The world of UV Filters never stands still.
From fast-changing regulations to new formulations and sustainability technology, it’s an ever-transforming landscape. The DSM UV Task Force keeps our customers at the frontline of these advances, by bringing together comprehensive knowledge and services from across this evolving regulatory environment. Check out our regulatory map for the latest updates.
Under ASEAN Mutual Recognition Arrangement and ASEAN Cosmetic Directive (with reference to EU regulations) sunscreens regulated as cosmetic products and harmonized between the member states by the Asean Cosmetic Committee (ACC) and do not require a pre-market approval, but notification with a Product Information File (PiF) submission.
Positive listing of restricted or permitted ingredients such as allowed UV-filters in the ANNEX VII including concentrations, specifications, directions and conditions of use.
Sunscreen products are regulated as functional cosmetics versus general cosmetics by the Ministry of Food & Drug Safety (MFDS, formerly KFDA) under the Cosmetics Act. Marketing Authorization Holder principle regulates a pre-market authorization of sunscreen products, requiring grant of a license issued by MFDS.
Positive listing of permitted UV-filter ingredients including concentrations, directions and conditions of use that are additional covered by a Notification of Safety Standards from KFCC.
Sunscreen products are regulated as general and medicated cosmetics by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Device Act and do not require a pre-market approval but notification. The regulation includes the list of permitted UV-filter for cosmetic or quasi drug use including concentrations, specifications, directions and conditions of use.
Sunscreens are regulated as special cosmetics by the China NMPA (National Medical Product Administration) via Cosmetic Supervision Administration Regulation (CSAR) and require a pre-market approval including a review by the Safety and Technical Standards for Cosmetics (under secondary legislation).
New UV-filters are regulated as high-risk ingredient and are subject to NCI registration.
A positive listing of permitted UV-filter ingredients including concentrations, specifications, directions and conditions of use is also available.
Sunscreens are classified as cosmetic products by the EU commission under the Regulation (EC) No 1223/2009 and do not require a pre-market approval (except for “nano” products) but notification.
Annex VI of the EU Cosmetic regulation includes the list of permitted UV-filter ingredients including concentrations, specifications, directions and conditions of use. Currently, 31 UV Filters are permitted for use in the EU.
PARSOL® HMS (Homosalate) will be restricted to its use in face product with a maximum of 7.34 %. Check the new blog article on how to replace Homosalate for future-proof SPF formulations
PARSOL® EHS (Ethylhexyl Salicylate) required a CLP self-classification as Aquatic Chronic 1 due to an environmental study on daphnia.
For PARSOL® MCX (Ethylhexyl Methoxycinnamate) a new CLP self-classification as Aquatic Chronic 2 has been triggered by some morphologic findings in fish, whereas an endocrine disruptive property could be excluded.
PARSOL® 1789 (Butyl Methoxydibenzoylmethane) new environmental safety studies revealed no toxic effects and current CLP classification on a long-term aquatic hazard could be revoked.
Sunscreens are classified as cosmetic products, with the South American trade bloc regulating manufacturing and distribution of personal hygiene, cosmetics and perfume products through amended Resolution No. 44⁄18 from 2018. This resolution must be incorporated into the legal systems of each member country and may include some differences.
In Brazil, pre-market approval required for sunscreen products listed in Annex VIII of Technical Regulation RDC 237/2018 (incl. sunscreens) as regulated by ANVISA (Brazilian Health Regulatory Agency).
ANVISA RDC 600/2022 includes the list of permitted UV-filter ingredients including concentrations, specifications, directions and conditions of use.
Sunscreens are regulated as over-the-counter (OTC) drug products and require pre-market registration by the US Food and Drug Administration (FDA). FDA’s latest proposed order (PO) regulation from 2021. The PO contains an overview of the permitted active (API) ingredients including concentrations, indications, directions and conditions of use that have been proposed by FDA under the recent OTC drug reform provisions required by the 2020 CARES Act.
Sunscreens are regulated as Medicinal Products which require premarket-authorization. Unlike in the USA, Canada has a separate category for sunscreen products, namely Natural Health Products (NHPs). Depending on the ingredients, a product can be classified as NHP or as non-prescriptive drug product. Sunscreen products are products that are intended to be applied to the skin to prevent sunburn and related conditions of sun exposure are regulated under the Primary Sunscreen Monograph. Sunscreen products that are intended to be applied to the face or skin as makeup or skincare products which carry limited sunscreen claims are regulated under the secondary sunscreen monograph. Each monograph lists the permitted medicinal and non-medicinal ingredients, including concentrations, indications, directions and conditions of use, allowed for each intended sunscreen use category.
Under the most recent regulatory proposals made by FDA in the 2021 PO, only two of sixteen UV filter active ingredients that are currently used in sunscreen products within the United States are defined as generally recognized as safe and effective (GRASE). For twelve of the remaining UV filters, additional safety data are needed to support GRASE status. In response, the Personal Care Products Council (PCPC) Sunscreen Consortium was formed to support and defend the GRASE status previously held by seven commonly used UV filters, with the aim of ensuring that adequate UV filters remain available to protect the US population from the dangers of UV exposure.
Read the new blog article to learn about the PCPC Sunscreen Consortium ongoing work within the UV industry
