In the dynamic world of beauty and cosmetics, the journey from concept to launch goes beyond crafting an innovative product formula or creating a compelling brand identity.

Navigating the complex regulatory landscape is a crucial step that every beauty brand must master. Compliance, product development, and operational excellence are essential for both emerging and established brands aiming for success.

Highlighted in this article are key points noted in a fireside chat between Cherie Buziak from BeautyEdge LLC and Sara Bumby from First Impact New York.

The Importance of Regulation in Product Development

Regulatory compliance isn’t merely a backdrop to product development; it’s the very framework that supports it. While brands often focus on formulation, sensory experiences, claims, and market targeting, regulatory guidelines form the structure that enables these aspects to be implemented legally and ethically.

According to Sara Bumby from First Impact New York City, “Brands can run into serious trouble if they overlook regulatory details, even unintentionally.”

Top Priorities when considering Regulatory Compliance

1. Understanding Mocra Regulations: The Modernization of Cosmetic Regulation Act (Mocra) is pivotal in the U.S. beauty landscape. It governs product safety, reporting, and transparent labeling. Compliance ensures that a product is legally marketable, preventing potential recalls and legal implications.

1. Global Standards and Variations: For brands eyeing international expansion, it’s essential to understand that regulations differ widely. The European Union’s standards, for example, are more stringent than those in the U.S., with specific requirements on ingredients, safety assessments, and labeling. Per Bumby, aligning with these global standards requires a proactive approach to avoid disruptions when entering new markets.

2. Claims Substantiation: Whether a product promises “anti-ageing” benefits or “24-hour hydration,” each claim must be backed by scientific evidence. This is not only a regulatory requirement but also builds consumer trust.

Balancing Creativity and Compliance

Regulation is the key that connects all aspects of work in the beauty industry. It makes sure that the creativity involved in developing products—whether it’s a new formula or an eye-catching marketing claim—follows the rules and can be defended. Failing to comply with these regulations can lead to fines or harm a brand’s reputation, risks that no brand, big or small, can afford to take.

In a rapidly evolving industry where consumer expectations for transparency and efficacy continue to grow, regulatory compliance has become as essential as the products themselves. Brands must not only develop standout products but must do so within a complex matrix of compliance standards. Ensuring these standards are met requires expertise, foresight, and dedication.

Establishing Accountability and Accurate Claims in Beauty Marketing

In an era where transparency is not just valued but demanded, consumers expect truth in advertising and integrity in claims. When brands approach First Impact, one of Sara’s first priorities is an exhaustive review of their copy, website, and any existing brand book. This foundational step ensures that all language aligns with regulatory standards, facilitating seamless communication for PR teams, marketing agencies, and influencers.

The Responsibility of Compliance Across Platforms

A critical aspect is that brands are fully accountable for all claims made, whether through their packaging, digital platforms, or spokespersons. “Brands need to realize that they are responsible for what their influencers say in the market,” Bumby stressed. This level of responsibility extends beyond a brand’s internal team to third parties, which makes setting up clear, substantiated claims from the beginning paramount.

Brands must also be aware that today’s retail landscape, split between brick-and-mortar and e-commerce, operates on an equal playing field regarding compliance.

This uniformity underscores that regulations apply universally, regardless of where a product is sold or how it is marketed.

Clarifying Responsibility Between Brands and Manufacturers

One point that often confuses new beauty entrepreneurs is the extent of responsibility when working with contract or private label manufacturers. While manufacturers can provide data on active ingredients, they are not liable for the claims brands make based on that data. At the end of the day, it’s your responsibility as the brand to ensure stability testing, efficacy testing, and that all claims have the necessary supporting documentation.

For example, while a manufacturer might provide data showing that a formulation contains vitamin E and highlight its benefits, this alone is insufficient to make broad claims against that one ingredient. Brands must invest in testing the final formulation to substantiate claims accurately. This includes conducting consumer science tests or, when applicable, clinical studies, using tools and methodologies to validate claims rigorously.

Types of Claims and Documentation

Consumer Science Testing: This involves trials conducted with real users under controlled conditions to gather feedback and demonstrate how the product performs. These tests are crucial because they show results based on the final product, not just its individual components.

Clinical Studies: Using specialized equipment and scientific measurements, clinical studies provide quantitative data on a product’s performance. These studies can support claims like “reduces the appearance of fine lines by x% in two weeks,” provided they are backed by reliable results from an independent testing facility.

Building a Foundation of Trust

For new brands, navigating these regulatory demands can seem daunting. However, it is this diligence that lays the groundwork for credibility and trust in an increasingly skeptical market. Developing a brand that is both innovative and compliant requires commitment from day one.

By integrating regulatory expertise into their development process, brands can confidently launch products that meet not only creative aspirations but the rigorous standards of today’s regulatory environment.

For beauty brands looking to succeed in today’s market, regulatory compliance is non-negotiable. As Sara Bumby and Cherie Buziak discussed, understanding and adhering to these guidelines from the outset not only protects the brand legally but also builds trust with consumers. Brands must take responsibility for their claims, ensure they have proper documentation, and work closely with their contract manufacturers to substantiate product
efficacy.

This transparency and attention to regulation will set a brand apart in the
competitive beauty industry.

Sara Bumby President, Co-Founder at First Impact New York are dedicated to providing a wide range of services for the beauty industry, production management, product development, custom formulas, consulting, focus groups and much more.

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From January to August 2024, several significant regulatory developments occurred in the APAC region. Notably, China introduced a transition period along with several regulatory documents for safety assessments and amended the Safety and Technical Standards for Cosmetics. Taiwan eliminated the category of specific purpose cosmetics and implemented unified management for all cosmetics. Additionally, updates regarding cosmetic ingredients, particularly the prohibition of specific substances, remain a key focus across various countries. It is crucial for enterprises to stay informed about these changes and adjust their strategies to comply with regulatory requirements.

Here are brief updates on key developments.

1. China

1.1 NMPA Amends the Safety and Technical Standards for Cosmetics 2015

On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:

1. Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
2. Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
3. Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.

The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.

1.2 China Sets Transition Period for Submitting Complete Safety Assessment Reports and Issues Multiple Regulatory Documents to Clarify Safety Assessment Requirements

Under CSAR framework, cosmetics registrants and notifiers are required to submit product safety assessment documents during registration and notification. Until May 1, 2024, they have the option to submit a simplified safety assessment report. However, from May 1, 2024 onwards, the full version of the assessment report must be submitted.

Considering industry challenges, China’s National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024.

To guide companies, in April and July 2024, NMPA issued several new regulatory documents related to safety assessment. This includes guidelines that classify submission requirements based on risk management principles and provide self-examination points for the assessment reports.

ChemLinked Comments

With these supporting policies and optimization measures, the full safety assessment report system can be effectively implemented in China’s cosmetics industry.

Although the NMPA has provided a transition period for companies, it is advisable to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.

2. Taiwan

2.1 TFDA Amends Cosmetic Ingredient Use Requirements

Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, January 4, 2024 and May 30, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.

2.2 Taiwan Cancels Specific Purpose Cosmetics Category and Implements Unified Management for All Cosmetics

On July 1, 2019, Taiwan enacted the Cosmetic Hygiene and Safety Act, its primary regulation for cosmetics. According to the Act, the category of specific purpose cosmetics was discontinued as of July 1, 2024. From that date, all cosmetics in Taiwan are regulated under a unified management system, resulting in changes to the scope of application and expressions of Taiwan’s cosmetic regulations, including ingredient lists, pre-market notification, Product Information Files (PIF), Good Manufacturing Practices (GMP), and product labeling.

Beginning July 1, 2024, manufacturers and importers of cosmetics previously classified as specific purpose must complete product notifications, establish product-specific PIFs, ensure GMP compliance, and meet updated labeling requirements before marketing their products in Taiwan.

3. South Korea

3.1 South Korea Bans THB in Cosmetics

On December 7, 2023, South Korean Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.

The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.

3.2 South Korea Consults on Cosmetic Safety Standard

On August 2, 2024, the Ministry of Food and Drug Safety (MFDS) released a notice to solicit public feedback of the modifications to Cosmetic Safety Standard till October 3, 2024. The authority proposed to designate one new UV filter, delete one UV filter, and enhance the usage limits of six restricted ingredients.

MFDS Consults on Cosmetic Safety Standard: Enhancing Management of UV filters, D4, D5, and Other Ingredients as below;

4. Japan

4.1 Japan Approves a New Ingredient for Rinse-off Hair Styling Products

On March 8, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a proposal for the Standards for Cosmetics, inviting public consultation. The proposal requests the inclusion of “Cysteamine Hydrochloride” as an ingredient for rinse-off hair styling products. The proposal was finalized on July 12, 2024, and came into force upon issuance.

ChemLinked Comments

Cosmetic manufacturers and distributors are required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.

5. ASEAN

5.1 ASEAN Updates ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes

The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to discuss the latest developments in ASEAN cosmetic industry and related regulations, annexes related to ingredients.

On July 1, 2024, the Singapore Health Sciences Authority (HSA) issued the updated ingredient annexes approved during the 39^th ACSB meeting. The key amendments include:

1) Annex II – List of Prohibited Ingredients: 1 revised

2) Annex III – List of Restricted Ingredients: 3 revised, 1 added

3) Annex VI – List of Permitted Preservatives: 9 revised

4) Annex VII – List of Permitted UV Filters: 2 revised

In addition to the amendments mentioned above, there are also some updates to the CAS No. information for 56 entries in the annexes.

ChemLinked Comments

The amendments to the ingredient annexes of ACD apply to all ASEAN member states. However, the timeline for each member state to formally adopt these amendments may vary. So far, member states such as Malaysia, Singapore, Vietnam, and the Philippines have adopted these amendments.

6. Indonesia

6.1 Indonesia Proposes to Amend Cosmetic Ingredient Use Requirements

On March 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the Technical Requirements for Cosmetic Ingredients for public consultation until March 19, 2024. The proposed amendments include:

1) Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;

2) Appendix I: List of Restricted Ingredients – 1 revised;

3) Appendix III: List of Permitted Preservatives – 2 deleted;

4) Appendix IV: List of Permitted Sunscreens – 1 revised;

5) Appendix V: List of Prohibited Ingredients – 75 added.

ChemLinked Comments

The proposed amendments to Indonesian cosmetic ingredients align with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 36^th, 37^th, and 38^th ACSB meetings.

For salicylic acid in Appendix I List of Restricted Ingredients, the only adjustment is the serial number in the usage requirements, which is a result of the removal of two preservatives from Appendix III. The usage limit and conditions for salicylic acid remain unchanged.

7. Thailand

7.1 Thailand Amends Cosmetic Ingredient Use Requirements

From January to August 2024, Thailand issued several announcements regarding revisions to the requirements for cosmetic ingredients. Some of these announcements were formal revisions, while others were drafts. The updates are as follows:

1) List of Prohibited Ingredients: 2 added, 1 revised, and 56 proposed for addition.

2) List of Restricted Ingredients: 8 added, 1 revised, 1 deleted, 3 proposed for addition, and 1 proposed for revision.

3) List of Permitted Colorants: 1 revised and 1 proposed for revision.

4) List of Permitted Preservatives: 1 revised.

5) List of Permitted Sunscreens: 1 added and 1 proposed for revision.

ChemLinked Comments

As a member of ASEAN, Thailand has been somewhat delayed in adopting the revisions to the ingredient use requirements outlined in the ACD. The above adjustments aim to align with previous updates from the ACD.

8. New Zealand

8.1 New Zealand EPA Bans PFAS in Cosmetics

On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.

To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:

1. Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
2. Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
3. Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.

9. Australia

9.1 Australia Adopts Updated Sunscreen Standards

On April 11, 2024, the TGA announced the adoption of the Australian/New Zealand Standard: Sunscreen products – Evaluation and Classification (AS/NZS 2604:2021) (amended) into therapeutic goods legislation framework. This updated standard enhances testing and labeling requirements for sunscreens available in the Australian market. Notable changes compared to its predecessor include:

• Incorporation of the latest ISO Standards for sunscreen testing, including “ISO 24444:2019 Cosmetics—Sun Protection Test Methods—In Vivo Determination of the Sun Protection Factor (SPF),” “ISO Standard 24443:2021 Determination of Sunscreen UVA Photoprotection in Vitro,” and “ISO 16217:2020 Cosmetics—Water Immersion Procedure for the Determination of Water Resistance.”
• Introduction of a new flow chart to guide sponsors (product owners) in determining the applicable sections of the standard for primary and secondary sunscreens.
• Addition of labeling instructions for aerosol and spray pump pack sunscreens, advising consumers on the appropriate amount for effective protection against UV radiation, and cautioning against spraying these products on the face or in windy conditions to avoid product inhalation.

Further Reading

• China Expands Recognized Ingredient Safety Data for Safety Assessment Report
• Taiwan Restructures Cosmetic Ingredient Lists, Effective July 1, 2024
• Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 15 Revised and 1 Added
• Australia Adopts Updated Sunscreen Standards

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

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During the period from January to March 2024, several noteworthy regulatory developments have taken place globally. Notably, the Chinese mainland plans to introduce a transition period for safety assessment and makes amendments to Safety and Technical Standards for Cosmetics. Moreover, countries/regions including South Korea, Japan, Malaysia, Vietnam, the EU, the US, and New Zealand have also implemented some regulatory changes. Here are brief updates on these developments.

1. EU

EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics

On May 23, 2023, the European Union (EU) notified WTO of a draft Commission Regulation proposing revisions to the ingredient lists in Regulation (EC) No 1223/2009 concerning the use of nanomaterials in cosmetics. On March 15, 2024, the EU published the finalized regulation in the Official Journal, and it came into effect on April 4, 2024. The regulation includes the following amendments:

1. Ban on 12 nanomaterials: Due to insufficient safety data and concerns regarding potential health risks to consumers, the EU has prohibited the use of 12 specific nanomaterials in cosmetics;
2. Restriction on Hydroxyapatite (nano): The Scientific Committee on Consumer Safety (SCCS) assessed Hydroxyapatite (nano) and determined that it can be safely used in cosmetics under certain restrictions. Consequently, it is added to the list of restricted ingredients.

Starting from February 1, 2025, cosmetic products containing the 12 banned nanomaterials, or containing Hydroxyapatite (nano) that do not comply with the restrictions may not be placed on the EU market. From November 1, 2025, these products may not be made available on the EU market.

New Update to Candidate List of SVHCs

On January 23, 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs, expanding the list by five substances and bringing the total number of SVHCs to 240. The newly added substances are:

• 2,4,6-tri-tert-butylphenol (2,4,6-TTBP)
• 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol (UV-329)
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
• Bumetrizole (UV-326)
• Oligomerization and alkylation reaction products of 2-phenylpropene and phenol (OAPP)

Additionally, the entry for DBP was updated to include its endocrine disrupting properties for the environment.

In March 2024, ECHA initiated a consultation to identify two substances proposed by Norway and France as SVHCs. The public can provide comments on these proposals until April 15, 2024. Once identified as SVHCs, both substances will be added to the Candidate List. The two substances under consideration are:

• Bis(α,α-dimethylbenzyl) peroxide
• Triphenyl phosphate

ECHA Consults on Recommending Five Substances for Authorization List

On February 7, 2024, European Chemicals Agency (ECHA) released a draft 12th recommendation to the European Commission, which recommends the inclusion of 5 substances to the REACH Authorisation List.

1. Melamine
2. Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof
3. S-(tricyclo[5.2.1.0 2,6]deca-3- en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O- (isopropyl or isobutyl or 2- ethylhexyl) phosphorodithioate
4. Diphenyl(2,4,6- trimethylbenzoyl)phosphine oxide
5. Barium diboron tetraoxide

ECHA is looking for further information on the uses of these substances in scope of authorization, their possible exemptions from the authorisation requirement and on the structure and complexity of the supply chains. The consultations are open until May 7, 2024.

ECHA Announces Next Steps for PFAS Restriction Proposal

In March 2024, the European Chemicals Agency (ECHA) delineated a schedule for evaluating the PFAS restriction proposal, with attention given to various sectors, including cosmetics. This evaluation will have implications for manufacturers globally, who will need to make adjustments to align with the new standards.

2. US

MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing

On January 8, 2024, the U.S. Food and Drug Administration (FDA) introduced new submission tools to supplement the existing electronic submission portal, Cosmetic Direct. These tools include Structured Product Labeling (SPL) Xforms, as well as Form FDA 5066 and Form FDA 5067. These additions offer stakeholders increased flexibility in meeting their specific needs in cosmetic facility registration and product listing.

1. Structured Product Labeling (SPL) Xforms: This tool serves as an SPL authoring tool, facilitating the creation of SPL file containing information on cosmetic product facility registration and product listing;
2. Form FDA 5066 and Form FDA 5067: These forms are designated for paper submissions. Form FDA 5066 is used for cosmetic facility registration, while Form FDA 5067 directs at cosmetic product listing.

3. China

NMPA Plans to Set a Transition Period for Submission of the Full Version of Safety Assessment Report

Until May 1, 2024, China National Medical Products Administration (NMPA) allows a simplified version of cosmetic safety assessment report for registration or notification. However, starting from May 1, 2024, the full version of the report is required. This transition poses challenges for the industry due to difficulties such as lack of ingredient toxicological data and shortage of safety assessment personnel.

To optimize safety assessment management, NMPA is formulating measures in four aspects:

1. Setting a six-month transition period. Registrants and notifiers who have already started safety assessments before May 1, 2024, will be permitted to submit a simplified report within a specified timeframe;
2. Strengthening technical guidance by introducing draft guidelines for Threshold of Toxicological Concern (TTC) Method and Read Across, and formulating guidelines for physical and chemical stability, preservative challenges, and packaging material compatibility testing;
3. Integrating ingredient data resources by establishing a cosmetic ingredient safety database;
4. Innovating assessment report management mechanisms by categorizing cosmetics into three tiers based on risk levels. Category 1 cosmetics require complete safety assessment reports, while Category 2 and Category 3 cosmetics only need safety assessment conclusions.

ChemLinked Comments

The above measures are still in draft form and yet to be implemented. Companies are advised to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.

NMPA Amends the Safety and Technical Standards for Cosmetics 2015

On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:

1. Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
2. Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
3. Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.

The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.

4. Taiwan

TFDA Amends Cosmetic Ingredient Use Requirements

Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, and January 4, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.

5. South Korea

South Korea Bans THB in Cosmetics

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.

The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.

6. Japan

Japan Plans to Approve a New Ingredient for Rinse-off Hair Styling Products

The Ministry of Health, Labour and Welfare (MHLW) of Japan introduced a proposal for the Standards for Cosmetics on March 8, 2024. The proposal seeks to include “Cysteamine Hydrochloride” as an ingredient in hair styling products exclusively intended for hair application and rinsing off.

ChemLinked Comments

The revised standards are anticipated to be implemented in late June 2024. Cosmetic manufacturers and distributors will be required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.

7. Malaysia

Malaysia Amends Cosmetic Ingredient Use Requirements

On January 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, the amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in the List of Prohibited Ingredients;
2. Revising 5 ingredients in the List of Restricted Ingredients;
3. Revising 1 ingredient, CI 45430 (2), in the List of Permitted Colorants;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the List of Permitted Preservatives;
5. Adding 2 ingredients to, and revising 1 ingredient in the List of Permitted UV Filters.

ChemLinked Comments

Most of the aforementioned revisions align with the updates made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 38^th ASEAN Cosmetic Scientific Body (ACSB) meeting. It is crucial for enterprises to stay informed about the updated ingredient usage requirements and refrain from incorporating newly prohibited ingredients into their cosmetic production processes. In cases where newly added or revised restricted ingredients are used, enterprises are recommended to ensure compliance with their updated usage conditions.

8. Vietnam

Vietnam Amends Cosmetic Ingredient Use Requirements

Drug Administration of Vietnam (DAV) released Official Letter No. 589/QLD-MP on March 4, 2024, to announce the updated use requirements for cosmetic ingredients. The amendments are:

1. Adding 15 ingredients to, and revising 4 ingredients in Annex II List of Substances Which Must Not Form Part of the Composition of Cosmetic;
2. Revising 5 ingredients in the Annex III List of Substances Which Cosmetic Products Must not Contain Except Subject to Restrictions and Conditions Laid Down;
3. Revising 1 ingredient, CI 45430 (2), in the Annex IV List of Colouring Agents Allowed for Use in Cosmetic Products;
4. Deleting 1 ingredient, Methenamine 3-chloroallylochloride, from the Annex VI List of Preservatives Which Cosmetic Products May Contain;
5. Adding 2 ingredients to, and revising 1 ingredient in the Annex VII List of Permitted UV Filters Which Cosmetic Products May Contain.

ChemLinked Comments

The above changes align with the updates to ACD passed by the 38^th ACSB meeting. Cosmetic companies are advised to proactively review cosmetic ingredients during production, import, and trade, in order to mitigate the risk of product recalls.

9. New Zealand

New Zealand EPA Bans PFAS in Cosmetics

On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.

To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:

1. Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
2. Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
3. Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.

Conclusion

In conclusion, recent global regulatory updates demonstrate ongoing efforts to enhance and refine the cosmetics regulatory framework. China, in particular, is exploring ways to optimize safety assessment management. It is crucial for enterprises to stay updated on these management measures.

Furthermore, updates related to ingredients, especially the prohibition of certain substances, remain a significant area of focus in multiple countries globally. Stakeholders are advised to closely monitor these updates, adjust their strategies to comply with regulatory requirements, and ensure the quality and safety of cosmetic products in the market.

Further Reading

• China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)
• EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
• MoCRA Updates: FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing
• New Zealand EPA Bans PFAS in Cosmetics

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In this day and age, navigating what it means to be cruelty-free can be a daunting task for both companies and consumers alike. With so much misinformation circulating and no federal oversight into labelling requirements, companies can self-identify as being cruelty-free without having to substantiate their claims. And in turn, shoppers are inundated with renditions of cute bunnies on packaging allowing them to (in many cases) believe a product is free of animal testing, when in fact, there is no oversight on logos, labels, or claims.

In order to combat the rampant confusion, the Leaping Bunny Program in North America was established in 1996. The Program is operated by the Coalition for Consumer Information on Cosmetics, a group of animal protection organizations whose members include American Anti-Vivisection Society (Chair of CCIC), Animal Alliance of Canada, Humane Society of the United States, National Anti-Vivisection Society, and Rise for Animals. The Leaping Bunny Program certifies companies to be free of new animal testing at all stages of product development in accordance with its Corporate Standard of Compassion for Animals. Its mission is to connect compassionate consumers to cruelty-free companies using its well-established Standard.

In order for a company to become Leaping Bunny certified, it must create a supply chain management system that is free of animal testing at all stages of product development after a company’s chosen fixed cut-off date. This system must include all manufacturers and/or raw material suppliers.

In addition, all companies must annually recommit to the Leaping Bunny Program through a modified application, which ensures that their supply chain management system is up-to-date with all current suppliers and manufacturers. Companies must also open their supply chain management system up to independent audits, during which time individual products are cross-checked with company declarations and actual orders for said ingredients and/or formulations that make up the selected products.

Further, companies applying for certification who wish to register their products for domestic importation into China, where animal testing on imported cosmetics is still the rule and not the exception, are required to undergo both pre- and post-market audits to ensure no animal testing has been conducted.

The CCIC strives to make certification as accessible to as many brands as possible. Therefore, there is no cost for companies to get certified. The only cost is an optional one: should a company qualify for certification, become certified, and wish to use the Leaping Bunny Logo in marketing and packaging materials, it will be required to license the logo through paying a low, one-time fee, based on the company’s gross annual sales.

Regulations around animal testing on cosmetics have seen their first major change since 1938, with the recent passage of the Modernization of Cosmetic Regulation Act of 2022. This new law requires companies to substantiate and document safety for their products, but there are no specifics as to how to determine this, i.e., there is no federal animal testing ban in place that would preclude using animals. Further, some ingredients in sunscreens that have been safely used for decades are now under consideration for mandatory animal testing by the FDA.

To date, there are 11 states (California, Hawai’i, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon and Virginia) with animal testing bans in place along with 42 countries worldwide. It is important to note that while bans are in place, animal testing can still happen due to other regulatory requirements such as chemical management programs, e.g., REACH in the European Union or country-specific mandates, e.g. China. Therefore, it’s more important than ever for consumers to be able to rely on a list that goes above and beyond to ensure animal testing is kept out of the supply chain.

For more information on the Leaping Bunny Program, visit leapingbunny.org or download the free smartphone app Cruelty Free for a complete list of certified cruelty-free companies updated every 24 hours.

Author Bio

Kim Paschen is Director of the Leaping Bunny Program, a well-established cruelty-free certification program for personal care and household products that guarantees products to be free of animal testing at all stages of product development. She oversees day-to-day operations of the program to ensure its integrity in addition to working with certified companies on a wide variety of promotions.

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Recap and Latest Developments

Animal testing is banned in many countries. South Korea was one of the pioneers that protected animal rights since 2013. According to South Korea’s Cosmetics Act, no cosmetics or cosmetic ingredients for which animal testing was conducted, should be distributed in South Korea. The ban on animal testing also applies to imported cosmetics.

To guide cosmetic enterprises in smoothly conducting safety tests, the Korean authority has published twenty-nine guidelines on alternative animal testing methods. This article summarises all Korean officially published alternative animal testing methods, along with the latest developments.

Alternative Animal Testing Guidelines Published by MFDS

Exemptions from Animal Testing Ban

However, MFDS specifies six situations which animal testing can be adopted on cosmetics:

1. Situation when animal testing is needed to determine the standards for using raw materials requiring a specific restriction on usage, such as preservatives, coloring or sun-blocks, or to assess hazards of cosmetics raw materials, etc., posing risks to public health;
2. Situation when animal testing is needed because no alternative to animal testing exists;
3. Situation when animal testing is needed to export cosmetics following the statutes and regulations of the exporting country;
4. Situation when animal testing is needed for product development following the statutes and regulations of the importing country;
5. Situation when raw materials developed through animal testing conducted under other statutes and regulations are used for the manufacture, etc. of cosmetics;
6. Other cases prescribed by MFSD, where it is impractical to conduct alternatives to animal testing.

Latest Developments

On October 18, 2023, Ministry of Food and Drug Safety (MFDS) issued a new alternative animal testing guideline, named Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation(Acute Eye Damage or Irritation) Test using Reconstructed human Cornea-like Epithelium (RhCE)(인체각막유사 상피모델을 이용한 안 유해성 시험법). This guideline is established based on the latest OECD-approved alternative testing methods. The “eye damage or irritation” refers to harmful effects such as damage or irritation that occur when the test substance comes into contact with the eyes. RhCE eye irritation test method is expected to help enterprises develop safer cosmetic products without animal testing.

Further Reading

• South Korea Modifies the Cosmetic Safety Standard: Ingredients and CAS No.
• South Korea Revises Cosmetic Colorant Requirement
• Exploring the Use of Animal Testing in Japanese Cosmetics
• US Moves Towards National Ban on Cosmetic Animal Testing

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

On October 5, 2023, UK released a guidance introducing the management of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) within the cosmetics regulatory framework. Applicable to England, Scotland, and Wales, the guidance outlines the regulatory requirements for CMR substances, and describes the exemption application process for their continued use.

Regulatory Requirements for CMR Substances

Article 15 of the UK Regulation (EC) 1223/2009 (Cosmetics Regulation) sets out provisions on the use of CMR substances in cosmetics. To ensure comprehensive protection of human health, CMR substances categorized as 1A, 1B, and 2 in the following documents are prohibited for use in cosmetics:

• The Regulation 1272/2008 on Classification, Labelling and Packaging of Substances and Mixturein Great Britain (GB CLP Regulation);
• The GB Mandatory Classification and Labelling List (GB MCL List).

However, where an exemption has been granted by the Secretary of State (SoS), such substances can be permitted for use in cosmetics. The exemption can only happen when an application is submitted by an interested party and when all the criteria for exemption listed in Article 31 of the UK Cosmetics Regulation are fulfilled.

Exemption Application for CMR Substances

For CMR substances that meet the exemption criteria above, interested parties intending to apply for exemption should submit their applications to the Office for Product Safety and Standards (OPSS) via email at cmrenquiries@beis.gov.uk. In the application, any scientific data submitted for the safety assessment should include all relevant elements as prescribed in The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. Besides, it is required to submit original study reports and literature in full for all data referred to in the safety assessment. Confidential and commercially sensitive data should only be submitted if it is relevant to the exemption application, and be clearly marked in the submission.

Articles 37 and 37A of the GB CLP Regulation establish two procedures for substances to receive a mandatory 1A, 1B or 2 CMR classification, and be added to the GB MCL List by the Health and Safety Executive (HSE). During each procedure, a GB MCL Technical Report concerning the CMR substance is published at a specific step. Interested parties should submit their exemption application no later than 18 months from the date of the Technical Report’s publication. Upon receiving the application, OPSS requires an additional 12 months to conduct a substance evaluation. Following the evaluation, the substances deemed eligible for exemption will be included in the restricted or permitted ingredient lists, while those considered ineligible will be added to the prohibited ingredient list.

Further Reading

• UK to Impose Restrictions on the Use of Butylated Hydroxytoluene
• UK SAG-CS Publishes Opinions on Butylated Hydroxytoluene and Kojic Acid
• EU REACH to Restrict Intentionally-added Microplastics in Cosmetics

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

Characteristics of new cosmetic ingredients notified in China from Q1 to Q3 2023:

• NCIs sources: chemical sources remain dominant; plant extracts are on the rise;
• Use purpose: skin protectant, moisturizer and antioxidant account for more than half;
• Notifiers: Chinese domestic enterprises account for 74.3%;
• Future trends: the total number of NCI notifications is expected to grow, with a focus on ingredients that have already been allowed for use in cosmetics abroad and ingredients sourced from diverse fields.

Following explosive growth in 2022, the number of NCI notifications continues to grow in 2023. According to information from NMPA’s data query platform, 35 NCIs were notified from Q1 to Q3 2023. This trend suggests that ingredient innovation has become a core focus for beauty enterprises to maintain a competitive edge.

