Date: 2019-04-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2019/650 of 24 April 2019 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Regulation (EU) 2019/650 amends Annex III to Regulation (EC) No 1925/2006, specifically regarding the use of Yohimbe (Pausinystalia yohimbe K. Schum Pierre ex Beille) in foods. Due to the lack of scientific data demonstrating its safety, Yohimbe is moved from Part C to Part A of Annex III, effectively prohibiting its use in food. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment:** Amends Annex III to Regulation (EC) No 1925/2006.
* **Substance:** Concerns Yohimbe (Pausinystalia yohimbe K. Schum Pierre ex Beille) and its preparations.
* **Justification:**
* No scientific data was submitted to the European Food Safety Authority (EFSA) within the required timeframe to demonstrate the safety of Yohimbe.
* This lack of data prompted the prohibition of its use in food.
* **Regulatory Action:**
* Yohimbe bark and its preparations are added to Part A of Annex III, which lists prohibited substances.
* Yohimbe bark and its preparations are removed from Part C of Annex III.
* **Entry into Force:** The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Food Business Operators:**
* *Impact:* Prohibited from using Yohimbe (Pausinystalia yohimbe K. Schum Pierre ex Beille) and its preparations in food products.
* *Action Required:* Cease the use of Yohimbe bark and its preparations originating from Yohimbe Pausinystalia yohimbe K. Schum Pierre ex Beille in food products.
* **Member States:**
* *Impact:* Required to enforce the regulation and ensure compliance within their jurisdiction.
* *Action Required:* Implement and enforce the changes to Annex III of Regulation (EC) No 1925/2006 regarding Yohimbe.
* **Consumers:**
* *Impact:* Yohimbe will no longer be present in food products sold in the European Union.
* *Action Required:* No specific action required.
Key Entities Referenced
Council of the European Union: A Council of ministers representing different member states.
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 1925/2006: Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods.
European Parliament: The directly elected parliamentary assembly of the European Union.
Yohimbe Pausinystalia yohimbe K. Schum Pierre ex Beille: A plant whose bark is the source of yohimbine, which has been subject to scrutiny regarding its use in food products within the European Union.
Commission Regulation EU 2015/403: Commission Regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Ephedra species and Yohimbe Pausinystalia yohimbe K. Schum Pierre ex Beille.
Brussels: The de facto capital city of the European Union, located in Belgium.
25.4.2019 EN Official Journal of the European Union L 110/21
COMMISSION REGULATION (EU) 2019/650
of 24 April 2019
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the
Council as regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006
on the addition of vitamins and minerals and of certain other substances to foods (1), and in particular Article 8(5)
thereof,
Whereas:
(1) In accordance with Article 8(2) of Regulation (EC) No 1925/2006, taking into account the possible harmful
effects on health associated with the use of Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) and its
preparations in foods, and the persisting scientific uncertainty, this substance has been placed under Union
scrutiny and was included in Part C of Annex III to Regulation (EC) No 1925/2006 by means of Commission
Regulation (EU) 2015/403 (2).
(2) Pursuant to Article 8(5) of Regulation (EC) No 1925/2006, within four years from the date a substance has been
listed in Part C of Annex III, a decision shall be taken to generally allow the use of a substance listed in Part C of
Annex III or to list it in Part A or B of Annex III, as appropriate, taking into account the opinion of the
European Food Safety Authority (‘the Authority’) on any files submitted for evaluation by food business
operators, or any other interested parties as mentioned in Article 8(4).
(3) Pursuant to Article 5(2) of Commission Implementing Regulation (EU) No 307/2012 (3), only files submitted
within 18 months from the entry into force of a decision that includes a substance to Part C of Annex III to
Regulation (EC) No 1925/2006 shall be taken into account by the Authority as being a valid file for the purposes
of a decision as laid down in Article 8(5) of Regulation (EC) No 1925/2006.
(4) Considering that interested parties have not submitted any scientific data to the Authority to demonstrate the
safety of Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille) within the time limit referred to in
Article 5(2) of Implementing Regulation (EU) No 307/2012, Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre
ex Beille) and its preparations should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which
means that their use in food will be prohibited.
(5) Regulation (EC) No 1925/2006 should therefore be amended accordingly.
(6) 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
Annex III to Regulation (EC) No 1925/2006 is amended as follows:
(1) in Part A, the following entry is added:
‘Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)’;
(1) OJ L 404, 30.12.2006, p. 26.
(2) Commission Regulation (EU) 2015/403 of 11 March 2015 amending Annex III to Regulation (EC) No 1925/2006 of the European
Parliament and of the Council as regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille (OJ L 67,
12.3.2015, p. 4).
(3) Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of
Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and
of certain other substances to foods (OJ L 102, 12.4.2012, p. 2).L 110/22 EN Official Journal of the European Union 25.4.2019
(2) in Part C, the following entry is deleted:
‘Yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)’.
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.
Done at Brussels, 24 April 2019.
For the Commission
The President
Jean-Claude JUNCKER