Adverse Events & Safety Substantiation

Section 605 of the Modernisation of Cosmetics Regulation Act 2022 (MoCRA) outlines the management of adverse and serious adverse events related to cosmetic products in the U.S., defining responsibilities for the U.S. Responsible Person (RP). An adverse event is any negative health-related event associated with cosmetic use, while a serious adverse event includes more severe outcomes like death, life-threatening experiences, hospitalization, disability, birth defects, infections, or significant disfigurement.

Adverse Events

Section 605 of MoCRA details the definitions, requirements and expectations of adverse events, serious adverse events and how these are to be managed by the US Responsible Person (RP).

An adverse event is defined as ‘any health-related event associated with the use of a cosmetic product that is adverse.’ This could include the outcome of a consumer misusing a product which leads to a health-related event such as skin irritation or a rash that does not require any medical intervention or treatment.

A serious adverse event is defined as ‘an adverse event that:

  1. results in:
  1. Requires based on reasonable medical judgement, a medical or surgical intervention to prevent an outcome described in section (a).’

Consumers are to report adverse events via the labelling information on the product detailing who the US RP is. As a reminder, this needs to include a domestic address, domestic telephone number or electronic contact information such as a website or email address. The US RP receiving the adverse report must ensure there is a process for receiving and processing adverse and serious adverse event information. 

Only adverse events that are defined as serious (following a review by the US RP)  are required to be reported to the FDA by the US RP within 15 business days after the report is received by the US RP. The serious adverse event itself must take place in the US. The form to report a serious adverse event is Form 3500A and must be completed and sent to the FDA via email with a copy of the product label.

The form is available following this Link

The form and product label are to be emailed to this email address -

It is the responsibility of the US RP to ensure there is an internal process for reporting and communicating with the FDA when reporting serious adverse events. This may include setting up a standard operating procedure to ensure communications are managed in accordance with business processes. 

If within 1 year of submitting a serious adverse event report to the FDA, the US RP receives new and material medical information related to the report that was initially sent to the FDA, the US RP must submit this new information to the FDA no later than 15 business days after receipt of the new information.

If the FDA believe that serious adverse event was caused by a fragrance or flavour ingredient in the formulation, the US RP is required to provide the FDA with either a list of ingredients of that fragrance or flavour or categories of ingredients in the fragrance of flavour within 30 days. 

MoCRA stipulates that records must be kept. The US RP must keep and maintain a record of all adverse events within the US for 6 years. If the brand is a small business in accordance with the definition within MoCRA, records only need to be kept for 3 years. It is important to ensure record keeping and maintenance procedures are in place as the FDA can request to see adverse event records anytime during an inspection. It is highly recommended that there is an internal process for managing FDA inspections. 

The deadline to comply with Section 605 is 29th December 2023. There is no extension to this deadline and the FDA will enforce the above requirements from this date. 

Safety Substantiation

Section 608 of MoCRA details the FDA’s expectations for safety substantiation: 

The Responsible Person for a cosmetic product must ensure and maintain records supporting that there is adequate substantiation of safety of such cosmetic products.’

Section 608 then goes into detail on the definitions of ‘adequate substantiation of safety’ & ‘safe.’ The ‘adequate substantiation of safety’ is defined as: ‘tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that the product is safe.’

There are some key details within this definition to consider to meet the requirements of Section 608. For instance, the definition alludes to the fact that the safety substantiation must be completed by a toxicologist who has the experience to evaluate cosmetic products and their ingredients. They can also rely on various sources such as tests, studies, research or analysis when concluding whether a product is safe or not. 

The definition of ‘safe’ within MoCRA is as follows: ‘the cosmetic product, including any ingredient therefore, is not injurious to users under the conditions of use as prescribed in the labelling therefore, or under such conditions of use as are customary or usual.’ Therefore, if a product is used in accordance with its instructions it is determined as safe, even if following those instructions results in minor skin irritation or reaction as long as it does not require medical intervention or treatment (section 608 [c] [2]). 

MoCRA does not stipulate that a UK/EU Cosmetic Product Safety Report meets the substantiation requirement. However, within the industry it is thought that the following will suffice:

The deadline to comply with Section 608 is 29th December 2023. There is no extension to this deadline and the FDA will enforce the above requirements from this date. 

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