There are many practical differences in the regulation of cosmetics in various jurisdictions around the world. However an important feature common to all schemes is the onus on the manufacturer to produce a safety assessment before marketing a cosmetic product.

The history of cosmetic regulation is tightly intertwined with the discipline of toxicology and safety assessment. One of the first modern legislative instruments used to control the use of cosmetics was the establishment of the United States Food, Drug and Cosmetic (FD&C) Act in 1938. This legislation was enacted in part due to adverse reactions of a product called Lash Lure. Importantly, the FD&C was also the first law to prescribe animal toxicity testing (1958).

Trust vs. Regulatory Responsibilities

The common denominator for government, suppliers of cosmetic products and the public is the idea of trust. Underlying trust is that cosmetic products, when used in the manner that they are intended (or even in forseeable misuse), are safe.

For cosmetics, safety assessment is usually encoded in legal/regulatory responsibilities and a requirement for manufacturers to assess the risks of their products before placing them on the market.

The dilemma for all is how to demonstrate safety when it is not possible in an objective manner to draw a line between "safe" and "unsafe" exposures to cosmetics. Safety implies the absence of risk, but for scientists, it is practically impossible to prove something that does not exist. In reality, safety is translated in the modern world as the assessment of risk and the subsequent management of it. The scientific process for safety assessment of cosmetics has emerged over the past two decades as a discipline allowing for a consistent, conservative and standardized approach. The complex nature of such safety assessments leads to the temptation in some sections of the community to call for zero-risk policies.

EU Test Ban on Animal Experimentation

The European Union (EU) test ban on animal experimentation marked an important change in the safety assessment process between the EU and the rest of the world. The 7th amendment to the EU Cosmetics Directive prohibits animal-tested cosmetics in Europe after 2013. It was intended that the 2013 deadline could be further extended in case alternative and validated methods were not available in time. It is now apparent that for many important toxicity endpoints alternative methods are not available.

These include skin sensitization, repeat dose toxicity, carcinogenicity, and reproductive toxicity. The test ban can be partly credited with the rapid development of alternative in vitro testing techniques that have been validated and approved by the Organisation for Economic Co-operation and Development (OECD) for endpoints such as skin and eye irritation, skin penetration and phototoxicity. In addition the test ban has promoted screening procedures based on previous knowledge (e.g. structure activity relationships) or exposure (e.g. the use of threshold of toxicology concern).

The plausibility of whether a very small exposure to a chemical can translate to health effects in people has been a community conundrum for decades. The conundrum continues as scientific advances are made in understanding the biological events such as the importance of chemical induced endocrine activity or epigenetic changes in disease formation. There is no doubt that basic toxicity testing in animals is needed to address such questions.

Regulation

The extent of regulation and the content of cosmetic regulations differ around the world. In the US, Australia and some parts of Asia and Africa, premarket notification or registration of cosmetic products is not required. The burden is on the manufacturer to sell products that are safe and are accompanied by clear instructions to ensure the product can be used safely. The manufacturer is responsible for product assurance. Such self regulation approaches may work best in jurisdictions where legal instruments around product liability are robust.

Most other parts of world have specific laws or arrangements specifying requirements for cosmetics before they are placed on the market. These work by regulating; premarket registration and approval, and/or, notification and post market surveillance systems (including product quality during manufacture).

Pre-market notification is a very common regulatory instrument worldwide and is a requirement in Europe, Canada, Japan, and South East Asia (ASEAN countries). The South American countries belonging to the Mercosur trading block also have a mixture of premarket notification for some products (those with comparatively low risk) and product registration requirements for other cosmetic products.

There are different definitions of what constitutes a cosmetic and these differences relate to the extent of what constitutes a physiological effect. For instance in Australia and Canada any product that claims to have a physiological effect is considered a medicine/therapeutic while in other schemes some physiological effects are considered cosmetic. In Europe and Japan, the definition extends to protection and keeping in good order (thus intimating a physiological interaction).

The practical significance of different definitions is that the same product is regulated differently. For most categories of cosmetics the distinction is clear and definitions aligned. However for some borderline products, the differences in definitions are important. For example some sunscreens and dental products are regulated as therapeutic goods in Australia and Canada, while in Japan and the EU the same products are regulated as cosmetics.

Allowable Ingredients

One of the fundamental building blocks of cosmetic regulations is the control of allowable ingredients by their function. Thus if colorants, preservatives or UV filters are not present on a positive (allowed) ingredients list, it is not allowed to be present in a cosmetic product. In addition if an ingredient is on a restricted use (negative) list then the ingredient cannot be used in a cosmetic product.

Ingredient lists vary between jurisdictions and whilst some jurisdictions maintain their own expert evaluation of ingredients and their own lists (Europe, USA, Canada) other jurisdictions without the expertise and/or financial capability adopt available ingredient lists according to local requirements. For instance the EU positive list for colorants includes approximately 150 compounds while the US list contains less than 70. In Brazil, the allowable list of UV filters is based on the EU list, however includes UV filters approved in the US and not in the EU.

The primary ingredient reviews underpinning listings are mainly conducted in the EU and the US. Expert committees with high levels of technical competence conduct these reviews. In the US the review panel is funded by industry while in the EU it is funded by the European Commission.

Conclusion

Although there are important differences in the definition, regulation and control of cosmetics between international borders, safety assessment is a common thread for the continued global community trust in cosmetics.