(1)

Council Regulation (EC) No 147/2003 (2) imposes a general ban on the provision of technical advice, assistance, training, financing or financial assistance related to military activities, to any person, entity or body in Somalia.

(2)

By paragraph 7 of Resolution 1907 (2009), the UN Security Council calls upon Member States to inspect all cargo going to or coming from Somalia, where they believe that the cargo contains items prohibited either by paragraphs 5 and 6 of that Resolution or the general and complete arms embargo to Somalia, for the purpose of ensuring strict implementation of those provisions.

(3)

Decision 2010/231/CFSP provides for the inspection of certain cargoes to and from Somalia and, in the case of aircraft and vessels, for the supply of additional pre-arrival and pre-departure information in respect of goods brought into or out of the Union. That information must be provided in accordance with the provisions on entry and exit summary declarations of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (3).

(4)

This measure falls within the scope of the Treaty and, therefore, notably with a view to ensuring its uniform application by economic operators in all Member States, Union legislation is necessary in order to implement it.

(5)

Regulation (EC) No 147/2003 should be amended accordingly,

(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation. By means of Commission Regulation (EC) No 246/2006 (2) Sanabel Relief Agency Limited (Sanabel) was added to Annex I.

(2)

On 29 September 2010 the General Court annulled Regulation (EC) No 881/2002 in so far as it concerned Sanabel (3) holding that the rights of the defence, the right to judicial review and the right to property had not been respected.

(3)

Following receipt of a statement of reasons from the UN Al Qaida and Taliban Sanctions Committee, the Commission communicated this statement to Sanabel in August 2009. In July 2010 it has communicated a related statement of reasons which it had just received from the Sanctions Committee. Sanabel has submitted its observations on these statements of reasons.

(4)

The list of persons, groups and entities to whom the freezing of funds and economic resources should apply, drawn up by the UN Al Qaida and Taliban Sanctions Committee, currently comprises Sanabel.

(5)

Pursuant to Article 7c(3) of Regulation (EC) No 881/2002, after having carefully considered the observations received from Sanabel, and given the preventive nature of the freezing of funds and economic resources, the Commission considers that the listing of Sanabel is justified for reasons of its association with the Taliban, Usama bin Laden or the Al-Qaida network.

(6)

In view of this, the listing decision concerning Sanabel should be replaced by a new decision confirming its inclusion in Annex I to Regulation (EC) No 881/2002.

(7)

This new decision should apply from 11 February 2006, given the preventive nature and objectives of the freezing of funds and economic resources under Regulation (EC) No 881/2002 and the need to protect legitimate interests of the economic operators, who have been relying on the decision made in 2006.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Review of Listings under Regulation 881/2002,

(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation. By means of Regulation (EC) No 246/2006 (2) Ghunia Abdrabbah, Al-Bashir Mohammed Al-Faqih and Tahir Nasuf were added to Annex 1. This followed the decision of the United Nations Sanctions Committee, established pursuant to Security Council Resolution 1267(1999) concerning Al-Qaida and the Taliban and Associated Individuals and Entities, to add them to its Consolidated List.

(2)

On 29 September 2010 the General Court (3) annulled Regulation (EC) No 881/2002 in so far as it concerned Mr Abdrabbah, Mr Al-Faqih and Mr Nasuf, holding that the rights of the defence, the right to judicial review and the right to property had not been respected.

(3)

A statement of reasons was provided by the Commission to Mr Abdrabbah, Mr Al-Faqih and Mr Nasuf, respectively, on 22 September 2009, 7 August 2009 and 11 August 2009, after commencement of the Court proceedings referred to above. Accordingly the failure identified by the General Court has been addressed.

(4)

In view of this, the listing decision concerning Mr Abdrabbah, Mr Al-Faqih and Mr Nasuf should therefore be replaced by a new decision made pursuant to Article 7a(1) of Regulation (EC) No 881/2002, in order to ensure consistency with the decision of the United Nations Sanctions Committee and taking into account the objectives of the freezing of funds and economic resources under Regulation (EC) No 881/2002.

(5)

This new decision should apply from 11 February 2006, given the preventative nature and objectives of the freezing of funds and economic resources under Regulation (EC) No 881/2002 and the need to protect legitimate interests of the economic operators, who have been relying on the decision made in 2006.

(6)

Mr Abdrabbah, Mr Al-Faqih and Mr Nasuf have already had an opportunity to submit observations on the statements of reasons provided to them as envisaged by Articles 7a(3) and 7c(3) of Regulation (EC) No 881/2002. The Commission has communicated those observations to the Sanctions Committee and is in the process of conducting its review of its decisions to impose restrictive measures on them, which is being conducted under the procedure referred to in Article 7b(2) of Regulation (EC) No 881/2002. The results of the review will be communicated to Mr Abdrabbah, Mr Al-Faqih and Mr Nasuf.

(1)

Article 8(1) of Commission Regulation (EC) No 507/2008 of 6 June 2008 laying down detailed rules for the application of Council Regulation (EC) No 1673/2000 on the common organisation of the markets in flax and hemp grown for fibre (2) lays down that the apportioning of 5 000 tonnes of short flax fibre and hemp fibre as national guaranteed quantities, as provided for in Article 94 (1a), of Regulation (EC) No 1234/2007 for the marketing year 2010/2011, must be effected before 16 November of the marketing year in progress.

(2)

To that end, Denmark has sent the Commission information relating to areas covered by sale/purchase contracts, processing commitments and processing contracts, and estimated flax and hemp straw and fibre yields.

(3)

Conversely, no flax or hemp fibre will be produced for the 2010/2011 marketing year in Italy, Greece, Ireland or Luxembourg.

(4)

On the basis of estimates of production resulting from the information provided, total production in the five Member States concerned will not reach the overall quantity of 5 000 tonnes allocated to them, and the national guaranteed quantities as set out below should be set.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

—

Denmark

84 tonnes;

—

Greece

0 tonnes;

—

Ireland

0 tonnes;

—

Italy

0 tonnes;

—

Luxembourg

0 tonnes.

(1)

Directive 91/414/EEC provides that, on request, the inclusion of an active substance may be renewed.

(2)

The Commission has received letters from several producers requesting a renewal for active substances included in Annex I to Directive 91/414/EEC and for which the inclusion period is to expire in 2011 and 2012.

(3)

It is necessary to provide for a procedure for the submission and appraisal of applications for the renewal of the inclusion in Annex I to Directive 91/414/EEC of those active substances.

(4)

Periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.

(5)

Producers wishing to secure the renewal of active substances covered by this Regulation should be required to apply to the relevant rapporteur Member State.

(6)

Where two or more applications for the same active substance have been submitted separately and fulfil the requirements, the rapporteur Member States should communicate the updated contact details of each applicant to the other applicants to facilitate the submission of joint dossiers and to avoid, whenever possible, duplication of studies involving vertebrate animals.

(7)

In order to ensure the efficiency of renewal procedures, rapporteur Member States should organise, prior to the submission of the dossiers, a meeting to discuss the state of the art of the active substance and consider whether and, if necessary, how the dossiers submitted for the first inclusion are to be updated.

(8)

The dossiers submitted for renewal should include new data relevant to the active substance and new risk assessments to reflect any changes in data requirements and any changes in scientific or technical knowledge since the active substance was first included in Annex I to Directive 91/414/EEC, as reflected in guidance documents published by the Commission and in relevant opinions from the Scientific Committee on Plants or the European Food Safety Authority (hereinafter ‘the Authority’). The range of uses submitted should reflect the representative uses. The applicant should demonstrate, on the basis of the data submitted, that for one or more preparations the requirements of Article 5 of Directive 91/414/EEC will be fulfilled.

(9)

The applicants should list separately vertebrate studies to be submitted with the dossier and the rapporteur Member States should make such lists available on request to promote early discussions on the sharing of vertebrates data to avoid duplication of vertebrate studies.

(10)

Technical or scientific information about an active substance, in particular with regard to potentially dangerous effects, submitted within the relevant period by third parties should be taken into consideration in the evaluations. The applicants should be given the opportunity to comment on such information.

(11)

The renewal assessment reports prepared by the rapporteur Member States may, where necessary, be the subject of a consultation of experts organised by the Authority on request of the Commission before they are submitted to the Standing Committee on the Food Chain and Animal Health.

(12)

The rules on data protection of Article 13 of Directive 91/414/EEC are intended to provide an incentive to applicants to assemble the detailed studies required under Annexes II and III to that Directive. However, data protection should not be extended artificially by the production of new studies which are not needed to decide on the renewal of an active substance. To this end, applicants should be required to identify explicitly which studies are new compared to the original dossier used for the first inclusion of the substance in Annex I to Directive 91/414/EC and to provide justification for their submission.

(13)

In view of the particular situation, where parts of the renewal procedure still take place while Directive 91/414/EEC applies while the decisions on the renewals will be taken under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (2), applicants are encouraged, as regards the format of the updating statement and the format and content of the dossier, to pay particular attention to the specific guidance documents published by the Commission.

(14)

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)

‘producer’ means the person who manufactures the active substance on his own or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation;

(b)

‘applicant’ means a producer who applies for the renewal of the inclusion of an active substance referred to in column A of Annex I;

(c)

‘rapporteur Member State’ means the Member State which evaluates an active substance, as listed in column B of Annex I for the respective active substance;

(d)

‘co-rapporteur Member State’ means a Member State which cooperates in the evaluation carried out by the rapporteur Member State, as listed in column C of Annex I for the respective active substance;

(e)

‘inclusion’ means inclusion of an active substance in Annex I to Directive 91/414/EEC;

(f)

‘renewal’ means renewal of the inclusion of an active substance in Annex I to Directive 91/414/EEC.

(1)

Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (2) lays down rules for the control, monitoring, surveillance and restrictions on movements of animals, in relation to bluetongue, in and from the restricted zones.

(2)

Article 8 of Regulation (EC) No 1266/2007 lays down conditions for exemption from the exit ban provided for in Directive 2000/75/EC. Article 8(1) of that Regulation provides that movements of animals, their semen, ova and embryos, from a holding or semen collection or storage centre located in a restricted zone to another holding or semen collection or storage centre are to be exempted from that exit ban provided that they comply with the conditions set out in Annex III to that Regulation or with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of the bluetongue virus and protection against attacks by vectors, required by the competent authority of the place of origin and approved by the competent authority of the place of destination, prior to the movement of such animals.

(3)

Article 9(a) of Regulation (EC) No 1266/2007 provides that, until 31 December 2010, and by way of derogation from the conditions set out in Annex III to that Regulation, Member States of destination may require that the movement of certain animals which are covered by the exemption, provided for in Article 8(1) thereof, be subjected to additional conditions, on the basis of a risk assessment taking into account the entomological and epidemiological conditions in which animals are being introduced. Those additional conditions specify that the animals must be less than 90 days old, they must have been kept since birth in vector protected confinement and they must have been subject to certain tests referred to in Annex III to that Regulation.

(4)

Fifteen Member States and Norway have notified the Commission that they have applied that transitional measure. The outcomes of the risk assessments that were carried out, which are publicly available on the Commission’s website, show that the introduction of bluetongue in those Member States and in Norway as a result of animal movements from restricted zones could have a major negative impact.

(5)

The overall disease situation as regards bluetongue has improved considerably since 2008. However the virus is still present in parts of the Union.

(6)

For the sake of harmonized implementation, Member States have requested for specific criteria for the ‘vector proof establishment’ which is an important requirement for a number of the conditions set out in Annex III of Regulation (EC) No 1266/2007 and aims at the protection of animals against attacks by vectors. Currently, the World Organization for Animal Health (OIE) is working on a definition of a vector-protected establishment or facility. The outcome of this work shall serve as input for the Commission to define criteria for the vector proof establishment as referred to in Annex III of the Regulation.

(7)

Pending the development of the criteria for a vector proof establishment, the period of application of the transitional measures provided for in Article 9(a) of Regulation (EC) No 1266/2007 should be prolonged for another six months.

(8)

Regulation (EC) No 1266/2007 should therefore be amended accordingly.

(9)

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

(1)

Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (2) lays down the animal health conditions and certification requirements for imports into the Union of ornamental aquatic animals intended for closed ornamental facilities.

(2)

Article 11 of Regulation (EC) No 1251/2008 provides that ornamental fish of species susceptible to one or more of the diseases listed in Part II of Annex IV to Directive 2006/88/EC and intended for closed ornamental facilities are only to be imported into the Union from third countries, territories, zones or compartments listed in Annex III to that Regulation. Epizootic ulcerative syndrome (EUS) is listed in Part II of Annex IV to Directive 2006/88/EC as an exotic disease of certain susceptible species of fish.

(3)

Article 20(5) of Regulation (EC) No 1251/2008 provides that for a transitional period until 31 December 2010, Member States may authorise the import of ornamental aquatic animals of species susceptible to EUS intended solely for closed ornamental facilities from third countries or territories that are members of the World Organisation for Animal Health (OIE).

(4)

Part II.2 of the model animal health certificate applicable to ornamental aquatic animals intended for closed facilities set out in Part B of Annex IV to Regulation (EC) No 1251/2008 sets out certain import requirements related to EUS. The second sub-paragraph of Article 20(5) of that Regulation provides that these requirements shall not apply during the transitional period referred to above.

(5)

Further studies are needed at present to assess more precisely the risks associated with the import into the Union of such ornamental aquatic animals. In order not to disrupt trade in those animals, it is appropriate to prolong until 31 December 2012 the period of application of the transitional measures currently laid down in Article 20(5) of Regulation (EC) No 1251/2008.

(6)

In addition, certain other transitional provisions currently laid down in Article 20 of that Regulation are no longer applicable. In the interests of conciseness and clarity of Union legislation, it is appropriate to delete those provisions.

(7)

Regulation (EC) No 1251/2008 should therefore be amended accordingly.

(8)

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

(1)

Council Regulation (EU) No 53/2010 of 14 January 2010 fixing for 2010 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in waters where catch limitations are required (2), lays down quotas for 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 53/2010 of 14 January 2010 fixing for 2010 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in waters where catch limitations are required (2), lays down quotas for 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 53/2010 of 14 January 2010 fixing for 2010 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in waters where catch limitations are required (2), lays down quotas for 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 53/2010 of 14 January 2010 fixing for 2010 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in waters where catch limitations are required (2), lays down quotas for 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EU) No 53/2010 of 14 January 2010 fixing for 2010 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in waters where catch limitations are required (2), lays down quotas for 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Council Regulation (EC) No 1359/2008 of 28 November 2008 fixing for 2009 and 2010 the fishing opportunities for Community fishing vessels for certain deep-sea fish stocks (2) lays down quotas for 2009 and 2010.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2010.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

(1)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included pyridaben.

(2)

In accordance with Article 11e of Regulation (EC) No 1490/2002 the applicant withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of pyridaben.

(3)

Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

(4)

The application was submitted to the Netherlands, which had been designated rapporteur Member State by Regulation (EC) No 451/2000. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)

The Netherlands evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 15 June 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on pyridaben to the Commission on 28 May 2010 (6). The draft assessment report, the additional 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 28 October 2010 in the format of the Commission review report for pyridaben.

(6)

It has appeared from the various examinations made that plant protection products containing pyridaben may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include pyridaben in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

(7)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit further information to confirm the results of the risk assessment on the basis of most recent scientific knowledge as regards the exposure to the aqueous photolysis metabolites W-1 and B-3, the long term risk for mammals, the assessment of fat soluble residues.

(8)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

(9)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing pyridaben to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(10)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (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.

(11)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(12)

Decision 2008/934/EC provides for the non-inclusion of pyridaben and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning pyridaben in the Annex to that Decision.

(13)

It is therefore appropriate to amend Decision 2008/934/EC accordingly.

(14)

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

(1)

According to the Protocol on Transitional Provisions annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community, the legal effects of the acts of the institutions, bodies, offices and agencies of the Union adopted prior to the entry into force of the Treaty of Lisbon are preserved until those acts are repealed, annulled or amended in implementation of the Treaties.

(2)

Accordingly, Article 25 of Decision 2008/615/JHA is applicable and the Council must unanimously decide whether the Member States have implemented the provisions of Chapter 6 of that Decision.

(3)

Article 20 of Decision 2008/616/JHA provides that decisions referred to in Article 25(2) of Decision 2008/615/JHA are to be taken on the basis of an evaluation report based on a questionnaire. With respect to automated data exchange in accordance with Chapter 2 of Decision 2008/615/JHA, the evaluation report is to be based on an evaluation visit and a pilot run.

(4)

According to Chapter 4, point 1.1 of the Annex to Decision 2008/616/JHA, the questionnaire drawn up by the relevant Council Working Group concerns each of the automated data exchanges and has to be answered by a Member State as soon as it believes it fulfils the prerequisites for sharing data in the relevant data category.

(5)

Bulgaria has completed the questionnaire on data protection and the questionnaire on dactyloscopic data exchange.

(6)

A successful pilot run has been carried out by Bulgaria with Austria.

(7)

An evaluation visit has taken place in Bulgaria and a report on the evaluation visit has been produced by the Austrian/Spanish evaluation team and forwarded to the relevant Council Working Group.

(8)

An overall evaluation report, summarising the results of the questionnaire, the evaluation visit and the pilot run concerning dactyloscopic data exchange has been presented to the Council,

(1)

A Risk Assessment Report on 4-methylmethcathinone (mephedrone) was drawn up on the basis of Article 6 of Decision 2005/387/JHA by a special session of the extended Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction, and was subsequently received by the Commission on 3 August 2010.

