COMMISSION IMPLEMENTING REGULATION (EU) 2022/965
of 21 June 2022
authorising the placing on the market of kernels from the edible variety of
Jatropha curcas
L. as a novel food and amending Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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‘ Jatropha curcas L. (edible variety) kernels |
Specified food category |
Maximum levels (g/100g) |
The designation of the novel food on the labelling of the foodstuffs containing it shall be “kernels from edible Jatropha curcas L.” |
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Authorised on 12 July 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: “JatroSolutions GmbH”, Echterdinger Strasse 30, 70599 Stuttgart, Germany. During the period of data protection, the novel food kernels from the edible variety of Jatropha curcas L. is authorised for placing on the market within the Union only by “JatroSolutions GmbH”, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “JatroSolutions GmbH”. End date of the data protection: 12 July 2027.’ |
Kernels as such, candied or sugar preserved and as processed nuts |
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Cereal bars |
5 |
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Breakfast cereals |
5 |
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Dried fruits |
5 |
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Authorised Novel Food |
Specification |
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‘ Jatropha curcas L. (edible variety) kernels |
Description: The kernels are obtained from the seeds of the ripe fruits of the edible variety of the Jatropha curcas L. plants that produce kernels with non-detectable levels of phorbol esters, following a series of steps involving the cleaning and de-husking of the fruits to obtain the seeds, the drying of the seeds, the cleaning of the seeds to remove debris and other residues, mechanical deshelling of the seeds to obtain the kernels, and the hydrothermal treatment (> 120 °C for 40 minutes) of the kernels to reduce anti-nutrients and the microbiological load. As the edible variety of the Jatropha curcas L. plants, producing kernels that contain non-detectable levels of phorbol esters, are phenotypically undistinguishable from the non-edible variety, only the appropriate edible variety of Jatropha curcas L. plants should be used in the production of the novel food. The entire production process must ensure that the mixing of edible and non-edible kernels does not occur. The absence of mixing of edible with non-edible kernels shall be confirmed by analytical controls for phorbol esters carried on each batch of the seeds after the seed-drying step and before the deshelling step according to the sampling procedure of Table A. Five laboratory samples extracted from each aggregate sample are de-shelled, ground, and analysed for phorbol esters using a validated UHPLC-UV-MS(b) method. Only the batches in which phorbol esters are undetectable in all five samples are further processed to the seed deshelling and kernel hydrothermal treatment steps. Table A |
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Batch weight (tons) |
Weight or number of sublots |
Number of incremental samples |
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≥ 500 |
100 tons |
100 |
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> 100 and < 500 |
5 sub-lots |
100 |
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> 10 and ≤ 100 |
5 sub-lots |
100 |
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> 5,0 and ≤ 10 |
- |
80 |
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> 1 and ≤ 5,0 |
- |
60 |
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> 0,1 and ≤ 1,0 |
- |
30 |
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≤ 0,1 |
- |
10 |
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Each sub-lot shall be sampled separately. Aggregate samples are composed by a minimum of 10 incremental samples. The minimum amount of an aggregate sample shall be 3,5 kg. This amount may increase proportionally according to the number of incremental samples taken. |
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Characteristics/Composition:
Contaminants:
(a) TPAeq: 12-O-tetradecanoylphorbol-13-acetate equivalent; (b)Validated Ultra-High-Performance Liquid Chromatography coupled to Ultraviolet Spectrophotometry and Mass Spectrometry (UHPLC-UV-MS) method for detection of phorbol ester peaks; (c) Limit of Detection (Only batches with concentrations of PEs below the LOD can be fully processed.); CFU: Colony Forming Units’ |