Annex I: New initiatives

d)Revision of the Council Directive laying down detailed arrangements for the exercise of the right to vote and to stand as a candidate in municipal elections by citizens of the Union residing in a Member State of which they are not nationals (legislative, incl. impact assessment, Article 22 TFEU, Q4 2021)

c)Revision of the Council Directive laying down detailed arrangements for the exercise of the right to vote and stand as a candidate in elections to the European Parliament for citizens of the Union residing in a Member State of which they are not nationals (legislative, incl. impact assessment, Article 22 TFEU, Q4 2021)

Initiative to extend the list of EU crimes to all forms of hate crime and hate speech (legislative, incl. impact assessment, Article 83 TFEU, Q4 2021)

d)Revision of the Directive on the freezing and confiscation of the proceeds of crime (legislative, incl. impact assessment, Articles 82 and 83 TFEU, Q4 2021)

Communication on the EU’s humanitarian aid in the context of the COVID-19 pandemic and beyond (non-legislative, Q1 2021)

c)EU 2021 Rail Corridor Initiative, including the revision of the Rail Freight Corridor Regulation and actions to boost passenger rail (non-legislative and legislative, incl. impact assessment, Article 91 TFEU, Q3 2021)

b)Minimising the risk of deforestation and forest degradation associated with products placed on the EU market (legislative, incl. impact assessment, Q2 2021)

a)Action plan for the development of organic production: on the way to 2030 (non-legislative, Q1 2021)

l)Revision of the Third Energy Package for gas (Directive 2009/73/EU and Regulation 715/2009/EU) to regulate competitive decarbonised gas markets (legislative, incl. impact assessment, Article 194 TFEU, Q4 2021)

j)Revision of the Regulation setting CO2 emission performance standards for new passenger cars and for new light commercial vehicles (legislative, incl. impact assessment, Article 192(1) TFEU, Q2 2021)

f)Revision of the Regulation on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry (legislative, incl. impact assessment, Article 192(1) TFEU, Q2 2021)

e)Amendment of the Energy Efficiency Directive to implement the ambition of the new 2030 climate target (legislative, incl. impact assessment, Article 194 TFEU, Q2 2021)

d)Amendment to the Renewable Energy Directive to implement the ambition of the new 2030 climate target (legislative, incl. impact assessment, Article 194 TFEU, Q2 2021)

a)Revision of the EU Emissions Trading System (ETS), including maritime, aviation and CORSIA as well as a proposal for ETS as own resource (legislative, incl. impact assessment, Q2 2021)

Annex II: REFIT initiatives

No. Title Simplification objective / potential (short explanation of the REFIT objective of the revisions, and simplification potential for evaluations and fitness checks)

A European Green Deal

1. Revision of geographical indications This revision will strengthen geographical indications (GIs) for all agricultural sectors while maintaining the specificities of GIs in the wines and spirit drinks sectors. The fundamental structure of the EU GIs system is sound. The proposal will: increase the applicability of GIs for farmers and producers of sustainable products; increase the attractiveness of GIs notably for producers in the ‘low use’ Member States; correct legislative gaps including in the scope of coverage; improve protection and enforcement especially on the internet; empower GI producer groups; better valorise the GI scheme notably through use of the GI logos; modernise management of the GI registers. The traditional specialities guaranteed scheme (TSG), which has not after 28 years delivered the expected benefits for producers and consumers, will be replaced by a more-effective and flexible labelling mechanism essentially managed by Member States while providing EU level protection, where needed, through appropriate instruments. The proposed initiative will, as far as possible, merge the technical and procedural rules on geographical indications, provide for a single GI registration procedure and digital submission of applications by EU and non-EU applicants, with a view to shortening registration times. A simplified system would become more attractive to producers, be more understandable to consumers, and become easier to promote and lead to higher sales as the GI concept becomes better known. The evaluation is on-going. Planned adoption: Q4/2021; Legislative; Legal basis: Articles 43 and 118 of the TFEU. Impact assessment is envisaged.

