Grace period

WG changes in existing authorizations

Once a plant protection product is authorized, any following Board decision on that authorization may have consequences for the use of the product. The use of the product is legally defined in the conditions – in Dutch ‘Toepassingsvoorwaarden’ and ‘Overige Toepassingsvoorwaarden’ - stated in the Legal Instructions for Use – in Dutch ‘Wettelijk Gebruiksvoorschrift’ (‘WG). Upon every decision that changes the WG, a new version of the WG is established. This version has a version number: the W-code. Together with a change  in WG the  W-code is increased with 1 (W.x is increased to W.(x+1)). The current version of the WG version W.x may attract grace periods.

Grace periods apply in case of WG restrictions

In case decisions on existing authorizations do not lead to changes in the WG, the WG version (W-code) stays the same and there is no need for defining grace periods.
In case the new WG with the W-code W.(x+1) is in at least one aspect restricted compared to the current WG with W-code W.x , grace periods apply to the WG version W.x. So this also applies in case the new WG contains a combination of restrictions and extensions.
Where the new WG version W.(x+1) only contains extensions and no restrictions as compared to the current WG version W.x, grace periods do not apply, meaning that product labelled with the current WG version W.x can be sold and used without limit. The new WG version W(x+1) needs however to be used for any new batch of product packed after the Board decision is signed.

EXTENSION	RESTRICTION
Adding new crop	Withdrawal of crops
Adding newly claimed diseases/pests	Withdrawal of claimed diseases or pests
Dose increase	Dose reduction
Frequency increase	Frequency decrease
Shorter minimum interval	Longer minimum interval
Wider range of crop stages or application period	Limitation of the crop stages or application period
Adding  LDS or split application or new application method	Withdrawal of application methods
PHI decrease	PHI increase
Release of restriction sentences	Adding new or more severe restrictions
Etc.	Withdrawal of whole authorization
	Etc.

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

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.

Ctgb policy on grace periods

The Ctgb policy on grace periods is based on articles 20 and 46 of PPPR (EU) 1107/2009 and is laid down in a special board decision: Besluit Beleidsregel Respijttermijnen voor Gewasbeschermingsmiddelen (in Dutch, published in the Goverment Paper 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.

• Grace periods only apply to those cases in which a new Board decision leads to a restriction of the use of a product as defined by the new WG version as compared to the current WG version.
• As a condition for granting grace periods by the Board, applicants have to apply for grace periods with a sound argumentation for the reason why and the length applied for. See below under procedures.
• All cases where grace periods apply will be handled following the same policy, whether originating from a decision under (EU) 1107/2009 or under 91/414 EC through the transitional law of art 80 of (EU) 1107/2009. 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 principle, no grace period can be granted, where the reasons for withdrawal, amendment or non-renewal of the authorisation are related to the protection of human and animal health or the environment. However, the Board takes into account the provisions in the Regulation, as well as the principles of good governance. Therefore, the Board weighs possible risks against the interests of the producer and end user and will, risk permitting, try to avoid the grace period for use to end before the current or soon to start application season.
• In principle, no grace period will be granted if an authorisation is withdrawn at the request of the authorisation holder or expires on a predetermined expiration date because no renewal or extension was applied for. The authorisation holder cannot be surprised by the expiration of the authorization and is obliged to proactively inform other stakeholders in the chain about his or her intention to no longer support the authorisation or to withdraw it on request. Current stocks held by the authorisation holder or their suppliers are not taken into account. However, following a substantiated request from the authorisation holder to the Board, a grace period can be granted. See under procedures.

Grace periods may also apply to previous WG versions

In an earlier decision on the product authorization, grace periods might be set for the previous WG version; e.g. W.(x-1).  Such grace periods will not be extended by a new decision determining grace periods for WG version W.x. Grace periods are specified for each WG version (W-code).
However, grace periods in the new decision may not only apply to the current WG version W.x but also to previous versions of the WG in the following cases:

• No grace periods were set for WG version W.(x-1) in the earlier decision, because the WG change in that decision was only an extension and therefore grace periods did not apply.  As a consequence the use of product labelled with WG version W.(x-1) is still legally valid. To avoid confusion in such cases, when grace periods apply for WG version W.x, the same grace periods will apply to WG version W.(x-1) irrespective of whether the new WG version W(x+1) is actually restricted compared to WG version W(x-1).
• When WG version W.(x-1) received long grace periods, it may occur that the risk identified for WG version W.x also applies to WG version W.(x-1). If in such a case the grace periods for WG version W.x are set short while the grace periods for WG version W.(x-1) are still valid, it may be necessary to also shorten the grace periods for the earlier WG version W.(x-1) in the new decision.

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).

Grace periods on derived trade permits and parallel trade permits

The same principles as set out for original authorizations hold for derived trade permits and parallel trade  permits. Derived trade permits and parallel trade permits shall be withdrawn by the Ctgb upon expiration or withdrawal of the mother authorisation. The authorisation holder of the mother authorization is obliged to actively inform the holders of the derived trade permits about the intention to request withdrawal. A grace period is possible in case the holder of the derived or parallel trade permit timely submits a withdrawal on request with a substantiated argumentation for grace periods. Grace periods for derived or parallel trade permits may differ from the grace period for the  mother authorization or reference product as stock and market situations may differ; e.g. the mother authorizationis not marketed and needs no grace periods as the product is solely marketed and used through a derived trade permit.