title: Commission Implementing Regulation (EU) 2016/1833 of 17 October 2016 concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.) (Text with EEA relevance)

text:
               18.10.2016

               EN

               Official Journal of the European Union

               L 280/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1833
   of 17 October 2016
   concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.)
   (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) 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 such authorisation.

               (2)

               In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               That application concerns the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets to be classified in the additive category ‘zootechnical additives’.

               (4)

               The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 October 2014 (2) and 22 October 2015 (3) that, under the proposed conditions of use, the preparation of kidney bean lectins (Phaseolus vulgaris lectins) does not have an adverse effect on animal health, human health or the environment. It further concluded that the additive should be considered as a respiratory sensitizer and there is a potential hazard by inhalation exposure. The Authority has also concluded that it can have some potential to improve the performance of the piglets during the post-weaning period. 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 the preparation of kidney bean lectins (Phaseolus vulgaris lectins) 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 preparation should be authorised as specified in the Annex to this Regulation.

               (6)

               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
   The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that 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, 17 October 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  EFSA Journal 2015;13(1):3903.

      (3)  EFSA Journal 2015;13(11):4276.

      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

                  Units of activity animal/day

                     Category of zootechnical additives. Functional group: other zootechnical additives (performance enhancer in weaned piglets)

                  4d13

                  Biolek Sp. z o.o.

                  Kidney bean lectins

                     Additive composition

                  Preparation of kidney bean lectins (Phaseolus vulgaris lectins), having a minimum of activity: 1 280  HAU/g (1)

                     Characterisation of the active substance

                  Mixture of phytohaemagglutinin (PHA) isoforms: PHA-E4, PHA-E3L, PHA-E2L2, PHA-EL3, PHA-L4

                  CAS (PHA-L) 9008-97-3

                     Analytical methods
                      (2)

                  For the quantification of the kidney bean lectin in the additive:
                  Haemagglutination assay

                  Suckling piglets

                  14 days

                  220 HAU

                  660 HAU

                              1.

                              In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

                              2.

                              The additive shall be fed only via a complementary feed to suckling piglets from 10th to 14th day of age with the maximum dose of:

                                          —

                                          220 HAU/suckling piglet/day for 3 days or

                                          —

                                          660 HAU/suckling piglet (in one day).

                              3.

                              On the label of the additive, the instructions for use via complementary feed shall be indicated.

                              4.

                              For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                  7 November 2026

         (1)  1 HAU (Haemagglutination Activity Units) is the amount of material (1 mg/ml) in the last dilution giving 50 % agglutination (clumping) of the red blood cells.

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


title: Commission Implementing Regulation (EU) No 1207/2014 of 10 November 2014 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               11.11.2014

               EN

               Official Journal of the European Union

               L 326/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 1207/2014
   of 10 November 2014
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
   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, 10 November 2014.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

      (1)  OJ L 347, 20.12.2013, p. 671.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  AL

                  71,7

                  MA

                  81,7

                  MK

                  67,1

                  ZZ

                  73,5

                  0707 00 05

                  AL

                  79,4

                  JO

                  194,1

                  MK

                  74,3

                  TR

                  130,6

                  ZZ

                  119,6

                  0709 93 10

                  MA

                  65,4

                  TR

                  115,9

                  ZZ

                  90,7

                  0805 20 10

                  MA

                  107,4

                  TR

                  74,4

                  ZZ

                  90,9

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  MK

                  74,3

                  TR

                  65,2

                  ZZ

                  69,8

                  0805 50 10

                  AR

                  78,7

                  MA

                  52,7

                  TR

                  88,3

                  ZZ

                  73,2

                  0806 10 10

                  BR

                  281,7

                  LB

                  302,8

                  PE

                  285,4

                  TR

                  145,3

                  US

                  323,5

                  ZA

                  133,6

                  ZZ

                  245,4

                  0808 10 80

                  AR

                  153,3

                  BA

                  46,1

                  BR

                  53,5

                  CA

                  136,0

                  CL

                  85,8

                  CN

                  68,5

                  NZ

                  148,1

                  US

                  193,3

                  ZA

                  154,5

                  ZZ

                  115,5

                  0808 30 90

                  CN

                  85,3

                  ZA

                  57,4

                  ZZ

                  71,4

         (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2015/1012 of 23 June 2015 amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin (Text with EEA relevance)

text:
               27.6.2015

               EN

               Official Journal of the European Union

               L 162/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1012
   of 23 June 2015
   amending Annex I to Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-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 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 15(5) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 669/2009 (2) lays down rules concerning the increased level of official controls to be carried out on imports of feed and food of non-animal origin listed in Annex I thereto (‘the list’), at the points of entry into the territories referred to in Annex I to Regulation (EC) No 882/2004.

               (2)

               Article 2 of Regulation (EC) No 669/2009 provides that the list is to be reviewed on a regular basis, and at least quarterly, taking into account at least the sources of information referred to in that Article.

               (3)

               The occurrence and relevance of recent food incidents notified through the Rapid Alert System for Food and Feed, the findings of audits to third countries carried out by the Food and Veterinary Office, as well as the quarterly reports on consignments of feed and food of non-animal origin submitted by Member States to the Commission in accordance with Article 15 of Regulation (EC) No 669/2009 indicate that the list should be amended.

               (4)

               In particular, the list should be amended by deleting the entries for commodities for which the available information indicates an overall satisfactory degree of compliance with the relevant safety requirements provided for in Union legislation and for which an increased level of official controls is therefore no longer justified. The entry in the list concerning beans from Kenya should therefore be deleted.

               (5)

               In addition, the list should be amended by increasing the frequency of official controls for the commodities for which the same sources of information show a higher degree of non-compliance with the relevant Union legislation, thereby warranting an increased level of official controls. The entries in the list concerning coriander leaves, basil, mint, parsley, chilli peppers and okra from Vietnam, and vine leaves from Turkey, should therefore be amended accordingly.

               (6)

               In order to ensure consistency and clarity, it is appropriate to replace Annex I to Regulation (EC) No 669/2009 by the text set out in the Annex to this Regulation.

               (7)

               Regulation (EC) No 669/2009 should therefore be amended accordingly.

               (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
   Annex I to Regulation (EC) No 669/2009 is replaced by the text set out in 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.
   It shall apply from 1 July 2015.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 June 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 165, 30.4.2004, p. 1.

      (2)  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 11).

      ANNEX

         ‘ANNEX I

            Feed and food of non-animal origin subject to an increased level of official controls at the designated point of entry

                     Feed and food
                     (intended use)

                     CN code (1)

                     TARIC sub-division

                     Country of origin

                     Hazard

                     Frequency of physical and identity checks (%)

                     Dried grapes (vine fruit)

                     0806 20

                        Afghanistan (AF)

                     Ochratoxin A

                     50

                           (Food)

                                 —

                                 Almonds, in shell

                                 —

                              0802 11

                        Australia (AU)

                     Aflatoxins

                     20

                                 —

                                 Almonds, shelled

                                 —

                              0802 12

                           (Food)

                                 —

                                 Groundnuts (peanuts), in shell

                                 —

                              1202 41 00

                        Brazil (BR)

                     Aflatoxins

                     10

                                 —

                                 Groundnuts (peanuts), shelled

                                 —

                              1202 42 00

                                 —

                                 Peanut butter

                                 —

                              2008 11 10

                                 —

                                 Groundnuts (peanuts), otherwise prepared or preserved

                                 —

                                 2008 11 91;
                                 2008 11 96;
                                 2008 11 98

                           (Feed and food)

                                 —

                                 Yardlong beans (Vigna unguiculata spp. sesquipedalis)

                                 —

                                 ex 0708 20 00;
                                 ex 0710 22 00

                        10

                        10

                        Cambodia (KH)

                     Pesticide residues (2)
                         (3)

                     50

                                 —

                                 Aubergines

                                 —

                                 0709 30 00;
                                 ex 0710 80 95

                        72

                           (Food — fresh, chilled or frozen vegetables)

                     Chinese celery (Apium graveolens)

                     ex 0709 40 00

                        20

                        Cambodia (KH)

                     Pesticide residues (2)
                         (4)

                     50

                           (Food — fresh or chilled herb)

                     Brassica oleracea (other edible Brassica, “Chinese Broccoli”) (5)

                     ex 0704 90 90

                        40

                        China (CN)

                     Pesticide residues (2)

                     50

                           (Food — fresh or chilled)

                     Tea, whether or not flavoured

                     0902

                        China (CN)

                     Pesticide residues (2)
                         (6)

                     10

                           (Food)

                                 —

                                 Aubergines

                                 —

                                 0709 30 00;
                                 ex 0710 80 95

                        72

                        Dominican Republic (DO)

                     Pesticide residues (2)
                         (7)

                     10

                                 —

                                 Bitter melon (Momordica charantia)

                                 —

                                 ex 0709 99 90;
                                 ex 0710 80 95

                        70

                        70

                           (Food — fresh, chilled or frozen vegetables)

                                 —

                                 Yardlong beans (Vigna unguiculata spp. sesquipedalis)

                                 —

                                 ex 0708 20 00;
                                 ex 0710 22 00

                        10

                        10

                        Dominican Republic (DO)

                     Pesticide residues (2)
                         (7)

                     20

                                 —

                                 Peppers (sweet and other than sweet) (Capsicum spp.)

