Parallel trade enables the circulation of authorised plant protection products within the European Union. A plant protection product which is authorised in another EU Member State can be placed on the market in Belgium, with a permit for parallel trade. In order to prevent unacceptable risks to public health, animals and plants, and the environment, a plant protection product is only authorised for parallel trade if it is identical or equivalent to a product which is already authorised in Belgium.
Requirements for parallel trade
The requirements for a permit for parallel trade are laid down in article 52 of European Regulation (EC) No. 1107/2009.
The criteria which are used to assess the equivalence of a plant protection product are summarised here for information purposes:
- The product to be imported and the reference product (= product authorised in Belgium) are identical in terms of
- identity and content of active substance(s), protective substance(s) and synergist(s)
- producer
- type of formulation (e.g. SL, WG, etc.)
- target market (professional or non-professional use)
- The products are identical or equivalent in terms of
- nature and content of co-formulants
- packaging (type, size and shape)
For products for non-professional (amateur) use there are several additional requirements for the packaging and the measuring cup (see checklist for products for amateur use, annex 9 to our guide).
The criteria are described in detail in the European guidance document. This document clarifies the implementation of article 52 of Regulation (EC) No. 1107/2009.
Applying for a permit for parallel trade
Follow this procedure to obtain a permit for parallel trade:
- Complete the application form and email it with the label proposal for the product to our service (paralleltrade@health.fgov.be)
- You will receive an invoice for the administrative procedure which also serves as an acknowledgement of receipt.
- For products for non-professional use, the packaging must be sent by post to our service (see contact details). This packaging will be evaluated by an efficacy expert, after which the Approval Committee of pesticides for agricultural use will issue an advisory opinion.
- The equivalence of the plant protection products in question will be assessed by means of a technical evaluation.
- You will receive the official permit if the products are considered to be equivalent (and a positive opinion of the Approval Committee was given for a product for non-professional use). The expiry date of the permit will be assimilated to the expiry date of the authorisation of the reference product in Belgium.
- You will receive a registered letter with the reasons for the refusal if the products are considered not to be equivalent or if the packaging of a product for non-professional use didn’t comply with the national requirements.
- Contrary to the rules concerning the trade name of a plant protection product (see guide, section 3.2), a parallel product may have an identical trade name to the reference product in Belgium. In addition, different parallel products based on the same reference product, may have an identical trade name, which differs from the trade name of the reference product. All other rules still apply. It is the responsibility of the permit holder to verify if there is no violation of the trademark law.
For more detailed information on the evaluation procedure and the criteria used during a technical evaluation, please refer to the European guidance document.
Applying for a prolongation of a permit for parallel trade
Follow this procedure to obtain a prolongation of a permit for parallel trade:
- Complete the application form for prolongation and email it with the label proposal for the product to our service (paralleltrade@health.fgov.be), at least 45 days before the expiry date of the permit (or as soon as the autorisation of the reference product has been prolonged).
- If there is less than 2 years between the last technical evaluation of the permit and the current expiry date of the permit:
- You will receive by email the confirmation of receipt of the administrative prolongation request.
- You will receive the new official permit with an adapted period of validity.
- If there is more than 2 years between the last technical evaluation of the permit and the current expiry date of the permit:
- You will receive an invoice for the administrative procedure which also serves as an acknowledgement of receipt.
- The equivalence of the plant protection products in question will be assessed by means of a technical evaluation.
- You will receive the new official permit if the products are still considered to be equivalent. The expiry date of the permit is again assimilated to the expiry date of the authorisation of the reference product in Belgium.
- You will receive a registered letter with the reasons for the refusal, if the products are no longer considered to be equivalent, and a new official permit with the modified period of validity, granting grace periods for the disposal of the remaining stocks if there is no unacceptable risk to public health or the environment:
- Placing on the market and storage of the product by the permit holder is still possible until the original expiry date of the permit.
- Placing on the market and storage by third parties is still possible up to a maximum of 6 months after the original expiry date of the permit.
- Use is still possible up to a maximum of 18 months after the original expiry date of the permit.
- These grace periods are also communicated in a press release.
- If the permit expires while the evaluation procedure is ongoing, the product cannot be imported until the permit is renewed.
- The conditions for prolongation are mentioned on the permit.
Voluntary withdrawal of a permit for parallel trade
You can voluntarily withdraw a valid parallel trade permit at any time. In order to dispose of stocks available on the market, grace periods for sales by third parties and for use may be imposed.
Follow this procedure for voluntary withdrawal of an authorisation:
- Notify our service of your request for withdrawal by e-mail (paralleltrade@health.fgov.be), at least 2 weeks before the expiration date of the permit, specifying the required grace periods.
- Depending on the stocks available, the withdrawal will take place via different procedures:
- If the product was never imported, the permit will be withdrawn with immediate effect, you will receive a letter confirming the withdrawal of the authorisation and the new permit with the adapted validity period.
- If the maximal grace periods fall within the current validity period of the authorisation, whereby the expiry date of the authorisation may or may not be brought forward, you will receive a letter confirming the grace periods and the permit with the adapted validity period.
- If the maximal grace periods exceed the current period of validity of the permit, an administrative prolongation is required to grant the required grace periods. You will receive an invoice confirming the application. After payment, you will receive a letter confirming the grace periods and the new permit with an adjusted validity period.
- In the last 2 cases, the withdrawal date and grace periods are communicated by means of a press release. In all cases, the expiration date and grace periods will be added to the list of " délais pour utilisation de stocks " on Phytoweb. After this, the validity period of the permit can no longer be modified.
Inspections of parallel trade
It is possible to import permitted plant protection products from the date indicated on the permit. The permit also has an expiration date after which imports, sale and use are no longer possible. In case of a withdrawal, the specific grace periods for placing on the market by the permit holder or by third parties and for use are mentioned on the permit.
Follow this procedure to notify of an import:
- Notify all imports of plant protection products by completing the form 'import declaration'.
- Send this form within 48 hours after import by email to our service (paralleltrade@health.fgov.be and tra@afsca.be).
- The complete lot needs to be retained for at least 48 hours after declaring the import at the first place of delivery in Belgium.
- Retain for each lot a product in its original packaging with the original label for the purposes of an inspection. In addition, retain a second sample of packaging as it is placed on the market in Belgium (if it is repackaged). These packagings must be kept at the first place of delivery in Belgium for up to 2 months after the declaration of import.
The inspection of imported products will be carried out by the FASFC (Federal Agency for the Safety of the Food Chain).