Serious Undesirable Effects (SUEs)

Since the 6th Amendment to the Cosmetics Directive (1997) adverse effects attributable to a cosmetic product have been required to be kept in the Product Information File (PIF).  This requirement remains under the new EU Cosmetics Regulation, but additionally, any Serious Undesirable Effect (SUE) now has to be reported.  Article 23 to the Regulation states the Responsible Person and Distributors must report an SUE to the Competent Authority of the Member State where the SUE has occurred.  When an SUE is reported to a Competent Authority, the authority then has to alert the authorities in all other Member States.  A report can also come from a consumer or a healthcare professional.
 
Article 2 of the Regulation provides definitions of both undesirable effects and serious undesirable effects. 

Undesirable Effect means

'an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product'.

Serious Undesirable Effect means

'an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death’.

Harmonised reporting and guidance

Guidance

Key to the whole process is a harmonised approach to investigation and reporting.  The European Commission has issued guidelines on the reporting of SUEs through its post market surveillance group, PEMSAC (Platform European Market Surveillance and Administrative Co-operation).
 
Any undesirable effect (UE), whether it is deemed to be ‘serious’ or not, does need to be investigated to make sure it is attributable to the cosmetic product in question.  In order to determine this, it is important that a causality assessment is performed.  The PEMSAC guidelines also cover the causality assessment. 

Reporting

As well as an agreed assessment of causality, it is also important to have a common reporting system.  Three separate reporting forms have been devised, enabling a structured and harmonised submission of all important factors related to the SUE, as well as any other relevant information.
 
Form A is for reports of SUEs made to the Competent Authority by the Responsible Person or Distributor.  Once a Competent Authority has been notified of an SUE having occurred in its country, it completes Form B, which provides a brief summary and perspective of the case, and transmits it to all other Competent Authorities with the Form A received from the RP.  When the initial notification comes from a Distributor, it is mandatory that the Competent Authority informs the RP, which means the company will receive the Form B and Form A in this instance.  
 
Form C is for Competent Authorities transmitting SUEs reported by health professionals or end users to other Competent Authorities and the RP.
 
Each incident should be given an unique code, so that reports can be cross-referenced.  It is likely that more than one submission will be made per event, as more information is gathered over time.  The forms may be used in any of these submissions and the content of each report submitted should be identified i.e. “initial report”, “follow-up report” or eventually “closed”.
 
The forms are part of the Commission guidelines and are available from the Commission’s website.
 
Any UE or SUE must be addressed as part of the Cosmetic Product Safety Report; therefore the safety assessor will need to be informed when an SUE has occurred.

Timescales

The Regulation states that the information to be notified must be done so “without delay” or “immediately”.  The guidance defines these terms as 20 calendar days.  However, this is 20 days from when anyone in the company is informed of a possible SUE.
 
The legal text specifies what needs to be reported: the SUE; the name of the cosmetic product concerned, enabling its specific identification; and corrective measures taken, if any.  However more information will be required in order to carry out the causality assessment which may not be possible within the 20 days.

UK reporting

In the event of an SUE occurring in the UK, the Responsible Person (or Distributor, depending on who has the duty to report under the Regulation) should in the first instance make contact with their local Trading Standards department and share the information on Form A.  The Trading Standards Officer will make a record of the dialogue with the RP/Distributor, complete a Form B and forward the forms to the Department for Business Innovation and Skills (BIS).