Harmonised standards: what they are and how to find the list

A harmonised standard is a European standard that CEN, CENELEC or ETSI wrote after the European Commission asked for it, to support an EU product law (Regulation (EU) No 1025/2012, Art. 2(1), point (c), and Annex I). Using one is voluntary. It gives you a presumption of conformity only once the Commission has published its reference in the Official Journal of the European Union, and only for the requirements the standard covers.

What you do:

1. Open the Commission’s harmonised standards service and pick the page for your product law. It names the Commission implementing decisions that publish the references. Those decisions, in the Official Journal, are the legal list.
2. Check each standard your supplier or lab names against that list. The number, the year and any amendment must match a published reference, and no withdrawal date may have passed (Blue Guide, section 4.1.2.5).
3. Read the note under the entry. A restriction or a notice means the standard gives no presumption for the part it names.
4. Check what the standard covers. Its informative annex, usually called Annex ZA, ZB or ZZ, names the legal requirements it is aimed at (Blue Guide, section 4.1.2.2 and footnote 187). For every other requirement you need another proof.
5. Name the standards you applied, with their version and date, in your declaration of conformity, and keep the test evidence in the technical documentation (Blue Guide, sections 4.3 and 4.4).
6. If no harmonised standard covers a requirement, or you apply one only in part, show conformity another way. Some laws then send the product to a notified body (Art. 19(3)Directive 2009/48/EC, Toy Safety DirectiveArticle 19, paragraph 3Click opens the article on EUR-Lex.; Art. 12(4)Directive 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)Article 12, paragraph 4Click opens the article on EUR-Lex.; from 20 January 2027 Art. 25(3)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 25, paragraph 3Click opens the article on EUR-Lex.).
7. Check the list again when it changes, and update the declaration when the version of a standard you applied changes (Blue Guide, section 4.4).

How the marking, the declaration and the technical file fit together is on CE marking.

A harmonised standard is a European standard written for an EU law

EU law sorts standards into four kinds (Regulation (EU) No 1025/2012, Art. 2(1), points (a) to (d), and Art. 2(9)):

• an international standard is adopted by an international standardisation body: ISO, IEC or ITU;
• a European standard is adopted by a European standardisation organisation: CEN, CENELEC or ETSI (Annex I);
• a harmonised standard is a European standard adopted on the basis of a request made by the Commission for the application of EU harmonisation legislation;
• a national standard is adopted by a national standardisation body.

Every kind is a technical specification “with which compliance is not compulsory”. The word “harmonised” says nothing about publication. A standard is harmonised once it is adopted on a Commission request. It gives a presumption only after its reference is published (Blue Guide, section 4.1.2.2).

An EN reference tells you the body, the number, the year and the amendments

A reference such as EN 71-1:2014+A1:2018 reads in parts. The table takes the forms that appear in the Commission’s lists.

The presumption starts when the reference is published and covers only what the standard covers

Each product law says the same thing in its own article. Equipment that conforms with harmonised standards, or parts of them, whose references are published in the Official Journal is presumed to conform with the requirements those standards cover. The table gives the article for each law and where its references are published.

Three limits sit inside that rule:

• It starts on publication. The Commission’s decisions say it in the same words: compliance “confers a presumption of conformity […] from the date of publication of the reference of such standard in the Official Journal of the European Union”.
• It covers the requirements the standard covers. Where a standard covers only some of the requirements, the presumption exists only to that extent. For the rest you use other technical specifications (Blue Guide, sections 4.1.2.2 and 4.1.2.3).
• It needs the standard applied, not named. Writing a harmonised standard into the declaration without applying it, or its relevant parts, gives no presumption (Blue Guide, footnote 188).

You may use another way, but then the proof is yours

Standards are voluntary: a standard is a specification “with which compliance is not compulsory” (Art. 2(1) of Regulation (EU) No 1025/2012). The Commission says the same of harmonised standards: “The use of these standards remains voluntary. Manufacturers, other economic operators, or conformity assessment bodies are free to choose another technical solution to demonstrate compliance with the mandatory legal requirements” (Commission).

What changes is who carries the burden. Without a presumption you show, in the technical file, how the standards or specifications you used meet the legal requirements (Blue Guide, section 4.1.3). A standard that is not on the list, or whose reference was withdrawn, can still be used. It gives no presumption.

