This is a list of questions and answers regarding the following new EC legislation:
- Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market
- Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides
- Regulation (EC)1185/2009 concerning statistics on pesticides
This note is intended to provide answers to the most commonly asked questions about this new legislation and the latest information we have on various activities.
- Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market)
- Directive 2009/128/EC (establishing a framework for Community action to achieve the sustainable use of pesticides)
- Regulation (EC) 1185/2009 (concerning statistics on pesticides)
Q. What are the main provisions of the new legislation?
A. Link to documents giving main provisions of:
Q. How is it being implemented in the UK?
A . CRD established an implementation programme of ten projects to cover the whole package. Most have now completed their work and issued guidance on new arrangements in Regulatory Updates.
Q. What is the timetable for transposition?
A. The legislation for the PPP (Authorisation) Regulation (EC) No 1107/2009 and the Sustainable Use Directive (2009/128/EC) was published on 24 November 2009. The PPP Regulation (EC) No 1107/2009 has applied since 14 June 2011. Two new sets of Regulations came into force in the UK on 24 September 2011. They comprise:
The deadline for Member States to bring in national laws to transpose the Sustainable Use Directive 2009/128/EC was 26 November 2011. In common with a number of other Member States the UK missed this deadline, but we are working hard towards getting the new legislation in place within a couple of months.
The Statistics Regulation was published on 10 December 2009 and came into force on 30 December 2009. The first year of sales data is required for 2011 and for pesticide use a representative selection of crops for one year during the period 2010-2014.
2. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market
ACTIVE SUBSTANCE APPROVAL CRITERIA
Q. What will be the impact of the application of hazard, rather than risk based, criteria?
A. Link to UK’s assessment of the potential impact of the agreed text.
Now these criteria are agreed we will do our best to make them work in a sensible and proportionate way.
Q. How will the criteria for endocrine disruptors be developed?
A. A project has been initiated by the Commission (led by DG Environment) to develop specific scientific criteria for determination of endocrine disrupting properties. The Commission expect that the full four years provided by the Regulation for this work will be required, i.e. until 14 December 2013. In the meantime the interim definitions in the Regulation (paragraph 3.6.5 of Annex II) will apply.
CRD has initiated an independent project to develop a definition and associated criteria in order to engage in the EU discussion.
Q. How will the derogation for substances ‘necessary to control a serious danger to plant health’ (Article 4(7)) work?
A. It is anticipated that some guidance will be developed as part of the active substance renewal programme on the type of information required. It is not expected, however, that the Commission will accept derogations under this Article in anything but exceptional circumstances.
Q. When will new criteria such as assessment of cumulative and synergistic effects or assessment of estuarine and coastal waters apply?
A . These criteria will apply when scientific methods accepted by the European Food Safety Authority (EFSA) are available to assess such effects. EFSA are currently establishing priorities for the development of new guidance.
Q. Efficacy is now a requirement for active substance approval. What efficacy dossier will be required?
A . Guidance has been developed on this point for the active substance renewal programme. A reduced dossier for existing substances with products already authorised by Member States has been developed. Work is also in progress to develop guidance for new active substances. See CRD Efficacy Guidelines page for further information.
Q. Now that substance classification is critical to the decisions to be made on the substance approval how will the PPP procedure be integrated with procedures operated by the European Chemicals Agency (ECHA)?
A. The integration of the Plant Protection Product (PPP) active substance work and the substance classification is still under discussion with ECHA and EFSA. Regulation (EC) No 1107/2009 does allow the Commission to take decisions on substance approval without a definitive classification having been agreed, but we think this is undesirable.
Q. How will the necessary new data requirements be developed?
A. Initially, the data requirements and uniform principles have been transferred from Directive 91/414/EEC as they are, by means of Regulations (EU) No 544/2011 (active substance requirements), 545/2011 (PPP requirements) and 546/2011 (uniform principles). The Commission is currently completing work on updated data requirements which will in due course replace those in Regulations 544 and 545/2011. They will undertake a further project to update the uniform principles to reflect the new data requirements.
[Note that links in paragraph above go to the Eurlex European Law website]
Q. What are the requirements for labelling under the Regulation?
A. Labelling requirements have been transferred from Directive 91/414/EEC as they are, by means of Regulation (EU) 547/2011.
[Note that the link in the paragraph above goes to the Eurlex European Law website]
RENEWAL OF SUBSTANCE APPROVALS
Q. How will the renewal programme be organised?
A. Seven substances have been considered in the first phase of the renewal programme under Commission Regulation (EC) No 737/2007. A further 31 substances are included in the second phase of the programme under Commission Regulation (EU) No 1141/2010. The organisation of the third phase is currently under discussion.
[Note that the links in the paragraph above go to the Eurlex European Law website]
RENEWAL OF PRODUCT AUTHORISATIONS
Q. The procedures under Article 43 for product renewal do not appear to be the same as those currently in place for product re-registration under 91/414/EEC.
A. They are not the same, specifically the periods provided are much shorter. The Commission has published guidance on its website to supplement the Regulation's provisions.
Guidance Documents page on European Commission website
Q. How will the new zonal authorisation system work?
A. The basic rules for zonal authorisations are set out in the Regulation (Article 33-39 for zonals and 40-42 for mutual recognition). A guidance document has been published by the Commission on its website to supplement these provisions.
Guidance Documents page on European Commission website
CANDIDATES FOR SUBSTITUTION AND COMPARATIVE ASSESSMENT
Q. How is the Commission planning to establish the list of candidates for substitution by December 2013 as required by Article 80 (7)?
A. At present we have no indications how this is to be done.
Q. Is there any guidance on how comparative assessment will be conducted?
A. A guidance document for considering efficacy aspects has been developed by EPPO (European and Mediterranean Plant Protection Organisation). CRD contributed to the drafting process. See CRD Efficacy Guidelines page for further information.
Sweden has taken a lead in drafting guidance for considering other aspects of the assessment, which is being considered by Member States.
Q. How will adjuvants be regulated in the future?
A. Adjuvants are included in the new Regulation (Article 58) and are to be authorised in accordance with procedures which will be established in a separate Commission Regulation. In the meantime, we continue to apply existing national provisions under a derogation in Article 81(3).
Q. How will the transition between Directive 91/414/EEC and Regulation (EC) No 1107/2009 be managed?
A. The transitional measures are set out in Article 80. Regulation (EU) No 540/2011 has transferred all active substances listed in Annex I to Directive 91/414/EEC to a list of substances deemed to have been approved under the Regulation. Generally, the principle of transitional measures is that anything concerning active substances or applications for product authorisations that were pending when the new Regulation came into force (14 June 2011) will be evaluated under the rules of Directive 91/414/EEC. As always with transitional measures there are specific complicated cases, particularly products containing voluntarily withdrawn and resubmitted substances, and CRD has published some specific guidance on the transitional measures for UK authorisation holders in Regulatory Update 11/2011.
Q. Where are the CRD procedures available?
A. The procedures have been notified through Regulatory Updates in 2011. For further information see the links to Regulatory Updates below:
Regulatory Update 20/2011
Changes to the authorisation template as a consequence of Regulation (EC) No 1107/2009 and changes to the documentation you are required to submit
Regulatory Update 21/2011
Changes to data protection and data sharing as a consequence of Regulation (EC) No 1107/2009 [ now superseded by 31/2012}
Regulatory Update 22/2011
Commenting on applications as a consequence of Regulation (EC) No 1107/2009 and confirmation that CRD will not evaluate products for which an authorisation has not been requested in the UK
Regulatory Update 26/2011
Annex I Approvals and re-registration requirements: July 2011
Regulatory Update 27/2011
CRD to issue authorisations for plant protection products for Northern Ireland.
Regulatory Update 31/2011
Notification form for zonal applications
Regulatory Update 32/2011
Changes to templates and revocation procedures as a consequence of Regulation (EC) No 1107/2009
Regulatory Update 33/2011
New UK Enforcement and Fees and Charges Regulations
Regulatory Update 34/2011
Revision of application forms as a consequence of Regulation (EC) No 1107/2009
Regulatory Update 43/2011
Which guidance should be used for assessments submitted under Regulation EC No 1107/2009 ?
Q. There are provisions in Regulation (EC) No 1107/2009 for provision of information to neighbours and access to records. How will these be implemented in the UK?
A. The information provisions in Regulation (EC) No 1107/2009 and those in Article 10 of the Sustainable Use Directive were the subject of a public consultation which set out various options for implementation. The outcome, set out in the Government response published on 15 December 2011, was as follows;
Spray Records: The requirement in the PPP Regulation to keep a record of information on pesticides and to make relevant information available on request is directly applicable and the Statutory Instrument to support the application of the PPP Regulation in the UK will contain the necessary enforcement provisions. The Government will continue to require disclosure of pesticide application records (or any other relevant information on pesticides) where this is considered necessary.
Advance notification: The Government did not believe it was appropriate to introduce a statutory requirement for operators to provide advance notice of planned spray operations to members of the public living adjacent to sprayed land. We will continue to encourage farmers and spray operators to develop good relationships with their neighbours.
Further information on the Consultation
Directive 2009/128/EC Sustainable Use Directive
Q. How is the Sustainable Use Directive going to be transposed in the UK?
A. The UK’s longstanding and rigorous regulatory regime for pesticides (including plant protection products) and other existing statutory and voluntary controls place it in a good position with respect to many of the areas covered by the Directive. In a number of areas only minor changes to current arrangements are necessary to meet the new requirements. Implementation will proceed on the basis of making those changes necessary for the UK approach to be consistent with the requirements of the Directive.
Further information on the Consultation
Regulation 1185/2009 concerning statistics on pesticides
Q. What is purpose of the new legislation?
A. The legislation is part of the EU Thematic Strategy on the sustainable use of pesticides, particularly to provide data to measure the impact of the Thematic Strategy and the new directive on the sustainable use of pesticides. It does this by requiring member states to collect statistical data on pesticides on both the sales (placing on the market) and use of pesticides.
Q. How is it being implemented in the UK?
The Pesticide Usage Surveys (PUS) (as of April 2011) are being carried out by a consortium of the Food and Environment Research Agency (Fera) and GFK Kynetec. Currently, they are collecting survey data on outdoor vegetables and edible protected crops. The survey results will continue to be published on the PUS STATS Website hosted by Fera.
The Office for National Statistics (ONS) is collecting the required sales data on our behalf. Following the pilot survey carried out in 2011 collecting the 2010 data as part of their PRODucts of the European COMmunity (PRODCOM) survey, it has been decided that the British Crop Production Council (BCPC) will use their contacts with the Plant Protection Product industry to provide ONS with the raw data for this survey. We expect this to provide a higher response rate that is more targeted to those who can provide the necessary information. The first sales report is due to be provided to Eurostat by the beginning of 2013
Q. What is timetable for implementation?
A. The legislation was published on 10 December 2009 and came into force on 30 December 2009. The first year of sales data is required for 2011 and for pesticide use a representative selection of crops for one year during the period 2010-2014.