The long awaited sun-drenched days of summer are not far away.<\/p>\n
Which makes this an ideal occasion to have a look at the regulatory issues specific to the commercialisation of sunscreen products in Europe. This summary<\/strong> aims to provide a clear and structured overview of the requirements that you need to know about to ensure the compliance of your sunscreen products, it will also take a very quick look at the main regulatory differences for the rest of the world.<\/p>\n According to the European regulations, sunscreen products are cosmetic products<\/strong>.<\/p>\n The European Commission recommendation dated 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto, defines a \u2018sunscreen product\u2019 as any preparation […] intended to be placed in contact with the human skin with a view exclusively or mainly to protecting it from UV radiation by absorbing, scattering or reflecting radiation.<\/p>\n Sunscreen products must therefore comply with Cosmetic regulation (EC) 1223\/2009 <\/b>and European Commission recommendation 2006\/647\/CE.<\/b><\/p>\n The product\u2019s labels and any claims made concerning them are regulated by the same legal texts along with (EU) Regulation n\u00b0655\/2013<\/b> which establishes the common criteria. The ARPP Cosmetics Products recommendation v.8<\/b> also serves as a reference.<\/p>\n (EC) Regulation 1223\/2009 lists the UV-filters authorised for use in cosmetic products along with their maximum permitted concentrations.<\/p>\n A sunscreen product has the principle function<\/span> of protecting the skin against ultraviolet rays. It must comply with the European Commission Recommendation of 22 September 2006.<\/p>\n A product for which protection from the sun is its secondary function<\/span> does not have the principle function of protecting the skin against UV rays, but claims to have a complementary sun protection action, such as a day cream with an SPF for example.<\/p>\n The SPF (Sunburn Protection Factor)<\/b> is an index which represents the degree of protection afforded by the product.<\/p>\n The efficacy of a sunscreen product must meet the following criteria and requirements:<\/p>\n Tests applying the standardised reproducible methods set out in Recommendation 2006\/647\/EC\u00a0(currently under European Commission review) must be completed to check the efficacy of the products and establish their SPF:<\/p>\n Two alternative SPF calculation methods, proposing more ethical, rapid and reliable solutions, were approved by the ISO in December 2024:<\/p>\n The protection factor must be indicated on the label alongside the protection category: low, medium, high or very high protection<\/b>.<\/p>\n Each category is the equivalent of a standardised degree of protection against UVB and UVA rays corresponding to the indicated solar protection factor.<\/p>\n Sunscreen products must bear warnings<\/strong> stating that they do not provide 100% protection as well as advice on other precautions that should be taken in addition to their use.<\/p>\n They must also include usage instructions clearly stating that a sufficient quantity must be applied to achieve the indicated protection efficacy.<\/p>\n Developing a sunscreen product is a lot more than just writing the SPF on the label!!<\/p>\n In Europe, these products are classed as cosmetics, but they must meet strict formulation, efficacy testing and labelling requirements. Whilst the regulatory framework may be very clear, a certain amount of expertise is required to achieve full compliance without making any mistakes.<\/p>\n The rules in application around the globe vary: OTC medication (Over The Counter drugs) in North America<\/strong>, therapeutic products in Australia<\/strong>, special conditions in China<\/strong> and Brazil<\/strong>… Each market has its own specific constraints, sometimes costly, often highly technical and always worth anticipating.<\/p>\n Launching a sunscreen is therefore all about anticipating, adapting and being well advised. CLEAR<\/strong> is here to help you to transform these regulatory challenges into solid successful projects.<\/p>\n","protected":false},"excerpt":{"rendered":" The long awaited sun-drenched days of summer are not far away. Which makes [\u2026]<\/span><\/p>\n","protected":false},"author":113,"featured_media":2411,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[99,172,114,101,113],"_links":{"self":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2412"}],"collection":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/users\/113"}],"replies":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/comments?post=2412"}],"version-history":[{"count":3,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2412\/revisions"}],"predecessor-version":[{"id":2420,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/posts\/2412\/revisions\/2420"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/media\/2411"}],"wp:attachment":[{"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/media?parent=2412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/categories?post=2412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clearorg.eu\/en\/wp-json\/wp\/v2\/tags?post=2412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}A DEFINITION \u2026<\/b><\/h5>\n
\u2026AND THE APPLICABLE EUROPEAN TEXTS<\/b><\/h5>\n
PRINCIPLE or SECONDARY FUNCTION ?<\/b><\/h5>\n
THE EFFICACY OF SUNSCREEN PRODUCTS\u00a0DEPENDS ON STANDARDISED METHODS <\/b><\/h5>\n
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LABELS AND WARNINGS<\/b><\/h5>\n
CONCLUSION<\/b><\/h5>\n