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Section: Regulations > Safety

'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.

The bigger impact is that concerns over the potential endocrine-disrupting effects of bisphenols will no doubt put other cosmetic ingredients with the same alleged effects front and center (again), drawing interest from regulators.

Endocrine Disruptors in the EU, SCCS Opinions and NGO Pressure to Crack Down

From November 2022–February 2023, organizations in seven European Union member states tested 121 products and found bisphenols of high concern in 47 of them, per Chemical Watch. NGOs are urging regulators to impose stricter regulation on all bisphenols.

Eu D5 D6 Restriction Cosmetic Safety Regulation Adobe Stock 470991125

EU Lays Down the Law on Cyclic Silicones D5, D6 — Now What?

It happened. On May 16, 2024, the European Union officially adopted new restrictions on siloxanes D5 and D6, as promised. What drove this decision? And what can the industry do now?

Product safety is paramount for fast-moving consumer goods such as cosmetics and personal care products. Recent recalls and class action suits highlight this fact.

Benzene, Methanol and Lead Headline Recent Class Actions and FDA Alerts

Methanol in hand sanitizers and lead in a baby skin care are cited in the latest U.S. Food and Drug Administration recall notices, while benzene content in dry shampoo and spray sunscreens persists among class action suits. Following is a roundup.

L to R: Jaeran Lee, Ph.D., president of KCII and Anne Marie Api, Ph.D., president of RIFM.

RIFM and Korean Institute Finalize Fragrance Safety Assessment and Regulatory Information Collab

RIFM president Anne Marie Api, PhD., commented, “The signing of this Memorandum of Understanding, or MoU, with KCII marks another significant step forward in ensuring that the world can safely enjoy their favorite fragranced products."

The U.S. Food and Drug Administration (FDA) has issued stern warnings regarding methylene chloride, a banned substance detected in four gel nail polish removers.

Regulation and Safety Update: Methylene Chloride in Nail Products, Europe on PFAS, U.S. Recall Alerts and Talc Settlement Setback

This roundup highlights recent headlines in cosmetic safety and regulations, including FDA alerts on banned substances in nail products and efforts in the EU and France to curb PFAS. Updates on talc and recalled products are also noted.

The products include skin brightening lotions, creams, gels and soaps that contain hydroquinone, mercury and its compounds.

Kenya Bans 400+ Soaps and Skin Brighteners

The products reportedly contain mercury and hydroquinone compounds, which according to the Kenya Bureau of Standards (KEBS), can only be used with a physician's oversight.

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.

The UK and EU have made robust regulatory changes due to recently trending ingredient concerns. Updated guidances for lilial, DHA and cyclic silicones are outlined here, along with other regional updates.

European Regulatory Update: UK and EU Ingredient Management

The UK and EU have made robust regulatory changes due to recently trending ingredient concerns. Updated guidances for lilial, DHA and cyclic silicones are outlined here, along with other regional updates.

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P&G Detects Benzene in Antiperspirant and Body Sprays, Issues Recall

P&G has voluntarily recalled specific lots of Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products due to the detection of benzene.

Cyclic silicones and microplastics face bans under REACH but both contribute to the aesthetics and performance of color cosmetics.

How Cyclic Silicone and Microplastic Bans Impact Color Cosmetic Formulating

Cyclic silicones and microplastics face bans under REACH but both contribute to the aesthetics and performance of color cosmetics. This article describes these bans and what replacing them means for color cosmetic formulating.

China's National Institutes for Food and Drug Control (NIFDC) plans to introduce a more systematic and comprehensive standard consistent with the current industry situation.

China Drafts 2022 Safety and Technical Standard for Cosmetics

This draft will supersede the 2015 edition, which includes the overarching technical standards for cosmetics safety supervision and testing in China. Public comments will be accepted through April 30, 2022.

woman shopping in bulk product refill store natural zero waste concept AdobeStock_564462886.jpg

Microbiological Considerations for Refillable Bulk Cosmetics: Survey and Commentary

The commercial sale of refillable products in bulk now includes liquid galenic formulas. Their diverse flow chains pose unique microbial challenges, as shown here, underlining the importance of flow chain planning and assessment tools/strategies.

WomenOnBeachApplyingSunscreen_850x425

FDA Moves to Improve Quality, Safety and Efficacy of Sunscreens

The U.S. Food and Drug Administration announced recent activities that are part of its ongoing implementation of new authorities for certain over-the-counter drugs including sunscreens.

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J&J Voluntarily Recalls Benzene-containing Neutrogena and Aveeno Spray Sunscreens

Johnson & Johnson Consumer Inc. is voluntarily recalling all lots of five Neutrogena and Aveeno aerosol sunscreens as some were found to contain low levels of benzene.

Color Cosmetics Makeup Adobe Stock 215717433

Health Canada Updates Hotlist Ingredients: Colorants, Benzophenone, Talc and More

Concerns including adverse developmental and maternal effects were cited for the four ingredients added. Five amendments also were made, updating the hotlist for the first time since 2022. This follows a recent recall over henna cones containing phenol.

The inner packaging of a serum and product kit containing said serum listed SPF when the product has no SPF.

FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

In recent months, the U.S. Food and Drug Administration (FDA) reported six voluntary recalls for an impermissible color additive, mislabeled SPF and several contaminants. It also urged companies to be "recall ready" and provided final guidance to do so.

Germany, Denmark, the Netherlands, Norway and Sweden have submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) under REACH. The ECHA will publish the detailed proposal, reportedly one of the broadest in the EU’s history, on Feb. 7, 2023.

ECHA Adds to Hazardous Chemicals List, Reviews PFAS and Classification Proposals

The ECHA has added one cosmetic-related ingredient to the "hazardous" list, and received a five-nation proposal to restrict PFAS and three intentions/proposals to harmonize classification of cosmetic-related substances. See which ones are named.

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