Presented at the conference on market surveillance organised by the German presidency on 4 and 5 November, the new Regulation (EU) 2019/1020 will introduce significant changes from January 2021 concerning market surveillance and regulatory compliance in the European common market and cooperation between national market authorities.
Some elements of the new Regulation, published in June 2019, will come into force from 1 January 2021, while full implementation of its market surveillance provisions is scheduled for July 2021 when it will replace the market surveillance provisions in articles 15 to 29 of Regulation (EC) No 765/2008. Covering 70 regulations and directives, including REACH, the CPR, the Machinery directive and Ecodesign, the regulation also targets product-specific legislation for medical devices, Personal Protection Equipment (PPE), toys, footwear, lifts, and more.
Inspections by market surveillance authorities have revealed relatively high rates for non-compliance in several key sectors, including toys (32%), construction products (47%), low voltage electrical equipment (34%), electromagnetic and radio equipment (58%), PPE (40%), medical devices (42%), cosmetics (38%) and machinery (28%). Of the cases investigated for non-compliance, 6% were for products posing serious risks, 16% for high risks, 22% for medium risks and 32% for low risks. The remaining 24% of investigations found that products were in fact compliant. It should be noted that non-compliance is not just a matter of inadequate documentation: substantive or technical non-compliance accounted for 46% of toys tested, 77% of LED lighting equipment, 44% and 67% for solar panel inverters in consecutive years, 68% of repeaters for mobile phones and 51% of drones (more information).
In light of this, the new regulation makes a series of adjustments aiming at improving conformity, notably by clarifying the roles of economic operators it defines. To the three actors previously identified (manufacturer, importers and authorised representative) article 4 of the new regulation adds a fourth category: the “fulfilment service provider”. This new operator is specifically for e-commerce sellers who supply their consumers directly via a digital platform without a physical presence in the EU. Overall, with the entry into force of the regulation, no product may be put on the European market any longer without one of the four economic operators identified in article 4 being established within the EU and taking legal responsibility for the goods in question.
From a regulatory compliance point of view, these operators will also be responsible for verifying that the EU Declaration of Conformity (DOC) or Declaration of Performance (DOP) is drawn up and kept at the disposal of market surveillance authorities (article 4.3(a)). They will be responsible for informing market surveillance authorities if they believe a product presents a risk (article 4.3(c)) and they can be asked to take immediate corrective action to remedy a case of non-compliance (article 4.3(d)). Last but not least, article 4 also requires that the economic operator’s name, registered trade name or registered trade mark, and contact details including the postal address are indicated on the product, its packaging or accompanying documentation (article 4.4).
From the perspective of SBS, the entry into force of the new Regulation 2019/1020 is a welcome step towards establishing a level playing field for SMEs across all sectors. Non-compliance issues harm SMEs, which often have to deal with anti-competitive behaviour in some markets. Furthermore, non-compliant products distort the market and drive prices artificially low as they do not meet legal requirements under EU regulations which guarantee consumers’ safety.
Likewise, standards are part of the solution for non-compliant products, particularly when they are cited in the Official Journal of the European Union (so-called harmonised standards, hENs), by providing presumption of conformity, facilitating market surveillance activities. They also help to ensure that the methods used by different Notified Bodies to test product conformity are similar or equivalent. Standards also provide the support needed when declaring the relevant essential characteristics and requirements in the DOC or DOP.
All these reasons will motivate SBS involvement as SME representatives in the soon to be created “Union Product Compliance Network”, as provided for in the regulation. It will strive to promote the adoption of common European benchmarks for market surveillance activities, supporting the role of standards as tools for compliance. Indeed, effective market surveillance complemented by a well-performing standardisation system are both key components for consumer safety in an innovative common market.
