EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11321/2018 CIS 
(POOL/E5/2018/11321/11321 -EN 
CIS.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the status of certain products as feed additives within the scope of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council and on the withdrawal 
from the market of certain feed additives  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the status of certain products as feed additives within the scope of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council and on the withdrawal 
from the market of certain feed additives  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard t o Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council of 22 September 2003 on additives for use in animal nutrition1, and in particular 
Articles 2(3) and 10(5)  thereof,  
Whereas:  
(1) Regulation (EC) No 1831/2003 provides for the authorisa tion of additives for use in 
animal nutrition and for the grounds and procedures for granting such authorisatio n. In 
particular, Article 10(2) , in conjunction with Article 10(7)  of that Regulation provide s 
for specific procedures for the re -evaluation of a dditives authorised pursuant to 
Council Directive 70/524/EEC2 and Council Directive 82/471/EEC3. 
(2) Article 10(5) of Regulation (EC) No 1831/2003 imposes an obligation on the 
Commission to adopt a Regulation withdrawing from the market feed additives for 
which no notification referred to in Article 10(1)(a) of that Regulation was supplied 
within a specif ied period. The same obligation applies to feed additives for which no 
applications in accordance with Article 10(2) and (7) of Regulation (EC) No 
1831/2003 were submitted before the deadline provided for in those provisions, or for 
which an application wa s submitted but subsequently withdrawn.  
(3) Therefore, such feed additives should be withdrawn from the market. As Article 10(5) 
of Regulation (EC) No 1831/2003 does not differentiate between authorisations issued 
with a time limit and authorisations without a time limit, for clarity reasons it is 
appropriate to provide for the withdrawal from the market of feed additives whose 
limited authorisation periods pursuant to Directive 70/524/EEC have already expired.  
(4) In the case of feed additives for which applications have been submitted only for 
certain animal species or categories of animals, or applications have been withdrawn 
only for certain animal species or categories of animals, the withdrawal from the 
market should only concern the animal species a nd categories of animals for which no 
application has been submitted or the application has been withdrawn.   
                                                 
1 OJ L 268, 18.10.2003, p. 29.  
2 Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 
14.12.1970, p. 1).  
3 Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition 
(OJ L 213, 21.7.1982, p. 8).  EN 2  EN (5) As a consequence of the withdrawal from the market of the feed additives, it is 
appropriate to repeal the provisions authorising them , where such p rovisions are still 
in force . Conse quently, Commission Regulations (EC) No 2439/19994 and (EC) No 
358/20055 should be amended  accordingly . 
(6) As regards feed additives whose authorisation did not expire until the date of entry 
into force of this Regulation,  it is appropriate to allow a transitional period for 
interested parties , within which existing stocks of the additives concerned, 
premixtures, feed materials and compound feed which have been produced with those 
additives may be used up, taking account of t he shelf -life of certain feed containing the 
additives in question.   
(7) The withdrawal from the market of the products listed in Annex I does not prevent 
them from being authorised or subject to  a measure concerning their status in 
accordance with Regulation (EC) No 1831/2003.  
(8) For several  substances, micro -organisms or preparations (referred to as “ products ”), 
there is uncertainty whether they are feed additives within the scope of Regulation 
(EC) No 1831/2003.  This uncertainty  may result from the inclusion of certain products 
both in the Register of feed additives referred to in Article 17 of Regulation (EC) No 
1831/2003 and in the Catalogue of feed materials established in accordance with 
Article 24 of Regulation (EC) No 767/2 009 of the European Parliament and of the 
Council6.  The uncertainty may also derive from various doubts or questions expressed 
by national competent authorities responsible for official controls or by economic 
operators concerning the classification of ce rtain products, taking into account in 
particular the guidelines established by Commission Recommendation 2011/25/EU7. 
(9) Such uncertainty about  the status of certain products with regard to feed additives 
within the scope of Regulation (EC) No 1831/2003 may jeopardise the marketing of 
feed products throughout the Union, since the distinction between feed additives and 
other feed products has imp lications for the conditions of  their placing on the market, 
depending on the relevant applicable legislation.  
(10) In or der to allay the uncertainty regarding the status as feed additives of certain 
products, it is appropriate to adopt relevant measures under Regulation (EC) N o 
1831/2003, clarify ing that status.  Such measures would bring consistency in the 
treatment of the products concerned and would facilitate the work of the national 
competent authorities responsible for official controls, while helping the interested 
economic operators to act in a framework providing for an appropriate level of legal 
certainty.  
                                                 
4 Commission Regulation (EC) No 2439/1999 of 17 November 1999 on the conditions for the 
authorisation of additives belonging to the group “binders, anti -caking agents and coagulants” in 
feeding stuffs (OJ L 297, 18.11.1999, p. 8).  
5 Commission Regulation (EC) No 358/2005 of 2 March 2005 concerning the authorisation without a 
time limit of certain additives and the authorisation of new uses of additives already authorised in 
feedingstuffs (OJ L 57 , 3.3.2005, p. 3).  
6  Regulation (EC) No 767/2009 of the E uropean 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 (EC) No 
1831/2003 and repealing Council Direct ive 79/373/EEC, Commission Directive 80/511/EEC, Council 
Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 
2004/217/EC (OJ L 229, 1.9.2009, p. 1).  
7 Commission Recommendation 2011/25/EU of 14 January 2011 establis hing guidelines for the 
distinction between feed materials, feed additives, biocidal products and veterinary medicinal products 
(OJ L 11, 15.1.2011, p. 75).  EN 3  EN (11) To determ ine whether products are feed additives within the scope of Regulation (EC) 
No 1831/2003, it is appropriate to refer to the guidelines for the distinction between 
feed additives, feed materials and other products, established by Recommendation 
2011/25/EU. 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. Useful criteria for the 
differenti ation between feed additives and feed materials include the production and 
processing method, the chemical definition and the level of standardisation or 
purification, the safety conditions and mode of use, the functionality of the product 
concerned. In ad dition, for the sake of consistency, products with similar properties 
should be classified by analogy.  
(12) The products sodium citrates, potassium citrates, sorbitol, mannitol and calcium 
hydroxide are included in the Register of feed additives as existing pro ducts for which 
no applications in accordance with Article 10(2) of Regulation (EC) No 1831/2003 
were submitted before the deadline prescribed by that provision. They have also been 
included in the Catalogue of feed materials by Commission Regulation (EU) No 
575/20118. However, a re -examination of the profile of those products with regard to 
the criteria proposed in Recommendation 2011/25/EU led to the conclusion that they 
should be considered as feed additives within the scope of Regulation (EC) No 
1831/20 03. In particular, they are defined by their specific functions referred to in the 
Register of feed additives and their feed additives status allows improved scope for an 
effective management thereof in terms of safety and mode of use. In addition, account  
is taken of their classification as additives for use in food.  
(13) The feed additives status of  the products sodium citrates, potassium citrates, sorbitol, 
mannitol and calcium hydroxide makes it necessary to  withdraw  them  from the market  
as provided for by A rticle 10(5) of Regulation (EC) No 1831/2003. However, a longer 
transitional period should be allowed for the withdrawal from the market of those 
additives and of feed containing them , in order to take account of the  legal uncertainty 
about  their classific ation,  allow ing interested parties to submit a new application for 
authorisation of those feed additives under the procedures set out in Regulation (EC) 
No 1831/2003.  
(14) Most of t he products listed in Annex II are included in the Catalogue of feed materials 
established by Commission Regulation (EU) No 68/20 139. However,  they are all , in 
addition,  either listed in the Register of feed additives or have been subject to a 
withdrawal from the market as feed additives under Article 10(5) of Regulation (EC) 
No 1831/ 2003. In order to provide legal certainty concerning the status of those 
products, their respective profiles were examined in the light of the criteria proposed 
in Recommendation 2011/25/EU, leading to the conclusion that they should no longer 
be considere d as feed additives within the scope of Regulation (EC) No 1831/2003.  
(15) As regards the labelling of the products listed in Annex II which are still allowed on 
the market as feed additives, and the labelling of premixtures, feed materials and 
compound feed containing those products, a transitional period should be provided for 
to allow feed business operators t o adapt. Furthermore , those products should be 
deleted from the Register of feed ad ditives.  
                                                 
8  Commission Regulation (EU) No 575/2011 of 16 J une 2011 on the Catalogue of feed materials (OJ L 
159, 17.6.2011, p. 25).  
9  Commission Regulation  (EU) No 68/2013 of 16 J anuary 2013 on the Catalogue of feed materials (OJ L 
29, 30.1.2013, p. 1).  EN 4  EN (16) The products xylitol, ammonium lactate and ammonium acetate are included in the 
Catalogue of feed materials established by Regulation (EU) No 68/2013. However, 
some doubts have been expressed notably by national competent authorities 
responsible f or official controls as to their legal status, which led to an examination of 
their respective profiles based on the criteria proposed in Recommendation 
2011/25/EU. Based on that examination, it has been concluded that those products 
should be considered a s feed additives within the scope of Regulation (EC) No 
1831/2003. In particular, the characteristics of xylitol are very similar to those of 
mannitol and sorbitol, which are co nsidered as feed additives, and the classification of 
xylitol as a feed additiv e by analogy would bring consistency in the treatment of those 
similar products. In addition, account is taken of the classification of xylitol as 
additive for use in food. As regards ammonium lactate and ammonium acetate, they 
are chemically well -defined substances that are purified and exerting a specific 
function defined in Article 5(3) of Regulation (EC) No 1831/2003 and their feed 
additives status allows improved scope for an effective management thereof in terms 
of safety and mode of use. Moreover, a classification of ammonium lactate and 
ammonium acetate as feed additives would bring  consistency with other similar 
products considered as feed additives , such as ammonium propionate or ammonium 
formate . 
(17) As a result of the classification of xylitol, ammon ium lactate and ammonium acetate as 
feed additives 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 
new status of those products , including the sub mission of an application for 
authorisation , and the further processing thereof,  under the procedures set out in 
Regulation (EC) No 1831/2003.  
(18) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Plan ts, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Withdrawal from the market  
The feed additives specified in Annex I shall be withdrawn from the market in respect of the 
animal species or categories of animals as specified in that Annex.  
Article 2  
Transitional measures for the feed additives to be withdrawn  from the market  
1. Existing stocks of the feed additives listed in Chapter s I.A and I.C of Annex I may 
continue to be placed on the market and used until [ 12 months from the date of entry 
into force of this Regulation – Date to be inserted by the Service respo nsible for the 
publication ]. 
2. Premixtures produced with the additives referred to in paragraph 1 may continue to 
be placed on the market and used until [ 15 months from the date of entry  into force of 
this Regulation – Date to be inserted by the Service re sponsible for the publication ]. 
3. Compound feed and feed materials produced with the additives referred to in 
paragraph 1 or with the premixtures referred to in paragraph 2 may continue to  be 
placed on the market and used until [ 24 months from the date of entry into force of 
this Regulation – Date to be inserted by the Service re sponsible for the publication ]. EN 5  EN 4. By way of derogation from  paragraphs 1, 2 and 3, t he feed additives sodium citrates, 
potassium citrates, sorbitol, mannitol and calcium hydroxide listed in Chapter I.A  of 
Annex I, and feed produced with those additives, may continue to be placed on the 
market and used until [ 7 years from the date of entry into fo rce of this Regulation – 
Date to be inserted by the Service responsible for the publication ]. 
Article 3  
Amendment to Regulation (EC) No 2439/1999  
 
In the Annex to Regulation (EC) No 2439/1999, entry E 558 on bentonite -montmorillonite is 
deleted.  
Article 4  
Amendment to Regulation (EC) No 358/2005  
In Annex II to Regulation (EC) No 358/2005, entry E 141 on chlorophyll copper complex is 
deleted.  
Article 5  
Products not considered as feed additives within the scope of Regulation (EC) No 
1831/2003  
1. The substances , micro -organisms or preparations (referred to as “products”)  set out 
in Annex II are not feed additives within the scope o f Regulation (EC) No 
1831/2003.  
2. Products r eferred to in paragraph 1 which are lawfully on the market and are labelled 
as feed additives and premixtures before [3 years from the date of entry into force of 
this Regulation – Date to be inserted by the Service responsible for the publication ] 
may continue to be placed on the market until stocks are exhausted. The same applies 
to feed materials or compound feed which refer to those products in their labelling as 
feed additives in accordance with Regulation (EC) No 767/2009.  
Article 6 
Products considered as feed additives within the scope of Regulation (EC) No 1831/2003  
1. The su bstances , micro -organisms or preparations (referred to as “products”)  set out 
in Annex III  are feed additives within the scope of Regulation (EC) No 1831/2003.  
2. Products referred to in paragraph 1 may continue to be placed on the market and used 
until [ 7 years from the date of entry into force of this Regulation – Date to be 
inserted by the Service responsible for the publication ]. 
Article 7 
Entry into force  
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.  EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN