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:
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.
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.
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).
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.
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.
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:
Bifidobacterium/Lactobacillus/Soybean Seed Extract Ferment Filtrate, notified on September 21, 2023
Cell Culture of Saussurea Involucrate, notified on September 25, 2023
Microcitrus australasica (F. Muell.) Swingle extract, notified on September 25, 2023
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.
September 5, 2023
Beijing Municipal MPA
September 28, 2023
September 18, 2023
Shandong Center for Food and Drug Evaluation & Inspection
September 20, 2023
China Issues Sixteen Cosmetics-related Standards in September
In September, China issued sixteen cosmetics-related standards. The essential information is as follows:
September 7, 2023
Standardization Administration, SAMR
April 1, 2024
September 1, 2023
Beijing Daily Chemical Association
September 1, 2023
Guangdong Association for Instrumental Analysis
September 12, 2023
October 10, 2023
September 12, 2023
Foshan Biomedical Engineering Society
September 13, 2023
Fujian Association of Fragrance Flavour and Cosmetic Industries
September 14, 2023
Guangdong Cosmetic Quality Management Association
September 15, 2023
Shandong Cosmetic Industry Association
August 29, 2023
September 18, 2023
November 19, 2023
September 22, 2023
China Anti-Aging Promotion Association
September 21, 2023
September 27, 2023
Guangdong Cosmetic Association
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.
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:
Incorrect labeling of information, including brand, manufacturer, ingredients information;
Presence of undeclared or prohibited ingredients in the products.
Packaging defects that may compromise product integrity or pose a risk to consumers.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The United States
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.
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.
The European Union
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.
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.
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.
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.
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.