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Section: Regulations > Regional

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[interview] U.S. FDA on MoCRA: New Authority, Fragrance Allergens, Animal Testing and More

In this interview, the FDA describes its new MoCRA-mandated authorities, 5 requirements for industry (and how it will enforce them), the mandate for listing fragrance allergens, why animal testing was omitted from MoCRA and more.

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days.

FDA Releases Update to Ongoing Activities Related to Serious Adverse Event Reporting for MoCRA

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days.

FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

The end of February was busy for the U.S. Food and Drug Administration (FDA), which published two letters on the Time and Extent Applications (TEAs) for diethylhexyl butamido triazone (Uvasorb HEB) and amiloxate (Neo Heliopan E 1000), finding insufficient scientific evidence to claim either as generally recognized as safe and effective (GRASE) and denying their addition to the OTC Sunscreen Monograph.

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.

Regulatory Review—Cosmetic Ingredient Update: The Ugly, the Good and the Bad

This review takes a look at updates to ingredient regulations as of the first quarter in 2012. While “the ugly” refers to the EU Chemical Agency’s (ECHA’s) release of the first ingredients to be evaluated under REACH, the good news relates to the battle in Canada to save D5. “The bad” are the state of California’s addition of three ingredients to the Proposition 65 list, as well as Health Canada’s caution against labeling using generic terms.

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Meet the Alternative to the Feinstein Bill

The Safe Cosmetics Modernization Act, an alternative to last year's proposed Personal Care Products Safety Act, makes sense and is supported by ICMAD. Here's why.

Recent ATPs and Their Effect in the EU and Abroad

The recast of the directive, known as the 8th Amendment, has been proposed. This amendment currently is in review by the European Parliament and Council of Ministers. If an agreement is reached, the personal care industry will see many sweeping changes, as reported in the June 2008 edition of this column.

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

Sunscreens and Pipe Dreams for their Regulation in the US

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

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Why the FDA's 'Sunscreens in the Bloodstream' Study is Flawed

A recent study published in the Journal of the American Medical Association tested the potential systemic absorption of certain sunscreens. Results identified their presence in subjects' bloodstreams; however, as industry expert David Steinberg explains, the study is misleading and fails to consider crucial variables.

The “Period After Opening” in the Jungle of EU Product Labeling

In the EU, a newly required “Period After Opening” designation on product labels has re-focused consumer information to address both a product’s safety and its functional performance over time. This has implications for consumers and for product testers.

The Future of Hair Dyes Under the New EU Regulation: A Discussion

The “recast” of the 1976 Cosmetics Directive was intended to make things simpler, but does it? This article reviews and comments on the EU’s regulatory position on hair dyes, as of the first half of 2013.

The European Regulation for Cosmetics: Who is the Responsible Person?

The Cosmetics Regulation (EC) No 1223/20091 is the main regulatory framework for finished products when placed on the EU market and introduces the notion of the responsible person.

Recent ATPs and Their Effect in the EU and Abroad

The recast of the directive, known as the 8th Amendment, has been proposed. This amendment currently is in review by the European Parliament and Council of Ministers. If an agreement is reached, the personal care industry will see many sweeping changes, as reported in the June 2008 edition of this column.

The Future of Hair Dyes Under the New EU Regulation: A Discussion

The “recast” of the 1976 Cosmetics Directive was intended to make things simpler, but does it? This article reviews and comments on the EU’s regulatory position on hair dyes, as of the first half of 2013.

Regulatory Review: The Proposed Amendment for Sunscreen Products in the United States

The US Food and Drug Administration (FDA) published the long-awaited Proposed Rules (PR) for sunscreens in the Federal Register. This column reviews some of the changes included in the amendment, citing pages of this document to provide additional details.

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Into the Weeds: Walking the Regulatory Line of CBD in Cosmetics

There is no outright prohibition against CBD-containing cosmetics, but this does not mean hemp products will no longer be regulated. This article reviews the ins and outs of CBD cosmetic compliance as the current U.S. legislation stands.

Article sponsored by Ashland

Unifying U.S. Cosmetic Regulation: The Challenges of the Personal Care Products Safety Act

The Personal Care Products Safety Act, a bill introduced this past April, proposes regulation of the cosmetics and personal care industry like no other legislation since the U.S. Food, Drug and Cosmetic Act of 1938. Perhaps the greatest issue for it to resolve, or fail to, is uniformity of that regulation.

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When it Comes to CBD, the FDA Wants to See the Receipts

The agency held its first hearing on cannabidiol (CBD) in Silver Spring, Maryland, on Friday, May 31, 2019.

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