First, a big shout out to Dene Godfrey for wishing us a belated 3rd birthday!! How on earth did I miss this? Personal Care Truth launched May 17, 2010.

The time has flown by like the wind. In that time, we’ve seen several drafts/attempts at changing cosmetic legislation, truthful and science backed posts from our wonderful experts and contributors and lively discussions from our readers.

Kristin and I would like to thank you for your support of our efforts to bringing truth to the cosmetic industry. All the credit goes to our fabulous experts, contributors and readers. Without y’all, PCT would have been “just another blog”. Our experts/contributors brought facts, science and truth to the cosmetic industry! Many thanks, y’all!

Kristin and I continue to fund PCT with personal money and greatly appreciate donations from people who support our efforts.

We look forward to what the future brings and hope you will continue to support and contribute to the dialogue. We are still over the moon excited at the response we continue to receive.

Thank you bunches!!

As a beginning chemist, one of the most frustrating things for me as I started my career was the product ingredient lists. While all the products had cosmetic ingredient listings, the ingredient were rarely things that I learned about in college. The cosmetics industry just does not use the same naming system for ingredients as the one you learned in college.

The college system of naming is the IUPAC system. The great thing about this system is that it allows you to figure out the chemical structure of any material from its name alone. Unfortunately, it also leads to incredibly long names for the ingredients so it isn’t practical to use it for naming cosmetics.

The cosmetic system is the one created by the PCPC and listed in the INCI Dictionary. They use a whole different set of naming conventions which lead to shorter names but also make it impossible to ascertain most ingredients structures from the name. Oh well, you don’t really need to know the molecular structure to be a good cosmetic chemist.

Ingredients are not the same

One of the things I wanted to point out in this post is that not all ingredients are the same even if they have the same name. To understand why, let’s look at an ingredient like Sodium Lauryl Sulfate (SLS).

SLS is a pretty straightforward molecule. It is a surfactant with a 12-carbon chain backbone attached to a SO4 group and ionically bonded with a sodium ion.

But when you buy Sodium Lauryl Sulfate from one supplier, you might not be getting the same chemical as when you buy your ingredients from another supplier. Why?

It turns out that this is because of the way sodium lauryl sulfate is produced. To create SLS, you react Lauryl Alcohol with Sulfur Trioxide gas. This is further neutralized with Sodium Hydroxide to produce SLS. The key part of this reaction is the “Lauryl Alcohol” and the way that it gets produced.

Lauryl Alcohol

Lauryl alcohol can be obtained from a number of sources including from the fatty acids of plant oils and crude oil. Unfortunately, these sources are a mixture of fatty acids and it is incredibly difficult to isolate only the C12 molecules. So, instead of starting the production of SLS with pure Lauryl Alcohol, most companies start with a mixture that is mostly Lauryl Alcohol but contains a number of other residual fatty alcohols.

Therefore, the chemical properties and quality of the SLS will vary from raw material supplier to raw material supplier depending on the quality and type of starting material for their SLS. The more pure the starting Lauryl Alcohol source, the better controlled the SLS end properties will be.

This same thing applies to most any other cosmetics ingredients that you might use. It’s pretty rare that a cosmetic ingredient is pure. It is nearly always a mixture of the main ingredient you want and some residual ingredients that you might not.

Time and time again I see arguments put forward for avoiding the use of petrochemical-derived ingredients in cosmetics. Leaving aside the nonsensical claim that they are all dangerous (fortunately, a view shared only amongst a small minority of ill-informed/naive people), there seem to be 2 main issues:

1)      Oil is not a renewable resource

2)      Oil exploration and processing  are harmful to the environment

Whilst it could be argued that oil IS a renewable resource (in terms of the fact that oil could be produced wherever geological conditions are suitable), there is no doubt that current usage vastly outstrips the relatively slow natural processes that produce the material, so it is not sustainable – a different matter entirely!

There is also little doubt that oil exploration can be harmful to the local environment (to varying degrees), and to the wider environment when things go badly wrong – fortunately, a rare occurrence.

Whilst oil is clearly not a sustainable resource, there is still quite a lot left. It is estimated that there are 1.3 trillion barrels of oil remaining (http://www.imeche.org/knowledge/themes/energy/energy-supply/fossil-energy/when-will-oil-run-out) . 1 barrel weighs approximately 130kg (depending upon the density of the oil, which is variable), so this equates to approximately 169,000,000,000kg of oil (or 169 million tonnes, if you prefer). Although estimates vary, it is suggested that known reserves will be exhausted within 40 years, but I don’t see this as yet another reason not to use petrochemically-derived ingredients. What else would we do with the oil if we just stopped retrieving it? Whilst there may be some environmental considerations during extraction, there is no environmental penalty from there being no oil left in the ground.

As a contrast, let’s take a look at an ingredient that is popular in products aimed at those who prefer the more natural angle for their cosmetics – Dead Sea mud. This natural ingredient is taken from only one place – the Dead Sea (no surprise there, I suspect!). That fact alone should ring alarm bells – only one very small area is available for providing this popular ingredient for use in cosmetics globally.

The Dead Sea has a surface area of 810km² (http://en.wikipedia.org/wiki/Dead_Sea). Whilst the surface area doesn’t give a direct indication of the total surface area of the sea bed, it’s a good enough approximation for the purpose of illustrating an important point. The area of the sea bed and the depth of the mud are required for any calculation of the total quantity of mud available for mining. I have no precise figures for either, so I will take an approximation from the surface area and an overestimate of the depth of the mud as being 0.005km (= 5 meters – especially as it makes the calculation much easier!) – giving a total volume of mud of 4.05km³ (810 x 0.005). In order to arrive at a figure comparable to the actual weight of remaining oil reserves, I then need to convert this volume to a weight, for which I require the density of the mud. I can find no data on this, so I will have to make an educated (and deliberately exaggerated) guess at 3g/cm³ (= 3kg/litre). This gives a total weight of 4.05 x 3 = 12.15; 12.15 x 100,000,000 (the number of litres in 1km³) to give a total weight of 1,215,000,000kg (or 1.215 million tonnes). Bear in mind that this figure is highly likely to be an absolute maximum, as I believe I have overestimated both the depth of the mud and the density – the actual figure could well be less than half of that I’ve just calculated.

Whilst I fully appreciate that the rate of use of Dead Sea mud is tiny compared with that of oil, this is still a finite resource. It is probably renewable but, as for oil, the rate of usage will greatly outpace the rate of renewal and is, therefore, not sustainable.  Additionally, the removal of the mud has a much more direct impact on the immediate environment than does the removal of oil (in most cases), especially when that effect is combined with the effects of removing other minerals from the Dead Sea. In fact, the Dead Sea is already looking like a significant environmental disaster (http://en.wikipedia.org/wiki/Dead_Sea) and the continual removal of mud from the sea will only make things worse. Well before we reach the point where there is no more mud left to extract, the environment of the Dead Sea will be beyond repair. Also, as with oil, Dead Sea mud is not without serious political issues (http://en.wikipedia.org/wiki/Ahava).

So, given the fact that oil is not a sustainable resource and has environmental issues, and that Dead Sea mud has exactly the same two issues (arguably even more so, environmentally), why are petrochemicals not acceptable and even positively vilified by some, (although oil is natural and petrochemicals are, therefore, nature-derived) whereas Dead Sea mud is a highly lauded ingredient in many cosmetics?

Several possible reasons may be offered – confusion; ignorance; hypocrisy?

If anyone has more accurate data for any part of my calculation, I welcome this, but I think it is unlikely to change the basic premise that there is, essentially, no difference in the arguments against using either petrochemicals or Dead Sea mud. The natural lobby can’t have it both ways. Or am I missing something? If I am, please tell me!

Published on The National Law Review

Safe Cosmetics and Personal Care Products Act of 2013 Mirrors Toxic Substances Control Act (TSCA) Proposals, Would Greatly Expand FDA Authority Over Cosmetics

Representative Janice Schakowsky (D-IL), with fifteen co-sponsors, has introduced legislation in the House of Representatives to dramatically increase Food and Drug Administration (FDA) oversight of chemicals in cosmetics and other personal care products.[1] The Safe Cosmetics and Personal Care Products Act of 2013, H.R. 1385,[2] includes a number of provisions also included in the Safe Chemicals Act of 2013, S. 696, a bill to modernize the Toxic Substances Control Act (TSCA).[3] The bill would fundamentally transform the regulation of cosmetics and their ingredients. It expands on prior proposals in a number of respects.[4] The bill, introduced March 21, 2013, has been referred to the House Committee on Energy and Commerce and to the Committee on Education and the Workforce.

The bill would add a major new subchapter to the Federal Food, Drug, and Cosmetic Act (FFDCA) chapter on cosmetics.[5] This new subchapter would impose significant new obligations on FDA and on “brand owners,” the entities responsible for bringing a cosmetic to market, whether domestic or foreign establishments. Obligations would also be imposed on ingredient manufacturers and suppliers. The key provisions are as follows:

Labeling

• FDA currently requires cosmetic ingredients to be listed on a label, except that a flavor or fragrance may be listed as such,and trade secret ingredients may be listed as “other ingredients.” Incidental ingredients present at insignificant levels andwithout technical or functional effect do not have to be listed.[6]

• The bill would require all ingredients to be listed by name. Contaminants would have to be listed if present at more than 1part per billion (or lower in some circumstances).

• Like the Safe Chemicals Act of 2013, there would be no trade secret protection for ingredient names. There would be tradesecret protection for the concentration of cosmetic ingredients used in a finished cosmetic.

• Nanomaterials would have to be identified as “nano-scale,” using standard of 1% of particles having at least 1 dimension of 100 nanometers or less.

• Vendors of cosmetics sold over the Internet would have to include the ingredient list on their websites.

Safety Standard

• Currently, FDA requires manufacturers to establish the safety of each ingredient and finished cosmetic prior to marketing,and to label any cosmetic whose safety has not been established with a warning.[7] FDA itself does not routinely reviewcosmetics or their ingredients for safety.

• Like the Safe Chemicals Act of 2013, the bill would establish a “reasonable certainty of no harm” standard. Under thisstandard, FDA would have to evaluate whether a cosmetic or an ingredient in a cosmetic would be reasonably certain tocause no harm to members of the general population or any vulnerable population (including pregnant women, children,salon and spa workers, and cosmetic manufacturing plant workers) by aggregate exposure to the cosmetic or ingredient,taking into account possible harmful effects from low-dose exposures (a reference to endocrine effects), additive effects from repeated exposure over time, and cumulative exposures from all sources.[8]

• The bill would require FDA to ensure that the likely exposure to all sources of the ingredient or cosmetic, includingenvironmental sources, would result in either “not more than a 1 in a million risk for any adverse health effect in anyvulnerable population at the lower 95th percentile confidence interval,” or exposure in a concentration “shown to produce no adverse health effects, incorporating a margin of safety of at least 1,000 and considering the impact of cumulativeexposure from all sources.”

Safety Determinations

• FDA would have to review and evaluate the safety of all cosmetics and ingredients, taking into account informationsubmitted by brand owners as well as “authoritative sources” including the Environmental Protection Agency, the International Agency for Research on Cancer, the National Toxicology Program, the California Environmental Protection Agency, and “any other authoritative international, Federal, and State entity,” as determined by FDA.

• FDA would have to place an ingredient on a list of ingredients that are prohibited or restricted in light of the safety standard, or a list of ingredients that are safe without limits or restrictions (at any concentration), or a list of priority for which additional information is needed. FDA would have to place at least 300 chemicals on one of those lists within 2 years of enactment, and at least 100 per year thereafter. Where needed, FDA would have to specify restrictions on concentration or use necessary for an ingredient to satisfy the safety standard. Manufacturers would have to comply with prohibitions or restrictions within 1 year of listing. Cosmetics containing ingredients on the prohibited list would be considered adulterated.

• For an ingredient on the list of priority chemicals, within 2 years of listing, FDA would have to determine whether the ingredient qualifies for either of the other two lists. If there were to be insufficient information, FDA would have to prescribe minimum data requirements. Brand owners would have to either supply the information or eliminate the ingredient within 18 months of the insufficient information determination. If FDA were to fail to classify a priority chemical as either meeting the safety standard or not meeting the safety standard within 5 years of listing as a priority chemical, the ingredient could not be used in cosmetics.

• FDA would have to annually publish a list of “contaminants of concern” linked to severe acute reactions or long-term adverse health effects.

• Any person could petition FDA for prioritization, listing or delisting of ingredients, or listing of contaminants of concern. FDA would have to respond within 6 months of any “reasonable” petition, as determined by FDA rules.

Reporting

• A brand owner would have to submit to FDA “all data and information that the brand owner can access” regarding the safety of the cosmetic and of its ingredients. The required information would span a wide range of chemical identity, hazard, risk,and use information. The information would have to be updated annually or within 60 days of receiving information on adverse effects suspected to be caused by an ingredient or a cosmetic.

• If a brand owner were to request that a supplier or manufacturer of an ingredient provide any of the information required to be submitted to FDA, the supplier or manufacturer would have to provide it to the brand owner within 90 days of the request.

• A provision would be added for mandatory reporting by brand owners of any serious adverse event associated with the use of a brand owner’s cosmetic, similar to FDA’s current reporting requirements for drugs and medical devices.

• FDA would have to maintain a database of all non-confidential information received under the above requirements.

• Brand owners would have to submit to FDA a cosmetic and ingredient statement providing product use and ingredient information and any warnings and directions for use from the cosmetic label or insert. Failure to submit this statement would render all cosmetics sold by the brand owner misbranded.

• As under the Safe Chemicals Act of 2013, chemical identity could not be claimed confidential business information.

Testing

• FDA would be authorized to require any brand owner to conduct testing to demonstrate that a cosmetic meets the safety standard.

• Suppliers could also be required to conduct testing regarding listed “contaminants of concern.”

• FDA would have to require alternative testing methods where practicable and would have to encourage other means to minimize the use of animal testing of ingredients and cosmetics. FDA would have to publish a list of the alternative testing methods every three years.

Establishment Registration and Cosmetic Listing

• FDA currently encourages voluntary registration of cosmetic manufacturing establishments and filing of finished cosmetic ingredient composition statements.[9]

• The bill would require annual registration of domestic and foreign establishments manufacturing cosmetics for the U.S. market, along with annual fees. Microbusinesses (those with annual sales from cosmetics of less than $2 million) would be exempt from this requirement. Registration information would include the gross receipts or sales by the establishment from cosmetics, but would not be subject to the Freedom of Information Act. FDA would have to maintain a list of registered establishments.

• Each brand owner would be required to report annually to FDA information about each cosmetic that it markets, including a list of ingredients.

Other Requirements

• New enforcement provisions would be added regarding random annual product sample audits, notification of adulterated or misbranded cosmetics, and orders to recall or cease distribution. FDA could require information about, and from, the supply chain.

• FDA would have to issue guidance prescribing good manufacturing practices for cosmetics and ingredients.[10]

• An Interagency Council on Cosmetic Safety would be established among FDA, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and EPA.

• There would be no preemption of differing state or local regulations.[11]

• The bill would also require OSHA to promulgate an occupational safety and health standard regarding material safety data sheets for cosmetics.

Representative Schakowsky has introduced similar bills twice before,[12] and neither got out of committee, even when the Democrats controlled the House of Representatives. In 2012, with a Republican majority in the House, more moderate cosmetic bills were introduced, but none of them got out of committee either.[13] Thus, this bill is unlikely to be enacted. However, it does highlight the continued concerns of some legislators regarding chemicals in products and the sufficiency of information available to regulators and the public regarding such chemicals. It also illustrates the embrace by such legislators of ambitious requirements for regulatory programs as a means of dealing with large numbers of chemicals in commerce.

[1] Press Release, Reps. Schakowsky, Markey Statement on Introducing the Safe Cosmetics and Personal Care Products Act (Mar. 21, 2013), http://schakowsky.house.gov/index.php?option=com_content&view=article&id=3289.

[2] H.R. 1385, available at http://www.gpo.gov/fdsys/pkg/BILLS-113hr1385ih/pdf/BILLS-113hr1385ih.pdf.

[3] See Beveridge & Diamond, P.C., Safe Chemicals Act, First TSCA Reform Bill of 113th Congress, Reintroduced (Apr. 16, 2013), [link]. The bill also includes provisions similar to those in the Toxic Chemicals Safety Act of 2010, H.R. 5820, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5820ih/pdf/BILLS-111hr5820ih.pdf, the House TSCA modernization bill which Representative Schakowsky co-sponsored.

[4] See Beveridge & Diamond, P.C., Will FDA Get New Authority to Regulate Cosmetics? (July 5, 2012), http://www.bdlaw.com/news-1386.html; Beveridge & Diamond, P.C., Cosmetics Safety Bill Would Incorporate TSCA Bill Provisions (Aug. 2, 2010), http://www.bdlaw.com/news-935.html.

[5] The bill would not alter the FFDCA’s definition of the term “cosmetic” as “(1) articles intended to be rubbed, poured, 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) articles intended for use as a component of any such articles; except that such term shall not include soap.” 21 U.S.C. § 321(i). The bill would add a new, broad definition of “ingredient.”

[6] 21 C.F.R. Part 701.

[7] 21 C.F.R. § 740.10.

[8] This standard would go beyond the somewhat similar standards in FDA’s color additive and food additive regulations, 21 C.F.R. §§ 70.3(i), 170.3(i).

[9] 21 C.F.R. Parts 710, 720.

[10] FDA already has such guidance. See FDA, Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (1997, updated 2008), http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.

[11] See Beveridge & Diamond, P.C., States Propose to Regulate Chemicals While Congress Debates TSCA (Feb. 25, 2013),http://www.bdlaw.com/news-1446.html (noting various state proposals to regulate chemicals in cosmetics).

[12] See “Safe Chemicals Act of 2010,” H.R. 5786, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5786ih/pdf/BILLS-111hr5786ih.pdf, and “Safe Chemicals Act of 2011,” H.R. 2359, http://www.gpo.gov/fdsys/pkg/BILLS-112hr2359ih/pdf/BILLS-112hr2359ih.pdf.

[13] See Beveridge & Diamond, P.C., Will FDA Get New Authority to Regulate Cosmetics? (July 5, 2012), http://www.bdlaw.com/news-1386.html.

© 2013 Beveridge & Diamond PC

About the Author

Alexandra M. (“Andie”) Wyatt
Associate

Alexandra M. (“Andie”) Wyatt is an Associate in the Washington, D.C. office of Beveridge & Diamond, P.C., with a general environmental, regulatory, and litigation practice.
awyatt@bdlaw.com

202-789-6086
www.bdlaw.com

Source URL: http://www.natlawreview.com/article/safe-cosmetics-and-personal-care-products-act-2013-mirrors-toxicsubstances-control-

Personal Care Truth received permission from the author, Alexandra M. Wyatt, to re-post her article.

Statement on the Safe Cosmetics and Personal Care Products Act of 2013 (H.R.1385) Introduced in Congress by Representatives Jan Schakowsky (D-IL) and Edward Markey (D-MA)

For Immediate Release:
April 9, 2013

PAMELA BUSIEK
President & CEO
Independent Cosmetic Manufacturers And Distributors

STEVE SLEEPER
Executive Director
Professional Beauty Association

LEZLEE WESTINE
President & CEO
Personal Care Products Council

• File with FDA product ingredient reports disclosing all of the ingredients used in those products.

• Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents. When requested by a consumer or other stakeholder, or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products.

(3) New FDA Ingredient Review Process. Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable.

(4) New FDA Oversight of CIR Findings. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if FDA agrees with these findings. If there are instances in which it does not agree with a CIR ingredient review, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products.

(5) FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide “Good Manufacturing Practices” requirements.

“We believe our proposed measures would further enhance the effectiveness of the FDA cosmetic regulatory structure, and we look forward to continuing to work with Congress toward that goal.”

###

Reposted with permission. View the original news on the Personal Care Products Council website.

The bill text for H.R. 1385 Safe Cosmetics and Personal Care Products Act of 2013 is finally available. Read the entire bill here or visit Thomas.gov.

—————————————————————

HR 1385 IH

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the `Safe Cosmetics and Personal Care Products Act of 2013′.

(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. 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.

`In this subchapter:

`(1) BRAND OWNER- The term `brand owner’ means the entity responsible for bringing a cosmetic to market.

`(2) CONTAMINANT- The term `contaminant’ means unintended substances, such as those that can originate from sources outside the chemical pathway, chemical processes, storage of primary substances, instability of the packaging or harmful byproducts of the manufacturing process.

`(3) DOMESTIC ESTABLISHMENT- The term `domestic establishment’ means an establishment located in any State that brings a cosmetic to market.

`(4) FOREIGN ESTABLISHMENT- The term `foreign establishment’ means an establishment that brings a cosmetic to market and exports those cosmetics to the United States.

`(5) INGREDIENT- The term `ingredient’ means a chemical in a cosmetic, including–

`(A) chemicals that provide a technical or functional effect;

`(B) 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;

`(C) processing aids that are present by reason of having been added to a cosmetic during the processing of such cosmetic;

`(D) substances that are present by reason of having been added to a cosmetic during processing for their technical or functional effect;

`(E) the components of a fragrance, flavor, or preservative; and

`(F) any individual component that the Secretary deems an ingredient for purposes of this chapter.

`(6) MANUFACTURER- The term `manufacturer’ means the entity that produces ingredients or combines one or more ingredients to produce a cosmetic product.

`(7) MICROBUSINESS- The term `microbusiness’ means a business–

`(A) that is a brand owner as defined in this subchapter; and

`(B) that has annual sales receipts for cosmetic products that do not exceed $2,000,000.

`(8) 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

`(B) purchased by a consumer in,

a hair salon, nail salon, beauty salon, spa, or other establishment that provides cosmetic treatment services for humans.

`(9) 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;

`(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.

`(10) 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.

`(11) SERIOUS ADVERSE EVENT- The term `serious adverse event’ means–

`(A) an acute or chronic response that results in death, a life-threatening experience, short- or long-term hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or

`(B) requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

`(12) SUPPLIER- The term `supplier’ means the entity that supplies ingredients, raw materials, or specific components of a cosmetic product, including packaging.

`(13) VULNERABLE POPULATIONS- The term `vulnerable populations’ includes pregnant women, infants, children, the elderly, 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.

`SEC. 612. REGISTRATION OF ESTABLISHMENTS AND REGISTRATION FEES.

`(a) Registration-

`(1) IN GENERAL- Beginning 1 year after the date of the enactment of this subchapter, and annually thereafter, any brand owner (except for microbusinesses) engaged in bringing a cosmetic to market for use in the United States shall register with the Secretary and pay to the Secretary the applicable fee, as established under the fee schedule in subsection (e).

`(2) RULES FOR DOMESTIC AND FOREIGN ESTABLISHMENTS- To be registered under paragraph (1)–

`(A) as a domestic establishment, the owner, operator, or agent in charge of the domestic establishment shall submit a registration to the Secretary; or

`(B) as a foreign establishment, the owner, operator, or agent in charge of the foreign establishment shall–

`(i) submit a registration to the Secretary; and

`(ii) include with the registration the name of the United States agent for the foreign establishment.

`(3) NEW ESTABLISHMENTS- Any brand owner that initially brings a cosmetic to market after the date on which the requirements of paragraph (1) apply shall, not later than 60 days after the date on which the establishment brings a cosmetic to market, register with the Secretary and pay the applicable fee, as required under paragraph (1).

`(b) Submission of Registration-

`(1) IN GENERAL- In order to register under subsection (a), an establishment (referred to in this section as the `registrant’) shall submit to the Secretary, with respect to any cosmetics that the establishment brings to market, all of the following:

`(A) Any information necessary to notify the Secretary of the name, address, and legal status of each establishment at which, and all trade names under which, the registrant brings cosmetics to market.

`(B) A description of the establishment’s activities with respect to cosmetics, including a list of all cosmetic products brought to market by the establishment and the functions of such cosmetics.

`(C) The gross receipts or sales for the establishment from cosmetics.

`(2) NOTIFICATION OF CHANGES- When submitting the annual registration, the registrant shall notify the Secretary of changes to the information described in paragraph (1).

`(c) Procedure- Upon receipt of a completed registration submitted under subsection (a), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered establishment.

`(d) List of Registered Establishments-

`(1) MAINTENANCE OF LIST- The Secretary shall–

`(A) compile, maintain, and update as appropriate, a list of establishments that are registered under this section;

`(B) make such list publicly available;

`(C) remove from such list the name of any establishment that fails to register in accordance with this section; and

`(D) indicate on such list any establishment which has had its registration suspended or cancelled by the Secretary under this section.

`(2) APPLICATION OF FOIA-

`(A) REGISTRATION DOCUMENTS- Any registration documents submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code.

`(B) OTHER INFORMATION- Information derived from–

`(i) the list under paragraph (1); or

`(ii) registration documents submitted pursuant to this section,

shall not be subject to disclosure under section 552 of title 5, United States Code, except to the extent that such information discloses the identity or location of a specific registrant.

`(e) Fee Schedule- A schedule of fees shall be developed by the Secretary to provide for oversight and enforcement of this subchapter. The fee structure shall–

`(1) be prorated based on the establishment’s gross receipts or sales; and

`(2) only be assessed on companies with annual gross receipts or sales of cosmetics that exceed $10,000,000.

`(f) Suspension and Cancellation of Registration-

`(1) CRITERIA FOR SUSPENSION- Registration under this section is subject to suspension if the Secretary finds–

`(A) the information submitted by the establishment for registration under subsection (a) is incomplete, inaccurate, or out of date;

`(B) the establishment fails to notify the Secretary of changes required under subsection (b)(2);

`(C) the establishment fails to pay registration fees, as required under subsection (a), in a timely manner; or

`(D) the establishment violates any portion of this chapter.

`(2) SUSPENSION OF REGISTRATION- If the Secretary determines that an establishment is subject to suspension under this subsection and that it is appropriate to suspend the registration of such establishment, the Secretary shall–

`(A) suspend the registration of such establishment; and

`(B) provide a notice of suspension to such establishment.

`(3) CANCELLATION- If the establishment fails to correct the issue that resulted in the suspension under paragraph (2) before the last day of the 30-day period beginning on the date that the establishment receives notice under such paragraph, the Secretary may cancel the registration of such establishment.

`(g) Recordkeeping- All establishments that are required to register under this section shall maintain records that include a current list of suppliers and manufacturers, if the registrant does not manufacture or package its own product. Those records shall be accessible by the Secretary upon request for review or audit.

`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.

`(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).

`(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.

`(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 brand owner 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.

`(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.

`(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) brand owners and Internet vendors of such cosmetics.

`SEC. 614. SAFETY STANDARD AND GOOD MANUFACTURING PRACTICES.

`(a) Safety Standard-

`(1) IN GENERAL- Taking into account the expected use of a cosmetic, the Secretary shall establish a safety standard that, with respect to a cosmetic or an ingredient in a cosmetic provides a reasonable certainty of no harm (as such term is defined in section 611(7)) from exposure to the cosmetic or ingredient and protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient.

`(2) STANDARDS FOR ESTABLISHING SAFETY STANDARD- In establishing the safety standard under paragraph (1), the Secretary shall ensure that–

`(A) the likely level of exposure to all sources of the ingredient or cosmetic (including environmental sources) that will result under the safety standard presents not more than a 1 in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval; or

`(B) the safety standard results in exposure to the amount or concentration of an ingredient or cosmetic that is shown to produce no adverse health effects, incorporating an margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources (including environmental sources).

`(3) USE OF OTHER FEDERAL STANDARDS- If any Federal agency has promulgated a standard for an ingredient that satisfies the requirements under paragraph (1), the Secretary may treat such standard as the safety standard under paragraph (1) for purposes of such ingredient.

`(4) APPLICATION OF SAFETY STANDARD- The Secretary may only determine that an ingredient or a cosmetic meets the safety standard under paragraph (1) if there is a reasonable certainty of no harm from exposure to the ingredient or cosmetic.

`(b) Good Manufacturing Practices-

`(1) IN GENERAL- The Secretary shall issue guidance prescribing good manufacturing practices for cosmetics and ingredients, including quality control procedures that the Secretary determines are necessary, and shall update such regulations as necessary.

`(2) CONSIDERATION OF SMALL BUSINESS- In developing the guidance under paragraph (1), the Secretary shall consider how such practices will impact small businesses.

`SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.

`(a) Required Submission of All Safety Information-

`(1) IN GENERAL- Brand owners of cosmetics shall submit to the Secretary (in an electronic format that the Secretary shall determine) all data and information that the brand owner can access regarding the safety of the–

`(A) ingredients listed on the cosmetic label under section 613 for a cosmetic; and

`(B) cosmetic itself.

`(2) REQUIRED INFORMATION- The required data and information under paragraph (1) shall include, for each ingredient in a cosmetic and for the cosmetic, the following:

`(A) Functions and uses.

`(B) Data and information on the physical, chemical, and toxicity of each such ingredient or cosmetic.

`(C) Exposure and fate information.

`(D) Results of all safety tests that the brand owner can access or has conducted.

`(E) Any other information used to substantiate the safety of such ingredient and cosmetic.

