Methodological guidelines

Methodological Guidelines on Directive 2015/1535/EU of the European Parliament and of the Council of 9 September 2015 on the procedure for the provision of information in the field of technical regulations and rules on information society services

Table of Contents

I. INTRODUCTION
II. BASIC CONCEPTS AND DEFINITIONS
1. Products
2. Services
3. Technical regulation
III. PROCEDURE FOR NOTIFICATIONS FROM THE CZECH REPUBLIC
1. Notification of the proposal
2. Suspension of work
3. Exceptions to the suspension period
4. Information on the adoption of the Regulation
5. Penalties for failure to notify a technical regulation
6. Regulations not covered by Directive 2015/1535/EU
IV. PROCEDURE FOR NOTIFICATIONS FROM MEMBER STATES

I. INTRODUCTION

Directive 2015/1535/EU of the European Parliament and of the Council of 9 September 2015 on the procedure for the provision of information in the field of technical regulations and rules on information society services (published in the Official Journal of the EU on 17 September 2015 and entered into force on 7 October 2015), (hereinafter "Directive 2015/1535/EU"), is intended to help prevent the creation of new technical barriers to trade within the European Union ("EU"). It requires Member States to notify the European Commission ("Commission") of draft technical regulations and then observe a standstill period of at least three months before the adoption of the regulation to allow other Member States and the Commission to comment on potential barriers to trade. To this end, it is therefore necessary to have a single point of contact in each Member State for communication with the Commission. In the Czech Republic, according to Act No 22/1997 Coll., this contact point is the Czech Office for Standards, Metrology and Testing (hereinafter referred to as 'ÚNMZ').

II. BASIC CONCEPTS AND DEFINITIONS

1. Products

Product definition

Article 1(1)(a):

'product' [means, for the purposes of this Directive,] any industrially produced product and any agricultural product, including fishery products

Directive 2015/1535/EU applies to all manufactured products and agricultural products. In determining the scope of Directive 2015/1535/EU, it is also necessary to take into account, for example, that the CJEU, when deciding on measures under Articles 34-36 TFEU (formerly Articles 28-30 of the Treaty establishing the European Community), included among goods "all products which can be valued in monetary terms and as such be the subject of commercial transactions."

Two other definitions are related to the product definition - technical specifications and other requirements:

Technical Specifications

Article 1(1)(c):

'technical specification' [means, for the purposes of this Directive,] a specification contained in a document which sets out the required characteristics of a product, such as quality levels, performance indicators, safety or dimensions, including product requirements such as trade name, terminology, symbols, testing and test methods, packaging, product labelling or nameplate marking and conformity assessment procedures;

The term 'technical specification' shall also include manufacturing methods and processes used in relation to agricultural products as referred to in the second subparagraph of Article 38(1) of the Treaty on the Functioning of the European Union, products intended for human and animal consumption and medicinal products within the meaning of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council, as well as manufacturing methods and processes relating to other products where they affect their characteristics.

The technical specification sets out the required characteristics of the product. The list given in Article 1(1)(c) is illustrative; it includes, for example, the composition of the product, its shape, weight, packaging, promotion, durability, energy consumption, etc.

A specification may serve multiple purposes: for example, consumer protection, environmental protection, public health or safety, quality improvement, fairness in commercial transactions.

In the field of agriculture, products for human and animal consumption and pharmaceuticals, production methods and practices generally affect the product itself (for example, the obligation to use certain equipment for hygiene reasons). The effect on the product is precisely the reason for the notification of the relevant production methods and practices, with the specific exception of regulations concerning the organisation of work, which do not affect the products.

The tests and test methods, set out as examples of technical specifications, refer to the technical and scientific methods used to assess the characteristics of a given product. Also mentioned are the conformity assessment procedures used to ensure that the product meets the specific requirements. These are the responsibility of a specialised body, whether public or private, or of the manufacturer. The inclusion of these parameters in the scope of Directive 2015/1535/EU is of utmost importance, as testing and conformity assessment procedures can have negative consequences for trade under certain conditions. The multiplicity and unevenness of national systems of conformity certification can cause technical barriers to trade in the same way as product specifications.

