Suitable for brand owners
Navigating the complexities of cosmetic product compliance in the U.S. market requires meticulous attention to regulatory requirements, especially under the Modernization of Cosmetics Regulation Act (MoCRA). The introduction of MoCRA has brought significant changes to how cosmetic products are regulated, emphasizing the need for stringent adherence to safety and labeling standards. This regulatory landscape demands a dedicated Responsible Person (RP) for each cosmetic product, a role pivotal in ensuring that all products meet the necessary legal and safety standards before they reach consumers.
According to the MoCRA, it is mandatory to have a Responsible Person designated for each cosmetic product placed on the US market. The Responsible Person can be the manufacturer, packager, or distributor, and their name and address must be labeled on the packaging. Additionally, the label must contain a domestic phone number, a domestic address or an electronic contact information (such as a website) as a way to contact the RP in case of any adverse events, The US RP can't be formally outsourced to a third party (like for example in the EU), but a consulting company can be hired as a “silent RP” who manages all responsibilities in the background.
CE.way can support your company as a regulatory expert to assist with Responsible Person's duties, ensuring compliance with all applicable regulatory requirements.
This includes:
Advice on establishments of product safety substantiation
Keeping safety substantiation documentation available to the authorities
Free regulatory consultation on US regulatory requirements for future products
Receive, evaluate, and record adverse events
Report and record serious adverse events
Represent you before the FDA
Support you in case of recalls, registration suspensions, inspections
Inform you about any potential regulatory changes
Ensuring general compliance with the other provisions of the MoCRA
Handling FDA inspections/questions and assistion the brand and the FDA
1990 $ / year
Suitable for non-US based manufacturing facilities
The landscape of cosmetic regulation in the United States has undergone significant changes with the introduction of the Modernization of the Cosmetics Regulation Act (MoCRA). This pivotal legislation has introduced stringent requirements for cosmetic products, emphasizing the need for enhanced safety, compliance, and transparency in the industry. A key provision under MoCRA is the mandate for non-US facilities to have a dedicated in-country representative, highlighting the importance of a direct and accountable liaison with regulatory bodies.
Modernization of the Cosmetics Regulation Act (MoCRA) legislation for cosmetic products in the USA, dictates that non-US facilities must appoint an in-country representative, known as a US Agent. US Agent is a legal entity or a person in a position to communicate efficiently with the FDA (and other stakeholders) and comply with the legal obligations of a foreign manufacturing facilities that must be executed from the US territory.
CE.way can provide expert representation as your US Agent, facilitating seamless communication with regulatory authorities and ensuring your products' compliance with US regulations:
Initial facility registration
Providing US-based address for FDA communication
Initiating communication between FDA and facility
990 $ / year
The responsible person must ensure that their products marketed in the US-territory are listed with the FDA through the FDA Direct portal. The listing must include details such as the product name, type, and ingredients. Cosmetic product listing is due by July 2024 and new cosmetic products shall be listed within 120 days following their marketing in interstate commerce. Product listings must be updated annually.
US Responsible Person is required to maintain records of product listings and their respective ingredients, updating this information annually. The necessary information required are:
name and contact of the U.S. RP, as it appears on the product
product name and whether it contains any fragrances or flavors
cosmetic category to which it belongs
complete list of ingredients
list of facilities, where the product is manufactured and their FEI number
possibly previous Product Listing Number
CE.way can help with performing product listings and updates as individual services or part of our MOCRA compliance packages.
The Modernization of Cosmetics Regulation Act (MoCRA) introduces pivotal responsibilities for the Responsible Person (RP) associated with a cosmetic product, emphasizing the critical nature of safety substantiation.
MoCRA requires the Responsible Person of a cosmetic product to maintain records justifying the safety of the product. While the Amendment is non-prescriptive about the method to adequately substantiate the safety of cosmetic products, it clarifies that “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 a cosmetic product is safe.”
Product safety substantiation documentation should be demonstrated according to current industry standards, and within the industry it is widely accepted that a similar approach should be followed to that of EU Regulation 1223/2009, which is commonly used in many countries around the world.
This includes:
Scientific demonstration of product and ingredient safety
Supported and accompanied by the necessary documentation about raw materials, finished product and packaging
Supported by necessary in-depth studies, tests, analyses, trials and information (in other words, the toxicological data)
Documentation should be valid and up-to-date
Evaluation of the safety inherent in the product and ingredients, that is the toxicological evaluation based on scientific data should be performed by qualified expert (safety assessor)
In addition, it’s worth noting that an official method for detecting the presence of asbestos in products containing talc will soon be published. Furthermore, the FDA will be involved in evaluating the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, including assessing any associated risks. Following these evaluations, the Responsible Persons will need to adjust cosmetic products as necessary in line with these assessments.
With more than decade of expertise with safety substantiation documentation preparation, CE.way’s team of highly qualified safety assessors is able to support you with every step to ensure your cosmetic product is safe and compliant before entering the US market.
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