`(3) DEADLINES-

`(A) INITIAL SUBMISSION- A brand owner shall submit the data and information required under paragraph (1)–

`(i) in the case of an ingredient or cosmetic which is marketed for sale in interstate commerce on or before the date of the enactment of this subchapter, not later than 1 year after such date; and

`(ii) in the case of an ingredient or cosmetic which is not marketed for sale on or before such date–

`(I) not later than the end of the 14-month period beginning on the date of the enactment of this subchapter; or

`(II) if the ingredient or cosmetic is first marketed for sale in interstate commerce after the end of the period described in subclause (I), not later than 60 days after the date on which such ingredient or cosmetic is first marketed for sale.

`(B) UPDATES-

`(i) IN GENERAL- Subject to clause (ii), a brand owner shall update the data and information submitted under subparagraph (A) annually.

`(ii) ADVERSE HEALTH EFFECTS- In the case of information related to an adverse health effect that is suspected to be caused by an ingredient or a cosmetic, a brand owner shall update the information not later than 60 days after receiving such information.

`(4) SUPPLIER AND MANUFACTURER INFORMATION-

`(A) USE OF SUPPLIER OR MANUFACTURER INFORMATION- In order to meet the requirements of paragraph (1) with respect to an ingredient, a brand owner may submit safety data and information provided by the supplier or manufacturer of the ingredient or cosmetic.

`(B) SUPPLIER OR MANUFACTURER PROVISION OF INFORMATION- If a brand owner requests that a supplier or manufacturer of an ingredient provide to such brand owner any of the data and information described under paragraph (2) or under section 617, such supplier or manufacturer shall provide such data and information to such brand owner not later than 90 days after receiving such request.

`(b) Database-

`(1) INITIAL PUBLICATION- Not later than 1 year after the date of the enactment of this subchapter, the Secretary shall publish a comprehensive, publicly accessible database containing all nonconfidential information (as such term is used under section 623) submitted under subsection (a)(1).

`(2) UPDATES- Not later than 90 days after the Secretary receives new or updated information under subsection (a)(3)(B), the Secretary shall update the database under paragraph (1) with such information.

`(c) Review and Evaluation of Information-

`(1) IN GENERAL- Based on the data and information submitted under subsection (a)(1), available from an authoritative source (as such term is defined in paragraph (3), including data described under section 627(b)), and such other information as the Secretary may have available, the Secretary shall review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce.

`(2) CONSIDERATION OF NANOMATERIALS- The Secretary shall–

`(A) monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetics (including progress in the standardization of testing methods and specific size definitions for nanomaterials); and

`(B) consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1).

`(3) AUTHORITATIVE SOURCE DEFINED- For purposes of this paragraph, the term `authoritative source’ means–

`(A) the Environmental Protection Agency;

`(B) the International Agency for Research on Cancer;

`(C) the National Toxicity Program through the National Institutes of Health;

`(D) the California Environmental Protection Agency; and

`(E) any other authoritative international, Federal, and State entity, as determined by the Secretary.

`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).

`(2) CONSIDERATIONS- In determining the placement of an ingredient on a list under subsection (a), the Secretary shall consider whether the ingredient–

`(A) reacts with other substances to form harmful contaminants;

`(B) is found to be present in the body through biomonitoring;

`(C) is found in drinking water or air;

`(D) is a known or suspected neurological or immunological toxicant, respiratory asthmagen, carcinogen, teratogen, or endocrine disruptor, or have other toxicity concerns (including reproductive or developmental toxicity); or

`(E) is known to persist in the environment or bioaccumulate.

`(3) PRIORITIZATION 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.

`(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

`(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.

`(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).

`(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.

`(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–

`(A) which, because of a lack of authoritative information on the safety of the ingredient, cannot be included on–

`(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–

`(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.

`(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 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) publicly declares the reasons for such finding.

`(4) 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 brand owner 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 the Secretary receives 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.

`SEC. 617. TREATMENT OF COSMETICS BASED ON INGREDIENT LISTS.

`(a) In General- Subject to subsections (b)(4) and (d)(4) of section 616, a brand owner may only distribute in interstate commerce a cosmetic that meets the safety standard under section 614(a).

`(b) Presumption Related to the Safety of Cosmetics-

`(1) IN GENERAL- Subject to paragraph (2), for purposes of subsection (a), the Secretary shall presume that the following cosmetics meet the safety standard under section 614(a):

`(A) A cosmetic that is made solely of ingredients on the list under section 616(c)(1) (relating to ingredients that are safe without limits).

`(B) A cosmetic that is made solely of ingredients on the list under section 616(b)(1)(B) (relating to ingredients subject to restrictions) and the use of each of such ingredients in such cosmetic is in compliance with the restrictions on the use of such ingredients specified under section 616(b)(2).

`(C) A cosmetic that is made solely of ingredients described under subparagraph (A) and subparagraph (B).

`(2) EXCEPTIONS- The Secretary may require that a brand owner demonstrate that a cosmetic meets the safety standard under section 614(a) (including by requiring that the brand owner conduct safety testing, or request such safety testing from relevant suppliers and manufacturers, of a cosmetic described under paragraph (1)) if the cosmetic–

`(A) contains penetration enhancers, sensitizers, estrogenic chemicals, or other similar ingredients;

`(B) contains ingredients that react with each other or with other substances to form harmful byproducts; or

`(C) the Secretary has any additional reason to believe that such cosmetic does not meet the safety standard under section 614(a).

`(3) GUIDANCE- If, under paragraph (2), the Secretary requires that a brand owner demonstrate that a cosmetic meets the safety standard under section 614(a), the Secretary shall provide the brand owner with guidance on the data and information that the Secretary requires to evaluate whether the cosmetic meets the safety standard under such section.

`(c) Notification of Failure of Secretary To Act- If the Secretary fails to act by an applicable deadline under section 616 or this section, brand owners and manufacturers of an ingredient or a cosmetic affected by such failure of the Secretary to act shall issue to the Secretary, the public, and each known customer of the ingredient or cosmetic, a written notice that a determination by the Secretary of the safety of the ingredient for use in cosmetics is pending.

`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 contaminants of concern linked to severe acute reactions or long-term adverse health effects, including–

`(1) ingredients used in cosmetics that may contain contaminants of concern;

`(2) combinations of ingredients that may create contaminants of concern when such ingredients interact;

`(3) contaminants of concern that may leech from product packaging into a cosmetic; and

`(4) any other contaminant of concern identified by the Secretary that are present in cosmetics.

`(b) Evaluation; Labeling- The Secretary shall use the process described in sections 615 and 616 to evaluate contaminants of concern for possible elimination or restriction in cosmetics. The Secretary shall require that a contaminant on the list under subsection (a) be declared on the label of a cosmetic, in the same manner as an ingredient under section 613.

`(c) 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

`(B) maximum allowable detection limits for each contaminant in an ingredient or cosmetic.

`(3) UPDATE- The Secretary shall annually update the requirements under paragraph (1).

`(d) 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–

`(A) the supplier expects may be used in a cosmetic;

`(B) the supplier suspects may contain a contaminant of concern; and

`(C) is not listed under subsection (a); and

`(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).

`(e) Brand Owner Requirements- Not later than 1 year after the promulgation of the rule under subsection (b)(1), a brand owner of a cosmetic shall, with respect to each ingredient that the brand owner uses in a cosmetic–

`(1) obtain, from each supplier or manufacturer 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 brand owner were a supplier.

`SEC. 619. COSMETIC AND INGREDIENT STATEMENTS.

`(a) In General- Beginning 1 year after the date of the enactment of this subchapter, each brand owner of a cosmetic intended to be marketed in the United States shall submit electronically to the Secretary, for each cosmetic that is intended to be marketed in the United States, a statement containing–

`(1) the registration number of the brand owner;

`(2) the brand name and the product name for the cosmetic;

`(3) the applicable use for the cosmetic;

`(4) the ingredient list as it appears on the cosmetic label or insert, including the particle size range of any nanoscale cosmetic ingredients;

`(5) any warnings and directions for use from the cosmetic label or insert; and

`(6) the title and full contact information for the individual responsible for submitting and maintaining such statement.

`(b) New Cosmetics- Any brand owner that begins to market a cosmetic after the date of the enactment of this subchapter shall comply with the requirements of subsection (a) beginning on the later of the following:

`(1) The end of the 18-month period beginning on the date of the enactment of this subchapter.

`(2) The 6-month period after the date on which the establishment begins to manufacture such cosmetic.

`(c) Notification of Changes- The brand owner shall notify the Secretary annually of any change to the information required under subsection (a).

`(d) Procedure- Upon receipt of a completed statement described under subsection (a), the Secretary shall notify the brand owner of the receipt of such statement and assign a cosmetic statement number.

`(e) List- The Secretary shall compile, maintain, and update as appropriate, a list of cosmetics for which statements are submitted under this section.

`(f) Access to Safety Information- The cosmetic and ingredient statements collected under this section shall be added to the publicly accessible database created by the Secretary under section 615(b).

`SEC. 620. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED COSMETICS.

`(a) Notification of Adulterated or Misbranded Cosmetics-

`(1) IN GENERAL- A responsible party that has reason to believe that a cosmetic, when introduced into or while in interstate commerce, or while held for sale (regardless of whether such sale is the first sale of such cosmetic) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse event shall notify the Secretary of the identity and location of the cosmetic.

`(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation or guidance.

`(3) RESPONSIBLE PARTY DEFINED- For purposes of this subsection, the term `responsible party’ means a brand owner, manufacturer, packager, retailer, or distributor of the cosmetic.

`(b) Voluntary Recall- The Secretary may request that any person who distributes a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily–

`(1) recall such cosmetic; and

`(2) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

`(c) Order To Cease Distribution-

`(1) IN GENERAL- If the Secretary has reason to believe that–

`(A) the use of, or exposure to, a cosmetic may cause serious adverse event;

`(B) the cosmetic is misbranded; or

`(C) the cosmetic is marketed, manufactured, packaged, or distributed by an unregistered brand owner;

the Secretary shall have the authority to issue an order requiring any person who distributes such cosmetic to immediately cease distribution of such cosmetic.

`(2) CEASE DISTRIBUTION AND NOTICE- Any person who is subject to an order under paragraph (1) shall immediately cease distribution of such cosmetic and provide notification as required by such order.

