On June 1 and 21, 2023, Jiangsu and Guangdong MPA issued notices respectively, ordering relevant notifiers to make corrections for imported general cosmetics whose annual reports were not submitted by the March 31, 2023 deadline. The required corrections must be completed by June 30, 2023, failing which will lead to the cancellation of their cosmetic notifications.
On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) issued nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.
On June 12, 2023, China NIFDC initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics, along with the introduction of seven test methods for cosmetic ingredients.
On June 15, 2023, the China State Administration for Market Regulation (SAMR) issued the Guidelines on the Code of Conduct for Blind Box Operations (Trial). The Guidelines clearly stipulates the situations that food and cosmetics should not be sold in the form of blind boxes.
On June 19, 2023, SAMR announced a transitional period for commodities, including cosmetics, with a net content of less than 1 g. These products will be given an additional 12 months to comply with the Measures on Metrological Supervision and Administration of Quantitatively Packed Commodities, which took effect on June 1, 2023. Commodities produced or imported before the end of the transition period on June 1, 2024 can continue to be sold until the end of their shelf life.
National and Provincial MPAs Crack Down on Non-Uniqueness of Cosmetic Registration/Notification Numbers
On June 21, 2023, CNPHARM.COM reported that National Medical Products Administration (NMPA) would conduct special inspections to investigate and combat the illegal act of using the same special cosmetics registration certificate number or general cosmetics notification number for multiple products, which is manifested by illegally marking the text, trademarks, logos other than the ones in cosmetic registration notification dossiers on product labels, or in other ways.
According to the latest update from GACC on June 28, 2023, four batches of cosmetics were rejected in May. Two batches imported from France and Germany failed customs inspection due to the lack of required qualified documentation, while another two batches imported from Hong Kong SAR were rejected due to non-compliant labeling.
China NMPA Approves Three New Cosmetic Ingredients
In June, NMPA updated the notification status of three NCIs. The basic information about these new NCIs is as follows:
Ethyl Methicone (CAS No. 63148-54-9), notified on June 14, 2023
Cyclopeptide-161, notified on June 20, 2023
Tripeptide-105, notified on June 20, 2023
Guangzhou, Beijing and Shandong Authorities Publish FAQs Regarding Cosmetics Notification
In June, Guangzhou Administration for Market Regulation (AMR), Beijing Municipal MPA, and Shandong Center for Food and Drug Evaluation & Inspection released five batches of FAQs concerning cosmetics notification, including requirements for cosmetic labelling, efficacy claim evaluation, product formula, claims of specific ingredients, the person in charge of quality and safety, notification change, etc.
June 8, 2023
June 27, 2023
June 27, 2023
June 27, 2023
Beijing Municipal MPA
June 30, 2023
Shandong Center for Food and Drug Evaluation & Inspection
China Issues Four Cosmetics-related Group Standards in June
In June, China issued four cosmetics-related group standards. The essential information is as follows:
June 12, 2023
Guangdong Cosmetics Quality Management Association
June 12, 2023
Guangdong Chamber of Daily Used Chemicals
June 12, 2023
June 15, 2023
Zhejiang Health Products & Cosmetics Industry Association
In June 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) released nine notices regarding non-compliant cosmetics and quasi-drugs, which included shampoo, mouthwash, hand cream, etc., totaling more than 36 batches. Among them, over 20 batches of were rejected due to ingredient-related issues, while 15 batches of cosmetics and one batch of quasi-drug were recalled due to incorrect labeling information.
On June 5, 2023, the Environment and Labor Committee proposed to legislate the Special Act on Microplastic Reduce and Control.
Microplastics generated from daily-used plastic products is being blamed for causing a series of health hazards and environmental problems. However, in South Korea, although there are limits to using plastics, such like the ban of colorful plastics and PET bottles in South Korea, the regulations to reduce and control the usage of microplastic generation are insufficient. Part of the reason is the lack of surveys and impact studies on microplastics. Therefore, the authority now enacts the law to establish a comprehensive countermeasure system to microplastic, including surveys on microplastics, microplastic’s usage, emission, and reduction, in order to protect public health and the environment.
On June 22, 2023, the Ministry of Food and Drug Safety (MFDS) revised the Enforcement Rule of Cosmetics Act. To remove the barriers on employing cosmetics responsible managers, the experience requirements are optimized, including removing the work experience requirement for custom cosmetic manufacturing managers and deleting the education requirements of specific courses for those majored in nursing.
On June 5, 2023, the Philippines Food and Drug Administration (FDA) initiated the third round of consultation on the updated application guidelines for the License to Operate (LTO). Compared to the two drafts previously released in May and October of last year, the new draft introduces stricter guidelines for initial, renewal and variation applications for the LTO, details the circumstances under which the LTO may be cancelled, and strengthens the requirements for the Qualified Person.
On June 8, 2023, the Department of Islamic Development Malaysia (JAKIM) and the Indonesian Halal Product Assurance Organization (BPJPH) signed a Memorandum of Cooperation (MOC) to facilitate halal trade between the two countries.
The MOC includes mutual recognition between JAKIM and BPJPH as halal certification bodies. As a result, Malaysian halal products and logos certified by JAKIM can enter the Indonesian market without obstacles, and products manufactured in Indonesia and labeled with the BPJPH halal logo can enter the Malaysian market with ease.