                                 —

                                 0709 60 10;
                                 ex 0709 60 99

                        20

                           (Food — fresh, chilled or frozen vegetables)

                                 —

                                 0710 80 51;
                                 ex 0710 80 59

                        20

                     Strawberries (fresh)

                     0810 10 00

                        Egypt (EG)

                     Pesticide residues (2)
                         (8)

                     10

                           (Food)

                     Peppers (sweet and other than sweet) (Capsicum spp.)

                     0709 60 10;
                     ex 0709 60 99;

                        20

                        Egypt (EG)

                     Pesticide residues (2)
                         (9)

                     10

                           (Food — fresh, chilled or frozen)

                     0710 80 51;
                     ex 0710 80 59

                        20

                     Betel leaves (Piper betle L.)

                     ex 1404 90 00

                        10

                        India (IN)

                     Salmonella (10)

                     50

                           (Food)

                     Sesamum seeds

                     1207 40 90

                        India (IN)

                     Salmonella (10)

                     20

                           (Food — fresh or chilled)

                                 —

                                    Capsicum annuum, whole

                                 —

                              0904 21 10

                        India (IN)

                     Aflatoxins

                     20

                                 —

                                    Capsicum annuum, crushed or ground

                                 —

                              ex 0904 22 00

                        10

                                 —

                                 Dried fruit of the genus Capsicum, whole, other than sweet peppers (Capsicum annuum)

                                 —

                              0904 21 90

                                 —

                                 Nutmeg (Myristica fragrans)

                                 —

                                 0908 11 00;
                                 0908 12 00

                           (Food — dried spices)

                     Enzymes; prepared enzymes

                     3507

                        India (IN)

                     Chloramphenicol

                     50

                           (Feed and food)

                                 —

                                 Nutmeg (Myristica fragrans)

                                 —

                                 0908 11 00;
                                 0908 12 00

                        Indonesia (ID)

                     Aflatoxins

                     20

                           (Food — dried spices)

                                 —

                                 Peas with pods (unshelled)

                                 —

                              ex 0708 10 00

                        40

                        Kenya (KE)

                     Pesticide residues (2)
                         (11)

                     10

                           (Food — fresh or chilled)

                     Mint

                     ex 1211 90 86;

                        30

                        Morocco (MA)

                     Pesticide residues (2)
                         (12)

                     10

                           (Food — fresh or chilled herb)

                     ex 2008 99 99

                        70

                     Table grapes

                     0806 10 10

                        Peru (PE)

                     Pesticide residues (2)
                         (13)

                     10

                           (Food — fresh)

                     Watermelon (Egusi, Citrullus lanatus) seeds and derived products

                     ex 1207 70 00;
                     ex 1106 30 90;
                     ex 2008 99 99

                        10

                        30

                        50

                        Sierra Leone (SL)

                     Aflatoxins

                     50

                           (Food)

                                 —

                                 Groundnuts (peanuts), in shell

                                 —

                              1202 41 00

                        Sudan (SD)

                     Aflatoxins

                     50

                                 —

                                 Groundnuts (peanuts), shelled

                                 —

                              1202 42 00

                                 —

                                 Peanut butter

                                 —

                              2008 11 10

                                 —

                                 Groundnuts (peanuts), otherwise prepared or preserved

                                 —

                                 2008 11 91;
                                 2008 11 96;
                                 2008 11 98

                           (Feed and food)

                     Peppers (other than sweet) (Capsicum spp.)

                     ex 0709 60 99

                        20

                        Thailand (TH)

                     Pesticide residues (2)
                         (14)

                     10

                           (Food — fresh or chilled)

                     Betel leaves (Piper betle L.)

                     ex 1404 90 00

                        10

                        Thailand (TH)

                     Salmonella (10)

                     50

                           (Food)

                                 —

                                 Yardlong beans (Vigna unguiculata spp. sesquipedalis)

                                 —

                                 ex 0708 20 00;
                                 ex 0710 22 00

                        10

                        10

                        Thailand (TH)

                     Pesticide residues (2)
                         (15)

                     20

                                 —

                                 Aubergines

                                 —

                                 0709 30 00;
                                 ex 0710 80 95

                        72

                           (Food — fresh, chilled or frozen vegetables)

                                 —

                                 Dried apricots

                                 —

                              0813 10 00

                        Turkey (TR)

                     Sulphites (16)

                     10

                                 —

                                 Apricots, otherwise prepared or preserved

                                 —

                              2008 50 61

                           (Food)

                                 —

                                 Sweet peppers (Capsicum annuum)

                                 —

                                 0709 60 10;
                                 0710 80 51

                        Turkey (TR)

                     Pesticide residues (2)
                         (17)

                     10

                           (Food — fresh, chilled or frozen vegetables)

                     Vine leaves

                     ex 2008 99 99

                        11; 19

                        Turkey (TR)

                     Pesticide residues (2)
                         (18)

                     50

                           (Food)

                                 —

                                 Pistachios, in shell

                                 —

                              0802 51 00

                        United States (US)

                     Aflatoxins

                     20

                                 —

                                 Pistachios, shelled

                                 —

                              0802 52 00

                           (Food)

                                 —

                                 Dried apricots

                                 —

                              0813 10 00

                        Uzbekistan (UZ)

                     Sulphites (16)

                     50

                                 —

                                 Apricots, otherwise prepared or preserved

                                 —

                              2008 50 61

                           (Food)

                     Dried grapes (vine fruit)

                     0806 20

                        Uzbekistan (UZ)

                     Ochratoxin A

                     50

                           (Food)

                                 —

                                 Coriander leaves

                                 —

                              ex 0709 99 90

                        72

                        Vietnam (VN)

                     Pesticide residues (2)
                         (19)

                     50

                                 —

                                 Basil (holy, sweet)

                                 —

                                 ex 1211 90 86;
                                 ex 2008 99 99

                        20

                        75

                                 —

                                 Mint

                                 —

                                 ex 1211 90 86;
                                 ex 2008 99 99

                        30

                        70

                                 —

                                 Parsley

                                 —

                              ex 0709 99 90

                        40

                           (Food — fresh or chilled herbs)

                                 —

                                 Okra

                                 —

                              ex 0709 99 90

                        20

                        Vietnam (VN)

                     Pesticide residues (2)
                         (19)

                     50

                                 —

                                 Peppers (other than sweet)(Capsicum spp.)

                                 —

                              ex 0709 60 99

                        20

                           (Food — fresh or chilled)

                                 —

                                 Pitahaya (dragon fruit)

                                 —

                              ex 0810 90 20

                        10

                        Vietnam (VN)

                     Pesticide residues (2)
                         (19)

                     20

                           (Food — fresh or chilled)

         (1)  Where only certain products under any CN code are required to be examined and no specific subdivision under that code exists, the CN code is marked “ex”.

         (2)  Residues of at least those pesticides listed in the control programme adopted in accordance with Article 29(2) of 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 (OJ L 70, 16.3.2005, p. 1) that can be analysed with multi-residue methods based on GC-MS and LC-MS (pesticides to be monitored in/on products of plant origin only).

         (3)  Residues of Chlorbufam.

         (4)  Residues of Phenthoate.

         (5)  Species of Brassica oleracea L. convar. Botrytis (L) Alef var.Italica Plenck, cultivar alboglabra. Also known as “Kai Lan”, “Gai Lan”, “Gailan”, “Kailan”, “Chinese bare Jielan”.

         (6)  Residues of Trifluralin.

         (7)  Residues of Acephate, Aldicarb (sum of aldicarb, its sulfoxide and its sulfone, expressed as aldicarb), Amitraz (amitraz including the metabolites containing the 2,4-dimethylaniline moiety expressed as amitraz), Diafenthiuron, Dicofol (sum of p, p′ and o,p′ isomers), Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram) and Methiocarb (sum of methiocarb and methiocarb sulfoxide and sulfone, expressed as methiocarb).

         (8)  Residues of Hexaflumuron, Methiocarb (sum of methiocarb and methiocarb sulfoxide and sulfone, expressed as methiocarb), Phenthoate and Thiophanate-methyl.

         (9)  Residues of Dicofol (sum of p, p′ and o,p′ isomers), Dinotefuran, Folpet, Prochloraz (sum of prochloraz and its metabolites containing the 2,4,6-Trichlorophenol moiety expressed as prochloraz), Thiophanate-methyl and Triforine.

         (10)  Reference method EN/ISO 6579 or a method validated against it as referred to in Article 5 of Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).

         (11)  Residues of Acephate and Diafenthiuron.

         (12)  Residues of Flubendiamide.

         (13)  Residues of Ethephon.

         (14)  Residues of Formetanate: Sum of formetanate and its salts expressed as formetanate(hydrochloride), Prothiofos and Triforine.

         (15)  Residues of Acephate, Dicrotophos, Prothiofos, Quinalphos and Triforine.

         (16)  Reference methods: EN 1988-1:1998, EN 1988-2:1998 or ISO 5522:1981.

         (17)  Residues of Diafenthiuron, Formetanate: Sum of formetanate and its salts expressed as formetanate(hydrochloride) and Thiophanate-methyl.

         (18)  Residues of Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram) and Metrafenone.

         (19)  Residues of Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram), Phenthoate and Quinalphos.’


title: Commission Implementing Regulation (EU) No 21/2012 of 11 January 2012 entering a name in the register of protected designations of origin and protected geographical indications [Vulture (PDO)]

text:
               13.1.2012

               EN

               Official Journal of the European Union

               L 9/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 21/2012
   of 11 January 2012
   entering a name in the register of protected designations of origin and protected geographical indications [Vulture (PDO)]
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to 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), and in particular the first subparagraph of Article 7(4) thereof,
   Whereas:

               (1)

               Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Vulture’ was published in the Official Journal of the European Union
                   (2).

               (2)

               As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name contained in the Annex to this Regulation is hereby entered in the register.
   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, 11 January 2012.

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

            Member of the Commission

      (1)  OJ L 93, 31.3.2006, p. 12.

      (2)  OJ C 133, 4.5.2011, p. 13.

      ANNEX
      Agricultural products intended for human consumption listed in Annex I to the Treaty:

         Class 1.5.   Oils and fats (butter, margarine, oil, etc.)

      ITALY
      Vulture (PDO)


title: Commission Implementing Regulation (EU) No 1039/2013 of 24 October 2013 modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2 Text with EEA relevance

text:
               25.10.2013

               EN

               Official Journal of the European Union

               L 283/43

         COMMISSION IMPLEMENTING REGULATION (EU) No 1039/2013
   of 24 October 2013
   modifying the approval of nonanoic acid as an existing active substance for use in biocidal products for product-type 2
   (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 the third subparagraph of Article 89(1) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes nonanoic acid.

               (2)

               Nonanoic acid has been included into Annex I to Directive 98/8/EC for use in product-type 2 through Commission Directive 2012/41/EU (4), and is therefore considered as approved for that product-type by virtue of Article 86 of Regulation (EU) No 528/2012.

               (3)

               Furthermore, nonanoic acid has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 10, masonry preservatives, as defined in Annex V to that Directive. The evaluation covered use as an algaecide for the curative treatment of construction materials. That specific use is now covered by product-type 2 as defined in Annex V to Regulation (EU) No 528/2012.

               (4)

               Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 3 April 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (5)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

               (6)

               It appears from that report that biocidal products used as an algaecide for the curative treatment of construction materials and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

               (7)

               The existing approval of nonanoic acid for product-type 2 does not cover the conditions resulting from the evaluation of products used as an algaecide for the curative treatment of construction materials. It is therefore appropriate to complement that existing approval with those conditions. For the purpose of allowing all interested parties to prepare themselves to meet the new requirements following from the recent redefinition of biocidal product-types, it is furthermore appropriate to modify the date of approval originally provided for by Directive 2012/41/EU.

               (8)

               Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

               (9)

               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
   Nonanoic acid shall be approved as an active substance for use in biocidal products for product-type 2, subject to the specifications, the new conditions and the new date of approval 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, 24 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 167, 27.6.2012, p. 1.

      (2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

      (3)  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).

      (4)  Commission Directive No 2012/41/EU of 26 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2 (OJ L 327, 27.11.2012, p. 28).

      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 (2)

                  Nonanoic acid, Pelargonic acid

                  IUPAC Name: Nonanoic acid
                  EC No: 203-931-2
                  CAS No: 112-05-0

                  896 g/kg

                  1 October 2015

                  30 September 2025

                  2

                  The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
                  Authorisations are subject to the following conditions:

                              1.

                              Unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means, authorisation shall be subject to the following conditions:

                                          (a)

                                          Instructions for use informing on how to minimize aerosol exposure.

                                          (b)

                                          Authorisation of products for non-professional users are subject to the packaging being designed to minimise user exposure.

                              2.

                              Authorisation of products used as algaecide for outdoor remedial treatment of construction materials shall be subject to safe operating procedures and risk mitigation measures in order to protect the environment.

         (1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 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.

         (2)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm