24.5.2016   

EN

Official Journal of the European Union

L 135/1

(1)

Section 1 of Chapter II of Title I of Part II of Regulation (EU) No 1308/2013 of the European Parliament and of the Council (4) provides for a school fruit and vegetables scheme and a school milk scheme.

(2)

The experience gained with the application of the current school schemes, together with the conclusions of the external evaluations and subsequent analysis of different policy options and of the social difficulties faced by Member States, point to the conclusion that the continuation and strengthening of the two school schemes is of the utmost importance. In the current context of declining consumption of fresh fruit and vegetables and milk products, especially among children, and of an increasing incidence of child obesity as a result of consumption habits geared to highly processed foods which, in addition, are often high in added sugars, salt, fat or additives, the Union aid to finance the supply to children in educational establishments of selected agricultural products should do more to promote healthy eating habits and the consumption of local products.

(3)

The analysis of different policy options indicates that a unified approach under a common legal and financial framework is the most appropriate and effective way of meeting the specific objectives that the common agricultural policy is pursuing through school schemes. Such an approach would allow Member States to maximise the impact of distribution within a fixed budget and increase management efficiency. However, in order to take into account the differences between fruit and vegetables, including bananas, and milk and milk products, i.e. ‘school fruit and vegetables’ and ‘school milk’ as defined in this Regulation, and their supply chains, certain elements, such as the respective budgetary envelopes, should remain separate. In the light of the experience with the current schemes, participation in the school scheme should continue to be voluntary for Member States. Taking into account the different consumption patterns across Member States, it should be possible for participating Member States and regions to choose, in the context of their strategies, which of the products eligible for supply to children in educational establishments they wish to distribute. Member States could also consider introducing targeted measures in order to address declining milk consumption in the target group.

(4)

A trend of declining consumption of, in particular, fresh fruit and vegetables and drinking milk has been identified. It is therefore appropriate to focus distribution under the school scheme on those products as a priority. This would also help to reduce the organisational burden on schools and to increase the impact of the distribution within a limited budget and would be in line with the current practice, as those products are the ones most frequently distributed. However, in order to follow nutritional recommendations on calcium absorption and to promote the consumption of specific products or to respond to particular nutritional needs of children in their territory, and given the increase in problems associated with intolerance to lactose in milk, Member States should be allowed, provided that they already distribute drinking milk or lactose-free versions thereof, to distribute other milk products without added flavouring, fruit, nuts or cocoa, such as yoghurt and cheese, which have beneficial effects on children's health. Member States should also be allowed to distribute processed fruit and vegetable products, provided that they already distribute fresh fruit and vegetables. Furthermore, efforts should be made to ensure the distribution of local and regional products. In cases where Member States consider it necessary for the attainment of the objectives of the school scheme and the goals stated in their strategies, they should be allowed to supplement the distribution of the abovementioned products with certain other milk products and milk-based drinks. All those products should be fully eligible for Union aid. However, in the case of non-agricultural products, only the milk component should be eligible. In order to take into account scientific developments and to ensure that distributed products meet the objectives of the school scheme, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of supplementing the list of excluded flavour enhancers set out in this Regulation and defining the maximum levels for added sugar, added salt and added fat in processed products.

(5)

Accompanying educational measures that support distribution are necessary in order to make the school scheme effective in reaching its short- and long-term objectives of increasing the consumption of selected agricultural products and shaping healthier diets. Given their importance, such measures should support the distribution of school fruit and vegetables and school milk. As accompanying educational measures, they represent a critical tool for reconnecting children with agriculture and the variety of Union agricultural products, particularly those produced in their region, with the help, for example, of nutrition experts and farmers. In order to meet the objectives that the school scheme is pursuing, Member States should be allowed to include in their measures a wider variety of agricultural products as well as other local, regional or national specialities, such as honey, table olives and olive oil.

(6)

So as to promote healthy eating habits, Member States should ensure the appropriate involvement of their national authorities responsible for health and nutrition in the drawing up of a list of the products to be supplied, or the appropriate authorisation by those authorities of that list, in accordance with national procedures.

(7)

In order to ensure the efficient and targeted use of Union funds and to facilitate the implementation of the school scheme, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the identification of costs and measures that are eligible for Union aid.

(8)

The Union aid should be allocated separately for school fruit and vegetables and school milk in line with the voluntary approach to distribution. That aid should be allocated to each Member State taking into account the number of six- to ten-year-old children in that Member State and the degree of development of the regions within that Member State, so as to ensure that higher aid is allocated to less developed regions, to the smaller Aegean Islands and to the outermost regions in view of their limited agricultural diversification and the frequent impossibility of finding certain products in the region concerned, which results in higher transport and storage costs. Moreover, in order to allow Member States to maintain the scale of their current schemes for school milk and with a view to encouraging other Member States to take up the distribution of milk, it is appropriate to combine those criteria with the historical use of the Union aid for the supply of milk and milk products to children, with the exception of Croatia, for which a specific amount is to be determined.

(9)

In the interest of sound administration and budget management, Member States wishing to participate in the distribution of the eligible products should submit every year requests for Union aid.

(10)

A national or regional strategy should be a condition for a Member State's participation in the school scheme. Any Member State wishing to participate should present a strategy in the form of a document covering a period of six years and setting out its priorities. Member States should be allowed to update their strategies regularly, in particular in the light of evaluations and reassessments of priorities or targets and of the success of their schemes. Furthermore, strategies may contain specific elements related to the implementation of the school scheme which will enable Member States to achieve efficiencies in the management, inter alia, of aid applications.

(11)

In order to promote awareness of the school scheme and to increase the visibility of Union aid, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the obligation by Member States to clearly publicise the Union support for implementing the scheme, including in relation to publicity tools and, if appropriate, the common identifier or graphic elements.

(12)

In order to ensure the visibility of the school scheme, Member States should explain in their strategy how they will ensure the added value of their schemes, especially where products financed under the Union scheme are consumed at the same time as other meals provided to children in an educational establishment. In order to ensure that the educational purpose of the Union scheme is attained and effective, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the rules concerning the distribution of the products financed under the Union scheme in relation to the provision of other meals in educational establishments and their preparation.

(13)

In order to verify the effectiveness of the school scheme in the Member States, financing should be provided by the Union for initiatives to monitor and evaluate the results achieved, with particular attention being paid to medium-term changes in consumption.

(14)

The co-financing principle for the distribution of school fruit and vegetables should be abolished.

(15)

This Regulation should not affect the division of regional or local competences within Member States.

(16)

Regulation (EU) No 1308/2013 and Regulation (EU) No 1306/2013 of the European Parliament and of the Council (5) should therefore be amended accordingly. In order to take into account the periodicity of the school year, the new rules should become applicable as from 1 August 2017,

(1)

Section 1 of Chapter II of Title I of Part II is replaced by the following:

‘Section 1

Aid for the supply of fruit and vegetables and of milk and milk products in educational establishments

Article 22

Target group

The aid scheme intended to improve the distribution of agricultural products and improving children's eating habits is aimed at children who regularly attend nurseries, pre-schools or primary or secondary-level educational establishments which are administered or recognised by the competent authorities of Member States.

Article 23

Aid for the supply of school fruit and vegetables and of school milk, accompanying educational measures and related costs

1.   Union aid shall be granted in respect of children in the educational establishments referred to in Article 22:

The Council shall, in accordance with Article 43(3) TFEU, lay down limits for the proportion of Union aid covering measures and costs referred to in points (b) and (c) of the first subparagraph of this paragraph.

2.   For the purposes of this Section:

3.   Member States wishing to participate in the aid scheme established pursuant to paragraph 1 (“the school scheme”) and requesting the corresponding Union aid shall, taking into account national circumstances, prioritise the distribution of products of either or both of the following groups:

4.   Notwithstanding paragraph 3, in order to promote the consumption of specific products and/or to respond to particular nutritional needs of children in their territory, Member States may provide for the distribution of products of either or both of the following groups:

5.   In cases where Member States consider it necessary for the attainment of the objectives of the school scheme and the goals stated in the strategies referred to in paragraph 8, they may supplement the distribution of products referred to in paragraphs 3 and 4 with products listed in Annex V.

In such cases, the Union aid shall be paid only for the milk component of the distributed product. That milk component shall not be lower than 90 % by weight for products of Category I of Annex V and 75 % by weight for products of Category II of Annex V.

The level of Union aid for the milk component shall be fixed by the Council in accordance with Article 43(3) TFEU.

6.   Products distributed under the school scheme shall not contain any of the following:

Notwithstanding the first subparagraph of this paragraph, any Member State may, after obtaining the appropriate authorisation from its national authorities responsible for health and nutrition in accordance with its national procedures, decide that eligible products referred to in paragraphs 4 and 5 may contain limited quantities of added sugar, added salt and/or added fat.

7.   In addition to products referred to in paragraphs 3, 4 and 5 of this Article, Member States may provide for the inclusion of other agricultural products under the accompanying educational measures, in particular those listed in points (g) and (v) of Article 1(2).

8.   As a condition for its participation in the school scheme, a Member State shall draw up, prior to its participation in the school scheme, and subsequently every six years, at national or regional level, a strategy for the implementation of the scheme. The strategy may be amended by the authority responsible for drawing it up at national or regional level, in particular in the light of monitoring and evaluation and of the results achieved. The strategy shall at least identify the needs to be met, the ranking of the needs in terms of priorities, the target group, the results expected to be achieved and, if available, the quantified targets to be attained in relation to the initial situation, and lay down the most appropriate instruments and actions for attaining those objectives.

