http://www.legislation.gov.uk/id/eur/2016/673

Commission Implementing Regulation (EU) 2016/673

of 29 April 2016

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 2092/911, and in particular Article 13(3), Article 16(1) and (3)(a) and Articles 19(3), 20(3), 21(2), 22(1) and 38(a), thereof,

Whereas:

(1)

Seaweeds and other algae are covered by Chapter 12 of the Brussels nomenclature, which is listed in Annex I to the Treaty. Seaweeds and other algae are therefore agricultural products falling within point (a) of the first subparagraph of Article 1(2) of Regulation (EC) No 834/2007. Since ‘other algae’ includes ‘micro-algae’, micro-algae are covered by the scope of Regulation (EC) No 834/2007.

(2)

As in Commission Regulation (EC) No 889/20082 no detailed production rules have been laid down until now for micro-algae used as food and questions arose as regards which production rules operators have to respect when growing micro-algae for use as food, there is a need to clarify the situation and lay down detailed production rules for such products.

(3)

The production of micro-algae resembles that of seaweed in many aspects, even though it does not take place in the sea. Moreover, when they are further used as feed for aquaculture animals, micro-algae, like multi-cellular marine algae and phytoplankton, are already subject to the detailed production rules for the collection and farming of seaweed on the basis of Article 6a of Regulation (EC) No 889/2008. Therefore, it is appropriate to clarify that the detailed production rules for seaweed should also apply to the production of micro-algae for further use as food.

(4)

The transitional measures for the use of non-organic juveniles and of seed from non-organic bivalve shellfish hatcheries in organic production provided for in Article 25e(3) and in the third subparagraph of Article 25o(1) of Regulation (EC) No 889/2008 ends on 31 December 2015, implying that after that date all juveniles and all shellfish seed used in organic production have to be organic. Since it appeared that organic juveniles and organic shellfish seed are not available in sufficient quantities, that date should be postponed with 1 year to give time to operators to develop organic juveniles and organic shellfish seed in sufficient quantities.

(5)

In accordance with Article 29d(4) of Regulation (EC) No 889/2008 the Commission is to re-examine the use of certain oenological practices, processes and treatments before 1 August 2015 with a view to phase out or to further restrict those practices.

(6)

The Commission requested the Expert group for technical advice on organic production (‘EGTOP’) to evaluate the effect of those oenological practices, processes and treatments on certain essential characteristics of organic wine and whether alternative techniques are available to replace them. EGTOP recommended3 to continue allowing their use in organic wine production due to the lack of viable alternatives at present. It also recommended reassessing those techniques after a certain period with the same purpose as today, that is to phase them out or further restrict them. Therefore, the deadline of 1 August 2015 should be extended with 3 years.

(7)

Competent authorities have the possibility to authorise exceptions from the production rules for animals on a temporary basis where specific circumstances would prevent operators from continuing or recommencing organic production. In particular, in case of high mortality of animals caused by health or catastrophic circumstances, they can allow that a herd or a flock is reconstituted or renewed with non-organic animals, when organically reared animals are not available. It should be clarified that in such case the respective conversion period still needs to be respected in relation to the non-organic animals introduced in the herd or the flock.

(8)

In addition, since the possibilities to use non-organic juveniles in organic production have been limited in recent years, it is appropriate to provide for similar exceptional production rules in case of high mortality for aquaculture animals.

(9)

Annex II to Regulation (EC) No 889/2008 lists the products that are authorised for use in organic production in accordance with Article 12(1)(h) and Article 16(1)(a) of Regulation (EC) No 834/2007. Those products have been classified into 7 groups on the basis of different criteria, such as the use or the origin. It is useful to simplify the presentation and to use only the criteria of origin for the classification.

(10)

The right column of the table in Annex II to Regulation (EC) No 889/2008 specifies the description, compositional requirement and conditions for use of the products listed in that Annex, which include micro-organisms and substances. The conditions for use of those products in organic production, and in particular the corresponding use category (such as insecticide, acaricide or fungicide) must, however, comply with the conditions for use for active substances as set out in the Annex to Commission Implementing Regulation (EU) No 540/20114 for farming in general. If the use is restricted by that Regulation for farming in general, the authorisations for use are also restricted for organic production. In addition, experience has shown that the conditions for use of the products listed in Annex II to Regulation (EC) No 889/2008 are very often the same in organic agriculture as in conventional agriculture and that restrictions of use are limited.

(11)

The system should therefore be simplified to avoid that Annex II to Regulation (EC) No 889/2008 lists uses that are not approved anymore under Implementing Regulation (EU) No 540/2011. At the same time, it should be indicated that all uses that are approved for farming in general by Implementing Regulation (EU) No 540/2011 are automatically authorised for use in organic production, except where it is specifically indicated that more restrictive conditions apply to certain uses.

(12)

In accordance with the procedure provided for in Article 16(3) of Regulation (EC) No 834/2007, Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annex II to Regulation (EC) No 889/2008. Those dossiers have been examined by EGTOP and the Commission.

(13)

In its recommendations5, EGTOP concluded, inter alia, that the substances carbon dioxide, kieselgur (diatomaceous earth), fatty acids and potassium bicarbonate comply with the organic objectives and principles. Therefore, those substances should be included in Annex II to Regulation (EC) No 889/2008. In addition, in order to align the names of active substances with Implementing Regulation (EU) No 540/2011, it is appropriate to change the name of fatty acid potassium salt (soft soap) into fatty acids.

(14)

According to Article 23 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council6 basic substances are substances which are useful in plant protection, but are not predominantly used for this purpose. Many of them have traditionally been used in organic farming before even being classified as basic substances. Among those, there are numerous foodstuffs of plant or animal origin. It is appropriate to authorise the use of those basic substances in organic farming and therefore include them in Annex II to Regulation (EC) No 889/2008 if they fulfil the two criteria of being covered by the definition of ‘foodstuff’ in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council7 and having plant or animal origin.

(15)

Annex VI to Regulation (EC) No 889/2008 lists the feed additives that are authorised in organic products in accordance with Article 14(1)(d) and Article 16(1)(d) of Regulation (EC) No 834/2007.

(16)

To align to the approach taken in Regulation (EC) No 1831/2003 of the European Parliament and of the Council8, the presentation of Annex VI should be modified. In particular, the left column of the table of Annex VI should be amended by indicating the specific ID number of the additives or the functional groups and the classification in the group of ‘technological additives’ and ‘nutritional additives’ should be aligned to the classification used in Regulation (EC) No 1831/2003. The name of the substances of the group of ‘zootechnical additives’ in Section 4 of Annex VI to Regulation (EC) No 889/2008 should also be aligned to the wording of Regulation (EC) No 1831/2003.

(17)

In accordance with the procedure provided for in Article 16(3) of Regulation (EC) No 834/2007, Member States have submitted dossiers on certain feed additives to the other Member States and the Commission, in view of their authorisation and inclusion in Annex VI to Regulation (EC) No 889/2008. Those dossiers have been examined by EGTOP and the Commission. Based on the recommendations from EGTOP with regard to feed materials and feed additives9, the use of the following substances which EGTOP has considered compatible with the organic principles and objectives should be authorised: selenised yeast, dicopper chloride trihydroxide (TBCC) and zinc chloride hydroxide monohydrate (TBZC).

(18)

In the light of the changes introduced by Commission Implementing Regulations (EU) No 131/201410, (EU) 2015/86111 and (EU) 2015/115212, it is necessary to substitute the substances ‘tocopherol-rich extracts of natural origin’, ‘E2 iodine’ and ‘E3 cobalt’, which do not exist anymore, by the new ones from the same category respectively. In addition, certain inaccuracies as regards the identification numbers of bentonite-montmorillonite and clinoptilolite in the functional group ‘(d) Binders, and anti-caking agents’ should be corrected.

(19)

Annex VIII to Regulation (EC) No 889/2008 lists certain substances that are authorised in the production of processed organic food, yeast and yeast products in accordance with Article 19(2)(b) and Article 21 of Regulation (EC) No 834/2007.