`(3) APPEAL-

`(A) 24 HOURS- A person subject to an order under paragraph (1) may appeal such order to the Secretary within 24 hours of the issuance of such order.

`(B) CONTENTS OF APPEAL- Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).

`(C) INFORMAL HEARING- Except as provided in subsection (e), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days (or less as determined by the Secretary) after such an appeal is filed, unless the parties jointly agree to an extension.

`(D) IMPACT ON RECALL- If an appeal is filed under subparagraph (A), the Secretary may not amend the order to require a recall under subsection (d) until after the conclusion of the hearing under subparagraph (C).

`(4) VACATION OF ORDER- If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph (1), the Secretary shall vacate the order.

`(d) Order To Recall-

`(1) AMENDMENT- Except as provided under subsection (e) and subject to subsection (c)(3)(D), if the Secretary determines that a recall of a cosmetic subject to an order under subsection (c) is appropriate, the Secretary shall amend the order to require a recall.

`(2) CONTENTS- An amended order under paragraph (1) shall–

`(A) specify a timetable in which the recall will occur;

`(B) require periodic reports to the Secretary describing the progress of the recall; and

`(C) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.

`(3) NONDELEGATION- An amended order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.

`(4) DETERMINATION- If the Secretary determines that inadequate grounds exist to support the amendment made to the order under paragraph (1), the Secretary shall remove such amendment from such order.

`(e) Emergency Recall Order-

`(1) IN GENERAL- If the Secretary has credible evidence or information that a cosmetic subject to an order under subsection (c) presents an imminent threat of serious adverse event, the Secretary may issue an order requiring any person who distributes such cosmetic–

`(A) to immediately recall such cosmetic; and

`(B) to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.

`(2) RECALL AND NOTICE- Any person who is subject to an emergency recall order under this subsection shall immediately recall such cosmetic and provide notification as required by such order.

`(3) APPEAL-

`(A) 24 HOURS- Any person subject to such an order may appeal such order to the Secretary within 24 hours of the issuance of such order.

`(B) CONTENTS OF APPEAL- Such appeal may include a request for an informal hearing and a description of any efforts to recall such cosmetic undertaken voluntarily by the person, including after a request under subsection (b).

`(C) INFORMAL HEARING- An informal hearing shall be held as soon as practicable after the appeal is filed under subparagraph (A), but not later than 5 calendar days after such an appeal is filed, or fewer days (as determined by the Secretary), unless the parties jointly agree to an extension.

`(4) VACATION OF ORDER- If the Secretary determines that inadequate grounds exist to support the actions required by the order under paragraph (1), the Secretary shall vacate the order.

`(5) NONDELEGATION- An order under this subsection may only be issued by the Secretary or an official designated by the Secretary, and may not be delegated to another official or employee.

`(f) Notice to Consumers and Health Officials- The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the cosmetic was, or may have been, distributed and to appropriate State and local health officials.

`(g) Supply Chain Information-

`(1) IN GENERAL- In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, the Secretary shall request that the brand owner named on the label of such cosmetic (as required under section 602(b)(1)) submit all of the following information:

`(A) The name and place of business of the manufacturer, packager, supplier, or distributor from which such entity received the cosmetic or ingredients for manufacturing such cosmetic.

`(B) The name and place of business of any entity (including any retailer) that was provided with such cosmetic by the entity named on the label.

`(2) COLLECTION OF ADDITIONAL SUPPLY CHAIN INFORMATION- In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, to the extent necessary to protect the safety of the public, the Secretary may request that any entity (including a supplier of an ingredient, manufacturer, packer, distributor, or retailer) in the supply chain of such cosmetic submit to the Secretary information that is similar to the information described under subparagraphs (A) and (B) of paragraph (1).

`(3) MAINTENANCE OF RECORDS- Any entity in supply chain of a cosmetic (including the brand owner named on the label of a cosmetic) shall–

`(A) maintain records sufficient to provide the information described in subparagraphs (A) and (B) of paragraph (1); and

`(B) provide such information to the Secretary upon the request of the Secretary.

`(h) Savings Clause- Nothing contained in this section shall be construed as limiting the authority of the Secretary to issue an order to cease distribution of, or to recall, a cosmetic under any other provision of this Act.

`SEC. 621. PETITIONS.

`(a) In General- The Secretary shall complete and publish a review, and, if appropriate, immediately revise related, relevant information, including ingredient lists, ingredient restrictions or prohibitions, or ingredient or cosmetic safety determinations, not later than 6 months after the date on which the Secretary receives from any individual or entity a reasonable petition–

`(1) to prohibit or restrict an ingredient for use in cosmetics and list such ingredient on the list under section 616(b);

`(2) to remove an ingredient from the list of ingredients that are safe without limits under section 616(c);

`(3) to add an ingredient to the priority assessment list under section 616(d); or

`(4) to add an ingredient to the list of contaminants under section 618.

`(b) Reasonable Petition- Not later than 1 year after the date of the enactment of this Act, the Secretary shall issue rules specifying the criteria which the Secretary will use to determine if a petition submitted under this section is a reasonable petition.

`SEC. 622. MANDATORY REPORTING OF SERIOUS ADVERSE EVENTS.

`(a) Submission of Report on Serious Adverse Events- The Secretary shall require that the brand owner of a cosmetic whose name appears on the label of a cosmetic marketed in the United States submit to the Secretary a report containing information received concerning any serious adverse event associated with the use of the cosmetic.

`(b) Timing of Report- A report under subsection (a) shall be submitted to the Secretary not later than 15 business days after information concerning the serious adverse event is received at the place of business of the brand owner.

`(c) Content of Report- A report under subsection (a) shall include the following information, to the extent to which the brand owner submitting the report has been able to verify the information:

`(1) The identity of the individual experiencing the adverse health event.

`(2) An identifiable report of such effect.

`(3) The name of the cosmetic suspected of causing such effect.

`(4) A description of the adverse health event.

`(d) Public Availability and Privacy-

`(1) PUBLIC AVAILABILITY- Subject to paragraph (2), the serious adverse event reports collected by the Secretary under this section shall be submitted electronically and shall be made accessible to the public.

`(2) PRIVACY-

`(A) PERSONALLY IDENTIFIABLE INFORMATION- Notwithstanding any other provision of law, personally identifiable information in serious adverse event reports provided to the Secretary under this section, shall not–

`(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

`(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

`(B) TREATMENT OF INFORMATION UNDER PRIVACY ACT AND FOIA- A report submitted to the Secretary under this section, shall be considered to be a record about an individual under section 552a of title 5, United States Code (commonly referred to as the `Privacy Act of 1974′) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the `Freedom of Information Act’), and shall not be publicly disclosed unless all personally identifiable information is redacted.

`SEC. 623. NONCONFIDENTIAL INFORMATION.

`(a) Information Available to Public- Subject to subsection (c) and section 622(d)(2), all nonconfidential information submitted pursuant to this subchapter shall be made available to the public, including the following types of information:

`(1) The name, identity, and structure of a chemical substance, contaminant, or impurity that is an ingredient.

`(2) All information concerning function, exposure, toxicity data, health hazards, and environmental hazards for a cosmetic.

`(3) The functions of ingredients in cosmetics.

`(4) Fragrance, flavor, and colorants in a cosmetic.

`(b) Confidential Information- The concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public under subsection (a).

`(c) Petition for Information To Remain Confidential-

`(1) IN GENERAL- The Secretary shall create a process for an entity to petition for nonconfidential information described in subsection (a) to remain confidential if the entity shows that there would be a serious negative impact to the entity’s commercial interests if such information were disclosed to the public.

`(2) LIMITATION- The Secretary may not approve a petition under paragraph (1) to the extent that such petition would prevent the public disclosure of–

`(A) the name, identity, and structure of any chemical substance, contaminant, or impurity that is an ingredient;

`(B) all health and safety data related to that substance, contaminant, or impurity; or

`(C) any data used to substantiate the safety of that substance, contaminant, or impurity.

`SEC. 624. ANIMAL TESTING ALTERNATIVES.

`(a) In General- To minimize the use of animal testing of ingredients and cosmetics, the Secretary shall–

`(1) require, where practicable, alternative testing methods that–

`(A) do not involve the use of an animal to test the chemical substance;

`(B) provide information that is equivalent or superior in scientific quality to the animal testing method; and

`(C) use fewer animals than conventional animal-based tests when nonanimal methods are impracticable, including the use of tests that combine multiple endpoints; and

`(2) encourage, where practicable–

`(A) estimation of toxicological properties of a chemical through the use of testing information for one or more structurally similar chemicals where such estimates provide information of sufficient scientific quality;

`(B) the formation of industry consortia to conduct testing to avoid duplication of tests; and

`(C) funding for research and validation of alternative test methods, in accordance with this subsection.

`(b) List of Alternative Testing Methods- Not later than 1 year after the date of the enactment of this subchapter, and triennially thereafter, the Secretary shall publish a list of the alternative testing methods described in subsection (a).

`SEC. 625. PRODUCT TESTING AND REVIEW AUDIT.

`The Secretary shall conduct annual audits of random samples of cosmetics to assess or test for acute negative reactions, pathogen hazards, contaminants, leaching of packaging additives, mislabeling, or other relevant issues of concern (as determined by the Secretary).

`SEC. 626. RESOURCES FOR SMALL BUSINESSES.

`The Secretary shall provide technical support to assist small businesses in carrying out the requirements of this subchapter.

`SEC. 627. INTERAGENCY COOPERATION.

`(a) Interagency Council on Cosmetic Safety- There is established an Interagency Council on Cosmetic Safety for the purpose of sharing data and promoting collaboration on cosmetic safety between the Food and Drug Administration, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and the Environmental Protection Agency.

`(b) Use of Data From Federal Sources- For purposes of this subchapter, the Secretary, as appropriate, shall request and utilize ingredient and cosmetic toxicity, use, and exposure data from other Federal agencies.

