The procedure applicable to technical regulations

• Pages: 42-56

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The communication and distribution of information on draft technical regulations and the possible reactions open to the Commission and the Member States

Article 8

1. Subject to Article 10, Member States shall immediately communicate to the Commission any draft technical regulation, except where it merely transposes the full text of an international or European standard, in which case information regarding the relevant standard shall sufice; they shall also let the Commission have a statement of the grounds which make the enactment of such a technical regulation necessary, where these have not already been made clear in the draft.

Where appropriate, and unless it has already been sent with a prior communication, Member States shall simultaneously communicate the text of the basic legislative or regulatory provisions principally and directly concerned, should knowledge of such text be necessary to assess the implications of the draft technical regulation.

Member States shall communicate the draft again under the above conditions if they make changes to the draft that have the efiect of significantly altering its scope, shortening the timetable originally envisaged for implementation, adding specifications or requirements, or making the latter more restrictive.

Where, in particular, the draft seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated efiects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10 (4) of Council Regulation (EEC) No. 793/93 in the case of an existing substance or in Article 3 (2) of Directive 67/548/EEC, in the case of a new substance.

The Commission shall immediately notify the other Member States of the draft and all documents which have been forwarded to it; it may also refer this draft, for an opinion, to the Committee referred to in Article 5 and, where appropriate, to the committee responsible for the field in question.

With respect to the technical specifications or other requirements or rules on services referred to in the third indent of the second subparagraph of point 11 of Article 1, the comments or detailed opinions of the Commission or the Member States may concern only aspects which may hinder trade, or, in respect of rules on services, the free movement of services or the freedom of establishment of service operators, and not the fiscal or financial aspect of the measure.

2. The Commission and the Member States may make comments to the Member State which has forwarded a draft technical regulation; that Member State shall take such comments into account as far as possible in the subsequent preparation of the technical regulation.

3. Member States shall communicate the definitive text of a technical regulation to the Commission without delay.

4. Information supplied under this Article shall not be confidential except at the express request of the notifying Member State. Any such request shall be supported by reasons.

   In cases of this kind, if necessary precautions are taken, the Committee referred to in Article 5 and the national authorities may

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   seek expert advice from physical or legal persons in the private sector.

5. When draft technical regulations form part of measures which are required to be communicated to the Commission at the draft stage under another Community act, Member States may make a communication within the meaning of paragraph 1 under that other act, provided that they formally indicate that the said communication also constitutes a communication for the purposes of this Directive.

   The absence of a reaction from the Commission under this Directive to a draft technical regulation shall not prejudice any decision which might be taken under other Community acts.

   Article 8 lists the obligations of the Member States and the Commission respectively under the procedure for the provision of information in the field of technical regulations, and the possible reactions open to them, apart from reactions relating to standstill periods to be respected before the adoption of the notified drafts, which are referred to in Article 9 of the Directive.

   First stage: the obligation to inform

   1. The Member States’ obligations

      1. General rules

      In order to guarantee the transparency of national initiatives, Article 8 requires the Member States to communicate immediately to the Commission any draft technical regulation which they plan to adopt.

      The full text of the draft regulation must usually be sent. However, when the draft involves the incorporation in full of an international or European standard into internal law, the Member State may make reference to the standard rather than communicate the full text.⁵⁵The Member State must also send the Commission the text of the basic legislative and regulatory provisions, informing it of the legal context of the notified draft and enabling it to assess the implications (for example, the text to be amended by the draft). If these basic legislative and regulatory provisions are not sent, the Commission can request them on receipt of the draft.

      This obligation is coupled with an obligation to notify the grounds justifying the enactment of the proposed measures.⁵⁶

      The nature of the grounds given obviously does not prejudge the action which will be taken with regard to the notification of the draft technical regulation.

      In practice, each Member State nominates a central unit which is to be responsible for sending information to the Commission and to the national ministries (a list of these central units and their addresses is given in Annex 1 to this booklet). Notification to the Commission takes the form of a message to the relevant Commission unit.

      This ‘notification message’is coded in seventeen points, each of which corresponds to a specific item of information. In point 9, for example, the Member State notifying the draft must explain, in a maximum of ten lines, the raison d’être of the draft legislation.

      At the end of the national process of adopting regulatory provisions, the Member States must send the Commission the de-

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      finitive text of the technical regulation (see Article 8(3)). The Commission will thus be in a position to consider whether the Member State has adapted its text to Community law and, if appropriate, to take any measures necessary.

      If, therefore, the Member State has adopted a text without taking account of the detailed opinions issued by the Commission or the other Member States on the draft regulation, the Commission can initiate the infringement procedure provided for in Article 226 of the Treaty.⁵⁷Where the Commission sends a detailed opinion to the notifying Member State which the latter then fails to take into account, the detailed opinion in question can serve as a basis for drafting a letter of formal notice. The Member States themselves can bring the matter before the Commission, under Article 227 of the Treaty, in order to institute an enforcement action before the Court of Justice of the European Communities against a Member State which they consider to have failed to fulfil its obligations.⁵⁸2. Specific cases

      2.1. Single notification valid for multiple acts. Under Directive 98/34/EC, Member States are not obliged to communicate again a draft technical regulation which has already been communicated under another Community act. In this case, they must indicate that the communication in question also applies for the purposes of Directive 98/34/EC. This provision of the Directive (see Article 8 (5)), refiects the Commission’s desire to reduce bureaucracy in the event of overlapping notification procedures, where several Community directives require Member States to inform the Commission of their intention to legislate in a specific area, i.e. to notify the same text at the draft stage. Member States are not, however, released from the requirement to comply with the obligations specified in each Community act. Following the oficial communication that it is valid for several Community procedures, the national draft is thus examined on its own merits on the basis of each Community act to which it refers, and is the subject of a Commission opinion under each procedure.

      This is why the absence of a Commission reaction to such a text under Directive 98/34/EC ‘shall not prejudge any decision which might be taken under other Community acts’ (see the second subparagraph of Article 8 (5)).

      The Member States are responsible for indicating all the procedures under which the national draft is notified, on the basis of the information provided in the text of the Community legislation governing the field covered by the draft.

      In practice, a ‘one-stop shop’ has been established for the food sector,⁵⁹with a view to reducing Member States’ administrative costs.

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      In accordance with this system, Member States always notify their drafts under Directive 98/34/EC, independently of the notification procedure(s) which may be legally applicable. Member States shall clearly indicate, at the time of communication, the procedures in accordance with which they intend to submit their drafts.

      When the subject of the draft is exclusively covered by a specific procedure, the 98/34/EC procedure is set aside; if this is not the case, the part which is not covered by the specific procedure will be examined by the Commission under Directive 98/34/EC and, for the remainder, the specific procedure will take its course.⁶⁰Furthermore, with regard to protection of the environment, Directive 94/62/EC relating to packaging and packaging waste⁶¹ expressly stipulates that the procedure under Directive 98/34/ EC applies to all draft measures which Member States plan to adopt in this area.

      2.2. Basic legislation already sent. With the same concern for efficiency, Member States are exempt from the obligation to send the Commission the text of the basic legislative and regulatory provisions concerning a draft technical regulation, if this text has already been sent with a prior communication. This is the case, for example, when a draft technical regulation which has already been notified must be notified again because it has been significantly amended (see the third subparagraph of Article 8(1)).

      2.3. Additional documentation. Conversely, Directive 98/34/EC introduces a new obligation for Member States with regard to draft technical regulations designed to limit the marketing or use of a substance, a preparation or a chemical product for reasons of public health, the protection of consumers or the environment (c.f. the fourth subparagraph of Article 8(1)).

      In addition to the obligation to communicate the text of the draft and notify the grounds for its enactment, Member States must also supply additional documentation to the Commission.

      In order to fulfil this obligation, they must send a summary of or references to all the relevant data available on the substance, the preparation or the chemical product concerned and any known substitute, the foreseeable efiects of the measure, and the results of the risk analysis.

      In this respect, the Directive specifies that the analysis must be carried out in accordance with the general principles laid down in two Community acts: Council Regulation 793/93/EEC of 23 March 1993,⁶²in the case of existing substances and Council Directive 67/548/EEC⁶³(as amended by subsequent directives), in the case of new substances.

      2.4. New notification. Member States must notify again a draft which has already been examined under the provisions of Directive 98/34/EC, if they have made significant amendments to the text in the meantime.

      The third subparagraph of Article 8(1) specifies that amendments made to the text are considered to be significant if they

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      have the efiect of altering its scope, shortening the timetable originally envisaged for implementation, adding specifications or requirements, or making the latter more restrictive.

      If a Member State nevertheless has doubts whether the amendments made to its technical regulation since the initial notification are significant, it can consult the Commission’s services on the need for a fresh notification.

      It should be emphasised that notification is not necessary in the case of a simple restatement of provisions which are already applicable (for example, in the event of consolidation), and which are without added legal efiect or of course in the cases provided for by Article 10 (e.g. integration in the text of remarks made by the Commission in a detailed opinion, see hereinafter).

   2. The obligations of the Commission

      When the Commission has been notified of a new draft national technical regulation, it must transmit all the information communicated by the notifying Member State to all the other Member States (the draft will simultaneously be sent to all the Commission departments which may be concerned by the notified regulation as a result of their specific or horizontal responsibilities).

      This communication of information enables all the Member States to be fully involved in the monitoring procedure laid down by the Directive.

      The Commission also places the notified drafts and their translations on its Website, which ofiers all the economic operators in the internal market the opportunity to express their views on draft national legislation (except where the notifying Member State expressly requests, with justification, that the information communicated to the Commission should exceptionally be treated as confidential with regard to economic operators).

      The Directive makes provision for allowing the Commission to submit the draft to the Standing Committee (see Chapter IV) or ‘to the committee responsible for the field in question’ for an opinion. These are committees which cover sectoral directives, like the TCAM Committee, established by Directive 1999/5/EC⁶⁴ for the telecommunications sector or the ‘Recreational Craft Committee’, established by Directive 94/25/EC⁶⁵for the recreational craft sector.

      In practice, the Commission is responsible for administering the procedure for the provision of information in the field of technical regulations. The whole procedure, including the reactions to the notified projects, is based on a system of electronic data exchange, transmitted in accordance with a nomenclature set up by the Commission.

      The Directorate-General for Enterprise and Industry (DG ENTR)⁶⁶ acts as the central point for the receipt of all messages, texts and notifications communicated by the Member States, regardless of the field of the draft regulation (telecommunications, mechanical engineering, food and agricultural products, transport, construction, Information Society services, etc.).

      The information which is circulated under the procedure is re-communicated by the Commission to all the Member States, firstly in the language of the notifying Member State and then

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      in the form of translations into all or some of the oficial languages of the Union.

      Second stage: possible reactions open to the Commission and the Member States

      During the three months following the notification of a draft (this period corresponds to the standstill period referred to in Article 9(1)), the Commission and the Member States examine the notified text in order to ascertain its compatibility with Community law, particularly with Articles 28 and 30, 43 and 49 of the Treaty, but also with the sectoral Directives involved, and to reach a decision, where necessary, on its consistency with the concerned provisions.

      The results of this evaluation can give rise to two types of reaction by the Commission and the Member States (the Commission has, in addition, a specific option: ‘blockage’ of the draft as a result of harmonisation work, which will be examined below in the comments on Article 9 of the Directive). The various reactions, whose impact is proportional to the seriousness of the findings, are as follows:

1. The Commission and/or the Member States can decide that the draft technical regulation is not of a nature to form barriers to the free movement of goods and services and to the freedom of establishment.

   In this case, neither the Commission nor the Member States react during the three-month period.⁶⁷At the end of this period, the notifying Member State can adopt its draft regulation, without further obligation.

   This right does not, however, exclude subsequent intervention by the Commission, outside the procedure under Directive 98/34/EC, if the regulation as finally adopted should prove to be contrary to the Treaty or to secondary legislation.

2. The Commission and the Member States can send comments or a detailed opinion to the Member State which notified the draft technical regulation.

   Comments are sent when the notified text, although in accordance with Community law, raises issues of interpretation or calls for details of the arrangements for its implementation. They can also give an overall assessment of the measure, having regard to the general principles of Community law and policies implemented in this context, or inform the Member State of its future obligations with regard to acts to be adopted on a Community level.

   Directive 98/34/EC provides, in Article 8 (1) (last subparagraph), that the comments and detailed opinions issued with regard to technical specifications, ‘other requirements’ or rules on services linked to fiscal or financial measures, can only relate to aspects which may create barriers to the free movement of goods or, in respect of rules on services, the free movement of services or the freedom of establishment of service operators, and not to the fiscal or financial side of the measure. The Member States’ fiscal powers are thus not under scrutiny in this respect. The drafts concerned also benefit from special treatment with regard to the standstill periods (see Article 10(4): no period is laid down for the adoption of these texts by Member States).

   Under the Directive, the notifying Member State has no formal obligation to reply to the comments received. In practice, however, the Member State frequently does so on a voluntary basis and this increases the dialogue.

   The Directive stipulates that the Member States must take comments into account ‘as far as possible’ (Article 8(2)). Member

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   States do, however, generally take account of the comments they receive.

   Detailed opinions (mentioned later, together with their consequences, in the analysis of Article 9 of the Directive) are sent by the Commission or the Member States when they consider that the draft measure envisaged would, if adopted, create obstacles to the free movement of goods, the freedom to provide services or the freedom of establishment of service operators within the internal market. These detailed opinions seek to obtain an amendment to the proposed measure, in order to remove at source any resulting barriers to such freedoms.

   These issues relate to the illegality of the draft in terms of Community law, through a breach of Article 28, 43 or 49 of the Treaty. The most frequent breaches of these provisions are the absence in the text of a clause of mutual recognition of equivalent technical specifications or of rules on services established by another Member State, or the fact that some of the provisions of the draft are disproportionate to the pursued objective. Furthermore, the detailed opinion may relate to a breach of a Community harmonisation directive, a regulation or a decision.

   A detailed opinion may not, under any circumstances, be issued against draft regulations which seek manufacturing prohibitions but which do not constitute a potential barrier to the free movement of goods.

   Member States must reply to a detailed opinion addressed to them by the Commission or another Member State. Although the Directive does not specify the time allowed for reply, it is nevertheless desirable that a response be made as soon as possible in the interests of eficiency, preferably during the standstill periods of six or four months, respectively for goods and Information society services.

   If the Commission considers that the reply to its detailed opinion is unsatisfactory, it can use, if the draft is actually adopted, the procedure referred to in Article 226 of the Treaty. In the same case, a Member State has the right, in the event of adoption of the notified draft, to institute the infringement proceedings provided for by Article 227 of the Treaty.

3. The Commission can announce a Community initiative on the subject of the proposed national measure or announces its finding that such initiative exists. This is known as ‘blockage’. The consequences of this reaction, which is for the exclusive use of the Commission, are described in Article 9 (3), (4) and (5) of the Directive.

   The obligation to observe the standstill periods

   Article 9

   1. Member States shall postpone the adoption of a draft technical regulation for three months from the date of receipt by the Commission of the communication referred to in Article 8 (1).

2. Member States shall postpone:

   - for four months the adoption of a draft technical regulation in the form of a voluntary agreement within the meaning of the second indent of the second subparagraph of point 11 of Article 1,

   - without prejudice to paragraphs 3, 4 and 5, for six months the adoption of any other draft technical regulation (except for draft rules on services), from the date of receipt by the Commission of the communication referred to in Article 8(1) if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the efiect that the measure envisaged may create obstacles to the free movement of goods within the internal market;

   - without prejudice to paragraphs 4 and 5, for four months the adoption of any draft rule on services, from the date of receipt

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   by the Commission of the communication referred to in Article 8(1) if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the efiect that the measure envisaged may create obstacles to the free movement of services or to the freedom of establishment of service operators within the internal market.

   With regard to draft rules on services, detailed opinions from the Commission or Member States may not afiect any cultural policy measures, in particular in the audiovisual sphere, which Member States might adopt in accordance with Community law, taking into account of their linguistic diversity, their specific national and regional characteristics and their cultural heritage.

   The Member State concerned shall report to the Commission on the action it proposes to take on such detailed opinions. The Commission shall comment on this reaction.

   With respect to rules on services, the Member States concerned shall indicate, where appropriate, the reasons why the detailed opinions cannot be taken into account.

   Article 9 relates to the timing involved in notification. The date of receipt by the Commission of the draft national technical regulation communicated by a Member State and of all the requested documents is the signal for the beginning of a period during which the Member State concerned is strictly obliged not to adopt the draft in question.

   This period is commonly known as the standstill period.

   The three-month period referred to in Article 9(1) is the initial standstill period. It represents the period which is considered to be necessary in order to allow the Commission and the other

   Member States to examine the notified draft text and to react to it if necessary.⁶⁸In addition to this period, the notifying Member State is subject to an additional standstill period, varying in length according to the nature of the text and the type of reaction it receives.

   Although comments sent to the Member State do not result in an extension of the initial three-month standstill period, the same does not apply to detailed opinions sent by the Commission or the other Member States.

   In the event of a detailed opinion relating to a voluntary agreement, the Directive stipulates that the Member States must respect a standstill period of four months (Article 9(2)). It adds only one month to the initial standstill period so that the Member States do not lose time in gaining the benefit of measures, the efiectiveness of which is a satisfactory alternative to legislation.

   One should point out that the same ‘additional one-month rule’ applies in the event of a detailed opinion concerning draft rules on Information Society services.

   The standstill period is extended to six months for all other drafts which are the subject of a detailed opinion.

   A Member State to which such an opinion is addressed must inform the Commission of the actions it intends to take (revocation of the disputed text, justification for retaining it, or the amendment of certain provisions in order to render them compatible with the rules of the internal market), irrespective of whether another Member State and/or the Commission was the author. The Commission will comment, in turn, on the actions envisaged by the Member State in response to the detailed opinion, in order to let the Member State know whether

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   these measures are suited to eliminate the barriers to the free movement of goods, the free movement of services or the freedom of establishment of service operators which may have resulted from the adoption of the text, or whether the justification given for retaining the text is acceptable.

   3. With the exclusion of draft rules relating to services, Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 8 (1) if, within the three months following that date, the Commission announces its intention of proposing or adopting a directive, regulation or decision on the matter in accordance with Article 189 of the Treaty.

4. Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 8 (1) if, within the three months following that date, the Commission announces its finding that the draft technical regulation concerns a matter which is covered by a proposal for a directive, regulation or decision presented to the Council in accordance with Article 189 of the Treaty.

5. If the Council adopts a common position during the standstill period referred to in paragraphs 3 and 4, that period shall, subject to paragraph 6, be extended to 18 months.

   Paragraphs (3), (4) and (5) of Article 9 stipulate much longer standstill periods as a result of the blockage imposed by the Commission - and by the Commission alone - following examination of the draft.

   This reaction, the most serious consequence for the Member States in terms of time, is intended to prevent the notified draft from adversely afiecting a legislative harmonisation process which has commenced at Community level.

   The blockage of a draft national regulation can be imposed by the Commission in three specific cases:

1. Paragraph (3) covers the first case: the Commission announces its intention to propose or adopt a directive, regulation or decision (in other words any of the binding Community acts under Article 249 (former Article 189) of the Treaty on the same subject as the text of the draft technical regulation.

   This paragraph does not specify what is meant by ‘the intention’ to propose, but it concerns an intention that has been explicitly expressed, for example through inclusion in the Commission’s annual legislative programme.

   Member States must then respect a standstill period of 12 months.

   In the field of Information Society services, the Commission cannot require postponement of the adoption of a draft simply by stating its intention to propose or adopt a binding Community act relating to the subject of the text. The fact that the Commission is in the process of drawing up a draft Community act is not suficient to justify a waiting period of twelve months for the Member State concerned.

2. In the second case (paragraph (4)), the Commission finds that the notified draft technical regulation concerns a matter which is covered by a proposal for a directive, regulation or decision presented to the Council.

   In this case, as in the preceding case, the notifying Member State must respect a standstill period of 12 months. Contrary to the preceding case, this efiect applies also in the field of Information Society services.

3. Paragraph (5) envisages the third specific case, when the Council adopts a common position during the twelve-month blockage imposed in the two previous situations.

   The Directive then stipulates that the standstill period imposed on the Member States is extended to 18 months.

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   It should be emphasised that the ‘common position’ referred to represents a stage of the Community legislative process under the procedures of co-operation⁶⁹and co-decision,⁷⁰the first involving the European Parliament in the Council’s decision-making power and the second giving it the power to adopt, jointly with the Council, certain regulations, decisions and directives.

   These two procedures provide for a second reading of the text by the Parliament, which explains the need to extend the standstill period.

   6. The obligations referred to in paragraphs (3), (4) and (5) shall lapse:

   - when the Commission informs the Member States that it no longer intends to propose or adopt a binding Community act,

   - when the Commission informs the Member States of the withdrawal of its draft or proposal,

   - when the Commission or the Council has adopted a binding

   Community act.

   Paragraph (6) concerns the expiry of the standstill periods imposed on the Member States in the case of the Commission blocking a draft technical regulation.

   Since blockage postpones the adoption of national legislation without precise knowledge of the length of the process which will lead to the final approval of Community legislation, the Commission uses this instrument with caution.

   It is logical that, where Community action which is envisaged or in progress does not produce a result, the standstill obligations imposed by paragraphs (3), (4) and (5) should lapse in order to allow the Member States to complete the postponed legislative work at a national level and to adopt the technical regulation.

   These standstill obligations also lapse when the Council, together with the Parliament in case of co-decision, or when the Commission adopts the announced binding Community act.

   7. Paragraphs 1 to 5 shall not apply in cases where:

   - for urgent reasons, occasioned by serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or the preservation of plants and, for rules on services, also for public policy, notably the protection of minors, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible or

   - for urgent reasons occasioned by serious circumstances relating to the protection of the security and the integrity of the financial system, notably the protection of depositors, investors and insured persons, a Member State is obliged to enact and implement rules on financial services immediately.

   In the communication referred to in Article 8, the Member State shall give reasons for the urgency of the measures taken. The

   Commission shall give its views on the communication as soon as possible. It shall take appropriate action in cases where improper use is made of this procedure. The European Parliament shall be kept informed by the Commission.

   This paragraph provides that the standstill periods are not applicable when a Member State, in order to respond to an urgent and unforeseeable situation such as, for example, a natural disaster (the need to protect people, the atmosphere, soil or water), an epidemic, an animal epidemic, etc., is obliged to pre-

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   pare technical regulations for immediate introduction, without having time to consult the Commission and the other Member States beforehand.

   Concerning rules on services, Member States can invoke the urgency clause also for urgent reasons, occasioned by serious and unforeseeable circumstances relating to public policy, notably the protection of minors. This new concept refiects the special importance attached by the Community legislator to the protection of minors in the context of the new services.

   The urgency clause may also be invoked, where rules relating to financial services are concerned, for urgent reasons occasioned by serious circumstances relating to the protection of the security and the integrity of the financial system, notably the protection of depositors, investors and insured persons. This special and less strict form of urgency clause is provided for exclusively in the field of Information Society financial services on account of certain risks and requirements specific to this sector.

