EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/2722369/2023  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the status of attapulgite as a feed additive within the scope of Regulation (EC) No 
1831/2003 of the European Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the status of attapulgite as a feed additive within the scope of Regulation (EC) No 
1831/2003 of the European Parliament and of the Council  
(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 on additives for use in animal nutrition1, and in particular Article 2(3) thereof,  
Whereas:  
(1) For the substance attapulgite , there is uncertainty whether it is a feed additive within 
the scope of Regulation (EC) No 1831/2003. This uncertainty results from various 
questions  or doubts  expressed by national competent authorities responsible for 
official controls or by economic operators concerning the classification of that 
substance , which is  current ly inclu ded in the Catalogue of feed materials established 
by Commission Regulation (EU ) No 68/20132.  
(2) Such uncertainty about the status of a product with regard to feed additives  may 
jeopardise the marketing of feed products throughout the Union, since the distinction 
between feed additives and other feed products has a major role as regard s the 
conditions of their placing on the market, under  the respective applicable legislation.   
(3) In order to allay the uncertainty regarding the status of attapulgite as a feed additive, it 
is appropriate to adopt a relevant measure under Regulation (EC) No 1831/2003, 
determining that status. Such measure would bring consistency in the treatment of the 
substance  concerned and would facilitate the work of the national competent 
authorities responsible for official controls, while helping the interested economi c 
operators to act in a framework providing for an appropriate level of legal certainty.  
(4) To determine whether a product is a feed additive within the scope of Regulation (EC) 
No 1831/2003, it is appropriate to refer to the guidelines for the distinction be tween 
feed additives, feed materials and other products, established by Recommendation 
2011/25/EU3. In particular, those guidelines provide for several criteria to be 
simultaneously considered in a case -by-case evaluation, in order to create a profile of 
each specific product, taking into account all its characteristics. Among the criteria for 
the differentiation between feed additives and feed materials are the production and 
processing method, the chemical definition and the level of standardisation or 
purification, the safety and mode of use and the functionality of the product concerned. 
                                                 
1 OJ L 268, 18.10.2003 , p. 29. 
2 Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials (OJ L 
29, 30.1.2013, p. 1).  
3 Commission Recommendation 2011/25/EU of 14 January 2011 establish ing guidelines for the 
distinction between feed materials, feed additives, biocidal products and veterinary medicinal products 
(OJ L 11, 15.1.2011).   
EN 2  EN In addition, for the sake of consistency, products with similar properties should be 
classified by analogy . 
(5) Based on an examination of the criteria in Recommendation 201 1/25/EU, it has been 
concluded that attapulgite should be considered as a feed additive within the scope of 
Regulation (EC) No 1831/2003 . Attapulgite is essentially used in order to perform 
technological functions in feed, such as binding, anti -caking or r educing mycotoxins 
contamination of feed, or even zootechnical functions by affecting animals’ gastro -
intestinal flora or digestibility of feed, which are typical of feed additives’ 
functionality. In addition,  the characteristics and properties of attapulg ite are very 
similar to those of other clay minerals which are considered as feed additives . 
Therefore,  the classification by analogy  of attapulgite as a feed additive would bring 
consistency in the treatment of those similar products.  
(6) As a consequence of the classification of attapulgite as a feed additive within the scope 
of Regulation (EC) No 1831/2003, it is appropriate to provide for a transitional period 
which would allow interested parties to adapt to the status of that substance, including 
for the p urposes of submission of an application for authorisation as a feed additive, 
and the further processing  of such application  in accordance with Regulation (EC) No 
1831/2003.  
(7) The measures provided for in this Regulation are in accordance with the opinion of  the 
Standing  Committee  on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Attapulgite is a feed additive within the scope of Regulation (EC) No 1831/2003.  
 
Article 2  
The substance referred to in Article 1 may continue to be placed on the market and used in 
accordance with the rules applicable to feed materials  until [OP please insert the date = 7  
years  after the date of entry into force of this Regulation] . 
 
Article 3 
This Regulation shall enter into force on the  twentieth  day follo wing 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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN