Policies & Guidelines
Policies and guidelines are provided for the items listed below; they are included in the FCC as supplemental information and are intended to aid a sponsor in submitting new monographs or revisions to existing monographs, as well as provide background information to the FCC user. All interested sponsors are encouraged to contact the FCC staff for additional information.
- General Policy
- Arsenic Specifications
- Fluoride Limits
- Heavy Metals Limits
- Microbiological Attributes
- FCC Submission Process and Guidelines
It is the policy of the FCC to set maximum limits for trace impurities wherever they are deemed to be important for a particular food ingredient, and to set levels consistent with food safety and good manufacturing practice. Maximum limits for inorganic trace impurities (e.g., arsenic, cadmium, fluoride, lead, mercury, selenium) are included in FCC monographs for which consumer safety or manufacturing experience indicates their desirability. No limits for arsenic, lead, and other heavy metals are included in FCC monographs for flavor chemicals because of the very low levels at which these substances are added to foods. All requests to increase maximum limits for trace impurities in FCC monographs shall be considered on the basis of the toxicological risk involved, the principles of good manufacturing practice, and the availability of the substances from other sources that meet the FCC limits.
The FCC recognizes the issue of food allergens, but current limitations regarding (1) the threshold levels and (2) the analytical methods to detect allergens at very low levels have thus far prevented the inclusion in FCC monographs of specifications related to allergens. However, food ingredient manufacturers should consider that Codex Alimentarius in section 18.104.22.168 of General Standards for the Labeling of Prepackaged Foodsi states: “The following foods and ingredients are known to cause hypersensitivity and shall always be declared:
- Cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products of these;
- Crustacea and products of these;
- Eggs and egg products;
- Fish and fish products;
- Peanuts, soybeans and products of these;
- Milk and milk products (lactose included);
- Tree nuts and nut products; and
- Sulphite in concentrations of 10 mg/kg or more."
Arsenic specifications are included in FCC monographs only when there is specific scientific basis to believe that arsenic constitutes a likely contaminant in the substance in question.
The FCC has established limits for fluoride in numerous monographs. For phosphates, this reflects the natural occurrence of fluoride in the inorganic phosphate starting material. Fluoride limits in other monographs may reflect the natural occurrence of fluoride in the article or in reagents used in food additive manufacture. Following issuance of the Fluoride Limits (Guideline) in earlier editions of the FCC, considerable research has been completed demonstrating the cariostatic (caries preventing) properties of fluoride. Fluoride is now added to many municipal water supplies to provide a level of 1 mg/L, and many dental products and over–the–counter dietary supplements are formulated with it. During and after the time the Food Chemicals Codex, Fourth Edition, was in preparation, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, The National Academies, completed a comprehensive review of fluoride (IOM, 1997).ii The committee reviewed the literature, noted the toxicological manifestations of fluoride in animals and humans, and established a general No Observed Adverse Effect Level (NOAEL) of 10 mg/day. As fluoride has the ability to induce fluorosis—mottling of the primary teeth of young children—an upper limit (UL) of 0.7 mg/day was established for infants, with increasing ULs assigned to older children. In addition, an Adequate Intake (AI) of 3 mg/day was assigned for adult females and of 4 mg/day for adult males, with the UL for both being 10 mg/day.
The intake of fluoride as a constituent of substances described in FCC monographs, even at the maximum limits established for fluoride, is not expected to significantly add to the human daily fluoride intake from other sources and is well within the various limits described in the Institute of Medicine’s committee report. Nonetheless, given that toxicological manifestations have been amply demonstrated for fluoride, as described in the report, the maintenance of fluoride limits in drinking water and food, and thus food additives, appears consistent with sound public health policy. Therefore, the FCC considers that maintaining fluoride limits for relevant food additives and ingredients is justified. Because of the difficulties in analyzing for fluoride in food ingredients, the FCC intends to adopt new analytical methods for fluoride as soon as adequate validation is submitted. Furthermore, in view of the considerable variation in fluoride limits for additives and ingredients in various national and international standards, harmonization of fluoride limits between the FCC and other compendia is desirable.
The FCC notes the importance of providing limits for individual heavy metals as required by the source and composition of individual food additives. Thus, the FCC removes from most monographs the general heavy metals (as lead) limits and tests and, based on the current level and availability of scientific information and on the policy stated below, and replaces them with limits and tests for specific heavy metals such as lead, cadmium, and mercury as may be relevant to each substance. The FCC recognizes the desirability of lowering exposure to lead and other heavy metals, especially as to infants and children. Overall exposure to heavy metals in general and lead in particular is a public health concern. Diet is a significant source of lead exposure, though not the largest one. While ingestion of FCC substances does not represent the major source of dietary lead, it is desirable to lower the lead limits for all FCC substances, particularly for those substances consumed in high amounts.
Therefore, the FCC policy is to reduce lead and other heavy metals limits to the lowest extent feasible, especially given that more recent evidence shows deleterious neurobehavioral effects occurring in children exposed to lead at levels below those previously considered acceptable. In setting limits for lead and other heavy metals, the FCC considers the amount of a food ingredient consumed, the feasibility of manufacturing a product within these limits, and the availability of analytical methods to ensure compliance. The constraints of Good Manufacturing Practices (GMPs) and the availability of reliable analytical methods are often limiting factors in setting lower limits for lead and other heavy metals. The FCC regards as one of its goals the assurance of the safety of properly used food ingredients. This means that FCC specifications respond and conform to scientific innovations involving manufacturing methods, analytical techniques, toxicology and food safety issues.
Manufacturers, vendors, and users of FCC substances are expected to exercise GMPs and to establish food safety assurance systems such as Hazard Analysis and Critical Control Points (HACCP) to ensure that FCC substances are safe and otherwise suitable for their intended use. FCC substances are expected to meet applicable regulatory requirements, including microbiological criteria, for safety and quality. According to Codex Alimentarius recommendations for establishing and applying microbiological criteria for foods, ‘‘Mandatory (regulatory) microbiological criteria shall apply to those products and/or points of the food chain where no other more effective tools are available, and where they are expected to improve the degree of protection to the consumer. Where these are appropriate they shall be product–type specific and only applied at the point of the food chain specified in the regulation."iii In addition, businesses may develop microbiological criteria for specific food additives or ingredients, processes, and products. The General Policy for microbiological safety and quality of FCC substances is that such substances be produced, handled, and used in food processing following GMPs and applicable food safety systems. Therefore, the FCC does not list specific microbiological criteria for FCC substances other than those for which scientifically valid data are available to the FCC that support the need for such criteria. In such cases, the Codex Alimentarius principles for establishing and applying microbiological criteria have been followed.
These principles include the following:
- Microbiological criteria should be established and applied only where there is a definite need and their application is practical.
- Consideration is given to
- The evidence of actual or potential hazards to health;
- The microbiological status of raw material(s);
- The effect of processing on the microbiological status of the ingredient or food additive;
- The likelihood and consequences of microbial contamination and/or growth during subsequent handling, storage, and use;
- The category(ies) of consumers concerned; and
- The intended use of the ingredient or food additive.
- The sampling plan, method, and handling are stated.
- The microorganism(s) included in the criteria is (are) widely accepted as relevant to the particular ingredient or food additive—as pathogen(s), as indicator organism(s), or as spoilage organism(s).
- Limits used in the criteria are based on microbiological data appropriate to the ingredient or food additive and other similar substances.
i FAO/WHO Food Standards. Codex Alimentarius. General standard for the labelling of prepackaged foods. Codex Stan 1–1985 (Rev. 1–1991). Available at: http://www.codexalimentarius.net
ii IOM (Institute of Medicine). 1997. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington, DC: National Academy Press.
iii Codex Alimentarius Commission. 1997. Joint FAO/WHO Food Standards Programme, Codex Committee on Food Hygiene, Supplement to Volume 1B–1997. Principles for the Establishment and Application of Microbiological Criteria for Foods. CAC/GL 21–1997. Pp. 47–54.