A ‘Serious Undesirable Effect (SUE)’ occurs when a normal or reasonably foreseeable use of a cosmetic product results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, or an immediate vital risk or death.

An SUE notification does not necessarily mean that a cosmetic product is unsafe or non-compliant with regulations. Rather, a cosmetic product can have an undesirable effect due to an individual’s allergy or sensitivity to specific ingredients.

In the United Kingdom (UK), a Responsible Person (RP)/distributor can use the SUE form to notify the Office for Product Safety and Standards (OPSS) about serious undesirable effects reported by health professionals or end users.

The UK cosmetics regulation requires RPs and distributors to notify all serious undesirable effects which are known to them, or which may be reasonably expected to be known to them. Due to their potential medical seriousness, all SUE cases should be notified, and information on these cases should be kept available by the RP for the OPSS. The act of notifying an SUE should not be construed as an admission of liability by the company.

Notifying SUE – Subsequent Actions by an RP

• Analysis of the Data: A human health issue could be identified from one report or, more likely, from several similar SUE reports associated with the same product. As required, a trend analysis that takes into consideration the nature, severity, and/or frequency of the issue should be performed. Other factors could include possible predisposing factors on the part of the end users who had experienced the undesirable effect.
• Inclusion in the Cosmetic Product Safety Report (CPSR): The UK cosmetics regulation requires the inclusion of “all available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products,” which also includes “statistical data,” in the CPSR.
• Information to the Public: The UK cosmetics regulation requires that the existing data on undesirable effects and serious undesirable effects resulting from the use of a cosmetic product be made accessible to the public by any appropriate means.
• Corrective Actions: Following the assessment of Post-marketing Surveillance (PMS) data, along with other sources of safety data, a company can undertake several actions, if required. The measures taken should be proportional to the nature and/or frequency of the SUE and must be subject to the same rigorous risk assessment exercise. If an SUE requires corrective measures, these actions have to be notified to the OPSS.

Requirements for Notifying an SUE

• Information on the identity of the cosmetic product.
• A description of the product risk, including a summary of any test results or analysis.
• The nature and duration of any corrective measures proposed. (e.g., reformulation, recall, etc.).
• Information on supply chains and product distribution.

SUE, introduced by Health Authorities (HAs), helps manufacturers and other healthcare professionals ensure the safety of cosmetic products that are placed on the UK market. Thus, keeping abreast of the Regulatory requirements is necessary. To know more about SUE, cosmetovigilance, and similar systems, reach out to Freyr experts today.