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Document 52017SC0284

COMMISSION STAFF WORKING DOCUMENT on the implementation of the actions foreseen in the annual Union work programme for European standardisation for 2018 Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS The annual Union work programme for European standardisation for 2018

SWD/2017/0284 final

Brussels, 25.8.2017

SWD(2017) 284 final

COMMISSION STAFF WORKING DOCUMENT

on the implementation of the actions foreseen in the annual Union work programme for European standardisation for 2018

Accompanying the document

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

The annual Union work programme for European standardisation for 2018

{COM(2017) 453 final}


1. A New Boost for Jobs, Growth and Investment

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

1

Proposal for a regulation of the European Parliament and of the Council laying down rules on the marking available on the market of CE marked fertilising
products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009.

COM (2016)157





More and more manufacturers in the EU are developing innovative fertilising products including nutrients or organic matter recycled from bio-waste. But diverging national rules and standards make it difficult for producers of organic fertilisers to sell and use them across the EU single market.

The future Regulation will create a level playing field for all fertilising products. At the same time, new common requirements for quality, safety and labelling will allow European farmers to make informed choices, contributing to making food production more cost and resource effective.

The harmonised standards will help economic operators and competent authorities to verify the compliance of CE marked fertilising products against the future legal requirements.

In the absence of harmonised standards, the application of the new rules would be impossible.
Harmonised standards will help to increase the safety and the efficacy of CE mark fertilising products. Producers will be able to offer their products to a wider group of customers, enjoying possible price premiums from offering a product backed by the widely recognized quality guarantee of the CE marking.

According to estimates about 120.000 jobs could be created thanks to recycling of bio-wastes in organic-based fertilisers. By levelling the playing field for all fertilisers. Research, innovation and investment in the circular economy will be encouraged and will generate value from secondary domestically sourced resources which would otherwise be disposed as waste.

CEN will be requested to develop harmonised standards for the control of CE marked fertilising products. A preliminary screening exercise on available test methods has allowed to identify relevant EN or ISO standards and where gaps need to be filled in

               

2. A Connected Digital Single Market

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

2

Communication: ICT Standardisation Priorities for the Digital Single Market COM(2016)176

Overcome the current lack of an agreed set of measurements and tools to assess quality of broadband/internet and availability of fixed and mobile services across the EU territory. Assess the reliability of measurements of fixed and mobile network performance and QoS provided. Assess availability, reliability, resilience of critical telecom infrastructure

Pan European set of internet Quality of Service measurements and tools to support DSM policy development and the monitoring of progress towards the achievement of EU broadband objectives, support the planning and deployment of EU funded broadband measures (ESIF, EFSI, CEF), aid in the monitoring and implementation of EU regulation on Communication Services including the user rights and consumer protection aspects set within the TSM regulation. Ensure the reliable delivery of fixed, wireless/mobile including 5G innovative services and its pan European applications (eg: in the fields of transport/Connected cars, eHealth, education, smart energy delivery, GIS-related services, etc.). Aid in the assessment of the availability, reliability, resilience of critical telecom infrastructure/services to deliver essential services (eg: energy) Benchmark QoS of broadband across the EU areas at the highest level of resolution possible.

Development of standards building on relevant work from BEREC on QoS on fixed and wireless/mobile services

3

Radio Equipment Directive (2014/53/EU) OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishes a regulatory framework for the making available on the market and putting into service in the Union of radio equipment

Establishing standards facilitating the development of 5G technological advances in the 26 GHz band (24.25 – 27.50 GHz) and higher mm-wave bands that are identified as candidate bands to be used for 5G (IMT-2020) services.

To enable increased sharing such as for example adaptive beamforming, including the flexibility needed to enable access for different 5G applications.

Development of Harmonised Standards

4

DIRECTIVE (EU) 2016/797

Standards for the succession of GSM-R as the radio communication system for railways, in order to mitigate the risk of GSM-R obsolescence, to follow the pace of innovation and
to ensure that the radio communication part of ERTMS will be standardised and available in a timely manner; Reengineering of NeTex (passengers) versus Transmodel and; Developing railway standards on IT-Security

maintain Railway interoperability by harmonisation of communication system in support of ERTMS;
ensure that physical model of NeTex (multimodal data exchange in passenger transport) will be also available as conception model in Transmodel ;

ensure safety of ever more connected railway systems.

Development of Harmonised Standards

5

COM (2011) 144 final: White Paper Roadmap to a Single European Transport Area – "Towards a
competitive and resource efficient transport system; COM (2009) 8: Maritime Transport Strategy 2018; COM (2013) 913 and SWD (2013) 524: Urban Mobility Package and C(2015)2259

setting- up an expert group on Digital Transport and Logistics ('the Digital Transport

and Logistics Forum')

Establish standards enabling efficient information exchange between stakeholders (public and private) along the whole supply chain, and to facilitate the flow, access and use of data

Digitalisation in transport and logistics is an important driver for efficiency, simplification, lowering costs, and a better use of resources. Digitalisation also creates new opportunities for business and has the potential to change the way cargo and traffic flows will be organised and managed in the future. To support this process, DG MOVE established the Digital Transport and Logistics Forum (DTLF), a consultative platform for the cooperation between stakeholders in a cross-modal and cross-sectorial perspective. The issue of standards would be one of the aspects to improve interoperability and facilitate data sharing between the actors operating in the logistic chains.

Ancillary action for the cooperation as regards the standards of information exchange



3. A Resilient Energy Union with a Forward-Looking Climate Change Policy

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

6

Ambient air quality directives (Directive 2008/50/EC and Directive 2004/107/EC)

Support for the local and regional monitoring of air quality with mobile and portable monitoring devices that meet the data quality objectives in the Ambient Air Quality

Directives. Support fot the implementation of the Ambient Air Quality Directives. In order to ensure that the information collected on air pollution is sufficiently representative and comparable across the Community, it is important that standardised measurement techniques and common criteria for the number and location of measuring stations are used for the assessment of ambient air quality. Techniques other than measurements can be used to assess ambient air quality and it is therefore necessary to define criteria for the use and required accuracy of such techniques.

The standards for air quality sensors would support for the local and regional monitoring of air quality with mobile and portable monitoring devices and the statistical processing of data in a user-friendly way. The problem to be solved is that the performance of the current generation of air quality sensors does not meet the data quality objectives in the Ambient Air Quality Directives. The standard is necessary because Member states S have identified problems with the relatively cheap sensors used by the public to measure air quality, because these sensors do not meet the data quality objectives in the Ambient Air Quality Directives . All over Europe, citizen scientists, NGOs, companies and administrations are increasingly monitoring local and regional air quality. They often use mobile monitors, portable devices and biological tools. These ways are claimed to be useful to perform measurements in or near hotspots and to establish air quality benefits near infrastructure projects to compare the situation before and after, especially if no official monitoring station is nearby. Such ways could also raise awareness of e.g. school pupils and provide support among citizens for air quality measures. The developement of a standard for air quality sensors would promote innovation, increase the quality of the portable devices and impact on jobs and competitiveness in the EU market of these sensors.

Development of a standard for the local and regional monitoring of air quality with mobile and portable monitoring devices that meet meet the data quality objectives in the Ambient Air Quality Directives.

7

Directive 2010/75/EU on industrial emissions (IED)

The Directive 2010/75/EU on industrial emissions (IED) and the Commission Decisions establishing conclusions on Best Available Technique (BAT), require suitable monitoring of: the emissions of ammonia (HN3) to the air; the emissions of chlorine (and chlorine dioxide) to the air; hydrogen fluoride or total gaseous fluorides from different industrial sectors and refer to EN (or where EN standards not available ISO, national or other international equivalent) standards. There is therefore a need to develop EN standard where no EN and ISO standard are currently available.

• The standard will be used for the continuous monitoring of ammonia (NH3) to air from the use of SCR/SNCR (e.g. in large combustion plants) and for continuous and periodic monitoring of emissions of ammonia from other industrial sectors, including production of cement, lime and magnesium oxide, glass, non-ferrous metals, pulp, paper and board, refining mineral oil and gas, intensive rearing of poultry and pigs and organic chemicals. Standardised methods for monitoring will contribute to harmonised and better compliance assessment.
• The standard will contribute to the quality of the measurement equipment and of the reported data. The standard on emissions of chlorine (and chlorine dioxide) to the air will be used for the periodic monitoring of chlorine from different industrial sectors like production of chlor-alkali, organic chemicals, non-ferrous metals and (possibly) also for monitoring of chlorine dioxide from chlor-alkali production. Standardised methods for monitoring will contribute to improved and harmonised compliance assessment. The standard will contribute to the quality of the measurement equipment and of the reported data.

• The standard on fluorides will be used for the periodic or continuous monitoring of hydrogen fluoride or total gaseous fluorides from different industrial sectors like production of iron and steel, glass, non-ferrous metals, large combustion plants and waste incineration plants. Standardised methods for monitoring will ensure reliable, representative and comparable data and contribute to improved and harmonised compliance assessment. The standard will contribute to the quality of the measurement equipment and of the reported data.

Development of a Standard to support the implementation of the Industrial Emissions Directive

8

Directive 2009/125/EC
establishing a framework for the setting of ecodesign requirements for energy-related products and associated implementing Regulations

Standards meeting the requirements which the below listed energy-related products covered by implementing measures must fulfil in order to be placed on the market and/or put into service: computers, displays, servers and data storage devices, commercial refrigeration, electric motors, fans, lighting products, household cold appliances, standard air compressors, machine tools and external power supplies

The standards will decrease the energy consumption of the products thus reducing the environmental impacts and achieving energy savings which also leads to economic savings for businesses and end-users

Development pf standards

9

EU Renewable Energy Directive 2009/28/EC and the Commission's legislative proposal COM (2016) 767 final of 30 November 2016 on recast of the EU Renewable Energy

Developing energy labels and energy performance certificates for district heating and cooling systems, thereby building on and completing the existing standards for calculation of the energy performance of district heating and cooling

·         Provide information to end-consumers, therefore contributing to one of the three key objectives of the clean energy package

Development of energy performance certificates and energy labels reflecting the measurement and calculation of Performance of District Heating and Cooling

10

EU Renewable Energy Directive 2009/28/EC

Develop standards for a 20/25 ethanol blend in petrol.

At present the ethanol blend wall is limited to 10vol% ethanol in petrol. The EU has ambitious targets for defossiling transport and higher blends can contribute DG ENER is already supporting CEN to carry out research on the topic via 3 research contracts. The final results are expected by the end of 2017-early 2018. Based on the final results and in consultation with other EC services as well as the stakeholders and CEN the Commission may decide to send a mandate to CEN.

Development of standards

11

Directive 2003/87/EC

Update of EN 16258:2012 "Methodology for calculation and declaration of energy consumption and GHG emissions of transport services" with the objective to harmonise with other standards and their implementing rules for emission accounting from transport services at the global level

Logistic chains are often of international dimension, creating a need for the alignment and implementation of standards at a global scale. This action will therefore contribute to international harmonisation efforts, facilitating global approaches on GHG emissions and fuel consumption reduction and also fostering cooperation with non-EU regions and countries.

Ancillary action to establish cooperation with the global standardisation bodies (e.g. ISO) for a harmonised standard for emission accounting from transport services

12

Communication on Green Infrastructure COM (2013)249, COM (2013)216 on adaptation to climate change and referring to COM (2014)445 on resource efficiency opportunities in the building sector

The Communication COM(2013)249 on an EU Strategy for Green Infrastructure identifies standards as possibly contributing to 'growing the market' for green infrastructure solutions. The Commission, taking into account e.g results of the study " Supporting the Implementation of Green Infrastructure" will ask for the development of technical standards, particularly in relation to physical building blocks and procedures, which could increase the deployment of Green Infrastructure.

