title: Council Recommendation of 8 July 2014 on the National Reform Programme 2014 of Austria and delivering a Council opinion on the Stability Programme of Austria, 2014

text:
               29.7.2014

               EN

               Official Journal of the European Union

               C 247/92

         COUNCIL RECOMMENDATION
   of 8 July 2014
   on the National Reform Programme 2014 of Austria and delivering a Council opinion on the Stability Programme of Austria, 2014
   2014/C 247/18
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 121(2) and 148(4) thereof,
   Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (1), and in particular Article 5(2) thereof,
   Having regard to the recommendation of the European Commission,
   Having regard to the resolutions of the European Parliament,
   Having regard to the conclusions of the European Council,
   Having regard to the opinion of the Employment Committee,
   Having regard to the opinion of the Economic and Financial Committee,
   Having regard to the opinion of the Social Protection Committee,
   Having regard to the opinion of the Economic Policy Committee,
   Whereas:

               (1)

               On 26 March 2010, the European Council agreed to the Commission's proposal to launch a new strategy for growth and jobs, Europe 2020, based on enhanced coordination of economic policies, which focuses on the key areas where action is needed to boost Europe's potential for sustainable growth and competitiveness.

               (2)

               On 13 July 2010, the Council, on the basis of the Commission's proposals, adopted a Recommendation on the broad guidelines for the economic policies of the Member States and the Union (2010 to 2014) and, on 21 October 2010, it adopted a decision on guidelines for the employment policies of the Member States (2), which together form the ‘integrated guidelines’. Member States were invited to take the integrated guidelines into account in their national economic and employment policies.

               (3)

               On 29 June 2012, the Member States' Heads of State or Government decided on a Compact for Growth and Jobs, providing a coherent framework for action at national, EU and euro area levels using all possible levers, instruments and policies. They decided on action to be taken at the level of the Member States, in particular expressing full commitment to achieving the objectives of the Europe 2020 Strategy and to implementing the country-specific recommendations.

               (4)

               On 9 July 2013, the Council adopted a Recommendation (3) on Austria's National Reform Programme for 2013 and delivered its opinion on Austria's updated Stability Programme for 2012-2017. On 15 November 2013, in line with Regulation (EU) No 473/2013 of the European Parliament and of the Council (4), the Commission presented its opinion on Austria's draft budgetary plan for 2014.

               (5)

               On 13 November 2013, the Commission adopted the Annual Growth Survey, marking the start of the 2014 European Semester for economic policy coordination. Also, on 13 November 2013, the Commission, on the basis of Regulation (EU) No 1176/2011 of the European Parliament and of the Council (5), adopted the Alert Mechanism Report, in which Austria was not identified as one of the Member States for which an in-depth review would be carried out.

               (6)

               On 20 December 2013, the European Council endorsed the priorities for ensuring financial stability, fiscal consolidation and action to foster growth. It underscored the need to pursue differentiated, growth-friendly fiscal consolidation, to restore normal lending conditions to the economy, to promote growth and competitiveness, to tackle unemployment and the social consequences of the crisis, and to modernise public administration.

               (7)

               On 8 April 2014, Austria submitted its 2014 National Reform Programme and, on 29 April 2014, its 2014 Stability Programme. In order to take account of their interlinkages, the two programmes have been assessed at the same time.

               (8)

               The objective of the budgetary strategy outlined in the 2014 Stability Programme is to meet the medium-term objective of a structural deficit of no more than 0.45 % of GDP by 2016, which reflects the requirements of the Stability and Growth Pact. The general government deficit has been sustainably brought below 3 % of GDP in 2013. The (recalculated) structural balance was planned to remain constant in 2014 and to improve by 0,3 percentage points of GDP in 2015, falling significantly short of the required adjustment in both years. Expenditure growth will also deviate significantly from the expenditure benchmark over 2014-15. On 12 May 2014, Austria announced a set of additional revenue and expenditure measures. Provided that these measures are strictly and timely implemented, Austria's budgetary strategy no longer implies a planned significant deviation from the adjustment path towards the medium-term objective in 2014. At the same time, the planned adjustment path towards the medium-term objective still presents risks with respect to compliance with the requirements of the Stability and Growth Pact. According to the Stability Programme, general government gross debt will significantly increase from close to 74,5 % of GDP in 2013 to 79 % of GDP in 2014, due to the impact of the establishment of a Liquidation Entity for the assets of Hypo Alpe Adria, while the debt will start decreasing from 2015 onwards.
               The macroeconomic scenario underpinning the budgetary projections in the Stability Programme is plausible and was prepared by an independent body, the Austrian Institute of Economic Research (WIFO). The Commission services 2014 Spring forecast expects that the deficit will remain below 3 % in 2014 and 2015. However, it projects a deterioration of the structural balance in 2014 and an improvement by only 0,1 % of GDP in 2015. Based on its assessment of the Stability Programme and the Commission forecast as well as its assessment of the additional measures announced on 12 May, pursuant to Regulation (EC) No 1466/97, the Council is of the opinion that Austria has sustainably corrected its excessive deficit, but that a risk of significant deviation from the adjustment path towards the medium-term objective in 2014 and 2015 remains.

               (9)

               In line with the Treaty on Stability Coordination and Governance, Austria has strengthened its fiscal framework in 2012 through a reform of the Austrian Internal Stability Pact. The mandate of the Austrian Fiscal Council was expanded as from November 2013 in response to the requirements of the Fiscal Compact. The need for a thorough reform of the relations of different levels of government to better streamline their respective responsibilities, remains, however, as recognised in the coalition agreement.

               (10)

               Medium and long-term pension and healthcare expenditures and to a lesser degree those for long-term care pose a risk to the sustainability of public finances. In 2014, some measures to limit access to early retirement schemes and to increase incentives for staying longer in employment have entered into force. Still, the effective retirement age of 58,4 years in 2012 is well below the EU average. It remains considerably below the statutory retirement age (by 5,6 years for men and by 2,6 years for women in 2012). The National Reform Programme contains relatively ambitious short-term targets to raise the effective retirement age by 1,6 years between 2012 and 2018, and their implementation will have to be closely monitored. The recent reforms to the pension system are likely to reduce the sustainability risks to some degree, if accompanied by improvements in labour market conditions that allow older workers to stay longer in employment. There are however no plans to introduce measures with a more structural and long-term effect, such as accelerating the harmonisation of the statutory retirement age for men and women and aligning the retirement age with changes in life expectancy, which would additionally contribute to longer working lives and the financial sustainability of the pension system.

               (11)

               Efficient allocation of resources in the Austrian health system is hampered by a complex governance structure and a relatively strong focus on the large and costly hospital sector. Some measures have been taken to implement healthcare reform and to increase the cost‐effectiveness of public spending. However, they may not be sufficient to address structural weaknesses in the sector and there remains a need to set more ambitious targets for shifting from inpatient to outpatient care and to reinforce preventive healthcare, for which public spending is below the EU average. The measures announced to strengthen primary care provision and to develop integrated care programmes for chronic diseases are welcomed. The long-term care fund, which was extended to 2016 with an additional EUR 650 million and is planned to be further extended to 2018 with an extra EUR 700 million, provides an interim solution for the financing of care services. The financial sustainability of long-term care will require attention also beyond this timeline.

               (12)

               Austria's tax system continues to be characterised by a high tax and social security burden on labour, in particular for low-income earners. Labour taxes account for 24,7 % of GDP in 2012, one of the highest in the Union. The tax wedge amounts to almost 50 % of labour costs. High social contributions and entry income taxes are likely to lower incentives to work for individuals with low earnings potential and for second earners.
               The recently adopted tax package includes limited measures to reduce the tax burden on labour but does not exploit the potential for a tax shift towards taxes less detrimental to growth, such as recurrent taxes on immovable property, where estimates of taxable values are outdated.

