title: Commission Implementing Regulation (EU) No 415/2012 of 15 May 2012 amending for the 171st time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network

text:
               16.5.2012

               EN

               Official Journal of the European Union

               L 128/7

         COMMISSION IMPLEMENTING REGULATION (EU) No 415/2012
   of 15 May 2012
   amending for the 171st time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network, (1) and in particular Article 7(1)(a) and 7a(5) thereof,
   Whereas:

               (1)

               Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

               (2)

               On 7 May 2012 and 9 May 2012 the Sanctions Committee of the United Nations Security Council decided to remove two natural persons from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply after considering the de-listing requests submitted by these persons and the Comprehensive Reports of the Ombudsperson established pursuant to United Nations Security Council Resolution 1904(2009).

               (3)

               Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly.

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the 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, 15 May 2012.

            For the Commission, On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 139, 29.5.2002, p. 9.

      ANNEX
      Annex I to Regulation (EC) No 881/2002 is amended as follows:

                  (1)

                  The following entries under the heading ‘Natural persons’ are deleted:
                  ‘Kamal Ben Mohamed Ben Ahmed Darraji (alias Kamel Darraji). Address: Via Varzi 14/A - Busto Arsizio, Varese, Italy. Date of birth: 22.7.1967. Place of birth: Menzel Bouzelfa, Tunisia. Nationality: Tunisian. Passport No: L029899 (Tunisian passport issued on 14.8.1995, expired on 13.8.2000). Other information: (a) Italian Fiscal Code: (i) DDR KML 67L22 Z352Q, (ii) DRR KLB 67L22 Z352S, (b) Resided in Italy as at December 2009. Date of designation referred to in Article 2a(4)(b): 23.6.2004.’

                  (2)

                     ‘Ibrahim Abdul Salam Mohamed Boyasseer (alias (a) Abu Al-Banaan, (b) Ibrahim Bouisir, (c) Ibrahim Buisir; (d) Ibrahim Abdul Salem Mohamed Buisir; (e) Ibrahim Buwisir; (f) Ibrhm Buwisir. Address: 20 Hillview Grove, Ballinteer, Dublin 16, Ireland. Date of birth: 1.9.1962. Place of birth: Benghazi, Libya. Nationality: (a) Libyan, (b) Irish. National Identification No: 6977094P (Irish Personal Public Service number). Passport No: L038300 (Irish passport issued in Dublin, Ireland on 4 September 2002, cancelled on 14 May 2009). Date of designation referred to in Article 2a(4)(b): 4.2.2009.’


title: Commission Implementing Regulation (EU) No 890/2013 of 16 September 2013 approving minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Amarene Brusche di Modena (PGI))

text:
               18.9.2013

               EN

               Official Journal of the European Union

               L 247/24

         COMMISSION IMPLEMENTING REGULATION (EU) No 890/2013
   of 16 September 2013
   approving minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Amarene Brusche di Modena (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular the second subparagraph of Article 53(2) thereof,
   Whereas:

               (1)

               In accordance with the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Amarene Brusche di Modena’ registered under Commission Regulation (EC) No 1028/2009 (2).

               (2)

               The purpose of the application is to amend the specification by indicating the sugar content of the fruit at the time of picking and during processing as well as the amount of sugar (saccharose) that may be added before the concentration process and by authorising containers using formats and materials different from those provided for at the time of registration.

               (3)

               The Commission has examined the amendments in question and decided that they are justified. Since the amendments are minor within the meaning of the third subparagraph of Article 53(2) of Regulation (EU) No 1151/2012, the Commission may approve them without following the procedure set out in Articles 50 to 52 of the Regulation,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The specification for the protected geographical indication ‘Amarene Brusche di Modena’ is hereby amended in accordance with Annex I to this Regulation.
   Article 2
   Annex II to this Regulation contains the consolidated single document setting out the main points of the specification.
   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, 16 September 2013.

            For the Commission, On behalf of the President,
         Dacian CIOLOȘ

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  OJ L 283, 30.10.2009, p. 39.

      ANNEX I
      In the specification for the protected geographical indication ‘Amarene Brusche di Modena’, the following amendments are approved:

         Method of production

      The required sugar content for the fruit used for the production of the ‘Amarene Brusche di Modena’ PGI should be reduced at the time of picking by 2° Brix in years where the cumulative rainfall was higher than 80 mm in June.
      At the processing stage, sugar content of 2° Brix less than that measured at the time of picking is permitted, if the fruit is subject to hydrocooling.
      In order to avoid misinterpretation, it is specified that the amount of sugar (saccharose) which may be added prior to the concentration process must not exceed 35 % of the product.

         Labelling

      The specification indicates that for the purpose of packaging the jam ‘Amarene Brusche di Modena’, containers using formats and materials different from those previously provided for may also be used, provided that they are suitable for food use. This will enable producers to adapt the packaging to constantly changing market requirements.

      ANNEX II

         CONSOLIDATED SINGLE DOCUMENT

      Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (1)

         ‘AMARENE BRUSCHE DI MODENA’

      EC No: IT-PGI-0105-01065 – 30.11.2012

         PGI ( X ) PDO ( )

      1.   Name

      ‘Amarene Brusche di Modena’
      2.   Member State or Third Country

      Italy
      3.   Description of the agricultural product or foodstuff

      3.1.   Type of product

                  Class 1.6.

                  Fruit, vegetables and cereals, fresh or processed

            3.2.   Description of the product to which the name in (1) applies

      When released for consumption, ‘Amarene Brusche di Modena’ PGI jam has a soft consistency and a characteristic intense red-brown colour with dark tinges. It has a refractive index of between 60° and 68° Brix at 20 °C. The typical acidity level is between 2,5 and 3,5 pH. The finished product contains 70 % fresh fruit.
      The distinctive flavour of ‘Amarene Brusche di Modena’ PGI jam is a good balance of sweet and sour, with an acidic tinge. At the time of marketing, ‘Amarene Brusche di Modena’ jam has a minimum sugar content of 60 %.
      3.3.   Raw materials (for processed products only)

      The raw material from which ‘Amarene Brusche di Modena’ PGI jam is made comprises sour cherries from orchards growing the varieties Amarena di Castelvetro, Amarena di Vignola dal peduncolo corto (short stalk), Amarena di Vignola dal peduncolo lungo (long stalk), Amarena di Montagna, Amarena di Salvaterra, Marasca di Vigo, Meteor, Mountmorency and Pandy.
      At the time of picking, the fruit must be ripe, i.e. be of uniform colour across at least 90 % of the fruit and have the following characteristics:

                  —

                  colour of skin (when ripe): light to dark red,

                  —

                  colour of flesh: yellow or orange,

                  —

                  colour of juice: colourless to yellowish,

                  —

                  sugar content: > 16° Brix,

                  —

                  acidic content: medium to moderately high > 18 g/l malic acid,

                  —

                  yield in juice: > 75 %.

            In years with cumulative rainfall of more than 80 mm in the month of June, as measured in the meteorological stations closest to fruit-growing holdings, the minimum sugar content of the fruit at the time of picking may be reduced by 2° Brix.
      3.4.   Feed (for products of animal origin only)

      —
      3.5.   Specific steps in production that must take place in the defined geographical area

      The cherries must be grown and the ‘Amarene Brusche di Modena’ jam produced in the geographical area delineated under point 4, where conditions are ideal for the cultivation of cherry trees, as explained under point 5.1.
      3.6.   Specific rules concerning slicing, grating, packaging, etc.

      The jam must be packaged in the geographical area delineated under point 4 in order that the origin and monitoring of the product can be guaranteed, so that it does not lose the special characteristics described under point 3.2 above and to prevent subsequent pasteurisation, which could affect the typical flavour, based as it is on the right balance between acidity and sweetness.
      ‘Amarene Brusche di Modena’ PGI jam is packaged in jars or tins with a capacity of 15 ml, 212 ml, 228 ml, 236 ml, 314 ml, 370 ml, 2 650 ml and 5 000 ml or using other formats and materials suitable for food contact. The 2 650 ml and 5 000 ml capacity containers are for professional use.
      3.7.   Specific rules concerning labelling

      The ‘Amarene Brusche di Modena’ PGI logo consists of a letter ‘A’ featuring, instead of the cross-line, a picture of a sour cherry with a stalk and a leaf. The logo takes up a 74 × 74 mm square. Below it, on three lines, are set out the words AMARENE BRUSCHE DI MODENA I.G.P. The size of the logo may be adapted in proportion to the different packaging sizes.

      The wording ‘Amarene Brusche di Modena’ must be in Italian.
      4.   Concise definition of the geographical area

      The fruit is grown and ‘Amarene Brusche di Modena’ PGI jam produced in an area made up of the administrative territory of the municipalities of Bastiglia, Bomporto, Campogalliano, Camposanto, Carpi, Castelfranco Emilia, Castelnuovo Rangone, Castelvetro di Modena, Cavezzo, Concordia sul Secchia, Finale Emilia, Fiorano Modenese, Formigine, Guiglia, Maranello, Marano sul Panaro, Medolla, Mirandola, Modena, Montese, Nonantola, Novi di Modena, Pavullo nel Frignano, Prignano sul Secchia, Ravarino, S. Cesario sul Panaro, S. Felice sul Panaro, S. Possidonio, S. Prospero sul Secchia, Sassuolo, Savignano sul Panaro, Serramazzoni, Soliera, Spilamberto, Vignola and Zocca in the Province of Modena, and the neighbouring parts of the Province of Bologna, limited to the following municipalities: Anzola nell’Emilia, Bazzano, Castel d’Aiano, Castello di Serravalle, Crespellano, Crevalcore, Monte S. Pietro, Monteveglio, San Giovanni in Persiceto, Sant’Agata Bolognese, Savigno and Vergato.
      5.   Link with the geographical area

      5.1.   Specificity of the geographical area

      The area in which ‘Amarene Brusche di Modena’ PGI jam is produced is characterised by very deep soil which is generally fertile and well-structured, fairly porous and permeable, with essentially a silt-loam composition and traces of clay. Hence it is ideally suited to growing sour cherry trees, which need permeable, well-drained and cool ground. The particular structure and texture of the soil mean that it has good porosity and drains well, and therefore that the ground is well aerated. The area in question is criss-crossed by a dense network of natural and man-made waterways. The climate type tends to be sub-humid, and sub-arid in the lower-lying parts of the low plain around Modena; such conditions are particularly conducive to the cultivation of sour cherry trees.
      5.2.   Specificity of the product

      The ‘Amarene Brusche di Modena’ protected geographical indication differs, in particular, from other products belonging to the same category of goods by virtue of the particular organoleptic and chemical and physical characteristics of the raw material, which in turn come from the variety of sour cherries grown in the area of production, and by virtue, above all, of the characteristic flavour of the jam, which strikes a good balance between sweetness and sourness, with an acidic tinge. Another important distinguishing characteristic is the natural production process, which is based on concentrating the fruit through thermal evaporation without the use of thickeners, colourings or preservatives, the high ratio of fruit to added sugar and the absence of further processing prior to packaging.
      5.3.   Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI)

