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Jatin an overview of sunscreen regulations in the world


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Various types of traditional medicine (TM) and medical practices referred to as complementary or alternative medicine (CAM), have been increasingly used in both developing and developed countries. One of the major components of the WHO Traditional Medicine Strategy is to promote the integration of TM and CAM into national health care systems where appropriate. Development of national policy and regulations are an essential indicator of the level of integration of such medicine within a national health care system.
The use of medicinal plants is the most common form of traditional medication worldwide. Regulation of herbal medicines is a key means of ensuring safety, efficacy and quality of herbal medicinal products. WHO has been receiving an increasing number of requests from governments for guidance on how to regulate herbal medicines.
During the last four years, many countries have established, or initiated the process of establishing national regulations regarding herbal medicines. WHO has been conducting a global survey on national policy on traditional medicine and on the regulation of herbal medicines; aiming to:
Collect updated and comprehensive information on TM/CAM policies and regulations of herbal medicines
Clarify the current situation, in each country, on the TM/CAM national policies and regulation of herbal medicines, and their major challenges on these particular area
Identify the specific needs on capacity building for TM/CAM policy development including establishment of regulations of herbal medicines, and the type of direct support WHO should provide to Member States
Monitor the impact of the WHO Strategy for Traditional Medicine in relation to present national policy and regulation on TM/CAM/herbal medicines.

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Jatin an overview of sunscreen regulations in the world

  2. 2. An Overview Of Sunscreen Regulations In The World Abstract: Among cosmetics, the category of sunscreens is certainly a fascinating one for a cosmetologist (the sort of expert that supposedly has knowledge of chemistry, toxicology, dermatology, rheology, and even marketing, etc.). The development of sunscreens brings along many technical and toxicological issues, which stem from the requirement of having contrasting ingredients for opposite needs in the same formula. Good spreadability is in contrast with water resistance, and the proper level of filters is in contrast with the quality of the texture and solvents needed for product .stability. Once a potential solution is found for these issues, the development process of a new product is usually further complicated by marketing and regulatory issues. Many useful and practical - and in fact safe - ingredients cannot be used due to a bad reputation they have in web-based blogs and forums or simply because there has been scare mongering, which leads the 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. Keywords: Sun produces light and warmth but also Ultraviolet (UV) radiation. UV radiation cannot be seen or felt. o It is UV radiation, not the warmth or brightness of the sun that causes changes to skin color, damage to eyes, and other bad health effects. BENEFIT • Light • Photosynthesis • Outdoor environment for physical activity • Production of vitamin D • Happy & positive feelings; good mood • Keeps up warm • Hepls plants grow • Makes vitamin D • Kills germs
  3. 3. HARMS • Suntan • Sunburn • Premature aging • Liver spots • Loss of elasticity • Suppression of immune system • Skin cancer • Wrinkles • Eye damage Introduction: From the regulatory perspective (2), we can identify some major geographic areas to consider, though the European approach (and this is reasonable due to the dimension of that market) is paving the way for many other areas, which have eventually adopted the same concept and set of rules. We can broadly identify: • European Union EEA (Switzerland, Norway, Iceland) • USA • Canada • Japan • South Korea • Brazil • China • Taiwan • ASEAN countries • MERCOSUR Countries • RUSSIA • Australia • New Zealand • Middle East/Arabic countries (Turkey, Emirates, Morocco, Egypt) • India • African countries (South Africa, Nigeria, Tanzania) • Ecuador • Others It’s not easy to compare the different regulations available, largely because cosmetics are defined in different ways. Moreover, in the case of sunscreens, these are classified as “over the Counter” (OTC) products in the USA (this means they are regarded as drugs and not as cosmetics) or according to specific provisions like in Australia. The
  4. 4. classification is not the only critical point or main hurdle in the development of an internationally-recognised formula, since each authority has developed specific lists of allowed UV filters and their own systems to calculate, test and label the SPF factor. It is quite an extensive task to go into detail for each of the aforesaid world areas. Therefore, we will provide an overview of the main markets which should be interesting for those companies that are looking to take their products to the global market. EUROPEAN UNION, SWITZERLAND, NORWAY AND ICELAND We can start with the European Union. The current EU Regulation (3) EC/1223/09 replaced the previous system based on Directive 76/768 providing all member states with the same legal framework, based on the negative and positive lists of ingredients. The same framework is also applied in New Zealand, some of the Middle East/Arabic countries, Turkey and ASEAN countries. In these areas the EU regulation is accepted and applied as it is or with minor changes. The main point in this case is to check whether the local legislative status of some of the ingredients is updated. According to the definition given by the Regulation, a “cosmetic product” means any substance or mixture which is intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with the sole purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Among these functions, the protection of skin from damage due to sun exposure is referred to as a cosmetic action. Therefore, in Europe, sunscreens are considered as cosmetics. In Europe, the system is constantly updated as technical progress evolves, on the basis of the Scientific Committee on Consumer Safety’s (SCCS) recommendations on safety of ingredients. The Committee provides recommendations on health and safety risks (chemical, biological, mechanical and other kinds of physical risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products, etc.) and services (e.g. tattooing, artificial sun tanning, etc.). These recommendations usually lead to an update of regulations, whose annexes have to be considered for formulating a sunscreen. These are: I Cosmetic product safety report II List of substances banned in cosmetic products III List of substances which cosmetic products must not contain according to restrictions IV List of colourants allowed in cosmetic products V List of preservatives allowed in cosmetic
  5. 5. products VI List of UV filters allowed in cosmetic products The current list has 28 filters listed along with specific limits of concentration and with some specific warnings for the labelling of the products. The testing and labelling is also included in the Commission Recommendation of September the 22nd, 2006 on the efficacy of sunscreens and the claims made relating thereto. This recommendation sets some specific guidelines regarding the UVA/UVB ratio of protection, specific labelling warnings and the labelled category of protection starting from low protection (SPF 6) to very high protection (SPF 50+). • Minimum efficacy - lowest allowed claim SPF 6 • UVA protection must be at least 1/3 of UVB protection (UVA/UVB ratio) • Critical wavelength for testing is at least 370 nm • Precautions and usage instructions – recommendations for protection must be shown in labeling • 4 protection categories (4) (see extract from recommendation) • Testing made according to SPF + UVA method (in vitro systems preferred for ethical reasons) USA The sunscreens are classified in the USA as “over the counter” (OTC) drugs and the main reference documents are the Final Rule (5) published in 2011 and the Sunscreens Innovation Act published in 2014. The classification as OTC means that all the limits due to the approval process and strict definition of labelling have their effect in this category of products. The Sunscreen Innovation Act has been approved with the declared purpose to make some of the new filters already in use in the EU and in other countries available to the US market. The Act has also been developed according to the “material time and material extent concept”, meaning that active ingredients that have been marketed “to a material extent” and “for a material time” in a foreign market and are obviously supported by safety data can be added to an OTC (therefore to sunscreens) drug monograph. The decision made in 1970 by the FDA to place sunscreens products in the OTC category is actually blocking some of the new sunscreens available in Europe. It has been a long time since the FDA has approved a new sunscreen due to the lack of safety data, as well as insufficient funds. The Sunscreen Innovation Act didn’t change the situation too much and the prospect of seeing miloxate, bemotrizinol, bisoctrizole, drometrizole trisiloxane, ecamsule, enzacamene, iscotrizinol, and octyl triazone approved in the US market is still
  6. 6. far away. The complex work of developing sunscreens is certainly not easy due to the fact that some of the allowed filters are not particularly useful for the textures being developed today due to their technical characteristics. Many of the aspects the Final Rule deals with are mostly labelling matters. Label wording is strictly regulated, such as where and how to write relevant information like water resistance or, in the case of sunscreens with a broad spectrum (SPF >15), which products can bear the claim: ‘‘if used as directed with other sun protection measures, (the product) decreases the risk of skin cancer and early skin ageing caused by the sun’’. One part of the regulatory system for sunscreens is represented by the monograph, which essentially provides a standard for active ingredients. If a monograph has been issued for a product, all a company has to do to be allowed to market it is to demonstrate that it has met the standards of that monograph. This method allows new formulas to be introduced to the market and is different from the aforesaid regulations on new ingredients. Twenty-four Ingredients are currently regulated by the FDA through its various final monographs. Sunscreen Ingredients Regulated by OTC Monograph (21 CFR 352.10) (6): • Aminobenzoic acid (PABA) up to 15% • Avobenzone up to 3% • Cinoxate up to 3% • Dioxybenzone up to 3% • Homosalate up to 15% • Menthyl anthranilate up to 5% • Octocrylene up to 10% • Octyl methoxycinnamate up to 7.5% • Octyl salicylate up to 5% • Oxybenzone up to 6% • Padimate O up to 8% • Phenylbenzimidazole sulfonic acid up to 4% • Sulisobenzone up to 10% • Titanium dioxide up to 25% • Trolamine salicylate up to 12% • Zinc oxide up to 25% • Ensulizole up to 4% • Homosalate up to 15% • Meradimate up to 5% • Octinoxate up to 7.5% • Octisalate up to 5% • Octocrylene up to 10% • Oxybenzone up to 6% • Padimate O up to 8%
  7. 7. A new monograph is underway, but we’ll have to wait until 2019-2020 to anticipate solving some of the open questions relating to sprays and other forms (powders, wipes), ingredients, high SPF values, etc. In some cases, single states, e.g. California, have specific state rules that make it more complex, such as the PROPOSITION 65 of the State of California of January the 1st, 2015, requiring to print the following warning on labels of products containing the cancer- causing chemical benzophenone: “WARNING: This product contains benzophenone, a chemical known to the State of California to cause cancer.” CANADA Health Canada has issued a regulatory framework for cosmetics which is a blend of the EU and US regulations. Cosmetics are regulated under a framework that resembles the European one (e.g. with a hotlist of ingredients), while sunscreens are classified in different ways according to the single ingredient and may fall either under the Natural Health Product or the Drug Products regulations. A monograph (last revision issued on 23/06/2015) entitled “Sunscreen monograph” collects all the points referred to this class of products. For the marketing of a product a Product Licence Application must be filed. Canada’s monograph includes sprays and powders. It refers to all products including those referred to as secondary sunscreens. In fact, specific provisions are given for labelling broad spectrum and UVA protection, whereas certain claims are not allowed, unless supported by existing scientific data. ASEAN As previously stated, the cosmetic directive for ASEAN (7) countries is quite the same as the EU regulatory framework. Differences may arise due to a delay in adopting the EU approach and decisions and because of a specific warning that is mandatory, i.e. “Do not stay too long in the sun, even while using a sunscreen” that must be put onto products sold as primary sunscreens. The ASEAN scientific committee act like the SCCS, but the adoption of the directive is not homogeneous over the Member Countries. It must be highlighted that no claim should be made that implies that a “100% protection against UVA and UVB radiation” is guaranteed and that “reapplication of the product is unnecessary” e.g. whole day protection. Examples of recommended warnings: • Do not stay too long in the sun while using a sunscreen • Re-apply frequently to maintain protection, especially after sweating, swimming or toweling
  8. 8. • The use of sunscreens is one way to reduce the dangers from sun exposure • Instructions for use to ensure that sufficient quantity is applied, e.g. pictogram, illustration, etc • Over-exposure to the sun is a serious health threat The following SPF classifications are recommended JAPAN The classification of sunscreens as cosmetics simplifies the process for these products, as a great part of the requests are linked to the JCIA self- regulating standards. The UV filters are among the ingredients that are regulated. The minimum SPF may even be as low as just 2 while the maximum is 50+. The request to add specific warnings such as “reapply every 2-3 hours and reapply after towelling” is still in discussion. Some attention must be paid to claims like “prevents wrinkles”, which is not permitted, while the claim “prevents fine lines caused by dryness of skin” may be allowed provided it is substantiated by testing. CHINA The rapid change of the regulatory profile for cosmetics is due to many aspects: the growing market, the needs of protection, the request for quality exports and the change of the governing body from MOH to the more structured SFDA. China has approved many changes, such as the approved ingredients list (now under further revision) and has identified a classification as “special use cosmetics” for sunscreens. This means that registration of a product with the State Food and Drug Administration (SFDA) will check the safety and efficacy of the product, along with the SPF and other parameters. The list of permitted filters is the same as the EU, which is due to the close exchange between the EU commission and Chinese authorities looking for harmonisation of regulations. The maximum level is SPF 50 while for UVA the rates are PA +, ++. +++. An issue which is always in discussion is China’s request (in general for cosmetics) for animal testing and, in this case, the in- vivo UVA mandatory testing. HONG KONG Surprisingly, it is the easiest country to register cosmetics in since no specific rule is in place for import, and customs normally require the products to meet the regulations in one of the “developed countries” e.g. EU, USA, China, Australia. KOREA Korea distinguishes different classes of cosmetics (their system resembles the Chinese regulations) and classifies sunscreens as “Functional Cosmetics” with specific provisions. Products must be sampled for registration and reports on test methods for both active
  9. 9. ingredients and finished products must be provided. The dossier must include information of the origin, development and final formulation. The maximum allowed SPF is 50+ and the result of SPF or efficacy data and testing must be provided by a test supervisor (similarly to the safety assessor in EU regulations) with more than 5 years of experience. A specific process is required for new sunscreen active ingredients, which need to be supported by a dossier that must include extensive safety data. In Korea the manufacturer must also provide all information on the fragrance used, including a components list of the fragrance. TAIWAN Like many Far East Asian countries, in Taiwan sunscreens are classified as medicated cosmetics. This means registration requires a GMP certificate. The labelling regulations are similar to other systems worldwide, with the SPF numeric value (max 50+) and the UVA protection grade that can be up to PA ++++. The list of allowed filters is the same as in the EU, but with different allowed concentrations. AUSTRALIA The sunscreen regulations in Australia are full of important requirements that reflect the high level of attention towards sun protection in Australia. This specific need is due to the geographical and meteorological position of this country. Sunscreens are classified mainly as therapeutic and cosmetic sunscreens (8). Therapeutic sunscreens include: • primary sunscreens with SPF 4 or more • secondary sunscreens – except those regulated as cosmetics • primary or secondary sunscreens with SPF 4 or more that contain an insect repellent • products containing sunscreen agents with SPF less than 4 that are currently defined as listable sunscreens (specific situation to be checked in detail) Cosmetic sunscreens are products that contain an ingredient with sunscreen properties but the primary purpose of the product is neither to be a sunscreen nor a therapeutic molecule. These products are regulated as cosmetics by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS) rather than therapeutic goods, which are classified by the TGA. Among the specific rules for Australia, a norm regulates the allowed filters and their amount, and there are a number of specific rules for claims. These are different between the two categories. Therapeutic sunscreens with a broad spectrum protection (SPF of 30 or higher) may have these indications on the label:
