USA Regulatory News

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requ...

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The previous deadline of December 29, 2023, has been pushed back to July 1, 2024, providing the cosmetics industry with additional time to comply with these regulatory obligations.

This decision comes in the wake of the FDA's commitment to facilitating a smooth transition for industry stakeholders in complying with the new regulatory landscape mandated by MoCRA. The Agency recognizes the importance of ensuring that cosmetic manufacturers and processors have adequate time to submit facility registration and product listing information.

Background and Timeline:

1. Suspension of Voluntary Cosmetic Registration Program (VCRP): In March 2023, the FDA announced the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the imminent implementation of the facility registration and product listing authorities mandated by MoCRA.
2. Draft Guidance on Cosmetic Product Regulations: By August 2023, the FDA issued draft guidance on cosmetic product facility registration and product listing, aligning with the requirements set forth by MoCRA. This draft, once finalized, will offer crucial recommendations and instructions for individuals submitting cosmetic product facility registrations and product listings to the FDA.
3. Introduction of Electronic Submission Portal: In September 2023, the FDA introduced an opportunity for public comment on its newly developed draft electronic submission portal named "Cosmetics Direct," along with the paper forms (Forms FDA 5066 and 5067). Emphasizing the importance of electronic submissions for efficiency, the Agency anticipates the availability of electronic submission options and supporting documentation in early December 2023.

Details of the Delayed Enforcement:

The FDA's decision to delay enforcement aims to provide regulated industries with the necessary time to comply with MoCRA's new authorities, which include facility registration and product listing requirements. Specifically, the delay extends to July 1, 2024, for both the statutory deadline of December 29, 2023, and specific registration and listing requirements.

This extension also includes a grace period for owners or operators of facilities that commenced manufacturing or processing a cosmetic product after December 29, 2022, and for cosmetic products first marketed after that date.

MoCRA Authorities and Exemptions:

Cosmetic product manufacturers and processors are required to register their facilities, update information promptly, and renew registrations every two years. Responsible persons, such as manufacturers, packers, or distributors, must list each cosmetic product marketed, including ingredients, and provide annual updates.

Exemptions are granted to certain small businesses. However, such exemptions do not apply to facilities that manufacture or process, or to responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

As the FDA extends the MoCRA implementation deadline, industry stakeholders are encouraged to take advantage of the additional time granted to ensure a seamless transition to compliance with the new regulations.

On November 20, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a proposed rule designed to enhance protection against two toxic chemicals—decabromodiphenyl ether (decaBDE) and phenol,...

On November 20, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a proposed rule designed to enhance protection against two toxic chemicals—decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)). These persistent, bioaccumulative, and toxic (PBT) chemicals, previously subject to risk management provisions under the Toxic Substances Control Act (TSCA), are now the focus of enhanced workplace safety measures and water release restrictions.

The proposed rule aims to protect workers, communities, and critical industries such as nuclear energy, transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production.

The 2021 Rule

In response to TSCA, EPA moved quickly to address five PBT chemicals to protect human health and the environment, finalizing risk management rules in January 2021. In February, a review was initiated to ensure adherence to science and law, considering feedback from manufacturers who anticipated compliance challenges. In March, prompted by Biden-Harris Administration directives, EPA sought public input on the PBT rules, leading to proposed amendments for two of the five chemicals. Notably, the regulations for the remaining three PBT chemicals (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD) and pentachlorothiophenol (PCTP)) remain unchanged.

Details of the proposed rule

Under the proposed rule, EPA is targeting two specific PBT chemicals:

DecaBDE: A flame retardant widely used in nuclear power and aerospace applications, decaBDE has been linked to adverse health effects. EPA's 2021 rule prohibited its manufacture, processing, and distribution, with exceptions. The new proposal introduces further measures by requiring personal protective equipment (PPE) for specific decaBDE activities, prohibiting water releases during production, and extending the compliance date for certain applications crucial for nuclear facilities.

PIP (3:1): This versatile chemical found in hydraulic fluids, coatings, electronics, and various industries poses risks to aquatic life and human health. The proposed rule extends compliance dates for certain applications, introduces worker protections, and outlines a phase-out approach for certain uses of PIP (3:1). EPA will host a public webinar to provide an overview of the proposed rule, with a 45-day comment period after publication.

The proposed measures will strengthen protection against these hazardous chemicals while ensuring that essential uses can continue safely.

For more details and to provide public comments, visit www.regulations.gov (Docket: EPA-HQ-OPPT-2023-0376).

Effective November 17, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) has included coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers in the ...

Effective November 17, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) has included coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers in the list of chemicals known to cause cancer in California. This addition is made under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, as outlined in the Health and Safety Code.

The decision to list these chemicals was based on information provided in a public notice published in the California Regulatory Notice Register on September 22, 2023.

Understanding Proposition 65

Proposition 65, established in November 1986 as a ballot initiative, protects California’s drinking water sources from contamination by chemicals known to cause cancer, birth defects, or other reproductive harm. It mandates businesses to inform Californians of potential exposure to such chemicals and to provide warnings.

These chemicals may be present in products, homes, workplaces, or released into the environment. Proposition 65 empowers Californians to make informed decisions about their chemical exposures and prohibits businesses from knowingly discharging significant amounts of listed chemicals into drinking water sources.

OEHHA’s Determination

Coal-tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers meet the criteria to be listed as known to cause cancer under Proposition 65.

The International Agency for Research on Cancer (IARC) categorizes coal-tar pitch and fluoro-edenite fibrous amphibole as Group 1 ("carcinogenic to humans") and silicon carbide whiskers as Group 2A ("probably carcinogenic to humans"). IARC found sufficient evidence of carcinogenicity in humans and animals for coal-tar pitch and fluoro-edenite fibrous amphibole, and in animals for silicon carbide whiskers.

For an updated Proposition 65 chemical list, refer to the OEHHA website.

On 20 October 2023, the United States Environmental Protection Agency (EPA) issued a rule that strengthens reporting requirements for per- and polyfluoroalkyl substances (PFAS) to the Toxics Release I...

On 20 October 2023, the United States Environmental Protection Agency (EPA) issued a rule that strengthens reporting requirements for per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI). The rule eliminates an exemption that allowed facilities to withhold information on PFAS when the chemicals were used in low concentrations.  

PFAS are commonly referred to as "forever chemicals" and are found in low concentrations in a variety of products. By removing of the reporting exemption, the rule applies to all industry sectors, including metal mining and chemical manufacturing, as well as federal facilities that manufacture or use any of the 189 PFASs listed in the TRI. This rule ensures that facilities can no longer withhold information regarding the amounts of PFAS that they manage or release into the environment. 

Toxics Release Inventory 

EPA’s TRI Toxics Tracker (TRI) compiles annual data from various industries, including manufacturing, mining, power generation and chemical production. It includes information on the quantities of chemicals released into the environment or managed as waste.  

This data helps communities understand how local facilities handle listed chemicals and supports informed decisions by businesses, governments, non-governmental organizations (NGOs), and the public. EPA's updated online TRI tools, such as the TRI-listed chemicals, allow communities to map reporting facilities, view chemical releases, waste management, and pollution prevention efforts. 

PFAS in the Toxics Release Inventory 

The 2020 National Defense Authorization Act (NDAA) initially added 172 PFAS chemicals to the TRI for reporting in 2021, with a framework for adding more in the future. Facilities were required to report if they used more than 100 pounds of these substances, a lower threshold than most other TRI-listed chemicals.  

However, the previous administration's codification of the NDAA did not address the availability of the de minimis exemption or other reporting burden reduction provisions, which had allowed facilities reporting to TRI to avoid reporting minimal concentrations of PFAS chemicals.  

The new rule nullifies the prior exemption for all chemicals on the TRI list of chemicals of special concern, including lead, mercury, and dioxins that accumulate in the body over time. 

California's Governor signed Assembly Bill No. 496 (AB496) on October 8, 2023, making it illegal to manufacture and sell cosmetics containing 26 specific substances in the state. This regulatory m...

California's Governor signed Assembly Bill No. 496 (AB496) on October 8, 2023, making it illegal to manufacture and sell cosmetics containing 26 specific substances in the state. This regulatory measure expands on California's Toxic-Free Cosmetics Act, passed in 2020 which restricted the use of 24 harmful chemicals in cosmetics, including mercury and formaldehyde.

California's Toxic-Free Cosmetics Act forbids a person or business from manufacturing, selling, delivering, holding, or offering for sale in commerce any cosmetic product containing any of several specified intentionally added ingredients, except under certain conditions, beginning January 1, 2025. A list of the prohibited ingredients can be found here and it includes for example:

• Endocrine-disrupting chemicals like Dibutyl phthalate, Diethylhexyl phthalate

• Phenyl diamine salts and parabens

• Polyfluoroalkyl substances like sulphonates, acids, and more

 From January 1, 2027, Assembly Bill No. 496 would broaden this prohibition by including specific prohibited ingredients. A list of the ingredients prohibited under AB496 can be found here and it includes:

• Borates, tetraborates, octaborates, and boric acid salts and esters

• Anthraquinone, and dyes which are found in some hair-coloring products

• Aldehydes and more. 

These chemicals are associated with a higher risk of cancer, genetic flaws, harm to the developing fetus, decreased fertility, severe skin burns, and organ or eye damage. Furthermore, they can cause long-term harm to aquatic organisms. They are no longer allowed in cosmetics and personal care products sold in the European Union but are allowed in personal care products sold in the United States.

A cosmetic product that meets the requirements of Assembly Bill No. 496 may contain trace amounts of an ingredient due to natural or synthetic impurities, resulting from manufacturing processes, storage, or packaging migration, but this does not constitute a violation.

On October 20, 2023, the U.S. Environmental Protection Agency (EPA) released updated Toxics Release Inventory (TRI) data on the management of toxic chemical waste. The updated TRI data includes the ...

On October 20, 2023, the U.S. Environmental Protection Agency (EPA) released updated Toxics Release Inventory (TRI) data on the management of toxic chemical waste. The updated TRI data includes the preliminary data set released on August 4, 2023, which included releases, and pollution prevention activities that took place in 2022 at more than 20,000 industrial and federal facilities nationwide were as reported by the U.S. Environmental Protection Agency (EPA).  

General Information on the 2022 Updated Data  

The 2022 TRI Chemical List data has been updated, to include industries such as metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment that manufactured or used quantities of substances on the TRI Chemical List  during 2022. The dataset released on October 20, provides an update to the preliminary 2022 data released in August of 2023. The updated dataset includes revised and late facility submissions that were received by EPA on or before October 18, 2023. 

The EPA has updated its EPA’s TRI Toxics Tracker to help communities locate TRI-reporting facilities, track chemical releases, and learn about waste management practices. The 2022 TRI National Analysis will provide a comprehensive analysis of the data including trends in releases, industry reporting on waste management and discussion of facility efforts to reduce pollution. EPA will publish the full analysis of the 2022 data in the beginning of 2024. 

Contract Sterilization Facilities Updated Data 2022  

EPA has initiated reporting requirements for ethylene oxide (EtO), from 29 Contract Sterilization Facilities (CTFs) that were not previously subject to TRI reporting requirements. These facilities either release EtO or manage it as waste. EPA extended the TRI reporting requirements for EtO in December 2021 to facilities that are likely to exceed an “otherwise used” TRI reporting threshold of 10,000 pounds per year. 

As of October 3, 2023, EPA has received TRI EtO reporting forms from 26 out of the 29 CTFs. In 2022, the 26 CTFs reported that they managed more than 6 million pounds waste associated with ethylene oxide production, of which 9,133 pounds were released on-site into the air. 

The U.S. Environmental Protection Agency (EPA) on October 26, 2023, unveiled a comprehensive plan to improve the assessment of pesticides to quickly and effectively assess potential endocrine-disrupti...

The U.S. Environmental Protection Agency (EPA) on October 26, 2023, unveiled a comprehensive plan to improve the assessment of pesticides to quickly and effectively assess potential endocrine-disrupting effects in humans. This initiative will strengthen the Agency's ability to safeguard against such effects when making pesticide-related decisions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to implement the Endocrine Disruptor Screening Program (EDSP) under Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Understanding Endocrine Systems and Disruptors

Endocrine systems, which regulate hormones in various living organisms, play a central role in processes ranging from development and reproduction to metabolism. Endocrine disruptors are chemicals that interfere with the natural functions of hormones. EPA established the EDSP in 1996 to evaluate how pesticides and other chemicals might affect the estrogen, androgen, and thyroid systems. However, challenges have hampered its effective implementation. EPA lacked efficient methods to rapidly test numerous chemicals for endocrine-disrupting effects and often did not provide clear explanations for collecting the necessary endocrine data.

The Path Forward

EPA's strategic plan involves using its FIFRA process to collect human health endocrine data to improve the efficiency of endocrine-related decision-making. The Agency will prioritize around 400 conventional pesticide active ingredients that are either being registered for the first time or are under registration review. In cases where existing data align with the findings of the FFDCA EDSP, EPA will use this information to expedite decisions and reduce the need for additional testing.

EPA is releasing a scientific paper to clarify which existing data can be used to support endocrine disruption findings. For 403 conventional pesticides, EPA has established sufficient estrogen and androgen data for 86 chemicals to make EDSP decisions regarding their potential effects on human systems. Additionally, 52 pesticide chemicals are now part of this plan, and EPA is communicating its final EDSP decisions regarding their potential effects on the human endocrine system.

Remaining Challenges

As the science on the human endocrine system, especially the thyroid, continues to evolve, EPA anticipates seeking scientific peer review in 2025 to assess advances and its current approach to thyroid assessments.

In the short term, EPA has identified 30 high-priority pesticides that require additional data on potential human estrogen and androgen effects. Preliminary data suggest that these pesticides may affect the endocrine system. The Agency is inviting the public to submit data or comments on these chemicals during a 60-day public comment period. To fill the remaining data gaps, EPA intends to issue FIFRA human health data requests for these pesticides in the spring of 2024. For a second group of 126 conventional pesticides with limited endocrine data, the Agency is seeking information to evaluate their endocrine data needs. Moreover, EPA will determine which of the 161 additional conventional pesticides will require updated endocrine data in the coming years during the registration review process.

The public comment period for this initiative opened on Friday October 27, and stakeholders are encouraged to submit their contributions via Docket EPA-HQ-OPP-2023-0474 at www.regulations.gov.