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Section: Regulations > Regional

US and EU Regulations Update

United States – OTC Drug Review Call for Data On December 31, 2003, the FDA announced a call for data for an OTC drug review, for drugs that have not been reviewed as of this date. These include drugs sold before 5/11/72 (when the OTC drug review began) and identified by OTC category. Also included are OTC drugs marketed before 12/4/75 and described the DA’s general regulatory policy. The call for data covers these categories of ingredients, some of which have been considered to be cosmetics, not drugs: nasal moisturizer drug products, urinary analgesic/antiseptic drug products, urinary acidifiers and alkalinizers, aloe vera and urea, wrinkle remover products, lubricants and vaginal moisturizers.

EU Regulatory Update: CLP Deadlines and Consequences

The European Union’s adaptation of the Globally Harmonized System (GHS) is Regulation (EC) No. 1272/2008 on the classification, labeling and packaging (CLP) of substances and mixtures, which entered into force on Jan. 20, 2009.

REACH Update: SIEF Tasks and Registration Requirements

Substance Information Exchange Forums (SIEFs) are operational and critical for data-sharing and the subsequent preparation of joint registration dossiers. A SIEF is established when companies have agreed that their substance is the same.

David Steinberg discussed preservatives and particularly, preservative regulations in the U.S., Canada and the EU; their usage in products; and how the outlook on preservatives impacted the cosmetic industry.

Midwest SCC Outlines Preservative Formulating and Regulations

At the May 2021 Midwest SCC virtual meeting, David Steinberg discussed preservatives; particularly regulations in the U.S., Canada and the EU, as well as their use in products and how the outlook on preservatives impacts the cosmetic industry.

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IMCD and Mibelle Secure Partnership in Mexico

IMCD Mexico has secured an agreement with Mibelle Biochemistry for the exclusive distribution of cosmetic actives and functional food ingredients.

Accutane's Exit Could Fuel the Development of Topical Acne Treatments

Roche Holding AG has pulled its oral acne medication Accutane (isotretinoin), which could pave the way for its increased topical use or for the development of new topical treatments for severe acne.

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California Group Questions Safety of Triclosan in Antibacterial Products

Recent statements questioning the environmental safety of triclosan have been disputed by the Soap and Detergent Association (SDA).

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Global Cosmetic Regulatory Changes You Should Be Aware Of

During in-cosmetics Global 2019 in Paris, Percefoni Doufou-Shafiq, senior regulatory specialist, UL, highlighted several regulatory amendments as well as proposed restrictions that will impact both the U.S. and EU markets.

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.

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SCCP Re-evaluates Toluene and Benzophenone-3

The European Commission (EC) is requesting opinions from its Scientific Committee on Consumer Products (SCCP) on benzophenone-3 and toluene.

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Halal Regulations: Where Culture and Cosmetics Meet

For Muslims, additional rules for cosmetics are mandated by a unique source, the Quran, which implies further safety considerations related to the specific care of one's body. Halal certification, outlined here, is essentially a synonym for the careful supervision over all formula and production details, and its guarantee has gained interest from an increasing number of consumers.

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.

EU and US Discuss Animal Testing

A framework has been established between the European Union (EU) and the United States that is expected to produce greater cooperation in the cosmetic and personal care industry.

Evonik Opens Business and Innovation Center

Evonik released a news statement indicating the opening of its new Business and Innovation Center in Richmond, Virginia.

Recent ATPs and the 8th Amendment

Why does the Cosmetic Directive need the 8th Amendment? Some feel it is necessary since the directive has been changed 55 times, including seven amendments and 48 Adaptations to Technical Progress (ATPs). While the industry waits to see what this new amendment will bring, more ATPs have been published, as are described here. Science moves on contrary to political wishes.

Updates from Europe and the United States

European Updates The European Union (EU) Commission has not issued any changes to the Annexes of the Cosmetic Directive since September 2003 and lags in publishing many changes that have been approved. Adaptation to Technical Progress (opinions put through the EU and Ad Hoc committee review process) will be further delayed because they must be published in all EU languages. As of May 2004, the EU expanded from 15 to 25 countries, complicating the translation list.

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[update] US FDA Orders Lead Ingredient Out of Hair Color

The final ruling is a response to a color additive petition over safety concerns of lead acetate, which allows for gradual color change in "progressive" hair dyes.

PCPC Responds to Report of "Harmful Chemicals" in Personal Care

The Personal Care Products Council (PCPC) has responded to a study by the Silent Spring Institute that claims to have found harmful chemicals in a variety of personal care and household products.

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