This chapter presents an overview of regulations for cosmetics and personal care products in Australia, Brazil, Canada, India, and Russia. These countries are upwardly mobile nations with great potential for growth in the cosmetic and personal care markets. Each of these countries has its own set of changing and evolving rules and regulations that must be navigated through and carefully followed by cosmetic companies that aim to market their products in these countries. Cosmetic product manufacturers cannot decide to put their products on these markets without a lot of effort and careful study. Claim substantiation data, product stability tests, and microbiological tests including correct packaging and formulae must be available; it takes months and sometimes years before products can be sold in these countries. The chapter discusses the major regulatory agencies, definitions and product classifications of cosmetic products, product registration requirements, certifications needed, regulations related to ingredients, general labeling requirements, advertising and claim substantiations, and import regulations applicable to cosmetic products from foreign companies in these countries.

The list of possible cosmetic and antiaging claims of cosmeceuticals is almost endless, and actually increases daily with new discoveries of physiological effects in the skin. Whatever the claim, though, the basic dossier necessary to get away with it all in the eyes of lawyers, regulatory supervisory bodies, and in the end, judges, needs credibility based on data, their quality, their amount, their presentation, and their pertinence to the claim being made. The credibility of efficacy of a cosmetic product should be based on data obtained on the ingredients and/or the finished product. These data may come from studies carried out on human volunteers (such as self evaluation by consumers, with trained investigators, and/or with instrumental methods) or from studies on objects other than human volunteers. This chapter reviews some of the evaluation criteria and widely used methods and protocols and the legal framework for claim substantiation in the cosmetic industry. Several methods, in vitro and in vivo, are being used to establish cosmetic claim substantiation of cosmetics. It is very difficult to study complete finished formulations in in vitro models, as most ingredients (surfactants, preservatives, solvents including glycerin) are not compatible with the fragile cells in monolayer experiments; however, ex vivo protocols have several advantages in such studies. In the evaluation of the veracity of a claimed cosmetic effect, nothing can beat the in vivo (or clinical) tests, as they yield good statistical significance, possibly against a positive benchmark or untreated skin, which can explain, at least partially, the mechanisms behind the observed macroscopic effects.

In the early part of this decade, the European Commission signaled that it would seek to define a good manufacturing practice (GMP) for the manufacture of cosmetics. Although GMP was already a requirement in the Cosmetics Directive 76/768/EEC and its amendments, there was actually no definition of what that good manufacturing practice should be. Following petitioning from industry, the commission ceased work on its own document and signaled it would make reference to the new ISO standard for GMP for cosmetic manufacturing (IS0 22716), which was published in November 2007. The European Federation for Cosmetic Ingredients (EFfCI) took the initiative to define a GMP for ingredients to avoid application of the GMP for final cosmetic products and IS0 227 I6 drafts to the manufacture of cosmetic ingredients as well. Potentially this could have resulted in inappropriate controls and unreasonable costs being imposed on the cosmetic ingredient suppliers. This chapter explains why it was necessary to separately define a GMP recommendation for cosmetic ingredients, rather than accepting the GMP, which has been defined for cosmetics or pharmaceutical starting materials and gives a brief overview of the key features of the EFfCI guide. The emphasis in the guide is for cosmetic suppliers to concentrate on implementing the key GMP principles during the manufacture and supply of these ingredients. The successful implementation of the EFfCI GMP Guide will not prevent cosmetic manufacturers from placing other requirements on their suppliers, such as the audits hinted at in ISO 22716:2007. But at least once auditors arrive, they should observe a facility which is making cosmetic products that are safe and fit for their purpose.

The manufacturing industries have been experiencing increasing pressure from regulatory and government agencies and society in general on issues concerning human health and the environment. Green chemistry helps chemists and materials scientists to incorporate sustainable principles into their practices of creating products and developing processes. The field of green chemistry, since its beginnings in the early 1990s, has been growing in the scientific community at an ever-increasing rate. Green chemistry is a set of principles that speak to the design scientist at the earliest part of a product development program. It incorporates downstream implications at the fundamental molecular level. By anticipating potential problems around scale-up associated with regulatory and toxicological issues, it is possible to not only reduce costs from a variety of internalized and externalized sources but also streamline operations by increasing efficiency and time to market. This chapter discusses the twelve principles of green chemistry in the context of the cosmetics and personal care industries, and how the concerns can be addressed at a fundamental level. The cosmetics and personal care industry is taking initiatives to strive toward greener processes and products. However, as with all industrial sectors, much more work needs to be done. The need for more alternatives can be seen as a hurdle or as an opportunity.

All industries whose products are chemistry based are under increased regulatory compliance requirements. Regulatory compliance is an investment, not expenditure; those that adopt and implement them successfully gain competitive advantage. Achieving the required level of data accuracy to satisfy the implied requirements of product safety regulatory compliance mandates that all reporting related to formulation development and maintenance, procurement, inventory handling, production, and QA must be accurate. Satisfying the data accuracy prerequisites lays the foundation for leveraging regulatory compliance into a competitive advantage and an increased bottom line profit. There are seven key “ingredients” that contribute to this foundation: process-batch Enterprise Resource Planning (ERP), organizing the workplace (“5S” and Lean Manufacturing), making transactional reporting easier, data security and validation, compliance integrated into work activities, visibility into the warehouse (stockroom) and factory operations, and cycle counting. Workplace organization through simple analysis techniques such as “5S” and Lean Manufacturing makes procedures simple and mistake proof, and eliminates the waste of time, movement, and money throughout the enterprise. An ERP system has a centralized and complete database on every transaction associated with a product, formula, customer, department, supplier, inventory, customer order, purchase order, work-cell, schedule, batch, QA, cost, and financial ledgers. By placing personal computers networked to the process-batch ERP system using a user interface familiar to the workforce in a location easy to access by authorized personnel. Access to the ERP system is controlled through a role that each system user has assigned to them and Dual Electronic Signatures (DES). Process-batch ERP has predesigned “windows” that provide the authorized visibility needed to take prompt corrective action. Cycle counting is an important contributor to data accuracy and leveraging regulatory compliance into a competitive advantage. Concerns centered on bioterrorism have driven the many new regulatory compliance requirements.

This chapter provides a brief outline of the history of identifying fragrance substances responsible for perfume allergy risk in cosmetics, their selection and implementation into EU cosmetics legislation, and the global impact of this regulation on manufacturers, dermatologists, toxicologists, and cosmetic customers. One purpose of the Directive 2003/1S/EC of February 27, 2003 (commonly called 7th Amendment) was to specify the 26 perfume and aromatic composition substances that have been identified in fragrance-sensitive customers as cause of contact-allergic reactions. With the enforcement of the 7th Amendment (March 11, 2003), the INCI or substance names of these ingredients have to be mentioned on cosmetic ingredient labels in descending order, if their concentrations in the formulation exceed 0.001% (10 ppm) in leave-on products and 0.01% (100 ppm) in rinse-off products. Identification of the “26 Allergens” in accordance with the requirements of the 7th Amendment can be done by analytic studies, raw material questionnaires, or the downgrading system created by the German consumer magazine Ökotest. Scientific investigations and publications of the last six to seven years reflect upon, comment on, and protest against the disclosure of the “26 allergens.” The Risk and Policy Analysis report about the impact of European regulation on the EU cosmetics industry of September 2007 points out that the average total cost to fulfill the demands of the 7th Amendment were 81,2508€.

All cosmetic products are composed of at least one, most often many, chemical substances. However, in many cases “ingredients” found in cosmetic products are not wholly identified in their exact molecular composition or structure. This chapter addresses and clarifies the questions of what constitutes a “cosmetic ingredient”; what legislative framework governs their manufacturing, sale, and use; and how can the industry (both the ingredient suppliers and the finished product formulators) cope with the requirements that differ widely around the world? Any cosmetic product may be formulated with any type of ingredient (single substance or blend) as long as the ingredient is not prohibited by a specific “negative” list. There are two sides to the legal obligations with respect to ingredients used in cosmetic products: the supplier's side and the downstream user's side (formulators). Cosmetic ingredients (substances or blends) are regulated as chemical substances, and thus fall under the legislation ruling manufacturing, handling, transport, and labeling of chemicals and, if applicable, hazardous or dangerous substances. Legal frameworks and requirements for the manufacturer (or importer) of cosmetic finished products are many, and widely differ from country to country. These requirements include correct labeling of ingredients and possession of the product information package by product importer. The consequence of this general state of cosmetic legislation is that the entire legal responsibility for the safety, efficacy, and legal conformity of the finished product lies with the manufacturer or importer (the “marketer”). It follows from this that this entity (person or company) depends, in part, on the supplier of ingredients to furnish the relevant information. The chapter presents an overview of the global regulatory issues for the cosmetic industry, and describes what kind of information on ingredients is necessary, useful, obligatory, and why, and who provides it.

REACH is a European regulation on registration, evaluation, authorization, and restriction of chemicals (REACH), which was enforced on June 1, 2007. This chapter provides guidance on what typical requirements and responsibilities are under REACH, and what options companies have in addressing the REACH requirements and responsibilities, especially when dealing with the complexities of a supply chain. The main aims of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances in the internal market, and the enhancement of competitiveness and innovation. REACH is principally broken down into five stages: Material Safety Data Sheets (MSDSs), Preregistration, Registration, Authorization, and Restrictions. The first step in preparing for REACH is to assess products and define them as substances, preparations, or articles. Cosmetics generally fall under the definition of preparations; thus all ingredients require registration. Preregistration is free and only basic substance and company information needs to be submitted. Preregistration is required only for substances that could potentially be imported or manufactured in excess of 1 ton (per legal entity) in the following year. Registration is the largest, most important part of REACH. Complete substance identification (including compositional information of multiconstituent substances), testing data, and safety assessments must be submitted to the European Chemicals Agency (ECHA). The authorization and restriction requirements target known and suspected carcinogens, mutagens, and reproductive toxins as well as persistent bioaccumulative toxins and other chemicals of similar risk. Companies can use a two-phased approach to meet the requirements of REACH: phase 1 should address the identification of requirements, responsibilities, preregistration, and timelines, and phase 2 should focus on the execution of responsibilities including documentation, supply chain data gathering, and registration.

The global success of a brand relies on the ability to create packaging and brand image within the right regulatory framework. The first element in a product packaging is to consider how it is defined; in some countries, a product might be a drug, a cosmetic, or a separate group entirely, depending on the perspective of the regulatory agency. The second key element is the ingredients—from a labeling perspective. The last key element is the packaging component itself—the bottle, tube, vial, carton, plastic sleeve, etc. Many innovative product packaging ideas, shapes, styles, and materials have been developed, however the packaging components must meet the regulatory issues. This chapter discusses the regulatory requirements applied to the basic primary and secondary packaging components in the United States and European Union (EU). The “Statement of Identity” (SOI) is a mandatory requirement in almost all cosmetics markets unless the product function is obvious from the presentation (the packaging component). The net quantity of contents (weight claim) labeled on primary and secondary packaging is one of the most highly regulated requirements. Warnings and instructions for use of products are required to be labeled when mandated by regulation or when deemed necessary for the safe use of the product by the consumer. Typically, prominent and conspicuous warning statements must appear on both the inner and outermost packaging. In most countries, the ingredient listing using INCI names must be placed only on the outermost packaging. The name and address of the manufacturer, packer, or distributor is required in all countries. In addition to these basic regulations, there will always be additional labeling regulations that must be satisfied, depending on the country or region in which the product is to be marketed.

The term “cosmeceutical” has been widely used by the cosmetic industry to refer to cosmetics that also possess drug-like effects. Antiaging products are among the fastest growing segment of the skin-care market; many of them are claimed as “cosmeceuticals,” able to deliver rejuvenation benefits far beyond skin moisturization or merely covering up wrinkles. A significant amount of media coverage has been devoted to the topic of antiaging in recent years. Antiaging medicine practitioners claim that human life expectancy could be dramatically increased through certain chemical and/or lifestyle interventions including caloric restriction, genetic manipulation, antioxidants, hormone treatments, stem cell replacement therapies, and so on. New “cosmeceutical” products allegedly incorporating the benefit of such advanced medical interventions arrive at the storefront at an increasingly alarming rate. A market trend report published in 2005 stated that sales of “cosmeceuticals” in the United States would reach $12.4 billion in 2004 and continue to grow to over $16 billion by 2010. It is estimated that an average American encounters at least 1,500 advertising messages daily; many of them contain age-reversing, appearance-rejuvenating claims. In the United States, there are several regulatory mechanisms of advertising, labeling, and classification of consumer cosmetic products, including the Federal Trade Commission Act (FTC Act) enforced by the Federal Trade Commission (FTC), voluntary industry framework, private judicial actions targeting false and misleading advertising, and state laws. This chapter presents a brief overview of US and global cosmetic regulations. In the US, the US Food and Drug Administration (FDA) can only take postmarket enforcement actions on cosmetic products; premarket approval requirements are applied only for color additives in cosmetic products. The FDA's Voluntary Cosmetic Registration Program (VCRP) is not a requirement, safety-testing requirements are not mandatory, and good manufacturing practices (GMP) are encouraged.