Characteristics of NCIs Notified from Q1 to Q3 2023

1. NCIs sources: chemical sources remain dominant; plant extracts are on the rise

From Q1 to Q3 2023, most of the notified NCIs were derived from chemical sources, while a few were from plants, biotechnology, animals and hydrolysis technology.

Due to the low safety risk associated with the ingredient structure of chemical ingredients (polymers), only skin and eye irritation/corrosion tests and skin phototoxicity tests are required. These alternative test methods are already incorporated into the Safety and Technical Standards for Cosmetics (STSC). As many foreign countries/regions, including the EU, the US, and Japan, currently prohibit animal testing in cosmetics, notifiers from these countries/regions prefer to notify chemical ingredients (polymers).

Despite the dominance of chemical ingredients, enterprises are increasingly interested in plant-derived ingredients. As consumers are increasingly seeking out safe, clean, and sustainable beauty products, products that contain plant-derived ingredients are gaining greater recognition. This trend is demonstrated by the rise in plant-derived NCIs notifications. “Consumers are becoming more conscious of the safety of the products they use, and they prefer ingredients that are both effective and safe. Therefore, many enterprises are focusing on developing ingredients using plant extraction technology and fermentation technology,” according to Lei Zhang, Chief Engineer of Tianjin Shangmei.

2. Use purpose: skin protectant, moisturizer and antioxidant account for more than half

Most notified NCIs are primarily used as skin protectants, followed by those for moisturizing and anti-oxidation purposes.

“Skin protectant is a relatively general type of ingredient, which can include functions such as moisturizing, repairing, nourishing, firming, etc. The reason why functional ingredients are notified as skin protectants is to allow for more possibilities in their development. The current technology may limit the research of NCIs. To avoid the application for an update of the NCI’s technical requirements in case new functions are discovered in subsequent research, it’s more convenient to notify the ingredient as a skin protectant.” Zhang explained.

3. Notifiers: Chinese domestic enterprises account for 74.3%

According to NMPA’s data query platform, overseas enterprises are the main notifiers of the 42 NCIs notified in 2022. However, from Q1 to Q3 2023, 26 out of the 35 NCIs notified are from Chinese domestic enterprises, accounting for 74.3%. Among these, Shenzhen Winkey Pharmaceutical R&D Co., Ltd. (hereinafter referred to as “Winkey”) is the most active applicant, with 4 NCIs notified within nine months.

According to the marketing department head of Winkey, the increase in Chinese domestic notifiers this year can be attributed to their experience gained in the past. Previously, these enterprises were still in a groping stage, but they have since learned from their experiences and are now considering how to utilize R&D resources and platforms to better prepare for NCI notifications and avoid detours.

New regulations and market demands have motivated Chinese enterprises to challenge the monopoly of overseas enterprises in the cosmetic ingredients field. Their high enthusiasm to notify NCI indicates that the NCI market is very thriving.

4. Future trends: the total number of NCI notifications is expected to grow, with a focus on ingredients that have already been allowed for use in cosmetics abroad

1) A Significant Increase in NCI Notifications

Lei Zhang predicts a significant increase in NCI notifications in the long term. She said, “market competition has intensified, and many enterprises are actively pursuing this track.”

2) Focus on Ingredients Allowed for Use in Cosmetics Abroad

Shuquan Lao, the China Regional Director of Symrise’s Cosmetic Ingredients Department, believes that future NCI notifications may include ingredients that have been included in the international ingredient catalogue but have not yet been listed in Inventory of Existing Cosmetic Ingredients in China (IECIC). Notably, among the 35 NCIs notified from Q1 to Q3 2023, the majority have already been allowed for use in cosmetics abroad and are included in the International Cosmetic Ingredient Dictionary and Handbook and have their own INCI name.

The International Cosmetic Ingredient Dictionary and Handbook (16th Edition) currently includes 22,620 cosmetic ingredients, while IECIC only includes 8,972. This significant difference in the number of ingredients listed in Chinese and international catalogues means that there is a huge space for the great number of ingredients that have been used in cosmetics abroad to be introduced into China for NCI notification.

3) Focus on Ingredients Sourced from Diverse Fields

Companies are currently placing emphasis on ingredients that find applications across multiple industries. Some of the notified NCIs are sourced from diverse fields such as medicine, food, and health food. Examples of such ingredients include Acetylneuraminic Acid, Tissue Culture of Saussurea Involucrata, and Euphausia Superba Oil. Of particular interest is the increasing number of notifications for β-Nicotinamide Mononucleotide (NMN), which has garnered the attention of four companies that have completed a total of five notifications for NMN.

NMN holds significant popularity as a health food ingredient in certain countries, where it is renowned for its claimed anti-aging function and has earned the moniker of the “elixir of aging.” The skincare industry also anticipates the use of NMN for its anti-aging function.

However, it is important to note that NMN has yet to receive approval for use in drugs, health foods, and foods in China. Its notification as a new cosmetic ingredient represents just the initial step towards market availability. The notified NCIs will then undergo a three-year monitoring period, during which additional research data and clinical applications will be accumulated to establish its safety.

