Date: 2016-01-26Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2016/87 of 22 January 2016 on the withdrawal from the market of existing products derived from MON 863 (MON-ØØ863-5) and repealing Decisions 2010/139/EU, 2010/140/EU, 2010/141/EU authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON863×MON810×NK603 (MON-ØØ863-5×MON-ØØ81Ø-6×MON-ØØ6Ø3-6), MON863×MON810 (MON-ØØ863-5×MON-ØØ81Ø-6) and MON863×NK603 (MON-ØØ863-5×MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2016) 204) (Text with EEA relevance)
Executive Summary:
This Commission Implementing Decision EU 2016/87 addresses the withdrawal from the market of existing products derived from genetically modified maize MON 863 and its stacked events. It repeals Decisions 2010/139/EU, 2010/140/EU, and 2010/141/EU, which previously authorized the placing on the market of these products. The decision follows a request from Monsanto Europe S.A. to end authorizations for these products.
Key Points / Main Content:
* **Withdrawal of Products:**
* Food additives, feed materials, and feed additives produced from MON863 maize, notified as existing products, must be withdrawn from the market no later than the date of publication of this decision in the Official Journal of the European Union.
* **Repeal of Previous Decisions:**
* Decisions 2010/139/EU, 2010/140/EU, and 2010/141/EU are repealed as of the date of publication of this decision.
* **Amendment of Community Register:**
* The Community Register of genetically modified food and feed will be updated to reflect this decision.
* **Rationale for the Decision:**
* Monsanto Europe S.A. requested the termination of authorizations due to a commercial decision not to market these products in the EU anymore.
* Monsanto Europe S.A. withdrew the application for renewal of authorization for continued marketing of existing food and feed additives produced from MON 863 maize.
* MON 863 maize has not been commercially cultivated since 2011 in third countries, and the commercial phase-out is complete.
* Decisions 2005/608/EC and 2006/68/EC expired on January 12, 2016, and no renewal applications were lodged.
Impact Analysis:
* **Monsanto Europe S.A.:**
* *Impact:* Required to cease marketing products containing, consisting of, or produced from genetically modified maize MON 863. Addressed as the recipient of this decision.
* *Action Required:* Ensure products are withdrawn from the market by the date of publication of this decision.
* **European Commission:**
* *Impact:* Responsible for implementing and enforcing the decision, as well as updating the Community Register of genetically modified food and feed.
* *Action Required:* Publish the decision in the Official Journal of the European Union and update the Community Register.
* **Food and Feed Industry:**
* *Impact:* Companies using MON 863 maize-derived products in food additives, feed materials, and feed additives must discontinue their use.
* *Action Required:* Identify and remove affected products from the market by the date of publication of this decision.
* **Member States:**
* *Impact:* National authorities are responsible for ensuring compliance with the decision within their respective territories.
* *Action Required:* Monitor and enforce the withdrawal of affected products from the market.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
MON 863: A genetically modified maize (corn) variety developed for resistance to corn rootworm.
MON863MON810NK603: A genetically modified maize variety, stacked event.
Regulation EC No 1829/2003: A European Parliament and Council regulation on genetically modified food and feed.
European Food Safety Authority (EFSA): The European Union agency that provides independent scientific advice on risks related to food and feed safety.
Monsanto Europe S.A.: The European subsidiary of Monsanto (now Bayer), an agricultural company. Addressed in Article 3 of the document.
Brussels: The de facto capital city of the European Union, located in Belgium. The decision was made here.
Vytenis Andriukaitis: Member of the European Commission.
L 17/14 EN Official Journal of the European Union 26.1.2016
DECISIONS
COMMISSION IMPLEMENTING DECISION (EU) 2016/87
of 22 January 2016
on the withdrawal from the market of existing products derived from MON 863 (MON-ØØ863-5)
and repealing Decisions 2010/139/EU, 2010/140/EU, 2010/141/EU authorising the placing
on the market of products containing, consisting of, or produced from genetically
modified maize MON863×MON810×NK603 (MON-ØØ863-5×MON-ØØ81Ø-6×MON-ØØ6Ø3-6),
MON863×MON810 (MON-ØØ863-5×MON-ØØ81Ø-6) and MON863×NK603 (MON-ØØ863-
5×MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of
the Council
(notified under document C(2016) 204)
(Only the Dutch and French texts are authentic)
(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 1829/2003 of the European Parliament and of the Council of 22 September 2003
on genetically modified food and feed (1), and in particular its Articles 8(6) and 20(6), as well as its Articles 9(2)
and 21(2) thereof,
Whereas:
(1) By Commission Decision 2005/608/EC (2), the placing on the market of feed containing or consisting of
MON 863 maize and MON 863 maize in products consisting of it or containing it for any other uses than food
and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the
European Parliament and of the Council (3), until 12 January 2016.
(2) By Commission Decision 2006/68/EC (4), the placing on the market of food containing, consisting of, or
produced from MON 863 maize is authorised in accordance with Regulation (EC) No 258/97 of the European
Parliament and of the Council (5), until 12 January 2016.
(3) Food additives, feed materials and feed additives produced from genetically modified maize MON 863 were
placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing
products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.
(4) On 13 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with
Articles 8(4), 11, 20(4) and 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for continued
marketing of existing food additives, feed materials and feed additives produced from MON 863 maize which
were previously notified in accordance with Article 8(1)(b) and Article 20(1)(b) of that Regulation (‘the
application’). On 30 March 2010, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in
accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 and concluded that the new
information provided in the renewal application and the review of the scientific literature that has been published
since the previous scientific opinions on MON 863 maize by EFSA do not require changes of the opinions.
(1) OJ L 268, 18.10.2003, p. 1.
(2) Commission Decision 2005/608/EC of 8 August 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC
of the European Parliament and of the Council, of a maize product (Zea mays L., line MON 863) genetically modified for resistance to
corn rootworm (OJ L 207, 10.8.2005, p. 17).
(3) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment
of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(4) Commission Decision 2006/68/EC of 13 January 2006 authorising the placing on the market of foods and food ingredients derived
from genetically modified maize line MON 863 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the
European Parliament and of the Council (OJ L 34, 7.2.2006, p. 26).
(5) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food
ingredients (OJ L 43, 14.2.1997, p. 1).26.1.2016 EN Official Journal of the European Union L 17/15
Therefore it reiterated its previous conclusions that MON 863 maize is unlikely to have an adverse effect on
human and animal health or the environment in the context of its proposed uses. In its opinion EFSA considered
all the specific questions and concerns raised by the Member States in the context of the consultation of the
national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC)
No 1829/2003.
(5) By Commission Decisions 2010/139/EU (1), 2010/140/EU (2) and 2010/141/EU (3), the placing on the market of
food and feed containing, consisting of, or produced from MON863×MON810×NK603 maize,
MON863×MON810 maize and MON863×NK603 maize is authorised in accordance with Regulation (EC)
No 1829/2003, until 1 March 2020.
(6) On 29 June 2015, Monsanto Europe S.A. asked the Commission to put an end to all the authorisations granted
by the Commission to products containing, consisting or produced from genetically modified maize MON 863,
as single event and in stacked events, following a commercial decision of the company not to market these
products anymore in the EU.
(7) As a consequence, Monsanto Europe S.A. withdrew the application for the renewal of the authorisation for
continued marketing of existing food additives, feed materials and feed additives produced from MON 863 maize
submitted on 13 April 2007 for which EFSA published an opinion on 30 March 2010 and asked the European
Commission to repeal Decisions 2005/608/EC, 2006/68/EC, 2010/139/EU, 2010/140/EU and 2010/141/EU.
(8) As MON 863, as single event or in stacked events, has not been commercially cultivated since 2011 in third
countries and the commercial phase out is completed, it is not necessary to provide for a limited period of time
within which existing stocks of the product may be used up.
(9) Decisions 2005/608/EC and 2006/68/EC expire on 12 January 2016. Since no applications for the renewal of
the authorisation granted in these decisions have been lodged by Monsanto Europe S.A, the products covered in
these decisions should not be placed on the market after this date.
(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
1. Food additives produced from MON-ØØ863-5 maize notified as existing products under Article 8(1)(b) of
Regulation (EC) No 1829/2003 as well as feed materials and feed additives produced from MON-ØØ863-5 maize
notified as existing products under Article 20(1)(b) shall be withdrawn from the market no later than the date of the
publication of this Decision in the Official Journal of the European Union.
2. Decisions 2010/139/EU, 2010/140/EU and 2010/141/EU shall be repealed on the date of the publication of this
Decision in the Official Journal of the European Union.
Article 2
The entries in the Community Register of genetically modified food and feed, referred to in Article 28 of Regulation (EC)
No 1829/2003, regarding MON-ØØ863-5 maize, MON-ØØ863-5×MON-ØØ81Ø-6×MON-ØØ6Ø3-6, MON-ØØ863-
5×MON-ØØ81Ø-6 and MON-ØØ863-5×MON-ØØ6Ø3-6 shall be adapted in order to take account of this Decision.
(1) Commission Decision 2010/139/EU of 2 March 2010 authorising the placing on the market of products containing, consisting of, or
produced from genetically modified maize MON863×MON810×NK603 (MON-ØØ863-5×MON-ØØ81Ø-6×MON-ØØ6Ø3-6)
pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 55, 5.3.2010, p. 68).
(2) Commission Decision of 2010/140/EU of 2 March 2010 authorising the placing on the market of products containing, consisting of, or
produced from genetically modified maize MON863×MON810 (MON-ØØ863-5×MON-ØØ81Ø-6) pursuant to Regulation (EC)
No 1829/2003 of the European Parliament and of the Council (OJ L 55, 5.3.2010, p. 73).
(3) Commission Decision 2010/141/EU of 2 March 2010 authorising the placing on the market of products containing, consisting of, or
produced from genetically modified maize MON863×NK603 (MON-ØØ863-5×MON-ØØ6Ø3-6) pursuant to Regulation (EC)
No 1829/2003 of the European Parliament and of the Council (OJ L 55, 5.3.2010, p. 78).L 17/16 EN Official Journal of the European Union 26.1.2016
Article 3
This Decision is addressed to Monsanto Europe S.A., Scheldelaan 460, Haven 627, 2040 Antwerp, Belgium.
Done at Brussels, 22 January 2016.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission