With summer now fully underway, consumers’ attention has returned to sun protection and choosing from the many sunscreens available on the market today. There has been focus recently in social media on sunscreen ingredients, so if developing a new sunscreen is in your plans, what should you know? Let’s start with a simple multiple choice question:
- Over-the-counter (OTC) drugs
- Natural health products
- All of the above
Did I say simple? That may not be completely accurate! The answer is actually (d) All of the above. Depending on where you market your sunscreen, it may be classified in any of these categories. Although there are classification differences, there are shared similarities when it comes to ensuring consumer protection from the sun’s rays. In this blog we will briefly discuss the regulations and requirements in Canada, the USA and Europe, focusing on allowable ingredients and label claims as well as testing requirements.
Sunscreen products are regulated as OTC drug products in the USA. This means that the product must comply with the existing Sunscreen Drug Products for Over-The-Counter Human Use monograph (21 CFR 352). The Sunscreen Monograph lists the ingredients permitted in sunscreens as well as labeling requirements for sunscreen products, which includes a Drug Facts panel.
If you want to use an ingredient in your sunscreen product that is not included in this monograph, a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required. This has been an area of contention for sunscreen developers, as this has proven to be a long and arduous process. The list of ingredients contained in the Sunscreen Monograph has not been updated since 1999, and the FDA has dragged their heels in reviewing new sunscreen ingredients. As a response to industry concerns, the FDA has recently announced the Sunscreen Innovation Act (SIA), a process to review the safety and efficacy of new sunscreen active ingredients. Hopefully this process will allow a greater variety of safe and effective sunscreens to make their way into the US market.
So, how do you determine the Sun Protection Factor (SPF) value of your sunscreen product? And what claims can be made? There are two effectiveness test procedures required for OTC sunscreens: The Sun Protection Factor (SPF) test and The Broad Spectrum Test, as well as an optional Water Resistance Test [21 CFR 201.327].
Sunscreens cannot claim to be “waterproof” or “sweatproof” or identified as “sunblock.” They can only claim to help prevent sunburn unless they are Broad Spectrum SPF 15 or higher. Broad Spectrum means the product protects against both UVA and UVB rays. If the product passes the Broad Spectrum Test, the product can be labelled as “Broad Spectrum”, and with an SPF of 15 or higher, can claim to reduce the risk of skin cancer and early skin aging. Additionally, sunscreens that pass the Water Resistance Test can be labelled as “water resistant”.
Sunscreen products are regulated as cosmetics in Europe. This means that the product must comply with the cosmetic regulations (EC No 1223/2009), which includes permitted ingredients, product safety, notification and labelling requirements.
As in the USA, sunscreen efficacy must also be proven in the EU based on standardized, reproducible criteria. Originally in 2006, the “Recommendation on the efficacy of sunscreen products and the claims made relating to them” was adopted, which set out prohibited claims, precautions, labeling and minimum efficacy standards. While the test methods in this document are still valid, more recent methods standardized by the European Standardisation Organization (CEN) are considered the reference methods within the EU. These test methods include: In Vivo Determination of the Sun Protection Factor (EN ISO 24444:2010) and In Vitro Determination of Sunscreen UVA Photoprotection (EN ISO 24443:2012).
As per the Recommendation, claims indicating UVB and UVA protection are only permitted if the product meets specific SPF and critical wavelength levels. Additionally, the efficacy of the product is recommended to be indicated on the label by referencing standardized categories of ‘low’, ‘medium’, ‘high’ and ‘very high’ protection. To market a sunscreen as “water resistant”, it must also be tested, with the “(Colipa) Guidelines for Evaluating Sun Product Water Resistance, 2005” being the widely accepted method in Europe.
Depending on their ingredients, sunscreen products are regulated as either Natural Health Products (NHPs) or drug products in Canada under the NNHPD Sunscreen Monograph. Sunscreens containing Titanium Dioxide, Zinc Oxide or PABA are considered NHPs and they require a NPN (natural product number). The Sunscreen Monograph also lists the ingredients which are considered drug products. Products containing these ingredients require a DIN (drug identification number).
The Sunscreen Monograph provides an overview of the test procedures required to make “SPF” and “Broad Spectrum” claims. These values must be determined using a standardized and reproducible method, and include both the FDA methods or ISO methods discussed previously for the USA and Europe.
All sunscreen products can carry a SPF claim and can be promoted to help prevent sunburn. As in the USA, products can also be promoted as “broad spectrum” and “water/sweat resistant” if they pass the associated tests. Similarly, claims to decrease the risk of skin cancer and early skin aging are permissible for products which are broad spectrum SPF 15 or higher.
REGISTRATION / LICENSING REQUIREMENTS
Once the product is tested and ready to market, what registrations and / or licences are required?
For the USA, facility registration is a requirement. As sunscreens are considered drug products in the USA, domestic and foreign manufacturers, packagers or labellers are required to register their establishments with the FDA submit an annual list of their drug products.
In Europe, as cosmetics, sunscreen products must undergo a safety assessment via a Cosmetic Product Safety Report (CPSR) and be registered into the Cosmetic Product Notification Portal (CPNP) prior to being placed on the market.
Finally, in Canada, depending on the classification of the sunscreen product (NHP or drug), the product will require registration via an NPN submission or DIN submission. Additionally, sunscreens classified as drugs will also require facility registration and must be manufactured, packaged, labelled and distributed by facilities with a Drug Establishment Licence.
NHP Consulting has expertise working with OTC drugs, cosmetics and natural health products, and can provide assistance with your sunscreen product registrations, safety reports, product labelling and facility registration. Contact us to learn more and see how we can help.