Env_Comm_8th_Nov_2016_bentazone

07.11.2016

Dear Honorable Member of the Committee for Environment, Public Health and Food Safety,
I am writing to ask that you vote against a draft motion for resolution tabled by Pavel Poc: ‘Objection pursuant to Rule 106(2) and (3) renewal of the approval of the active substance Bentazone’- a copy of the draft motion is attached. The motion has been tabled for a vote in Environment Committee tomorrow, 8th November.

As representatives of the European Crop Protection Industry, we disagree with this draft motion for Resolution and ask that you vote against it, for the following reasons:

1. The Netherlands, as Rapporteur Member State, and EFSA concluded in their scientific evaluations for the renewal of the active substance, that Bentazone is safe when used appropriately, within the framework of 1107/2009.
2. The request for confirmatory data is a solution provided for in Regulation 1107/2009 as part of renewal procedures, where new requirements are established during the evaluation process or as a result of new scientific and technical knowledge. This applies regardless of the opinion issued by the European Ombudsman.
3. Bentazone has not been identified as an Endocrine Disruptor under the current interim criteria.
4. This motion to object neglects the impact of such a measure on EU agriculture. Pesticides, including products containing bentazone, are a vital tool in EU farmers’ toolbox and in ensuring the region’s food security. We need our farmers to remain productive and competitive, while ensuring the protection of human health and the environment.

It is important that MEPs protect the decision-making process agreed for the approval and renewal of active substances, and fully support the role of EU scientific bodies which are regarded amongst the best in the World. We hope we can rely on your support in this matter.

Yours sincerely,

Graeme Taylor
ECPA


Background information: The EU Regulatory system:  The EU system for approval and renewal of active substances is governed by the regime of Regulation 1107/2009 and the Regulations concerning the renewal programmes. The scientific assessment is assigned to a rapporteur Member State and to the EFSA. The process and roles played by rapporteur Member States, the EFSA and other regulatory bodies as established by the legislation must be respected by all institutions (EU and National).  It is paramount the European Parliament as the representative of EU citizens, both respect and protect the role of Member States acting as rapporteurs, the agency and the regulatory authorities.  According to the legislation, the approval and renewal of active substances rely entirely on the assessments of the Rapporteur Member State (for bentazone it was The Netherlands) and EFSA, and the decision of the Commission supported by a vote in the Standing Committee on Phytopharmaceuticals (SCoPAFF).  The Netherlands, as Rapporteur Member State, and EFSA concluded in their scientific evaluations for the renewal of the active substance, that Bentazone is safe when used appropriately, within the framework of 1107/2009. Confirmatory data:  The request for confirmatory data is a solution provided for in renewal procedures in case new requirements are established during the evaluation process or as a result of new scientific and technical knowledge - see Art. 14(1) & Art. 6(f)- this applies regardless of the opinion issued by the Ombudsman.  This procedure is an implementation of the right to be heard, in particular when the applicant had no possibility to address new requests arising from a change in the scientific knowledge during the course of the assessment - the Ombudsman did not state that confirmatory data requests cannot be made, the Ombudsman stated that recourse to them shall be made in a restrictive way.  These submissions can be made in exceptional cases- see Annex II, point 2.2 - (a) new data requirements, or (b) the information can be considered confirmatory in nature as it would only increase confidence in the decision - this is aligned with the Ombudsman’s opinion. Endocrine Mode of Action:  Bentazone has not been identified as an Endocrine Disruptor under the current interim criteria.