ETSI General Assembly: SBS candidates elected to Vice-Chair and Board positions
On 2 December, SBS expert Massimo Vanetti was elected vice chair of the ETSI General Assembly, while DIGITAL SME secretary-general and SBS member Sebastiano Toffaletti was re-elected as a member of the board. These election results confirm the excellent work accomplished in recent years in strengthening the voice of SMEs at ETSI.
Commenting on the elections, Mr Toffaletti said that standards are a powerful tool to facilitate SMEs’ digital transformation and innovativeness. Mr Vanetti’s election is formal recognition of his far-reaching engagement to promote the interests of small businesses in standardisation, as demonstrated earlier this year by the success achieved in convincing India to adopt oneM2M as a national standard.
ETSI counts over 900 member organisations including all the major global tech companies, and its appointment of SBS representatives highlights the growing recognition of SMEs as the motor behind innovation in the digital economy in Europe.
The first national seminar for SBS was hosted this year by Företagarna, the Swedish business owners’ federation. It was held online on 1 December, with support from SIS, the Swedish Institute for Standards, and SEK Svensk Elstandard which is responsible for electrical standardisation in Sweden. The objective of the seminar was to inform local SMEs about standards and foster an exchange of views between SMEs and the representatives of the Swedish standardisation system.
Speakers included SBS President Gunilla Almgren and business representatives from sectors such as furniture, electrical equipment and medical technology who shared first-hand experiences with standards.
Participants raised concerns about the difficulty of finding the appropriate standard to apply to a product or service and the lack of information about the authorities responsible for verifying their implementation. One of the main outcomes of the discussion was thus the importance of strengthening cooperation between the different SME and standardisation actors to raise SME awareness.
Recording of the webinar (in Swedish)
On 26 November, DIGITAL SME hosted a live event with speakers from the European Commission, the telecommunications industry, ETSI, and SMEs to discuss and explore the benefits of using standards to enhance accessibility and SMEs’ competitiveness in industrial IoT. With more than 50bn connected devices by 2025, the potential for SMEs to provide innovative solutions is huge. Standards play an important role in helping SMEs access new markets, enhance their competitiveness through interoperability, and provide better security without reinventing the wheel. The recent decision by the Indian government to adopt oneM2M as a national standard is a prime example of such opportunities.
SBS expert Marco Cogliati presented the case of using IoT in the lift sector and the positive impact which IoT provides in terms of efficient lift management, reduced costs and accurate exchange of data between the different actors, thanks to the interoperability made feasible by standards.
The main conclusions of the event concentrated on the benefits for SMEs of both IoT and standardisation. For SMEs to reap all the benefits of IoT they need to rethink and review their business processes and become digital by design. The various initiatives of the European Commission in IoT and standardisation can help SMEs to take advantage of IoT as part of a broader data-based ecosystem. SMEs can save time and effort by using standards; standards can also help them reach a clear vision for the future. The involvement of SMEs in the standardisation process through active membership and presence on technical committees can influence the way standards are written to incorporate SMEs’ views and concerns.
The Circular Economy study group – a sub-group of the EU Multi-Stakeholder Platform on ICT Standardisation – has submitted its final report on ICT standardisation supporting circular economy to the European Commission. In the report, to be published soon, SBS asserted that SMEs are the driving force beyond the European Commission’s Twin Transition.
Since 99% of companies in Europe are SMEs, the European Commission’s vision for the twin transition needs to be translated into the ability for SMEs to embrace climate neutrality and digitalisation – the two pillars for the transformation of Europe into a globally competitive, climate-neutral digitalised economy and society. This depends on three interconnected dimensions: (1) sustainable B2B digitalisation, (2) green(er) technologies and circular economy – right to repair, access to data and competition rules capable of ensuring an open after-sales market, and (3) a policy and regulatory framework that enable innovation. European digital enterprises, especially SMEs, can play a decisive role in digitalising the economy, as long as there is a level-playing field and Europe invests in them. At the same time, it is important for the digital transformation to take place in a sustainable manner and for it to support the environmental goals of the Green Deal and the Circular Economy Action Plan.