(2)

Mephedrone is a synthetic cathinone which is legally produced and distributed mainly in Asia, while final packaging seems to occur in Europe. Mephedrone is mostly sold as powder, but also as capsules or tablets. It is commercially available on the Internet, from ‘head shops’ and from street-level dealers. On the Internet, mephedrone is often marketed as ‘plant food’, ‘bath salt’, or ‘research chemical’. It is very rarely marketed as a ‘legal high’ (licit psychoactive substance) and there is usually no reference or concrete information about its potential psychoactive effects.

(3)

Mephedrone’s specific effects are difficult to assess because it is primarily used in combination with substances like alcohol and other stimulants. Mephedrone is deemed to have similar physical effects to other stimulant drugs, in particular ecstasy (MDMA). However, its relatively short duration of action, leading to repeated dosing, is more analogous to cocaine. Some evidence suggests that it may be used as an alternative to illicit stimulants, that it has a high abuse liability and a potential to cause dependency. More in-depth studies would be required to explore in detail the dependence potential of this drug.

(4)

There are two reported fatalities in the Union in which mephedrone appears to be the sole cause of death. There are at least another 37 deaths in which mephedrone has been detected in post-mortem samples.

(5)

Twenty two Member States have reported seizures of mephedrone in powder or tablets. There is little information that may suggest large-scale processing or distribution of mephedrone and the involvement of organised crime. Some evidence suggests that where mephedrone has been controlled, the drug continues to be available on the illicit market.

(6)

Mephedrone has no established or acknowledged medical value or use in the Union and there is no indication that it may be used for any other legitimate purposes.

(7)

Mephedrone is currently not under assessment and has not been under assessment by the United Nations system. Eleven Member States control mephedrone under drug control legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances. Two Member States apply control measures to mephedrone under their medicines legislation.

(8)

The Risk Assessment reveals limited scientific evidence and points out that further studies are needed on the overall health and social risks of mephedrone. However, because of its stimulant properties, its ability to produce dependence in users, its potential attractiveness, the risk to health, the lack of medical benefits, and therefore the need to apply precaution, mephedrone should be controlled.

(9)

Since eleven Member States already control mephedrone, placing it under control across the Union may help avoid problems in cross-border law enforcement and judicial cooperation,

(1)

A flood constitutes a disaster within the meaning of Title XVII C of Regulation (EC) No 1186/2009; whereas there is consequently reason to authorize the duty-free importation of goods which satisfy the requirements of Articles 74 to 80 of the abovementioned Regulation (EC) No 1186/2009.

(2)

In order that the Commission may be suitably informed of the use made of the goods admitted duty-free, the Government of Hungary must communicate the measures taken to prevent such goods imported duty-free from being employed otherwise than for the use laid down.

(3)

The Commission should also be informed of the extent and the nature of the importations made.

(4)

Other Member States have been consulted as laid down in Article 76 of Regulation (EC) No 1186/2009,

(1)

Commission Decision 2010/221/EU of 15 April 2010 approving national measures for limiting the impact of certain diseases in aquaculture animals and wild aquatic animals in accordance with Article 43 of Council Directive 2006/88/EC (2) allows certain Member States to apply placing on the market and import restrictions on consignments of those animals in order to prevent the introduction of certain diseases, including spring viraemia of carp (SVC), provided that the Member States have either demonstrated that they, or certain demarcated areas, are free of the disease in question (‘disease-free areas’) or that they have established an eradication programme to obtain such freedom.

(2)

Annex I to Decision 2010/221/EU lists the disease-free areas and Annex II thereto lists the areas with approved eradication programmes.

(3)

Annex II to Decision 2010/221/EU currently lists Great Britain as an area of the United Kingdom with approved eradication programme for SVC. That Member State has now submitted information demonstrating that its eradication programme has been successfully completed and that Great Britain should be regarded as free of SVC and listed in Annex I, instead of in Annex II, to that Decision as regards that disease.

(4)

Hungary has submitted to the Commission applications for the approval of national measures as regards SVC. Hungary has also conducted targeted surveillance of SVC for the last two years which has demonstrated that its entire territory is free of SVC. Hungary should therefore be listed in Annex I to Decision 2010/221/EU as free of SVC.

(5)

Annexes I and II to Decision 2010/221/EU should therefore be amended accordingly.

(6)

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