Repackaging and the Letter of Access under article 10

Modified on Wed, 18 Sep at 10:37 AM

Sometimes when pursuing a commercial transaction a company who has developed and sells EU fertilising products, such as Plant Biostimulants, wants to sell their product to another company who then sells the product in a local market using their own brand. In doing so they repackage the product.

If they do this FPR introduces stringent requirements, these are defined in article 10 and 11:

Article 10

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 6, where that importer or distributor places an EU fertilising product on the market under his or her name or trademark or modifies an EU fertilising product already placed on the market in such a way that compliance with this Regulation may be affected.

Article 11

Packaging and repackaging by importers and distributors

Where an importer or distributor packages or repackages an EU fertilising product and is not considered a manufacturer pursuant to Article 10, that importer or distributor shall (a) ensure that the packaging bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’; and (b) keep a specimen of the original information referred to in Article 6(7) or Article 8(4) at the disposal of the market surveillance authorities for 5 years after having made the EU fertilising product available on the market.

This article implies that the company who repackages the product becomes the manufacturer under FPR if they dont respect the conditions of article 11.

This has significant legal implications (article 6) and means this company needs to hold access to the technical documentation including information such as the ingredient list. This is practically not possible as a company selling to a repackager will never want to provide such information for Intellectual Property reasons.

The solution to this is that the 2 companies sign a Letter of Access (LoA).

A Letter of Access (LoA) is a document by which the owner of data agrees to the use of such data under the specific terms and conditions by the receiving party for the purpose of fulfilling their legal obligations. Practically whenever a third party or authority would invoke the obligations for holding of the technical documentations the repackager could rely on the original manufacturer.

EFCI Register does not provide the letter of access, it is a private agreement between 2 companies to be set up and agreed by their legal teams. We can provide input and indicate if we see any areas missing from FPR's legal requirements on request.

EFCI Register can also give a certificate to the company who received the LOA so that it can fulfill the obligation of conformity assessment under article 6.

This is mandatory for repackaging of Plant Biostimulants as the repackaging company needs a certificate in their own name.

Note, if you do respect the conditions of article 11 above repackaging can be done.

Useful!
The Letter of Access itself is something that has a rich (legal) history and track record. It was originally defined to solve the same problem FPR introduces for Plant Protection Products. From that point of view it is recognised as it ensures legal 'access' to the relevant data as required for the responsibilities of a manufacturer. Of course there are other obligations, such as the requirement to do conformity assessment or hold a TD for 5 years, but with a LOA these can be covered. 

See also here for context of the LOA for PPP: https://english.ctgb.nl/plant-protection/assessment-framework/registration-manual/letter-of-access. Note however that PPP and FPR are different legal contexts and thus the guidance from PPP are merely there to provide historical context.