
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, and in particular Article 22(1) thereof,
Whereas:

(1) Article 25l(3)(b) of Commission Regulation (EC) No 889/2008 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, 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 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 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 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 in the wine sector 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, 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:
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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:
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(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.
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((3)) in Article 27(1), point (f) is replaced by the following:
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(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, 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, their use is authorised by that Directive, or
— in products regulated by Commission Directive 2006/141/EC, 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:
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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 I

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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
Authorisation NameCompound 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 dilutionFactory 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 productionOnly vegetable and animal household wasteOnly when produced in a closed and monitored collection system, accepted by the Member StateMaximum 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 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

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 relating to fertilisersCadmium 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 P205Use 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 origine.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 2003/2003Only 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 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 areasWhen applicable, extraction should be done in a way to cause minimal impact on the aquatic systemOnly sediments derived from sources free from contaminations of pesticides, persistent organic pollutants and petrol like substancesMaximum 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



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ANNEX II

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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. 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, 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 originSubstances 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 
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ANNEX III

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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 
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”

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