title: Commission Directive 2010/86/EU of 2 December 2010 amending Council Directive 91/414/EEC to include haloxyfop-P as an active substance  Text with EEA relevance

text:
               3.12.2010

               EN

               Official Journal of the European Union

               L 317/36

         COMMISSION DIRECTIVE 2010/86/EU
   of 2 December 2010
   amending Council Directive 91/414/EEC to include haloxyfop-P as an active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second 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 haloxyfop-R. By Commission Decision 2007/437/EC (4) it was decided not to include haloxyfop-R in Annex I to Directive 91/414/EEC.

               (2)

               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).

               (3)

               The application was submitted to Denmark, 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 those that were the subject of Decision 2007/437/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008. In that application the ISO name, ‘haloxyfop-P’, is used to refer to the active substance rather than the previously used term, ‘haloxyfop-R’.

               (4)

               Denmark evaluated the new information and 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 3 April 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 haloxyfop-P to the Commission on 9 October 2009 (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 haloxyfop-P.

               (5)

               The additional report by the rapporteur Member State and the new conclusion by the EFSA concentrate on the concerns that lead to the non-inclusion. Those concerns were in particular the potential contamination of groundwater - and possibly drinking water – by a number of metabolites and the risk to mammals.

               (6)

               The new data submitted by the applicant show the following. The metabolites concerned are neither of toxicological, nor of biological relevance and they present a low risk from an ecotoxicological point of view.

               (7)

               Consequently, the additional data and information provided by the applicant permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.

               (8)

               It has appeared from the various examinations made that plant protection products containing haloxyfop-P 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 were examined and detailed in the Commission review report. It is therefore appropriate to include haloxyfop-P in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (9)

               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 the inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the applicant submit information confirming the groundwater exposure assessment as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.

               (10)

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

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on 1 January 2011.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 2 December 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  OJ L 163, 23.6.2007, p. 22.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority: Conclusion on the peer review of the pesticide risk assessment of the active substance haloxyfop-P (haloxyfop-R) EFSA Journal 2009; 7(11): 1348. [102 pp.]. doi:10.2903/j.efsa.2009.1348. Available online: www.efsa.europa.eu

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘314

                     Haloxyfop-P
                     CAS No:
                     Acid: 95977-29-0

                        Ester: 72619-32-0

                     CIPAC No:
                     Acid: 526

                        Ester: 526.201

                     Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2- pyridyloxy)phenoxy]propanoic acid

                        Ester: Methyl (R)-2-{4-[3-chloro-5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionate

                     ≥ 940 g/kg

                        (Haloxyfop-P-methyl ester)

                     1 January 2011

                     31 December 2020

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on haloxyfop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 operator safety: conditions of use shall prescribe the use of adequate personal protective equipment;

                                 —

                                 protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;

                                 —

                                 consumer safety as regards the occurrence in groundwater of metabolites DE-535 pyridinol and DE-535 pyridinone.

                           The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the groundwater exposure assessment as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Directive 2010/28/EU of 23 April 2010 amending Council Directive 91/414/EEC to include metalaxyl as active substance (Text with EEA relevance)

text:
               24.4.2010

               EN

               Official Journal of the European Union

               L 104/57

         COMMISSION DIRECTIVE 2010/28/EU
   of 23 April 2010
   amending Council Directive 91/414/EEC to include metalaxyl as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Metalaxyl is one of the substances listed in Annex I to 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 (2).

               (2)

               As a consequence of the judgment of the Court of Justice of 18 July 2007 in Case C-326/05 P Industrias Químicas del Vallés v Commission
                   (3), which annulled Commission Decision 2003/308/EC (4) concerning the non-inclusion of metalaxyl in Annex I to Council Directive 91/414/EEC, the Commission adopted Regulation (EC) No 1313/2007 of 8 November 2007 amending Regulations (EC) No 2076/2002 as regards the extension of the time period referred to in Article 8(2) of Council Directive 91/414/EEC with respect to metalaxyl and (EC) No 2024/2006 as regards the deletion of the derogation concerning metalaxyl (5) and Regulation (EC) No 416/2008 of 8 May 2008 amending Regulation (EEC) No 3600/92 as regards the assessment of the active substance metalaxyl in the framework of Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (6).

               (3)

               Article 266 TFEU requires the institution whose act has been declared void to take the necessary measures to comply with the judgment of the Court of Justice. It is therefore necessary to assess metalaxyl once more taking into account the additional information submitted.

               (4)

               An additional assessment report has been submitted by the rapporteur Member State Portugal, which has been peer reviewed by the Member States and the Commission and finalised within the Standing Committee on the Food Chain and Animal Health on 12 March 2010 in the format of the Commission review report for metalaxyl.

               (5)

               The review of metalaxyl did not reveal any open questions to be addressed by the European Food Safety Authority which has taken over the role of the Scientific Committee on Plants.

               (6)

               It has appeared from the various examinations made that plant protection products containing metalaxyl 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 were examined and detailed in the Commission review report. It is therefore appropriate to include metalaxyl in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing metalaxyl can be granted in accordance with the provisions of that Directive.

               (7)

               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.

               (8)

               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 6 months after inclusion to review existing authorisations of plant protection products containing metalaxyl 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.

               (9)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 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.

               (10)

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

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 December 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 January 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metalaxyl as an active substance by 31 December 2010.
   By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to metalaxyl are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing metalaxyl as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 June 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning metalaxyl. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing metalaxyl as the only active substance, where necessary, amend or withdraw the authorisation by 30 June 2014 at the latest; or

               (b)

               in the case of a product containing metalaxyl as one of several active substances, where necessary, amend or withdraw the authorisation by 30 June 2014 or by the date fixed for such an amendment or withdrawal in the respective directive or directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 July 2010.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 23 April 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 366, 15.12.1992, p. 10.

      (3)  [2007] ECR I-6557.

      (4)  OJ L 113, 7.5.2003, p. 8.

      (5)  OJ L 291, 9.11.2007, p. 11.

      (6)  OJ L 125, 9.5.2008, p. 25.

      ANNEX
      In Annex I to Directive 91/414/EEC, the following row is added at the end of the table:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘309

                     Metalaxyl
                     CAS No 57837-19-1
                     CIPAC No 365

                     Methyl N-(methoxyacetyl)-N-(2,6-xylyl)-DL-alaninate

                     950 g/kg
                     The impurity 2,6-dimethylaniline was considered of toxicological concern and a maximum level of 1 g/kg is established.

                     1 July 2010

                     30 June 2020

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.
                     Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


Avis juridique important

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31979L1072

Eighth Council Directive 79/1072/EEC of 6 December 1979 on the harmonization of the laws of the Member States relating to turnover taxes - Arrangements for the refund of value added tax to taxable persons not established in the territory of the country

Official Journal L 331 , 27/12/1979 P. 0011 - 0019 Finnish special edition: Chapter 9 Volume 1 P. 0084  Greek special edition: Chapter 09 Volume 1 P. 0111  Swedish special edition: Chapter 9 Volume 1 P. 0084  Spanish special edition: Chapter 09 Volume 1 P. 0116  Portuguese special edition Chapter 09 Volume 1 P. 0116