Other requirements

Article 1(1)(d):

'other requirements' [means, for the purposes of this Directive,] a requirement other than a technical specification imposed on a product, in particular for reasons of consumer or environmental protection, which has an impact on its post-marketing life cycle, such as conditions of use, recycling, reuse or disposal, where these conditions may significantly affect the composition or nature of the product or its marketing

Other requirements include the requirements that are imposed on the product during its use, i.e. after it has been placed on the market or put into service. To be considered 'other requirements', the requirements must affect the composition or nature of the product or its placing on the market or putting into service. For example, a regulation that provides for a system of reuse of packaging or separate collection of certain products (e.g. discharged batteries) is likely to contain provisions in the category of other requirements.

2. Services

Definition of service

Article 1(1)(b):

'service' [means, for the purposes of this Directive,] any information society service, that is to say any service provided usually as a rule, for remuneration, remotely, electronically and at the individual request of the service recipient.

For the purposes of this definition:

- 'distance service' means a service provided without the simultaneous presence of the parties,

- 'electronically provided service' means a service sent from an origin and received at its destination by means of electronic data processing and storage equipment (including digital compression) and as a whole sent, transmitted or received by wire, radio, optical or other electromagnetic means;

- 'service at the individual request of the recipient of the service' means a service provided by data transmission at the individual request.

Examples of services not included in this definition are given in Annex I.

This Directive does not apply to:

- radio broadcasting services,

- television broadcasting services referred to in Article 1(1)(e) of Directive 2010/13/EU of the European Parliament and of the Council.

To be an information society service, a service must be provided remotely, electronically and at the individual request of the beneficiary. These three conditions must be fulfilled simultaneously; if only one of them is missing, then the activity cannot be considered an information society service. The condition that the service must be 'normally provided for consideration' is based on the interpretation of the general concept of 'service' under Article 50 of the Treaty establishing the European Community.

(a) is the service provided "remotely"?

This term refers to situations where the service is provided by means of a remote communication technique characterised by the fact that the parties (i.e. the service provider and the recipient) are not physically present at the same time.

Examples of services provided remotely:

- general on-line services: electronic newspapers and magazines; electronic libraries; databases, information on current events, weather reports, traffic information, local newspapers, environmental information; browsing (search engines), computer graphics, etc;

- online educational services for students of private educational centers provided at home: interactive courses, virtual universities and schools, guide services for students and families, etc.;

- surveillance activities provided remotely: remote health checks or online surveillance of private homes or business premises from surveillance centres.

- online consumer services: product and service information and reviews, discount searches, etc.

b) is the service provided "electronically"?

This term includes services whose individual components are transmitted, transported and received over an electronic network. The service must be transported from the point of origin to the point of destination electronically (processing and storage) and via telecommunication channels.

Examples of services provided electronically:

- online entertainment offered on the Internet: video games on demand; music on demand; video on demand; sporting events on demand; lotteries, betting and gambling; virtual expeditions to archaeological sites, monuments and museums, etc.;

- services for access to the Internet and the World Wide Web: electronic mail, discussion forums, data transfer, discussions;

- online legalization services: authentication, registration, dating and verification services (receipt confirmation, checking the simultaneous execution of delivery and payment, etc.), electronic stamps, etc;

- on-line telecommunications services: video telephones, video conferencing, telephone and fax services requiring data processing and storage, etc.

(c) is the service provided "at the individual request of the beneficiary"?

These services are provided in response to the individual request of the recipient. This interactive aspect characterises information society services and distinguishes them from other services which are distributed regardless of the recipient's request. However, Directive 2015/1535/EU does not apply to radio broadcasting services and television broadcasting services covered by Article 1(1)(e) of Directive 2010/13/EU of the European Parliament and of the Council.