               (13)

               The Austrian labour market continues to perform well with the lowest unemployment rate in the Union (2013: 4,9 %). However, the future challenges resulting from population ageing and a potentially shrinking work force call for a better use of the underutilised labour market potential of older workers, women and migrants. The employment rate of older workers remains below the EU average (44,9 % as against 50,3 %), although this rate has increased substantially since 2000, by almost 15 percentage points to 44,9 % in 2013. Measures to curb early retirement are becoming effective in 2014 and further measures to strengthen incentives for exiting the labour market later are in preparation. Nevertheless, difficulties for older workers to stay in or re-enter employment remain. Migrants continue to face obstacles to full integration in the labour market and significantly higher unemployment rates, partly due to remaining barriers to the recognition of their qualifications, while they constitute an increasing part of the labour force. While the female employment rate of 70,8 % in 2013 is relatively high, it is far less favourable in full-time equivalents (55,6 % in 2012). Austria has one of the highest percentages of women in part-time employment and a high concentration of women in low-pay employment. As a consequence, the gender pay and pension gap is one of the highest in the Union. Although some measures have been taken to improve childcare and long-term care services, availability is still limited.

               (14)

               Austria has improved educational outcomes in all categories as measured by the OECD's 2012 students' skills survey, but reading achievements still remain below the EU average and the socio-economic background continues to have significant influence on educational achievements. While overall the early school leaving target has been met, the rate for foreign born pupils, who constitute a growing number of pupils, was more than three times higher than for those born in Austria (18,5 % as against 5,7 % in 2012). Insufficient emphasis is put on prevention of early school leaving and a nationwide strategic approach for high-quality early childhood education still needs to be developed. Some reforms to various aspects of the school system, in particular the roll-out of the New Middle School programme, are ongoing or have just been adopted. The potential of New Middle School to mitigate the negative effects of early assignment of pupils to different school types after four years of elementary school (‘early tracking’) for the socially disadvantaged and to improve learning outcomes has to be monitored closely. In higher education, increasing numbers of enrolled students put pressure on finances and organisation, while the percentage of students completing their programmes remains below the EU average. Improving educational outcomes remains highly important in order to facilitate the pathway from education to employment.

               (15)

               There are still significant regulatory barriers which hamper companies and individual professionals in offering their services in Austria. Legislation regulating specific professions limits company forms and imposes shareholding requirements, while at the same time access to individual professions is subject to specific professional qualifications and the establishment of interdisciplinary service companies remains difficult. The combination of these requirements creates barriers to entering the market and exercising professional services which limits competition. With respect to professional qualification requirements, Austria is participating in the EU-wide mutual evaluation exercise and has updated its database of regulated professions as a first step to assessing the justification and proportionality of professional qualification requirements.

               (16)

               Publication requirements in EU procurement legislation aim at ensuring competition and equal-treatment through better information about contract opportunity, which is a key condition for market access. A higher degree of competition among bidders generally results in more favourable offerings for procuring entities including substantial cutting of prices. However, the value of calls for tenders published by Austrian authorities and entities under EU procurement legislation was 1,5 % of GDP and 6,6 % of total public expenditure on works, goods and services in 2012, well below the EU averages of 3,4 % and 17,7 %, respectively. This situation creates considerable costs for the Austrian taxpayer and for businesses in terms of foregone business opportunities.

               (17)

               Despite increases in the budget of the Austrian Federal Competition Authority, it remains significantly understaffed in comparison with the authorities of other Member States of a similar or smaller size. The Austrian freight and passenger railway markets would benefit from further efforts to foster competition, as recommended by the Council in 2013.

               (18)

               While overall banking sector capitalisation continued to improve in 2013, further efforts to strengthen capital buffers appear warranted considering the risk profile of banks. The Council recommended in 2013 that Austria speed up the restructuring of nationalised and partly nationalised banks. Currently, the legal framework for the wind-down of Hypo Alpe Adria is to be presented for adoption by Parliament by summer. The organisational preparation of setting up the respective asset management company (AMC) is in progress. The AMC is expected to become operational in autumn. Österreichische Volksbanken AG and the bad bank of Kommunalkredit, KA Finanz, continue their restructuring or their wind down, respectively, in line with EU state aid decisions. Transparent and decisive steps to complete the restructuring of nationalised banks would be essential to safeguard financial stability and to minimise the negative effects on public finances.

               (19)

               In the context of the European Semester, the Commission has carried out a comprehensive analysis of Austria's economic policy. It has assessed the National Reform Programme and the Stability Programme. It has taken into account not only their relevance for sustainable fiscal and socio-economic policy in Austria but also their compliance with EU rules and guidance, given the need to reinforce the overall economic governance of the Union by providing EU-level input into future national decisions. Its recommendations under the European Semester are reflected in recommendations (1) to (5) below.

               (20)

               In the light of this assessment, the Council has examined the Stability Programme, and its opinion (6) is reflected in particular in recommendation (1) below.

               (21)

               In the context of the European Semester, the Commission has also carried out an analysis of the economic policy of the euro area as a whole. On this basis, the Council has issued specific recommendations addressed to the Member States whose currency is the euro (7). As a country whose currency is the euro, Austria should also ensure the full and timely implementation of those recommendations,

         HEREBY RECOMMENDS that Austria take action within the period 2014-2015 to:

               1.

               Following the correction of the excessive deficit, reinforce the budgetary measures for 2014 in the light of the emerging gap of 0,5 % of GDP based on the Commission services 2014 Spring forecast and after taking into account additional consolidation measures announced by Austria, pointing to a risk of significant deviation relative to the preventive arm of the Stability and Growth Pact requirements. In 2015, significantly strengthen the budgetary strategy to ensure that the medium-term objective is reached and, thereafter, maintained, and ensure that the debt rule is met in order to keep the general government debt ratio on a sustained downward path. Further streamline fiscal relations between layers of government, for example by simplifying the organisational setting and aligning spending and funding responsibilities.

               2.

               Improve the long-term sustainability of the pension system, in particular by bringing forward the harmonisation of the statutory retirement age for men and women, by increasing the effective retirement age and by aligning the retirement age to changes in life expectancy. Monitor the implementation of recent reforms restricting access to early retirement. Further improve the cost effectiveness and sustainability of healthcare and long-term care services.

               3.

               Reduce the high tax wedge on labour for low-income earners by shifting taxation to sources less detrimental to growth, such as recurrent taxes on immovable property, including by updating the tax base. Reinforce measures to improve labour market prospects of people with a migrant background, women and older workers. This includes further improving childcare and long-term care services and the recognition of migrants' qualifications. Improve educational outcomes in particular for disadvantaged young people including those with a migrant background, by enhancing early childhood education and reducing the negative effects of early tracking. Further improve strategic planning in higher education and enhance measures to reduce dropouts.

               4.

               Remove excessive barriers for services providers, including as regards legal form and shareholding requirements and with respect to setting up interdisciplinary services companies. Review whether restrictions on entry into and conduct in regulated professions are proportionate and justified by general interest. Identify the reasons behind the low value of public contracts open to procurement under EU legislation. Substantially strengthen the resources of the Federal Competition Authority.

               5.

               Continue to closely oversee and advance effectively the orderly restructuring of the nationalised and partly nationalised banks.

      Done at Brussels, 8 July 2014.

            For the Council

            The President

         P. C. PADOAN

      (1)  OJ L 209, 2.8.1997, p. 1.

      (2)  Maintained for 2014 by Council Decision 2014/322/EU of 6 May 2014 on guidelines for the employment policies of the Member States for 2014 (OJ L 165, 4.6.2014, p. 49).

      (3)  OJ C 217, 30.7.2013, p. 1.

      (4)  Regulation (EU) No 473/2013 of the European Parliament and of the Council of 21 May 2013 on common provisions for monitoring and assessing draft budgetary plans and ensuring the correction of excessive deficit of the Member States in the euro area (OJ L 140, 27.5.2013, p.11).