Developing green infrastructure technical standards will contribute substantially to green Infrastructure implementation, and as such to new green Infrastructure markets. While GI is increasingly becoming used more broadly, the available information and uptake of green Infrastructure is fragmented. Standards will be used across different sectors (finances, buildings, water, transport, public health, industry, climate, rural abandonment and energy). They will set recognized quality level, build trust and confidence necessary to stimulate demand as well as further innovation in the sector, new skills, competitiveness, jobs and green growth.

Development of standards

4. A Deeper and Fairer Internal Market with a Strengthened Industrial Base

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

13

Directive (EU) 2016/1629 of the European Parliament and of the Council of 14 September 2016 laying down technical requirements for inland waterway vessels, amending Directive 2009/100/EC and repealing Directive 2006/87/EC

Annex II of Directive (EU) 2016/162 introduces into EU law the ES-TRIN standard (see: https://www.cesni.eu/en/documents ). It is a mandatory set of EU standards that a vessel has to comply with in order to be authorised to navigate in waterways of European dimensions. The set of standards cover multiple issues, from stability parameters, navigational equipment, safety and environmental parameters of engines, gears and tools, etc., etc. The ES-TRIN standard is established by the European Committee for Inland Navigation Standards (CESNI), on the basis of the work of experts from the Member States and third countries. The aim is to transpose the work performed by CESNI in the European standardisation system through the CEN/TC 15 on Inland navigation vessels and develop European standard(s).

CESNI is a standardisation body of key importance for the European inland navigation industry. The ES-TRIN standard requires constant examination and upgrade to ensure technological progress, competitiveness of the fleet and adequate levels of safety and environmental performance. The particular nature of CESNI as standardisation body under EU law has to be clarified. The current situation results in a lack of legal certainty, which has a potentially negative impact on the achievement of deeper and fairer internal market for the EU inland navigation sector.

Strengthen the role of CESNI as the body in charge of developing European standard for the inland navigation sector.

14

Priorities of Space Strategy COM (2016) 705 & Commission implementing decision on the adoption of the work programme for 2017 and on the financing of the European satellite navigation programme

Further to a EGNSS downstream standardisation study (finalised in 7/2017) on the state of play, gaps and priorities for future EGNSS standardisation needs, follow-up action is planned in view of establishing a roadmap on EGNSS downstream standardisation and launching standardisation activities in priority areas.

The study investigates EGNSS downstream standardisation needs in ten EGNSS market application areas, incl. LBS, Aviation, RPAS, Maritime, Road, Rail, Multimodal transport, Agriculture, Timing and Synchronisation. Follow-up standardisation action is planned in those areas where added value and impact on jobs, competitiveness is highest.

Roadmap for EGNSS downstream standardisation & implementation of roadmap

15

Priorities of Space Strategy COM (2016) 705 & Commission implementing decision on the adoption of the work programme for 2017 and on the financing of the European satellite navigation programme

Develop technical solution for implementation of multi-constellation/ dual frequency by drafting EUROCAE dual frequency multi-constellation Minimum Operational Performance Specifications

This action will ensure that Galileo is included within and compatible with relevant standards, where not being included would hinder uptake of Galileo services in the aviation market segment.

Preparation of relevant technical standards and promotion of Galileo within EUROCAE.

16

Communication on End-to-End eProcurement (COM(2013)453), Public Procurement Directives (2017/24/EU), Communication on the Digital Single Market Strategy (COM/2015/0192)

Supporting standardization initiatives, to improve the functioning of the single market in Europe

Savings up to 100 BEUR each year, it will make Europe much more competitive and robust. And as Public Procurement has many spill-over effects in Europe it will spread innovation

Interoperability and standardisation is a key strategy to remove technical barriers or extra costs when suppliers bid on a plurality of systems. In order to achieve a true single market, bidders including SMEs ideally should be able to communicate and participate easily in multiple markets. As well it is important to understand the single market and to improve it with better policies. Potential areas of interest for standardisations are therefore data/contract registries, eESPD, accreditation of eProcurement platforms, eCatalogue and eForms

17

Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)

Mainly related to new (emerging) technologies and machinery, standards necessary for specific machinery below, as a market need identified via the open public consultation for the evaluation study of the Directive on machinery: 1) Additive manufacturing machinery (3D printing); 2) Collaborative robots; 3)Automated machines and vehicles; 4)Wind turbines; 5)Food machines

New harmonised standards for specific types of machinery mentioned hereafter will fill in the existing gap for such innovative products which are developed at a fast pace and their spread on the European market becomes increasingly wider. In order to overcome the current situation of self-certification conformity procedures and as such, availability of European harmonised standards is highly important both for ensuring safety and market access. Further to this, relevant international standardisation activities should be taken into account.

Develop harmonised standards

18

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and;

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

The new Regulation reinforces safety and performance requirements for medical devices, to keep pace with technological and scientific progress. It further harmonises and clarifies the regulatory requirements to support their uniform application by the operators. Therefore, the review of the existing standards is necessary in order to align them to the requirements of the new Regulation.
New standardisation requests may be considered for new types of devices, new regulated practices, or in view of the more detailed safety and performance requirements.

uniform application of the legal requirements for placing medical devices on the market facilitation of the free movement of medical devices in the internal market

review / update of all the existing standards (in particular, review of the scope of each standard in the light of the requirements of the new Regulation)
possible development of new standards, in order to cover such matters as: (i) new types of devices; (ii) new regulated practices; (iii) more detailed safety and performance requirements

19

Regulation (EU) 305/2011, in conjunction with Drinking Water Directive 98/83/EC , and and related to Regulation (EC) No 1935/2004 including Regulation 10/2011

Construction products Regulation (EU) 305/2011 and Drinking Water Directive 98/83/EC do not set out limits for the transfer of substances that are components of materials to drinking water they are in contact with (only exist for food in contact with materials). Hygienic and safety requirements and test methods for construction products in contact with water intended for human consumption have been developed in a rudimentary way by TC164, but further specific standardisation work on hygiene and safety for products and materials in contact with drinking water is urgently needed.  A replacement of mandate to CEN M/136rev2 concerning the execution of standardisation work for harmonised standards on construction products in contact with water intended for human consumption is ongoing.

Including the assessment of the product performance when in contact with drinking water in all relevant product Ens under the CPR; harmonising the technical approach in several MS regulating in this field currently working with different methods;

Amending harmonised product standards on products and materials in contact with drinking water. The Commission is gathering data and information for replacing M/136

20

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and repealing Regulation (EC) No 216/2008 of the European Parliament and of the Council

To help industry conformity with the new regulation and its implementing rules, it will be necessary to develop of standards in the field of drones, in particular on identification, geofencing and other technical requirements that will be in the new legislation.

Supporting the essential requirements for unmanned aircraft

Development of standards

21

Directive 2014/28/EU on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses

The Directive on civil explosives has the purpose to create an EU single market for this product category, whenever they meet the essential safety requirements established with the Directive. To facilitate the work of economic operators, notified bodies and market surveillance authorities in ensuring that explosives for civil uses meet these essential safety requirements, several harmonised standards have been developed by CEN following a mandate from the Commission. For explosives complying with these harmonised standards there is a presumption of conformity with the essential safety requirements. The current harmonised standards fo explosives have been adopted between 2002 and 2005; technical progress has made a revision of the standards necessary, in order to include in their scope new products and new technology which have been introduced after their adoption.