Moreover, European standardisation organisations (ESOs) can drive forward this twin transition by supporting SMEs with standardisation. Their privileged role and involvement with industry puts ESOs in a good position to offer more support to European SMEs that embrace digital transformation and circularity through standardisation. SMEs in many sectors struggle to find reliable sources of information and knowledge, or use cases for the adoption of new technologies. ESOs are in a position to serve strategic EU interests by investing more in guidance and practical instruction, and providing a long-term vision for European companies on the digital transformation and circular economy.
The EU Commission has rightly recognised the PPE and textile care sector as one of the main sectors for the potential of the circular economy. Given the potential for the reuse of textiles in both the B2B and B2C sector, SBS would like to stress that it is not just the value chains in production and the consumption of raw materials that are important for the sustainability of certain products but that the usage cycle is of utmost importance. For textiles, this is where the greatest potential for sustainability lies. In addition, the current COVID-19 crisis put pressure on policy makers to balance sustainability goals against the availability of masks, which influenced their decision to consider disposable masks as a quick and available solution despite the availability of reusable masks.
As part of its active engagement at European level, SBS submitted a contribution jointly with ECOS titled “Reflections on the sustainability aspects of the PPE supply chains/reusability/circular economy” to increase awareness of the issue of reusability and calling for it to be considered in public procurement. SBS’s contribution on the reusability and sustainability of PPE and textiles and their impact on EUs plans to promote circular economy is based on the last two published position papers (European legislation and standardisation to support sustainable business models for the PPE and textile care industry and Personal Protective Equipment during the coronavirus crisis and beyond). The contribution highlights (1) EC policies with regard to EU GPP Criteria, the Green Deal, and the Action Plan on Circular Economy, (2) Strengthening local supply chains for PPE products – especially half filtering masks, (3) Making PPE products more circular, and (4) Incorporating reusability, sustainability, and circular economy in public procurement.
The 2020 edition of the SBS Lift Seminar, held online on 10 December, focused on the ongoing revision of the EN 81 series of standards, which is fundamental for the lift sector.
In the first part, Esfandiar Gharibaan, CEN/TC Chairman, introduced the revision of the EN 81 series standards within CEN/TC10 on lifts. Mr. Gharibaan illustrated the current status of the revision of standards for lifts and the next steps and phases, underlining the importance of harmonised standards and the multiple benefits they bring to SMEs.
Vesa Katajisto, Policy Officer and Technical Desk Officer of DG GROW presented the Commission’s expectations concerning the revision. He referred to Mandate M/549 on lifts, to the content of the expected revised standards and to the work that the Commission carries out with harmonised standards to ensure the smooth functioning of the internal market. This will also benefit SMEs, whose participation in European standardisation processes was strongly encouraged by both hosts.
Other speakers included SBS experts Luciano Faletto (ISO/TC178) and Ivan Ferrarini (CEN/TC10 WG1) who presented on technical questions and the impact of Brexit. Both experts are working with the Task Force on Harmonised Standards under CEN/TC 10.
On 3 December, lift SMEs met online to discuss the role of standardisation in workplace safety, underlining how it is crucial to involve and train SMEs in order to support their safe growth. In particular, speakers highlighted the importance of standard EN 81-20, which deals with safety rules for lift construction and installation. Speakers included the European Commission (DG EMPL), EU-OSHA, the European Agency for Safety and Health at Work, and several EFESME national members, national associations of lift SMEs.
The first panel provided information on projects and initiatives, such the Enterprise Europe Network, carried out by the European Union and its agencies to help European companies – especially SMEs – comply with workplace safety requirements and the difficulties they may encounter when approaching such a delicate and important topic.
Later, EFESME’s German, Italian and Spanish members explained how workplace safety is addressed in their countries by presenting the different legislative approaches in each.
The event highlighted the importance of safety standards and showed that SMEs are ready to make use of tools provided by the EU and comply with policies to help themselves to thrive.