      (5)  Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, p. 25).

      (6)  Under Article 5(2) of Regulation (EC) No 1466/97.

      (7)  See page 141 of the current Official Journal.


title: 2005/178/EC:  Commission Recommendation of 1 March 2005 concerning a coordinated Community monitoring programme for 2005 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain other products of plant origin and national monitoring programmes for 2006Text with EEA relevance

text:
               8.3.2005

               EN

               Official Journal of the European Union

               L 61/31

         COMMISSION RECOMMENDATION
   of 1 March 2005
   concerning a coordinated Community monitoring programme for 2005 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain other products of plant origin and national monitoring programmes for 2006
   (Text with EEA relevance)
   (2005/178/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community, and in particular Article 211 thereof,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 7(2)(b) thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 4(2)(b) thereof,
   Whereas:

               (1)

               Directives 86/362/EEC and 90/642/EEC provide that the Commission should progressively work towards a system which would permit the estimation of dietary exposure to pesticides. To make realistic estimations possible, data on the monitoring of pesticide residues should be available in a number of food products which constitute major components of the European diet. It is generally recognised that major components of the European diet are constituted by some 20 to 30 food products. In view of the resources available at national level for pesticide residue monitoring, Member States are only able to analyse samples of eight products each year within a coordinated monitoring programme. Pesticide uses show changes within the timescale of three-year cycles. Each pesticide should thus generally be monitored in 20 to 30 food products over a series of three-year cycles.

               (2)

               Residues of the pesticides covered by this Recommendation should be monitored in 2005, as this will allow using these data for the estimation of actual dietary exposure to them.

               (3)

               A systematic statistical approach to numbers of samples to be taken in each coordinated monitoring exercise is necessary. Such an approach has been set out by the Commission of the Codex Alimentarius (3). On the basis of a binomial probability distribution, it can be calculated that examination of 613 samples allows with a certainty of more than 99 %, the detection of a sample containing pesticide residues above the limit of determination (LOD), provided that less than 1 % of products of plant origin contain residues above that limit. Collection of these samples should be apportioned between Member States on the basis of population and consumer numbers, with a minimum of 12 samples per product and per year.

               (4)

               Guidelines concerning quality control procedures for pesticide residue analysis are published on the Commission website (4). It is agreed that these guidelines should be applied as far as possible by the analytical laboratories of the Member States and should be reviewed continuously in the light of experience gained in the monitoring programmes.

               (5)

               Directives 86/362/EEC and 90/642/EEC require Member States to specify the criteria applied in drawing up their national inspection programmes. Such information should include the criteria applied in determining the numbers of samples to be taken and analyses to be carried out and the reporting levels applied, the criteria by which the reporting levels have been fixed and details of accreditation under Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (5) of the laboratories carrying out analyses. The number and type of infringements and the action taken should also be indicated.

               (6)

               Maximum residue levels for baby food have been established in accordance with Article 6 of Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (6) and Article 6 of Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (7).

               (7)

               Information on the results of monitoring programmes is particularly appropriate for treatment, storage and transmission by electronic/informatic methods. Formats have been developed for supply of data by e-mail from the Member States to the Commission. Member States should therefore be able to send their reports to the Commission in the standard format. The further development of such a standard format is most effectively undertaken by the development of guidelines by the Commission.

               (8)

               The measures provided for in this recommendation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HEREBY RECOMMENDS:

               1.

               Member States are invited, during the year 2005, to take and analyse samples for the product/pesticide residue combinations set out in Annex I, on the basis of the number of samples of each product allocated to them in Annex II, reflecting as appropriate, national, Community and third country share of the Member State’s market.
               Preferably for pesticides posing an acute risk, e.g. OP-esters, endosulfan and N-methylcarbamates, reasonable number of samples of the products: pears, potatoes, carrots, oranges or mandarines, and cucumbers should also be subjected to individual analysis of the individual units in the second laboratory sample in case such pesticides are detected and particularly if it is the produce of a single producer. The number of units should be in line with Commission Directive 2002/63/EC (8).
               Two samples should be taken. If the first laboratory sample contains a detectable residue of a targeted pesticide, the units of the second sample should be analysed individually.
               At least 10 samples of baby food based mainly on vegetables, fruits or cereals should be taken by each Member States.
               Samples should be taken from produce originating from organic farming. The number of samples should be in proportion to the market share of organic produce in each Member State, with a minimum of one sample.

               2.

               Member States are invited to report the results of the analysis of samples tested for the product/pesticide residue combinations set out in Annex I by 31 August 2006 at the latest, indicating:

                           (a)

                           the analytical methods used and reporting levels achieved, in accordance with the quality control procedures set out in the Quality Control Procedures for Pesticide Residue Analysis;

                           (b)

                           the number and type of infringements and the action taken.

                     The report should be produced in a format, including the electronic format, conforming to the guidance to the Member States with regard to implementation of Commission recommendations concerning coordinated Community monitoring programmes provided by the Standing Committee on the Food Chain and Animal Health.
               The result on samples taken from produce originating from organic farming should be reported in a separate datasheet.

               3.

               Member States are invited to send to the Commission and to the other Member States, by 31 August 2005 at the latest, the information required under Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC concerning the 2004 monitoring exercise to ensure, at least by check sampling, compliance with maximum pesticide residue levels including:

                           (a)

                           the results of their national programmes concerning pesticide residues;

                           (b)

                           information on their laboratories quality control procedures and, in particular, information concerning aspects of the guidelines concerning quality control procedures for pesticide residue analysis which they have not been able to apply or have had difficulty in applying;

                           (c)

                           information on accreditation in accordance with the provisions of Article 3 of Directive 93/99/EEC (including type of accreditation, accreditation body and copy of accreditation certificate) of the laboratories carrying out the analyses;

                           (d)

                           information about the proficiency tests and ring tests in which the laboratory has participated.

               4.

               Member States are invited to send to the Commission, by 30 September 2005 at the latest, their intended national programme for monitoring maximum pesticide residue levels fixed by Directives 90/642/EEC and 86/362/EEC for the year 2006, including information on:

                           (a)

                           the criteria applied in determining the number of samples to be taken and analyses to be carried out;

                           (b)

                           the reporting levels applied and the criteria by which the reporting levels have been fixed; and

                           (c)

                           details of accreditation, under Directive 93/99/EEC of the laboratories carrying out analyses.

      Done at Brussels, 1 March 2005.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).

      (2)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2004/115/EC (OJ L 374, 22.12.2004, p. 64).

      (3)  Codex Alimentarius, ‘Pesticide Residues in Foodstuffs’, Rome, 1994, ISBN 92-5-203271-1, volume 2, p. 372.

