(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union. Traditional food from a third country is a novel food defined in Article 3 of Regulation (EU) 2015/2283.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 15(4) of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a traditional food from a third country.

(4)

On 23 January 2018, the company Obà Food Srl. (‘the applicant’) submitted a notification to the Commission of the intention to place decorticated grains of Digitaria exilis (Kippist) Stapf (‘Fonio’) on the Union market as a traditional food from a third country within the meaning of Article 14 of Regulation (EU) 2015/2283. The applicant requests for decorticated grains of Digitaria exilis (Kippist) Stapf to be consumed as such or as a food ingredient by the general population.

(5)

The documented data, presented by the applicant, demonstrate that decorticated grains of Digitaria exilis (Kippist) Stapf have a history of safe food use in West African countries, in particular Guinea, Nigeria and Mali.

(6)

Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 28 February 2018, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).

(7)

No duly reasoned safety objections to the placing on the market within the Union of decorticated grains of Digitaria exilis (Kippist) Stapf were submitted to the Commission by Member States or the Authority within the four-month period laid down in Article 15(2) of Regulation (EU) 2015/2283.

(8)

The Commission should therefore authorise the placing on the market within the Union of decorticated grains of Digitaria exilis (Kippist) Stapf and update the Union list of novel foods.

(9)

Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union. Traditional food from a third country is a novel food defined in Article 3 of Regulation (EU) 2015/2283.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 15(4) of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a traditional food from a third country. On 5 April 2018, the company Sorghum Zrt. (‘the applicant’) submitted a notification to the Commission of the intention to place syrup from Sorghum bicolor (L.) Moench on the Union market as a traditional food from a third country within the meaning of Article 14 of Regulation (EU) 2015/2283. The applicant requests for the authorisation for syrup from Sorghum bicolor (L.) Moench to be consumed as such or to be used as a food ingredient by the general population.

(4)

The documented data, presented by the applicant, demonstrate that syrup from Sorghum bicolor (L.) Moench have a history of safe food use in the United States.

(5)

Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 30 April 2018, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).

(6)

No duly reasoned safety objections to the placing on the market within the Union of syrup from Sorghum bicolor (L.) Moench were submitted to the Commission by Member States or the Authority within the four-month period laid down in Article 15(2) of Regulation (EU) 2015/2283.

(7)

The Commission should therefore authorise the placing on the market within the Union of syrup from Sorghum bicolor (L.) Moench and update the Union list of novel foods.

(8)

Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,

(1)

Rules should be established to ensure that the risk assessment referred to in Article 42(4) of Regulation (EU) 2016/2031 is conducted within a reasonable period of time and on the basis of a timely processing of technical dossiers.

(2)

In order for that risk assessment to be conducted, an application should be submitted to the Commission only by the National Plant Protection Organisation, within the meaning of the International Plant Protection Convention, of the third country. This is necessary to ensure that all the necessary elements for the assessment of the risk associated with plants, plant products or other objects to be introduced in the Union territory are certified by the responsible public authority of the third country. This would be necessary for the credibility and justification of the risk assessment as a basis of measures taken pursuant to Article 42(4) of Regulation (EU) 2016/2031. Those provisions should apply without prejudice to the right of the Commission to submit requests to the European Food Safety Authority (EFSA) to issue scientific opinions pursuant to Article 29 and provide scientific or technical assistance pursuant to Article 31 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (2).

(3)

The technical dossier should contain data on the commodities to be introduced into the territory of the Union, as well as data on the identification of pests potentially associated with the commodity in the exporting country, data on national phytosanitary mitigation measures, inspections and treatments and processing of the commodity and contact details of the natural person responsible for liaising with the Commission and EFSA. Such data are essential in order to perform the commodity risk assessment and to identify the pest species for which phytosanitary mitigation measures may be required.

(4)

In order to provide EFSA with all the necessary elements to conduct the risk assessment, the technical dossier should contain the information specified in the EFSA document entitled ‘Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031 (3)’.

