15.2.2014   

EN

Official Journal of the European Union

L 45/1

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For pyridalyl the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Sumitomo Chemical Agro Europe S.A.S. for the inclusion of the active substance pyridalyl in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 8 January 2009.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance pyridalyl (4) on 24 May 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for pyridalyl.

(5)

It has appeared from the various examinations made that plant protection products containing pyridalyl may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the use which was examined and detailed in the Commission review report. It is therefore appropriate to approve pyridalyl.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing pyridalyl. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

(11)

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

(a)

in the case of a product containing pyridalyl as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

(b)

in the case of a product containing pyridalyl as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

15.2.2014   

EN

Official Journal of the European Union

L 45/7

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For valifenalate the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/586/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC Hungary received on 2 September 2005 an application from Isagro S.p.A. (4) for the inclusion of the active substance valifenalate in Annex I to Directive 91/414/EEC. Decision 2006/586/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 19 February 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (5) additional information was requested from the applicant on 18 July 2011. The evaluation of the additional data by Hungary was submitted in the format of an updated draft assessment report in April 2012.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance valifenalate (6) on 31 May 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for valifenalate.

(5)

It has appeared from the various examinations made that plant protection products containing valifenalate may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve valifenalate.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing valifenalate. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (8) should be amended accordingly.

(11)

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

(a)

in the case of a product containing valifenalate as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

(b)

in the case of a product containing valifenalate as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

15.2.2014   

EN

Official Journal of the European Union

L 45/12

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For thiencarbazone the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/566/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 13 April 2007 an application from Bayer CropScience AG for the inclusion of the active substance thiencarbazone in Annex I to Directive 91/414/EEC. Decision 2008/566/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 17 December 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 7 July 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report in April 2012.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance thiencarbazone (5) on 17 June 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 13 December 2013 in the format of the Commission review report for thiencarbazone.

(5)

It has appeared from the various examinations made that plant protection products containing thiencarbazone may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve thiencarbazone.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing thiencarbazone. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

(11)

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

(a)

in the case of a product containing thiencarbazone as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

(b)

in the case of a product containing thiencarbazone as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

15.2.2014   

EN

Official Journal of the European Union

L 45/17

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

15.2.2014   

EN

Official Journal of the European Union

L 45/19

(1)

Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

(2)

Article 136(2) of Regulation (EC) No 1234/2007 lays down that, in order to calculate the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

(3)

Under Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products covered by CN codes 1001 19 00, 1001 11 00, ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00, 1002 90 00, 1005 10 90, 1005 90 00, 1007 10 90 and 1007 90 00 is the daily cif representative import price determined as specified in Article 5 of that Regulation.

(4)

Import duties should be fixed for the period from 16 February 2014 and should apply until new import duties are fixed and enter into force.

(5)

Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

15.2.2014   

EN

Official Journal of the European Union

L 45/22

(1)

Pursuant to Article 4 of Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (2), copper was notified for use, inter alia, in product-types 2, 5 and 11, as defined in Annex V to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (3).

(2)

No complete dossier was submitted in support of the inclusion of copper in Annex I, IA or IB to Directive 98/8/EC within any of the relevant deadlines. Pursuant to Commission Decision 2012/78/EU of 9 February 2012 concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (4) read in combination with Article 4(2) of Regulation (EC) No 1451/2007, copper shall no longer be placed on the market for use in product-types 2, 5 or 11 as of 1 February 2013.

(3)

Pursuant to Article 5 of Regulation (EC) No 1451/2007, the United Kingdom, Spain, the Netherlands and Poland have submitted separate applications to the Commission for permission to allow the placing on the market of biocidal products containing copper for the uses indicated by ‘Yes’ in the Annex to this Decision.

(4)

The Commission made the applications publicly available by electronic means. Comments were received and were made publicly available.

(5)

It follows from the applications that transmission of Legionella has been associated, in particular, with use of water such as drinking water, bathing water, showering water and water in cooling towers. Furthermore, it follows that Legionella can be fatal, especially in vulnerable groups such as hospital patients. According to the applications, selection of a suitable system for Legionella control is complex and depends on a number of parameters such as system design, age, complexity and water chemistry.

(6)

It also follows from some of the applications, that biocidal products containing copper are used to prevent growth of organisms in the main water inlet for offshore oil and gas platforms, where that use is essential to avoid blocking the inlet of water used for, inter alia, processing, drinking water and bathing water production, and firefighting, since blocking that inlet could be fatal for the health and safety of the staff at the installation.

(7)

Some comments received during the public consultation have pointed to the existence of alternative methods for water system disinfection. However, the Member States having submitted the applications have argued that, in their territories, it is necessary to have an adequate range of technical and economic feasible alternatives available to control Legionella, and, where relevant, to reduce the risk of blocking the main water inlet for offshore installations. This has been confirmed in some of the public consultations by users of the products in question, such as hospitals.

(8)

It therefore appears likely that not allowing use for Legionella control, or where relevant for preventing growth of organisms in the water inlet for offshore oil and gas platforms, in those Member States would currently pose a serious risk for public health. The requested derogations for essential use are therefore currently necessary.

(9)

However, unless a complete application for approval of copper for use in the relevant product-types is submitted without undue delay, users of biocidal products containing copper should implement alternative methods for Legionella control or organism growth prevention. It is therefore appropriate to require that, in such a case, users in those Member States are actively informed in due time to allow them to ensure that those alternative methods are effective before the biocidal products containing copper have to be withdrawn from the market,

15.2.2014   

EN

Official Journal of the European Union

L 45/24

(1)

Directive 2009/156/EC lays down animal health conditions for the importation into the Union of live equidae. In accordance with Article 13(1)(a) one of the conditions for the authorisation of imports of equidae into the Union is that the third country has been free from Venezuelan equine encephalomyelitis for a period of two years.

(2)

Commission Decision 93/195/EEC (3) provides models of health certificates for the re-entry of registered horses after temporary export to participate in racing, competition or cultural events.

(3)

Commission Decision 2004/211/EC (4) establishes a list of third countries, or parts thereof where regionalisation applies, from which Member States are to authorise the importation of live equidae and semen, ova and embryos thereof. That list is set out in Annex I to that Decision.

(4)

Commission Implementing Decision 2013/167/EU (5) amending the list in Annex I to Decision 2004/211/EC provides that temporary admission of registered horses, re-entry after temporary export of registered horses for racing, competition and cultural events, imports of registered equidae and equidae for breeding and production, and imports of semen, ova and embryos of the equine species from Mexico are currently not authorised.

(5)

The Commission has received a risk assessment carried out by the French competent authorities relating to the re-entry of horses scheduled for temporary export to Mexico-City (Mexico). That assessment contains comprehensive details of the biosecurity measures applied by the Théâtr équestre Zingaro for the protection of the health status of their horses during their residence in Mexico-City as well as the quarantine measures imposed by the French competent authorities on those horses upon their return.

(6)

Given the degree of veterinary supervision, the agreed routine health checks and the separation from equidae of lower health status, it is possible to lay down specific animal health and the veterinary certification conditions for the re-entry of these horses after their temporary export for a period of less than 90 days to participate in specific equestrian cultural events in Mexico-City.

(7)

Decision 93/195/EEC should therefore be amended accordingly.

(8)

Since the measures provided for in this Decision concern only a region of high altitude and during dry and tempered winter season with a reduced risk of vector born transmission of vesicular stomatitis or certain subtypes of Venezuelan equine encephalitis, the re-entry of registered horses for racing, competition and cultural events after temporary export for a period of less than 90 days to the Metropolitan area of Mexico-City, a region in which Venezuelan equine encephalomyelitis has not been reported for more than 2 years, should be authorised.

(9)

The entry for that third country in Annex I to Decision 2004/211/EC should therefore be amended.

(10)

Decision 2004/211/EC should therefore be amended accordingly.

(11)

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

(1)

in Article 1, the following indent is added:

(2)

a new Annex X is added as set out in Annex I to this Decision.

15.2.2014   

EN

Official Journal of the European Union

L 45/29

(1)

Xylella fastidiosa (Well and Raju) (hereinafter ‘the specified organism’) is listed in Section I of Part A of Annex I to Directive 2000/29/EC as a harmful organism not known to occur in the Union, the introduction of which into, and spread within, all Member States is prohibited.