The strategy may contain specific elements relating to the implementation of the school scheme, including those intended to simplify its management.

9.   Member States shall determine in their strategies the list of all the products to be supplied under the school scheme either through regular distribution or under accompanying educational measures. Without prejudice to paragraph 6, they shall also ensure the appropriate involvement of their national authorities responsible for health and nutrition in drawing up that list, or the appropriate authorisation by those authorities of that list, in accordance with national procedures.

10.   Member States shall, in order to make the school scheme effective, also provide for accompanying educational measures, which may include, inter alia, measures and activities aimed at reconnecting children with agriculture through activities, such as farm visits, and the distribution of a wider variety of agricultural products as referred to in paragraph 7. Those measures may also be designed to educate children about related issues, such as healthy eating habits, local food chains, organic farming, sustainable production or combating food waste.

11.   Member States shall choose the products to be featured in distribution or to be included in accompanying educational measures on the basis of objective criteria which shall include one or more of the following: health and environmental considerations, seasonality, variety and the availability of local or regional produce, giving priority to the extent practicable to products originating in the Union. Member States may encourage in particular local or regional purchasing, organic products, short supply chains or environmental benefits and, if appropriate, products recognised under the quality schemes established by Regulation (EU) No 1151/2012.

Member States may consider, in their strategies, prioritising sustainability and fair-trade considerations.

Article 23a

Financing provisions

1.   Without prejudice to paragraph 4 of this Article, the aid under the school scheme allocated for the distribution of products, the accompanying educational measures and the related costs referred to in Article 23(1) shall not exceed EUR 250 million per school year.

Within that overall limit, the aid shall not exceed:

2.   The aid referred to in paragraph 1 shall be allocated to each Member State taking into account the following:

The allocations for the Member States concerned shall ensure that higher aid is allocated to the outermost regions listed in Article 349 TFEU in order to take into account the specific situation of those regions in the sourcing of products and to promote such sourcing between outermost regions that are in geographical proximity to each other.

The allocations for school milk resulting from the application of the criteria laid down in this paragraph shall ensure that all Member States are entitled to receive at least a minimum amount of Union aid per child in the age group referred to in point (a) of the first subparagraph. That amount shall not be lower than the average use of Union aid per child across all Member States under the school milk scheme which applied prior to 1 August 2017.

Measures on the fixing of indicative and definitive allocations and on reallocation of Union aid for school fruit and vegetables and for school milk shall be taken by the Council in accordance with Article 43(3) TFEU.

3.   Member States wishing to participate in the school scheme shall submit every year their request for Union aid, specifying the amount requested for the school fruit and vegetables and the amount requested for the school milk that they wish to distribute.

4.   Without exceeding the overall limit of EUR 250 million laid down in paragraph 1, any Member State may transfer once per school year up to 20 % of either one or the other of its indicative allocations.

That percentage may be increased up to 25 % for the Member States with outermost regions listed in Article 349 TFEU and in other duly justified cases, such as where a Member State needs to address a specific market situation in the sector covered by the school scheme, its particular concerns regarding low consumption of either one of the groups of products, or other societal changes.

Transfers may be made either:

The transfers referred to in point (a) of the third subparagraph may not be made from the indicative allocation for the group of products for which the Member State concerned requests an amount exceeding its indicative allocation. Member States shall notify to the Commission the amount of any transfers between indicative allocations.

5.   The school scheme shall be without prejudice to any separate national school schemes which are compatible with Union law. Union aid provided for in Article 23 may be used to extend the scope or effectiveness of any existing national school schemes or school distribution schemes providing school fruit and vegetables and school milk but shall not replace funding for those existing national schemes, except for free distribution of meals to children in educational establishments. If a Member State decides to extend the scope of an existing national school scheme or to make it more effective by requesting Union aid, it shall indicate in the strategy referred to in Article 23(8) how this will be achieved.

6.   Member States may, in addition to Union aid, grant national aid for the financing of the school scheme.

Member States may finance that aid by means of a levy on the sector concerned or by means of any other contribution from the private sector.

7.   The Union may also finance, pursuant to Article 6 of Regulation (EU) No 1306/2013, information, publicity, monitoring and evaluation measures relating to the school scheme, including measures to raise public awareness of the scheme's objectives, and related networking measures aimed at exchanging experience and best practices in order to facilitate the implementation and management of the scheme.

The Commission may develop, in accordance with Article 24(4) of this Regulation, a common identifier or graphic elements to enhance the visibility of the school scheme.

8.   Member States participating in the school scheme shall publicise, at school premises or other relevant places, their involvement in the scheme and the fact that it is subsidised by the Union. Member States may use any suitable publicity tools, which may include posters, dedicated websites, informative graphic material, and information and awareness-raising campaigns. Member States shall ensure the added value and the visibility of the Union school scheme in relation to the provision of other meals in educational establishments.

Article 24

Delegated powers

1.   In order to promote the healthy eating habits of children and to ensure that the aid under the school scheme is aimed at children in the target group referred to in Article 22, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 concerning rules on:

2.   In order to ensure the efficient and targeted use of Union funds and to facilitate the implementation of the school scheme, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 concerning:

3.   In order to take account of scientific developments, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 in order to supplement the list of artificial flavour-enhancers referred to in point (e) of the first subparagraph of Article 23(6).

In order to ensure that products distributed in accordance with Article 23(3), (4) and (5) meet the objectives of the school scheme, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 in order to define the maximum levels for added sugar, added salt and added fat which may be allowed by Member States under the second subparagraph of Article 23(6) and which are technically necessary to prepare or manufacture processed products.

4.   In order to promote awareness of the school scheme and to increase the visibility of Union aid, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 requiring the Member States participating in the school scheme to clearly publicise the fact that they are receiving Union support to implement the scheme, including in relation to:

5.   In order to ensure the added value and the visibility of the school scheme, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 in respect of the rules concerning the distribution of products in relation to the provision of other meals in educational establishments.

6.   Taking into account the need to ensure that the Union aid is reflected in the price at which the products are available under the school scheme, the Commission shall be empowered to adopt delegated acts in accordance with Article 227 requiring Member States to explain in their strategies how this will be achieved.

Article 25

Implementing powers in accordance with the examination procedure

The Commission may, by means of implementing acts, adopt the measures necessary for the application of this Section, including those concerning:

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 229(2).

(*)  Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).’;"

(2)

Article 217 is replaced by the following:

‘Article 217

National payments for the distribution of products to children

Member States may make national payments for supplying to children in educational establishments the groups of eligible products referred to in Article 23, for accompanying educational measures related to such products and for the related costs referred to in point (c) of Article 23(1).

Member States may finance those payments by means of a levy on the sector concerned or by means of any other contribution from the private sector.’;

(3)

in Article 225, the following points are added:

(4)

Annex V is replaced by the following:

24.5.2016   

EN

Official Journal of the European Union

L 135/11

(1)

The harmonised index of consumer prices (HICP) is designed to measure inflation in a harmonised manner across Member States. The Commission and the European Central Bank (ECB) use the HICP in their assessment of price stability in the Member States under Article 140 of the Treaty on the Functioning of the European Union (TFEU).

(2)

Harmonised indices are used in the context of the Commission's macroeconomic imbalance procedure, as established by Regulation (EU) No 1176/2011 of the European Parliament and of the Council (3).

(3)

Price statistics of high quality and comparability are essential for those responsible for public policy in the Union, researchers and all European citizens.

(4)

The European System of Central Banks (ESCB) uses the HICP as an index in order to measure the achievement of the ESCB's price stability objective under Article 127(1) TFEU, which is of particular relevance for the definition and implementation of the monetary policy of the Union under Article 127(2) TFEU. Pursuant to Articles 127(4) and 282(5) TFEU, the ECB is to be consulted on any proposed Union act in its fields of competence.

(5)

The objective of this Regulation is to establish a common framework for the development, production and dissemination of harmonised indices of consumer prices and of the house price index (HPI) at Union and national level. This does not preclude, however, the possibility of extending the application of the framework, in the future, if necessary, to the subnational level.

(6)

Council Regulation (EC) No 2494/95 (4) established a common framework for setting up harmonised indices of consumer prices. That legal framework needs to be adapted to current requirements and technical progress, thereby further improving the relevance and comparability of harmonised indices of consumer prices and the HPI. On the basis of the new framework established by this Regulation, work on a set of supplementary indicators on price evolution should be initiated.

(7)

This Regulation takes into account the Commission's better regulation agenda and, in particular, the Commission communication of 8 October 2010 entitled Smart regulation in the European Union. In the statistical field, the Commission has set as a priority the simplification and improvement of the regulatory environment in statistics, as referred to in the Commission communication of 10 August 2009 on the production method of EU statistics: a vision for the next decade.

(8)

The HICP and the harmonised index of consumer prices at constant tax rates (HICP-CT) should be broken down into categories of the European classification of individual consumption according to purpose (ECOICOP). Such classification should ensure that all European statistics relating to private consumption are consistent and comparable. The ECOICOP should also be consistent with the UN COICOP, which is the international standard classifying individual consumption according to purpose, therefore the ECOICOP should be adapted to align it with changes to the UN COICOP.

