Annex Changes

The European re-registration procedure has been ongoing since the passing of Council Directive 91/ 414/EC in 1991. Initially a list of 90 active ingredients (ais) were selected; since then, three more lists — covering most products with existing registrations in the EU market — have been issued. The target is to re-register through listing in Annex 1 and maintain full access to the marketplace.

While 831 products have been called for re-registration, only 478 are recognized as commercially significant agrochemical ais. To date, only 90 — all from List 1 and 2 — have been accepted to Annex 1. The registrants of 242 of the commercially significant ais have either decided not to support the products through re-registration, or re-registration has been refused; most of these products left the EU market as of July 2003. An additional 146 existing ais — most from List 3 — await a decision.

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Current Status of EU Annex 1 Acceptance/Re-registration
List No. of Products Products of
Commercial
Significance
Accepted
into
Annex 1
Re-registration
admissable/
pending
Not accepted
Not
supported
Existing Products
1 90 90 59 0 31
2 148 114 31 2 81
3 389 263 0 135 128
4 204 11 0 9 2
Total 831 478 90 146 242
New A.I.s     72 31 7
Total Existing + New a.i.s 162 177  

*as active ingredients for crop protection.
Source: Phillips McDougall April 2007

Since 1994, 72 new ais have been accepted to Annex 1, with 31 more from the original list awaiting approval, their registration dossiers deemed complete.

Of over 500 ais registered in the EU in 1991, 242 existing ais have left, or are now in the process of leaving. If all existing and new ais awaiting approval achieve acceptance, then the EU market will be limited to 339 ais.

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Clearly, a market opportunity exists to replace products that have already left the market. Most of the new ais that weren’t accepted were actually withdrawn by the applicants, often because the registration dossier was incomplete. These products are: alanycarb, azafenidin, chlorfenapyr, fluazolate, flusulfamide, pyridafol, and a biological agent to control zucchini yellow mosaic virus.

Most products not being re-registered are herbicides and insecticides; the review procedure has much less impact on fungicides.

Insecticides account for the greatest share of products not re-registered, notably the organophosphates, carbamates, and acaricides. Although the impact is spread throughout a wider range of chemistries in the herbicide sector — the next most greatly affected — again it is the older classes where the greatest reductions have been seen; notably the ureas, triazines, carbamates, and acetamides. The major impact in the fungicide sector has occurred in the carboxamide and triazole sectors.

The deadline for completion of the re-registration procedure for List 1 products was the end of 2006. As this deadline approached, six ais still awaited published decisions. Re-registration is generally for seven years, after which time the registration is reviewed again.

In the case of these six products, the EU Commission proposed a shorter re-registration period to the European Council. For fenarimol, flusilazole, methsmidophos, and procymidone, a shorter precauionary 18-month authorization period was proposed, with a three-year precautionary authorization period for dinocap and carbendazim.

New ais are approved for registration on Annex 1 for 10 years, with a review after that time. Under current proposals, data on active substances remains protected for the first 10 years after the substances has been authorized (except for data on tests on vertebrate animals, which has to be shared in order to avoid duplication of the animal testing). After 10 years, it has been proposed that all data must be shared by the company/producer.

After Annex 1 acceptance, products must be authorized at the individual state level. However, to avoid duplication of work, speed-up the decision-making process, and reduce market fragmentation, a mutual recognition of authorization between stated has been proposed. State level authorization would be divided between three zones: North, Central, and South, defined on factors such as similar climatic and ecological conditions. The first zone includes Denmark, Estonia, Latvia, Lithuanina, Finland, and Sweden; the second, Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Slovenia, and UK; and the third Spain, Greece, France, Italy, Cyprus, Malta, and Portugal.

The Commission aims to complete the first re- registration of existing ais in 2008. To date, 90 approvals for existing ais have been made, while 146 decisions await; the registration dossiers for a large number of the products are considered complete.

Sales in the EU-27 of the unre-registered 234 products were estimated at over US $1 billion in 2003, the last full year for many of these products on the EU market. Many products had an obvious replacement; a racemic mixtures was not re-registered, for example, but a single isomer product was. Taking these into account, it’s believed that opportunities to replace products in the EU market  have a sales value of around US $780 million. Although the procedure is set for completion in 2008, if some existing ais that have been accepted on Annex 1 are not re-approved at the seven-year review, future market opportunities due to this procedure may occur.

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