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 controlText with EEA relevance.

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 OJ L 189, 20.7.2007, p. 1. , and in particular Article 22(1) thereof, Whereas: (1) Article 25l(3)(b) of Commission Regulation (EC) No 889/2008 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). 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 Judgment of the Court of Justice of 5 November 2015, C-137/13, ECLI:EU:C:2014:2335. , 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 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). 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 Final Report on Fertilisers (II) https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en. 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 Final report on plant protection (III) https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en.

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 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). in the wine sector Final report on Wine https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en. 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 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 , 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 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). , 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 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). , their use is authorised by that Directive, or in products regulated by Commission Directive 2006/141/EC 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).; , their use is authorised by that Directive. (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

Annex

ANNEX I

Annex

ANNEX I Fertilisers, soil conditioners and nutrients referred to in Article 3(1) and Article 6d(2) Note: Aauthorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007Bauthorised under Regulation (EC) No 834/2007 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). 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). OJ L 304, 21.11.2003, p. 1. 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). Authorisation Name Compound products or products containing only materials listed hereunder: Description, compositional requirements, conditions for useAFarmyard manure Product comprising a mixture of animal excrements and vegetable matter (animal bedding). Factory farming origin forbidden ADried farmyard manure and dehydrated poultry manureFactory farming origin forbiddenAComposted animal excrements, including poultry manure and composted farmyard manure includedFactory farming origin forbiddenALiquid animal excrements Use after controlled fermentation and/or appropriate dilution Factory farming origin forbidden BComposted 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 APeatUse limited to horticulture (market gardening, floriculture, arboriculture, nursery)AMushroom culture wastesThe initial composition of the substrate shall be limited to products of this AnnexADejecta of worms (vermicompost) and insectsAGuanoAComposted or fermented mixture of vegetable matterProduct obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas productionBBiogas 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 must not be from factory farming origin. The Processes have to be in accordance with Commission Regulation (EU) No 142/2011. 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 AProducts and by-products of plant origin for fertilisersExamples: oilseed cake meal, cocoa husks, malt culmsBHydrolysed proteins of plant originASeaweeds 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 ASawdust and wood chipsWood not chemically treated after fellingAComposted barkWood not chemically treated after fellingAWood ashFrom wood not chemically treated after fellingASoft 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 relating to fertilisers Cadmium content less than or equal to 90 mg/kg of P205 AAluminium-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) ABasic slagProducts as specified in point 1 of Annex IA.2. of Regulation 2003/2003ACrude potassium salt or kainitProducts as specified in point 1 of Annex IA.3. of Regulation 2003/2003 APotassium sulphate, possibly containing magnesium saltProduct obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium saltsAStillage and stillage extractAmmonium stillage excludedA Calcium carbonate (chalk, marl, ground limestone, Breton ameliorant, (maerl), phosphate chalk) Only of natural originAMagnesium and calcium carbonate Only of natural origin e.g. magnesian chalk, ground magnesium, limestone AMagnesium sulphate (kieserite)Only of natural originACalcium chloride solutionFoliar treatment of apple trees, after identification of deficit of calciumACalcium sulphate (gypsum) Products as specified in point 1 of Annex ID. of Regulation (EC) No 2003/2003 Only of natural origin A, BIndustrial lime from sugar productionBy-product of sugar production from sugar beet and sugar caneAIndustrial lime from vacuum salt productionBy-product of the vacuum salt production from brine found in mountainsAElemental sulphurProducts as specified in Annex ID.3 of Regulation 2003/2003ATrace elementsInorganic micronutrients listed in part E of Annex I to Regulation 2003/2003ASodium chlorideOnly mined saltAStone meal and claysBLeonardite (Raw organic sediment rich in humic acids)Only if obtained as a by-product of mining activitiesBXyliteOnly if obtained as a by-product of mining activities (e.g. by-product of brown coal mining)BChitin (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 or organic aquacultureB

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

Annex

ANNEX II

Annex

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 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). . More restrictive conditions for use for organic production are specified in the second column of each table

1. Substances of plant or animal origin Obtained from sustainable fisheries or organic aquaculture 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). NameDescription, compositional requirement, conditions for useAllium sativum (Garlic extract)Azadirachtin extracted from Azadirachta indica (Neem tree)Basic substances (including:. Lecithins, sucrose, fructose, vinegar, whey, chitosan hydrochloride, and Equisetum arvense etc.) Only those basic substances as defined by Article 23 of Regulation (EC) No 1107/2009 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. BeeswaxOnly as pruning agent/wound protectantCOS-OGAHydrolysed proteins excluding gelatineLaminarinKelp shall be either grown organically in accordance with Article 6d or harvested in a sustainable way in accordance with Article 6cPheromonesOnly in traps and dispensers.Plant oilsAll uses authorised, except herbicide.Pyrethrins extracted from Chrysanthemum cinerariaefoliumPyrethroids (only deltamethrin or lambdacyhalothrin)Only in traps with specific attractants; only against Bactrocera oleae and Ceratitis capitata WiedQuassia extracted from Quassia amaraOnly as Insecticide, repellentRepellents by smell of animal or plant origin/sheep fatOnly on non-edible parts of the crop and where crop material is not ingested by sheep or goatsSalix spp. Cortex (aka willow bark extract)
2. Micro-organisms or substances produced by micro-organisms NameDescription, compositional requirement, conditions for useMicro-organismsNot from GMO originSpinosad

1. Substances other than those mentioned in Sections 1 and 2 NameDescription, compositional requirement, conditions or restrictions to useAluminium silicate (Kaolin)Calcium hydroxideWhen used as Fungicide, only in fruit trees, including nurseries, to control Nectria galligenaCarbon dioxideCopper 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 phosphateOnly as attractant in trapsEthyleneOnly indoor uses as plant growth regulator may be authorised. Authorisations shall be limited to professional users.Fatty acidsAll uses authorised, except herbicideFerric phosphate (iron (III) orthophosphate)Preparations to be surface-spread between cultivated plantsKieselgur (diatomaceous earth)Lime sulphur (calcium polysulphide)Paraffin oilPotassium and sodium hydrogen carbonate (aka potassium/sodium bicarbonate)Quartz sandSulphur

Annex

ANNEX III

Annex

ANNEX VIIIa Products and substances authorised for use or addition in organic products of the wine sector referred to in Article 29c For the individual yeast strains: if available, derived from organic raw material. Derived from organic raw material if available. Type of treatment in accordance with Annex I A to Regulation (EC) No 606/2009Name of products or substancesSpecific conditions, restrictions within the limits and conditions set out in Regulation (EC) No 1234/2007 and Regulation (EC) No 606/2009Point 1: Use for aeration or oxygenation Air Gaseous oxygen Point 3: Centrifuging and filtration Perlite Cellulose Diatomeceous earth Use only as an inert filtering agentPoint 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 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 Plant proteins from wheat or peas Isinglass Egg white albumin Tannins Potato proteins Yeast protein extracts 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 Point 27: Addition Meta-tartaric acid Point 28: Use Acacia gum (= 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