title: Commission Implementing Regulation (EU) No 637/2012 of 13 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch  Text with EEA relevance

text:
               14.7.2012

               EN

               Official Journal of the European Union

               L 186/20

         COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012
   of 13 July 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch
   (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)(c) thereof,
   Whereas:

               (1)

               The active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of 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 (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its views on the draft review reports for iron sulphate (6), repellents by smell of animal or plant origin/tall oil crude (7) and repellents by smell of animal or plant origin/tall oil pitch (8) on 16 December 2011. The draft review reports and the views 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 1 June 2012 in the format of the Commission review reports for iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch.

               (3)

               The Authority communicated its views on iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch to the notifiers, and the Commission invited them to submit comments on the review reports.

               (4)

               It is confirmed that the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch are to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (5)

               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 necessary to amend the conditions of approval of iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch. It is, in particular, appropriate to require further confirmatory information as regards those active substances.

               (6)

               The Annex to Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (7)

               A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval.

               (8)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing repellents by smell of animal or plant origin/tall oil crude as active substances in order to comply with the Annex to this Regulation by 1 May 2013.
   Article 3
   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 November 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 July 2012.

            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 344, 20.12.2008, p. 89.

      (4)  OJ L 379, 24.12.2004, p.13.

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance iron sulfate. EFSA Journal 2012;10(1):2521. Available online: www.efsa.europa.eu/efsajournal.htm

      (7)  Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil crude. EFSA Journal 2012;10(2):2543. Available online: www.efsa.europa.eu/efsajournal.htm

      (8)  Conclusion on the peer review of the pesticide risk assessment of the active substance tall oil pitch. EFSA Journal 2012;10(2):2544. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  Row 235 on the active substance iron sulphate is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧235

                                 Iron sulphate:

                                          Iron(II)sulfate anhydrous: CAS No 7720-78-7

                                          Iron(II)sulfate monohydrate: CAS No 17375-41-6

                                          Iron(II)sulfate heptahydrate: CAS No 7782-63-0

                                    CIPAC No 837

                              Iron(II)sulphate
                              or
                              iron(2+) sulfate

                              Iron(II)sulfate anhydrous: ≥ 350 g/kg total iron.
                              Relevant impurities:

                                          arsenic, 18 mg/kg

                                          cadmium, 1,8 mg/kg

                                          chromium, 90 mg/kg

                                          lead, 36 mg/kg

                                          mercury, 1,8 mg/kg

                                    expressed on the basis of the anhydrous variant

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as herbicide may be authorised.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to:

                                          —

                                          the risk for operator;

                                          —

                                          the risk to children/residents playing on treated turf;

                                          —

                                          the risk to surface waters and to aquatic organisms.

                                    Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.
                              The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.‧

                  (2)

                  Row 250 on the active substance Repellents by smell of animal or plant origin/tall oil crude is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (2)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧250

                                 Repellents by smell of animal or plant origin/tall oil crude:
                              CAS No 8002-26-4
                              CIPAC No 911

                              Not available

                              The qualitative parameters below comprise the specification of repellents by smell of animal or plant origin/tall oil crude:

                                          acid number: min. 125 mgKOH/g

                                          water content: max. 2 %

                                          rosin acid content: min. 35 % (proposed)

                                          ash content: max. 0,2 %

                                          pH: approx. min. 5,5

                                          unsaponifiables: max. 12 %

                                          free mineral acids: max. 0,02 %

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent applied by glove or brush may be authorised.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorisation is granted.
                              In this overall assessment Member States shall pay particular attention to:

                                          —

                                          the protection of operator, worker and bystander;

                                          —

                                          the risk to non target species.

                                    Conditions of use shall include, where appropriate, risk mitigation measures.
                              The Member States concerned shall request the submission of confirmatory information as regards:

                                          (a)

                                          the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;

                                          (b)

                                          the toxicological profile of repellents by smell of animal or plant origin/tall oil crude.

                                    The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.‧

                  (3)

                  Row 251 on the active substance Repellents by smell of animal or plant origin/tall oil pitch is replaced by the following:

                              Number

                              Common Name, Identification Numbers

                              IUPAC Name

                              Purity (3)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‧251

                                 Repellents by smell of animal or plant origin/tall oil pitch:
                              CAS No 8016-81-7
                              CIPAC No 912

                              Not available

                              Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on repellents by smell of animal or plant origin/tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              In assessing applications to authorise plant protection products containing repellents by smell of animal or plant origin/tall oil pitch for uses other than as a repellent in forestry applied by glove or brush, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary information is provided before such an authorization is granted.
                              In this overall assessment Member States shall pay particular attention to:

                                          —

                                          the protection of operator, worker and bystander;

                                          —

                                          the risk to non target species.

                                    Conditions of use shall include risk mitigation measures, where appropriate.
                              The Member States concerned shall request the submission of confirmatory information as regards:

                                          (a)

                                          the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;

                                          (b)

                                          the toxicological profile of repellents by smell of animal or plant origin/tall oil pitch.

                                    The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.‧

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

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

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


title: Commission Implementing Regulation (EU) No 1201/2011 of 18 November 2011 concerning the classification of certain goods in the Combined Nomenclature

text:
               23.11.2011

               EN

               Official Journal of the European Union

               L 305/8

         COMMISSION IMPLEMENTING REGULATION (EU) No 1201/2011
   of 18 November 2011
   concerning the classification of certain goods in the Combined Nomenclature
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1), and in particular Article 9(1)(a) thereof,
   Whereas:

               (1)

               In order to ensure uniform application of the Combined Nomenclature annexed to Regulation (EEC) No 2658/87, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

               (2)

               Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

               (3)

               Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

               (4)

               It is appropriate to provide that binding tariff information which has been issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature but which is not in accordance with this Regulation can, for a period of three months, continue to be invoked by the holder, under Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (2).

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.
   Article 2
   Binding tariff information issued by the customs authorities of Member States, which is not in accordance with this Regulation, can continue to be invoked for a period of three months under Article 12(6) of Regulation (EEC) No 2913/92.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 November 2011.

            For the Commission, On behalf of the President,
         Algirdas ŠEMETA

            Member of the Commission

      (1)  OJ L 256, 7.9.1987, p. 1.

      (2)  OJ L 302, 19.10.1992, p. 1.

      ANNEX

                  Description of the goods

                  Classification
                  (TARIC code)

                  Reasons

                  (1)

                  (2)

                  (3)

                  A liquid crystal display (LCD) panel (so-called "LCD module"), with a diagonal measurement of approximately 66 cm (26 inches), consisting of an active matrix liquid crystal layer sandwiched between two sheets of glass, fitted with connectors.
                  Between the first sheet of glass and the layer of liquid crystal there is a thin film transistor (TFT) matrix that provides the appropriate voltage to the pixels.
                  Between the layer of liquid crystal and the second sheet of glass there is an RGB filter that controls the colours of the picture displayed.
                  Several connectors in the form of straps are attached to the panel. Each connector consists of miniature integrated circuits (so-called "source drivers IC") on flexible printed circuits. Printed circuit boards (PCBs) are connected to the “source drivers IC”. The "source drivers IC" allow power and control signals to pass through, as well as convert and transmit data from the PCBs to the individual pixels of the active liquid crystal matrix.
                  The module is used in the manufacture of monitors or reception apparatus for television of heading 8528.

