The law
What a harmonised standard is, and why it is voluntary
A harmonised standard is a technical document cited in the Official Journal. Citation gives a presumption of conformity, not a duty.
A harmonised standard is a technical document that a European standards body writes at the request of the European Commission. You do not have to follow one, because a harmonised standard stays voluntary.
The Commission cites the document in the Official Journal of the European Union. That citation creates a presumption of conformity, which moves the work of proof away from you. It does not create a duty.
If you get that second point wrong, you spend money early. A supplier can quote a real standard number, a real citation and a real date, and still be wrong. The law does not force you to buy the text. Each digital product passport standard costs between 190 and 370 EUR on the distributor listings.
Three steps turn a European standard into a harmonised standard
The word harmonised describes the process, not the content. Three parties act, in order.
| Step | Who acts | What happened for the passport |
|---|---|---|
| The request | The European Commission | Standardisation Request M/604, and the amendment M/604_Amd1 |
| The drafting | CEN and CENELEC, the two European standards bodies | Joint committee CEN/CLC/JTC 24, with its secretariat at DIN |
| The citation | The European Commission, in the Official Journal | Implementing Decision (EU) 2026/1736, in force since 15 July 2026 |
The committee is CEN/CLC/JTC 24. The request that set its work is M/604. The citation came in an implementing act. An implementing act is a rule the Commission makes to apply an existing law the same way across the Union.
A standard that finishes the first two steps and not the third is still a European standard. It is not harmonised, so it gives you no presumption of conformity.
Citation gives a presumption of conformity, not a duty
A presumption of conformity means an authority starts from the position that your product meets the legal requirement. You built the product to the cited standard, so the authority treats that requirement as met.
That is the full legal effect. Citation adds no obligation to the standard. It does not make the text a law, and it does not make the text mandatory reading.
A presumption is a starting position, and it moves the work of proof away from you. The page on presumption of conformity sets out how far it reaches.
You may meet the requirement another way, and then you must prove it
The cited standard is one route to compliance.
You may design your own method and meet the same legal requirement. The presumption then does not apply. You must produce your own evidence, and you must convince the authority on the evidence alone.
So the choice is about effort, not about legality. The cited standard is the route with the least work of proof.
A standard that is not cited gives you nothing
Two more passport standards exist in draft. They are prEN 18239 and prEN 18246.
CEN and CENELEC still list both as under approval. The formal vote closed on 16 July 2026. Nobody has published either text, and the Commission has cited neither.
So neither draft gives a presumption of conformity today. Do not accept either as a requirement. A draft can change before publication.
The Commission cited six standards for the passport
The six numbers below are not a continuous range. There is no EN 18217 and no EN 18218. A range written from the lowest number to the highest invents two documents that do not exist.
- EN 18216, data exchange protocols
- EN 18219, unique identifiers
- EN 18220, data carriers
- EN 18221, data storage, archiving, and persistence
- EN 18222, application programming interfaces for product passport lifecycle management and searchability
- EN 18223, system interoperability
The official titles are in the six standards. The Decision that cites them sits in the Official Journal.
The presumption covers how a passport is built, not if you need one
Read the table below before you act on any conformity claim. The ecodesign regulation is the Ecodesign for Sustainable Products Regulation (ESPR), Regulation (EU) 2024/1781.
| Item | Where it sits |
|---|---|
| Legal basis of the Decision | Article 10(6) of Regulation (EU) No 1025/2012 on European standardisation |
| Source of the presumption | ESPR Article 41(2) |
| Requirements the presumption covers | ESPR Articles 10 and 11 |
| The article that makes a passport a condition of market access | ESPR Article 9, which the Decision does not mention |
Articles 10 and 11 carry the technical requirements for a passport. Article 9 is the article that decides if your product needs one at all.
As at August 2026 the Commission has adopted no delegated act for any product group. So no ESPR passport duty exists yet, and the presumption has no practical effect for any group. See the legal basis for the two laws that matter.
One passport duty is settled, and it comes from a different law. The battery regulation, Regulation (EU) 2023/1542, is in force. Its passport duty applies from 18 February 2027 to three categories:
- each light means of transport (LMT) battery, such as an e-bike battery
- each industrial battery with a capacity greater than 2 kilowatt hours
- each electric vehicle battery
The page on batteries covers that duty.
Harmonised standards are older than the passport, and you may use one already
This mechanism runs across European product law. It is not new, and it is not special to passports.
If you export a skincare cream, you meet the same pattern under the cosmetics regulation, Regulation (EC) No 1223/2009. Its Article 8 requires good manufacturing practice. If you apply the harmonised standard ISO 22716, you get a presumption of conformity.
You may use another method to meet Article 8. You must then show the authority your own proof. The passport standards work the same way.
A title is not a scope statement
The six texts are behind a paywall. This site has not bought them, so this site states no normative content for any of the six.
Warning: do not take a standard title as a description of what the standard requires. The title of EN 18220 ends with the words "Data carriers". That title does not tell you which carriers the text permits, or what it demands of each one.
The scope summaries in circulation come from the slides of a CEN and CENELEC webinar, and not from the standards. A distributor page that describes a standard is promotional copy, and it is not a normative text. The page on why the texts are paywalled covers the reason for both.
One example shows the cost. Many pages state a count of permitted product identifier schemes, and name one scheme among them. That count is unverified, because the standard that would settle it sits behind a paywall. See identifier schemes.
No law forces you to buy any of the six texts, so ask which article creates your duty
Warning: do not buy any of the six texts because a supplier says the law requires them.
- Ask which of the six the product implements, by number.
- Ask if a delegated act covers your product group. Today none does.
- Ask the supplier to show you the article that creates your duty.
- Treat any scope claim about the six as unverified, unless the person quotes the purchased text.
If you export from New Zealand, read what this means for New Zealand exporters next.