EU Issues Guidance on Parallel Trade of Plant Protection Products
20 July 2012
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
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 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
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
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
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
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
- the procedure for examining
- post-permit issues
- parallel trade applications for personal
- 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.
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
content of active ingredients, safeners and
Another criterion is identical composition
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
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
- 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
- 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
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
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
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.
For further information, please contact
(1) Regulation (EC) No 1107/2009 of the European
Parliament and of the Council of 21 October 2009 concerning the
placing of plant protection products on the market and repealing
Council Directives 79/117/EEC and 91/414/EEC, OJ EU L 309,
(2) Guidance Document from the European
Commission concerning the parallel trade of plant protection
products under Regulation 1107/2009, SANCO/10524/2012, 31.05.2012,