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Section: Regulations > Safety

In the case of fluctuating PET results for w/o products, it can be useful to increase the number of samples to verify the results.

Determining Preservative Efficacy in W/O Formulas, Part II: Making Microbiological Safety Assessments

The relevance of microbiological tests for w/o formulas has been questioned, mandating a more holistic approach. This second article in a series examines the failure rate of PETs for w/o products but looks at why this does not mean insufficient stability.

Eighteen studies identified complications such as rash, irritation, immune system disorders, stratum corneum DNA damage and hormonal disruption.

Literature Review Connects Sunscreen Absorption with Potential Adverse Effects

A literature review published in Dermatology Research suggests the potential adverse effects, i.e., irritation, rashes, hormone disruption, etc., of sunscreen ingredients absorbed into human skin and present in human plasma and urine.

This two-part series will explore the current regulatory environment for color additives in the U.S. (Part I) and global (Part II) cosmetic markets. It will also examine the unique chemistry of naturally derived colors and their benefits.

Red Tape and Golden Opportunities in Natural Cosmetic Colorants, Part I

This two-part series will explore the current regulatory environment for color additives in the U.S. (Part I) and global (Part II) cosmetic markets. It will also examine the unique chemistry of naturally derived colors and their benefits.

The 'Skin Facts!' Initiative aims to help consumers understand the potential risks and to help identify whether the products they purchase contain these harmful ingredients.

FDA Issues Warnings, Pushes Consumer Education of OTC Skin Lightening Products

The FDA is once again cracking down on companies selling skin lightening products containing hydroquinone or mercury. Its public health campaign, Skin Facts!, urges consumers to get educated on skin care ingredients.

The NMPA gave notice of this format change on Aug. 19, 2022, stating it will deliver electronic certificates via the administration’s online platform,

China Moves Special Use Cosmetic, Ingredient Certificates to E-format

Starting on Oct. 1, 2022, China’s National Medical Products Administration (NMPA) will only issue registration certificates, including those that are updated or extended, for special use cosmetics and new ingredients electronically.

DSM has gained the support of 11 U.S congress members in order to change the ruling of sunscreen as a 'weather-related' protector into a more broad definition in order to require employers to provide sunscreen for employees.

DSM Gains Congressional Support to Declare Sunscreen as PPE

DSM has gained the support of 11 U.S. Congress members to change the designation of sunscreen as a "weather-related" protector to a more critical component of PPE, in order to require employers to provide sunscreen for employees.

With an increase in sustainability, consumer focus and particularities from consumers about health concerns, the press release from PASS furthers the discussion of regulations in sunscreen and other application products.

PASS Weighs in on NAS Report Finding Insufficient Data for Sunscreen Bans

Responding to increased interest in sustainability and consumer health concerns, the Public Access to SunScreens (PASS) Coalition released a statement responding to recent NAS findings and furthering the discussion of regulations in sunscreens.

The company announced in 2020 that it would stop selling the baby powder in the United States and Canada.

Report: J&J Ending Sales of Talc-based Baby Powder in 2023

Reuters reports that J&J faces about 38,000 lawsuits from consumers claiming the products caused cancer due to contamination with asbestos. J&J continues to deny the allegations.

'...There is currently insufficient relevant and reliable scientific data to conduct realistic ERAs and there is not enough scientific data to support sunscreen ingredient bans,' wrote the Personal Care Products Council (PCPC).

PCPC on NAS Report: 'Not Enough Data to Ban Sunscreens'

The Personal Care Products Council has released a statement responding to the National Academy of Sciences Report, "Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health."

Revisions include adding “special cosmetics” and “cosmetics using new ingredients” to the key categories of sampling testing.

China Revises Cosmetic Sampling Testing Rules, Calls for Comments

The measures will focus on testing in children’s cosmetics, special cosmetics and cosmetics containing new ingredients. Measures are open to public comment through July 14, 2022.

Patient applying psoriasis relief cream

FDA Approves Dermavant’s VTAMA Cream, 1%, for the Treatment of Plaque Psoriasis in Adults

Approved for mild, moderate and severe psoriasis with no restrictions on duration of use or body surface, see why VTAMA Cream, 1%, may help your patients.

'I’m glad we were able to work in this legislation to ensure the FDA can, at long last, provide meaningful oversight to cosmetics and dietary supplements.'

US Senate Bill to Strengthen Cosmetic Oversight Advances

Among other changes, the bill would make the FDA's Voluntary Cosmetic Registration Program mandatory.

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.

Henkel is conducting this voluntary recall with the knowledge of the U.S. Food and Drug Administration.

Henkel Recalls Alterna Bond Repair Leave-in Heat Protection Spray

Henkel has so far received no reports of harm or injury in connection with this product.

The company responded stating its entire sun-care range is free of the two ingredients that are harmful toward reefs: oxybenzone and octinoxate.

Bondi Sands 'Reef Friendly' Sunscreen Hit with Class Action Suit

The class action suit in the United States alleges the company's sunscreens claim to be "reef friendly" while they are harmful to the environment.

As the first quarter of 2022 came to a close, several regulatory changes were announced in the Asia-Pacific region. Following is an overview, which includes ingredient restrictions, claims guidelines, adverse reactions and more.

Asia-Pacific Regulatory Update: GMPs, Safety, Ingredient Restrictions, Claims and More

As the first quarter of 2022 came to a close, several regulatory changes were announced in the Asia-Pacific region. Following is an overview, which includes ingredient restrictions, claims guidelines, adverse reactions and more.

The FDA has received reports of serious side effects including skin rashes, facial swelling and discoloration from the use of skin brighteners containing hydroquinone.

FDA Flags 12 Companies for Illicit Hydroquinone-containing Skin Brighteners

The products contain the active drug hydroquinone, rendering them unapproved over-the-counter (OTC) drugs rather than cosmetics.

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.

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