Safe Cosmetics Act 2011: Cover, Table of Contents and Sec 611. Definitions
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 introduces you to the cover, table of contents and SEC 611 Definitions.
The highlighted SEC’s below link back to the breakdown of that SEC on PCT.
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.
112TH CONGRESS, 1ST SESSION, H. R. 2359
To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes.
Ms. SCHAKOWSKY (for herself, Mr. MARKEY, Ms. BALDWIN, Mr. MORAN, Ms. WOOLSEY, Mr. BLUMENAUER, Ms. CHU, Mr. GUTIERREZ, Ms. LEE of California, Mr. FRANK of Massachusetts, and Ms. WASSERMAN SCHULTZ) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and the Workforce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the ‘‘Safe Cosmetics Act of 2011’’.
(b) TABLE OF CONTENTS.—The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Cosmetic regulation.
‘‘SUBCHAPTER A—ADULTERATED AND MISBRANDED COSMETICS
‘‘SUBCHAPTER B—REGULATION OF COSMETICS
‘‘Sec. 611. Definitions.
‘‘Sec. 612. Registration of establishments and registration fees.
‘‘Sec. 613. Ingredients labels on cosmetics.
‘‘Sec. 614. Safety standard and good manufacturing practices.
‘‘Sec. 615. Cosmetic and ingredient safety information.
‘‘Sec. 616. Lists of ingredients and required responses.
‘‘Sec. 617. Treatment of cosmetics based on ingredient lists.
‘‘Sec. 618. Treatment of contaminants.
‘‘Sec. 619. Cosmetic and ingredient statements.
‘‘Sec. 620. Notification, nondistribution, and recall of adulterated or misbranded cosmetics.
‘‘Sec. 621. Petitions.
‘‘Sec. 622. Mandatory reporting of adverse health effects.
‘‘Sec. 623. Nonconfidential information.
‘‘Sec. 624. Animal testing alternatives.
‘‘Sec. 625. Product Testing and Review Audit.
‘‘Sec. 626. Resources for small businesses.
‘‘Sec. 627. Interagency cooperation.
‘‘Sec. 628. Savings clause.
‘‘Sec. 629. Authorization of appropriations.
Sec. 3. Worker issues.
SEC. 2. COSMETIC REGULATION.
(a) IN GENERAL.—Chapter VI of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361 et seq.) is amended— (1) by inserting before section 601 the following: ‘‘Subchapter A—Adulterated and Misbranded Cosmetics’’; and (2) by adding at the end the following: ‘‘Subchapter B—Regulation of Cosmetics ‘‘SEC. 611. DEFINITIONS.
Federal Food, Drug, and Cosmetic Act Referred to above:
SEC. 601. [21 USC §361] Adulterated Cosmetics:
A cosmetic shall be deemed to be adulterated— 1(a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: ‘‘Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.’’, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term ‘‘hair dye’’ shall not include eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
(e) If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a). FDA
To the above section of the current law this new law adds:
‘‘In this subchapter:
‘‘(1) DOMESTIC ESTABLISHMENT.—The term ‘domestic establishment’ means an establishment located in any State that manufactures or packages cosmetics.
‘‘(2) FOREIGN ESTABLISHMENT.—The term ‘foreign establishment’ means an establishment that manufactures or packages cosmetics that are exported to the United States.
‘‘(3) MANUFACTURER.—The term ‘manufacturer’ only includes manufacturers that determine the final formulation of a cosmetic.
‘‘(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;
In the case of handcrafted soap this means that your label will read Cocos Nucifera, Aqua, Sodium Hydroxide instead of what it is transformed into Sodium Cocoate. It gives the consumer the misconception that their soap bar still contains un-reacted lye. For more information on the process of handcrafted soap making read here.
Ingredient lists are going to start to get hard to follow and long. In addition, it will be a nightmare to write an accurate ingredient list due to the fact that each ingredient will have multiple components in them all at different percentages. Currently today if we write an ingredient list the order of predominance is pretty cut and dry. You write your ingredient list from the highest percentage to the lowest and you are done. But when each single ingredient now must list the 2, 3, 4…maybe 10 components that went into the creation of the single ingredient and all of those things must fall onto the ingredient list with the other ingredients in predominance of order we have a mess on our hands.
Here is a made up example :
Surfactant 1 = 5 “ingredients”
Surfactant 2 = 3 “ingredients”
Preservative = 7 “ingredients”
Fragrance = 29 “ingredients”
Color = 5 “ingredients”
Now let’s pretend that I wrote that list in order of predominance and this is our current ingredient list: Aqua, INCI for Surfactant 1, INCI for Surfactant 2, INCI for Preservative, Fragrance, Color.
As a side note it is currently the law that all ingredients in a preservative bundle must be listed. For instance: Germaben II must list Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben.
Under H.R. 2359 the manufacturer of the cosmetic must now determine how to write the 49 “ingredients” onto the ingredient list in the correct order. In order to accurately write the ingredient list the percentage of each component of each ingredient would have to be know, which would make every formula of every ingredient have to be disclosed. Otherwise your new list would not follow the current international laws that require all cosmetic ingredient list to fall into order of predominance.
