Looking for answers to your 2015/1535 doubts? Find bellow the most common questions we get asked about.
Directive (EU) 2015/1535 sets up a procedure which imposes an obligation upon the Member States to notify to the Commission all the draft technical regulations concerning products and Information Society Services before they are adopted in national law. It replaces Directive 98/34/EC without any substantial changes (codification).
Directive (EU) 2015/1535 applies to all industrially manufactured, agricultural and fishery products
Directive (EU) 2015/1535 applies only to Information Society services
An Information Society service is a service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services. (You can find more information in Article 1(1)b of Directive (EU) 2015/1535).
The term ‘technical regulation’ is defined in Article 1(1)f of Directive (EU) 2015/1535. It covers, on the one hand technical specifications, other requirements or rules on Information Society services which are laid down by the Member States, the observance of which is compulsory, de jure or de facto, for the marketing or use of a product, for the provision of a service or the establishment of a service operator, and on the other hand regulations or administrative provisions prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider.
The technical regulation is compulsory ‘de jure’ when compliance whit it is made mandatory by a measure emanating directly from the relevant public authorities or attributable to the latter. Compliance with the technical specifications or other requirements or rules on services which it contains is compulsory for the marketing or use of the products or services in question.
The technical regulation is compulsory ‘de facto’ when the technical specifications, other requirements or rules on survives are not laid down by a formal and binding act of the Member State concerned, but where the State encourages its observance. The Directive provides a non-exhaustive list of examples of ‘de facto’ technical regulations including voluntary agreements and ‘fiscal and financial measures’
Technical specifications or other requirements or rules on services which are linked to fiscal or financial measures affecting the consumption of products or services by encouraging compliance with such technical specifications or other requirements or rules on services.
Three cumulative conditions have to be fulfilled: the draft measure has to contain technical specifications or other requirements or rules on services; these technical specifications or other requirements or rules on services have to be linked to fiscal or financial measures, and the fiscal or financial measures have to affect the consumption of products or services by encouraging compliance with such technical specifications or other requirements or rules on services.
The technical regulation shall be notified to the Commission at a draft stage, i.e. before adoption.
The text of the technical regulation should be at a stage of preparation at which substantial amendments can still be made (Article 1(1)g of Directive (EU) 2015/1535).
The standstill period is a period during which the notified draft technical regulation cannot be adopted by the Member State concerned. The notification of a draft technical regulation has the effect to open a three months standstill period which can be extended depending on the type of reaction issued by the Commission or other Member States.
During the three months standstill period the Commission and the other Member States examine the notified draft technical regulation in order to ascertain its compatibility with EU law and the principles of the free movement of goods and services. The extended standstill period allows a dialogue with the notifying Member State or prevents it from adopting the draft legislation in case of harmonisation work at EU level.
The three months standstill period following the notification does not apply to draft ‘fiscal and financial measures’, accepted urgency procedure and legislation of the Member States prohibiting manufacture insofar as they do not impede the free movement of products.
According to Article 5(1), third indent of Directive (UE) 2015/1535, Member States shall notify the draft again if they make significant changes to that draft that have the effect of altering its scope, shortening the timetable for implementation, adding specifications or requirements, or making these specification and requirements more restrictive.
The Commission and other Member States may issue comments or detailed opinions. The Commission can also block a draft technical regulation.
Comments are sent when the notified draft text, although in accordance with EU 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 EU law and policies, or to inform the Member States of its future obligations with regard to EU acts to be adopted or implemented.
The delivery of comments does not have the effect of extending the standstill period. Therefore, the Member State concerned can adopt the notified measure after the end of the three months standstill period. The notifying Member State has no formal obligation to reply to the comments received. However, it shall take the comments into account as far as possible in the subsequent preparation of the technical regulation.
A detailed opinion is sent when it is considered that the draft technical regulation may create obstacles to the free movement of goods, the freedom to provide services or the freedom of establishment of services operators within the internal market. The detailed opinion seeks to obtain the amendment of the proposed measure, in order to remove at source any resulting barriers to such freedoms.
The delivery of a detailed opinion has the effect of extending the standstill period to six months for products and four months for Information Society services and voluntary agreements. The Member State concerned must take into account the detailed opinion and reply explaining the actions it intends to take in order to comply with it (revocation of the draft text, justification for retaining it or the amendment of certain provisions in order to render them compatible with EU law).
The Directive does not specify the time for a Member State concerned by a detailed opinion to reply. It is nevertheless desirable that a response is made as soon as possible in the interest of efficiency, preferably during the standstill period of six or four months.
