On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing (draft guidance), which explained in detail the two mandatory obligations for enterprises from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): facility registration and product listing. The consultation period for this draft will run until September 7, 2023.

Facility registration: All entities engaged in the manufacture or processing of cosmetic products for the U.S. market—regardless of their geographical location—must register their facilities with the FDA. Facilities in operation when MOCRA was enacted must complete registration with the FDA by December 29, 2023. New facilities must be registered within 60 days after they begin manufacturing or processing cosmetics, or within 60 days after December 29, 2023, whichever is later. 

 Product listing: Responsible person for cosmetics intended for sale in the U.S., namely, manufacturer, packer and distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product, including product ingredients, with the FDA. Existing cosmetic products, which were already on the market prior to the enactment of MoCRA, must be listed with the FDA no later than December 29, 2023. For new products introduced to the market after MoCRA’s enactment, the listing with the FDA should be done within 120 days from the date of their initial marketing.

Key Updates

This draft guidance refines the statutory requirement for cosmetic facility registration and product listing. It clarifies the definitions of key terms such as “contract manufacturer”, “responsible person”, “facility”, “DUNS number”, etc., and offers comprehensive guidance on the entities responsible for submitting applications for registration and listing, the necessary dossiers, submission methods, submission deadlines, and exemptions from registration and listing requirements, etc.

For a comprehensive understanding of the procedures for facility registration and product listing, please refer to the following two articles:

• MoCRA Updates: How to Conduct Cosmetic Product Facility Registration in the U.S.?
• MoCRA Updates: How to Conduct Cosmetic Product Listing in the U.S.?

Moreover, the draft guidance introduces additional details, including the rollout schedule for a new electronic portal for enterprises to submit registration and listing, as well as the adoption of the FDA Establishment Identifier (FEI) as the facility registration number.

• New Electronic Submission Portal

FDA has announced its plan to launch a new electronic submission portal in October 2023. This portal will serve as the designated platform for submitting facility registration and product listing information. Businesses are strongly encouraged to utilize electronic submissions as it enhances the efficiency and timeliness of data submission. As an alternative, the paper form is also being developed.

In line with this, the FDA is inviting industry players to partake in user acceptance testing pilot program to evaluate the future new electronic submission portal. This initiative, accepting up to nine participants, aims to gather valuable feedback from them for portal improvement. Interested stakeholders can apply electronically via eRLC.testing@fda.hhs.gov.

• Adoption of FDA Establishment Identifier (FEI)

FDA will employ the FDA Establishment Identifier (FEI) as the required facility registration number. Prior to initiating the facility registration process, facility owners or operators are required to obtain an FEI number.

Notably, responsible persons are obligated to obtain relevant FEI numbers for each manufacturing or processing facility associated with their cosmetic products, as the facility registration number is a prerequisite for product listing submission. Small businesses exempt from registration can utilize their facility name/address in lieu of the facility registration number for product listing.

ChemLinked Suggestions

Considering the imminent launch of the new submission portal in October 2023, it’s urgent to act. To ensure a seamless transition into the new regulatory landscape, ChemLinked recommends stakeholders take the following proactive measures:

• Organize and sort out existing cosmetic products. This should encompass comprehensive details such as product names, labels, and ingredient information. This groundwork will significantly accelerate the registration process once the submission system is accessible.
• Initiate FEI Number Application: For enterprises yet to acquire an FEI Number, it’s recommended to initiate the application promptly. This critical step is essential for a smooth engagement with the impending product listing submission.

Further Reading

• Decoding U.S. Modernization of Cosmetics Regulations Act of 2022 (MoCRA)
• MoCRA Updates: How to Conduct Cosmetic Product Facility Registration in the U.S.?
• MoCRA Updates: How to Conduct Cosmetic Product Listing in the U.S.?
• Explanation of MoCRA Regulation (Video)

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

Author

Winnie Xu

ChemLinked Regulatory Analyst, REACH24H Consulting Group

Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences.

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On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

This new cosmetic legislation establishes a federal standard for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.

For years, the US Food and Drug Administration (FDA) had relatively loose regulations on cosmetics. Cosmetics business registration and product listing are voluntary rather than mandatory. FDA can issue a warning letter to cosmetic products or companies involved in violations and deny the entry of such products at ports. Still, FDA has no right to order a mandatory recall of unqualified cosmetics.

Focusing on product safety, MoCRA sets out a number of key provisions and new requirements to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) and increase FDA’s oversight over cosmetics and ingredients thereof. It marks the first significant reform to the US cosmetics regulation since the enactment of the FD&C Act in 1938.

Key Provisions of MoCRA

Some of the key points of MoCRA are summarized below:

1.Mandatory Facility Registration and Product Listing

MoCRA stipulates that one year after MoCRA is formally promulgated, “responsible persons” (i.e., manufacturers, packers, and distributors of a cosmetic product whose name appears on the product label) will be subject to mandatory facility registration and product listing requirements.

Specifically, all existing US domestic and foreign facilities that manufacture or process cosmetic products for sale in the United States must register with FDA within one year after MoCRA’s enactment. All facility registrations must be renewed every two years. Notably, facilities engaged solely in the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products are not required to register.

Regarding listing, responsible persons shall list each cosmetic product with FDA, including its ingredients and where the cosmetic product is manufactured. The product listings shall be updated annually. It is worth noting that a single listing submission may include multiple cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.

2. Cosmetic Safety Substantiation

MoCRA requires responsible persons to ensure and maintain records supporting “adequate substantiation” that shows that a cosmetic product is safe, and establishes a safety standard that products must meet to be marketed in the US. Cosmetic products without adequate safety substantiation will be considered adulterated.

3.Updated Cosmetic Labeling Requirements

MoCRA updates the labeling requirements for cosmetics, including:

• The requirement to include contact information through which the responsible person can receive adverse event reports on cosmetic product labels, which will be effective two years after the date of enactment of MoCRA;
• The requirement to include a notice that only licensed professionals may use the product on the labels of cosmetics products for professional use, which will be effective one year after the date of enactment of MoCRA;
• The requirement for disclosure of fragrance allergens on product labels. The disclosed information shall be consistent with FDA’s new regulations.

4.Mandatory Adverse Event Reporting

MoCRA requires that responsible persons submit reports of serious adverse events to FDA no later than 15 days after learning the issue, and maintain all records related to health-related adverse events associated with the use of its product for six years. Exceptionally, small businesses need only maintain such records for three years.

Besides, MoCRA expands the definition of “serious adverse event” to include infections or “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual.”

5.FDA’s Increased Oversight

In addition to the above new requirements for cosmetic manufacturers, packers, and distributors, MoCRA greatly expands FDA’s rulemaking and enforcement authority over cosmetics. It mandates FDA to issue good manufacturing practices (GMPs) regulations and develop regulations that establish and require standardized testing methods for asbestos in cosmetics. It also grants FDA’s mandatory recall authority for a cosmetic product and expands FDA’s access to certain records.

Latest Updates

The implementation and enforcement of MoCRA’s detailed legislation may take years for the FDA, as it will need to develop necessary regulations. Over the next 2-3 years, the FDA will dedicate efforts towards developing necessary implementing regulations, including mandatory GMP regulations for cosmetic manufacturers.

Recently, FDA held a virtual public listening session on good manufacturing practices, seeking input and expertise from stakeholders to inform the development of GMP regulations for the cosmetics industry. The regulations will be formulated with reference to suggestions and opinions put forward by enterprises at the listening session.

Representatives from various organizations and businesses presented public comments, sharing perspectives and suggestions on GMP for cosmetic products. Key themes and concerns emerged, highlighting the importance of addressing safety, quality, and consistency in GMPs regulations to protect consumers and support industry growth.

• Safety and Quality Assurance: Many speakers emphasized the necessity for robust GMPs to ensure the safety and quality of cosmetic products. They called for comprehensive guidelines encompassing manufacturing processes, ingredient safety, labeling requirements, and product testing;
• Compliance and Enforcement: Effective compliance mechanisms and enforcement actions were highlighted as crucial for ensuring adherence to GMPs. Suggestions included regular inspections, mandatory reporting of adverse events, and appropriate penalties for non-compliance;
• Small Business Considerations: Representatives from small cosmetics businesses emphasized the need for adaptable and feasible GMP guidelines tailored to smaller enterprises. They stressed the significance of providing sufficient support, resources, and education to facilitate compliance without burdening small businesses excessively;
• Ingredient Transparency: Speakers advocated for clearer labeling requirements, including the disclosure of potential allergens, fragrance components, and other potentially harmful substances;
• International Harmonization: Participants stressed the importance of aligning GMP regulations with international standards to facilitate global trade and ensure consistency in quality and safety measures.

The listening session fostered an open and inclusive discussion on the development of GMP regulations for the cosmetics industry. It emphasized the significance of ensuring safety, quality, and transparency in cosmetic manufacturing processes while considering the diverse needs of different stakeholders, including small businesses.

The FDA will utilize the insights and recommendations shared during the session to develop GMP regulations that prioritize public health and promote responsible manufacturing practices in the cosmetics industry.

ChemLinked Comments

MoCRA’s passage is set to have a significant and far-reaching impact on the cosmetics industry. For example, it will require US and foreign facilities that manufacture or process cosmetic products for US distribution to register with the FDA. This mandatory registration must be renewed every two years, adding complexity to proceedings. While major manufacturers may not have an issue with this, smaller manufacturers could face challenges.

Previously, the US had different regulations from other countries, with the Voluntary Cosmetic Registration Program (VCRP) in place. However, this non-mandatory registration system for cosmetic products was decommissioned in March. Each product will require separate registration, creating a bigger burden for brands with a wide range of products.

Stakeholders interested in entering the US market should carefully study the regulatory changes and comply with the corresponding deadlines. Facility registration and product listing will take effect one year after MoCRA’s enactment. Adequate preparations in advance can mitigate compliance risks and increase the chances of successful market entry.

Further Reading

• Decoding U.S. Modernization of Cosmetics Regulations Act of 2022 (MoCRA)
• US FDA Stops the VCRP System and Will Launch a New System for Facility Registrations and Product Listings
• Explanation of MoCRA Regulation (Video)

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

Author

Winnie Xu

ChemLinked Regulatory Analyst, REACH24H Consulting Group

Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences.

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There’s been a surge in demand for personal insect repellents, says data from September 2018. From aerosols and wipes to sunscreens containing repellents, consumers have access to a wide range of effective protection methods.  The marketplace is there, so we’ve compiled the regulatory requirements you need to remain compliant.

Firstly, manufacturers should always refer to Federal Insecticide and Fungicide Act (FIFRA) as governed under the Environmental Protection Agency (EPA). The FIFRA act gives the EPA authority to regulate the registration, production, distribution, sale and use of pesticides.

It is important to note that insect repellents are regulated as pesticides in the United States because their active ingredients are pesticides. This means that any product being sold or distributed that makes claims for pesticide purposes, implies a pesticide use or contains one or more pesticide ingredients must comply with the FIFRA guidelines.

Personal care companies can enter the pesticide space by getting a federal registration for their own product. Companies can also become what’s known as a Sub-Registrant for a product that is already federally registered by another company.

Pesticide product manufacturers must register their facility with the EPA ahead of starting insect repellent production.

Additionally, manufacturers should refer to state laws and regulations, as pesticides must also be registered in every state the product is due to be sold in.

Already got a product? Learn more about the INCI Naming system.

Discover how you can remain US Claims Compliant and accurately promote your product. We’ve pulled the insights you need from the Benchmarking Company’s research published in October 2019 and presented at in-cosmetics North America 2019.

Marketing claims drive consumers’ purchasing decisions and, in the beauty world, you don’t need to look far to find one. Examples of claims include: ‘93% of women look for efficacy claims before purchasing a beauty product’ or ‘83% trust ‘men like them’ saying a product works more than a brand saying the same thing’.

So, how do brands make marketing claims and mitigate regulatory risk? To start, they’ll need to refer to these three parts of the regulatory and legal landscape:

1. The Regulator: FDA – regulates cosmetics under the authority of two important laws about cosmetics marketed in the US: The Federal Food, Drug, and Cosmetic Act, and the Fair Packaging and Labelling Act.
2. The Enforcer: FTC – for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them.
3. A “class action” lawsuit is one in which a group of people with the same or similar injuries caused by the same product or action sue the defendant as a group

According to the FDA, a cosmetic is anything intended to be applied to the human body to cleanse, beautify, or alter its appearance. It is not anything intended to treat or mitigate a disease or to affect the structure of the function of the body.

