TPD Notification requirements
A requirement of the TPD is for manufacturers and producers to submit a notification to the authorities for any products they intend to market. The notification requires specialist software to create xml files for submission through a secure web-based portal system designed in such a way that facilitates the collection and assessment of data.
What data is to be submitted in the TPD notification?
The requirements include:
Administrative details such as the contact details of the producer , description of product and declarations on production conformity.
Scientific data including the classification of each ingredient according to regulation EC 1272/2008, all known toxicological studies and emissions testing data.
Sales information, the volume of sales, preference of consumer groups and mode of sales is to be reported .
What is the notification procedure?
Once the data has been uploaded to the system, there are a number of steps in the process.
- Validation – an automated IT system checks the notification for completeness. The notification cannot be deemed to be submitted until confirmation of a successful submission is received.
- Assessment – agency staff will assess a sample of the submitted notification to ensure the information meets the requirements of the TPD and local requirements.
- Questions/Requests – assessors may have questions or requests for more information on any data submitted such as the manufacturing process or the analytical measurement methods.
- Re-Assessment/Approval – regulatory authority accepts or rejects the applicants response. Only where submitted data is deemed insufficient by the assessor may the applicant be contacted.
When to make a TPD notification?
Submission of the different types of information – scientific and sales – are subject to different timescales. Scientific data is to be submitted 6 months before launch of a new product or when a significant modification occurs to an already notified product. Sales data is to be reported annually.
There is a transitional period in place for those products currently on the market and new products launched (supplied) after May 2016 . From 20th November 2016 any new product launched must be notified before placing on the market.
Costs of a TPD notification
Under TPD rules Member States are allowed to charge a fee for the notification. The UK fees are as follows :
Annual fee: £60
New Notification: £150
Substantial Modification to existing notification: £80
The European Commission has published the Implementing Decision 2015/2183 on the notification format.
How can we help?
We have a thorough understanding of the notification requirements. We can help you to prepare and submit notifications – read about our TPD Notification Service here. Please contact us for more information.
 Producer is defined as the manufacturer or importer responsible for the submitted data.
 Non-confidential data is to be made available to the public. The type of data to be regarded as confidential (and not published) is determined by the submitter.
 Transition period applies to the UK but may not apply to all Member States.
 Fee will vary across the EU (see Country-Specific Information)