                  8529909244

                  Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 2(b) to Section XVI and by the wording of CN codes 8529, 8529 90 and 8529 90 92 and TARIC code 8529909244.
                  As the LCD module is equipped with “source drivers IC” which are more than electrical connections (i.e. for the supply of power), classification under heading 9013 as active matrix liquid crystal devices is excluded (see also the HS Explanatory Notes to heading 9013 (1)).
                  As the module consists of a TFT liquid crystal layer sandwiched between two sheets of glass and equipped with control electronics for pixel addressing used in the manufacture of monitors or reception apparatus for television of heading 8528, it is considered to be a part for use solely or principally with apparatus of heading 8528 under CN code 8529 90 92.
                  The product is therefore to be classified under TARIC code 8529909244 as an LCD module solely consisting of one or more TFT glass or plastic cells, not combined with touch screen facilities, with or without backlight unit, with or without inverters and one or more printed circuit boards with control electronics for pixel addressing only.


title: Commission Implementing Regulation (EU) No 629/2014 of 12 June 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance methyl nonyl ketone  Text with EEA relevance

text:
               13.6.2014

               EN

               Official Journal of the European Union

               L 174/33

         COMMISSION IMPLEMENTING REGULATION (EU) No 629/2014
   of 12 June 2014
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance methyl nonyl ketone
   (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 the second alternative of Article 21(3) and Article 78(2) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 608/2012 (2) amended Implementing Regulation (EU) No 540/2011 (3) as regards the conditions of approval of the active substance methyl nonyl ketone setting the condition that the notifier provides further confirmatory information in the form of studies on the specification with supporting batch data and validated methods of analysis.

               (2)

               The notifier submitted additional information taking the form of studies on the specification with supporting batch data and validated methods of analysis to the rapporteur Member State Belgium within the time period provided for its submission.

               (3)

               Belgium assessed the additional information submitted by the notifier. It submitted its assessment, in the form of a revised draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 25 November 2013.

               (4)

               The revised draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 16 May 2014 in the format of the Commission review report for methyl nonyl ketone.

               (5)

               The Commission invited the notifier to submit its comments on the review report for methyl nonyl ketone.

               (6)

               The Commission has come to the conclusion that the further confirmatory information showed that the minimum purity of the active substance should be set at 985 g/kg.

               (7)

               Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. Member States should be provided with time to amend or withdraw authorisations for plant protection products containing methyl nonyl ketone where necessary.

               (8)

               For plant protection products containing methyl nonyl ketone, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the entry into force of this Regulation.

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Amendment to Implementing Regulation (EU) No 540/2011
   In the column ‘Purity’ of row 238, methyl nonyl ketone, of Part A of the Annex to Implementing Regulation (EU) No 540/2011, the purity is replaced by ‘≥ 985 g/kg’.
   Article 2
   Transitional measures
   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing methyl nonyl ketone as active substance by 3 January 2015.
   Article 3
   Grace period
   Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 3 January 2016 at the latest.
   Article 4
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 June 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil (OJ L 177, 7.7.2012, p. 19).

      (3)  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 (OJ L 153, 11.6.2011, p. 1).


title: Commission Implementing Regulation (EU) No 104/2013 of 4 February 2013 amending Regulation (EU) No 185/2010 as regards the screening of passengers and persons other than passengers by Explosive Trace Detection (ETD) equipment in combination with Hand Held Metal Detection (HHMD) equipment  Text with EEA relevance

text:
               5.2.2013

               EN

               Official Journal of the European Union

               L 34/13

         COMMISSION IMPLEMENTING REGULATION (EU) No 104/2013
   of 4 February 2013
   amending Regulation (EU) No 185/2010 as regards the screening of passengers and persons other than passengers by Explosive Trace Detection (ETD) equipment in combination with Hand Held Metal Detection (HHMD) equipment
   (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 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (1), and in particular Article 4(3) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 272/2009 of 2 April 2009 supplementing the common basic standards on civil aviation security laid down in the Annex to Regulation (EC) No 300/2008 of the European Parliament and of the Council (2) provides that the implementing rules to be adopted pursuant to Article 4(3) of Regulation (EC) No 300/2008 may allow the use of explosive trace detection (ETD) equipment and hand held metal detection (HHMD) equipment for screening of persons (passengers and persons other than passengers).

               (2)

               Experience has shown that hand searches of passengers and persons other than passengers are not always the most efficient means of screening certain parts of the person, in particular where those parts are not readily accessible such as certain headgear, plaster casts or prosthesis.