While it would be great for sales to say your product ‘repairs’ or ‘regenerates’ etc., you cannot make these assertions as a personal care professional.

Properly-worded claims are important for regulatory compliance and legal risk mitigation. Although marketing claims are key, how brands communicate claims is as important as the claim itself.

We’ve covered claims, now we reveal everything you need to know about the INCI Naming system.

Want to make sense of INCI names? We’ve put together a guide detailing the purpose and process, using material first published in October 2019.

INCI, which stands for International Nomenclature Cosmetic Ingredient, is the systematic name used internationally to identify cosmetic ingredients.

Originally developed for ingredient labelling, INCI names serve many purposes, from allergen identification to meeting regulatory standards, including the key U.S. Fair Packaging and Labelling Act, which makes ingredient listing a legal requirement.

INCI names are developed by the International Nomenclature Committee (INC); a diverse group of scientists with backgrounds in the industry, academia, and government. The INC meets generally during the months of February, April, June, September and November.

INCI names are assigned through an application process, where requests are submitted through an electronic application system. Applications are typically made by suppliers and are subject to review by the INC, who create names by consensus. The whole application process takes 3 – 6 months.

INCI names themselves are based on material composition, with the source often utilised in the name. Current practice refers to REACH criteria, which expresses that an ingredient is considered a single constituent or well-defined substance.

Blended mixtures are named by each component and identified in descending order of concentration. Components are declared on the finished product label in proper placement with regard to entire formulation.

Need more regulations information? Check out our step by step guide on being US Claims-Compliant.

Elevated concern over insect-borne illnesses has led to an increased demand for personal insect repellants. These products are available in many forms such as aerosols, liquid pump sprays, personal pen-sized repellants, wipes, lotions and creams. Personal insect repellents provide for adult, child and pet’s wellbeing alike; some even incorporate sun screens as added protections.

The obvious consumer market exists, so the question remains: When does a cosmetic product become subject to the Federal Insecticide and Fungicide Act (FIFRA) as governed under the Environmental Protection Agency? The pesticide/biocide industry can be difficult to navigate.

The FIFRA statute gives the EPA authority to regulate the registration, production, distribution, sale and use of pesticides. FIFRA defines a pesticide, in part, as “any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest” while a “Pest is defined to broadly include any insect, rodent, nematode, fungus, weed or any other form of terrestrial or aquatic plant or animal life or virus, bacteria or other microorganism.”

Any substance or product being sold or distributed that makes any such claim for pesticidal purposes, imply a pesticide use, consist of one or more pesticidal active ingredients or possess knowledge that the substance or product will be used as a pesticide are all subject to FIFRA and must be registered unless otherwise exempted.

Personal care companies can enter the pesticide space by either obtaining a federal registration for their own product or by becoming a Sub-Registrant for a product that is already federally registered by another company.

Pesticide products fall into three basic categories: Conventional Pesticides, Antimicrobial Pesticides and Biopesticides with each category having its own registration requirements. All pesticide applications are organized into two parts consisting of the Administrative Information (which includes the registration fee, identity of the applicant and product along with its draft labeling) and Product Data (consisting of product chemistry and performance, along with respective toxicological data as required within the three product categories).

All producers of a pesticide product must register their facility with the EPA prior to production and file annual production reports along with annual maintenance fees with the Agency.

In addition to Federal Law (FIFRA), the registration and use of pesticides are also subject to state laws and regulations as pesticides must also be registered in each state or territory for which the product is to be sold.

All pesticide products are governed under FIFRA and are exempt from TSCA. The Global Harmonized System (GHS) is not incorporated into the FIFRA Labeling requirements by the EPA and are labeled in accordance with 40 CFR Part 156 for all components of the product. It is important to note that pesticide products may still be subject to OSHA requirements to develop a Safety Data Sheet (SDS) based on GHS.

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