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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.

Sunscreen Claims: Demystified?

As you know, sunscreen products are regulated by the U.S. Food and Drug Administration (FDA) as drugs because they are “intended” to prevent disease (skin cancer). As such, they are required to follow the rules and regulations as mandated by the FDA. Thus, they must use Drug Facts labeling; list the drugs (sunscreen actives) using the proper drug nomenclature; list the percentage of drug used; specify the drug function (sunscreen) and label; warnings and directions for use, etc.

Cosmeceutical Regulations–A Global Overview

Cosmeceuticals are not regulated as such in the Europeon Union, United States or Japan. In the EU, most are considered cosmetics; in the United States, most are seen as drugs that probably have not been approved by the U.S. Food and Drug Administration (FDA). In Japan, they are regulated as quasi-drugs. As you can see, we go from the extremes of limited regulated cosmetics in the EU to pre-approvals in Japan, and fi nally a lack of enforcement in the United States.

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.

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.

Canadian Cosmetic Ingredient Labeling

The global harmonization of ingredient labeling is forever a dream that formulators will chase as new regulations are accepted and product labels are changed accordingly to meet each country’s specifications. In November 2004, Health Canada issued new cosmetics ingredient labeling requirements. 1 Before they were issued, Canada did not require ingredient declarations on labels. If ingredients were listed, formulators faced the unique challenge posed by French language laws in the province of Quebec—if a U.S.-approved label was used, the label needed translating into French, including all International Nomenclature Cosmetic Ingredient (INCI) designations.

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?

Canada Adds Isoprene and Epichlorohydrin to Ingredient Hotlist

The Canadian government announced the publication of final conclusions and initial risk management approaches for Batch 2 substances in the Chemicals Management Plan. Batch 2 included 16 substances.

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

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.

Numbing Products Reported to Cause Health Concerns

Topical anesthetics desensitize nerve endings that lie near the surface of the skin with anesthetic drugs such as lidocaine, tetracaine, benzocaine and prilocaine in a cream, ointment or gel.

SCCP Assesses Tea Tree Oil

When exposed to air and heat, tea tree oil is prone to oxidation and yields epoxides and other oxidation products that contribute to its skin sensitizing potential.

ECVAM Approves Harmonized Lymph Node Assay Standards

ECVAM's Scientific Advisory Committee has endorsed the scientific validity of the harmonized ECVAM performance standards for the Local Lymph Node Assay.

California EPA Publishes Green Chemistry Policies

As part of its Green Chemistry Initiative, the California Environmental Protection Agency (EPA) has published its six policy recommendations to strengthen the protection of public health.

Looking Ahead at Asia’s Personal Care Industry

The following Q&A delves into the trends and issues facing the person care market in Asia. The answers are given by personal care experts

REACH: Taking Steps to Register Preregistered Substances

To ensure sufficient time to organize data-sharing and prepare registration dossiers, potential registrants are recommended to perform the necessary follow-up steps as soon as possible.