The Modernization of Cosmetics Regulation Act (MoCRA) focusses on increased product safety and manufacturer accountability. Cosmetics products have to be regulated so that they are safe for repeated and regular use. Notably, safety substantiation is one of the core tenets of MoCRA. Thus, cosmetics companies should brace themselves for increased scrutiny under MoCRA guidelines for the cosmetics industry. With new guidelines and record keeping requirements, cosmetics companies will have to review current practices to ensure compliance with MoCRA. Moreover, they have to mandatorily fulfil MoCRA safety substantiation requirements. The MoCRA guidelines require the responsible person to maintain records proving their cosmetics product’s safety. The substantiation records can include tests, studies, or analyses that are deemed sufficient by qualified industry experts. Hence, in this blog, we will specifically shed light on the safety substantiation requirements of MoCRA.

What are the key MoCRA requirements?

MoCRA has laid down stringent quality and regulatory standards for the cosmetics industry. MoCRA guidelines focus on safeguarding consumer health. The aim is to improve transparency and strengthen reporting guidelines. Thus, compliance with the MoCRA guidelines is mandatory for cosmetics business to market their products in the US.

1. Cosmetic product listing
2. Cosmetics facility registration
3. Cosmetics good manufacturing practices
4. Safety substantiation
5. Cosmetics product labelling guidelines
6. Fragrance allergen disclosure
7. Adverse events reporting
8. Record keeping requirements

The MoCRA has been implemented to modernize and transform the US FDA cosmetic regulations. The guidelines are comprehensive and elaborate increasing the accountability of cosmetics manufacturers. Therefore, cosmetics manufacturers or processors need to understand and comply with the MoCRA guidelines.

What are the MoCRA safety substantiation requirements?

The MoCRA has laid down various requirements and guidelines that cosmetics manufacturers are expected to comply with. Among the various mandatory requirements, safety substantiation is one of primary ones. The responsibility of ensuring product safety and efficacy has been placed on the cosmetics manufacturer or producer.

MoCRA requires the responsible person to maintain records demonstrating the cosmetics product’s safety and efficacy. Thus, it is the responsible person’s duty to ensure there is adequate safety substantiation for their products. Additionally, they should have their cosmetics products evaluated for safety by a qualified expert. Furthermore, products lacking proper safety substantiation will be considered as misbranded and adulterated. This can lead to product recalls and regulatory sanctions. Therefore, meeting the MoCRA safety substantiation requirements is of paramount importance. The documentation to prove cosmetics product safety should be ready within the December 29, 2023 deadline.

What is cosmetics product safety and how to ensure it?

A cosmetics product is considered safe, if it does not harm users under conditions of use prescribed on the label. It is the duty of the responsible person to ensure cosmetics product safety. To determine cosmetics product safety, responsible person must rely on tests, studies, or analyses deemed sufficient by qualified industry experts. The cosmetics product safety can be ensured at two levels, raw material and product.

• Raw material level: The cosmetics product safety primarily depends on the raw materials used and their respective composition levels. The product raw materials are qualified based on their composition, specification, origin, and impurities declaration. Additionally, the percentage of raw materials used in product formulation and number of impurities present impact the final product quality. Furthermore, safety of individual ingredients is determined using study data and scientific reviews. Notably, the US FDA takes cosmetic ingredient reviews (CIR) into consideration while analysing the cosmetic ingredient safety. 
• Product level: The cosmetics product safety can be ensured at the product level. Physicochemical, microbiological, and clinical testing data can be used to determine safety at the product level. Furthermore, usage direction and precautionary measures should be clearly mentioned on the product label. This has to be ensured because the product safety depends on how it is used.

The data obtained from the cosmetics product safety tests should be properly documented. Furthermore, the responsible person should maintain proper records of the product safety test results.

How to comply with MoCRA safety substantiation requirements?

As per MoCRA safety substantiation requirements, the responsible person will be required to adequately substantiate a cosmetics product for safety and efficacy. Additionally, they will be required to maintain sufficient records to document the evidence. Furthermore, all safety substantiation documentation should be ready by December 29, 2023.

However, MoCRA has not provided any specific or rigid tests for particular product ingredients. Additionally, it does not provide any guidelines on how to test a cosmetics product for safety. Nevertheless, MoCRA has clearly stated that the cosmetics product safety must be clearly demonstrated using data obtained from scientifically robust methods.

Safety substantiation is not a very new concept for the cosmetic industry. Previously, all cosmetics products had to be properly substantiated for safety prior to marketing. Moreover, those that did not meet this requirement benchmark were considered misbranded. However, the previous regulatory guidelines did not explicitly and stringently require cosmetics companies to conduct safety substantiation. On the other hand, MoCRA removes any room for doubt and mandates companies to substantiate the safety of each of their cosmetics products. It has made review and evaluation of cosmetics product safety a common requirement in the cosmetics industry. Furthermore, it has added the requirement for proper documentation of safety substantiation. Thus, MoCRA has made product safety information easily accessible to the FDA authorities.

MoCRA safety substantiation requirements underscore the importance of a robust framework covering data utilization and supplementary testing. Moreover, this cosmetics product safety substantiation framework will be required to demonstrate unwavering commitment to cosmetics regulatory guidelines.  

MoCRA safety substantiation requirements and guidelines

MoCRA safety substantiation requirements do not explicitly state how to substantiate cosmetics product safety. However, it guides the responsible person to use tests, research, studies, and analyses, deemed sufficient by scientifically trained experts, to evaluate the safety of the products. The tests should provide evidence to sufficiently support product safety.

Furthermore, FDA recommends cosmetics manufacturers to use available relevant safety data for individual ingredients or products with similar formulation for safety substantiation. Manufacturers can find the information in relevant scientific databases. On the other hand, raw material suppliers can provide cosmetic companies with safety information on individual cosmetic ingredients. Notably, US FDA mentions animal testing is not a requirement for validating the safety of a cosmetic product. In fact, it encourages development and use of methods alternative to animal testing. Furthermore, it accepts toxicological test data as a safety substantiation for cosmetics products and their ingredients. Notably, in case of queries, the manufacturer may have to justify why it considered the particular information sufficient to demonstrate the safety of a product. Hence, adequate safety substantiation of the cosmetics product and proper documentation of evidence are critical for compliance with MoCRA guidelines.

To be safe, we recommend preparing safety assessment reports that meet international standards to comply with MoCRA safety substantiation requirements. Additionally, we recommend you customise the reports and data to suit MoCRA guidelines.

Choose Pharmadocx Consultants as your trusted MoCRA compliance partner 

MoCRA has introduced new guidelines for cosmetics facilities, manufacturing process, adverse event reporting, and safety substantiation. Notably, MoCRA safety substantiation requirements have placed new heightened importance on product safety. However, understanding and complying with the MoCRA guidelines for cosmetics industry is a cumbersome task. We at Pharmadocx Consultants have extensive knowledge of the MoCRA guidelines and requirements. Email at [email protected] or call/Whatsapp on 9996859227 and we will be more than happy to help you in every step of your cosmetics regulatory journey.