Barley Rice Protein Discussion Paper

Committee Paper for Discussion - ACNFP/155/03

Advisory Committee for Novel Foods and Processes 

Application for Authorisation of Barley Rice Protein as a Novel Food.

Application number RP19 

Issue

The Committee reviewed the draft safety assessment output for this application in September 2022. Further information on which to base the ACNFP’s assessment was sought. Members are invited to consider the response from the applicant and whether it addresses the requests for information satisfactorily or if further information is required.

Background

1. On the 9 January 2021, the FSA received a dossier from Evergrain for authorisation of barley rice protein, a mixture of protein from barley at levels of 0-100% and rice at levels of 0-60%. The applicant intends to market the product within the food categories: bakery products, breakfast cereals, spreadable fats and dressings, grain products and pastas, snack foods, jam, marmalade and other fruit spreads, candy/confectionery, dairy and dairy imitates, dessert sauces and syrups, meat imitates, soups and soup mixes, savoury sauces, legume-based spreads, nut-based spreads, energy drinks, foods and beverages intended for sportsmen and meal replacements for weight control.

2. The Committee reviewed draft safety assessment for this application at the 155^th ACNFP meeting of September 2022. The Committee identified several areas where additional information was required from the applicant to inform the safety evaluation of their application. Information was requested on the:

• Composition
• Nutritional Information

3. The applicant has provided a response to the Committee on these areas and the Committee is asked whether this addresses the outstanding questions on the dossier.

4. To inform the discussion and further development of an opinion. The FSA’s request for further information and the applicant’s response are included as Annexes A and B (confidential), respectively. An updated draft opinion is provided in Annex C and reflects the responses from the applicant.

The applicant’s response

Composition

5. The Committee sought further clarification on how the 24 month shelf life was identified, in particular whether other measures were considered, apart from microbiological analysis. In their response the applicant provided analysis of a another accelerated stability study with 1 production batch of Barley Rice Protein under the same conditions for up to 24 weeks, The applicant provided evaluation of the sensory properties of Barley Rice Protein, along with proximate parameters and microbiological contaminants. The applicant also noted an EFSA review for a similar type of novel food, which was tested under accelerated conditions and use of the Arrhenius equation to yield a shelf-life of approximately 2 years.

6. The Committee sought clarification on data presented for analysis of mycotoxins. The applicant clarified that the same validated method was used for all analyses with an LOQ for the aflatoxins analyses of 1 µg/kg

7. The Committee sought clarification on results presented for analysis of mycotoxins, which were recorded as not measured. The applicant responded by explaining why these results were recorded as not measured and provided analyses for mycotoxins in 6 additional batches of Barley Rice Protein, demonstrating the levels to be below the LOQ,

Nutritional Information

8. The Committee sought information on the regulatory limits employed for the analysis of antinutrients. The applicant noted regulatory limits do not exist in the EU or UK, but OECD have highlighted that barley and rice contain common antinutrients and levels of these compounds have not been present at unsafe levels in both barley and rice.

Committee Action Required

• The Committee is asked whether the response from the applicant is sufficient to address its concerns in regard to the issues discussed at the last meeting.
• If so, the Committee is asked, whether it is content to recommend approval of Barley Rice Protein produced by Evergrain. A draft opinion is provided for consideration at Annex C.
• ·If not, the Committee is asked to indicate what further data is required and the feedback that should be given to the applicant.

ACNFP Secretariat October 2022 

Annexes 

Annex A – Request for further information 

Annex B – Applicant’s response to request for further information 

Annex C - A draft opinion for consideration