Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

Rep. Janice Schakowsky, with Reps. Ed Markey and Tammy Baldwin among the co-sponsors, introduced H.R. 5786, the "Safe Cosmetics Act of 2010" on 07/20/2010. The act would amend Chapter VI of the Federal Food, Drug & Cosmetic Act by adding new language regarding the marketing, labelling, testing and regulation of cosmetic manufacturers, packagers and distributors.

Two sections of the bill would affect the use of nanotechnology and nanoparticles in cosmetics:

`SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY.

`(d) Nanomaterials in Cosmetics- The Secretary shall--

 

`(1) monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and

 

`(2) consider scale specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

 

SEC. 618. COSMETIC AND INGREDIENT STATEMENTS.

`(e) 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 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; 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.

Other sections of the bill would require:

Domestic manufacturers, packagers and distributors and foreign manufacturers, packagers and distributors who export to the United States to register annually with the Secretary of Health and Human Services (HHS); registration would include information about locations of facilities and trade names, numbers of employees at each location, gross receipts of sales and names and addresses of materials suppliers

Labels on each package of cosmetics would need to name each ingredient in descending order of dominance in the cosmetic. Internet vendors would need to post this information on their websites.

Within one year of the bill's enactment into law

manufacturers and distributors of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to the Secretary regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels under section 613, including--

 

`(i) functions and uses;

 

`(ii) exposure and fate information;

 

`(iii) tests of finished cosmetics; and

 

`(iv) any other information used to substantiate the safety of such cosmetics or ingredients.

 

The Secretary would, not later than 1 year following enactment, create a publicly accessible database of non-confidential information submitted by manufacturers and distributors.

Within two years of enactment, the Secretary would publish and periodically update lists of prohibited, restricted and safe ingredients

Manufacturers, packagers and distributors would be required to submit reports "containing information received concerning any serious adverse event associated with the use of the cosmetic". These reports would be available to the public via the HHS website.

Other provisions would require to the Secretary of Labor to

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-

 

(A) IN GENERAL- Each manufacturer or importer selling any cosmetic for professional use shall--

 

(i) obtain or develop an expanded 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 product ingredient associated with any chemical hazard, that has been indicated by authoritative bodies or scientific studies to be linked to health hazards including mutation, reproductive or developmental toxicity, neurotoxicity, endocrine disruption, asthma, or other immunological toxicity; and

 

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

 

(B) PROFESSIONAL USE DEFINED- In this paragraph, the term `professional use' has the meaning given such term in section 611 of the Federal Food, Drug, and Cosmetic Act.

 

(2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide expanded 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 an expanded 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 expanded 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 expanded material safety data sheet in other languages, including Spanish and Vietnamese.

 

(b) Contents of Expanded Material Safety Data Sheet- An expanded 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)(i)(II); and

 

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

 

H.R. 5786 has been referred to the House Committee on Energy and Commerce and the House Committee on Education and Labor.

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

 Friends of the Earth - Australia (FOE-Aus) recently released a new report examining the presence of nanoparticles in cosmetics produced by such well known companies as Revlon, Max Factor, and The Body Shop.

In the press release accompanying the report, FOE-Aus noted that the labeling on cosmetics containers didn't reflect the presence of nanoparticles in the product:

“Of the ten products we surveyed, only one listed the use of nano-ingredients on the label. The government’s failure to require mandatory labeling of nano-ingredients denies women the capacity to make an informed choice about what they put on their skin.”
 

While this may be a legitimate complaint for the Australian regulatory agencies to consider, FOE-Aus loses much of its credibility by suggesting that the "big cosmetics companies" and nanotechnologies companies view Australian women as "guinea pigs" and by calling for

 a stop to sales of cosmetics that contain nano-ingredients, until the safety science catches up, and new laws are introduced to make companies test the safety of their products and to label all nano-ingredients,” said Ms Miller. “We are also calling for public participation in decision making about nanotechnology management”.
 

Considering the pace of legislation through any parliamentary body tends to be a slow process and that the issuance of regulations affecting labeling of products by the appropriate agencies would also be a long process, FOE-Aus is effectively calling for a moritorium on nano-based cosmetics for an unknown period of time.

It would be one thing if the report released by FOE-Aus supported these claims and demands. However, the report supports nothing at all.

As the report notes under the heading, "A General Note on the Study's Limitations":

This study was conducted with a limited budget and should be considered to be preliminary rather than comprehensive. Only a small number of observations of each sample were made. . . . While observations in this study of certain particle sizes does indicate that they were present in the cosmetics sampled, observations may not be statistically representative of the full sample. (Emphasis added.)

In another section of the report, we find this statement:

. . .  the particulates shown are those observed via SEM [ Scanning Electron Microscopy] and may not be representative of the average particle in the analysis. Such statistical analyses are time consuming to perform . . . and furthermore require human assisted particle identification to insure correct results. (Emphasis added)

According to anarticle in the Sydney Morning Herald, the Australian Cosmetic Trade Association has dismissed the report. Considering the limited number of products that were tested - just walk into the "Beauty Aids" section of any CVS and there will be more cosmetics than anyone can count -  and the limitations of the testing procedures that were done on them, the report that FOE-Aus presents is a weak base on which to make broad assertions about the safety of those products or to demand the shut down of an industry.

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."

• Email This
• Print
• Comments
• Trackbacks
• Share Link