Date: 2022-05-13Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/736 of 11 May 2022 amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived products (notified under document C(2022) 3009) (Only the German text is authentic) (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2022/736 amends Decisions 2007/305/EC, 2007/306/EC, and 2007/307/EC, extending the tolerance period for traces of specific genetically modified oilseed rapes (Ms1xRf1, Ms1xRf2, and Topas 192) and their derived products in food and feed. The tolerance is valid until 31 December 2025. BASF SE is required to continue monitoring and reporting on the presence of these GMOs.
Key Points / Main Content:
Tolerance Period Extension:
* Extends the tolerance period for the presence of Ms1xRf1, Ms1xRf2, and Topas 192 oilseed rapes in food and feed until 31 December 2025.
* The tolerated presence remains at a maximum of 0.1 mass fraction, and must be adventitious or technically unavoidable.
BASF SE Responsibilities:
* Must continue implementing an in-house program to ensure the effective withdrawal of ACS BN71 oilseed rape.
* Required to gather data on the presence of genetically modified organisms in oilseed rape shipments from Canada to the Union.
* Needs to report to the Commission on the implementation of the in-house program and the presence of GMOs in shipments from Canada by 1 January 2025.
* Must ensure the continued availability of certified reference materials for control laboratories.
Amendments to Existing Decisions:
* Decision 2007/305/EC is amended regarding reporting obligations.
* Decision 2007/306/EC is amended regarding reporting obligations.
* Decision 2007/307/EC is amended regarding the in-house program and reporting obligations.
Community Register:
* The Commission will modify entries in the Community Register of genetically modified food and feed to reflect this decision.
Impact Analysis:
BASF SE:
* Impact: Responsible for continued monitoring, data gathering, program implementation, and reporting.
* Action Required: Continue implementing the in-house program, gather data on GMO presence in shipments from Canada, report to the Commission by 1 January 2025, and ensure the availability of reference materials.
Control Laboratories:
* Impact: Need to perform analyses to monitor the presence of the specified GMOs.
* Action Required: Utilize available certified reference materials to conduct analyses.
European Commission:
* Impact: Receives reports from BASF SE and modifies the Community Register of genetically modified food and feed.
* Action Required: Review reports from BASF SE and update the Community Register accordingly.
Food and Feed Producers/Operators:
* Impact: Allowed a tolerance for the presence of specified GMOs in their products until 31 December 2025, provided it meets the specified conditions.
* Action Required: Ensure that the presence of GMOs remains within the permitted limits (0.1 mass fraction) and is adventitious or technically unavoidable.
Key Entities Referenced
European Union: Political and economic union of European countries.
Commission Implementing Decision EU 2022/736: A decision by the European Commission amending previous decisions regarding the tolerance period for traces of genetically modified oilseed rape.
Regulation EC No 1829/2003: Regulation of the European Parliament and the Council on genetically modified food and feed.
Bayer CropScience AG: The original authorisation holder for the GM material (oilseed rape), which indicated it would not seek renewal of authorisation.
BASF SE: The current addressee of the decisions regarding the withdrawal of the GM material from the market, following a change from Bayer CropScience AG.
Canada: The only country where the genetically modified oilseed rapes Ms1xRf1, Ms1xRf2 and Topas 192 were cultivated for commercial purposes and from where the oilseed rape commodities are imported into the Union.
Ms1xRf1 ACSBN47xACSBN14 hybrid oilseed rape: A genetically modified hybrid oilseed rape, subject to the tolerance period for traces.
Topas 192 ACSBN71 oilseed rape: A genetically modified oilseed rape, subject to the tolerance period for traces.
L 136/108 EN Official Journal of the European Union 13.5.2022
COMMISSION IMPLEMENTING DECISION (EU) 2022/736
of 11 May 2022
amending Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the tolerance period for
traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-
BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well
as their derived products
(notified under document C(2022) 3009)
(Only the German text is 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 the Council of 22 September 2003on
genetically modified food and feed(1), and in particular Article 8(6) and Article 20(6) thereof,
Whereas:
(1) Commission Decisions 2007/305/EC(2), 2007/306/EC(3) and 2007/307/EC(4) lay down the rules for the
withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape, Ms1xRf2 (ACS-
BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape respectively, as well
as their derived products (‘GM material’). Those decisions were adopted after the authorisation holder, the company
Bayer CropScience AG, had indicated to the Commission that it had no intention of submitting an application for the
renewal of the authorisation of the GM material in accordance with Article 8(4), first subparagraph, Article 11,
Article 20(4) and Article 23 of Regulation (EC) No 1829/2003.
(2) All three decisions provided for an initial transitional period of 5 years during which food and feed containing,
consisting of or produced from the GM material were allowed to be placed on the market in a proportion no higher
than 0,9 % and provided that that presence was adventitious or technically unavoidable. The purpose of the
transitional period was to take into account the fact that minute traces of that GM material could sometimes be
present in the food and feed chains, even after Bayer CropScience AG stopped selling seeds derived from the
genetically modified organisms and even if all measures were taken to avoid the presence of the GM material.
(3) Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC also set out a series of measures that Bayer CropScience
AG had to take in order to ensure the effective withdrawal from the market of the GM material and laid down
reporting obligations on the addressee.
(4) Despite the measures taken by Bayer CropScience AG to prevent the presence of the genetically modified organisms
in accordance with Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC, minute traces were detected in oilseed
rape commodities. Commission Implementing Decision 2012/69/EU(5) amended all three decisions in order to
extend the transition period until 31 December 2016, and reduced the tolerated presence of the GM material in
(1) OJ L 268, 18.10.2003, p. 1.
(2) Commission Decision 2007/305/EC of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-
BNØØ1-4) hybrid oilseed rape and its derived products (OJ L 117, 5.5.2007, p. 17).
(3) Commission Decision 2007/306/EC of 25 April 2007 on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-
BNØØ2-5) hybrid oilseed rape and its derived products (OJ L 117, 5.5.2007, p. 20).
(4) Commission Decision 2007/307/EC of 25 April 2007 on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape
and its derived products (OJ L 117, 5.5.2007, p. 23).
(5) Commission Implementing Decision 2012/69/EU of 3 February 2012 amending Decisions 2007/305/EC, 2007/306/EC
and 2007/307/EC as regards the tolerance period for traces of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape,
Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as of their
derived products (OJ L 34, 7.2.2012, p. 12).13.5.2022 EN Official Journal of the European Union L 136/109
food and feed to 0,1 % mass fraction. The three decisions were further amended by Commission Implementing
Decision (EU) 2016/2268(6) in order to extend the transition period until 31 December 2019 and then by
Commission Implementing Decision (EU) 2019/1562(7)in order to extend the transition period until 31 December
2022.
(5) Furthermore, Commission Implementing Decision (EU) 2019/1117(8) amended Decisions 2007/305/EC,
2007/306/EC and 2007/307/EC as regards the addressee, from Bayer CropScience AG to BASF SE.
(6) In October 2021, BASF Belgian Coordination Center CommV, a branch of BASF SE, reported that despite the
measures taken, minute traces had still been detected, in a further decreasing trend, in oilseed rape commodities in
recent years. Such persisting presence of traces could be explained by the biology of oilseed rapes, since seeds can
remain dormant for long periods, as well as by farm practices which have been employed to harvest the seeds and
which may have resulted in accidental spillage, the level of which was difficult to estimate at the time of adoption of
Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC, and Implementing Decisions 2012/69/EU, (EU)
2016/2268 and (EU) 2019/1562.
(7) Against this background, it is appropriate to extend the transitional period until 31 December 2025 to allow for
further decrease of the remaining traces of Ms1xRf1, Ms1xRf2 and Topas 19/2 oilseed rapes in the food and feed
chain.
(8) In order to further contribute to the removal of the GM material, it is also appropriate that BASF SE continues to
implement the in-house programme required in accordance with Decisions 2007/305/EC, 2007/306/EC
and 2007/307/EC and to gather data on the presence of such material in oilseed rape commodities imported into
the Union from Canada, the only country where GM oilseed rape Ms1xRf1, Ms1xRf2 and Topas 19/2 were
cultivated for commercial purposes. BASF SE should report to the Commission on both aspects by 1 January 2025.
(9) BASF SE should continue to ensure the continued availability of certified reference materials to enable control
laboratories to perform their analysis during the transitional period.
(10) Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC should therefore be amended accordingly.
