EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 re levance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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 22(1) thereof , 
Whereas:  
(1) Article 25l(3)(b) of  Commission Regulation (EC) No 889/20082 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 shrimp s 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, ami no 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 -137/1 33, 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 foo dstuff to be placed on the market.  
(3) Regulation (EU) 2018/ 848 of the European Parliament and of the Council4 will allow 
the use of minerals  (trace elements included), vitamins, amino acids or micronutrients  
in organic infant formula and follow -on formula an d processed organic cereal -based 
foods and baby food when the ir 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 en sure consistency with the upcoming 
                                                 
1 OJ L 189, 20.7.2007 , p. 1.  
2 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of 
organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).  
3 Judgment of the Court of Justice of 5 November 2015, C -137/13,  ECLI:EU:C:201 4:2335 . 
4 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic 
production and labelling of organic products and repealing Council Regulation (EC) No 834/20 07 (OJ 
L 150, 14.6.2018, p. 1).  
EN 2  EN organic legislation it is appropriate to allow the ir 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 suffic iently 
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 pr oduction 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 th e 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 app ropriate to extend the period  in which it is allowed to use a 
limite d 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 sta tus 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 effectiv eness, 
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 Orga nic Production (EGTOP) 
and the Commission.  
(10) In its recommendations with regard to fertilisers5 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 p rinciples 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 products6 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 
                                                 
5 Final Report on Fertili sers (II) https://ec.europa.eu/agriculture/organic/eu -policy/expert -
advice/documents/final -reports_en . 
6 Final report on plant protection (III) https://ec.europa.eu/agriculture/organic/eu -policy/expert -
advice/documents/final -reports_en .  
EN 3  EN 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 
606/20097 in the w ine sector8 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), " di-
ammonium phosphate", "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 disinfecting9, EGTOP 
concluded, inter alia, that sodium hydroxide should also be ava ilable 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:  
Articl e 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, only products 
listed in Section 1 of Annex VII 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 appl ies both 
                                                 
7 Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for 
implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, 
oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1).  
8 Final report on Wine https://ec.europa.eu/agriculture/organic/eu -policy/expert -advice/documents/final -
reports_en . 
9 Final report on cleaning and disinfecting 
https://ec.europa.eu/agriculture/organic/sites/orgfarming/files/docs/body/final_report_egtop_on_cleanin
g_disinfection_en.pdf  
  
EN 4  EN 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), vitamin s, 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, wi th 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 characteristi cs 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 u se 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 re gulated by Commission Directive 2006/141/EC***, their use is authorised by 
that Directive.  
*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 Reg ulations 
(EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).  
** 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).  
*** Commission D irective 2006/141/EC of 22 December 2006 on infant formulae and 
follow -on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1). ';  
(4) in Article 42(b), the date '31 December 2018' is replaced by '31 December 2020';  
(5) in Article 43, th e 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 1 a 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 83 4/2007 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 State s, it shall notify the Member State or States 
concerned , the other Member States a nd 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;   
EN 5  EN (9) In Annex VII, the heading of Section  1 is replaced by the following:  '1. P roducts for 
cleaning and disinfection of buildings and installations for livestock production referred to in 
Article 23(4) and products for cleaning and disinfecting  frames , hives and combs in 
beekeeping referred to in Article 25(1) '; 
(10) 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.  
This Regulation shall be binding in its entirety and directly applicable in the Member States in 
accordance with the Treaties.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker