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Section: Regulations > Regional

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.

Requirements range from creating an adverse event reporting system, and maintaining current and complete safety substantiation records, to ensuring facilities are registered with the FDA and more.

[poll results] How prepared are you for MOCRA requirements?

The Modernization of Cosmetics Regulation Act (MOCRA) goes in to effect on Dec. 29, 2023, giving the U.S. Food and Drug Administration increased authority over cosmetics. Are you ready for it? We want to know - please take our 1-click poll.

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.

Loose plastic glitter used as a cosmetic product can continue being sold until Oct. 16, 2029, for leave-on cosmetics.

How the EU Microplastics Ban Affects Glitter

The European Commission's (EC's) ban on microplastics intentionally added to cosmetics went into effect on Oct. 17, 2023. This includes some forms of glitter, individually and in mixtures, which the commission explained in a recent Q&A.

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.

A Modernization of Cosmetics Regulation Act (MoCRA) Compliance Checklist

Your proactive work to ensure compliance will help the industry move forward, increase consumer trust and loyalty and strengthen your own business.

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.

The draft guidance is intended to help ensure the safety of cosmetic products that many consumers use day-to-day. The FDA is accepting comments on the draft guidance until Sept. 7.

FDA Issues Draft Guidance for Cosmetics Company Product Registration and Submission

The draft guidance is intended to help ensure the safety of cosmetic products that many consumers use day-to-day. The FDA is accepting comments on the draft guidance until Sept. 7.

The EC's roadmap will include legislative and non-legislative actions to further reduce animal testing and aim to ultimately move to an animal-free regulatory system under chemicals legislation.

European Commission to Expedite Phasing Out of Animal Testing

Responding to the ECI, the EC provided a comprehensive overview of the EU's legislative and policy framework for animal testing and proposed creating a "roadmap" to further reduce animal testing.

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.

One guideline is to include quantitative information from control groups; specifically, companies should fully describe the comparator used.

FDA Finalizes Guidance on DTC Drug, Biologicals Promotional Labeling

While cosmetics are not drugs, the industry could take inspiration from the U.S. Food and Drug Administration's (FDA's) guidance from the Office of Prescription Drug Promotion on labeling direct-to-consumer (DTC) drugs and biological products.

Canada will now join more than 40 jurisdictions and major markets that have already passed laws to end or limit cosmetics animal testing and/or sales.

Canada Officially Bans Animal Testing for Cosmetics

On June 22, 2023, Canadian officials passed measures through the Budget Implementation Act, Bill C-47, prohibiting the sale of cosmetics that rely on new animal testing data to establish product safety.

'Canada's legislation is expected to pass soon and, when it does, the United States will be the only country in North America without a national ban on animal testing for cosmetics.'

Canada Commits to End Animal Tox Testing While MoCRA Misses the Mark

Bill S-5 in Canada has passed with royal assent to end animal testing for chemical toxicity; cosmetics are expected to be next. Meanwhile, MoCRA in the U.S. missed the chance to address this major industry issue, one source critiques.

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.

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