EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 889/2008 laying down detailed rules for the 
implementation of Council Regulation (E C) No 834/2007 on organic production and 
labelling of organic pr oducts with regard to organic pr oduction, labelling and control 
(Text with EEA relevance)   
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 889/2008 l aying down detailed rules for the 
implementation of Council Regulation (E C) 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 13(3) , Article 16(1) and (3)(a) and Ar ticles 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 Treat y. Seaweeds and other algae are therefore 
agricultural products falling within  point (a) of the first subpa ragraph 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 889/2008
2 no detailed production rules have 
been laid down until now for micro-algae us ed as food and questions arose as regards 
which production rules operators have to re spect when growing micro-algae for use as 
food, there is a need to clarify the situa tion and lay down detailed production rules for 
such products. 
(3) The production of micro-algae resembles th at of seaweed in many aspects, even 
though it does not take place in the sea. More over, when they are fu rther used as feed 
for aquaculture animals, micro-algae, like multi-cellular marine algae and 
phytoplankton, are already subject to the de tailed production rule s for the collection 
and farming of seaweed on the basis of Ar ticle 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 ha tcheries in organic producti on provided for in Article 
25e(3) and in the third subparagraph of 25o(1) of Regulation (EC) No 889/2008 ends 
on 31 December 2015, implying that after that date al l juveniles and all shellfish seed 
used in organic production have  to be organic. Since it a ppeared that organic juveniles 
                                                 
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).  
EN 3   EN and organic shellfish seed are not available in  sufficient quantities, that date should be 
postponed with one year to give time to ope rators to develop organic juveniles and 
organic shellfish seed in  sufficient quantities.  
(5) In accordance with Article 29d(4) of Regul ation (EC) No 889/ 2008 the Commission is 
to re-examine the use of certain oenologica l practices, processes a nd 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 te chnical advice on organic 
production ('EGTOP') to evaluate the effect of those oenological practices, processes 
and treatments on certain essential charac teristics of organic wine and whether 
alternative techniques are availabl e to replace them. EGTOP recommended3 to 
continue allowing their use in organic wi ne production due to the lack of viable 
alternatives at present. It also recomm ended reassessing thos e techniques after a 
certain period with the same purpose as toda y, that is to phase them out or further 
restrict them. Therefore, th e deadline of 1 August 2015 should  be extended with three 
years. 
(7) Competent authorities have the possibility to authorise exceptions from the production 
rules for animals on a temporary basis wh ere specific circumstances would prevent 
operators from continuing or recommenceing or ganic production. In pa rticular, 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 availa ble.  It should be clarified that in such 
case the respective conversion period still need s to be respected in relation to the non-
organic animals introduced in  the herd or the flock. 
(8) In addition, since the possibilities to us e non-organic juveniles in organic prodution 
have been limited in recent years, it is appropriate to provide for similar exceptional 
production rules in case of high mort ality 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 ha ve been classified  into 7 groups on 
the basis of different criteria, such as the us e or the origin. It is useful to simplify the 
presentation and to use only the crit eria of origin for the classification. 
(10) The right column of the ta ble in Annex II to Regulation (EC) No 889/2008 speciffies 
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 produc tion, 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 A nnex to Commission 
Implementing Regulation (EU) No 540/2011
4 for farming in general. If the use is 
restricted by that Regulation for farming in general, the authorisa tions for use are also 
restricted for organic production. In additi on, experience has shown that the conditions 
for use of the products listed in Annex II to Regulation (EC) No 889/2008 are very 
                                                 
3 Final report:  
http://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports/ 
4 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).  
EN 4   EN often the same in organic agriculture as  in conventional ag riculture 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 appr oved 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 Impl ementing 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 procedur e provided for in Article 16 (3) of Regulation (EC) No 
834/2007, Member States have submitted dossier s on certain substances  to the other 
Member States and the Commi ssion, in view of their auth orisation and inclusion in 
Annex II to Regulation (EC) No 889/2008. T hose 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), fa tty 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 Impl ementing Regulation (EU) No 540/2011, it is 
appropriate to change the name of fatty aci d 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 f oodstuffs 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 Re gulation (EC) No 889/2008 if they fulfil the 
two criteria of being covere d by the definition of 'foodstuff ' in Article 2 of Regulation 
(EC) No 178/2002 of the European Parliament and of the Council
7 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) In accordance with the procedur e provided for in Article 16 (3) of Regulation (EC) No 
834/2007, Member States have submitted dossi ers 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 additives
8, the use of the following substances which 
                                                 
5 Final report:  
 http://ec.europa.eu/agriculture/organic/eu-policy/ expert-advice/documents/final-reports/egtop-final-
report-on-ppp-ii_en.pdf 
6 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). 
7 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). 
8 Final report: 
  
EN 5   EN EGTOP has considered compatible with th e organic principles and objectives should 
be authorised: selenised y east, dicopper chlo ride trihydroxide (TBCC) and zinc 
chloride hydroxide monohydrate (TBZC).  
(17) In the light of the changes introduced by Commission Implementing Regulations (EU) 
No 131/20149, (EU) 2015/86110 and (EU) 2015/115211, 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 identifica tion numbers of bentonite-
montmorillonite and clinoptilolite under the category "(d) Binders, anti-caking agents 
and coagulants" should be corrected. 
(18) The name of the substances of the group of  “zootechnical additives” in Section 4 of 
Annex VI to Regulation (EC) No 889/2008 shoud be aligned to the wording of 
Regulation (EC) No 1831/2003 of the Eur opean Parliament and of the Council12. The 
name of the substances "enzymes and micr oorganisms" should therefore be changed  
into "digestibility enhancers or gut flora stabiliser". 
(19) Annex VIII to Regulation (EC) No 889/2008 lists certai n substances that are 
authorised in the production of processe d organic food, yeast an d yeast products in 
accordance with Article 19(2)(b) and Ar ticle 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 solu tion (E 551) and the specific pu rity criteria of bentonite. 
The existing authorisation of kaolin (E 559) should be withdrawn as under Regulation 
(EC) No 1333/2008 the use of that additiv e was authorised until 31 January 2014.  
(21) In accordance with the procedur e provided for in Article 21 (2) of Regulation (EC) No 
834/2007, Member States have submitted dossi ers 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 EG TOP with regard to food additives14, the use 
of the following substances which EGTOP has considered compatible with the organic 
                                                                                                                                                         
 http://ec.europa.eu/agriculture/organic/eu-policy/ expert-advice/documents/final-reports/egtop-final-
report-feed-ii_en.pdf 
9 Commission Implementing Regulation (EU) No 131/2014 of 11 February 2014 amending 
Implementing Regulation (EU) No  601/2013 concerning the auth orisation of cobalt(II) acetate 
tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydr oxide (2:3) monohydrate, cobalt(II) sulphate 
heptahydrate and coated granulated cobalt(II) carbon ate hydroxide (2:3) monohydr ate as feed additives 
(OJ L 41, 12.2.2014, p. 3). 
10 Commission Implementing Regulation (EU) 2015/861 of 3 June 2015 concerning the authorisation of 
potassium iodide, calcium iodate anhydrous and coated granulated calcium iodate anhydrous as feed 
additives for all animal species (OJ L 137, 4.6.2015, p. 1). 
11 Commission Implementing Regulation (EU) 2015/1152 of 14 July 2015 concerning the authorisation of 
tocopherol extracts from vegetable oils, tocopherol-r ich extracts from vegetable oils (delta rich) and 
alpha-tocopherol as feed additives for all animal species (OJ L 187, 15.7.2015, p. 5). 
12 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of  22 September 2003 
on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). 
13 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of  16 December 2008  
on food additives (OJ L 354, 31.12.2008, p. 16). 
14 Final reports: 
  
EN 6   EN principles and objectives should be aut horised: beeswax (E 901), carnauba wax (E 
903),  gellan gum (E 418) a nd erythritol (E 968).  
(23) In addition, the conditions for the use of the following additives should be amended 
following the recommendation of EGTOP: su lphur dioxide, potassium metabisulphite, 
tocopherol-rich extract, lecith ins, citric acid, sodium citr ate, tartaric acid, glycerol, 
sodium carbonate, silicon dioxide gel or co lloidal 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 quali ties for the organi c food production are 
currently not available in sufficient quantitie s. Taking account of the temporary lack of 
the different qualities of the or ganic lecithin needed for th e organic production of food, 
it should be provided that du ring a transitional period of three years lecithin not 
derived from organic raw ma terial may be used in th e production of organic food. 
(24) Based on the recommendations from EGTO P regarding processing aids, acetic 
acid/vinegar, thiamin hydrochloride, di ammonium phosphate, sodium carbonate and 
wood fibre should be authoris ed. As regards sodium carbona te, citric acid, sodium 
hydroxide, vegetable oils, bentonite, bees wax 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 deri ved from organic produc tion, given that those 
processing aids are now available in thei r 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 wh ich 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 produc tion 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 af ter the entry into 
force of this Regulation. 
(29) In order to allow continuity and a prolonga tion of the possibility to use non-organic 
juveniles and seed from non-organic bivalv e shellfish hatcheries, the amendment of 
Articles 25e(3) and 25o(1) of Regulation (E C) No 889/2008 should apply retroactivly 
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 mont hs after the entry into force of this 
Regulation.   
                                                                                                                                                         
 http://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-
reports/final_report_egtop_on_organic_food_en.pdf 
 http://ec.europa.eu/agriculture/organic/eu-policy/ expert-advice/documents/final-reports/egtop-final-
report-food-ii_en.pdf 
 http://ec.europa.eu/agriculture/organic/eu-policy/ expert-advice/documents/final-reports/egtop-final-
report-food-iii_en.pdf  
EN 7   EN (31) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee on organic production,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Amendment of Regulation (EC) No 889/2008 
Regulation (EC) No 889/2008 is amended as follows: 
(1) Article 6a is replaced by the following:  
"Article 6a 
Scope  
This Chapter lays down detailed  production rules for seaweed.  
For the purposes of this Chapter "seaweed " includes multi-cellular marine algae or 
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), th e third subparagraph is replaced by the following:  
"However, the maximum percentage of seed fro m non- organic bivalve shellfish hatcheries 
that may be introduced to the organic produc tion 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 subpa ragraph is amended as follows:  
(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 animal s are not available and provided that the 
respective conversion period has been a pplied to the non-organic animals;"; 
(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 Re gulation (EU) No 508/ 2014 of the European 
Parliament and of the Council*, the renewa l or reconstitution of the aquaculture 
stock with non-organic aquacu lture 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. 
* Regulation (EU) No 508/2014 of the Europ ean Parliament and of the Council of 15 
May 2014 on the European Maritime and Fisheries Fund and repealing Council 
Regulations (EC) No 2328/2003, (EC) No  861/2006, (EC) No 1198/2006 and (EC) 
No 791/2007 and Regulation (EU) No 1255/2011 of  the European Parliament and of 
the Council (OJ L 149, 20.5.2014, p. 1)."  
(6) Annex II is replaced by the text set out in Annex I to this Regulation;  
EN 8   EN (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 2 
 
Entry into force and application  
This Regulation shall enter into force on the se venth day following that of its publication in 
the Official Journal of  the European Union . 
The following points of Article 1 shall ap ply from the date indicated for them: 
(a) point (1) shall apply from […] [ Publications Office please fill in  the date that is 12 months 
after the date of entry into force of this Regulation ]; 
(b) points (2) and (3) shall apply from 1 January 2016; (c) point (8) shall apply from […] [ Publications Office please fill in the date that is 6 months 
after the date of entry into force of this Regulation].   
 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  […]