Recent in Updates by Region (page 27 of 28)

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.

Canada Updated

At the December 2003 Society of Cosmetic Chemists annual meeting, I presented a one-day session on international cosmetic regulations, and concluded by saying that 2004 would be the year of Canada. So far in 2004, three major changes have occurred.

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.

California Update

On August 26, 2004, the entire cosmetic industry dodged a bullet--or rather, Armageddon–by a single vote. The California Assembly rejected a bill that would have prohibited California companies from making or selling cosmetic/personal care items that contain phthalates and other ingredients considered under this law as toxic. The vote was 4 in favor, 5 opposed and 10 others either abstained or weren’t present.

Implementing 21 CFR Part 11 in Cosmetics

21 CFR Part 11 specifies the comprehensive set of administrative, procedural and technical controls that must be implemented when data files, records and signatures are created, maintained or archived in an electronic format as part of a program to comply with FDA rules. In the cosmetics industry, specific applications are in development and testing of OTC drugs and color additives.

USP: Setting Ingredient Standards

This article gives an overview of the standards-setting process used in the United States Pharmacopeia and National Formulary (USP–NF), an annual publication that helps to ensure the integrity of ingredients used in cosmetics, toiletries and other personal care products.

Effect of New Regulations on Hair Colouring Products in the EU

The author suggests that current and evolving regulations may lead to a positive list and fewer allowed raw materials for hair colouring products in the European Union.

World Progress in Cosmetics Regulation

There have been several important changes from the U.S. Food and Drug Administration (FDA), Japan and the European Union (EU) which will affect cosmetics sold in these countries. The additions in Japan and the safety issues raised by the Scientifi c Committee on Consumer Products (SCCP) in the EU will impact formulators worldwide by permitting once-restricted ingredients, requesting more safety evaluations or changing labeling requirements.

Industry Updates in the European Union

Since my last column on Europe,1 the European Union (EU) Commission issued two new Adaptations to Technical Progress (ATP) and the EU’s Scientific Committee on Consumer Products (SCCP) issued several opinions. There was some good news and some bad news.

California Revisited

With the 2005 session of California’s Senate and House, 2 new bills were introduced that could restrict and regulate cosmetics uniquely to California. These bills are Assembly Bill 908 and Senate Bill 484. By D. Steinberg

The Name Game--SCCP Replaces SCCNFP

By order of the European Commission, in 2004 the Scientific Committee on Cosmetics and Non-Food Products (SCCNFP) became officially known as the Scientific Committee on Consumer Products (SCCP). What does this name change signify, and why was it necessary?

Federal Laboratory Technology

The Federal budget for research and development proposed for the fiscal year 2003 is $112 billion. About $59 billion is for defense-related R&D, and about $53 billion is non-defense related.

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