China Accepts Previous Submission Codes for Compound Ingredients

The Cosmetic Safety Information Submission Platform does not support applications for new submission codes for compound ingredients that do not have existing codes; During cosmetic product notification process, notifiers are allowed to fill in the previously obtained submission code for compound ingredients to associate ingredient safety information. On September 4, 2023, China National Institutes for Food and Drug Control (NIFDC) introduced and enforced three Guidelines 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. With the implementation of these Guidelines, updates were made to the Cosmetic Ingredients Safety Information Submission Platform and the Cosmetics Registration and Notification Information Service Platform. Among these updates, two changes have received significant attention: 1. In the registration and notification process of cosmetic products, the registrant and notifier are no longer allowed to use previously…

Oct. 08th, 2023

U.S. Seeks Feedback on Electronic Portal and Paper Forms for MoCRA Cosmetic Facility Registration and Product Listing

On September 18, 2023, the U.S. Food and Drug Administration (FDA) unveiled its newly developed draft 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. Companies have the option to choose either electronic submission via Cosmetics Direct or paper submission methods. However, the FDA encourages electronic submission to enhance the efficiency and timeliness of data submission. Moreover, by utilizing the electronic submission method, companies can conveniently access their previous registrations and listing submissions as well as view the Submission ID for accepted submissions. Cosmetics Direct Cosmetics Direct incorporates the necessary information for registration and listing submissions from the Paper Forms FDA 5066 and 5067 into a standardized electronic format. New users who wish to access the Cosmetics Direct Home Page are required to create a new account by submitting the…

Oct. 08th, 2023

Unlocking Compliance: China\’s Finalized Technical Guidance for Filling and Submitting Cosmetic Ingredient Safety Information

Consisting of 11 parts, the Guidelines specifies cosmetic registrants’ and notifiers’ responsibility for ingredient quality and safety, refines the requirements for filling in and submitting ingredient safety information, as well as gives instructions on handling changes to ingredient safety information. Background According to the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), when applying for cosmetic registration and notification, it is required to submit ingredient safety information. On March 27, 2023, National Medical Products Administration (NMPA) announced to extend the transition period of the cosmetic ingredient safety information submission policies to January 1, 2024. Since then, the cosmetic registrant or notifier shall fill in and submit the ingredient safety information documents for all ingredients used in the product formula per relevant regulations and technical specifications. In May 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety…

Oct. 08th, 2023

Navigating Japan\’s Cosmetics Registration: A Comprehensive Regulatory Overview

Regulatory Overview In the \”Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices\” (2023 revision) implemented in Japan since 1960 by the Cabinet Office, Chapter 4 Production and Sales of Pharmaceuticals, Quasi-drugs, and Cosmetics and Chapter 13 stipulates that Japanese manufacturers or distributors intending to import and sell cosmetics manufactured or sold outside Japan must obtain a cosmetic manufacturing license for foreign manufacturers (Article 13-3 of the Act). Foreign manufacturers are required to submit relevant applications to the Pharmaceutical and Medical Device Agency (PMDA) of Japan, before exporting to Japan. The definitions of foreign cosmetics production distributor and foreign cosmetics manufacturer in Japan are as follows: Foreign cosmetic production distributors refer to companies registered outside Japan that engage in the production and sale of cosmetics outside Japan and distribute them to end customers. Foreign cosmetic manufacturers refer to companies registered outside Japan that engage in…

Sep. 26th, 2023

EU Proposes 11 Changes to Cosmetic Ingredient Lists, Including Prohibition and Restrictions on 9 Substances

The EU introduced 11 changes to the ingredient lists in Cosmetics Regulation, including: 1) Adding one prohibited ingredient, and eight restricted ingredients; 2) Amending the use requirements for two permitted preservatives. On June 8, 2023, EU notified WTO of a draft regulation that aims at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft proposes to prohibit and restrict the use of certain cosmetic ingredients respectively, following the opinions from the Scientific Committee on Consumer Safety (SCCS), and is open for comments until August 7, 2023. List of Prohibited Ingredients: One Added 4-Methylbenzylidene Camphor (CAS No. 36861-47-9 / 38102-62-4) is currently regulated under the Cosmetics Regulation as a permitted UV-filter. As per opinion SCCS/1640/21, the use of this substance in cosmetics was potentially risky to human health. Therefore, the draft proposes to prohibit its use, and delete the corresponding entry from the list of permitted UV-filters. List of Restricted Ingredients:…

Jun. 30th, 2023

EU Proposes Union-Wide Ban on PFHxA in Cosmetics to Address Environmental and Health Risks

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 19, 2023, the EU notified WTO of a draft regulation aiming at amending Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics. It is currently open for comment until August 18, 2023. PFHxA, its salts, and related substances are persistent in the environment and have hazardous properties, making them difficult to eliminate from water, which can lead to their accumulation in the environment and increased exposure for both the environment and humans. To address these risks, the draft proposes that these substances shall not be used in cosmetics in a concentration equal to or greater than 25 ppb for…

Jun. 30th, 2023

China\’s NIFDC Seeks Public Feedback on Updates to Prohibited Cosmetic Ingredients and Test Methods

China is moving towards updating the Inventory of Prohibited Ingredients for Cosmetics and adopting more toxicological test methods for cosmetic ingredients, as well as animal testing alternatives. On June 12, 2023, China\’s National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics, along with the introduction of test methods for cosmetic ingredients. Interested parties are invited to provide their feedback and suggestions until July 15, 2023, by submitting the \”Opinion Feedback Form\” via email to hzpbwh@nifdc.org.cn. Five New Prohibited Ingredients The proposed update to the Inventory of Prohibited Ingredients for Cosmetics is the addition of five prohibited prostaglandin analogs. Entry No. English Name Chinese Name CAS No. 1286 Bimatoprost 比马前列素 155206-00-1 1287 Latanoprost 拉坦前列素 130209-82-4 1288 Tafluprost 他氟前列素 209860-87-7 1289 Tafluprost ethyl amide, (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-Difluoro-4-phenox y-1-buten-1-yl]-3,5-dihydroxycyclopentyl}-N-ethyl-5- heptenamide 他氟乙酰胺 1185851-52-8 1290 Travoprost 曲伏前列素 157283-68-6 Seven Test Methods Additionally, the consultation highlights the…

Jun. 29th, 2023

EU Proposes Stricter Restrictions on D4, D5, and D6 in Cosmetics

The European Union (EU) has introduced new amendments to Annex XVII of Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The proposed amendments, which were notified to the World Trade Organization (WTO) on June 22, 2023, aim to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics, as well as other consumer and professional products. Under the proposed amendments, the use of D4, D5, and D6 in a concentration equal to or greater than 0.1% by weight of the respective substance would be strictly restricted, with a two-year transitional period. These substances would not be allowed to be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures. Leave-on cosmetics would have a three-year transitional period, as the Commission recognizes that reformulating these products would incur significant costs for the cosmetic industry. Exceptionally, the proposed…

Jun. 29th, 2023

EU SCCS Consults on Opinions About Butylparaben and Methylparaben

On June 8, 2023, EU Scientific Committee on Consumer Safety (SCCS) published preliminary opinions respectively on the use of Butylparaben (CAS No. 94-26-8) and Methylparaben (CAS No. 99-76-3) in cosmetics. The views are open for comments until August 21, 2023. Endocrine disruptors (EDs) are chemical substances that can alter the functioning of the endocrine system and consequently produce adverse effects on human health. Regarding the management of EDs, Regulation (EC) No 1223/2009 (Cosmetics Regulation) does not contain specific provisions. Instead, substances identified as EDs, including Butylparaben and Methylparaben, are currently subject to the general safety assessment of SCCS. To ensure their safe use in cosmetics, the European Commission requested SCCS to conduct safety assessments on Butylparaben and Methylparaben. Based on the assessments of all available information, including the potential endocrine effects, SCCS considers the use of Butylparaben and Methylparaben in cosmetics to be safe as shown below: Source: ChemLinked Reference Links SCCS—Preliminary Opinion Open for…

Jun. 29th, 2023

Decoding Halal Certification Regulations for Food and Cosmetics in Indonesia, Malaysia and India

Halal food and cosmetics market is expanding due to the increasing Muslim population and the growing focus on the importance of halal certification. According to relevant reports, the halal food market in ASEAN is expected to reach US$1.1 trillion in 2024, while the halal cosmetics market is expected to reach US$7.6 billion in 2024. Indonesia, Malaysia, and India are the main consumer markets for halal food and cosmetics. Indonesia\’s large Muslim population of approximately 236 million is driving the growth of halal products, particularly among the young population. Indonesia is also making a strategic move to develop an Islamic economy, which includes implementing mandatory halal certification requirements for all halal products that enter, circulate, and are traded in the country. From October 17, 2024, all halal food and beverage products sold in Indonesia must have a halal certification, while from October 17, 2026, all halal cosmetic products sold in Indonesia must also…

Jun. 25th, 2023
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