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Section: Regulations > Regional

FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

'May Contain' Ingredient Disclosures

The US Code of Federal Regulations lists1 the rules for displaying ingredients, and besides outlining the content that must be included and its order of appearance, the regulation describes use of the “may contain” clause, which while legally only applies to pigments, has been abused and is thus the main topic of this column.

EU Regulatory Update: Cosmetic Ingredients Under EU Scrutiny

In the EU, numerous mandates for new scientific opinions have been posted in 2011, with a specification of the assessment criteria and goals. The application areas mostly focus on the new and ongoing ingredient assessments of hair dyes, preservatives and UV filters.

Industry Debate: US FDA vs. Sunscreens

During last month’s NYSCC Suppliers' Day, several attendees expressed frustration regarding the delay of the US Food and Drug Administration’s Final Sunscreen Monograph. Cosmetics & Toiletries asked its LinkedIn members to comment. Here’s what the market had to say.

EU Regulation No. 1223/2009, Part III: The Responsible Person

This column is the last in a three- part series on the European Union’s (EU) Regulation No. 1223/2009,1 which was published on Dec. 22, 2009.

EU Regulation No. 1223/2009 Part 2: Prohibited Ingredients, Definitions and More

In total, EC No. 1223/2009, often called the Recast or the 8th Amendment, is comprised of a preamble with 71 parts (justification), 40 articles (replacing the old 15) and 10 annexes (replacing the old nine).

The Impact of Junk Science on R&D: A Review of the 'Dirty Dozen'

Last spring, the David Suzuki Foundation, an environment conservation group based in Vancouver, published a report online describing what it called the “dirty dozen” cosmetic ingredients consumers should avoid. The group went so far as to provide a downloadable pocket guide of the 12 ingredients for consumers to use when they shop to avoid purchasing products containing these ingredients.

EU Regulatory Update: Provisions for CMRs

The first application deadline for Regulation (EC) No. 1223/2009, the recast of the Cosmetics Directive, is approaching. As of Dec. 1, 2010, the new provisions [Article 15(1&2)] on use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) will apply and Article 4b of the Cosmetics Directive 76/768/EEC will be repealed.

Comparatively Speaking: cGMP vs. ISO

Tony O'Lenick draws on the expertise of Joe Albanese of 3V Inc. to discuss the differences between cGMP compliance and ISO certification.

EU Regulation No. 1223/2009 Part 1: Product Safety

The European Union (EU) has published the long-awaited Regulation No. 1223/2009 on Dec. 22, 2009. At 151 pages, it is a lengthy read and when it goes into effect on July 11, 2013, it will make the EU the most highly regulated cosmetics industry in the world.

EU Regulatory Update: Enforcing REACH

Responsibility for the enforcement of REACH lies with the EU Member States and is divided into two pillars—the catalogue of penalties applicable for infringements and a system of official controls.

From California to Colorado: Three Battles Against Cosmetics

In 2004, State Assemblyperson Judy Chu (D–Monterey Park, CA) fired the first bullets at the cosmetics industry by introducing a bill in California to ban certain ingredients from all cosmetics sold in the state.

EU Regulation Update: Tackling the Animal Testing Ban

The European Federation for Cosmetic Ingredients (EFfCI) has developed an approach for its members to address animal testing bans imposed by the 7th Amendment to the EU Cosmetics Directive.

The FDA's 'Wish List': A Unified Agenda

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the publication of a semiannual inventory of the rulemaking under development, and the US Department of Health and Human Services (HHS) publishes this wish list for the FDA. The latest came out on Dec. 7, 2009.

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.

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.

EU Regulatory Update: Recast of the Cosmetics Directive Published

Regulation (EC) No 1223/2009 was published on Dec. 22, 2009 with the intent to simplify rules and procedures related to the marketing of cosmetic products, a need resulting from different implementations of the Cosmetics Directive.

Net Contents of a Cosmetic: The ‘E’ Mark and Units of Measure

Recently, some European Union member states have expressed concern over the misuse of the Estimated Symbol (℮), often referred to as the “e” mark, on product labels. In addition, some regulators have argued that the International System of Units, known as the metric system, should be used on all product labels to indicate the net contents of a finished product. Both of these concerns have fueled the present column in which the author debates how product labels should indicate the net contents of a cosmetic product. In closing, he comments on the jurisdiction of the CPSC in the United States.

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