`SEC. 628. SAVINGS CLAUSE.

`Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard for performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control.

`SEC. 629. AUTHORIZATION OF APPROPRIATIONS.

`There are authorized to be appropriated such sums as may be necessary to carry out this subchapter for each of the fiscal years 2014 through 2018.’.

(b) Adulterated and Misbranded Cosmetics-

(1) ADULTERATED COSMETICS- Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended in paragraph (a)–

(A) by striking `, except that this provision shall not apply to coal-tar hair dye’ and all that follows through `or eyebrow dyes’; and

(B) by adding at the end the following:

`(f) If it is manufactured in a manner that fails to comply with section 617(a).

`(g) If it is imported, distributed, or marketed and–

`(1) it contains an ingredient on the list under section 616(b)(1)(A), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic; or

`(2) it contains an ingredient on the list under section 616(b)(1)(B), such ingredient is being used in a manner that violates the limit on use or concentration of such ingredient under section 616(b)(2), and the manufacturer has not complied with section 616(b)(4) with respect to such ingredient and such cosmetic.

`(h) If it is marketed by a brand owner that, with respect to such cosmetic, is required to demonstrate, under section 617(b)(2), that the cosmetic meets the safety standard and the brand owner has not yet submitted the required data under section 617(b)(3).’.

(2) MISBRANDED COSMETICS- Section 602 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362) is amended–

(A) in paragraph (a), by inserting `or fails to meet the requirements of section 613 or 618(b)’ before the period; and

(B) by adding at the end the following:

`(g) If it–

`(1) was brought to market by a brand owner that failed to register and pay the applicable fee as required under section 612;

`(2) is brought to market, manufactured, packaged, distributed, or sold in retail by a brand owner, manufacturer, packager, distributor, or retailer, respectively, who fails to notify the Secretary as required under section 620(a)(1);

`(3) is distributed in violation of an order under section 620(c);

`(4) is not recalled as required by an order under subsection (d) or (e) of section 620;

`(5) is manufactured in a manner that fails to comply with good manufacturing practices prescribed by the Secretary under section 614(b); or

`(6) is brought to market by a brand owner who fails–

`(A) to submit the statement required under section 619; or

`(B) notify the Secretary of changes to information contained in such report, as required by such section.’.

(3) ADDITIONAL PROHIBITIONS- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended–

(A) in paragraph (e), by inserting `612,’ after `564,’ each place it appears; and

(B) by adding at the end the following:

`(ccc) The failure of a brand owner, manufacturer, or supplier of a cosmetic or an ingredient for use in a cosmetic to submit and update data and information as required under section 615(a).

`(ddd) The manufacture, importation, distribution, or marketing of an ingredient for use in a cosmetic that is on the list under section 616(b)(1)(A).

`(eee) The failure of a supplier of an ingredient for use in a cosmetic–

`(1) to provide data and information as required by section 615(a)(4)(B); or

`(2) comply with the testing requirements under section 618(c).

`(fff) The failure of a manufacturer to comply with the requirements of section 618(d).

`(ggg) The failure of a brand owner of a cosmetic to comply with the requirement of reporting serious adverse events under section 622.’.

SEC. 3. WORKER ISSUES.

(a) In General- The Secretary of Labor shall promulgate an occupational safety and health standard under section 6 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that requires the following:

(1) MANUFACTURERS AND IMPORTERS- Each manufacturer or importer selling any cosmetic for professional use shall–

(A) obtain or develop a material safety data sheet described in subsection (b) for each such cosmetic or personal care product that–

(i) the manufacturer or importer produces or imports; and

(ii) includes a hazardous chemical, or a product ingredient associated with any chemical hazard, that is classified as a health hazard in accordance with the criteria found in section 1910.1200(d) of title 29 of the Code of Federal Regulations, and any successor regulations; and

(B) make the material safety data sheet available to distributors and employers, including salon owners, in English and, upon request, in other languages, including Spanish and Vietnamese.

(2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide material safety data sheets described in subsection (b) in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations.

(3) EMPLOYERS- Each employer, including any operator of a salon, shall–

(A) have a material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer’s business;

(B) make such material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations; and

(C) upon request, provide employees with translations of such material safety data sheet in other languages, including Spanish and Vietnamese.

(b) Contents of Material Safety Data Sheet- A material safety data sheet for a cosmetic or personal care product for professional use described in this section shall–

(1) contain the information required in a material safety data sheet under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations, for each hazardous chemical, or product ingredient associated with any chemical hazard, described in subsection (a)(1)(A)(ii); and

(2) include the following statement: `This material safety data sheet is also available in multiple languages by contacting the manufacturer, using the contact information provided on this sheet.’.

(c) Professional Use Defined- In this section, the term `professional use’ has the meaning given such term in section 611(6) of the Federal Food, Drug, and Cosmetic Act, except to the extent that such term applies to a product that is sold as a retail product in any of the establishments listed under such definition.

END

Facing More Over Regulation, Yet Again

The Safe Cosmetics and Personal Care Products Act of 2013 legislation is simply a new premise added onto an old Bill revisiting my industry once again.  These proposals have been rewritten so many times the past few years, I have lost count and basically was so sick and tired of the whole process for the most part, after putting in many hours of research and participation to stop it since it was initiated back in ’08, I withdrew from the whole process for a time.

The many different versions fortunately, were so onerous to small manufacturers and with the overreaching regs without scientific evidence to back up the claims offered, it simply couldn’t hold any ground for legislators thus far, especially during our economic downturn.

But once again, Jan Schakowsky (D. Ill) and Edward Markey (D. Mass.) are attempting to revive legislation that has been defeated before by creating more regulation based on “no” science evidence but merely, supposition, theory and what we call the “precautionary principal.”  If we suspect harm, we must ban!

In this newest piece of legislation, these two state Reps are claiming, “it will close major loopholes in the federal law that allows companies to use ingredients in cosmetics and personal care products known to damage human health and the environment.”

Show Me The Science Please!

But to date, there literally has been no peer reviewed science presented to back up the claim; products in our industry have and / or will cause harm to the end user, when the fact of the matter is, they have been used safely for decades.  Nor is it any personal care products manufacturers intent to cause harm to the public, let alone use anything remotely toxic for human consumption.  Many studies have been published including those by the EPA, which verify and have shown testing on animals, such as mice, does not extrapolate to humans.  Furthermore, the dosages are so extremely high in order to cause harm, that no average consumer will ever be exposed to such a dose once, much less over a lifetime.  I have provided in previous articles these studies as pertained to past attempts of legislation to over regulate our industry.

At PCT (Personal Care Truth) they have provided a neat breakdown of other attempts of regulations, outlining the major points of the legislation known as H.R.4262 Cosmetics Safety Enhancement Act of 2012 and H.R. 4395 Cosmetic Safety Amendments Act of 2012.  These of course never went anywhere, but it bears repeating that this is an ongoing concern for the personal care products and cosmetic industry.  Also feel free to further explore PCT for science data and factual research based on evidence only, not fear or paranoia brought about by certain self proclaimed officials (NGO’s).

An overview below is an initial outline of what they are trying to accomplish, yet the final draft on this has yet to be seen.

• Cosmetic and Ingredient Testing and Safety: FDA would establish a list of ingredients prohibited from being used in cosmetics.  This includes carcinogens and reproductive and developmental toxins.

• Post Market Testing: Requires the Secretary of HHS to conduct annual random sample tests for pathogens or contaminants in cosmetic products.

• Registration of Cosmetic Companies and Registration Fees: Cosmetics companies would be required to register with FDA and pay a registration fee based on annual gross receipts or sales.  Small businesses with less than $2 million in revenues from cosmetics would be exempt from registration; businesses with less than $10 million in revenues from cosmetics would be exempt from registration fees.

• Market Restrictions: Provides the FDA with recall authority for products that are misbranded, adulterated, or otherwise fail to meet the safety standard and can request a voluntary recall or order the ceasing of distribution of any such cosmetic product.

• Mandatory Reporting of Adverse Health Effects: Cosmetic manufacturers, packagers, and distributors would have to provide the FDA with reports of adverse health effects associated with the use of a cosmetic.

• Worker Issues: Requires companies that manufacture cosmetics for salon use to provide information on any health hazards linked with those cosmetics.

• States Rights: States may set more stringent standards.

Without seeing the final draft, it is hard to say what direction they are trying to take this, however based on these initial outlines the “States Rights” portion is still problematic.

The Negative Impact This Could Have On Our Industry

Although the entire industry standard has always been about providing safe products for consumers, allowing states to set possibly stricter standards will be far overreaching and detrimental.  This is where the incredible, onerous paperwork would begin.  My products are sold globally, yet primarily in the U.S. and to perhaps require me now to have different labeling practices, or different formulating practices, etc. so I can sell to various states…I mean can you imagine?  This will make it impossible at not only accomplishing any continued success due to the time an money it will take, but make many entrepreneurs either say “oh forget this” or won’t even be able to start up at all due to the financial obligations it will require to accomplish this major task as it is written in the legislation.

California is a prime example and epitomizes the overreach of their state government of continually trying to take away free choice in the market place through a belief of harm when there actually is minimal to none under this context.  I have many customers in this state who love our products and with the stroke of the pen over an ideology of something they deem hazardous without science or by ignoring it, can literally prevent customers in this state from further receiving our products if they are determined to target the latest ingredient as unsafe, whatever it may be.  In fact, Titanium Dioxide is under consideration for being added to Prop. 65.  This is a main sun blocking agent found in the majority of mineral makeup products.

Other states can follow similar legislation if the current legislation above is passed.  This is not a question as to me being overly concerned since this is no joke or something I am just bloviating about.  Simply refer to the Dunkin’ Donuts issue over something as simple as Coffee and the natural constituent it has within the coffee bean, known as “Acrylamide”.  This article is quite telling and other links are provided with continued research done and the conclusions to that research.  Basically, the Swedish study was overblown and inaccurate, yet look at the harm it caused multiple industries in the state of California.