  10. 10. • ‘May assist in preventing some skin cancers.’ • ‘May reduce the risk of some skin cancers.’ • ‘Can aid in the prevention of solar keratoses.’ • ‘Can aid in the prevention of sunspots.’ In Australia nano titanium dioxide and zinc oxide are commonly used in sunscreens and the labels of therapeutic sunscreens are not required to declare the particle sizes of ingredients. For the labelling of secondary sunscreens, which limits the SPF to under 15 (and for make-up up to 50+), a broad spectrum activity is mandatory and the levels are as usual - Low, Medium, High, Very High - but there is a wider range of SPF values in the low class (4, 6, 8, 10). NEW ZEALAND In New Zealand sunscreens are classified as cosmetics and the standards for cosmetics is clearly linked to the EU regulation, which is usually applied (updated) as it is. Otherwise, the recommendation is to market sunscreens that comply with the Australian Standard (AS/NZS 2604). INDIA The cosmetic regulation in India dates back to rather old regulations and the marketing of products must deal with a lot of bureaucracy (a typical statement you can hear in India is that “the British invented bureaucracy, the Indians perfected it! “), in some cases with standards and laws that conflict themselves. Cosmetics in India must be registered and the claims allowed refer to water resistance, sunblock, broad spectrum along with SPF value and the UVA protection expressed as PA++. A specific rule (9), recently passed, regards packaged goods. Packaged goods require cosmetics to bear a red or brown dot for non vegetarian products and a green dot for vegetarian products. The application is still not very clear as there is no definition of “vegetarian cosmetics”- this point has to be checked during the registration process. RUSSIA The growing market of Russia has seen the regulations being updated quite a lot. It has to be noted that there is a common market known as the Single Customs Union (10), which includes Russia, Belarus and Kazakhstan. Sunscreens are classified as cosmetics according to the Technical Regulation for the Safety of Cosmetic Products that resembles the EU regulation. Registration is obligatory according to the GOST standards and allowed filters are in the annex V of the regulation, which is similar to the EU annex. Also the labelling has guidelines similar to the EU regulations, with a products required to show a maximum SPF of 50+, the PA +++ and the
  11. 11. broad-spectrum feature. Due to the climate conditions, products needs to be evaluated for stability. MERCOSUR As occurs in Europe, Russia and Asia, South America also has a Common Market Group. The MERCOSUR includes Argentina, Brazil, Paraguay and Uruguay and a technical regulation establishing labelling and safety requirements for sunscreens has been in place since 2012 (even if the application in some countries, namely Brazil, may be different). According to regulations, a sun product is a preparation intended to be in contact with the skin and lips with the objective of providing protection against UVB and UVA radiation by dispersing or reflecting the radiation. Products that claim protection against UV radiation as an added benefit rather than as their main objective fall under the scope of the regulation, too. The technical framework is derived from the 2006 EU recommendation and requires the sun protection factor, the water resistance feature and that UVA protection is at least 1/3 of the UVB. Products must be registered, while labelling has a separate set of rules. The sun protection factor is marked as “FPS” or the words “Factor de Protección Solar” plus the UVA logo. In the case of products that have the sunscreen protection as an added benefit the minimum SPF must be 2 and FPUVA also 2, while a specific warning is needed: “this product is not a sunscreen”. Rules on claims require that they do not contain language suggesting total protection from solar radiation nor can they be labelled with statements claiming to provide 100 percent protection against UV radiation, or stating that the product does not need to be reapplied under any circumstances. The definition “Broad Protection” is not accepted. Specific warnings are (refer to the EU recommendation) that (1) sunscreens need to be reapplied to maintain their effectiveness; (2) they help prevent sunburn; (3) a doctor should be consulted if applied to children under six months; (4) prolonged sun exposure by children should be avoided; they do not provide any protection against sunstroke; (5) they should be applied abundantly before sun exposure; (6) they should be re-applied after sweating profusely, bathing, swimming, drying oneself with a towel and exposure to the sun; and (7) if the applied quantity is not sufficient, the level of protection will be significantly reduced.
  12. 12. Also the categories are the same of those in Europe with Low, Medium, High, very High, with the maximum SPF allowed being 50+. It must be underlined that in Brazil the list of allowed sunscreens is broader than in the EU and in the US and that for the cosmetic products the age limit for children is up to 12 years old. ISRAEL AND THE MIDDLE EAST Laws in this area have recently undergone many changes, with the basic structure of the European regulation EC/1223/09 being adopted to establish a system of local laws and technical standards. Yet, due to many bureaucratic burdens, each country had previously gone through its own process of developing regulations. However, the main aspects related to the allowed filters and SPF values are now the same. ECUADOR Recently, this country has adopted a specific standard that is mainly based on regulation EC/1223/09, including the technical part in the annexes. TESTING Testing of sun care products is according to local regulations and, due to historical reasons, it can appear rather complex. A more detailed description of each standard would require more space than this short overview allows. Sun Protection Factor (UVB) The ISO 24444:2010 is in fact applied in Europe, Israel, Canada, Mercosur, Mexico, Chile and Andean, Australia, South Africa, Korea, Taiwan, Asean and Russia. The US FDA 2011 is accepted in USA, Canada, Mercosur, Mexico, Chile and Andean, Korea, China, Taiwan and ASEAN. China, Korea and Mercosur have also their own standards, but also accept others, so hopefully in the future there will be only one system. All systems provide a measurement that can be used to label the SPF value. With regard to UVA testing, the situation is almost the same since we can count on the ISO 24443 (or 24442) and the corresponding US FDA broad spectrum test from the 2011 monograph. As for water resistance testing for packaging claims (water proof is no longer accepted), this is more diverse around the world and mainly reflects the different approach of each governing body - this topic has substantial importance as it may greatly affect the safety of consumers, as it may offer the illusion of being protected also while bathin Cosmetic Sunscreens Some products contain an ingredient with sunscreening properties but the primary purpose of the product is neither sunscreening nor therapeutic. These products are regulated as cosmetics by the National Industrial Chemicals Notification & Assessment Scheme (NICNAS) rather than by the TGA as therapeutic goods. In
  13. 13. accordance with the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, these products are not regulated under the Therapeutic Goods legislation and are not required to be included in the ARTG. For the purpose of these Guidelines such products are called ‘cosmetic sunscreens’. They may also be referred to as ‘excluded’ sunscreens. A cosmetic sunscreen product must meet the definition of a cosmetic under the Industrial Chemicals (Notification and Assessment) Act 1989 and any requirements set out in the current Cosmetics Standard and NICNAS Cosmetics Guidelines. Requests for regulatory information and enquiries about cosmetic products should be directed to NICNAS. Industrial Chemicals (Notification and Assessment) Act 1989 defines a. cosmetic as follows: ‘Cosmetic means: a. substance or preparation intended for placement in contact with any external part of the human body, including: i. the mucous membranes of the oral cavity; and ii. the teeth; with a view to iii. altering the odours of the body iv. changing its appearance v. cleansing it; vi. maintaining it in good condition vii. perfuming it viii. protecting it; or b. substance or preparation prescribed by regulations made for the purposes of this paragraph; but does not include c. therapeutic good within the meaning of the Therapeutic Goods Act 1989 d. a substance or preparation prescribed by regulations made for the purposes of this paragraph. The current Cosmetics Standard and the associated NICNAS Cosmetics Guidelines should be consulted for guidance on the conditions applying to the following secondary sunscreen products for them to be regulated as cosmetics rather than therapeutic goods: a. Make-up products for the face and nails: · tinted bases or foundation (liquids, pastes or powders) with sunscreen · products (tinted or untinted) intended for application to the lips with sunscreen. b. Skin care products: · some moisturising products with sunscreen for dermal application, including antiwrinkle, anti-ageing and skin whitening products
  14. 14. · some sunbathing products (for example, oils, creams or gels, including products for tanning without sun and after sun care products). The Cosmetics Standard and NICNAS Cosmetics Guidelines include specific requirements regarding the presentation and labelling of cosmetic sunscreen products. Sponsors are responsible for ensuring that such products comply with those requirements. Failure to comply with those requirements may make the product concerned a therapeutic good that must be listed or registered in the ARTG. Other mandatory requirements applying to the labelling of all cosmetic products are set out in Cosmetic & toiletries ingredient labelling published by the Australian Competition & Consumer Commission (ACCC). Regulatory Categories Of Sunscreens Most therapeutic sunscreens marketed in Australia are currently defined as ‘listable’ therapeutic goods which means that they must be ‘listed’ in the ARTG. Other sunscreen products must be ‘registered’ in the ARTG, while others are exempt from registration or listing (see below). General information on listing and registration of therapeutic goods is available on the TGA Internet site. Exempt Sunscreens A therapeutic sunscreen product is ‘exempt’ under Item 8(g) of Schedule 5 of the Regulations if: · the SPF established by testing according to AS/NZS 2604:2012 is less than 4, and · the label claims comply with AS/NZS 2604:2012, and · the product does not have an indication for the treatment of a serious disease, condition, ailment or defect . Exempt therapeutic sunscreens do not require registration or listing in the ARTG, but are treated as therapeutic goods in all other respects and must comply with all relevant parts of the Therapeutic Goods legislation, including relevant standards such as the Labelling Order (Therapeutic Goods Order No. 69, and amendments) and the Therapeutic Goods Advertising Code. Listing Of Therapeutic Sunscreens The majority of therapeutic sunscreen products require listing in the ARTG in accordance with Item 7 of Part 1 of Schedule 4 of the Regulations. Information on the listing process using the TGA’s Electronic Listing Facility (ELF) and details of what information needs to be provided for listed products are provided in the Electronic Listing Facility (ELF) User Guide. Under Item 7 of Part 1 of Schedule 4 of the Regulations, sunscreen products are eligible for listing where they come within
  15. 15. the following description: ‘Sunscreen preparations for dermal application (other than preparations for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 to the Therapeutic Goods Advertising Code), if: a. the claimed sun protection factor has been established by testing according to the method described in Standard AS/NZS 2604:2012, as in force from time to time; and b. the performance statements and markings on the label comply with that Standard; and c. the sunscreen preparation only contains ingredients that are specified in a determination under paragraph 26BB(1) of the Act; and d. if a determination under paragraph 26BB(1) of the Act specifies requirements in relation to ingredients being contained in the sunscreen preparation—none of the requirements have been contravened. The SPF of therapeutic sunscreens must be determined by testing on human skin in accordance with the sunscreen standard AS/NZS 2604:2012 which references the International Organisation for Standardisation procedure ISO 24444:2010 Cosmetics – Sun Protection test methods – In vivo determination of SPF (Sun Protection Factor). Note that, where in vivo SPF test results have been produced using the US FDA static SPF test procedure described in FDA Sunscreen Drug Products for OTC Human Use: Final Monograph, the individual SPF results may be used to calculate the mean SPF and the label SPF provided they meet the statistical criteria set out in ISO 24444:2010 as referenced in AS/NZS 2604:2012. Therapeutic sunscreen products may only contain active sunscreening ingredients that are included in the list of sunscreening agents permitted as active ingredients in therapeutic sunscreens and are within the maximum concentrations stated in the list. Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure that the finished product is safe for its intended purpose. Sunscreen products that make therapeutic claims other than sunscreening (for example, reduction of free radicals in or below the skin, or claims relating to reduction of UV induced immune suppression) and/or contain active therapeutic ingredients that are not included in the list of sunscreening agents permitted as active ingredients (see subsection 9.1) are not ‘listable sunscreen preparations’ and must be registered in the ARTG as OTC or prescription medicines depending on the active ingredients
  16. 16. contained and therapeutic claims made Subsection 4.1 lists the therapeutic claims permitted for listed sunscreens. Australian regulatory Registration Of Therapeutic Sunscreens Sunscreens that are not ‘listable’, ‘exempt’ or ‘cosmetic’ (excluded) are evaluated by the TGA for quality, safety and efficacy as registered therapeutic goods under section 25 of the Act. Data to support the quality, safety and efficacy of such products are required as detailed under the relevant chapters of the Australian Regulatory Guidelines for OTC Medicines (ARGOM). Products in this category include:  products that contain a sunscreen active ingredient that is not included in the list of sunscreening agents permitted as active ingredients (see subsection 9.1)  products that make any therapeutic claims other than the sunscreening claims permitted under section 4 ‘Labelling and advertising’, or that are for the treatment of a disease, condition, ailment or defect specified in Part 1 or 2 of Appendix 6 of the Therapeutic Goods Advertising Code  products that contain substances that are scheduled in the SUSMP  products that contain a sunscreening active ingredient combined with a claimed therapeutic active ingredient that is not a permissible active ingredient in a listed medicine in accordance with section 26BB of the Ac  products that are not otherwise ‘listable’, ‘exempt’ or ‘excluded’. Responsibility Of Sponsors To Report Adverse Reactions It is a standard condition of listing or registration of a medicine that the sponsor has an appropriate system of pharmacovigilance and that the sponsor reports to the TGA adverse reactions experienced by users of the sponsor’s products. This requirement applies to sponsors of therapeutic sunscreens. Details of the TGA’s requirements for pharmacovigilance and the reporting of adverse reactions can be found on the TGA Internet site. Labelling and advertising The labelling and advertising of therapeutic sunscreen products included in the ARTG must comply with the relevant requirements of each of the following:
  17. 17.  the Labelling Order, Therapeutic Goods Order No 69 (or any subsequent order amending or replacing TGO 69)  the Therapeutic Goods Advertising Code (as updated from time to time)  the Australian/New Zealand Standard AS/NZS 2604:2012 Sunscreen products – Evaluation and classification  the current edition of Required Advisory Statements for Medicine Labels (RASML). A check list is provided at the end of this document (Appendix 1) to assist sponsors in designing their sunscreen labels in accordance with the requirements of the documents listed above. However, the check list is not exhaustive and sponsors are responsible for ensuring that their labelling complies with all of the relevant legislative requirements. TGO 69, the Therapeutic Goods Advertising Code and the RASML do not apply to cosmetic sunscreens. General As required by sections 2 and 3 of the Labelling Order (TGO 69), the label (or labels) must: · be printed on or firmly and securely attached to the container · be unlikely to become detached or defaced or illegible during use · be positioned so that it will not be damaged or removed when the container is opened · not be obscured by any other label or object · be printed in English · be printed in lettering that is clear, distinct and legible, and the height of letters with ascenders or descenders is not less than 1.5 mm (except for the AUST L or AUST R number, which may be 1 mm high). As prohibited by section 4 of the Therapeutic Goods Advertising Code, the labelling must be free from claims, statements or pictures that: · are likely to arouse unwarranted and unrealistic
  18. 18. expectations of the product’s effectiveness · are false, unbalanced, unsubstantiated, misleading or likely to mislead the user · abuse the trust or exploit the lack of knowledge of consumers or contain language that could bring about fear or distress · encourage or are likely to encourage inappropriate use · indicate or imply that the product is infallible, unfailing, magical, miraculous, or effective in all cases · indicate or imply that the product cannot cause harm Australian regulatory guidelines for sunscreens V1.1 January 2016 Page 12 of 43 Therapeutic Goods Administration · indicate or imply that other competitor products are harmful or ineffectual · indicate or imply that the product is endorsed by any government agency, hospital or other facility providing healthcare services, individual healthcare professional or group of healthcare professionals. Therapeutic sunscreens that are ‘listable’ are permitted to carry the following coded indications provided that the sunscreen meets the requirements of AS/NZS 2604:2012 for the indications designated: 1. A broad spectrum sunscreen with an SPF of 30 or higher is permitted to carry the following indications: · ‘May assist in preventing some skin cancers.’ · ‘May reduce the risk of some skin cancers.’ · ‘Can aid in the prevention of solar keratoses.’ · ‘Can aid in the prevention of sunspots.’ 2. A broad spectrum sunscreen with an SPF of 4 or higher is permitted to carry the following indication: · ‘Can aid in the prevention of premature skin ageing.’ In principle, indications considered appropriate for listed sunscreens are those that can be used safely and effectively without the intervention of a healthcare practitioner. For medicines generally this includes diseases, disorders or conditions that are normally of
