Date: 2019-03-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2019/387 amends Implementing Regulation (EU) 2017/2470, authorising an extension of use for Schizochytrium sp. ATCC PTA-9695 oil as a novel food. It also approves a change in the designation and specific labeling requirements for this oil. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union (12 March 2019).
Key Points / Main Content:
* **Authorisation and Extension of Use:**
* Extends the use of Schizochytrium sp. ATCC PTA-9695 oil to fruit and vegetable purees.
* This extension aligns with Article 12(1) of Regulation (EU) 2015/2283.
* **Change of Designation and Labelling:**
* Authorises the deletion of the strain specification "ATCC PTA-9695" from the designation of the novel food and its labeling.
* Ensures consistency in designation and labeling across all oils from Schizochytrium sp. authorised as novel foods.
* **Amendment to Union List of Novel Foods:**
* The entry for Schizochytrium sp. ATCC PTA-9695 oil in the Union list of authorised novel foods under Implementing Regulation (EU) 2017/2470 is amended as specified in the Annex.
* Conditions of use and labelling requirements as per the Annex are included in the amended entry.
* **Specifications:**
* The wording "ATCC PTA 9695" is included in the specifications for proper identification of the novel food in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470.
Impact Analysis:
* **Food Manufacturers:**
* Impact: Can now use Schizochytrium sp. ATCC PTA-9695 oil in fruit and vegetable purees, and are allowed to change the designation and labelling requirements for products containing Schizochytrium sp. ATCC PTA-9695 oil.
* Action Required: Update product formulations and labels to reflect the authorised extension of use and the new designation, ensuring compliance with the specified conditions and labelling requirements in the Annex.
* **Consumers:**
* Impact: Will see a change in the labeling of products containing Schizochytrium sp. ATCC PTA-9695 oil, with the removal of the strain designation "ATCC PTA-9695".
* Action Required: No direct action required; however, consumers should be aware of the change in labeling for products containing this novel food.
* **Regulatory Bodies:**
* Impact: Responsible for enforcing the updated regulations regarding the use and labeling of Schizochytrium sp. ATCC PTA-9695 oil.
* Action Required: Update monitoring and enforcement procedures to reflect the changes outlined in the regulation, ensuring compliance by food manufacturers.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Parliament: One of the legislative bodies of the European Union, directly elected by EU citizens.
Council of the European Union: A legislative body of the European Union comprising ministers from member states.
European Commission: An executive body of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Schizochytrium sp. ATCC PTA9695 oil: A novel food derived from the microalgae Schizochytrium sp., specifically the strain ATCC PTA9695, used as a source of DHA (docosahexaenoic acid).
DSM Nutritional Products Europe: A company that requested changes to the conditions of use for Schizochytrium sp. ATCC PTA9695 oil.
Regulation EU 2015/2283: A regulation of the European Parliament and of the Council on novel foods.
Commission Implementing Regulation EU 2017/2470: A Commission Implementing Regulation establishing the Union list of authorised novel foods.
12.3.2019 EN Official Journal of the European Union L 70/17
COMMISSION IMPLEMENTING REGULATION (EU) 2019/387
of 11 March 2019
authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food
and the change of the designation and of the specific labelling requirement of Schizochytrium
sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the
Council, and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be
placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470 (2)
establishing a Union list of authorised novel foods was adopted.
(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on
the placing on the Union market of a novel food and on the updating of the Union list.
(4) Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC)
No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from
the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods.
(5) Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae
Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.
(6) On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to
change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of
Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium
sp. (ATCC PTA-9695) oil to fruit and vegetable purees.
(7) The proposed extension of use of the novel food does not change the safety considerations that supported the
authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to
fruit and vegetable purees and it does not either pose any safety concern. Taking into account those consider
ations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.
(8) On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the
Commission to authorise the change of the designation and of the specific labelling requirement for Schizo
chytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The
application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the
novel food as listed in the Union list and from the labelling of foods containing it.
(1) OJ L 327, 11.12.2015, p. 1.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(3) Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the
micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European
Parliament and of the Council (OJ L 90, 2.4.2015, p. 7).
(4) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods
ingredients (OJ L 43, 14.2.1997, p. 1).
(5) Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae
Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending
Commission Implementing Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9).L 70/18 EN Official Journal of the European Union 12.3.2019
(9) The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium
sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of
foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers.
(10) There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel
foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on
the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will
ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods
without having a negative impact on human health and consumer interests.
(11) Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel
food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC
PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel
food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex
to Implementing Regulation (EU) 2017/2470 should be amended accordingly.
(12) The Commission did not request an opinion from the European Food Safety Authority in accordance with
Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil,
the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695)
oil and the subsequent updating of the Union list are not liable to have an effect on human health.
(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. The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470,
referring to the substance Schizochytrium sp. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this
Regulation.
2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling
requirements laid down in the Annex to this Regulation.
Article 2
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Article 3
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.
Done at Brussels, 11 March 2019.
For the Commission
The President
Jean-Claude JUNCKERANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 1 (Authorised novel foods) is replaced by the following:
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Schizochytrium sp. Specified food category Maximum levels of DHA The designation of the novel food on
(ATCC PTA-9695) oil the labelling of the foodstuffs con
taining it shall be ‘Oil from the mi
Dairy products except milk-based drinks 200 mg/100 g or for cheese products
croalgae Schizochytrium sp.’’
600 mg/100 g
Dairy analogues except drinks 200 mg/100 g or for analogues to cheese
products 600 mg/100 g
Spreadable fats and dressings 600 mg/100 g
Breakfast cereals 500 mg/100 g
Food Supplements as defined in Directive 250 mg DHA/day for general population
2002/46/EC
450 mg DHA/day for pregnant and lactating
women
Total diet replacement for weight control as 250 mg/meal
defined in Regulation (EU) No 609/2013
and meal replacements for weight control
Milk-based drinks and similar products in 200 mg/100 g
tended for young children
Foods intended to meet the expenditure of
intense muscular effort, especially for
sportsmen
Foods bearing statements on the absence or
reduced presence of gluten in accordance
with the requirements of Commission Im
plementing Regulation (EU) No 828/2014
Foods for special medical purposes as de In accordance with the particular nutritional
fined in Regulation (EU) No 609/2013 requirements of the persons for whom the
products are intended
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70/19Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
Bakery products (breads, rolls, and sweet 200 mg/100 g
biscuits)
Cereal bars 500 mg/100 g
Cooking fats 360 mg/100 g
Non-alcoholic beverages (including dairy 80 mg/100 ml
analogue and milk-based drinks)
Infant formula and follow-on formula as de In accordance with Regulation (EU)
fined in Regulation (EU) No 609/2013 No 609/2013
Processed cereal-based foods and baby foods 200 mg/100 g
for infants and young children as defined in
Regulation (EU) No 609/2013
Fruit/vegetable puree 100 mg/100 g
(2) The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:
Authorised novel food Specification
‘Schizochytrium sp. The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.
(ATCC PTA-9695) oil
Peroxide value (PV): ≤ 5,0 meq/kg oil
Unsaponifiables: ≤ 3,5 %
Trans-fatty acids: ≤ 2,0 %
Free fatty acids: ≤ 0,4 %
Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %
DHA content: ≥ 35 %’
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