Insights on Cosmetic Regulations from the CAFFCI Annual Meeting: EU, UK, US, Japan, and South Korea

On October 18, 2024, the 13^th International Cosmetics High-level Forum of the China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI) Annual Meeting & Expo (CAME) took place in Nanjing, China, supported by REACH24H Consulting Group. Attendants include representatives from cosmetics associations in Japan, South Korea, the EU, the UK, and the US, as well as experts and businesses from the Chinese domestic and international cosmetics industry.

The forum featured five key speeches addressing various topics, including revisions to EU cosmetics regulations, the overview of UK cosmetics regulations, progress on the MoCRA, regulatory requirements for quasi-drugs in Japan, and the pilot program for electronic labels for cosmetics in South Korea. Below are the key points from each speech.

1. Future Revision Direction of EU Cosmetic Products Regulation (CPR)

In 2023, the European cosmetics market reached €96 billion, making it the second largest globally. Gerald Renner, Director of Technical Regulatory Affairs at Cosmetics Europe (CE), provided an analysis of the current situation of the EU cosmetics market, future regulatory revisions, and ongoing discussions regarding ingredient requirements.

He noted that while the revision timeline of CPR would not proceed as initially planned, assessments are still ongoing. Future revision efforts would focus on optimizing the regulatory processes for CMR substances, systematic risk approach for endocrine disruptors, risk assessment of mixtures; updating the definition of nanomaterials; reorganizing scientific advice; and introducing electronic labels. Additionally, the discussions on ingredient requirements include the oversight and evaluation of endocrine disruptors, CMR substances, whitening agents, and nanomaterials.

Source: CAME

2. Overview of UK Cosmetic Regulations

Nicolas Shaw Núñez, Director of Regulation at the Cosmetic, Toiletry and Perfumery Association (CTPA), provided an overview of UK cosmetics regulations. After Brexit, cosmetics intended for the UK market (England, Scotland, and Wales) must comply with UK regulations, while Northern Ireland continues to adhere to EU regulations. The main differences between UK and EU regulations involve three key areas: responsible person (RP), product notification portal, and ingredient management.

Source: CAME

In the UK, cosmetics enterprises must designate an RP responsible for ensuring that the product information file (PIF) and labels meet regulatory requirements, that ingredients comply with UK lists of prohibited, restricted, and permitted ingredients, and that notification is completed via the Submit Cosmetic Notification (SCPN) portal before products can be marketed.

CTPA has published a frequently updated summary document outlining the differences in the use conditions for cosmetic ingredients between the EU and the UK. Interested companies can download the PDF here.

Additionally, Nicolas revealed that the UK had issued a statutory guidance on green claims, and the Product Regulation and Metrology Bill would become law in spring 2025.

3. Overview of US Cosmetics Market and MoCRA Implementation Progress

Natalie Obermann, Vice President of Global Strategy at the Personal Care Products Council (PCPC), provided an overview of the U.S. cosmetics market, highlighting key terms, regulatory requirements, and the latest developments related to the Modernization of Cosmetics Regulations Act (MoCRA).

Source: CAME

In 2023, the US cosmetics market reached $119 billion, reflecting stable growth. Consumer trends indicated a heightened focus on health, which drove the demand for dermocosmetics and sunscreen products. 2023 also saw a rising interest in natural and organic cosmetics, alongside increasing expectations for ingredient transparency and sustainability. Data shows that ingredient formulations influence purchasing decisions, with consumers willing to pay 20% more for high-quality ingredients.

Since the enactment of MoCRA, several provisions have taken effect, including facility registration, product listing, safety substantiation, labeling for professional-use cosmetics, and adverse event reporting. Moving forward, the FDA plans to establish standardized testing methods for detecting asbestos in talc-containing cosmetics, as well as publish guidelines for fragrance allergen labeling, good manufacturing practices, and frequently asked questions for the electronic submissions portal (Cosmetic Direct). Other plans include establishing mandatory recall and record access guidelines, as well as updating cosmetic labeling guidelines.

4. Japanese Quasi-drug Regulatory Requirements

Akinari Hotta, a member of the China Division of the Japan Cosmetic Industry Association (JCIA), outlined the quality management requirements for quasi-drug ingredients and products in Japan. He noted that quasi-drugs must obtain a license before they can be marketed. Akinari also discussed the classification of anti-wrinkle products, noting that those targeting deep wrinkles are regulated as quasi-drugs, with four ingredients currently approved for this purpose. Products that address shallower wrinkles and reduce fine lines through moisturizing effects are not classified as quasi-drugs.

The application documents for quasi-drugs include the product name, formulation, specifications, manufacturer, packaging company, efficacy claims, and quality inspection reports. The review primarily focuses on the efficacy, safety, and quality specifications of the ingredients.

Quasi-drug ingredients are strictly regulated by four lists: Permitted Active Ingredients, Permitted Additives, Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021), and List of Patented Quasi-drug Ingredients of Enterprises.

For ingredients on the "Permitted Active Ingredients" list, safety or efficacy documentation is not required during the application process, provided their specifications and addition amounts meet the list's requirements. Similarly, for ingredients on the "Permitted Additives" list, safety documentation is not necessary as long as the concentration below the specified upper limit. Additionally, ingredients that comply with the JSQI and the List of Patented Quasi-drug Ingredients, and whose addition amounts are consistent with previously approved ranges, are also exempted from safety or efficacy documentation.

Source: CAME

5. South Korea's Electronic Labeling Pilot Project

In South Korea, while mandatory labeling items for cosmetic packaging are increasing, the trend toward simplified packaging has reduced the readability of physical labels. Moreover, frequent changes in label content often necessitate the replacement or disposal of the original packaging, contributing to environmental pollution. In response, the South Korean Ministry of Food and Drug Safety (MFDS) launched a cosmetics electronic labeling pilot project in March 2024, set to run until February 2026. In this context, Yeon Jaeho, vice president of the Korea Cosmetics Association (KCA), provided an update on the pilot's progress and discussed the challenges that need to be addressed.

Yeon Jaeho noted that 14 low-risk cosmetics categories from 6 companies had been participating in the electronic labeling pilot. Key information such as price, barcode, production number, and expiration date must be displayed on the physical packaging, while additional details can be accessed via a QR code that links to an electronic label on the website. The pilot aims to enhance the readability of physical labels, conserve packaging resources, and foster enterprises’ creativity in packaging design. However, challenges remain, including how to assist consumers without smartphones or those unable to scan codes, as well as how to address potential issues with store network connectivity. These concerns require attention.

Source: CAME