In some laws the choice also decides who checks the product. A toy built to harmonised standards that cover all its safety requirements goes through internal production control (module A). A toy for which no such standard exists, one built without them or with them only in part, or one covered by a standard published with a restriction that applies to that toy, goes to EC-type examination by a notified body (Art. 19(2)Directive 2009/48/EC, Toy Safety DirectiveArticle 19, paragraph 2Click opens the article on EUR-Lex., Art. 19(3)Directive 2009/48/EC, Toy Safety DirectiveArticle 19, paragraph 3Click opens the article on EUR-Lex.). The Machinery Directive sets the same fork for the machines on Annex IV: internal checks by the manufacturer only if the machine was built to harmonised standards that cover all the relevant requirements, and otherwise EC type-examination or full quality assurance (Art. 12(3)Directive 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)Article 12, paragraph 3Click opens the article on EUR-Lex., Art. 12(4)Directive 2006/42/EC, Machinery Directive (consolidated text of 30 May 2026)Article 12, paragraph 4Click opens the article on EUR-Lex.). From 20 January 2027 the Machinery Regulation does the same for the machines on Annex I, Part B: self-assessment only if the machine was built to the harmonised standards or common specifications for its category that cover all the requirements (Art. 25(3)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 25, paragraph 3Click opens the article on EUR-Lex., Art. 54Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 54Click opens the article on EUR-Lex.).

The current list is the set of implementing decisions in the Official Journal

Since 1 December 2018 the Commission has published and withdrawn references by implementing decisions in the Official Journal. Its pages for the low-voltage, toy, machinery, EMC, protective-equipment and RoHS laws say so, and each lists the decisions for its law. The steps to read a list:

1. Open the base decision for your law from the table above or from the Commission’s page.
2. Open every amendment listed with it. A later amendment can add, restrict or withdraw a reference. The low-voltage page lists the base decision, four amendments from 19 April 2024 to 22 July 2025 and one separate decision, 2025/1464, for EN 60335-2-14:2006.
3. For the EMC and machinery laws, read the Commission communication of 2018 in the OJ C series too. The Commission says the later decisions “may modify references published in the Communication”.
4. Subscribe to the RSS feed if you want to hear of changes. Several of the Commission’s law pages, among them toys, machinery, EMC, radio equipment and protective equipment, offer one.

The Commission also posts a summary list for each law. It “reproduces information already published in the L or C series of the OJ”, and it carries the Commission’s own warning: “The summary does not as such generate legal effects” (Commission, low-voltage page). Use it to find a reference, then confirm in the decision. On the low-voltage page the Commission adds: “NOTE: For the moment (from April 2025 onwards) summary lists are not updated because of maintenance work on relevant databases.”

A superseded standard stays valid until the withdrawal date in the Official Journal

When a standard is revised, the Commission publishes the new reference and, in most cases, sets a date on which the old one stops giving a presumption. Until that date both versions give it. The Commission sets the date, can make the period short for safety reasons, and can extend it (Blue Guide, section 4.1.2.5). After the date only the new version gives a presumption.

If you declare conformity yourself, by internal production control, this is your job. The Blue Guide says it is “particularly essential in cases where manufacturers declare conformity themselves (in case of internal production control)” to check each publication of the list and confirm that the standards they applied are still valid.

A reference can be published with a restriction

Where an EU country or the European Parliament considers that a harmonised standard does not entirely satisfy the requirements it aims to cover, it tells the Commission. The Commission then decides to publish, not to publish or to publish with restriction the reference, or to maintain, maintain with restriction or withdraw it (Regulation (EU) No 1025/2012, Art. 11(1)). That article does not apply where a product law has its own objection procedure (Art. 28), as the Toy Safety Directive has in its Art. 14. The restriction is printed under the entry in the decision. Three examples from the decisions:

• EN 71-1:2014+A1:2018, toys. For clauses 3.19 and 4.15.1 as they apply to wave rollers, a ride-on toy where the child is seated and steers and propels it with the feet, the standard “does not confer a presumption of conformity” with the toy safety requirements in Art. 10(2)Directive 2009/48/EC, Toy Safety DirectiveThe whole regulationClick opens the law on the EU Publications Office. of Directive 2009/48/ECDirective 2009/48/EC, Toy Safety DirectiveThe whole regulationClick opens the law on the EU Publications Office. and Part I, point 3, of Annex II to it. The restriction was published by Implementing Decision (EU) 2025/1785, which rests on Art. 14(2) of that Directive. A toy the restriction applies to, a wave roller, goes the notified-body route (Art. 19(3)Directive 2009/48/EC, Toy Safety DirectiveArticle 19, paragraph 3Click opens the article on EUR-Lex., point (c)).
• EN 60335-1:2012, household appliances. Decision (EU) 2025/1457 of 16 July 2025 maintains the standard with a restriction on “the part of clause 20.2 which refers to the test probe that is similar to test probe B”. The Commission acted on Germany’s formal objection.
• EN 18031-1, -2 and -3, radio equipment. Each is published with restrictions and notices, for example for equipment that lets the user choose not to set a password. The details are in Cyber Resilience Act.

