The JRC in Geel, Belgium, has a long proven expertise in the production of Certified Reference Materials (CRMs) for the quantification of Genetically Modified Organisms (GMOs).
The Reference Materials Unit of the JRC gives biotech companies the possibility to develop GMO CRMs as required in:
A set of GMO CRMs is typically composed of CRMs with a GMO mass fraction of nominal 0, 0.1, 1, 10 and 100 (m/m) %.
Due to intellectual property rights, a Material Transfer and distribution Agreement (MTA) is required for each GMO event for which GMO CRMs shall be developed. JRC has developed a template for this:
Changes to this MTA need to be agreed with the legal service of the JRC.
JRC and the biotech company will also need to agree on a number of characteristics of the required raw materials for the CRM production, including:
- type
- amount
- delivery date
Typically, these are 10 kg of untreated seeds of the GMO event (including information about the zygosity) and 30 kg of untreated non-GMO seeds (preferable of a near isogenic parental line).
All seed materials need to be of seed quality (proven purity of > 99 %), clean from any harvest debris and preferably of the same size. They need to be accompanied by a phytosanitary certificate (alternatively a letter confirming the origin of the material and an analysis certificate stating the purity and the methods used to establish the purity).
The raw materials need to be shipped by the biotech company to the JRC site in Geel within an agreed time frame, following IATA rules and providing the airway bill number in a timely manner to the JRC for custom clearance.
Additionally, the biotech company needs to provide to the JRC in Geel, the event-specific quantification method that was already submitted (or is intended to be submitted) for validation to the EU-RL GMFF. The method will be treated confidentially until published by the EU-RL GMFF.
If there are no unforeseen complications, the JRC can produce sets of GMO CRMs within an estimated time frame of 14 months for matrices such as soya, maize, rapeseed and cottonseed seeds, as well as sugar beets and potato tubers.
For other matrices longer development times are required and need to be negotiated with the JRC.
Interested biotech companies may contact the JRC via the official mailbox JRC-RM-DISTRIBUTION@ec.europa.eu to agree on the timing and other details related to production of GMO CRMs.