As a general rule, products for research are expected to be duty free. This is the contribution of our modern, western and progressive society to the development and progress of science. Especially when it comes down to research in healthcare area. No government would want to hear that with their actions they increase healthcare costs, make healthcare inaccessible or impede researcher's work by adding import duty costs on important testing materials.
This is the theory. Of course, some biological products may be used also for different purposes so they become subject to import duty. For example, if their intended use is no longer research or healthcare products manufacturing but gets into the area of - let's say - food or feed manufacturing. In this case import duty would doubtlessly apply.
For exactly the above reason the latest EU customs regulation - Regulation (EU) No. 1101/2014 - looks at Bovine Serum Albumin in two different ways. Where the product is considered "Unfit, or to be rendered unfit, for human consumption" it is duty free. In other cases it becomes subject to import duty. BSA being a very popular product for research or healthcare products manufacturing and being mostly imported from the United States (the US is the biggest BSA manufacturer in the world) is expected to be released from import duty if it is used for the abovementioned purposes.
Here the logic ends - unfortunately. Since in the recent months EU customs have taken a completely different approach to BSA imports.
Whenever BSA comes in its liquid form and supplemented with a preservative (1% Sodium Azide) then it is considered "Rendered unfit for human consumption" and is duty free. That's fine.
Most commonly BSA comes in a lyophilized form - and for this reason unpreserved. In this case it is no longer considered by customs as "Unfit for human consumption". It gets classified under a different customs code and becomes subject to import duty!
The fact that a veterinary health certificate accompanies every shipment of Bovine Serum Albumin into the EU, and that the veterinary declaration states the product is considered "Unfit for human consumption" means obviously nothing.
According to the Veterinary health certificate that accompanies each Bovine Serum Albumin import the imported products:
"...consist exclusively of blood products not intended for human or animal consumption..."
and have been prepared with
"blood of slaughtered animals, which is rejected as unfit for human consumption in accordance with Union legislation"
The veterinarian clearly states that each BSA - liquid or lyophilized - is unfit for human consumption. This is however not the view of the EU customs authorities - if the lyophilized product has not been "rendered unfit" by addition of e.g. Sodium Azide it is classified under a different HTS code and subjected to 6.4% import duty calculated over product price and shipping costs.
THE AFTERMATH:
WE HAVE
One and the same product, two different physical forms only.
One and the same intended use.
One and the same veterinary certification - the product is UNFIT for human consumption.
BUT
Two different HTS codes.
Two different import duty approaches.
Thousands of kilograms of BSA are imported annually into the EU at the price of several hundred dollars per kilogram. If additional 6.4% duty is applied upon importation someone will have to come up for this price increase.
WHO ARE THE LOSERS?:
- researchers - who need a bigger budget for their projects
- diagnostic manufacturers - who need to pay more for their raw materials
- manufacturers of medical devices - for the same reason
- patients - because the additional costs are transferred over to them
IS THERE A SOLUTION?
Yes - a discussion with the EU customs authorities is urgently required to clarify the current situation. Too many companies are affected at present. Professional organizations need to step in and start a discussion with EU lawmakers. Because laws and regulations must make sense again.
We will continue keeping you posted on the further clarification efforts in this case. Stay tuned and relax.
