Photoprotection has evolved from a seasonal product into an essential part of the daily skincare routine, driving a transformation of the market and the regulatory requirements that impact this category.
The periodic re-evaluation of UV filters, the increasing demand for scientific evidence to support cosmetic claims, and the growing interest in developing more sustainable formulations are reshaping the way brands design and launch sunscreen products.
In this context, developing a sunscreen is no longer just about achieving a high SPF. It requires integrating regulatory, toxicological, technical, and quality considerations from the earliest stages of product development to ensure safety and regulatory compliance throughout the product’s entire lifecycle.
A Growing Market with Increasing Regulatory Requirements
Growing awareness of the harmful effects of solar radiation has driven the use of sunscreen products. As a result, consumer expectations regarding product performance, safety, and regulatory compliance have also increased.
European authorities continue to review the available scientific evidence on approved UV filters. In recent years, this has led to changes in the conditions of use for certain ingredients, as well as the restriction or withdrawal of specific UV filters.
For brands, this means continuously monitoring the evolving regulatory landscape and assessing the potential impact of these changes on both existing and future formulations.
Innovation Goes Beyond Formulation
Innovation in photoprotection is not limited to incorporating new active ingredients or developing more pleasant textures. It also requires ensuring that every development decision is aligned with the applicable regulatory requirements.
Today, the development of a sunscreen product should take into account aspects such as:
- Selection of UV filters authorized in the European Union.
- Compatibility and stability of UV filter combinations.
- Toxicological profile of the ingredients.
- Photostability of the formulation.
- Compatibility between the product and its packaging.
- Stability and preservation studies.
- Safety assessment (CPSR).
- Compliance with the labelling requirements established under Regulation (EC) No 1223/2009.
Integrating these considerations from the earliest stages of development helps reduce regulatory risks and avoid costly reformulations later in the product lifecycle.
Cosmetic Claims: Increasing Demand for Scientific Evidence
Consumers are looking for sunscreen products that not only protect against UV radiation but also provide additional benefits such as hydration, antioxidant activity, protection against pollution, or support for the skin barrier.
However, any cosmetic claim must comply with the common criteria established under European legislation and be supported by adequate scientific evidence.
Claims such as “Suitable for sensitive skin,” “Blue light protection,” or “Repairing action” require robust technical and scientific substantiation before they can be included on product labels or used in marketing communications.
New Formats, Same Regulatory Requirements
Solar mists, sticks, sunscreen serums, and compact sunscreens continue to gain popularity thanks to their ease of application and reapplication.
However, the product format does not change the applicable regulatory obligations. Every new presentation must demonstrate its intended safety of use and comply with the same quality, stability, and safety assessment requirements as any other cosmetic product.
In addition, certain formats may require a specific consumer exposure assessment, particularly when they alter the amount of product applied or the predominant route of exposure.
The Challenge of Formulating with the Future in Mind
One of the main challenges for brands is developing products that not only comply with current regulations but are also capable of adapting to future regulatory changes.
The recent regulatory developments affecting certain UV filters highlight the importance of designing robust formulations that can accommodate potential changes in the conditions of use of specific ingredients.
Integrating a regulatory perspective from the earliest stages of product development helps minimize risks, reduce the costs associated with reformulation, and extend the commercial lifespan of the product.
Regulatory Aspects to Review Before Product Launch
Before placing a sunscreen product on the market, it is advisable to verify that the development process addresses, among other aspects:
- Appropriate selection of UV filters authorized for use.
- Compliance with the concentration limits established in Annex VI of Regulation (EC) No 1223/2009.
- An up-to-date safety assessment.
- Stability testing and packaging compatibility studies.
- Sufficient evidence to support cosmetic claims.
- Labelling review in accordance with the applicable legislation.
- Ongoing monitoring of regulatory changes that may affect the formulation.
Conducting a thorough technical and regulatory review before launch helps minimize potential issues during commercialization and facilitates access to new markets.
Is Your Sunscreen Portfolio Ready for Upcoming Regulatory Changes?
If you are developing a new photoprotection range, it is worth considering the following questions:
- Is the formulation designed with the evolving regulatory landscape for UV filters in mind?
- Are your cosmetic claims supported by sufficient scientific evidence?
- Does the safety assessment reflect the product’s intended use?
- Will the formulation remain stable throughout its entire shelf life?
- Does the packaging provide adequate protection for the formulation?
- Is there a strategy in place to manage future regulatory changes?
Addressing these questions from the earliest stages of product development can help avoid delays, unnecessary reformulations, and additional costs.
Conclusion
Photoprotection will continue to be one of the fastest-growing categories in the European cosmetics market, but it is also one of the most demanding from both a technical and regulatory perspective.
The success of a new sunscreen product will depend not only on its efficacy and sensory performance but also on a brand’s ability to develop products that are safe, technically robust, and prepared to meet the challenges of an evolving regulatory landscape.
At cosmeticsinMind, we support brands and manufacturers throughout the entire sunscreen product development process with an integrated approach that combines formulation expertise, safety assessment, regulatory compliance, and technical support.
Our services include:
- Custom sunscreen formulation development.
- Regulatory strategy for European and international markets.
- Cosmetic Product Safety Report (CPSR) and Product Information File (PIF) support.
- Review of labelling, formulations, and cosmetic claims.
- Stability testing and packaging compatibility studies.
- Manufacturing coordination and industrial scale-up.
- Technical support before and after product launch.
If you are developing a new photoprotection range or need to review the regulatory compliance of an existing sunscreen formulation, we would be pleased to help.