EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX 
SANTE/ 8817637/2022 
[…](2023) XXX draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX 
concerning the authorisation of guanidinoacetic acid and a preparation of 
guanidinoacetic acid as feed additives for chickens reared for breeding and chickens 
reared for laying in feed and in water for drinking, and chickens for fattening in water 
for drinking (holder of authorisation: Alzchem Trostberg GmbH), and correcting and 
amending Implementing Regulation (EU) 2016/1768  
 
(Text with EEA relevance) 
  
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX 
concerning the authorisation of guanidinoacetic acid and a preparation of 
guanidinoacetic acid as feed additives for chickens reared for breeding and chickens 
reared for laying in feed and in water for drinking, and chickens for fattening in water 
for drinking (holder of authorisation: Alzchem Trostberg GmbH), and correcting and 
amending Implementing Regulation (EU) 2016/1768  
 
(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 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 such authorisation.  
(2) The additive guanidinoacetic acid was authorised as a substance and as a preparation 
for use in feed for chickens for fattening, weaned piglets and pigs for fattening by 
Commission Implementing Regulation (EU) 2016/17682. 
(3) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was 
submitted for the authorisation of new uses of guanidinoacetic acid and a preparation 
of guanidinoacetic acid. The application was accompanied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003.  
(4) That application concerns the authorisation of guanidinoacetic acid and a preparation 
of guanidinoacetic acid as feed additives for all animal species for use in feed and in 
water for drinking, requesting those additives to be classified in the category 
‘nutritional additives’ and in the functional group ‘amino acids, their salts and 
analogues’. 
(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 
September 20223 that, under the proposed conditions of use in feed and in water for 
drinking, guanidinoacetic acid and a preparation of guanidinoacetic acid are safe for 
chickens for fattening, chickens reared for breeding, chickens reared for laying, piglets 
and pigs for fattening for use in feed and in water for drinking, and safe for consumers 
and the environment. The Authority further concluded that guanidinoacetic acid is not 
 
1 OJ L 268, 18.10.2003, p. 29. 
2  Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 concerning the authorisation 
of guanidinoacetic acid as a feed additive for chickens for fattening, weaned piglets and pigs for 
fattening and repealing Commission Regulation (EC) No 904/2009 (OJ L 270, 5.10.2016, p. 4). 
3 EFSA Journal 2022;20(5):7269.  
EN 2  EN toxic by inhalation, that it is not an irritant to skin and eyes and that it is not a dermal 
sensitiser. The Authority recommended to consider that the proposed maximum safe 
levels of the additives are based on the assumption that the feed contains sufficient 
methyl donors (other than methionine, e.g. choline, betaine and folic acid) and vitamin 
B12.  
(6) The Authority also concluded that the additives have the potential to be efficacious for 
chickens reared for laying and for breeding, chickens for fattening, weaned piglets and 
pigs for fattening.  This efficacy is related to an improvement of performance 
parameters in those animal species. In its opinions on guanidinoacetic acid adopted on 
27 January 20164 and 28 September 2022, the Authority stated that this additive 
should not be considered as belonging to the functional group ‘amino acids, their salts 
and analogues’, because guanidinoacetic acid is exclusively converted to creatine and 
cannot be converted back to an amino acid, while the functional group ‘amino acids, 
their salts and analogues’ comprises substances which finally enter the metabolism of 
the body and as such take part in the protein synthesis pathways. The Authority further 
concluded that to support a new nutritional effect of the additives concerned, relevant 
evidence of their efficacy in pigs and poultry should be provided. The Authority did 
not consider that there is a need for specific requirements of post-market monitoring. It 
also verified the report on the method of analysis of the feed additives in feed and in 
water submitted by the Reference Laboratory set up by Regulation (EC) No 
1831/2003.  
(7) Guanidinoacetic acid and the preparation of guanidinoacetic acid should therefore be 
re-allocated to the category ‘zootechnical additives’ and the functional group “other 
zootechnical additives”, taking into account the considerations from the Authority in 
relation to the effects of the additives on animal’s zootechnical performance and the 
fact that they do not correspond to the type of products included in the functional 
group ‘amino acids, their salts and analogues’.  
(8) Pursuant to Commission Regulation (EC) No 429/20085 and the Authority’s guidance 
on the assessment of the efficacy of feed additives6, a minimum of three studies should 
be provided to demonstrate efficacy for the relevant target species and categories of 
animals as regards zootechnical additives affecting animal production or performance. 
Accordingly, additional studies should be provided by the applicant with regard to the 
use of guanidinoacetic acid and the preparation of guanidinoacetic acid for weaned 
piglets and pigs for fattening. 
(9) Implementing Regulation (EU) 2016/1768 provides that guanidinoacetic acid is 
allowed to be placed on the market and used as an additive consisting of a preparation, 
but the composition of such preparation has erroneously not been specified in the 
terms of the authorisation. A more accurate description of guanidinoacetic acid 
authorised both as a substance and as a preparation by Implementing Regulation (EU) 
2016/1768 should be provided for, by  specifying the composition of the additive 
authorised as a preparation. A different identification number should also be assigned 
to distinguish between the two forms of additive.  
 
4  EFSA Journal 2016;14(2):4394. 
5  Commission 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 the authorisation of feed 
additives (OJ L 133, 22.5.2008, p. 1). 
6  EFSA Journal 2018 ;16(5) :5274.  
EN 3  EN (10) Both the re-allocation of the additives to the functional group ‘other zootechnical 
additives’, including the mention of the holder of the authorisation, and the 
specification of the composition of the preparation of guanidinoacetic acid should be 
reflected in the authorisation granted by Implementing Regulation (EU) 2016/1768, 
which should therefore be corrected accordingly. 
(11) In addition, the authorisation granted by Implementing Regulation (EU) 2016/1768 
should provide for specific labelling requirements concerning the storage and stability 
conditions of the additives and premixtures concerned. That authorisation should also 
no longer refer to users’ safety procedures and measures, based on the conclusions of 
the Authority’s opinion of 28 September 2022. Furthermore, due to the authorisation 
of guanidinoacetic acid and of the preparation of guanidinoacetic acid for use both in 
feed and in water for drinking, it is appropriate to provide that the simultaneous use of 
the additives in feed and in water for drinking is not permitted, in order to avoid any 
risk of exceeding the safe levels of use for the target animals. Implementing 
Regulation (EU) 2016/1768 should therefore be amended accordingly. 
(12) The assessment of guanidinoacetic acid and of the preparation of guanidinoacetic acid 
shows that the conditions for authorisation, as provided for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied as regards their use for chickens for fattening, 
chickens reared for laying and chickens reared for breeding. Accordingly, the use of 
those additives should be authorised for use in feed and in water for drinking. As 
regards the use in feed, the authorisation granted by this Regulation should only 
concern chickens reared for breeding and chickens reared for laying.  
(13) Since safety reasons do not require the immediate application of the modifications to 
the conditions of authorisation of the additives authorised by Implementing Regulation 
(EU) 2016/1768, it is appropriate to provide for a transitional period for interested 
parties to prepare themselves to meet the new requirements resulting from those 
modifications. In particular, the re-allocation of the additives to the category 
‘zootechnical additives’ results in the granting of the related authorisation to a specific 
holder. The transitional period should therefore allow interested parties to submit an 
application for authorisation of the additives concerned belonging to the category 
‘zootechnical additives’, and it should take account of the time needed to process such 
an application in accordance with Regulation (EC) No 1831/2003. However, the 
transitional period should not exceed the expiry date of the authorisation granted by 
Implementing Regulation (EU) 2016/1768. 
(14) 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 
Authorisation 
The substance and the preparation specified in Annex I, belonging to the additive category 
‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, are 
authorised as additives in animal nutrition, subject to the conditions laid down in that Annex. 
Article 2 
Correction and amendment to Implementing Regulation (EU) 2016/1768 
1. The title of Implementing Regulation (EU) 2016/1768 is replaced by the following:  
EN 4  EN “Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 
concerning the authorisation of guanidinoacetic acid and a preparation of 
guanidinoacetic acid as feed additives for chickens for fattening, weaned piglets and 
pigs for fattening (holder of authorisation: Alzchem Trostberg GmbH) and repealing 
Commission Regulation (EC) No 904/2009”. 
2. Article 1 of Implementing Regulation (EU) 2016/1768 is replaced by the following: 
“The substance and the preparation specified in the Annex, belonging to the additive 
category ‘zootechnical additives’ and to the functional group ‘other zootechnical 
additives’, are authorised as additives in animal nutrition subject to the conditions 
laid down in that Annex.”. 
3. The Annex to Implementing Regulation (EU) 2016/1768 is replaced by Annex II to 
this Regulation. 
Article 3 
Transitional measures 
The substance and the preparation specified in Annex II, for use in feed for chickens for 
fattening, weaned piglets and pigs for fattening, and feed containing them, may continue to be 
placed on the market and used until 25 October 2026 in accordance with the rules applicable 
before [the date of entry into force of this Regulation – Date to be inserted by the Service 
responsible for the publication ]. 
 
Article 4 
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 LEYEN