Chair: Dorothée André

All Member States were represented.

Adoption of the agenda

MORNING SESSION:

1. Presentation of the results of the evaluations of the GMO legislation

1.1. GM food and feed – FCEC – Food Chain Evaluation Consortium

1.2. GMO cultivation- EPEC- European Policy Evaluation Consortium

The presentations by the two consultants were followed by questions from Member States (MS) to the contractors. The Commission then presented the press release and questions and answers documents that accompanied the publication of the evaluations as well as the main follow up work that the Commission is undertaking. This

presentation was followed by additional questions by 3 MS.

The Commission concluded the meeting by  inviting Member States to transmit comments in written if they wish and noting that the point will  be put again in the

agenda of the next meeting of this committee (SCFCAH) and 2001/18/EC Competent Authorities (CA) meetings, in case Member States did not have sufficient time to

prepare their views on the evaluation reports. Booklets of the two evaluations will be distributed at the next meetings of the SCFCAH and of the CA.

AFTERNOON SESSION:

1. Ruling of the European Court of Justice on the regulatory status of genetically modified pollen in honey.

The Commission presented briefly the consequences of the judgement on genetically modified (GM) pollen in honey as regards  authorisation and labelling requirements.

Regarding MON810 pollen, EFSA adopted on 20 October 2011 a statement on MON810 pollen confirming its safety and an application for the authorisation of MON810 pollen will be soon submitted by Monsanto. The Commission recalled that notifications under the Rapid Alert System for Food and Feed should be issued when there is a serious risk to health which does not appear to be the case as, according to the EFSA statement, MON810 pollen does no pose a safety problem. It must be reminded that there is no harmonised method for detection and quantification.

The Commission explained that no new data on impact have been received that it is analysing how the Court comes to the conclusion that pollen in honey is an ingredient and if the status of pollen in honey should be further clarified

A representative of the Joint Research Centre (JRC) explained that on the extraction and detection methods, work is still ongoing. JRC currently encounters practical problems on the quantification of GM pollen to total pollen but is actively working to overcome these difficulties. In order to ensure harmonisation of methods also with third countries, Argentinean experts will meet experts of the JRC.

Some Member States stressed that the ruling is having and will have significant impact on EU's and third country's honey trade. Some EU operators are asking for GM pollen free certificates and maps with the localisation of GM fields and hives. Member States were informed that Argentina, Brazil, Uruguay, Mexico and Canada have raised the issue of the trade impact due to the ruling (TBT) in the framework of the last committee.

One Member State asked whether the Court could be challenged or if the legislation could be modified (honey Directive) to address the status of the pollen. The

Commission replied that the Court cannot be challenged but a legislative proposal could clarify the existing legislation.

Another Member States stressed that the ruling should be applied without delay, that coexistence rules for field trials should be put in place and that consumers must be protected by avoiding non-authorised GM pollen in honey.

Commission's view is that the GM legislation applies to GM  pollen in honey, that safety has to be ensured which is the case when positive EFSA statements are available and that full authorisation has to be delivered for GMOs with incomplete scope for pollen. 3

2. Draft Commission Regulation on implementing rules concerning applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations No (EC) 641/2004 and (EC) No 1981/2006 - State- ofplay.

Point not addressed.

3. EFSA opinion on application for the placing on the market of genetically modified MON89034x1507xMON88017x59122 maize and all sub-combinations of the individual events for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Dow and Monsanto – Presentation by EFSA.

EFSA presented the updated opinion on MON89034x1507xMON88017x59122 which was adopted in November 2011 and addressed questions raised by Member States during the consultation period. Some Member States sent additional comments after the adoption of the opinion which were duly addressed by EFSA in its presentation.

4. EFSA opinion on application for the placing on the market of genetically modified MON89034x1507xNK603 maize and  all sub-combinations of the individual events for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto – Presentation by EFSA.

EFSA presented the updated opinion on MON89034x1507xNK603 which was adopted in November 2011 and addressed questions raised by Member States during the consultation period. Some Member States sent additional comments after the adoption of the opinion which were duly addressed by EFSA in its presentation.

5. Draft Commission Implementing Decision repealing Commission Decision 2008/289/EC and introducing new emergency measures regarding unauthorised genetically modified organisms in rice  products originating from People's Republic of China. (Art. 53(1) of Regulation (EC) No 178/2002) (Opinion of the Committee via the examination procedure)

Following on from the SCFCAH meeting (see item 3 of the Agenda) of the 24th of October a revised Decision on import requirements for Chinese rice products was presented to the Committee. The 2 main  points which continued to be of concern focussed on import requirements and the proposed analytical screening method. On import controls the Commission proposed a requirement for consignments to be notified in advance of arrival at the designated point of entry in order to achieve  greater harmonisation with Regulation 669/2009/EC on increased controls for food of non animal origin. On the analytical method the Commission again highlighted the

lack of available screening methods, and that the current  construct-specific methods are too narrow in scope and may give rise to a high number of false negatives which is of greater concern than false positives. To provide greater assurance in the use of the proposed method, the EU Reference Laboratory for GM food and feed agreed to prepare an enhanced guidance document for Official Control Laboratories, in addition to the organisation of training workshop for Member State National Reference Laboratories. The Commission representative also highlighted that it was the objective that at the next review of the Decision, Committee members would agree on one single screening method in place of the options which are now proposed.

Following the discussion, an amended draft implementing Decision on emergency measures regarding unauthorised genetically modified rice in rice products originating from China and repealing Decision 2008/289/EC was presented and submitted for an opinion to the Committee.

The following reasons were mentioned by a Member State for not supporting the draft Decision:

• Concerns over resource requirements for 100% testing for imports  Vote: Qualified majority (333 votes in favour, 12 abstentions)

6. Draft Commission Implementing Decision authorising the placing on the market of products containing, consisting of,  or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the  Council. (Art. 7(3) and Atr. 19(3) of Regulation (EC) No 1829/2003) (Opinion  of the Committee via the examination procedure)

The draft Commission Implementing Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 pursuant to Regulation (EC) No 1829/2003 on genetically modified food and feed was presented and submitted to the Committee for an opinion.

Vote: No opinion (190 votes in favour, 113 votes against, 42 abstentions)

The following reasons were mentioned by Member States for not supporting the draft

Decision:

- toxicological studies are not considered as satisfactory;

- data on the comparative analysis between the GM soybean and its counterpart are not considered as satisfactory;

- precautionary principle invoked;

- assessment on the use of glufosinate  and its residues not included in the application is considered as needed;

- lack of long term studies;

- no history of safe exposure;

- the Regulation on GM food and feed is not considered as the right legal basis to authorise products other than food and feed containing and consisting of GMOs;

- negative public opinion and perception to GMO;

- political reasons.

The Chair indicated that the Commission would be invited to submit a proposal to the Appeal Committee in accordance with Regulation (EU) No 182/2011.

Declaration from the Austrian delegation

"Austria objects the placing on the market of genetically modified soybean A5547-127 (ACS-GM006-4) due to the following reasons:

The risk assessment which has been carried  out is not suitable to give a scientific proof for the safety of this product:  This concerns in particular the ambiguous

establishment of substantial equivalence between the GM product and its conventional counterpart according to the outcome of the compositional analysis which showed a high number of statistically significant differences between the conventional counterpart and soybean A5547-127, the assumption of a history of safe consumption

of the modified PAT protein, which, however, does not occur in conventional food and feed, and the omission of a toxicological assessment of whole GM food and feed in an animal safety study. Data on effects  after long term exposure with A5547-127 containing food or feed and on reproduction are missing.

From the Austrian point of view, products others than food and  feed containing or consisting of soybean A5547-127 (ACS-GM006-4), are not within the scope of EURegulation 1829/2003 but under Directive 2001/18/EC."

7. Draft Commission Implementing Decision renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified soybean 40-3-2 (MON-Ø4Ø32-6)  pursuant to Regulation (EC) No 1829/2003. (Art. 7(3) and 19(3) and 11(3) and 23(3) of Regulation (EC) No 1829/2003) (Opinion of the Committee via the examination procedure)

The draft Commission Implementing Decision renewing the authorisation for continued marketing of products containing, consisting of, or produced from genetically modified soybean 40-3-2 pursuant to Regulation (EC) No 1829/2003 on genetically modified food and feed was presented and submitted to the Committee for

an opinion.

Vote: No opinion (190 votes in favour, 80 votes against, 75 abstentions)

The following reasons were mentioned by Member States for not supporting the draft Decision:

- allergernicity studies are not considered as satisfactory;

- environmental risk assessment is not considered as satisfactory;

- data on the comparative analysis between the GM soybean and its counterpart are not considered as satisfactory;

- precautionary principle invoked;

- assessment on the use of glyphosate and its residues not included in the application is considered as needed;

- lack of long term studies;

- no history of safe exposure;

- the Regulation on GM food and feed is not considered as the right legal basis to authorise products other than food and feed containing and consisting of GMOs;

- negative public opinion and perception to GMO;

- political reasons.

The Chair indicated that the Commission would be invited to submit a proposal to the Appeal Committee in accordance with Regulation (EU) No 182/2011.

Declaration from the Austrian delegation

"Austria objects the placing on the market of genetically modified soybean 40-3-2 (MON-04032-б) due to the following reasons:

a. The risk assessment which has been  carried out is not  suitable to give a scientific proof for the safety of this product: This concerns in particular the insufficient analysis of molecular characterisation and gene-expression, the poor quality of the comparative assessment which indicated statistically significant differences of several  compounds between soybean 40-3-2 and its conventional comparator as well as of the environmental risk assessment.

b. A history of exposure/safe consumption of soybean 40-3-2 in Europe cannot be demonstrated because no post-market monitoring for food and feed safety has been performed.

c. From the Austrian point of view, products others than food and feed containing or consisting of soybean 40-3-2 (MON-04032-б), are not within the scope of EU-Regulation 1829/2003 but under Directive 2001/18/EC."

Dorothée André

Head of Unit