               (3)

               Trials have demonstrated the effectiveness of the combined use of ETD and HHMD in such cases. Moreover, the use of ETD and HHMD may facilitate the screening process and be experienced to be a less intrusive means of screening than a hand search, thus constituting an improvement in the experience of persons screened.

               (4)

               It is thus useful and justified to allow these methods for screening of those parts of the person where a hand search is considered inefficient and/or undesirable such as certain headgear, plaster casts or prosthesis.

               (5)

               This Regulation respects the fundamental rights and observes the principles recognised by the Charter of Fundamental Rights of the European Union, notably the human dignity, the freedom of religion, the non-discrimination, the rights of persons with disabilities, and the right to liberty and security. In so far as it limits those rights and principles, such limitation is made genuinely to meet objectives of general interest and the need to protect the rights and freedoms of others, respecting the conditions laid down in Article 52 of the Charter. This Regulation must be applied in accordance with those rights and principles.

               (6)

               Commission Regulation (EU) No 185/2010 (3) should therefore be amended accordingly.

               (7)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee on Civil Aviation Security set up by Article 19(1) of Regulation (EC) No 300/2008,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Regulation (EU) No 185/2010 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 97, 9.4.2008, p. 72.

      (2)  OJ L 91, 3.4.2009, p. 7.

      (3)  OJ L 55, 5.3.2010, p. 1.

      ANNEX
      The Annex to Regulation (EU) No 185/2010 is amended as follows:

                  (1)

                  letter (f) is added to point 1.3.1.1 as follows:

                              ‘(f)

                              explosive trace detection (ETD) equipment combined with hand held metal detection (HHMD) equipment.’;

                  (2)

                  point 1.3.1.2 is replaced by the following:

                              ‘1.3.1.2.

                              Points 4.1.1.3 – 4.1.1.6 and 4.1.1.10 – 4.1.1.11 shall apply to the screening of persons other than passengers.’;

                  (3)

                  letter (e) is added to point 4.1.1.2 as follows:

                              ‘(e)

                              explosive trace detection (ETD) equipment combined with hand held metal detection (HHMD) equipment.’;

                  (4)

                  new point 4.1.1.11 with the following wording is added:

                              ‘4.1.1.11.

                              Explosive trace detection (ETD) equipment in combination with hand held metal detection (HHMD) equipment may only be used in cases where the screener considers a hand search of a given part of the person to be inefficient and/or undesirable.’.


title: Commission Implementing Regulation (EU) No 571/2014 of 26 May 2014 approving the active substance ipconazole, 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:
               27.5.2014

               EN

               Official Journal of the European Union

               L 157/96

         COMMISSION IMPLEMENTING REGULATION (EU) No 571/2014
   of 26 May 2014
   approving the active substance ipconazole, 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 ipconazole the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/20/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 30 March 2007 an application from Kureha GmbH for the inclusion of the active substance ipconazole in Annex I to Directive 91/414/EEC. Decision 2008/20/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, the United Kingdom, submitted a draft assessment report on 22 May 2008. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 20 May 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of an updated draft assessment report in November 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 (5) on the peer review of the pesticide risk assessment of the active substance ipconazole on 2 April 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 20 March 2014 in the format of the Commission review report for ipconazole.

               (5)

               It has appeared from the various examinations made that plant protection products containing ipconazole 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 ipconazole.

               (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 ipconazole. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

               (9)

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

               (10)

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

               (11)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Approval of active substance
   The active substance ipconazole, 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 ipconazole as an active substance by 28 February 2015.
   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 ipconazole 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 August 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 ipconazole as the only active substance, where necessary, amend or withdraw the authorisation by 29 February 2016 at the latest; or

               (b)

               in the case of a product containing ipconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 29 February 2016 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 September 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 26 May 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

      (3)  Commission Decision 2008/20/EC of 20 December 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of ipconazole and maltodextrin in Annex I to Council Directive 91/414/EEC (OJ L 1, 4.1.2008, p. 5).

      (4)  Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (OJ L 53, 26.2.2011, p. 51).

      (5)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance ipconazole. EFSA Journal 2013;11(4):3181. [76 pp.] doi:10.2903/j.efsa.2013.3181. Available online: www.efsa.europa.eu/efsajournal

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

      (7)  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 (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

                  Ipconazole
                  CAS No
                  125225-28-7 (mixture of diastereoisomers)
                  115850-69-6 (ipconazole cc, cis isomer)
                  115937-89-8 (ipconazole ct, trans isomer)
                  CIPAC No 798

                  (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

                  ≥ 955 g/kg
                  Ipconazole cc: 875 – 930 g/kg
                  Ipconazole ct: 65 – 95 g/kg

                  1 September 2014

                  31 August 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 ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              1.

                              the risk to granivorous birds;

                              2.

                              the protection of workers and operators;

                              3.

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

                        The applicant shall submit confirmatory information as regards:

                              (a)

                              the acceptability of the long-term risk to granivorous birds;

                              (b)

                              the acceptability of the risk to soil macro-organisms;

                              (c)

                              the risk of enantio-selective metabolisation or degradation;

                              (d)

                              the potential endocrine disrupting properties of ipconazole for birds and fish.The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.

         (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

                     ‘73

                     Ipconazole
                     CAS No
                     125225-28-7 (mixture of diastereoisomers)
                     115850-69-6 (ipconazole cc, cis isomer)
                     115937-89-8 (ipconazole ct, trans isomer)
                     CIPAC No 798

                     (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol

                     ≥ 955 g/kg
                     Ipconazole cc: 875 – 930 g/kg
                     Ipconazole ct: 65 – 95 g/kg

                     1 September 2014

                     31 August 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 ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 1.

                                 the risk to granivorous birds;

                                 2.

                                 the protection of workers and operators;

                                 3.

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

                           The applicant shall submit confirmatory information as regards:

                                 (a)

                                 the acceptability of the long-term risk to granivorous birds;

                                 (b)

                                 the acceptability of the risk to soil macro-organisms;

                                 (c)

                                 the risk of enantio-selective metabolisation or degradation;

                                 (d)

                                 the potential endocrine disrupting properties of ipconazole for birds and fish.The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.’

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


title: Commission Implementing Regulation (EU) No 378/2013 of 24 April 2013 approving the active substance Paecilomyces fumosoroseus strain FE 9901, 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:
               25.4.2013

               EN

               Official Journal of the European Union

               L 113/5

         COMMISSION IMPLEMENTING REGULATION (EU) No 378/2013
   of 24 April 2013
   approving the active substance Paecilomyces fumosoroseus strain FE 9901, 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 Paecilomyces fumosoroseus strain FE 9901 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2008/565/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Belgium received on 4 February 2004 an application from FuturEco S.L. for the inclusion of the active substance Paecilomyces fumosoroseus strain FE 9901 in Annex I to Directive 91/414/EEC. Decision 2008/565/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 29 March 2007.

               (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 Paecilomyces fumosoroseus strain FE 9901 (4) on 20 August 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 Paecilomyces fumosoroseus strain FE 9901.

               (5)

               It has appeared from the various examinations made that plant protection products containing Paecilomyces fumosoroseus strain FE 9901 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 Paecilomyces fumosoroseus strain FE 9901.

               (6)

               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.

               (7)

               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 Paecilomyces fumosoroseus strain FE 9901. 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.

               (8)

               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.

               (9)

               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.

               (10)

               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 Paecilomyces fumosoroseus strain FE 9901, 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 Paecilomyces fumosoroseus strain FE 9901 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 Paecilomyces fumosoroseus strain FE 9901 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 Paecilomyces fumosoroseus strain FE 9901 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 Paecilomyces fumosoroseus strain FE 9901 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 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 October 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 24 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 181, 10.7.2008, p. 49.

      (4)  EFSA Journal 2012; 10(9):2869. 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

                     Paecilomyces fumosoroseus strain FE 9901
                  Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490

                  Not applicable

                  Minimum 1,0 × 109 CFU/g
                  Maximum 3,0 × 109 CFU/g

                  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 Paecilomyces fumosoroseus strain FE 9901, 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 the protection of operators and workers, taking into account that Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser.
                  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

                     ‘39

                        Paecilomyces fumosoroseus strain FE 9901
                     Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490

                     Not applicable

                     Minimum 1,0 × 109 CFU/g
                     Maximum 3,0 × 109 CFU/g

                     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 Paecilomyces fumosoroseus strain FE 9901, 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 the protection of operators and workers, taking into account that Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser.
                     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 597/2012 of 5 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea  Text with EEA relevance

text:
               6.7.2012

               EN

               Official Journal of the European Union

               L 176/54

         COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012
   of 5 July 2012
   amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea
   (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)(c) thereof,
   Whereas:

               (1)

               The active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea were included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, these substances are deemed to have been approved under that Regulation and are listed in Part A of 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 (5).

               (2)

               In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority (hereinafter ‘the Authority’) presented to the Commission its views on the draft review reports for aluminium ammonium sulphate (6) on 6 December 2011, for fat distillation residues (7), repellents by smell of animal or plant origin/fish oil (8) and urea (9) on 16 December 2011. The draft review reports and the views 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 1 June 2012 in the format of the Commission review reports for aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea.

               (3)

               The Authority communicated its views on aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea to the notifiers, and the Commission invited them to submit comments on the review reports.

               (4)

               It is confirmed that the active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea are to be deemed to have been approved under Regulation (EC) No 1107/2009.

               (5)

               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 necessary to amend the conditions of approval of aluminium ammonium sulphate, fat distillation residues, repellents by smell of animal or plant origin/fish oil and urea. It is, in particular, appropriate to require further confirmatory information as regards those active substances. At the same time certain technical adaptations should be made, in particular the name of the active substances ‘Repellents by smell of animal or plant origin/fish oil’ and ‘fat distillation residues’ should be replaced respectively by ‘fish oil’ and fat distillation residues. The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

               (6)

               A reasonable period of time should be allowed before the application of this Regulation in order to allow Member States, notifiers and holders of authorisations for plant protection products to meet the requirements resulting from amendment to the conditions of the approval.

               (7)

               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
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
   Article 2
   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 November 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 5 July 2012.

            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 344, 20.12.2008, p. 89.

      (4)  OJ L 379, 24.12.2004, p. 13.

      (5)  OJ L 153, 11.6.2011, p. 1.

      (6)  Conclusion on the peer review of the pesticide risk assessment of the active substance aluminium ammonium sulphate, EFSA Journal 2012;10(3):2491. Available online: www.efsa.europa.eu/efsajournal.htm

      (7)  Conclusion on the peer review of the pesticide risk assessment of the active substance fat distillation residues, EFSA Journal 2012;10(2):2519. Available online: www.efsa.europa.eu/efsajournal.htm

      (8)  Conclusion on the peer review of the pesticide risk assessment of the active substance fish oil, EFSA Journal 2012;10(2):2546. Available online: www.efsa.europa.eu/efsajournal.htm

      (9)  Conclusion on the peer review of the pesticide risk assessment of the active substance urea, EFSA Journal 2012;10(1):2523. Available online: www.efsa.europa.eu/efsajournal.htm

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  Row 219 on the active substance aluminium ammonium sulphate is replaced by the following:

                              Number

                              Common name, identification numbers

                              IUPAC name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘219

                              Aluminium ammonium sulphate
                              CAS No 7784-26-1 (dodecahydrate), 7784-25-0 (anhydrous)
                              CIPAC No 840

                              Aluminium ammonium sulphate

                              ≥ 960 g/kg (expressed as dodecahydrate)
                              ≥ 502 g/kg (anhydrous)

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised.
                              PART B
                              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 aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;

                                          (b)

                                          the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.

