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)

• CELEX: Implementing Regulation (EU) 2022/965
• Articles: 5

Article 1

1.   Kernels from the edible variety of Jatropha curcas L. are authorised to be placed on the market within the Union.

Kernels from the edible variety of Jatropha curcas L. shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company ‘JatroSolutions GmbH’  ( 13 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 12 July 2022, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of ‘JatroSolutions GmbH’.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from 12 July 2022 without the agreement of ‘JatroSolutions GmbH’.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘

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.”

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

Cereal bars

5

Breakfast cereals

5

Dried fruits

5

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised Novel Food

Specification

‘

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

Batch weight (tons)

Weight or number of sublots

Number of incremental samples

≥ 500

100 tons

100

> 100 and < 500

5 sub-lots

100

> 10 and ≤ 100

5 sub-lots

100

> 5,0 and ≤ 10

-

80

> 1 and ≤ 5,0

-

60

> 0,1 and ≤ 1,0

-

30

≤ 0,1

-

10

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.

Characteristics/Composition:

Moisture: ≤ 3,0 %

Total fat: 54,0 – 61,0 %

Total protein: 21,0 – 32,0 %

Total fibre: 6,0 – 10,0 %

Ash: 3,0 – 5,0 %

Contaminants:

Phorbol esters (μg TPA eq (a) /g kernel) (b) : ≤ 0,75 (LOD) (c)

Lead: ≤ 0,20 mg/kg

Cadmium: ≤ 0,20 mg/kg

Sum of aflatoxins B1, B2, G1, G2: ≤ 4,0 μg/kg

Microbiological criteria:

Total aerobic microbial count: ≤ 1 000 CFU/g

Total yeast/moulds count: ≤ 100 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella sp.: Absent in 25 g

Listeria monocytogenes : ≤ 100 CFU/g

(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’