The Personal Care Products Council (the “Council”) (formerly the Cosmetic, Toiletry, and Fragrance Association) is providing these comments in response to the NSF Draft Standard 305: Organic Personal Care Products (“Draft” or “Draft Standard”).
Based in Washington, D.C., the Council is the leading national trade association representing the $250 billion global cosmetic and personal care products industry. Founded in 1894, the Council's more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products that millions of consumers rely on everyday, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.
The Council represents the vast majority of stakeholders that would be affected by NSF’s Draft Standard once adopted by the American National Standard (“ANS”). Thus, we urge NSF to seriously consider the comments contained herein.
Issues with the Draft NSF Standard for Organic Personal Care Products
The Council finds that the Draft Standard is substantially flawed and far from ready to advance to ANS at this time. We urge NSF to continue development of the Draft and allow for more opportunities for public comment prior to advancing the standard to ANS. While not an exhaustive list, we find examples of deficiencies in four major areas:
1. Draft Standard includes provisions that are in conflict with federal law.
2. Draft Standard Annexes contain issues of concerns.
3. The Draft Standard references sources that are not authoritative.
4. Draft Standard contains confusing inconsistent information.
1. Draft Standard includes provisions that are in conflict with federal law.
The Draft Standard is not consistent with current federal law. NSF appears to recast a number of terms in a way that conflicts with longstanding statutory and regulatory standards.
a. Over-the-counter
In the Draft Standard, NSF defined “over-the-counter” as: “(Of drugs and non-drugs) Sellable without a prescription and without a visit to a medical professional.” This definition is in direct conflict with FFDCA in that there is no legally recognized non-drug OTC.
b. Order of ingredients
The Draft Standard’s order of ingredient listing is not consistent with federal law and may be confusing or potentially misleading. In the Draft, NSF states:
Ingredients at a concentration of more than 1% shall be listed on the label in descending order of predominance, in their concentration by weight. Ingredients that are present at a concentration of 1% or less shall be listed in any order after the ingredients present at a concentration of more than 1% or as required by federal regulation.
This ingredient listing conflicts with FDA regulation and mandated by the Fair Package Labeling Act. Legally, a cosmetic product’s order of ingredients may appear in one of three ways. The Draft Standard’s ordering scheme is inconsistent with federal law and, if followed, may cause a product’s label to be misleading.
c. Ingredient Labeling
In the Draft Standard, NSF outlines ingredient labeling practices that augment current regulatory and INCI standards. NSF lacks authority to revise regulation or INCI nomenclature. In Section 7.7 of the Draft, NSF states:
Each organic personal care product shall list the ingredients on its label using the International Nomenclature for Cosmetic Ingredients (INCI) labeling system as found in the most recent edition of the International Cosmetic Ingredient (ICI) Dictionary and Handbook as applicable. The list of ingredients shall appear on the outer label of the personal care product. Extra descriptive or marketing terminology, unless specified in 7, shall not be deemed acceptable in the ingredient list.
Emphasis added. The wording in the Standard “unless specified in 7” indicates that there are exceptions to FDA labeling regulations.
Also, in Section 7.5.2 of the Draft Standard, NSF states:
products in packages described in 7 CFR 205.301(c) shall: – In the ingredient statement, identify each organic ingredient with the word “organic” or with an asterisk or other reference mark that is defined below the ingredient statement to indicate that the ingredient is organically produced.
NSF has no authority to make such changes to INCI nomenclature or federal regulation.
2. Draft Standard Annexes contain issues of concerns.
The Draft Standard includes information on GMPs. This is well beyond the scope of this document, is of limited utility, and appears to be written for food handling. If a standard is to reference GMP, a much more thorough treatment would be needed and should be consistent with existing international standards (i.e., ISO 22716:2007).
3. Draft Standard use of Annexes is inappropriate.
In the Draft Standard, some of the information contained in the Annexes appears to be an integral part of the meaning of the standard itself. In footnote format, NSF states:
The information contained in this Annex is not part of this American National Standard (ANS) and has not been processed in accordance with ANSI’s requirements for an ANS. As such, this Annex may contain material that has not been subjected to public review or a consensus process. In addition, it does not contain requirements necessary for conformance to the Standard.
NSF cannot exclude the annexes or separate them from the standards development process as they appear to contain information necessary for conformance to the Draft Standard. In addition, alkaline, alkylation, audit, batch, biodegradable, catalyst, and many other terms are defined within the Draft Standard, but never used within the document; and the definitions are not necessarily the same in the Draft Standard and the annexes.
4. The Draft Standard references sources that are not authoritative.
The Draft Standard references sources that are not authoritative. For example, NSF’s reference to EWG reports is not appropriate. To the extent that data or opinions are referenced, the source of the data or the opinions should be by a recognized, authoritative body. Environmental Working Group (“EWG”) is not an authoritative body; but rather a nonprofit organization that synthesizes data from primary references in a way that is not necessarily consistent with the conclusions of authoritative bodies, such as the Cosmetic Ingredient Review or Europe’s Scientific Committee for Cosmetic Products. |
