EN    EN EN 
SANCO/10613/2010REV1  
EN    EN  EUROPEAN COMMISSION 
Brussels,  
 
  
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
on the status of certain products with re gard to feed additives within the scope of 
Regulation (EC) No 1831/2003 
(Text with EEA relevance) 
 
  
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
on the status of certain products with re gard to feed additives within the scope of 
Regulation (EC) No 1831/2003 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council of 22 September 2003 on additi ves for use in animal nutrition
1, and in particular 
Article 2(3) thereof, 
Whereas: 
(1) For certain substances, micro-organisms or  preparations, referred to as products, 
there is uncertainty whether th ey are feed additives. This  uncertainty concerns some 
products which are authorised as feed addi tives included in the Register of feed 
additives and also included in the Catalogue of feed materials provided for in Article 
24 of Regulation (EC) No 767/2009 of the Eu ropean Parliament and of the Council 
of 13 July 2009 on the placing on the market and use of feed, amending European 
Parliament and Council Regulation (E C) No 1831/2003 and repealing Council 
Directive 79/373/EEC, Commission Dire ctive 80/511/EEC, C ouncil Directives 
82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC  and 96/25/EC and Commission 
Decision 2004/217/EC2, some products which are neither authorised as feed additives 
nor included in the Catal ogue of feed materials and some products which are 
authorised as feed additives,  but could be included in th e Catalogue of feed materials 
in accordance with the conditions la id down in Regulation (EC) No 767/2009. 
(2) To avoid inconsistencies in the treatment of  such products, to facilitate the work of 
the national competent control authorities a nd to lighten the burden of the interested 
parties, as regards certain products it is necessary to a dopt a Regulation determining 
those products that are not feed additives.  
(3) For that determination all th e characteristics of the products concerned have to be 
taken into account. 
                                                 
1 OJ L 268, 18.10.2003, p. 29.  
2 OJ L 229, 1.9.2009, p. 1.  
EN 3   EN (4) From a comparison between the character istics of the products  included in the 
Register of feed additives on the one ha nd and of the products mentioned in the 
Catalogue of feed materials on the other hand, several criter ia may be derived for the 
classification of products as feed material , feed additive or other products. Useful 
criteria for this differentiation are am ongst others the production and processing 
method, the level of standardisation, the homogenisation, the purity, the chemical 
definition and the mode of use of the produc ts. For the sake of consistency, products 
with similar properties should be classifi ed by analogy. For products for which there 
were doubts whether they were feed additiv es, an examination has been carried out 
taking into account these criteria. 
(5) Based on that examination, the products set out in the Annex should not be 
considered as feed additives within the scope of Regula tion (EC) No 1831/2003. 
(6) As regards the labelling of the products whic h were authorised as feed additives and 
the labelling of feed ma terials and compound feed containing those products, a 
transitional period should be provided to allow feed business operators to adapt. 
Furthermore those products should be deleted from the Register of feed additives.  
(7) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The substances, micro-organisms  and preparations (referre d to as ‘products’) , as set out in the 
Annex, are no feed additives within th e scope of Regulati on (EC) No 1831/2003. 
Article 2 
The products listed under Part 1 of the Annex sh all not longer be consid ered as authorised 
feed additives within the scope of Regulation (EC) No 1831/2003. 
Article 3 
Products set out in Part 1 of the Annex which ar e labelled as feed additives and pre-mixtures 
in accordance with Regulation (EC) No 1831/2003 may continue to be placed on the market 
until [… Office of publications please insert date th ree years after date of publication of this 
Regulation]  and remain on the market until stocks are exhausted. The same applies to feed 
materials or compound feed which refer to these products in thei r labelling as feed additives 
in accordance with Regulation (EC) No 767/2009. 
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union .  
EN 4   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
Products which are not feed additives  
within the scope of Regulation (EC) No 1831/2003 
PART 1. P RODUCTS WHICH WERE AUTHORISED AS FEED ADDITIVES  
1.1 Calcium carbonate 
1.2 Sodium dihydrogen orthophosphate 1.3 Disodium hydrogen orthophosphate 1.4 Trisodium orthophosphate  1.5 Sodium sulphate 1.6 Calcium tetrahydrogen diorthophosphate 1.7 Calcium hydrogen orthophosphate 1.8 Tetrasodium diphosphate 1.9 Pentasodium triphosphate 1.10 Dicalcium diphosphate  1.11 Calcium sulphate, dihydrate 1.12 Sodium carbonate 1.13 Sodium hydrogen carbonate 
1.14 Sodium, potassium and calcium salts of edib le fatty acids with at  least four carbon 
atoms / stearates 
1.15 Mono- and diglycerides of fatty aci ds with at least four carbon atoms 
1.16 Mono- and di-glycerides of ed ible fatty acids with  at least four car bon atoms esterified 
with the following acids: acetic, lactic, ci tric, tartaric, mono- and diacetyltartaric 
1.17 Glycerol 1.18 Propane-1,2-diol 1.19 Pectins  
P
ART 2. P RODUCTS WHICH WERE NOT AUTHORISED AS FEED ADDITIVES  
2.1 Potassium chloride  
EN 6   EN 2.2 Calcium chloride 
2.3 Calcium sodium phosphate 2.4 Sodium magnesium phosphate 2.5 Methyl sulfonyl methane (MSM) 2.6 Plain caramel 2.7 Glucosamine, Chitosamine (amino sugar (m onosaccharide) being part of the structure 
of the polysaccharides chitosa n and chitin, produced, for ex ample, by the hydrolysis of 
crustacean and other arthropods exoskeletons  or by fermentation of a grain such as 
maize or wheat) 
2.8 Chondroitin sulphate (polysaccharide with re peating unit consisting of an amino sugar 
and D-glucuronic acid, sulphate esters of chondroitin are major structural components 
of cartilage, tendons and bones) 
2.9 Hyaluronic acid (glucosamineglucan (polys accharide) with repeating unit consisting 
of an amino sugar (N-acetyl-D-glucosamine ) and D-glucuronic acid present in the 
skin, synovial fluid and the umbilical cord, produced, for example, from animal tissue 
or by bacterial fermentation) 
2.10 Egg powder (dried eggs without shells or  a mixture of dried albumen and dried egg 
yolk) 
2.11 Lactulose (disaccharide (4-O-D-galactopyra nosyl-D-fructose) obtained from lactose 
through the isomerisation of glucose to fructo se. Naturally present in heat treated milk 
and milk products) 
2.12 Plant sterols (phytosterols ar e a group of steroid alcohols, naturally occurring in plants 
in small quantities and presented as free st erols or esterified with fatty acids) 
2.13 Tagetes flower meal (ground meal of dried flowers of Tagetes sp ) 
2.14 Paprika meal (ground meal of dried fruits of Capsicum sp ) 
2.15 Chlorella suspension or meal  (suspension of the living C hlorella sp  in water or dried 
and ground meal of C hlorella sp ) 
2.16 Algae meal (dried and ground meal of micro-algae such as Schizochytrium sp ., the 
cells of which have been inactivated) 
2.17 Fermentation products and by-pr oducts (fermented feed mate rials after inactivation of 
the fermentative micro-organism and ferm entation by-product (d ried and ground by 
product of solid state or liquid fermentation)  after extraction of the active component 
or activity, inactivation of the micro-organi sm and with only residual content(s) of 
active component(s) or activity remaining in the product) .