Frequently asked questions
What is Directive 98/34/EC?
What is the notification procedure?
How does the notification system work?
When do you send “comments”?
Is there any obligation to respond to comments?
When do you send a “detailed opinion”?
Is there any obligation to respond to a detailed opinion?
Does the Commission confirm that a Member State is free to make a regulation once the standstill period has ended?
Do all national regulations require notification?
What if a regulation is not notified?
How does it benefit industry?
Where can I get further information?
What is Directive 98/34/EC?
The Directive, commonly known as the Technical Standards Directive, lays down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services. By providing transparency at the legislative proposal stage, the Directive is intended to help promote the free movement of goods and avoid the creation of new technical barriers to trade within the Community.
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What is the notification procedure?
The procedure requires Member States to notify technical regulations to the Commission in draft, and then generally to observe a standstill period of at least three months before adopting the regulation, in order to allow other Member States and the Commission an opportunity to raise concerns about potential barriers to trade. For standards, there is a separate procedure which requires the national standardisation bodies of Member States to provide information on new work items which they are planning to initiate so that interested sectors in various Member States can consider them and their comments be taken into account.
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How does the notification system work?
It is based on Member States consulting each other and the Commission before they adopt technical regulations and to modify their drafts if necessary. The Directive requires Member States to communicate to the Commission any draft technical regulation which they plan to adopt using the notification form available on our website.
Each Member State has a central contact point for the Directive which coordinates notifications of new national technical regulations as well as those received from other Member States, as well as responses to the notifications. The UK contact point is in the Department for Business Innovation & Skills and can be contacted by email 9834@bis.gsi.gov.uk
When a new technical regulation is notified, the notification form (in pdf) is completed by the Department proposing the measure, specifying the content and reasons for its enactment. The completed form is then sent to the central contact point for processing and forwarding to the Commission, together with the draft text of the regulation to be notified, impact assessment if one is available and other relevant documentation that would help the Commission and other Member States in assessing the measure.
The Commission then transmits all the information communicated by the notifying Member State to all the other Member States and allocates a 3 month standstill period. The date of receipt by the Commission of the draft national technical regulation communicated by a Member State and of all the re¬quested documents is the beginning of the 3 month standstill period during which the Member State concerned is strictly obliged not to adopt the draft notified regulation. During this standstill period, the Commission or Member States can respond with comments or a detailed opinion (see below).
When notifications from other Member States are received, the central contact point forwards them to the lead Department and other Departments with an interest, providing an opportunity to submit comments or detailed opinions if they feel this is appropriate.
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When do you send “comments”?
Comments are sent when the notified text, although in accord¬ance 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, hav¬ing 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. Comments do not extend the initial 3 month standstill period.
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Is there any obligation to respond to comments?
Under the Directive, the notifying Member State has no formal obligation to reply to the comments received. In practice, how¬ever, Members State frequently do so on a voluntary basis and generally take account of comments they receive. All responses to comments should be emailed to the central contact point for forwarding to the Commission.
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When do you send a “detailed opinion”?
Detailed opinions are sent by the Commission or the Member States when they consider that the draft measure envisaged would, if adopted, create obsta¬cles 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 ob¬tain an amendment to the proposed measure, in order to re¬move at source any resulting barriers to such freedoms. A detailed opinion received on a notification extends the initial 3 month standstill period by another 3 months, ie to a total of 6 months.
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Is there any obligation to respond to a detailed opinion?
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 pos¬sible in the interests of efficiency, preferably during the stand¬still periods of six or four months, respectively for goods and information society services. All responses to detailed opinions should be emailed to the central contact point for forwarding to the Commission.
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Does the Commission confirm that a Member State is free to make a regulation once the standstill period has ended?
No confirmation is received from the Commission. Once a standstill period for any particular notification has ended, the originator is free to make the regulation provided that no comments or opinions have been received and/or there are no issues still outstanding as result of a detailed opinion. It is a good idea to check with the central point just after the standstill period has ended, in case any last minute comments or opinions have been submitted.
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Do all national regulations require notification?
No. Only those technical regulations that come within the scope of the Directive require notification and there are certain exceptions allowed in the Directive. The Directive defines what is a 'technical regulation' and it is very wide in scope, for example it includes codes of practice and voluntary agreements so Departments have to check whether the regulations they wish to enact come within the scope of notification. If they do, the Department should notify the regulations at a draft stage and observe the standstill period before adopting the regulation.
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What if a regulation is not notified?
The Commission can initiate infraction proceedings for failure to notify a national regulation that comes within the scope of the Directive. If in doubt measures should be notified in draft since a non-notified measure which should have been notified will be unenforceable. It is not possible to make a notification if a regulation is already in force.
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How does it benefit industry?
By means of transparency and exchange of information at a legislative draft stage, the notification process prevents new obstacles to the free movement of goods in the Community.
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Where can I get further information?
The central contact point in BIS will be happy to give you further information or answer your queries. In addition to the information that is already available on our website, you may also find the Commission’s website on Directive 98/34/EC helpful from where you can download reference documents for example, the text of the Directive, Commission’s guidance document, their reports on the functioning of the Directive and case law as well as the ability to search their database of notifications already made by Member States: http://ec.europa.eu/enterprise/tris/index_en.htm.