EIGHTH COUNCIL DIRECTIVE  of 6 December 1979  on the harmonization of the laws of the Member States relating to turnover taxes - Arrangements for the refund of value added tax to taxable persons not established in the territory of the country  (79/1072/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonization of the laws of the Member States relating to turnover taxes - Common system of value added tax (uniform basis of assessment) (1), and particular Article 17 (4) thereof,  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas, pursuant to Article 17 (4) of Directive 77/388/EEC, the Council is to adopt Community rules laying down the arrangements governing refunds of value added tax, referred to in paragraph 3 of the said Article, to taxable persons not established in the territory of the country;  Whereas rules are required to ensure that a taxable person established in the territory of one member country can claim for tax which has been invoiced to him in respect of supplies of goods or services in another Member State or which has been paid in respect of imports into that other Member State, thereby avoiding double taxation;  Whereas discrepancies between the arrangements currently in force in Member States, which give rise in some cases to deflection of trade and distortion of competition, should be eliminated;  Whereas the introduction of Community rules in this field will mark progress towards the effective liberalization of the movement of persons, goods and services, thereby helping to complete the process of economic integration;  Whereas such rules must not lead to the treatment of taxable persons differing according to the Member State in the territory of which they are established;  Whereas certain forms of tax evasion or avoidance should be prevented;  Whereas, under Article 17 (4) of Directive 77/388/EEC, Member States may refuse the refund or impose supplementary conditions in the case of taxable persons not established in the territory of the Community ; whereas steps should, however, also be taken to ensure that such taxable persons are not eligible for refunds on more favourable terms than those provided for in respect of Community taxable persons;  Whereas, initially, only the Community arrangements contained in this Directive should be adopted ; whereas these arrangements provide, in particular, that decisions in respect of applications for refund should be notified within six months of the date on which such applications were lodged ; whereas refunds should be made within the same period ; whereas, for a period of one year from the final date laid down for the implementation of these arrangements, the Italian Republic should be authorized to notify the decisions taken by its competent services with regard to applications lodged by taxable persons not established within its territory and to make the relevant refunds within nine months, in order to enable the Italian Republic to reorganize the system at present in operation, with a view to applying the Community system;  Whereas further arrangements will have to be adopted by the Council to supplement the Community system ; whereas, until the latter arrangements enter into force, Member States will refund the tax on the services and the purchases of goods which are not covered by this  (1)OJ No L 145, 13.6.1977, p. 1. (2)OJ No C 26, 1.2.1978, p. 5. (3)OJ No C 39, 12.2.1979, p. 14. (4)OJ No C 269, 13.11.1978, p. 51.   Directive, in accordance with the arrangements which they adopt pursuant to Article 17 (4) of Directive 77/388/EEC,  HAS ADOPTED THIS DIRECTIVE:    Article 1 For the purposes of this Directive, "a taxable person not established in the territory of the country" shall mean a person as referred to in Article 4 (1) of Directive 77/388/EEC who, during the period referred to in the first and second sentences of the first subparagraph of Article 7 (1), has had in that country neither the seat of his economic activity, nor a fixed establishment from which business transactions are effected, nor, if no such seat or fixed establishment exists, his domicile or normal place of residence, and who, during the same period, has supplied no goods or services deemed to have been supplied in that country, with the exception of:    (a) transport services and services ancillary thereto, exempted pursuant to Article 14 (1) (i), Article 15 or Article 16 (1), B, C and D of Directive 77/388/EEC;       (b) services provided in cases where tax is payable solely by the person to whom they are supplied, pursuant to Article 21 (1) (b) of Directive 77/388/EEC.          Article 2 Each Member State shall refund to any taxable person who is not established in the territory of the country but who is established in another Member State, subject to the conditions laid down below, any value added tax charged in respect of services or movable property supplied to him by other taxable persons in the territory of the country or charged in respect of the importation of goods into the country, in so far as such goods and services are used for the purposes of the transactions referred to in Article 17 (3) (a) and (b) of Directive 77/388/EEC and of the provision of services referred to in Article 1 (b).   Article 3 To qualify for refund, any taxable person as referred to in Article 2 who supplies no goods or services deemed to be supplied in the territory of the country shall:    (a) submit to the competent authority referred to in the first paragraph of Article 9 an application modelled on the specimen contained in Annex A, attaching originals of invoices or import documents. Member States shall make available to applicants an explanatory notice which shall in any event contain the minimum information set out in Annex C;       (b) produce evidence, in the form of a certificate issued by the official authority of the State in which he is established, that he is a taxable person for the purposes of value added tax in that State. However, where the competent authority referred to in the first paragraph of Article 9 already has such evidence in its possession, the taxable person shall not be bound to produce new evidence for a period of one year from the date of issue of the first certificate by the official authority of the State in which he is established. Member States shall not issue certificates to any taxable persons who benefit from tax exemption pursuant to Article 24 (2) of Directive 77/388/EEC;       (c) certify by means of a written declaration that he has supplied no goods or services deemed to have been supplied in the territory of the country during the period referred to in the first and second sentences of the first subparagraph of Article 7 (1);       (d) undertake to repay any sum collected in error.          Article 4 To be eligible for the refund, any taxable person as referred to in Article 2 who has supplied in the territory of the country no goods or services deemed to have been supplied in the country other than the services referred to in Article 1 (a) and (b) shall:   (a) satisfy the requirements laid down in Article 3 (a), (b) and (d);  b) certify by means of a written declaration that, during the period referred to in the first and second sentences of the first subparagraph of Article 7 (1), he has supplied no goods or services deemed to have been supplied in the territory of the country other than services referred to in Article 1 (a) and (b).   Article 5 For the purposes of this Directive, goods and services in respect of which tax may be refundable shall satisfy the conditions laid down in Article 17 of Directive 77/388/EEC as applicable in the Member State of refund.  This Directive shall not apply to supplies of goods which are, or may by, exempted under item 2 of Article 15 of Directive 77/388/EEC.    Article 6 Member States may not impose on the taxable persons referred to in Article 2 any obligation, in addition to those referred to in Articles 3 and 4, other than the obligation to provide, in specific cases, the information necessary to determine whether the application for refund is justified.   Article 7 1. The application for refund provided for in Articles 3 and 4 shall relate to invoiced purchases of goods or services or to imports made during a period of not less than three months or not more than one calendar year. Applications may, however, relate to a period of less than three months where the period represents the remainder of a calendar year. Such applications may also relate to invoices or import documents not covered by previous applications and concerning transactions completed during the calendar year in question. Applications shall be submitted to the competent authority referred to in the first paragraph of Article 9 within six months of the end of the calendar year in which the tax became chargeable.  If the application relates to a period of less than one calendar year but not less than three months, the amount for which application is made may not be less than the equivalent in national currency of 200 European units of account ; if the application relates to a period of a calendar year or the remainder of a calendar year, the amount may not be less than the equivalent in national currency of 25 European units of account.  2. The European unit of account used shall be that defined in the Financial Regulation of 21 December 1977 (1), as determined on 1 January of the year of the period referred to in the first and second sentences of the first subparagraph of paragraph 1. Member States may round up or down, by up to 10 %, the figures resulting from this conversion into national currency.  3. The competent authority referred to in the first paragraph of Article 9 shall stamp each invoice and/or import document to prevent their use for further application and shall return them within one month.  4. Decisions concerning applications for refund shall be announced within six months of the date when the applications, accompanied by all the necessary documents required under this Directive for examination of the application, are submitted to the competent authority referred to in paragraph 3. Refunds shall be made before the end of the abovementioned period, at the applicant's request, in either the Member State of refund or the State in which he is established. In the latter case, the bank charges for the transfer shall be payable by the applicant.  The grounds for refusal of an application shall be stated. Appeals against such refusals may be made to the competent authorities in the Member State concerned, subject to the same conditions as to form and time limits as those governing claims for refunds made by taxable persons established in the same State.  5. Where a refund has been obtained in a fraudulent or in any other irregular manner, the competent authority referred to in paragraph 3 shall proceed directly to recover the amounts wrongly paid and any penalties imposed, in accordance with the procedure applicable in the Member State concerned, without prejudice to the provisions relating to mutual assistance in the recovery of value added tax.  In the case of fraudulent applications which cannot be made the subject of an administrative penalty, in accordance with national legislation, the Member State concerned may refuse for a maximum period of two years from the date on which the fraudulent application was submitted any further refund to the taxable person concerned. Where an administrative penalty has been imposed but has not been paid, the Member State concerned may suspend any further refund to the taxable person concerned until it has been paid.   Article 8 In the case of taxable persons not established in the territory of the Community, Member States may refuse refunds or impose special conditions.  Refunds may not be granted on terms more favourable than those applied in respect of taxable persons established in the territory of the Community.   Article 9 Member States shall make known, in an appropriate manner, the competent authority to which the application referred to in Article 3 (a) and in Article 4 (a) are to be submitted.  The certificates referred to in Article 3 (b) and in Article 4 (a), establishing that the person concerned is a taxable person, shall be modelled on the specimens contained in Annex B.  (1)OJ No L 356, 31.12.1977, p. 1.    Article 10 Member States shall bring into force the provisions necessary to comply with this Directive no later than 1 January 1981. This Directive shall apply only to applications for refunds concerning value added tax charged on invoiced purchases of goods or services or in imports made as from that date.  Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.   Article 11 By away of derogation from Article 7 (4), the Italian Republic may, until 1 January 1982, extend the period referred to in this paragraph from six to nine months.   Article 12 Three years after the date referred to in Article 10, the Commission shall, after consulting the Member States, submit a report to the Council on the application of this Directive, and in particular Articles 3, 4 and 7 thereof.   Article 13 This Directive is addressed to the Member States.     Done at Brussels, 6 December 1979.  For the Council  The President  L. PRETI     ANNEX A SPECIMEN >PIC FILE= "T0015646">    >PIC FILE= "T0015647">     ANNEX B SPECIMEN CERTIFICATE OF STATUS OF TAXABLE PERSON >PIC FILE= "T0015648">    ANNEX C Minimum information to be given in explanatory notes    A. The application shall be drawn up on a form printed in one of the official languages of the European Communities. This form shall, however, be completed in the language of the country of refund.       B. The application shall be completed in block capitals and be submitted, by 30 June of the year following that to which the application relates, to the competent authority of the State to which the application is made (see D below).       C. The VAT registration number in the country of refund shall be given, if it is known to the applicant.       D. The application shall be submitted to the relevant competent authorities, i.e. for:      - Belgium : ...           - Denmark : ...           - Germany : ...           - France : ...           - Ireland : ...           - Italy : ...           - Luxembourg : ...           - the Netherlands : ...           - the United Kingdom : ...                  E. The application shall refer to purchases of goods or services invoiced or to imports made during a period of not less than three months or more than one calendar year. However, it may relate to a period of less than three months where this period represents the remainder of a calendar year. Such an application may also relate to invoices or import documents not covered by previous applications and concerning transactions made during the calendar year in question.       F. In 9 (a), the applicant shall describe the nature of the activities for which he has acquired the goods or received the services referred to in the application for refund of the tax (e.g. participation in the International ... Fair, held in ... from ... to ..., stand No ..., or international carriage of goods as from ... to ... on ...).       G. The application shall be accompanied by a certificate issued by the official authority of the State in which the applicant is established and which provides evidence that he is a taxable person for the purposes of value added tax in that State. However, where the competent authority referred to in D above already has such evidence in its possession, the applicant shall not be bound to produce new evidence for a period of one year from the date of issue of the first certificate.       H. The application shall be accompanied by the originals of the invoices or import documents showing the amount of value added tax borne by the applicant.      I.  The application may be used for more than one invoice or import document but the total amount of VAT claimed for 19.. may not be less than:  Bfrs/Lfrs ...  Fl ...  DM ...  Dkr ...  £ ...  FF ...  £ Irl ...  Lit ...  if the period to which it relates is less than one calendar year but not less than three months or less than:  Bfrs/Lfrs ...  Fl ...  DM ...  Dkr ...  £ ...  FF ...  £ Irl ...  Lit ...  if the period to which it relates is one calendar year or less than three months,     J.  Exempted transport services are those carried out in connection with the international carriage of goods, including - subject to certain conditions - transport associated with the transit, export or import of goods.     K.  Any refund obtained improperly may render the offender liable to the fines or penalties laid down by the law of the State which has made the refund.     L.  The authority in the country of refund reserves the right to make refunds by cheque or money order addressed to the applicant.


