Exemption information

The law of 8 March 2023 does not refer to a ‘request’ for derogation, but rather to exemption information, for a very specific reason:

This is not a prior authorisation procedure.

The economic operator assesses for itself whether compliance would result in a fundamental change to the product/service or would constitute a disproportionate burden (see Art. 16).

It simply informs OSAPS of this assessment (Art. 16, §7), without requesting prior validation. OSAPS will then verify this self-assessment as part of its checks.

In summary:

• There is no request for authorisation to be sent to OSAPS.
  
• There is an obligation to provide information, documented and justified, to OSAPS.
  
• This information is subject to ex post verification.
  

This is why the procedure is not referred to as a “request” but as exemption information.

No.

As long as your product or service benefits from the transition period, you do not need to apply for an exemption — even if it is not compliant.

The transition period is specifically designed to give you time to bring your products or services into compliance.

You should only consider an exemption if, at the end of this period, you believe that compliance would:

• result in a fundamental change to your product or service, or
  
• constitute a disproportionate burden.
  

In this case, exemption information must be submitted before or at the same time as a declaration of non-compliance.

Yes.

Introducing an exemption implies that you have identified a non-compliance. It is therefore necessary to declare it.

When making the declaration, simply specify that you have introduced an exemption for the same product or service.

OSAPS will process your exemption and declaration simultaneously.

No.

You can submit an exemption information without authentication directly on Guichet.lu.

However, using a professional MyGuichet account allows you to pre-fill forms automatically, saving you valuable time if you need to submit multiple exemption informations.

Important: OSAPS only accepts exemption informations submitted online via Guichet.lu.

You must carry out an internal assessment and put together a justified case.

Step 1: Identify non-compliance

Before you can consider an exemption, you must check whether your product or service complies with the legal requirements.

This involves comparing its characteristics with the requirements defined by law. If any gaps are identified, you must submit a declaration of non-compliance.

Step 2: Justify the request for exemption

You must then demonstrate, with supporting documentation, why compliance would be:

• either a disproportionate burden,
  
• or a fundamental change to the product or service.
  

If you are seeking an exemption on the grounds of disproportionate burden, you must carry out a cost-benefit analysis.

Important: A simple cost-benefit analysis is not sufficient to justify an exemption. It must be accompanied by a detailed argument and supporting documents demonstrating the impossibility or inefficiency of compliance.

The OSAPS will examine whether the information provided is sufficient to justify the application of an exemption (fundamental change or disproportionate burden).

You will only be contacted if:

• information is missing or deemed insufficient to assess your situation,
  
• a targeted or random control is triggered.
  

Please note: You may be contacted in connection with your declaration of non-compliance. Even if the two procedures are related, they must remain separate in their administrative processing.

No.

The exemption information remains valid without time limit, as long as the conditions justifying it remain unchanged.

It expires:

• if you withdraw the product or service from the market,
  
• or if OSAPS questions the exemption following an inspection or a report.
  

In the event of a substantial change to the product or service, or if the conditions for the exemption are no longer met, you must update your file.