Starbucks and other food companies were sued as well over this ingredient and labeling practices based on how their current legislation reads, allowing zealots to become litigious even without any proof of harm or without even using the product, just based on a label they research and finding noncompliance.

Acrylamide isn’t added, but is naturally occurring, and coffee has been shown in multiple studies as to its’ many health benefits, such as reducing stroke, colon cancer, heart disease and many other forms of cancer.  This type of targeting of ingredients based on theory rather than on the practicality or science of products we have used for generations, safely, is unfortunate for many consumers.  Frankly, I’ll keep drinking my cup of Joe for the health benefits it is proven to provide to the coffee drinker.

Food Police….Just The Real Facts (Science) Please

There are certainly many foods you may want to avoid with elevated levels of this constituent if you are concerned, but to avoid it overall in our diets, is next to impossible, especially when this ingredient is also found in lower levels in Apples, Broccoli, Asparagus, Green Beans, Spinach, Cherries, Carrots, Onions, Potatoes, Olives, Cocoa (chocolate), Plums and Prunes, to name a short list.  Should we ignore the obvious health benefits of these foods to override undue fear of a tiny amount of constituent they contain?…..

I pause and wonder, why are food growers exempt from having this label?  Clearly there is a certain amount of hypocrisy in these regs.  So basically, you can eat the food containing lead or acrylamide under Prop 65, but you can’t use it in a skincare product without testing it first for the safe levels allowed, or you must place the prop 65 warning label on the item.  Last I checked, ingesting a chemical of concern is far more likely to cause harm than smearing it on your skin which is actually an impermeable barrier to protect the body.  When it comes to our government, this type of obtuse thinking has absolutely baffled me.

Let me state however, most of the foods with elevated levels of Acrylamide, we shouldn’t be eating anyway based on the other well known health problems they cause with consumption of these same foods.  Some interesting facts and figures about this constituent and how it is formed are in the links below:

FDA Study On Foods Containing Acrylamides

Acrylamide Facts: Q & A

Don’t Misunderstand This Viewpoint

I believe that Prop. 65 was headed in the right direction for a safer environment and to reduce hazardous chemical use when it was created back in 1986, and I am all in for reducing environmental toxins, but only unless and until the scientific evidence supports the objective.  But unfortunately, through the proposals and passing of amendments of the original legislation, pushed by power hungry, ambitious NGO’s, unscrupulous parties have exploited Prop. 65 by those wanting to make a buck or push an environmental agenda against certain ingredients which can also contain constituents in question, and then trying to extrapolate harm through a theory rather than from actual science.

Basically, to show a further example as it relates to this latest cosmetic and personal care products act; acrylamide can be found in cocoa butter which is used in many skincare products for application on the skin.  So because of Prop. 65, as I understand it, if this ingredient along with its’ constituent is being used, supposedly a warning label is required on the product in the state of California which reads:

And any amount seems to trigger the Prop. 65 regulation.  Again, an ingredient applied to the skin does not extrapolate to causing harm or injury of similar in the same way as something we may ingest or inhale, but the personal care product containing a questionable ingredient would be affected nonetheless based on California mandate.  For me, this is government run amok beyond best intentions.  And it worries me to say the least since my wonderful customers in California and others should this spread federally, could have their personal choice be removed of enjoying the many benefits our mineral makeup and skincare products offer to the consumer.

On Google images you can view a virtual sea of Prop. 65 warning labels as they pertain to many industries.  After looking at these, it strikes me as odd that California State Legislators are declaring some sort of omnipotence over its citizens as to what is best for all, and overkill on warning about the possibility of harm which in turn will more than likely create an apathetic public due to this bombardment.  Basically becoming ineffectual!  Consumers will want what they want and will recognize the absurdity this has become based on how Prop. 65 went from a good cause to being grossly abused…..but the final question is, at what cost to everyone?

Key Points Of Why Legislation Similar to Prop 65 Would Cause Undue Hardship To Small Business

• For one, putting the warning label on a product is not required if the amount of the identified hazardous chemical is below the danger level. But, without the government’s classification of the allowable level, it is the business’ responsibility to find out what the level is using acceptable scientific methods. This would mean additional expense and effort for the business owner.  This alone would add cost to products which will be passed on to the consumer or wipe out the business altogether if this cost is absorbed by the company.  Ultimately this is a lose, lose proposition.

• Secondly, when a certain product has the warning sign, it may be because the manufacturer chose to put it on due to the chemical being actually present, even without verifying if it has exceeded the safe level or if it may even be zero. The business owner would rather include the warning rather than risk violating the law or spending effort and money to determine a chemical’s safety level.  Also a tact they may choose to implement in order to avoid being sued by litigators who have nothing better to do than destroy cottage industry.

• Thirdly, it is not a violation of Prop 65 to post a warning, however unnecessary. These warning signs have become so commonplace that consumers don’t take notice anymore and it loses its purpose to educate and inform them.  Hence the reason they are now ineffectual to say the least and consumer safety is not actually improved at all.

• Fourthly, now instead of growing a business or working on creation of personal care and cosmetic products, onerous research and inordinate amounts of time will be spent keeping tabs on all 50 states making sure they have not added some new piece of legislation or named some new chemical or its’ constituent, whether it be synthetic or natural, to the list deemed unsafe or causing harm.  Without this knowledge, a company could end up being in noncompliance.  Remember Dunkin’ Donuts?

Beyond Comprehension

Maybe it’s just me, but when I see states legalizing Marijuana and people treating it like the next best thing since McDonalds, basically ignoring and violating federal law themselves, but yet legislators want federal law with this latest proposed upcoming legislation, stipulating states can impose stricter regulations, it just seems to me our state and federal governments don’t have a clue.

They only seem to do what feels good at the moment instead of comprehending the all encompassing ramifications this type of regulation will cause to many entrepreneurs and consumers alike.  And quite frankly, I am at a loss ….yet still believe, allow the consumer to choose best for their families with their hard earned dollar.  Stop over regulating job creators right out of business or policing our decisions as to which products to buy by eliminating them altogether through overreaching regulation….. that is NOT Consumer Freedom!

The LA Times wrote an article about Prop 65 showing two sides of this argument and attorney Lisa Halko has it correct.  She clearly shows the argument with the problem of targeting constituents of an ingredient (natural or otherwise as natural products will not be exempt) or foodstuff and this is what the personal care products and cosmetic industry as a whole knows will come to pass at a federal level.

You can read Rep. Markey’s and Rep. Schakowsky’s remarks HERE….which are full of innuendo and as overstated as they are, in my opinion, are designed to scare consumers since I reiterate……Where is the SCIENCE?  And as consumers, we too should be demanding they show us the science, not base an entire summary of harm on the “precautionary principle.”

Until the final draft, the key points listed look tame initially, but review the links above on past proposed legislation to see how onerous and out of touch this legislation would have been as it relates to financial harm. And the drafts were created out of skewed science and research provided by NGO’s such as the Environmental Working Group and The Campaign for Safe Cosmetics to create hyperbole.  It has been these sister organizations M.O. to find and locate and then cherry pick a non peer reviewed single study, twist it and use it for their financial gain, ignoring all other actual peer reviewed research studies which refute the Swedish study, such as Acrylamide shown in the Dunkin’ Donuts link above, since the true and correct science would not fit with their agenda.  Scaring consumers is big business and business is GOOD it seems!

With each passing day of new regulations becoming commonplace, our government contributes to a stifling environment not conducive to the needs and growth of small businesses anymore.  They literally are making it more difficult to next to impossible for start-ups to even gain a foothold, and the future of our industry is in the proverbial cross hairs of our federal and state legislators as I conclude this article. (sigh)

Here we go again, y’all! Reps Edward J. Markey (D-Mass.) and Jan Schakowsky (D-Ill.) introduced the Safe Cosmetics and Personal Care Products Act of 2013, yesterday. According to the press release on Rep. Markey’s website, the bill is intended to “closes major loopholes in the federal law that allows companies to use ingredients in cosmetics and personal care products known to damage human health and the environment.”

I was curious as to when we would see a piece of cosmetic legislation show back up. It was last March and April when H.R.4262 Cosmetics Safety Enhancement Act of 2012  and H.R. 4395 Cosmetic Safety Amendments Act of 2012, were introduced.

From Rep. Ed Markey’s press release issued yesterday:

Key provisions in the Safe Cosmetics and Personal Care Products Act of 2013, which has 14 original co-sponsors, include:

–Cosmetic and Ingredient Testing and Safety: FDA would establish a list of ingredients prohibited from being used in cosmetics.  This includes carcinogens and reproductive and developmental toxins.

–Post Market Testing: Requires the Secretary of HHS to conduct annual random sample tests for pathogens or contaminants in cosmetic products.

–Registration of Cosmetic Companies and Registration Fees: Cosmetics companies would be required to register with FDA and pay a registration fee based on annual gross receipts or sales.  Small businesses with less than $2 million in revenues from cosmetics would be exempt from registration; businesses with less than $10 million in revenues from cosmetics would be exempt from registration fees.

–Market Restrictions: Provides the FDA with recall authority for products that are misbranded, adulterated, or otherwise fail to meet the safety standard and can request a voluntary recall or order the ceasing of distribution of any such cosmetic product.

–Mandatory Reporting of Adverse Health Effects: Cosmetic manufacturers, packagers, and distributors would have to provide the FDA with reports of adverse health effects associated with the use of a cosmetic.

–Worker Issues: Requires companies that manufacture cosmetics for salon use to provide information on any health hazards linked with those cosmetics.

–States Rights: States may set more stringent standards.

At the time of writing this post, the bill has not been made public. Please keep an eye out for an update. When the bill is made available, we will post it in its entirety.

To read Rep. Ed Markey’s press release, click here.

Stay tuned…………..

