it results in a food additive regulation, which allows anyone who meets the regulation's conditions of use to use the additive. Whereas an FCN only allows the manufacturer identified in the FCN to use the product under the intended use conditions.

The FDA's toxicological evaluation is based on a tiered approach and is consistent with the general principle that increased exposure results in increased potential health risks; however, the inherent toxicity of a structural/functional class of compounds is also taken into account, as evidenced by the separate biocides requirements. The FDA's TOR exemption procedure and the tiered testing method used to examine the safety of FCSs both employ this technique to identify endpoints of concern at exposure levels.

• DC of ≤ 0.5µg/kg (i.e. EDI of ≤1.5 µg/person/day)
  • No toxicity testing recommended
  • Available information should be submitted and discussed
  • Structural similarity of the substance with the carcinogens and toxic chemicals must be discussed

• CDC  > 0.5µg/kg but ≤50µg/kg
  • Genetic toxicity tests on substances
    • Test for gene mutations in bacteria
    • An in vitro cytogenetic test in mammalian cells.
• CDC > 50µg/kg but < 1000µg/kg
  • Genetic toxicity tests on substances
    • Test for gene mutations in bacteria
    • An in vitro cytogenetic test in mammalian cells.
    • An in vivo test for chromosomal damage using rodent hematopoietic cells
  • Potential toxicity of the substance should be evaluated by two sub chronic oral toxicity tests, one in rodent and other in a non-rodent species.
  • Results from these studies or other available information may trigger the need for longer term (1-year or 2-year) or specialised tests.
• CDC ≥1000 µg/kg
  • Bioassays of carcinogenicity in two rodent species during a two-year period (one study should include in utero phase)
  • A teratology phase was added to a two-generation reproductive research in rats.
  • Other specialised studies, if needed

• Food Contact Material (FCMs) regulation consulting/customized consulting report
• Regulatory compliance analysis/new substance assessment
• Declaration of Compliance (DoC) editing/auditing
• Food Contact Notification (FCN)
• Lab selection and testing supervision

• Identification of compliance requirements under various guidelines including all data requirements.​ 

• Data gap analysis and pre-assessment support​ 

• Technical documentation support​ 

• Pre and post-submission support and technical liaison with authorities. 

• Regulatory compliance training
• Regulation translation
• Consultation with a competent authority
• Supplier management