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An Overview of Sunscreen Regulations in the World

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An Overview of Sunscreen Regulations in the World REVIEW GIULIO PIROTTA Senior Consultant, Neovita, Uboldo, VA, Italy Giulio Pirotta An overview of sunscreen regulations in the world Among cosmetics, the category of sunscreens is certainly a It’s not easy to compare the different regulations available, fascinating one for a cosmetologist (the sort of expert that largely because cosmetics are defined in different ways. supposedly has knowledge of chemistry, toxicology, dermatology, Moreover, in the case of sunscreens, these are classified as rheology, and even marketing, etc.). The development of “over the Counter” (OTC) products in the USA (this means they sunscreens brings along many technical and toxicological issues, are regarded as drugs and not as cosmetics) or according to which stem from the requirement of having contrasting specific provisions like in Australia. ingredients for opposite needs in the same formula. Good The classification is not the only critical point or main hurdle in spreadability is in contrast with water resistance, and the proper the development of an internationally-recognised formula, level of filters is in contrast with the quality of the texture and since each authority has developed specific lists of allowed solvents needed for product stability. UV filters and their own systems to calculate, test and label Once a potential solution is found for these issues, the the SPF factor. development process of a new product is usually further It is quite an extensive task to go into detail for each of the complicated by marketing and regulatory issues. Many useful and aforesaid world areas. Therefore, we will provide an overview practical - and in fact safe - ingredients cannot be used due to a of the main markets which should be interesting for those bad reputation they have in web-based blogs and forums or companies that are looking to take their products to the simply because there has been scare mongering, which leads the global market. developer to avoid parabens, alumina and nano ingredients (1). The other side of the coin is the burden of regulations that classify sunscreens in very different ways in different areas of the world. EUROPEAN UNION, SWITZERLAND, NORWAY AND ICELAND From the regulatory perspective (2), we can identify some We can start with the European Union. The current EU major geographic areas to consider, though the European Regulation (3) EC/1223/09 replaced the previous system based approach (and this is reasonable due to the dimension of that on Directive 76/768 providing all member states with the same market) is paving the way for many other areas, which have legal framework, based on the negative and positive lists of eventually adopted the same concept and set of rules. ingredients. The same framework is also applied in New We can broadly identify: Zealand, some of the Middle East/Arabic countries, Turkey and • European Union and EEA (Switzerland, Norway, Iceland) ASEAN countries. In these areas the EU regulation is accepted • USA and applied as it is or with minor changes. The main point in this • Canada case is to check whether the local legislative status of some of • Japan the ingredients is updated. • South Korea According to the definition given by the Regulation, a • Brazil “cosmetic product” means any substance or mixture which is • China intended to be placed in contact with the external parts of the • Taiwan human body (epidermis, hair system, nails, lips and external • ASEAN countries genital organs) or with the teeth and the mucous membranes • MERCOSUR Countries of the oral cavity with the sole purpose of cleaning them, • RUSSIA perfuming them, changing their appearance, protecting them, • Australia keeping them in good condition or correcting body odours. • New Zealand Among these functions, the protection of skin from damage • Middle East/Arabic countries (Turkey, Emirates, due to sun exposure is referred to as a cosmetic action. Morocco, Egypt) Therefore, in Europe, sunscreens are considered as cosmetics. • India In Europe, the system is constantly updated as technical • African countries (South Africa, Nigeria, Tanzania) progress evolves, on the basis of the Scientific Committee on • Ecuador Consumer Safety’s (SCCS) recommendations on safety of • Others ingredients. The Committee provides recommendations on Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol. 10(4) - July/August 2015 17 health and safety risks (chemical, biological, mechanical and and octyl triazone approved in the US market is still far away. other kinds of physical risks) of non-food consumer products The complex work of developing sunscreens is certainly not (e.g. cosmetic products and their ingredients, toys, textiles, easy due to the fact that some of the allowed filters are not clothing, personal care and household products, etc.) and particularly useful for the textures being developed today due services (e.g. tattooing, artificial sun tanning, etc.). to their technical characteristics. Many of the aspects the Final Rule deals with are mostly labelling These recommendations usually lead to an update of matters. Label wording is strictly regulated, such as where and regulations, whose annexes have to be considered for how to write relevant information like water resistance or, in the formulating a sunscreen. These are: case of sunscreens with a broad spectrum (SPF >15), which I Cosmetic product safety report products can bear the claim: ‘‘if used as directed with other sun II List of substances banned in cosmetic products protection measures, (the product) decreases the risk of skin III List of substances which cosmetic products must not cancer and early skin ageing caused by the sun’’. contain according to restrictions One part of the regulatory system for sunscreens is represented IV List of colourants allowed in cosmetic products by the monograph, which essentially provides a standard for V List of preservatives allowed in cosmetic products active ingredients. If a monograph has been issued for a VI List of UV filters allowed in cosmetic products product, all a company has to do to be allowed to market it is to demonstrate that it has met the standards of that The current list has 28 filters listed along with specific limits of monograph. This method allows new formulas to be introduced concentration and with some specific warnings for the labelling to the market and is different from the aforesaid regulations on of the products. The testing and labelling is also included in the new ingredients. Commission Recommendation of September the 22nd, 2006 on the efficacy of sunscreens and the claims made relating Twenty-four Ingredients are currently regulated by the FDA thereto. This recommendation sets some specific guidelines through its various final monographs. regarding the UVA/UVB ratio of protection, specific labelling warnings and the labelled category of protection starting from Sunscreen Ingredients Regulated by OTC Monograph (21 CFR low protection (SPF 6) to very high protection (SPF 50+). 352.10) (6): • Minimum efficacy - lowest allowed claim SPF 6 • Aminobenzoic acid (PABA) up to 15% • UVA protection must be at least 1/3 of UVB protection • Avobenzone up to 3% (UVA/UVB ratio) • Cinoxate up to 3% • Critical wavelength for testing is at least 370 nm • Dioxybenzone up to 3% • Precautions and usage instructions – recommendations for • Homosalate up to 15% protection must be shown in labelling • Menthyl anthranilate up to 5% • 4 protection categories (4) (see extract from • Octocrylene up to 10% recommendation) • Octyl methoxycinnamate up to 7.5% • Testing made according to SPF + UVA method (in vitro • Octyl salicylate up to 5% systems preferred for ethical reasons) • Oxybenzone up to 6% • Padimate O up to 8% • Phenylbenzimidazole sulfonic acid up to 4% USA • Sulisobenzone up to 10% • Titanium dioxide up to 25% The sunscreens are classified in the USA as “over the counter” • Trolamine salicylate up to 12% (OTC) drugs and the main reference documents are the Final • Zinc oxide up to 25% Rule (5) published in 2011 and the Sunscreens Innovation Act • Ensulizole up to 4% published in 2014. The classification as OTC means that all the • Homosalate up to 15% limits due to the approval process and strict definition of • Meradimate up to 5% labelling have their effect in this category of products. • Octinoxate up to 7.5% The Sunscreen Innovation Act has been approved with the • Octisalate up to 5% declared purpose to make some of the new filters already in • Octocrylene up to 10% use in the EU and in other countries available to the US market. • Oxybenzone up to 6% The Act has also been developed according to the “material • Padimate O up to 8% time and material extent concept”, meaning that active ingredients that have been marketed “to a material extent” A new monograph is underway, but we’ll have to wait until and “for a material time” in a foreign market and are obviously 2019-2020 to anticipate solving some of the open questions supported by safety data can be added to an OTC (therefore relating to sprays and other forms (powders, wipes), ingredients, to sunscreens) drug monograph. high SPF values, etc. The decision made in 1970 by the FDA to place sunscreens products in the OTC category is actually blocking some of the In some cases, single states, e.g. California, have specific state new sunscreens available in Europe. It has been a long time rules that make it more complex, such as the PROPOSITION 65 since the FDA has approved a new sunscreen due to the lack of the State of California of January the 1st, 2015, requiring to of safety data, as well as insufficient funds. The Sunscreen print the following warning on labels of products containing the Innovation Act didn’t change the situation too much and the cancer-causing chemical benzophenone: “WARNING: This prospect of seeing miloxate, bemotrizinol, bisoctrizole, product contains benzophenone, a chemical known to the drometrizole trisiloxane, ecamsule, enzacamene, iscotrizinol, State of California to cause cancer.” 18 Monographic special issue: Sun care - H&PC Today - Household and Personal Care Today - vol.
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