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Monthly Recap: Global Cosmetic Regulatory Updates | June 2023

China

Jiangsu and Guangdong Medical Products Administrations (MPA) Require Corrections for Imported General Cosmetics with Pending Annual Reports

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.

China NIFDC Clarifies Detailed Registration Requirements for Special Cosmetics and New Cosmetic Ingredients

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.

China NIFDC Consults on Updates to Prohibited Ingredients and Toxicological Test Methods for Cosmetics

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.

China Implements Restrictions on Blind Box Sales of Cosmetics

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.

China Sets Transitional Period for Small Packaging Cosmetics

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.

In response to the NMPA's initiative, MPAs in provinces such as Guangdong, Zhejiang, Jiangxi, and the Tibet Autonomous Region have taken action.

China General Administration of Customs (GACC) Reports Rejection of Four Batches of Cosmetics in May

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:

  1. Ethyl Methicone (CAS No. 63148-54-9), notified on June 14, 2023

  2. Cyclopeptide-161, notified on June 20, 2023

  3. 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.

Release Date

Regulatory Authority

Batch

June 8, 2023

Guangzhou AMR

The 40th Batch

June 27, 2023

The 41st Batch

June 27, 2023

The 42nd Batch

June 27, 2023

Beijing Municipal MPA

The 22nd Batch

June 30, 2023

Shandong Center for Food and Drug Evaluation & Inspection

The 2nd batch

China Issues Four Cosmetics-related Group Standards in June

In June, China issued four cosmetics-related group standards. The essential information is as follows: 

Release Date

Initiator

Standard Name 

Effective Date

June 12, 2023

Guangdong Cosmetics Quality Management Association

T/GDCQMA 00X—202X Regulations for Cosmetic Stability Testing (Draft for Comments)

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June 12, 2023

Guangdong Chamber of Daily Used Chemicals

T/GDCDC 032-2023 Method for Exfoliating Effect Of Cosmetics

June 12, 2023

T/GDCDC 033-2023 Cosmetic Ingredients - Aillum Sativum Extract

June 15, 2023

Zhejiang Health Products & Cosmetics Industry Association

T/XXXX-2023 Determination of 23 Kinds of Stimulants in Cosmetics - High Performance Liquid Chromatography-Tandem Mass Spectrometry (Draft for Comments)

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Japan

PMDA: 36 Batches Cosmetics and Quasi-drugs Recalled in June

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.

South Korea

South Korea to Introduce Microplastic Control Act

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.

South Korea Revises the Enforcement Rule of Cosmetics Act

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.

Philippines

Philippines Launches a New Round of Consultation on Amended Requirements for LTO Application

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.

Malaysia

Malaysia and Indonesia Sign MoU on Mutual Recognition of Halal Certification

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.

Thailand 

Thailand Releases a New Prohibited Ingredient List and Revises Permitted Preservatives 

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. 

India

India Proposes Amendments to Cosmetics Rules 2020

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.

Australia

TGA Publishes Updated Guidelines for Sunscreens

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.

Australia Releases Guidance for Submitting Pre-Introduction Reports for Chemicals Classified as “Internationally-Assessed for Environment Only”

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

New EU Regulation on General Product Safety to Take Effect in 2024

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.

EU Calls for Data on the Safety of Cannabidiol (CBD) in Cosmetics

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.

EU SCCS Consults on Opinions About Butylparaben and Methylparaben

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. 

EU to Adopt 11 Changes to the Use Requirements for Cosmetic Ingredients

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. 

EU SCCS Finalizes the Opinion as to Salicylic Acid

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. 

EU SCCS Releases the Preliminary Opinion on Benzyl Salicylate

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.

EU to Implement a Union-wide Ban on PFHxA in Cosmetics

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.

EU Proposes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics

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

FDA Seeks Public Input on a Draft Guidance for Tattoo Inks

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.

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Canada

Canada Bans Cosmetic Animal Testing

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.

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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!

Further Reading

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