4.1.2 必須要件への適合：整合規格

Regulation (EU) No 1025/2012 (182) provides definitions for the terms ‘standard’, ‘national standard’, ‘European standard’, ‘harmonised standard’ and ‘international standard’.

—‘Standards’ are defined as technical specifications (183), adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory and which are either international, European, harmonised or national standards.

—‘European standards’ are ‘standards’ adopted by the ESOs listed in Annex I of Regulation (EU) No 1025/2012 (184).

—‘Harmonised standards’ are ‘European standards’ adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.

The definition of a ‘harmonised standard’ within the context of Regulation (EU) No 1025/2012 is not restricted to harmonised standards supporting harmonised product legislation as the Regulation mainstreams the use of harmonised standards in harmonisation legislation for services in similar way as in Union harmonisation legislation for products.

Harmonised standards are developed and adopted like other European standards following the internal rules of ESOs. According to these rules, all European standards must be transposed at national level by the national standardisation bodies. This transposition means that the European standards in question must be made available as national standards in an identical way, and that all conflicting national standards must be withdrawn in a given period.

Harmonised standards are European standards to which Regulation (EU) 1025/2012 and sectoral Union harmonisation legislation give a special meaning. However, it is important to note that the definition of a harmonised standard does not contain any reference to the publication of its reference in the OJEU. As long as a reference of a harmonised standard is not published in the OJEU the harmonised standard, or parts thereof, does not give presumption of conformity with the essential or other requirements it aims to cover. The ESOs are formally requested to draft harmonised standards via a standardisation request issued by the Commission. The role and preparation of the Commission’s standardisation request to the ESOs is detailed in the ‘Vademecum on European standardisation’ (185).

In order to provide presumption of conformity, a harmonised standard must match the relevant essential or other legal requirements of the relevant piece of legislation in line with the relevant standardisation request and be referenced in the OJEU. A harmonised standard may contain specifications relating not only to essential requirements but dealing with other non-regulated issues. In such a case, these specifications are to be clearly distinguished from those covering the essential requirements. A harmonised standard does not necessarily have to cover all essential requirements but it must be always clear which requirements are ‘aimed to be covered’ (186) as otherwise a manufacturer complying with a harmonised standard, referenced in the OJEU, does not know against which requirements a ‘presumption of conformity’ will apply and public authorities and notified bodies do not know against which essential requirements they must accept a presumption of conformity.

The relevant essential or other legal requirements aimed to be covered are usually indicated in a separate informative annex (187) to a harmonised standard. When essential requirements are covered only partially, it should be clearly indicated in the standard. In some cases the scope of a harmonised standard may also indicate the relevant requirements with sufficient clarity (e.g. when there is a clear reference to covered safety related risks). This information on the ‘aimed coverage of essential or other requirements’ given in a harmonised standard thereby determines the scope and the limits of the so-called ‘presumption of conformity with legal requirements’.

A clear distinction must be made between ‘conformity with a standard’ and ‘presumption of conformity (when applying (188) a harmonised standard)’. ‘Conformity with a standard’ usually makes a reference to a situation where a standard is ‘fully applied’. This is for instance the case of voluntary certification against a standard. For the purposes of ‘presumption of conformity’ it is sufficient to apply only those provisions relating to the essential or other legal requirements aimed to be covered.

Harmonised standards never replace legally binding essential requirements. A technical specification given in a harmonised standard is not an alternative to a relevant essential or other legal requirement but only a possible technical means to comply with it. In risk related harmonisation legislation this means in particular that manufacturers always, even when using harmonised standards the references of which are published in the OJEU, remain fully responsible for assessing all the risks of their product in order to determine which essential (or other) requirements are relevant. After this assessment a manufacturer may then choose to apply technical specifications given in harmonised standards the references of which are published in the OJEU to implement ‘risk reduction measures’ (189) which are specified by harmonised standards. In risk related harmonisation legislation harmonised standards the references of which are published in the OJEU most commonly provide certain means to reduce or remove risks while manufacturers remain fully responsible for risk assessment to identify relevant risks and to identify relevant essential requirements in order to select suitable harmonised standards the references of which are published in the OJEU or other specifications.

Where harmonised standards fail to indicate clearly the essential requirements aimed to be covered such standards may become less useful for manufacturers and market surveillance authorities as there is less legal certainty on the real ‘scope of presumption of conformity’. An unclear or incorrect indication of the essential requirements aimed to be covered may also lead, in some cases, to formal objections against harmonised standards (see point 4.1.2.5). Where a harmonised standard covers only part of the essential requirements identified as relevant by manufacturers or only certain aspects thereof, they additionally have to use other relevant technical specifications or develop solutions in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature in order to meet the essential requirements of the legislation in question. In a similar way when manufacturers choose not to apply all the provisions given in a harmonised standard, and which normally would provide presumption of conformity, they need, on the basis of their own risk assessment, to indicate in their technical documentation how the compliance is reached or that relevant essential requirements are not relevant for the product.

Occasionally standards may contain errors or offer different possible readings. If manufacturers find such an error or uncertainty, they should first make contact with the national standardisation body to seek for clarification.

Union harmonisation legislation may set out that Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the OJEU (190).

European standards, including harmonised standards, may be based fully or partially on international ISO or IEC standards. However, the presumption of conformity is possible only when applying the European version published by reference in the Official Journal, because of possible technical modifications introduced in it to ensure adequate compliance with the legal requirements. Additionally ISO and IEC versions do not contain information about which provision of the standard is relevant for which essential requirement, as this information is only included in their European version.

The objective of publishing the reference in the OJEU is to set the date from which the presumption of conformity takes effect. Publication of references of harmonised standards is managed by means of Commission Implementing Decisions. Publication in the OJEU is the ultimate goal for a harmonised standard and the end of the process which started when the relevant Commission standardisation request was issued.

Publication of references is not an automatic action and the Commission must perform certain checks and assessments before publication takes place. The Commission may thus refuse to publish the references or, where appropriate, may set certain restrictions which are published together with the references.

In a situation where a formal objection procedure has been already initiated prior to the publication of a reference in the OJEU, there is a doubt whether a harmonised standard entirely satisfies the requirements it aims to cover within the meaning of Article 11(1) of Regulation (EU) No 1025/2012. Because of this doubt, the Commission cannot publish the reference according to Article 10(6) of Regulation (EU) No 1025/2012 and a Commission Implementing Decision within the meaning of Article 11(1) must be taken.

The recourse to harmonised standards referenced in the OJEU and which give a presumption of conformity remains voluntary (191). Manufacturers can choose whether or not to apply such harmonised standards or parts thereof. However, if manufacturers choose not to apply a harmonised standard, they must demonstrate that the products are in conformity with essential requirements by the use of other means of their own choice (for example by means of any existing technical specifications including all other available standards). If the manufacturer applies only a part of a harmonised standard or the harmonised standard does not cover entirely all relevant essential requirements, the presumption of conformity exists only to the extent the harmonised standard corresponds to the essential requirements. For that reason it is necessary that each harmonised standard contains clear and correct information on legal (essential) requirements covered.

Compliance with harmonised standards is, according to certain Union harmonisation acts, an option having effect on the applicable conformity assessment procedure, and sometimes opens the possibility for conformity assessment without the intervention of a third party or for a larger choice of procedures (192).

Article 11(1) of Regulation (EU) No 1025/2012 contains a provision for a formal objection procedure according to which the publication of references of harmonised standards in the OJEU can be challenged (193) by Member States and the European Parliament. This situation might arise prior to the publication of the reference of the harmonised standard in the OJEU or in the case of a harmonised standard the reference of which has already been published in the OJEU.

In both cases, where a Member State or the European Parliament (194) considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it has to inform the Commission thereof. After consulting the Member States (195), the Commission will adopt a decision:

—to publish, not to publish or to publish with restrictions the reference to the harmonised standard concerned in the OJEU, or

—to maintain, to maintain with restrictions or to withdraw the references to the harmonised standard concerned in or from the OJEU.

Where a Member State has raised an action under a safeguard clause (196) against a product which complies with a harmonised standard and where such a safeguard action is considered justified, the Commission has a responsibility to initiate an objection against the relevant harmonised standard.

The procedure to challenge a harmonised standard and its outcome does not affect its existence as a harmonised standard or as a European standard as only the ESOs can make decisions on the revision or withdrawal of their deliverables. In addition to the controls available to the Commission, only this objection procedure gives the European Parliament and the Member States a possibility to control the presumption of conformity i.e. the legal effect, which stems from the publication of the reference in the OJEU. Provided the formal objection is justified, it may only lead to the withdrawal, restriction or prevention of such a publication in the OJEU. In the first two cases, this means that the harmonised standard in question will no longer give presumption of conformity or presumption of conformity with the essential requirements is restricted. In the last case (prevention) it means that the standard does not give presumption of conformity at all.

A harmonised standard can be challenged at any moment after its adoption by CEN, Cenelec or ETSI as a European standard.

Furthermore, the reference may be removed from the OJEU by the Commission, without applying formal objection procedures, in certain exceptional cases where the relevant edition of a harmonised standard is not anymore reviewed or updated by the ESO itself and where the ESO itself does not regard it as a standard. Such cases include situations where the harmonised standard in question has been withdrawn by the relevant ESO without any intention to adopt a revised harmonised standard. The concept of essential requirements is based on the assumption that the harmonised standards reflect generally acknowledgeable state of the art and the ESO review harmonised standards regularly in accordance with the relevant standardisation request. When it is evident that a harmonised standard is not anymore recognised as a standard by the relevant ESO itself or where the standard is not anymore revised or available as a national standard such a document cannot be, as a rule, used anymore to provide presumption of conformity. The purpose of Article 11 of Regulation (EU) No 1025/2012 is to provide a procedure to challenge only valid harmonised standards, not withdrawn harmonised standards or draft harmonised standards which cannot be regarded as adopted European standards in the context of definitions given in Article 2 of Regulation (EU) No 1025/2012.

Another specific situation where the Commission may need to remove references from the OJEU without formal objection relates to cases where publication in the OJEU is done by a mistake or where a reference of a document which cannot be regarded as a harmonised standard is published. The latter case may include cases where the standard is not covered by a standardisation request or where the standard does not cover any essential requirements or where the standard was not correctly adopted by respective ESO following the recognised standardisation principles.

According to Regulation (EU) No 1025/2012 the Commission is obliged to inform stakeholders (197) on all pending formal objections against harmonised standards before formal decisions are taken.

Harmonised standards translate the essential requirements or other legislative requirements into detailed technical specifications, methods of measurement to assess and/or declare the compliance with the essential requirements and, in some cases, numerical values to allow compliance with the essential requirements. Like any technical document, they are subject to change, or in other words to a revision.

The formal decision to revise a harmonised standard is taken by the ESOs. This takes place on the basis of their own initiative (198), or following a standardisation request from the Commission directly or, indirectly, based on a Commission decision after a formal objection. The need for revision can result from the changes of the scope of the Union harmonisation act (such as an extension of the scope to other products or a modification of the essential requirements), from the fact that the Commission or a Member State challenges the contents of the harmonised standard, indicating that it could no longer give presumption of conformity with the essential requirements, as a result of technological development or due to market demand.

When a harmonised standard is revised, the revision must be covered by a standardisation request to maintain the possibility of giving presumption of conformity. Unless the contrary can be deduced, the terms and conditions of the original standardisation request apply also for the revision of the harmonised standard. This does not exclude the possibility of a new or revised standardisation request, in particular where the revision is related to shortcomings with respect to the essential requirements.

To give presumption of conformity, the revised harmonised standard must satisfy the general conditions according to the Union harmonisation legislation: the harmonised standard is based on a standardisation request, it is presented by the relevant ESO to the Commission and its reference is published by the Commission in the OJEU.

It is under the exclusive competence of the Commission to decide on dates when the references of the superseded harmonised standards are withdrawn from the OJEU. In most common cases a withdrawal date set by the Commission and published in the OJEU allows for a ‘transitional or coexistence period’ during which both the withdrawn (superseded) harmonised standard and the revised (superseding) harmonised standard give a presumption of conformity simultaneously. The ‘transitional or coexistence period’ points to the time period between the date of publication of a reference of a revised harmonised standard in the OJEU and the date of withdrawal from the OJEU of the reference of the superseded harmonised standards.

It is the responsibility of the Commission to ensure that such transitional periods are of sufficient length but at the same time not disproportionately long. After a transitional period, only the revised (superseding) harmonised standard gives a presumption of conformity.

The Commission may consider that, for safety or other reasons, the superseded version of the harmonised standard must cease to give a presumption of conformity after a relatively short transitional period or even immediately. If circumstances allow, the Commission may consult the Member States and the ESOs prior to taking a decision to reduce the period during which both versions of the standard give a presumption of conformity. If necessary, the initially set transitional period might also be extended by the Commission.

Unless decided otherwise on the basis of a proposal by the Commission, the removal of the reference of a harmonised standard from the OJEU after its revision does not automatically invalidate existing certificates issued by notified bodies; it only concerns the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced according to the old certificate may still benefit from the continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies. However, manufacturers must keep themselves appraised of changes in the state of the art, assess the extent of the changes to the superseded version of the standard and, if necessary, take appropriate action. The kind of action to be taken by the manufacturer depends on the nature of the changes in the harmonised standards, in particular whether these changes are material with regard to the coverage of the essential requirements and whether they concern the product in question. In addition, the notified body shall also keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the relevant requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The reference of the revised harmonised standard, together with the information concerning the superseded version of the harmonised standard, and the date when the presumption of conformity of the superseded version of the standard ceases are published in the OJEU. It is in the interest of manufacturers to check every publication of the list of harmonised standards in the OJEU and to verify within it the validity of the harmonised standards they have applied in order to assess the conformity of their product. This is particularly essential in cases where manufacturers declare conformity themselves (in case of internal production control) and where manufacturer want to ensure continuous presumption of conformity for the products placed on the market.

In the context of guidelines (199) agreed between the Commission and the ESOs there is an expectation that all revised harmonised standards should contain specific information indicating significant changes to a revised or amended harmonised standards and this information should be made publicly available (free of charge) by the ESOs.