(9)

The HICP is based on observed prices, which include taxes on products. Hence, inflation is affected by changes to tax rates on products. For inflation analysis and for convergence assessment in Member States, information also needs to be collected on the impact of tax changes on inflation. To this end, the HICP should additionally be calculated on the basis of constant tax rate prices.

(10)

Establishing price indices for dwellings, and in particular for owner-occupied housing (OOH), is an important step towards further improving the relevance and comparability of the HICP. The HPI is a necessary basis for compiling the OOH price index. In addition, the HPI is an important indicator in its own right. By 31 December 2018, the Commission should prepare a report addressing the suitability of the OOH price index for integration into the HICP coverage. Depending on the results of that report, the Commission should, where appropriate, submit, within a reasonable time frame, a proposal for amending this Regulation with regard to integrating the OOH price index into the HICP coverage.

(11)

Early provisional information on the monthly HICP in the form of a flash estimate is crucial for monetary policy in the euro area. Therefore, such flash estimates should be provided by the Member States whose currency is the euro.

(12)

The HICP is designed to assess price stability. It is not intended to be a cost of living index. In addition to the HICP, research on a harmonised cost of living index should be initiated.

(13)

The reference period of the harmonised indices should be updated periodically. Rules for common index reference periods of the harmonised indices and their sub-indices integrated at different points in time should be established in order to ensure that the resulting indices are comparable and relevant.

(14)

In order to enhance the gradual harmonisation of harmonised indices of consumer prices and the HPI, pilot studies should be launched to assess the feasibility of using improved basic information or applying new methodological approaches. The Commission should take the necessary actions and find the right incentives, including financial support, to encourage such pilot studies.

(15)

The Commission (Eurostat) should verify the sources and methods used by Member States to calculate harmonised indices and should monitor the implementation of the legal framework by Member States. For that purpose, the Commission (Eurostat) should maintain a regular dialogue with the Member States' statistical authorities.

(16)

Background information is essential for assessing whether the detailed harmonised indices provided by the Member States are sufficiently comparable. In addition, transparent compilation methods and practices used in Member States help all stakeholders to understand the harmonised indices and further improve their quality. A set of rules for reporting harmonised metadata should therefore be established.

(17)

In order to ensure the quality of statistical data provided by Member States, the Commission should use the appropriate prerogatives and powers provided for in Article 12 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (5).

(18)

In order to ensure adaptation to changes to the UN COICOP, to amend the list of items regulated by implementing acts by adding items in order to take account of technical developments in the statistical methods and based on the evaluation of pilot studies, and to modify the list of sub-indices of ECOICOP that Member States are not required to produce in order to include games of chance in the HICP and the HICP-CT, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(19)

In order to ensure full comparability of the harmonised indices, uniform conditions are needed for the application of the ECOICOP for the purpose of the HICP and the HICP-CT; for the breakdown of the flash estimate of the HICP provided by Member States whose currency is the euro; for the breakdowns of the OOH price index and of the HPI; for the quality of weights of the harmonised indices; for improved methods based on voluntary pilot studies; for the appropriate methodology; for detailed rules on the rescaling of the harmonised indices; for the data and metadata exchange standards; for the revision of the harmonised indices and their sub-indices; and for technical quality assurance requirements regarding the content of annual standard quality reports, the deadline for providing the reports to the Commission (Eurostat) and the structure of the inventories and the deadline for providing the inventories to the Commission (Eurostat). In order to ensure such uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (6).

(20)

In adopting implementing measures and delegated acts in accordance with this Regulation, the Commission should consider, where appropriate, cost-effectiveness and ensure that those measures and acts do not impose a significant additional burden on Member States or respondents.

(21)

Since the objective of this Regulation, namely the creation of common statistical standards for harmonised indices of consumer prices and the HPI, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(22)

In the context of Article 7 of Regulation (EC) No 223/2009, the European Statistical System Committee has been asked to provide its professional guidance.

(23)

Regulation (EC) No 2494/95 should therefore be repealed,

(1)

‘products’ means goods and services as defined in paragraph 3.01 of Annex A to Regulation (EU) No 549/2013 of the European Parliament and of the Council (7) (‘ESA 2010’);

(2)

‘consumer prices’ means the purchase prices paid by households to purchase individual products by means of monetary transactions;

(3)

‘house prices’ means the transaction prices of dwellings purchased by households;

(4)

‘purchase prices’ means the prices actually paid by purchasers for products, including any taxes less subsidies on the products, after the deduction of discounts from standard prices or charges, excluding interest or services charges added under credit arrangements and any extra charges incurred as a result of failing to pay within the period specified at the time of purchase;

(5)

‘administered prices’ means prices that are either directly set or influenced to a significant extent by the government;

(6)

‘harmonised index of consumer prices’ or ‘HICP’ means the comparable index of consumer prices produced by each Member State;

(7)

‘harmonised index of consumer prices at constant tax rates’ or ‘HICP-CT’ means the index that measures changes in consumer prices without the impact of changes in tax rates on products over the same period of time;

(8)

‘tax rate’ means a tax parameter and may be a certain percentage of the price or an absolute tax amount levied on a physical unit;

(9)

‘owner-occupied housing price index’ or ‘OOH price index’ means the index that measures changes in the transaction prices of dwellings new to the household sector and of other products that the households acquire in their role as owner-occupiers;

(10)

‘house price index’ or ‘HPI’ means the index that measures changes in the transaction prices of dwellings purchased by households;

(11)

‘sub-index of the HICP or the HICP-CT’ means the price index for any category of the European classification of individual consumption according to purpose (ECOICOP) as set out in Annex I;

(12)

‘harmonised indices’ means the HICP, the HICP-CT, the OOH price index and the HPI;

(13)

‘flash estimate of the HICP’ means an early estimate of the HICP provided by Member States whose currency is the euro that may be based on provisional information and, if necessary, appropriate modelling;

(14)

‘Laspeyres-type index’ means the price index that measures the average change in prices from the price reference period to a comparison period using expenditure shares from a period prior to the price reference period, and where the expenditure shares are adjusted to reflect the prices of the price reference period.

A ‘Laspeyres-type index’ is defined as:

The price of a product is denoted by p, the price reference period is denoted by 0, and the comparison period is denoted by t. Weights (w) are expenditure shares of a period (b) prior to the price reference period, and are adjusted to reflect the prices of the price reference period 0;

(15)

‘index reference period’ means the period for which the index is set to 100 index points;

(16)

‘price reference period’ means the period to which the price of the comparison period is compared; for monthly indices, the price reference period is December of the previous year, and for quarterly indices, the price reference period is the fourth quarter of the previous year;

(17)

‘basic information’ means data covering:

(18)

‘household’ means a household as referred to in points (a) and (b) of paragraph 2.119 of Annex A to ESA 2010, irrespective of nationality or residence status;

(19)

‘economic territory of the Member State’ means the economic territory as referred to in paragraph 2.05 of Annex A to ESA 2010, with the exception that the extraterritorial enclaves situated within the boundaries of the Member State are included and the territorial enclaves situated in the rest of the world are excluded;

(20)

‘household final monetary consumption expenditure’ means that part of final consumption expenditure incurred:

(21)

‘significant change in the production method’ means a change that is estimated to affect the annual rate of change of a given harmonised index or part thereof in any period by more than:

(a)

less than or equal to 0,1 percentage points on average over one year against the previous year from an index compiled following the methodological approach of this Regulation, in the case of the HICP and the HICP-CT;

(b)

less than or equal to one percentage point on average over one year against the previous year from an index compiled following the methodological approach of this Regulation, in the case of the OOH price index and the HPI.

(i)

sampling and representativity;

(ii)

collection and treatment of prices;

(iii)

replacements and quality adjustment;

(iv)

index compilation;

(v)

revisions;

(vi)

special indices;

(vii)

treatment of products in specific areas.

(a)

for monthly indices, with the index for January of the following year after the index reference period;

(b)

for quarterly indices, with the index for the first quarter of the following year after the index reference period.

(a)

sub-indices of the HICP and of the HICP-CT accounting for less than one part in a thousand of the total expenditure;

(b)

sub-indices of the OOH price index and of the HPI accounting for less than one part in a hundred of the total owner-occupier housing expenditure and total purchases of dwellings, respectively.

(a)

15 calendar days, for the February to December indices, and 20 calendar days, for the January indices, after the end of the month for which the indices are calculated; and

(b)

85 calendar days after the end of the quarter for which the indices are calculated.

(a)

13 February each year for the monthly indices;

(b)

15 June each year for the quarterly indices.

(a)

annual standard quality reports covering the quality criteria referred to in Article 12(1) of Regulation (EC) No 223/2009;

(b)

annually updated inventories containing details of data sources, definitions and methods used;

(c)

further related information at the level of detail necessary to evaluate compliance with the comparability requirements and the quality of the harmonised indices, if requested by the Commission (Eurostat).

24.5.2016   

EN

Official Journal of the European Union

L 135/39

(1)

Council Regulation (EC) No 953/2003 (2) has been substantially amended several times (3). In the interests of clarity and rationality, that Regulation should be codified.

(2)

Many of the poorest developing countries are in urgent need of access to affordable essential medicines for the treatment of communicable diseases. Those countries are heavily dependent on imports of medicines as local manufacturing is scarce.

(3)

Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices. Therefore, those heavily reduced prices cannot be understood as a reference for the price to be paid for the same products in developed country markets.

(4)

Legislative and regulatory instruments are in place in most developed countries to prevent the importation, in certain circumstances, of pharmaceutical products, but such instruments risk becoming insufficient where substantial volumes of heavily discounted pharmaceuticals are sold to the poorest developing country markets, and the economic interest in trade diversion into high priced markets therefore may increase significantly.

(5)

There is a need to encourage pharmaceutical manufacturers to make pharmaceutical products available at heavily reduced prices in significantly increased volumes by ensuring through this Regulation that such products remain on the poorest developing country markets. Donations of pharmaceutical products and products sold under contracts awarded in response to competitive tenders from national governments or international procurement bodies, or under a partnership agreed between the manufacturer and the government of a country of destination should be able to qualify under this Regulation on equal conditions, bearing in mind that donations do not contribute to the improvement of access to such products on a sustainable basis.

(6)

It is necessary to provide for a procedure which identifies the products, countries and diseases covered by this Regulation.

(7)

This Regulation serves the purpose of preventing tiered-priced products from being imported into the Union. Exemptions are laid down for certain situations on the strict condition that it is ensured that the final destination of the products in question is one of the countries listed in Annex II.

(8)

Manufacturers of tiered-priced products should differentiate the appearance of tiered- priced products to facilitate the task of identifying them.

(9)

It will be appropriate to review the lists of the diseases and the countries of destination covered by this Regulation, as well as the formulae used to identify tiered-priced products in the light, inter alia, of the experience gained from its application.

(10)

With regard to tiered-priced products contained in travellers' personal luggage for personal use, the same rules as set out in Regulation (EU) No 608/2013 of the European Parliament and of the Council (4) apply.

(11)

Where tiered-priced products have been seized under this Regulation, the competent authority should be able, in accordance with national legislation and with a view to ensuring that the intended use is made of the seized products to the full benefit of the countries listed in Annex II, to decide to make them available for humanitarian purposes in those countries. In the absence of such decision, the seized products should be destroyed.

(12)

In order to add products to the list of products covered by this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to amend the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council,

(a)

the criteria for establishing what is a tiered-priced product;

(b)

the conditions under which the customs authorities shall take action;

(c)

the measures which shall be taken by the competent authorities in the Member States.

(a)

‘tiered-priced product’ means any pharmaceutical product which is used in the prevention, diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in accordance with one of the optional price calculations set out in Article 3, verified by the Commission or an independent auditor as provided for in Article 4 and entered in the list of tiered-priced products set out in Annex I;

(b)

‘countries of destination’ means the countries listed in Annex II;

(c)

‘competent authority’ means an authority designated by a Member State to determine whether goods suspended by the customs authorities in the respective Member State are tiered-priced products and to give instructions depending on the outcome of the review.

(a)

re-export to countries of destination;

(b)

placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to a country of destination.

(a)

no higher than the percentage set out in Annex III of the weighted average ex factory price charged by a manufacturer in markets of the Organisation for Economic Cooperation and Development (OECD) for the same product at the time of application; or

(b)

a manufacturer's direct production costs, with the addition of the maximum percentage which is set out in Annex III.

(a)

the product name and active ingredient of the tiered-priced product and sufficient information to verify which disease it prevents, diagnoses or treats;

(b)

the price offered in relation to either of the optional price calculations set out in Article 3 in sufficient detail to enable verification. Instead of submitting such detailed information, the applicant may submit a certificate, issued by an independent auditor, stating that the price has been verified and corresponds to one of the criteria set out in Annex III. The independent auditor shall be appointed in agreement between the manufacturer and the Commission. Any information submitted by the applicant to the auditor shall remain confidential;

(c)

the country or countries of destination to which the applicant intends to sell the product concerned;

(d)

the code number based on the Combined Nomenclature as set out in Annex I to Council Regulation (EEC) No 2658/87 (5) and, where appropriate, supplemented by TARIC subdivisions, to identify unambiguously the goods concerned; and

(e)

any measures taken by the manufacturer or exporter to make the tiered-priced product easily distinguishable from identical products offered for sale within the Union.

24.5.2016   

EN

Official Journal of the European Union

L 135/53

(1)

Europol was set up by Council Decision 2009/371/JHA (2) as an entity of the Union funded from the general budget of the Union to support and strengthen action by competent authorities of the Member States and their mutual cooperation in preventing and combating organised crime, terrorism and other forms of serious crime affecting two or more Member States. Decision 2009/371/JHA replaced the Convention based on Article K.3 of the Treaty on European Union, on the establishment of a European Police Office (Europol Convention) (3).

(2)

Article 88 of the Treaty on the Functioning of the European Union (TFEU) provides for Europol to be governed by a regulation to be adopted in accordance with the ordinary legislative procedure. It also requires the establishment of procedures for the scrutiny of Europol's activities by the European Parliament, together with national parliaments, subject to point (c) of Article 12 of the Treaty on European Union (TEU) and Article 9 of Protocol No 1 on the role of National Parliaments in the European Union, annexed to the TEU and to the TFEU (‘Protocol No 1’), in order to enhance the democratic legitimacy and accountability of Europol to the Union's citizens. Therefore, Decision 2009/371/JHA should be replaced by a regulation laying down, inter alia, rules on parliamentary scrutiny.

(3)

The ‘Stockholm programme — An open and secure Europe serving and protecting citizens’ (4) calls for Europol to evolve and become a hub for information exchange between the law enforcement authorities of the Member States, a service provider and a platform for law enforcement services. On the basis of an assessment of Europol's functioning, further enhancement of its operational effectiveness is needed to meet that objective.

(4)

Large-scale criminal and terrorist networks pose a significant threat to the internal security of the Union and to the safety and livelihood of its citizens. Available threat assessments show that criminal groups are becoming increasingly poly-criminal and cross-border in their activities. National law enforcement authorities therefore need to cooperate more closely with their counterparts in other Member States. In this context, it is necessary to equip Europol to better support Member States in Union-wide crime prevention, analyses and investigations. This was also confirmed in the evaluation of Decision 2009/371/JHA.

(5)

This Regulation aims to amend and expand the provisions of Decision 2009/371/JHA and of Council Decisions 2009/934/JHA (5), 2009/935/JHA (6), 2009/936/JHA (7) and 2009/968/JHA (8) implementing Decision 2009/371/JHA. Since the amendments to be made are of a substantial number and nature, those Decisions should, in the interests of clarity, be replaced in their entirety in relation to the Member States bound by this Regulation. Europol as established by this Regulation should replace and assume the functions of Europol as established by Decision 2009/371/JHA, which, as a consequence, should be repealed.

(6)

As serious crime often occurs across internal borders, Europol should support and strengthen Member States' actions and their cooperation in preventing and combating serious crime affecting two or more Member States. Given that terrorism is one of the most significant threats to the security of the Union, Europol should assist Member States in facing common challenges in this regard. As the Union law enforcement agency, Europol should also support and strengthen actions and cooperation in tackling forms of crime that affect the interests of the Union. Among the forms of crime with which Europol is competent to deal, organised crime will continue to fall within the scope of Europol's main objectives, as, given its scale, significance and consequences, it also calls for a common approach by the Member States. Europol should also offer support in preventing and combating related criminal offences which are committed in order to procure the means of perpetrating acts in respect of which Europol is competent or to facilitate or perpetrate such acts or to ensure the impunity of committing them.

(7)

Europol should provide strategic analyses and threat assessments to assist the Council and the Commission in laying down strategic and operational priorities of the Union for fighting crime and in the operational implementation of those priorities. Where the Commission so requests in accordance with Article 8 of Council Regulation (EU) No 1053/2013 (9), Europol should also carry out risk analyses, including in respect of organised crime, insofar as the risks concerned may undermine the application of the Schengen acquis by the Member States. Moreover, at the request of the Council or the Commission where appropriate, Europol should provide strategic analyses and threat assessments to contribute to the evaluation of states that are candidates for accession to the Union.

(8)

Attacks against information systems affecting Union bodies or two or more Member States are a growing menace in the Union, in particular in view of their speed and impact and the difficulty in identifying their sources. When considering requests by Europol to initiate an investigation into a serious attack of suspected criminal origin against information systems affecting Union bodies or two or more Member States, Member States should respond to Europol without delay, taking into account the fact that the rapidity of the response is a key factor in successfully tackling computer crime.

(9)

Given the importance of the inter-agency cooperation, Europol and Eurojust should ensure that necessary arrangements are established to optimise their operational cooperation, taking due account of their respective missions and mandates and of the interests of Member States. In particular, Europol and Eurojust should keep each other informed of any activity involving the financing of joint investigation teams.

(10)

When a joint investigation team is set up, the relevant agreement should determine the conditions relating to the participation of the Europol staff in the team. Europol should keep a record of its participation in such joint investigation teams targeting criminal activities falling within the scope of its objectives.

(11)

Europol should be able to request Member States to initiate, conduct or coordinate criminal investigations in specific cases where cross-border cooperation would add value. Europol should inform Eurojust of such requests.

(12)

Europol should be a hub for information exchange in the Union. Information collected, stored, processed, analysed and exchanged by Europol includes criminal intelligence which relates to information about crime or criminal activities falling within the scope of Europol's objectives, obtained with a view to establishing whether concrete criminal acts have been committed or may be committed in the future.

(13)

In order to ensure Europol's effectiveness as a hub for information exchange, clear obligations should be laid down requiring Member States to provide Europol with the data necessary for it to fulfil its objectives. While implementing such obligations, Member States should pay particular attention to providing data relevant to the fight against crimes considered to be strategic and operational priorities within relevant policy instruments of the Union, in particular the priorities set by the Council in the framework of the EU Policy Cycle for organised and serious international crime. Member States should also endeavour to provide Europol with a copy of bilateral and multilateral exchanges of information with other Member States on crime falling within Europol's objectives. When supplying Europol with the necessary information, Member States should also include information about any alleged cyber attacks affecting Union bodies located in their territory. At the same time, Europol should increase the level of its support to Member States, so as to enhance mutual cooperation and the sharing of information. Europol should submit an annual report to the European Parliament, to the Council, to the Commission and to national parliaments on the information provided by the individual Member States.

(14)

To ensure effective cooperation between Europol and Member States, a national unit should be set up in each Member State (the ‘national unit’). The national unit should be the liaison link between national competent authorities and Europol, thereby having a coordinating role in respect of Member States' cooperation with Europol, and thus helping to ensure that each Member State responds to Europol requests in a uniform way. To ensure a continuous and effective exchange of information between Europol and the national units, and to facilitate their cooperation, each national unit should designate at least one liaison officer to be attached to Europol.

(15)

Taking into account the decentralised structure of some Member States and the need to ensure rapid exchanges of information, Europol should be allowed to cooperate directly with competent authorities in Member States, subject to the conditions defined by Member States, while keeping the national units informed at the latter's request.

(16)

The establishment of joint investigation teams should be encouraged and Europol staff should be able to participate in them. To ensure that such participation is possible in every Member State, Council Regulation (Euratom, ECSC, EEC) No 549/69 (10) provides that Europol staff do not benefit from immunities while they are participating in joint investigation teams.

(17)

It is also necessary to improve the governance of Europol, by seeking efficiency gains and streamlining procedures.

(18)

The Commission and the Member States should be represented on the Management Board of Europol (the ‘Management Board’) to effectively supervise its work. The members and the alternate members of the Management Board should be appointed taking into account their relevant managerial, administrative and budgetary skills and knowledge of law enforcement cooperation. Alternate members should act as members in the absence of the member.

(19)

All parties represented on the Management Board should make efforts to limit the turnover of their representatives, with a view to ensuring the continuity of the Management Board's work. All parties should aim to achieve a balanced representation between men and women on the Management Board.

(20)

The Management Board should be able to invite non-voting observers whose opinion may be relevant for the discussion, including a representative designated by the Joint Parliamentary Scrutiny Group (JPSG).

(21)

The Management Board should be given the necessary powers, in particular to set the budget, verify its execution, and adopt the appropriate financial rules and planning documents, as well as adopt rules for the prevention and management of conflicts of interest in respect of its members, establish transparent working procedures for decision-making by the Executive Director of Europol, and adopt the annual activity report. It should exercise the powers of appointing authority vis-à-vis staff of the agency, including the Executive Director.

(22)

To ensure the efficient day-to-day functioning of Europol, the Executive Director should be its legal representative and manager, acting independently in the performance of his or her duties and ensuring that Europol carries out the tasks provided for by this Regulation. In particular, the Executive Director should be responsible for preparing budgetary and planning documents submitted for the decision of the Management Board and for implementing the multiannual programming and annual work programmes of Europol and other planning documents.

(23)

For the purposes of preventing and combating crime falling within the scope of its objectives, it is necessary for Europol to have the fullest and most up-to-date information possible. Therefore, Europol should be able to process data provided to it by Member States, Union bodies, third countries, international organisations and, under stringent conditions laid down by this Regulation, private parties, as well as data coming from publicly available sources, in order to develop an understanding of criminal phenomena and trends, to gather information about criminal networks, and to detect links between different criminal offences.

(24)

To improve Europol's effectiveness in providing accurate crime analyses to the competent authorities of the Member States, it should use new technologies to process data. Europol should be able to swiftly detect links between investigations and common modi operandi across different criminal groups, to check cross-matches of data and to have a clear overview of trends, while guaranteeing a high level of protection of personal data for individuals. Therefore, Europol databases should be structured in such a way as to allow Europol to choose the most efficient IT structure. Europol should also be able to act as a service provider, in particular by providing a secure network for the exchange of data, such as the secure information exchange network application (SIENA), aimed at facilitating the exchange of information between Member States, Europol, other Union bodies, third countries and international organisations. In order to ensure a high level of data protection, the purpose of processing operations and access rights as well as specific additional safeguards should be laid down. In particular, the principles of necessity and proportionality should be observed with regard to the processing of personal data.

(25)

Europol should ensure that all personal data processed for operational analyses are allocated a specific purpose. Nonetheless, in order for Europol to fulfil its mission, it should be allowed to process all personal data received to identify links between multiple crime areas and investigations, and should not be limited to identifying connections only within one crime area.

(26)

To respect the ownership of data and the protection of personal data, Member States, Union bodies, third countries and international organisations should be able to determine the purpose or purposes for which Europol may process the data they provide and to restrict access rights. Purpose limitation is a fundamental principle of personal data processing; in particular, it contributes to transparency, legal certainty and predictability and is particularly of high importance in the area of law enforcement cooperation, where data subjects are usually unaware when their personal data are being collected and processed and where the use of personal data may have a very significant impact on the lives and freedoms of individuals.

(27)

To ensure that data are accessed only by those needing access in order to perform their tasks, this Regulation should lay down detailed rules on different degrees of right of access to data processed by Europol. Such rules should be without prejudice to restrictions on access imposed by data providers, as the principle of ownership of data should be respected. In order to increase efficiency in the prevention and combating of crimes falling within the scope of Europol's objectives, Europol should notify Member States of information which concerns them.

(28)

To enhance operational cooperation between the agencies, and particularly to establish links between data already in the possession of the different agencies, Europol should enable Eurojust and the European Anti-Fraud Office (OLAF) to have access, on the basis of a hit/no hit system, to data available at Europol. Europol and Eurojust should be able to conclude a working arrangement ensuring, in a reciprocal manner within their respective mandates, access to, and the possibility of searching, all information that has been provided for the purpose of cross-checking in accordance with specific safeguards and data protection guarantees provided for in this Regulation. Any access to data available at Europol should, by technical means, be limited to information falling within the respective mandates of those Union bodies.

(29)

Europol should maintain cooperative relations with other Union bodies, authorities of third countries, international organisations and private parties, to the extent required for the accomplishment of its tasks.

(30)

To ensure operational effectiveness, Europol should be able to exchange all relevant information, with the exception of personal data, with other Union bodies, authorities of third countries and international organisations, to the extent necessary for the performance of its tasks. Since companies, firms, business associations, non-governmental organisations and other private parties hold expertise and information of direct relevance to the prevention and combating of serious crime and terrorism, Europol should also be able to exchange such information with private parties. To prevent and combat cybercrime, as related to network and information security incidents, Europol should, pursuant to the applicable legislative act of the Union laying down measures to ensure a high common level of network and information security across the Union, cooperate and exchange information, with the exception of personal data, with national authorities competent for the security of network and information systems.

(31)

Europol should be able to exchange relevant personal data with other Union bodies to the extent necessary for the accomplishment of its or their tasks.

(32)

Serious crime and terrorism often have links beyond the territory of the Union. Europol should therefore be able to exchange personal data with authorities of third countries and with international organisations such as the International Criminal Police Organisation — Interpol to the extent necessary for the accomplishment of its tasks.

(33)

All Member States are affiliated to Interpol. To fulfil its mission, Interpol receives, stores and circulates data to assist competent law enforcement authorities to prevent and combat international crime. Therefore, it is appropriate to strengthen cooperation between Europol and Interpol by promoting an efficient exchange of personal data whilst ensuring respect for fundamental rights and freedoms regarding the automatic processing of personal data. When personal data is transferred from Europol to Interpol, this Regulation, in particular the provisions on international transfers, should apply.

(34)

To guarantee purpose limitation, it is important to ensure that personal data can be transferred by Europol to Union bodies, third countries and international organisations only if necessary for preventing and combating crime that falls within Europol's objectives. To this end, it is necessary to ensure that, when personal data are transferred, the recipient gives an undertaking that the data will be used by the recipient or transferred onward to a competent authority of a third country solely for the purpose for which they were originally transferred. Further onward transfer of the data should take place in compliance with this Regulation.

(35)

Europol should be able to transfer personal data to an authority of a third country or an international organisation on the basis of a Commission decision finding that the country or international organisation in question ensures an adequate level of data protection (‘adequacy decision’), or, in the absence of an adequacy decision, an international agreement concluded by the Union pursuant to Article 218 TFEU, or a cooperation agreement allowing for the exchange of personal data concluded between Europol and the third country prior to the entry into force of this Regulation. In light of Article 9 of Protocol No 36 on transitional provisions, annexed to the TEU and to the TFEU, the legal effects of such agreements are to be preserved until those agreements are repealed, annulled or amended in the implementation of the Treaties. Where appropriate and in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (11), the Commission should be able to consult the European Data Protection Supervisor (EDPS) before and during the negotiation of an international agreement. Where the Management Board identifies an operational need for cooperation with a third country or an international organisation, it should be able to suggest to the Council that the latter draw the attention of the Commission to the need for an adequacy decision or for a recommendation for the opening of negotiations on an international agreement as referred to above.

(36)

Where a transfer of personal data cannot be based on an adequacy decision, an international agreement concluded by the Union or an existing cooperation agreement, the Management Board, in agreement with the EDPS, should be allowed to authorise a set of transfers, where specific conditions so require and provided that adequate safeguards are ensured. The Executive Director should be allowed to authorise the transfer of data in exceptional cases on a case-by-case basis, where such transfer is required, under specific strict conditions.

(37)

Europol should be able to process personal data originating from private parties and private persons only if those data are transferred to Europol by one of the following: a national unit in accordance with its national law; a contact point in a third country or an international organisation with which there is established cooperation through a cooperation agreement allowing for the exchange of personal data concluded in accordance with Article 23 of Decision 2009/371/JHA prior to the entry into force of this Regulation; an authority of a third country or an international organisation which is subject to an adequacy decision or with which the Union has concluded an international agreement pursuant to Article 218 TFEU. However, in cases where Europol receives personal data directly from private parties and the national unit, contact point or authority concerned cannot be identified, Europol should be able to process those personal data solely for the purpose of identifying those entities, and such data should be deleted unless those entities resubmit those personal data within four months after the transfer takes place. Europol should ensure by technical means that, during that period, such data would not be accessible for processing for any other purpose.

(38)

Taking into account the exceptional and specific threat posed to the internal security of the Union by terrorism and other forms of serious crime, especially when facilitated, promoted or committed using the internet, the activities that Europol should undertake on the basis of this Regulation, stemming from its implementation of the Council Conclusions of 12 March 2015 and the call by the European Council of 23 April 2015 in relation especially to those priority areas, in particular the corresponding practice of direct exchanges of personal data with private parties, should be evaluated by the Commission by 1 May 2019.

(39)

Any information which has clearly been obtained in obvious violation of human rights should not be processed.

(40)

Data protection rules at Europol should be strengthened and should draw on the principles underpinning Regulation (EC) No 45/2001 to ensure a high level of protection of individuals with regard to the processing of personal data. As Declaration No 21 on the protection of personal data in the fields of judicial cooperation in criminal matters and police cooperation, attached to the TEU and the TFEU, recognises the specificity of personal data processing in the law enforcement context, the data protection rules of Europol should be autonomous while at the same time consistent with other relevant data protection instruments applicable in the area of police cooperation in the Union. Those instruments include, in particular, Directive (EU) 2016/680 of the European Parliament and of the Council (12), as well as the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of the Council of Europe and its Recommendation No R(87) 15 (13).

(41)

Any processing of personal data by Europol should be lawful and fair in relation to the data subjects concerned. The principle of fair processing requires transparency of processing allowing data subjects concerned to exercise their rights under this Regulation. It should be possible nevertheless to refuse or restrict access to their personal data if, with due regard to the interests of the data subjects concerned, such refusal or restriction constitutes a necessary measure to enable Europol to fulfil its tasks properly, to protect security and public order or to prevent crime, to guarantee that a national investigation will not be jeopardised or to protect the rights and freedoms of third parties. To enhance transparency, Europol should make publicly available a document setting out in an intelligible form the applicable provisions regarding the processing of personal data and the means available to data subjects to exercise their rights. Europol should also publish on its website a list of adequacy decisions, agreements and administrative arrangements relating to the transfer of personal data to third countries and international organisations. Moreover, in order to increase Europol's transparency vis-à-vis Union citizens and its accountability, Europol should publish on its website a list of its Management Board members and, where appropriate, the summaries of the outcome of the meetings of the Management Board, while respecting data protection requirements.

(42)

As far as possible, personal data should be distinguished according to their degree of accuracy and reliability. Facts should be distinguished from personal assessments, in order to ensure both the protection of individuals and the quality and reliability of the information processed by Europol. In the case of information obtained from publicly available sources, particularly sources on the internet, Europol should as far as possible assess the accuracy of such information and the reliability of its source with particular diligence in order to address the risks associated with the internet as regards the protection of personal data and privacy.

(43)

Personal data relating to different categories of data subjects are processed in the area of law enforcement cooperation. Europol should make distinctions between personal data in respect of different categories of data subjects as clear as possible. Personal data concerning persons such as victims, witnesses and persons possessing relevant information, as well as personal data concerning minors, should in particular be protected. Europol should only process sensitive data if those data supplement other personal data already processed by Europol.

(44)

In the light of the fundamental right to the protection of personal data, Europol should not store personal data for longer than is necessary for the performance of its tasks. The need for continued storage of such data should be reviewed no later than three years after the start of its initial processing.

(45)

To guarantee the security of personal data, Europol and Member States should implement necessary technical and organisational measures.

(46)

Any data subject should have a right of access to personal data concerning him or her, a right to rectification if those data are inaccurate, and a right to erasure or restriction if those data are no longer required. The costs related to exercising the right of access to personal data should not represent a barrier to effectively exercising that right. The rights of the data subject and the exercise thereof should not affect the obligations incumbent upon Europol and should be subject to the restrictions laid down in this Regulation.

(47)

The protection of the rights and freedoms of data subjects requires a clear attribution of the responsibilities under this Regulation. In particular, Member States should be responsible for the accuracy of data, for keeping up to date the data they have transferred to Europol and for the legality of such data transfers. Europol should be responsible for the accuracy of data and for keeping up to date the data provided by other data suppliers or resulting from Europol's own analyses. Europol should ensure that data are processed fairly and lawfully, and are collected and processed for a specific purpose. Europol should also ensure that the data are adequate, relevant, not excessive in relation to the purpose for which they are processed, stored no longer than is necessary for that purpose, and processed in a manner that ensures appropriate security of personal data and confidentiality of data processing.

(48)

Europol should keep records of collection, alteration, access, disclosure, combination or erasure of personal data for the purposes of verifying the lawfulness of the data processing, self-monitoring and ensuring proper data integrity and security. Europol should be obliged to co-operate with the EDPS and to make logs or documentation available upon request, so that they can be used for monitoring processing operations.

(49)

Europol should designate a Data Protection Officer to assist it in monitoring compliance with this Regulation. The Data Protection Officer should be in a position to perform his or her duties and tasks independently and effectively, and should be provided with the necessary resources to do so.

(50)

Independent, transparent, accountable and effective structures for supervision are essential for the protection of individuals with regard to the processing of personal data as required by Article 8(3) of the Charter of Fundamental Rights of the European Union. National authorities competent for the supervision of the processing of personal data should monitor the lawfulness of personal data provided by Member States to Europol. The EDPS should monitor the lawfulness of data processing carried out by Europol, exercising his or her functions with complete independence. In this regard, the prior consultation mechanism is an important safeguard for new types of processing operations. This should not apply to specific individual operational activities, such as operational analysis projects, but to the use of new IT systems for the processing of personal data and any substantial changes thereto.

(51)

It is important to ensure strengthened and effective supervision of Europol and to guarantee that the EDPS can make use of appropriate law enforcement data protection expertise when he or she assumes responsibility for data protection supervision of Europol. The EDPS and national supervisory authorities should closely cooperate with each other on specific issues requiring national involvement and should ensure the consistent application of this Regulation throughout the Union.

(52)

In order to facilitate the cooperation between the EDPS and the national supervisory authorities, but without prejudice to the independence of the EDPS and his or her responsibility for data protection supervision of Europol, they should regularly meet within the Cooperation Board, which, as an advisory body, should deliver opinions, guidelines, recommendations and best practices on various issues requiring national involvement.

(53)

As Europol also processes non-operational personal data, unrelated to criminal investigations, such as personal data concerning staff of Europol, service providers or visitors, the processing of such data should be subject to Regulation (EC) No 45/2001.

(54)

The EDPS should hear and investigate complaints lodged by data subjects. The investigation following a complaint should be carried out, subject to judicial review, to the extent that is appropriate in the specific case. The national supervisory authority should inform the data subject of the progress and the outcome of the complaint within a reasonable period.

(55)

Any individual should have the right to a judicial remedy against a decision of the EDPS concerning him or her.

(56)

Europol should be subject to the general rules on contractual and non-contractual liability applicable to Union institutions, agencies and bodies, save as regards the rules on liability for unlawful data processing.

(57)

It may be unclear for the individual concerned whether damage suffered as a result of unlawful data processing is a consequence of action by Europol or by a Member State. Europol and the Member State in which the event that gave rise to the damage occurred should therefore be jointly and severally liable.

(58)

While respecting the role of the European Parliament together with national parliaments in the scrutiny of Europol's activities, it is necessary that Europol be a fully accountable and transparent internal organisation. To that end, in light of Article 88 TFEU, procedures should be established for the scrutiny of Europol's activities by the European Parliament together with national parliaments. Such procedures should be subject to point (c) of Article 12 TEU and to Article 9 of Protocol No 1, providing that the European Parliament and national parliaments are together to determine the organisation and promotion of effective and regular interparliamentary cooperation within the Union. The procedures to be established for the scrutiny of Europol's activities should take due account of the need to ensure that the European Parliament and the national parliaments stand on an equal footing, as well as the need to safeguard the confidentiality of operational information. However, the way in which national parliaments scrutinise their governments in relation to the activities of the Union is a matter for the particular constitutional organisation and practice of each Member State.

(59)

The Staff Regulations of Officials of the European Union (the ‘Staff Regulations’) and the Conditions of Employment of Other Servants of the European Union (the ‘Conditions of Employment of Other Servants’) laid down in Council Regulation (EEC, Euratom, ECSC) No 259/68 (14) should apply to Europol staff. Europol should be able to employ staff from the competent authorities of the Member States as temporary agents whose period of service should be limited in order to maintain the principle of rotation, as the subsequent reintegration of such staff members into the service of their competent authority facilitates close cooperation between Europol and the competent authorities of the Member States. Member States should take any measure necessary to ensure that staff engaged at Europol as temporary agents may, at the end of their term of service at Europol, return to the national civil service to which they belong.

(60)

Given the nature of the duties of Europol and the role of the Executive Director, the competent committee of the European Parliament should be able to invite the Executive Director to appear before it prior to his or her appointment, as well as prior to any extension of his or her term of office. The Executive Director should also present the annual report to the European Parliament and to the Council. Furthermore, the European Parliament and the Council should be able to invite the Executive Director to report on the performance of his or her duties.

(61)

To guarantee the full autonomy and independence of Europol, it should be granted an autonomous budget, with revenue coming essentially from a contribution from the general budget of the Union. The Union budgetary procedure should be applicable as far as the Union contribution and any other subsidies chargeable to the general budget of the Union are concerned. The auditing of accounts should be undertaken by the Court of Auditors.

(62)

Commission Delegated Regulation (EU) No 1271/2013 (15) should apply to Europol.

(63)

Given their specific legal and administrative powers and their technical competences in conducting cross-border information-exchange activities, operations and investigations, including in joint investigation teams, and in providing facilities for training, the competent authorities of the Member States should be able to receive grants from Europol without a call for proposals in accordance with point (d) of Article 190(1) of Commission Delegated Regulation (EU) No 1268/2012 (16).

(64)

Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council (17) should apply to Europol.

(65)

Europol processes data that require particular protection as they include sensitive non-classified and EU classified information. Europol should therefore draw up rules on the confidentiality and processing of such information. The rules on the protection of EU classified information should be consistent with Council Decision 2013/488/EU (18).

(66)

It is appropriate to evaluate the application of this Regulation regularly.

(67)

The necessary provisions regarding accommodation for Europol in The Hague, where it has its headquarters, and the specific rules applicable to all Europol's staff and members of their families should be laid down in a headquarters agreement. Furthermore, the host Member State should provide the necessary conditions for the smooth operation of Europol, including multilingual, European-oriented schooling and appropriate transport connections, so as to attract high-quality human resources from as wide a geographical area as possible.

(68)

Europol as established by this Regulation replaces and succeeds Europol as established by Decision 2009/371/JHA. It should therefore be the legal successor of all its contracts, including employment contracts, liabilities and properties acquired. International agreements concluded by Europol as established by Decision 2009/371/JHA and agreements concluded by Europol as established by the Europol Convention before 1 January 2010 should remain in force.

(69)

To enable Europol to continue to fulfil the tasks of Europol as established by Decision 2009/371/JHA to the best of its abilities, transitional measures should be laid down, in particular with regard to the Management Board, the Executive Director and staff employed under a contract of indefinite duration as a local staff member concluded by Europol as established by the Europol Convention, who should be offered the possibility of employment as a member of the temporary or contract staff under the Conditions of Employment of Other Servants.

(70)

The Council Act of 3 December 1998 (19) on Europol staff regulations has been repealed by Article 63 of Decision 2009/371/JHA. However, it should continue to apply to staff employed by Europol before the entry into force of Decision 2009/371/JHA. Therefore, transitional provisions should provide that contracts concluded in accordance with those staff regulations are to remain governed by them.

(71)

Since the objective of this Regulation, namely the establishment of an entity responsible for law enforcement cooperation at Union level, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(72)

In accordance with Article 3 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and to the TFEU, Ireland has notified its wish to take part in the adoption and application of this Regulation.

(73)

In accordance with Articles 1 and 2 and Article 4a(1) of Protocol No 21 on the position of the United Kingdom and Ireland in respect of the area of freedom, security and justice, annexed to the TEU and the TFEU, and without prejudice to Article 4 of that Protocol, the United Kingdom is not taking part in the adoption of this Regulation and is not bound by it or subject to its application.

(74)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the TEU and to the TFEU, Denmark is not taking part in the adoption of this Regulation and is not bound by it or subject to its application.

(75)

The EDPS has been consulted and issued an opinion on 31 May 2013.

(76)

This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union, in particular the right to the protection of personal data and the right to privacy as protected by Articles 8 and 7 of the Charter, as well as by Article 16 TFEU,

(a)

‘the competent authorities of the Member States’ means all police authorities and other law enforcement services existing in the Member States which are responsible under national law for preventing and combating criminal offences. The competent authorities shall also comprise other public authorities existing in the Member States which are responsible under national law for preventing and combating criminal offences in respect of which Europol is competent;

(b)

‘strategic analysis’ means all methods and techniques by which information is collected, stored, processed and assessed with the aim of supporting and developing a criminal policy that contributes to the efficient and effective prevention of, and the fight against, crime;

(c)

‘operational analysis’ means all methods and techniques by which information is collected, stored, processed and assessed with the aim of supporting criminal investigations;

(d)

‘Union bodies’ means institutions, bodies, missions, offices and agencies set up by, or on the basis of, the TEU and the TFEU;

(e)

‘international organisation’ means an organisation and its subordinate bodies governed by public international law, or any other body which is set up by, or on the basis of, an agreement between two or more countries;

(f)

‘private parties’ means entities and bodies established under the law of a Member State or third country, in particular companies and firms, business associations, non-profit organisations and other legal persons that are not covered by point (e);

(g)

‘private persons’ means all natural persons;

(h)

‘personal data’ means any information relating to a data subject;

(i)

‘data subject’ means an identified or identifiable natural person, an identifiable person being a person who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data or an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that person;

(j)

‘genetic data’ means all personal data relating to the genetic characteristics of an individual that have been inherited or acquired, which give unique information about the physiology or the health of that individual, resulting in particular from an analysis of a biological sample from the individual in question;

(k)

‘processing’ means any operation or set of operations which is performed upon personal data or sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction;

(l)

‘recipient’ means a natural or legal person, public authority, agency or any other body to which data are disclosed, whether a third party or not;

(m)

‘transfer of personal data’ means the communication of personal data, actively made available, between a limited number of identified parties, with the knowledge or intention of the sender to give the recipient access to the personal data;

(n)

‘personal data breach’ means a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data transmitted, stored or otherwise processed;

(o)

‘the data subject's consent’ means any freely given, specific, informed and unambiguous indication of his or her wishes by which the data subject, either by a statement or by a clear affirmative action, signifies agreement to personal data relating to him or her being processed;

(p)

‘administrative personal data’ means all personal data processed by Europol apart from those that are processed to meet the objectives laid down in Article 3.

(a)

criminal offences committed in order to procure the means of perpetrating acts in respect of which Europol is competent;

(b)

criminal offences committed in order to facilitate or perpetrate acts in respect of which Europol is competent;

(c)

criminal offences committed in order to ensure the impunity of those committing acts in respect of which Europol is competent.

(a)

collect, store, process, analyse and exchange information, including criminal intelligence;

(b)

notify the Member States, via the national units established or designated pursuant to Article 7(2), without delay of any information and connections between criminal offences concerning them;

(c)

coordinate, organise and implement investigative and operational actions to support and strengthen actions by the competent authorities of the Member States, that are carried out:

(d)

participate in joint investigation teams, as well as propose that they be set up in accordance with Article 5;

(e)

provide information and analytical support to Member States in connection with major international events;

(f)

prepare threat assessments, strategic and operational analyses and general situation reports;

(g)

develop, share and promote specialist knowledge of crime prevention methods, investigative procedures and technical and forensic methods, and provide advice to Member States;

(h)

support Member States' cross-border information exchange activities, operations and investigations, as well as joint investigation teams, including by providing operational, technical and financial support;

(i)

provide specialised training and assist Member States in organising training, including with the provision of financial support, within the scope of its objectives and in accordance with the staffing and budgetary resources at its disposal in coordination with the European Union Agency for Law Enforcement Training (CEPOL);

(j)

cooperate with the Union bodies established on the basis of Title V of the TFEU and with OLAF, in particular through exchanges of information and by providing them with analytical support in the areas that fall within their competence;

(k)

provide information and support to EU crisis management structures and missions established on the basis of the TEU, within the scope of Europol's objectives as set out in Article 3;

(l)

develop Union centres of specialised expertise for combating certain types of crime falling within the scope of Europol's objectives, in particular the European Cybercrime Centre;

(m)

support Member States' actions in preventing and combating forms of crime listed in Annex I which are facilitated, promoted or committed using the internet, including, in cooperation with Member States, the making of referrals of internet content, by which such forms of crime are facilitated, promoted or committed, to the online service providers concerned for their voluntary consideration of the compatibility of the referred internet content with their own terms and conditions.

(a)

be contrary to the essential interests of the security of the Member State concerned; or

(b)

jeopardise the success of an ongoing investigation or the safety of an individual.

(a)

supply Europol with the information necessary for it to fulfil its objectives, including information relating to forms of crime the prevention or combating of which is considered a priority by the Union;

(b)

ensure effective communication and cooperation of all relevant competent authorities with Europol;

(c)

raise awareness of Europol's activities;

(d)

in accordance with point (a) of Article 38(5), ensure compliance with national law when supplying information to Europol.

(a)

be contrary to the essential interests of the security of the Member State concerned;

(b)

jeopardise the success of an ongoing investigation or the safety of an individual; or

(c)

disclose information relating to organisations or specific intelligence activities in the field of national security.

(a)

a Management Board;

(b)

an Executive Director;

(c)

where appropriate, other advisory bodies established by the Management Board in accordance with point (s) of Article 11(1).

(a)

adopt each year, by a majority of two-thirds of its members and in accordance with Article 12, a document containing Europol's multiannual programming and its annual work programme for the following year;

(b)

adopt, by a majority of two-thirds of its members, the annual budget of Europol and exercise other functions in respect of Europol's budget pursuant to Chapter X;

(c)

adopt a consolidated annual activity report on Europol's activities and, by 1 July of the following year, send it to the European Parliament, the Council, the Commission, the Court of Auditors and the national parliaments. The consolidated annual activity report shall be made public;

(d)

adopt the financial rules applicable to Europol in accordance with Article 61;

(e)

adopt an internal anti-fraud strategy, proportionate to fraud risks, taking into account the costs and benefits of the measures to be implemented;

(f)

adopt rules for the prevention and management of conflicts of interest in respect of its members, including in relation to their declaration of interests;

(g)

in accordance with paragraph 2, exercise, with respect to the staff of Europol, the powers conferred by the Staff Regulations on the appointing authority and by the Conditions of Employment of Other Servants on the authority empowered to conclude a contract of employment of other servants (‘the appointing authority powers’);

(h)

adopt appropriate implementing rules giving effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations;

(i)

adopt internal rules regarding the procedure for the selection of the Executive Director, including rules on the composition of the selection committee which ensure its independence and impartiality;

(j)

propose to the Council a shortlist of candidates for the posts of Executive Director and Deputy Executive Directors and, where relevant, propose to the Council that their terms of office be extended or that they be removed from office in accordance with Articles 54 and 55;

(k)

establish performance indicators and oversee the Executive Director's performance, including the implementation of Management Board decisions;

(l)

appoint a Data Protection Officer, who shall be functionally independent in the performance of his or her duties;

(m)

appoint an accounting officer, who shall be subject to the Staff Regulations and the Conditions of Employment of Other Servants and functionally independent in the performance of his or her duties;

(n)

establish, where appropriate, an internal audit capability;

(o)

ensure adequate follow-up to findings and recommendations stemming from the internal or external audit reports and evaluations, as well as from investigations of OLAF and the EDPS;

(p)

define the evaluation criteria for the annual report in accordance with Article 7(11);

(q)

adopt guidelines further specifying the procedures for the processing of information by Europol in accordance with Article 18, after consulting the EDPS;

(r)

decide upon the conclusion of working and administrative arrangements in accordance with Article 23(4) and Article 25(1), respectively;

(s)

decide, taking into consideration both business and financial requirements, upon the establishment of Europol's internal structures, including Union centres of specialised expertise as referred to in point (l) of Article 4(1), upon a proposal of the Executive Director;

(t)

adopt its rules of procedure, including provisions concerning the tasks and the functioning of its secretariat;

(u)

adopt, where appropriate, other internal rules.

(a)

the day-to-day administration of Europol;

(b)

making proposals to the Management Board as regards the establishment of Europol's internal structures;

(c)

implementing decisions adopted by the Management Board;

(d)

preparing the draft multiannual programming and annual work programmes and submitting them to the Management Board, after having consulted the Commission;

(e)

implementing the multiannual programming and the annual work programmes and reporting to the Management Board on their implementation;

(f)

preparing appropriate draft implementing rules to give effect to the Staff Regulations and the Conditions of Employment of Other Servants in accordance with Article 110 of the Staff Regulations;

(g)

preparing the draft consolidated annual report on Europol's activities and presenting it to the Management Board for adoption;

(h)

preparing an action plan following up conclusions of internal or external audit reports and evaluations, as well as investigation reports and recommendations from investigations by OLAF and the EDPS, and reporting on progress twice a year to the Commission and regularly to the Management Board;

(i)

protecting the financial interests of the Union by applying measures to prevent fraud, corruption and any other illegal activity and, without prejudice to the investigative competence of OLAF, by effective checks and, if irregularities are detected, by recovering amounts wrongly paid and, where appropriate, by effective, proportionate and dissuasive administrative and financial penalties;

(j)

preparing a draft internal anti-fraud strategy for Europol and presenting it to the Management Board for adoption;

(k)

preparing draft internal rules for the prevention and management of conflicts of interest in respect of the members of the Management Board and presenting those draft rules to the Management Board for adoption;

(l)

preparing draft financial rules applicable to Europol;

(m)

preparing Europol's draft statement of estimates of revenue and expenditure and implementing its budget;

(n)

supporting the Chairperson of the Management Board in preparing Management Board meetings;

(o)

informing the Management Board on a regular basis regarding the implementation of Union strategic and operational priorities for fighting crime;

(p)

performing other tasks pursuant to this Regulation.

(a)

by Member States in accordance with their national law and Article 7;

(b)

by Union bodies, third countries and international organisations in accordance with Chapter V;

(c)

by private parties and private persons in accordance with Chapter V.

(a)

cross-checking aimed at identifying connections or other relevant links between information related to:

(b)

analyses of a strategic or thematic nature;

(c)

operational analyses;

(d)

facilitating the exchange of information between Member States, Europol, other Union bodies, third countries and international organisations.

(a)

for every operational analysis project, the Executive Director shall define the specific purpose, categories of personal data and categories of data subjects, participants, duration of storage and conditions for access, transfer and use of the data concerned, and shall inform the Management Board and the EDPS thereof;

(b)

personal data may only be collected and processed for the purpose of the specified operational analysis project. Where it becomes apparent that personal data may be relevant for another operational analysis project, further processing of that personal data shall only be permitted insofar as such further processing is necessary and proportionate and the personal data are compatible with the provisions set out in point (a) that apply to the other analysis project;

(c)

only authorised staff may access and process the data of the relevant project.

(a)

forms of crime in respect of which Europol is competent; and

(b)

other forms of serious crime, as set out in Council Framework Decision 2002/584/JHA (22).

(a)

a decision of the Commission adopted in accordance with Article 36 of Directive (EU) 2016/680, finding that the third country or a territory or a processing sector within that third country or the international organisation in question ensures an adequate level of protection (‘adequacy decision’);

(b)

an international agreement concluded between the Union and that third country or international organisation pursuant to Article 218 TFEU adducing adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals;

(c)

a cooperation agreement allowing for the exchange of personal data concluded, before 1 May 2017, between Europol and that third country or international organisation in accordance with Article 23 of Decision 2009/371/JHA.

(a)

necessary in order to protect the vital interests of the data subject or of another person;

(b)

necessary to safeguard legitimate interests of the data subject where the law of the Member State transferring the personal data so provides;

(c)

essential for the prevention of an immediate and serious threat to the public security of a Member State or a third country;

(d)

necessary in individual cases for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal sanctions; or

(e)

necessary in individual cases for the establishment, exercise or defence of legal claims relating to the prevention, investigation, detection or prosecution of a specific criminal offence or the execution of a specific criminal sanction.

(a)

a national unit in accordance with national law;

(b)

the contact point of a third country or an international organisation with which Europol has concluded, before 1 May 2017, a cooperation agreement allowing for the exchange of personal data in accordance with Article 23 of Decision 2009/371/JHA; or

(c)

an authority of a third country or an international organisation which is the subject of an adequacy decision as referred to in point (a) of Article 25(1) of this Regulation or with which the Union has concluded an international agreement pursuant to Article 218 TFEU.

(a)

the transfer is undoubtedly in the interests of the data subject, and either the data subject's consent has been given or the circumstances allow a clear presumption of consent; or

(b)

the transfer is absolutely necessary in the interests of preventing the imminent perpetration of a crime, including terrorism, for which Europol is competent; or

(c)

the transfer of personal data which are publicly available is strictly necessary for the performance of the task set out in point (m) of Article 4(1) and the following conditions are met:

(a)

necessary in order to protect the vital interests of the data subject or another person; or

(b)

necessary in order to safeguard legitimate interests of the data subject; or

(c)

essential for the prevention of an immediate and serious threat to public security of a Member State or a third country; or

(d)

necessary in individual cases for the purposes of the prevention, investigation, detection or prosecution of criminal offences for which Europol is competent; or

(e)

necessary in individual cases for the establishment, exercise or defence of legal claims relating to the prevention, investigation, detection or prosecution of a specific criminal offence for which Europol is competent.

(a)

a national unit in accordance with national law;

(b)

the contact point of a third country or an international organisation with which Europol has concluded, before 1 May 2017, a cooperation agreement allowing for the exchange of personal data in accordance with Article 23 of Decision 2009/371/JHA; or

(c)

an authority of a third country or an international organisation which is the subject of an adequacy decision as referred to in point (a) of Article 25(1) or with which the Union has concluded an international agreement pursuant to Article 218 TFEU.

(a)

processed fairly and lawfully;