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 616 List of Ingredients and Required Responses.
KEY: All Plain Text is directly from H.R. 2359 as it is written and Green is my commentary.
‘‘SEC. 616. LISTS OF INGREDIENTS AND REQUIRED RESPONSES.
‘‘(a) PLACEMENT ON LIST.—
‘‘(1) IN GENERAL.—Based on an initial review and evaluation of an ingredient under subsection (c), the Secretary shall place the ingredient on one of the following lists:
‘‘(A) The prohibited and restricted list under subsection (b).
‘‘(B) The safe without limits list under subsection (c).
‘‘(C) The priority assessment list under subsection (d).
Okay, stay with me, this gets dicey.
‘‘(2) CONSIDERATIONS.—In determining the placement of an ingredient on a list under subsection (a), the Secretary shall consider whether the ingredient—
What isn’t clear in this entire section is how these things will be weighed or considered. Is it a good thing or a bad thing if an ingredient does any of the following? Once these things are considered what will the Secretary do with this information?
‘‘(A) reacts with other substances to form harmful contaminants;
I can only guess here that they are aiming at things like nitrosamines. Nitrosamines are produced from nitrites and amines. They can be formed under strongly acidic conditions and high temperatures. Most references to nitrosamines are related to food. Our stomach is a highly acidic condition and fried food can enhance the formation of nitrosamines. Technically speaking what happens is that food hits the acidic (pH 1.4) condition of the stomach the nitrite forms nitrous acid, which is protonated (addition of a proton to an atom, molecule or ion) and splits into the nitrosonium cation and water which reacts with the amine to produce nitrosamine.
To address the pH issue of nitrosamines possibly forming as it relates to cosmetics. Water has a pH of 7 so there isn’t a possibility of your shower gel, lotion, shampoo, hand soap or cleanser becoming highly acidic when it comes in contact with water. Many cosmetics have a pH range of 4.5 to 6 because the pH of human skin ranges from 4.5 to 6. Amines are nitrosated best in an aqueous solution at pH levels of 3 – 3.4 which your shampoo, lotion shower gel, hand soap, or cleanser have no potential to ever reach.
Nitrosamines are generally produced at temperatures of 350-375 degrees F, like fried food and not cosmetics. All the research regarding nitrosamines being cancer causing is related to foods, beer, tobacco, and have absolutely nothing what-so-ever to do with cosmetics. There is one study that found N-nitrosodimethylamine (NDMA) in drinking water in California which was found to be a by-product of drinking water treatment. In California the notification level of NDMA is .0003 milligrams per liter in drinking water.
Humans are exposed to nitrosamine contamination in foods from the amine and amide groups including: beer, fish, dates, kiwifruit, cheese, limes, oranges, passionfruit, tangerine, broccoli, cauliflower, dill pickles, and olives. These foods have high and very high levels avocados, bananas, fig, grapes, lemon, mandarins, pineapples, plums, raspberry, egg plant, mushrooms and tomato, but especially sauerkraut and spinach. Oh wait, I’m not done yet because we still have the amide group which include anything with Vitamin B3 and other B vitamins including thiamine, riboflavin, pantothenic acid, pyridoxine, cyanocobalamin, and folic acid. And of course all yeast, meat, fish, milk, eggs, green vegetables, and cereal grains.
There are other cosmetic ingredients that are said to “form harmful contaminants” by the EWG and CFSC that when looked at scientifically and logically are not actually harmful in parts per billion in cosmetics. You are exposed to far more of all these things in your food, the water and environment than you are in cosmetics. But that is why they are expecting you to try to anticipate and guess all the exposures of everything imaginable. They have no clue and there is no way to differentiate the cosmetic verses all other possible environmental causes.
‘‘(B) is found to be present in the body through biomonitoring;
Since formaldehyde is found in the human body what does that mean about how it will be handled on the list?
‘‘(C) is found in drinking water or air;
Such as formaldehyde, 1-4 dioxane, lead, arsenic and so forth, but I’m still not sure what it will mean when they consider the fact that anything can be found in water or air.
‘‘(D) is a known or suspected neurological or immunological toxicant, respiratory asthmagen, carcinogen, teratogen, or endocrine disruptor, or have other toxicological concerns (including reproductive or developmental toxicity); or
Is known or suspected! I’m okay with what is known and proven scientifically, but suspected! The EWG and CFSC suspect just about everything of most of these concerns. Lavender and Tea tree were wrongly suspected of causing man-boobs (moobies) in adolescent boys. To allow suspicion to govern cosmetics or anything else is dangerous. Look back at history and you can find that the entire platform of the CFSC is based on suspicion and not science. Listen to founding member of CFSC Susan Roll testifying here.
‘‘(E) is known to persist in the environment or bioaccumulate.
‘(3) PRIORITIZIATION OF INGREDIENTS THAT ARE FOOD.—In placing ingredients on the lists under paragraph (1), the Secretary shall prioritize the placement of ingredients that are food (as such term is defined under section 201(f)) on such lists.
Later you will see that this bill calls for 300 ingredients to be reviewed in the first year. There are more than 300 food grade ingredients. Does this mean that they will only focus on food grade cosmetic ingredients? Of course not. But if you haven’t read ahead, as I have, you might see this as a promising sign for the natural industry.
‘‘(b) PROHIBITED AND RESTRICTED LIST.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that are identified by the Secretary—
‘‘(A) as prohibited for use because the Secretary determines that such ingredients are unsafe for use in cosmetics in any amount because such ingredients fail to meet the safety standard under section 614(a); or
I wonder if we are going to get a really nifty long 1342 banned ingredient list like the EU that contains things like warfarin, radioactive substances, vaccines, asbestos and petroleum – as if we actually use any of those things in cosmetics. I hope this list will be based on actual cosmetic and food grade ingredients that are banned for real scientific reasons. The FDA does have a list of banned and restricted ingredients. I know the list isn’t long enough to be as impressive as the EU list, but it doesn’t fill space with ingredients that have never been and never will be used in cosmetics.
‘‘(B) as being subject to necessary restrictions in use or concentration to allow the use of the ingredient in a cosmetic to satisfy the safety standard.
‘‘(2) SPECIFICATION OF RESTRICTIONS.—In the case of any ingredient listed under paragraph (1)(B), the Secretary shall specify the restrictions on use or concentration that are necessary to satisfy the safety standard for such ingredient.
The sad thing is that once an ingredient is listed as restricted that listed will be used against it. Japan lists certain ingredients as having a restricted use level. It doesn’t mean that the ingredient is bad, it just means that it was designed for lower level use. For instance, phenoxyethanol has been tested on the skin and eyes and it is non-irritating and non-sensitizing at levels of 2.2% or lower. It is effective at 1% and is on the restricted in Japan to a level of 1%. The EWG has used that restriction as a mark against phenoxyethanol. That is like saying that water is bad simply because it is recommended that you drink 8 x 8 cups of water per day. True, if you drink too much you can have water intoxication or water poisoning, but that doesn’t make water bad in and of itself. The same is true of setting levels of ingredient usage in cosmetics. All things in excess are bad, common sense anyone or how about just scientific sense.
‘‘(3) UPDATES.—The Secretary shall, at a minimum, annually update the list under paragraph (1),including any—
‘‘(A) determinations under subsection (d)(3); or
‘‘(B) new information that demonstrates that an ingredient fails to meet the safety standard, or requires restrictions on use to meet such standard.
‘‘(4) MANUFACTURER REQUIREMENTS.—Not later than 1 year after the date that an ingredient is placed on a list under subsection (b), any manufacturer using such ingredient in a cosmetic shall reformulate such cosmetic to—
‘‘(A) eliminate the use of the ingredient, if it is listed under paragraph (1)(A); or
‘‘(B) modify the use of the ingredient if it is listed under paragraph (1)(B), to meet the restrictions specified under paragraph (2).
This is perfectly fine as long as real science, and not suspicion and hearsay, is the basis for where an ingredient is placed on the lists. Reformulation is a real cost and burden on businesses that should be taken seriously and not haphazardly. A new formula must be tested for effectiveness, stability and safety as is the law already.
‘‘(c) SAFE WITHOUT LIMITS LIST.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall issue, by regulation, a list of ingredients that the Secretary has determined are safe for use in cosmetics, without limits or restrictions.
‘‘(2) STANDARD FOR INCLUSION IN LIST.—The Secretary may only include an ingredient on the list under paragraph (1) if the Secretary determines that the ingredient meets the safety standard under section 614(a), regardless of—
‘‘(A) the type and form of cosmetic the ingredient is used in; and
‘‘(B) the concentration of the ingredient that is used in a cosmetic.
‘‘(3) UPDATES AND REDETERMINATIONS.—The Secretary shall annually update the list under paragraph (1) and may redetermine whether an ingredient distributed in commerce meets the safety standard if, in the judgment of the Secretary, new information raises a credible question as to whether the ingredient continues to meet the safety standard.
It is important to note here that the testing of an ingredient can take years to determine the outcome. For instance, it can take 3-5 years, a set of test rats or mice and millions of dollars to test one ingredient for carcinogenicity. So who is supposed to do that? I thought this bill was friendly to small businesses.
‘‘(d) PRIORITY ASSESSMENT LIST AND RELATED SAFETY DETERMINATIONS.—
‘‘(1) IN GENERAL.—Not later than 2 years after the date of the enactment of this subchapter, the Secretary shall develop and publish a priority assessment list of not less than 300 ingredients—
“The National Toxicology Program spits out a handful of tests each year. If this is going to be upgraded by, say, 50 times, then this testing alone is going to require billions of dollars per annum. And it will involve a lot more killing of animals than happens currently. Costs will be massively increased, because they will have to acquire new testing facilities to carry out all the extra testing. These days, a carcinogenesis report on a single substance runs to several hundred pages. And even then, after all that time, money and effort, sometimes the conclusions are unclear – we still don’t know whether, or in what amounts, the substance might pose a risk to humans.” Robert Tisserand You can read more on this topic in Robert’s blog post Negative Bias.
‘‘(A) which, because of a lack of authoritative information on the safety of the ingredient, cannot be included on—
According to the EWG the list of ingredients that don’t have enough safety data to make this sort of conclusion is massive. The EWG is wrong. The CIR Expert Panel has made a conclusive decision from the safety data, but the authors of this bill have already proven that they won’t rely on the CIR Expert Panel. They would rather believe the hype of the EWG rather than science which tells me this is less about safety and more about money.
‘‘(i) the list under subsection (b) (relating to prohibited and restricted ingredients); or
‘‘(ii) the list under subsection (c) (relating to ingredients that are safe without limits); and
‘‘(B) for which the Secretary has determined it is a priority to conduct a safety determination under paragraph (3).
‘‘(2) ANNUAL ADDITION OF INGREDIENTS.—
After the list is developed under paragraph (1), the Secretary shall annually add at least 100 additional ingredients to such list until all ingredients that are used in the formulation or manufacture of cosmetics have been added—
In the meantime what are cosmetic companies to do? Since they refuse to rely on the safety data of the CIR Expert Panel. Cosmetic chemists will have a list of 300 ingredients they are allow to formulate with and the rest of the ingredients will be at risk of being removed by the hundreds each year. The FDA does not even have any scientist with the expertise to do this type of testing and studies. Who will they employee to do this, third party labs, EWG psuedo-scientists, new government employees yet to be hired?
‘‘(A) to such list;
‘‘(B) to the list under subsection (b); or
‘‘(C) to the list under subsection (c).
‘‘(3) DETERMINATION OF WHETHER INGREDIENT MEETS SAFETY STANDARD.—
‘‘(A) REVIEW OF PRIORITY INGREDIENTS.—During the 2-year period following the date on which an ingredient is placed on the list under paragraph (1), the Secretary shall—
‘‘(i) collect data and information on such ingredient; and
‘‘(ii) review and evaluate the safety of such ingredient.
Again, I hope the Secretary is one seriously educated individual with an incredible amount of time. Each ingredient may have hundreds of pages of scientific research to be reviewed.
‘‘(B) DETERMINATION OF LIST PLACEMENT.—Not later than the end of the period under subparagraph (A), the Secretary shall issue a determination, based on the review and evaluation under such clause, that—
‘‘(i) the ingredient meets the requirements for inclusion on a list under subsection (b) (relating to prohibited and restricted ingredients) or subsection (c) (relating to ingredients that are safe without limits); or
‘‘(ii) insufficient information exists to place the ingredient on either such list.
‘‘(C) GUIDANCE IN THE CASE OF INSUFFICIENT INFORMATION.—If the Secretary determines under subparagraph (B) that, with respect to an ingredient, insufficient information exists to place such ingredient on either of the lists under subsection (b) or subsection (c), the Secretary shall provide guidance to manufacturers on the data and information (including minimum data requirements and safety testing protocols) that the Secretary requires to evaluate whether the ingredient meets the safety standard under section 614(a) for purposes of placing such ingredient on such a list.
‘‘(D) COMMENT PERIOD.—Upon issuing the determination under subparagraph (B), and, if applicable, the guidance under subparagraph (C), the Secretary shall provide a period of not less than 60 days for public comment on the determination before applying such determination to an ingredient, except that a shorter period for comment may be provided if the Secretary—
‘‘(i) finds that it would be in the public interest to have a shorter period; and
‘‘(ii) publically declares the reasons for such finding.
‘‘(4) MANUFACTURER RESPONSE TO INADEQUATE INFORMATION.—Not later than 18 months after the date that the Secretary issues guidance under paragraph (3)(C) with respect to an ingredient subject to a determination under paragraph
(3)(B), a manufacturer using such ingredient in a cosmetic shall—
‘‘(A) reformulate such cosmetic to eliminate the use of the ingredient; or
‘‘(B) provide the Secretary with the data and information specified in such guidance.
‘‘(5) EVALUATION OF ADDITIONAL DATA AND INFORMATION.—With respect to an ingredient, not later than 6 months after a manufacturer provides the Secretary with the data and information under paragraph (4)(B) the Secretary shall review such data and information and shall make a redetermination under paragraph (3)(B) for such ingredient, subject to the comment period under paragraph (3)(D).
‘‘(6) LIMITATION.—If the Secretary has not placed an ingredient on either of the lists under subsection (b) and subsection (c) by the end of the 5-year period beginning on the date that such ingredient is first placed on the list under subsection (d), beginning on the first day after such period such ingredient may not be—
‘‘(A) used in a cosmetic; and
‘‘(B) manufactured, imported, distributed, or marketed for use in cosmetics.