Kayla has done a fabulous job breaking down the Safe Cosmetics Act of 2011. We are starting at the end of the bill and working our way to the beginning. Here is the post that breaks down SEC 613 Ingredients Labels on Cosmetics.
NOTE: All Plain Text is directly from H.R. 2359 as it is written, Yellow is from the FDA regulations and Green is my commentary and this blog post has a special section that is in Blue to show previous text from The Safe Cosmetic Act 2011.
‘‘SEC. 613. INGREDIENTS LABELS ON COSMETICS.
‘‘(a) IN GENERAL.—Subject to subsections (b) and (c), the Secretary shall require that the label on each package of cosmetics (including cosmetics distributed for retail sale and professional use) bears a declaration of the name of each ingredient in such cosmetic in descending order of predominance.
‘‘(b) ADJUSTMENTS FOR LABEL SIZE.—
‘‘(1) RULES FOR SMALL PRODUCTS.—Not later than 6 months after the date of the enactment of this subchapter, the Secretary shall issue regulations that apply to any cosmetic for which the product packaging is not of sufficient size to bear or contain a label that meets the requirements of subsection (a).
‘‘(2) REQUIREMENTS FOR PUBLIC DISCLOSURE.—Such regulations shall establish requirements for listing ingredients on the label of such cosmetics and additional requirements for public disclosure of the ingredients in such cosmetics.
I’ve included a section of the current cosmetic labeling laws to clear up any misconceptions about current laws.
The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper. FP&L Act requirements, e.g., ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container. The labeling requirements are codified at 21 CFR 701 and 740. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements may be considered misbranded and may be subject to regulatory action.
The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase “Manufactured for ……” or “Distributed by ……” or similar, appropriate wording.
The Tariff Act of 1930 requires that all imported articles state on the label the English name of the country of origin.
Declaration of Ingredients
Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration (21 CFR 701.3). Cosmetics not customarily distributed for retail sale, e.g., hair preparations or make-up products used by professionals on customers at their establishments and skin cleansing or emollient creams used by persons at their places of work, are exempt from this requirement provided these products are not also sold to consumers at professional establishments or workplaces for their consumption at home.
The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase. It may appear on any information panel of the package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card. The letters must not be less than 1/16 of an inch in height (21 CFR 701.3 (b)). If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches (21 CFR 701.3(i)).
The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared without regard for predominance. The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3(c)); those accepted by the FDA as exempt from public disclosure may be stated as “and other ingredients” (21 CFR 701.3(a)).
Cosmetics which are also drugs must first identify the drug ingredient(s) as “active ingredient(s)” before listing the cosmetic ingredients (21 CFR 701.3(d)).
All label statements required by regulation must be in the English language and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase (21 CFR 701.2). FDA
Current labeling laws are quite thorough already. My guess is that this section is solely for the purpose of adding section (c) below and because in their new definition of an ingredient that includes processing aids and reagents that are long longer present in the final product.
Another alarming issue is that the changes proposed in this bill will cause American products to be out of step with the rest of the world.
The major change that I see from the current law is that professional products will be required to bear an ingredient list. I don’t see any issue with that, but it is misleading to assume that professionals are not protected under current law. Professional use products are regulated by OSHA along with state and local agencies and because they are not sold to the public they producers have not wasted money on printing ingredients on the packaging itself but instead every professional product sold does come with an MSDS and INCI Ingredient list. This is just smoke and mirrors to try and convince you that they are somehow protecting you by requiring something that already happens in a different format.
‘‘(c) SPECIAL RULE FOR CONTAMINANTS.—The Secretary shall require, in the case of a contaminant, that a contaminant be declared on the label of a cosmetic, in the same manner as an ingredient under subsection
(a), if the contaminant is present at the lower of the following levels:
‘‘(1) A level that is greater than one part-per billion by weight of product formation.
‘‘(2) A level that is greater than one percent of the restriction on the concentration for such contaminant for such use, as determined by the Secretary under section 616(a)(2).
“Technically feasible detection limits” is defined as 1 ppb (part per billion is 0.000000001 of your finished product. Part (1) and part (2) do not say either one or the other which leads me to believe that they are covering their bases to be certain that no matter what it must be declared on the label. This means that your sweet orange essential oil is going to now need to list phthalates because they can be detected at higher than 1 ppb and all your fragrance oils will have a very long list of components. “Common contaminants include biocides and phthalates, and traces of heavy metals have been found in cold-pressed citrus oils.” Robert Tisserand
‘‘(d) LABELING OF NANOMATERIALS IN COSMETICS.—The Secretary may require that—
‘‘(1) minerals and other particulate ingredients be labeled as ‘nano-scale’ on a cosmetic ingredient label or list if not less than 1 percent of the ingredient particles in the cosmetic are 100 nanometers or smaller in not less than 1 dimension; and
‘‘(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.
I don’t specialize in nanotechnology so I don’t have much expertise to offer regarding this section except that you will now be required to disclose the nanometers of all your powered products in detail on your labels.
‘‘(e) LABELING OF INGREDIENTS IN COSMETICS SOLD THROUGH INTERNET COMMERCE.—The Secretary shall require—
‘‘(1) in the case of a cosmetic sold on the Web site of an Internet vendor, that the manufacturers and distributors of such cosmetic provide to such Internet vendor a list of the ingredients of the cosmetic; and
‘‘(2) that each Internet vendor display the list of ingredients of a cosmetic sold by such vendor on the Web page that is the primary Web page providing information relating to the sale of such cosmetic on the Web site of the vendor.
I agree that all ingredient lists should be fully disclosed on the internet. Consumers shouldn’t be surprise by the ingredients listed on the packaging of a product that they purchased online. This is a good thing as it does provide full disclosure up front. We have always offered the full INCI ingredient list for all our manufactured products.
‘‘(f) TRADE SECRETS.—Notwithstanding any other provision of law, an ingredient required to be listed on a label under this section shall not be treated as a trade secret.
This is something that could easily be missed as you read through this bill. It is tucked inside a good long list of requirements right after a few that aren’t very alarming. But don’t be fooled by the placement or lack of attention around this section. Since you are required in section 611 to add all reagents, processing aids, contaminants and individual components of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter. This means that all trade secrets for manufacturing ingredients, flavors and fragrances are gone. In order to accurately label in order of predominance you must know the percentage of every component of an ingredient. It isn’t enough to simply paste the order given by the manufacturer because it must merge with the order and quantity of components of other ingredients in your formula.
I’ve included below in blue Section 611 of The Safe Cosmetics Act from previous page or you can go back to my blog covering this section here.
In section 611. ‘‘(4) INGREDIENT.—
‘‘(A) IN GENERAL.—The term ‘ingredient’ means a chemical in a cosmetic, including—
‘‘(i) chemicals that provide a technical or functional effect;
‘‘(ii) chemicals that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient;
‘‘(iii) processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetic;
‘‘(iv) substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect;
‘‘(v) the components of a fragrance, flavor, or preservative; and
‘‘(vi) any individual component of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter.
‘‘(B) TREATMENT OF CONTAMINANTS.—
For purposes of sections 614 through 617, the term ‘ingredient’ also includes—
‘‘(i) contaminants present at levels above technically feasible detection limits; and
‘‘(ii) contaminants that may leach from container materials or form via reactions over the shelf life of a cosmetic and that may be present at levels above technically feasible detection limits.
‘‘(g) APPLICATION.—Beginning 18 months after the date of the enactment of this subchapter, the requirements of this section shall apply to—
‘‘(1) all cosmetics that are available for retail sale; and
‘‘(2) manufacturers, distributors, and Internet vendors of such cosmetics.