Does the note "ceases to have legal effect on January 20, 2027" in the list of harmonized standards mean that these standards can no longer be used?
If a piece of equipment has already been designed in accordance with EN ISO 12100 and EN ISO 13849-1—incorporating ESPE (Electro-Sensitive Protective Equipment,
such as safety light curtains or safety laser scanners)—must the original assessment be completely redone once the new Machinery Regulation comes into force?
Even if the standard number remains unchanged, why is it necessary to re-verify its "harmonized" status under the new regulation?
These issues are often conflated because the term "valid standard" can actually refer to two distinct concepts:
First, whether the text of the standard can still serve as a technical basis; and second, whether applying it grants a "presumption of conformity" under the current
regulatory framework.
The regulatory transition in 2027 requires us to address these two questions separately.
It is also important to define the scope of this discussion:
This article focuses on machinery—including equipment equipped with ESPE protective systems—that is placed on the EU market or put into service for the first time
on or after January 20, 2027.
For products already legally placed on the market under the Machinery Directive prior to January 20, 2027, the new Machinery Regulation provides separate transitional
arrangements. These should not be confused with projects that span the transition period—for instance, equipment designed in 2026 but placed on the market for the
first time in 2027 or later, which includes ESPE-based safety solutions.
I. The Expiration of the Old List: What Exactly Is Ending?
The EU has explicitly stated that the decisions regarding the application of harmonized standards under the Machinery Directive will cease to have effect upon the transition
to the new regulation. Article 2 of Commission Implementing Decision (EU) 2026/2015, published on September 7, 2026, stipulates:
Implementing Decision (EU) 2023/1586 is repealed with effect from January 20, 2027.
Implementing Decision (EU) 2023/1586 is the primary implementing decision under the Machinery Directive 2006/42/EC that publishes references to harmonized standards;
the harmonized references for the IEC 61496 series—which apply to ESPE (Electro-Sensitive Protective Equipment)—are also established via this decision.
What is being repealed here is the decision concerning the references to harmonized standards under the Machinery Directive. This does not mean that the texts of the EN
standards listed in the annex are being withdrawn, nor does it render the technical specifications for ESPE products themselves invalid.
These two aspects should be verified separately:
Therefore, the end of the legal validity of a standard's reference under the old Machinery Directive does not mean that its technical content, ESPE selection and verification
methods automatically expire on the same day.
The opposite is also true: the standard catalog shows "current", and this status alone does not mean that it has been harmonized and cited under the new machinery
regulations, even if it is a commonly used ESPE-related standard.
Standard versions and regulatory references are two lines that need to be tracked separately.
2. Presumption of compliance, why can’t it be automatically inherited with the standard number?
Article 7 (2) of the Machinery Directive 2006/42/EC links the presumption of conformity to the reference of harmonized standards published by OJEU, and the presumption
is limited to the basic health and safety requirements covered by the standard. ESPE protection and safety control loops are within the scope of this mechanism.
Article 20 (1) of the new Machinery Regulation 2023/1230 continues this mechanism but corresponds to Annex III of the new Regulation.
The two key qualifications in this article are:
the references of which have been published in the Official Journal of the European Union
Its citation has been published in the Official Journal of the European Unionand:
covered by those standards or parts thereof
Covered by these standards or parts thereof
This means that to obtain the presumption of conformity under this mechanism, we cannot only look at the standard name, but also look at:
Under which statute the citation is published;
Which specific version and revision is being cited;
What basic health and safety requirements are covered by the standard;
Whether OJEU imposes restrictions on citations, the ESPE standard (EN IEC 61496) also needs to be checked against this set of rules.
"Previously cited under the Machinery Directive" cannot automatically deduce "it will continue to have the same presumption of conformity under the Machinery Regulations
in the future".
Even if the new list continues to reference the same standard number in the future, its corresponding regulatory requirements, coverage and limitations will also need to be
rechecked, and ESPE's Type classification, failure considerations, and compliance boundaries of the mute function will all need to be re-confirmed.
The presumption of conformity is not an unlimited guarantee of compliance for the entire machine. Risks not covered by the standard, usage conditions beyond its scope
of application, and technical requirements that are not actually met cannot be completed by listing a standard number. ESPE’s installation distance, shielding logic, and
anti-interference risks are typical points that are easy to miss.
3. How does the EU prepare to inherit existing standards?
This switch does not require equipment manufacturers to throw away all existing standard systems. The finalized ESPE solution can also serve as the technical basis.
