Colorants in Plastic Packaging: A Chronology

1958 -- Congress passes the Food Additives Amendment (Pub. L. No. 85-929, 72 Stat. 1784)

• requires pre-market clearance of substances that meet the definition of "food additive."
• defines "food additive" as:

  [A]ny substance the intended use of which results or may reasonably be expected to result in its becoming a component . . . . of any food if such substance is not generally recognized to be safe under the conditions of its intended use; except that such term does not include

  * * *

  (4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this Act. . . .

• Food Additives Amendment contained an interim provision for the continued use of food ingredients that were in commercial use at the time of passage (see below for discussion of "extension list").

1960 -- Congress passes the Color Additives Amendment (Pub. L. No. 86-628, 74 Stat. 397)

• applies only to products that actually color food (and drugs and cosmetics) in a way that is visible to the naked eye (21 C.F.R. § 70.3(f))
• defines "color additive" as:

  [A] material which -

  (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and

  (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

• The Color Additives Amendment has no significance in the regulation of colorants for plastic food packaging.

Late 1950s/Early 1960s -- The FDA publishes an "extension list" of substances, including some colorants, which can be used as additives until FDA explicitly promulgates regulations covering such substances.

1964 -- The last extension list is published in 1964 and expires in 1966.

Since FDA had not promulgated a regulation dealing with colorants for plastics, the agency developed a policy of writing letters stating that until a colorant for plastics regulation could be promulgated, colorants on this 1964 extension list could continue to be used.

1972 -- FDA proposes a regulation covering colorants for plastics. 37 Fed. Reg. 11255 (June 6, 1972).

The agency at that time proposed to (a) amend existing regulations that listed colorants by deleting the colorants and (b) combine these scattered listings in one "Colorants for Plastics" regulation. The proposal also carried forward some of the colors on the 1964 extension list and added several products for which food additive petitions had been filed.

Because the adoption of the regulation was long delayed, FDA allowed the use of colorants listed in the 1972 colorants regulation "until a final regulation is promulgated." In addition, at the time, a few stand-alone regulations cleared certain colorants for use in food packaging, including 21 C.F.R. § 175.300 (the can coatings regulation), which listed various colorants, and 21 C.F.R. § 178.3970, which then cleared ultramarine blue.

1983 -- FDA promulgates a new Section 178.3297, "Colorants for Polymers." 48 Fed. Reg. 46773 (October 14, 1983).

Although ostensibly adopting the 1972 proposal, the main purpose was the promulgation of a definition for a "colorant." This regulation left room for the ultimate inclusion of a list of colorants, including those in the 1972 proposal, but for many years only listed three products with limitations. The Preamble acknowledged that the 1972 colorants could continue to be used

1988 -- FDA issues a "Tentative Final Rule" "finalizing" the 1972 proposal, and listing many of the 1972 colorants. 53 Fed. Reg. 11401 (April 6, 1988).

1991 -- FDA issues Final Rule on Colorants for Polymers. 56 Fed. Reg. 42927 (August 30, 1991).

FDA asserts:

1. "all colorants in polymers will migrate at some level to the food with which the polymers come into contact . . . [and] that all colorants used in polymers are food additives," and
2. only FDA has authority to determine if a material is a food additive. The Society of the Plastics Industry files Objections and a Petition for Reconsideration of the 1991 Colorants Regulation.

1993 -- FDA issues response to 1991 objections and petitions for reconsideration of the 1991 Colorants for Polymers Rulemaking, denying the petition for reconsideration. 58 Fed. Reg. 67318 (December 21, 1993).

However, FDA clarifies its Preamble language to state as follows:

In the preamble, FDA did not intend to imply that firms could not make their own determination as to whether a particular use of a specific substance does not meet the definition of a food additive.

1994 -- FDA issues Threshold of Regulation Rule. See 60 Fed Reg. 36582 (July 17, 1995).

• FDA's "threshold of regulation" exempts from regulation as food additives food- contact substances that may migrate to food at low levels, provided that certain criteria are met.

  In particular, under the threshold of regulation, substances that are not known to be carcinogens, and do not contain known carcinogenic constituents that have a TD50 value less than 6.25 mg/kg body weight per day, are eligible for exemption from regulation as food additives if their dietary concentrations are 0.5 ppb or below, or if they are currently regulated for direct addition to food and the dietary exposure to them resulting from the proposed indirect use is less than 1 percent of the dietary intake from the direct additive uses.

• FDA states in the Preamble that nothing in the new rules "prevent[s] a company from making its own determination that a particular use of a substance does not meet the definition of a 'food additive' in section 201 (s) of the Act." 60 Fed. Reg. at 36589.
• Currently, some 19 Threshold of Regulation letters address 27 colorants.
• See http:vm.cfsan.fda.gov/~dms/opa-torx.html

1997 -- The Food and Drug Administration Modernization Act is enacted, allowing for the filing of Food Contact Notifications seeking FDA clearance of a food contact substance, including colorants use in packaging. The FCN system is implemented in early 2000.

• FCNs become effective in 120 days unless formal substantive objections are interposed by FDA.
• Generally replaces Food Additive Petitions and Threshold of Regulation filings.
• Only applies to submitter and its customers.
• As of 10/01/01, 12 effective FCNs address 13 different colorant substances.