(11) 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
Amendments to Decision 2007/305/EC
Decision 2007/305/EC is amended as follows:
(1) the second paragraph of Article 1 is replaced by the following:
‘By 1 January 2025, the addressee shall report to the Commission on the implementation of that programme and on
the presence of those genetically modified organisms in the oilseed rape shipments from Canada to the Union.’;
(6) Commission Implementing Decision (EU) 2016/2268 of 14 December 2016 amending Decisions 2007/305/EC, 2007/306/EC
and 2007/307/EC as regards the tolerance period for traces of Ms1×Rf1 (ACS-BNØØ4-7×ACS-BNØØ1-4) hybrid oilseed rape,
Ms1×Rf2 (ACS- BNØØ4-7×ACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived
products (OJ L 342, 16.12.2016, p. 34).
(7) Commission Implementing Decision (EU) 2019/1562 of 16 September 2019 amending Decisions 2007/305/EC, 2007/306/EC
and 2007/307/EC as regards the tolerance period for traces of Ms1×Rf1 (ACS-BNØØ4-7×ACS-BNØØ1-4) hybrid oilseed rape,
Ms1×Rf2 (ACS-BNØØ4-7×ACS-BNØØ2-5) hybrid oilseed rape and Topas 19/2 (ACS-BNØØ7-1) oilseed rape, as well as their derived
products (OJ L 240, 18.9.2019, p. 13).
(8) Commission Implementing Decision (EU) 2019/1117 of 24 June 2019 amending Decisions 2007/305/EC, 2007/306/EC
and 2007/307/EC as regards a change of the addressee of the Decisions (OJ L 176, 1.7.2019, p. 59).L 136/110 EN Official Journal of the European Union 13.5.2022
(2) paragraph 1 of Article 2 is replaced by the following:
‘1. The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and
the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape in food or feed products notified under Article
8(1)(a) and Article 20(1), point (a), of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2025,
provided that this presence is:
(a) adventitious or technically unavoidable; and
(b) in a proportion no higher than 0,1 % mass fraction’.
Article 2
Amendments to Decision 2007/306/EC
Decision 2007/306/EC is amended as follows:
(1) the second paragraph of Article 1 is replaced by the following:
‘By 1 January 2025, the addressee shall report to the Commission on the implementation of this program and on the
presence of those genetically modified organisms in the oilseed rape shipments from Canada to the Union.’;
(2) paragraph 1 of Article 2 is replaced by the following:
‘1. The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5 and
the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape in food or feed products notified under Article
8(1)(a) and Article 20(1)(a) of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2025, provided
that this presence is:
(a) adventitious or technically unavoidable; and
(b) in a proportion no higher than 0,1 % mass fraction.’.
Article 3
Amendment to Decision 2007/307/EC
Paragraphs 1 and 2 of Article 1 of Decision 2007/307/EC are replaced by the following:
‘1. The addressee shall implement an in-house programme in order to ensure the effective withdrawal from the market
of ACS- BNØØ7-1 oilseed rape in breeding and seed production and shall gather data on the presence of that genetically
modified organism in the oilseed rape shipments to the Union from Canada.
By 1 January 2025, the addressee shall report to the Commission on the implementation of that programme and on the
presence of those genetically modified organisms in the oilseed rape shipments from Canada to the Union.
2. The presence of material which contains, consists of or is produced from ACS-BNØØ7-1 oilseed rape in food or feed
products notified under Article 8(1)(a) and Article 20(1), point (a), of Regulation (EC) No 1829/2003 shall be tolerated until
31 December 2025, provided that this presence is:
(a) adventitious or technically unavoidable; and
(b) in a proportion no higher than 0,1 % mass fraction.’.13.5.2022 EN Official Journal of the European Union L 136/111
Article 4
Modification of the entries in the Community Register of genetically modified food and feed
The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of Regulation
(EC) No 1829/2003, regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-
BNØØ1-4 oilseed rape, ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5
oilseed rape, and ACS-BNØØ7-1 oilseed rape shall be modified by the Commission in order to take account of this
Decision.
Article 5
Addressee
This Decision is addressed to BASF SE, Carl-Bosch-Str. 38, 67063 Ludwigshafen, Germany.
Done at Brussels, 11 May 2022.
For the Commission
Stella KYRIAKIDES
Member of the Commission