Examples of services provided at the individual request of the beneficiary:

- online tourist services: booking of airline and train tickets, booking of hotels, booking of museum and theatre tickets; tourist information, car rental, etc.;

- online services for businesses: information, management and assistance on stock, inventory, shipping, contracts, accounting, etc.;

- online agency services: real estate advertising, marketing, PR and job placement, marriage agencies, auctions and auctioneeering, etc.;

- online professional services: lawyers, consultants, tax advisors, accountants, translators, computer experts and software specialists, technicians, designers, fashion designers, psychologists, doctors (computer medicine), etc. consisting of services such as database access, data management, consulting, diagnostics, preparation of plans, projects and proposals, personalized search and selection of information, addresses and job offers, etc.;

- online financial services: insurance and banking services (especially telebanking and electronic payments), investment and stock exchange services.

Definition of service is related to the definition of service regulation in Article 1(1)(e):

Service regulation

Article 1(1)(e):

'service regulation' [means, for the purposes of this Directive,] a requirement of a general nature relating to access to and supply of services within the meaning of point (b), in particular provisions relating to the service provider, the services themselves and the recipient of the services, with the exception of regulations which are not specifically aimed at the services defined in that point.

This Directive shall not apply to rules concerning matters governed by Union legislation in the field of telecommunications services covered by Directive 2002/21/EC of the European Parliament and of the Council.

This Directive shall not apply to provisions relating to matters governed by Union financial services legislation which are listed in a non-exhaustive manner in Annex II to this Directive.

With the exception of Article 5(3), this Directive shall not apply to rules issued by or for regulated markets within the meaning of Directive 2004/39/EC of the European Parliament and of the Council or issued by or for other markets or entities carrying out clearing or settlement operations on those markets.

For the purposes of this definition:

- a regulation shall be deemed to be specifically aimed at information society services if, having regard to its reasoning and the substance of its wording, it is the specific intention and purpose of all or some of its individual provisions to regulate such services directly and specifically,

- a regulation shall not be deemed to be specifically aimed at information society services if it affects those services only indirectly or in a secondary manner.

Rule of thumb for services is a requirement that relates to access to and operation of services, in particular of the service provider, the recipient of the services or the services themselves.

Examples that are likely to be the prescription for information society services:

- Measures concerning the conditions for setting up:

A draft law containing provisions governing the issuance of electronic money: conditions relating to professional qualifications and reputation, financial guarantees, the obligation to obtain a licence and provisions for its issuance, etc.

- Measures relating to the conditions for operating online:
Draft decree on procedures for online legal practice: prohibition to practice as a company; incompatibility of the profession with other activities; binding fee schedules; general prohibition of commercial promotion or certain forms of advertising, etc.

- Measures relating to the online service provider:
Draft regulation on the activities of online tax advisors: required professional experience, special registration procedures, requirements such as good standing and financial guarantees, etc.

- Measures relating to the delivery of online services:
Draft law on procedures related to online architectural services: binding provisions for contractual relations, fee schedules, prohibition of promotional offers, etc.

- Measures concerning the recipient of online services:
Draft regulation on participation in certain Internet gambling: possibility and facilities for participation set in the light of certain criteria (age); prohibition on participation in unauthorised projects, etc.

In order for a specific service regulation to be covered by Directive 2015/1535/EU, it must be "specifically aimed at information society services". Therefore, Article 1(1)(e) contains certain definitions that facilitate the understanding of the term by stating what "specifically targeted" does and does not mean:

This also implies that not only draft regulations which are focused on information society services as a whole (e.g. the law on electronic signature) should be notified, but also draft regulations of a more general nature, part of which (even just one paragraph or section) is specifically focused on these services.

On the other hand, it is not necessary to notify draft rules which are only indirectly, implicitly or incidentally related to information society services, i.e. which concern economic activities in general without taking into account the typical technical procedures for the provision of information society services (e.g. a measure which prohibits the distribution of certain material by any means of transmission, including the Internet or electronic mail, among the various possible means of dissemination).

3. Technical regulation

Article 1(1)(f):

'technical regulation' means technical specifications and other requirements or rules for services, including the relevant administrative provisions, compliance with which is mandatory de jure or de facto for the placing on the market, the provision of a service, the establishment of a service provider or the use in a Member State or in a major part thereof, as well as the laws, regulations and administrative provisions of the Member States prohibiting the manufacture, importation, sale or use of a product or prohibiting the provision or use of a service or the establishment of a service provider, with the exception of those set out in Article 7.

The technical regulations de facto include

- laws, regulations or administrative provisions of a Member State which refer either to technical specifications, other requirements or rules for services, or to professional rules or rules of good practice which themselves contain a reference to technical specifications, other requirements or rules for services, compliance with which gives rise to a presumption of conformity with the requirements imposed by those laws, regulations or administrative provisions to which a public authority is a party and which, in the public interest, provide for compliance with technical specifications, other requirements or rules for services, with the exception of specifications for tendering in public procurement procedures, (iii) technical specifications, other requirements or rules for services which relate to fiscal or financial measures affecting the consumption of products or services by calling for compliance with those technical specifications, other requirements or rules for services; however, this shall not apply to technical specifications, other requirements or service regulations relating to national social security systems.

These are technical regulations adopted by the bodies designated by the Member States and included in the list drawn up and, where appropriate, updated by the Commission in the Committee referred to in Article 2.

The same procedure shall apply when this list is amended.

To be considered a technical regulation, a technical specification, other requirement or service regulation must meet the following conditions:

- must be 'binding'. This feature, inherent in documents prepared by public authorities, is the major difference between a technical regulation and a technical standard prepared by private bodies, which is essentially voluntary;

- must affect the marketing, putting into service or use of industrial or agricultural products or the provision of a service, and must be applicable throughout all or most of the State.

The binding nature of a technical specification, other requirement or service regulation can be given in two ways:

de jure, where compliance with a technical specification, other requirement or service regulation is made mandatory by law. For example, the conditions for the small-scale production of jam and preserved fruit laid down by the Decree will be considered as a technical regulation which is de jure binding. The same applies to the prohibition on the use of plastic bottles for the marketing of mineral waters laid down in the Decree, etc.

de facto, where the technical specification is not laid down in a formal and binding regulation by the State concerned, but where the State encourages compliance with it; as a result of the similar effects they may have on trade, such measures are considered equivalent to binding regulations.

A demonstrative list of de facto technical regulations is given in Article 1(1)(f)(i) to (iii) and are divided into three categories:

- legal and administrative provisions are measures adopted by national authorities which refer to technical specifications or other requirements usually laid down by bodies other than the State (for example, a national standardisation body) which are not binding as such (standards, professional rules or rules of good practice) but compliance with which is recommended as compliance with them is a prerequisite for compliance with such a provision.

This is the case, for example, where insurance legislation exempts users of products that comply with certain non-binding standards from the obligation to certify compliance with binding requirements, as these products benefit from the presumption of compliance with those requirements.

- Agreements concluded between economic operators which lay down technical specifications or other requirements for certain products are not binding, given that the private sector is the originator. However, they are de facto considered as technical regulations when a State is one of the parties to these agreements.

Such agreements are often used in Scandinavia in sectors such as the automotive industry or the chemical industry, in most cases for environmental reasons: to reduce harmful emissions from vehicles or leakage of harmful substances into water, to promote the use of certain types of packaging, etc. These agreements allow for greater flexibility in implementing the measures necessary to achieve the objectives of the legislation, and the voluntary participation of the industries concerned ensures that they are achieved.

- the tax or financial measures referred to in the third indent are put forward by national authorities for purposes other than those traditionally pursued by the tax laws of the Member States. They are considered to be effective instruments for the implementation of policies established at national (national) level, in particular with regard to the protection of the environment and consumers, given that they are essentially aimed at influencing the behaviour of the latter in relation to a specific product.

Examples include in particular cases of tax breaks granted to "clean vehicles" that meet the relevant emission limits or are equipped with catalytic converters. Experience has shown that Member States have often linked the concessions to conditions which have resulted in the system in place constituting a barrier to trade and therefore necessitating a review of such rules by the Commission. This category includes in particular those measures that encourage the purchase of products that meet the relevant specifications by providing financial services (for example, subsidies for the purchase of certain heating equipment or the use of alternative energy sources such as wind power) or, on the contrary, discourage purchases (for example, the withdrawal of grants in the construction industry if certain materials have been used). This category also includes tax and financial measures that can influence consumption by encouraging compliance with 'other requirements' (for example, exemptions from environmental tax for the packaging of certain products when a deposit system is set up, or exemptions from environmental tax for certain products when a collection and sorting system is in place).