The aim of this action is to increase the safety of civil explosives and the quality of conformity assessments for these products, by bringing into line the existing harmonised standards with the current level of technology in this sector, and by closing gaps deriving by the fact that newer, but already widely used products (in particular, electronic detonators) are not covered at all by the existing harmonised standards. The update of the harmonised standards for explosives will have a positive impact for economic operators, notified bodies and market surveillance authorities.

Revision of the current harmonised standards EN 13630, EN 13631, EN 13763, EN 13857 and EN 13938 and development of a new standard for electronic detonators (in case it would not be possible to include it in one of the above-listed harmonised standards)

22

DIRECTIVE (EU) 2016/797

- Close open points of the rail Technical Specifications
for Interoperability

-Issuing new/updated EN Standards allowing simpler and clearer TSIs.


Specific topics include:

- Rolling stock standards for 1520 mm track gauge: extend the scope of existing standards (e.g. dynamic behaviour)

- Update standards to establish normative limits to track geometry defects for speeds over 300 Km/h.

Increase harmonisation of RST and INF functional requirements at EU level. Consequently, better safety level and removal of technical barriers.

Development/revision of Harmonised Standards

23

Regulation 1907/2006 (REACH)

Harmonisation of an analytical method to determine the migration of polycyclic aromatic hydrocarbons (PAHs) from plastic and rubber. The restriction in entry 50 of Annex XVII will be reviewed in late 2017 and may include a migration based derogation from the content limit already established.

This standard will support the implementation of the restriction defined in entry 50 of Annex XVII to REACH, relative to PAHs in consumer articles containing plastic and rubber components.

Development of a harmonised standard. The standard would rely on initial method development work currently being undertaken by DG JRC Directorate D, which should conclude in late 2017.

24

Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres

European harmonised standards in the ATEX sector are currently developed under the Mandates M/BC/CEN/92/46 and M/BC/CEN/92/8 issued for the previous Directive 94/9/EC. It is necessary to consolidate and update the mandate for the new Directive 2014/34/EU taking into consideration the Standardisation Regulation (EU) No 1025/2012

As for the other EU harmonisation legislation for products in the internal market, referred to the "New Approach" and the "New Legislative Framework", harmonised standards are a very useful mean to get presumption of conformity with the essential requirements they aim to cover. A new consolidated and updated mandate would improve the legal and technical bases for the work to be developed by the European Standardisation Organisations (CEN and CENELEC)

Development of harmonised standards for the ATEX legislation

25

Directive on General Product Safety 2001/95/EC

To improve safety of consumer products not covered by Union harmonisation legislation.

European standards developed and referenced under GPSD improve safety of consumers, help Member States to enforce the general safety requirement contained in the GPSD and provide legal certainty to businesses, therefore improving the functioning of the internal market.

Development of standards

   

5. An Area of Justice and Fundamental Rights Based on Mutual Trust

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

26

Communication on a new EU approach to the detection and mitigation of CBRN-E risks (COM(2014) 247); Communication Implementing the European Agenda on Security: EU action plan against illicit trafficking in and use of firearms and explosives (COM(2015) 624); Communication Security Industrial Policy Action Plan for an innovative and competitive Security Industry (COM(012)417))

Investigate if there is a possibility to set minimum standards and/or recommendations for minimum detection capabilities for detection equipment in other areas than aviation (e.g. rail, stadiums, shopping malls).

The action's aim is to address the existing gap in this area in order to ensure a better protection level and increase security.

Study assessing the possibility of setting (minimum) standards in the area of detection equipment in other areas than aviation, in view of the development of such standards.

6. A Stronger Global Actor

Ref.

Policy/legislative reference

Objective

Aim /impact of the action

Type of action

27

Communication (2016)950: European Defence Action Plan (EDAP)

The Commission is committed in the EDAP to considering supporting the development of standards in the field of defence that Member States have identified as necessary for co-operative projects in priority areas.

Supporting Member States to develop joint defence capabilities while fostering a competitive and innovative industrial base.

Development of standards

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