EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/11231/2014 ANNEX 
(POOL/G2/2014/11231/11231-EN 
ANNEX.doc) […](2014) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION REGULATION (EU) No …/.. 
amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council 
as regards requirements for the placing on th e market and conditions of use of additives 
consisting of p reparations  
 EN 2   EN ANNEX  
Annexes III and IV to Regulation (EC) 1831/2003 are amended as follows: 
(1) Annex III is replaced by the following text: 
"ANNEX III  
1. SPECIFIC LABELLING REQUIREME NTS FOR CERTAIN ADDITIVES 
AND FOR PREMIXTURES. 
(a) Zootechnical additives, cocci diostats and histomonostats:  
– the expiry date of the guarantee or the storage life from the date of 
manufacture,  
– the directions for use, and  
– the concentration. 
(b) Enzymes, in addition to th e abovementioned indications:  
– the specific name of the activ e component or components in 
accordance with their enzyme activities, in conformity with the authorisation given; 
– the International Union of Biochemi stry identification number, and  
– instead of concentration: units of activity (units of activity per gram 
or units of activity per millilitre). 
(c) Micro-organisms:  
– the expiry date of the guarantee or the storage life from the date of 
manufacture,  
– the directions for use,  
– the strain identification number, and  
– the number of colony-forming units per gram. 
(d) Nutritional additives:  
– the active-substance level, and  
– the expiry date of the guarantee of  that level or storage life from the 
date of manufacture. 
(e) Technological and sensory additives  with the exception of flavouring 
compounds:  
– the active substance level. 
(f) Flavouring compounds:  
– the incorporation rate in premixtures. EN 3   EN 2. ADDITIONAL LABELLING AND INFORMATION REQUIREMENTS 
FOR CERTAIN ADDITIVES CONSIS TING OF PREPARATIONS AND 
PREMIXTURES CONTAINING SUCH PREPARATIONS.  
(a) Additives belonging to the categories referred to in Article 6(1)(a), (b) 
and (c) and consisting of preparations: 
(i) the indication on the packaging or container of the specific name, 
the identification number and the level of any technological additive contained in the prepara tion for which maximum levels are 
set in the correspond ing authorisation; 
(ii) the following information via any written medium or 
accompanying the preparation: 
– the specific name and the id entification number of any 
technological additive contai ned in the preparation, and 
– the name of any other substanc e or product contained in the 
preparation, indicated in descending order by weight. 
(b) Premixtures containing additives be longing to the categories referred to 
in Article 6(1) (a), (b) and (c ) and consisting of preparations: 
(i) if appropriate, the indication on the packaging or container that the 
premixture contains technologica l additives included in additive 
preparations, for which maximum levels are set in the corresponding authorisation; 
(ii) upon request from the purchaser or the user, information on the 
specific name, the identification nu mber and an indication of the 
level of technological additives re ferred to in point (i) of this 
paragraph included in the additive preparations." 
(2) In Annex IV, the following point 5 is added: 
"5. Technological additives or other substances or products contained in additives 
consisting of preparations shall only modify the physico-chemical 
characteristics of the active substance of  the preparation and shall be used in 
accordance with their conditions of aut horisation where such provisions are 
provided for. 
Physico-chemical and biological compa tibility between the components of the 
preparation shall be ensured in relation to the effects desired."