title: Commission Implementing Regulation (EU) 2018/1254 of 19 September 2018 concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect (Text with EEA relevance.)

text:
                  20.9.2018

                  EN

                  Official Journal of the European Union

                  L 237/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1254
         of 19 September 2018
         concerning the denial of authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group of vitamins, pro-vitamins and chemically well-defined substances having similar effect
         (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 or denying such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Riboflavin (vitamin B2) was authorised without a time limit by Directive 70/524/EEC as a feed additive belonging to the group of vitamins, pro-vitamins and chemically well-defined substances having similar effect, for all animal species. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of riboflavin, with a purity of minimum 80 %, produced by the genetically modified strain Bacillus subtilis KCCM-10445, as a feed additive for all animal species. The applicant requested that the additive be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (4)

                     In 2010, in accordance with Article 7(3)(f) of Regulation (EC) No 1831/2003 and Article 3 of Commission Regulation (EC) No 378/2005 (3), the applicant sent samples of the feed additive, in a form in which the feed additive was intended to be placed on the market, to the Reference Laboratory under Regulation (EC) No 1831/2003 (‘the Reference Laboratory’). In 2013, in accordance with Article 3(3) of Regulation (EC) No 378/2005, the applicant supplied the Reference Laboratory with new samples to replace those expired.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 4 December 2013 (4) that neither the production strain nor its recombinant DNA (‘rDNA’) was detected in the final product having regard to the information provided by the applicant and that therefore, the final product did not raise any safety concern with regard to the genetic modification of the production strain. It was also concluded that the additive did not have an adverse effect on animal health, human health or the environment.

                     (6)

                     However, the Commission was informed by the Reference Laboratory that, in the context of an official control performed by a national competent authority, the presence of viable cells and of rDNA from the production strain was detected in some reference samples of the additive by a national laboratory competent for official controls. Those reference samples consisted of a first set submitted to the Reference Laboratory in 2010 together with the application for authorisation and an updated set submitted to the Reference Laboratory in 2013. Such detection resulted from the use of a polymerase chain reaction (‘PCR’) analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004 of the European Parliament and of the Council (5).

                     (7)

                     The Commission and the Reference Laboratory informed the applicant on those findings and gave him the opportunity to provide a suitable method of analysis both for the detection of rDNA and for the presence of viable cells from the production strain in order to proceed to further analysis of various samples of the additive. For that purpose, the applicant requested several laboratories, established both in China and in a Member State, to perform new analyses of the samples. The results of those analyses were negative as regards the detection of both rDNA and viable cells from the specific production strain. However, it appeared that the new analyses carried out by the applicant did not concern the samples submitted in 2010 to the Reference Laboratory.

                     (8)

                     In parallel, at the request of the Commission and the Reference Laboratory, further analyses of the samples of the additive were carried out by a national laboratory competent for official controls. On its basis, it was concluded that viable cells from the production strain were present in the samples of 2010 and that rDNA from the production strain was present in the samples of 2010 and 2013. That laboratory sent samples to another national laboratory competent for official controls for further analysis, which confirmed the presence of rDNA from the production strain in the samples of 2010 and 2013. Those results were obtained through the use of a PCR analysis method developed by a national laboratory competent for official controls in accordance with Article 11(2) of Regulation (EC) No 882/2004.

                     (9)

                     In 2015, in order to resolve the divergence of results, it was agreed between the Commission and the Reference Laboratory on one hand and the applicant on the other hand that each of them would request an independent laboratory accredited for a PCR method to perform further analysis of the additive. For that purpose, the samples of 2010 and 2013 would be used and the applicant was invited to provide, among others, samples in the form in which the additive was placed on the market at that time. It was agreed that both the analytical methods used by the applicant and by the national laboratories competent for official controls would be shared and used.

                     (10)

                     However, the applicant subsequently refused to have the samples submitted in 2010 and 2013 analysed and to provide samples corresponding to the additive placed on the market in 2015. The applicant refused to further cooperate with the Commission and the Reference Laboratory as long as a ‘unified analysis standard’ method for the detection of rDNA in riboflavin was not established under Union legislation.

                     (11)

                     Under Regulation (EC) No 1831/2003, the burden is on the applicant to adequately and sufficiently demonstrate that the additive satisfies the conditions for authorisation laid down in that Regulation, its implementing measures (6) and applicable Authority's guidance (7), in particular through the submission of relevant samples of the additive, all information related to the genetic modification of the production strain, the PCR-based method used, the protocol for extraction of the DNA and other relevant data allowing the Authority to determine the absence of rDNA or viable cells from the production strain.

                     (12)

                     On the basis of those data indicating the presence of viable cells and rDNA from the production strain in the additive, in August 2016 the Commission requested the Authority to deliver a new opinion on the safety of riboflavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 as a feed additive for all animal species.

                     (13)

                     In order to undertake its assessment, the Authority requested the applicant to provide supplementary information and data, related in particular to the method of analysis for the detection of the presence of viable cells of the production strain in the additive. Such supplementary information and data was submitted by the applicant. The Authority also requested the Reference Laboratory to provide further information and data concerning the analyses performed by the national laboratories competent for official controls, which was also furnished.

                     (14)

                     The Authority concluded in its opinion of 7 March 2018 (8) that the new data provided by the national laboratory competent for official controls show that reference samples of the additive contain viable cells and/or DNA from the production strain. The production strain Bacillus subtilis KCCM-10445 carries four antimicrobial resistance genes, three of them introduced by genetic modifications. Therefore, the Authority concluded that the additive poses a risk for the target species, consumers, users and the environment due to the potential for the spread of viable cells and DNA of a genetically modified strain-harbouring genes coding for resistance to antimicrobials of human and veterinary importance.

                     (15)

                     Consequently, it has not been established that riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 does not have an adverse effect on animal health, human health or the environment, when used as a feed additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’.

                     (16)

                     As referred to in Article 7(3)(i) of Regulation (EC) No 1831/2003, an additive falling within the scope of the Union legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms should be subject to an authorisation granted in accordance with that legislation. Such authorisation has not been granted for the genetically modified strain Bacillus subtilis KCCM-10445 detected in the additive.

                     (17)

                     The assessment of riboflavin (80 %) produced by the genetically modified strain Bacillus subtilis KCCM-10445 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are therefore not satisfied.

                     (18)

                     Accordingly, the authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, should be denied. As explained to the applicant on the occasion of exchanges with the Commission which took place after the adoption of the Authority's opinion of 7 March 2018, the denial of authorisation of the additive set out in this Implementing Regulation is without prejudice to the possibility of submitting a new application for authorisation in accordance with Regulation (EC) No 1831/2003.

                     (19)

                     Therefore, the additive riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 and feed containing it should be withdrawn from the market as soon as possible. For practical reasons, however, a limited period should be allowed for the withdrawal from the market of the existing stocks of the additive and feed containing riboflavin (80 %) produced by Bacillus subtilis KCCM-10445, in order to enable operators to comply properly with the withdrawal obligation while taking into account legitimate factors relevant to the matter under consideration.

                     (20)

                     In particular, as riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 represents a significant part of the Union market concerning riboflavin to be used in feed, any risk of adverse effects on animal health or welfare due to an undersupply of animals with riboflavin should be avoided by providing the operators sufficient time to adapt to the situation.

                     (21)

                     In addition, the time and resources needed to retrieve and withdraw from the market premixtures containing the additive riboflavin (80 %) produced by Bacillus subtilis KCCM-10445, and further down in the feed chain feed materials and compound feed produced with that additive or those premixtures, should be considered. Such practical constraints for withdrawing the products from the market are even more acute for feed intended for non-food producing animals, as this type of feed usually involves higher inclusion rates of riboflavin, longer shelf life and more complex destruction methods. Therefore, the time periods for the withdrawal from the market of the respective feed products concerned should be provided accordingly.

                     (22)

                     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
            Denial of authorisation
            The authorisation of riboflavin (80 %) produced by Bacillus subtilis KCCM-10445 as a feed additive belonging to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ (‘the additive’) is denied.

            Article 2
            Withdrawal from the market

               1.   Existing stocks of the additive referred to in Article 1 shall be withdrawn from the market by 10 November 2018.

               2.   Existing stocks of premixtures produced with the additive referred to in paragraph 1 shall be withdrawn from the market by 10 January 2019.

               3.   Feed materials and compound feed intended for food-producing animals, which have been produced with the additive referred to in paragraph 1 or with premixtures referred to in paragraph 2 before 10 January 2019 shall be withdrawn from the market by 10 April 2019.

               4.   Feed materials and compound feed intended for non-food producing animals, which have been produced with the additive referred to in paragraph 1 or with premixtures referred to in paragraph 2 before 10 January 2019 shall be withdrawn from the market by 10 July 2019.

            Article 3
            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, 19 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

            (3)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8).

            (4)  EFSA Journal 2014;12(1):3531.

            (5)  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 (OJ L 165, 30.4.2004, p. 1).

            (6)  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

            (7)  In particular, Guidance for the preparation of dossiers for nutritional additives (EFSA Journal 2012;10(1):2535) and Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (EFSA Journal 2011;9(6):2193).

            (8)  EFSA Journal 2018;16(3):5223.


title: Commission Implementing Regulation (EU) 2018/1278 of 21 September 2018 approving the low-risk active substance Pasteuria nishizawae Pn1 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  24.9.2018

                  EN

                  Official Journal of the European Union

                  L 239/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1278
         of 21 September 2018
         approving the low-risk active substance Pasteuria nishizawae Pn1 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 22 in conjunction with Article 13(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Syngenta Crop Protection AG submitted to Denmark on 27 February 2015 an application for the approval of the active substance Pasteuria nishizawae Pn1.

                     (2)

                     In accordance with Article 9(3) of that Regulation, Denmark, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 3 July 2015.

                     (3)

                     On 19 December 2016, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested on 23 May 2017 that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 17 October 2017.

                     (5)

                     On 11 January 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Pasteuria nishizawae Pn1 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                     (6)

                     On 11 March 2018, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Pasteuria nishizawae Pn1 and a draft Regulation providing that Pasteuria nishizawae Pn1 is approved.

                     (7)

                     The applicant was given the possibility to submit comments on the review report.

                     (8)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to approve Pasteuria nishizawae Pn1.

                     (9)

                     The Commission further considers that Pasteuria nishizawae Pn1 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Pasteuria nishizawae Pn1 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Pasteuria nishizawae Pn1 is a wild-type strain of a micro-organism naturally occurring in the environment. It is an obligate parasite of cyst nematodes. Pasteuria nishizawae Pn1 spores only germinate when in contact with a cyst nematode. Infectivity to any other organism, including humans and immunocompromised patients can be excluded. Therefore as the micro-organism cannot develop outside the obligate host, its resistance to antimicrobials used in human or veterinary medicines can be excluded: the criterion set in point 5.2.1 of Annex II of Regulation (EC) No 1107/2009 is considered fulfilled.

                     (10)

                     It is therefore appropriate to approve Pasteuria nishizawae Pn1 for a period of 15 years.

                     (11)

                     In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain generic conditions as Pasteuria nishizawae Pn1 is a micro-organism.

                     (12)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

                     (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
            Approval of active substance
            The active substance Pasteuria nishizawae Pn1, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            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, 21 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance Pasteuria nishizawae Pn1. EFSA Journal 2018;16(1):5159, 19 pp. doi:10.2903/j.efsa.2018.5159.

            (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                           Pasteuria nishizawae Pn1
                        Culture collection: ATCC Safe Deposit (SD-5833)
                        CIPAC No
                        Not allocated

                        Not applicable

                        minimum concentration 1 × 1011 spores/g

                        14 October 2018

                        14 October 2033

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pasteuria nishizawae Pn1, and in particular, Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
                        Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.

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

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

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘13

                              Pasteuria nishizawae Pn1
                           Culture collection: ATCC Safe Deposit (SD-5833)
                           CIPAC No
                           Not allocated

                           Not applicable

                           minimum concentration 1 × 1011 spores/g

                           14 October 2018

                           14 October 2033

                           For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pasteuria nishizawae Pn1, and in particular Appendices I and II thereof, shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.
                           Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.’

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


title: Commission Implementing Regulation (EU) 2018/1584 of 22 October 2018 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (Text with EEA relevance.)

text:
                  23.10.2018

                  EN

                  Official Journal of the European Union

                  L 264/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1584
         of 22 October 2018
         amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (1), and in particular Article 22(1) thereof,
         Whereas:

                     (1)

                     Article 25l(3)(b) of Commission Regulation (EC) No 889/2008 (2) allows to supplement natural feed in the grow-out stage of penaeid shrimps and freshwater prawns (Macrobrachium spp.) as referred to in Section 7 of Annex XIIIa to that Regulation. For those shrimps and prawns in earlier life stages in nurseries and hatcheries supplementation of feed, in particular the need for cholesterol, is essential for their development. It is therefore necessary to extend the supplementation of feed with cholesterol to those shrimps and prawns also in their earlier life stages.

                     (2)

                     In accordance with Article 27(1)(f) of Regulation (EC) No 889/2008 minerals (trace elements included), vitamins, amino acids and micronutrients can be used in the processing of organic food only as far as their use is legally required in the foodstuffs in which they are incorporated. According to the judgment of the Court of Justice of the European Union in case C-137/13 (3), the use of these substances in the processing of organic food is legally required only when a provision of Union law or a provision of national law compatible therewith directly requires that that substance be added to a foodstuff in order for that foodstuff to be placed on the market.

                     (3)

                     Regulation (EU) 2018/848 of the European Parliament and of the Council (4) will allow the use of minerals (trace elements included), vitamins, amino acids or micronutrients in organic infant formula and follow-on formula and processed organic cereal-based foods and baby food when their use is authorised by the relevant Union legislation. In order to avoid a gap between the current interpretation of the use of these substances in foods for infants and young children and to ensure consistency with the upcoming organic legislation it is appropriate to allow their use in the production of organic baby foods for infants and young children.

                     (4)

                     Article 42 of Regulation (EC) No 889/2008 allows, under certain conditions and when organic reared pullets are not available, for non-organically reared pullets for egg production of not more than 18 weeks to be brought into an organic livestock unit until 31 December 2018.

                     (5)

                     Production of organically reared pullets for egg production is not sufficiently available, both in terms of quality and quantity, on the Union market to meet the needs of laying hen farmers. In order to allow more time for the production of organically reared pullets for egg production and to establish detailed rules for the production of organically reared pullets, the period of application of the exceptional production rules for non-organically reared pullets for egg production of not more than 18 weeks should be extended until 31 December 2020.

                     (6)

                     Article 43 of Regulation (EC) No 889/2008 allows the use of a maximum of 5 % of non-organic protein feed for porcine and poultry species per period of 12 months for the calendar year 2018.

                     (7)

                     Organic protein supply is not sufficiently available, both in terms of quality and quantity, on the Union market to meet the nutritional requirements of pigs and poultry raised on organic farms. The production of organic protein crops is still lagging behind demand. It is therefore appropriate to extend the period in which it is allowed to use a limited proportion of non-organic protein feed for porcine and poultry species until 31 December 2020.

                     (8)

                     Article 30(2) of Regulation (EC) No 834/2007 provides for the communication of information related to irregularities or infringements affecting the organic status of a product. Experience shows that the current tools to communicate information in case a Member State finds irregularities or infringements with regard to a product coming from that Member State need to be improved. To enhance efficiency and effectiveness, such communications should take place via the system referred to in Article 94(1) of Regulation (EC) No 889/2008.

                     (9)

                     In accordance with the procedure set out in Article 16(3) of Regulation (EC) No 834/2007, several Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II and VIIIa to Regulation (EC) No 889/2008. Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (EGTOP) and the Commission.

                     (10)

                     In its recommendations with regard to fertilisers (5) EGTOP concluded, inter alia, that the substances ‘industrial lime from sugar production’ on the basis of sugar cane and ‘xylite’ comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex I to Regulation (EC) No 889/2008.

                     (11)

                     In its recommendations with regard to plant protection products (6) EGTOP concluded, inter alia, that the substances ‘Allium sativum (garlic extract)’, ‘COS-OGA’, ‘Salix spp. Cortex (aka willow bark extract)’ and ‘sodium hydrogen carbonate’ comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex II to Regulation (EC) No 889/2008.

                     (12)

                     In its recommendations with regard to products and substances used or added in organic products during certain stages of the production process and as type of treatment in accordance with Annex I A to Commission Regulation (EC) No 606/2009 (7) in the wine sector (8) EGTOP concluded, inter alia, that the substances ‘potato proteins’, ‘yeast protein extracts’ and ‘Chitosan derived from Aspergillus niger’ for clarification (point 10 of Annex I A to Regulation (EC) No 606/2009), ‘inactivated yeast, autolysates of yeast and yeast hulls’ for addition (point 15 of that Annex), ‘yeast mannoproteins’, and ‘Chitosan derived from Aspergillus niger’ for use (points 6, 35 and 44 of that Annex) comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex VIIIa to Regulation (EC) No 889/2008.

                     (13)

                     In its recommendations with regard to products for cleaning and disinfecting (9), EGTOP concluded, inter alia, that sodium hydroxide should also be available for organic beekeeping.

                     (14)

                     Regulation (EC) No 889/2008 should therefore be amended accordingly.

                     (15)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee on Organic Production,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Regulation (EC) No 889/2008 is amended as follows:

                        (1)

                        in Article 25, paragraph 1 is replaced by the following:

                           ‘1.   For the purpose of cleaning and disinfection of frames, hives and combs, sodium hydroxide may be used.
                           For the purpose of protecting frames, hives and combs, in particular from pests, only rodenticides (to be used only in traps), and appropriate products listed in Annex II, are permitted.’;

                        (2)

                        in Article 25l(3), point (b) is replaced by the following:

                                    ‘(b)

                                    the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) referred to in Section 7 of Annex XIIIa may comprise a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries. In order to secure the quantitative dietary needs of those shrimps and prawns, organic cholesterol may be used to supplement their diets. Where organic cholesterol is not available, non-organic cholesterol derived from wool, shellfish or other sources may be used. The option to supplement their diet with cholesterol applies both in the grow-out stage and in earlier life stages in nurseries and hatcheries.’;

                        (3)

                        in Article 27(1), point (f) is replaced by the following:

                                    ‘(f)

                                    minerals (trace elements included), vitamins, amino acids and micronutrients, provided that:

                                                (i)

                                                their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or

                                                (ii)

                                                as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers:

                                                            —

                                                            in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council (*1), their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned,

                                                            —

                                                            in products regulated by Commission Directive 2006/125/EC (*2), their use is authorised by that Directive, or

                                                            —

                                                            in products regulated by Commission Directive 2006/141/EC (*3), their use is authorised by that Directive.

                           (*1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35)."

                           (*2)  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)."

                           (*3)  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).’;"

                        (4)

                        in Article 42(b), the date ‘31 December 2018’ is replaced by ‘31 December 2020’;

                        (5)

                        in Article 43, the second subparagraph is replaced by the following:
                        ‘The maximum percentage of non-organic protein feed authorised per period of 12 months for those species shall be 5 % for calendar years 2018, 2019 and 2020.’;

                        (6)

                        in Article 92a, the following paragraph 1a is inserted:

                           ‘1a.   Where a Member State finds irregularities or infringements relating to the application of this Regulation with regard to a product coming from that Member State and bearing indications as referred to in Title IV of Regulation (EC) No 834/2007 and in Title III of this Regulation or in Annex XI to this Regulation, and if such irregularities or infringements have implications for one or more other Member States, it shall notify the Member State or States concerned, the other Member States and the Commission without delay via the system referred to in Article 94(1) of this Regulation.’;

                        (7)

                        Annex I is replaced by the text set out in Annex I to this Regulation;

                        (8)

                        Annex II is replaced by the text set out in Annex II to this Regulation;

                        (9)

                        Annex VIIIa is replaced by the text set out in Annex III to this Regulation.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 189, 20.7.2007, p. 1.

            (2)  Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).

            (3)  Judgment of the Court of Justice of 5 November 2015, C-137/13, ECLI:EU:C:2014:2335.

            (4)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

            (5)  Final Report on Fertilisers (II) https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en.

            (6)  Final report on plant protection (III) https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en.

            (7)  Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1).

            (8)  Final report on Wine https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en.

            (9)  Final report on cleaning and disinfecting https://ec.europa.eu/agriculture/organic/sites/orgfarming/files/docs/body/final_report_egtop_on_cleaning_disinfection_en.pdf

            ANNEX I
            ‘

                     ANNEX I

                        Fertilisers, soil conditioners and nutrients referred to in Article 3(1) and Article 6d(2)

                        Note:

                                 A

                                 :

                                 authorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007

                                 B

                                 :

                                 authorised under Regulation (EC) No 834/2007

                                 Authorisation

                                 Name
                                 Compound products or products containing only materials listed hereunder:

                                 Description, compositional requirements, conditions for use

                                 A

                                 Farmyard manure

                                 Product comprising a mixture of animal excrements and vegetable matter (animal bedding).
                                 Factory farming origin forbidden

                                 A

                                 Dried farmyard manure and dehydrated poultry manure

                                 Factory farming origin forbidden

                                 A

                                 Composted animal excrements, including poultry manure and composted farmyard manure included

                                 Factory farming origin forbidden

                                 A

                                 Liquid animal excrements

                                 Use after controlled fermentation and/or appropriate dilution
                                 Factory farming origin forbidden

                                 B

                                 Composted or fermented mixture of household waste

                                 Product obtained from source separated household waste, which has been submitted to composting or to anaerobic fermentation for biogas production
                                 Only vegetable and animal household waste
                                 Only when produced in a closed and monitored collection system, accepted by the Member State
                                 Maximum concentrations in mg/kg of dry matter:
                                 cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable

                                 A

                                 Peat

                                 Use limited to horticulture (market gardening, floriculture, arboriculture, nursery)

                                 A

                                 Mushroom culture wastes

                                 The initial composition of the substrate shall be limited to products of this Annex

                                 A

                                 Dejecta of worms (vermicompost) and insects

                                 A

                                 Guano

                                 A

                                 Composted or fermented mixture of vegetable matter

                                 Product obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production

                                 B

                                 Biogas digestate containing animal by-products co-digested with material of plant or animal origin as listed in this Annex

                                 Animal by-products (including by-products of wild animals) of category 3 and digestive tract content of category 2 (categories 2 and 3 as defined in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1) must not be from factory farming origin.
                                 The Processes have to be in accordance with Commission Regulation (EU) No 142/2011 (2).
                                 Not to be applied to edible parts of the crop

                                 B

                                 Products or by-products of animal origin as below:

                                             Blood meal

                                             Hoof meal

                                             Horn meal

                                             Bone meal or degelatinised bone meal

                                             Fish meal

                                             Meat meal

                                             Feather, hair and “chiquette” meal

                                             Wool

                                             Fur (1)

                                             Hair

                                             Dairy products

                                             Hydrolysed proteins (2)

                                             (1)

                                             Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable

                                             (2)

                                             Not to be applied to edible parts of the crop

                                 A

                                 Products and by-products of plant origin for fertilisers

                                 Examples: oilseed cake meal, cocoa husks, malt culms

                                 B

                                 Hydrolysed proteins of plant origin

                                 A

                                 Seaweeds and seaweed products

                                 As far as directly obtained by:

                                             (i)

                                             physical processes including dehydration, freezing and grinding

                                             (ii)

                                             extraction with water or aqueous acid and/or alkaline solution

                                             (iii)

                                             fermentation

                                 A

                                 Sawdust and wood chips

                                 Wood not chemically treated after felling

                                 A

                                 Composted bark

                                 Wood not chemically treated after felling

                                 A

                                 Wood ash

                                 From wood not chemically treated after felling

                                 A

                                 Soft ground rock phosphate

                                 Product as specified in point 7 of Annex IA.2. to Regulation (EC) No 2003/2003 of the European Parliament and of the Council (3) relating to fertilisers
                                 Cadmium content less than or equal to 90 mg/kg of P205

                                 A

                                 Aluminium-calcium phosphate

                                 Product as specified in point 6 of Annex IA.2. of Regulation (EC) No 2003/2003,
                                 Cadmium content less than or equal to 90 mg/kg of P205
                                 Use limited to basic soils (pH > 7,5)

                                 A

                                 Basic slag

                                 Products as specified in point 1 of Annex IA.2. of Regulation 2003/2003

                                 A

                                 Crude potassium salt or kainit

                                 Products as specified in point 1 of Annex IA.3. of Regulation 2003/2003

                                 A

                                 Potassium sulphate, possibly containing magnesium salt

                                 Product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts

                                 A

                                 Stillage and stillage extract

                                 Ammonium stillage excluded

                                 A

                                 Calcium carbonate
                                 (chalk, marl, ground limestone, Breton ameliorant, (maerl), phosphate chalk)

                                 Only of natural origin

                                 A

                                 Magnesium and calcium carbonate

                                 Only of natural origin
                                 e.g. magnesian chalk, ground magnesium, limestone

                                 A

                                 Magnesium sulphate (kieserite)

                                 Only of natural origin

                                 A

                                 Calcium chloride solution

                                 Foliar treatment of apple trees, after identification of deficit of calcium

                                 A

                                 Calcium sulphate (gypsum)

                                 Products as specified in point 1 of Annex ID. of Regulation (EC) No 2003/2003
                                 Only of natural origin

                                 A, B

                                 Industrial lime from sugar production

                                 By-product of sugar production from sugar beet and sugar cane

                                 A

                                 Industrial lime from vacuum salt production

                                 By-product of the vacuum salt production from brine found in mountains

                                 A

                                 Elemental sulphur

                                 Products as specified in Annex ID.3 of Regulation 2003/2003

                                 A

                                 Trace elements

                                 Inorganic micronutrients listed in part E of Annex I to Regulation 2003/2003

                                 A

                                 Sodium chloride

                                 Only mined salt

                                 A

                                 Stone meal and clays

                                 B

                                 Leonardite (Raw organic sediment rich in humic acids)

                                 Only if obtained as a by-product of mining activities

                                 B

                                 Xylite

                                 Only if obtained as a by-product of mining activities (e.g. by-product of brown coal mining)

                                 B

                                 Chitin (Polysaccharide obtained from the shell of crustaceans)

                                 Only if obtained from sustainable fisheries, as defined in Article 3(e) of Council Regulation (EC) No 2371/2002 (4) or organic aquaculture

                                 B

                                 Organic rich sediment from fresh water bodies formed under exclusion of oxygen
                                 (e.g. sapropel)

                                 Only organic sediments that are by-products of fresh water body management or extracted from former freshwater areas
                                 When applicable, extraction should be done in a way to cause minimal impact on the aquatic system
                                 Only sediments derived from sources free from contaminations of pesticides, persistent organic pollutants and petrol like substances
                                 Maximum concentrations in mg/kg of dry matter:
                                 cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable

               ’

               (1)  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).

               (2)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

               (3)  OJ L 304, 21.11.2003, p. 1.

               (4)  Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (OJ L 358, 31.12.2002, p. 59).

