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20 GLOBAL REGULATIONS


The safety of a cosmetic relies on its ingredients Cosmetic regulations are built on a common principle that the safety of a product primarily relies on the safety of its ingredients. To that end, regulations of cosmetics across various regions are mainly interested in the quantity of a given substances within a formula as well as the final cosmetic product type in which the substance is included. To stay on theme, here too we find a degree of


variability. Once again, you will find that different limits and exceptions are found in different regions, creating circumstances where a formula is compliant in one market but not another. The United States largely looks to the


Federal Food, Drug, and Cosmetic Act of 1938, which regulates a small number of substances. By contrast, you will find more than 4,000 substances in EU Regulation 1223/2009 on cosmetics, which builds a comprehensive framework for the regulation of cosmetics in Europe. EU Regulation 1223/2009 on cosmetics


introduced a detailed list of prohibited substances along with limits on permitted ingredients. Afterwards, several other countries began using the EU standard as reference for implementing their own laws and regulations. China, for example, has implemented a similar approach for regulating cosmetics, albeit with some modifications. Knowing that different countries will define limits on the ingredients of cosmetics with their own safety standards in mind, companies must track these requirements to stay compliant. Formulating a product to less defined


regulations, such as the Federal Food, Drug, and Cosmetic Act might limit the global reach of a product, especially when compared to the more rigid standards of EU Regulation 1223/2009 on cosmetics. When compliance steps are taken during


the early stages of new product development, companies can gain a competitive advantage,


PERSONAL CARE July 2021


reducing the number of reworks and back and forth between Regulatory Affairs and the lab. In researching and documenting different regulations as part of the innovation process, manufacturers gain insights into market strategies. Using a PLM solution (Product Lifecycle


Management) capable of managing limits on specific ingredients and tracking substances according to regulation assures products stay compliant. A solution with traceability reduces human error, giving visibility into how compliance steps have been executed during each stage of production.


Regulation also comes from within With no consensus from global governing bodies, the cosmetics industry has learned to look inward for best practices. By creating and demonstrating responsible practices, industry groups have established international standards for protecting consumers. This is especially true for fragrances, where


the International Fragrance Association, or IFRA, have helped to develop standards adopted throughout the world. By basing decisions on highly scientific studies, IFRA is able to provide guidance on products made from complex ingredients, especially substances with natural origins being used in perfumes. Self-regulating industry groups like IFRA


help companies align practices and standards to existing global regulations. This includes evaluating and understanding maximum dosages and substance limits for products. By sorting through the confusing regulatory space for manufacturers, groups like IFRA support the creation of complex products, such as face creams, fragrances, or candles, that are in agreement with existing expectations. Technology solutions that account for


guidance from industry groups like IFRA make compliance checks easier. Certain PLM solutions are capable of reaching the levels of granularity needed for regulatory affairs specialists to successfully perform their duties,


including analysis on formulas and the ability to create IFRA certificates that can be shared with customers.


It is only natural to be confused “Natural” claims in beauty products are a complex discussion in and of itself. Natural is one of the most popular trends in the beauty and cosmetics industry, but with no regulation defining the term, “natural” has become a prime use case for compliance confusion. For example, is water natural? Some say yes,


others say no. Considering that water is often the first ingredient in several cosmetics, this distinction makes a difference. Often, naturality standards are relative


to the number of natural ingredients in a formula. The same is true for vegan and organic claims. These attributes can be difficult and time consuming to verify, especially when silos in the lifecycle create splits between the lab, the suppliers, and regulatory team. But safety is still top of mind for companies making natural claims. Consumers believe natural products are


safer than synthetic ingredients, even if that is not necessarily true. Of the 26 cosmetic allergens, 18 are from natural ingredients. Because of this, there is a greater need for safety in natural beauty products. The allergen-prone and potentially harmful


risks associated with some of these natural ingredients, including essential oils and fragrances, make the guidance from IFRA particularly useful. Fragrances and essential oils are complex


natural extracts which often contain allergens. More complex than synthetic ingredients, extracts and essential oils are regulated by IFRA’s globally accepted standards. Clear labelling of allergens is very important for consumers and manufacturers. After a product is assessed for safety, it must be transparently labelled. Failing to do so not only risks reputational damage but puts consumers at risk.


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