No one will be exempt from this labeling puzzle.
‘‘(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.
One of the promises that came out of the announcement of this new bill was that “All botanicals will be listed as what they are on the label and will not need to be broken down into their organic compounds.” For example, Coconut Oil will still be listed with the INCI name Cocos Nucifera (Coconut Oil). This isn’t remotely what the above passage says with the addition of, “‘‘(vi) any individual component of a petroleum-derived, animal-derived, or other ingredient that the Secretary deems an ingredient for purposes of this chapter.” Essential oils fall under the “fragrance” category and are botanicals.
‘‘(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
Later in this bill “technically feasible detection limits” is defined as 1 ppb (part per billion). Just to visualize that for you they mean that if a “contaminant” is in your finished product at 1 part per 1,000,000,000. That means that it makes up 0.000000001 of your finished product. Formaldehyde is in everything, including your own body, at technically feasible detection limits.
‘‘(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.
Again the language here does not leave out botanicals. Further into this draft bill I will cover this topic in more depth.
‘‘(5) MICROBUSINESS.—The term ‘microbusiness’ means a business—
‘‘(A) that is engaged in the manufacturing or packaging of cosmetics; and
‘‘(B) that has annual sales receipts for cosmetic products that do not exceed $2,000,000.
This is a definition that will be used later in the bill to exempt from fees and registration but it DOES NOT exempt small businesses from all of the other components of this bill, nor is there a limit or a stop-gap measure placed on the FDA or Congress for changing or raising these new fees for anyone.
‘‘(6) PROFESSIONAL USE.—The term ‘professional use’ means the use of any cosmetic—
‘‘(A) by an employee (within the scope of the employment of such employee) of; or
This means EVERYONE; soapmakers, aromatherapists, manufacturers, crafters and small businesses.
‘‘(B) purchased by a consumer in, a hair salon, nail salon, beauty salon, spa, or other establishment that provides cosmetic treatment services for humans.
‘‘(7) REASONABLE CERTAINTY OF NO HARM.—
With respect to an ingredient or cosmetic, the term ‘reasonable certainty of no harm’ means that no harm will be caused to members of the general population or any vulnerable population by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from—
‘‘(A) low-dose exposures to the cosmetic or ingredient; or
‘‘(B) additive effects resulting from repeated exposure to the cosmetic or ingredient over time; or
‘‘(C) cumulative exposure resulting from all sources, including both the cosmetic or ingredient and environmental sources.
Does anyone else hear the alarm bells ringing here? How on earth can any person with a big or small business take into account the additive effects of products consumers are using and environmental sources? I can’t possibly know how much of anything is in the drinking water of every household, what other products they use, their diet, family history, what they clean their house with, employment history and exposures, medical history and so forth. Can you? This is the most ridiculous requirement on the face of the earth and you will find it repeated over and over again in this draft bill. It is unscientific overregulation promoted by political propaganda that will harm us all, consumer and businesses alike.
‘‘(8) REPRODUCTIVE OR DEVELOPMENTAL TOXICITY.—With respect to an ingredient or cosmetic, the term ‘reproductive or developmental toxicity’ means that the ingredient or cosmetic can contribute to biologically adverse effects on the development of humans or animals, including effects on the female or male reproductive system, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions of the body that are dependent on the integrity of the reproductive system as well normal fetal development.
Someone please show me the science (not the regurgitated misinformation from EWG and CFSC) that any ingredient in cosmetics causes birth defects or in any way acts as a reproductive or developmental toxic agent. If you inject or force feed a pregnant rat with high doses of an ingredient that is designed to by applied to the skin you are destined to get negative results. Of course, if my cat drank my tea tree essential oil everyday of her life she would be dead or infertile. But if I apply tea tree to my skin every day I won’t suffer the same consequences. I work in the cosmetic industry with a higher than normal exposure to ingredients and have three perfectly healthy children. If it was true that cosmetic ingredients caused these issues there would be an abnormally high number of infertile men and women that work in the industry with an equally high percentage of birth defects among our children. This is not the case, if anything, those working around essential oils tend to have a stronger immune system, but the EWG likely will never disclose those scientific facts to their political pawns.
‘‘(9) VULNERABLE POPULATIONS.—The term ‘vulnerable populations’ includes pregnant women, infants, children, the elderly, people with compromised immune systems, and highly exposed populations, including workers employed by hair salons, nail salons, beauty salons, spas, other establishments that provide cosmetic treatment services for humans, and cosmetic manufacturing plants.
I fall into this category in many ways, but most importantly as someone who suffers from asthma. I still don’t support this legislation. It is still not clearly defined, nor is there any limit placed on the government here as they continue to overstep their authority into an industry that has one of the highest product safety record of all industries. Making an unscientific claim does not make it true but it does make uneducated people like the EWG, backed by the extreme Tides Foundation, able to gain more political moxie thereby controlling this industry. You need to make your voice known to your State Reps and shut this bill down before it derails this industry forever.
More about the author: Kayla Fioravanti is the Vice President, Chief Formulator, ARC Registered & Certified Aromatherapist for Essential Wholesale and its lab division Essential Labs. Read more from this author