Consumer Health – USA/Europe/Asia/ROW Regulatory News – April 2024

USA

New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry

FDA published final guidance New Dietary Ingredient Notification Procedures and Timeframes. This guidance focuses on frequently asked questions about the NDIN submission and review process. This guidance finalizes Section V (“NDI Notification Procedures and Timeframes”) of the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues) in addition to several related questions from other sections of the draft guidance.

New Dietary Ingredient Notifications and Related Issues

The U.S. Food and Drug Administration (FDA) published a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance expands upon and replaces the recommendations related to Master Files for new dietary ingredient notifications (NDINs) in the 2016 revised draft guidance.

New Dietary Ingredient Notification Master Files for Dietary Supplements

This guidance expands upon and replaces the recommendations related to Master Files in the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues).

EUROPE

Consults on the Opinion About Silver

EU Scientific Committee on Consumer Safety (SCCS) published the preliminary opinion on the use of Silver (CAS No. 7440-22-4) in cosmetic products. The opinion remains open for comments until May 5, 2024

ASIA

China

Technical documents on cosmetics safety assessment

NIFDC published technical documents on cosmetics safety assessment. The technical documents needed for cosmetics safety assessment during the transition period from May 1, 2024 to May 1, 2025, have all been finalized and released. Index of Cosmetics Safety Assessment Data from Authoritative Organizations, Ingredient Usage Information of Marketed Cosmetic Products, FAQ on Ingredient Usage Information of Marketed Cosmetic Products are some of the finalized documents.

Thailand

Changes in ingredients requirements

The Thai Food and Drug Administration (Thai FDA) approved the amendments to the country’s cosmetic ingredient lists, following a period of public consultation. These amendments, effective immediately, bring Thailand’s cosmetic regulations in line with the updates to the ASEAN Cosmetic Directive (ACD) adopted during previous ASEAN Cosmetic Committee Meetings.

Hong Kong

First-Phase Disposable Plastic Tableware Regulation

Hong Kong SAR officially implemented the first-phase disposable plastic tableware regulation, under the Product Eco-responsibility (Amendment) Bill 2023. Regarding the regulation on disposable plastic tableware, the Amendment Bill bans the local sale of nine types of disposable plastic tableware, and prohibits catering premises from providing customers with such products, and is implemented in two phases.

Indonesia

Amendment to BPOM Regulation on Processed Food Labels

Indonesia BPOM released the Second Amendment to BPOM Regulation No. 31 of 2018 on Processed Food Labels, which came into effect on April 5, 2024. However, BPOM provides a four-year grace period for stakeholders to ensure compliance with the new requirements. As per the second amendment, due to the risks associated with Bisphenol A (BPA) in bottled drinking water, BPOM has reinforced the labeling requirements for bottled drinking water. New labeling rules are as followings: Information regarding storage methods on the bottled drinking water label must include the words “store in a clean and cool place, keep away from direct sunlight and objects with pungent smell”.

Korea

Notice on designation (removal) of raw material ingredients subject to domestic import ban

MFDS published raw materials which are subject to ban from entering the country. The ingredients banned are diphenhydramine, raspberry, pomegranate seeds, yellow oleander.

ROW

Australia

Assessed listed medicines evidence guidelines

TGA published Assessed listed medicines evidence guidelines version 1.2. This guidance applies to assessed listed medicines that are eligible for evaluation by the TGA’s Complementary and Over-the-counter Medicines Branch (COMB). The assessed listed medicines pathway offers sponsors a way to list products with low risk ingredients in the Australian Register of Therapeutic Goods (ARTG) after we have pre-market assessed the efficacy evidence.  The pathway sits between the standard listed (lower risk) and registered (higher risk) pathways. It allows sponsors to list products with higher level indications than standard listed medicines without meeting the extensive requirements for registration, provided that the product has strong scientific evidence to support it.

AICIS fees and charges proposal 2024-25

AICIS published consultation on fees and charges proposal. The purpose of this consultation is to provide industry and other interested stakeholders with an opportunity to comment on AICIS’s proposed fees and charges for 2024-25. Specifically, AICIS are seeking feedback on the potential impact of the changes prior to seeking approval from Government.

Industrial Chemicals Categorisation Guidelines

Industrial Chemicals Categorisation Guidelines were published in Australia. These Guidelines are designed to help an introducer to categorise an industrial chemical introduction for the purposes of the Industrial Chemicals Act 2019 and must be used in conjunction with the Industrial Chemicals (General) Rules 2019 (the IC General Rules). Replaced specific guidelines with ‘an acceptable test guideline for’ ready biodegradability and transformation in aquatic sediment systems.

Canada

Plastic products reporting for 2024-2026

The Canada Department of the Environment published a notice under subsection 46(1) of the Canadian Environmental Protection Act, 1999 requiring comprehensive reporting from entities involved in the manufacturing or management of plastic resins and certain plastic products to the Federal Plastics Registry. Non-compliance with the Notice may result in penalties under the Act.

Modification to list of permitted supplemental ingredients

Health Canada issued M-SIS-24-01, announcing the modification to the List of Permitted Supplemental Ingredients. This modification newly permits the use of phosphatidylserine (soy) as a kind of other supplemental ingredients in the list.