(5)

It is appropriate that, after acknowledging receipt of the technical dossier, the Commission examine whether it contains the required information and may ask, where necessary, for additional information or clarifications so that it is ensured that the application contains all the required and appropriate elements for the risk assessment.

(6)

Rules should be established concerning the conduct of risk assessment by EFSA, its communication with the applicant and the publication of that assessment, in order to ensure a transparent, efficient and timely risk assessment process.

(7)

In order to avoid that the disclosure of certain information harms the competitive position of certain third parties, the provisions concerning confidentiality of Regulation (EC) No 178/2002 should apply accordingly.

(8)

For reasons of legal certainty, this Regulation should apply from the same date as Regulation (EU) 2016/2031.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Pursuant to Article 42(3) of Regulation (EU) 2016/2031, on the basis of a preliminary assessment, the Commission is to adopt implementing acts provisionally listing high risk plants, plant products or other objects that present a pest risk of unacceptable level for the Union territory.

(2)

Since the adoption of Regulation (EU) 2016/2031, several preliminary assessments have been carried out concerning whether plants and plant products originating in third countries present a pest risk of an unacceptable level for the Union territory. Those assessments concluded that because certain plants and plant products fulfil one or more of the criteria set out in Annex III to that Regulation, they could qualify as ‘high risk plants’ or ‘high risk plant products’ within the meaning of Article 42 of that Regulation. The same preliminary risk assessments also concluded that seeds and in vitro material of those ‘high risk plants’ should be excluded from the scope of this Regulation as the level of pest risk is at an acceptable level. Moreover, naturally or artificially dwarfed woody plants for planting should also be excluded from the scope of this Regulation as their import is subject to specific requirements under Council Directive 2000/29/EC (2) that reduce the pest risk to an acceptable level and will also be subject to the special requirements of Article 41 of Regulation (EU) 2016/2031 from 14 December 2019.

(3)

Plants for planting, other than seeds, in vitro material and naturally or artificially dwarfed woody plants for planting, of Acacia Mill., Acer L., Albizia Durazz., Alnus Mill., Annona L., Bauhinia L., Berberis L., Betula L., Caesalpinia L., Cassia L., Castanea Mill., Cornus L., Corylus L., Crataegus L., Diospyros L., Fagus L., Ficus carica L., Fraxinus L., Hamamelis L., Jasminum L., Juglans L., Ligustrum L., Lonicera L., Malus Mill., Nerium L., Persea Mill., Populus L., Prunus L., Quercus L., Robinia L., Salix L., Sorbus L., Taxus L., Tilia L., Ulmus L., and plants of Ullucus tuberosus Loz., are known to host commonly hosted pests known to have a major impact on plant species which are of major economic, social or environmental importance to the Union. Those plants are also known to commonly harbour pests without showing signs of infection, or to have a latent period for the expression of those signs. This reduces the possibility for detecting the presence of such pests during inspections carried out when those plants are introduced into the Union territory. Moreover, those plants for planting are usually introduced into the Union in the form of shrubs or trees and they are usually present in the Union in such form. In light of this, the existing measures governing the introduction of the plants for planting listed in Annex I to this Regulation and plants of Ullucus tuberosus Loz. originating from third countries are not considered to be sufficient to prevent the entry of pests. Therefore the plants for planting listed in Annex I and plants of Ullucus tuberosus Loz. should be listed as high risk plants within the meaning of Article 42(1) of Regulation (EU) 2016/2031, and their introduction into the Union territory should be provisionally prohibited.

