EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10798/2020 CIS 
(POOL/E5/2020/10798/10798 -EN.docx) 
CIS 
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the denial of authorisation of phosphoric acid 60% on silica carrier as a feed 
additive belonging to the functional groups of preservatives  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
concerning the denial of authorisation of phosphoric acid 60% on silica carrier  as a feed 
additive belonging to the functional groups of preservatives  
(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 P arliament and of the 
Council of 22 September 2003 on additives for use in animal nutrition1, and in particular 
Article 9(2) thereof,  
Whereas:  
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in 
animal nutrition and for the grounds and procedures for granting or denying such 
authorisation. Article 10 of that Regulation provides for the re -evaluation of additives 
authorised pursuant to Council Directive 70/524/EEC2.  
(2) Orthophosphoric acid was authorised without a time limit by Directive 70/524/EEC  as 
a feed additive for all animal species . The additive was subsequently entered in the 
Register of Feed Additives as an existing product, in accordance with Article 10(1) of 
Regulation (EC) No 1831/2003 .  
(3) In accordance with Article 10 (2) of Regulation (EC)  No 1831/2003  in conjunction 
with Article 7 thereof, two  applications for re -evaluation  of orthophosphoric acid were 
submitted  to the Commission .  
(4) The first of those applications concerned  a preparation of orthophosphoric acid (67% -
85,7%) w/w (aqueous solution) . That preparation  was authorised by Commission 
Implementing Regulation (EU) No 1055/20133 for 10 years as a feed additive  for all 
animal species .  
(5) The second application was  submitte d for the re-evaluation of phosphoric acid 60% on 
silica carrier as a feed additive for all animal species . The applicant requested  the 
additive  to be classified in the additive category ‘technological additives ’ and in the 
functional group ‘preservatives ’. The application was  accompanied by the particulars 
and documents required under Article 7(3) of Regulation (EC) No  1831/2003.  
(6) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 
March 20204 that considering the limited dat a provided in the original dossier and the 
                                                 
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 Commission Implementing Regulation (EU) No 1055/2013 of 25 October 2013 concerning the 
authorisation of a preparation of orthophosphoric acid as a feed additive for all animal species (OJ L 
288, 30.10.2013 , p. 57). 
4 EFSA Journal 2020;18(4):6064 . EN 2  EN absence of response from the applicant to the several requests from the Authority for 
additional information , initially on 22 July 2011 and finally on 3 March 2020 , the 
Authority was not in a position to deliver a n opinion on the safety and efficacy of 
phosphoric acid 60% on silica carrier as a feed additive for all animal species . 
(7) In addition, on 8 May 2020 the Commission requested the applicant to communicate 
information on the follow -up of the application  concer ned, but no response was 
provided . 
(8) According to Article 5(1) of Regulation (EC) No 1831/2003, the applicant must 
adequately and sufficiently demonstrate , in accordance with the implementing 
measures5 to Regulation (EC) No 1831/2003,  that the additive satisfies the conditions 
for authorisation laid down in that Regulation.  
(9) As the applicant  did not provide the requested information and data allowing the 
Authority to as sess the safety and efficacy of phosphoric acid 60% on silica carrier , it 
has not been established that , under the proposed conditions of use,  the additive does 
not have an adverse effect on animal health, human health or the environment, and that 
it has at least one  of the characteristics set out in Article 5(3)  of Regulation (EC) No 
1831/2 003.  
(10) The assessment of phosphoric acid 60% on silica carrier shows that the conditions for 
authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not 
satisfied . Accordingly, the authorisation of th e additive should be denied . 
(11) Therefore, phosphoric acid 60% on silica carrier , as an existing product  within the 
meaning of Article 10 of Regulation (EC) No 1831/2003 , as well as feed containing it, 
should be withdrawn from the  market . However, a limited period should be allowed 
for the withdrawal from the market of the existing stocks of the additive  and its 
premixtures , and feed containing them , in order to enable operators to comply properly 
with the withdrawal obligation .  
(12) 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  
Denial of authorisation  
The authorisation of  phosphoric acid 60% on silica carrier  as a feed additive , belonging to the 
additive category  ‘technological additives’ and to the functional group  ‘preservatives ’, is 
denied . 
                                                 
5 Commiss ion Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of 
Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the 
preparation and the presentation of applications and the assessment and t he authorisation of feed 
additives (OJ L 133, 22.5.2008, p. 1).  EN 3  EN Article 2  
Withdrawal from the market  
1. Existing stocks of t he additive referred to in Article 1 , and of premixtures containing it, 
shall be withdrawn from the market by  [6 months after the date of entry into force of this 
Regulation – Date to be inserted by the Service responsible for the publication ].  
2. Feed materials and compound feed intended for food -producing animals , which have been 
produced with the additive  or the premixtures  referred to in paragraph 1 before [6 months 
after the date of entry into force of this Regulation – Date to be inserted by the Service 
responsible for the publication ], shall be withdrawn from the market by [12 months after the 
date of entry in to force of this Regulation – Date to be inserted by the Service responsible for 
the publication ]. 
3. Feed materials and compound feed intended for non -food-producing animals, which have 
been produced with the additive or the premixtures referred to in paragraph 1 before [6 
months after the date of entry into force of this Regulation – Date to be inserted by the Service 
responsible for the publication ], shall be withdrawn from the market by [24 months after the 
date of entry into force of this Regulation – Date to be inserted by the Service responsible for 
the publication ]. 
Article 3 
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.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LE YEN