Monthly Recap: Global Cosmetic Regulatory Updates | September 2023

China Implements Technical Guidelines for Children Cosmetics

On August 31, 2023, China National Institutes for Food and Drug Control (NIFDC) released and implemented the finalized Technical Guidelines for Children Cosmetics. The Guidelines introduces enhanced requirements pertaining to safety assessments and testing of children cosmetics, children cosmetics specifically designed for the Chinese market, children sunscreens, ingredients use in children cosmetics, as well as labeling and claims of such products.

China Implements Two Cosmetic Regulations

On September 1, 2023, China National Medical Products Administration (NMPA) implemented the Supervision and Administration Measures on Online Operation of Cosmetics, clarifying the regulatory objects and authorities of cosmetics online operation, the management responsibilities of cosmetics e-commerce platforms, and the obligations of cosmetic operators on the e-commerce platforms.

On the same day, China's State Administration for Market Regulation (SAMR) implemented the revised national standard, titled GB 23350-2021 Requirements of Restricting Excessive Package—Foods and Cosmetics. This updated standard sets forth more detailed packaging requirements for 31 categories of foods and 16 categories of cosmetics.

China Implements Three Regulations for Submitting Cosmetic Ingredient Safety Information

On September 4, 2023, China NIFDC introduced and enforced three Guidelines related to the submission of safety information of cosmetic ingredients. These guidelines are as follows:

• Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients;

• Guidelines for Submitting Information on the Cosmetic Ingredient Safety Information Submission Platform;

• Technical Guidelines for Filling in and Submitting Cosmetic Formula.

In conjunction with the implementation of these regulations, the Cosmetic Ingredients Safety Information Submission Platform and the Cosmetics Registration and Notification Information Service Platform underwent successive upgrades. These upgrades introduced changes such as that previously obtained submission codes for compound ingredients can no longer associate with safety information. Moreover, the application for new submission codes for compound ingredients without existing codes is no longer supported on these platforms.

China Allows the Use of Previously Obtained Submission Codes for Compound Ingredients

On September 14, 2023, the General Cosmetics Notification System issued an announcement regarding system updates. As per the announcement, the system has restored the filling in and submitting functions of the submission code for compound ingredients. This means that notifiers are now able to continue to use the submission code they have previously obtained for compound ingredients to associate with the corresponding ingredient safety information.

However, it is important to note that the Cosmetic Safety Information Submission Platform still does not support applications for new submission codes for compound ingredients.

China Consults on Three Technical Guidelines for Toxicological Tests of New Cosmetic Ingredients

On September 7, China NIFDC solicited public comments on the Technical Guidelines for Immunotoxicity Test (Draft for Comments), Technical Guidelines for Toxicokinetic Test (Draft for Comments), and Technical Guidelines for Reproductive and Developmental Toxicity Test (Draft for Comments). The three drafts aim to guide the safety assessment of cosmetic products and new cosmetic ingredients (NCIs).

China General Administration of Customs (GACC): Two Batches of Cosmetics Rejected in August

On September 19, 2023, GACC updated the list of rejected food and cosmetics in August. Two batches of cosmetics imported from France and Japan failed customs inspection due to the lack of required qualified documentation.

China Simplifies Notification Document Requirements for Marketed Toothpastes

On September 25, 2023, China NMPA issued an announcement regarding the implementation of toothpastes supervision regulations and the simplification of notification document requirements for toothpastes already available in the market. 

China Seeks Public Input on Revised Provisions for Toothpaste Notification Dossiers Management

On September 25, 2023, China released the draft of Provisions for Management of Toothpaste Notification Dossiers for public consultation until October 18, 2023. This draft consists of 3 chapters and 33 articles, covering general provisions, user information requirements, toothpaste notification data requirements, and more.

China NMPA Approves Four New Cosmetic Ingredients

In September, NMPA updated the notification status of four NCIs. The basic information about these new NCIs is as follows:

1. Bifidobacterium/Lactobacillus/Soybean Seed Extract Ferment Filtrate, notified on September 21, 2023

2. Cell Culture of Saussurea Involucrate, notified on September 25, 2023

3. Microcitrus australasica (F. Muell.) Swingle extract, notified on September 25, 2023

4. Schizophyllum Commune Mycelium Ferment Extract, notified on September 27, 2023

Guangzhou, Beijing and Shandong Authorities Publish FAQs Regarding Cosmetics Notification

In September, Guangzhou Administration for Market Regulation (AMR), Beijing Municipal Medical Products Administration (MPA), and Shandong Center for Food and Drug Evaluation & Inspection released four batches of FAQs concerning general cosmetics notification, including requirements for children cosmetic, efficacy claim, product formula, soap, toothpaste, etc.

China Issues Sixteen Cosmetics-related Standards in September

In September, China issued sixteen cosmetics-related standards. The essential information is as follows: 

Taiwan Adopts Changes to Particulars of Specific Purpose Cosmetics That May Be Voluntarily Modified

On September 6, 2023, TFDA approved the revised Particulars of Specific Purpose Cosmetics That May Be Voluntarily Modified (the Particulars) with immediate effect. Cosmetic enterprises are now allowed to delete the separately-listed specific purpose ingredients from product labels at their discretion.

PMDA: 473 Batches Cosmetics and Quasi-drugs Recalled in September

In September 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued recalls for over 400 batches of products, involving 22 kinds of cosmetics and quasi-drugs. The reasons for the recalls are as follows, listed in descending order of percentage:

1. Incorrect labeling of information, including brand, manufacturer, ingredients information;

2. Presence of undeclared or prohibited ingredients in the products.

3. Packaging defects that may compromise product integrity or pose a risk to consumers.

JCIA Issues Cosmetic Safety Statement

Currently, the marine discharge of ALPS-treated water from the Fukushima Daiichi Nuclear Power Plant is taking place. In relation to this, the Japan Cosmetic Industry Association (JCIA) has explained the efforts of the Japanese government and announced that there are no safety concerns regarding cosmetics manufactured domestically in Japan. Consumers can use them with peace of mind.

South Korea to Manage Eyelash Perm Products as Cosmetics

As disclosed by the Ministry of Food and Drug Safety (MFDS) on September 12, 2023, the eyelash perm products are to be managed as cosmetics. MFDS plans to classify the eyelash perm products as eye makeup items, which requires cautionary labeling, side effects monitor, the safety verification of ingredients and products, etc. Starting in the second half of this year, the authority will begin the process of revising relevant regulations.

South Korea to Revise the Labeling Requirements Related to Extracts

On September 12, 2023, the Korea Cosmetic Association disclosed a notice to announce the up-coming modification related to extract labeling requirements for cosmetics. The extracted substance and the extracting solvent are to be indicated individually. If the extracting solvent is removed and does not exist in the final product, the labeling of solvent can be exempted.

South Korea Revises Cosmetic Colorant Requirement

On September 21, 2023, MFDS officially modified this regulation, changing its name to Types and Standards for Cosmetic Colorants. Testing methods are removed from the regulation. At the same time, the authority issued a guideline named Guideline for Cosmetic Colorant Testing Methods, serving as an informative document, which provides the testing methods for each colorant based on international standards for enterprises’ reference. 

Indonesia BPOM Clarifies Issues Surrounding Sunscreen Cosmetics

On September 4, 2023, Indonesian Food and Drug Administration (BPOM) clarified the following issues surrounding sunscreen cosmetics with SPF values that had sparked widespread discussions on social media.

• BPOM assesses the safety, efficacy, and quality of these cosmetics, including their compliance with manufacturing regulations. Both in vivo and in vitro testing methods are employed to determine the SPF value;

• After supervising and inspecting sunscreen cosmetics that were notified between 2020 and 2023, two situations was found: 1) some notifiers couldn't provide sufficient evidence for the SPF value; 2) their products did not meet the claimed SPF value. Consequently, these products were subjected to administrative penalties;

• BPOM will continue to conduct pre-market and post-market supervision to ensure that notified cosmetics meet the safety, efficacy, and quality standards.

Indonesia and South Korea Signs a Memorandum of Understanding (MoU) on Halal Product Assurance

On September 7, 2023, Indonesia and South Korea signed a MoU on Halal Product Assurance. The Indonesian government aims to provide ease of access for South Korean products in Indonesia after halal certification. 

Australia Consults on Changes to Chemical Introduction Categorization, Reporting, and Record-keeping Under AICIS

On September 15, 2023, the Australian Government invited the public to give their comments on a suite of proposed changes to the chemical introduction categorization, reporting and record-keeping obligations under the Australian Industrial Chemicals Introduction Scheme (AICIS). Comments are welcome before November 9, 2023.

Australia Adds Two Cosmetic Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)

On September 19, 2023, the Australian Government announced the addition of two industrial chemicals to the AIIC under Section 83 of the Industrial Chemicals Act 2019. The two chemicals are:

• 4,8,11-Dodecatrienal (CAS No. 1000399-21-2): This chemical has been assessed for use by professionals and consumers as a fragrance ingredient in cosmetic, personal, and household products.

