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. 618 Treatment of Contaminants.
KEY: All Plain Text is directly from H.R. 2359 as it is written and Green is my commentary.
‘‘SEC. 618. TREATMENT OF CONTAMINANTS.
‘‘(a) PUBLICATION OF LIST.—Not later than 1 year after the date of the enactment of this subchapter, and annually thereafter, the Secretary shall publish a list of—
‘‘(1) ingredients used in cosmetics that may contain contaminants;
A list of cosmetics? Or a list of cosmetic ingredients? Is the Secretary going to go about the business badmouthing cosmetic companies by compiling a list of finished cosmetics that “may” contain contaminants? What will the EWG do with itself without their full time job of blacklisting companies if the FDA is going to take it over? How will the EWG justify asking you for $5 every other week to support their cause.
I can promise you one thing. All cosmetics companies that are not registered and did not pay their fee will be at the top of the list of cosmetics that “may contain contaminants” because they won’t have proven to the FDA that they don’t.
‘‘(2) combinations of ingredients that may create contaminants when such ingredients interact;
‘‘(3) contaminants that may leech from product packaging into a cosmetic; and
Now they are talking pre-market testing of your cosmetic as it reacts to the packaging.
‘‘(4) any other contaminant of cosmetics identified by the Secretary.
Translation: And anything else we couldn’t think of right now to add to this bill but might think of later.
‘‘(b) REQUIREMENTS FOR TESTING.—
‘‘(1) IN GENERAL.—Not later than 1 year after the date of enactment of this subchapter, the Secretary shall establish, by rule, requirements for testing ingredients and cosmetics for contaminants listed under subsection (a).
‘‘(2) CONTENTS.—The requirements under paragraph (1) shall include—
‘‘(A) testing methods and applicable protocols; and
Premarket testing of cosmetics. There is a misperception that cosmetic ingredients are untested. That couldn’t be further from the truth. I’ve been formulating a new shampoo and I’ve had at my fingertips a variety of test results to help guide me in choosing the right ingredients to not only fit my standards for human safety but also environmental impact. I have studies on the biodegradability, oral toxicity, eye irritation, contact sensitization, skin irritation, inhalation studies, 28 day subchronic toxicity study, mutagenicity, carcinogenicity, mammalian toxicity, studies on how ingredients interact, what percentages are best used, by products, pH, and every other detail you can think of needing to know before using the ingredient in a products.
‘‘(B) maximum allowable detection limits for each contaminant in an ingredient.
Premarketing testing that includes a search for anything at parts per billion that might occur in nature, from your packaging, from the reaction of ingredients and so forth.
A closer look at this shows it isn’t the cosmetic ingredients themselves that they are demanding pre-market testing on, since most of those have a massive amount of pre-market testing already, it would be testing for finished products that they are seeking. Since it is already illegal to sale a product that is contaminated in any way it isn’t the already required microbiological testing that they want, it is testing to show that from nature or as a by-product finished cosmetics do not contain anything from their list of ‘dangers’.
In order to show small businesses and consumers the impact of the legislation would require I researched the cost of having one batch of a single product one scent tested to prove that it is free of contaminants and ingredients that will be focused on.
Here is a likely list of tests it would take to get approval:
$440.00 Paraben results in ppm
$950.00 Nitrosamine results in ppm
$950.00 Phthalate Free results in ppm
$700.00 per metal Heavy Metals (Lead, Arsenic, Cadmium) results in ppm
$275.00 Mercury results in ppm
$1185.00 Standard 9 Metals
$750.00 1,4 Dioxane results in ppm
$275.00 Formaldehyde results in ppm
$300.00 Ethylene Oxide results in ppm
$450.00 Residuals results in ppm
$1500.00 Fragrance allergens
$350.00 Fragrance Allergens Confirmation test per sample, per per allergen
Total $8125.00 or more pre-market testing per product
If testing was required per lot number per SKU of product the prices of cosmetics would sky rocket. Even if the testing was required per formulation per SKU the testing would put the majority of small businesses out of business over night. The testing is not only over the top, but it is uncalled for since all cosmetic chemicals are pre-market tested, all FD&C colors are premarket tested per lot per color and the ingredients are known to be safe based on testing and history.
‘‘(3) UPDATE.—The Secretary shall annually update the requirements under paragraph (1).
‘‘(c) SUPPLIER REQUIREMENTS.—Not later than 1 year after the promulgation of the rule under subsection
(b)(1), a supplier of an ingredient that is used in a cosmetic shall, with respect to such ingredient—
‘‘(1) comply with the requirements under subsection (b)(1) for any ingredient listed under subsection (a);
‘‘(2) conduct similar testing on any ingredient that—
So even if the testing is already done the supplier need to conduct similar testing and duplicate the results?
‘‘(A) the supplier expects may be used in a cosmetic;
The supplier has to guess what other ingredients a manufacturer may or may not use in a formula and test their ingredient against all those possibilities. All this and the manufacturer will need to conduct tests of the actual formula that they create. I’m thinking we should all shut down and open testing facilities because that is where the money is going to be.
‘‘(B) the supplier suspects may contain a contaminant; and
‘‘(C) is not listed under subsection (a); and
If it isn’t on the list that the Secretary creates then the supplier needs to conduct tests to prove that it does or does not contain a contaminant.
‘‘(3) upon the sale of an ingredient to the manufacturer, provide to the manufacturer specifications for the ingredient that—
‘‘(A) include the levels of contaminants present in such ingredient; and
‘‘(B) are based on the results of the tests under paragraph (1) and paragraph (2).
‘‘(d) MANUFACTURER REQUIREMENTS.—Not later than 1 year after the promulgation of the rule under subsection (b)(1), a manufacturer of a cosmetic shall, with respect to each ingredient that the manufacturer uses in a cosmetic—
‘‘(1) obtain, from each supplier of the ingredient, specifications for the ingredient that include—
‘‘(A) the level of each contaminant present in the ingredient; and
‘‘(B) the detection limits of the analytical test used to detect the contaminant; or
‘‘(2) comply with the requirements under paragraphs (1) and (2) of subsection (c) for the ingredient, in the same manner as if the manufacturer were a supplier.
After the supplier of the ingredient complies with “the requirements under paragraphs (1) and (2) of subsection (c) for the ingredient” the manufacturer must repeat the entire process. Someone start passing out the red tape, please.