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

China NIFDC Consults 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 updates 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 introduction…

Jun. 19th, 2023

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

On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released 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. Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application) Guidelines for the Approval of Registration Change of Imported Special Cosmetics Guidelines for the Approval of Initial Registration of Imported Special Cosmetics Guidelines for the Approval of…

Jun. 13th, 2023

China Seeks Feedback on Guidelines for Submitting Cosmetic Ingredient Safety Information via Official Platform

Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform clarifies the application scope of the platform, the submission principles, necessary documents, and the obligations of cosmetics registrants and notifiers. 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 January 1, 2024, the cosmetic registrant and 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. On May 12, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform (the Guidelines). Any…

Jun. 13th, 2023

China Proposes Technical Guidance for Cosmetics Ingredient Safety Submission

Consisting of 11 parts, the draft 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. On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (the Guidelines). Any suggestions can be sent to hzppjzx@nifdc.org.cn by May 20, 2023. The Guidelines consists of 11 parts and systematically outlines vital points and technical principles for filling in and submitting ingredient safety information, covering aspects of ingredient basic information, brief descriptions of ingredient production technique, necessary quality control requirements, limit requirements for risk substances, etc. It should be noted that, the Guidelines is applicable to situations where cosmetic registrants or notifiers fill in and submit ingredient safety information in cosmetic registration or notification documents on their own, and…

Jun. 13th, 2023
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