   These exceptional circumstances do not exempt the Member State from the obligation to inform the Commission of the planned measures and clearly justify its request for urgency at the time when the text is communicated. The Commission has to assess whether the use of the urgency procedure is justified and to give its views on the communication as quickly as possible.

   In practice, the Commission carries out a very thorough analysis of the reasons given, on the basis of the two criteria contained in this paragraph: the seriousness of the situation and (apart from financial services) its unforeseeable nature.

   If the Commission considers that these criteria are not met, it disputes the justification of urgency; conversely, the Commission may accept application of this procedure. This does not prejudice the Commission’s assessment on the merits, namely its analysis of whether the measure adopted may form a barrier to trade in any way.

   In the event of the adoption of measures whose urgency has been disputed, without observance of the standstill period, the Commission can launch the infringement procedure referred to in Article 226 of the Treaty against the Member State concerned for breach of the obligations provided by the Directive.

   Exceptions to the obligation to notify or observe standstill periods

   Article 10

   This Article supplements Articles 8 and 9 of the Directive, by stating the statutory exceptions to the obligation to notify a draft national technical regulation. It also provides for certain exceptions to the obligation to comply with the standstill periods stipulated in Article 9.

   1. Articles 8 and 9 shall not apply to those laws, regulations and administrative provisions of the Member States or voluntary agreements by means of which Member States:

   - comply with binding Community acts which result in the adoption of technical specifications or rules on services;

   - fulfil the obligations arising out of international agreements which result in the adoption of common technical specifications or rules on services in the Community;

   The limits to this exception can best be illustrated with reference to the fundamental objective of the Directive, which is the elimination of unjustified trade barriers.

   If the Member States adopt the same set of rules as required by a Community Directive, trade barriers and difierences between national laws are removed at the same time, and the procedure laid down by Directive 98/34/EC is no longer needed.

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   This reasoning is the same with regard to international agreements: when such an agreement contains precise provisions and there is no scope for divergence, the adoption by the twenty-five Member States of a uniform set of rules is not, in principle, likely to result in trade barriers.

   The situation is difierent when the Community act or the international agreement is implemented through measures which may difier from one Member State to another, or when uniform provisions, which have to be transposed, are supplemented by rules which are of purely national origin.

   Several judgments have clarified the scope of the exception laid down in the first indent of Article 10(1) of Directive 98/34/ EC, whereby Member States are not obliged to notify texts by means of which they comply with binding Community acts which result in the adoption of technical specifications or rules on Information Society services.

   In the joined Albers, Van den Berkmortel and Nuchelmans cases⁷¹, the Court considered that in issuing the prohibition on administering Clenbuterol to fattening cattle, the Netherlands honoured its obligations under Directive 86/469/EEC concerning the examination of animals and fresh meat for the presence of residues, and was therefore exempt, under Article 10, from the duty of notification.

   Conversely, the Court specified, in the Unilever judgment⁷²that Article 10 of the Directive may not be invoked when a provision of a directive allows the Member State suficient room for manoeuvre. This was the case in point. Italy had asserted that Council Directive 79/112/EEC on the labelling of foodstufis imposed the obligation to include in the labelling, particulars of the place of origin or provenance of the product in cases where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the foodstu?. According to the Court, this provision is drafted in general terms which leaves suficient room for manoeuvre for it to be concluded that national rules on labelling relating to the origin of olive oil cannot be regarded as national provisions conforming to a binding Community act within the meaning of the first indent of Article 10(1) of the Notification Directive.

   This restrictive interpretation of the first indent of Article 10(1) of the Directive was confirmed by the Court in ‘the Canal Satélite Digital’ judgment⁷³. In this judgment, the Court reiterated that Article 10 of Directive 98/34/EC shows that Articles 8 and 9 do not apply to laws, regulations or administrative provisions of Member States, or to voluntary agreements entered into by them, whereby Member States comply with binding Community measures which result in the adoption of technical specifications. To the extent that the national legislation at issue in the main proceedings transposed Directive 95/47/EC on the use of standards for the transmission of television signals, and to that extent only, there would be no obligation to notify under the Notification Directive. However, having regard to the content of Directive 95/47, the Court considered that the national legislation in question, in so far as it established a system of prior administrative authorisation, - which in fact is not provided by Directive 95/47/EC - could not qualify as legislation whereby the Member State complies with a binding Community measure resulting in the adoption of technical specifications.

   The same reasoning applies to measures adopted to conform with an international agreement which contains specific provisions for the implementation of which no possibility of divergence is laid down. Measures adopted to conform with an agreement to which all the Member States are party come

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   within this exception; if these are measures adopted to conform with an international agreement to which not all the Member States are party, they must be notified.

   - make use of safeguard clauses provided for in binding Community acts;

   The Member States do not have to notify the Commission of the draft provisional measures which they are authorised to take under the safeguard clause contained in Community Directives, in accordance with Article 95 of the Treaty. This Article lays down in paragraph 10 that ‘The harmonisation measures (....) shall, in appropriate cases, include a safeguard clause author-ising the Member States to take, for one or more of the non-economic reasons referred to in Article 30, provisional measures subject to a Community control procedure’.

   These non-economic reasons can relate to public morality, public order or public security; the protection of the health and life of humans, animals or plants, the protection of national treasures possessing artistic or archaeological value or the protection of industrial and commercial property.

   - apply Article 8 (1) of Council Directive 92/59/EEC;⁷⁴The Member States do not have to notify draft national technical regulations relating to the application of Article 12 (1) of the Directive on general product safety.

   This Article provides that ‘where a Member State adopts or decides to adopt, recommend or agree with producers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent, restrict or impose specific conditions on the possible marketing or use, within its own territory, of products by reason of a serious risk, it shall immediately notify the Commission thereof through RAPEX⁷⁵. It shall also inform the Commission without delay of modification or withdrawal of any such measure or action (…)’.

   - restrict themselves to implementing a judgment of the Court of Justice of the European Communities;

   The Member States do not have to notify national measures which have the sole objective of implementing a judgment of the Court of Justice relating to an aspect other than the notification of a technical regulation. Judgments by this Court, which is responsible for ensuring compliance with Community law, must be enforced immediately.

   - restrict themselves to amending a technical regulation within the meaning of point 11 of Article 1, in accordance with a Commission request, with a view to removing an obstacle to trade or, in the case of rules on services, to the free movement of services or the freedom of establishment of service operators.

   The Member States are not required to notify national measures aimed solely at amending a technical regulation in order to remove obstacles in response to a request, for instance through a detailed opinion or comments, from the Commission (for example, a request for the inclusion of a mutual recognition clause, based on Article 28 of the Treaty), since these measures are precisely in accordance with the objective of Directive 98/34/EC.

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   2. Article 9 shall not apply to the laws, regulations and administrative provisions of the Member States prohibiting manufacture insofar as they do not impede the free movement of products.

3. Article 9 (3) to (6) shall not apply to the voluntary agreements referred to in the second indent of the second subparagraph of point 11 of Article 1.

4. Article 9 shall not apply to the technical specifications or other requirements or the rules on services referred to in the third indent of the second subparagraph of point 11 of Article 1.

   Under the terms of paragraphs (2) and (4), a standstill period does not apply to measures seeking to prohibit manufacturing, to the extent that these do not obstruct the free movement of goods within the Community, or to technical specifications or other requirements or rules on services linked to fiscal or financial measures.

   In the first case, it is obvious that postponement of the adoption of measures only makes sense if the manufacturing prohibitions present a potential risk of constituting a technical barrier to trade in the internal market. In the second case, it was considered inopportune to require postponement of adoption of measures linked to the fiscal system of the Member States.

   As far as draft regulations concerning fiscal or financial measures are concerned, the absence of the standstill obligation for the notifying Member State does not exclude the Commission or another Member State from reacting to these drafts by means of comments or detailed opinions (See Article 8 (1)).

   Under the terms of paragraph (3), the blockage and the standstill obligations applicable to draft national regulations concerning a subject covered by current or imminent Community work, do not apply to voluntary agreements.

   * * *

   It may be concluded from the reading of Articles 8, 9 and 10 of Directive 98/34/EC that the information procedure applicable to technical regulations is quite complex. The handbook produced by the Commission departments explains in detail how the procedure operates in practice.⁷⁶Furthermore, the Directive’s provisions on technical regulations impose very strict obligations on the Member States (much more restrictive than those applicable to standards), which are balanced by the right to react to draft national regulations being prepared by other Member States and by the saving of time and of much more complex procedures, both at Community and national levels, which would result from ex post procedures purely limited at removing already existing regulatory obstacles.

   Where the Member States fail to meet their obligation to communicate their draft technical regulations to the Commission, or do not observe the standstill periods laid down in the Directive, the Commission can institute infringement proceedings, under Article 226 of the Treaty, as already mentioned.

   When the Member State concerned does not comply, the procedure leads to a judgment of failure to fulfil obligations by the Court of Justice.⁷⁷Private individuals can, for their part, rely on the fact that technical regulations with which they are required to comply, but which have not been notified, cannot be enforced against

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   them.⁷⁸Furthermore, the Unilever judgment laid down that even a measure which is notified but which is subsequently adopted during the standstill period laid down in Article 9 of Directive 98/34/EC, cannot be enforced against individuals.⁷⁹

   [55] This reference enables the Commission, and the Member States which wish to do so, to obtain without dificulty the text of the standard which has been made compulsory.

   [56] An examination of the grounds presented shows that they most often relate to the protection of persons or animals, the environment, public safety, or to consumer information.

   [57] Article 226 (former Article 169) provides that ‘If the Commission considers that a Member State has failed to fulfil an obligation under this Treaty, it shall deliver a reasoned opinion on the matter after giving the State concerned the opportunity to submit its observations. If the State concerned does not comply with the opinion within the period laid down by the Commission, the latter may bring the matter before the Court of Justice.’

   [58] Article 227 (former Article 170) provides that ‘A Member State which considers that another Member State has failed to fulfil an obligation under thisTreaty may bring the matter before the Court of Justice. Before a Member State brings an action against another Member State for an alleged infringement of an obligation under this Treaty, it shall bring the matter before the Commission. The Commission shall deliver a reasoned opinion after each of the States concerned has been given the opportunity to submit its own case and its observations on the other party’s case both orally and in writing. If the Commission has not delivered an opinion within three months of the date on which the matter was brought before it, the absence of such opinion shall not prevent the matter from being brought before the Court of Justice’.

   [59] A sector with overlapping notification procedures (see in this connection Directive 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstufis, OJ L 109, 6.5.2000, p. 29; Council Regulation (EC) 315/93 of 8 February 1993 relating to the establishment of Community procedures regarding contaminating substances in foodstufis, OJ L 37, 13.2.1993, p. 1, and Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstufis, OJ L 175, 19.7.1993, p. 1). The latter directive will be repealed, as from 31 december 2005, by Regulation (EC) 852/2004 of the European Parliament and of the Council of 29 april 2004 on the hygiene of foodstufis, OJ L 139, 30.4.2004, p. 1.

   [60] Thus, for example, when a draft national technical regulation lays down specifications for the labelling of foodstufis which exceed the requirements of Directive 2000/13/EC, the procedure referred to in Article 19 of that Directive shall apply.

   [61] Directive 94/62/EC of the European Parliament and Council of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10) as amended by Directive 2004/12/EC of 11 February 2004 (OJ L 47, 18.2.2004, p. 26).

   [62] Regulation on the evaluation and control of the risks of existing substances (OJ L 84, 5.4.1993, p. 1) as amended by Regulation No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

   [63] Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ 196, 16.8.1967, p. 10.

   [64] Directive 1999/5/EC of the European Parliament and Council of 9 March 1999 relating to radio and telecommunications terminal equipment, including the mutual recognition of their conformity, OJ L 91, 7.4.1999, p.1.

   [65] Directive 94/25/EC of the European Parliament and Council of 16 June 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft, OJ L 164, 30.6.1994, p. 15 (amended by Directive 2003/44/EC of 16 June 2003, OJ L 214, 26.8.2003, p. 18).

   [66] See Annex 1 to this booklet.

   [67] Although it is not sent to the notifying Member State, the decision not to follow up the notification is a formal decision by the Commission.

   [68] With the exception of: a) urgent cases, b) laws, regulations or administrative provisions by Member States prohibiting manufacture, as long as these do not form barriers to the free movement of goods (see Article 10(2)), c) technical specifications or other requirements linked with financial or fiscal measures (see Article 10(4)).

   [69] Procedure established by the Single European Act in 1986 and then introduced as Article 189c of the EC Treaty by the Maastricht Treaty. (Today Article 252).

   [70] Article 189b, introduced into the EC Treaty by the Maastricht Treaty. (Today Article 251).

   [71] Case C-425/97 ‘Albers’, Case C-426/97 ‘Van den Berkmortel’, Case C-427/97 ‘Nuchelmans’ [1999] ECR I-2947.

   [72] Case C-443/98 ‘Unilever’ [2000] ECR I-7535.

   [73] Case C-390/99 ‘Canal Satélite Digital’ [2002] ECR I-607.

   [74] Directive of 29 June 1992 on general product safety, OJ L 228, 11.8.1992, p. 24. This Directive has been repealed by Directive 2001/95/EC of 3 December 2001 on general product safety. The relevant article is Article 12(1) of Directive 2001/95/EC.

   [75] RAPEX, whose legal basis is Directive 2001/95/EC on General Product Safety, serves as a single rapid alert system for dangerous consumer products. All non-food products intended for consumers or likely under reasonably foreseeable conditions to be used by consumers are included within the scope of RAPEX, with the exception of pharmaceutical and medical products.

   [76] Standing Committee Document 94/94 - final of 8 June 1995 and Standing Committee Document S-42/98 (def).

   [77] Reference is made to these judgments in Point V of the bibliography.

   [78] Case C-194/94 ‘CIA Security’ [1996] ECR I-2201 and Case C-226/97 ‘Lemmens’ [1998] ECR I-3711.

   [79] Case C-443/98 ‘Unilever’ [2000] ECR I-7535.