]]> http://personalcaretruth.com/2013/03/cosmetic-legislation-introduced-the-safe-cosmetics-and-personal-care-products-act-of-2013/feed/ 3 http://personalcaretruth.com/2013/03/how-deep-do-skin-care-actives-have-to-go-to-work-2/ http://personalcaretruth.com/2013/03/how-deep-do-skin-care-actives-have-to-go-to-work-2/#comments Fri, 22 Mar 2013 09:00:15 +0000 Amanda Foxon-Hill http://personalcaretruth.com/?p=5524

Well, that all depends on what your skin care active is intending to do and how well you can deliver it to its target site and that’s not easy.   I’ve drawn up a slightly wordy and messy diagram to show you where stuff happens in the skin as a way of helping you visualise your products pathway.  For example, a cream that says that it works ‘like botox but without the injection’  would have to reach as far down as the dermis to have any impact on the nerves that control muscle contraction, better still it would need to go way past that, through the subcutis and into the muscle to be really effective.  Of course, this is all possible – deep heat has been making those sorts of claims for years, but it does require a bit of work to get the right dose to the right site at the right time.

So, here is a quick breakdown of where you need your actives to get to in order for them to work.

• Epidermis.  This is easy – just pop it on and as long as your active is stable for long enough and is at the right dose you should get a positive result.   Exfoliants, anti-bacterials, barrier forming, moisturisers, smoothing, anti-inflammatories, anti-oxidants, sunscreens, brightening, whitening, pigmentation evening chemicals and ingredients that calm or warm the system can all work here. Ingredients such as Arnica which help to reduce bruising also get to work in the epidermis by gently stimulating the circulation to help speed up the healing process. Finally ingredients such as hyaluronic acid and most collagen and elastin rich products mostly work here by increasing the hydration which gives the skin a plump, wrinkle-free look for as long as the product remains moist!
• Dermis. This is quite a bit harder to get to.  Also it is important that products designed to get into the dermis are carefully formulated as the dermis does contain blood vessles and as such can allow chemicals to enter the bloodstream.   Structure building actives such as collagen and elastin need to be in here to ‘re-build’ the skin, ingredients that wish to stimulate hair follicles or help with micro-circulation also have to go into here and so do topical botox actives that work on the nerves.
• Subcutis.  This is really tricky to get to and is generally accessed via needle by cosmetic surgeons who want to plump up ageing skin to make it look younger (you know that procedure when they inject your butt fat into your face????).  Otherwise here sit your sweat glands and the muscles that contract to give us goose bumps.  You don’t need actives to get down this far to affect sweat glands – the glands can be accessed from the surface of the skin (such as in an anti-perspirant) thankfully!
• Muscle Layer.  This is where the botox injections get to and where some topical treatments reach in order to help with muscle healing.  More and more cosmetics that want to either ‘work out’ or relax muscles are using something called phonophoresis to help deliver their topical cures to the muscle tissue. Phonophoresis uses ultrasound to ‘push’ products through the skin. This article is pretty easy to read and very interesting.  Cosmetics using this technology have been around for a while now and in some cases it really does work!

So, as you see the average cosmetic doesn’t really have to go very far to be effective which is quite  a relief as when it comes to every-day skin care I’m a big fan of all things shallow.

Take care and love your skin.

In this article, I will cover two aspects of scare stories/claims made about cosmetic ingredients:

1)      We are gradually creating a “toxic planet” (an actual claim made in a LinkedIn discussion!)

2)      Modern synthetic chemicals don’t have the same history of human exposure/safe use

I have chosen to discuss these two claims because they are linked – by using numbers to demonstrate the argument.

Whilst there is no doubt that there ARE pollutants in the environment, and they are created by human activity, it seems that it is impossible for many commentators to maintain any sense of proportion about the extent to which this pollution exists, and the causes. It is not uncommon to see ALL synthetic chemicals being blamed, on the basis that they don’t break down in the environment, i.e. they accumulate, both in our bodies AND in the environment.  There is no evidence that the majority of synthetic chemicals (used in cosmetics) do anything other than degrade, some slowly, some rapidly; a few extremely slowly. Many studies have shown a presence of a number of synthetic substances in human urine. This presence demonstrates that the material is being excreted and, whilst it is possible that not the entire quantity of the substance to which the body is exposed is excreted, there are no studies demonstrating accumulation of these same substances in human tissues, as far as I am aware.

So, if our planet is becoming so “toxic”, why are we not dropping like flies from all the polluting synthetic chemicals?

If we take the world population figures from 1950 and examine them at intervals, we can see that it is not immediately apparent that our “toxic planet” is having much effect:

Source: U.S. Census Bureau, International Data Base.

At the time of writing, the global population has now exceeded 7 billion. This is a global figure but let’s take the figures for a developed country (USA), where the possibility of contact with “thousands of toxics” is much greater:

Source: U.S. Census Bureau, International Data Base.

The data for the USA should not be compared directly to the global figures, as populations increase or decrease at different rates in different regions, but the point is that there has been almost a 3-fold increase in world population in the 60 year period during which more synthetic substances have been made available than ever before, and a doubling of the USA population. If we go back a little further, to 1900, the world population was estimated at between 1.55 and 1.77 billion. It seems quite astonishing that such a massive growth in population can take place against the background of the rampant toxicity claimed by some. (“Toxic soup” is another favourite phrase used to describe the Armageddon that is apparently being created by synthetic substances!)

Moreover, another factor needs to be considered – longevity. Life expectancy in the USA (and all developed countries) has been steadily increasing since before 1900. In that year, an American could expect to enjoy absorbing toxic chemicals for 47 years; by 2000, this had increased dramatically to 77 years (SOURCE: E. Arias, “United States Life Tables, 2001,” National Vital Statistic Reports 52, no. 14 (2004): table 11). So, considering the massive increase in population in combination with an astonishing (and continuing)  increase in life span of that rapidly increasing population, it seems unlikely that cosmetics are quite as toxic as some would have us believe.

Moving on to the second topic – it is often claimed that natural substances must be safe because of their long history of safe use. This statement is facile because it only considers periods of time. It is not sufficient to claim that a certain substance has been used for over 2000 years. It is also necessary to consider the number of people exposed to the substance, and over what period of time each person is exposed.

Early archeological evidence suggests that cosmetics may have first been used in 4000 BC in Egypt. At that time, the world population is estimated to have been 7 million, although some estimates might suggest it could have been in the region of 20 million. As stated earlier, the total population was 1.77 billion by 1900. One way to assess the exposure to cosmetic ingredients could be to calculate the average population in one year and the maximum number of years each person could be exposed to these ingredients. It is not a perfect picture, and many assumptions and approximations must be included, but it does enable a comparison to be made between pre-1900 and post 1900 exposure on the slightly (?) flawed assumption that mostly natural ingredients were used before 1900 and mostly synthetic after 1900. The first problem is to estimate the average value for the world population between 4000 BC and 1900 AD, as the growth in population is mostly in evidence after 1750 with an increase from 961 million to 1.77 billion in only 150 years. Splitting these periods gives an average population of approximately 160 million between 4000 BC and 1750 AD, and 1.36 billion between 1750 and 1900. A typical life expectancy for most of the period from 4000 BC to 1750 AD was 30 years (less during the period of the Black Death!).  Life expectancy in more recent times has increased from 77 to 82 in the UK over the period from 1980 – 2006.

It is impossible to carry out a precise calculation, but it is very clear that the human population is many times greater in the past 100 years, and that most humans are also living much longer – well over double the life expectancy of around 250 years ago.

If it is assumed that all humans are exposed to cosmetics since 4000 BC (purely for the sake of comparison), there were far fewer humans around to be exposed for the first 5000 years compared with the last 100 years, and they were not living anywhere near as long. The significantly shorter lifespan means that exposure to natural substances was far less for each individual, and it could be argued (rather mischievously) that it may have been the use of unsafe natural substances that were responsible for the limited lifespan! Certainly lead poisoning from natural sources has been a factor in many deaths over the centuries, prior to a better understanding of chemistry and toxicology.

Taking a look from a different angle, using the ever-popular Head & Shoulders anti-dandruff shampoo as an example, this product was launched in 1961, and so has just over 50 years of exposure to a large population. Currently, 29 million bottles (250ml each) are reported to be sold each year. I can only guess at calculating how many different individual consumers are exposed based on that figure, but I will assume that each consumer uses 4 bottles each year (based on using 10ml each wash, and washing the hair 100 times each year). That equates to almost 7.5 million individuals being exposed to those (mostly synthetic) ingredients regularly and, presumably, over several years. I appreciate that a rinse-off product isn’t the best example for exposure, but it is the numbers that are important, rather than the actual product, as the exposure figures also work in the same way for leave-on products. Over 50 years (despite sales not always being at their current level), this adds up to a significant amount of exposure to a small number of substances, especially when one considers that most of the components are very common ingredients in many other personal care products.  I can find no evidence of adverse effects beyond the usual minor irritation suffered by a small minority of susceptible individuals. It is likely that 10s of millions of individuals have used that product over the 50 years since it was first launched; taking an average usage by 5 million consumers each year gives 250 million – an exposure figure that is surely equivalent to exposure to any widely-used natural substance (are there even any such substances that are so widely used?) over a much longer period of time.

One further point to consider is the fact that many of the “natural” ingredients being touted for use in cosmetics in more recent times often come from specific, limited locations, where the local exposure will be very restricted (i.e. to the local population) – these cannot begin to compare in mass exposure to a large proportion of the synthetic ingredients being used.

I realise that this is not the most coherent of arguments in terms of hard and fast numbers, but I hope that the basic principles that I have outlined are very clear.

In summary, given the massive increase in human population, the toxic effect claimed for synthetic ingredients in cosmetics is difficult to substantiate, and exposure to the natural ingredients being used in cosmetics should not be assumed to be safer than synthetic purely based on any history of use, as a long history of use on a small population may not be as indicative of safety as a relatively short history of use on a large population. Natural ingredients need to be assessed for safety just as much as synthetics!

I anticipate that some people may have interesting data to support (or destroy) my assertions, and that is what I am looking for here, as I see this article as the vehicle to initiate a healthy debate on the points I’ve raised!