Directive 2015/1535/EU does not cover tax and financial legislation as such; it only covers technical specifications or "other requirements" related to tax or financial measures aimed at changing consumer behaviour. Tax or financial measures as such are not subject to scrutiny by the Commission or Member States; only aspects of technical specifications or other requirements that may create barriers to trade.

III. PROCEDURE FOR NOTIFICATIONS FROM THE CZECH REPUBLIC

1. Notification of the proposal

Article 5(1):

In addition to the exemptions referred to in Article 7, Member States shall notify the Commission without delay of any draft technical regulation, except where such a regulation merely transposes the full text of an international or European standard and where information on the relevant standard is sufficient; Member States shall at the same time communicate to the Commission the reasons why it is necessary to issue such a technical regulation, if they have not already been given in the draft itself.

Where appropriate, and unless this has already been done with the previous communication, Member States shall simultaneously notify the texts of the basic laws or regulations which are principally and directly affected, where knowledge of these texts is necessary to assess the effects of the proposed technical regulation.

In particular, where a proposal seeks to restrict the placing on the market or use of a chemical substance, preparation or product on grounds of protection of public health, consumers or the environment, Member States shall also provide either a summary of all relevant data on the substance, preparation or product concerned and on known and available substitutes, or references to them where such data are available, and communicate the anticipated effects of the measure on public health and the protection of consumers and the environment, together with a risk analysis carried out in an appropriate manner in accordance with the general principles of risk assessment for chemicals set out in the relevant part of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.

The starting point for Directive 2015/1535/EU is the obligation for Member States to notify each draft technical regulation to the Commission and then, except for the emergency procedures described below, to comply with an initial three-month standstill period during which the regulation may not be adopted.

A technical regulation is sent to the Commission in draft form, i.e. in a state where substantial changes can still be made. If the Commission or Member States make comments on the draft technical regulation requesting that the text of the draft be amended, such amendment must be possible. As each country has different rules for the legislative process, there is no precise timing for when the proposal should be sent to the Commission and this is left to the discretion of the individual countries.

The proposer of the draft technical regulation is required to ensure that the draft is transmitted to the contact point (together with the completed form) and can subsequently be notified to the Commission. The submitter also determines at what stage the proposal will be sent to the contact point. They must take into account that once the Commission receives such a proposal, there is a three-month time limit (in the case of a detailed opinion, there is an extension of the standstill period) and the proposal cannot be accepted before the expiry of this time limit.

Other legislation or documents needed by the Commission and Member States to comprehensively assess the effects of the proposal should be provided alongside the proposal - e.g. if the proposal is for a technical regulation which is an implementing regulation of a law, the law which contains the power to issue that implementing regulation should also be provided.

If the draft technical regulation restricts the placing on the market or use of a chemical (dangerous) substance, preparation or product on the grounds of protection of public health, consumers or the environment, a risk assessment must be attached. This allows the Commission and Member States to determine the proportionality of the measure in view of the expected impacts on public health and the protection of consumers and the environment.

A partial exemption from the obligation to notify draft technical regulations is provided for cases where the technical regulation merely adopts the full text of an international or European standard; notification of the relevant standard is sufficient and it is not necessary to transmit the text of the draft to the Commission.

Article 5(1):

Member States shall, in accordance with the conditions set out in the first and second subparagraphs of this paragraph, communicate a draft technical regulation to the Commission again if they make amendments to it which substantially alter its scope, shorten the period of time originally envisaged for its introduction or add or tighten specifications or requirements.

Where the draft technical regulation is amended as above-mentioned, the submitter shall resubmit such amended draft to the Commission. This means that the Commission and the Member States are again given the opportunity to comment on the new proposal and the new three-month standstill period must therefore be respected again. The whole notification process is therefore once again starting from scratch.

2. Suspension of work

Suspension of work shall begin on the date on which the draft technical regulation is received by the Commission. This date shall be clearly indicated by the Commission, as well as the date on which the period of suspension ends. Period of suspension shall shall last three monthsduring which the Commission and the Member States have the opportunity to comment on the draft technical regulations sent to them. Their comments may take the form of either a comment or a detailed opinion, or they may be a communication from the Commission that harmonisation will take place on the matter.

(a) Reminder

Article 5(2):

The Commission and the Member States may forward comments to the Member State which has submitted a draft technical regulation, which the Member State shall take into account as far as possible in the subsequent preparation of the technical regulation.

Comments made by the Commission or Member States at draft regulation are only recommendations. However, Member States are invited by the Commission to respond to the comments, i.e. to send a statement on whether or not they have taken these comments into account and why.

(b) Detailed opinion

A detailed opinion is applied by the Commission or a Member State where it considers that a draft technical regulation may create obstacles to the free movement of goods in the internal market. If such a detailed opinion is applied, this means that the initial three-month suspension period is further extended (by one or three months, depending on which category the technical regulation falls into). At the same time, the Member State is obliged to report to the Commission on the measures it intends to take on the basis of these detailed opinions.

Article 6(2):

Member States shall postpone:

- four months for the adoption of a draft technical regulation which takes the form of a voluntary agreement within the meaning of Article 1(1)(f), second subparagraph, point (ii),

- without prejudice to paragraphs 3, 4 and 5 of this Article, the adoption of any other draft technical regulation (other than a draft regulation for services) for six months from the date on which the Commission receives the communication referred to in Article 5(1), if the Commission or another Member State delivers a detailed opinion within three months of that date indicating that the envisaged measure is likely to create obstacles to the free movement of goods in the internal market;

- without prejudice to paragraphs 4 and 5, the adoption of any proposal for a service regulation four months after the date on which the Commission receives the communication referred to in Article 5(1), if the Commission or another Member State delivers a detailed opinion within three months of that date indicating that the envisaged measure is likely to create obstacles to the free movement of services or the freedom of establishment of service providers in the internal market.

Detailed opinions of the Commission or of Member States on draft rules for services shall not affect cultural policy measures, in particular in the audiovisual field, which Member States could adopt in accordance with Union law, taking into account their linguistic diversity, national and regional specificities and cultural heritage.

The Member State concerned shall report to the Commission on the measures it intends to take on the basis of these detailed opinions. The Commission shall comment on those measures.

In the case of service regulations, the Member State concerned shall, where appropriate, state the reasons why it cannot take the detailed opinions into account.

Article 6(3) to (6):

(3) With the exception of draft regulations relating to services, Member States shall postpone the adoption of a draft technical regulation for 12 months from the date on which the Commission receives the communication referred to in Article 5(1) if, within three months of that date, the Commission notifies its intention to propose or adopt a directive, regulation or decision on the matter in accordance with Article 288 TFEU.

Member States shall postpone the adoption of a draft technical regulation for 12 months from the date on which the Commission receives the communication referred to in Article 5(1) if, within three months of that date, the Commission notifies its finding that the draft technical regulation concerns a matter which falls within the scope of a draft directive, regulation or decision submitted to the European Parliament and the Council in accordance with Article 288 TFEU.

5. If the Council adopts a position at first reading during the period of suspension of work referred to in paragraphs 3 and 4, this period shall, subject to paragraph 6, be extended to 18 months.

6. The obligations referred to in paragraphs 3, 4 and 5 shall cease:

- where the Commission informs the Member States that it no longer intends to propose or adopt binding acts;

- if the Commission informs the Member States that it has withdrawn its proposal or intention;

- once the European Parliament and the Council or the Commission have adopted a binding act.

3. Exceptions to the suspension period

The obligation to postpone the approval of a draft technical regulation does not apply in the following cases:

- technical specifications or other requirements or rules for the services referred to in point (iii) of the second subparagraph of Article 1(1)(f);

- legislation and administrative measures prohibiting production, unless they impede the free movement of products;

- use of the "emergency procedure"

Article 6(7):

The provisions of paragraphs 1 to 5 shall not apply in cases where the

- a Member State is compelled, for reasons of urgency caused by serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or plants and, in the case of service regulations, public policy, in particular the protection of young people, to prepare technical regulations at very short notice so that they can be issued and implemented without delay, without any consultation being possible; or

- a Member State is compelled, on imperative grounds of urgency caused by serious circumstances relating to the protection of the safety and integrity of the financial system, in particular the protection of depositors, investors and policy holders, to issue and implement financial services regulations without delay.

In the communication referred to in Article 5, the Member State shall justify the urgency of the measures concerned. The Commission shall comment on the communication without delay. It shall take appropriate measures in cases of incorrect application of this procedure. The Commission shall regularly inform the European Parliament.

Although these cases are not covered by the obligation to postpone approval of draft technical regulation and a State may adopt the regulation without a period of suspension of work, such a technical regulation, however urgent, must be notified to the Commission at the draft stage - there are no exceptions to this rule.

The non-use of the standstill period does not affect the possibility for the Commission and the States to comment on such a draft technical regulation.

4. Information on the adoption of the Regulation

Article 5(3):

Member States shall communicate the final version of the technical regulation to the Commission without delay.

Once the suspension period (either the basic three-month period or the extended period) has expired, the draft regulation can be adopted. Once adopted, the Member State is obliged to send the final text of the regulation as officially published to the Commission. The transmission of the final text allows the Commission to see whether the State has taken into account the comments or detailed opinions forwarded to it.

If the regulation is not adopted for some reason (e.g. the relevant ministry decides that the proposal is too controversial and withdraws it), the Commission must also be informed.

5. Failure to notify a technical regulation

According to the case law of the Court of Justice of the European Union (Judgment C-194/94 in CIA Security International SA v Signalson SA and Securitel SPRL), Articles 5 and 6 of Directive 2015/1535/EU are precise and unconditional and individuals are therefore able to invoke these provisions before national courts. The aim of the Directive is not only to inform the Commission of draft technical regulations, but above all to eliminate barriers to trade. Therefore, draft technical regulations are sent to the Commission and to other Member States and they are given the opportunity to react to these proposals and to suggest amendments which would constitute less of a restriction on the free movement of goods than is proposed. The Commission also has the opportunity to propose harmonisation in the area covered by the proposal.

The fact that a technical regulation has not been notified, although it should have been notified, is a breach of an obligation under Directive 2015/1535/EU and renders such a technical regulation inapplicable and unenforceable against individuals. If an individual in a particular case invokes a breach of this obligation before a national court, the court is obliged to refuse to apply such a technical regulation.

6. Regulations not covered by Directive 2015/1535/EU

Directive 2015/1535/EU does not apply to the following:

(a) the provisions referred to in Article 7(1)

The provisions of Articles 5 and 6 shall not apply to the laws, regulations and administrative provisions of the Member States or to voluntary agreements by which Member States:

- comply with binding Union acts leading to the adoption of technical specifications or rules for services;

- fulfil obligations arising from international agreements leading to the adoption of common technical specifications or rules for services in the Union;

- benefit from the safeguard clauses contained in binding Union acts;

- apply Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council;

- are limited to compliance with the judgment of the Court of Justice of the European Union;

- shall be limited, in accordance with a request from the Commission, to amending a technical regulation referred to in Article 1(1)(f) of this Directive with a view to removing barriers to trade or, in the case of regulations for services, to the free movement of services or the freedom of establishment of service providers.

Article 7(1) lists the regulations that are exempted from the scope of Directive 2015/1535/EU. These national measures mostly pursue the objective of removing obstacles to free movement and are subject to EU supervision and therefore do not need to be notified to the Commission or delayed.

However, it is important to note that the exemption provided for in Article 7(1) does not apply to regulations which, although transposing an EU legal act (most often a Directive), also regulate matters going beyond the transposed EU legal act. In such a case, the draft regulation will be subject to the notification requirement.

For example, legislation implementing a Directive which imposes additional consumer protection requirements to those set out in the Directive will be subject to the obligations set out in Directive 2015/1535/EU. Similarly, legislation which at some point in the future will amend the provisions of the implementing legislation should be notified under Directive 2015/1535/EU as it will not be adopted in time for the Directive.

(b) radio broadcasting services (see Article 1(2)(a) of Directive 2015/1535/EU);

(c) television broadcasting services referred to in Article 1(1)(e) of Directive 2010/13/EU of the European Parliament and of the Council (see Article 1(2)(b));

(d) telecommunications services

Article 1(3):

This Directive shall not apply to rules concerning matters governed by Union law in the field of telecommunications services covered by Directive 2002/21/EC of the European Parliament and of the Council.

According to Directive 2002/21/EC of the European Parliament and of the Council, 'electronic communications service' means a service normally provided for remuneration which consists wholly or mainly in the transmission of signals over electronic communications networks, including telecommunications services and transmission services on networks used for radio broadcasting, with the exception of services providing content or exercising editorial control over content transmitted over electronic communications networks and services; the term does not include information society services as defined in Article 1 of Directive 2015/1535/EU which do not consist wholly or mainly in the transmission of signals over electronic communications networks.

This means that in the future, all proposals for regulations on telecommunications services - i.e. including those not covered by the general exemption in Article 7(1) - will not fall within the scope of Directive 2015/1535/EU. The reason for this exemption is that most telecommunications issues are already harmonised at European level.

Several pieces of Union legislation are related to telecommunications services:

- Directive 2002/77/EC on competition in the markets for electronic communications networks and services;

- Directive 2002/21/EC establishing a common regulatory framework for electronic communications networks and services (Framework Directive);

Article 1(4):

This Directive shall not apply to provisions relating to matters governed by Union financial services legislation, examples of which are set out in Annex II.

The reason for this exemption is the same as for telecommunication services - such rules are part of the already existing and sufficiently established legal framework of the Union. Annex II of Directive 2015/1535/EU contains a demonstrative list of financial services:

Examples of financial services referred to in Article 1(4)

- Securities services

- Insurance and reinsurance operations

- Banking services

- Operations related to pension funds

- Services related to futures or options transactions

These services include in particular:

(a) securities services as referred to in the Annex to Directive 2004/39/EC; services of collective investment undertakings,

(b) services related to activities listed in Annex I to Directive 2013/36/EU of the European Parliament and of the Council and subject to mutual recognition;

(c) operations covered by the insurance and reinsurance operations referred to in Directive 2009/138/EC of the European Parliament and of the Council;

(d) regulations issued by or for regulated markets or issued by or for other markets or entities conducting clearing or settlement operations on those markets.

Article 1(5):

In this case, it is a partial exception.

The reason for exempting these rules from the scope of Directive 2015/1535/EU is the need to urgently adopt instruments that deal with online services related to highly mobile and highly volatile financial markets where the situation can change suddenly and unpredictably.

The only obligation to which these rules are subject, in the interests of at least minimum transparency, is their ex post notification under Article 5(3), i.e. the transmission of the final, already approved text of the rule.

Examples:

- draft regulation on computerised trading and settlement on the stock exchange;

- draft regulation on clearing systems used for electronic transactions on the stock exchange;

- draft regulation relating to procedures for the provision and conclusion of electronic trades in securities traded on financial markets other than stock exchanges.

IV. PROCEDURE FOR NOTIFICATIONS FROM MEMBER STATES

The Czech Republic has the opportunity to comment on draft technical regulations from other Member States as well as from the European Free Trade Association countries and Turkey. These proposals are publicly available on the website Commission and are also sent to the contact points in each Member State.

ÚNMZ submits draft technical regulations to the relevant ministries and professional organisations. Only one official statement may be made for the Czech Republic on each proposal, which must be forwarded to the Commission via the contact point. The Commission will then send such a statement (comment or detailed opinion) to the Member State that has drafted the proposal.