Implementing a framework for quality in an evolving regulatory environmentBy Bartley D Maxon of Dow Home & Personal Care, and Uma J Kale of Dow Consumer Solutions - 09/03/2018
Much of the cosmetics industry lacks an overarching global standard. In the USA, the industry is largely self-regulated but is overseen by the Food & Drug Administration (FDA). The Cosmetic Ingredient Review (CIR) Expert Panel assesses the safety of cosmetics ingredients, and works with the FDA, the cosmetics industry and consumers in an effort to keep cosmetics safe. However, the list of substances prohibited or restricted by regulation in the US identifies 11 items. In comparison, in the European Union and Brazil, prohibited or restricted cosmetic ingredients number in the hundreds.
In addition to jurisdictional variation, the growing popularity of multi-functional cosmetics adds another layer of complexity. Scientific advances and growing consumer demands have given rise to product categories that straddle the traditional boundary between cosmetics and pharmaceuticals. Products that make therapeutic claims or offer functional properties beyond cleansing or changing the appearance of the body often fall under a regulatory “grey area.” These products, like sunscreens or anti-acne treatments, are regulated as cosmetics in some jurisdictions and as over-the-counter (OTC) pharmaceuticals elsewhere.
Throughout the supply chain, there is a desire to operate under a single solution that meets global compliance, but this is a challenging task.
Walking the quality–cost tightrope
Figure 1 presents some of the complexity of quality control and regulatory compliance for the manufacture of cosmetic and pharmaceutical ingredients. As the end use application or ingredient category moves from industrial to pharmaceutical, there are increased requirements for validation, documentation and testing, making the holistic view of one category to another vastly different.
Many chemical companies find themselves operating across the regulatory landscape and a broad spectrum of finished product categories. For instance, silicones are widely used in the cosmetic, OTC and topical pharmaceutical product segments for superior aesthetics and multi-functionality. They are also used as release agents in food applications and API in anti-flatulent drug products.
The growth of multi-functional cosmetics and regional variations in product categories, standards and regulations presents challenges and opportunities in today’s global marketplace. Through partnership, transparency and a flexible framework, suppliers can establish a quality system with manufacturing processes and controls that can satisfy the desired balance of customer expectations, industry standards and emerging trends.
This article is adapted from one published by TKS Publisher in the January/February issue of Household & Personal Care Today 2018:13(1).