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What is PDRN?
PDRN (Polydeoxyribonucleotide) is a DNA-derived compound obtained mainly from salmon sperm extracts through controlled purification processes. It consists of DNA fragments with molecular weights between 350 and 500 kDa, and it is known for its regenerative and anti-inflammatory properties.
Originally used in medical and aesthetic treatments such as skin healing, tissue repair or mesotherapy, PDRN has recently entered the cosmetic market as a premium ingredient positioned for skin rejuvenation and recovery.
Where is PDRN used?
In cosmetics, PDRN is typically found in serums, ampoules, creams and post-procedure skincare lines.
Manufacturers claim benefits such as:
- Stimulating cell renewal and collagen synthesis.
- Enhancing skin elasticity and hydration.
- Supporting recovery after dermatological treatments (e.g. laser, microneedling, peeling).
Its stability in emulsions and compatibility with various textures make it suitable
Why has PDRN become so popular?
The growing demand for “bio-regenerative” skincare and the influence of K-beauty innovations have made PDRN one of the most talked-about cosmetic actives in K-Beauty.
Marketing claims often highlight its DNA-repair activity, though this effect need to be proven in cosmetic concentrations.
Social media trends, combined with clinical results from medical-grade products, have contributed to the confusion between cosmetic and pharmaceutical uses of PDRN, a key aspect to clarify from a regulatory standpoint.
Are there restrictions or regulatory concerns?
At the moment, PDRN is not specifically listed in any Annex (II, III, IV, V or VI) of the EU Cosmetics Regulation (EC) No 1223/2009, meaning it is not explicitly prohibited nor restricted. However, several points require careful assessment:
- Source and purity: DNA extracted from animal origin (salmon) must be traceable and compliant with hygiene and safety standards.
- Function and intended use: Cosmetic formulations cannot claim pharmacological or tissue-healing effects.
- Safety evaluation: Its biological nature demands an individual safety assessment within the CPSR (Cosmetic Product Safety Report).
- Regulatory positioning: In some regions (Korea, Italy), PDRN is regulated as a medical ingredient in injectables, which may create confusion when used in cosmetics.
- Vegan compliance: Due to its animal origin, PDRN is classified as a non-vegan cosmetic ingredient, although plant-based alternatives have emerged. In fact, alternative approaches had already been developed to mimic its regenerative effects without violating vegan standards.
- Market-specific registration: In the EU, products containing PDRN must be notified via the CPNP (Cosmetic Product Notification Portal). In the UK, post-Brexit, notification is required through the SCPN (Submit Cosmetic Product Notification). In the US, under the new MoCRA (Modernization of Cosmetics Regulation Act), manufacturers must ensure facility registration and product listing, along with substantiated safety data.
For these reasons, products containing PDRN should be evaluated case by case to confirm that the ingredient and its concentration are safe for topical application and do not lead to borderline classification.
How to include PDRN in your CPSR and PIF
When developing a cosmetic containing PDRN, the following documentation is essential for the CPSR Part A & B and Product Information File (PIF):
- INCI identification and CAS/EC data (if available).
- Supplier specifications including purity, molecular weight and origin.
- Toxicological profile and potential sensitisation data.
- Analytical certificate confirming absence of contaminants or residual proteins.
- Stability and compatibility in the final formulation.
- Safety assessment performed by a qualified toxicologist.
- Cosmetic claims substantiation: Provide scientific evidence to support any efficacy claims made on packaging or marketing materials, especially those related to regeneration, anti-aging, or post-procedure recovery.
Proper documentation ensures that the PDRN ingredient is fully traceable and that the cosmetic remains within the regulatory scope of the EU Cosmetics Regulation.
How Cosmeservice can help you
At Cosmeservice, we support brands and manufacturers in the regulatory evaluation of innovative ingredients such as PDRN.
Our regulatory team assists throughout the entire process, from ingredient review and classification to the preparation and validation of CPSR and PIF documentation for products containing biotechnological actives.
Contact our experts at info@cosmeservice.com to ensure your PDRN products meet all cosmetic safety and documentation requirements.
References
- Regulation (EC) No 1223/2009 on Cosmetic Products.
- SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 12th revision (2023).
- Kim, J. et al. (2022). Polydeoxyribonucleotide in dermatology and cosmetic medicine: clinical potential and safety aspects. Journal of Cosmetic Dermatology, 21(6).
- Rho, S., & Lee, J. H. (2023). Polydeoxyribonucleotide (PDRN) in dermatology: Mechanism and clinical applications. Journal of Skin Study and Care, 3(2), Article e159728.
- EU CosIng Database
