Withdrawal of pesticide product authorisations and permits

When a new authorisation is issued for an existing product, any previous authorisations are superseded and withdrawn.

Reasons for withdrawal

We may take the decision to withdraw an authorisation or permit under the conditions specified in Regulation 1107/2009. These may include, but are not restricted to, the following:

Active substances are included or renewed on the list of approved active substances but products containing the active substance are not successfully renewed.
Active substances are withdrawn from the list of approved active substances.
Active substances in the list of approved active substances are subject to additional restrictions.
Significant safety or efficacy concerns are identified with the product or a specific use.
Changes to maximum residue levels (MRLs) where a use is no longer accommodated.
Specific concerns identified with a product, for example unacceptable co-formulant.
A requirement for the submission of data to continue with the authorisation of the product or a specific use is not met.
Data submitted in support of an application do not support the continuing authorisation of the product or a specific use.
A product or a specific use is commercially withdrawn by the authorisation holder.
False or misleading information was submitted to support an authorisation or permit.
For housekeeping purposes: if we issue a new authorisation or permit for a product, we will automatically withdraw the previous authorisation(s) to ensure that a product does not have a number of extant authorisations at the same time

Procedures for issuing and publishing withdrawals

Monthly withdrawals that happen as a result of a new authorisation being issued, are published on the HSE website shortly after each month end. Other withdrawals are issued and published as required. The reason for each withdrawal can be found in the explanatory notes section, under the withdrawal table on the withdrawal notice

You can access notices issued since 1 June 2004 using the Pesticides Register.

Where a product or use authorisation is withdrawn for safety reasons (for example following a review or following the setting of new maximum residue levels (MRLs)), we will send an electronic copy of the withdrawal notice to the authorisation holder. This will also be published on HSE's website.

Blanket Amendment

Blanket amendments only amend the current authorisation or permit. They do not replace or revoke the previous notices (for example expiry date or additional technical specification).

Types of withdrawal and grace periods

Unless there are safety concerns, when we withdraw an authorisation or permit it will receive either a 'phased' withdrawal with an appropriate grace period or an immediate withdrawal. Withdrawal notices clarify both the type of withdrawal (phased or immediate) and time-scale of the withdrawal.

Withdrawals and associated grace periods vary depending on the reason for withdrawal and degree of concern. The most common grace periods and the reasons for applying them are set out below.

In some cases, the relevant grace period is reduced to ensure that the authorisation or permit does not continue beyond the date already set based on the approval status of the active substance.

When an active substance approval is withdrawn, the grace period is likely to be determined as part of the withdrawal decision and relates to all products containing that active substance.

'24+24' phased withdrawal

This is applied where there are no safety concerns (including no changes in required assessment standards or amendments to the label) and where the expiry date for the active substance approval allows. Expiry dates of the authorisations or permits cannot extend beyond the expiry date of an active substance. If the phased withdrawal will extend beyond the expiry date of an active substance then the withdrawal period will be shortened accordingly.

This grace period allows:

24 months for sale and distribution of existing stocks
48 months for disposal, storage and use of existing stocks (a further 24 months)

This grace period may apply:

when authorisations or permits are withdrawn for house-keeping purposes and changes have been made that affect the authorisation conditions or the label
where an authorisation or permit has been replaced by a new one and there are no safety concerns.

For a summary refer to ID ‘S2’ in the withdrawal table.

'0+6+12' phased withdrawal

This grace period will be specified when there is a need for tighter control of withdrawal of the product from the supply chain or where the authorisation or permit holders are aware of the impending deadlines.

This withdrawal allows:

immediate withdrawal for sale and distribution for any person holding an authorisation or permit
6 months for sale and distribution of existing stocks by persons other than the authorisation or permit holder
18 months for disposal, storage and use of existing stocks by any person (a further 12 months)

This grace period may apply when:

products or uses are commercially withdrawn and the authorisation or permit holder has confirmed that they have no remaining stocks of the product, but there are stocks of product still in the supply chain
products or uses are withdrawn due to safety or efficacy concerns under '0+0 immediate withdrawal' below.

For a summary, refer to ID ‘P’ in the withdrawal table.

'0+0' immediate withdrawal

This is applied when:

products or uses are withdrawn due to a significant safety concern - if necessary, we will initiate enforcement action to recall existing stocks in the supply chain
products or uses are commercially withdrawn and there are no stocks of the product in the supply chain
a new authorisation or permit has been issued that does not change any of the conditions of use in the existing authorisation or permit (for example continuing authorisation)
a product has additional active source details added (or modified, such as a source removed and replaced by another source) but no other conditions of authorisation change

Where an immediate withdrawal is implemented:

no further stocks of the product in line with the withdrawn authorisation can be placed on the market
existing stocks in the supply chain cannot be used up

Where there are stocks in the supply chain that are subject to a product recall, an authorisation or permit for storage only may be issued to allow for disposal of the product.

Individual withdrawal dates may also be set to reflect the severity of the concern.

For a summary, refer to ID ‘I’ in the withdrawal table.

'6+12' EU standard withdrawal

In line with Article 46 of Regulation 1107/2009, the standard withdrawal period of 6 months for sale and distribution and a further 12 months for storage, use and disposal, will be applied where required as a result of a decision.

For a summary, refer to ID ‘S1’ in the withdrawal table.

Extension of a grace period

Where a grace period has been given for safety reasons, it cannot be extended. An extension would also not normally be granted following application of the standard 24 + 24 grace period.

However, if a shorter grace period was originally requested by the authorisation or permit holder when commercially withdrawing a product or use, it may be possible to extend this to the maximum grace period of 24 + 24 months. You can request such an extension by applying to HSE. Provide with your application:

a covering letter fully explaining your request and detailing the requirements below
completed application form CRD2
letters of access to third party data
any previous relevant correspondence for example a copy of the parent product authorisation, previous authorisation, trials permit or EAMU as appropriate, or any written advice previously provided by HSE

Grace period for permits for trial purposes

Permits for trial purposes do not authorise the placing of products on the market and usually are withdrawn immediately.

Grace period for extensions of authorisation for minor use

Extensions of authorisation expire on the final expiry date of use for the authorised product and do not require a phased withdrawal. If an Extension of authorisation needs to be withdrawn before the final expiry date of use for the authorised product, it will be withdrawn immediately or with a short date, for example 3 months.

Status of marketing companies with respect to persons other than the authorisation holder

Notices of authorisation refer to both the 'authorisation holder' and the 'marketing company' where the latter is declared by the applicant to be a different company as identified by the company registration number.

We recognise that:

there is a significant range of commercial relationships between authorisation holders and marketing companies
the marketing company position in the supply chain will vary

In some cases, marketing companies will sell their product on to distributors and other agents for sale to the end user, and in other cases will sell direct to the end user themselves. It is difficult to cover all eventualities and it must also be recognised that those higher in the supply chain must take responsibility for ensuring others have adequate time to sell out their stocks.

HSE's interpretation is that the 'marketing company' as named on the notice of authorisation is not considered to be a person holding an authorisation (that is, the 'authorisation holder') and therefore falls into the category 'persons other than the authorisation holder', and is entitled to the additional sell out period allocated to this group.

When the authorisation holder and marketing company is the same, the notice of authorisation refers to the authorisation holder only. In this case, the marketing company, which is also the authorisation holder, can be considered a 'person holding an authorisation' and therefore is not entitled to the additional sell out period which, in this case, is intended for persons further down the supply chain.