                                    This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.’

                  (2)

                  Row 229 on the active substance fat distillation residues is replaced by the following:

                              Number

                              Common name, identification numbers

                              IUPAC name

                              Purity (2)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘229

                              Fat distillation residues
                              CAS No: not allocated
                              CIPAC No 915

                              Not available

                              ≥ 40 % of cleaved fatty acids
                              Relevant impurity: Ni maximum 200 mg/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).
                              PART B
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on fat distillation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.’

                  (3)

                  Row 248 on the active substance repellents by smell of animal or plant origin/fish oil is replaced by the following:

                              Number

                              Common name, identification numbers

                              IUPAC name

                              Purity (3)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘248

                              Fish oil
                              CAS No 100085-40-3
                              CIPAC No 918

                              Fish oil

                              ≥ 99 %
                              Relevant impurity:

                                          Dioxine max. 6 pg/kg for animal feed

                                          Hg max. 0,5 mg/kg feed derived from fish and other sea food processing

                                          Cd max. 2 mg/kg feed of animal origin except in feed for domestic pets

                                          Pb max. 10 mg/kg

                                          PCBs max. 5 mg/kg

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.
                              PART B
                              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 fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit confirmatory information as regards the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.’

                  (4)

                  Row 257 on the active substance urea is replaced by the following:

                              Number

                              Common name, identification numbers

                              IUPAC name

                              Purity (4)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘257

                              Urea
                              CAS No 57-13-6
                              CIPAC No 913

                              Urea

                              ≥ 98 % w/w

                              1 September 2009

                              31 August 2019

                              PART A
                              Only uses as attractant and fungicide may be authorised.
                              PART B
                              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 urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.
                              Conditions of use shall include, where appropriate, risk mitigation measures.
                              The notifier shall submit confirmatory information as regards:

                                          (a)

                                          the analysis method for urea and for the impurity biuret;

                                          (b)

                                          the risk for operators, workers and bystanders.

                                    The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016.’

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

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

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

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


title: Commission Implementing Regulation (EU) No 860/2012 of 20 September 2012 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Implementing Regulation (EU) No 971/2011 for the 2011/12 marketing year

text:
               21.9.2012

               EN

               Official Journal of the European Union

               L 255/25

         COMMISSION IMPLEMENTING REGULATION (EU) No 860/2012
   of 20 September 2012
   amending the representative prices and additional import duties for certain products in the sugar sector fixed by Implementing Regulation (EU) No 971/2011 for the 2011/12 marketing year
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Council Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2), and in particular Article 36(2), second subparagraph, second sentence thereof,
   Whereas:

               (1)

               The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2011/12 marketing year are fixed by Commission Implementing Regulation (EU) No 971/2011 (3). Those prices and duties were last amended by Commission Implementing Regulation (EU) No 805/2012 (4).

               (2)

               The data currently available to the Commission indicate that those amounts should be amended in accordance with Article 36 of Regulation (EC) No 951/2006.

               (3)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Implementing Regulation (EU) No 971/2011 for the 2011/12 marketing year, are hereby amended as set out in the Annex hereto.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 September 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 178, 1.7.2006, p. 24.

      (3)  OJ L 254, 30.9.2011, p. 12.

      (4)  OJ L 244, 8.9.2012, p. 9.

      ANNEX

         Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 1702 90 95 from 21 September 2012

                  (EUR)

                  CN code

                  Representative price per 100 kg net of the product concerned

                  Additional duty per 100 kg net of the product concerned

                  1701 12 10 (1)

                  34,90

                  0,68

                  1701 12 90 (1)

                  34,90

                  4,14

                  1701 13 10 (1)

                  34,90

                  0,82

                  1701 13 90 (1)

                  34,90

                  4,43

                  1701 14 10 (1)

                  34,90

                  0,82

                  1701 14 90 (1)

                  34,90

                  4,43

                  1701 91 00 (2)

                  42,53

                  4,71

                  1701 99 10 (2)

                  42,53

                  1,58

                  1701 99 90 (2)

                  42,53

                  1,58

                  1702 90 95 (3)

                  0,43

                  0,26

         (1)  For the standard quality defined in point III of Annex IV to Regulation (EC) No 1234/2007.