      The application for recognition of ‘Amarene Brusche di Modena’ jam as a PGI is justified by the product’s fame and reputation. The jam’s reputation is documented by abundant bibliographical references attesting to the special know-how, passed down over the centuries among the locals, in dealing with the need to process quickly a fruit that does not keep well and creating a product renowned and appreciated especially for the natural way in which it is produced.
      To illustrate the product’s reputation, one cannot ignore the existence of a production base, in the area delineated under point 4 above, that already at the start of the last century was home to many cherry orchards and centres for the collection and cold storage of cherries, as well as a number of small-scale businesses and small and medium-sized jam producers. Farmers involved in producing the jam make up a pool of over 350 skilled workers and bring considerable production value. The first trials involving the intensive cultivation of cherry trees were conducted in 1882 by Luigi Mancini, a lawyer and owner of the ‘La Colombarina’ estate near Vignola, although in fact the renowned botanist Giorgio Gallesio recorded as early as 1820 the practice of planting cherry trees around country cottages so that the fruit could be used for making syrups, preserves, jams, puddings and cakes, in line with the solid family tradition of preparing cherries in the rural province of Modena.
      There are many centuries-old recipes that testify to the use of the product for preparing typical local cakes, both in the home and on a small-scale commercial basis, from the oldest to the most recent, involving the use of the jam for home-made tarts, in particular. Evidence of this can be found in two Modenese manuscripts from the 19th century which explain how to prepare the jam; one of the manuscripts consists of four notebooks kept by four generations of middle-class house-owners and was published in 1970; the other, published in 2001, was written by Ferdinando Cavazzoni, maker of sweetmeats and preserves for the Molza family.

         Reference to publication of the specification

      [Article 5(7) of Regulation (EC) No 510/2006]
      The Ministry launched the national objection procedure with the publication of the proposed amendments to the specification for the ‘Amarene Brusche di Modena’ PGI in the Official Gazette of the Italian Republic (Gazzetta Ufficiale della Repubblica Italiana) No 246 of 20 October 2012.
      The full text of the product specification is available on the following website: http://www.politicheagricole.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/3335
      or alternatively:
      by going directly to the home page of the Ministry of Agricultural, Food and Forestry Policy (http://www.politicheagricole.it) and clicking on ‘Qualità e sicurezza’ (on the top right of the screen) and then on ‘Disciplinari di Produzione all’esame dell’UE’.

         (1)  OJ L 93, 31.3.2006, p. 12. Replaced by Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1).


title: Commission Implementing Regulation (EU) 2016/1929 of 4 November 2016 approving Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, as an active substance for use in biocidal products of product-type 18 (Text with EEA relevance )

text:
               5.11.2016

               EN

               Official Journal of the European Union

               L 299/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1929
   of 4 November 2016
   approving Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, as an active substance for use in biocidal products of product-type 18
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 90(2) thereof,
   Whereas:

               (1)

               France received on 30 January 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, in Annex I of that Directive for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012.

               (2)

               France submitted the assessment report together with its recommendations on 29 May 2015 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

               (3)

               The opinion of the European Chemicals Agency was formulated on 16 February 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

               (4)

               According to that opinion, biocidal products of product-type 18 and containing Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

               (5)

               It is therefore appropriate to approve Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

         HAS ADOPTED THIS REGULATION:
   Article 1

      Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351, is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.
   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 November 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 167, 27.6.2012, p. 1.

      (2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

      ANNEX

                  Common Name

                  IUPAC Name
                  Identification Numbers

                  Minimum degree of purity of the active substance (1)

                  Date of approval

                  Expiry date of approval

                  Product type

                  Specific conditions

                     Bacillus thuringiensis subsp. kurstaki, serotype 3a3b, strain ABTS-351

                  Not applicable

                  No relevant impurities

                  1 March 2017

                  28 February 2027

                  18

                  The authorisations of biocidal products are subject to the following conditions:

                              1.

                              The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

                              2.

                              In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                          (a)

                                          professional users;

                                          (b)

                                          general population exposed to spray drift;

                                          (c)

                                          soil compartment when the product is applied before a rain event.

         (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.


title: Commission Implementing Regulation (EU) 2017/660 of 6 April 2017 concerning a coordinated multiannual control programme of the Union for 2018, 2019 and 2020 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (Text with EEA relevance. )

text:
               7.4.2017

               EN

               Official Journal of the European Union

               L 94/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/660
   of 6 April 2017
   concerning a coordinated multiannual control programme of the Union for 2018, 2019 and 2020 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin
   (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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), in particular Article 29(2) thereof,
   Whereas:

               (1)

               By Commission Regulation (EC) No 1213/2008 (2) a first coordinated multiannual Community control programme, covering the years 2009, 2010 and 2011, was established. That programme continued under consecutive Commission Regulations. The latest one was Commission Implementing Regulation (EU) 2016/662 (3).

               (2)

               Thirty to forty foodstuffs constitute the major components of the diet in the Union. Since pesticide uses show significant changes over a period of three years, pesticides should be monitored in those foodstuffs over a series of three-year cycles to allow consumer exposure and the application of Union legislation to be assessed.

               (3)

               The European Food Safety Authority (the Authority), submitted a scientific report on a design assessment of the pesticide monitoring program. It concluded that an MRL exceedance rate above 1 % could be estimated with a margin of error of 0,75 % by selecting 683 sample units for a minimum of 32 different food items (4). Collection of those samples should be apportioned among Member States according to population numbers, with a minimum of 12 samples per product and per year.

               (4)

               Analytical results from the previous official control programmes of the Union have been taken into account to ensure that the range of pesticides covered by the control programme is representative for the pesticides used.

               (5)

               Guidance concerning ‘Analytical quality control and validation procedures for pesticide residues analysis in food and feed’ is published on the Commission website (5).

               (6)

               Where the residue definition of a pesticide includes other active substances, metabolites, breakdown or reaction products, those compounds should be reported separately as far as they are measured individually.

               (7)

               Implementing measures, such as the Standard Sample Description (SSD) (6)
                   (7) for submitting results of pesticide residues analysis, relating to the submission of information by Member States have been agreed by Member States, the Commission and the European Food Safety Authority.

               (8)

               For the sampling procedures, Commission Directive 2002/63/EC (8), which incorporates the sampling methods and procedures recommended by the Codex Alimentarius Commission, should apply.

