Grace period plant proctection products

WG changes in existing authorizations- W-code

The use of the product is legally defined in the conditions for use – in Dutch ‘Toepassingsvoorwaarden’ and ‘Overige Toepassingsvoorwaarden’ - stated in the Legal Instructions for Use – in Dutch ‘Wettelijk Gebruiksvoorschrift’ (WG). When a plant protection product is authorized for the first time, the WG does not receive a suffix W-code (=W0). However, any following Board decision on that authorization may have consequences for the use of the product as defined in the WG. Each newly authorized version of the WG is marked by a code W(x+1) that is 1 higher than the previous version Wx. With publication of the Ctgb Board decision in the Staatscourant, the new WG becomes the Legal instruction for Use. The previous version of the WG may attract grace periods.

Grace periods only apply in case of WG restrictions

• the entire authorization is withdrawn/expiring.
• amendments in which the use according to the new WG is in at least one aspect restricted compared to the previous WG, e.g., use/claim withdrawn, more strict mitigation, higher PHI, lower frequency, or dose, etc.
• amendments in which the new WG contains a combination of restrictions and extensions.

• Where the new WG only contains extensions and no restrictions relevant for the existing uses as defined by the previous WG, grace periods do not apply.

Restriction in the conditions for use as stated in the WG can be triggered by a Ctgb evaluation, an EU evaluation or by request from the applicant. In all cases grace periods can be applied for.

Changes in classification or other changes in the authorization do not trigger grace periods.

Ctgb policy on grace periods

The Ctgb policy on grace periods is based on articles 20 and 46 of Regulation (EU) 1107/2009 and is laid down in a special board decision: Besluit Beleidsregel Respijttermijnen voor Gewasbeschermingsmiddelen (in Dutch. Published in the Staatscourant of August 31, 2016). As required by Dutch law, the text of the document is in Dutch, but the most important elements are explained below.

• As a precondition for granting grace periods by the Board, applicants must actively request for grace periods with a sound argumentation for the reason why and the length applied for. See below under procedures.
• Maximum grace periods are 6 months for distribution and sales and an additional 12 months for use, storage and removal as based on article 46 of PPPR (EU) 1107/2009, in case the restriction of use is not triggered by risk for humans, animals or the environment.
• As far as the reason for restriction, withdrawal or expiration is related to the risks for human, animals and environment, the Board weighs possible risks against the interests of the producer and user, e.g., the surprise element, agronomical factors, economic factors, etc. Grace periods will be set shorter in case of heavier, acute, and more concrete risks. When unacceptable (acute) risk is foreseen, the Board may decide to no grace periods.
• Risk permitting, Ctgb will time the end of the grace period to for use with the end of the current or soon-to-start application season.

Grace periods may also apply to previous WG versions

• It is not uncommon that an authorization has more than 1 valid WG version when no grace periods applied to pre-previous WG versions. If then the newest WG is restricted compared to the previous WG, the grace periods set for the previous WG version automatically apply to all still valid pre previous WG versions.
• When the new WG is restricted because of a significant risk and short grace periods are set, it may happen that this risk is also relevant for a pre previous WG version with a still valid grace period. In those cases, it may be necessary to shorten the grace period for the pre previous WG-version as well.

• Which grace period applies to which WG version can be traced back in the individual decisions in appendix I (BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING), and the Ctgb database will also be updated with grace periods specified per WG version (W-code).

Legal implications and function of grace periods

By law it is forbidden to market, to use or to hold stocks of non-approved plant protection products or of an approved product intended for a non-approved use. In case the currently authorized use becomes restricted by a new Board decision, (part of) the currently permitted use becomes illegal from the date of entry into force of the new Board decision and new WG version. However, where a Member State (partially) withdraws, restricts or does not renew an existing authorisation for a PPP, it may grant grace periods (article 46, PPPR (EC) 1107/2009). During the grace periods it is allowed to market, hold stocks, or use the plant protection product under the old conditions (WG version W.x) while the new conditions (WG version W.(x+1)) are already into force or the use of the PPP is no longer authorized at all.
The grace periods are intended as a transitional period for authorizations holders and users to anticipate on the phase out of the product or specific uses or to prepare for more restricted conditions for use. Authorization holders need time to inform the supply chain and end users, to sell out or relabel existing stocks. End users have time to use up existing stocks and they may have to look for and test alternatives for their crop and situation.

For movements of the product in the chain between producer and end user in The Netherlands this means the following:

• Until the date of expiry of the authorization – there are no limitations in production for the Dutch market, placing on the market including import and producing new commercial packing units from bulk for the Dutch market, distribution, sales, storage and use. The existing stock for the Dutch market is determined on the date of expiry of the authorization, and from that date new production for the Dutch market is no longer permitted.
• Until the end of the grace period for sales -– there are no limitations in placing on the market existing stock predestined for the Dutch market including import and producing new commercial packing units from bulk, distribution, sales, storage and use. After the sales period has expired, any downward movements of the product in the supply chain including placing existing stock on the market, import, producing new commercial packing units from bulk, distribution and sales (including sales from retail tot consumer in case of non-professional use) are no longer allowed.
• Until the end of the grace period for use – only storage, use and upward movement of product in the supply chain - e.g. shipping back remaining product to the authorization holder or distributor, for removal - are allowed. After the grace period for use has expired, use, storage and possession of the product become illegal.