Notification Requirements

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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 notification procedure?

 

Once the data has been uploaded to the system, there are a number of steps in the process.

  1. 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.
  2. Assessment – agency staff will assess a sample of the submitted notification to ensure the information meets the requirements of the TPD and local requirements.
  3. 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.
  4. 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)