Permit conditions
Granting of parallel trade permits
Re-instated GB parallel trade products will not receive an authorisation but will be re-granted a ‘permit’.
As before, the parallel trade product will receive a MAPP number and its details will be included on the ‘e-@pprovals’ database, available on HSE’s product database.
The parallel trade permit will specify the:
- permit holder
- reference product
- Member State of origin from which the source product must be obtained
- source product’s registration number
- name of the authorisation holder in that Member State
Reflecting changes made to the reference product
A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the reference product. Consequently, parallel trade permits automatically mirror changes made to the provisions of the reference product’s authorisation.
For example, if the following changes were made to the reference product’s authorisation, then no amendment of the parallel trade permit would be necessary and the permit would be deemed to incorporate the same changes:
- change of authorisation holder or marketing company where they do not result in a change of MAPP (registration) number
- individual uses/recommendations withdrawn
- change or addition of container (not including returnable or refillable containers)
- addition of crops or recommendations
- alteration of any condition of use or marketing
- extension of expiry dates, for example, following the submission of confirmatory data
It is, therefore, vital that permit holders keep up-to-date with changes made to the relevant reference product authorisation. Amendments to these authorisations will be published within 7 days following amendment, and will be available to the public by searching the ‘e-@pprovals’ database on HSE’s product database.
While no practical change is required to be made to the parallel trade permit issued to the permit holder, because changes to the provisions of the reference product’s authorisation are deemed to apply automatically, the changes may well result in additional obligations for the permit holder. For example, the requirement to alter product packaging or labelling.
Source product is withdrawn
When a source product is withdrawn, permit holders must notify HSE not more than 6 months after the expiry date for sale of that product. Where permit holders have not notified HSE about the withdrawal of a source product, but HSE becomes aware that a source product has been withdrawn, HSE will take the same action that it takes in response to notifications received by the permit holder.
Where all source products for a parallel trade product have been withdrawn from the market for reasons not related to the protection of human and animal health or the environment, HSE will withdraw the parallel trade permit allowing a period of time for sale of existing stock in the GB market and a further ‘use up’ grace period for product users.
For further information read our guidance on thewithdrawal of authorisations and permits.
Further information or sampling that may be required after the parallel trade permit has been granted
Article 67 of Assimilated Regulation 1107/2009 requires, amongst others, importers of plant protection products to keep records of the products that they import, export, store or place on the market for at least 5 years.
Regulation 1107/2009 on legislation.gov.uk
The relevant information contained in these records must be produced to HSE on request. To ensure that parallel trade products continue to meet the requirements of the parallel trade permit, and in particular the criteria regarding being identical, HSE may require the provision of such information at any time after the permit has been granted for a plant protection product.
As is the case for authorised products, HSE will routinely obtain samples and carry out chemical analysis of parallel trade products to determine whether they are consistent with their parallel trade permits. The permit holder will only be contacted in the event of a concern being identified as a result of this analysis and may be required to provide information on the origin of batches of the product (read the section on record keeping below for further information).
Reasons for amending or withdrawing parallel trade permits
HSE may withdraw a parallel trade permit if the authorisation or permit of the source product is withdrawn in the Member State of origin because of safety or efficacy reasons (per Article 52A(10) of The Plant Protection Products (Miscellaneous Amendments) Regulations 2023 but without prejudice to Article 44).
In addition, on the basis that Article 44 of Regulation 1107/2009 (withdrawal or amendment of an authorisation) applies to parallel traded products via the operation of Article 52A(9 to 12), HSE shall withdraw or amend a parallel trade permit, as appropriate, for any of the following reasons:
- The requirements of Article 29 (for authorisation for placing on the market) are not or are no longer satisfied. For example, the reference product is renewed (also known as re-registered) following renewal of the active substance.
- False or misleading information was supplied on the basis of which the permit was reinstated.
- A condition included in the permit has not been met. For example, the source product is no longer available in the Member State of origin.
- The manner of use and amounts used can be modified on the basis of developments in scientific and technical knowledge.
- The permit holder fails to comply with its obligations under The Plant Protection Products (Miscellaneous Amendments) Regulations 2023.
Batch variation
The parallel trade product will be granted allowance for the same batch-to-batch variation in formulation as is granted to the corresponding reference product.
Packaging requirements
The form, material and size of the packaging of the parallel trade product must be the same or equivalent as that for the reference product. Repackaging of the source product may be permitted provided that the original condition of the product, including its safety (for human or animal health or the environment) and its efficacy, is not adversely affected. For example:
- re-packaging must not adversely affect the storage stability of the product
- the chosen container design must not adversely affect operator safety
Where products are permitted to be re-packaged, permit holders must ensure that:
- each container contains only material from one batch of the source product.
- the product is re-packaged in the EU or UK (the exact location of the site where repackaging takes place must be as provided to HSE before. This information is detailed in the CRD5 application form previously submitted).
Returnable or refillable containers are not allowed for parallel trade products.
Labelling requirements
All plant protection products, including parallel trade products, must be labelled in accordance with Regulation 547/2011which implements Article 65(1) of Regulation 1107/2009.
Regulation 547/2011 on legislation.gov.uk
Permit holders, among other things, are required to add the following to the parallel trade product label:
- the name and address of the permit holder and marketing company (if relevant)
- product registration number (MAPP number)
- the formulation batch number and production date of the source product
- the name and address of the company legally responsible for final packaging and labelling, or final labelling, if different from that of the permit holder or marketing company
The instructions and classification on the label of the parallel trade product must be consistent with those on the reference product, for example, they must not make any additional claims regarding use and safety.
Permit holders can add their own batch number to the label should they wish to do so, but this is in addition to the requirement to add the source product formulation batch number and production date.
Permit holders should be aware that it is an offence under The Plant Protection Products Regulations 2011 (PPPR 2011)to fail to comply with labelling requirements specified within PPPR 2011 (combined effect of regulations 17 and 23).
Record keeping
Article 67(1) of Regulation 1107/2009 applies to parallel traded products via the operation of Article 52(7). Thus, permit holders must keep records for at least 5 years of the plant protection products they import, export, store or place on the market. Article 67 does not specify the nature of the records to be kept, however, HSE has set out examples below of records that may assist compliance with Article 67(1):
- dates of purchase of source product
- details of company or individual selling source product
- name and authorisation/registration number of source product purchased
- formulation batch number and production date of source product purchased
- amount of each batch of source product purchased and imported
- date of entry of each batch of source product into GB
- storage location(s) prior to placing on the market
- details of where re-packaged and/or re-labelled
- sales information, including for export out of GB (similar to above)
Invoices may contain some of the above information and so it is advisable that these are retained.
HSE may request information under Article 67 at any time, for various reasons, including:
- regulatory purposes
- as a result of a concern regarding the parallel trade product’s compliance with the provisions of its parallel trade permit
- to ensure that the formulation of the product continues to be supported by an authorisation in the Member State of origin
Permit holders should be aware that it is an offence under PPPR 2011to fail to comply with the record keeping requirements specified in PPPR 2011 (combined effect of regulations 19 and 23).
Transport and handling
All Permit holders should ensure that they comply with any legislation controlling the transportation and handling of chemical substances.