         (2)  For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007.

         (3)  Per 1 % sucrose content.


title: Commission Implementing Regulation (EU) No 740/2011 of 27 July 2011 approving the active substance bispyribac, 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:
               28.7.2011

               EN

               Official Journal of the European Union

               L 196/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011
   of 27 July 2011
   approving the active substance bispyribac, 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 bispyribac the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/305/EC (3).

               (2)

               In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 26 February 2002 an application from Bayer CropScience for the inclusion of the active substance bispyribac (also called bispyribac sodium, according to the form in which the active substance is contained in the representative formulation on which the dossier is based) in Annex I to Directive 91/414/EEC. Decision 2003/305/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 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 1 August 2003.

               (4)

               The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) in the format of the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac on 12 July 2010 (4). 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 17 June 2011 in the format of the Commission review report for bispyribac.

               (5)

               It has appeared from the various examinations made that plant protection products containing bispyribac 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 bispyribac.

               (6)

               Without prejudice to the obligations provided for by 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 6 months after approval to review authorisations of plant protection products containing bispyribac. 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.

               (7)

               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.

               (8)

               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.

               (9)

               In the interest of clarity, Commission Directive 2011/22/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bispyribac as active substance (7) should be repealed.

               (10)

               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 bispyribac, 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 bispyribac as active substance by 31 January 2012.
   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 Part B of 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 bispyribac 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 July 2011 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 Part B of 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 bispyribac as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2013 at the latest; or

               (b)

               in the case of a product containing bispyribac as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2013 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
   Repeal
   Directive 2011/22/EU is repealed.
   Article 5
   Entry into force and date of application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 August 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 27 July 2011.

            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 112, 6.5.2003, p. 10.

      (4)  EFSA Journal (2010) 8(1):1692, Conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac (unless otherwise stated all data evaluated refer to the variant bispyribac-sodium)). doi:10.2903/j.efsa.2010.1692. Available online: www.efsa.europa.eu

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

      (6)  OJ L 153, 11.6.2011, p. 1.

      (7)  OJ L 59, 4.3.2011, p. 26.

      ANNEX I

                  Common Name, Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Bispyribac
                  CAS No
                  125401-75-4
                  CIPAC No
                  748

                  2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid

                  ≥ 930 g/kg (referred to as bispyribac-sodium)

                  1 August 2011

                  31 July 2021

                  PART A
                  Only uses as herbicide in rice may be authorised.
                  PART B
                  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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                  In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
                  Conditions of authorisation shall include risk mitigation measures where appropriate.
                  The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (2), M04 (3) and M10 (4).
                  They shall ensure that the applicant provides such information to the Commission by 31 July 2013.

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

         (2)  2-hydroxy-4,6-dimethoxypyrimidine.

         (3)  2,4-dihydroxy-6-methoxypyrimidine.

         (4)  sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.

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

                     ‘1

                     Bispyribac
                     CAS No
                     125401-75-4
                     CIPAC No
                     748

                     2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid

                     ≥ 930 g/kg (referred to as bispyribac-sodium)

                     1 August 2011

                     31 July 2021

                     PART A
                     Only uses as herbicide in rice may be authorised.
                     PART B
                     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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
                     In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
                     Conditions of authorisation shall include risk mitigation measures where appropriate.
                     The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (1), M04 (2) and M10 (3).
                     They shall ensure that the applicant provides such information to the Commission by 31 July 2013.

         (1)  2-hydroxy-4,6-dimethoxypyrimidine.

         (2)  2,4-dihydroxy-6-methoxypyrimidine.

         (3)  sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.’