Guidelines on the operation of the new EU rules on the parallel trade of plant protection products under Regulation 1107/2009 have been issued by the European Commission.
Background
Regulation 1107/2009 concerning the placing of plant protection products on the market(1) introduced harmonised rules on parallel trade for the first time. For a fuller analysis of the Regulation please refer to our earlier Bulletin from last summer.
In Article 28.2(e) of the Regulation it states that plant protection products for which a parallel trade permit has been issued are exempted from an authorisation. The requirements and the procedure for granting parallel trade permits are set out in Article 52 of the Regulation.
In 2010, national regulators and industry representatives were critical that certain parts of the Regulation’s text were ambiguous and would lead to different interpretations. The Commission guidance document aims to facilitate the implementation of Article 52 of the Regulation in a harmonised and consistent way across EU member states.
Parallel Trade
Parallel trade involves imports by third parties of licensed products, or products covered by an exclusive selling arrangement into a licensee’s allocated sales territory, in circumstances where those products have been marketed in other territories under licence from or with the agreement of the licensor.
From paragraph 1 of Article 52 of the Regulation, the following three basic conditions must be met in order for an EU Member State to grant a parallel-trade permit:
a. the product for which the application is submitted is authorised in the Member State of origin, and the reference product is authorised in the Member State of introduction;
b. the parallel-traded product and the reference product are of “identical composition”; and
c. an application is submitted in the Member State of introduction.
If these conditions are satisfied, an applicant does not need to provide evidence to prove that the product is safe and efficacious, only that it is identical to one which has already been assessed to be safe and
efficacious. As a result, the permit procedure is cheaper, quicker and simpler than for a normal authorisation.
Under paragraph 2 of Article 52, where identical products are approved in different Member States, a simplified procedure for granting permits is provided, although there is a strict deadline of 45 working days for the examination and issuing of a decision, starting on the day when the application is considered as complete.
What the Guidance Covers
The European Commission guidance document (1) on the parallel trade of plant protection products under Regulation 1107/2009 covers the following areas:
- the criteria for granting parallel trade permits
- the procedure for examining applications
- post-permit issues
- parallel trade applications for personal use
- renewals of permits
- transitional measures
The guidance document concludes that the introduction of a plant protection product in the following cases does not fulfil the general conditions for parallel trade:
a. Products imported from and authorised in a third country
b. Products introduced from a Member State other than that stated in the permit
c. Products which are themselves parallel traded products.
Common Origin
With regard to manufacturers of parallel-traded and reference products, products should either have the same manufacturer, or information should be provided to show that the manufacturer of the reference product operates as an “associated undertaking” or “under licence” of the other manufacturer. This is referred to as "common origin".
Specification and content of active ingredients, safeners and synergists
Another criterion is identical composition relating to specification and content of active ingredients, safeners and synergists. The guidance states that the two products being compared should contain active ingredients, safeners or synergists from the same manufacturer from the same source.
They may also come from other sources of this manufacturer, provided that these sources had been assessed as equivalent at the time of the original product approval.
"the same or equivalent"
The guidance recognises the concerns raised over the phrase “the same or equivalent” when referring to co-formulants, and packaging size, material and form. It presents an interpretation to encourage Member States to assess applications in a harmonised way.
For co-formulants, it proposes that applications should be rejected if the product contains co-formulants that:
- have never been assessed by the Member State of introduction in the context of a product approval;
- lead to a worse classification according to the globally harmonised system ("GHS") in view of safety or toxicity; or
- contain quantitative variations that account for more than 10% of the formulation.
With regard to the latter point, the Commission acknowledges that Member States will require criteria for qualitative and quantitative variations, otherwise they may fail to meet the 45-day decision deadline.
The guidance puts forward two categories of co-formulants and a range of permitted deviations from the declared content. Category 1 is for “significant” co-formulants that are essential for the functioning, safety or stability of the product. Any variations should only be within the small margins suggested. Category 2 covers substances such as inert fillers and some dyes and odorants, for which Member States may be more flexible over changes.
Repackaging
The guidance states that applications should always include information on the size, material and form of packaging, even if there is no repackaging.
According to the Commission guidance document, Regulation 1107/2009 does not prohibit repackaging but, “this is a crucial step in the parallel trade of plant protection products that usually creates the most concerns for Member States”. This particularly relates to efforts to ensure that products repacked in third countries are excluded from the system.
Parallel traders must provide the exact location of the repackaging plant to the Member State of introduction, “once this information is available to them and well before re-packaging actually takes place”. A change in location at a later stage should be reflected on the label and notified to the Member State.
Packaging sizes should follow the same rules as for approvals, namely that the size, or range of sizes, should be the same as stated on the authorisation certificate. Similarly, it will be assumed that a packaging material and form is equivalent if it is one of the materials and forms tested and approved for the reference product.
Transitional Measures
Under the transitional measures provisions, existing permits will remain valid. However, their renewal will require a complete set of documents to be submitted for assessment under the new rules.
