Essential requirements of directives and standards: the meaning of annex ZA, ZB or ZZ in harmonised standards

Creation of an annex ZA/ZZ for a harmonized standard

An answer to the question what information are provided by the above-mentioned annexes is given in the development process of a harmonized standard with presumption of conformity.

The legal acts of the European Commission (like the Machinery Directive or the Low Voltage Directive) contain requirements for products that fall under the scope of the respective directive or regulation. To clarify how the legal requirements can be implemented, “harmonized standards” can provide the technical details.

Within its annual work program, the EU-Commission issues so-called standardization mandates to the European organisations of standardisation. Within those mandates the Commission determines concrete requirements of its harmonization legislation. The organisations of standardization need to consider these requests when generating the harmonized standards.²

CEN and CENELEC pass the mandate on to the authorized technical committee which subsequently draws up the harmonized standard. For quite some time all harmonized standards must contain an informative annex (annex ZA, ZB or ZZ). Therein the responsible technical committee refers to the relationship between the sections of the legal requirements and the respective sections of the harmonized standard.³

The ESOs publish the newest version of a standard. In the following CEN and CENELEC verify together with the Commission to what extend the published standard corresponds to the original mandate and whether the “essential or other legal requirements ‘aimed to be covered’ are clearly indicated and covered by the standard.”⁴ Meanwhile, independent consultants are involved within this verification. These consultants assist the CEN/CENELEC technical committees as well as the EU-Commission and evaluate to what extend the directive’s requirements are represented within the harmonised standard. This includes a verification of the annex ZA/ZZ, which is commented in the scope of the consulting activity.⁵

If all requirements are fulfilled, the harmonised standard is published in the Official Journal of the EU for the respective harmonization legislation. This means that the sections contained within an annex ZA/ZZ of a harmonized standard trigger presumption of conformity with the requirements of the EU-directive and the regulations of the European Free Trade Association (EFTA).⁶

Content of informative annexes

A harmonized standard created on behalf of the Commission does not necessarily need to cover all essential requirements of the legal act. At least the standard needs to point out clearly which requirements in detail shall be covered. This may occur in a clearly arranged tabular manner within the annex ZA/ZZ.

Strictly speaking – according to the Blue Guide⁷ - when creating the informative annex ZA/ZZ, the standardization organizations can merely point out an intention which sections of a standard in their view belongs to the respective sections of a directive.

By listing the harmonized standard within the Official Journal of the EU the European Commission confirms this intention or, with a non-publication, rejects it.⁸

The CEN-Guide 414 contains specifications on how the informative annex can be structured:

In the first two paragraphs the standardisation mandate of the EU-Commission is summed up. furthermore, the relationship between the sections of a standard, the requirements of the directive as well as the EU Official Journal is disclosed.

The actual annex ZA, the correlation of a standard’s sections with the requirements of the underlying directive, appears in a follow-up passage or in a tabular form.

In concluding, the annex contains warning notices. They may indicate that the standard is subject to another legal act or that only when the listing in the Official Journal has occurred a user can take the presumption of conformity as granted.

Originally, the technical committees had been given more leeway in creating an informative annex as there had been more opportunities to set it up. The annex ZA, for instance, could be drawn according to Option A.1 and structured as follows:¹⁰

Table 1: Option A.1 of an annex ZA⁹

Within a harmonized standard option A.1 would be structured as the following:

This kind of structure can be found only in more ancient standard.

Meanwhile the EU-Commission accepts explicitly informative annexes with the type “option C” of the CEN-Guide. This version determines that essential requirement of a directive listed in a column assigns to a section of a harmonized standard:¹¹

Table 2: Option C of an annex ZA¹²

This means that when creating a standard, technical committees can explicitly hand in an annex ZA/ZZ with this detailed frame at CEN/CENELEC. The European Organisations of Standardisation can then give the generated standard including its annex over to the commission for a further examination. An example is given here:¹³

An important note is stated in warning 1: it underlines that only the listing within the Official Journal of the EU triggers presumption of conformity.
 

Denominations of annexes - ZA, ZB, ZZ…?

When a CEN technical committee creates a harmonized standard, the informative annex is named ZA, in the case of CENELEC it is named ZZ.

If a harmonized standard shall cover the requirements of several legal acts, the denomination is changed into ZA/ZB (CEN) and ZZA/ZZB (CENELEC), respectively. This is primarily the case if a legal act undergoes a revision and the requirements that shall be met have changed.

A special case emerges if globally applicable standards from the international organisations of standardization ISO and IEC are adopted into the European standardization. In this case annex ZA always covers the normative references of international publications with the corresponding European publications. The informative annex that covers the requirements of EU-directives and its corresponding sections of standards is renamed into Annex ZB for CEN-standards.
 

Information for Safexpert users

Once a successor standard is published for a standard contained in an IBF data package, the standard is adopted with the status “adopted/ratified, intended to be published as harmonised standard” into the safexpert database.

This illustrates that issuer CEN/CENELEC expects a listing of the standard within the Official Journal of the EU, but it has not occurred yet. Hence the sections listed in annex ZA do not (yet) trigger presumption of conformity.

When the harmonized standard ist published within the Official Journal, the IBF experts change the status and take note of the legal base (Commission Implementing Decision) and means of publication (EU-Official Journal) in the bibliographical data of the data set.

With the Safexpert Change Assistant Safexpert offers an analytical tool on a sectional level of standards. Whenever you apply a section of a standard as a measure within your project, you can easily display, verify and even change the respective section via mouse click with the section of the successor document.

Conclusion

The informative annexes ZA, ZB, ZZ, … initiated by the EU-Commission can be regarded as a useful help. Engineers can herby see rapidly which essential safety and health requirements of a legal act are covered by the standard.

In the case of newer editions of standards users are provided an exact comparison of sources of information of single requirements and the appropriate sections of a standard.

Footnotes:
¹See 2016/C 272/01: Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016
²See Regulation (EU) No. 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation
³See CEN/CENELEC-Webinar: 'Harmonized Standards under the Machinery Directive' (https://www.cencenelec.eu/media/CEN-CENELEC/Events/Webinars/2021-10-18_webinar_harmonized_standards_machinery_directive.pdf )
⁴See 2016/C 272/01: Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016
⁵See KAN Brief 3/10: “Serving the quality of standards: CEN/CENELEC Consultants“ (https://www.kan.de/en/publications/kanbrief/the-eu-and-standardization/serving-the-quality-of-standards-cencenelec-consultants )
⁶See EN ISO 13857:2019, Annex ZA
⁷See 2016/C 272/01: Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016
⁸See 2016/C 272/01: Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016
⁹CEN Guide 414 - Safety of machinery – Rules for the drafting and presentation of safety standards Edition 3, 2017-10-11
¹⁰See EN 13378:2001+A1:2013-01- Pasta processing plants - Pasta presses - Safety and hygiene requirements
¹¹See:https://www.cencenelec.eu/media/CEN-CENELEC/AreasOfWork/CEN%20sectors/Mechanical%20and%20Machines/Intro/annex-za_zz_-machinery_directive.pdf
¹²See CEN Guide 414 - Safety of machinery – Rules for the drafting and presentation of safety standards Edition 3, 2017-10-11
¹³See EN ISO 13854:2019 - Safety of machinery - Minimum gaps to avoid crushing of parts of the human body (ISO 13854:2017)

Posted on: 2021/12/15