SPF Sunscreens and Cosmetic Regulation
Learn about sunscreens with BELAB
Awareness about the risks of sun exposure is on the rise, leading to a significant change in skin protection habits. Now, more than ever, people are opting for sunscreens with a high sun protection factor (SPF) not only during the summer but all year round.
Everything you need to know about sunscreens and SPF
Sun protection is an essential part of skin care, especially when it comes to preventing the damaging effects of the sun's ultraviolet (UV) rays. Using sunscreen properly not only prevents sunburn, but is also crucial in reducing the risk of premature aging and the development of diseases such as skin cancer.
What is sunscreen?
A sunscreen is a product designed to protect the skin from the harmful effects of UV radiation, which comes primarily from the sun. Sunscreens may contain chemical or mineral filters that help absorb or reflect these UV rays before they damage the skin.
There are two main types of UV radiation that affect the skin:
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UVA rays: They penetrate deeply into the skin and are responsible for premature aging and the appearance of wrinkles.
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UVB rays: These are the main cause of sunburn and contribute significantly to the development of skin cancer.
What is SPF?
SPF (Sun Protection Factor) is a measure of the level of protection a sunscreen offers against UVB rays.
The higher the SPF, the longer it will protect you from sunburn, although it does not translate into total protection.
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SPF 15 : Blocks approximately 93% of UVB rays.
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SPF 30 : Blocks approximately 97% of UVB rays.
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SPF 50 : Blocks approximately 98% of UVB rays.
It is important to note that no sunscreen offers 100% protection, so in addition to using a product with SPF, it is advisable to take other protective measures such as wearing appropriate clothing, seeking shade and avoiding sun exposure during peak hours.
Sun protection and broad spectrum
When choosing a sunscreen, make sure it offers broad-spectrum protection , meaning it will protect against both UVA and UVB rays. UVA rays, while they don't cause visible burns, can deeply damage the skin and accelerate aging, while UVB rays are primarily responsible for sunburn.
SPF: Mandatory Tests for Sunscreens
Cosmetic Regulation
To comply with European recommendations, sunscreens must undergo specific tests to assess their degree of protection against UVA and UVB rays.
These include:
• In vivo SPF test according to ISO 24444
• In vivo or in vitro UVA protection factor according to ISO 24443 , in addition to the critical wavelength
• Sunscreens must have an SPF of at least 6 , UVA protection of at least 1/3 of the labeled SPF, and a critical wavelength greater than 370nm.
SPF Protectors: Regulatory Framework
SPF: International Cosmetic Regulation
Sunscreens are subject to strict regulations in different regions to ensure their safety and effectiveness. Below is a brief introduction to the regulatory framework in the European Union (EU), United Kingdom (UK), United States (USA) and Dubai/United Arab Emirates (UAE).
SPF: European Union
EC 1223/2009
In the European Union, sunscreens are classified as cosmetics and are regulated under the Cosmetic Products Regulation (Regulation (EC) No 1223/2009) . This regulation sets strict standards to ensure the safety and efficacy of cosmetics marketed in the EU.
Key Aspects of Regulation in the EU
Cosmetic Regulation: SPF & CPNP
Safety Assessment: All sunscreens must undergo a safety assessment by a qualified professional before being released to the market. This assessment includes an analysis of ingredients, expected exposure, and safety for consumers.
SPF and broad spectrum protection: The Regulation states that sunscreens must provide protection against both UVB and UVA rays. In addition, they must comply with regulations on SPF, which must be verified through standardized tests to ensure their effectiveness.
List of ingredients : Regulation (EC) No 1223/2009 requires that all ingredients used in the product are clearly listed on the packaging under their INCI name (International Nomenclature of Cosmetic Ingredients), facilitating transparency for consumers.
Ban on certain ingredients: There are specific ingredients that are banned or restricted in cosmetics in the EU. Permitted sun filters are listed in Annex VI of the Regulation, and only these can be used in sunscreens marketed on the European market.
Warning Label: All products must bear appropriate warnings, such as "Reapply frequently" or "Avoid sun exposure during peak hours," to inform the consumer of proper use and precautions.
Product notification : All cosmetic products must be registered on the Cosmetic Product Notification Portal (CPNP) before being placed on the market in the EU, ensuring that authorities can access relevant product information in the event of a control or incident.
SPF: Cosmetic Regulation in the United Kingdom
Cosmetic Regulation: SPF & MHRA
Following Brexit, the UK has adopted the EU Cosmetics Products Regulation framework into its legislation, with some adaptations to reflect that it is no longer an EU member state. Regulation in the UK is administered by the Medicines and Healthcare products Regulation Office (MHRA) and remains largely parallel to that in the EU.
Safety assessment: As in the EU, sunscreens in the UK must undergo a safety assessment before they are put on the market. A qualified safety assessor must confirm that the product is safe for consumers.
Registration with the UK Responsible Person: In the UK, cosmetic products must be registered with the UK Submit Cosmetic Product Notification (SCPN), and must have a UK-based Responsible Person to ensure that the product complies with applicable regulations.
List of ingredients : As in the EU, ingredients must be clearly listed on the label, using the INCI nomenclature.
UVA and UVB protection: Products must also provide broad-spectrum UVA and UVB protection and meet sun protection factor (SPF) regulations.
Rules on advertising and labeling claims
In both the EU and the UK, there are strict regulations on the claims that can be made on sunscreen labelling and advertising:
Ban on misleading claims : Labeling a sunscreen as “total blocking” or “100% protection” is not allowed, as no sunscreen can guarantee complete UV protection.
Clear instructions : Labels should clearly specify UVA and UVB protection, as well as the SPF level. They should also include recommendations on how often to reapply.
Implications for Manufacturers and Consumers
SPF Cosmetic Regulation: Manufacturers and Consumers
For manufacturers, Regulatory coherence between the EU and the UK facilitates the marketing of sunscreens in both markets, although specific differences need to be taken into account, especially in terms of notification and legal representation.
For consumers, These regulations ensure that sunscreens available on the market are safe and effective, offering reliable protection against the damaging effects of sun exposure. It is crucial that consumers follow the usage instructions provided on the label to maximize the effectiveness of the product.
In both the EU and the UK, sunscreen regulation is focused on ensuring the safety and efficacy of these essential products. Although there are specific differences in regulatory implementation post-Brexit, the shared commitment to consumer protection remains a fundamental pillar in both territories.
SPF: United States
FDA Regulations
The regulation of sunscreens in the United States, especially those categorized as over-the-counter (OTC) drugs, is an area of rigorous oversight by the Food and Drug Administration (FDA).
The classification of sunscreens as OTC is due to their essential role in preventing sunburn and potentially reducing the risk of skin cancer and premature aging caused by exposure to ultraviolet (UV) rays.
Monograph on Sunscreens
A key component of the regulation is the "Sunscreen Monograph," a document that sets out conditions under which sunscreens can be considered safe and effective, and therefore marketed without requiring prior individual approval by the FDA.
The monograph details aspects such as:
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Permitted active ingredients and their concentrations.
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Test methods for determining Sun Protection Factor (SPF) and broad spectrum protection.
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Labeling requirements, including directions for use and warnings.
Labeling and Claims
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SPF (Sun Protection Factor): Should indicate the level of protection against UVB rays.
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Broad Spectrum Protection: Indicates whether the product offers balanced protection against both UVA (which can contribute to skin cancer and premature aging) and UVB.
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Water Resistance: If a product claims to be water resistant, it must specify how long it remains effective when swimming or sweating, based on standard tests.
Regulatory Updates and Challenges
The science and technology behind sunscreens is constantly evolving, prompting the FDA to periodically review and update its regulations. This includes re-evaluating the safety of active ingredients and considering approval of new ingredients that may offer additional or enhanced benefits.
Active Ingredients
The sunscreen monograph identifies active ingredients that have been recognized as safe and effective for use in sunscreens. Any new ingredient that is to be used requires the submission of a New Drug Application (NDA) for review and approval by the FDA.
Implications for Consumers
Consumers should be aware of the importance of using sunscreens that comply with FDA regulations to ensure effective protection against sun damage. It is essential to read and follow labeling instructions, paying particular attention to SPF, broad spectrum protection, and water resistance claims.
SPF: Canada
In Canada, cosmetic products containing Sun Protection Factor (SPF), such as sunscreens, are regulated under a specific framework that ensures the safety and efficacy of these products. Health Canada is the agency responsible for regulating health and cosmetic products, including sunscreens, and classifies them as either over-the-counter (OTC) drugs or cosmetics, depending on their ingredients and claims.
Key aspects of SPF regulation in cosmetics in Canada:
A key component of the regulation is the "Sunscreen Monograph," a document that establishes conditions under which sunscreens can be considered safe and effective, and therefore, marketed without the need for individual prior approval by the FDA. .
The monograph details aspects such as:
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Allowed active ingredients and their concentrations.
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Test methods to determine Sun Protection Factor (SPF) and broad spectrum protection.
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Labeling requirements, including instructions for use and warnings.
SPF: Dubai / UAE
In Dubai and the United Arab Emirates (UAE), cosmetic products containing Sun Protection Factor (SPF), such as sunscreens, are subject to strict regulation to ensure their safety and effectiveness. Local authorities, primarily the Emirates Authority for Standardization and Metrology (ESMA) and Dubai Municipality, monitor compliance with these regulations in line with international standards and Gulf Cooperation Council (GCC) guidelines.
Key aspects of SPF regulation in cosmetics in Dubai/UAE:
A key component of the regulation is the "Sunscreen Monograph," a document that establishes conditions under which sunscreens can be considered safe and effective, and therefore, marketed without the need for individual prior approval by the FDA. .
The monograph details aspects such as:
-
Allowed active ingredients and their concentrations.
-
Test methods to determine Sun Protection Factor (SPF) and broad spectrum protection.
-
Labeling requirements, including instructions for use and warnings.