ISSN 1977-0677
Official Journal
of the European Union
L 240
English edition
Legislation
Volume 62
18 September 2019
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ISSN 1977-0677 |
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Official Journal of the European Union |
L 240 |
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English edition |
Legislation |
Volume 62 |
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Contents |
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II Non-legislative acts |
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REGULATIONS |
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Commission Regulation (EU) 2019/1561 of 17 September 2019 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlormequat in cultivated fungi ( 1 ) |
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DECISIONS |
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(1) Text with EEA relevance. |
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EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
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18.9.2019 |
EN |
Official Journal of the European Union |
L 240/1 |
COMMISSION REGULATION (EU) 2019/1561
of 17 September 2019
amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlormequat in cultivated fungi
(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) and Article 16(1)(a) thereof,
Whereas:
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(1) |
For chlormequat, maximum residue levels (MRLs) are set in Annex II to Regulation (EC) No 396/2005. |
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(2) |
The MRLs for chlormequat were recently modified by Commission Regulation (EU) 2017/693 (2) in accordance with Article 12(1) of Regulation (EC) No 396/2005. In that framework, a temporary MRL for cultivated fungi was set at 0,9 mg/kg due to monitoring data showing that residues occurred on untreated cultivated fungi at a level higher than the limit of determination where such residues may result from cross-contamination of cultivated fungi with straw lawfully treated with chlormequat. |
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(3) |
Mushroom growers submitted to the Commission recent monitoring data specifically on oyster mushrooms showing that residues occur in those products at higher levels than the current temporary MRL set for cultivated fungi. Those residues result from a cross-contamination of cultivated fungi with straw lawfully treated with chlormequat. Several Member States submitted additional monitoring data from official controls performed specifically on oyster mushrooms, which confirmed those findings. |
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(4) |
Germany compiled and evaluated an application for modification of the existing MRL in accordance with Article 6(3) of Regulation (EC) No 396/2005 and forwarded the evaluation report to the Commission. |
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(5) |
The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals and gave a scientific statement on the proposed MRL (3). It forwarded that statement to the applicant, the Commission and the Member States and made it available to the public. |
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(6) |
The Authority concluded in its scientific statement that the modification to the MRL requested by Germany was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. |
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(7) |
In light of the Authority's conclusions on risk to consumers, the MRL for oyster mushrooms should be set at the level corresponding to the 95th percentile of all the sample results while maintaining the existing MRL for other cultivated fungi. That MRL will be reviewed; the review will take into account the information available within 13 April 2021. |
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(8) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(9) |
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
Annexes II and III to Regulation (EC) No 396/2005 are 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.
Done at Brussels, 17 September 2019.
For the Commission
The President
Jean-Claude JUNCKER
(2) Commission Regulation (EU) 2017/693 of 7 April 2017 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bitertanol, chlormequat and tebufenpyrad in or on certain products (OJ L 101, 13.4.2017, p. 1).
(3) EFSA scientific reports available online: http://www.efsa.europa.eu:
Statement on the dietary risk assessment for the proposed temporary maximum residue level for chlormequat in oyster mushrooms. EFSA Journal 2019;17(5):5707.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
in Annex II, the column for chlormequat is deleted; |
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(2) |
in Part A of Annex III, the following column for chlormequat is added: ‘Pesticide residues and maximum residue levels (mg/kg)
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(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
DECISIONS
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18.9.2019 |
EN |
Official Journal of the European Union |
L 240/13 |
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
(notified under document C(2019) 6524)
(Only the German text is authentic)
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 2003 on genetically modified food and feed (1), and in particular Article 8(6) and Article 20(6) thereof,
Whereas:
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(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 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 respectively, as well as their derived products (‘GM material’). Those decisions have been adopted after the authorisation holder, the company Bayer CropScience AG, indicated to the Commission that it had no intention of submitting an application for the renewal of the authorisation of that GM material in accordance with the first subparagraph of Article 8(4), Article 11, Article 20(4) and Article 23 of Regulation (EC) No 1829/2003. |
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(2) |
All three Decisions provided for an initial transitional period of five years during which food and feed containing, consisting of or produced from this 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 that 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 had decided to stop selling seeds derived from those genetically modified organisms and even if all measures were taken to avoid the presence of that GM material. |
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(3) |
Despite the measures taken by Bayer CropScience AG to prevent the presence of those genetically modified organisms in accordance with Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC, minute traces have been still 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 that GM material in food and feed to 0,1 % mass fraction. The three Decisions have been further amended by Commission Implementing Decision (EU) 2016/2268 (6) in order to extend the transition period until 31 December 2019. |
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(4) |
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 this GM material and laid down reporting obligations on the addressee. |
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(5) |
Furthermore, Commission Implementing Decision (EU) 2019/1117 (7) amended the three Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC as regards the addressee, following a request submitted on 1 August 2018 by Bayer CropScience AG to transfer its rights and obligations, pertaining to all its notifications, applications and authorisations for genetically modified products, to BASF Agricultural Solutions Seed US LLC, being represented in the Union by BASF SE (Germany). Therefore, Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC should be addressed to BASF SE. |
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(6) |
In October 2018, BASF SE reported that despite the measures taken, minute traces have been still detected, in a further decreasing trend, in oilseed rape commodities in recent years. This persisting presence of traces can be explained by the biology of oilseed rapes which can remain dormant for long periods as well as by farm practices which have been employed to harvest the seeds which may have resulted in accidental spillage, the level of which was difficult to estimate at the dates of adoption of Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC, and Implementing Decisions 2012/69/EU and (EU) 2016/2268. |
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(7) |
Against this background, it is appropriate to extend the transitional period for another three years until 31 December 2022 to allow for the complete removal of the remaining traces of Ms1×Rf1, Ms1×Rf2 and Topas 19/2 oilseed rapes in the food and feed chain. |
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(8) |
In order to further contribute to the removal of that GM material, it is also appropriate that the addressee 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 those oilseed rapes were cultivated for commercial purposes. BASF SE should report to the Commission on both aspects by 1 January 2022. |
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(9) |
BASF SE should ensure the continued availability of certified reference materials to enable control laboratories to perform their analysis during that transitional period. |
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(10) |
Decisions 2007/305/EC, 2007/306/EC and 2007/307/EC should therefore be amended accordingly. |
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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
Decision 2007/305/EC is amended as follows:
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(1) |
Article 1 is replaced by the following: ‘Article 1 The addressee shall implement an in-house program in order to ensure the effective withdrawal from the market of ACS-BNØØ4-7, ACS-BNØØ1-4 and of the hybrid combination ACS-BNØØ4-7×ACS-BNØØ1-4 oilseed rape in breeding and seed production and shall gather data on the presence of those genetically modified organisms in the oilseed rape shipments to the Union from Canada. By 1 January 2022, 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.’ |
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(2) |
Article 2 is replaced by the following: ‘Article 2 1. The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7×ACS-BNØØ1-4 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 2022, provided that this presence:
2. The addressee shall ensure the availability of certified reference material for ACS-BNØØ4-7×ACS-BNØØ1-4 oilseed rape via the American Oil Chemists Society at https://www.aocs.org/crm.’ |
Article 2
Decision 2007/306/EC is amended as follows:
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(1) |
Article 1 is replaced by the following: ‘Article 1 The addressee shall implement an in-house program in order to ensure the effective withdrawal from the market of ACS-BNØØ4-7, ACS-BNØØ2-5 and of the hybrid combination ACS-BNØØ4-7×ACS-BNØØ2-5 oilseed rape in breeding and seed production and shall gather data on the presence of those genetically modified organisms in the oilseed rape shipments to the Union from Canada. By 1 January 2022, 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.’ |
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(2) |
Article 2 is replaced by the following: ‘Article 2 1. The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7×ACS-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 2022, provided that this presence:
2. The addressee shall ensure the availability of certified reference material for ACS-BNØØ4-7×ACS-BNØØ2-5 oilseed rape via the American Oil Chemists Society at https://www.aocs.org/crm.’ |
Article 3
Article 1 of Decision 2007/307/EC is replaced by the following:
‘Article 1
1. The addressee shall implement an in-house program 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 2022, 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. 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)(a) of Regulation (EC) No 1829/2003 shall be tolerated until 31 December 2022, provided that this presence:
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(a) |
is adventitious or technically unavoidable; and |
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(b) |
is in a proportion no higher than 0,1 % mass fraction. |
3. The addressee shall ensure the availability of certified reference material for ACS- BNØØ7-1 oilseed rape via the American Oil Chemists Society at https://www.aocs.org/crm.’
Article 4
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-BNØØ4-7×ACS-BNØØ1-4 oilseed rape, ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7×ACS-BNØØ2-5 oilseed rape, and ACS-BNØØ7-1 oilseed rape shall be modified in order to take account of this Decision.
Article 5
This Decision is addressed to BASF SE, Carl-Bosch-Str. 38, D-67063 Ludwigshafen, Germany.
Done at Brussels, 16 September 2019.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
(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 Ms1×Rf1 (ACS-BNØØ4-7×ACS-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 Ms1×Rf2 (ACS-BNØØ4-7×ACS-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 Ms1×Rf1 (ACS-BNØØ4-7xACS-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 of their derived products (OJ L 34, 7.2.2012, p. 12).
(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) 2019/1117 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).