On November 14, 2018, the Department of Health and Human Services (HHS) of the U.S. Food and Drug Administration (FDA) notified of a proposed rule to amend several sections in the Code of Federal Regulations (CFR) based on the “petition, submitted by the Flexible Vinyl Alliance (FVA) [on July 3, 2018], requesting that we amend our food additive regulations to no longer provide for the use of 26 ortho-phthalates [(or substances identified as ‘ortho-phthalates’ in the petition)] in various food-contact applications because these uses have been permanently abandoned.”

In particular, the amendments are proposed for the §§175, 176, 177, and 178 of the 21 CFR “to revoke the approvals for 26 substances that the petition identifies as ortho-phthalates” because “the food additive uses have been permanently abandoned.” FDA notes that some of these 26 substances are “subject of approvals in multiple food additive regulations for different uses.” Therefore, the FDA provides a list of “the regulations that would be affected by this FAP [(food additive petition)],” identifying “the specific ortho-phthalates that the regulation authorizes,” and specifically asks for comments on whether all of the identified uses have indeed been abandoned.

The affected regulations include:

§ 175.105 “Adhesives”

§ 175.300 “Resinous and polymeric coatings”

§ 175.320 “Resinous and polymeric coatings for polyolefin films” and

§ 175.380 “Xylene-formaldehyde resins condensed with 4,4’-ispropylidenediphenol-epichlorohydrin epoxy resins”

§ 175.390 “Zinc-silicon dioxide matrix coatings”

§ 176.170 “Components of paper and paperboard in contact with aqueous and fatty foods”

§ 176.180 “Components of paper and paperboard in contact with dry food”

§ 176.300 “Slimicides”

§ 177.1010 “Acrylic and modified acrylic plastics, semirigid and rigid”

§ 177.1200 “Cellophane”

§ 177.1210 “Closures with sealing gaskets for food containers”

§ 177.1400 “Hydroxyethyl cellulose film, water-insoluble”

§ 177.1460 “Melamine-formaldehyde resins in molded articles”

§ 177.1590 “Polyester elastomers”

§ 177.2420 “Polyester resins, cross-linked”

§ 177.2600 “Rubber articles intended for repeated use”

§ 178.3740 “Plasticizers in polymeric substances”

§ 178.3910 “Surface lubricants used in the manufacture of metallic articles”

FDA clarifies that although the regulatory text itself would not be amended in four of the above instances, namely the §§ 175.380, 175.390, 177.1210, and 179.1400, these regulations would nonetheless “be affected because they authorize certain uses of [the 26 listed] substances . . . by cross-referencing other regulations.”

FDA confirms that “if the FAP is granted in full, none of the [26 listed] ortho-phthalates . . . would be authorized for food additive use in FDA’s food additive regulations.” However, “some of the substances are the subject of prior sanction authorizations” and the proposed action “does not pertain to those prior sanction uses.”

FDA further clarifies that they are “not requesting comments on the safety of these uses . . . because such information is not relevant to abandonment, which is the basis of the proposed action,” and that such comments will not be considered in the evaluation of this FAP. A separate petition by several non-governmental organizations, filed by FDA in May 2016, has requested to ban the use of 30 ortho-phthalates based on safety considerations (FPF reported). This petition is still under consideration (FPF reported).

Public comments can be submitted until January 14, 2019.

Read more

FDA HHS (November 14, 2018). “Flexible Vinyl Alliance; filing of food additive petition.


FDA HHS (November 14, 2018). “21 CFR Parts 175, 176, 177, and 178 [Docket No. FDA-2018-F-3757] Flexible Vinyl Alliance; filing of food additive petition.(pdf)