Annex H: RP687 - Lactiplantibacillus plantarum as a feed additive for all animal species

Background 

Name of applicant:

Chr. Hansen A/S

Address of applicant:

10-12 Boege Allé
2970
Hoersholm
Denmark

FSA/FSS Safety Assessment 

FSA/FSS has undertaken a safety assessment of application RP687 for the use of Lactiplantibacillus plantarum (DSM 26571) as a feed additive for all animal species, from Chr. Hansen A/S.

FSA/FSS has reviewed the EFSA opinion (EFSA Journal 2021;19(10):6898) and confirm that it is adequate for UK considerations and therefore a full safety assessment of this application was not performed by FSA and FSS. Please see the earlier section titled ‘Our safety assessment process’ to understand how and when we make use of EFSA opinions.

It is the FSA/FSS opinion that Lactiplantibacillus plantarum (DSM 26571), as described in this application, is safe and is not liable to have an adverse effect on the target species, worker safety, environmental safety and human health at the intended concentrations of use. The proposed terms of authorisation are set out below.

Any relevant provisions of retained EU law

Under the requirements of the Regulation for feed additives: 

1. Article 16 and points 1(c), 1(e) and 2 of Annex III: Labelling and packaging requirements apply, if authorised. 
2. Article 21: Analytical methods have been verified by the European Reference Laboratory as used for the control of Lactiplantibacillus plantarum (DSM 26571) in animal feed as detailed in the EURL analytical method evaluation report (FAD-2019-0091). Valid analytical methods exist for: 

• The identification of the bacterial strain L. Plantarum (DSM 26571) 
• the enumeration (bacterial count) of the bacteria in the feed additive. 

    3. Annex IV: The general conditions of use must be complied with, where applicable for the individual feed additive authorisation  

Proposed terms of authorisation

1: Additive details

2: Additive composition 

Solid preparation of Lactiplantibacillus plantarum (DSM 26571) containing a minimum of 1 x 1011 CFU/g additive. 

3: Characterisation / identification of the active substance(s) 

Viable cells of Lactiplantibacillus plantarum (DSM 26571)

4: Conditions of use

5: Other Provisions

1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 
2. Minimum content of the additive when not combined with other micro-organisms as silage additives: 1 x 108 CFU/kg of easy, moderately difficult and difficult to ensile fresh material.  

6: Analytical methods 

For enumeration (colony count) of the feed additive:
Spread plate method on MRS agar (BS EN 15787:2021) 

For identification of bacterial strain:
Pulsed Field Gel Electrophoresis (PFGE)

Other relevant information (separate to terms of authorisation)

1: Supplementary information

• Feed additives are subject to UK health and safety legislation. The safety assessment identified that particular consideration should be given to hazards as a:
  • respiratory sensitiser.
• Definitions of silage, in accordance with Retained EU Regulation 429/2008:
  • Easy to ensile forage: >3 % soluble carbohydrates in fresh material.
  • Moderately difficult to ensile forage: 1.5-3.0% soluble carbohydrates in fresh material.
  • Difficult to ensile forage: <1.5 % soluble carbohydrates in the fresh material.
• Major animal species and their subgroups are defined in Annex IV of Retained EU Regulation 429/2008.