TROPICAL AGRICULTURE ASSOCIATION

(London & South-East Regional Group)

London - 27th March 2001.

 

"Recent Developments in EU Pesticides Regulations and their Impact on imports of Tropical Fresh Produce".

(Presentation by David Hirst - UK Representative for COLEACP)

(COLEACP Website- www.coleacp.org)

 

Harmonisation of EU Regulations on Pesticides

 

¨     Background:

 

In order to meet the needs of a growing world population, from the mid-20th century, there has been an intensification of agricultural production. A major contributory factor in this development has been the increasing use of synthetic agricultural chemicals, fertilizers and crop protection products, enabling yields to be maximised and controlling the pests and diseases that are liable to develop in monoculture situations. This is particularly true in tropical conditions, where the pressure from pests and diseases tends to be higher, and is unrelieved by a cold winter.  Without the benefit of chemicals, the losses to crops would seriously threaten the capability of producers to export economically. In many cases, with current knowledge and resources, it would be virtually impossible. 

 

Consumers in the developed world have become accustomed to increasingly high standards of quality and uniformity of fresh produce.  Retailers have translated this expectation into ever greater pressure on their suppliers for higher quality, larger volumes, year-round supplies and at lower cost,  to satisfy their customers' needs and to increase their own market share in a highly competitive trading environment. This could not have been achieved without the help of a whole range of agricultural chemicals.

 

In general, the controlled use of these chemicals, under the principles of Good Agricultural Practice, should represent no measurable hazards to human health and the environment. Wide safety margins are now built into the approval procedures and permitted residue levels. The monitoring of residues in food products, certainly in UK and other EU countries, is strictly enforced. Those chemicals which have proved to be more hazardous in the past or which raise concerns for human health or the environment have been or are being progressively withdrawn in favour of safer alternatives.

 

There is now also a strong movement towards more natural means of crop protection under Integrated Crop and Pest Management systems and a resurgence of demand for organically grown produce which have all followed on from the recent increase in public awareness of the desirability of healthy eating.

Negative publicity about food additives, pesticide residues and the occurrence of high profile "food scares" such as outbreaks of E-coli, Salmonella, Listeria, Dioxins, Aflatoxin, BSE, etc have served to highlight their concerns. There have been demands for greater controls over what goes into our food, and fresh produce has been held up as a potential danger due the residues of pesticides that are used in its production and storage.

 

The results of systematic random sampling carried out by the EU authorities (the PSD in UK) regularly indicate that over 70% of all samples contain no measurable pesticide residues, and that of the remainder, only a handful ever exceed the permitted levels, none of which have yet approached a level representing a hazard to human health.  Fresh produce is in reality one of the safest forms of food we eat and also highly beneficial to our health.  Nevertheless, the public misconception, encouraged by media reports, of fruit and vegetables treated indiscriminately with a cocktail of toxic chemicals before being put onto our plates is not easily corrected.

 

 

¨     Pesticide Regulations before 1993.

 

In the European Union, until 1993, each of the Member-States was responsible for setting its own legislation on pesticide approvals and permitted residues, which in the UK came under the Control of Pesticides Regulations (1986), administered by the Pesticides Safety Directorate of MAFF.

A confusing situation developed in Europe as a whole, where inconsistencies in regulations between member-states caused problems for exporters and importers and seriously hampered the free movement of goods across borders within the trading area.

 

 

¨     Council Directive 91/414/EC.

 

Against this background, in 1991 the European Commission brought out the Council Directive 91/414/EC concerning the placing of plant protection products on the market. Under this Directive, in July 1993 a programme was set in motion to harmonise regulations relating to pesticide approvals and residues throughout the Member-States.

 

There were two main thrusts to this harmonisation programme:

 

-         A review of Active Substances:

 

The first objective was to complete a review of all of the 823 active substances that had been approved for use in crop protection products within the EU prior to July 1993. It was planned, vastly over-optimistically as it turned out, to complete this work by 1998.

This review procedure provided for the establishment of Annex 1, a positive list of approved active substances for the EU. For new active substances, the evaluation procedure for inclusion in Annex 1 also applies once scientific data has been provided allowing approval of the product.

 

-         Setting of Maximum Residue Levels (MRLs) for crop/chemical combinations: 

 

Equally ambitious, this programme set out to establish harmonised EU MRLs for every crop/chemical combination, within the framework of a series of EC directives. 

The definition of MRL is the maximum concentration of a pesticide residue permitted in or on a food product or animal feed. It is expressed as milligrams per kilogram or ppm. And is generally monitored at the point of retail, or less usually, wholesale.

It is not intended to represent a food-safety level and is invariably set well below any point at which human or animal health can be affected. It is related to the usage of a pesticide that gives adequate control of the targeted pest or disease within agreed parameters for safe use, taking into account public and occupational health and environmental considerations.

These considerations include the Acceptable Daily Intake (ADI) of each chemical, which is the amount that can be consumed by an individual human on a daily basis throughout a lifetime without any adverse result. Special dietary situations may also be relevant.

 

As the regulations classify fruit and vegetables into 126 different products, with 823 active substances to be considered, this makes a total of 103,698 MRLs to be harmonised throughout the EU. To ease the burden of this work, it has been divided among the leading member states, the so-called Rapporteur Member States (RMS).

 

When data from trials of an approved pesticide are submitted for the setting of an MRL for a specific crop use, after due consideration, the RMS may agree to approve an MRL. The file is then subjected to scrutiny by various committees, including the Standing Committee on Plant Health (SCPH), and after a series of such procedures, an EU MRL may be allocated for the combination under review. This can take up to 3 years.

 

 

If no such submission is made, or the data is not considered adequate, then the MRL will be set, by default, at the "Limit of Determination" (LOD) which is equivalent to analytical zero. In most cases this will preclude the use of this substance on the crop in question, since there can be no guarantee of zero residue following its use.

 

-         Import Tolerances.

 

Where an MRL or approval for use of an active substance for crops grown in Europe does not exist, applications for MRLs for imported produce grown outside the EU may result in the granting of  "Import Tolerances" for those specific crop/chemical combinations. However, the procedures for approval of an Import Tolerance are exactly the same as for any other MRL.

 

-         Progress to date:

 

The first stage of the review programme began in 1995 with the first data submissions. Progress has been painfully slow, and of the first list of 90 compounds reviewed, 11 have been placed on Annex 1 and 15 have been withdrawn. Decisions on the remaining 64 of the first list have still not been made.

In order to speed up the procedure, the European Commission has set a revised deadline of July 2003 for these decisions to be made. It is expected that many more substances will then be withdrawn due to lack of supporting data supplied by the manufacturers.

Additionally, data submission deadlines have been set for all of the other 700-plus substances and it is expected that those that are not supported will also be withdrawn after 2003. A 12 months period of grace will be then allowed for consumption of stocks and conversion to alternative means of protection.

It is forecast that only 250 to 300 of the original 823 substances are likely to survive the process. This gives rise to concerns that insufficient alternative treatments will be available to growers, leading to pest and disease resistance. On current form, tropical and other minor crops will be the hardest hit. There are also likely to be economic repercussions, particularly on poorer farmers, when most of the older, generic and therefore cheaper pesticides are withdrawn, as they are most likely to be, since manufacturers will not wish to support them, there being no further commercial incentive.

 

¨     Enforcement.

 

When Member-States were responsible for their own legislation, there was a considerable variation between observance and enforcement of the rules from one country to another.

In the UK the Food Safety Act was always applied rigorously and suitable penalties were imposed on the fairly rare occasions when breaches of pesticide residue regulations were discovered in the course of random sampling of products for residues. But in general it all went on quietly and without much awareness on the part of the public.

 

 

However, in recent years, the annual and now quarterly publication of the Working Party on Pesticides Report (WPPR) (now the PRC - Pesticide Residues Committee) with the names of those retailers found in breach of the regulations, has brought the whole question out into the open. This so-called "naming and shaming" policy has laid retailers open to the serious consequences of exposure for selling produce containing illegal pesticide residues and they have become highly sensitised to the risks involved.

The new Food Standards Agency has added its weight to these pressures to be seen to be acting in the interests of public health.

 

 

 

 

 

 

¨   Response to the Harmonisation Programme.

 

-         In Europe.

 

Agro-chemical companies have submitted data packages to support MRLs where the pesticide usage on a crop is sufficient to make the high costs of data generation commercially worth their while.  They also have to consider whether the active substance is out of patent and whether, in the long term, it will continue to have EC approval.