(4)

Fruits of Momordica L. are known to host and provide a significant pathway for the introduction and establishment of the pest Thrips palmi Karny, which is known to have the potential to have a major impact on plant species which are of a major economic, social or environmental importance to the Union territory. However, this pest does not occur in all third countries nor in all areas within a third country where it is known to occur. Certain third countries also have effective mitigation measures in place for that pest. In view of this, fruits of Momordica L. that originate in third countries or parts thereof where that pest is known to occur and which lack effective mitigation measures for that pest qualify as high risk plants, within the meaning of Article 42(1) of Regulation (EU) 2016/2031, and therefore, the introduction into the Union of those plants should be provisionally prohibited.

(5)

Wood of Ulmus L. is known to host and provide a significant pathway for the introduction and establishment of the pest Saperda tridentata Olivier. That pest is known to have a major impact on plant species which are of a major economic, social or environmental importance to the Union territory. However, this pest does not occur in all third countries, nor in certain areas within a third country where it is known to occur. In view of this, wood of Ulmus L. originating from third countries or areas of third countries where Saperda tridentata Olivier is known to occur, qualifies as a high risk plant product, within the meaning of Article 42(1) of Regulation (EU) 2016/2031. Therefore the introduction into the Union of that wood should be provisionally prohibited.

(6)

Those plants and plant products referred to in recitals (3), (4) and (5) are not listed in accordance with Article 40 to Regulation (EU) 2016/2031, or only listed with regard to certain third countries. Moreover, and in accordance with the respective preliminary assessments, they are not sufficiently covered by the requirements referred to in Article 41 of that Regulation with regards to all third countries, and not subject to the temporary measures of Article 49 of that Regulation.

(7)

Those plants and plant products referred to in recitals (3), (4) and (5) are not yet subject to a complete risk assessment that is required to conclude whether they pose a risk at an unacceptable level by virtue of the likelihood that they host a Union quarantine pest, or whether that risk can be reduced to an acceptable level by applying certain measures. Where demand for the importation of those plants and plant products is identified, they are to be subject to a risk assessment that will be carried out in accordance with an implementing act to be adopted pursuant to Article 42(6) of Regulation (EU) 2016/2031.

(8)

According to Article 73 of Regulation (EU) 2016/2031, the Commission is to provide, by means of implementing acts, that for plants other than the plants included in the list referred to in Article 72(1), a phytosanitary certificate is required for their introduction into the Union territory.

(9)

However, those implementing acts are to provide that a phytosanitary certificate is not required for those plants where an assessment which is based on evidence about pest risks and experience with trade demonstrates that such a certificate is not necessary.

(10)

Since the adoption of that Regulation, various assessments have been carried out concerning the pest risk and experience with trade of several plants, other than plants for planting, originating from third countries.

(11)

According to those assessments, fruits of Ananas comosus (L.) Merrill, Cocos nucifera L., Durio zibethinus Murray, Musa L. and Phoenix dactylifera L. do not host Union quarantine pests or pests subject to measures adopted pursuant to Article 30 of Regulation (EU) 2016/2031, or commonly hosted pests which may impact on plant species grown in the Union. Moreover, there have been no pest outbreaks linked to the introduction of those fruits from one or more third countries. Neither have those fruits been subject to repetitive interceptions due to the presence of Union quarantine pests or pests subject to the measures adopted pursuant to Article 30 of that Regulation during their introduction into the Union territory.

(12)

In view of the fact that those fruits fulfil all of the criteria of Annex VI to Regulation (EU) 2016/2031, no phytosanitary certificate should be required for their introduction into the Union territory.

(13)

The lists to be established under Article 42(3) and Article 73 of Regulation (EU) 2016/2031 both concern import rules which are based on similar criteria for risk assessment, as set out in Annexes III and VI to that Regulation. They are focused on the risks posed by the respective plants and plant products, instead of the risks of specific pests. They have been elaborated under a common risk assessment methodology and shall be updated under the same methodology, on the basis of the available technical and scientific evidence. It is therefore appropriate to integrate them in one Regulation.

(14)

As Regulation (EU) 2016/2031 applies from 14 December 2019, and in order to ensure a consistent application of all rules concerning the introduction into the Union of plants, plant products and other objects, this Regulation should apply from the same date.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Plants, Animals, Food and Feed,

(1)

On 22 June 2018, the Council decided in accordance with Article 121(4) of the Treaty on the Functioning of the European Union (‘TFEU’) that a significant observed deviation from the adjustment path toward the medium-term budgetary objective of -1 % of GDP existed in Romania.

(2)

In view of the established significant deviation, the Council on 22 June 2018 issued a Recommendation (2) for Romania to take the necessary measures to ensure that the nominal growth rate of net primary government expenditure (3) does not exceed 3,3 % in 2018 and 5,1 % in 2019, corresponding to an annual structural adjustment of 0,8 % of GDP in each year. It also recommended that Romania use any windfall gains for deficit reduction, while budgetary consolidation measures should ensure a lasting improvement in the general government structural balance in a growth-friendly manner. The Council established a deadline of 15 October 2018 for Romania to report on the action taken in response to that Recommendation.

(3)

On 27 and 28 September 2018, the Commission undertook an enhanced surveillance mission in Romania for the purpose of on-site monitoring under Article -11(2) of Regulation (EC) No 1466/97. After having transmitted its provisional findings to the Romanian authorities for comments, the Commission reported its findings to the Council on 21 November 2018. Those findings were subsequently made public. The Commission report finds that the Romanian authorities maintain the 2018 headline deficit target of just below 3 % of GDP and thus do not intend to act upon the Council recommendation of 22 June 2018. In 2019, the Government plans to lower the headline deficit to 2,38 % of GDP, but the measures remain to be specified.

(4)

On 16 October 2018, the Romanian authorities submitted a report on action taken in response to the Council Recommendation of 22 June 2018 (4). In the report, the authorities reiterated that their target for 2018 remains a headline deficit of 2,96 % of GDP. For 2019, the authorities target a deficit of 2,38 % of GDP. The report does not mention new measures for 2018. For 2019, the report relies on containing expenditures on compensation of employees and goods and services, without backing it by sufficiently detailed and adopted or at least credibly announced measures. On the revenue side, the report mentions a prolongation of already existing measures and some actions aimed at increasing tax compliance. Overall, the fiscal impact of the reported measures falls short of the requirement stated in the Council Recommendation of 22 June 2018.

(5)

In 2018, based on the Commission 2018 autumn forecast, the growth of net primary government expenditure is set to amount to 11,3 %, well above the expenditure benchmark of 3,3 %. The structural balance is set to remain broadly stable in 2018, at 3,3 % of GDP. Therefore, both pillars point to a risk of a deviation from the recommended adjustment. The expenditure benchmark points to a deviation of 2,3 % of GDP. The structural balance confirms this reading, indicating a smaller deviation of 0,8 % of GDP. The structural balance is positively impacted by a significantly higher GDP deflator and by a higher point estimate for potential GDP growth compared to the medium-term average underlying the expenditure benchmark. This impact is partially offset by the impact of an increase of public investment, which is smoothed out in the expenditure benchmark. Therefore, the overall assessment confirms the deviation by a wide margin from the adjustment recommended by the Council.

(6)

In 2019, based on the Commission 2018 autumn forecast, the growth of nominal government expenditure, net of discretionary revenue measures and one-offs is set to amount to 7,5 %, well above the expenditure benchmark of 5,1 % (deviation of 0,7 % of GDP from the recommended adjustment). The structural balance is set to decrease by 0,1 % of GDP, reaching a deficit of 3,4 % (deviation of 0,9 % of GDP). Therefore, as both pillars point to a deviation from the required adjustment by a similar margin in 2019, the overall assessment confirms the deviation from the adjustment recommended by the Council.

(7)

Moreover, the Commission 2018 autumn forecast projects a general government deficit of 3,3 % in 2018 and 3,4 % in 2019, which is above the 3 %-of-GDP Treaty reference value.

(8)

The above findings lead to the conclusion that Romania's response to the Council Recommendation of 22 June 2018 has been insufficient. The fiscal effort falls short of ensuring that the nominal growth rate of net primary government expenditure does not exceed 3,3 % in 2018 and 5,1 % in 2019, which corresponds to an annual structural adjustment of 0,8 % of GDP in each year,

(1)

In accordance with Regulation (EC) No 549/2004, the Member States are to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. Regulation (EC) No 549/2004 also provides that the Commission is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of Article 11(6) of that Regulation. Detailed rules in this regard have been set out in Commission Implementing Regulation (EU) No 390/2013.

(2)

Following the assessment of the performance plans, the Commission adopted Implementing Decision (EU) 2015/348 (3) which established, inter alia, that the local targets in the key performance area of cost-efficiency of Portugal and Romania included in the performance plan of South-West FAB and Danube FAB, respectively, were consistent with the Union-wide performance targets for the second reference period (2015-2019).

(3)

The Commission subsequently adopted Impementing Decision (EU) 2018/1782 (4), allowing targets in the key performance area of cost-efficiency for the years 2018 and 2019 for air navigation services of Portugal and Romania to be revised in accordance with Article 17(1) of Implementing Regulation (EU) No 390/2013.

(4)

On that basis, Portugal and Romania each revised those targets and amended their performance plans accordingly.

(5)

The documentation submitted by Portugal and Romania was assessed by the Performance Review Body (‘PRB’), which assists the Commission in the implementation of the performance scheme pursuant to Article 3 of Implementing Regulation (EU) No 390/2013. The report from the PRB on the assessment of the revised targets for Portugal was submitted to the Commission on 20 September 2018 and updated on 12 October 2018.

(6)

The report from the PRB on the assessment of the revised targets for Romania was submitted to the Commission on 16 October 2018.

(7)

The Commission assessed those amended plans and in particular the revised targets, in accordance with Article 14 of Implementing Regulation (EU) No 390/2013, taking into account the documentation received and the reports from the PRB. The consistency of the targets in the key performance area of cost-efficiency, expressed in en route and terminal determined unit costs, with the Union-wide targets has been assessed in accordance with the principles laid down in point 5, in conjunction with point 1, of Annex IV to Implementing Regulation (EU) No 390/2013. The Commission took account of, in particular, the trend of en route determined unit costs over the second reference period in relation to the targeted reduction of 3,3 % per year on average and over the combined period of the first and the second reference period (2012-2019) in relation to the targeted reduction of 1,7 % per year on average. It also took into account the level of en route determined unit costs in comparison to Member States having a similar operational and economic environment.

(8)

As regards Portugal, the assessment showed that the revised targets are based on a planned reduction of its en route determined unit costs over the second reference period by 2 % per year on average. This is below the targeted reduction of the average Union-wide en route determined unit costs over that period. However, Portugal's revised target for 2019 is based on planned en route determined unit costs that are significantly lower (– 30 %) than the average en route determined unit costs of Member States having a similar operational and economic environment to the one of Portugal. Over the combined period of the first and the second reference period the planned en route determined unit costs decrease at a significantly higher rate (– 4 %) than the Union-wide target. The Commission therefore considers that the revised targets of Portugal for the years 2018 and 2019 are consistent with the Union-wide targets in the key performance area of cost-efficiency for the second reference period.

(9)

As regards Romania, the assessment showed that the revised targets are based on a planned reduction of its en route determined unit costs over the second reference period by 3,2 % per year on average. This is marginally below the targeted reduction of the average Union-wide en route determined unit costs over that period. Romania's revised target for 2019 is based on planned en route determined unit costs that are lower (– 1,5 %) than the average en route determined unit costs of Member States having a similar operational and economic environment to the one of Romania. Over the combined period of the first and the second reference period the planned en route determined unit costs decrease at the same rate (– 1,7 %) than the Union-wide target. The Commission therefore considers that the revised targets of Romania for the years 2018 and 2019 are consistent with the Union-wide targets in the key performance area of cost-efficiency for the second reference period.

(10)

Implementing Decision (EU) 2015/348 should therefore be amended, so as to take account of the revised targets of Portugal and Romania.

(1)

Regulation (EU) 2016/796 gives the European Union Agency for Railways (‘the Agency’) power to take individual decisions in the fields of vehicle authorisation, safety certification and ensuring harmonised implementation of European Railway Traffic Management System (‘ERTMS’) trackside. It also establishes Boards of Appeal before which such individual decisions of the Agency may be appealed.

(2)

The Commission published a call for expressions of interest on 25 May 2018 on the website of the Directorate-General for Mobility and Transport with a deadline for submission of the applications set at 30 June 2018. The Commission received applications from 46 candidates.

(3)

The Commission assessed those applications against the criteria specified in the call for expressions of interest. Those included the criteria of eligibility, the criteria relating to technical and professional capacity, the knowledge requirements and the criteria for the disciplines subject to the Agency's decision, namely vehicle authorisation, single safety certification and ERTMS. In order to avoid potential conflicts of interest, candidates who had worked in the Agency in the previous two years were excluded from the selection procedure. Following the assessment of the applications, 40 candidates were selected as qualified experts for the Boards of Appeal and placed on the list,

(1)

In accordance with Regulation (EU) No 517/2014, the placing on the Union market of at least 100 tonnes of CO2 equivalent of hydrofluorocarbons (‘HFCs’) per year by producers or importers is subject to quantitative limits in order to ensure their gradual reduction.

(2)

Pursuant to Article 16 of Regulation (EU) No 517/2014 the quantitative limits – quotas — are calculated based on reference values determined by the Commission on the basis of the annual average of the quantities of HFCs the producers or importers have reported under Article 19 of Regulation (EU) No 517/2014 to have lawfully placed on the market from 1 January 2015 and onwards, while excluding quantities of HFCs for the uses referred to in Article 15(2) of Regulation (EU) No 517/2014 during the same period, on the basis of available data, in accordance with Annex V to that Regulation.

(3)

In accordance with Article 16(5) of Regulation (EU) No 517/2014 HFC quotas are allocated to producers or importers as listed in the Annex to Commission Implementing Decision (EU) 2017/1984 (2) which are established within the Union or to importers from third countries having mandated an only representative established within the Union as listed in the Annex to Implementing Decision (EU) 2017/1984.

(4)

In light of the notification under Article 50 on the Treaty on European Union by the United Kingdom and with a view to ensuring that the reference values and quotas for producers and importers established within the United Kingdom reflect the lawful placing on the market of HFCs in the Union of 27 Member States after the withdrawal of the United Kingdom, the reference values for these companies should be re-calculated for 2019 for the period following the withdrawal on 30 March 2019.

(5)

For the period from 1 January to 29 March 2019 the reference values determined in Implementing Decision (EU) 2017/1984 should remain valid and applicable. For the determination of the quota for producers and importers established within the United Kingdom the reference values for the period up to and including 29 March and the period thereafter will be weighted by the number of days the United Kingdom is a Member State of the Union in 2019.

(6)

For companies established within the United Kingdom the newly re-calculated reference values as determined in this Decision are based on additional verified data submitted by these companies to the Commission and complementing the reporting already made pursuant to Article 19 of Regulation (EU) No 517/2014 by differentiating between HFCs placed on the market within the United Kingdom and in the Union of 27 Member States. For companies that have not submitted additional data it should be assumed that all HFCs were placed on the market within the United Kingdom and no reference value should be determined.

(7)

The re-calculated reference values are established for the case that Union law ceases to apply to and in the United Kingdom on 30 March 2019.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 24 of Regulation (EU) No 517/2014.