   
  
G/SPS/N/EU/562  
 
26 April 2022  
(22-3321) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Preparation of a kind used in animal nutrition (HS code: 2309)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Commission Implementing Regulation  (EU) 2022/653 
concerning the authorisation of a preparation of the leaves extract of Meliss a officinalis  L. 
as a feed additive for all animal species (Text with EEA relevance) . Language(s):  English, 
French and Spanish . Number of pages:  5 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3045_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3045_00_f.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_3045_00_s.pdf  
6. Description of content:  The leaves extract of Melissa officinalis  L. was authori zed 
without a time limit in accordance with Directive  70/524/EEC as a feed additive for all 
animal species. That additive was subsequently entered in the Register of feed additives as 
an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No  1831/2003. 
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with 
Article 7 thereof, an application was submitted for the re -evaluation of a preparation of the 
leaves extract of Melissa officinalis  L. for all animal species. Th e applicant requested the 
additive to be classified in the additive category 'sensory additives' and in the functional 
group 'flavouring compounds'. That application was accompanied by the particulars and 
documents required under Article 7(3) of Regulation  (EC) No 1831/2003. The applicant 
requested the preparation of the leaves extract of Melissa officinalis  L. to be authori zed 
also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow 
the authori zation of flavouring compounds for use in water for drinking. Therefore, the use 
of the preparation of the leaves extract of Melissa officinalis  L. in water for drinking should 
not be allowed. The European Food Safety Authority ('the Authority') concluded in its 
opinions of 28 January 2 020 and 29 September 2021 that, under the proposed conditions 
of use, the preparation of the leaves extract of Melissa officinalis  L. does not have adverse 
effects on animal health, consumer health or the environment. The Authority also 
concluded that the exposure of users to dusts from the additive is not of concern. 
However, no data was provided on irritant properties for eyes or skin, thus no conclusion 
could be drawn on these aspects. Due to the nature of the additive, it may be assumed to 
be potentiall y both a skin and respiratory sensitiser. Therefore, the Commission considers 
that appropriate protective measures should be taken to prevent adverse effects on human 
health, in particular as regards the users of the additive. The Authority concluded, that  the 
preparation of the leaves extract of Melissa officinalis  L. is recogni zed to flavour food and G/SPS/N/EU/562  
 
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  its function in feed would be essentially the same as that in food, therefore, no further 
demonstration of efficacy is considered necessary. It also verified  the report on the 
methods of analysis of the feed additive in feed submitted by the Reference Laboratory set 
up by Regulation (EC) No 1831/2003.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Code of practice on Good Animal Feeding 
CAC/RCP  54-2004 
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM nu mber) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 20 April 2022  
Proposed date of publication (dd/mm/yy) : 21 April 2022  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation will enter into force on the twentieth day following its 
publication in the Official Journal of the European Union.  
[X] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa. eu 
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
 