Korean Regulatory Update 2017: Get Authorized

Oct 11th, 2017

Ben Teoh, Contributing Consultant, Penang, Malaysia

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Editor's note: As an update to our 2013 coverage of Korean Cosmetic Regulations, here, author and consultant Ben Teoh provides another look at the current status of cosmetic regulations this region.

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The FDA reminded consumers to check its blacklist of hand sanitizers they should not use due to methanol content, insufficient active ingredient or false and misleading/unproven claims.

FDA on Hand Sanitizers, Topical Irritation Testing and Biosimilars

Recent FDA activities include education for consumers on hand sanitizers and biosimilars, and guidance for testing the irritation/sensitization potential of topicals in relation to abbreviated new drug applications. Following is a roundup.

PrimalHyal™ Hydra[+], the novel cationic HA

PrimalHyal™ Hydra[+], the novel cationic HA

Givaudan Active Beauty expands the boundaries of skin hydration with the launch of PrimalHyal™ Hydra[+], a new cationic HA crafted by white biotech. This unique cosmetic active outperforms standard HA hydration benefits by at least a factor of 2.

'As a leader in cruelty free beauty, we're celebrating this milestone and reflecting on the passionate hard work from our campaign partner, Cruelty Free International, our retail teams and of course, our activist customers.'

Canada Set to Ban Animal Testing for Cosmetics, Body Shop Responds

The Canadian government's proposed amendments in Budget 2023 will prohibit the sale of cosmetics that rely on new animal testing data or display misleading product labeling pertaining to animal testing.

'The FDA has stopped accepting and processing submissions to the VCRP as a result of [the] FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).'

U.S. FDA Shuts Down Voluntary Cosmetic Registration Program

In an unexpected move, the U.S. Food and Drug Administration (FDA) has shuttered the Voluntary Cosmetic Registration Program (VCRP) and underscored this data will not migrate to the MOCRA portal.

'This new Brazilian norm is a welcome next step in the right direction ... However, a domestic testing ban on its own will not prevent the import and sale of newly animal-tested cosmetics from other countries.'

Brazil Prohibits Animal Testing for Cosmetics, Mandates Alternatives

The use of vertebrate animals, except human beings, in the R&D and quality control of personal hygiene products, cosmetics and perfumes that use ingredients or compounds with safety and efficacy already scientifically proven is prohibited.

The chemicals include some borate compounds, lily aldehyde, cyclotetrasiloxane, trichloroacetic acid, styrene and certain colors (see full list below).

[update] 26 More Chemicals That Could Get Your Products Banned in California

Assembly Bill 496, introduced on Feb. 7, 2023, proposes the addition of 26 chemicals to the state of California's existing Toxic-free Cosmetics Act. If passed, the bill would ban cosmetics containing them from being sold in the state.

PFAS are used in cosmetic products to condition and smooth the skin, or to adjust product consistency and texture. They may also be unintentionally added and present as impurities.

Five European Nations, ECHA Propose PFAS Bans/Restrictions

Five European nations submitted a proposal in January to the European Chemicals Agency (ECHA) to restrict and/or ban PFAS. The agency released details of the proposal on Feb. 7, 2023, and announced next steps.

A letter from the FDA to Valisure, dated Dec. 5, 2022, highlighted 'methodological deficiencies' and 'analytic descrepancies' in the company's testing.

FDA, Unilever and GSK Challenge Valisure's Benzene Findings, Test Methods

The FDA recently raised concerns over the test methods of Valisure, the Connecticut-based lab whose reports over benzene in sunscreen and dry shampoo products from Unilever, GSK and others have prompted recalls and class action suits.

'We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.'

U.S. FDA, Congress to Write CBD its Own Rules for Food, Supplements

After careful review, the U.S. Food and Drug Administration (FDA) has concluded that a regulatory pathway specific to CBD, rather than CBD foods and supplements, is needed to balance CBD product demand with the potential risks.

If you have registered under the Voluntary Cosmetic Registration Program (VCRP), you may be covered for the initial registration. However, cosmetic product registrations must be updated annually. New products must be registered within 120 days of introduction into interstate commerce.

7 Implications of the Modernization Act for Cosmetics

President Biden signed HR 2617 into law. What does this mean for cosmetic manufacturers? "A lot," according to Steinberg & Associates. The 1,653-page bill includes 14 pages on cosmetics. Read on to learn more.

The carcinogenicity hazard of titanium dioxide is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity.

European Union Annuls Carcinogenic Titanium Dioxide Label

The carcinogenicity hazard of titanium dioxide is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity.