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PDRN treatment has moved from aesthetic medicine clinics to the shelves: it is now sold as PDRN skincare, in the form of a PDRN cream, serum, ampoule or post-procedure care line, almost always with salmon DNA as the main active. For a brand, however, the challenge is no longer that the ingredient is fashionable, but knowing what it can promise and what it must document when it is incorporated into a cosmetic.
A year after this active began appearing in high-end cosmetics, it is worth reviewing what European regulation currently says about PDRN, how a medical PDRN treatment differs from a cosmetic PDRN product, and what customers and authorities expect from each formula.
What PDRN treatment is and where salmon DNA comes from
PDRN, or polydeoxyribonucleotide, is a mixture of purified DNA fragments obtained mainly from salmon or trout sperm. Depending on the grade and the supplier, these fragments have molecular weights ranging from about 50 to 1,500 kDa, which is why the ingredient is also referred to as “salmon DNA PDRN”. It is attributed regenerative and anti-inflammatory properties, linked to the activation of adenosine A2A receptors.
Its original use was medical: skin healing, tissue repair and mesotherapy. PDRN treatment reached cosmetics much later, and today it is found in serums, ampoules, creams and formulas for care after procedures such as laser or microneedling.
PDRN treatment in a clinic or a cosmetic PDRN product: where the difference lies
A PDRN treatment in a clinic is administered under the skin, in direct contact with the tissue to be repaired. In some markets, such as South Korea or Italy, these injectable products are regulated as medical-use ingredients or products, and their status depends on their composition and purpose.
A cosmetic PDRN product, by contrast, is something else. Regulation (EC) 1223/2009 only considers as cosmetic what is applied to the external parts of the body with the exclusive or main purpose of cleaning them, changing their appearance, protecting them or keeping them in good condition. For example, a PDRN cream or a PDRN serum is applied to intact skin, and high-molecular-weight DNA fragments are poorly absorbed by that route.
This does not invalidate the cosmetic use of PDRN, but it sets the limit of what can be promised. The clinical evidence for the injectable treatment does not simply carry over to a topical cosmetic, so any claim must be supported by data obtained at the concentrations and via the actual route of application of the product.
What European regulation says today about PDRN treatment
PDRN still does not appear in any of Annexes II, III, IV, V or VI of Regulation (EC) 1223/2009, so it is neither explicitly banned nor restricted. In addition, in the European Commission’s CosIng database, the animal-origin DNA used as PDRN is registered under the INCI name Sodium DNA, with a skin-conditioning function.
There is also, for now, no SCCS opinion on this ingredient. Indeed, we have reviewed the committee’s public list of mandates and, at the time of writing, there is no request for an assessment of PDRN.
However, the absence of a numerical limit does not exempt the brand from anything. Product safety (Article 3), the safety assessment and the PIF (Articles 10 and 11), labelling (Article 19) and claim substantiation (Article 20) remain enforceable.
What a PDRN product must meet before reaching the market
Although there is no limit to consult, there are five aspects that a brand must resolve case by case before launching a PDRN cream, serum or ampoule:
- Origin and purity: salmon or trout DNA must be traceable and meet hygiene standards, with certificates ruling out residual proteins and contaminants.
- Name on the label: in the ingredients list it is declared as Sodium DNA. “PDRN” works as a trade name or claim, but it does not replace the INCI name, and the declared active must be the one actually advertised.
- Claims: they must meet the six common criteria of Regulation (EU) 655/2013 (legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making) and be consistent with the evidence in the PIF. In particular, expressions such as “regenerates the skin’s DNA” or “treats scars” suggest a therapeutic function.
- Individual safety assessment: given its biological nature, PDRN requires its own assessment within the CPSR, not a generic reference to the ingredient.
- Vegan status: as it comes from animal DNA, a salmon PDRN product cannot be presented as vegan, although plant-based alternatives that seek to mimic its effect exist.
Notification follows. In the European Union, the product is notified through the CPNP. Likewise, in the United Kingdom, following Brexit, it is notified through the SCPN. Finally, in the United States, MoCRA requires facility registration and product listing, as well as safety data supporting the ingredient.
What documentation a cosmetic PDRN treatment needs in the CPSR and the PIF
When including PDRN in a formula, this documentation is essential for Parts A and B of the CPSR and for the PIF:
- INCI identification (Sodium DNA) and CAS/EC data, where available.
- Supplier specifications: purity, molecular weight and origin of the DNA.
- Toxicological profile and sensitisation data.
- Analytical certificate confirming the absence of contaminants or residual proteins.
- Stability and compatibility studies in the final formula.
- Safety assessment signed by a qualified toxicologist.
- Scientific justification for each efficacy claim, especially those relating to regeneration, anti-ageing or recovery after procedures.
As a result, with this file, an ingredient without specific regulation remains within the safe scope of the Cosmetics Regulation. If you would like to see how it is built, we explain it in our guide to the cosmetic product safety report (CPSR).
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 make sure your PDRN skincare products meet all cosmetic safety and documentation requirements.
FAQs
What is a PDRN treatment?
It is a treatment based on polydeoxyribonucleotide, DNA fragments purified from salmon or trout. In aesthetic medicine it is applied under the skin to promote tissue repair, and in cosmetics it is incorporated into PDRN skincare such as topical creams, serums and ampoules.
Is a PDRN treatment in a clinic the same as a PDRN cream?
No. The clinic treatment is an intervention with medical or health status, whereas a PDRN cream is a topical cosmetic subject to Regulation (EC) 1223/2009. That is why the evidence for the former does not on its own justify the claims of the latter.
Is PDRN banned or restricted in the EU?
No. It does not appear in any Annex to Regulation (EC) 1223/2009 and has no SCCS opinion. That said, the product must be safe and its claims truthful and demonstrable.
How is PDRN declared in the ingredients list?
With the INCI name Sodium DNA. The term “PDRN” may be used as a trade name or claim, but it does not replace the INCI name, and the declared ingredient must match the active being advertised.
Can a PDRN serum say that it “regenerates the skin’s DNA”?
This is not advisable. That claim suggests a pharmacological or tissue-repair effect, characteristic of a medicinal product. Instead, it is preferable to say that the product “supports recovery” or “improves the appearance” of the skin, always with evidence specific to topical use.
What notification does a PDRN product need in each market?
In the EU, the CPNP. Likewise, in the UK, the SCPN. Finally, in the United States, the facility registration and product listing required by MoCRA.
References
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
- Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products
- European Commission: CosIng cosmetic ingredient database
- European Commission: SCCS mandates (list of requests for scientific opinion)