• Oils, sandalwood, santalene synthase-modified Rhodobacter sphaeroides-fermented, from D-glucose, oxidized (CAS No. 2576531-09-2): This chemical has been assessed as a fragrance ingredient in finished products used by both workers and consumers.

Australia Consults on 20 Draft Evaluation Statements on Industrial Chemicals

On September 29, 2023, the Australian Government initiated a public consultation, seeking feedback on 20 draft evaluation statements. These evaluation statements aim to provide safety information regarding the use, import, and manufacture of industrial chemicals. The consultation will remain open until November 27, 2023.

New Zealand to Update the Cosmetic Product Group Standards

Environmental Protection Authority (EPA) held a public hearing on September 20, 2023, to consider the proposed changes to the Cosmetic Products Group Standard. At the hearing, the Ministry of Health suggested adding labelling requirements for fluoride concentrations in toothpaste.

On this point, the decision-making committee (DMC) needed additional information to make the decision. Therefore, the Ministry of Health is required to provide further information around the labelling of fluoride toothpaste, such as the mandatory label phrasings, impact of fluoride in toothpaste, etc.

EPA indicated that they would publish the afterward measures and decisions. Stay tuned on Chemlinked for the follow-ups and the final revision of the Cosmetic Product Group Standard.

US Consults on Electronic Portal and Paper Forms for Cosmetic Facility Registration and Product Listing

On September 18, 2023, the U.S. Food and Drug Administration (FDA) unveiled its newly developed draft of electronic submission portal (Cosmetics Direct), Paper Form FDA 5066-Registration of Cosmetic Product Facility and Paper Form FDA 5067-Cosmetic Product Listing for public consultation. The period for public consultation will last until October 18, 2023.

US Reintroduces the New Humane Cosmetics Act

On September 12, 2023, a bipartisan group of legislators reintroduced an updated version of the Humane Cosmetics Act in the U.S. House of Representatives. The purpose of this legislation is to put an end to animal-based testing for cosmetics within the United States and prohibit the sale of any cosmetic product that has been tested on animals after the date of enactment. The reintroduced act will undergo review and deliberation in Congress. If it receives a majority vote of approval, it will lead to a nationwide ban on the animal-tested cosmetics one year after its enactment.

EU SCCS Releases Final Opinion on Children’s Exposure to Methyl Salicylate

On May 16, 2023, EU Scientific Committee on Consumer Safety (SCCS) published a draft opinion on the use of Methyl Salicylate (CAS No. 119-36-8) in cosmetics intended for children. On September 22, 2023, SCCS released the finalized opinion. In comparison to the draft, the final opinion includes the product category of hair conditioner in the safe use opinion for children aged 0.5-3 years.

EU REACH to Restrict Intentionally-added Microplastics in Cosmetics

On September 27, 2023, EU introduced stricter restrictions on products, including cosmetics, that contain intentionally-added microplastics. Under these restrictions, synthetic polymer microparticles falling within the designated scope shall not be placed on the market as individual substances. Additionally, if they are present in mixtures to confer a sought-after characteristic, their concentrations shall be below 0.01% by weight. To provide sufficient time for the development of suitable alternatives and minimize costs for the cosmetic industry, transitional periods ranging from 4-12 years are granted. 

Brazil Formulates Temporary Management Requirements for Hair Styling Cosmetics

On September 8, 2023, the Brazilian Government Gazette published RDC Resolution No. 814, establishing temporary management requirements for hair styling cosmetics. The Resolution stipulates that ointment hair styling agents that do not need to be rinsed after use, whether they are domestically produced or imported, should be registered with the Brazilian National Health Supervision Agency (ANVISA) through its electronic system. The Resolution is set to take effect from September 15, 2023, with a transition period of 6 months. 

Ukraine to Develop Regulations on Procedures for Cosmetic Information Notification

On September 13, 2023, the Ministry of Health of Ukraine released a draft order aimed at approving the notification procedures of information on cosmetic products. This proposed document stipulates that manufacturers, importers, and distributors of cosmetics imported or made in Ukraine shall submit product information to the Ministry of Health of Ukraine through an electronic system before the cosmetics are made available on the Ukrainian market.

Norway to Revise Regulations on the Labeling of Fragrance Allergens in Cosmetics

On September 29, 2023, the Norwegian Food Safety Authority issued consultation document No. 2023/207005, proposing to amend the labeling regulations for fragrance allergens in cosmetics. The consultation period for this document will conclude on October 27, 2023. The revisions include the addition of 56 new fragrance allergens, updates to the names of certain fragrance allergens, and more.