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Section: Regulations > Safety

October was the deadline but it came and went without a MOCRA portal to show for it.

FDA to Industry: Review SLP Guides, Gather Data Until MOCRA Portal Launches

October was the deadline but it came and went without a MOCRA portal to show for it. As the industry waits, the FDA advised members to continue collecting data and reviewing guidance documents — including the latest one for Structured Product Labeling.

According to the company, the tool can save organizations hours in time typically spent on regulatory and retailer standards review.

Cosmex AI Takes Regulatory Compliance for Cosmetics to the Next Level

Those who were wondering how artificial intelligence (AI) might take cosmetic product development to the next level now have their answer. Cosmex AI can scan 30,000+ ingredients to instantly indicate if a product complies with regulators or retailers.

According to the European Environmental Bureau, this indicates the commission 'bows to chemical and farm industry pressure yet again.'

EC Delays REACH Yet Again, 'Abandoning' Chemical Reform

The European Commission's 2024 Work Program was recently rolled out with a glaring omission — REACH provisions, "backtracking on its pledges made under the 2020 Chemicals Strategy for Sustainability," per the EU Observer. This was not the first time.

The three-judge appeals panel reportedly wrote that 'the lower court failed to fulfill its 'gatekeeping role' of assessing whether the plaintiffs’ experts based their testimony on sound science.'

$223 M Talc Verdict Against J&J Overturned on 'Junk Science'

According to NJBiz, in an Oct. 3 ruling, a federal appeals court overturned a $223 million jury award and ordered a new trial because the awarding jurors were allowed to hear "improper scientific testimony" linking J&J's talc-based products to cancer.

This article provides regulatory updates primarily in China and India, as well as Thailand and South Korea. Topics include formula submissions, new ingredients/safety, Korean standards, India cosmetics rules and more.

Formulas, New Ingredients/Safety, South Korean Standards, India Rules 2020 and More

This article provides regulatory updates primarily in China and India, as well as Thailand and South Korea. Topics include formula submissions, new ingredients/safety, Korean standards, India cosmetics rules and more.

For certain 'leave-on' cosmetic products, per the new restriction, due to their low contribution to the overall emissions of microplastics, as well as the potentially large impact on the cosmetics industry, the agency's committee for socio-economic analysis considered two additional measures as appropriate alternatives to the ban.

European Commission Adopts Measures Restricting Intentional Microplastics

The measures will prohibit the sale of microplastics and of products to which microplastics have been added intentionally and that release those microplastics when used.

All updates were effective immediately upon release except the revised test methods, which are scheduled to come into force on March 1, 2024.

China Updates: Benzene Limit, 19 Test Method Revisions, Benvitimod/Tapinarof Ban

China’s National Medical Products Administration (NMPA) recently issued Notice No. 41, limiting benzene impurities in cosmetics, revising five and adding 14 test methods, and banning the tapinarof skin treatment for psoriasis.

Chemist Naturals Formulating Concept Preservation Adobe Stock 187290417

The Preservative Quagmire

In this commentary, consultant Steve Schnittger, Ph.D., previously the vice president of global microbiology and fermentation in R&D for the Estée Lauder Cos., shares his thoughts and suggestions about preservation — a major pain point for the industry.

Nanomaterials Data Submission Request Uk Adobe Stock 616588391

UK Seeks Data, Reports on Testing the Safety of Nanomaterials in Cosmetics

The UK's Office for Product Safety and Standards (OPSS) is calling for data and any scientific information related to assessing the safety of nanomaterials in cosmetics.

J&J, in the meantime, is suing four doctors who published studies linking talc-based personal care and cancer based on 'junk science,' per Reuters.

J&J's Second Talc-related Bankruptcy Attempt Denied

For a second time this year, the courts have ruled against Johnson & Johnson's (J&J's) appeal to file for bankruptcy under the subsidiary LTL Management to settle talc-related suits.

While the company stands by its science, it is ending the global sales of baby powder containing mineral starch and switching to a formula based on corn starch,

$18.8 M Payout in J&J Talc Lawsuit Could Upset Settlement Offer

The ruling could sway individuals in the tens of thousands of other cases to also pursue claims in front of a jury, pressuring the judge overseeing the settlement case.

Talc Bottle Tipped J&j Ltl Management Talc Settlement Adobe Stock 488810926

J&J's Talc Bankruptcy Settlement to be Put to the Test

Reuters reports J&J's second appeal for a proposed $8.9 billion settlement and bankruptcy claim through subsidiary LTL Management will be tested this week as a New Jersey judge reconsiders the company's eligibility.

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.

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 guides are regularly revised to incorporate the progress of scientific knowledge in general and the experience gained particularly in the field of testing and safety evaluation of cosmetic ingredients.

11 Changes to SCCS Guides for Cosmetics Safety Testing — Plus a Note on 'Nano'

The European Union's (EU's) Scientific Committee on Consumer Safety (SCCS) recently updated its notes of guidance (NoG) for cosmetics and cosmetic ingredient safety testing, emphasizing alternatives to animal testing and more.

The legislation follows recent negative reports about materials such as PFAS and formaldehyde, including a 2022 NIH study that noted, 'Women who used chemical hair straightening products were at higher risk for uterine cancer compared to women who did not report using these products.' These concerns have most often impacted Black women in particular, but could conceivably also impact any person with textured hair.

Washington State Law Addresses Cosmetic Chemicals Targeting 'Vulnerable' Populations

As of January 1, 2025, the law prevents the manufacture, sale and distribution of products containing the targeted materials.

In short, AB 2771 is a complete ban up and down the supply chain on the intentional inclusion of PFAS chemicals in cosmetic products, and companies have a little under two years to prepare for and comply with the ban. Here's how.

What California’s PFAS Law Could Mean for the Cosmetics Industry Nationwide

While it is not entirely possible to avoid potential litigation, companies can reduce their risk of suit by paying close attention to labelling, advertising and other representations about the safety, contents and ESG impacts of their products.

On May 8, 2023, a federal judge ordered J&J and the attorneys representing the plaintiffs to begin settlement negotiations while the second bankruptcy filing is reviewed.

J&J's $8.9 B Talc Offer Rejected, Mediations Ordered, Bankruptcy Revisited

Last month, J&J agreed to pay $8.9 billion through subsidiary LTL Management to settle lawsuits alleging its talc products caused cancer. Mediations to negotiate those settlements have been ordered while a second bankruptcy filing is under review.

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