title: Commission Implementing Regulation (EU) No 1352/2013 of 4 December 2013 establishing the forms provided for in Regulation (EU) No 608/2013 of the European Parliament and of the Council concerning customs enforcement of intellectual property rights

text:
                  18.12.2013

                  EN

                  Official Journal of the European Union

                  L 341/10

         COMMISSION IMPLEMENTING REGULATION (EU) No 1352/2013
         of 4 December 2013
         establishing the forms provided for in Regulation (EU) No 608/2013 of the European Parliament and of the Council concerning customs enforcement of intellectual property rights
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (1), and in particular Article 6(1) and Article 12(7) thereof,
         After consulting the European Data Protection Supervisor,
         Whereas:

                     (1)

                     Regulation (EU) No 608/2013 sets out the conditions and procedures for action by the customs authorities where goods suspected of infringing an intellectual property right are, or should have been, subject to customs supervision or customs controls in accordance with Council Regulation (EEC) No 2913/92 (2).

                     (2)

                     In accordance with Regulation (EU) No 608/2013 persons and entities duly entitled may submit an application to the competent customs department requesting that customs authorities take action on those goods (application) and may also request the extension of the period during which the customs authorities are to take action in accordance with a previously granted application (extension request).

                     (3)

                     In order to ensure uniform conditions for the application and for the extension request, standard forms should be established.

                     (4)

                     Those standard forms should replace those provided for in Commission Regulation (EC) No 1891/2004 (3) implementing Council Regulation (EC) No 1383/2003 (4), which is to be repealed by Regulation (EU) No 608/2013.

                     (5)

                     Regulation (EC) No 1891/2004 should therefore be repealed.

                     (6)

                     Regulation (EU) No 608/2013 shall apply from 1 January 2014 and, therefore, this Regulation should also be applicable from the same date.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, referred to in Article 34(1) of Regulation (EU) No 608/2013,

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The application requesting that customs authorities take action with respect to goods suspected of infringing an intellectual property right (application) referred to in Article 6 of Regulation (EU) No 608/2013 shall be made by using the form set out in Annex I to this Regulation.

               2.   The request for extension of the period during which the customs authorities are to take action (extension request) referred to in Article 12 of Regulation (EU) No 608/2013 shall be made by using the form set out in Annex II to this Regulation.

               3.   The forms set out in Annexes I and II shall be completed in accordance with the notes on completion set out in Annex III.

            Article 2
            Without prejudice to Article 5(6) of Regulation (EU) No 608/2013, the forms set out in Annexes I and II to this Regulation may, where necessary, be completed legibly by hand.
            Those forms shall contain no erasures, overwritten words or other alterations and shall be made up of two copies.
            The handwritten forms shall be completed in ink and block capitals.

            Article 3
            Regulation (EC) No 1891/2004 is repealed.

            Article 4
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 January 2014.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 December 2013.

                  For the Commission

                  The President

               José Manuel BARROSO

            (1)  OJ L 181, 29.6.2013, p. 15.

            (2)  Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (OJ L 302, 19.10.1992, p. 1.).

            (3)  Commission Regulation (EC) No 1891/2004 of 21 October 2004 laying down provisions for the implementation of Council Regulation (EC) No 1383/2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (OJ L 328, 30.10.2004, p. 16.).

            (4)  Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights (OJ L 196, 2.8.2003, p. 7).

            ANNEX I

            Text of image

               1
               COPY FOR THE COMPETENT CUSTOMS DEPARTMENT
               1
               EUROPEAN UNION – APPLICATION FOR ACTION
               1. Applicant
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               EORI-No:
               TIN No:
               National registration No:
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               For official use
               Date of receipt
               Registration number of application
               INTELLECTUAL PROPERTY RIGHTS
               APPLICATION FOR ACTION BY CUSTOMS AUTHORITIES
               under Article 6 of Regulation (EU) No 608/2013
               2 (*). Union application
               National application
               3 (*). Status of applicant
               Right-holder
               Group of producers of products with a Geographical Indication or representative of such group
               Person or entity authorised to use the IP right
               Operator entitled to use a Geographical Indication
               IP collective rights management body
               Inspection body or authority competent for a Geographical Indication
               Professional defence body
               Exclusive license holder covering two or more Member States
               4. Representative submitting the application in the name of the applicant:
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Evidence of the representatives power to act is enclosed
               Fax: (+)
               5 (*). Type of right to which the application refers
               National trademark (NTM)
               Geographical Indication/Designation of origin:
               Community trademark (CTM)
               for agricultural products and foodstuff (CGIP)
               International registered trademark (ITM)
               for wine (CGIW)
               Registered national design (ND)
               for aromatised drinks based on wine products (CGIA)
               Registered Community design (CDR)
               for spirit drinks (CGIS)
               Unregistered Community design (CDU)
               for other products (NGI)
               International registered design (ICD)
               as listed in Agreements between the Union and third countries (CGIL)
               Copyright and related right (NCPR)
               Plant variety right:
               Trade name (NTN)
               national (NPVR)
               Topography of semiconductor product (NTSP)
               Community (CPVR)
               Patent as provided for by national law (NPT)
               Supplementary protection certificate:
               Patent as provided for by Union law (UPT)
               for medicinal products (SPCM)
               Utility model (NUM)
               for plant protection products (SPCP)
               6 (*). Member State or, in the case of a Union application, Member States in which customs action is requested
               ALL MEMBER STATES
               BE
               BG
               CZ
               DK
               DE
               EE
               IE
               EL
               ES
               FR
               HR
               IT
               CY
               LV
               LT
               LU
               HU
               MT
               NL
               AT
               PL
               PT
               RO
               SI
               SK
               FI
               SE
               UK
               7. Representative for legal matters
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               8. Representative for technical matters
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               9. In case of a Union application, the details of the designated representatives for legal and technical matters are included in annex no …
               10. Small consignment procedure
               I request the use of the procedure in Article 26 of Regulation (EU) No 608/2013 and, where requested by the customs authorities, agree to cover the costs related to the destruction of goods under this procedure.
               (*) these are mandatory fields and shall be filled in
               (+) at least one of these fields shall be filled in

            Text of image

               11 (*). List of rights to which the application refers
               No
               Type of right
               Registration number
               Date of registration
               Expiry date
               List of goods to which the right refers
               For further rights see annex no …
               Restricted handling
               Authentic goods
               12. Goods details (*)
               Restricted handling
               IP right no:
               Goods description (*):
               CN tariff number:
               Customs value:
               European average market value:
               National market value:
               See enclosed annex no …
               13. Goods distinctive features (*)
               Restricted handling
               Position on the goods (*):
               Description (*):
               See enclosed annex no …
               14. Place of production (*)
               Restricted handling
               Country:
               Company:
               Address:
               Town:
               See enclosed annex no …
               15. Involved companies (*)
               Restricted handling
               Role:
               Name (*):
               Address:
               Town:
               See enclosed annex no …
               16. Traders (*)
               Restricted handling
               See enclosed annex no …
               17. Goods clearance details and distribution information
               Restricted handling
               See enclosed annex no …
               18. Packages
               Restricted handling
               Kind of packages:
               Number of items per package:
               Description (incl. distinctive features):
               See enclosed annex no …
               19. Accompanying documents
               Restricted handling
               Type of document:
               Description:
               See enclosed annex no …

            Text of image

               Infringing goods
               20. Goods details
               Restricted handling
               IP right no:
               Goods description:
               CN tariff number:
               Minimum value:
               See enclosed annex no …
               21. Goods distinctive features
               Restricted handling
               Position on the goods:
               Description:
               See enclosed annex no …
               22. Place of production
               Restricted handling
               Country:
               Company:
               Address:
               Town:
               See enclosed annex no …
               23. Involved companies
               Restricted handling
               Role:
               Name:
               Address:
               Town:
               See enclosed annex no …
               24. Traders
               Restricted handling
               See enclosed annex no …
               25. Goods distribution information
               Restricted handling
               See enclosed annex no …
               26. Packages
               Restricted handling
               Kind of packages:
               Number of items per package:
               Description (incl. distinctive features):
               See enclosed annex no …
               27. Accompanying documents
               Restricted handling
               Type of document:
               Description:
               See enclosed annex no …

            Text of image

               28. Additional information
               Restricted handling
               See enclosed annex no …
               29. Undertakings
               By signing I undertake to:
               notify immediately the competent customs department that granted this application of any change in the information provided by me within this application or attachments in accordance with Article 15 of Regulation (EU) No 608/2013.
               forward to the competent customs department that granted this application any update on the information as referred to in point (g), (h) or (i) of Article 6(3) of Regulation (EU) No 608/2013 that are relevant to customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) included in this application.
               assume liability under the conditions laid down in Article 28 of Regulation (EU) No 608/2013 and bear the costs as referred to in Article 29 of Regulation (EU) No 608/2013.
               I agree that all the data submitted with this application may be processed by the European Commission and by the Member States.
               30. Signature (*)
               Date (DD/MM/YYYY)
               Applicant's signature
               Place
               Name (Block capitals)
               For official use
               Decision by customs authorities (within the meaning of Section 2 of Regulation (EU) No 608/2013)
               The application is completely granted.
               The application has been partially granted (for the granted rights see attached list).
               Date of adoption (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               Expiry date of the application:
               Any request for extension of the period that customs authorities are to take action should be received by the competent customs department at the latest 30 working days before the expiry date.
               The application has been rejected.
               A reasoned decision stating the grounds for partial or complete rejection and information concerning the appeal procedure are attached.
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department

