State of play of action included in the annual Union work programme for European standardisation for 2016

Item Legal basis Objective Type of action Status

1. Procedure 2012/0340/COD The current European standard EN 301 549 was adopted under mandate M376 from the Commission. Parts of the standard refer to Web accessibility. After the adoption of the Directive on accessibility of public sector bodies' web sites (currently under discussion by the European Parliament and the Council) a follow up is necessary to establish harmonized standards for the presumption of conformity for the accessibility requirements set out in the Directive. That follow up should be coherent with the ongoing revision process. Development of Harmonised Standards The proposal for a Directive on accessibility of public sector bodies' web sites (COM (2012) 721) is currently under discussion by the European Parliament and the Council. Implementation of the scheduled action by end of 2016 There is a revision on-going of on the current version of the EN 301 549 to improve certain accessibility aspects and improve alignment with other existing international standards.

2. Regulation (EU) No 1007/2011 and Commission Report to the EP and the Council COM(2013) 656 final The present labelling and marking schemes rely on physical labels. With the uptake of eCommerce and online retailing, traditional labelling is becoming less effective to convey information to consumers. It is expected that eLabelling will also facilitate demonstrating and verifying eCompliance with regulatory requirements, while keeping labelling costs at affordable levels, in particular to SMEs Development of standards in the field of electronic labelling of finished textile products Under discussion

3. Directive 2011/24/EU on the application of patients' rights in cross-border healthcare Directive on patients’ rights in cross-border healthcare established the eHealth Network (eHN) of representatives of national authorities responsible for eHealth. Its objective is to work towards delivering sustainable economic and social benefits of European eHealth systems and services, and in particular to promote their interoperability. The new joint action on eHealth, liaising with Standardisation Organisations and other relevant stakeholders, will support the eHealth Network in taking policy decisions on standardisation initiative in the eHealth sector to boost interoperability, in line with the Work Plan 2015-1018 of the eHealth Network. In particular, it will explore the option of starting a standardisation process of specific elements of the guidelines adopted by the eHealth Network as well as of other cross-border eHealth services, such as interoperability aspects of telemedicine. In this regards, the Commission will support member states co-operation on interoperability by further developing and validating specifications and components and also through standardisation mandates if necessary. In addition a special effort should be dedicated to interoperability and harmonised coding of clinical databases, screening databases, genetic databases, cancer registries and, more in general, of all health-related databases (in the medium term to make it possible to interface health data with e.g. environmental, food safety, safety at work data Development of Technical Specifications and/or Standards Under discussion

4. COM(2012) 736 eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century Directive 2011/24/EU on the application of patients' rights in cross-border healthcare Creation of the International Patient Summary: The objective of this action is to participate in the standardisation of the International Patient Summary and ensure an European presence in the development of this standard. This work is performed under the auspices of the Transatlantic Economic Council and is formalised in the EU-US eHealth/Health IT Memorandum of Understanding, its roadmap and annex. Standardisation activity should take into consideration the patient summary guidelines endorsed by the eHealth Network. Development of Technical Specifications and/or Standards Under discussion

5. COM(2012) 736 eHealth Action Plan 2012-2020 - Innovative healthcare for the 21st century Directive 2011/24/EU on the application of patients' rights in cross-border healthcare Creation of an European standard on quality criteria for the development of health and wellness apps. In order to enhance the quality of health and wellness apps, the Commission has proposed in the 2016 Rolling Plan for ICT standardisation a standard on quality criteria for the development of health and wellness apps (e.g. functionality, usability, reliability). The standard could be based on the publicly available specification PAS:277 recently published by the British Standards Institution (BSI) and would provide guidance to app developers by setting out principles to follow throughout the app development life cycle, including testing, maintenance and risk management. Development of Technical Specifications and/or Standards Under discussion

6. Priorities of EU space strategy (COM(2011)152) Standardization of location authentication based on the Commercial Service and the Open Service of Galileo. Development of performance standards and associated test procedures to standardise the location authentication. The activities will upgrade the interfaces between elements in the chain, in particular from the GNSS signals to the final location services. The work may address standardization groups such as OMA, 3GPP, CEN/CENELEC, ETSI, IMO. Development of standards Under discussion

7. Communications 2009 (538), (2010) 584 and 2014 (451) on the development of a Common Information Sharing Environment for the EU maritime domain, joint Communication form the COM and the High Representative of 6 March 2014 (2014)9 providing elements for a European Union maritime security strategy, European Union Maritime Security Strategy (EUMSS) adopted by the Council on 24th June 2014, EUMSS action plan adopted by the Council on 16th December 2014. The Common Information Sharing Environment for the surveillance of the EU maritime domain (maritime CISE) action seeks to enhance automatic information sharing between the national authorities involved in maritime surveillance, including defence. The development of standards enabling national systems to become interoperable is instrumental to promote and ease cross-sector and cross-border information sharing. Development of harmonised standards The launch of the action, foreseen for the 2nd quarter of 2016, will have to be postponed of approximately 10 months due to the unexpected delay suffered by the MS-led preparatory project called 'EUCISE 2020' funded under FP7. The aim of EUCISE 2020 is to set-up and test a prototype solution for decentralised information exchange among national legacy systems used for maritime surveillance, and to deliver refined recommendations on standardisation needs for ICT interoperability standards. Shift this action in the 2017 UWP with the following timelines: - Launch of the process in the Commission: 1st quarter of 2017 - Deadline for delivery by the standardisers: end of 2019.

8. Priorities of EU space strategy (COM(2011)152) Standardization activities for the Galileo Timing Service and the Galileo Search and Rescue Return Link Service. These standardization activities will address the standardisation of user receiver components including receiver chip, calibration of location timing receivers and processing of GNSS signals to obtain precise timing products. The actions will develop performance standards to standardise timing services provision and will investigate the use of the RLS for remote beacon activation of ELT in aircraft Development of standards Under discussion

9. Towards a competitive and resource-efficient transport system’ (COM (2011) 144 final of 28 March 2011 Objective is to facilitate the flow, access and use of information in transport, in order to enhance efficiency and reduce costs of transport operations In this framework, the Commission may request standardisation activities. Under discussion, considering the Commission Decision C(2015)2259 setting up an Expert Group on Digital Transport and Logistics;

Communication

10. Directive 2010/40/EU ("ITS Directive") The Commission is considering issuing a standardisation request with respect to access to in-vehicle data. This will be developed within the framework of the Cooperative ITS initiative (platform, working group, master plan) Technical reports / technical specifications / standards C(2016) 808 final -M/546

COMMISSION IMPLEMENTING DECISION

of 12.2.2016 on a standardisation request to the European standardisation organisations as regards Intelligent Transport Systems (ITS) in urban areas in support of Directive 2010/40/EU

of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport

11. Ecodesign/Energy Labelling Directive Further standardisation requests in support of Commission Regulations implementing the Ecodesign Directive (e.g. televisions, smart appliances, machine tools and welding equipment) will be issued as individual mandates. Development of harmonised standards A standardisation request on welding equipment (listed as new action in 2015) in support of a possible Ecodesign Regulation has been prepared in 2015 and is ready for adoption in April 2016. DG ENER for the other products mentioned. Deadline for delivery by standardisers: Q3 2018

12. Ecodesign/Energy Labelling Directive Where the Commission considers it likely that new measures (i.e. Commission Regulations or Commission Delegated Regulations) on Ecodesign and/or Energy Labelling will be proposed for products under the Ecodesign Working Plan 2012-14, new standardisation requests in these fields could be issued. Development of harmonised standards No further standardisation requests are foreseen.

13. Ecodesign/Energy Labelling Directive Standardisation requests in support of new Commission Regulations implementing the Ecodesign/Energy Labelling Directive on the taps and showers products will be issued as individual mandates. Development of standards Under discussion

14. 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 Commission is currently initiating a research and innovation policy agenda to further develop and upscale the use of nature-based solutions and to promote the market for them in Europe and worldwide– including Green Infrastructure elements and adaptation measures. This refers as well to the sustainable construction of buildings (such as with green roofs and walls). The development of protocols for functional or performance based specifications and measurement and testing methodologies, leading eventually to standardisation, would help the assessment of the cost-effectiveness of nature-based solutions in economic, social and environmental terms, support public procurement of such solutions and overall stimulate the market for them. In addition to the above mentioned activities under Horizon 2020, a dedicated feasibility study is needed to involve relevant stakeholders to scan the area on this particular subject, based on and complementing actions towards standardisation prepared by other services. Development of standards The Communication COM(2013)249 on the strategy on Green Infrastructure identifies standards as possibly contributing to 'growing the market' for Green Infrastructure solutions. The Commission will assess how technical standards, particularly in relation to physical building blocks and procedures, could increase the deployment of Green Infrastructure. Green Infrastructure-related standards are due to start in 2016 and deliver by 2020. We expect that 2017 will be a standard year of continued implementation.

15. Regulation (EU) No 517/2014 An external consultant has been carrying out for DG CLIMA a survey in Member States to find out where the obstacles and gaps are as regards standards to enabling a broader uptake of alternative, climate-friendly technologies. Results were discussed with stakeholders (Consultation Forum) and are available in 4th quarter 2015. These results will be the basis for drafting a mandate to European standardization organisations. Development of (harmonised) standards The external study and the consultation of stakeholders were concluded as foreseen and the preparation of a mandate is in progress.

16. Industrial Emissions Directive (IED)2010/75/EU The Minamata Convention regulates i.e. emissions of mercury from industrial processes at a global level. Under the Industrial Emissions Directive there is an obligation to monitor mercury emissions from relevant sources, in particular coal fired power plants and waste incineration plants. Some Member States are applying more frequent emission monitoring at the most relevant sources. There is a need for a reliable and practical standardised method allowing both short term and long term mercury emission monitoring. Such a method could be based on the existing US EPA standard. Activity taking place in the context of the Global Earth Observation (GEO) initiative, Task: "HE-02-C1: Global Mercury Observation System" https://www.earthobservations.org/ts.php?id=171 and the FP7 funded project "Global mercury Observation System – GMOS" http://www.gmos.eu/ that should be taken into account when the new standards will take place. Development of standard method for determining total gaseous mercury using sorbent traps for periodic and long term measurements Under discussion

17. Industrial Emissions Directive (IED)2010/75/EU A new BREF on production of wood-based panels is under preparation and the BAT conclusions are scheduled to be adopted by the Commission in 2015. The need to develop a European standard for the monitoring of formaldehyde was highlighted in this document. The standard could also be applied in other industrial sectors where this pollutant is emitted. Development of standard for formaldehyde emissions monitoring Under discussion

18. COM(2013)18 Directive 2014/94/EU Standardisation will be needed to implement the Clean Power for Transport package, including the European Alternative Fuels Strategy and the Directive 2014/94/EU of 22 October 2014 on the deployment of alternative fuels infrastructure. In addition to already ongoing work of CEN. CENELEC and ETSI under the existing mandates in support of the implementation of this directive, standardisation work on labelling is also needed for meeting the requirement of the directive to provide the users with simple and easy to understand information on the compatibility of their vehicles with the fuels or electricity re-charging points. Development of standards Under discussion

19. Regulation (EU) 305/2011 Completion of the Internal Market for construction products Development of harmonised standards and introduction of thresholds/classes of performance in new and revised harmonised standards on construction products. Development of assessment methods related to essential characteristics of the product performance related to Basic Requirements on Construction Works under the CPR ongoing

20. Directive 94/62/EC on Packaging and Packaging Waste (reference to the interinstitutional file: 2013/0371 (COD) Develop a standard for home compostable plastic packaging (definitions of biodegradability and compostability). Development of standards Under discussion

21. Directive on General Product Safety 2001/95/EC The Commission will request the development of standards under the GPSD Directive for certain consumer products selected in consultation with national and stakeholder experts of the Consumer Safety Network. Development of standards The action is ongoing.

22. Regulation No 524/2013 on consumer ODR (and Directive 2013/11/EU on consumer ADR) Define elements, messages and message flows in order to facilitate the interoperability of case management systems in charge of supporting out-of- court (alternative) dispute resolution cases Study / Development of Harmonised Standards / Development of standards The action is postponed due to further reflection needed in light of the finalisation and launch of the ODR platform on 09/01/2016

23. Directive 2008/57/EC Close open points of the rail Technical Specifications for Interoperability namely in the field of aerodynamic effect on ballast for high speeds, eddy current brake, track geometry quality levels, load limits and variable gauge wheel sets Development of standards The action is ongoing.

24. Directive 2009/48/EC on the safety of toys. OJEU L 170, 30.6.2009, p. 1. Directive 2009/48/EC is the legal basis to ensure the free movement of toys that provide a high level of safety for children under 14 years of age. The Directive requires toys to be safe with regard to physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity. Ensuring a high level of safety throughout the EU and by all stakeholders as well as the free movement of toys in the Internal Market requires standardised specifications. These specifications need to keep up with new scientific-technical and market developments, such as the development of innovative toys, and reports about accidents with toys. The available specifications therefore require updates as appropriate, the establishment of new specifications is of a lower priority. Programming work on updates of standards covering all requirements for toys, and development of new standards if appropriate. New actions by the standardisers are being programmed for example on activity toys (in-house toy trampolines) and on tests for chemicals in toys in accordance with recent amendments of Directive 2009/48/EC.

25. Directive 2014/53/EU improved security and compliance of software defined radio Development of harmonised standards M/536 - C(2015)5376 of 04/08/2015 COMMISSION IMPLEMENTING DECISION on a standardisation request to the European Committee for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/EU of the European Parliament and of the Council

26. Proposal for a Regulation of the European Parliament and of the Council on personal protective equipment (PPE) - Ref. 2014/0108 (COD) Align the European harmonised standards to the provisions of the new Regulation, especially on new and/or modified essential health and safety requirements Development of Harmonised Standards Under discussion

27. Proposal for a Regulation of the European Parliament and of the Council on cableway installations - Ref. 2014/0107 (COD) Align the European harmonised standards to the provisions of the new Regulation Development of Harmonised Standards Under discussion

28. Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, OJ L 338, 13.11.2004, p. 4) Regulation (EU) No 1935/2004 provides the legal basis for several specific measures on food contact materials. These include Regulation 10/2011 (OJ L 12, 15.1.2011, p. 1) on plastic materials, Directive 84/500/EEC on ceramic articles and Regulation (EC) No 450/2009 on Active and Intelligent Materials. These acts set out limits for the transfer of substances that are components of materials to the food they are in contact with. The transfer of more than 1000 relevant substances may need to be determined in analytical testing. Yet only a very limited number of standardized methods are available. Certain emerging issues (oligomer migration, multi-analytical methods) call for the establishment of different standards to prevent that they develop into a non-tariff barriers. Moreover testing for specific substances may be selected according to internal market/trade relevance. To this end COM services (JRC) are already collaborating with ISO TC166 (ceramic ware, glass-ceramic ware and glass dinnerware in contact with food -- Release of lead and cadmium). Programming work on development priorities, Development of Standards for oligomer migration, multi-analytical methods, specific substances (according to tras/internal market relevance) Internal work to prepare a mandate is being started, aiming at a completed draft mandate by the end of Q2. The work has been narrowed down to standardised methods and analytical data for the determination of certain specific substances. The focus will give priority to multi-analytical methods, followed by methods for single substances. Methods for oligomer migration are being considered as well, but these may need further development before being ready for standardisation.

29. Directive 2008/50/EC Directive 2008/50/EC states that modelling technique can be used to assess the air quality. In order to ensure comparability of models throughout Europe, validated standard is needed as regards the use of model. development of EN standard Under discussion

30. Directive 2008/50/EC Directive 2008/50/EC requires Member States to establish Air Quality Plans when the level of pollution is above the limit value(s). One part of the above Plans consists of identification of the factors contributing to the pollution. The Commission expects to send a mandate to ESO to develop a harmonised methodology for source identification and quantification (source apportionment). development of EN standard Under discussion

31. Proposal for a Regulation on Appliances Burning Gaseous Fuels (GAR) - Ref. 2014/0136 (COD) Develop standards for products and aspects covered by the GAR, with updating and extension of existing standards and/or new standards when necessary to cover the new requirements of the GAR, as well as for new/innovative product standards Development of Harmonised Standards Under discussion