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 [1], 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 [2].
What is the TPD 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 [3]. 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 [4]:
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.
Notes:
[1] Producer is defined as the manufacturer or importer responsible for the submitted data.
[2] 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.
[3] Transition period applies to the UK but may not apply to all Member States.
[4] Fee will vary across the EU (see Country-Specific Information)