            Text of image

               Personal data protection and the central database for the processing of applications for action.
               Where the European Commission processes personal data contained in this application for action Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply. Where the competent customs authority of a Member State processes personal data contained in this application for action the national provisions implementing Directive 95/46/EC will apply.
               The purpose of the processing of personal data of the application for action is the enforcement of intellectual property rights by customs authorities in the Union in accordance with Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               The controller with respect to the processing of the data in the central database is the national competent customs department where the application has been submitted. The list of competent customs departments is published on the website of the Commission:
               http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/right_holders/index_en.htm.
               The access to all personal data of this application is granted through UserID/Password to customs authorities in the Member States and the Commission.
               Personal data forming part of the information that falls under restricted handling will only be accessible by customs authorities of the Member States as indicated in box 6 of the application through UserID/Password.
               In accordance with Article 22 of Regulation (EU) No 608/2013, without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share personal data and information contained in the application with the relevant authorities in third countries.
               Replies to data fields marked with an * and to at least one of the fields marked “+” are obligatory to be filled in. In case of failure to fill in these obligatory data, the application shall be rejected.
               The data subject has a right of access to the personal data relating to him or her that will be processed through the central database and, where appropriate, the right to rectify, erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.
               All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent customs department where the application was submitted.
               The legal basis for processing the personal data for the enforcement of intellectual property rights is Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               Personal data shall not be stored longer than six months from the date the decision granting the application has been revoked or the relevant period during which customs authorities are to take action has expired. That period shall be specified by the competent customs department when granting the application and shall not exceed one year from the day following the date of adoption of the decision granting the application. However, where customs authorities have been notified of proceedings initiated to determine a possible infringement of goods under the application, personal data shall be kept for six months after the proceedings have been concluded.
               Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1). Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor (http://www.edps.europa.eu/EDPSWEB/).

            Text of image

               2
               COPY FOR THE APPLICANT
               2
               EUROPEAN UNION – APPLICATION FOR ACTION
               1. Applicant
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               EORI-No:
               TIN No:
               National registration No:
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               For official use
               Date of receipt
               Registration number of application
               INTELLECTUAL PROPERTY RIGHTS
               APPLICATION FOR ACTION BY CUSTOMS AUTHORITIES
               under Article 6 of Regulation (EU) No 608/2013
               2 (*). Union application
               National application
               3 (*). Status of applicant
               Right-holder
               Group of producers of products with a Geographical Indication or representative of such group
               Person or entity authorised to use the IP right
               Operator entitled to use a Geographical Indication
               IP collective rights management body
               Inspection body or authority competent for a Geographical Indication
               Professional defence body
               Exclusive license holder covering two or more Member States
               4. Representative submitting the application in the name of the applicant:
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Evidence of the representatives power to act is enclosed
               Fax: (+)
               5 (*). Type of right to which the application refers
               National trademark (NTM)
               Geographical Indication/Designation of origin:
               Community trademark (CTM)
               for agricultural products and foodstuff (CGIP)
               International registered trademark (ITM)
               for wine (CGIW)
               Registered national design (ND)
               for aromatised drinks based on wine products (CGIA)
               Registered Community design (CDR)
               for spirit drinks (CGIS)
               Unregistered Community design (CDU)
               for other products (NGI)
               International registered design (ICD)
               as listed in Agreements between the Union and third countries (CGIL)
               Copyright and related right (NCPR)
               Plant variety right:
               Trade name (NTN)
               national (NPVR)
               Topography of semiconductor product (NTSP)
               Community (CPVR)
               Patent as provided for by national law (NPT)
               Supplementary protection certificate:
               Patent as provided for by Union law (UPT)
               for medicinal products (SPCM)
               Utility model (NUM)
               for plant protection products (SPCP)
               6 (*). Member State or, in the case of a Union application, Member States in which customs action is requested
               ALL MEMBER STATES
               BE
               BG
               CZ
               DK
               DE
               EE
               IE
               EL
               ES
               FR
               HR
               IT
               CY
               LV
               LT
               LU
               HU
               MT
               NL
               AT
               PL
               PT
               RO
               SI
               SK
               FI
               SE
               UK
               7. Representative for legal matters
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               8. Representative for technical matters
               Company:
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               Website:
               9. In case of a Union application, the details of the designated representatives for legal and technical matters are included in annex no …
               10. Small consignment procedure
               I request the use of the procedure in Article 26 of Regulation (EU) No 608/2013 and, where requested by the customs authorities, agree to cover the costs related to the destruction of goods under this procedure.
               (*) these are mandatory fields and shall be filled in
               (+) at least one of these fields shall be filled in

            Text of image

               11 (*). List of rights to which the application refers
               No
               Type of right
               Registration number
               Date of registration
               Expiry date
               List of goods to which the right refers
               For further rights see annex no …
               Restricted handling
               Authentic goods
               12. Goods details (*)
               Restricted handling
               IP right no:
               Goods description (*):
               CN tariff number:
               Customs value:
               European average market value:
               National market value:
               See enclosed annex no …
               13. Goods distinctive features (*)
               Restricted handling
               Position on the goods (*):
               Description (*):
               See enclosed annex no …
               14. Place of production (*)
               Restricted handling
               Country:
               Company:
               Address:
               Town:
               See enclosed annex no …
               15. Involved companies (*)
               Restricted handling
               Role:
               Name (*):
               Address:
               Town:
               See enclosed annex no …
               16. Traders (*)
               Restricted handling
               See enclosed annex no …
               17. Goods clearance details and distribution information
               Restricted handling
               See enclosed annex no …
               18. Packages
               Restricted handling
               Kind of packages:
               Number of items per package:
               Description (incl. distinctive features):
               See enclosed annex no …
               19. Accompanying documents
               Restricted handling
               Type of document:
               Description:
               See enclosed annex no …

            Text of image

               Infringing goods
               20. Goods details
               Restricted handling
               IP right no:
               Goods description:
               CN tariff number:
               Minimum value:
               See enclosed annex no …
               21. Goods distinctive features
               Restricted handling
               Position on the goods:
               Description:
               See enclosed annex no …
               22. Place of production
               Restricted handling
               Country:
               Company:
               Address:
               Town:
               See enclosed annex no …
               23. Involved companies
               Restricted handling
               Role:
               Name:
               Address:
               Town:
               See enclosed annex no …
               24. Traders
               Restricted handling
               See enclosed annex no …
               25. Goods distribution information
               Restricted handling
               See enclosed annex no …
               26. Packages
               Restricted handling
               Kind of packages:
               Number of items per package:
               Description (incl. distinctive features):
               See enclosed annex no …
               27. Accompanying documents
               Restricted handling
               Type of document:
               Description:
               See enclosed annex no …

            Text of image

               28. Additional information
               Restricted handling
               See enclosed annex no …
               29. Undertakings
               By signing I undertake to:
               notify immediately the competent customs department that granted this application of any change in the information provided by me within this application or attachments in accordance with Article 15 of Regulation (EU) No 608/2013.
               forward to the competent customs department that granted this application any update on the information as referred to in point (g), (h) or (i) of Article 6(3) of Regulation (EU) No 608/2013 that are relevant to customs authorities' analysis and assessment of the risk of infringement of the intellectual property right(s) included in this application.
               assume liability under the conditions laid down in Article 28 of Regulation (EU) No 608/2013 and bear the costs as referred to in Article 29 of Regulation (EU) No 608/2013.
               I agree that all the data submitted with this application may be processed by the European Commission and by the Member States.
               30. Signature (*)
               Date (DD/MM/YYYY)
               Applicant's signature
               Place
               Name (Block capitals)
               For official use
               Decision by customs authorities (within the meaning of Section 2 of Regulation (EU) No 608/2013)
               The application is completely granted.
               The application has been partially granted (for the granted rights see attached list).
               Date of adoption (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               Expiry date of the application:
               Any request for extension of the period that customs authorities are to take action should be received by the competent customs department at the latest 30 working days before the expiry date.
               The application has been rejected.
               A reasoned decision stating the grounds for partial or complete rejection and information concerning the appeal procedure are attached.
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department

            Text of image

               Personal data protection and the central database for the processing of applications for action.
               Where the European Commission processes personal data contained in this application for action Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply. Where the competent customs authority of a Member State processes personal data contained in this application for action the national provisions implementing Directive 95/46/EC will apply.
               The purpose of the processing of personal data of the application for action is the enforcement of intellectual property rights by customs authorities in the Union in accordance with Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               The controller with respect to the processing of the data in the central database is the national competent customs department where the application has been submitted. The list of competent customs departments is published on the website of the Commission:
               http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/right_holders/index_en.htm.
               The access to all personal data of this application is granted through UserID/Password to customs authorities in the Member States and the Commission.
               Personal data forming part of the information that falls under restricted handling will only be accessible by customs authorities of the Member States as indicated in box 6 of the application through UserID/Password.
               In accordance with Article 22 of Regulation (EU) No 608/2013, without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share personal data and information contained in the application with the relevant authorities in third countries.
               Replies to data fields marked with an * and to at least one of the fields marked “+” are obligatory to be filled in. In case of failure to fill in these obligatory data, the application shall be rejected.
               The data subject has a right of access to the personal data relating to him or her that will be processed through the central database and, where appropriate, the right to rectify, erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.
               All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent customs department where the application was submitted.
               The legal basis for processing the personal data for the enforcement of intellectual property rights is Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               Personal data shall not be stored longer than six months from the date the decision granting the application has been revoked or the relevant period during which customs authorities are to take action has expired. That period shall be specified by the competent customs department when granting the application and shall not exceed one year from the day following the date of adoption of the decision granting the application. However, where customs authorities have been notified of proceedings initiated to determine a possible infringement of goods under the application, personal data shall be kept for six months after the proceedings have been concluded.
               Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1). Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor (http://www.edps.europa.eu/EDPSWEB/).

            ANNEX II

            Text of image

               1
               COPY FOR THE COMPETENT CUSTOMS DEPARTMENT
               1
               EUROPEAN UNION – REQUEST FOR EXTENSION
               1. Holder of the decision
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               For official use
               Date of receipt
               INTELLECTUAL PROPERTY RIGHTS
               REQUEST FOR EXTENSION OF THE PERIOD FOR ACTION
               under Article 12 of Regulation (EU) No 608/2013
               2 (*). I request the extension of the period during which the customs authorities are to take action in respect of the following application
               Registration number of application: /
               I confirm, that there are no changes in the information concerning the application for action and its annexes.
               I provide the following information concerning the application for action.
               See enclosed annex no …
               Any request for extension of the period that customs authorities are to take action should be received by the competent customs department at the latest 30 working days before the expiry date.
               3. Signature (*)
               Date (DD/MM/YYYY)
               Signature of the holder of the decision
               Place
               Name (Block capitals)
               For official use
               Decision by customs authorities (within the meaning of Section 2 of Regulation (EU) No 608/2013)
               The request for extension is completely granted.
               The request for extension has been partially granted (for the granted rights see attached list).
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               Expiry date of the application:
               The request for extension has been rejected.
               A reasoned decision stating the grounds for partial or complete rejection and information concerning the appeal procedure are attached.
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               (*) these are mandatory fields and shall be filled in
               (+) at least one of these fields shall be filled in

