This morning, the Competitiveness Council adopted a new regulation on machinery, which was discussed during CZ PRES. The OHIM team that led the negotiations has reached a preliminary political agreement with the European Parliament and the European Commission in December 2022. The Regulation replaces the existing Machinery Directive 2006/42/EC and creates a framework for the placing of safe machinery and related products on the EU market and will thus be directly binding not only on Member States but will also apply to all natural and legal persons in the Member States.
The new Regulation covers, among other things, the risks associated with digitalisation and new technologies by modifying the basic health and safety requirements and introducing mandatory third-party risk assessments for six categories of so-called "high-risk" groups of machinery. Safety information will have to be provided with each product. The Regulation also brings advantages for manufacturers in the context of digitisation, who will only be able to provide instructions for use of machinery in digital form. However, customers will be able to request free paper instructions until a certain time after the purchase of the machinery.
After the signature of the President of the European Parliament and the President of the Council, the Regulation will be published in the Official Journal of the European Union, enter into force on the 20th day after its publication and be directly applicable in all Member States for 42 months thereafter.
The official press release can be found at the following link: New rules for machinery: Council gives its final approval - Consilium (europa.eu)
On 11/11/2022, the European Commission published on the "Have your say" portal the results of the ongoing evaluation of the New Legislative Framework (NLF), which is made up of Decision 768/2008/EC and Regulation 765/2008/EC. The results of a public consultation, an online targeted survey, a stakeholder consultation organised by the European Commission and an external study were used in the evaluation.
The NLF aims to strengthen the internal market and improve the quality of conformity assessment of products placed on the market. Given the changes that have taken place since the adoption of those rules, in particular in the context of digitisation, the circular economy and the integration of environmental aspects into product legislation, it was necessary to assess whether the NLF remains fit for purpose and ensures that products placed on the Union market are safe and comply with the applicable legislation. The implementation of the NLF was evaluated with regard to its four specific objectives, which are to strengthen the New Approach, to promote coherence and consistency of EU harmonisation legislation, to strengthen the conformity assessment system, and to enhance the clarity and credibility of the CE marking.
A detailed evaluation report and summary is available under the link below.
Industrial products - evaluation of the new legislative framework (europa.eu)
On 31 October 2022, on the occasion of a joint meeting of the Governments of the Czech Republic and Ukraine, the "Memorandum of Understanding and Cooperation in the field of Standardization, Metrology and Conformity Assessment between the Office for Technical Standardization, Metrology and State Testing and the Ministry of Economy of Ukraine" and the related Action Plan for the period 2022-2024 were signed in Kiev. The Memorandum provides a framework for deepening mutual cooperation in the above-mentioned areas in order to contribute to the removal of barriers to mutual trade and strengthen economic relations between the two countries. The Action Plan then specifies specific areas of cooperation over the next two years according to the current needs and interests of both sides.
The text of both signed documents in Czech, Ukrainian and English is available here.
On 12 October 2022, CZPRES reached a preliminary agreement in a political trialogue on the revised text of Regulation (EU) No 1025/2012 on European standardisation under the responsibility of the Office for the Protection of the European Standardisation System, which participated in the discussion of the draft. The aim of this draft Regulation is to ensure that, in the case of standards requested by the EC, voting rights within the relevant European standardisation organisation can be exercised only and exclusively by representatives of the national standardisation organisations of the MS, EEA and candidate countries.
For more information, see the EU Council press release: https://www.consilium.europa.eu/cs/press/press-releases/2022/10/12/council-and-european-parliament-agree-on-adapting-eu-standardisation-rules/
In mid-September 2022, the European Commission published Decision to set up a High Level Forum on European Standardisation announced in EU strategy for European standardisation issued by the European Commission in February 2022.
The High-Level Forum on European Standardisation (hereinafter referred to as the Forum) will be composed of 60 experts from EU and EEA Member States, European standardisation organisations and national standardisation bodies, industry and civil society, including consumer organisations and environmental and social stakeholders, and academia. The Forum's role will be to advise the European Commission on all matters related to standardisation, to coordinate the effective representation of European interests in (international) standardisation fora and to identify and implement standardisation priorities. Members of the Forum, excluding Member State authorities and other public bodies, will be selected through a public call for applications, which will be published in the coming weeks in the Register of Expert Groups of the European Commission. The Forum will be chaired by a representative of the European Commission's Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
On 30 March 2022, the European Commission presented a package on the circular economy (https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2013) draft regulation on the marketing of construction products.
The draft Regulation is a comprehensive amendment of the existing Regulation (EU) No 305/2011 and aims in particular to address the identified shortcomings of the currently applicable Regulation and to take into account the objectives of the Green Deal for Europe specified in the Circular Economy Action Plan or the Communication on the Renovation Wave.
The main elements of the proposal include clarification of the scope of the regulated area (including the inclusion of reused and 3D printed building products and prefabricated houses), the introduction of environmental, functional and safety requirements for building products; the definition of the so-called "safety requirements". The introduction of a harmonised zone (an area within which EU Member States will not be able to apply their own national requirements, while introducing a specific mechanism to take account of specific national requirements within the harmonised technical specifications); setting sustainability requirements for construction products, reducing the administrative burden for SMEs and micro-enterprises, strengthening the enforcement powers of supervisory authorities and expanding the role of the Contact Points for Construction Products.
The text of the Regulation, including annexes and related documents, is available at the links below:
Until 12 July 2022, you can join the general debate on the draft Regulation and express your views via the European Commission's public portal "Have your say" at Construction products - review of EU rules (europa.eu).
On 21 June 2022, the Chairman of the "Office for Technical Standardization, Metrology and State Testing" and the Director of the Ukrainian Standardization Organization "Ukrainian Scientific Research and Training Center for Standardization, Certification and Quality problems" signed a Memorandum of Understanding in the field of standardization. The Memorandum provides a framework for cooperation in specific areas of standardization according to the needs and interests of both sides through consultations, exchange of information and experience, organization of joint meetings for stakeholders and expert study visits.
The text of the Memorandum is available here.
On 2 February 2022, the EC published its Standardisation Strategy, which followed on from the Revised Industrial Strategy of May 2021. The Strategy was accompanied by the publication of a draft amendment to Regulation (EU) No 1025/2012 on European Standardisation and the regular Report on the implementation of this Regulation.
On 26 May 2021, in connection with the entry into force of the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, as amended ("MDR"), the European Commission announced the termination of the chapter on medical devices Mutual recognition agreements between the European Union and Switzerland (Mutual Recognition Agreement, (MRA)).
Swiss manufacturers are treated like any other third country manufacturer intending to place devices on the EU market. Existing certificates issued under the MRA by notified bodies in Switzerland are no longer recognised as valid as of 26 May 2021 and economic operators (affected EU manufacturers, authorised representatives, importers and distributors) as well as EU market surveillance authorities and customs authorities in the Member States are obliged to act in accordance with the MDR.