LegalizeCommission Implementing Regulation (EU) 2022/1365 of 4 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA (Text with EEA relevance)
Article 1
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘ Schizochytrium sp. oil rich in DHA and EPA’ is replaced by the following:
| Authorised novel food | Conditions under which the novel food may be used | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data Protection |
|---|---|---|---|---|---|
| Schizochytrium sp. oil rich in DHA and EPA | Specified food category | Maximum levels of DHA and EPA combined | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women | 3 000 mg/day | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women | 450 mg/day | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Food supplements as defined in Directive 2002/46/EC for children from 18 months to 18 years of age | 250 mg/day | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Milk based drinks and similar products intended for young children | 200 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | 200 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen | 200 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 [^E0001] | 200 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Bakery products (breads, rolls and sweet biscuits) | 200 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Breakfast cereals | 500 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Cooking fats | 360 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Dairy analogues, except drinks | 600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Dairy products except milk-based drinks | 600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Cereal/nutrition bars | 500 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Spreadable fats and dressings | 600 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Fish analogues | 300 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ | ||
| Schizochytrium sp. oil rich in DHA and EPA | Meat analogues | 300 mg/100 g | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’ |
Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2014/828/oj).
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