The first deadline for the new European Poison Centre Notification system has already been extended and now sits just over three months away. If you have a mixture on the market which has human health or physical hazards and is destined for consumer or professional use somewhere down the line, you need to notify each member state by the 1st January 2021. With this in mind, where are the member states in terms of readiness, how many different languages will you need and how much is each direct submission cost?
Member States Already Connected to the ECHA Submission System
Of thirty member states, only six are connected to the ECHA submission system. This means that 80% of member states are not yet ready to accept your submission through the ECHA portal. You can still get your submission ready to go, to make sure you meet the deadline, but you cannot yet submit to any member states except Denmark, Estonia, Germany, Lithuania, Poland and Slovenia.
How can you submit?
Seventy percent of member states only accept submissions via the ECHA portal so it is probably a good idea to get access to this system if you have a broad European market. Twenty percent of member states are flexible and will accept submissions through existing channels or the new ECHA portal. Ten percent are yet to declare.
How many languages will I need?
An English language submission will get you through just over half of the member states. The remaining member states require different language submissions. Finland requires submissions in two languages: Finnish and Swedish. This is perhaps the most difficult part of a pan European submission and perhaps holds the bulk of hidden costs.
How much will the submission cost?
It will take someone’s time to put the submission together and to make the submission. It may take someone’s time to translate the submission. Some member states are also charging fees for the submission at the local level. Two thirds of member states have declared there will be no fees but 40% of member states are either still considering or have not yet declared. Hungary and Italy will levy charges at the member state level.
When can I go to market?
Almost two thirds of member states will allow you to go to market on successful submission through the ECHA Submission System. Almost a quarter of member states will require you to wait until the state appointed body has downloaded the notification. The remaining four member states are yet to declare.
What should I be doing now?
At this stage, you should be aware of your product portfolio including all downstream use. You should be compiling submissions, ready for the time when each member state goes live on the ECHA submission portal. Member states may have been slow to get up to speed but the deadline date of the 1st January 2021 is unlikely to change and any late submissions may impact on legal sales, especially for those countries requiring member state notification before you can go to market.