When no harmonised standard exists, the law may give another route

Three cases, each in the text of the law.

Common specifications. Under the Machinery Regulation the Commission may adopt implementing acts that set common specifications, but only if it asked the standards bodies for a harmonised standard and the request was refused, the standard was not delivered on time or does not comply with the request, and no reference has been published and none is expected within a reasonable period (Art. 20(3)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 20, paragraph 3Click opens the article on EUR-Lex.). A machine that conforms with them is presumed to meet the requirements they cover (Art. 20(6)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 20, paragraph 6Click opens the article on EUR-Lex.). When a harmonised standard’s reference is published for the same requirements, the Commission repeals the common specification (Art. 20(7)Regulation (EU) 2023/1230, Machinery Regulation (consolidated text of 27 July 2026)Article 20, paragraph 7Click opens the article on EUR-Lex.).

International and national standards. Under the Low Voltage Directive, where harmonised standards have not been drawn up and published, electrical equipment that complies with the safety provisions of the relevant IEC standards, once the publication procedure in the Directive has been applied to them, counts as complying with the safety objectives. If those are not published either, so does equipment made to the standards in force in the EU country of manufacture, if it gives an equivalent level of safety (Art. 13Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 13Click opens the article on EUR-Lex., Art. 14Directive 2014/35/EU, Low Voltage Directive (consolidated text of 30 May 2026)Article 14Click opens the article on EUR-Lex.).

GPSR. GPSR’s text speaks of “European standards”, not harmonised standards. A product is presumed to meet the general safety requirement if it conforms to the relevant European standards whose references the Commission published, as far as the risks they cover are concerned (Art. 7(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1Click opens the article on EUR-Lex., point (a)). Where no relevant European standard exists, a product that conforms to the health and safety requirements of the national law of the country where it is sold is presumed to meet it, if that law complies with Union law (Art. 7(1)Regulation (EU) 2023/988, General Product Safety RegulationArticle 7, paragraph 1Click opens the article on EUR-Lex., point (b)). GPSR’s text names no common specifications. Where the presumption does not apply, Art. 8Regulation (EU) 2023/988, General Product Safety RegulationArticle 8Click opens the article on EUR-Lex. lists what to weigh instead, among them other European standards, international standards, national standards and the state of the art. Where appropriate, the technical documentation lists the European standards applied, and names the parts applied where a standard was applied only in part (Art. 9(2)Regulation (EU) 2023/988, General Product Safety RegulationArticle 9, paragraph 2Click opens the article on EUR-Lex.); what that file holds is on GPSR technical documentation.

CEN and CENELEC standards are bought from national standards bodies, ETSI standards are free

CEN and CENELEC do not sell standards. They say: “CEN and CENELEC do not distribute or sell standards”, and European Standards may be purchased from CEN National Members and Affiliates and from CENELEC National Committees and Affiliates (CEN-CENELEC). Each national member adopts a European Standard as a national standard, so it is in that member’s catalogue. These are the national standardisation organisations of 34 countries. European Standards come in English, French and German (CEN-CENELEC).

ETSI is different. It publishes “thousands of freely-available technology standards” (ETSI). Most references in the radio equipment list are in the EN 300, 301 and 303 series, which are ETSI standards (Implementing Decision (EU) 2022/2191, Annex), so for radio equipment the free ETSI copy is the first place to look.

Get the European version. The presumption is possible “only when applying the European version published by reference in the Official Journal”, and the ISO and IEC versions “do not contain information about which provision of the standard is relevant for which essential requirement” (Blue Guide, section 4.1.2.3).

The Commission’s lists give the reference and the title, not the text.

Great Britain has its own list, called designated standards

For the Great Britain market the government publishes designated standards. A designated standard is one the government recognises by publishing its reference on GOV.UK in a formal notice of publication. Following it gives a presumption of conformity “which can be countered by evidence” (UK government). The government can designate a standard in full, not at all, or with restriction, and where a new designated standard replaces an old one there is a transition period in which both give the presumption. Designated standards are prefixed “BS”, “EN”, “EN ISO” or “EN IEC”. In Northern Ireland, where there is alignment with relevant EU rules, the European harmonised standards are the relevant ones. GOV.UK also says a business can CE mark its product for the Great Britain market under continued recognition, and that EU harmonised standards, like designated standards, give a presumption of conformity (UK government). The UK declaration of conformity is on declaration of conformity.