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As part of the tasks of the PRZ, the publication "Placing Products on the Internal Market of the European Economic Area. Procedures of economic operators - Services of testing, inspection and certification organisations of the Czech Republic - EU Member State - for economic operators. Version 2023".

This publication is intended to increase the awareness of manufacturers, on the placing of products on the internal market of the European Economic Area, and other economic operators (authorised representatives, importers, distributors), based in the countries of the European Economic Area, especially those based in the Czech Republic, and is also useful for employees of authorised/notified persons, notified bodies and recognised independent organisations, providers of complete order processing services and end users of products. It can also be useful for associations of economic operators, training and educational organisations and institutions, public authorities and, finally, for other professionals.

On 13 December 2023, the Spanish Presidency managed to reach a preliminary political agreement with the European Parliament and the European Commission on the text of the new Construction Products Regulation in the framework of the 3rd political trialogue. This preliminary agreement will be further formally confirmed by both institutions.

The Regulation will replace the existing Regulation (EU) No 305/2011, establish harmonised rules for the placing on the market of construction products, strengthen the internal market and remove existing barriers to free movement on the market, and ensure that these products comply with the principles of the circular economy and Member States' regulatory requirements.

A key role of the legal framework is played by the harmonised technical specifications that must be used for the mandatory placing on the market of a product. Priority is given to the creation of standards and their harmonisation by publication of a reference in the Official Journal of the EU, but there will be a fall-back solution to allow the EC to adopt harmonised technical specifications through implementing acts in the event of a blocked standardisation system.

The new rules will promote sustainability and digitalisation in the field of construction products. The documents that the manufacturer must supply with the product will be able to be provided electronically. The digital product passport will also allow structured product data to be used, for example, in market surveillance or BIM design. The customer will be able to take sustainability into account when selecting a product, as the manufacturer will declare the environmental footprint of the product. The EC will be empowered to set minimum requirements for the environmental performance of construction products, which will be used by the contracting authority if it decides to apply sustainability requirements to the harmonised products in question in public procurement. This instrument will promote the sustainability of construction in the public sector.

The transition period from the old to the new legal framework will last for 15 years from the date of entry into force of the new Regulation (i.e. until 2039). This will ensure sufficient time for an orderly transition of harmonised technical specifications from the old to the new legal framework and minimise the risk of de-harmonisation of any product or product group.

Link to the press release in English here:

https://www.consilium.europa.eu/en/press/press-releases/2023/12/13/circular-construction-products-council-and-parliament-strike-provisional-deal/

Smoke and heat extraction devices (SHSD) are an important and frequently used product for ensuring fire safety in buildings. These devices create and maintain a smoke-free layer above the floor in the event of a fire by means of smoke extraction, directing the movement of smoke and heat generated by the fire and ensuring its removal from the building. ZOCTs also help to remove hot and toxic gases released during the initial stages of a fire. When ZOKTs are used, the ventilation creates smoke-free spaces below and the smoke layer in the updraft is spread out. These devices have an indispensable role in facilitating the evacuation of people from buildings and other objects, in the intervention of firefighting units, in reducing fire damage and financial losses, in preventing smoke from spreading to other parts of the building, in facilitating firefighting by improving visibility, in reducing roof temperatures and in slowing the spread of fire.

The individual components of these systems are regulated by Regulation (EU) 305/2011 of the European Parliament and of the Council in a similar way to electrical fire alarm systems (EFS) and fixed fire extinguishing systems (FES). The marketing of complete ZOKT systems is carried out in accordance with Government Regulation No.163/2002 Coll., as amended. In Annex 2 of the National Standard 163/2002 Coll., these products are listed in Table 10 TECHNICAL EQUIPMENT OF BUILDINGS, under serial number 3: Stable fire systems (products for fire alarm/detection, stable fire fighting, fire and smoke control and explosion suppression). The conformity assessment procedure is in accordance with Article 5a of the General Regulation No 163/2002 Coll., with the mandatory participation of a third independent party, the so-called authorised person. Their list is given in the Information Portal for Construction Products under hereby by reference (line 10/3). To ensure the correct functioning of the ZOKT, it is necessary to assess the requirements for the entire system. The methodology for the assessment of ZOKT is available on the website of the Coordination Centre for Construction Products under hereby link, list of components under hereby by reference.

Invitation to the seminar - 22.2.2024

 

 

On 29 June 2023, Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive (EU) 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC was published in the Official Journal of the European Union.

This Regulation will create a legal framework for the placing on the market and putting into service of machinery. It will be directly binding on Member States and all economic operators, including manufacturers, importers and distributors in EU Member States. It will be implemented in the Czech legal system by adapting Act No. 90/2016 Coll., on the assessment of conformity of specified products when they are placed on the market, as amended. At the same time, the existing Government Regulation No. 176/2008 Coll., on technical requirements for machinery, as amended, will be repealed.

Specifically, the obligations of manufacturers of machinery and related products are regulated in particular by Article 10 and those of manufacturers of incomplete machinery by Article 11 of this Regulation.

Annex III with essential health and safety requirements takes into account the risks associated with digitalisation and new technologies.

The Regulation will allow manufacturers to provide instructions for use of machinery in digital form. However, the user will be able to request a printed manual from the manufacturer free of charge at the time of purchase. For machinery for non-professional users, the manufacturer will provide safety information in written form.

The Machinery Regulation will be directly applicable from 19 January 2027. EC type-examination certificates and approval decisions issued in accordance with the current Directive 2006/42/EC for machinery will remain valid until their expiry date.

Articles 26 to 42 of the Regulation, which concern the notification of conformity assessment bodies, apply already 6 months after the date of entry into force of the Regulation.

Main changes to the EP and Council Regulation (EU) 2023/1230 compared to the existing Directive 2006/42/EC:

  1. Alignment with the new legislative framework:
    • Definition,
    • obligations of economic operators,
    • reporting.
  2. Scope:
    • exclusion of vehicles covered by specific EU rules.
  3. Introduces a new term - related products:
    • include interchangeable attachments; safety components; lifting accessories; chains, ropes and belts; removable mechanical transmission devices.
  4. Definition of safety component:
    • a physical or digital component, including software.
  5. Significant change in machinery:
    • the definition and duties of the person who carries it out.
  6. Digitalization and new technologies:
    • Risk assessment of autonomous machines and machines with self-developing behaviour using machine learning approaches (with artificial intelligence),
    • cyber safety - in a remote-controlled machine, a communication failure or faulty connection must not lead to a dangerous situation,
    • adaptation of basic requirements to the operator/user (psychological load, machine information about planned events,
    • surveillance functions for autonomous mobile machines,
    • reliable and safe control systems for machinery with embedded systems with fully or partially self-learning behaviour using machine learning approaches.
  7. Power of the European Commission to issue common specifications.
  8. "high risk" machinery - categorisation into 2 parts:
    • Part A - 6 categories (mandatory participation of notified body in conformity assessment),
    • Part B - 19 categories,
    • clearly defined conditions for the review of these categories of machinery.

 

The European Commission would like to hear views on the proposal for a Regulation of the European Parliament and of the Council on the safety of toys, which it adopted on 28 July 2023. Feedback on the proposal can be given for a period of 8 weeks. All feedback received will be summarised by the European Commission and submitted to the European Parliament and the Council to contribute to the legislative debate on the proposal. The feedback received will be published on the European Commission's website below. The eight-week feedback period will be extended each day until the adopted proposal is available in all EU languages. Website: Protecting children from unsafe toys and strengthening the Single Market - revision of the Toy Safety Directive (europa.eu)

On 28 July 2023, the European Commission adopted and published a proposal for a Regulation of the European Parliament and of the Council on toy safety to replace Directive 2009/48/EC of the European Parliament and of the Council on toy safety. The proposal revises the current rules to protect children from potential risks in toys. Toys placed on the EU market are already among the safest in the world. The proposed rules will further improve this protection, in particular from harmful chemicals. They also aim to reduce the high number of unsafe toys still sold in the EU, especially online, and thus increase the level playing field between EU-made and imported toys. At the same time, they will continue to ensure the free movement of toys within the single market. Building on existing rules, the proposal updates the safety requirements that toys must meet to be placed on the EU market, whether they are made in the EU or elsewhere. More specifically, the proposal will ensure: Increased protection against harmful chemicals: The proposal not only maintains the current ban on substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), but also bans the use of other harmful chemicals in toys. The proposal focuses on chemicals that are particularly harmful to children. For example, it will ban the use in toys of chemicals that affect the endocrine system (endocrine disruptors) and chemicals that affect the respiratory system or are toxic to a specific organ. Strengthening enforcement: The proposal ensures that only safe toys are sold in the EU. All toys will have to have a digital product passport which will contain information on compliance with the proposed Regulation. Importers will have to submit digital product passports for all toys at EU borders, including toys sold online. The new IT system will check all digital product passports at external borders and identify consignments that need detailed checks at customs. National inspectors will continue to be responsible for carrying out checks on toys. In addition, where there are dangerous toys presenting risks not clearly foreseen by the Regulation, the proposal ensures that the Commission has the power to require that these toys be withdrawn from the market. Website: Commission steps up protection of children from unsafe toys (europa.eu)

NANDO database - change in connection with the integration into the Single Market Compliance Space (SMCS) portal The Department of State Testing of the Institute of State Testing informs the professional public that the existing electronic databases have been merged at the level of the European Commission NANDO (New Approach Notified and Designated Organisations) a Noise (noise emission system according to Directive 2000/14/EC). A new portal called Single Market Compliance Space (SMCS). This common virtual space serves to ensure the flow of information between market surveillance authorities, notifying authorities, accreditation bodies, notified bodies and designated bodies. In the future, the involvement of third country manufacturers and importers is also envisaged. The link to the European Commission website is here: https://webgate.ec.europa.eu/single-market-compliance-space/secure/welcome . The Department of State Testing of the Office of the Ministry of Industry and Trade will continue to provide the activities of the notifying authority for EU sectoral legislation, now through SMCS Input instead of the existing NANDO Input. The roll-out of the new system entails an increased frequency of problems with individual notifications/notifications.

On 29 June 2023, Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC was published in the Official Journal of the European Union. This Regulation will create a legal framework for the placing on the market and putting into service of machinery. It will be directly binding on Member States and on all natural and legal persons in EU Member States. The Machinery Regulation covers, among other things, the risks associated with digitisation and new technologies. This is reflected in the essential health and safety requirements for machinery. The Regulation allows manufacturers to provide instructions for the use of machinery in digital form. However, the user can request a printed manual from the manufacturer free of charge at the time of purchase. Safety information for non-professional users will be supplied with the machinery in written form. The Machinery Regulation will enter into force on the 20th day after its publication in the Official Journal of the European Union. 42 months after that, it will be directly applicable in all EU Member States. Articles 26 to 42 of the Regulation, which concern the notification of conformity assessment bodies, will apply only 6 months after the date of entry into force of the Regulation. EC type-examination certificates and approval decisions issued in accordance with Directive 2006/42/EC remain valid until their expiry date. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1230&qid=1688045683751 On 4 July 2023, a corrigendum to the Regulation was published in the OJEU: https://eur-lex.europa.eu/legal-content/EN/TXT/?toc=OJ:L:2023:169:TOC&uri=uriserv:OJ.L_.2023.169.01.0035.01.ENG  

The European Commission has announced that it is accepting applications for the 2023 edition of the EU Product Safety Award. The EU Product Safety Award celebrates innovative business initiatives and research that improve consumer safety. This year, it focuses on business initiatives that go beyond the requirements set out in EU legislation and supporting standards, and aims to improve the safety of teenagers (e.g. by improving the safety of products/e-shops commonly used by young people, or by awareness-raising initiatives focusing on the safety risks faced by this age group). For the first time, the initiative will also recognise researchers working on consumer product safety. Companies and researchers have 3 months to apply in order to receive recognition for their work. Interested parties can apply here: Safety Gate: the EU rapid alert system for dangerous non-food products (europa.eu) .

The MDCG 2022-18 explains the conditions under which Article 97 of the MDR can be applied, allowing manufacturers to continue to supply products to the market that have expired certificates issued under the MDD or AIMDD and are not yet certified under the new legislation. In this context, the existing legislation will also be modified to reflect this de facto extension of the "legacy devices" regime. This is a transitional solution to facilitate the transition to MDRs and IVDRs for economic operators and to avoid a shortage of medical devices on the market, in line with the recommendations set out in MDCG 2022-14.

Two Commission Implementing Regulations (EU) were published on 2 December 2022

Both Regulations enter into force on the twentieth day after their promulgation (22 December 2022). However, Regulation No 2022/2346 shall apply from 22 June 2023, except for the provisions of Article 2(3), which shall apply from 22 December 2022. This is a transitional provision for products with a valid certificate under Directive 93/42/EEC covered by this Regulation.

Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the product groups without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

 

Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down detailed rules for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the reclassification of groups of certain active products without an identified medical purpose

On 5 December 2022, the European Commission issued the Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93

Article 40 of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 provides that "By 1 January 2013 and every five years thereafter, the Commission shall, in cooperation with the Member States, draw up and submit to the European Parliament and the Council a report on the implementation of this Regulation". In this respect, the Commission has adopted and published a report, see the following link: EUR-Lex - 52022DC0679 - EN - EUR-Lex (europa.eu).

The report provides an overview of how the provisions of Regulation (EC) No 765/2008 relating to accreditation and CE marking have been implemented between 2018 and 2022. The report confirms that the European accreditation infrastructure created by Regulation (EC) No 765/2008 has demonstrated its added value. The report also confirms that accreditation faces the challenge of strengthening its robustness and reliability and keeping it in line with the state of the art.

The report does not propose any changes to the European legal framework. This report is not an assessment of the current relevance and coherence of the framework for accreditation and CE marking. These aspects are assessed in the framework of the "Evaluation of the new legislative framework (NLF)" carried out by the Commission in 2022 ( see Industrial products - evaluation of the new legislative framework (europa.eu).

Consultation on the European semiconductor supply chain

(European semiconductor value chain consultation)

The European Commission and Member States have launched a consultation on the semiconductor supply chain consisting of two surveys, one for suppliers and one for end-users of semiconductors. The Commission will analyse the results of the consultation and, in cooperation with European Semiconductor Expert Group (ESEG) propose a monitoring mechanism that will include the identification of appropriate early warning indicators of future supply chain failures, thereby preventing semiconductor supply crises.

On 8 February 2022, the Commission published Recommendationsto enable rapid and coordinated monitoring of the European semiconductor supply chain, focusing on risks that may disrupt, threaten or adversely affect supply. On the basis of this recommendation, a permanent mechanism for monitoring the semiconductor supply chain should be prepared, as proposed under the Chip Regulation (draft regulation).

The survey on the European Commission's website is open to manufacturers (here.), as well as end users (here.).

CEN and CENELEC webinar: informative annex ZA/ZZ for the Machinery Directive

This webinar will provide participants with practical information on the preparation of CEN and CENELEC harmonised standards, which will be published by reference in the Official Journal of the European Union (OJEU) under the Machinery Directive. It will cover:

The webinar takes place Thursday 6 October 2022 online from 14:00 to 16:30, registration is compulsory. Organised by CEN and CENELEC.

You can register at the following link:

Webinar Registration - Zoom

Please note that the Government of the United Kingdom of Great Britain and Northern Ireland published updated information on its website on 29 June 2022 regarding the importation of products into the UK market. More information can be found on this website:

Guidance on using the UKCA marking
Guidance on using the UKNI marking
Guidance on placing goods on the market in Great Britain
Guidance on placing goods on the market in Northern Ireland
A-Z of industry guidance to understand requirements for product types
UKMCAB database of UK conformity assessment bodies (approved bodies)
Guidance on placing construction products on the market in Great Britain
Guidance for regulating medical devices in the UK
Guidance on placing Civil Explosives on the market
Guidance on restrictions of Hazardous Substances in Electrical and Electronic Equipment (RoHS in EEE) Regulations
Guidance for rail interoperability
Guidance for the manufacturing and marketing of fertilisers
Guidance for designated standards for cableway installations

Časová osa pro zavádění UKCA

Timeline for the introduction of UKCA labelling for products outside specific sectors - taken from the presentation (here.) of the UK government's Department for Business, Energy & Industrial Strategies

We would like to draw your attention to two activities in connection with the proposed revision of the Construction Products Regulation (CPR):

Seminar - new CPR: questions and answers:  CPR Q and Agenda

Invitation and registration: Draft invitation to CPR