Twinning Project SR 13 IB EC 01

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Twinning Project SR 13 IB EC 01 Strengthening Capacities of National Quality Infrastructure (NQI) and Conformity Assessment (CA) Services in the Republic of Serbia Activity 2.1 Trainings and consultancy for raising capacities of MoE for full enforcement of the Regulation 764/2008/EC and implementation of principles of Directive 1535/2015/EC

Seminar on raising awareness of notification of technical regulations Belgrade, 12 April 2017 Participation of economic operators in notification of technical regulations and functioning of PCP in the Czech Republic Viktor Vodička, UNMZ

Scope Free movement of goods in the non-harmonised area How does it work? Participation of economic operators in the notification procedure Functioning of the PCP in the Czech Republic Useful links

Free movement of goods in the non-harmonised area 1. Many sectors are subject to common EU rules across the EU Member States. 2. They provide a clear and predictable legal framework, both for citizens and businesses. 3. If manufacturers follow these rules, their products can be sold freely in the market.

Free movement of goods in the non-harmonised area 4. In the majority of sectors (e.g. electronic and electric equipment, machinery, lifts, medical devices etc.), EU legislation is limited to essential health, safety, and environmental protection requirements. 5. Non-harmonised sectors are not subject to common EU rules and may come under the national rules; however Member States must ensure they do not create undue barriers to trade.

Free movement of goods in the non-harmonised area Mutual recognition principle is essential for products which are not harmonised or which are harmonised only partly. At the EU level, it guarantees that the products lawfully produced or marketed in one EU country can be sold in another, and this is possible even if the product does not fully comply with the technical rules of the other EU country.

Free movement of goods in the non-harmonised area A non-exhaustive list of products which are not subject to the EU s harmonisation legislation can be checked https://ec.europa.eu/growth/single-market/goods/free-movementsectors/mutual-recognition/products-list_en Mutual recognition principle applies not only to the EU Member States, but also to the EEA Countries (Norway, Iceland, Liechtenstein), Switzerland and Turkey

How does it work? It works trough: application of Arts. 34-36 TFEU + case law notification procedure ( 1535/2015 Directive ) application of mutual recognition principle ( Regulation 764/2008 )

How does it work? The Arts. 34-36 TFEU state: that quantitative restrictions on imports and exports, and all measures having equivalent effect, shall be prohibited between Member States, and that prohibitions or restrictions to the free movement of goods, whether they are justified or not, shall be subject of the Court (ECJ) decision, not of a Member State (e.g. market surveillance authority) decision

How does it work? The Directive 1535/2015 allows : to examine technical regulations for (both industrial and agricultural) products and for online services (including e-commerce) that other EU countries intend to introduce, and to prevent the creation of new barriers to trade which are forbidden in the EU and likely to affect your activities as the manufacturers / distributors of goods

How does it work? The Regulation 764/2008 defines: the rights and obligations for public authorities and enterprises that wish to market their products in another EU country, and the possibilities how the country can deny mutual recognition of a non-harmonised product

Participation of economic operators in the notification procedure The notification procedure covers: all industrially manufactured products, as well as agricultural and fishery products information society services (i.e. services normally provided for remuneration supplied at a distance by electronic means and at the individual request of a recipient of the services)

Participation of economic operators in the notification procedure It applies to all drafts of technical regulations including: technical specifications and other requirements rules on services regulations 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

Participation of economic operators in the notification procedure You shall understand: competent authorities must inform the Commission and other Member States of any draft technical regulation before its adoption there is a standstill period of at least 3 months, during which the measure cannot be put in place and you can examine the proposed texts and respond (comment)

Participation of economic operators in the notification procedure Initial standstill Comments Products Information Society Services Voluntary Agreements 3 months (from the date the EC gets all relevant documents) No further standstill Detailed opinion 6 months (3+3) 4 months (3+1) 4 months (3+1) Intention to propose an EU Directive Existing proposal for an EU Directive 12-18 months (3+9/15) 12-18 months (3+9/15) n.a. 12-18 months (3+9/15) n.a. n.a.

Participation of economic operators in the notification procedure Anyone, who was informed of a project or activity which could cause problems or create barriers to his/her professional activities, can make his/her opinion to the EC. Anyone can subscribe to the mailing list and receive alerts when new notifications are published. Anyone can search the TRIS database. Anyone can make use of interactive statistics and read the reports published.

Participation of economic operators in the notification procedure 1. Notification form has to be prepared specifying the content of a measure and reasons for its introduction. 2. Notification form, the draft and supporting documents (i.e. Regulatory Impact Assessment) has to be passed to the Member State designated body which must pass it to the EC at a stage when substantial amendments of the draft can still be made.

Participation of economic operators in the notification procedure 3. The Commission sets the standstill period (3 months) as from the day of a complete notification and circulates the measure to other Member States trough the Technical Regulations Information System (the TRIS database). 4. The EC and other countries have the opportunity to examine the draft text and come with their respond appropriately.

Participation of economic operators in the notification procedure 5. The comments (the draft appears to comply with EU law but requires further clarification) shall be taken into account as far as possible. 6. The detailed opinion (the draft may create barriers to the EU trade or EU secondary legislation) has the effect of extending the standstill period by additional time; during which the measure concerned cannot be adopted.

Participation of economic operators in the notification procedure 7. The EC can also block the draft for a more long period of time if the EU harmonisation work is to be undertaken or is already underway in the field. 8. At the end, the Member State concerned is bound to inform the EC of the final text of the measure as soon as the draft has been adopted or to indicate that the notified draft has been abandoned.

Participation of economic operators in the notification procedure 9. And also, the notifying State is obliged to re-notify the draft measure, with the application of a new standstill period, if the draft technical regulation undergoes any substantial changes. The notification procedure is a tool for information, prevention and dialogue and it helps you to anticipate and prevent the creation of barriers to trade.

Participation of economic operators in the notification procedure http://ec.europa.eu/growth/tools-databases/tris/en/ Note: In TRIS database various search criteria such as notification number, country, date, product, key words etc. are available and can be searched by the individual businesses operators and SMEs.

Participation of economic operators in the notification procedure Notifications per selected countries 250 230 230 221 200 150 100 50 129 121 83 34 20 20 19 0

Participation of economic operators in the notification procedure Notifications per product sectors 600 511 477 400 200 0 225 182 179 158 152 149 135 127 117 109 27

Participation of economic operators in the notification procedure Benefits of the procedure: barriers to the internal market and protectionist measures are detected MSs can ascertain the degree of compatibility of their drafts with the EU law economic operators can make their voices heard and to adapt their activities in advance ( right of scrutiny )

Participation of economic operators in the notification procedure All those who are preparing and drafting national rules and regulations must be aware that: the rules and regulations cannot be enforced by the public authorities against individuals, when the given standstill period has not been respected, and also that, the courts cannot enforce against individuals such rules or provisions, which have been adopted in breach of the obligation to duly notify them before the adoption

Participation of economic operators in the notification procedure

Functioning of the PCP in the Czech Republic the Product Contact Point in the Czech Republic - PROCOP is established within the Ministry of Industry and Trade the team provides also other services to business operators (i.e. SOLVIT, Points of Single Contact etc.)

Functioning of the PCP in the Czech Republic the team helps to companies with remedies it is a network of experts which exists at each relevant authority and the PCP works in close cooperation with them on specific sectors (e.g. on construction products)

Functioning of the PCP in the Czech Republic The PCP provides according to the Regulation 764/2008 the economic operators with information: which technical rules are applicable to a specific type of product in the other Member State, as to whether that type of product is e.g. subject to a requirement for prior authorization etc. under the laws and regulations of this Member State

Functioning of the PCP in the Czech Republic The PCP provides according to the Regulation 764/2008 the economic operators with information: what are the contact details of the competent authorities of the other Member State, including the authorities responsible for supervising the implementation of the technical rules in question

Functioning of the PCP in the Czech Republic The PCP provides according to the Regulation 764/2008 the economic operators with information: which remedies are available to the economic operators in case of a dispute with the competent authorities

The PCP: Functioning of the PCP in the Czech Republic responds free of charge and within 15 working days of receiving the information requests, and also provides personalised advice to users

Useful links 764/2008 Regulation: http://eur-lex.europa.eu/legal-content/en/txt/?uri=celex:32008r0764 Commission interpretative communication on facilitating the access of products to the markets of other Member States - the practical application of mutual recognition: http://eur-lex.europa.eu/legalcontent/en/txt/?uri=uriserv:oj.c_.2003.265.01.0002.01.eng&toc=oj:c:2003:265:toc

Useful links Guide to the application of the Treaty provisions governing the free movement of goods: http://bookshop.europa.eu/en/free-movement-of-goods-pbnb3109160/ Arts. 34-36 TFEU: http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=celex:12012e/txt:en:pdf#page=15 Case Law relevant to the Directive 1535/2015: http://ec.europa.eu/growth/tools-databases/tris/en/about-the-20151535/case-law/

Thank you for your attention..