2. Ozone layer protection – revision of EU rules The evaluation of the Ozone Regulation concluded that there is scope for simplification, clarity and better coherence. The Regulation could also be updated with the latest technological developments. Planned adoption: Q4/2021; Legislative; Legal basis: Article 192 of the TFEU. Impact assessment is envisaged.

3. Revision of Regulation (EC) No 1013/2006 on Shipments of Waste This initiative responds to the priorities announced in the European Green Deal, the new Circular Economy Action. The Commission will propose a revision of the Waste Shipment Regulation on basis of its evaluation to reduce the shipments of problematic waste outside of EU, update the shipment procedures to reflect the objectives of the circular economy and improve enforcement. Planned adoption date: Q2/2021; Legislative; Legal basis: Article 192 of the TFEU. Impact assessment is envisaged.

4. Revision - Update of concentration limit values of persistent organic pollutants in waste - Amendments to Annexes IV and V on waste of the Regulation on persistent organic pollutants in waste This initiative responds to the priorities announced in the new Circular Economy Action Plan. The Commission will propose a revision of the Regulation on POPs Annexes IV and V on waste to ensure that such waste is managed in an environmentally sound way and achieve safer recycling. Planned adoption date: Q2/2021; Legislative; Legal basis: Article 192 of the TFEU. Impact assessment is envisaged.

5. Revision of Directive 94/62/EC on Packaging and Packaging Waste Directive in order to reinforce the essential requirements for packaging to be placed on the EU market This initiative responds to the priorities announced in the European Green Deal, the new Circular Economy Action Plan and a specific legal mandate in the Packaging and Packaging Waste Directive. The Commission will propose a revision of the essential requirements for packaging to ensure their reuse and recycling, uptake of recycled content and improve their enforceability. The initiative will also envisage measures to tackle over-packaging and to reduce packaging waste. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 114 of the TFEU. Impact assessment is envisaged.

6. Revision of Directive 2010/75/EU on industrial emissions The revision of the Industrial Emissions Directive (IED) is part of the revision of EU measures on pollution from large industrial plants, announced in the European Green Deal. The revision aims at enhancing the directive’s contribution to the zero pollution objective and its consistency with climate, energy and circular economy policies. It will ensure that the directive is fit for purpose of accompanying the upcoming industrial transformation. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 192 of the TFEU; Impact assessment is envisaged.

7. Revision of the Regulation of the European Parliament and of the Council on Statistics on Agricultural Input and Output (SAIO) SAIO is meant to cater for needs stemming from the Common Agricultural Policy post-2020 and the European Green Deal, in particular the Farm to Fork Strategy. The aim is to update agricultural statistics legislation, reduce the burden to provide data, take account of new data needs and ensure better comparability of collected data. It brings together under a common integrated legal frame: o agricultural production statistics including organic farming statistics o agricultural price statistics, and o statistics on plant protection products and on nutrients. Planned adoption date: Q1/2021; Legislative; Legal basis: Article 338 (1) of the TFEU. No impact assessment is envisaged.

8. Revision of the Regulation of the European Parliament and of the Council on European Fishery Statistics, repealing Regulation (EC) No 1921/2006, Regulation (EC) No 762/2008, Regulation (EC) No 216/2009, Regulation (EC) No 217/2009 and Regulation (EC) No 218/2009 The aim of the revision is to streamline and simplify the data collections needed to produce European fishery statistics. It will also align European fishery statistics with the data and information needs of the reformed common fisheries policy. It covers statistics on catches, on landings of fishery products and on aquaculture. Main targets are to use as much as possible the administrative data collected for the Common Fisheries Policy and to reduce the burden on Member States. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 338 of the TFEU. Impact assessment is envisaged.

9. Revision of the Construction Products Regulation (EU No 305/2011) Construction is one of the 14 flagship industrial ecosystems at the centre of the recovery plan. The revision, mentioned in the European Green Deal and the Circular Economy Action Plan, will add a framework for environmental and circularity requirements for construction products, contributing to greater energy and material efficiency in buildings. The initiative will tackle the main issues identified in the evaluation, particularly the problems linked with the development of harmonised technical specifications and especially the blockage of standardisation to improve market surveillance and to deal with still existing problems with national marks or national additional requirements/tests. As a result, it will improve the functioning of the Internal Market for construction products. In addition, it will provide the framework to develop and implement environmental and sustainability criteria for construction products. The evaluation of the CPR has shown that CPR compliance costs represent 0.6% to 1.1% of the sector’s turnover, mainly borne by manufacturers. The analysis confirms the existence of economies of scale in compliance activities and shows that costs can be quite substantial for SMEs, particularly micro-enterprises. Despite the lack of firm evidence regarding the impacts of the CPR on the internal market, stakeholders generally perceive a positive impact of the CPR on cross-border trade. Planned adoption date: Q3/2021; Legislative; Legal basis: Article 114 of the TFEU. Impact assessment is envisaged.

10. Revision of Regulation (EC) No 1831/2003 on additives for use in animal nutrition The Feed Additives Regulation, adopted in 2003 sets out rules for authorising feed additives and placing them on the market. The evaluation performed identified factors that have hampered achievement of some objectives, consequently, a revision is required. In line with the action plan of the Farm to fork strategy, the main aim of the proposal is to contribute to a more sustainable food production system by establishing new criteria to promote the authorisation of feed additives with positive effects on animal welfare and on the environment. It will also build up mechanisms to promote innovation in feed additives, particularly those contributing to reducing the use of antibiotics, improving animal welfare and mitigating climate change effects. It also aims at streamlining the processes to gain efficiencies in risk assessment to bring innovative feed additives earlier to the market and reduce the administrative burden for authorisation holder applications. Planned adoption date: Q4/2021; Legislative; Legal basis: Articles 43 and 168(4)(b) of the TFEU. Impact assessment is envisaged.

11. Evaluation of the Sewage Sludge Directive 86/278/EEC The Sewage Sludge Directive 86/278/EEC aims to encourage the correct use of sewage sludge in agriculture and to regulate its use in order to prevent harmful effects on soil, vegetation, animals and humans. Adopted 30 years ago, the Directive does not fully match the current needs and expectations, such as the regulation of emerging contaminants like pharmaceuticals and microplastics. This evaluation will assess the performance of the Directive and analyse the risks and opportunities related to the management of sewage sludge. It will cover the standard evaluation criteria of effectiveness, efficiency, coherence, relevance and EU added value. The administrative costs will be assessed and particular attention will be paid to impacts on SMEs and micro-enterprises.

12. Evaluation of Directive 2007/2/EC establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) The INSPIRE Directive set up an EU wide digital space for sharing spatial data for protecting the environment. This evaluation will assess whether it has contributed to improve the effectiveness and efficiency of measures to protect the environment. It will also assess whether the directive is still relevant for its stakeholders and coherent with other legislation, notably in the context of the new Green Deal data space initiative.

A Europe fit for the Digital Age

13. Revision of Regional Aid Guidelines The objective of the initiative is to revise the regional State aid guidelines that were to expire at the end of 2020, and are prolonged until 31 December 2021, in order to promote the economic development of certain disadvantaged areas within the European Union as enshrined in Articles 107 (3)(a) and (c) of the Treaty on the Functioning of the European Union. The Regional aid guidelines represent one of the State aid tools that will foster the implementation of the objectives of the European Green Deal and the Digital Strategy. A limited modification of the current Regional aid guidelines is needed to mitigate the consequences of the transition to a green economy. Planned adoption date: Q1/2021; non-legislative, Legal basis: Articles 107 and 108 of the TFEU. No impact assessment is envisaged.

14. Revision of the Energy and Environmental Aid Guideline The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2021). The ongoing Fitness Check has shown that the current rules have worked well but should be updated to reflect regulatory, technological and market developments and accompany adequately the twin digital and green transformation of the economy. In its Communications on the “European Green Deal” and on the “Sustainable Europe Investment Plan”/”European Green Deal Investment Plan”, the Commission committed to revise the EEAG by 2021 to support a cost-effective transition of the economy and industry to climate neutrality by 2050. The revision should provide a modernised and simplified framework enabling public authorities to reach the EU objectives in a cost effective manner with minimum distortions of competition and trade in the Union. In particular, the revision will have to facilitate appropriate measures further promoting a modern decarbonised and circular economy, while ensuring limited distortions of competition and adequate safeguards to the integrity of the single market. The revision should ensure that the revised rules are fit for new technological and market developments and ensure a fair and undistorted transformation of the economy in the next years of economic recovery. Planned adoption date: Q4/2021; non-legislative; Legal basis: Articles 107 and 108 of the TFEU. Impact assessment is envisaged.

15. Revision of the Risk Finance Guidelines The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2021). The ongoing Fitness Check has shown that the current rules have worked well, but should be updated to reflect regulatory, technological and market developments and accompany adequately the current Commission priorities and the economic recovery. Planned adoption date: Q4/2021; non-legislative; Legal basis: Articles 107 and 108 of the TFEU. No impact assessment is envisaged.

16. Revision of the Framework for State aid research, development and innovation The current rules have no expiry date. However, the ongoing Fitness Check has shown that the current rules have worked well, but should be updated in a targeted manner to reflect regulatory, technological and market developments and accompany adequately the current Commission priorities and the economic recovery. Planned adoption date: Q4/2021; non-legislative; Legal basis: Articles 107 and 108 of the TFEU. No impact assessment is envisaged.

17. Revision of the Communication on Important Projects of Common European Interest The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2021). The ongoing Fitness Check has shown that the current rules have worked well, but should be updated in a targeted manner to reflect regulatory, technological and market developments and accompany adequately the current Commission strategic priorities and the economic recovery. Planned adoption date: Q4/2021; non-legislative; Legal basis: Articles 107 and 108 of the TFEU. No impact assessment is envisaged.

18. Revision of the State Aid General Block Exemption Regulation (GBER) in light of the Green Deal The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2023). The ongoing Fitness Check has shown that the current rules have worked well but should be updated to reflect regulatory, technological and market developments and accompany adequately the twin digital and green transformation of the economy. The revision should provide a modernised and simplified framework enabling public authorities to reach the EU objectives in a cost effective manner with minimum distortions of competition and trade in the Union. Planned adoption date: Q4/2021; Legislative; Legal basis: Articles 107 and 108 of the TFEU. No impact assessment is envisaged.

19. Revision of the Guidelines on State aid to the Agricultural and Forestry Sectors and in Rural Areas and Agricultural Block Exemption Regulation (ABER) The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2021). The on-going evaluation has shown that the current rules have worked well but that there is scope for procedural simplification as well as adjustments to increase the effectiveness of certain aid measures. The State aid framework must continue to be closely linked to the legislation under the Common Agricultural Policy, in particular the future regulation on support for national strategic plans. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 107 and 108 of the TFEU. Impact assessment is envisaged.

20. Revision of the Guidelines on State aid for the fishery and aquaculture sector, Block Exemption Regulation (FIBER) and Regulation on de minimis The current rules are applicable until 31 December 2020 (and will be prolonged until 31 December 2021). The on-going evaluation has shown that the current rules have worked well but that there is scope for procedural simplification. The State aid framework must continue to be closely linked the legislation under the Common Fishery Policy, in particular the future regulation on the European Maritime and Fisheries Fund. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 107 and 108 of the TFEU. Impact assessment is envisaged.

21. Revision of the Machinery Directive 2006/42/EC The initiative aims to: (I)address the risks stemming from new technologies while allowing for technical progress (II)simplify the requirements for documentation, by allowing digital formats, hence reducing administrative burden for economic operators, with an additional positive impact on environmental costs (III)improve the legal clarity of some major concepts and definitions in the current text of the Directive (IV)ensure coherence with other Directives and Regulations for products and improve enforcement of the legislation through the alignment to the New Legislative Framework (V)reduce costs of transposition by converting the Directive into a Regulation. Planned adoption date: Q2/2021; Legislative; Legal basis: Article 114 of the TFEU. Impact assessment is envisaged

22. Revision - Computer reservation systems The Regulation on a CRS Code of Conduct establishes a regulatory framework for Computerised Reservation Systems (CRS) for air transport products. The overall general objectives of the Regulation were to prevent abuse of market power and ensure market efficiency and the protection of consumer interests. Planned adoption: Q4/2021; Legislative; Legal basis: Articles 91 and 100(2) of the TFEU. Impact assessment is envisaged.

23. Evaluation of the Commission Notice on market definition in EU competition law Over the past few years, change is happening at an ever more rapid pace, and the world is becoming increasingly digital and interconnected. The current Market Definition Notice dates from 1997 and may therefore not address all pertinent questions arising today when defining the relevant product and geographic market. The Commission has also gained a lot of experience in market definition all these years, techniques have evolved and the EU courts have provided additional guidance. The Commission will evaluate whether its 1997 Notice on market definition requires updating to ensure that it is accurate and up to date and that it sets out a clear and consistent approach to market definition in both antitrust and merger cases across different industries, in a way that is easily accessible. The Commission must ensure that its guidance in antitrust and merger enforcement continues to take into account fully digitisation and technological developments in the current global context.

24. Evaluation of State aid rules for broadband infrastructure deployment The State aid rules applicable to the broadband sector aim at the deployment of pro-competitive broadband networks, ensuring that the public funds are steered into areas that need it most (mainly rural areas), while preventing the crowding out of private investment. The evaluation of these rules aims at verifying how they have functioned, whether they respond to the technological and socio-economic developments and are appropriate to meet the new EU objectives.

25. Evaluation of State aid rules for health and social services of general economic interest The goal of the evaluation is to verify to which extent the rules on health and social Services of General Economic Interest (SGEIs) reached the envisaged objectives under the 2012 SGEI package, namely to support Member States in funding services of general economic interest that are of key importance to citizens and society as a whole while preserving the key aspects of State aid control.

26. Evaluation of the ‘New Legislative Framework for Products’ (Decision No 768/2008/EC on a common framework for the marketing of products and the accreditation and CE marking provisions of Regulation (EC) No 765/2008). The objective of this evaluation is to assess the effectiveness, efficiency, relevance, coherence and EU added value of Decision No 768/2008/EC on a common framework for the marketing of products and the accreditation and CE marking provisions of Regulation (EC) No 765/2008. It should also assess if these instruments are fit for the digital age and a greener economy and if they accelerate our green and digital transition and our economic resilience.

27. Evaluation of the Electromagnetic Compatibility Directive 2014/30/EU The Electromagnetic Compatibility Directive 2014/30/EU (EMCD) addresses electrical equipment placed on the EU market. Its scope covers a high and increasing number of products, both for consumer and professional use. The objectives of the EMCD are to ensure the functioning of the internal market by requiring equipment to comply with an adequate level of electromagnetic compatibility. More specifically, the Directive seeks to ensure that electromagnetic disturbances produced by equipment do not affect the correct functioning of other such equipment, and that such equipment has an appropriate level of immunity to electromagnetic disturbances so that it can function as intended. The purpose of the evaluation is to assess if the EMCD is still fit for purpose in terms of effectiveness, efficiency, relevance, coherence and EU added value.

An Economy that Works for People

28. Revision of Regulation (EU) No 909/2014 of the European Parliament and of the Council of 23 July 2014 on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012 (CSDR) The initiative is based on the experience gathered six years after the entry into force of CSDR, in a limited number of areas practical issues with the application of the new framework have arisen. The forthcoming proposal will therefore set out a number of targeted modifications of CSDR, aimed at simplifying the rules as well as making them more proportionate and less burdensome for stakeholders. These areas may include: (a) cross-border provision of services by Union CSDs and handling of relevant applications (b) the procedures and conditions under which CSDs have been authorised to designate credit institutions or themselves to provide banking-type ancillary services (c) rules relating to internalised settlement (d) Fintech / use of technological innovation Planned adoption date: Q2/2021; Legislative; Legal basis: Article 114 of the TFEU. Impact assessment is envisaged.

29. Evaluation of three passenger rights Regulations on: the rights of persons with disabilities and persons with reduced mobility when travelling by air (Regulations No 1107/2006), the rights of passengers when travelling by sea and inland waterway and (Regulation (EU) No 1177/2010), and the rights of passengers in bus and coach transport (Regulation (EU) No 181/2011) Based on the conclusions of the evaluation, a study for a comparative analysis of the good practices of passenger rights across all transport modes, the outcome of the ongoing legislative procedures for rail and air passenger rights and considering also the lessons of the COVID-19 pandemic in the field of passenger rights.

30. Interim evaluation of the implementation of the Union Customs Code The evaluation will provide a comprehensive assessment of the implementation and impact of the UCC legal and IT framework, at both EU and Member States’ levels, since its entry into force in 2016. The UCC aims, amongst others, to streamline customs rules, procedures and processes, achieve a fully paperless environment and strengthen legal certainty and predictability of customs rules. The evaluation will assess the balance between customs controls and trade facilitation as well as the extent to which the current rules support legitimate economic activity and prevent unfair or illegal trade. Concerning the IT systems, the study should assess whether the automated processes set out in the UCC package have allowed for reinforced collaboration among customs authorities and interoperability between the different electronic systems. The evaluation will attempt to assess all costs of implementing the UCC, together with its electronic systems as well as the benefits of safer, more compliant trade and speedier procedures. The two criteria should then be set against each other in order to assess the ratio and judge the value for money. This assessment should include the regulatory costs and benefits related to the implementation and application of the UCC for all relevant stakeholders (compliance costs, administrative costs, administrative burdens, benefits, savings), as well as the potential for any further simplification and burden reduction, which would not, however, compromise customs objectives.

Promoting our European Way of Life

31. Revision of Directive 2003/109/EC on long-term residents As a follow-up to the 2019 Fitness check on legal migration, the revision of the long-term residents Directive will aim to improve its effectiveness, in particular intra-EU mobility rights. Planned adoption date: Q3/2021; Legislative; Legal basis: Article 79(2) of the TFEU. Impact assessment is envisaged.

32. Revision of Directive 2011/98/EU on the Single permit As a follow to the 2019 Fitness check on legal migration, the revision of the Single permit Directive will aim to simplify and clarify its scope and to ensure a minimum harmonisation of admission and residence conditions for low and medium skilled workers. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 79(2) of the TFEU. Impact assessment is envisaged.

33. Revision of Regulation 258/2012 on export authorisation, and import and transit measures for firearms Improve traceability of firearms (harmonised import markings), improve exchanges of information between national authorities, increase the security of export and import control procedures, better address the imports of easily convertible alarm and signal weapons, apply the whistle-blower-protection regime put in place with Directive (EU) No 2019/1937 to persons who report breaches of the amended Regulation. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 207 of the TFEU. Impact assessment is envisaged.

34. Revision - Maritime Accident Investigation The establishment of a permanent accident investigation body with adequate resources and expertise, able to respond at short notice, is seen as a heavy resource burden and time-consuming task for smaller Member States and States with small fleets. As a result, accidents are going unreported or are not being carried out in a timely, expert and independent manner with possible implications in terms of safety and accidents occurring. The revision could therefore help to focus better the use of resources and address shortages in expertise. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 100(2) of the TFEU. Impact assessment is envisaged.

35. Revision - Port State control The revision will look at the possibility of more use of electronic information to allow for more targeted inspections. This would allow the inspections to concentrate on operational issues rather than just being a documentation check. This would also allow for more concentration on environmental issues and the development of an incentive mechanism for newer/greener and quality shipping. It would help Member States with the recruitment retention and training of suitably qualified inspectors and making use of the inspection database to allow for better burden sharing between Member States. The revision will consider possibly broadening the scope of inspections to include foreign fishing vessels, which have been shown to be particularly dangerous. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 100(2) of the TFEU. Impact assessment is envisaged.

36. Revision - Flag State control The revision will primarily align with already agreed rules in the context of International Maritime Organisation (IMO). But, in terms of possible simplification, it will look at the possibility of modernising Member States ship registry into e-Registers for the keeping and exchanging of e-Certificates (ship related). This should support more efficient services as well as control and monitoring of vessels sailing under their flag. It also links to the simplification and administrative reduction objective of port State control, both for administrations and for industry (quicker turnaround times in ports). In addition, this would also allow for more concentration on environmental issues, in terms of the development of incentives (reward for compliance and not only punish for non-compliance) for good quality and green operators. Via the improved capacity building programme of the European Maritime Safety Agency, it would support Member States in the continuous updating and sharing of best practices (avoiding to ‘re-invent the wheel’ at national level). At the same time working towards greater harmonisation and common understanding to the benefit of a harmonised EU approach both for Administrations and for Industry. Overall improving attractiveness and competitiveness whilst maintaining high levels of safety, security and pollution prevention. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 100(2) of the TFEU. Impact assessment is envisaged.

37. Revision of blood, tissues and cells legislation The revision of Directive 2002/98/EC on safety and quality of human blood and blood components and of Directive 2004/23/EC on safety and quality of human tissues and cells and their implementing acts aims to update the blood, tissues and cells legal frameworks. The EU legislation provides high safety and quality standards for blood, tissues and cells (BTC). These were adopted in response to the transmission of diseases through BTC in the 80s and 90s. The initiative aims to update the current legislation to allow for more flexible alignment to scientific and technological developments. It aims to address the (re‑)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic. It will also address increasing commercialisation and globalisation of the sector. The revision aims at the removal from legislation of many technical provisions, which will allow faster updating of standards. Also, the revision would allow the possibility to merge the basic acts into a single instrument. Planned adoption date: Q4/2021; Legislative; Legal Basis Article 168(4)(a) of the TFEU. Impact assessment is envisaged.

38. Evaluation of Fishing Vessel safety The fishing sector is widely recognised as amongst the most hazardous professions. The current Directive 97/70/EC applies the technical provisions of the IMO 1993 Torremolinos Protocol (TP) an international agreement that has never come into force, to vessels of 24 metres and over. Its successor, the 2012 Cape Town Agreement – CTA, which retains most of the TP provisions, has also not yet entered into force and only by six EU Member States have ratified it. The evaluation of Directive 97/70/EC will address the issue of the non-ratification of the CTA and identify regulatory gaps in safety as well as potential updates to reflect technological developments since 1993, taking inspiration from improvements undertaken in the international merchant shipping sector, as well as in EU shipping legislation. It will also consider the feasibility of regulations at EU level for smaller fishing vessels (less than 24 metres), the sector in which a major proportion of accidents occur.

39. Evaluation of the Directive 2011/24/EU on the application on patient rights in cross-border healthcare Ten years after the Directive’s adoption, the evaluation will assess how the Directive’s objective to facilitate access to safe and high quality cross-border healthcare in another Member State has been met and how the Directive has promoted patient rights and cross-border cooperation between Member States for the benefit of EU citizens. The evaluation will look into the approaches implemented by Member States in practice, how effectively these are working and what areas still act as barriers to patients seeking healthcare across borders.

A New Push for European Democracy

40. Revision of the Directive 99/2008/EC on the protection of the environment through criminal law Based on the outcome of the evaluation, the revision of the Directive will ensure improved and more targeted tools to achieve the objectives and a more consistent interplay with other legislative instruments protecting the environment. The revision will also make use of the reinforced competence in the field of criminal law under the Lisbon Treaty. It will aim at providing better protection of the environment through criminal law in concert with other legislative and implementation measures. Planned adoption date: Q4/2021; Legislative; Legal basis: Article 83(2) of the TFEU. Impact assessment is envisaged.