Parliamentary questions
13 January 2016 / E-000227-16
Question for written answer
to the Commission
Rule 130
Bart Staes (Verts/ALE)

Q1.

There seem to be two similar derogations in Regulation 1107/2009. The semantics of the two definitions in Article4.7 (‘serious danger to plant health which cannot be contained by other available means’) and Article53 (‘danger which cannot be contained by other means’) remain unclear and the implementation and subsequent control remain uncertain.

1.What is the difference between the two derogations?

2.What is meant by and defined as ‘serious’ under Article4.7?

3.Can the Commission clarify how these two derogations will specifically be implemented (criteria, guidelines, checklists) and controlled under these definitions?

Answer given by MrAndriukaitis on behalf of the Commission
1.Emergency authorisations for plant protection products under Article53 of Regulation (EC) 1107/2009(1) are assessed and issued by Member States and valid on their territory only. They may not be issued for a period longer than 120days. In contrast, Article4(7) is implemented in the frame of the assessment of the application for approval at EU level of an active substance: its period of validity cannot exceed 5years and it is not restricted to one Member State only.
2.There is no further guidance on the interpretation of the term ‘serious’ in Article4(7).
3.For the implementation of Article53, a working document was elaborated by the Commission services(2). The information submitted by an applicant in the context of Article4(7) is assessed first by each relevant Member State where a claim is made. The rapporteur Member State (RMS) for the substance compiles this information and submits it to the European Food Safety Authority (EFSA). Finally the reports prepared by the Member States are assessed by EFSA. Following EFSA assessment, the Commission will submit a draft measure on the approval or non-approval of the substance to the opinion of the Standing Committee on Plants, Animals, Food and Feed. In the event that the substance is approved, authorisations by Member States of plant protection products containing active substances approved in accordance with Article4(7) may only be granted when it is necessary to control a serious danger to plant health in their territory.

(1) / Regulation (EC) No1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJL309, 24.11.2009, p.1‐50.
(2) / http://ec.europa.eu/food/plant/pesticides/guidance_documents/docs/working_document_emergency_authorisations_article53_en.pdf

Q2.

According to Directive2009/128/EC, pesticide use should be based on sustainable practices/IPM. However, the new derogation (Article4.7 of Regulation 1107/2009) for the very pesticides that are most harmful might undermine this goal.

1.On what criteria doDG SANCO and EFSA base their assessment of ‘available means’?

2.How does the Commission guarantee that the serious danger to plant health cannot be contained by other ‘available means’ including non-chemical methods?

3.Does the Commission agree that ‘available means’ does not include a whole range of alternatives to combat ‘resistance’, since resistance is caused by bad agricultural practices (monocultures, overdosing with pesticides, weak varieties) and is only worsened by increased spraying?

Answer given by MrAndriukaitis on behalf of the Commission
1 and 2. The assessment of applications in the frame of the implementation of Article4(7) of Regulation (EC) No1107/2009(1), including the terms ‘available means’, is a case-by-case exercise. It is documented in the draft assessment report of the rapporteur Member State and in the conclusions of the European Food Safety Authority (EFSA). ‘Available’ indicates that a solution should be accessible in the Member State(s)and not that a solution is available only elsewhere, for example under different climatic or agricultural conditions.
3.Resistance is caused by the ability of populations to adapt to emerging poisons (noxious elements) by inheritance of modified traits. This ability is a fundamental driver of biological evolution and biodiversity and, therefore, the occurrence of resistance cannot be reduced to bad agricultural practice. The Commission therefore does not agree that resistance management and the provisions of Article4(7) exclude each other.

(1) / Regulation (EC) No1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJL309, 24.11.2009, p.1‐50

Q3.

Subject: Compatibility between Regulation (EC) No1107/2009 and Directive2009/128/EC / / Answer(s)
According to Directive2009/128/EC, pesticide use should be based on sustainable practices/IPM. However, the new derogation (Article4.7 of Regulation 1107/2009) for the very pesticides that are most harmful might undermine this goal.
1.How does the Commission ensure that Integrated Pest Management (IPM) is used as a basis for the assessment of the derogation in Article4.7 and that such derogations do not contradict IPM?
2.What is included in the ‘methodology’ proposed by the EFSA working group(1), how did the Commission respond to this, and can the Commission provide all relevant documents and correspondence on this matter?

(1) / http://www.efsa.europa.eu/en/plant-health/working-group
Answer given by MrAndriukaitis on behalf of the Commission
1.Regulation (EC) 1107/2009(1) and Directive2009/128/EC(2) were adopted at the same time and pursue the same objectives. Integrated Pest Management (IPM) as laid down in Directive2009/128/EC ‘means careful consideration of all available plant protection methods and subsequent integration of appropriate measures (…)’. The absence of any alternative, proven by documented evidence, is the precondition for the derogation foreseen in Article4(7) of Regulation (EC) No1107/2009. Any possible progress in technology or science which might give reason for reconsideration of this evidence will be documented in the phasing-out plan which shall be drawn up by the concerned Member States. The remaining principles of IPM (like the consideration of threshold levels) apply and shall be enforced by Member States at the level of use, as for any other plant protection product authorisation.
2.So far no assessment under Article4(7) has been completed. The first case for the substance flumioxazin is ongoing and expert discussions on the methodology to be used are taking place.

(1) / Regulation (EC) No1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJL309, 24.11.2009, p.1‐50.
(2) / Directive2009/128/EC of the European Parliament and of the Council of 21.10.2009 establishing a framework for Community action to achieve the sustainable use of pesticides, OJL309, 24.11.2009, p.71‐86.

Q4.

Subject: Methodology used in Article4.7 of Regulation (EC) No1107/2009 / / Answer(s)
A new derogation for pesticides could open a Pandora’s box of loopholes, so can the Commission provide some clarity regarding the admissibility of the application made by industry?
1.What are the exact criteria used byDG SANCO and EFSA (and the Member States) to assess the admissibility — i.e.which data form the basis of this assessment and what decision criteria are used?
2.DoesDG SANCO have the capacity and the expertise to counter unfair claims made by industry (that may go to great lengths to demonstrate a ‘serious danger’ for any of their chemicals) — i.e.is theDG assisted by independent experts?
Answer given by MrAndriukaitis on behalf of the Commission
1.According to the provisions of Article4(7) of Regulation (EC) No1107/2009(1), the data which form the basis of the assessment are those contained in the dossier submitted by the applicant and declared admissible by the rapporteur Member State following the procedure laid down in Article9 of the regulation. For applications according to Article4(7) this includes a consultation of all Member States which are mentioned in the application.
Unlike the previous legislation, Regulation (EC) No1107/2009 no longer gives the Commission an active role in the decision-making on admissibility of applications for approval of an active substance.
2.The information submitted by an applicant in the context of the application of Article4(7) is assessed by independent experts from Member States' Competent Authorities and from the European Food Safety Authority (EFSA). It is first assessed by each relevant Member State in which a claim is made. The rapporteur Member State for the substance compiles this information and submits it to EFSA. The reports prepared by the Member States are assessed by EFSA with the involvement of the Plant Health Working Group leading to the production of a Scientific Report which is reviewed by a member of the EFSA Plant Health Panel.

(1) / Regulation (EC) No1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJL309, 24.11.2009, p.1‐50.

Q5.

Subject: Derogations under Article4.7 of Regulation (EC) No1107/2009 / / Answer(s)
In Article4.7 it is stated that derogations are possible in cases of serious danger to plant health which cannot be contained by other available means.
1.Would the Commission agree that this definition limits the use of Article4.7 to special cases such as quarantine pests?
2.Has the Commission, with the aim of helping to guide applicants, developed a list of cases that could qualify for use of the derogation under Article4.7? Does it agree that, for example, herbicides used against weeds competing against crops ought never to qualify as they are not phytosanitary threats?
3.Does the Commission offer Article4.7 derogations as a standard solution for any pesticide that does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of AnnexII?
Answer given by MrAndriukaitis on behalf of the Commission
1 and 2. Article4(7) of Regulation (EC) No1107/2009(1) is not limited to quarantine pests. Weeds for instance can also be considered a serious danger to plant health. Weeds are included in the objectives of national and international plant protection agreements(2), and the control of weeds is an important component of crop protection, for example for vector borne plant diseases.
The assessment of applications in the frame of the implementation of Article4(7), including the term ‘available means’, is a case-by-case exercise. It is documented in the draft assessment report of the rapporteur Member States and in the conclusions of the European Food Safety Authority (EFSA). There is no guidance document for Member States and applicants concerning Article4(7).
3.Under Regulation (EC) No1107/2009, Article4(7) is by no means a ‘standard solution’ and the conditions set in this Article have to be fulfilled in order for the derogation to be granted. Any applicant for the approval of a substance falling within the conditions of Article4(7) must submit information showing that these conditions are fulfilled.

(1) / Regulation (EC) No1107/2009 of the European Parliament and of the Council of 21.10.2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJL309, 24.11.2009, p.1‐50.
(2) / Schrader, G., & Unger, J. G. (2003). Plant quarantine as a measure against invasive alien species: the framework of the International Plant Protection Convention and the plant health regulations in the European Union. Biological Invasions, 5(4), 357-364.