Draft Guidelines on Outsourcing to Cloud Service Providers

Responding to this paper

ESMA invites comments on all matters in this paper and in particular on the specific questions summarised in Appendix 1. Comments are most helpful if they:

·       respond to the question stated;

·       indicate the specific question to which the comment relates;

·       contain a clear rationale; and

·       describe any alternatives ESMA should consider.

ESMA will consider all comments received by 1 September 2020.

All contributions should be made using the specific response form and submitted online using the form below.

Publication of responses

All contributions received will be published following the close of the consultation, unless you request otherwise. Please clearly and prominently indicate in your submission any part you do not wish to be publicly disclosed. A standard confidentiality statement in an email message will not be treated as a request for non-disclosure. A confidential response may be requested from us in accordance with ESMA’s rules on access to documents. We may consult you if we receive such a request. Any decision we make not to disclose the response is reviewable by ESMA’s Board of Appeal and the European Ombudsman.

Data protection

Information on data protection can be found at www.esma.europa.eu under the heading ‘Data protection’.




EMCDDA technical report on the new psychoactive substance N,Ndiethyl- 2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1Hbenzimidazole- 1-ethanamine (isotonitazene)

EMCDDA, Lisbon, June 2020

Summary

The purpose of this technical report is to provide an analysis of the available information on N,N-diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5-nitro-1H-benzimidazole-1-ethanamine (commonly known as isotonitazene), an opioid analgesic that has recently emerged on the drug market in Europe, to support a risk assessment of the substance that has been requested by the European Commission in accordance with Article 5c of Regulation (EC) No 1920/2006 (as amended).

Explanatory note: In the interests of public health protection the EMCDDA is releasing this report before formal copy editing and page layout in the EMCDDA house style. The final report will be available on this page in due course.

Download as PDF

Table of contents

  • 1. Summary
  • 2. Chemical and physical properties, methods and the precursors used for manufacture or extraction
    • 2.1 Background
    • 2.2 Names and chemical structur
    • 2.3 Physical properties
    • 2.4 Methods and chemical precursors used for the manufacture or extraction
    • 2.5 Methods for identification and analysis
    • 2.6 Dosage regimens
  • 3. Legitimate use
    • 3.1 Summary
    • 3.2 Medical use
    • 3.3 Industrial, commercial, and scientific use
  • 4. Pharmacological and toxicological properties
    • 4.1 Summary
    • 4.1 Pharmacodynamics
    • 4.2 Psychological and behavioural effects
    • 4.3 Safety pharmacolog
    • 4.4 Pharmacokinetics
    • 4.5 Toxicology
    • 4.6 Abuse liability and dependence producing potential
  • 5. Extent and patterns of use, availability, and potential for diffusion
    • 5.1 Summary
    • 5.2 Information from seizures
    • 5.3 Information from collected samples
    • 5.4 Information from biological samples
  • 6. Health risks
    • 6.1 Summary
    • 6.2 Acute health effects
    • 6.3 Chronic health effects
  • 7. Social risks
    • 7.1 Individual social risks
    • 7.2 Possible effects on direct social environment
    • 7.3 Possible effects on society as a whole
    • 7.4 Economic costs
    • 7.5 Possible effects related to the cultural context, for example marginalisation.
    • 7.6 Possible appeal to specific population groups within the general population
    • 7.7 Involvement of criminal groups in the manufacture, distribution and distribution methods, and trafficking
  • 8. Other relevant information
    • 8.1 Information on restrictive measures
  • 9. References

Main subject:

NPS




We need a paradigm shift in water management

​In this interview, Piotr Całbecki (PL/EPP), President of the Kujawsko-Pomorskie Region, answers five questions related to water management in the context of the COVID-19 and unabated global warming. The rapporteur of the CoR opinion on ‘The Water Framework Directive and the Floods Directive’ calls for a paradigm shift that places circularity and sustainability at the centre of our way of using natural resources, and water in particular. The draft opinion will voted on at the next ENVE Commission meeting on 8 June. The opinion is scheduled to be adopted at the 1-2 July plenary session alongside a high-level debate on the European Green Deal.

As the rapporteur on the Water Framework Directive, could you tell us why this topic is important for the EU and its regions and cities? How do you assess its implementation after 20 years of entering into force and what lessons can we draw?

The Water Framework Directive has had very positive effects. Not only by improving the ecological status of freshwater and costal ecosystems in Europe, but also by raising our society’s environmental awareness. However, after 20 years of implementation, new challenges as well as new solutions have arisen. Among the new challenges we face are the increasing symptoms of global warming and the urgent necessity to implement the European Green Deal and a new strategy to boost the circular economy and the bio-economy. First, we need systemic solutions, which will transform the threat of droughts into opportunities, starting by integrating the Water Framework Directive and the Flood Directives. In addition, we need to disseminate innovative solutions and exploit the opportunities created by eco-hydrology and nature-based solutions. These are effective tools, especially for mitigating intermediate impacts, such as non-point source pollutions from agriculture and urbanised areas, which generate about 50% of pollutants in some catchment areas.

You are the President of the Kujawsko-Pomorskie Region. Water scarcity and droughts are also a growing challenge in Poland. How important is it to involve regional and local authorities in water management?

The Kujawsko-Pomorskie Region is one of the most diversified regions in Poland when it comes to water resources. Yet, we also face problems that we need to solve urgently. Water levels in the Vistula river have dramatically decreased due to droughts in recent years. On the southern part of our region, intensive agricultural land has been exposed to water scarcity, which has generated soil erosion, non-point source pollution to lakes and rivers, and a long-term decline in sustainability. However, in the northern part of the region, large natural forests and lakes are a paradise for biodiversity. As a regional president with a university degree in the restoration of lakes, I am well placed to know that local and regional authorities are pivotal to water management. We are best placed to identify the specific challenges that each territory and community is facing, but we are also better positioned to develop tailored policies that consider those same specificities.

Climate change and the COVID-9 pandemic are having a great impact on water resources, services and delivery across Europe and around the world. What should be done to ensure that clean, good-quality water is accessible to everyone?

We have to change our perception of how we interact with nature. We must transform the ongoing mechanistic approach through which we allow ourselves to consume natural resources blindly and without control, not least as we are constantly depositing back waste and pollutants. We need to evolve and embrace an ecosystem approach that places circularity at the centre of our way of using natural resources, and water in particular. Sustainability in water management is not possible without responsible, inclusive decision-making that ensures clean water is accessible to everyone.

Your opinion will also contribute to the ZeroPollution Action Plan for air, water and soil that the European Commission will present next year. What would be your main message in this context?

My main message is that we need to change our relationship with nature and, consequently, to develop environmentally respectful policies. In the Anthropocene age in which we live, a period in which human activity is the dominant influence on climate and the environment, we must all become responsible decision-makers. Will we continue to degrade nature and pose a direct threat to human civilisation, or will we learn to manage resources in a sustainable way? We have a great opportunity to move towards a circular economy that is respectful to the environment, consuming water and other vital resources in a sustainable way. The Zero-Pollution Action Plan for air, water and soil is a pivotal point in that shift.

Your opinion concerns challenges related to floods, water pollution and the environmental consequences of human activity. What instruments do local and regional authorities need in order to respond better to these challenges?

The impact of human activity on the environment and water resources in particular have a cumulative effect and are  creating a dangerous spiral. We need a new paradigm based on scientific evidence that helps local and regional authorities to make the best policy choices. To achieve this, it is important to establish permanent cooperation between local and regional policy-makers and scientists. As an example, we are proud of mentioning our cooperation with Professor Maciej Zalewski, the director of the European Regional Centre for Ecohydrology (ERCE), the international institute of the Polish Academy of Sciences devoted to the study of interactions between water and ecological systems.

As a second step, we need additional instruments to reinforce education about sustainability, raising awareness in our communities and developing knowledge and values that lead to more sustainable patterns of living. The digital world brings huge opportunities for citizens to be directly involved in this endeavour. A mobile application recently developed by the project AMBER (Adaptive Management of Barriers in European Rivers) is a good example, as it also includes a ‘citizen science’ programme to involve authorities, NGOs and the public in data collection and dissemination. Today, the European Green Deal offers new opportunities, as it provides a coherent vision based on a solid inter-disciplinary framework. That is why I am optimistic about the future.

Notes:

The draft opinion ‘Fitness Check of the Water Framework Directive and the Floods Directive’ by rapporteur Piotr Całbecki (PL/EPP) is available in 23 EU languages and will be voted during the next ENVE commission meeting on 8 June. Meeting documents are downloadable here.

A third of EU’s land suffers from water stress. Water scarcity is a concern in many Member States. While climate change results in unpredictable weather patterns, increasing droughts and shortfalls in the quantity and quality of freshwater resources are to be expected. CoR Press Release 11/12/2018 on ‘Reusing water for agriculture and keeping our urban areas green.’

Press Contact:

David Crous
Tel.: +32 (0) 470 88 10 ​37
​david.crous@cor.europa.eu




COVID-19 could lead to more resilient EU asylum procedures

Initially limited by the emergency measures, national asylum authorities largely made strong efforts to resume services wherever possible, often within weeks. At the same time, Member States should be prepared for a possible ‘second wave’, while lessons learnt may contribute to more effective asylum procedures in the longer term.

A new report published by the European Asylum Support Office (EASO) outlines how the asylum and reception authorities of EU+ Member States were impacted by the outbreak of COVID-19 in February 2020. It further describes how national services adapted their working methods in the subsequent weeks and months in order to resume as many activities as possible.

The extraordinary national health measures taken to mitigate the COVID-19 pandemic affected the functioning of the asylum and reception systems of 30 European countries to differing degrees. The impact largely corresponded directly to the extent of the national emergency measures. In most cases, face-to-face services, such as the registration of applications and interviews were temporarily discontinued.

The emergency measures, however, did not necessarily equate to the complete suspension of asylum procedures and services. In more than 20 EU+ countries, asylum authorities continued many services through teleworking arrangements. This is reflected, for example, in the number of first instance decisions issued during this period.

National authorities also took measures to mitigate the impact on asylum seekers, such as by extending deadlines to lodge applications, introducing electronic access to information and communication, as well as automatically extending the validity of documents.

Member States also worked quickly, as well as in coordination with the European Commission and EASO, in order to adapt to the new circumstances. As early as the beginning of April, some authorities began conducting remote interviews. As national measures begin to be lifted, many national services are also resuming those asylum and reception services which could not be adapted.

EASO also issued recommendations on remote asylum interviews, while the European Commission issued guidance on the implementation of EU rules on asylum procedures in the context of COVID-19.

EASO’s report also cautions Member States to assess the procedures which were adapted as a result of emergency measures in case there is a need to revert to them as a result of a second wave. Furthermore, many of the adapted workflows show the potential to improve the resilience of national asylum systems. Member States should make efforts to incorporate these on a permanent basis.

Any further information may be obtained from the European Asylum Support Office on the following email address: press@easo.europa.eu.




Taxation: Council approves conclusions on future administrative cooperation and excise duty on tobacco

The Council today approved conclusions setting out political guidance and priorities in view of further reforms in two key areas of EU tax policy:

On both matters, the Council calls on the Commission to come forward with legislative proposals in order to address the issues and concerns set out in the conclusions.

Future evolution of administrative cooperation in the EU

Administrative cooperation helps national tax authorities collect and safeguard tax revenues. Close cooperation between these bodies is also vital to detect and reduce tax fraud.

The first directive on administrative cooperation (DAC) was adopted in 2011. Since then, the scope of the directive has been expanded on five occasions and now covers:

  • the exchange of information between national authorities on financial accounts information,
  • cross-border tax rulings and advance pricing agreements,
  • country specific reports which provide certain financial information concerning the largest multinational corporations,
  • access to beneficial ownership information,
  • information on potentially aggressive cross-border tax planning arrangements.

The conclusions stress that efforts to improve administrative cooperation to fight tax fraud and tax evasion are particularly relevant in the context of the need for recovery from the crisis caused by the COVID-19 pandemic.

Excise duty on tobacco

Excise duties are indirect taxes on the sale or use of specific products, such as alcohol, tobacco and energy.

Since 2011, EU legislation sets out common rules for taxing manufactured tobacco, including categories of products, minimum rates and structures to be applied. Manufactured tobacco is also subject to the common provisions for excisable goods under EU law.

The conclusions highlight in particular that the applicable rules have become less effective, as they are either no longer sufficient or too narrow to address current and future challenges related to certain products, such as liquids for e-cigarettes, heated tobacco products and other types of next-generation products which are entering the market.