The legislation, called the Safe Cosmetics Act of 2011, recognized that as the number of potentially harmful ingredients in personal care products has grown, so has the responsibility to monitor the industry selling them in order to protect the public. The regulation is needed, the legislators said, because "consumers are in the dark about the potentially harmful ingredients in personal care products."

The proposed legislation would have provided additional regulatory muscle to the Food and Drug Administration by requiring:

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.

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 annual random sample tests for pathogens or contaminants in cosmetic products.

Ingredient Labels on Cosmetics: The label on each package of cosmetics would be required to list the name of each ingredient. This includes the components of a fragrances and preservatives.

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.

Fast forward to 2012. The cosmetic industry has jumped into the fray. A number of industry associations are working with Congress to advance regulatory reforms. It is unclear whether the trade associations support the Safe Cosmetics Act of 2011

The House Energy and Commerce Subcommittee on Health will hold a hearing on March 27th to examine the state of the nation’s personal care products industry and discuss the regulation of products. The congressional hearing will begin at 10:15 a.m. You may be able to watch the hearing using this link:

http://www.ustream.tv/channelpopup/energyandcommerce2322

Find out more here:

http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9394

This is the first nanosilver product registered for use as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”).

EPA indicated that its review of the nature of use, methods and rates of application, and potential exposure levels did not indicate an unreasonable adverse effect on the environment or public health.

The product manufacturer will be required to conduct a number of additinal studies during the period of conditional registration, including toxicity tests and stability tests to determine if nanosilver breaks away from the pesticide or textiles treated with the pesticide. All testing must be completed during the next four years.

The Natural Resources Defense Council (“NRDC”) filed a lawsuitto block the conditional registration of the antimicrobial nanosilver product (Natural Resources Defense Council v. EPA, 9th. Cir., No. 12-70268, 1/26/12). The NRDC claims that more testing is needed to study nanosilver’s effects on human health and the environment.

The EPA notice of conditional registration is available here:

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-1012-0066

The new rule will mandate that if there is a material change to a product, such as a change in the product design, manufacturing process, or the source of component parts, companies must re-test and re-certify that the product complies with federal safety standards. In addition, companies must have to mainting records on the testing and certifications .

In an effort to reduce the burden on companies, the CPSC voted to allowing firms to use component part and finished product testing conducted by their suppliers, in order to meet the testing and certification requirements.

Firms are already required to do initial testing on some products, including among others, those with lead paint, those with small parts, full size and non-full size cribs, pacifiers and children’s metal jewelry. The new rules will require firms to go beyond initial testing to ensure that products continue to meet safety standards.

All domestic manufactures, importers and private labelers of children’s products will be required to test the products periodically to ensure continued compliance with federal safety standards.

Significant Debate

There is significant debate about the impact of the testing regiment. The new rules are expected to drive up testing costs. Small businesses can expect testing costs to exceed 12% of their revenues. Retailers may cram down expensive testing requirements, forcing small businesses out of the retail space. The proposed rules did not include a proposed exemption for low-volume manufacturers. The proposed rules also do not clarify what constitutes a compliant “reasonable program of testing” or the frequency of required testing under the law.

Children’s products that comply with the law may be labeled as “Meets CPSC Safety Requirements.” The labeling is voluntary.

The testing and certification rule will go into effect 15 months after it is published in the Federal Register.

The CPSC also voted (5-0) to move forward with a notice of proposed rulemaking on what constitutes representative samples for testing compliance. Under this proposal, a company could use product samples for periodic testing that are known to be representative of all the product manufactured or imported since their last periodic or certification test. Companies will be required to document their testing and keep those records.

The CPSC will continue to seek public comment on opportunities to reduce the cost of third party testing requirements as required by Congress.

As of 2009, the law prohibited a manufacturer, wholesaler, or retailer from the sale or distribution of a children's product (or product component) containing Lead at more than 90 parts per million (ppm) by weight, Cadmium at more than 40 ppm and Phthalates, individually or in combination, at more than 1000 ppm. Further, the law required the Washington Department of Ecology (DOE) to develop a list of Chemicals of High Concern for Children (CHCC) and to establish rules for manufacturers to report on their use of these chemicals in children’s products.

The DOE has now adopted its final Children’s Safe Product Act Reporting Rule setting forth requirements for chemcial reporting by manufacturers. Here is a summary of the law and the implementing regulations:

1. New Reporting Requirements

The regulations (1) establish the list of chemicals for which a manufacturer’s notice is required; (2) establish what manufacturers of children's products must do to comply with the notice requirements; and (3) clarify the enforcement processes the DOE will use if a manufacturer fails to provide notice as required.

2. What products and chemicals are subject to regulation? Under the CSPA, the manufacturer of a “children's product” is required to notify the DOE if a CHCC is present in the product or product component.

The term "children's product" includes but is not limited to toys, cosmetics, jewelry and baby products. A children's product does not include over the counter drugs, prescription drugs, food, dietary supplements, packaging, medical devices, or products that are both a cosmetic and a drug regulated by the Food and Drug Administration.

3. Who is required to provide notice to the DOE?

The law provides that a manufacturer of a children's product, or a trade organization on behalf of its member manufacturers, must provide notice to the department that the children's product contains a chemical on the CHCC list.

The definition of manufacturer includes any person or entity that produces a children's product, any importer that assumes ownership of a children's product, and any domestic distributor of a children's product. A retailer of a children's product is not a manufacturer unless it is also the producer, manufacturer, importer, or domestic distributor of the product.

The following hierarchy will determine which person or entity the department will hold primarily responsible for ensuring that the department receives a complete, accurate, and timely notice for the children's product:

(a) The person or entity that had the children's product manufactured, unless it has no presence in the United States. (b) The person or entity that marketed the children's product under its name or trademark, unless it has no presence in the United States. (c) The first person or entity, whether an importer or a distributor, that owned the children's product in the United States.

3. What are the notice requirements for a manufacturer of children’s products?

A manufacturer of children's products is required to notify the DOE when a CHCC is present in their children’s products or product component.

Each chemical on the CHCC list that is an intentionally added chemical present in a product component must be reported at any concentration above the practical quantification limit. Each chemical on the CHCC list that is a contaminant present in a product component must be reported at any concentration above 100 ppm.

A manufacturer need not file a notice with respect to any CHCC that occurs in a product only as a contaminant if the manufacturer had in place a manufacturing control program and exercised due diligence to minimize the presence of the contaminant in the component.

A manufacturer must provide notice on an annual basis for children's products that have been manufactured for sale in Washington during the 12 month period prior to the reporting. If the reporting party determines that there has been no change in the information required to be reported since the prior annual notice, the party may submit a written statement indicating that the previous reported data is still valid, in lieu of a new duplicate complete notice. If a CHCC is subsequently removed from the children's product component for which notice was given, the manufacturer may provide notice to the department.

4. What must the manufacturer include in its notice to the DOE?

The notice must include all of the following information:

(a) The name of the CHCC and its Chemical Abstracts Service registry number. ( b) The product category or categories in which it occurs. (c) The product component or components within each product category in which it occurs. (d) A brief description of the function, if any, of the CHCC in each product component within each product category. (e) The total amount of the CHCC by weight contained in each product component within each product category. The amount may be reported in ranges, rather than the exact amount. If there are multiple CHCC values for a given component in a particular product category, the manufacturer must use the largest value for reporting. (f) The name and address of the reporting manufacturer or trade organization and the name, address and phone number of the contact person for the reporting manufacturer or trade organization. When a trade organization is the reporting party, the report must include a list of the manufacturers on whose behalf the trade organization is reporting, and all of the information that would otherwise be required of the individual manufacturers. (g) Any other information the manufacturer deems relevant to the appropriate use of the product.

Reporting parties are not required to include specific formula information or the specific name and address of the facility which is responsible for the introduction of a CHCC into a children's product or product component.

If a reporting party believes the information being provided is confidential business information (CBI), in whole or in part, it may request that the department treat the information as confidential business information.

5. When must manufacturers begin to provide notice?

The notice requirement will be phased in based on various manufacturer categories and product tiers -- with the largest manufacturers of Tier 1 products (i.e., children’s products that can be “mouthed”) reporting within the next 12 months and the smallest manufacturers of Tier 3 products (products that have only short periods of dermal contact) reporting in 84 months.

6. How will the CSPA be enforced?

The DOE may obtain/sample children's products subject to possible reporting, and analyze their components for the presence of CHCCs. If the DOE finds that a children's product contains a chemical on the CHCC list that the manufacturer either has not reported, or has reported at a lesser amount, the DOE will notify the manufacturer in writing. The DOE will then afford the manufacturer 45 days from receipt of the DOE’s notification to respond to the findings before taking further enforcement action.

In determining whether a violation of the CSPA or these rules has occurred, the DOE will consider the manufacturer's timely explanation as to why it did not report the presence or accurate amount of the CHCC in the product.

If the manufacturer asserts that the CHCC is present in the component only as a contaminant, then the manufacturer must present evidence that it conducted a reasonable manufacturing control programs (such as ISO or ASTM standards) for the CHCC contaminant and exercised due diligence in the manufacturing process. Due diligence means ensuring the effectiveness of a manufacturing control program, use and enforcement of contract specifications, procedures to ensure the quality/purity of feedstock (whether raw or recycled), use and enforcement of specifications for manufacturing process parameters (e.g., drying and curing times when relevant to the presence of high priority chemicals in the finished children's product components), periodic testing for the presence and amount of CHCCs, auditing of contractor or supplier manufacturing processes, and other practices reasonably designed to ensure the manufacturer's knowledge of the presence, use, and amount of CHCCs in its children's product components. If the manufacturer contests the DOE’s findings regarding the presence or amount of the CHCC in the product component, the manufacturer may further analyze the component in question for presence of CHCC and provide the DOE with a copy of its own laboratory findings for the component.

If the DOE determines that a manufacturer has violated a requirement of the CSPA, it may require the manufacturer to pay a civil penalty, not to exceed $5,000 for each violation in the case of a first offense. Manufacturers who are repeat violators are subject to a civil penalty not to exceed $10,000 for each repeat offense. A single violation consists of a manufacturer failing to provide the required notice for the presence and accurate amount of each CHCC, in each applicable product category, in each applicable product component.

7. What chemicals are included on the CHCC list?

The list of CHCC chemicals can be found here.

The new standard will take effect August 14, 2011. However, the way the law was written, the lowered limit is retroactive. Currently there is legislation under consideration in the U.S. House of Representatives that may eliminate the retroactivity requirement.

For more information, please see our earlier blog posts or contact us if you have any questions.