(2)

On 21 October 2013 Italy informed the other Member States and the Commission of the presence of the specified organism in its territory, in two separate areas of the province Lecce, in the region of Apulia. Subsequently two further separate outbreaks have been identified in the same province. The presence of the specified organism was confirmed in respect of several plants species, including Olea europaea L., Prunus amygdalus Batsch, Nerium oleander L. and Quercus sp. L. showing leaf scorching and rapid decline symptoms. This is the first time the presence of the specified organism in the territory of the Union is confirmed. For several other plants species checks concerning its presence have not yet been concluded. The identification of the vector of the specified organism in Apulia is pending.

(3)

On 29 October 2013 the region Apulia took emergency measures for the prevention and eradication of the specified organism (2) in accordance with Article 16(1) of Directive 2000/29/EC.

(4)

Italy reported that the inspections it had carried out showed no presence of the specified organism in the neighbouring provinces of Brindisi and Taranto.

(5)

In response to a request by the Commission, the European Food Safety Authority, ‘the Authority’, adopted a statement on 25 November 2013 (3) which contains the following conclusions. The specified organism has probably a very broad range of host plants, including many cultivated and spontaneous plants common in Europe.

(6)

The main entry pathway for the specified organism is the movement of plants for planting, excluding seeds. The pathway of infective vectors of the specified organism transported on plant consignments is also of concern. Fruit and wood are minor pathways with negligible likelihood of introduction. Seeds, cut flowers and ornamental foliage are minor pathways with low likelihood of introduction. The movement of infected plants for planting is the most efficient way for long-distance dispersal of the specified organism.

(7)

In view of the nature of the specified organism, it is likely to spread rapidly and widely. In order to ensure that the specified organism does not spread to the rest of the Union, it is necessary to take measures immediately. Until more specific information becomes available concerning host range, vectors, pathways and risk reduction options, it is appropriate to prohibit movement out of areas possibly containing infected plants.

(8)

Taking into consideration the locations of the presence of the specified organism, the particular geographical situation of the administrative province of Lecce and the uncertainties concerning the criteria for demarcation, that entire province should be the subject of that prohibition, in order to apply that prohibition rapidly and effectively.

(9)

That prohibition should concern plants for planting, other than seeds, as those plants are the main pathway for the specified organism. However, extensive sampling and testing in the province of Lecce have found that plants for planting belonging to certain genera and species, and originating in infected parts of Lecce, are not infected by the specified organism. Based on that evidence the prohibition should not concern lots of plants for planting of those genera and species that have been sampled and tested concerning the presence of the specified organism. Moreover, it would be appropriate to also exempt from that prohibition plants for planting which have been grown in sites with complete physical protection against the introduction of the specified organism and which belong to genera and species subject to a certification scheme requiring them to be subject to official testing concerning the specified organism and found free from that organism.

(10)

In view of the limited information on the possible presence of the specified organism in the rest of the Union, Member States should conduct annual surveys concerning the presence of that organism in their territories. In view of the broad range of potential host plants, those surveys should be adapted to the specificities of each area, host plant and plant products, and the characteristics of the potential vectors.

(11)

In order to gather as much information as possible on the specified organism and its presence, Member States should ensure that relevant information is communicated to them.

(12)

Member States should immediately inform the Commission of the measures they have taken to comply with this Decision, to ensure an effective overview of the implementation of this Decision.

(13)

It is appropriate that the measures be reviewed by 30 April 2014, at the latest, in order to take into account more precise scientific and technical information that will become available, as well as the results of the ongoing inspections and tests carried out by the Italian authorities.

(14)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plant Health,

(a)

seeds;

(b)

lots of plants for planting of the genera and species listed in Annex I that have been sampled and tested concerning the presence of Xylella fastidiosa (Well and Raju) (hereinafter: ‘the specified organism’) and have been found free from that organism;

(c)

plants for planting of the genera and species listed in Annex II, which have been grown in sites with complete physical protection against the introduction of the specified organism and which are officially certified under a certification scheme requiring them to be subject to official testing concerning the presence of the specified organism, and found free from that organism.

15.2.2014   

EN

Official Journal of the European Union

L 45/34

(1)

Regulation (EC) No 178/2002 lays down the general principles governing food in general, and food safety in particular, at Union and national level. It provides for emergency measures to be taken by the Commission where there is evidence that food imported from a third country is likely to constitute a serious risk to human health.

(2)

Since October 2011, 142 notifications have been issued to the Rapid Alert System for Food and Feed due to the presence of a wide range of pathogenic salmonella strains in foodstuffs containing or consisting of betel leaves (‘Piper betle’, commonly known as ‘Paan leaf’ or ‘Betel quid’) originating in or consigned from Bangladesh.

(3)

Bangladesh has informed the Commission that from November 2012 there has been a ban on all betel leaves exports, pending the introduction of a programme for the export of pathogen-free betel leaves.

(4)

The Food and Veterinary Office (FVO) of the Directorate-General for Health and Consumers of the Commission carried out an audit in Bangladesh from 30 January to 7 February 2013 in order to assess the system of official controls for the export of plants to the Union. It found that the programme for the export of pathogen-free betel leaves was still being developed. The audit concluded that weaknesses were present in each stage of the export system, and in particular the pre-export inspection stage. Pre-export inspection is essential in order to ensure that only betel leaves which comply with that programme are exported to the Union.

(5)

Despite the measures introduced by Bangladesh and action taken by it against non-compliant exporters, betel leaves continue to be exported to the Union from Bangladesh and there are still a high number of rapid alerts.

(6)

That high level of contamination presents a serious risk for human health. It is therefore appropriate to suspend imports into the Union of foodstuffs containing or consisting of betel leaves from that third country, pending the receipt of sufficient guarantees from it.

(7)

In order to allow the time necessary for Bangladesh to provide feedback and to consider the appropriate risk management measures the temporary suspension of imports of betel leaves should be in force at least until 31 July 2014.

(8)

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

15.2.2014   

EN

Official Journal of the European Union

L 45/36

(1)

The Internal Market Information System (‘IMI’), formally established by the IMI Regulation, is a software application accessible via internet, developed by the Commission in cooperation with the Member States, to assist Member States in the practical implementation of information exchange requirements laid down in Union law pertaining to the internal market by providing a centralised communication mechanism to facilitate the cross-border exchange of information and mutual assistance.

(2)

Directive 2007/59/EC of the European Parliament and of the Council (2) sets out certain common rules for the certification of train drivers in order to overcome national differences thus contributing to the aims of Union policies on the freedom of movement of workers, freedom of establishment and freedom to provide services in the context of the common transport policy, in order to make it easier for train drivers to move from one Member State to another. This includes, in particular, the interconnection of national registries of train drivers’ licences and certificates.

(3)

The European Railway Agency (ERA) established by Regulation (EC) No 881/2004 of the European Parliament and the Council (3) was set up to support the Commission in ensuring an harmonised approach to rail interoperability and safety in the Union.

(4)

A ‘Feasibility Study of Interoperable Registers of Train Driving Licences and Complementary Certificates’ by the ERA and adopted on 2 April 2013, deemed that IMI was a suitable tool to implement an information exchange between national licence registers and recommended that a pilot project be organised

(5)

Commission Decision 2010/17/EC (4) sets out that the European Railway Agency is responsible for monitoring and reporting on the functioning of the pilot. The IMI Regulation requires the Commission to evaluate the outcome of the pilot.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Internal Market Information System Committee,

(a)

point (b) of Article 22(1) of Directive 2007/59/EC, in conjunction with points 4 and 5 of Annex I to Decision 2010/17/EC;

(b)

Article 29(2) of Directive 2007/59/EC;

(c)

Article 29(3) of Directive 2007/59/EC;

(d)

point (b) of Article 29(4) of Directive 2007/59/EC, for requests for further inspection or suspension.

(a)

point (b) of Article 29(4) of Directive 2007/59/EC for information to the Commission and other competent authorities;

(b)

point (c) of Article 29(4) of Directive 2007/59/EC for information to the Commission and other competent authorities;

(c)

the second subparagraph of Article 29(4) of Directive 2007/59/EC for information to the Commission and other competent authorities;

(d)

Article 29(5) of Directive 2007/59/EC, for referral to the Commission.

(a)

data protection issues;

(b)

cost-effectiveness;

(c)

effective translation functionalities;

(d)

user-friendliness;

(e)

overall user’s satisfaction.

15.2.2014   

EN

Official Journal of the European Union

L 45/40