Further Reading

• China Consults on Guidelines for Determination of New Cosmetic Ingredients
• Navigating China’s New Cosmetic Ingredient Notification and Registration Process (Video)
• Practical Insights on Registering and Notifying Plant-derived New Cosmetic Ingredients in China (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

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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EU adopts the 12th Revision of the SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation

On May 16, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the 12th Revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (the Notes of Guidance). Compared to its predecessor, the newly released Notes of Guidance provides updates on animal-free alternative testing methods, emphasizes aggregate exposure and children’s exposure in specific ingredients’ assessments, and gives instructions on assessing children’s exposure to cosmetics.

The Notes of Guidance

SCCS is an independent advisory body that offers opinions on the health and safety risks of non-food consumer products. One of its responsibilities is to recommend a set of guidelines for developing adequate studies used in the safety evaluation of cosmetic ingredients. This is done through the Notes of Guidance, a document that introduces different aspects of the testing and safety evaluation of cosmetic ingredients. While its emphasis is on ingredients, it also gives indirect guidance for the safety assessment of finished products.

To incorporate new knowledge as well as scientific and regulatory advances, the Notes of Guidance is regularly updated. Its most recent revision, SCCS/1628/21, was carried out in 2021. After that, several new addenda, opinions and memoranda that are important to the guidance’s content were adopted. On this basis, the 12th revision of Notes of Guidance is formed.

Highlights of the 12th Revision

Compared to the 11th revision, the new revision makes the following main changes:

1. Updating Animal-free Alternative Testing Methods

Regarding cosmetics and their ingredients, testing and marketing bans are in place to prohibit the use of animals. Additionally, there is an obligation to use only validated replacement alternatives. This is why for validated animal-free alternative methods for chemical hazard assessment, it is much harder to achieve compliance to Regulation (EC) No 1223/2009 (the Cosmetics Regulation) than with other regulatory frameworks in Europe.

Given the testing and marketing bans imposed by the Cosmetics Regulation, SCCS pays special attention to alternative methods that are suitable for the safety testing of cosmetic ingredients, and regularly updates the Notes of Guidance. In the 12th revision, SCCS provides updates on alternative methods to reflect the changes in this area, introducing changes for acute inhalation toxicity testing, skin irritation testing, defined approaches for eye irritation testing and skin sensitisation, as well as new in vitro methods for genotoxicity testing.

2. Emphasizing Aggregate Exposure and Children’s Exposure in the Assessment for Specific Ingredients

Endocrine disruptor (ED) refers to a substance or a mixture that alters one or more functions of the endocrine system, and consequently causes adverse effects in an intact organism, its progeny, populations or subpopulations. On March 31, 2023, the Commission Delegated Regulation (EU) 2023/707 formally introduced endocrine disruptor as a new hazard category. Following this formal introduction, the 12th revision underlines that when a cosmetic ingredient is suspected of having potential endocrine properties, SCCS will assess its risk for children according to age, taking into consideration the relevant cosmetic categories to which children of different ages are commonly exposed.

CMR substances are those classified as carcinogenic, mutagenic, or toxic for reproduction. Depending on properties, they are grouped under Category 1A, Category 1B and Category 2. As a general principle, CMR substances are banned for use in cosmetics. Exceptionally, they may be used in cosmetic under specific conditions where they have been evaluated safe by SCCS.

For CMR substances of Category 1A and 1B, the aggregate exposure from all sources shall be taken into consideration during the safety evaluation. This means that, as clarified by the 12th revision, not only the amount of the ingredient used in all cosmetic categories, but also the amounts coming from other sources (e.g., food, pesticides, industrial chemicals, etc.) should be considered. Moreover, the new revision adds that, since children are vulnerable, the safety assessment shall also take into consideration the exposure of children of different age groups.

3. Giving Instructions on Assessing Children’s Exposure to Cosmetics

To give a useful reference for safety assessors and agencies, Appendix 7 to the Notes of Guidance includes a literature overview of recent consumer exposure data of cosmetics, including different categories of cosmetics, frequency of use, amount per application, and amount per day. The data covers consumers from one or more particular countries and, in some cases, are stratified by age, gender, and cosmetic formulation. However, there is a lack of exposure data of cosmetic products for children of different age groups.

As mentioned above, the 12th revision draws attention to the exposure of children of different age groups when assessing the safety of EDs and CMR substances. In line with this focus, the 12th revision introduces recent studies and available data for calculating children’s exposure. Based on this, it further provides an example of different cosmetic categories to which children of different ages may be exposed.

In addition to these main changes, the 12th revision of the Notes of Guidance explains the rationale behind the exposure data used to evaluate sunscreen’s sun protection, stresses the importance of systematic literature review and the potential of in silico prediction, as well as introduces templates for describing Physiologically Based ToxicoKinetics (PBTK) models, parameter verification and analysis. Details of these changes can be found here.

Further Reading

• Cosmetics Regulation Focus: What Are the Impacts of the EU Chemicals Strategy for Sustainability?
• EU SCCS Releases Preliminary Opinion on Children’s Exposure to Methyl Salicylate
• EU SCCS Updates the Scientific Advice on HC Blue 18

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