As of the verification date of this article, the official page of the European Commission’s Machinery Harmonization Standards clearly states:
The implementation decision of coordinated standards under the new machinery regulations is being prepared, and it is planned to include most of the coordinated standards
that have been cited under the current machinery directive, including the EN IEC 61496 series corresponding to ESPE; for standards that have not fully covered the new or
updated requirements of the new regulations, the corresponding coverage gaps will be clarified. The official page expects the first list of mechanical regulations to be published
before the end of 2026.
The tense here needs to be preserved:
Being prepared does not mean that it has been officially announced; being expected to be included does not mean that a specific standard (including ESPE-related standards)
has obtained the presumption of compliance under the new regulations.
This verification did not retrieve the first officially published reference list of harmonized standards for machinery regulations. Therefore, this article does not list “which
standards have been completed” in advance.
CEN/CENELEC is also advancing response work. Its special event on September 14, 2026 covers gap analysis of new regulations, and the new Annex ZA/ZZ informative
addendum template.
These appendices are used to illustrate the correspondence between standard provisions and regulatory requirements. Annex ZA of the ESPE standard will state what basic
health and safety requirements the standard can support.
For equipment manufacturers, what they need to look at in the future may not only be “whether the standard number has been changed”, but also include:
Under the new regulations, which requirements does this standard support and which requirements still require additional proof? ESPE’s shielding, reset, fault response
and other functions are often the most vulnerable items.
Annex ZA/ZZ provides coverage relationship information; the legal basis for the presumption of conformity should still refer back to the official OJEU reference and its
conditions.
4. It will be easier to understand if you look at two commonly used standards.
Let’s first look at the current status that can be verified.
Currently, EN ISO 12100:2010, EN ISO 13849-1:2023, and the EN IEC 61496 series supporting ESPE are still referenced harmonized standards under the Machinery
Directive system. With the repeal of Implementing Decision (EU) 2023/1586 from January 20, 2027, the legal effect of their references under the Machinery Directive
will also end.
On the standard text side, the national standard versions corresponding to EN ISO 12100:2010, EN ISO 13849-1:2023 and ESPE's EN IEC 61496 series can still be
in their current status.
This just shows:
The expiration date of the legal validity cited by regulations is not the same status as whether the standard text itself is current.
Scenario 1: Risk assessment completed according to EN ISO 12100, including ESPE protection risk identification
Assume that an equipment manufacturer completes a risk assessment for packaging equipment in 2026 in accordance with EN ISO 12100:2010, which includes hazard
identification and safety distance verification of ESPE safety gratings, but the equipment will be put on the EU market for the first time after January 20, 2027.
Just because the old list has been discontinued does not mean that this risk assessment is entirely worthless.
Its identification of mechanical hazards, risk judgment and risk reduction processes, as well as ESPE’s protection strategies, may still form an important technical basis
for new projects. EN ISO 12100 itself is a standard for general design principles, risk assessment and risk reduction methods for machinery safety.
But it cannot be said the other way round:
“I used EN ISO 12100+ESPE, so Annex III of the new regulation is all met.”
The method framework can continue to be used, but specific risks and regulatory requirements still need to be compared. The risks of remote parameter modification
and multi-device linkage shielding newly added to ESPE need to be additionally evaluated.
This isn’t a border that won’t appear until 2027, either. The use of a general method standard cannot inherently replace the demonstration of compliance with specific
protective measures for the entire machine.
Scenario 2: Safety control design completed according to EN ISO 13849-1, including ESPE safety loop
Another equipment manufacturer designed the safety door interlocking and emergency stop circuit in accordance with EN ISO 13849-1:2023, and equipped it with an
ESPE safety scanner and completed relevant PL calculations and verifications.
Regulation switching will not automatically invalidate the original calculation results and verification records just because of the date change. The original test reports
of ESPE's own Type level and PL allocation still have technical reference value.
But manufacturers need to distinguish between two judgments:
First, whether these information are still applicable to the safety functions, structures, software versions and usage conditions of the actual delivered equipment. Once
the installation location and material shielding sequence of ESPE are changed, the original verification conclusions will no longer apply.
Second, whether the standard used (including EN IEC 61496 corresponding to ESPE) has been formally harmonized under the new machinery regulations, and what
requirements it can support.
For example, the device has added the function of remotely modifying ESPE shielding parameters. Reliability evaluations of the original safety functions may still be
useful, but a PL calculation alone cannot indicate that the risk of accidental or intentional modification of ESPE safety parameters has been controlled.
What this example illustrates is:
Evidence of old technology can be retained, but new risks associated with ESPE cannot be missed.
5. If the standard has not yet been cited by new regulations, can the standard still be used as a technical basis?
Yes, but it needs to be explained how it supports the device to meet regulatory requirements, and ESPE-related standards also follow this logic.
Item (f) of Annex IV Part A of the New Machinery Regulation clearly stipulates that when harmonized standards and common specifications are not adopted or only
partially adopted, the technical document shall describe other technical specifications adopted to meet the applicable basic health and safety requirements.
Item (g) further requires that technical documents include reports and/or results of design calculations, tests, inspections and inspections used to verify the compliance
of machinery or related products. ESPE’s type test report and loop PL verification report all fall into this category of evidence.
Therefore, just because a standard (such as ESPE’s EN IEC 61496) has not yet been referenced under the new regulation does not mean that its design principles,
calculation methods or test requirements have no compliance value at all.
The difference is:
It cannot only rely on its previous coordination status of the Machinery Directive to claim the presumption of conformity under the new machinery regulations; it is
necessary to use applicability analysis and technical evidence to explain which regulatory requirements the ESPE solution derived from it meets.
Under the new regulations, the relationship between several types of technical basis can be understood as follows:
"Common specifications" are not the same as "company specifications" (in-house standards) developed by manufacturers themselves.
Article 20(3) outlines the conditions under which the European Commission may establish common specifications. Furthermore, Article 20(7) stipulates that
if a harmonized standard is subsequently cited, the implementing act—or the relevant portion thereof—establishing the common specifications for the same
requirements must be repealed.
This serves as a conditional, supplementary mechanism; it is not intended to be a parallel set of standards that permanently duplicates harmonized standards.
Attention must also be paid to procedural boundaries.
For products listed in Annex I, Part B of the new regulation, choosing the "internal production control" procedure requires compliance with the harmonized
standards or common specifications applicable to that product category—covering all relevant requirements. This also applies to ESPE (Electro-Sensitive
Protective Equipment) when used as a safety component.
One cannot simply assume that a specific conformity assessment procedure remains valid just because an alternative technical solution can also demonstrate safety.
The technical merit of a standard, the presumption of conformity, and the conformity assessment procedure are distinct concepts that must be evaluated separately.
For instance, the selection and verification of ESPE must be assessed according to a three-tiered logical framework.
VI. Projects spanning multiple regulatory milestones: Where should you look first?
For projects involving equipment equipped with ESPE that are designed in 2026 and placed on the market in 2027, it is advisable to clarify three key questions
regarding the list of standards:
Is this version still appropriate for the actual equipment?
Beyond checking whether the standard is current, you must verify that the equipment type, operating conditions, and risk profile fall within the standard’s scope.
Parameters such as the detection height, response time, and safety distance of the ESPE must also be re-evaluated.
Even if an older version of a standard still contains relevant technical content, you cannot assume that using it is sufficient to demonstrate compliance once that
version has been revised or withdrawn.
Has it been formally cited under the new regulation?
Verify the specific version, amendments, the date the citation becomes applicable, and any associated restrictions. For the EN IEC 61496 series (covering ESPE),
you must specifically check the *Official Journal of the European Union* (OJEU).
Do not prematurely claim that a standard has been "harmonized" simply because the European Commission has included it in a transition or adoption plan—wait
until the new list is officially published.
How are requirements not covered by these standards addressed?
Retain existing risk assessments, calculations, and verification documentation (including ESPE test reports) that remain valid, while identifying any gaps resulting
from the new regulation's requirements or changes to the equipment. Technical documentation should clearly indicate which conclusions are supported by standards
and which require additional evidence. Aspects such as muting/blanketing management, anti-tampering measures, and fault diagnostics for ESPE (Electro-Sensitive
Protective Equipment) are frequently areas where gaps exist.
For series-produced equipment, Article 10(4) of the new regulation also requires due consideration of any changes to the harmonized standards, other technical
specifications, or common specifications used to declare conformity. Consequently, the status of standards applicable to the ESPE solutions integrated into
series-produced machinery must be continuously monitored.
Therefore, monitoring the status of standards cannot be limited to a one-time check at the start of a project.
For projects spanning multiple years, the essential task is to align existing technical justifications with the requirements of the new regulation:
Retain valid evidence, re-verify the status of cited standards, and address any previously uncovered areas—with safety-related sensing and protective equipment
(ESPE) being a key focus for such verification.
If you would like, I can prepare a separate self-assessment checklist for ESPE (based on EN IEC 61496) under the new Machinery Regulation.
Popular Products
