The development, production and dissemination of statistical information on the economic activities of Member States' businesses has so far been based on a number of individual legal acts. Those legal acts cover short-term and structural business statistics, statistics on production, intra-Union and extra-Union trade (international trade) in goods and services, foreign affiliates, research and development (R&D), innovation and information and communication technologies (ICT) usage and e‐commerce. Moreover, a common framework for business registers for statistical purposes in the Union was established by Regulation (EC) No 177/2008 of the European Parliament and of the Council.

This structure based on individual legal acts does not provide the necessary consistency across the individual statistical domains, nor does it promote an integrated approach towards the development, production and dissemination of business statistics. For the purpose of this Regulation, European business statistics should also cover R&D statistics in the higher education, government and private non-profit sectors. A common legal framework should be established to ensure consistency across European business statistics and facilitate the integration of the corresponding statistical processes.

Better integrated statistical processes based on common methodological principles, definitions and quality criteria should lead to harmonised statistics on the structure, the economic activities, the transactions and the performance of the business sector in the Union which meet the level of relevance and detail required to fulfil user needs.

The EuroGroups Register is intended to ensure that Union guidance, such as Commission Recommendation 2003/361/EC, which is of relevance for European business statistics, can be more effectively followed, in particular with respect to the identification of autonomous enterprises as defined in Article 3 of that Recommendation. Such Union guidance is needed to foster legal certainty and business predictability and to create a level playing field for Union-based small and medium-sized enterprises (SMEs).

International guidance, such as the Frascati Manual, which concerns R&D statistics, and the Oslo Manual, which concerns innovation data, and international agreements adopted by the United Nations, the Organisation for Economic Cooperation and Development, the International Monetary Fund and other international and supranational organisations, are of relevance for European business statistics. Such guidance should, to the extent possible, be followed in the development, production and dissemination of Union statistics and within the European framework for statistical business registers, in order to ensure that the Union statistics are comparable with those compiled by the Union's main international partners. However, Union standards, agreements and guidelines should be applied consistently when collecting data for European business statistics on the R&D inputs and innovation topics.

The administrative burden on businesses, in particular on SMEs, should be as limited as possible taking into account to the extent possible other data sources than surveys. For the purpose of alleviating the burden on enterprises it should be possible to establish different data requirements depending on the size and importance of the business economies of Member States.

The European Statistical System (ESS) Vision 2020 stated that data should be used across statistical domains for better analysing emerging phenomena (e.g. globalisation) and for better serving Union policies of high impact. The data output should be based on efficient and robust statistical processes of the ESS. The broader scope of the common legal framework for business statistics should enable the integration of interdependent production processes drawing upon multiple sources.

The Programme for the Modernisation of European Enterprise and Trade Statistics adopted pursuant to Decision No 1297/2008/EC of the European Parliament and of the Council, which ran from 2009 to 2013, aimed at helping to adapt the business and trade-related statistics to new data needs and adjust the system for the production of business statistics. The conclusions and recommendations resulting from that programme regarding the priorities and new sets of indicators, the streamlining of the framework for business-related statistics, the more efficient production of statistics on enterprise and trade and the modernisation of intra-Union trade in goods statistics should be translated into legally binding provisions.

There is a need for a more flexible approach within the framework for European business statistics to allow adaptations to methodological developments and a timely response to emerging and duly justified data-user needs resulting from the changing economic environment and the increasing globalisation and complexity of the business landscape. Such future adaptations should be supported by adequate cost-benefit analyses and resulting new data requirements should not impose a significant additional cost or burden on the Member States or on the respondents.

The role of national statistical business registers and the EuroGroups register as basic infrastructure for the collection and compilation of data for European business statistics should be enhanced. National statistical business registers should be used as the main source of information for statistical analysis of the business population and its demography, for the definition of the survey population and for establishing the link to administrative data sources.

To ensure the role of the national statistical business registers and the EuroGroups register, a unique identifier for all relevant units should be established and implemented.

The proper delineation of enterprise groups in the EuroGroups register with timely and reliable data should be achieved by the use of harmonised criteria and regular updating of the information on links of control between the legal units being part of the enterprise groups.

In order to improve the efficiency of the statistical production processes of the ESS and to reduce the statistical burden on respondents, national statistical authorities (NSAs) should have the right to access and use, promptly and free of charge, all national administrative records and to integrate those administrative records with statistics, to the extent necessary for the development, production and dissemination of European business statistics, in accordance with Article 17a of Regulation (EC) No 223/2009 of the European Parliament and of the Council.

Regulation (EC) No 223/2009 provides a reference framework for European statistics. In particular, it requires compliance with the principles of professional independence, impartiality, objectivity, reliability, statistical confidentiality and cost-effectiveness.

The exchange of and access to microdata by the NSAs producing business statistics and maintaining the European framework for statistical business registers should be introduced, for the development, production and dissemination of national or European business statistics or for increasing the quality of European business statistics. The exchange of microdata should be limited to duly justified cases.

The creation of an additional data source based on the exchange of microdata on intra‐Union exports of goods, together with the possibility to use innovative methodologies increases the flexibility for the Member States in their compilation of intra-Union trade in goods statistics, thereby enabling the Member States to reduce the response burden on businesses. The purpose of the exchange is the efficient development, production and dissemination of statistics on international trade in goods and the improvement of the quality of such statistics.

The negotiation, implementation and review of trade and investment agreements between the Union and third countries or multilaterally requires that the necessary statistical information on Member States′ trade flows with third countries be made available to the Commission.

A close link should be maintained between the system for collecting statistical information and the fiscal formalities related to the value added tax which exist in the context of trade in goods between Member States. That link makes it possible, in particular, for the purpose of intra-Union trade in goods statistics, to identify exporters and importers and to check the quality of the information collected.

The cross-border movement of goods, in particular from or to third countries, is subject to customs supervision as provided for under Regulation (EU) No 952/2013 of the European Parliament and of the Council. Customs authorities keep or have access to information or records concerning such movement. The information or records, which are related to or based on customs declarations, should be used for the production of statistics on Union trade in goods.

In order to produce statistics on international trade in goods and to improve the quality of those statistics, the NSAs in the Member States should exchange data on imports and exports of goods which involve the customs authorities of more than one Member State. To ensure harmonised compilation of the statistics, the exchange of those microdata between the NSAs should be mandatory.

To safeguard the quality and comparability of European business statistics or national accounts in line with the concepts and methodology of Regulation (EU) No 549/2013 of the European Parliament and of the Council, the exchange of confidential data should be allowed between the NSAs of Member States concerned, their respective national central banks, the European Central Bank (ECB) and the Commission (Eurostat) only for statistical purposes.

In order to carry out its tasks under the Treaties, especially tasks related to the functioning of the internal market, the Commission should have full, up-to-date and reliable information on the production of goods and services in the Union and on international trade flows. Enterprises also need such information in order to monitor their markets and the international dimension of those markets.

Members States or national competent authorities should endeavour to simplify the collection of data from European businesses to the extent possible. The NSAs should take account of the latest digital developments at the time when the instruments and methods for collecting data for statistics are being established and should be encouraged to implement innovative approaches.

There is a need to provide business statistics by sector of activity, in order to measure the productivity of businesses in the Union. In particular, there is an increasing demand for statistics on the services sector, which is the most dynamic sector of modern economies, especially in terms of that sector's potential for growth and employment creation and taking into account the relations with the manufacturing sector. This trend is further enhanced by the development of new digital services. The increasing demand for statistics is also the case for creative and cultural industries, as stated in the resolution of the European Parliament of 13 December 2016 on a coherent EU policy for cultural and creative industries. Statistics on trade in services are essential for monitoring the functioning of the internal market for services and the digital single market and assessing the impact of barriers on trade in services.

Regulation (EC) No 223/2009 constitutes the reference framework for this Regulation, including as regards the protection of confidential data. However, the very detailed level of information in the field of statistics on international trade in goods requires specific rules with regard to confidentiality. An importer or exporter of goods needs to submit a request to the NSA that statistical results allowing the indirect identification of such an importer or exporter are not disclosed. The NSA should consider the request to be justified where the statistical results allow the indirect identification of the importer or exporter. Otherwise, the NSA should be able to disseminate the statistical results in a form that make it possible for the importer or exporter to be identified indirectly.

The monitoring of the progress towards the goals set by the Europe 2020 strategy at Member State and Union level requires harmonised statistics on the Union economy regarding climate change and resource efficiency, R&D, innovation, the information society covering both market and non-market activities and on the business landscape as a whole, in particular on business demography and employment related to market activities. Such information allows decision makers to take informed policy decisions in order to develop an economy based on knowledge and innovation, improve access to the internal market for SMEs, develop entrepreneurship and improve sustainability and competitiveness.

Statistics on innovation and R&D activities are needed for the development and monitoring of policies that aim to strengthen the competitiveness of Member States and increase their medium and long-term potential for smart growth and employment. An expanding digital economy and the increased use of ICT are also among the important drivers of competitiveness and growth in the Union, and statistics are needed to support the related strategies and policies, including the completion of the digital single market.

Business statistics are also needed for the compilation of national and regional accounts in accordance with Regulation (EU) No 549/2013.

Reliable and timely statistics are necessary in order to report on the economic development in each Member State within the framework of the economic policy of the Union. The ECB needs quickly available short-term statistics in order to assess economic developments in the Member States in the context of the single monetary policy.

While maintaining the principle of providing business statistics on the entire economy, the data requirements should take into account, to the extent possible, simplifying measures for the purpose of alleviating the burden on the business economies of relatively small Member States, in accordance with the principle of proportionality. Additional requirements should not place a disproportionate administrative burden on respondents.

International standards, such as the Statistical Data and Metadata Exchange (SDMX) initiative, and statistical or technical standards elaborated within the ESS, such as metadata and validation standards, should be used to the extent relevant also for European business statistics. The ESS Committee (ESSC) has endorsed an ESS Standard for Quality Reports, in accordance with Article 12 of Regulation (EC) No 223/2009. Those standards should contribute to the harmonisation of quality assurance and reporting under this Regulation.

In order to take account of economic and technical developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to amend the types of statistical information, to further specify the details of the statistical information to be provided by the tax and customs authorities in accordance with Annexes V and VI, respectively, and to amend the detailed topics set out in Annex I and this Regulation by reducing the coverage rate for intra-Union exports of goods. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

In order to ensure uniform conditions for the implementation of this Regulation with regard to the details of the variables as well as the format, security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the European framework for statistical business registers, the arrangements for, content of and deadlines for transmission of quality and metadata reports, the standards for data and metadata transmission, and derogations from the requirements of this Regulation or from the delegated or implementing acts adopted pursuant thereto, implementing powers should be conferred on the Commission. For the same purpose, implementing powers should be conferred on the Commission with regard to specifying the arrangements for the provision and exchange of certain administrative records as well as the format, security and confidentiality measures and the procedure for the exchange of confidential data for the purpose of the intra-Union trade in goods statistics, the specifications of the relevant metadata, the timetable, the arrangements for the collection and compilation of the statistical information on intra-Union exports of goods provided to the Member State of import, the arrangements for the application of the coverage rate of the total intra‐Union exports of goods with regard to the reference period, setting out the technical specifications related to the statistical data elements for the statistical information on intra-Union trade in goods to be provided to the Member State of import and the related simplifications. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and the Council.

Where appropriate the Commission should conduct cost-benefit analyses and ensure that any action it puts forward does not impose a significant additional cost or burden on Member States or respondents, in particular on SMEs, taking into account the expected user benefits and that it leads to an increase in the quality of the statistics.

The Commission should be able to grant derogations from the application of this Regulation, or from delegated and implementing acts adopted pursuant thereto, where such application results in major adaptations to a national statistical system of a Member State in terms of organising additional surveys or making major adaptations to its statistical production system to accommodate new data sources or to allow for a combination of different sources.

Where new data requirements or improvements to data sets covered by this Regulation are needed, the Commission should be able to launch pilot studies to be carried out by the Member States on a voluntary basis. As a priority, the Commission should be able to launch pilot studies that cover international trade in services, real estate, financial indicators and environment and climate.

Since the objective of this Regulation, namely the establishment of a common framework for European business statistics cannot be sufficiently achieved by the Member States but can rather, for reasons of harmonisation and comparability, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

The measures set out in this Regulation should replace those of Regulations (EC) No 48/2004, (EC) No 638/2004, (EC) No 808/2004, (EC) No 716/2007, (EC) No 177/2008, (EC) No 295/2008 and (EC) No 471/2009 of the European Parliament and of the Council, Decision No 1608/2003/EC of the European Parliament and of the Council and Council Regulations (EEC) No 3924/91 and (EC) No 1165/98. Those acts should therefore be repealed.

The European Data Protection Supervisor has been consulted in accordance with Article 28(2) of Regulation (EC) No 45/2001 of the European Parliament and of the Council.

The ESSC has been consulted,