On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices, introducing a new list of prohibited ingredients for cosmetics, and revising the requirements for permitted preservatives. These notices officially came into effect on June 23, with some rules granting a transition period.
On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a 45-day public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of improving the regulation and quality control of cosmetics in India. The proposed changes cover the modification of terminologies, the introduction of new rules, the relaxation of certain regulatory requirements, and various other adjustments.
On May 9, 2023, the Therapeutic Goods Administration (TGA) of Australia published the updated Australian Regulatory Guidelines for Sunscreens (ARGS Version 3.0), aiming to align the guidelines with the data requirements for all ingredients proposed to be included in the Therapeutic Goods (Permissible Ingredients) Determination. The key changes in ARGS Version 3.0 include editorial changes to the overall text, the removal of specific details regarding sun protection factor (SPF) testing, and the amendments to Part B, which outlines the process of applying for a new sunscreen ingredient.
On June 1, 2023, the Australian Government released a new guidance to help businesses submit Pre-Introduction Reports (PIRs) for chemicals that are classified as “internationally-assessed for the environment but not human health” under the reported introduction category. This guide includes a detailed checklist to ensure businesses have all the necessary information before commencing the submission process, and provides instructions for completing the PIR form in the Australian Industrial Chemicals Introduction Scheme (AICIS) Business Services platform.
The European Union
On May 23, 2023, EU published Regulation (EU) 2023/988 on General Product Safety (GPSR) to repeal Directive 87/357/EEC and Directive 2001/95/EC. This new regulation imposes general safety requirement for applicable consumer products, details the obligations of economic operators and online marketplace providers, and establishes a market surveillance network. It has been effective since June 12, 2023, with a transitional period of 18 months.
In response to growing concerns over the use of CBD in cosmetics, the European Commission intended to request the Scientific Committee on Consumer Safety (SCCS) to conduct an assessment on CBD. To prepare for this mandate, on June 1, 2023, the Commission launched a public call for data and information. Any interested parties can submit scientific information relevant to the assessment before October 1, 2024.
On June 8, 2023, SCCS published preliminary opinions respectively on Butylparaben and Methylparaben for consultation until August 21, 2023. Based on the assessments of all available information, including the potential endocrine effects, SCCS concluded the maximum use concentration of these two substances as preservatives in cosmetics.
On June 8, 2023, EU notified WTO of a draft regulation aiming at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft proposes to add one prohibited ingredient and eight restricted ingredients, and amend the use requirements for two permitted preservatives. It is open for comments until August 7, 2023.
On December 15, 2022, SCCS initiated a two-month public consultation on the preliminary opinion on Salicylic Acid. Taking into account the feedback received, on June 9, 2023, SCCS finalized the safe use requirements for this substance in cosmetics. Compared to the current restrictions outlined in the Cosmetics Regulation, the final opinion now grants its use in oral products with specific maximum concentration.
On June 13, 2023, SCCS published the preliminary opinion on the safety of Benzyl Salicylate in cosmetics. In light of the data and information provided, SCCS proposed different concentration limits of Benzyl Salicylate based on product types.
On June 19, 2023, EU notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Once the draft takes effect, the use of PFHxA, its salts and related substances will be prohibited in cosmetics, with a 24-month transitional period.
On June 22, 2023, EU introduced new amendments to the Annex XVII to REACH through a draft regulation notified to WTO. This draft proposes to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics, as well as other consumer and professional products. It is currently open for comment until August 21, 2023.
The United States
On June 12, 2023, the U.S. Food and Drug Administration (FDA) launched a 90-day public consultation on a draft guidance, which aims at assisting tattoo ink manufacturers and distributors in identifying potential situations where tattoo ink may be contaminated with microorganisms and implementing measures to safeguard public health.
On April 20, 2023, the Budget Implementation Act, Bill C-47, was introduced and tabled in Parliament to proceed the implementation of the key commitments outlined in the Budget, including the prohibition of cosmetic animal testing. On June 22, 2023, Bill C-47 was passed by the Senate, which legally put an end to cosmetic testing on animals in Canada.
The beauty market in Southeast Asia is experiencing an unprecedented boom, fueled by a growing standard of living and an increasingly discerning consumer base. Consumers in this region are deliberate in their brand choices and actively seek products that align with their values. With their eyes glued to social media platforms, it's the perfect time for cosmetic brands to strategically enter the market and promote their brands via these influential channels.
To help global stakeholders discover the secrets of reaching cosmetics buyers in Southeast Asia through social media, ChemLinked will present a webinar on this topic on July 13, 2023. Click here for registration now!
Vietnam is a rapidly growing market with a high demand for cosmetic products. With a population of over 99 million and a rapidly growing middle class, Vietnam presents a great opportunity for businesses looking to expand their reach. However, exporting to Vietnam can be challenging without the proper knowledge and understanding of the country's regulations and market trends.
To assist global stakeholders to navigate the regulatory environment, ChemLinked will present a webinar on July 19, 2023 to provide a comprehensive guide on exporting cosmetics to Vietnam, including regulatory requirements, market trends, and other vital considerations. Click here for registration now!