The dialogue can continue as long as the notified daft technical regulation has not been adopted.
The Commission can block a draft technical regulation if it announces its intention of proposing an EU act (directive, regulation or decision) or its finding that the draft legislation concerns a matter which is covered by a proposal for an EU act presented to the Council. In the case of draft technical regulations containing rules on services, the Commission can block such draft acts only when it announces its finding that the draft legislation concerns a matter which is covered by a proposal for an EU act presented to the Council.
The blockage of a notified draft technical regulation extends the standstill period to 12 months from the date of the notification. The standstill period may be further extended to 18 months if the Council adopts a common position during the 12 months standstill period.
Yes, the reactions of the Commission to the national draft legislations notified after the 1st January 2022 are in principle publicly available. Namely, detailed opinions, comments and blocking decisions issued by the Commission are published 10 days after the expiry of the initial standstill of 3 months. The reactions of the Commission which have been issued on national draft legislations notified before the 1st January 2022 are still subject to individual access-to-document requests in line with Regulation (EC) 1049/2001.*
For what concerns the detailed opinions and comments issued by the Member States as of the 9th January 2023, they are available on public TRIS in case the Member State has agreed to their disclosure by ticking a dedicated box in the restricted TRIS. For reactions issued by Member States before the above-mentioned date and if the box remains unticked, such reactions remain undisclosed and subject to individual access-to-document requests in line with Regulation (EC) 1049/2001.
* certain exceptions to this rules can apply based on Article 4 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents.
Member States may invoke the urgency procedure foreseen in Article 6(7) of the Directive if, in order to respond to an urgent and unforeseeable situation, such as natural disaster, epidemic etc., they are obliged to adopt immediately technical regulations, without having time to consult the Commission and the other Member States beforehand. If the urgency procedure is accepted by the Commission the standstill period of three months does not apply and the measure can be adopted immediately.
No, these exceptional circumstances do not exempt the Member State from the notification obligation. The Member State must notify the draft measure and clearly justify its request for urgency. The Commission has to assess the justification provided by the Member State and give its views as soon as possible.
If the Commission considers that the criteria for the application of the urgency procedure are not met, it refuses the urgency and opens the three months standstill period.
Article 7 of Directive (EU) 2015/1535 contains exceptions to the notification obligation. The most common exceptions are when a Member State complies with binding EU acts, fulfils obligations arising out of international agreements, implements a judgement of the European Court of Justice or amend a technical regulation following a Commission request. However, according the case-law of the European Court of Justice ‘Unilever’ (case C-443/98), Member States must notify draft technical regulations implementing EU legislation when the latter allows sufficient room for manoeuvre to Member States.
According to the case-law of the European Court of Justice ’CIA-Security’ (Case C-194/94), national technical regulation which was not notified under Directive 98/34/EC but should have been can be declared by national courts as inapplicable to individuals.
According the case-law of the European Court of Justice Unilever’ (case C-443/98), a notified technical regulation adopted in breach of the standstill period can be declared by national courts as inapplicable to individuals.
The notification procedure ends with the adoption of the technical regulation and its communication to the Commission.
In principle, notified drafts are translated into all EU languages. They are then available to you on the Europa website, via the TRIS database (Technical Regulations Information System).
The TRIS system can be accessed free of charge, with no further formalities, and is updated daily. It allows you to browse the legislative initiatives of the Member States likely to be of interest to you or likely to have repercussions on your activities. In order to aid your search, notified drafts are classed in specific categories and sub-categories, depending on their aim and the area of activity concerned.
In this case, do not hesitate to issue your opinion or make your grievances known to the Commission or the competent offices in your Member State. Your reaction may be decisive. The 2015/1535 procedure is transparent and allows the Commission and all Member States to react, on an equal footing, to notified drafts. The aim is to ensure that these texts are brought into conformity with EU law.
There is no specific from to be used. The documents containing the concerns can be drafted in any EU language and should be sent to Unit B2 ‘Prevention of technical barriers’ of Directorate-General ‘Internal Market, Industry, Entrepreneurship and SMEs’ via ordinary mail or via electronic mail to the functional mailbox Grow-Notif-Infractions@ec.europa.eu.
There is no official deadline. However, stakeholders are invited to submit their concerns at least one month before the end of the three months standstill period.
The publication of the Commission reactions issued under the scope of Directive 20115/1535 has been implemented with respect to notifications received after 1 January 2022. In exceptional cases, the Commission reaction might not be published on the TRIS website, nevertheless, it can still be subject to a request for Access to Documents, which is also possible for the Commission’s reactions to notifications received prior to 1 January 2022.