  19. 19. a benign or selflimiting nature that the average consumer can be expected to evaluate or diagnose accurately. Some indications that relate to a serious disease condition, ailment or defect such as skin cancer are restricted except those allowed above which have been approved by the TGA for therapeutic sunscreens. The Act requires that, at the time of listing a medicine in the ARTG, a sponsor must certify that it holds the information or evidence to support indications and claims made in relation to the product. All indications and claims must be capable of substantiation – that is, evidence held by the sponsor must adequately demonstrate all indications and claims made for the product are true, valid and not misleading. Listed medicines are not subject to pre-market evaluation for efficacy at the time of listing. However, data supporting the indications may be requested by the TGA for review after listing of a medicine. Hence, the TGA may request copies of labelling and the results of pre-market SPF, broad spectrum performance, water resistance or stability testing. If requested, it is expected that this information will be available and can be provided to the TGA within a reasonable time of the request. Therapeutic sunscreens may also carry justified non- therapeutic claims (for example, ‘contains Vitamin E’, ‘contains aloe vera’, ‘moisturising’, ‘antioxidant’, ‘free radical barrier’) and information to support such claims may be requested by the TGA for review. If the certification by the sponsor that it holds this information or evidence is incorrect, the TGA can cancel the listing of the product from the ARTG. The labelling may also carry company logos, other symbols and consumer information provided these do not create confusion for Australian consumers and they do not conflict with the requirements of the Therapeutic Goods legislation, the Labelling
  20. 20. Order, the Sunscreen Standard or the Advertising Code. Labelling Of Immediate Container And Primary Pack · As required by subsection 3(2) of the Labelling Order and section 7 of the Sunscreen Standard AS/NZS 2604:2012, the main label on the container and the main label of the primary pack (for example, carton), if any, must contain all of the following information: · the product name Note: The use of the term ‘sunblock’ is not acceptable as part of a product name (or elsewhere on the label). · The term is a misnomer because sunscreens filter to varying degrees but do not completely block the sunburning radiation. · the name of the dose form, for example, ‘cream’ or ‘lotion’ · the sun protection factor (SPF) of the product preceded by the expression ‘Sun Protection Factor’ or ‘SPF’ marked in durable and legible characters and in such colour or colours as to afford a distinct contrast to the background colour and in letters not less than 1.5mm in height Note: A category description may also be given, for example, ‘low / medium or moderate / high / very high protection’. · [if relevant] the water resistance of the product (in hours or in minutes) established in accordance with AS/NZS 2604:2012 Note: The use of the terms ‘waterproof’ and ‘sweat proof’ are not acceptable. Sunscreens may be water resistant but none are completely waterproof, and even those with a high water resistance rating will gradually wash off the skin when immersed in water for long enough or through perspiration. · the statement ‘broad spectrum’ in letters not larger than those used for the SPF provided that the
  21. 21. product meets the criteria of broad spectrum protection from UV (or UVA and UVB) light as defined and measured by AS/NZS 2604:2012 · the net quantity of the goods (by volume in mL or weight in g) · the ARTG listing number preceded by ‘AUST L’ or registration number preceded by ‘AUST R’. Note: If the container is packed in an outer carton the listing or registration number must be on the main label of that carton and may be, but is not required to be, on the container as well. All of the following information must be included either on the main label or on a rear or side panel [see subsection 3(3)(c) of the Labelling Order]: · the names of all sunscreening active ingredients expressed using Australian Approved Names (AAN) Note: International Nomenclature of Cosmetic Ingredients (INCI) names may also be included in addition to (but not as a substitute for) the AANs. · the proportions of those ingredients either expressed as a percentage in terms of w/w or w/v or expressed as a weight in a stated weight or volume of the product using metric units of measurement (for example, mg/g or mg/mL). All of the following information must be included somewhere on the label(s) or container: · the recommended storage conditions ‘store below 25°C’ or ‘store below 30°C’, as applicable · the batch or lot number of the product, preceded by the batch number prefix using one of the formats specified in subsection 2(1) of the Labelling Order Nanoparticles In Sunscreens Nanoparticulate titanium dioxide and zinc oxide are commonly used in sunscreens. The labels of therapeutic sunscreens are not required to declare the
  22. 22. particle sizes of ingredients. The TGA’s policy on the safety of nanoparticulate ingredients in sunscreens is available from the TGA Internet site Reproducibility Of SPF Test Results The in vivo testing of the SPF of a sunscreen product according to the procedure in ISO 24444:2010 and AS/NZS 2604:2012 produces a reasonable estimate, but not a highly accurate and precise measure, of the true SPF of the product applied to the skin at a rate of 2 mg/cm2. The test data exhibit a considerable inherent variance which needs to be taken into account when interpreting the test results and labelling of the product, and also needs to be taken into account when interpreting the results of any subsequent retesting of the product. The test procedure in ISO 24444:2010 and referenced by AS/NZS 2604:2012 requires the product to be tested on a minimum of 10 subjects and for the arithmetic mean, standard deviation and 95% confidence interval (95% CI) for the mean to be calculated using the formula 95% CI = m ± t.s/√n, where ‘n’ is the number of individual SPF data, ‘m’ is the arithmetic mean of those data, ‘t’ is the value of Student’s t for n-1 degrees of freedom and p=0.05 (double sided), and ‘s’ is the standard deviation of the test data. There is a 95% probability that the true SPF of the product lies somewhere within the 95% CI. For the test to be considered valid, the 95% CI must fit within ± 17% of the mean and, if not, the product must be tested on further subjects (up to a maximum of 20) until the 95% CI based on the data for all subjects does fit within ± 17% of the mean. If testing on 20 subjects
  23. 23. does not bring the 95% CI within ± 17% of the mean the whole test must be rejected. In practice, use of more than 10 subjects would be necessary only if the coefficient of variation (CV = s/m) is greater than 24%, and testing on 20 subjects would only fail if the CV was greater than 37%. Statistical analysis of the SPF test data submitted to the TGA over recent years in support of SPF claims made for a large range of sunscreen products has shown that the data typically exhibit a relative standard deviation (RSD) or coefficient of variation (CV) in the range 5–20%. Only rarely is the CV less than 5% or greater than 20%. Thus, in the majority of cases, testing on 10 subjects would yield a 95% CI well within the ±17% limits and testing on additional subjects would not be required. Subsequent retesting of a sunscreen is likely to yield a mean SPF anywhere within the 95% CI from the original testing of the product or even a few SPF units beyond either end of that 95% CI. Consequently, if the original test result was close to the lower limit for a particular SPF claim allowed by the Standard, the retest result could be lower than that lower limit and appear to cast doubt on the validity of the labelled SPF claim. However, it would be necessary to retest the product several times and obtain consistently low mean results before any conclusion could be drawn about the labelled SPF being unjustified. Stability Test Requirements Therapeutic sunscreens marketed in Australia must be labelled with an ‘expiry’ or ‘use by’ date. That date must be supported by experimental data that support the shelf life of the sunscreen product in the container intended for
  24. 24. marketing (or at least a container made of the same materials and with similar shape, size and wall thickness to that of the market container) under the recommended storage conditions (that is, ‘Store below 25°C’ for product to be stored in airconditioned premises or ‘Store below 30°C’ for product to be stored at room temperature). The data must substantiate the physical, chemical and microbiological stability of the product for at least the claimed shelf life. Sponsors of all therapeutic sunscreen products are expected to have performed stability testing on each product to at least the standard set out in these Guidelines. The claimed shelf life and storage conditions for each product should be derived from the results of the stability testing on that product. Generation of adequate stability data to support the assigned shelf life for a therapeutic sunscreen is the responsibility of the sponsor. While the stability data supporting the shelf life of a sunscreen product are not required to be submitted to the TGA at the time of listing, they may be requested for review by the TGA at any time. Sponsors should, therefore, ensure that the data are available in a form suitable for submission to the TGA if and when requested. Stability testing guidelines for sunscreens, Guidelines for Stability Testing of Sunscreens April 1994, were developed by the Australian industry peak bodies and accepted by the TGA. They are now incorporated below with some minor amendments to improve clarity and consistency with the stability guidelines for medicines adopted by the TGA (see ARGOM chapter on Quality). This section (7) now supersedes
  25. 25. the Guidelines for Stability Testing of Sunscreens April 1994. Shelf Life Determination For a product exhibiting no discernable changes or trends, a 2-year shelf life for storage conditions of ‘store below 30°C’ (that is, storage at room temperature in Australia) may be supported by stability data covering 6 months storage at 40°C, and a 3-year shelf life for storage conditions of ‘store below 30°C’ may be supported by data covering either 9 months at 40°C or 6 months at 45°C. A shelf life of greater than 3 years should be supported by data from storage at 40°C covering at least half of the shelf life (for example, 2.5 years accelerated data would be required to support a 5-year shelf life). For a product exhibiting no discernable changes or trends, a 2-year shelf life for storage conditions of ‘store below 25°C’ (that is, the product should be stored in air-conditioned premises) may be supportedbystability data covering 6 months storage at 35°C, and a 3-year shelf life for storage conditions of ‘store below 25°C’ may be supported by data covering either 9 months at 35°C or 6 months at 40°C. A shelf life of greater than 3 years should be supported by data from storage at 35°C covering at least half of the shelf life. Generally, the maximum shelf life permitted for any therapeutic good is 5 years.
  26. 26. CONCLUSION As stated above, it’s not possible to provide detailed information on sunscreens regulations in a few pages, as each geographic area has its peculiarities. In the case of sunscreens, regulatory departments and the R&D must cooperate at a very early stage of the project for a new product (this is recommended anyway) in order to clearly identify the boundaries, potential problems and solutions. Given the variety of situations, it’s certainly not easy to claim to have an internationally-accepted formula and it may be better to have a framework structure with a standard set of filters one can adapt to each situation. R&D must maintain enough flexibility during development to adapt the formula in case of changes to rules and the regulatory affairs department should be able to spot changes to laws as soon as they are enforced. Certainly, the ability of a company to develop a sunscreen that is successful when placed on the global market is a difficult task and, when achieved, shows the skills of the people that work there. REFERENCES AND NOTES 1. The list is wide and the citations are only given as an example, every ingredient you can search on Google may have some issue, simply check the 2. Giulio Pirotta - How to classify cosmetics - A complete guide to classify Temperature above labeled storage conditions Time period Test time points Possible shelf life prediction +10°C 6 months 0, (1 or 2), (3 or 4), 6 months 2 years +10°C 9 months 6,9 months 3years +15°C 6 months 6 months 3years
  27. 27. and description of cosmetic products – in press 3. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products 4. COMMISSION RECOMMENDATION of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto (2006/647/EC) 5. 21 CFR Parts 201 and 310 Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the- Counter Human Use Federal Register/ Vol. 7 6, No. 117 / Friday, June 17, 2011 / Rules and Regulations 6. /cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=352 7. Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Viet Nam 8. Version 1.0 13 November 2012 The Australian regulatory guidelines for sunscreens (ARGS) 9. GSR 137 of 17 June 2014 10. The Customs Union Commission (Decree No. 526 of 28.01.2011)