      (4)  Document number SANCO/10476/2003, http://europa.eu.int/comm/food/plant/protection/resources/qualcontrol_en.pdf

      (5)  OJ L 290, 24.11.1993, p. 14. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (6)  OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

      (7)  OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

      (8)  OJ L 187, 16.7.2002, p. 30.
   ANNEX I
   Pesticide/product combinations to be monitored

               Pesticide residue to be analysed for

               2005

               2006 (1)

               2007 (1)

               Acephate

               (a)

               (b)

               (c)

               Aldicarb

               (a)

               (b)

               (c)

               Azinphos-methyl

               (a)

               (b)

               (c)

               Azoxystrobin

               (a)

               (b)

               (c)

               Benomyl group

               (a)

               (b)

               (c)

               Bifenthrin

               (a)

               (b)

               (c)

               Bromopropylate

               (a)

               (b)

               (c)

               Bupirimate

               (a)

               (b)

               (c)

               Captan

               (a)

               (b)

               (c)

               Carbaryl

               (a)

               (b)

               (c)

               Chlormequat (2)

               (a)

               (b)

               (c)

               Chlorothalonil

               (a)

               (b)

               (c)

               Chlorpropham

               (a)

               (b)

               (c)

               Chlorpyriphos

               (a)

               (b)

               (c)

               Chlorpyriphos-methyl

               (a)

               (b)

               (c)

               Cypermethrin

               (a)

               (b)

               (c)

               Cyprodinil

               (a)

               (b)

               (c)

               Deltamethrin

               (a)

               (b)

               (c)

               Diazinon

               (a)

               (b)

               (c)

               Dichlofluanid

               (a)

               (b)

               (c)

               Dicofol

               (a)

               (b)

               (c)

               Dimethoate

               (a)

               (b)

               (c)

               Diphenylamine (3)

               (a)

               (b)

               (c)

               Endosulfan

               (a)

               (b)

               (c)

               Fenhexamid

               (a)

               (b)

               (c)

               Fludioxonil

               (a)

               (b)

               (c)

               Folpet

               (a)

               (b)

               (c)

               Imazalil

               (a)

               (b)

               (c)

               Imidacloprid

               (a)

               (b)

               (c)

               Iprodione

               (a)

               (b)

               (c)

               Kresoxim-methyl

               (a)

               (b)

               (c)

               Lambda-cyhalothrin

               (a)

               (b)

               (c)

               Malathion

               (a)

               (b)

               (c)

               Maneb group

               (a)

               (b)

               (c)

               Metalaxyl

               (a)

               (b)

               (c)

               Methamidophos

               (a)

               (b)

               (c)

               Methidathion

               (a)

               (b)

               (c)

               Methiocarb

               (a)

               (b)

               (c)

               Methomyl

               (a)

               (b)

               (c)

               Myclobutanil

               (a)

               (b)

               (c)

               Oxydemeton-methyl

               (a)

               (b)

               (c)

               Parathion

               (a)

               (b)

               (c)

               Phosalone

               (a)

               (b)

               (c)

               Pirimicarb

               (a)

               (b)

               (c)

               Pirimiphos-methyl

               (a)

               (b)

               (c)

               Procymidone

               (a)

               (b)

               (c)

               Propargite

               (a)

               (b)

               (c)

               Pyretrins

               (a)

               (b)

               (c)

               Pyrimethanil

               (a)

               (b)

               (c)

               Spiroxamine

               (a)

               (b)

               (c)

               Thiabendazole

               (a)

               (b)

               (c)

               Tolcloflos-methyl

               (a)

               (b)

               (c)

               Tolylfluanid

               (a)

               (b)

               (c)

               Triadimefon

               (a)

               (b)

               (c)

               Vinclozolin

               (a)

               (b)

               (c)

                           (a)

                           Pears, beans (fresh or frozen), potatoes, carrots, oranges or mandarines, spinach (fresh or frozen), rice and cucumber.

                           (b)

                           Cauliflower, peppers, wheat, aubergines, grapes, peas (fresh/frozen, without pod), bananas and orange juice.

                           (c)

                           Apples, tomatoes, lettuce, strawberries, leek, head cabbage, rye or oats, peaches including nectarines and similar hybrids.

      (1)  Indicative for 2006 and 2007, subject to programmes which will be recommended for these years.

      (2)  Chlormequat should be analysed in pears and cereals only.

      (3)  Diphenylamine should be analysed in apples and pears only.
   ANNEX II
   Number of samples of each product to be taken by each Member State

               Code country

               Samples

               AT

               12

               BE

               12

               CY

               12

               CZ

               12

               DE

               93

               DK

               12

               ES

               45

               EE

               12

               EL

               12

               FR

               66

               FI

               12

               HU

               12

               IT

               65

               IE

               12

               LU

               12

               LT

               12

               LV

               12

               MT

               12

               NL

               17

               PT

               12

               PL

               45

               SE

               12

               SI

               12

               SK

               12

               UK

               66

               Total number of samples: 613


title: Council Recommendation (EU) 2016/211 of 12 February 2016 concerning the discharge to be given to the Commission in respect of the implementation of the operations of the European Development Fund (ninth EDF) for the financial year 2014

text:
               16.2.2016

               EN

               Official Journal of the European Union

               L 39/60

         COUNCIL RECOMMENDATION (EU) 2016/211
   of 12 February 2016
   concerning the discharge to be given to the Commission in respect of the implementation of the operations of the European Development Fund (ninth EDF) for the financial year 2014
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, signed in Cotonou on 23 June 2000 (1) and amended by the Agreement signed in Luxembourg on 25 June 2005 (2),
   Having regard to the Internal Agreement between Representatives of the Governments of the Member States, meeting within the Council, on the Financing and Administration of Community Aid under the Financial Protocol to the Partnership Agreement between the African, Caribbean and Pacific States and the European Community and its Member States signed in Cotonou (Benin) on 23 June 2000 and the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the EC Treaty applies (3) (the ‘Internal Agreement’) setting up, amongst others, the ninth European Development Fund (ninth EDF), and in particular Article 32(3) thereof,
   Having regard to the Financial Regulation of 27 March 2003 applicable to the ninth European Development Fund (4), and in particular Articles 96 to 103 thereof,
   Having examined the revenue and expenditure account and the balance sheet relating to the operations of the ninth EDF as at 31 December 2014 and the Annual Report of the Court of Auditors on the activities funded by the eighth, ninth, 10th and 11th European Development Funds (EDFs) concerning the financial year 2014, together with the Commission's replies contained in that Annual Report (5),
   Whereas:

               (1)

               Pursuant to Article 32(3) of the Internal Agreement, the discharge for the financial management of the ninth EDF is to be given to the Commission by the European Parliament on the recommendation of the Council.

               (2)

               The overall implementation by the Commission of the operations of the ninth EDF during the financial year 2014 has been satisfactory,

         HEREBY RECOMMENDS that the European Parliament give the Commission a discharge in respect of the implementation of the operations of the ninth EDF for the financial year 2014.

      Done at Brussels, 12 February 2016.

            For the Council

            The President

         J.R.V.A. DIJSSELBLOEM

      (1)  OJ L 317, 15.12.2000, p. 3.

      (2)  OJ L 209, 11.8.2005, p. 27.

      (3)  OJ L 317, 15.12.2000, p. 355.

      (4)  OJ L 83, 1.4.2003, p. 1.

      (5)  OJ C 373, 10.11.2015, p. 289.


title: 2013/172/EU: Commission Recommendation of 5 April 2013 on a common framework for a unique device identification system of medical devices in the Union  Text with EEA relevance

text:
               9.4.2013

               EN

               Official Journal of the European Union

               L 99/17

         COMMISSION RECOMMENDATION
   of 5 April 2013
   on a common framework for a unique device identification system of medical devices in the Union
   (Text with EEA relevance)
   (2013/172/EU)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
   Whereas:

               (1)

               Traceability of medical devices throughout the whole supply chain contributes to patient safety by facilitating vigilance, market surveillance and transparency in this sector.

               (2)

               The current regulatory framework for medical devices does not include specific provisions on traceability. Therefore, a recommendation paving the way to a reinforced regulatory approach on traceability of medical devices is needed.

               (3)

               The proposal from the European Commission for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (1) adopted on 26 September 2012, and the proposal from the European Commission for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (2) adopted on 26 September 2012, include provisions on traceability of medical devices and in vitro diagnostic medical devices, in order to improve patient health and safety.

               (4)

               The Council conclusions on innovation in the medical device sector (3) of 6 June 2011 invites the Commission and Member States to pay particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially personal health systems.

               (5)

               Significant efforts are being made at international level towards a globally harmonised approach on traceability and to establish a globally accepted unique device identification (UDI) system for medical devices.

               (6)

               UDI mechanisms, based on different national and/or regional traceability requirements, have already been developed and there is a risk that further diverging UDI mechanisms may be developed at these levels.

               (7)

               In future certain information contained in the UDI code could feed the Electronic Health Record according to Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (4) and the Digital Agenda for Europe (5),

         HAS ADOPTED THIS RECOMMENDATION:
   1.   INTRODUCTION

      Purpose of the Recommendation

               1.

               Traceability is currently not regulated by the medical device directives (6) while it is addressed in some cases at national and/or regional level. The differences and incompatibility between the traceability mechanisms may weaken and compromise the efficiency of the systems put in place.

               2.

               In addition, the development of different national and/or regional unique device identification mechanisms would oblige manufacturers to adapt their products to each mechanism in order to fulfil traceability obligations.

               3.

               The best way to ensure effective traceability of medical devices in the Union is to develop a UDI system harmonised at European level. The ongoing revision process of the current Directives on medical devices should empower the Commission to adopt detailed traceability requirements.

               4.

               In the meantime, should Member States decide to develop their own UDI mechanisms it is essential that these are made compatible with each other and with the future UDI system of the Union. This is important in order to avoid the risk of incompatible and divergent systems frustrating the objectives of the internal market and to facilitate the introduction of a harmonized UDI system of the Union.

               5.

               This Recommendation does not aim to define all the aspects of the UDI system. It should be taken as a tool to facilitate the compatibility of the traceability mechanisms established at national and/or regional level and to pave the way to the mandatory implementation of an internationally compatible UDI system of the Union.

      Scope of the Recommendation

               6.

               This Recommendation applies to medical devices, active implantable medical devices (other than devices which are custom-made or intended for clinical investigations) and in vitro diagnostic medical devices (other than those manufactured in health institutions and for performance evaluation), including their accessories.

      International activity on UDI

               7.

               At international level, in 2008 the Global Harmonization Task Force (GHTF) (7) set up an ad hoc working group with the purpose of developing an internationally coordinated approach on UDI.

               8.

               This group, gathering industry and regulators, was chaired by the European Commission and ceased its activity in September 2011, when the GHTF adopted a guidance (8) document on a ‘Unique Device Identification (UDI) System for Medical Devices’.

               9.

               The work of the GHTF towards a further harmonisation of the medical device regulatory framework is being carried out under the auspice of the International Medical Device Regulators Forum (IMDRF) (9).

               10.

               This Recommendation is aligned to the approach developed at international level.

      European activity on UDI

               11.

               In 2010, the European Commission set up a European UDI ad hoc Working Group, within the regulatory framework established by the directives on medical devices, in order to develop a coordinated approach, taking into account the progress made at both national and international level.

               12.

               The aim of the group is threefold:

                           (a)

                           first, it is intended to encourage contributions and monitor the reaction of Competent Authorities to the work carried out at international level;

                           (b)

                           second, it encourages the sharing of views and information on national initiatives developed by Member States and search for common solutions;

                           (c)

                           thirdly, it facilitates the convergence with the future Union legislation of national initiatives developed by Member States.

         2.   RATIONALE

               13.

               The primary objectives of a UDI system are patient safety (10) enhancement and patient care optimisation. It pursues these objectives by:

                           (a)

                           improving incident reporting;

                           (b)

                           facilitating efficient recalls and other field safety corrective actions (FSCA);

                           (c)

                           facilitating efficient post market actions by national competent authorities;

                           (d)

                           enabling queries in numerous data systems;

                           (e)

                           reducing the likelihood of medical errors linked to misuse of the device.

               14.

               The establishment of a UDI system could also support the achievement of other objectives such as the fight against counterfeiting, better distribution control, stock management and reimbursement issues.

               15.

               However, the objectives referred to in paragraph 14 should be seen as possible positive consequences of the UDI system.

      Improvement of incident reporting

               16.

               The use of a UDI is expected to improve incident reporting and offers the opportunity to gather all the incidents related to one medical device at Union level and, in case of an internationally accepted and compatible UDI, at international level. This will increase the potential for comparing results associated with each specific medical device.

      Efficient recalls and other field safety corrective actions

               17.

               The attribution of a unique identifier to a specific device and its use along the distribution chain (global use) will allow the unambiguous identification of the device itself.

               18.

               For traceability to be ensured, it is not sufficient that every manufacturer has developed its own traceability mechanism. The lack of a Union system used all along the supply chain could lead to negative outcomes inasmuch as each actor of the distribution chain might modify the coding developed by the manufacturer. This might give rise to errors in the encoding of medical devices which would in turn endanger the traceability of devices in case of FSCA. The use of the same coding language improves the tracking and tracing of medical devices.

      Efficient post market actions by national competent authorities

               19.

               A UDI system helps specifically to target identified products.

               20.

               In addition, it will provide an opportunity to ensure coordinated reactions by Member States.

      Queries in numerous data systems

               21.

               By using the same UDI in different data systems (both at regulatory and health institutions level) queries will become more efficient and it will be easier to perform searches in order to aggregate information. At the moment, this approach is not possible because each data system has its own identification tool.

      Reduction of medical errors

               22.

               It might be expected that, by using identification mechanisms, the number of cases where medical devices have been incorrectly selected will be reduced.

         3.   DEFINITIONS

   For the purposes of this Recommendation the following definitions apply:

               (a)

               ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

                           —

                           diagnosis, prevention, monitoring, treatment or alleviation of disease,

                           —

                           diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

                           —

                           investigation, replacement or modification of the anatomy or of a physiological process,

                           —

                           control of conception,

                     and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (11);

               (b)

               ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure (12);

               (c)

               ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

                           —

                           concerning a physiological or pathological state, or

                           —

                           concerning a congenital abnormality, or

                           —

                           to determine the safety and compatibility with potential recipients, or

                           —

                           to monitor therapeutic measures.

                     Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
               Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination (13);

               (d)

               ‘traceability’ means the ability to trace the history, application or location of that which is under consideration;

               (e)

               ‘unique device identification — UDI’ means a series of numeric or alphanumeric characters that is created through an internationally accepted device identification and coding standard and allows the unambiguous identification of specific medical devices on the market. The UDI comprises the device identifier and production identifier;

               (f)

               ‘device identifier’ means a unique numeric or alphanumeric code specific to a manufacturer and a device model;

               (g)

               ‘production identifier’ means a unique numeric or alphanumeric code that identifies data related to the unit of device production;

               (h)

               ‘UDI carrier’ means the way in which the unique device identification is conveyed by means of the Automatic Identification and Data Capture (14) (AIDC) and, if applicable, its human readable interpretation (HRI);

               (i)

               ‘UDI electronic system’ means a central repository/database storing device identifier codes and related/associated identifying information of specific devices placed on the Union market;

               (j)

               ‘human readable interpretation’ means a legible format of the data characters encoded in the AIDC symbol;

               (k)

               ‘direct part mark’ means any technology which can be used to fix a symbol on the surface of an item (e.g. producing two different surface conditions by laser etching, moulding, peening or other technologies like ink jet printing or flexography);

               (l)

               ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party (15);

               (m)

               ‘authorised representative’ means any natural or legal person established within the Union who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under the relevant Community legislation (16);

               (n)

               ‘importer’ means any natural or legal person established within the Union who places a device from a third country on the Union market (17);

               (o)

               ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market (18);

               (p)

               ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor (19);

               (q)

               ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients and/or the promotion of public health;

               (r)

               ‘user’ means the person, either professional or lay, who uses a device.

         4.   RISK BASED APPROACH

               23.

               Should Member States intend to establish a UDI system they should follow a risk based approach in accordance with the classification of the device.

               24.

               The UDI system should be implemented gradually, starting from highest risk class devices which should be the first to respect the condition to bear the UDI.

      UDI type

               25.

               The UDI should comprise two parts, a device identifier and a production identifier.

               26.

               The device identifier should contain static information (20) specific to a manufacturer and a device model and is also used as the ‘access key’ to information stored in a UDI database.

               27.

               The production identifier should contain dynamic information (21) identifying data related to the unit of device production and determine the level of traceability to be achieved.

               28.

               UDI should appear in both human readable format (human readable version composed of a series of numeric or alphanumeric characters) and in a format that can be read by an AIDC technology and conveyed via a carrier.

               29.

               If there are significant constraints limiting the use of both AIDC and HRI on the label, the AIDC format should be favoured. However, certain environments or use situations, such as home care, may warrant the use of HRI over AIDC.

               30.

               Member States should monitor that differentiation between the different classes of devices is based exclusively on the type of production identifier (dynamic information) in accordance with paragraph 31.

               31.

               As a general rule, the information provided by the production identifier (dynamic information) should vary according to the different risk classes as follows (22):

                           —

                           expiration date and/or manufacturing date for class I,

                           —

                           lot/batch number for class IIa,

                           —

                           lot/batch number for class IIb,

                           —

                           lot/batch number or serial number (23) for class III.

               32.

               Where appropriate, manufacturers may choose a production identifier (dynamic information) applicable to a higher class than the device in question.

      UDI application

               33.

               As a general rule, UDI should be applied to every packaging level for all classes of devices (24).

               34.

               UDI carrier (AIDC and HRI representation of the UDI) should be on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging (25).

         5.   CONDITIONS TO BE FULFILLED BY ECONOMIC OPERATORS, HEALTH INSTITUTIONS AND PROFESSIONAL USERS

               35.

               In order to achieve the objectives of the UDI system, while developing their own national UDI mechanisms, the economic operators and health institutions should store through the distribution chain information related to both the device identifier (static information) and the production identifier (dynamic information). Health institutions and, where feasible, professional users should use this information in their reporting of incidents. This will, in particular, allow a more efficient action in case of recall or withdrawal of products.

               36.

               Information related to the device identifier (static information) should be collected into the national UDI databases.

               37.

               Once the future European databank on medical devices (Eudamed) is established, information related to device identifier (static information) will be centralised at European level via a European UDI electronic system which will be part of the future Eudamed.

               38.

               As regards information related to production identifier (dynamic information), it should not be sent to the national UDI databases and will not be included in the European UDI electronic system.
               For the purpose of this Recommendation economic operators, health institutions and professional users should align with the following conditions.

      Manufacturers

               39.

               First, manufacturers should appropriately allocate a UDI (static and dynamic parts) to the medical devices they manufacture.

               40.

               Second, they should provide the required data elements (see Annex) to be included in the UDI database.

               41.

               Third, they should modify the labelling of their products in order to print the UDI code as far as practicable on the label of the device, its package, or on the device itself (direct part mark), and on all higher levels of packaging, as referred to in paragraph 34.

               42.

               Fourth, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information).

               43.

               Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied each specific product.

      Importers

               44.

               First, importers should verify that the manufacturer has appropriately allocated a UDI (static and dynamic parts) to the product before they put it on the Union market. Where an importer considers or has reason to believe that this condition has not been fulfilled, he should not place the device on the Union market until it is brought into conformity.

               45.

               Second, importers should not remove or modify the UDI, otherwise traceability will be impossible.

               46.

               Third, they should ascertain whether the device has already been registered in the UDI database of the Member State where the device has been placed on the Union market.

               47.

               If the device has already been registered, importers should verify that the device identifier (static information) on the product corresponds to that in the UDI database.

               48.

               If the device has not yet been registered, the importers should align with the conditions concerning the registration of the information related to the device identifier (static information).

               49.

               Fourth, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information).

               50.

               Fifth, they should keep an electronic record of the economic operator who has supplied them with a device.

               51.

               Lastly, they should keep electronic record of the economic operator, health institution or professional users to whom they have supplied the device.

      Authorised representatives

               52.

               Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he should designate a single authorised representative in the Union. The designation must be effective at least for all devices of the same model.

               53.

               The authorised representatives should have access, on request, to the record of both device identifier (static information) and production identifier (dynamic information) related to the product(s) for which he is appointed.

      Distributors

               54.

               First, before making a device available on the market distributors should verify that the manufacturer and, where applicable, the importer has appropriately allocated a UDI (static and dynamic parts) to the product. Where a distributor considers or has reason to believe that this condition has not been fulfilled, he should not make the device available on the Union market until it is brought into conformity.

               55.

               Second, distributors should not remove or modify the UDI, otherwise traceability will be impossible.

               56.

               Third, they should keep an electronic record of both device identifier (static information) and production identifier (dynamic information).

               57.

               Fourth, they should keep an electronic record of the economic operator who has supplied them with a device.

               58.

               Lastly, they should keep an electronic record of the economic operator, health institution or professional users to whom they have supplied a device.

      Health institutions

               59.

               First, health institutions should keep an electronic record of both device identifier (static information) and production identifier (dynamic information) of medical devices entering these organisations. Information related to both device identifier (static information) and production identifier (dynamic information) in respect of devices for which incidents are reported should be used by health institutions in their reporting of incidents.

               60.

               Second, for certain medical devices, such as those used for high risk procedures and/or specifically intended to be used for high risk patients, a link should be established between the device used and the patient treated with it. Therefore, health institutions should keep a record of which device has been used on which patient.

               61.

               Third, for certain devices such as implantable medical devices, health institutions should store both device identifier (static information) and production identifier (dynamic information) in the electronic patient record. Indeed, in case of recall, it should be possible to know exactly which medical device has been implanted to which patient.

      Professional users

               62.

               Where feasible, information related to both device identifier (static information) and production identifier (dynamic information) in respect of devices for which incidents are reported should be used by professional users in their reporting of incidents.

         6.   UDI NATIONAL DATABASES

      Data elements

               63.

               Member States who intend to establish a UDI system for medical devices are invited to build it on national UDI databases.

               64.

               For the purpose of this Recommendation, Member States are invited to promote the use of the Extensible Markup Language (XML), as a common format for data exchange between UDI databases, and take into account relevant specifications and semantic standards existing in the area.

               65.

               The data elements, which are listed in the Annex, should be introduced in UDI national databases and should correspond to the elements linked to the device identifier (static information).

      Done at Brussels, 5 April 2013.

            For the Commission

         Tonio BORG

            Member of the Commission

      (1)  COM(2012) 542 final

      (2)  COM(2012) 541 final.

      (3)  OJ C 202, 8.7.2011, p. 7.

      (4)  OJ L 88, 4.4.2011, p. 45.

      (5)  http://ec.europa.eu/digital-agenda/

      (6)  Council Directive 90/385/EEC (OJ L 189, 20.7.1990, p. 17), Council Directive 93/42/EEC (OJ L 169, 12.7.1993, p. 1), Directive 98/79/EC of the European Parliament and of the Council (OJ L 331, 7.12.1998, p. 1).

      (7)  The ‘Global Harmonization Task Force (GHTF)’ is a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonisation in the regulation of medical devices. The GHTF mission ended in December 2012.

      (8)  www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n2r3-2011-unique-device-identification-system-110916.pdf

      (9)  The ‘International Medical Device Regulators Forum (IMDRF)’ was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonisation. It is a voluntary group of medical device regulators from Australia, Brazil, Canada, China (observer), European Union, Japan, Russia (observer) and the United States who have come together to build on the strong foundational work of the ‘Global Harmonization Task Force on Medical Devices (GHTF)’. The ‘World Health Organization (WHO)’ participates in the IMDRF as an observer.

      (10)  Patient safety is understood as the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the processes of health care. These events include ‘errors’, ‘deviations’, ‘accidents’. Safety emerges from the interaction of the components of the system; it does not reside in a person, device or department. Improving safety depends on learning how safety emerges from the interactions of the components. Patient safety is a subset of health care quality.

      (11)  Article 1(2)(a) of Directive 93/42/EEC.

      (12)  Article 1(2)(c) of Directive 90/385/EEC.

      (13)  Article 1(2)(b) of Directive 98/79/EC.

      (14)  The Automatic Identification and Data Capture refers to the methods for automatically identifying objects, collecting data about them, and entering the data directly into computer systems.

      (15)  Article 1(2)(f) of Directive 93/42/EEC.

      (16)  Article 1(2)(j) of Directive 93/42/EEC.

      (17)  Article 2(5) of Regulation (EC) No 765/2008 of the European Parliament and of the Council (OJ L 218, 13.8.2008, p.30).

      (18)  Article 2(6) of Regulation (EC) No 765/2008.

      (19)  Article 2(7) of Regulation (EC) No 765/2008.

      (20)  This information does not vary from one to another device of the same specific model.

      (21)  This information varies according to the different way the production process is controlled (by expiration/manufacturing date, lot/batch number or serial number).

      (22)  In accordance with international guidance, possible exceptions and/or exemptions to the general rule, based on the device class, should be taken into account.

      (23)  The serial number allows the identification of the individual device unit.

      (24)  In accordance with international guidance, possible exceptions and/or exemptions to the general rule, based on the device class, should be taken into account.

      (25)  According to international guidance, pallets are not included in the notion of higher levels of packaging therefore UDI conditions do not apply to pallets.

      ANNEX

         DATA ELEMENTS OF THE NATIONAL UDI DATABASES

      National databases on UDI should include the following data elements:

                  (a)

                  quantity per package configuration;

                  (b)

                  if applicable, alternative or additional identifier(s);

                  (c)

                  the way how the device production is controlled (expiration date or manufacturing date, lot or batch number, serialisation number);

                  (d)

                  if applicable, the unit of use device identifier (when a UDI is not assigned to the device at the level of its unit of use, a ‘unit of use’ device identifier shall be assigned to associate the use of a device with a patient);

                  (e)

                  name and address of the manufacturer (as indicated on the label);

                  (f)

                  if applicable, name and address of the authorised representative (as indicated on the label);

                  (g)

                  Global Medical Device Nomenclature (GMDN) code or internationally recognised nomenclature code;

                  (h)

                  if applicable, trade/brand name;

                  (i)

                  if applicable, device model, reference, or catalogue number;

                  (j)

                  if applicable, clinical size (including volume, length, gauge and diameter);

                  (k)

                  additional product description (optional);

                  (l)

                  if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use);

                  (m)

                  if applicable, additional trade names of the device;

                  (n)

                  labelled as single use device (y/n);

                  (o)

                  if applicable, restricted number of reuses;

                  (p)

                  device packaged sterile (y/n);

                  (q)

                  need for sterilisation before use (y/n);

                  (r)

                  labelled as containing latex (y/n);

                  (s)

                  labelled as containing DEPH (y/n);

                  (t)

                  URL for additional information, e.g. electronic instructions for use (optional);

                  (u)

                  if applicable, critical warnings or contraindications.


title: Council Recommendation of 12 July 2011 on the National Reform Programme 2011 of the Czech Republic and delivering a Council opinion on the updated Convergence Programme of the Czech Republic, 2011-2014

text:
               19.7.2011

               EN

               Official Journal of the European Union

               C 212/5

         COUNCIL RECOMMENDATION
   of 12 July 2011
   on the National Reform Programme 2011 of the Czech Republic and delivering a Council opinion on the updated Convergence Programme of the Czech Republic, 2011-2014
   2011/C 212/02
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 121(2) and 148(4) thereof,
   Having regard to Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies (1), and in particular Article 9(3) thereof,
   Having regard to the recommendation of the European Commission,
   Having regard to the conclusions of the European Council,
   Having regard to the opinion of the Employment Committee,
   After consulting the Economic and Financial Committee,
   Whereas:

               (1)

               On 26 March 2010, the European Council agreed to the Commission's proposal to launch a new strategy for jobs and growth, Europe 2020, based on enhanced coordination of economic policies, which will focus on the key areas where action is needed to boost Europe's potential for sustainable growth and competitiveness.

               (2)

               On 13 July 2010, the Council adopted a recommendation on the broad guidelines for the economic policies of the Member States and the Union (2010 to 2014) and, on 21 October 2010, adopted a decision on Guidelines for the employment policies of the Member States (2), which together form the ‘integrated guidelines’. Member States were invited to take the integrated guidelines into account in their national economic and employment policies.

               (3)

               On 12 January 2011, the Commission adopted the first Annual Growth Survey, marking the start of a new cycle of economic governance in the EU and the first European semester of ex-ante and integrated policy coordination, which is anchored in the Europe 2020 strategy.

               (4)

               On 25 March 2011, the European Council endorsed the priorities for fiscal consolidation and structural reform (in line with the Council's conclusions of 15 February and 7 March 2011 and further to the Commission's Annual Growth Survey). It underscored the need to give priority to restoring sound budgets and fiscal sustainability, reducing unemployment through labour market reforms and making new efforts to enhance growth. It requested Member States to translate these priorities into concrete measures to be included in their Stability or Convergence Programmes and National Reform Programmes.

               (5)

               On 29 April 2011, the Czech Republic submitted its 2011 National Reform Programme and on 5 May its 2011 Convergence Programme update covering the period 2011-2014. In order to take into account the interlinkages, the two programmes have been assessed at the same time.

               (6)

               The global financial crisis, channelled through the Czech economy's high trade openness, took a heavy toll on GDP growth and unemployment in the Czech Republic. Real GDP declined by 4,1 % in 2009, as a result of the fall in exports and in domestic investment. The unemployment rate increased significantly from 4,4 % in 2008 to 7,3 % in 2010, and the employment rate fell by two percentage points between 2008 and 2010. However, the high degree of exposure to international trade and a fast recovery in the Czech Republic's main trading partners have also facilitated a relatively quick rebound in the real GDP growth rate in 2010 to 2,3 % and will continue to support a moderate recovery.

               (7)

               Based on the assessment of the updated Convergence Programme pursuant to Regulation (EC) No 1466/97, the Council is of the opinion that the macroeconomic assumptions underpinning the Convergence Programme are plausible in the first two years of the Programme and favourable thereafter, when assessed against the Commission's medium-term projections of potential output according to the commonly agreed methodology. The Convergence Programme is based on a lower growth projection for 2012 compared with the Commission services' 2011 Spring forecast, mainly on account of a further sustained reduction in real government consumption expenditure, which is not taken up in the Commission services' no-policy-change forecast for 2012. The Convergence Programme foresees a reduction of the general government deficit below 3 % of GDP in 2013 and further to 1,9 % of GDP in 2014. The planned consolidation is mainly based on expenditure restraint. The proposed measures are broadly sufficient to reach the target by 2013, as recommended by the Council, but there are risks to the actual budgetary outcome of measures as presented in the Convergence Programme. Moreover, the attainment of the targets for the outer years of the Convergence Programme seems to rely on favourable cyclical conditions and further efficiency gains in public administration, which may become increasingly difficult to materialise. The achievement of the medium-term budgetary objective is foreseen beyond the horizon of the Convergence Programme. The average annual fiscal effort over the period 2010-2013 is slightly below 1 % of GDP recommended by the Council under the EDP procedure of 2 December 2009.

               (8)

               The Convergence Programme set out a clear objective to bring the deficit in public finances below 3 % of GDP by 2013. The challenge will be to ensure that measures underlying the path for the deficit reduction in 2011-2013, as well as in subsequent years, do not compromise long-term growth, especially by safeguarding expenditure on education and public R&D, and that they provide an adequate buffer for increases in expenditure entailed by demographic developments.

               (9)

               The budgetary consolidation strategy includes measures that affect VAT revenue: the lower VAT rate is planned to rise in 2012 and 2013, while the higher rate is to decrease in 2013. The government also intends to increase the number of firms liable to VAT from 2013. According to the Convergence Programme, these changes should result in an increase in tax receipts of 0,7 % of GDP in 2012 and further by 0,1 % of GDP in 2013. In addition, there seems to be further scope for boosting revenue from indirect taxes, which stood at 11,8 % of GDP in 2010, compared to the EU average of 13,4 %, and thereby possibly shift taxes away from labour. The envisaged tax reform will partly focus on this issue. Furthermore, the difference between actual VAT revenue and the theoretical VAT liability is estimated to be significantly above the EU average, substantiating the need for measures improving tax compliance. To this end, the Czech Republic has introduced new measures in 2011, aimed at tackling VAT fraud and reducing tax evasion.

               (10)

               Given that the budgetary impact of ageing is projected to be well above the EU average, the reform of the pension system is an important issue. The government has put forward two sets of proposals. The first package is expected to receive Parliamentary approval by September 2011 and targets the public Pay-As-You-Go pillar, which has been in deficit since 2009. It includes, among other measures, an increase in the statutory retirement age, which will be unified at 66 years and 8 months in 2041 for men and women born in 1975. For each subsequent age cohort, the retirement age will increase by two more months, without a predetermined limit. This set of parametric reforms should help address the fiscal sustainability problem; it may, however, not be sufficient to address all challenges presented by demographic pressures. The second package of measures, not yet approved by the government, would consist in the introduction of a voluntary second private pillar in 2013, with the aim to increase diversification in retirement incomes and support their future adequacy by promoting the development of private savings. However, the suggested form of the pillar creates few incentives to join the scheme and may actually add to the long-term pressures highlighted above. The operating costs of such pension funds also need to be carefully analysed and kept as low as possible to ensure the effectiveness of the system.

               (11)

               The labour market is perceived as moderately flexible and had not shown evidence of major dysfunctions before the global financial crisis. Yet, some structural weaknesses are evident. A key challenge concerns the severe difficulties that women with children face when re-integrating into the labour market after maternity leave. The issue is significant also because of its wider economic repercussions: longer periods out of work, a high gender employment gap, and very high gender pay gap. Early return to work remains difficult despite the government's effort to give parents greater choice in determining the length of parental leave. The problem can be attributed partly to the low willingness of firms to provide part-time employment contracts, often used by employees with small children in other Member States, and partly to limited availability of affordable childcare facilities. The National Reform Programme identifies a number of concrete measures to increase availability of childcare, including for children below the age of three.

               (12)

               While the overall unemployment rate and the long-term unemployment rate remain firmly below the EU average, the latter has been increasing as a consequence of the crisis, particularly among the 20- to 29-year-olds. The poorly educated as well as other low-wage earners face considerable difficulties in finding employment. The expenditure on active labour market policies and the share of participants in regular activation measures should be increased and these measures should be better targeted.

               (13)

               Inefficiencies in public administration, which weigh on the business environment, could be addressed by comprehensively implementing existing strategies. The government has launched a ‘better regulation’ agenda in 2007 and an anti-corruption strategy for the years 2011-2012. They announce measures that are important to improve the quality of the Czech legal and regulatory framework, which ranks below the EU average according to international surveys, and strengthen the confidence of businesses. A challenge is to stabilise the public administration, as frequent and far-reaching reorganisations impede its efficiency. For doing so, it would be important to adopt the Public Servant Act, which has been repeatedly postponed. The government has recently adopted measures to increase the transparency of public procurement. However, one element of the regulatory framework, namely the specific type of company shares that permit a fully anonymous transfer of wealth deserves attention.

               (14)

               The crisis is expected to have negativly impacted on potential growth. Improving human capital is important, despite the high ratio of young people enrolled in universities, and is hindered by insufficient quality of training, as illustrated by the low ranking of Czech tertiary education institutes in international surveys. Furthermore, spending per student, in comparable prices, is in the lower quarter of the Member States and is especially limited for primary education. The National Reform Programme outlines measures for all stages of education. A complex reform of tertiary education has been in preparation for several years. Ensuring quality and efficient tertiary education is important for competitiveness and innovation capacity.

               (15)

               The Commission has assessed the Convergence Programme and National Reform Programme of the Czech Republic. It has taken into account not only their relevance for sustainable fiscal and socio-economic policy in the Czech Republic but also their conformity with EU rules and guidance, given the need to reinforce the overall economic governance of the EU by providing EU-level input into future national decisions. In this light, the Commission considers that the focus on fiscal consolidation should be kept, while protecting growth-enhancing expenditure. The long-term sustainability of public finances depends, to a large extent, on the capacity to implement now the necessary pension reform. Raising labour market participation, in particular of women, and job opportunities for the long-term unemployed, are essential. Further steps to improve the quality of public services and the regulatory framework, as well as the quality of tertiary education, are crucial for competitiveness.

               (16)

               In light of this assessment, also taking into account the Council Recommendation under Article 126(7) of the Treaty on the Functioning of the European Union of 2 December 2009, the Council has examined the 2011 update of the Convergence Programme of the Czech Republic and its opinion (3) is reflected in particular in its recommendations 1 and 2 below. Taking into account the European Council conclusions of 25 March 2011, the Council has examined the National Reform Programme of the Czech Republic,

         HEREBY RECOMMENDS that the Czech Republic take action within the period 2011-2012 to:

               1.

               Implement the planned consolidation in 2011 and take countervailing measures of a permanent nature as needed in case of any revenue shortfalls or expenditure slippages. Adopt fiscal measures as planned in the Convergence Programme for 2012 and underpin the target for 2013 by more specific measures; subject to this, avoid cutting expenditure on growth-enhancing items. Improve the efficiency of public investments, and continue efforts to exploit the available space for increases in indirect tax revenue to shift taxes away from labour, improve tax compliance, and reduce tax evasion. Ensure an average fiscal effort over the period 2010-2013 of 1 % of GDP, in line with the Council recommendations on correcting the excessive deficit, which will allow meeting the EDP deadline with a sufficient margin in 2013.

               2.

               Implement the planned pension reform in order to improve the long-term sustainability of public finances and to ensure the future adequacy of pensions. Additional efforts should focus on further changes to the public pillar to ensure that the system is not a source of fiscal imbalances in the future, and on the development of private savings. With a view to raising the effective retirement age, measures such as a link between the statutory retirement age and life expectancy could be considered. Ensure that the envisaged funded scheme attracts broad participation, and is designed to keep administrative costs transparent and low.

               3.

               Enhance participation in the labour market by reducing the barriers for parents with young children to re-enter the labour market through increased availability and access to affordable childcare facilities. Increase the attractiveness and availability of more flexible forms of working arrangements, such as part-time jobs.

               4.

               Improve the performance of the public employment service in order to increase the quality and effectiveness of training, job search assistance and individualised services, linking funding of the programmes to results. In cooperation with stakeholders, extend tailor-made training programmes, for older workers, young people, low-skilled workers and other vulnerable groups.

               5.

               Take the necessary measures to improve the quality of public services in areas essential for the business environment. In this context speed up the implementation of the anti-corruption strategy in line with the identified targets, adopt the Public Servants Act to promote stability and effectiveness of the public administration and take steps to address the issue of anonymous share holding.

               6.

               Establish a transparent system of quality evaluation of academic institutions and link it to its funding in order to improve the performance of tertiary education.

      Done at Brussels, 12 July 2011.

            For the Council

            The President

         J. VINCENT-ROSTOWSKI

      (1)  OJ L 209, 2.8.1997, p. 1.

      (2)  Maintained for 2011 by Council Decision 2011/308/EU of 19 May 2011 on guidelines for the employment policies of the Member States (OJ L 138, 26.5.2011, p. 56).

      (3)  Foreseen in Article 9(3) of Regulation (EC) No 1466/97.