(20)

To be coherent with Regulation (EC) No 1333/2008 of the European Parliament and of the Council13, it is necessary to change the specific conditions of use of silicon dioxide gel or colloidal solution (E 551) and the specific purity criteria of bentonite. The existing authorisation of kaolin (E 559) should be withdrawn as under Regulation (EC) No 1333/2008 the use of that additive was authorised until 31 January 2014.

(21)

In accordance with the procedure provided for in Article 21(2) of Regulation (EC) No 834/2007, Member States have submitted dossiers on food additives, processing aids and certain other substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annex VIII to Regulation (EC) No 889/2008. Those dossiers have been examined by EGTOP and the Commission.

(22)

Based on the recommendations from EGTOP with regard to food additives14, the use of the following substances which EGTOP has considered compatible with the organic principles and objectives should be authorised: beeswax (E 901), carnauba wax (E 903), gellan gum (E 418) and erythritol (E 968).

(23)

In addition, the conditions for the use of the following additives should be amended following the recommendation of EGTOP: sulphur dioxide, potassium metabisulphite, tocopherol-rich extract, lecithins, citric acid, sodium citrate, tartaric acid, glycerol, sodium carbonate, silicon dioxide gel or colloidal solution and sodium hydroxide. Lecithin derived from organic raw material is available on the market, but appropriate qualities of such lecithin are needed for most of the uses in the organic food processing industry. The appropriate qualities for the organic food production are currently not available in sufficient quantities. Taking account of the temporary lack of the different qualities of the organic lecithin needed for the organic production of food, it should be provided that during a transitional period of 3 years lecithin not derived from organic raw material may be used in the production of organic food.

(24)

Based on the recommendations from EGTOP regarding processing aids, acetic acid/vinegar, thiamin hydrochloride, diammonium phosphate, sodium carbonate and wood fibre should be authorised. As regards sodium carbonate, citric acid, sodium hydroxide, vegetable oils, bentonite, beeswax and carnauba wax, the specific conditions should be amended.

(25)

For processing aids used in yeast production, it should be required that potato starch and vegetables oils be used only if derived from organic production, given that those processing aids are now available in their organic form in sufficient quantity and quality.

(26)

Finally, in Annexes II, VI and VIII to Regulation (EC) No 889/2008 it is no longer relevant to refer to the Regulation under which the products or substances had been authorised.

(27)

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

(28)

To allow operators and control authorities and control bodies a reasonable time to adapt to the fact that the detailed production rules for seaweed also apply to the production of micro-algae for further use as food, the amendment of Article 6a of Regulation (EC) No 889/2008 should apply as from 12 months after the entry into force of this Regulation.

(29)

In order to allow continuity and a prolongation of the possibility to use non-organic juveniles and seed from non-organic bivalve shellfish hatcheries, the amendment of Articles 25e(3) and 25o(1) of Regulation (EC) No 889/2008 should apply retroactively from 1 January 2016.

(30)

In order to give the possibility to operators to adapt to the modifications introduced in respect of certain products and substances for use in the production of processed organic food, yeast and yeast products, the amendments to Annex VIII to Regulation (EC) No 889/2008 should apply as from 6 months after the entry into force of this Regulation.

(31)

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

HAS ADOPTED THIS REGULATION:

Article 1Amendment of Regulation (EC) No 889/2008

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

(1)
Article 6a is replaced by the following:
‘Article 6aScope
This Chapter lays down detailed production rules for seaweed.
For the purposes of this Chapter “seaweed” includes multi-cellular marine algae, phytoplankton and micro-algae.’;
(2)
in Article 25e, paragraph 3 is replaced by the following:
‘3.
The maximum percentage of non-organic aquaculture juveniles introduced to the farm shall be 80 % by 31 December 2011, 50 % by 31 December 2014 and 0 % by 31 December 2016.’;
(3)
in Article 25o(1), the third subparagraph is replaced by the following:
‘However, the maximum percentage of seed from non- organic bivalve shellfish hatcheries that may be introduced to the organic production units shall be 80 % by 31 December 2011, 50 % by 31 December 2014 and 0 % by 31 December 2016.’;
(4)
in Article 29d(4), the date of ‘1 August 2015’ is replaced by ‘1 August 2018’;
(5)
in Article 47, the first subparagraph is amended as follows:
1. (a)
  point (a) is replaced by the following:
  ‘(a)
  in the case of high mortality of animals caused by health or catastrophic circumstances, the renewal or reconstitution of the herd or flock with non-organic animals, when organically reared animals are not available and provided that the respective conversion period are applied to the non-organic animals;’;
2. (b)
  the following point (f) is added:
  ‘(f)
  in the case of high mortality of aquaculture animals caused by circumstances listed in Article 57(1)(a) to (d) of Regulation (EU) No 508/2014 of the European Parliament and of the Council15, the renewal or reconstitution of the aquaculture stock with non-organic aquaculture animals, when organically reared animals are not available and provided that at least the latter two thirds of the duration of the production cycle are managed under organic management.’;
(6)
Annex II is replaced by the text set out in Annex I to this Regulation;
(7)
Annex VI is replaced by the text set out in Annex II to this Regulation;
(8)
Annex VIII is amended in accordance with Annex III to this Regulation.

Article 2Entry into force and application

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

The following points of Article 1 shall apply from the date indicated for them:

(a)
point (1) shall apply from 7 May 2017;
(b)
points (2) and (3) shall apply from 1 January 2016;
(c)
point (8) shall apply from 7 November 2016.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 April 2016.

For the Commission

The President

Jean-Claude Juncker

ANNEX I

‘ANNEX IIPesticides — 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 Commission Implementing Regulation (EU) No 540/201116. 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
Azadirachtin extracted from Azadirachta indica (Neem tree)
Basic substances
Only those basic substances within the meaning of Article 23(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council17 that are covered by the definition of “foodstuff” in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council18 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.
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.
17
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).
18
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
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, by way of derogation from the first paragraph, Member States may 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 4 preceding years does not exceed 6 kg.
Ethylene
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 hydrogen carbonate (aka potassium bicarbonate)
Quartz sand
Sulphur

Name	Description, compositional requirement, conditions for use
Azadirachtin extracted from Azadirachta indica (Neem tree)
Basic substances	Only those basic substances within the meaning of Article 23(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council17 that are covered by the definition of “foodstuff” in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council18 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.
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.

Name	Description, compositional requirement, conditions for use
Micro-organisms	Not from GMO origin.
Spinosad

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, by way of derogation from the first paragraph, Member States may 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 4 preceding years does not exceed 6 kg.
Ethylene
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 hydrogen carbonate (aka potassium bicarbonate)
Quartz sand
Sulphur

ANNEX II

‘ANNEX VIFeed additives used in animal nutrition referred to in Article 22(g), Article 24(2) and Article 25m(2)
Feed additives listed in this Annex must be authorised under Regulation (EC) No 1831/2003 of the European Parliament and of the Council19.
1.TECHNOLOGICAL ADDITIVES
(a)Preservatives
ID numbers or Functional groups
Substance
Description, conditions for use
E 200
Sorbic acid
E 236
Formic acid
E 237
Sodium formate
E 260
Acetic acid
E 270
Lactic acid
E 280
Propionic acid
E 330
Citric acid
(b)Antioxidants
ID number or Functional groups
Substance
Description, conditions for use
1b306(i)
Tocopherol extracts from vegetable oils
1b306(ii)
Tocopherol-rich extracts from vegetable oils (delta rich)
(c)Emulsifiers, stabilisers, thickeners and gelling agents
ID numbers or Functional groups
Substance
Description, conditions for use
E 322
Lecithins
Only when derived from organic raw material.
Use restricted to aquaculture animal feed.
(d)Binders and anti-caking agents
ID number or Functional groups
Substance
Description, conditions for use
E 535
Sodium ferrocyanide
Maximum dose rate of 20 mg/kg NaCl calculated as ferrocyanide anion.
E 551b
Colloidal silica
E 551c
Kieselgur (diatomaceous earth, purified)
1m558i
Bentonite
E 559
Kaolinitic clays, free of asbestos
E 560
Natural mixtures of stearites and chlorite
E 561
Vermiculite
E 562
Sepiolite
E 566
Natrolite-Phonolite
1g568
Clinoptilolite of sedimentary origin
E 599
Perlite
(e)Silage additives
ID number or Functional groups
Substance
Description, conditions for use
1k
Enzymes and micro-organisms
Use restricted to production of silage when weather conditions do not allow for adequate fermentation.
2.SENSORY ADDITIVES
ID number or Functional groups
Substance
Description, conditions for use
2b
Flavouring compounds
Only extracts from agricultural products.
3.NUTRITIONAL ADDITIVES
(a)Vitamins, pro-vitamins and chemically well-defined substances having similar effect
ID number or Functional groups
Substance
Description, conditions for use
3a
Vitamins and provitamins
Derived from agricultural products.
If derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals.
If derived synthetically, only vitamins A, D and E identical to vitamins derived from agricultural products may be used for ruminants; the use is subject to prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations.
(b)Compounds of trace elements
ID numbers or Functional groups
Substance
Description, conditions for use
E1 Iron
Ferric oxide
Ferrous carbonate
Ferrous sulphate, heptahydrate
Ferrous sulphate, monohydrate
3b201
Potassium iodide
3b202
Calcium iodate, anhydrous
3b203
Coated granulated calcium iodate anhydrous
3b301
Cobalt(II) acetate tetrahydrate
3b302
Cobalt(II) carbonate
3b303
Cobalt(II) carbonate hydroxide (2:3) monohydrate
3b304
Coated granulated cobalt(II) carbonate
3b305
Cobalt(II) sulphate heptahydrate
E4 Copper
Basic cupric carbonate, monohydrate
Cupric oxide
Cupric sulphate, pentahydrate
3b409
Dicopper chloride trihydroxide (TBCC)
E5 Manganese
Manganous oxide
Manganous sulfate, monohydrate
Manganous carbonate
E6 Zinc
Zinc oxide
Zinc sulphate monohydrate
Zinc sulphate heptahydrate
3b609
Zinc chloride hydroxide monohydrate (TBZC)
E7 Molybdenum
Sodium molybdate
E8 Selenium
Sodium selenite
Sodium selenate
3b8.10, 3b8.11, 3b8.12, 3b813 and 3b817
Selenised yeast inactivated
4.ZOOTECHNICAL ADDITIVES
ID number or Functional groups
Substance
Description, conditions for use
4a, 4b, 4c and 4d
Enzymes and microorganism in the category of “Zootechnical additives”’

ID numbers or Functional groups	Substance	Description, conditions for use
	E 200	Sorbic acid
	E 236	Formic acid
	E 237	Sodium formate
	E 260	Acetic acid
	E 270	Lactic acid
	E 280	Propionic acid
	E 330	Citric acid

ID number or Functional groups	Substance	Description, conditions for use
	1b306(i)	Tocopherol extracts from vegetable oils
	1b306(ii)	Tocopherol-rich extracts from vegetable oils (delta rich)

ID numbers or Functional groups	Substance	Description, conditions for use
	E 322	Lecithins	Only when derived from organic raw material. Use restricted to aquaculture animal feed.

Substance	Description, conditions for use
E 535	Sodium ferrocyanide	Maximum dose rate of 20 mg/kg NaCl calculated as ferrocyanide anion.
E 551b	Colloidal silica
E 551c	Kieselgur (diatomaceous earth, purified)
1m558i	Bentonite
E 559	Kaolinitic clays, free of asbestos
E 560	Natural mixtures of stearites and chlorite
E 561	Vermiculite
E 562	Sepiolite
E 566	Natrolite-Phonolite
1g568	Clinoptilolite of sedimentary origin
E 599	Perlite

ID number or Functional groups	Substance	Description, conditions for use
1k	Enzymes and micro-organisms	Use restricted to production of silage when weather conditions do not allow for adequate fermentation.

ID number or Functional groups	Substance	Description, conditions for use
2b	Flavouring compounds	Only extracts from agricultural products.

ID number or Functional groups	Substance	Description, conditions for use
3a	Vitamins and provitamins	Derived from agricultural products. If derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals. If derived synthetically, only vitamins A, D and E identical to vitamins derived from agricultural products may be used for ruminants; the use is subject to prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations.

ID numbers or Functional groups	Substance	Description, conditions for use
	E1 Iron	Ferric oxide Ferrous carbonate Ferrous sulphate, heptahydrate Ferrous sulphate, monohydrate
	3b201	Potassium iodide
3b202	Calcium iodate, anhydrous
3b203	Coated granulated calcium iodate anhydrous
	3b301	Cobalt(II) acetate tetrahydrate
3b302	Cobalt(II) carbonate
3b303	Cobalt(II) carbonate hydroxide (2:3) monohydrate
3b304	Coated granulated cobalt(II) carbonate
3b305	Cobalt(II) sulphate heptahydrate
	E4 Copper	Basic cupric carbonate, monohydrate Cupric oxide Cupric sulphate, pentahydrate
3b409	Dicopper chloride trihydroxide (TBCC)
	E5 Manganese	Manganous oxide Manganous sulfate, monohydrate Manganous carbonate
	E6 Zinc	Zinc oxide Zinc sulphate monohydrate Zinc sulphate heptahydrate
3b609	Zinc chloride hydroxide monohydrate (TBZC)
	E7 Molybdenum	Sodium molybdate
	E8 Selenium	Sodium selenite Sodium selenate
3b8.10, 3b8.11, 3b8.12, 3b813 and 3b817	Selenised yeast inactivated

ID number or Functional groups	Substance	Description, conditions for use
4a, 4b, 4c and 4d	Enzymes and microorganism in the category of “Zootechnical additives”’

ANNEX III

Annex VIII to Regulation (EC) No 889/2008 is amended as follows.

(1)
The note above the title of Section A, the note below the title of Section B and the first column of the tables in Sections A and B with the heading ‘Authorisation’ are deleted.

(2)

Section A is amended as follows:

(a)

the rows relating to sulphur dioxide, potassium metabisulphite, tocopherol-rich extract, lecithins, citric acid, sodium citrate, tartaric acid, glycerol, sodium carbonate, silicon dioxide, sodium hydroxide are replaced by the following rows:

‘E 220
Sulphur dioxide
X
X (Only for mead)
In fruit wines20 and mead with and without added sugar):100 mg21
E 224
Potassium metabisulphite
X
X (Only for mead)
In fruit wines20 and mead with and without added sugar):100 mg21.
E 30620
Tocopherol-rich extract
X
X
Anti-oxidant
E 32220
Lecithins
X
X
Milk products (²)
Only when derived from organic raw material22
E 330
Citric acid
X
X
E 331
Sodium citrate
X
X
E 334
Tartaric acid (L(+)–)
X
X (Only for mead)
E 422
Glycerol
X
From plant origin.
For plant extracts and flavourings
E 500
Sodium carbonate
X
X
E 551
Silicon dioxide gel or colloidal solution
X
X
For herbs and spices in dried powdered form
Flavourings and propolis
E 524
Sodium hydroxide
X
Surface treatment of “Laugengebäck” and regulation of acidity in organic flavourings
20
In this context, “fruit wine” is defined as wine made from fruits other than grapes (including cider and perry).
21
Maximum levels available from all sources, expressed as SO₂ in mg/l.
22
As from 1 January 2019.’

(b)

the following rows are inserted in the order of the code numbers:

‘E 418
Gellan gum
X
X
High-acyl form only
E 901
Beeswax
X
As a glazing agent for confectionary only.
Beeswax from organic beekeeping
E 903
Carnauba wax
X
As a glazing agent for confectionary only.
Only when derived from organic raw material’

(c)
the following row is added:
‘E 968
Erythritol
X
X
Only when derived from organic production without using ion exchange technology’

(3)

Section B is amended as follows:

(a)

the rows relating to sodium carbonate, citric acid, sodium hydroxide, vegetable oils, bentonite, beeswax and carnauba wax are replaced by the following rows:

‘Sodium carbonate
X
X
Citric acid
X
X
Sodium hydroxide
X
For sugar(s) production.
For oil production excluding olive oil production
Vegetable oils
X
X
Greasing, releasing or anti-foaming agent.
Only when derived from organic production
Bentonite
X
X
Sticking agent for mead (¹)
Beeswax
X
Releasing agent.
Beeswax from organic beekeeping
Carnauba wax
X
Releasing agent.
Only when derived from organic raw material’

(b)
the row relating to kaolin is deleted;

(c)

the following rows are added:

‘Acetic acid/vinegar
X
Only when derived from organic production.
For fish processing, only from biotechnological source, except if produced by or from GMO
Thiamin hydrochloride
X
X
Only for use in processing of fruit wines, including cider and perry and mead
Diammonium phosphate
X
X
Only for use in processing of fruit wines, including cider and perry and mead
Wood fibre
X
X
The source of timber should be restricted to certified, sustainably harvested wood.
Wood used must not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from micro-organisms)’

(4)
In Section C, the rows relating to potato starch and vegetable oils are replaced by the following rows:
‘Potato starch
X
X
For filtering
Only when derived from organic production
Vegetable oils
X
X
Greasing, releasing or anti-foaming agent
Only when derived from organic production’

Article 1Amendment of Regulation (EC) No 889/2008

‘Article 6aScope

‘3.

‘(a)

‘(f)

Article 2Entry into force and application

ANNEX I

‘ANNEX IIPesticides — Products referred to in Article 5(1)

1.Substances of plant or animal origin

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

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

ANNEX II

‘ANNEX VIFeed additives used in animal nutrition referred to in Article 22(g), Article 24(2) and Article 25m(2)

1.TECHNOLOGICAL ADDITIVES

(a)Preservatives

(b)Antioxidants

(c)Emulsifiers, stabilisers, thickeners and gelling agents

(d)Binders and anti-caking agents

(e)Silage additives

2.SENSORY ADDITIVES

3.NUTRITIONAL ADDITIVES

(a)Vitamins, pro-vitamins and chemically well-defined substances having similar effect

(b)Compounds of trace elements

4.ZOOTECHNICAL ADDITIVES

ANNEX III

‘E 220	Sulphur dioxide	X	X (Only for mead)	In fruit wines20 and mead with and without added sugar):100 mg21
E 224	Potassium metabisulphite	X	X (Only for mead)	In fruit wines20 and mead with and without added sugar):100 mg21.
E 30620	Tocopherol-rich extract	X	X	Anti-oxidant
E 32220	Lecithins	X	X	Milk products (²) Only when derived from organic raw material22
E 330	Citric acid	X	X
E 331	Sodium citrate	X	X
E 334	Tartaric acid (L(+)–)	X	X (Only for mead)
E 422	Glycerol	X		From plant origin. For plant extracts and flavourings
E 500	Sodium carbonate	X	X
E 551	Silicon dioxide gel or colloidal solution	X	X	For herbs and spices in dried powdered form Flavourings and propolis
E 524	Sodium hydroxide	X		Surface treatment of “Laugengebäck” and regulation of acidity in organic flavourings

‘Sodium carbonate	X	X
Citric acid	X	X
Sodium hydroxide	X		For sugar(s) production. For oil production excluding olive oil production
Vegetable oils	X	X	Greasing, releasing or anti-foaming agent. Only when derived from organic production
Bentonite	X	X	Sticking agent for mead (¹)
Beeswax	X		Releasing agent. Beeswax from organic beekeeping
Carnauba wax	X		Releasing agent. Only when derived from organic raw material’

‘Acetic acid/vinegar		X	Only when derived from organic production. For fish processing, only from biotechnological source, except if produced by or from GMO
Thiamin hydrochloride	X	X	Only for use in processing of fruit wines, including cider and perry and mead
Diammonium phosphate	X	X	Only for use in processing of fruit wines, including cider and perry and mead
Wood fibre	X	X	The source of timber should be restricted to certified, sustainably harvested wood. Wood used must not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from micro-organisms)’