In the UK the Horticultural Development Council, with the growers' support, were sufficiently forward-looking to take advantage of Specific Off-Label Approval (SOLA) arrangements.  They were able to establish some 700 MRLs for locally grown crops at a cost of about  £1.5 m. Other growers, manufacturers and interested parties within the EU have taken similar action to ensure that MRLs are established for important crop/chemical combinations.

 

 

-         Tropical crops

 

Due to poor communications and a lack of understanding of the real consequences of the changes, insufficient work has been done to support the setting of MRLs for imported tropical and sub-tropical crops and indeed many other so-called "minor" crops. While they may be very significant to the producer and even the producing country, many of them, including such items as pineapples, mangoes, avocadoes, sweet potatoes etc, have not attracted the attention of the chemical manufacturers as their potential return on the investment for trial work is insignificant.

The growers and the countries themselves generally do not have a mechanism for coordinating the funds and commissioning the necessary trial work.

 

The result has been that MRLs have been set, by default, at LOD for a wide range of these crops. For some crops, all the MRLs for all listed active substances have been set at the LOD.

This closing off has led to reluctance of the retail sector (notably in the UK), to accept products that have been treated with pesticides that have been so closed off. In some cases products have been de-listed. Recent examples are passion fruit and carambola.

This situation has become most critical for post-harvest fungicide treatments, which are essential when sea-freight is used for exports and where residues are most likely to remain on the surface of the product up to the point of retail.

 

 

 

¨     Impact on Imports.

 

Some EU import statistics (1999):

               

 

Tons

Million US $

Avocadoes

    88,900

         140 

Bananas

3,220,000

1,900

Litchis

    18,587

                  52.5

Mangoes

  114,386

                 127.5

Melons

  163,859

134

Papayas

    13,591

26

Pineapples

  333,045

195

Green Beans,

    75,598

134

 

 

¨     Impact on Exporters.

 

In 1999, DFID contracted the NRI to carry out an impact study of the effects of these changes in regulations on developing countries.

 

In their report they concluded that in the ACP countries alone, some 45 million people were dependent on horticultural exports to the EU for their livelihoods.

 

The legislation changes were likely to have a range of effects:

 

-         A fall in export production

-         Increased production costs

-         Higher risk of crop wastage and crop failure

-         Exclusion of small growers from the supply chain

-         Exclusion of smaller countries from the export trade

 

Smallholders were most affected:

 

-         Importers will exclude exporters relying on small outgrowers

-         Exporters will not source from smallholders where alternatives exist

-         Production costs will increase ( more expensive chemicals and controls)

-         Smallholders may turn to local markets/subsistence as an alternative

 

Workers would suffer:

 

-         Loss of jobs, especially in small-medium units

-         Increased seasonality of work and reduced job security

-         Reduced income

-         Social disruption.

 

 

¨     To summarise so far:

 

The EU harmonisation of pesticide regulations was initiated with the best of intentions:

-         to bring order to a confused situation

-         to enhance  consumer safety assurance

-         to allow freedom of movement of trade goods within the EU

 

The results so far have been:

-         a bureaucratic tangle

-         lack of and inappropriate communication of information

-         bewilderment on the part of the trade

-         serious potential and actual damage to the trade and specifically to developing countries and rural poor in those countries

-         a threat to private sector investment and development aid schemes based on export horticulture

-         effective trade barriers between Europe and the rest of the world

-         reduced consumer choice in European shops.

 

 

 

 

 

 

 

¨     How will this be addressed?:

 

COLEACP Pesticides Initiative Programme (PIP)

 

Early in 1999, during one of the regular meetings of the FPC Pesticide Management and Food Chemicals Committee, the PSD representative present was asked to give a presentation on new developments in EU legislation. It was clear from what he said that these changes would have far-reaching effects on the trade. The UK had evidently taken steps to look after the interests of its growers and this had benefited those across Europe. However, it seemed that nothing effective was being done to inform the producers and exporters in the developing countries. It was clear that the full impact of this legislation had not yet filtered through to them.

 

Further investigation revealed that there was massive ignorance of the consequences outside of Europe. While a steady drip-feed of information on the various Directives had been sent out in highly technical and "officialese" format over a period of years, very little of this, or the significance of it, had actually reached those whose businesses and livelihoods would be most affected by it.

The curtain was about to fall and the trade seemed to be  totally unprepared for it.

 

In June, 1999, a Working Group was formed with COLEACP the FPC, NRI and Audax Audits, a consultant on pesticide residue analysis. Various representations were made to the European Commission and a number of meetings held in Brussels with DG Development, DG Trade and DG Sanco, the Department responsible for the Harmonisation programme.

Eventually, by early 2000, the Commission became convinced that a real problem did in fact exist.  While they were adamant that no concessions could be made as to the timing or substance of the legislation, and no compromise on food safety would be entertained, they asked COLEACP to prepare a proposed action programme, to be funded by the Commission, that would support exporters, in ACP countries in particular, to maintain their competitive supplier status in the EU markets by helping them to comply with the new regulations.

 

This programme was presented in April 2000 and accepted in principle, but then had to go through a lengthy feasibility study by independent consultants. It was again revised and was finally re-presented and approved by the Commission in December. The EDF has agreed to support the programme to the tune of 29 million Euros over a period of 5 years.

It was hoped to have got it under way in February this year, but more bureaucratic delays in Brussels over contractual details have extended this date to May at the earliest.

 

Although it will be administered by a Management Unit based in Brussels, the PIP is designed to operate on a "bottom-up" system.

Requests for assistance will be formulated at national/industry level through the private sector. These will be checked and adjusted as necessary to comply with the requirements of the approval body, which is the ACP Group Secretariat in the Commission in Brussels.

 

Local "Task Forces" representing the trade will be set up to create dialogue. Excessive public sector influence will be discouraged.

 

 4 components of the PIP

 

·            Information Communication component. (Already in progress)

Aimed to provide up-to-date information to the trade in readily accessible and digestible form on all matters relating to pesticides. (e.g. Round Table meetings held in Nairobi, Ouagadougou (B. Faso), Kingston, Jamaica and Brussels in June/July 2000)

This will include databases of regulations, crop protocols and other essential information. It will also handle and circulate feed-back information from within the trade.

 

 

·         Regulations component.

 

This will focus on the preparation and defence of priority crop/chemical combinations to establish practical MRLs and Import Tolerances based on GAP.  Identification of these priorities will be made with the assistance of national Task Forces which are already being set up.

It has emerged from discussions with the RMS expert groups that a more liberal interpretation of extrapolation between similar crops with comparable GAP may be taken in the setting of certain MRLs for tropical crops.

There has also been some indication that the time taken for processing procedures of acceptable data could be drastically reduced to a matter of weeks rather than years as at present, provided that consumer health considerations were not compromised.

 

Assistance and advice will be provided to the national authorities to ensure that their national legislation is in conformation with the new regulatory requirements in the EU.

 

·         Good Practice and Food Safety component.

 

Implementation of Quality Management, Traceability systems, and codes of practice,

Improved crop and pest management systems (ICM/IPM) mainly through the exporter associations working with private companies.

Special attention will be given to the small-scale sector.

 

·         Capacity-building component.

 

This component operates at every level and throughout the programme, but especially through the national Task Forces and the Associations.

It aims, by setting up training schemes, to strengthen the local pool of expertise to encourage self-sufficiency.

It aims to maintain the continuity of the programme after the 5-year project is completed by reinforcing the local private-sector structures and enabling them to cope with future challenges to their place in the world markets.

 

 

¨     And in the meantime?

 

Producers and exporters are being advised to consult closely with their importers and to follow their guidance.

 

They should review the pesticides and treatment regimes they are using, cutting out any that may entail the risk of illegal residues

 

Harvest intervals should be revised upwards unless current data indicates that residues will not be found in any circumstances

 

Pesticides most likely to leave residues are those with longer harvest intervals. Producers should try to use only those that have shorter harvest intervals and are least persistent.

 

Post-harvest treatments are potentially the most risky. Where possible they should be avoided.

 

It is to be hoped that some degree of understanding will be exercised in the enforcement of the regulations over the next few months and years until the trade catches up.  The consequences of near total loss of crop protection chemicals for tropical crops is a daunting prospect indeed.