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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001note, and in particular Article 12(1) thereof,Whereas:
(1)Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470note has established a Union list of novel foods.
(3)On 20 May 2020, the company Wageningen Plant Research (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place Lemna minor and Lemna gibba plants on the Union market as novel food. The applicant requested for the novel food to be used as a vegetable, similar to other leafy vegetables, cooked or added to ready-to-eat products for the general population.
(4)On 27 October 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Lemna minor and Lemna gibba whole plant material as novel food.
(5)On 28 September 2022, the Authority adopted its scientific opinion on the ‘Safety of Lemna minor and Lemna gibba whole plant material as novel food pursuant to Regulation (EU) 2015/2283’note in accordance with Article 11 of Regulation (EU) 2015/2283.
(6)In its scientific opinion, the Authority concluded that the novel food, contains higher amounts of manganese as compared to the normally present concentration of manganese in other leafy vegetables, which may be of safety concern. Therefore, the safety of the novel food could not be established.
(7)Following the adoption of the scientific opinion, the applicant has requested to the Commission the possibility to address the safety concerns highlighted by the Authority in its conclusion by providing additional information showing that by reducing the manganese concentrations in the cultivation medium, the manganese content in Lemna gibba does not exceed the manganese content in leafy vegetables.
(8)On 30 April 2024, the Commission requested the Authority for scientific and technical assistance with respect to the EFSA scientific opinion on ‘Safety of Lemna minor and Lemna gibba whole plant material as novel food pursuant to Regulation (EU) 2015/2283’, in order to further evaluate whether the additional information provided by the applicant addresses the concerns related to the manganese intake.
(9)On 10 July 2024, the Authority adopted the ‘Scientific and technical assistance report on the evaluation of the safety of Lemna gibba and Lemna minor whole plant material as novel food’note. In its report, the Authority noted that the content of manganese in Lemna gibba was reduced to a level of 6 mg/kg fresh weight (FW), which is comparable to spinach which is found to have the highest content of manganese among leafy vegetables, with levels up to 9 mg/kg in FW. Thus, the Authority concluded that the content of manganese in the novel food has been reduced to levels not exceeding that in other leafy vegetables. The report also indicates that as both species of Lemna display similar manganese contents, it is considered reasonable to assume that under the newly applied cultivation conditions, an equivalent reduction in manganese content as obtained in Lemna gibba can be achieved in Lemna minor. In view of the above, EFSA considered that the maximum specification level for manganese in the novel food should be set at 6 mg/kg fresh weight.
(10)On that basis, the Commission considers that the scientific opinion and the technical report give sufficient grounds to establish that Lemna gibba and Lemna minor plants fulfil the conditions for their placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.
(11)It is appropriate that the inclusion of Lemna minor and Lemna gibba plants as novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
(12)Lemna minor and Lemna gibba plants should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(13)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
1.Lemna minor and Lemna gibba plants are authorised to be placed on the market within the Union.Lemna minor and Lemna gibba plants 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#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
(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 protectionHeat-treated Lemna minor and Lemna gibba | Specified food category | Maximum levels | 1.The designation of the novel food on the labelling of the foodstuffs containing it shall beLemna minor and Lemna gibba plants. | |Not specified |
(2)in Table 2 (Specifications), the following entry is inserted:Authorised Novel Food | SpecificationHeat-treated Lemna minor and Lemna gibba | Description/Definition:Lemna minor and Lemna gibba plant material cultivated under controlled conditions consisting of heat treated small green leaves with some minor white roots.Characteristics/compositionMoisture 91–95 g/100 gProtein (N × 6,25) 1–4 g/100 gCarbohydrates 1–3 g/100 gDietary fibre 0,5–3 g/100 gAsh 1–2 g/100 gFat 0,2–0,6 g/100 gOxalates (as calcium oxalate) < 1,6 g/kgBeta-carotene < 3,160 μg/100 gFolate < 38 μg/100 gPhylloquinone < 46 μg/100 gCopper < 2,5 mg/kgIron < 53 mg/kgManganese ≤ 6 mg/kgMolybdenum < 0,5 mg/kgZinc < 20 mg/kgChromium < 1 mg/kgBoron < 15 mg/kgContaminantsNitrate < 520 mg/kgNitrite < 1,75 mg/kgLead < 0,3 mg/kgCadmium < 0,2 mg/kgMercury < 0,05 mg/kgArsenic < 0,05 mg/kgMicrocystins < 23 μg/kgNodularins < 7 μg/kgIAA < 0,1 mg/kgMicrobiological criteriaTotal aerobic microbial count: < 5000 CFU/gEscherichia coli: < 100 CFU/gBacillus cereus: < 100 CFU/gCoagulase-positive staphylococci: Not detected in 10 gListeria monocytogenes: Absence in 25 gSalmonella spp. Absence in 25 gTotal yeast and mould count: < 100 CFU/gIAA: indole-3-acetic acid; CFU: colony forming unit.
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
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