title: Commission Directive 2006/41/EC of  7 July 2006  amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances   (Text with EEA relevance)

text:
               8.7.2006

               EN

               Official Journal of the European Union

               L 187/24

      COMMISSION DIRECTIVE 2006/41/EC
   of 7 July 2006
   amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Pursuant to Article 6(2) of Directive 91/414/EEC Belgium received, on 26 September 2001, an application from Sumitomo Chemical Takeda Agro Company Ltd, London, for the inclusion of the active substance clothianidin in Annex I to Directive 91/414/EEC. Commission Decision 2002/305/EC (2) 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.

               (2)

               Germany received an application pursuant to Article 6(2) of Directive 91/414/EEC on 16 October 2000 from Stähler Agrochemie GmbH & Co., KG (now Stähler International GmbH & Co., KG) (on behalf of the Taskforce Stähler Agrochemie GmbH & Co. KG, Tokuyama Europe GmbH and Tomen France SA) for the inclusion of the active substance pethoxamid in Annex I to Directive 91/414/EEC. Commission Decision 2001/626/EC (3) 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 those active substances, the effects on human 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 applicants. The designated rapporteur Member States submitted draft assessment reports concerning the substances to the Commission on 4 June 2003 (clothianidin) and 27 August 2002 (pethoxamid), respectively.

               (4)

               The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 27 January 2006 in the format of the Commission review reports for clothianidin and pethoxamid.

               (5)

               The review of clothianidin and pethoxamid did not reveal any open questions or concerns, which would have required a consultation of the Scientific Committee on Plants or of the European Food Safety Authority which has taken over the role of that Committee.

               (6)

               It has appeared from the various examinations made that plant protection products containing the active substances concerned 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 reports. It is therefore appropriate to include clothianidin and pethoxamid in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances may be granted in accordance with the provisions of that Directive.

               (7)

               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 provisional authorisations of plant protection products containing clothianidin or pethoxamid 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.

               (8)

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

               (9)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish by 31 January 2007 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 February 2007.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing clothianidin or pethoxamid as active substances by 31 January 2007. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to clothianidin or pethoxamid, respectively, are met, with the exception of those identified in part B of the entry concerning those active substances, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing clothianidin or pethoxamid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2006 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning clothianidin or pethoxamid. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing clothianidin or pethoxamid as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2008 at the latest; or

               (b)

               in the case of a product containing clothianidin or pethoxamid as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2008 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 August 2006.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 7 July 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/45/EC (OJ L 130, 18.5.2006, p. 27).

      (2)  OJ L 104, 20.4.2002, p. 42.

      (3)  OJ L 217, 11.8.2001, p. 14.

      ANNEX
      In Annex I to Directive 91/414/EEC the following rows are added at the end of the table:

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘123

                     Clothianidin
                     CAS No 210880-92-5
                     CIPAC No 738

                     (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

                     ≥ 960 g/kg

                     1 August 2006

                     31 July 2016

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clothianidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
                     In this overall assessment Member States

                                 —

                                 must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

                                 —

                                 must pay particular attention to the risk to granivorous birds and mammals when the substance is used as a seed dressing.

                           Conditions of use shall include risk mitigation measures, where appropriate.

                     124

                     Pethoxamid
                     CAS No 106700-29-2
                     CIPAC No 655

                     2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide

                     ≥ 940 g/kg

                     1 August 2006

                     31 July 2016

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pethoxamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
                     In this overall assessment Member States

                                 —

                                 must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,

                                 —

                                 must pay particular attention to the protection of the aquatic environment, in particular higher aquatic plants.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.

         (1)  Further details on identity and specification of active substances are provided in the review report.’


title: Commission Directive 2010/29/EU of 27 April 2010 amending Council Directive 91/414/EEC to include flonicamid (IKI-220) as active substance (Text with EEA relevance)

text:
               28.4.2010

               EN

               Official Journal of the European Union

               L 106/9

         COMMISSION DIRECTIVE 2010/29/EU
   of 27 April 2010
   amending Council Directive 91/414/EEC to include flonicamid (IKI-220) as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC France received on 23 December 2003 an application from ISK Biosciences Europe SA for the inclusion of the active substance flonicamid (IKI-220) in Annex I to Directive 91/414/EEC. Commission Decision 2004/686/EC (2) 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.

               (2)

               For that active substance, the effects on human 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 24 May 2005.

               (3)

               The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for flonicamid on 18 December 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 12 March 2010 in the format of the Commission review report for flonicamid.

               (4)

               It has appeared from the various examinations made that plant protection products containing flonicamid 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 include flonicamid in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (5)

               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 provisional authorisations of plant protection products containing flonicamid 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 transform existing provisional authorisations into full authorisations, amend them or withdraw them 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.

               (6)

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

               (7)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 28 February 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 March 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing flonicamid as active substance by 28 February 2011. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to flonicamid are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing flonicamid as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC, by 31 August 2010 at the latest Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning flonicamid. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing flonicamid as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2012 at the latest; or

               (b)

               in the case of a product containing flonicamid as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 September 2010.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 27 April 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 313, 12.10.2004, p. 21.

      (3)  EFSA Scientific Report (2010) 8(1):1445, Conclusion regarding the peer review of the pesticide risk assessment of the active substance flonicamid (IKI-220), available online at www.efsa.europa.eu

      ANNEX
      In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘310

                     Flonicamid (IKI-220)
                     CAS No 158062-67-0
                     CIPAC No 763

                     N-cyanomethyl-4-(trifluoromethyl)nicotinamide

                     ≥ 960 g/kg
                     The impurity toluene must not exceed 3 g/kg in the technical material.

                     1 September 2010

                     31 August 2020

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.
                     In this overall assessment, Member States must pay particular attention to:

                                 —

                                 the risk to operators and re-entry workers,

                                 —

                                 the risk to bees.

                           Conditions of authorisation shall include risk mitigation measures where appropriate.
                     The Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.’

         (1)  Further details on identity and specification of active substances are provided in the review report.