NSF International
August 22, 2008
Carrie Gregory
Personal Care Products Council (formerly CTFA)
gregoryc@personalcarecouncil.org
RE: Public Review Comment
Proposed draft for NSF 305 Organic personal care products (305i1r6)
Dear Ms. Gregory:
Thank you for your ballot and comment on NSF 305 Organic Personal Care Products, issue 1. Below are your
statements (in italics) and the responses of Task Group Chairs (in bold):
Comment#177
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.
The term "over-the-counter" is not used in the document. Therefore, the term "over-the-counter"
has been deleted.
b. Order of ingredients
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E-Mail: info@nsf.org Web:http://www.nsf.org
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.
The following modification has been made to 7.7.1 Order of ingredients:
7.7.1 Order of ingredients
Order of ingredients shall be labeled according to federal regulation in the jurisdiction where the
product shall be sold.
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.
The standard will allow for qualifying ingredients as "organic" or using an asterisk. This
information is necessary in order to inform the consumer which ingredients are organically
produced.
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).
The term `GMP' is not used in the body of the document but is included in an informational annex.
GMP has been deleted.
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.
Your comment has been reviewed and the annexes are compliant with ANSI requirements. The
annexes are provided to the user of the Standard as guidance and do not contain requirements to
meet the Standard.
The following terms are being deleted from the 3 Definitions: alkaline, allowed synthetic,
nonagricultural substance, over-the-counter, non-agricultural water, plant water, and tap water.
The following definitions are being moved to the appropriate annexes: alkylation, audit,
biodegradable, company, contamination, ethoxylation, Good Manufacturing Practices (GMP),
inspector, inspection, products, production location, records, and steam fractionation.
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.
Annex E has been modified to remove all references to EWG, Soil Association, etc and the Safe
Campaign.
Comment#178
5. Draft Standard contains confusing inconsistent information.
Providing accurate and consistent information is critical to the development and use of a meaningful
standard. We found a number of deficiencies throughout the Draft Standard including confusing
definitions and inconsistent use of terms.
a. Personal Care Product and Cosmetics
The Draft Standard uses the terms "cosmetics" and "personal care products" interchangeably.
Specifically, NSF states, "[t]his Standard does not differentiate between requirements for personal care
products and requirements for cosmetics. Therefore, for the purposes of this Standard, cosmetics are
considered personal care products." However, each term has a different meaning and it is not appropriate
to treat them synonymously.
The following are NSF's definitions for "cosmetics" and "personal care products":
· "Personal care product: A non-medicinal consumable product that is intended to be used in the topical
care and grooming of the body and hair and that is rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to a body, human or animal, for cleansing, beautifying, promoting
attractiveness, or altering the appearance without affecting the body's structure or functions. Personal
care products are specifically for use in such activities as cleansing, toning, moisturizing, hydrating,
exfoliating, conditioning, anointing, massaging, coloring/decorating, soothing, deodorizing, perfuming, and
styling."
· Cosmetic: (1) an article intended to rubbed, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance, and (2) an article, other than soap, intended for use as a component of any such
articles.
Furthermore, NSF's definition for "personal care product" appears internally flawed. For example, the term
is defined as a product "...intended to be used in the topical care and grooming..." but then states it can
be "... introduced into... a human or animal..." Emphasis added.
The following modification has been made to the definition for "personal care products":
3.45 personal care product: A Non-medicinal consumable cosmetic products (as defined in
3.16) and soap products (as defined in 3.59) that is intended to be used in the topical care and
grooming of the body and hair and that is rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to a body, human or animal, for cleansing, beautifying, promoting
attractiveness, or altering the appearance without affecting the body's structure or functions.
Personal care products are specifically for use in such activities as cleansing, toning,
moisturizing, hydrating, exfoliating, conditioning, anointing, massaging, coloring/decorating,
soothing, deodorizing, perfuming, and styling.
b. Section 1.2 Scope
The scope of the Draft Standard (as defined by NSF) renders the standard confusing and its application
unclear. The Federal Food, Drug, and Cosmetic Act ("FFDCA") defines cosmetics by their intended use,
as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied
to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."
However, in the Draft Standard the NSF changes the fundamental definition of cosmetic to one of end
use application:
Items covered by this Standard include, but are not limited to, rinse-off and leave-on personal care and
cosmetic products that are applied or used externally on any part of the body (e. g., hair, face, hands, and
feet) as well as oral care and personal hygiene products.
This scope also creates internal confusion within the Draft Standard as it does not appear to comport with
NSF's (or FDA's) definition for cosmetics.
The following modification has been made to 1.2 Scope:
1.2 Scope
This Standard specifies materials, processes, production criteria, and conditions that shall be met
in order for personal care products to make organic label and marketing claims under this
Standard.
Items covered by this Standard include, but are not limited to, rinse-off and leave-on personal care
and cosmetic products that are applied or used externally on any part of the body (e. g., hair, face,
hands, and feet) as well as oral care and personal hygiene products. : cosmetic products; rinse-
off and leave-on personal care products; oral care products; and personal hygiene products.
These products may be applied to or used externally on any part of the body (e.g., hair, face,
hands, and feet). This Standard does not differentiate between requirements for personal care
products and requirements for cosmetics. Therefore, for the purposes of this Standard, cosmetics
are considered personal care products.
Submitter Proposed Solution
In light of the non-exhaustive list of examples we have highlighted above, we believe NSF has a
considerable amount of development work to undertake before finalizing the Draft Standard; allowing for
several opportunities for public comment and following the ANSI Essential Requirements: Due process
requirements for American National Standards.
Thank you for reviewing the document and providing comments.
Please provide a written response via e-mail to Lorna Badman, Joint Committee on Personal Care Products
Secretariat, indicating whether your comment has been addressed. She can be reached at badman@nsf.org. If
a response is not received by September 5, 2008, NSF will consider your comment addressed.
Sincerely,
Ray Green
Ray Green
Chairperson
Joint Committee on Organic Personal Care Products
Cc: L. Badman