            ANNEX II
            ‘

                     ANNEX II

                        Pesticides — Plant protection products referred to in Article 5(1)

                     All the substances listed in this Annex have to comply at least with the conditions for use as specified in the Annex to Implementing Regulation (EU) No 540/2011 (1). More restrictive conditions for use for organic production are specified in the second column of each table
                     1.   Substances of plant or animal origin

                                 Name

                                 Description, compositional requirement, conditions for use

                                 Allium sativum (Garlic extract)

                                 Azadirachtin extracted from Azadirachta indica (Neem tree)

                                 Basic substances (including:. Lecithins, sucrose, fructose, vinegar, whey, chitosan hydrochloride (2), and Equisetum arvense etc.)

                                 Only those basic substances as defined by Article 23 of Regulation (EC) No 1107/2009 (3) which are food as defined in Article 2 of Regulation (EC) No 178/2002 and have plant or animal origin
                                 Substances not to be used as herbicides, but only for the control of pests and diseases.

                                 Beeswax

                                 Only as pruning agent/wound protectant

                                 COS-OGA

                                 Hydrolysed proteins excluding gelatine

                                 Laminarin

                                 Kelp shall be either grown organically in accordance with Article 6d or harvested in a sustainable way in accordance with Article 6c

                                 Pheromones

                                 Only in traps and dispensers.

                                 Plant oils

                                 All uses authorised, except herbicide.

                                 Pyrethrins extracted from Chrysanthemum cinerariaefolium

                                 Pyrethroids (only deltamethrin or lambdacyhalothrin)

                                 Only in traps with specific attractants; only against Bactrocera oleae and Ceratitis capitata Wied

                                 Quassia extracted from Quassia amara

                                 Only as Insecticide, repellent

                                 Repellents by smell of animal or plant origin/sheep fat

                                 Only on non-edible parts of the crop and where crop material is not ingested by sheep or goats

                                    Salix spp. Cortex (aka willow bark extract)

                           2.   Micro-organisms or substances produced by micro-organisms

                                 Name

                                 Description, compositional requirement, conditions for use

                                 Micro-organisms

                                 Not from GMO origin

                                 Spinosad

                           3.   Substances other than those mentioned in Sections 1 and 2

                                 Name

                                 Description, compositional requirement, conditions or restrictions to use

                                 Aluminium silicate (Kaolin)

                                 Calcium hydroxide

                                 When used as Fungicide, only in fruit trees, including nurseries, to control Nectria galligena

                                 Carbon dioxide

                                 Copper compounds in the form of: copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture, and tribasic copper sulphate

                                 Up to 6 kg copper per ha per year.
                                 For perennial crops, Member States may, by derogation from the previous paragraph, provide that the 6 kg copper limit can be exceeded in a given year provided that the average quantity actually used over a 5-year period consisting of that year and of the four preceding years does not exceed 6 kg.

                                 Diammonium phosphate

                                 Only as attractant in traps

                                 Ethylene

                                 Only indoor uses as plant growth regulator may be authorised. Authorisations shall be limited to professional users.

                                 Fatty acids

                                 All uses authorised, except herbicide

                                 Ferric phosphate (iron (III) orthophosphate)

                                 Preparations to be surface-spread between cultivated plants

                                 Kieselgur (diatomaceous earth)

                                 Lime sulphur (calcium polysulphide)

                                 Paraffin oil

                                 Potassium and sodium hydrogen carbonate (aka potassium/sodium bicarbonate)

                                 Quartz sand

                                 Sulphur

               ’

               (1)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

               (2)  Obtained from sustainable fisheries or organic aquaculture

               (3)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1).

            ANNEX III
            ‘

                     ANNEX VIIIa

                        Products and substances authorised for use or addition in organic products of the wine sector referred to in Article 29c

                                 Type of treatment in accordance with Annex I A to Regulation (EC) No 606/2009

                                 Name of products or substances

                                 Specific conditions, restrictions within the limits and conditions set out in Regulation (EC) No 1234/2007 and Regulation (EC) No 606/2009

                                 Point 1: Use for aeration or oxygenation

                                             —

                                             Air

                                             —

                                             Gaseous oxygen

                                 Point 3: Centrifuging and filtration

                                             —

                                             Perlite

                                             —

                                             Cellulose

                                             —

                                             Diatomeceous earth

                                 Use only as an inert filtering agent

                                 Point 4: Use in order to create an inert atmosphere and to handle the product shielded from the air

                                             —

                                             Nitrogen

                                             —

                                             Carbon dioxide

                                             —

                                             Argon

                                 Points 5, 15 and 21: Use

                                             —

                                             Yeasts (1)

                                 Point 6: Use

                                             —

                                             Di-ammonium phosphate

                                             —

                                             Thiamine hydrochloride

                                             —

                                             Inactivated yeast, autolysates of yeast and yeast hulls

                                 Point 7: Use

                                             —

                                             Sulphur dioxide

                                             —

                                             Potassium bisulphite or potassium metabisulphite

                                             (a)

                                             The maximum sulphur dioxide content shall not exceed 100 milligrams per litre for red wines as referred to in point 1(a) of Part A of Annex I B to Regulation (EC) No 606/2009 and with a residual sugar level lower than 2 grams per litre;

                                             (b)

                                             The maximum sulphur dioxide content shall not exceed 150 milligrams per litre for white and rosé wines as referred to in point 1(b) of Part A of Annex I B to Regulation (EC) No 606/2009 and with a residual sugar level lower than 2 grams per litre;

                                             (c)

                                             For all other wines, the maximum sulphur dioxide content applied in accordance with Annex I B to Regulation (EC) No 606/2009 on 1 August 2010, shall be reduced by 30 milligrams per litre.

