The procedure for the provision of information with regard to standards


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The provision of information to the Commission and the standardisation bodies on new subjects in the national standards programmes

Article 2

1. The Commission and the standardisation bodies referred to in Annexes I and II shall be informed of the new subjects for which the national bodies referred to in Annex II have decided, by including them in their standards programme, to prepare or amend a standard, unless it is an identical or equivalent transposition of an international or European standard.

Article 2 stipulates that the procedure for the provision of information in the field of standards is limited to new work which the national standardisation bodies are planning to initiate, at the time of its inclusion in the standards programme, in other words at a suficiently early stage to enable interested sectors in the various Member States to take part and their comments to be taken into account.

These new initiatives must be communicated under Directive 98/34/EC, whether their objective is to establish a new standard or amend an existing standard - but only if the envisaged standard does not arise from the ‘identical or equivalent’ transposition of an international or European standard.

The reason for this is simple: it is only ‘purely’ national standards that are likely to act as barriers to the proper functioning of the internal market. An international or European standard should not, in principle, jeopardise the free movement of goods within the European Community, since its technical specifications have been the subject of consensus on a much larger scale than the limits of national boundaries.

Identical transposition means that the national standard includes or refers in extenso the text of the international or European standard.

The inclusion in extenso of the European standard in sets of national standards is usually the rule. The harmonisation of national standards is achieved when products manufactured in accordance with national standards of one Member State may be considered to comply, without modification, with the national standards of the other Member States.

Equivalent transposition means that the text of the national standard contains certain difierences, of a technical nature, compared with the European reference standard, which will not in principle create barriers to the free movement of goods, and which the national standardisation body can be authorised to retain during a specified transition period.

In practice, the procedure for the provision of information in the field of standards began on 1 January 1985.

With regard to new standardisation initiatives in the areas of responsibility of CEN and CENELEC, the two European stand-ardisation bodies are responsible for the technical operation of the procedure by means of annual contracts concluded with the Commission and the EFTA Secretariat.

Since 1992, the Commission has included two clauses in these contracts regarding the quality of the information, according to which CEN and CENELEC undertake, firstly, to define clearly the internal rules necessary to ensure the accuracy, clarity and reliability of the notifications and, secondly, to equip their respective central secretariats with the resources necessary for monitoring the quality of the information received.

The information is communicated by the national standardisation bodies on a daily basis to the central secretariats of the two European bodies, where it is checked, processed and stored in a database. The results are then recorded, sector by sector, in a

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periodical register (monthly for CEN and quarterly for CENELEC) which is distributed to the members of CEN and CENELEC, in addition to the relevant departments of the Commission (Directorate-General for Enterprise and Industry) for examination and comments.

The publication of this register and its distribution on a national level, is a guarantee of the transparency of the information communicated under the 98/34/EC procedure.

It is essential that industry and all interested parties know of this instrument and have access to the information in order to be able to exercise the following options open to them:

- to comment on new standards initiatives relating to their sector of activity;

- to apply to take part in the work of the relevant technical committee of a standardisation body in another Member State (for example, a French company could apply to participate in the German committee).

- to suggest that the standard be prepared on a European rather than a national level.

This assumes that the national bodies are consulting industry by distributing the register as widely as possible, particularly through relays allowing easy access to the information.

It is important to emphasise that interested parties, particularly industry, in practice have only a relatively short period of time in which to react. In the case of subsequent litigation, the fact that an objection was not raised will inevitably be used against those who have not examined the register.

As far as new standardisation subjects in the field of telecommunications is concerned, ETSI has been involved in the information procedure since it was included in Annex I to Directive 98/34/EC. In practice, this participation is limited to the receipt and evaluation of data provided by the members of CEN and CENELEC and forwarded by the central secretariats of these two bodies, the reason being that national standardisation activity in the field of telecommunications is extremely limited.

2. The information referred to in paragraph 1 shall indicate, in particular, whether the standard concerned:

- will transpose an international standard without being the equivalent,

- will be a new national standard, or

- will amend a national standard.

The obligation on the national standardisation bodies to provide details of the nature of the new draft standard has the objective of ensuring transparency and facilitating the examination of notifications. It arises directly from the preceding paragraph. The three categories of standards listed are in fact those which do not correspond to the ‘identical or equivalent transposition of an international standard’ and must consequently be notified under Directive 98/34/EC.

- A new draft national standard could contain technical specifications which may constitute a barrier to the free movement of goods if the standard is used restrictively. This can only be ascertained by examining these specifications individually.

- A national standard transposing an international standard (ISO or IEC) may not be equivalent to the original document, since this transposition is not, as such, compulsory and since the national standardisation bodies can decide, on their own account, to make amendments if they consider that the technical specifications are not relevant to their own market. In this case, it is advisable to evaluate the technical specification of the transposed standard with regard to the part which difiers from the international standard.

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- A national standard can be amended in order to adapt it to the requirements of technical progress. The notification of the draft then makes it possible to examine whether the amendment (addition, modification or removal of certain technical specifications) could introduce new risks of technical barriers to trade within the Community.

In addition, in the course of this examination, the national stand-ardisation bodies, the European standardisation bodies and the Commission can, if they consider that the envisaged amendment would merit setting up a new subject for research on a European level, suggest the preparation of a European standard.

In the field of standardisation, the aim of Directive 98/34/EC is to ensure the transparency of national initiatives, but it also has a role to play in encouraging the development of European standardisation.

After consulting the Committee referred to in Article 5, the Commission may draw up rules for the consolidated presentation of this information and a plan and criteria governing the presentation of this information in order to facilitate its evaluation.

Although the operation of the procedure for the provision of information in the field of standards has been delegated by contract to CEN and CENELEC, the Commission itself supervises its proper functioning, in particular by retaining the option of suggesting that the two European standardisation bodies adopt a methodology for the presentation of the collected information, in order to ensure easier processing.

3. The Commission may ask for all or part of the standards programmes to be communicated to it.

It shall make this information available to the Member States in a form which allows the difierent programmes to be assessed and compared.

This paragraph supplements paragraph (1). It stipulates that the Commission must not only be informed of new national initiatives but that it must also have access to all the standards programmes drawn up by the national and European stand-ardisation bodies.

In order to fulfil this requirement, the latter are no longer under the obligation, as initially provided under Directive 83/189/EEC, of notifying their standards programmes on an annual basis (through the central secretariats of CEN and CENELEC), but they must communicate all or part of these programmes if the Commission so requests.

The Commission acts as a clearing house for forwarding this information to the Member States.

4. Where appropriate, the Commission shall amend Annex II on the basis of communications from the Member States.

This paragraph stipulates that the Commission has the authority to update the list of national standardisation bodies which appears in Annex II to the Directive. This updating is carried out by the Member States, which must provide the Commission with the necessary information.

5. The Council shall decide, on the basis of a proposal from the Commission, on any amendment to Annex I.

This paragraph stipulates that, unlike Annex II, the updating of Annex I, containing the list of oficially recognised European standardisation bodies, does not come under the exclusive jurisdiction of the Commission but requires a decision by the Council of Ministers on the basis of a proposal from the Commission.

Annex I to the Directive was, for example, amended in 1992 in order to add ETSI to the list of European standardisation bodies.53

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Communication of draft standards to the European and national standardisation bodies and the Commission

Article 3

The standardisation bodies referred to in Annexes I and II, and the Commission, shall be sent all draft standards on request; they shall be kept informed by the body concerned of the action taken on any comments they have made relating to drafts.

Directive 98/34/EC stipulates that once they are informed of the preparation of new standards initiatives in the various Member States, the national standardisation bodies, European standardisation bodies and the Commission shall have the right to require the standardisation body of a Member State to send the text of any draft standard which it has notified. The latter must comply with this request.

It is also required to inform all those who have commented on one of these drafts of the action taken: whether amendment to the draft, the withdrawal of the draft or the justification for retaining it.

Measures for which the Member States are competent

Article 4

Article 4 (like Article 7) sets out Member States’ obligations with regard to the organisation of the procedure for the provision of information in the field of standards. It is an obligation as to the result, not the means, because whilst a Directive must be transposed into internal law by the Member States to which it is addressed, the choice of transposition method is left to the Member States, as long as the objective pursued is attained.

Furthermore, the fact that most of the national standardisation bodies have the status of a private institution reduces the national authorities’ scope to give them orders. Hence the very fiexible wording of the Directive in this context.

1. Member States shall take all necessary steps to ensure that their standardisation bodies:

- communicate information in accordance with Articles 2 and 3,

This subparagraph stipulates that each Member State must ensure, by whatever means it considers necessary, that its standardisation body does in fact notify all new subjects for standards at the time they are entered in the annual work programme, supplies any draft standard which is requested by the standardisation body of another Member State, a European standardisation body or the Commission, and keeps them informed of the action taken on any comments made on the draft standard.

- publish the draft standards in such a way that comments may also be obtained from parties established in other Member States,

According to this subparagraph, each Member State must ensure that its standardisation body provides parties throughout the Union with the opportunity of commenting on national draft standards. This amounts to extending to the other Member States the public enquiry which, on a national level, is an essential stage at the end of the process of drafting the standard before validation and publication of the definitive text. This formal consultation of all socio-economic operators enables the national standardisation bodies to be sure that there is total consensus on the text.

Basically, each national body sends, on request, a copy of any draft standard to all the standardisation bodies of the other Member States. This copy is obviously written in the working language of the issuing body. The recipients are responsible for having it translated into their own language and organising a consultation on their own territory, in accordance with the procedures in force in the country (the draft standard is, for example, sent by the national body to the standards engineer responsible for the sector concerned, who in turn passes it on to

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the relevant standardisation committee which is composed of all the interested parties).

A questionnaire, usually attached to the draft standard by the body which prepared it, calls for comments regarding the objectives of Directive 98/34/EC (for example, ‘Do you think that such a draft may result in barriers to trade?’ ‘Do you think that it should be used as a basis for European work?’ ‘Would you like to be involved in the work of preparation on the standardisation committee? etc.).

The draft is then returned to the issuing body, with comments from all the economic and social operators of the various Member States of the Community.

- grant the other bodies referred to in Annex II the right to be involved passively or actively (by sending an observer) in the planned activities,

The Directive requires all the Member States to ensure that their respective bodies grant another national institute (AFNOR, DIN, BSI, etc.) the right to be involved in the work of preparing a standard, on the relevant technical committee. This right of involvement may be exercised passively or actively.

Active involvement assumes that an observer will be sent (a manufacturer, an economic operator or a standards engineer). If the manufacturer or economic operator is not available, and the decision is taken to send a standards engineer, the latter will need to know the position of industry in his country in order to have suficient knowledge of the market and to be able to say whether or not the draft standard risks prejudicing the free movement of goods on the market concerned.

Passive involvement is synonymous with involvement at a distance: for example, an expert will give an opinion on a draft

standard being prepared in another Member State, without attending the working meetings in the Member State concerned.

The possibility of intervention is evaluated by the national standardisation body, which chooses one or other type of involvement.

The Directive cannot formally require national bodies to accept the comments of other national bodies, but acceptance should, in principle, be guaranteed since all standardisation procedures stipulate that a standardisation body should endeavour to take these comments into account.

- do not object to a subject for standardisation in their work programme being discussed at European level in accordance with the rules laid down by the European standardisation bodies and undertake no action which may prejudice a decision in this regard.

In this subparagraph, the Directive calls on the Member States to make every efiort to ensure that their respective standardisation bodies do not attempt to impede the work of technical harmonisation being carried out by the European standardisation bodies, by preventing a draft standard which they intend to prepare on a national level from ultimately being prepared at the European level.

Directive 98/34/EC contains such a provision because the national standardisation bodies are all members of CEN and CENELEC and could therefore use their votes, in accordance with purely national interests, to oppose a draft standard being considered at a European level.54The Directive encourages them - through the Member States - to show the solidarity which is indispensable to the common aim of the Single Market.

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2. Member States shall refrain in particular from any act of recognition, approval or use by reference to a national standard adopted in breach of Articles 2 and 3 and of paragraph 1 of this Article.

Paragraph (2) stipulates that the Member States cannot abdicate their responsibilities by taking refuge behind those of their respective standardisation bodies, where the latter have adopted a standard in breach of a provision of Directive 98/34/EC. If they have been unable to prevent the adoption of a document of private origin and voluntary application that contravenes Community law, the Member States must prevent such a standard being used as a reference document, by refusing to recognise it or adopt it formally. In other words, if the national bodies act unreasonably, the national governments should not exploit the situation.

The Member States’ obligation to ensure that European technical harmonisation is not impeded

Article 7

1 Member States shall take all appropriate measures to ensure that, during the preparation of a European standard referred to in the first indent of Article 6 (3) or after its approval, their standardisation bodies do not take any action which could prejudice the harmonisation intended and, in particular, that they do not publish in the field in question a new or revised national standard which is not completely in line with an existing European standard.

This Article stipulates that the Member States must ensure that their respective standardisation bodies observe a standstill period when the work in progress at European level relates to the preparation of a European standard requested by the Commission. This eventuality is mentioned in the first indent of Article 6(3) of the Directive (see below), which provides that the Commission can request the European bodies to prepare a European standard.

In this case, therefore, the Member States must do everything possible to ensure that their standardisation bodies do not carry out any work on the mandated subject: whether with regard to the preparation of a new standard or the amendment of an existing one which is not a European standard in extenso.

This standstill period is an expression of the solidarity which must be exercised with a minimum of discipline once the decision has been made to work together on a European level. It is an integral part of the rules of procedure of the European standardisation bodies and is reinforced by Directive 98/34/EC.

The standstill obligation remains after the adoption of the European standard. As a result, when an industry requires standards in the fields covered by the requested standard, the work may not be carried out on national level. By this Article, therefore, the Directive provides the Community with the means of strengthening the activity of European standardisation.

2. Paragraph 1 shall not apply to the work of standards institutions undertaken at the request of the public authorities to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products.

Member States shall communicate all requests of the kind referred to in the preceding subparagraph to the Commission as draft technical regulations, in accordance with Article 8 (1), and shall state the grounds for their enactment.

Paragraph (2) of this Article concerns specific cases in which the standards are to be made compulsory. It refers to the State’s ability, in certain circumstances, to enforce compliance with the technical specifications for products contained in these standards.

In order to enforce the observance of standards which are essentially voluntary, the State may use two procedures:

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- it may request its country’s standardisation body to prepare standards in view of establishing technical regulations;

- the State can also make existing standards compulsory, and in doing so, transform them into technical regulations.

In such cases, the procedure applicable to technical regulations, described in the following Chapter, is used.

[53] Decision 92/400/EEC, already cited.

[54] A proposal to prepare a European standard, made by a national standardisation body to CEN or CENELEC, has to receive the support of a minimum of countries for the Central Secretariat of CEN or CENELEC to propose its acceptance to the Technical Board.