USA Regulatory News

On December 14, 2023, the U.S. Food and Drug Administration (FDA) has updated the instructions for reporting severe adverse events for cosmetic products as mandated by the Modernization of Cosmetics R...

On December 14, 2023, the U.S. Food and Drug Administration (FDA) has updated the instructions for reporting severe adverse events for cosmetic products as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA requires reporting of serious adverse events from December 29, 2023. 

A responsible person  must notify the FDA within 15 working days of significant adverse events involving cosmetic goods in the U.S., including a copy of the labeling on the retail packaging of the product. Additional medical or other information received by the responsible person within one year of the initial report, must be submitted to the FDA within 15 business days. 

The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product's label in accordance with section 4(a) of the Fair Packaging and Labeling Act or section 609(a) of the FD&C Act is considered. 

A serious adverse event is defined as an event that:  

(A)  Results in: 

• death  

• a life-threatening experience 

• inpatient hospitalization 

• a persistent or significant disability or incapacity 

• a congenital anomaly or birth defect 

• an infection 

• significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant change of appearance), other than as intended under customary or usual conditions of use. 

B) Necessitates a medical or surgical intervention based on reasonable medical judgment in order to  prevent an outcome mentioned in (A) above.

The FDA updated the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) web page in November 2023, recommending that industry responsible persons use the current MedWatch Form 3500A, which can be downloaded and completed at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF), to submit serious adverse event reports for cosmetics. 

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) introduced a new framework for identifying eye irritation and corrosion hazards in new chemicals evaluated under the Toxic Substances...

On January 8, 2024, the U.S. Environmental Protection Agency (EPA) introduced a new framework for identifying eye irritation and corrosion hazards in new chemicals evaluated under the Toxic Substances Control Act (TSCA). This standardized approach aims to enhance transparency and consistency in final risk assessments. The framework aligns with EPA's commitment to reduce animal testing, increase the efficiency of chemical reviews, and expedite market entry while safeguarding human health.

As part of TSCA requirements, EPA must assess new chemicals within 30 or 90 days, identify potential hazards and conduct risk assessments. Evaluation of eye irritation or corrosion is an integral part of this process. Traditionally, animal testing using rabbits was employed for this purpose, but its inconsistency, especially for mild to moderate irritation, has raised concerns about its applicability to humans.

HIGHLIGHT OF THE FRAMEWORK

The new framework is aimed at promoting alternative test methods known as New Approach Methodologies (NAMs). These methods eliminate or reduce testing on vertebrate animals while maintaining scientific rigor in assessing chemical hazards. In addition to promoting ethical practices, the transition to NAMs is expected to save time and money for stakeholders by eliminating the necessity for animal studies.

By emphasizing reproducible data, EPA aims to streamline decision-making by ensuring a standardized process for evaluating eye irritation or corrosion hazards in new chemical test data. It relies on peer-reviewed literature, accepted Organization for Economic Cooperation and Development (OECD) test guidelines, and other recognized risk assessments.

A BRIEF OVERVIEW OF THE FRAMEWORK

• Available data on the chemical substance are evaluated for quality and applicability.
  • Data are prioritized in the following order:
    • Data from human cell or tissue test methods.
    • Data from in-chemico, in vitro, or ex vivo test methods.
    • Data from in vivo test methods.
  • Where data from eye irritation or corrosion tests are not available, test methods that assess skin irritation or corrosion potential may be considered. 
• If eye and skin irritation or corrosion data are not available, other information may be considered. Where no data exists, a hazard determination may not be possible.
• Any relevant human data will be evaluated and incorporated on a case-by-case basis. 

EPA’s New Chemicals Program (NCP) prioritizes the use of methods that use sensitive human cells or tissues to identify non-irritating chemicals, such as OECD TG 492 (1). For the identification of irritating or corrosive chemicals, the NCP favors methods using human cells or tissues capable of assessing the full severity range, such as OECD TG 492B (2), along with reproducible and relevant in chemico, in vitro, or ex vivo methods. The NCP does not recommend the prospective use of the in vivo eye irritation test using live rabbits, such as the Draize test.

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by th...

On December 18, 2023, the U.S. Food and Drug Administration (FDA) released the final guidance for the industry regarding cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance supports stakeholders in submitting cosmetic product facility registrations and product listings to the FDA. It outlines submission responsibilities, necessary information, submission procedures, timelines, and specific exemptions from registration and listing requirements.

Portal

The guidance provides details about a newly launched electronic registration and listing portal called Cosmetics Direct. This portal is now accessible. Additionally, the FDA is in the process of creating paper forms, Form FDA 5066 and Form FDA 5067, to serve as alternative tools for submitting cosmetic product registration and listing information. These forms are expected to be available soon on the Registration & Listing of Cosmetic Product Facilities and Products platform.

The FDA will use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. To streamline the registration process, facility owners or operators are required to obtain an FEI number before submitting their facility registration. To check for an existing FEI number, please use the FEI Search Portal.

It is important for the responsible person to obtain the relevant FEI number(s) for each facility where their cosmetic products are manufactured or processed, as these facility registration number(s) are necessary for product listing submissions. In the case of a small business that is exempt from registration and does not have a facility registration number, the product listing can be submitted using the facility name and address.

Exemptions

MoCRA provides exemptions from facility registration and product listing for specific small businesses.

However, these exemptions do not apply to facilities or responsible persons associated with the manufacture or processing of certain cosmetic products, including the following:

• 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, under customary or usual conditions of use, are intended to change the appearance for more than 24 hours and removal by the consumer is not part of such conditions of use. 

Delayed Enforcement 

The FDA will not enforce the cosmetic product facility registration and product listing requirements for an additional six months after the December 29, 2023 deadline, until July 1, 2024. During this period, regulated industries will have more time to meet these obligations.

Additionally, the FDA will not enforce the registration requirement for facilities that begin cosmetic product manufacturing or processing after December 29, 2022, and the listing requirement for products first marketed after that date until July 1, 2024.

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a rep...

Effective December 29, 2023, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol S (BPS) to the Proposition 65 list as a reproductive toxicant, specifically targeting the female reproductive endpoint. The decision, made through the "State's Qualified Experts" mechanism, follows the conclusive findings of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) that BPS is a contributor to female reproductive toxicity.

The listing of BPS under Proposition 65, effective from December 29, 2023, highlights the potential hazards of the substance and necessitates warning requirements for significant exposures.

During the DARTIC meeting, OEHHA staff presented a comprehensive review of the scientific evidence regarding the female reproductive toxicity of bisphenol S. Following the presentation, the DARTIC voted unanimously (9-0) in favor of the determination that BPS induces female reproductive toxicity based on scientifically valid testing according to widely accepted principles. This led to the addition of BPS to the Proposition 65 list, specifically for female reproductive toxicity.

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 requires 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.

Understanding Bisphenol S

Bisphenol S (BPS) is a constituent of polyethersulfone (PES) plastic, commonly used in the manufacture of rigid plastic products and synthetic fibers used in clothing and textiles. Beyond its application in curing fast-drying epoxy glues, BPS serves as a corrosion inhibitor and is frequently used as a reactant in polymer reactions. BPS can improve color longevity in fabrics and is often chosen as a substitute for BPA in certain paper receipts. It can also be found in the protective coatings that line some food cans, and consumers should be aware that products labeled as "BPA-free" may contain BPS. The common characteristic of BPS and BPA as endocrine disruptors lies in the presence of the hydroxy group on the benzene ring, enabling them to mimic estradiol.

These developments highlight the ongoing efforts to identify and regulate potentially harmful substances. As stakeholders navigate these changes, it is increasingly important to stay informed about chemical listings and associated warnings.

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation...

On 14 December 2023, the U.S. Environmental Protection Agency (EPA) announced that it has prioritized the chemical 4,4'-Methylene bis(2-chloroaniline) (MBOCA) CAS RN: 101-14-4) for risk evaluation under the Toxic Substances Control Act (TSCA). Chemical companies will be required to submit records of the significant adverse impacts on human health and the environment caused by MBOCA. This action is consistent with EPA's mission to protect human health and the environment.  

EPA is collecting environmental and health data on a chemical for the first time in over 30 years, hoping that the data will improve its understanding of the chemical's potential adverse effects on human health or the environment and streamline the risk assessment process. 

MBOCA is used in various industrial applications, particularly in the manufacturing and processing of rubbers, plastics, polymers, resins, and other compounds. MBOCA is a potential human carcinogen, and its inclusion in the 2014 update to the TSCA Work Plan, indicates the need for more evaluation. EPA expects to start a risk review of MBOCA within 9-12 months, as the Agency recently started the statutory priority process for five chemicals, including MBOCA.  

Chemical companies are required to keep records of any reports regarding the chemical's adverse effects on the environment or human health. EPA is authorized by TSCA Section 8(c) to obtain copies of these records. 

EPA has published a Quick Guide to CDX Submissions and a TSCA Section 8(c) Recordkeeping and Reporting Fact Sheet to help respondents in meeting their obligations. Records should be submitted using the Agency's online Central Data Exchange (CDX) system.  

On December 21, 2023, the U.S. Environmental Protection Agency (EPA) released the much-anticipated 2023 Mercury Inventory Report, an important document that sheds light on the supply, use, and trade o...

On December 21, 2023, the U.S. Environmental Protection Agency (EPA) released the much-anticipated 2023 Mercury Inventory Report, an important document that sheds light on the supply, use, and trade of mercury in the United States. This is the second inventory report since the finalization of the 2018 Mercury Inventory Reporting Rule, reinforcing the nation's commitment to managing elemental mercury and mercury compounds as outlined in the 2016 amendments to the Toxic Substances Control Act (TSCA).

The 2023 report, a significant milestone, captures data effective from January 1, 2020, enforcing the 2016 TSCA amendment that bans the export of five mercury compounds. This information not only aids the United States in implementing the Minamata Convention on Mercury but also contributes to the global effort to protect human health and the environment from the adverse effects of mercury exposure.

Mercury, known to cause kidney damage, respiratory failure, and other severe health effects, poses a significant threat. The report highlights the importance of monitoring and regulating its supply, use, and trade. Mercury, being non-biodegradable, has the potential to accumulate in the environment over time.

Key highlights of the 2023 Mercury Inventory Report include:

1. Inactive Mercury Compounds: Thirty-one mercury compounds are now listed as "inactive" under the Chemical Substance Inventory since the 2020 report.
2. Decrease in Mercury Use: An overall decrease of approximately 13% in the use of mercury in the domestic manufacture, sale, and export of mercury-added products, signaling a shift toward effective alternatives.
3. Sector-specific Reductions: Notable reductions include a 20% decrease in mercury used for products like switches, relays, sensors, and valves, as well as a significant 56% decrease in the use of dental amalgam.
4. Low Totals in Specific Products: Mercury in domestically manufactured and imported batteries, measuring devices, and other miscellaneous products is reported to be less than 0.1 metric tons.

This comprehensive report contributes to the ongoing efforts to implement the Minamata Convention, addressing anthropogenic emissions and releases of mercury globally.

Background:

EPA's commitment to monitoring mercury dates back to March 2017 when the initial inventory report was published. Subsequent actions include the 2018 final rule, establishing reporting requirements for triennial inventories. The data comes directly from companies that manufacture, import, or use mercury, providing more reliable and complete information.

The 2023 Mercury Inventory Report builds on the foundation laid by its predecessor, the 2020 Report, which incorporated contextual reporting requirements resulting in more extensive information on the industries that purchased mercury-added products, the countries of origin and destination for imports and exports, and the specific ways that mercury was used in certain manufacturing processes. Late submissions and additional data were incorporated into the 2023 report, reflecting EPA's dedication to transparency and accuracy.

In November 2021, a final rule eliminated the exemption for persons importing pre-assembled products containing a mercury-added component, reinforcing EPA's commitment to refining regulations based on court orders.

The release of the 2023 Mercury Inventory Report highlights EPA‘s continued efforts to protect public health and the environment by closely monitoring and regulating the use of mercury in the United States.

On December 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will prioritize five toxic chemicals for risk evaluation under the Toxic Substances Control Act (TSCA), with risk...

On December 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will prioritize five toxic chemicals for risk evaluation under the Toxic Substances Control Act (TSCA), with risk evaluations initiated if the chemicals are designated as High Priority Substances within the 12-month statutory process. 

EPA intends to prioritize the following five chemicals under the Toxic Substances Control Act (TSCA).  

• Acetaldehyde (CAS RN 75-07-0), 

• Acrylonitrile (CAS RN 107-13-1), 

• Benzenamine (CAS RN 62-53-3), 

• 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CAS RN 101-14-4) 

• Vinyl Chloride (CAS RN 75-01-4). 

EPA plans to prioritize five chemicals each year, establishing a consistent pace for risk assessments. This is the first step towards regulating existing chemicals, assessing if health and environmental protection is needed. It also serves environmental justice by addressing the effects of toxic chemicals on workers, consumers, and communities. If a chemical poses an unacceptable risk, EPA must immediately initiate a risk management process to eliminate those risks. 

Details on the five substances 

Acetaldehyde, a probable human carcinogen is used primarily in the manufacture and processing of petrochemicals, adhesives, and other chemicals. Acetaldehyde may cause various health problems, including respiratory system irritation. 

Acrylonitrile, a probable human carcinogen, has adverse health effects, including respiratory system irritation. It is also used in the production and processing of various chemicals, including plastic materials, paints, and petrochemicals. 

Benzenamine, a probable human carcinogen, is used in the manufacture and handling of petrochemicals, resins, polymers, dyes, and pigments. Exposure to benzenamine can lead to various health problems, including adverse effects on blood, fetal development, and reproduction. 

MBOCA, is a probable human carcinogen. It is used in the manufacture and handling of resins, plastics, rubbers, and other chemicals. Extensive data indicate that exposure to MBOCA can damage genetic material in cells, potentially leading to adverse health effects, especially in infants and children. 

Vinyl chloride, a chemical used in the manufacture and processing of plastic materials like PVC and plastic resins, has been linked to various health problems, including liver poisoning.  It is also a known human carcinogen. In the 1970s, concerns raised by EPA and the White House Council on Environmental Quality led to the enactment of the "original" TSCA in 1976, which mandates the safe manufacture and use of chemicals and addresses the adverse health effects of vinyl chloride. 

Selection process 

EPA selected the five chemicals from the 2014 TSCA Work Plan for further assessment based on their hazards and exposure potential.  

The selection process considered factors such as their use, potential impact on overburdened communities, known hazards, and available information. EPA met with federal partners, industry, environmental organizations, labor organizations, state and local governments, and tribes to discuss the prioritization process. Following the Federal Register notice, EPA will open a public comment period and request further information on uses and potential risks of these chemicals.  

EPA expects to designate these chemicals as high priority for risk evaluation but will continue to review and consider information to make a final designation. The process will include assessing of the hazard and exposure potential, environmental effects, potential exposure, storage near drinking water sources, and chemical usage.