                                 Point 9: Use

                                             —

                                             Charcoal for oenological use

                                 Point 10: Clarification

                                             —

                                             Edible gelatine (2)

                                             —

                                             Plant proteins from wheat or peas (2)

                                             —

                                             Isinglass (2)

                                             —

                                             Egg white albumin (2)

                                             —

                                             Tannins (2)

                                             —

                                             Potato proteins (2)

                                             —

                                             Yeast protein extracts (2)

                                             —

                                             Casein

                                             —

                                             Chitosan derived from Aspergillus niger

                                             —

                                             Potassium caseinate

                                             —

                                             Silicon dioxide

                                             —

                                             Bentonite

                                             —

                                             Pectolytic enzymes

                                 Point 12: Use for acidification purposes

                                             —

                                             Lactic acid

                                             —

                                             L(+)Tartaric acid

                                 Point 13: Use for deacidification purposes

                                             —

                                             L(+)Tartaric acid

                                             —

                                             Calcium carbonate

                                             —

                                             Neutral potassium tartrate

                                             —

                                             Potassium bicarbonate

                                 Point 14: Addition

                                             —

                                             Aleppo pine resin

                                 Point 17: Use

                                             —

                                             Lactic bacteria

                                 Point 19: Addition

                                             —

                                             L-Ascorbic acid

                                 Point 22: Use for bubbling

                                             —

                                             Nitrogen

                                 Point 23: Addition

                                             —

                                             Carbon dioxide

                                 Point 24: Addition for wine stabilisation purposes

                                             —

                                             Citric acid

                                 Point 25: Addition

                                             —

                                             Tannins (2)

                                 Point 27: Addition

                                             —

                                             Meta-tartaric acid

                                 Point 28: Use

                                             —

                                             Acacia gum (2) (= gum arabic)

                                 Point 30: Use

                                             —

                                             Potassium bitartrate

                                 Point 31: Use

                                             —

                                             Cupric citrate

                                 Point 31: Use

                                             —

                                             Copper sulphate

                                 Point 35: Use

                                             —

                                             Yeast mannoproteins

                                 Point 38: Use

                                             —

                                             Oak chips

                                 Point 39: Use

                                             —

                                             Potassium alginate

                                 Point 44: Use

                                             —

                                             Chitosan derived from Aspergillus niger

                                 Point 51: Use

                                             —

                                             Inactivated yeast

                                 Type of treatment in accordance with Annex III, point A(2)(b) to Regulation (EC) No 606/2009

                                             —

                                             Calcium sulphate

                                 Only for “vino generoso” or “vino generoso de licor”

               ’

               (1)  For the individual yeast strains: if available, derived from organic raw material.

               (2)  Derived from organic raw material if available.


title: Commission Implementing Regulation (EU) 2018/1585 of 22 October 2018 establishing a derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from coast and the minimum sea depth for purse seines fishing in territorial waters of Croatia

text:
                  23.10.2018

                  EN

                  Official Journal of the European Union

                  L 264/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1585
         of 22 October 2018
         establishing a derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from coast and the minimum sea depth for purse seines fishing in territorial waters of Croatia
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea (1), and in particular Article 13(5) thereof,
         Whereas:

                     (1)

                     Article 13(3) of Regulation (EC) No 1967/2006 prohibits the use of purse seines within 300 metres of the coast or within the 50 m isobath where that depth is reached at a shorter distance from the coast.

                     (2)

                     At the request of a Member State, the Commission may allow a derogation from Article 13(3) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 13(5) and (9) are fulfilled.

                     (3)

                     On 20 June 2016 the Commission received a request from Croatia for a derogation from Article 13(3) of that Regulation, for the use of traditional purse seine ‘ciplarica’ fishing for mullets (Mugilidae), traditional purse seine ‘palamidara’ fishing for bonito (Sarda sarda), bullet tuna (Auxis rochei), little tunny (Euthynnus alletteratus) and greater amberjack (Seriola dumerili), traditional purse seine ‘oližnica’ fishing for sand smelt (Atherina boyeri) and traditional purse seine ‘igličara’ fishing for needle fish (Belone belone) within territorial Croatian waters.

                     (4)

                     The request concerns fishing activities already authorised by Croatia and covers vessels and gears which have a track record in the fishery of more than five years and operate under the management plan implemented by Croatia by Ministerial Ordinance (2) in accordance with Article 19(2) of Regulation (EC) No 1967/2006 on 30 March 2018 (‘Croatian management plan’).

                     (5)

                     The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the derogation requested by Croatia and the related management plan in April 2016, July 2016, October 2016 and March 2017. STECF highlighted need for clarifications on fishing gears used, bycatches, monitoring and scientific data. Croatia provided adequate clarifications to the Commission and revised accordingly the management plan by introducing additional measures on control, fleet management, data collection and monitoring.

                     (6)

                     The derogation requested by Croatia complies with the conditions set out in Article 13(5) and (9) of Regulation (EC) No 1967/2006.

                     (7)

                     In particular, there are specific geographical constraints given both the distinct morphological structure of Croatia, comprising of long coastline including numerous islands and the spatial distribution of the target species, which is exclusively limited in certain specific sites and zones in the coastal areas at depths of less than 50 meters. The fishing grounds are therefore limited.

                     (8)

                     The fishery cannot be undertaken with other gears, since only purse seines have the technical characteristic necessary to carry out this type of fishery.

                     (9)

                     Moreover, the fishery has no significant impact on the marine environment, as purse seines are very selective gears, they do not touch the seabed and cannot operate above the Posidonia oceanica seabed.

                     (10)

                     The request covers 52 vessels. The derogation requested by Croatia therefore affects a limited number of vessels, compared with the large distribution area of the purse seine fleet, representing less than 1 % of the entire Croatian fleet and 16 825,84 gross tonnage (GT).

                     (11)

                     Those vessels are included on a list communicated to the Commission in accordance with Article 13(9) of Regulation (EC) No 1967/2006.

                     (12)

                     The Croatian the management plan sets out all relevant definitions on the fisheries concerned and guarantees no further increase of the fishing effort in accordance with Article 13(9) of Regulation (EC) No 1967/2006 as fishing authorisations will be issued only to specified 52 vessels that are authorised to fish by Croatia. In this respect it is noted that in line with the Croatian management plan and the Ministerial Ordinance, use of purse seine ‘oližnica’ is permitted only in the fishing grounds in the area between Cape Lako and Cape Crna Punta and in the fishing subzones stated as ‘E4’ and ‘F2’, whereas for all traditional purse seines (‘ciplarica’, ‘palamidara’, ‘igličara’ and ‘oližnica’) fishing grounds exclude areas identified as national parks and special habitats, where fishing is strictly prohibited, which is the case for the area south-east from Cape St Peter.

                     (13)

                     The fishing activities concerned fulfil the requirements of Article 4 of Regulation (EC) No 1967/2006 which prohibits fishing above those habitats. Indeed, the seines are hauled in the water column and do not touch the seabed.

                     (14)

                     The requirements of Article 8(1)(h) of Regulation (EC) No 1967/2006 are not applicable since they relate to trawlers.

                     (15)

                     As regards the requirement to comply with Article 9(3) establishing the minimum mesh size, the Commission notes that in accordance with Article 9(7) of Regulation (EC) No 1967/2006, such derogation is not possible for purse seines. The Commission notes that Croatia did not authorise derogation from these provisions in its management plan.

                     (16)

                     The fishing activities concerned take place at a very short distance from the coast and therefore do not interfere with the activities of other vessels.

                     (17)

                     The management plan ensures that catches of species mentioned in Annex III of Regulation (EC) No 1967/2006 are minimal since the targeted species are mullets (Mugilidae), bonito (Sarda sarda), bullet tuna (Auxis rochei), little tunny (Euthynnus alletteratus), greater amberjack (Seriola dumerili), sand smelt (Atherina boyeri) and needle fish (Belone belone) which are not mentioned in Annex III of the Regulation (EC) No 1967/2006.

                     (18)

                     Fishing activities are highly selective and do not target cephalopods.

                     (19)

                     The management plan includes measures for the monitoring of fishing activities, thus fulfilling the conditions set out in Article 14 of Council Regulation (EC) No 1224/2009 (3).

                     (20)

                     The Croatian management plan includes measures for the monitoring of fishing activities, as provided for in the third subparagraph of Article 13(9) of Regulation (EC) No 1967/2006.

                     (21)

                     Consequently, the requested derogation should be granted.

                     (22)

                     Croatia should report to the Commission in regular intervals and in accordance with the monitoring plan provided for in the Croatian management plan.

                     (23)

                     A limitation in duration of the derogation will allow ensuring prompt corrective management measures in case the report to the Commission shows a poor conservation status of the exploited stock, while providing scope to enhance the scientific basis for an improved management plan.

                     (24)

                     The measures provided for in the Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Derogation

               1.   Article 13(3), first paragraph of Regulation (EC) No 1967/2006, shall not apply in the territorial waters of Croatia to the following fisheries:

                           (a)

                           mullets (Mugilidae) by purse seine ‘ciplarica’;

                           (b)

                           bonito (Sarda sarda), bullet tuna (Auxis rochei), little tunny (Euthynnus alletteratus), greater amberjack (Seriola dumerili) by purse seine ‘palamidara’;

                           (c)

                           sand smelt (Atherina boyeri) by purse seine ‘oližnica’; and

                           (d)

                           needle fish (Belone belone) by purse seine ‘igličara’.

               2.   The purse seines referred in paragraph 1 shall be used by vessels:

                           (a)

                           bearing a registration number set out in the Croatian management plan adopted by Croatia in accordance with Article 19 of Regulation (EC) No 1967/2006;

                           (b)

                           having a track record in the fishery for more than five years and not involving any future increase in the fishing effort deployed; and

                           (c)

                           holding a fishing authorisation and operating under the Croatian management plan.

            Article 2
            Monitoring plan and report
            Croatia shall communicate to the Commission, within three years following the entry into force of this Regulation, a report drawn up in accordance with the monitoring plan established in the Croatian management plan.

            Article 3
            Entry into force
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 26 October 2018 to 26 October 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 36, 8.2.2007, p. 6.

            (2)  Pravilnik o obavljanju gospodarskog ribolova na moru okružujućim mrežama plivaricom palamidarom, plivaricom ciplaricom, plivaricom lokardarom, plivaricom igličarom i plivaricom oližnicom, Narodne Novine, OJ 30/2018, as amended by Pravilnik o izmjenama Pravilnika o obavljanju gospodarskog ribolova na moru okružujućim mrežama plivaricom palamidarom, plivaricom ciplaricom, plivaricom lokardarom, plivaricom igličarom i plivaricom oližnicom, OJ 49/2018 and by Pravilnik o izmjenama i dopuni Pravilnika o obavljanju gospodarskog ribolova na moru okružujućim mrežama plivaricom palamidarom, plivaricom ciplaricom, plivaricom lokardarom, plivaricom igličarom i plivaricom oližnicom, OJ 62/2018

            (3)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).