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:
Regulation (EC) No 1829/2003 and
Regulation (EU) No 619/2011.
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 (classically seeds, in specific cases roots or tubers)
- amount
- delivery date
10 kg of untreated seeds of the GMO event (including information about the zygosity) and 20 kg of untreated non-GMO seeds (preferable of a near isogenic parental line and a similar thousand kernel weight (TKW)) are required.
All seeds need to be of seed quality (preferably with a genetic purity of at least 98 %), the seed lots need to be clean from any harvest debris and other (weed) seeds. The genetic purity of the seed needs to be confirmed by analysis (preferably more than 200 individual seeds of the GMO seeds tested for the presence of the GM-event and e.g. 8 pools of 400 non-GMO seeds tested to be negative for the GM-event).
The raw materials need to be shipped by the biotech company to the JRC site in Geel within an agreed time frame, taking EU regulation on plant importation (Regulation (EU) 2019/2072) and its amendment (EU) 2021/2285 on the requirements for the movement of plants and plant products within the Union into account. Goods falling under UN 3245 (genetically modified microorganisms or genetically modified organisms, class 9) shall be carried out in accordance with the applicable rules and regulations for the respective mode of transport (road, air, sea, or rail). Shipments arriving from outside the EU need to be accompanied by a phytosanitary certificate.
The Biotech company needs to arrange (pay and take over the full responsibility) for the shipment of the GMO materials to the site of the EC JRC in Geel, Belgium.
The JRC is an institution of the European Commission and is exempted from paying custom duties. Therefore, the airway bill number of the outgoing shipment needs to be provided in a timely manner to the JRC to initiate clearance from custom duties (The Belgium Diplomatic Exemption Form 136F will be filled by JRC).
Following Incoterms® 2020 this shipment shall be classified as ‘Delivered Duty paid (DDP)’.
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 European Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). The method will be treated confidentially by the JRC until completion of the method validation and publication by the EURL GMFF.
- a letter confirming the origin of the material
- and an analysis report stating the purity and the methods used to establish the purity (see above).
The JRC site in Geel holds a contained use permit to handle and store up to risk level 2 genetically modified organisms, embedded in the environmental permit, and both granted by the Belgian authorities.
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.