            Text of image

               Personal data protection and the central database for the processing of applications for action.
               Where the European Commission processes personal data contained in this extension request Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply. Where the competent customs authority of a Member State processes personal data contained in this extension request the national provisions implementing Directive 95/46/EC will apply.
               The purpose of the processing of personal data of the application for action is the enforcement of intellectual property rights by customs authorities in the Union in accordance with Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               The controller with respect to the processing of the data in the central database is the national competent customs department where the application has been submitted. The list of competent customs departments is published on the website of the Commission: http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/right_holders/index_en.htm.
               The access to all personal data of the application is granted through UserID/Password to customs authorities in the Member States and the Commission.
               Personal data forming part of the information that falls under restricted handling will only be accessible by customs authorities of the Member States as indicated in box 6 of the application through UserID/Password. In accordance with Article 22 of Regulation (EU) No 608/2013, without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share personal data and information contained in the application with the relevant authorities in third countries. Replies to data fields marked with an * are obligatory to be filled in. In case of failure to fill in these obligatory data, the extension request shall be rejected.
               The data subject has a right of access to the personal data relating to him or her that will be processed through the central database and, where appropriate, the right to rectify, erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.
               All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent customs department where the application was submitted.
               The legal basis for processing the personal data for the enforcement of intellectual property rights is Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               Personal data shall not be stored longer than six months from the date the decision granting the application has been revoked or the relevant period during which customs authorities are to take action has expired. That period shall be specified by the competent customs department when granting the extension request and shall not exceed one year from the day following the date of adoption of the decision granting the extension request. However, where customs authorities have been notified of proceedings initiated to determine a possible infringement of goods under the application, personal data shall be kept for six months after the proceedings have been concluded.
               Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1). Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor (http://www.edps.europa.eu/EDPSWEB/).

            Text of image

               2
               COPY FOR THE APPLICANT
               2
               EUROPEAN UNION – REQUEST FOR EXTENSION
               1. Holder of the decision
               Name (*):
               Address (*):
               Town (*):
               Postal Code:
               Country (*):
               Telephone: (+)
               Mobile: (+)
               Fax: (+)
               Email:
               For official use
               Date of receipt
               INTELLECTUAL PROPERTY RIGHTS
               REQUEST FOR EXTENSION OF THE PERIOD FOR ACTION
               under Article 12 of Regulation (EU) No 608/2013
               2 (*). I request the extension of the period during which the customs authorities are to take action in respect of the following application
               Registration number of application: /
               I confirm, that there are no changes in the information concerning the application for action and its annexes.
               I provide the following information concerning the application for action.
               See enclosed annex no …
               Any request for extension of the period that customs authorities are to take action should be received by the competent customs department at the latest 30 working days before the expiry date.
               3. Signature (*)
               Date (DD/MM/YYYY)
               Signature of the holder of the decision
               Place
               Name (Block capitals)
               For official use
               Decision by customs authorities (within the meaning of Section 2 of Regulation (EU) No 608/2013)
               The request for extension is completely granted.
               The request for extension has been partially granted (for the granted rights see attached list).
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               Expiry date of the application:
               The request for extension has been rejected.
               A reasoned decision stating the grounds for partial or complete rejection and information concerning the appeal procedure are attached.
               Date (DD/MM/YYYY)
               Signature and stamp
               Competent customs department
               (*) these are mandatory fields and shall be filled in
               (+) at least one of these fields shall be filled in

            Text of image

               Personal data protection and the central database for the processing of applications for action.
               Where the European Commission processes personal data contained in this extension request Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community Institutions and bodies and on the free movement of such data will apply. Where the competent customs authority of a Member State processes personal data contained in this extension request the national provisions implementing Directive 95/46/EC will apply.
               The purpose of the processing of personal data of the application for action is the enforcement of intellectual property rights by customs authorities in the Union in accordance with Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               The controller with respect to the processing of the data in the central database is the national competent customs department where the application has been submitted. The list of competent customs departments is published on the website of the Commission: http://ec.europa.eu/taxation_customs/customs/customs_controls/counterfeit_piracy/right_holders/index_en.htm.
               The access to all personal data of the application is granted through UserID/Password to customs authorities in the Member States and the Commission.
               Personal data forming part of the information that falls under restricted handling will only be accessible by customs authorities of the Member States as indicated in box 6 of the application through UserID/Password. In accordance with Article 22 of Regulation (EU) No 608/2013, without prejudice to applicable provisions on data protection in the Union and for the purpose of contributing to eliminating international trade in goods infringing intellectual property rights, the Commission and the customs authorities of the Member States may share personal data and information contained in the application with the relevant authorities in third countries. Replies to data fields marked with an * are obligatory to be filled in. In case of failure to fill in these obligatory data, the extension request shall be rejected.
               The data subject has a right of access to the personal data relating to him or her that will be processed through the central database and, where appropriate, the right to rectify, erase or block personal data in accordance with Regulation (EC) No 45/2001 or the national laws implementing Directive 95/46/EC.
               All requests for the exercise of the right of access, rectification, erasure or blocking shall be submitted to and processed by the competent customs department where the application was submitted.
               The legal basis for processing the personal data for the enforcement of intellectual property rights is Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights.
               Personal data shall not be stored longer than six months from the date the decision granting the application has been revoked or the relevant period during which customs authorities are to take action has expired. That period shall be specified by the competent customs department when granting the extension request and shall not exceed one year from the day following the date of adoption of the decision granting the extension request. However, where customs authorities have been notified of proceedings initiated to determine a possible infringement of goods under the application, personal data shall be kept for six months after the proceedings have been concluded.
               Complaints, in case of conflict, can be addressed to the relevant national data protection authority. The contact details of the national data protection authorities are available on the web-site of the European Commission, Directorate General for Justice (http://ec.europa.eu/justice/data-protection/bodies/authorities/eu/index_en.htm#h2-1). Where the complaint concerns processing of personal data by the European Commission, it should be addressed to the European Data Protection Supervisor (http://www.edps.europa.eu/EDPSWEB/).

            ANNEX III

               NOTES ON COMPLETION

            I.   SPECIFICATIONS OF THE BOXES OF THE APPLICATION FOR ACTION FORM SET OUT IN ANNEX I TO BE FILLED IN BY THE APPLICANT
            Fields in the form marked with an asterisk (*) are mandatory fields and shall be filled in.
            Where in a box one or more fields are marked with a plus sign (+) at least one of those fields shall be filled in.
            No data shall be entered in the boxes marked ‘for official use’.
            Box 1:   Applicant
            Details concerning the applicant shall be entered in this box. It shall contain information on the name and complete address of the applicant and his telephone, mobile telephone or fax number. The applicant may, where appropriate, enter his Taxpayer Identification Number, any other national registration number and his Economic Operator Registration and Identification Number (EORI-No), which is a number, unique throughout the Union, assigned by a customs authority in a Member State to economic operators involved in customs activities. The applicant may also enter, where appropriate, his e-mail address and his website address.
            Box 2:   Union/National application
            The appropriate box shall be ticked to indicate whether the application is a National or a Union application, as referred to in points (10) and (11) of Article 2 of Regulation (EU) No 608/2013.
            Box 3:   Status of the applicant
            The appropriate box shall be ticked to indicate the status of the applicant within the meaning of Article 3 of Regulation (EU) No 608/2013. The application shall include documents providing evidence to satisfy the competent customs department that the applicant is entitled to submit an application.
            Box 4:   Representative submitting the application in the name of the applicant
            Where the application is submitted by the applicant by means of a representative, details concerning that representative shall be entered in this box. The application shall include evidence of his powers to act as a representative in accordance with the legislation of the Member State in which the application is submitted and the corresponding box shall be ticked.
            Box 5:   Type of right to which the application refers
            The type(s) of the intellectual property rights (IPR) to be enforced shall be indicated by ticking the appropriate box.
            Box 6:   Member State or, in the case of a Union application, Member States in which customs action is requested
            The Member State or, in the case of a Union application, Member States in which customs action is requested shall be indicated by ticking the appropriate box.
            Box 7:   Representative for legal matters
            The details of the representative designated by the applicant to take charge of legal matters shall be indicated in this box.
            Box 8:   Representative for technical matters
            In case the representative for technical matters is different from the representative indicated in box 7, the details of the representative for technical matters shall be indicated in this box.
            Box 9:   Details of the designated representatives for legal and technical matters in case of a Union application
            In case of a Union application, the details of the representative or representatives designated by the applicant to take charge of technical and legal matters in the Member States indicated in box 6 shall be provided in a separate annex which shall contain the elements of information requested in boxes 7 and 8. In case a representative has been designated for more than one Member State, it shall be clearly indicated for which Member States he has been designated.
            Box 10:   Small consignment procedure
            Where the applicant wishes to request the use of the procedure for destruction of goods in small consignments set out in Article 26 of Regulation (EU) No 608/2013, this box shall be ticked.
            Box 11:   List of rights to which the application refers
            Information on the right or rights to be enforced shall be entered in this box.
            In the column ‘No’, sequential numbers shall be entered for each of the intellectual property rights to which the application refers.
            In the column ‘Type of right’, the type of IPR shall be indicated by using the appropriate abbreviations which appear in box 5 in brackets.
            In the column ‘list of goods to which the right refers’, the type of goods which are covered by the relevant IPR and with regard to which the applicant wishes to request customs enforcement shall be entered.
            Sub-box ‘Restricted handling’ in boxes 12-28
            Where the applicant wishes to request that information provided by him in boxes 12-28 be the subject of restricted handling within the meaning of Article 31(5) of Regulation (EU) No 608/2013, this sub-box shall be ticked.

               Page 2:   Information on authentic goods in boxes 12-19

            The applicant shall enter in boxes 12-19, as appropriate, specific and technical data on the authentic goods, information needed to enable the customs authorities to readily identify goods suspected of infringing IPR and information relevant to the customs authorities’ analysis and assessment of the risk of infringement of the IPR(s) concerned.
            Box 12:   Goods details
            Box 12 shall contain a description of the authentic goods, including get-up and graphic symbols, their Combined Nomenclature code and their value in the EU internal market. The applicant, where appropriate, shall provide images of those goods. The information shall be arranged per different type of goods or different assortment of goods.
            Box 13:   Goods distinctive features
            Box 13 shall contain information on the typical features of the authentic goods, such as markings, labels, security threads, holograms, buttons, hangtags and bar-coding, indicating the exact position of the features on the goods and their appearance.
            Box 14:   Place of production
            Box 14 shall contain information on the place of production of the authentic goods.
            Box 15:   Involved companies
            Box 15 shall contain information on authorised importers, suppliers, manufacturers, carriers, consignees or exporters. The information shall be arranged per different type of goods.
            Box 16:   Traders
            Box 16 shall contain information on persons or entities authorised to trade in products involving the use of the IPR(s) for which enforcement is sought. The information shall refer to name, address and registration numbers, such as EORI number, of those persons or entities. Likewise, the information shall comprise information on how licensees may demonstrate their authorisation to use the IPR(s) in question.
            Box 17:   Goods clearance details and distribution information
            Box 17 shall contain information on channels of distribution of the authentic goods, such as information related to central warehouses, dispatch departments, means of transport, transport routes and delivery, and on customs procedures and offices where the clearance of the authentic goods is carried out.
            Box 18:   Packages
            This box shall contain information on the packaging of the authentic goods, such as information on the following:

                        (a)

                        the kind of packages, indicated by using the relevant codes as given in Annex 38 to Commission Regulation (EEC) No 2454/93 (1);

                        (b)

                        typical features of the packages (for instance, markings, labels, security threads, holograms, buttons, hangtags and bar-coding), including the exact position of the features in the package;

                        (c)

                        special package designs (colour, shape);

                        (d)

                        where appropriate, images of those goods.

                  Box 19:   Accompanying documents
            Box 19 shall contain information on documents accompanying the authentic goods, such as brochures, operating instructions, warranty documents or other similar items.

               Page 3:   Information on infringing goods in boxes 20-27

            The applicant shall enter in boxes 20-27, as appropriate, information relevant to the customs authorities’ analysis and assessment of the risk of infringement of the IPR(s) concerned.
            Box 20:   Goods details
            Box 20 shall contain a description of goods suspected of infringing an intellectual property right (infringing goods), including get-up and graphic symbols. The applicant, where appropriate, shall provide images of those goods. The information shall be arranged per different type of goods or different assortment of goods.
            Box 21:   Goods distinctive features
            Box 21 shall contain information on the typical features of the suspected infringing goods, such as markings, labels, security threads, holograms, buttons, hangtags and bar-coding, indicating the exact position of the features on the goods and their appearance.
            Box 22:   Place of production
            Box 22 shall contain information on the known or suspected place of origin, provenance and delivery of the infringing goods.
            Box 23:   Involved companies
            Box 23 shall contain information on importers, suppliers, manufacturers, carriers, consignees or exporters who are suspected of being involved in infringements of the relevant intellectual property rights.
            Box 24:   Traders
            Box 24 shall contain information on persons or entities not authorised to trade in products involving the use of the IPR(s) for which enforcement is sought and who have been trading the products in the Union in the past.
            Box 25:   Goods distribution information
            Box 25 shall contain information on channels of distribution of the infringing goods, such as information related to warehouses, dispatch departments, means of transport, transport routes and places of delivery, and on customs procedures and offices where the clearance of the infringing goods is carried out.
            Box 26:   Packages
            This box shall contain information on the packaging of the suspected infringing goods, such as information on the following:

                        (a)

                        the kind of packages, indicated by using the relevant codes as given in Annex 38 to Regulation (EEC) No 2454/93;

                        (b)

                        typical features of the packages (for instance, markings, labels, holograms, buttons, hangtags and bar-coding), including the exact position of the features in the package;

                        (c)

                        special package designs (colour, shape);

                        (d)

                        where appropriate, images of those goods.

                  Box 27:   Accompanying documents
            Box 27 shall contain information on documents accompanying the suspected infringing goods, such as brochures, operating instructions, warranty documents or other similar items.
            Box 28:   Additional information
            The applicant may provide in box 28 any additional information relevant to the customs authorities’ analysis and assessment of the risk of infringement of the IPR(s) concerned such as specific information concerning planned deliveries of suspected infringing goods, including specific and detailed information on means of transport, containers and persons involved.
            Box 29:   Undertakings
            Do not amend the wording, or enter data in this box.
            Box 30:   Signature
            In box 30, the applicant or the representative of the applicant indicated in box 4 shall enter the place and date of completion of the application and shall sign. The signatory’s name shall be given in block capitals.
            II.   SPECIFICATIONS OF THE BOXES OF THE REQUEST FOR EXTENSION FORM SET OUT IN ANNEX II TO BE FILLED IN BY THE HOLDER OF THE DECISION
            Fields in the form marked with an asterisk (*) are mandatory fields and shall be filled in.
            In boxes where fields are marked with a plus (+) at least one of these fields shall be filled in.
            Do not enter data in the boxes marked ‘for official use’.
            Box 1:   Details concerning the holder of the decision
            Details concerning the holder of the decision shall be entered in this box.
            Box 2:   Extension request
            The application registration number including the first two digits representing the iso/alpha-2 code of the Member State that granted the application shall be entered in this box. The holder of the decision shall indicate whether he is requesting modifications to the information contained in the application by ticking the appropriate box.
            Box 3:   Signature
            In box 3, the holder of the decision or the representative of the holder of the decision shall enter the place and date of completion of the request and shall sign. The signatory’s name shall be given in block capitals.

               (1)  Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (OJ L 253, 11.10.1993, p. 1).


title: Commission Implementing Regulation (EU) No 350/2013 of 17 April 2013 approving the active substance bixafen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               18.4.2013

               EN

               Official Journal of the European Union

               L 108/9

         COMMISSION IMPLEMENTING REGULATION (EU) No 350/2013
   of 17 April 2013
   approving the active substance bixafen, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to 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 (1), and in particular Article 13(2) and Article 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For bixafen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/700/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 8 October 2008 an application from Bayer CropScience for the inclusion of the active substance bixafen in Annex I to Directive 91/414/EEC. Decision 2009/700/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 19 July 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the review of the pesticide risk assessment of the active substance bixafen (4) on 15 October 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and the draft assessment report was finalised on 15 March 2013 in the format of the Commission review report for bixafen.

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance bixafen, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing bixafen as an active substance by 31 March 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing bixafen as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 September 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

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

               (b)

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

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 October 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 17 April 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 240, 11.9.2009, p. 32.

      (4)  EFSA Journal (2012); 10(11):2917. Available online: www.efsa.europa.eu

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

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Bixafen
                  CAS No 581809-46-3
                  CIPAC No 819

                     N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

                  ≥ 950 g/kg

                  1 October 2013

                  30 September 2023

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              (a)

                              the residues of bixafen and of its metabolites in rotational crops;

                              (b)

                              the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

                              (c)

                              the risk to aquatic organisms;

                              (d)

                              the risk to soil and sediment-dwelling organisms.

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

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘43

                     Bixafen
                     CAS No 581809-46-3
                     CIPAC No 819

                        N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide

                     ≥ 950 g/kg

                     1 October 2013

                     30 September 2023

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the residues of bixafen and of its metabolites in rotational crops;

                                 (b)

                                 the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 (c)

                                 the risk to aquatic organisms;

                                 (d)

                                 the risk to soil and sediment-dwelling organisms.

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

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


title: Commission Implementing Regulation (EU) No 802/2013 of 22 August 2013 approving the active substance fluopyram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011  Text with EEA relevance

text:
               23.8.2013

               EN

               Official Journal of the European Union

               L 225/13

         COMMISSION IMPLEMENTING REGULATION (EU) No 802/2013
   of 22 August 2013
   approving the active substance fluopyram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to 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 (1), and in particular Articles 13(2) and 78(2) thereof,
   Whereas:

               (1)

               In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For fluopyram the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/464/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC, Germany received on 30 June 2008 an application from Bayer CropScience AG for the inclusion of the active substance fluopyram in Annex I to Directive 91/414/EEC. Decision 2009/464/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (3)

               For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 30 August 2011.

               (4)

               The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance fluopyram on 17 December 2012. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 July 2013 in the format of the Commission review report for fluopyram.

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

               In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (6) should be amended accordingly.

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance fluopyram, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
   Article 2
   Re-evaluation of plant protection products
   1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing fluopyram as an active substance by 31 July 2014.
   By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fluopyram as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 January 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
   Following that determination Member States shall:

               (a)

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

               (b)

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

         Article 3
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 4
   Entry into force and date of application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 February 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 August 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 309, 24.11.2009, p. 1.

      (2)  OJ L 230, 19.8.1991, p. 1.

      (3)  OJ L 151, 16.6.2009, p. 37.

      (4)  EFSA Journal 2013; 11(1):3052. Available online: www.efsa.europa.eu

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

      (6)  OJ L 153, 11.6.2011, p. 1.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Fluopyram
                  CAS No 658066-35-4
                  CIPAC No 807

                  N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide

                  ≥ 960 g/kg

                  1 February 2014

                  31 January 2024

                  For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms.
                  Conditions of use shall include risk mitigation measures, where appropriate.
                  The applicant shall submit confirmatory information as regards:

                              (1)

                              the long-term risk to insectivorous birds;

                              (2)

                              the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.

                        The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.

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

      ANNEX II
      In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                     Number

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     ‘51

                     Fluopyram
                     CAS No 658066-35-4
                     CIPAC No 807

                     N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide

                     ≥ 960 g/kg

                     1 February 2014

                     31 January 2024

                     For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms.
                     Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit confirmatory information as regards:

                                 (1)

                                 the long-term risk to insectivorous birds;

                                 (2)

                                 the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.

                           The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.’

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