               (9)

               It is necessary to assess whether maximum residue levels for food for infants and young children provided for in Article 10 of Commission Directive 2006/141/EC (9) and Article 7 of Commission Directive 2006/125/EC (10) are respected, taking into account only the residue definitions as they are set out in Regulation (EC) No 396/2005.

               (10)

               As regards single residue methods, Member States may be able to meet their obligations of analysis by having recourse to official laboratories already having the validated methods required.

               (11)

               Member States should submit by 31 August of each year the information concerning the previous calendar year.

               (12)

               In order to avoid any confusion due to an overlap between consecutive multiannual programmes, Implementing Regulation (EU) 2016/662 should be repealed in the interest of legal certainty. It should, however, continue to apply to samples tested in 2017.

               (13)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Member States shall, during the years 2018, 2019 and 2020, take and analyse samples for the pesticide/product combinations, as set out in Annex I.
   The number of samples of each product, including foods for infants and young children and products originating from organic farming shall be as set out in Annex II.
   Article 2
   1.   The lot to be sampled shall be chosen randomly.
   The sampling procedure, including the number of units, shall comply with Directive 2002/63/EC.
   2.   All samples, including those of foods intended for infants and young children, shall be analysed for the pesticides set out in Annex I in accordance with the residue definitions set out in Regulation (EC) No 396/2005.
   3.   For foods intended for infants and young children, samples shall be evaluated on the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers, taking into account the MRLs set out in Directives 2006/125/EC and 2006/141/EC. Where such foods can be consumed both as sold and as reconstituted, the results shall be reported on the non-reconstituted product as sold.
   Article 3
   Member States shall submit the results of the analysis of samples tested in 2018, 2019 and 2020 by 31 August 2019, 2020 and 2021 respectively. Those results shall be submitted in accordance with the Standard Sample Description (SSD).
   Where the residue definition of a pesticide includes more than one compound (active substance, metabolite and/or breakdown or reaction product), Member States shall report the analysis results in accordance with the full residue definition. In addition, the results of all analytes that are part of the residue definition shall be submitted separately, as far as they are measured individually.
   Article 4
   Implementing Regulation (EU) 2016/662 is repealed.
   However, it shall continue to apply to samples tested in 2017.
   Article 5
   This Regulation shall enter into force on 1 January 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 6 April 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 70, 16.3.2005, p. 1.

      (2)  Commission Regulation (EC) No 1213/2008 of 5 December 2008 concerning a coordinated multiannual Community control programme for 2009, 2010 and 2011 to ensure compliance with maximum residue levels of and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 328, 6.12.2008, p. 9).

      (3)  Commission Implementing Regulation (EU) 2016/662 of 1 April 2016 concerning a coordinated multiannual control programme of the Union for 2017, 2018 and 2019 to ensure compliance with maximum levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 115, 29.4.2016, p. 2).

      (4)  European Food Safety Authority; pesticide monitoring program: design assessment. EFSA Journal 2015;13(2):4005.

      (5)  Document No. SANTE/11945/2015 http://ec.europa.eu/food/plant/docs/plant_pesticides_mrl_guidelines_wrkdoc_11945_en.pdf in its most recent version.

      (6)  Standard sample description for food and feed (EFSA Journal 2010; 8(1): 1457).

      (7)  Use of the EFSA Standard Sample Description ver. 2.0 (SSD) for the reporting of data on the control of pesticide residues in food and feed according to Regulation (EC) No 396/2005 (EFSA Supporting publication 2015: EN-918).

      (8)  Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

      (9)  Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).

      (10)  Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

      ANNEX I
      PART A

         Products of plant origin
          (1)
         to be sampled in 2018, 2019 and 2020

                  2018

                  2019

                  2020

                  (b)

                  (c)

                  (a)

                  Table grapes (2)

                  Apples (2)

                  Oranges (2)

                  Bananas (2)

                  Strawberries (2)

                  Pears (2)

                  Grapefruits (2)

                  Peaches, including nectarines and similar hybrids (2)

                  Kiwi fruits (2)

                  Aubergines (2)

                  Wine (red or white) made from grapes. (If no specific processing factors for wine are available, a default factor of 1 may be applied. Member States are requested to report the wine processing factors used in the 'National Summary report')

                  Cauliflowers (2)

                  Broccoli (2)

                  Lettuces (2)

                  Onions (2)

                  Melons (2)

                  Head cabbages (2)

                  Carrots (2)

                  Cultivated fungi (2)

                  Tomatoes (2)

                  Potatoes (2)

                  Sweet peppers/bell peppers (2)

                  Spinaches (2)

                  Beans (dried) (2)

                  Wheat grain (3)

                  Oat grain (3)
                      (4)

                  Rye grain (3)

                  Virgin olive oil (If no specific oil processing factor is available, a default factor of 5 may be applied for fat soluble substances, taking into account an olive oil production standard yield of 20 % of the olive harvest; for non-fat soluble substances a default oil processing factor of 1 may be used. Member States are requested to report the processing factors used in the 'National Summary report')

                  Barley grain (3)
                      (5)

                  Brown rice (husked rice), defined as rice after the removal of the hull from paddy rice (6)

            PART B

         Products of animal origin
          (7)
         to be sampled in 2018, 2019 and 2020

                  2018

                  2019

                  2020

                  (d)

                  (e)

                  (f)

                  Bovine fat (8)

                  Cow's milk (9)

                  Poultry fat (8)

                  Chicken eggs (8)
                      (10)

                  Swine fat (8)

                  Sheep fat (8)

            PART C

         Pesticide/product combinations to be monitored in/on products of plant origin

                  2018

                  2019

                  2020

                  Remarks

                  2,4-D

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on grapefruits, table grapes, aubergines and broccoli in 2018; in and on lettuces, spinaches and tomatoes in 2019; in and on oranges, cauliflowers, brown rice and dried beans in 2020.

                  2-Phenylphenol

                  (b)

                  (c)

                  (a)

                  Abamectin

                  (b)

                  (c)

                  (a)

                  Acephate

                  (b)

                  (c)

                  (a)

                  Acetamiprid

                  (b)

                  (c)

                  (a)

                  Acrinathrin

                  (b)

                  (c)

                  (a)

                  Aldicarb

                  (b)

                  (c)

                  (a)

                  Aldrin and dieldrin

                  (b)

                  (c)

                  (a)

                  Azinphos-methyl

                  (b)

                  (c)

                  (a)

                  Azoxystrobin

                  (b)

                  (c)

                  (a)

                  Bifenthrin

                  (b)

                  (c)

                  (a)

                  Biphenyl

                  (b)

                  (c)

                  (a)

                  Bitertanol

                  (b)

                  (c)

                  (a)

                  Boscalid

                  (b)

                  (c)

                  (a)

                  Bromide ion

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on sweet peppers in 2018; in and on lettuces and tomatoes in 2019; in and on brown rice in 2020.

                  Bromopropylate

                  (b)

                  (c)

                  (a)

                  Bupirimate

                  (b)

                  (c)

                  (a)

                  Buprofezin

                  (b)

                  (c)

                  (a)

                  Captan

                  (b)

                  (c)

                  (a)

                  Carbaryl

                  (b)

                  (c)

                  (a)

                  Carbendazim and benomyl

                  (b)

                  (c)

                  (a)

                  Carbofuran

                  (b)

                  (c)

                  (a)

                  Chlorantraniliprole

                  (b)

                  (c)

                  (a)

                  Chlorfenapyr

                  (b)

                  (c)

                  (a)

                  Chlormequat

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on aubergines, table grapes, cultivated fungi and wheat in 2018; in and on tomatoes and oat in 2019; in and on carrots, pears, rye and brown rice in 2020.

                  Chlorothalonil

                  (b)

                  (c)

                  (a)

                  Chlorpropham

                  (b)

                  (c)

                  (a)

                  Chlorpyrifos

                  (b)

                  (c)

                  (a)

                  Chlorpyrifos-methyl

                  (b)

                  (c)

                  (a)

                  Clofentezine

                  (b)

                  (c)

                  (a)

                  It shall be analysed for all listed commodities except cereals.

                  Clothianidin

                  (b)

                  (c)

                  (a)

                  Cyfluthrin

                  (b)

                  (c)

                  (a)

                  Cymoxanil

                  (b)

                  (c)

                  (a)

                  Cypermethrin

                  (b)

                  (c)

                  (a)

                  Cyproconazole

                  (b)

                  (c)

                  (a)

                  Cyprodinil

                  (b)

                  (c)

                  (a)

                  Cyromazine

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on aubergines, sweet peppers, melons and cultivated fungi in 2018; in and on lettuces and tomatoes and in 2019; in and on potatoes, onions and carrots in 2020.

                  Deltamethrin

                  (b)

                  (c)

                  (a)

                  Diazinon

                  (b)

                  (c)

                  (a)

                  Dichlorvos

                  (b)

                  (c)

                  (a)

                  Dicloran

                  (b)

                  (c)

                  (a)

                  Dicofol

                  (b)

                  (c)

                  (a)

                  It shall be analysed for all listed commodities except cereals.

                  Diethofencarb

                  (b)

                  (c)

                  (a)

                  Difenoconazole

                  (b)

                  (c)

                  (a)

                  Diflubenzuron

                  (b)

                  (c)

                  (a)

                  Dimethoate

                  (b)

                  (c)

                  (a)

                  Dimethomorph

                  (b)

                  (c)

                  (a)

                  Diniconazole

                  (b)

                  (c)

                  (a)

                  Diphenylamine

                  (b)

                  (c)

                  (a)

                  Dithianon

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on table grapes in 2018; in and on apples and peaches in 2019; in and on pears and brown rice in 2020.

                  Dithiocarbamates

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except broccoli, cauliflowers, head cabbages, olive oil, wine and onions.

                  Dodine

                  (b)

                  (c)

                  (a)

                  Endosulfan

                  (b)

                  (c)

                  (a)

                  EPN

                  (b)

                  (c)

                  (a)

                  Epoxiconazole

                  (b)

                  (c)

                  (a)

                  Ethephon

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on sweet peppers, wheat and table grapes in 2018; in and on apples, peaches, tomatoes and wine in 2019; in and on oranges and pears in 2020.

                  Ethion

                  (b)

                  (c)

                  (a)

                  Ethirimol

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Etofenprox

                  (b)

                  (c)

                  (a)

                  Famoxadone

                  (b)

                  (c)

                  (a)

                  Fenamidone

                  (b)

                  (c)

                  (a)

                  Fenamiphos

                  (b)

                  (c)

                  (a)

                  Fenarimol

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Fenazaquin

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Fenbuconazole

                  (b)

                  (c)

                  (a)

                  Fenbutatin oxide

                  (b)

                  (c)

                  (a)

                  It shall only be in and on aubergines, grapefruits,sweet peppers and table grapes in 2018; in and on apples, strawberries, peaches, tomatoes and wine in 2019; analysed in and on oranges and pears in 2020.

                  Fenhexamid

                  (b)

                  (c)

                  (a)

                  Fenitrothion

                  (b)

                  (c)

                  (a)

                  Fenoxycarb

                  (b)

                  (c)

                  (a)

                  Fenpropathrin

                  (b)

                  (c)

                  (a)

                  Fenpropidin

                  (b)

                  (c)

                  (a)

                  Fenpropimorph

                  (b)

                  (c)

                  (a)

                  Fenpyroximate

                  (b)

                  (c)

                  (a)

                  Fenthion

                  (b)

                  (c)

                  (a)

                  Fenvalerate

                  (b)

                  (c)

                  (a)

                  Fipronil

                  (b)

                  (c)

                  (a)

                  Flonicamid

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on aubergines, table grapes, grapefruits, melons, sweet peppers and wheat in 2018; in and on apples, peaches, spinaches, lettuces, tomatoes, oat and barley in 2019; in and on potatoes, pears, brown rice and rye in 2020.

                  Fluazifop-P

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on aubergines, broccoli, sweet peppers and wheat in 2018; in and on strawberries, head cabbages, lettuces, spinaches and tomatoes in 2019; in and on cauliflowers, dried beans, potatoes and carrots in 2020.

                  Flubendiamide

                  (b)

                  (c)

                  (a)

                  Fludioxonil

                  (b)

                  (c)

                  (a)

                  Flufenoxuron

                  (b)

                  (c)

                  (a)

                  Fluopicolide

                  (b)

                  (c)

                  (a)

                  Fluopyram

                  (b)

                  (c)

                  (a)

                  Fluquinconazole

                  (b)

                  (c)

                  (a)

                  Flusilazole

                  (b)

                  (c)

                  (a)

                  Flutriafol

                  (b)

                  (c)

                  (a)

                  Folpet

                  (b)

                  (c)

                  (a)

                  Formetanate

                  (b)

                  (c)

                  (a)

                  Fosthiazate

                  (b)

                  (c)

                  (a)

                  Glyphosate

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on table grapes and wheat in 2018; in and on apples, peaches, wine, barley and oat in 2019; in and on pears, oranges and rye in 2020.

                  Haloxyfop including haloxyfop-P

                  (b)

                  (c)

                  It shall only be analysed in and on broccoli, grapefruits, sweet pepper and wheat in 2018; in and on strawberries and head cabbages in 2019. The substance is not to be analysed in or on any product in 2020.

                  Hexaconazole

                  (b)

                  (c)

                  (a)

                  Hexythiazox

                  (b)

                  (c)

                  (a)

                  It shall be analysed for all listed commodities except cereals.

                  Imazalil

                  (b)

                  (c)

                  (a)

                  Imidacloprid

                  (b)

                  (c)

                  (a)

                  Indoxacarb

                  (b)

                  (c)

                  (a)

                  Iprodione

                  (b)

                  (c)

                  (a)

                  Iprovalicarb

                  (b)

                  (c)

                  (a)

                  Isocarbophos

                  (b)

                  (c)

                  (a)

                  Isoprothiolane

                  (a)

                  It shall only be analysed in and on brown rice in 2020. The substance is not to be analysed in or on any product in 2018 and 2019.

                  Kresoxim-methyl

                  (b)

                  (c)

                  (a)

                  Lambda-cyhalothrin

                  (b)

                  (c)

                  (a)

                  Linuron

                  (b)

                  (c)

                  (a)

                  Lufenuron

                  (b)

                  (c)

                  (a)

                  Malathion

                  (b)

                  (c)

                  (a)

                  Mandipropamid

                  (b)

                  (c)

                  (a)

                  Mepanipyrim

                  (b)

                  (c)

                  (a)

                  Mepiquat

                  (b)

                  (c)

                  (a)

                  It shall only be analysed in and on cultivated fungi, and wheat in 2018; in and on barley and oat in 2019; in and on pears, rye and brown rice in 2020.

                  Metalaxyl and metalaxyl-M

                  (b)

                  (c)

                  (a)

                  Methamidophos

                  (b)

                  (c)

                  (a)

                  Methidathion

                  (b)

                  (c)

                  (a)

                  Methiocarb

                  (b)

                  (c)

                  (a)

                  Methomyl and thiodicarb

                  (b)

                  (c)

                  (a)

                  Methoxyfenozide

                  (b)

                  (c)

                  (a)

                  Monocrotophos

                  (b)

                  (c)

                  (a)

                  Myclobutanil

                  (b)

                  (c)

                  (a)

                  Oxadixyl

                  (b)

                  (c)

                  (a)

                  Oxamyl

                  (b)

                  (c)

                  (a)

                  Oxydemeton-methyl

                  (b)

                  (c)

                  (a)

                  Paclobutrazole

                  (b)

                  (c)

                  (a)

                  Parathion

                  (b)

                  (c)

                  (a)

                  Parathion methyl

                  (b)

                  (c)

                  (a)

                  Penconazole

                  (b)

                  (c)

                  (a)

                  Pencycuron

                  (b)

                  (c)

                  (a)

                  Pendimethalin

                  (b)

                  (c)

                  (a)

                  Permethrin

                  (b)

                  (c)

                  (a)

                  Phosmet

                  (b)

                  (c)

                  (a)

                  Pirimicarb

                  (b)

                  (c)

                  (a)

                  Pirimiphos-methyl

                  (b)

                  (c)

                  (a)

                  Procymidone

                  (b)

                  (c)

                  (a)

                  Profenofos

                  (b)

                  (c)

                  (a)

                  Propamocarb

                  (b)

                  (c)

                  (a)

                  It shall be only analysed in and on table grapes, melons, aubergines, broccoli, sweet peppers and wheat in 2018; in and on strawberries, head cabbages, spinaches, lettuces, tomatoes and barley in 2019; in and on carrots, cauliflowers, onions and potatoes in 2020.

                  Propargite

                  (b)

                  (c)

                  (a)

                  Propiconazole

                  (b)

                  (c)

                  (a)

                  Propyzamide

                  (b)

                  (c)

                  (a)

                  Prosulfocarb

                  (b)

                  (c)

                  (a)

                  Prothioconazole

                  (b)

                  (c)

                  (a)

                  It shall be only analysed in and on sweet peppers and wheat in 2018; in and head cabbages, lettuces, tomatoes, oat and barley in 2019; in and on carrots, onions, rye and brown rice in 2020.

                  Pymetrozine

                  (b)

                  (c)

                  It shall only be analysed in and on aubergines, melons and sweet peppers in 2018; in and on head cabbages, lettuces, strawberries, spinaches and tomatoes in 2019. The substance is not to be analysed in or on any product in 2020.

                  Pyraclostrobin

                  (b)

                  (c)

                  (a)

                  Pyridaben

                  (b)

                  (c)

                  (a)

                  Pyrimethanil

                  (b)

                  (c)

                  (a)

                  Pyriproxyfen

                  (b)

                  (c)

                  (a)

                  Quinoxyfen

                  (b)

                  (c)

                  (a)

                  Spinosad

                  (b)

                  (c)

                  (a)

                  Spirodiclofen

                  (b)

                  (c)

                  (a)

                  Spiromesifen

                  (b)

                  (c)

                  (a)

                  Spiroxamine

                  (b)

                  (c)

                  (a)

                  Tau-Fluvalinate

                  (b)

                  (c)

                  (a)

                  Tebuconazole

                  (b)

                  (c)

                  (a)

                  Tebufenozide

                  (b)

                  (c)

                  (a)

                  Tebufenpyrad

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Teflubenzuron

                  (b)

                  (c)

                  (a)

                  Tefluthrin

                  (b)

                  (c)

                  (a)

                  Terbuthylazine

                  (b)

                  (c)

                  (a)

                  Tetraconazole

                  (b)

                  (c)

                  (a)

                  Tetradifon

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Thiabendazole

                  (b)

                  (c)

                  (a)

                  Thiacloprid

                  (b)

                  (c)

                  (a)

                  Thiamethoxam

                  (b)

                  (c)

                  (a)

                  Thiophanate-methyl

                  (b)

                  (c)

                  (a)

                  Tolclofos-methyl

                  (b)

                  (c)

                  (a)

                  Tolylfluanid

                  (b)

                  (c)

                  (a)

                  It shall be analysed in and on all listed commodities except cereals.

                  Triadimefon and triadimenol

                  (b)

                  (c)

                  (a)

                  Triazophos

                  (b)

                  (c)

                  (a)

                  Trifloxystrobin

                  (b)

                  (c)

                  (a)

                  Triflumuron

                  (b)

                  (c)

                  (a)

                  Vinclozolin

                  (b)

                  (c)

                  (a)

            PART D

         Pesticide/product combinations to be monitored in/on products of animal origin

                  2018

                  2019

                  2020

                  Remarks

                  Aldrin and dieldrin

                  (d)

                  (e)

                  (f)

                  Bifenthrin

                  (d)

                  (e)

                  (f)

                  Chlordane

                  (d)

                  (e)

                  (f)

                  Chlorpyrifos

                  (d)

                  (e)

                  (f)

                  Chlorpyrifos-methyl

                  (d)

                  (e)

                  (f)

                  Cypermethrin

                  (d)

                  (e)

                  (f)

                  DDT

                  (d)

                  (e)

                  (f)

                  Deltamethrin

                  (d)

                  (e)

                  (f)

                  Diazinon

                  (d)

                  (e)

                  (f)

                  Endosulfan

                  (d)

                  (e)

                  (f)

                  Famoxadone

                  (d)

                  (e)

                  (f)

                  Fenvalerate

                  (d)

                  (e)

                  (f)

                  Heptachlor

                  (d)

                  (e)

                  (f)

                  Hexachlorobenzene

                  (d)

                  (e)

                  (f)

                  Hexachlorcyclohexan (HCH, Alpha-Isomer)

                  (d)

                  (e)

                  (f)

                  Hexachlorcyclohexan (HCH, Beta-Isomer)

                  (d)

                  (e)

                  (f)

                  Indoxacarb

                  (e)

                  It shall only be analysed in milk in 2019.

                  Lindane

                  (d)

                  (e)

                  (f)

                  Methoxychlor

                  (d)

                  (e)

                  (f)

                  Parathion

                  (d)

                  (e)

                  (f)

                  Permethrin

                  (d)

                  (e)

                  (f)

                  Pirimiphos-methyl

                  (d)

                  (e)

                  (f)

         (1)  For the raw commodities to be analysed, the parts of the products to which MRLs apply shall be analysed for the main product of the group or subgroup as listed in Part A of Annex I to Commission Regulation (EU) No 752/2014 of 24 June 2014 replacing Annex I to Regulation (EC) No 396/2005 of the European Parliament and of the Council (OJ L 208, 15.7.2014, p. 1) unless stated otherwise.

         (2)  Unprocessed products (including frozen products) shall be analysed.

         (3)  If no sufficient samples of rye, wheat, oat or barley grains are available, also rye, wheat, oat or barley whole grain flour can be analysed and a processing factor shall be reported. If no specific processing factors are available, a default factor of 1 may be applied.

         (4)  If no sufficient samples of oat grains are available, the part of the required sample number for oat grains that could not be taken, can be added to the sample number for barley grains, resulting in a reduced sample number for oat grains and a proportionately increased sample number for barley grains.

         (5)  If no sufficient samples of barley grains are available, the part of the required sample number for barley grains that could not be taken, can be added to the sample number for oat grains, resulting in a reduced sample number for barley grains and a proportionately increased sample number for oat grains.

         (6)  Where appropriate, also polished rice grain can be analysed. It shall be reported to EFSA whether polished or husked rice was analysed. If polished rice was analysed, a processing factor shall be reported. If no specific processing factors are available, a default factor of 0,5 may be applied.

         (7)  For the raw commodities to be analysed, the parts of the products to which MRLs apply shall be analysed for the main product of the group or subgroup as listed in Part A of Annex I to Regulation (EU) No 752/2014 unless stated otherwise.

         (8)  Unprocessed products (including frozen products) shall be analysed.

         (9)  Fresh (unprocessed) milk shall be analysed, including frozen, pasteurised, heated, sterilised or filtrated milk.

         (10)  Whole eggs without the shell shall be analysed.

      ANNEX II

         Number of samples referred to in Article 1

                  1.

                  The number of samples to be taken for each commodity and analysed for the pesticides listed in Annex I by each Member State is set out in the table in point (5).

                  2.

                  In addition to the samples required in accordance with the table in point (5), in 2018 each Member State shall take and analyse ten samples of processed cereal-based baby food.
                  In addition to the samples required in accordance with that table, in 2019 each Member State shall take and analyse ten samples of foods for infants and young children other than infant formulae, follow-on formulae and processed cereal-based baby food.
                  In addition to the samples required in accordance with that table, in 2020 each Member State shall take and analyse five samples of infant formulae and five samples of follow-on formulae.

                  3.

                  In accordance with the table in point (5), samples from commodities originating from organic farming shall, where available, be taken in proportion to the market share of those commodities in each Member State, with a minimum of 1.

                  4.

                  Member States using multi-residue methods may use qualitative screening methods on up to 15 % of the samples to be taken and analysed in accordance with the table in point (5). Where a Member State uses qualitative screening methods, it shall analyse the remaining number of samples by quantitative multi-residue methods.
                  Where the results of qualitative screening are positive, Member States shall use a usual target method to quantify the findings.

                  5.

                  Minimum number of samples per Member State per commodity:

                              Member State

                              Samples

                              Member State

                              Samples

                              BE

                              12

                              LU

                              12

                              BG

                              12

                              HU

                              12

                              CZ

                              12

                              MT

                              12

                              DK

                              12

                              NL

                              18

                              DE

                              97

                              AT

                              12

                              EE

                              12

                              PL

                              47

                              EL

                              12

                              PT

                              12

                              ES

                              50

                              RO

                              20

                              FR

                              71

                              SI

                              12

                              IE

                              12

                              SK

                              12

                              IT

                              69

                              FI

                              12

                              CY

                              12

                              SE

                              12

                              LV

                              12

                              UK

                              71

                              LT

                              12

                              HR

                              12

                                 TOTAL NUMBER OF SAMPLES: 683


title: Commission Implementing Regulation (EU) No 848/2014 of 4 August 2014 concerning the authorisation of L-valine produced by Corynebacterium glutamicum as a feed additive for all animal species and amending Regulation (EC) No 403/2009 as regards the labelling of the feed additive L-valine  Text with EEA relevance

text:
               5.8.2014

               EN

               Official Journal of the European Union

               L 232/13

         COMMISSION IMPLEMENTING REGULATION (EU) No 848/2014
   of 4 August 2014
   concerning the authorisation of L-valine produced by Corynebacterium glutamicum as a feed additive for all animal species and amending Regulation (EC) No 403/2009 as regards the labelling of the feed additive L-valine
   (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) and Article 13(2) thereof,
   Whereas:

               (1)

               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such authorisation.

               (2)

               In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-valine. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum (KCCM 80058) as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

               (4)

               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 8 October 2013 (2) that, under the proposed conditions of use, the L-valine produced by Corynebacterium glutamicum (KCCM 80058) does not have an adverse effect on animal health, human health or the environment and that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (5)

               The assessment of that substance shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation.

               (6)

               Commission Regulation (EC) No 403/2009 (3) authorised L-valine produced by Escherichia coli. In order to ensure the differentiation of the additives in the final feed, their identification number should be labelled on feed materials and compound feed together with their name and added amount.

               (7)

               Regulation (EC) No 403/2009 should therefore be amended accordingly. Since the modifications to the conditions of authorisation are not related to safety reasons, it is appropriate to provide for a transitional period during which existing stocks may be used up.

               (8)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Authorisation
   The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
   Article 2
   Amendment to Regulation (EC) No 403/2009
   In the ninth column of the Annex to Regulation (EC) No 403/2009, the following paragraph is added:
   ‘Where voluntary declaration of the additive is made on the labelling of feed materials and compound feed, the following shall be included:

               —

               name and identification number of the additive,

               —

               added amount of the additive.’

         Article 3
   Transitional measures
   Feed materials and compound feed as referred to in Article 2 which are produced and labelled before 25 February 2015 in accordance with the rules applicable before 25 August 2014 may continue to be placed on the market and used until the existing stocks are exhausted. As regards feed intended for pet animals, the time period for production and labelling referred to in the first sentence shall end 25 August 2016.
   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, 4 August 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 268, 18.10.2003, p. 29.

      (2)  EFSA Journal 2013; 11(10):3429.

      (3)  Commission Regulation (EC) No 403/2009 of 14 May 2009 concerning the authorisation of a preparation of L-valine as a feed additive (OJ L 120, 15.5.2009, p. 3).

      ANNEX

                  Identification number of the additive

                  Name of the holder of authorisation

                  Additive

                  Composition, chemical formula, description, analytical method.

                  Species or category of animal

                  Maximum age

                  Minimum content

                  Maximum content

                  Other provisions

                  End of period of authorisation

                  mg/kg of complete feed with a moisture content of 12 %

                     Category of nutritional additives. Functional group: amino acids, their salts and analogues.

                  3c370

                  —

                  L-valine

                     Additive composition

                  L-valine minimum 98 % (on dry matter basis)

                     Characterisation of the active substance

                  L-valine ((2S)-2-amino-3-methylbutanoic acid) produced by Corynebacterium glutamicum (KCCM 80058)
                  Chemical formula: C5H11NO2

                  CAS number: 72-18-4

                     Analytical method
                      (1)

                  For the determination of L-valine in the feed additive: Food Chemical Codex ‘L-valine monograph’.
                  For the determination of valine in premixtures, compound feed and feed materials: ion exchange chromatography coupled with post-column derivatisation and spectrophotometric detection (HPLC/VIS) — Commission Regulation (EC) No 152/2009 (OJ L 54, 26.2.2009, p.1).

                  All species

                  —

                              1.

                              Declarations to be made on the labelling of the additive:

                                          —

                                          moisture content.

                              2.

                              Where voluntary declaration of the additive is made on the labelling of feed materials and compound feed, the following shall be included:

                                          —

                                          name and identification number of the additive,

                                          —

                                          added amount of the additive.

                  25 August 2024

         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports