Regulations & EHS&S

Implementing a framework for quality in an evolving regulatory environment

By Bartley D Maxon of Dow Home & Personal Care, and Uma J Kale of Dow Consumer Solutions

Bartley D Maxon of Dow Home & Personal Care, and Uma J Kale of Dow Consumer Solutions, explain that the space between regulato

Bartley D Maxon of Dow Home & Personal Care, and Uma J Kale of Dow Consumer Solutions, explain that the space between regulatory imperative and consumer demand requires an unprecedented level of partnership between ingredient supplier and finished goods manufacturer.
Consistency in meeting high product performance standards is a hallmark of quality control, but we work in a marketplace where the regulatory landscape varies by jurisdiction, and consumer preferences evolve along cultural and regional lines. The globalization of the personal care market, the speed at which consumer trends come and go, the plethora of government regulations and the growing demand for ‘cosmeceutical’ products collectively create an environment which increases responsibility on the ingredient supplier to understand regulatory trends and requirements.
Moving targets
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.
Whether defined by jurisdiction or function, it’s critical to stay current on the regulatory status of ingredients. The vast majority of jurisdictional regulations and best practices are under nearly continuous scrutiny and revision.
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Singular solution
Throughout the supply chain, there is a desire to operate under a single solution that meets global compliance, but this is a challenging task.
Higher qualification expectations often call for increased traceability, process control and change management on the supplier side. These and other factors associated with stricter regulations generally result in higher ingredient costs. A quality system for active pharmaceutical ingredients (API) and excipients requires considerable investment, and greater time and resources to design and implement, than for cosmetic ingredients.
Another factor that impacts cost is the decreasing level of flexibility as product categories move from industrial grade to topical pharmaceuticals. At one end of the spectrum, ISO 9001 is a standard that gives suppliers and producers the flexibility to adapt their quality system requirements to meet varying industry needs. It does not define the end use of an ingredient nor does it prescribe specific requirements. At the other end of the spectrum, the GMP guide for API is specific to pharmaceutical applications and prescriptive in its requirements.   

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.

Clearly, a static standard of quality control might meet objectives in one product category, but fall short in another. The biggest challenge is establishing a flexible quality system that can balance customer expectations and emerging trends – while remaining compliant with current regulations.
End use familiarity
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.
To help navigate these regulatory waters, the supplier’s quality management system must balance a full range of factors. This includes regulatory and industry standards, adaptation to emerging trends and adherence to product performance. The quality framework would be built on quality risk management principles that identify three key steps in the process: risk analysis, mitigation and review (Figure 2).
Successful implementation of the three-step risk management process demands transparency between ingredient supplier and finished goods producers to determine the “where” and “why” of end-use applications. An ingredient manufacturer must work closely with its customers to understand use, evaluate governing standards and regulations, and apply these factors to the manufacturing process.
Working together
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.
Bartley D Maxon, Senior Technical Service & Development Scientist, Dow Home & Personal Care; Uma J Kale, PhD, Senior Regulatory Specialist, Dow Consumer Solutions.

This article is adapted from one published by TKS Publisher in the January/February issue of Household & Personal Care Today 2018:13(1).