Overview reportControls on the Marketing and Use of Plant Protection Products

DG Health andFood Safety

Health and Food Safety

Europe Direct is a service to help you find answers to your questions about the European Union.

Freephone number (*):

00 800 6 7 8 9 10 11

(*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you).

Online information about the European Union is available at: http://europa.eu/index_en.htmFurther information on the Health and Food Safety Directorate-General is available on the internet at: http://ec.europa.eu/dgs/health_food-safety/index_en.htm

Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information.

© Photos : http://www.istockphoto.com/, Health and Food Safety Directorate-General

Luxembourg: Publications Office of the European Union, 2017

Electronic versionISBN 978-92-79-53011-1doi:10.2875/596386Catalogue number: EW-BC-15-056-EN-N

Paper version:ISBN 978-92-79-53010-4doi:10.2875/090Catalogue number: EW-BC-15-056-EN-C

© European Union, 2017Reproduction is authorised provided the source is acknowledged.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2016-6004 - MR

OVERVIEW REPORT

ON A SERIES OF AUDITS CARRIED OUT IN EU MEMBER STATES

IN 2015 AND 2016

IN ORDER TO EVALUATE THE CONTROL SYSTEMS IN PLACE FOR THE

MARKETING AND USE OF PLANT PROTECTION PRODUCTS

Ref. Ares(2017)3239908 - 28/06/2017

I

produce high quality, safe food.

Executive Summary

This overview report provides a summary on the outcome of audits to Member States carried out by the Health and Food Safety Directorate General of the European Commission on official controls on the marketing and use of plant protection products in 2015 and 2016.

The European Union has a comprehensive regulatory system for plant protection products, comprising three stages. Firstly, the products must be authorised or granted a parallel trade permit in each Member State. Secondly, only products compliant with the conditions of the authorisation or parallel trade permit can legally be marketed. Thirdly, growers must use the product as instructed on the label, and in accordance with the principles of integrated pest management. This audit series examined controls at the second and third stages of this process. It showed that while control systems in the European Union were satisfactory at the third stage, i.e. controls on users, there were significant weaknesses at the second stage, in controlling that the actual products placed on the market complied with the stringent conditions of their authorisation or parallel trade permit.

In the majority of Member States, the risks associated with larger, higher-risk operators, specifically, importers, manufacturers and re-packers of PPPs, had not been sufficiently considered in the planning of controls. Consequently, the frequency and scope of controls at these operators was generally insufficient. Controls at these specialist operators were further weakened by the lack of specific training for inspectors and insufficient formulation analysis programmes. The majority of Member States do not conduct controls on plant protection products stated to be for use in other Member States or in non-European Union countries. This significant weakness in control systems can be easily exploited to place non-compliant products on the market. Controls on retailers were generally satisfactory.

Controls on users of plant protection products were generally satisfactory and Member States had restricted the use of specific neo-nicotinoid seed treatments, as required under European Union legislation. All Member States visited had taken significant steps in the implementation of those aspects of Directive 2009/128/EC on the sustainable use of pesticides which were examined. These included the establishment of operator training programmes and sprayer testing systems. Areas treated with plant protection products by aerial spraying have declined significantly in recent years, and this practice is now confined to limited areas, under derogation.

The highly developed control systems on users, coupled with the progress being made in the area of sustainable use, provide assurances to consumers on the responsible use of plant protection products. However, the lack of, or unsuitable controls upstream, at the production and marketing stages, compromise the system to guarantee the safety of the plant protection products.

II

TABLE OF CONTENTS

1. INTRODUCTION AND OBJECTIVES .................................................................12. BACKGROUND TO THE AUDIT SERIES...........................................................23. OVERVIEW OF MAIN FINDINGS AND CONCLUSIONS................................3

3.1. Organisation of Official Controls ......................................................................3

3.2. Controls on Marketing .......................................................................................5

3.3. Controls on Use..................................................................................................7

3.4. Controls relating to Sustainable Use..................................................................8

4. MATTERS FOR CONSIDERATION BY MEMBER STATES.........................105. ACTION TAKEN, OR PLANNED, BY COMMISSION SERVICES ...............10

5.1. Follow–up of Audit Recommendations ...........................................................10

5.2. Additional actions by Commission Services ...................................................10

6. ACKNOWLEDGEMENTS ....................................................................................11

III

ABBREVIATIONS & DEFINITIONS USED IN THIS REPORT

Abbreviation ExplanationCA(s) Competent Authority(ies)

EU European Union

IPM Integrated Pest Management

MS Member State(s)

OECD Organisation for Economic Co-operation and Development

PPP(s) Plant Protection Product(s)

PTP(s) Parallel Trade Permit(s)

1

1. INTRODUCTION AND OBJECTIVES

In 2015 and 2016, the Health and Food Safety Directorate General of the European Commission undertook a series of audits in eleven Member States (MS): Italy, Austria, Belgium, France, Greece, Croatia, the Netherlands, the Czech Republic, the United Kingdom, Luxemburg and Portugal. Annex II provides details of the audit dates and reference numbers. The individual audit reports are located at http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm.

Prior to this audit series, the Health and Food Safety Directorate General of the European Commission had carried out four series of audits to MS covering controls on marketing and use of plant protection products (PPPs), and the resultant residues. The overview reports of these audit series can be found at http://ec.europa.eu/food/audits-analysis/overview_reports/index.cfm. The most recent series, conducted during 2012-2014, and involving nineteen MS, found certain weaknesses in control systems, including some relevant to the marketing of PPPs.

The objective of this audit series was to evaluate the control systems in place for the marketing and use of PPPs under Regulation (EC) No 1107/2009 and some elements of Directive 2009/128/EC on the sustainable use of pesticides, and the actions taken to address recommendations arising from previous audits on PPPs. The series builds on the knowledge gained and examines in greater detail some of the weaknesses in control systems highlighted in the previous audit series.

The audits reviewed the designation of competent authorities (CAs) for official controls on PPPs, their co-operation and their resources for performance of controls. Controls on PPP manufacturers, importers, re-packing facilities, wholesalers/retailers and professional users were examined. Re-packing facilities are operators that re-package and/or re-label PPPs. Re-packers are closely associated with products marketed under parallel trade permits (PTPs), but are also be involved in repacking and/or re-labelling authorised PPPs.

The audits were carried out under the general provisions of European Union (EU) legislation, in particular Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council and Article 68 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council. A full list of the legal instruments referred to in this report is provided in Annex I and refers, where applicable, to the last amended version.

2

2. BACKGROUND TO THE AUDIT SERIES

PPPs, commonly referred to as pesticides, are mainly used to keep crops healthy and prevent them from being destroyed by disease and infestation. They include herbicides, fungicides, insecticides, acaricides, plant growth regulators and repellents. PPPs comprise both active substances, which may be a chemical or a micro-organism, and a range of other ingredients, such as adjuvants, which help the PPP adhere to the target pest.

PPPs are highly regulated under EU legislation so as to ensure a high level of protection of both human and animal health and the environment, and at the same time to safeguard the competitiveness of EU agriculture. PPPs must be authorised in each MS prior to marketing and use. The first step in this process is that active substances are approved at EU level. Following this, PPPs containing approved active substances may be authorised at MS level. Authorisation is only granted following a detailed evaluation of a package of studies relating to a precise formulation, which demonstrate that that specific formulation can be used safely. Consequently, when a PPP is authorised, the precise formulation and the specific source of the active substance is defined in the conditions of authorisation, as well as the conditions of use e.g. maximum dose and pre-harvest interval. The properties of PPPs are determined by both their active substances and their other ingredients, so compliance with all the conditions of the authorisation is critical to ensure the protection of both human health and the environment. This was highlighted during the 2016 discussions on PPPs containing glyphosate, where a commonly used co-formulant in some of these PPPs alters the nature of the product, and hence the measures necessary to ensure their safe use.

Finally, authorised PPPs may be marketed under PTPs, where they are bought in one MS and sold in another, where that particular PPP is already authorised. As with authorised PPPs, compliance with all the conditions of a PTP is critical to ensure human health and the environment is protected.

Based on the limited data provided by MS, the majority of active substances contained within PPPs marketed in the EU are manufactured abroad. Increasingly, formulation of PPPs is also moving to non-EU countries. In addition, there is a high level of trade within the EU, so that the majority of PPPs are not used in the MS in which they are actually imported or manufactured, with significant variation between MS, depending on the scale of the countries PPP manufacturing industry and ports, if indeed these are present in the MS.

In 2015, the Commission published an ad-hoc study on the trade of illegal and counterfeit pesticides in the EU, the executive summary of which is located at http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/index_en.htm. While the authors acknowledged that “no suitable or feasible method of estimating the size of the illegal PPP market among existing methodologies was identified”, the study estimated that illegal PPPs comprise approximately 10 % of the EU market, with considerable differences between MS. In the report and conclusions of the Awareness conference on Fake and Illicit Pesticides held in Alicante in 2012, the European Police Office (Europol) estimated that up to a quarter of PPPs sold in some MS are counterfeit or contain counterfeit ingredients. This report is at https://euipo.europa.eu/tunnel-web/secure/webdav/guest/document_library/observatory/documents/Knowledge-building-events/1392909557_pesticides_report_en.pdf.

3

Illegal PPPs, in an EU context, are typically high quality imitations, or counterfeits, of authorised PPPs. Nonetheless, illegal PPPs pose a risk to health and the environment. Furthermore, they damage the legitimate EU PPP industry through lost earnings, and the reputation of EU food producers. Operation Silver Axe, a Europol co-ordinated twelve day operation in November 2015, during which almost 200 tonnes of illegal PPPs were discovered entering the EU through air and seaports in seven MS, served to demonstrate the scale of the illegal PPP industry in Europe. Further information on this operation is at https://www.europol.europa.eu/newsroom/news/huge-seizures-of-190-tonnes-of-counterfeit-pesticides.

PPPs can be illegal under EU legislation for a number of reasons. The marketing and use of PPPs containing active substances not approved in the EU are illegal. Similarly, the marketing and use of PPPs that are not authorised or marketed under a PTP are illegal. In addition, PPPs that do not comply with the detailed conditions of their authorisation or PTP are illegal. Finally, while the EU operates as a single market, PPPs are authorised and granted PTPs at MS level, and consequently the use of a legal PPP in one MS can be illegal in a neighbouring MS, where it may not be authorised.

Six of the 19 MS visited in the 2012-2014 audit series were covered in this series. While the scope of the two audit series were broadly similar, there were some significant differences, making direct comparisons difficult. Some weaknesses were identified in both series, for example in the area of co-ordination and co-operation between CAs (Section 3.1) and formulation analysis (Section 3.2). On the other hand, significant progress has been made in other areas, most notably in the sustainable use of PPPs (Section 3.4).

3. OVERVIEW OF MAIN FINDINGS AND CONCLUSIONS

3.1. Organisation of Official Controls

CAs were clearly defined in all MS and risk-based control programmes covering marketing and use of PPPs were in operation. Co-ordination and co-operation between CAs responsible for controls on the marketing of PPPs and Customs, the CA for control of imports, was not effective in many cases, to the extent of being virtually non-existent in some cases. Customs have access to very detailed information on all imports prior to their arrival in the EU and analysis of this information in conjunction with, or based on guidance from, the CA responsible for controls on the marketing of PPPs can be very useful in establishing effective controls on imported PPPs.

All MS planned and implemented controls programmes independently, despite the highly integrated nature of the EU PPP industry. While this is not in breach of the legislation, patchwork controls of an integrated industry leads to inconsistent application of the legislation, e.g. while some MS conduct prioritised controls on PPP imports and re-packers, and have effective control systems, other MS do not prioritise controls in these areas. In this area, there is no EU-wide co-ordinated control programme, in contrast with PPP residue monitoring. The establishment of such a programme, particularly in the context of controls on importers, manufacturers and re-packers, could help in providing clear direction to MS in this area. There was ongoing, routine exchange of information between some MS, mainly relating to controls on imports, through the Organisation for Economic Co-operation and Development (OECD) network on illegal trade in pesticides and through informal contacts.

4

All MS had information on registered and revoked PPPs available online, typically supported by databases containing very detailed information on each product. The quality of information in, and the functionality of, these websites varied widely, with inaccurate or incomplete information in some cases. The failure to provide staff involved in controls with live, electronic access to this detailed data, while not explicitly required in legislation, limited the efficiency and effectiveness of controls in almost all MS. The precise formulation details of PPPs are commercially sensitive, and are treated as confidential by CAs. Nevertheless, without access to this information, inspectors cannot conduct some types of controls e.g. controlling manufacturers to ensure that the products manufactured comply with their defined formulation in line with their conditions of authorisation.

The system for the identification of risks, and prioritisation of controls, was not sufficient in most MS. Consequently, the frequency of controls on some types of higher-risk operators (e.g. manufacturers, importers and re-packers) was not sufficient, given the scale and inherent risks associated with these operators. For example, PPPs are typically imported in tens of tonnes whereas PPP retailers typically deal in individual packages. EU based manufacturers and re-packers can legitimately handle PPPs containing active substances prohibited in the EU, where the final customer is located outside the EU.

Similarly, the scope of controls on manufacturers, importers and re-packers was not sufficient, with the scope being the same as for retailers in most cases. Therefore, certain issues which are only relevant to these specialist operators were not addressed in routine controls, such as the source of the active substance used in the manufacture of PPPs. The use of active substances with known purity levels, from specific approved sources, is an important part of the EU PPP regulatory system and is defined in the conditions of authorisation for each product.

While all MS had training programmes for inspectors appropriate to controls on retailers and users, in almost all cases training was inadequate for inspectors involved in the more complex controls required at manufacturers, importers and re-packers of PPPs, which compromised the effectiveness of controls at these specialist operators. For example, in the case of manufacturers, detailed analysis of records relating to goods inwards, production and goods outwards is required to verify that PPPs are manufactured in line with their conditions of authorisation, compared to the relatively straightforward traceability checks required at PPP retailers.

Good practices: Austria requires that all operators involved in the PPP distribution chain are

registered and provide data on the PPP volumes handled annually, thus ensuring their risk-based control system is based on up to date, accurate data.

Croatia provides all inspectors with laptops and mobile printers. Inspectors have access to all data relating to PPPs while conducting inspections, thus ensuring effective and efficient controls.

The United Kingdom practice of changing the authorisation number at re-authorisation and when significant amendments are made greatly facilitates enforcement of the grace periods for sale, storage and use of PPPs. (Grace periods are the defined periods for the disposal, storage, placing on the market and use of existing stocks of PPPs following withdrawal or amendment of an authorisation).

5

Belgium has a dedicated team of investigators to deal with large scale cases of non-compliance and fraud in the food chain, including cases involving PPPs. These specialist investigators have the experience and knowledge necessary to investigate complex, cross-border cases, in contrast with the typical inspector responsible for routine controls.

3.2. Controls on Marketing

Nine of the eleven MS audited had a PPP manufacturing industry, although in terms of production volumes, the EU PPP manufacturing industry is concentrated in just a few MS. The vast majority of MS had no controls to verify that PPPs were manufactured using active substance(s) from the approved source(s) and with the correct quantity of the other specified ingredients, as defined in the authorisation. Inspections at manufacturers were generally confined to label checks of finished product, storage conditions and health and safety related issues.

While a small, but growing, number of MS conducted risk-based controls on PPP imports, equally there were large ports, and indeed large MS, where the risks associated with the importation of PPPs had not been considered when prioritising controls, resulting in an absence of risk-based controls on PPP imports in these MS/ports. Controls at airports, a realistic point of entry for high value PPPs, are in their infancy, with just one MS including airports in their risk-based control programme.

Picture 1. Many of the PPPs used in the EU are imported.

Controls on re-packers, which are recognised as a high-risk category of operator, ranged from excellent to weak, with most MS at either end of the spectrum.

The majority of MS had not recognised the importance of, and the risks associated with, large central distribution points in the PPP distribution system in their control programmes, and therefore did not conduct sufficient controls at this category of operator. These are large warehouses, typically located adjacent to large-scale PPP manufacturers or in close proximity to ports, where significant volumes of PPPs are stored, prior to delivery to the retailer. In many cases, PPPs destined for multiple MS, and in some cases non-EU countries, are stored in these warehouses.

MS are obliged to conduct controls on PPPs destined for other MS and for non-EU countries. For PPPs destined for other MS, MS are obliged to verify that an authorisation/PTP exists for the product and that the product is not used in their own territory. For PPPs destined for non-EU countries, MS are obliged to verify that the product is exported from their territory. Nine

6

of the eleven MS audited failed to comply with this requirement, and conducted controls solely on PPPs destined for use in their own territory.

Almost all MS conducted risk-based controls at retailers of PPPs. The control systems on these operators were generally effective, the exception being controls on the period of grace to sell existing stocks when changes are made to the conditions of authorisation, which was a weak point in some MS.

The majority of MS audited had a formulation analysis programme. This is a critical component in an effective control system to ensure that PPPs comply with the very detailed conditions of their authorisation or PTP. In all cases, the intensity of sampling and scope of analysis was considered insufficient to ensure that the PPPs placed on the market complied fully with conditions of their authorisation or PTP. MS generally analysed samples for the level of active substance and some physical chemical properties, with just some MS conducting more sophisticated analysis. The nature of many illegal PPPs in the EU means that sophisticated analytical techniques are typically necessary to detect these products.

MS have different interpretations of some of the definitions under PPP legislation, resulting in, for example, some MS not controlling PPPs in bulk 1 000 litre containers, and PPPs without their final label. Some MS believe that this weakness, coupled with the absence of controls on PPPs destined for other MS, is exploited by non-compliant operators, by deliberately establishing complex distribution chains involving many MS to market illegal PPPs.

MS have established systems to penalise non-compliant operators, so that sanctions are generally effective, proportionate and dissuasive. While MS could provide numerous examples of sanctions applied to retailers and users, due to the weaknesses in control systems at manufacturers, importers and re-packers, resulting in the absence of significant findings of non-compliances, in many cases MS were unable to provide examples of sanctions on these larger scale operators.

Picture 2. An inspection at a distributor of PPPs.

Good practices: The Netherlands CA co-operates very closely with Customs when controlling PPP

imports. The information provided to Customs prior to the arrival of the ship is analysed to detect suspect PPPs, and includes analysis of cargoes not declared as PPPs. Suspect cargoes are then selected for control. PPPs intended for all countries are controlled. Information on suspicious active substances and intermediate products (partially formulated PPPs) destined for other MS is communicated to the relevant MS. The result of the very detailed risk analysis are targeted controls within the Netherlands, and the provision of timely intelligence to other MS, both helping to

7

ensure an effective and efficient EU-wide control system.

Greece requires prior notification of entry into Greece of all consignments of PPPs for marketing under PTPs in its territory in order to prioritise controls on these products, as they have identified PTPs as a high risk category of PPPs in their control system.

In the Netherlands, in addition to financial sanctions and imprisonment, the proceeds of illegal activity, including assets accumulated from the marketing of illegal PPPs, can be recovered in the case of successful prosecutions.

3.3. Controls on Use

All MS conducted planned, routine, risk-based controls on users of PPPs. These focused on farmers claiming funds under the EU Basic Payment scheme, but all MS with one exception, conducted some routine controls on other categories of users. Inspections typically covered storage conditions, the products in store and records of use. In virtually all cases, the scope and frequency of inspections were sufficient to ensure a robust system of controls. In most MS, controls covered operator training and sprayer testing, despite the fact that these are only legally required from November 2015 and 2016, respectively.

The EU has prohibited the use of three active substances in the neo-nicotinoid chemical group (clothianidin, thiamethoxam and imidacloprid) and fipronil for use as seed treatments on certain crops, as these substances have been linked to bee health issues. All MS revoked, or revised, the authorisations for relevant PPPs. The EU seed industry has been pro-active in promoting good seed treatment practices at industry level under a Quality Assurance scheme and the safe use of treated seed at farm level through labelling of treated seed. Some MS reported that the restrictions on these seed treatments have resulted in the increased use of alternative PPPs, with a significant increase in total PPP use in the case of oil seed rape.

Picture 3. Maize seeds treated with PPPs to protect the young plant from pests.

8

3.4. Controls relating to Sustainable Use

All MS have published a National Action Plan outlining their plans for the sustainable use of pesticides, while two had already revised their National Action Plan voluntarily, in advance of the five year legal deadline. Ten of the eleven MS have chosen to focus on risk reduction, while France has chosen use reduction targets as a means to reduce risk, based on a quota system for each retailer.

In all MS visited, growers have access to integrated pest management (IPM) guidelines to guide them in their decision making. The voluntary development of these guidelines by CAs, industry and grower groups demonstrates the clear commitment of these stakeholders to the promotion of IPM. Compliance with the general principles of IPM is a legal requirement in all MS and all farmers met in the course of the audit series were growing their crops in line with the general principles of IPM, using tools such as rotation and resistant varieties, where feasible. Growers in all MS visited had access to timely data from pest monitoring systems. The scale and scope of these systems varied considerably, as is appropriate given the diversity of agronomic and climatic conditions between, and within, MS. MS are increasingly disseminating this monitoring data via email, and even text message, to ensure that this information reaches growers promptly, allowing them to take any required action promptly to address emerging pest issues.

All MS visited had established operator training programmes and sprayer testing systems. In some MS, such schemes were already in place prior to the Directive, while for other MS this was a considerable new body of work. All MS visited had schemes to dispose of empty PPP containers and remnants, so as to reduce the risk associated with empty packaging and old PPPs. Membership of quality assurance schemes can be a useful mechanism to promote good practices. Membership varies widely between MS and crop types, but is most common among fresh fruit and vegetable growers.

All MS audited had prohibited aerial spraying. However, derogations had been granted in seven of the MS. In all cases, derogations restricted aerial application to very limited areas, where the CA was satisfied that there were no viable alternatives. The areas treated under derogation have declined significantly in the last few years. The cases of France and the Czech Republic clearly demonstrate the scale of the reduction in aerial spraying. In France, the treated area has reduced by over 90 % between 2008 and 2014, and derogations are no longer possible from 2016. Similarly, in the Czech Republic, the area treated has declined by 98 %, from over 9 000 hectares in 2012 to just 140 ha in 2014, out of a total agricultural land area of four million hectares.

Picture 4. Rotation, involving crops such as oilseed rape, can be a key component of IPM.

9

Picture 5. Sprayer testing programmes help to ensure that application equipment works effectively.

Good practices: France has developed a demonstration farm network comprising approximately 1%

of all farms to promote IPM as part of their plan for the sustainable use of PPPs.

The Czech Republic has a very extensive system of pest monitoring with 85 agronomists undertaking 50 000 observations per year to provide the data to compile very detailed, crop-specific bulletins to guide growers in their decision making.

The voluntary development, and widespread dissemination, of IPM guidelines in all MS visited to guide growers in the sustainable use of PPPs.

The high participation rate in quality assurance schemes in both the Netherlands and the United Kingdom, estimated to cover over 90% of arable farms, membership of which requires compliance with some aspects of sustainable use.

The industry role in promoting good seed treatment practices via a Quality Assurance scheme and the safe use of treated seed at farm level through labelling of treated seed throughout the EU.

10

4. MATTERS FOR CONSIDERATION BY MEMBER STATES

The individual audit reports contained recommendations made to the CAs of the MS visited. The main deficiencies giving rise to recommendations included the following:

The risks associated with larger, higher-risk operators, specifically, importers, manufacturers and re-packers of PPPs had not being sufficiently considered in the planning of controls, resulting in an insufficient frequency and scope of controls at these operators.

The lack of specific training for inspectors responsible for the very technical controls required at importers, manufacturers and re-packers of PPPs.

Insufficient formulation analysis programmes.

The absence of controls on PPPs stated to be for use in other MS and non-EU countries.

Lack of, or insufficient, co-operation and co-ordination between CAs involved in controls.

5. ACTION TAKEN, OR PLANNED, BY COMMISSION SERVICES

5.1. Follow–up of Audit Recommendations

Following each audit, a copy of the draft audit report is sent to the national CA, with a request for an action plan to specify the actions to be undertaken, and the deadlines for their completion, to address each recommendation.

The actions taken to address recommendations are followed up through correspondence, dialogue and in subsequent audits to verify their implementation. In cases where the actions are insufficient to rectify the weakness, the Commission services actively pursue the matter with the authorities concerned.

Progress on the actions undertaken by MS to address recommendations is summarised in Country Profiles, which can be found at http://ec.europa.eu/food/audits-analysis/country_profiles/index.cfm.

5.2. Additional actions by Commission Services

An interim overview of the key findings and common weaknesses was presented to MS at the Standing Committee for Plants, Animals, Food and Feed meeting in March 2016 and it is planned to present this overview report at a future Standing Committee meeting.

The key messages from the audit series were also presented at a range of other relevant industry conferences/workshops, including the AgChem Forum in September 2015, the Operation Silver Axe I workshop in October 2015, the joint European Crop Protection

11

Association/European Crop Care Association conference in March 2016 and the British Crop Protection Council Congress in October 2016. The Health and Food Safety Directorate General are active in relevant international fora dealing with controls on the marketing and use of PPPs, and co-operate closely with other stakeholders including industry groups, OECD, the European Anti-Fraud Office (OLAF) and Europol in this area.

The Health and Food Safety Directorate General are currently developing the Plant Protection Product Application Management System (PPPAMS), http://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/pppams_en. Once completed, PPPAMS will facilitate controls, particularly for PPPs destined for use in other MS, by providing a single definitive list of all PPPs that can be marketed and used in all MS.

In response to the weaknesses in control systems, the Health and Food Safety Directorate General have established two new MS Working Groups in 2016, one focusing on general PPP enforcement issues, and one dealing specifically with PPP formulation analysis. It is envisaged that these Working Groups will facilitate greater co-operation, co-ordination and exchange of information between MS, leading to improved control systems.

6. ACKNOWLEDGEMENTS

The European Commission would like to acknowledge the contribution of the National Experts who gave of both their time and their expertise in contributing to the success of this audit series. National Experts are CA officials that work in the specific area being audited, and work with Commission officials as part of the audit team for the duration of the specific audit. Their detailed knowledge of technical aspects of the legislation and control systems contributed greatly to the value-added component of the audit series.

Finally, the European Commission would like to thank all the CA officials, industry representatives and growers met during the audit series for their co-operation and positive approach, which greatly facilitated our work.

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 178/2002 OJ L 31, 1.2.2002, p.

1-24 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 1107/2009 OJ L 309, 24.11.2009, p. 1-50

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC

Dir. 2009/128/EC OJ L 309, 24.11.2009, p. 71-86

Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides

Reg. 781/2013 OJ L 219, 15.8.2013, p. 22-25

Commission Implementing Regulation (EU) No 781/2013 of 14 August 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated with plant protection products containing this active substance

Reg. 485/2013 OJ L 139, 25.5.2013, p. 12-26

Commission Implementing Regulation (EU) No 485/2013 of 24 May 2013 amending Implementing Regulation (EU) No 540/2011, as regards the conditions of approval of the active substances clothianidin, thiamethoxam and imidacloprid, and prohibiting the use and sale of seeds treated with plant protection products containing those active substances

Reg. 540/2011 OJ L 153, 11/06/2011, p.0001-0186

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances

Reg. 547/2011 OJ L 155, 11/06/2011, p.0176-0205

Commission Regulation (EU) No 547/2011 of 08 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products

ANNEX II: DETAILS OF AUDITS UNDERTAKEN

Member State Dates of audit SANTE referencenumber

Italy 26/01/15 – 4/02/15 2015-7468

Austria 3/03/15 – 11/03/15 2015-7472

Belgium 21/04/15 – 29/04/15 2015-7470

France 22/06/15 – 1/07/15 2015-7481

Greece 14/09/15 – 22/09/15 2015-7475

Croatia 13/10/15 – 21/10/15 2015-7480

The Netherlands 17/11/15 – 26/11/15 2015-7483

The Czech Republic 19/01/16 – 27/01/16 2016-8753

The United Kingdom 19/04/16 – 29/04/16 2016-8755

Luxemburg 25/05/16 – 31/05/16 2016-8790

Portugal 14/06/16 – 24/06/16 2016-8789

The individual audit reports, Competent Authority comments on draft reports and Competent Authority responses to the recommendations made are at http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm.

HOW TO OBTAIN EU PUBLICATIONS

Free publications: • one copy:

via EU Bookshop (http://bookshop.europa.eu);

• more than one copy or posters/maps: from the European Union’s representations (http://ec.europa.eu/represent_en.htm); from the delegations in non-EU countries (http://eeas.europa.eu/delegations/index_en.htm); by contacting the Europe Direct service (http://europa.eu/europedirect/index_en.htm) or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) (*). (*) The information given is free, as are most calls (though some operators, phone boxes or hotels may charge you).

Priced publications: • via EU Bookshop (http://bookshop.europa.eu).

EW-BC-15-056-EN

-N

ISBN 978-92-79-53011-1doi:10.2875/596386