The Modernization of Cosmetics Regulation Act (MoCRA) has introduced the concept of responsible person in the US cosmetics regulatory framework. Furthermore, under this act, new facility registration rules, product listings, SAE reporting, and safety validation requirements have been introduced. In this blog, we will discuss the responsibilities and obligations of the MoCRA responsible person. Responsible person is required to comply with MoCRA regulations for adverse event receiving, record keeping, and serious adverse event reporting. We have created this guide to help you comply with MoCRA regulations for cosmetics industry.

What is a MoCRA responsible person?

The implementation of MoCRA has introduced a new role in the cosmetics industry, the responsible person. It is a mandatory requirement for companies marketing their cosmetics in the U.S. The responsible person is accountable for overseeing compliance with all new MoCRA requirements. As per MoCRA definition, responsible person is “the manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.” The responsible person can be based anywhere in or outside of the United States. Furthermore, a qualified authorized agent can be hired to deal with certain MoCRA requirements, such as adverse event reporting. 

The responsible person is expected to perform various duties as per MoCRA requirements. Some of the MoCRA responsible person duties are as follows:

1. Cosmetic product listings 
2. Safety substantiation 
3. Proper labelling for products intended for professional use
4. Fragrance allergen disclosure warnings
5. Voluntary product recall
6. Adverse event report receiving and record keeping 
7. Serious adverse event reporting to the FDA

Each of these aforementioned duties have their own set of requirements. Furthermore, MoCRA may add to the list of duties the responsible person is expected to perform.

What are the duties of the MoCRA responsible person?

MoCRA has listed various responsibilities and duties of the designated responsible person. The duties of the MoCRA responsible person are of paramount importance for compliance with MoCRA guidelines. The concept of a responsible person may be new to many cosmetics facilities and companies. Hence, we have discussed in detail the duties and obligations of the responsible person in cosmetics industry.

1. Cosmetics product listings 

The responsible person has to provide a comprehensive list of all marketed cosmetics products to the FDA. They are required to provide information on product ingredients. Additionally, they will be required to annually update each marketed cosmetic product with the FDA.

Product listings should contain the following information:

• Type of submission (initial, update to content, or abbreviated renewal) 
• The product name and cosmetics category to which it belongs to
• Product ingredients, including fragrances, flavours, or colours, used
• Facility registration number of the facility where the product is manufactured or processed
• Product listing number for previously assigned products
• Responsible person contact information 

2. Safety substantiation duties of the MoCRA responsible person

MoCRA guidelines require sufficient records supporting the safety of cosmetics products. The substantiation records can include tests, studies, or analyses deemed sufficient by qualified industry experts. Hence, the MoCRA responsible person has to maintain documents that demonstrate adequate safety substantiation of the cosmetics products. The FDA has not specified any particular safety substantiation tests, analyses, or documentation. Hence, the responsible person has to work with company experts to determine what test data would best substantiate the safety of their cosmetic products. Furthermore, the FDA may request access to safety substantiation documentation. Thus, the documentation should be recorded properly.

3. Cosmetics product labelling requirements

MoCRA guidelines require the cosmetics label to include a domestic address, phone number, or electronic contact information of the responsible person for receiving adverse event reports from consumers. It is the duty of the responsible to person to ensure this contact detail has been updated on the product label. Notably, products without the contact label will be considered misbranded by the FDA. Furthermore, MoCRA now requires that any ingredient considered allergen by the FDA should be mentioned on the cosmetics product label. Hence, the responsible person should ensure fragrance allergens are mentioned on the product labels. Moreover, cosmetics intended for professional use should carry the “professional use” label. It is also the responsibly of the responsible person to ensure compliance with this guideline.

4. MoCRA responsible person has the primary duty of reporting serious adverse events to the FDA

Serious adverse events associated with cosmetic product usage should be reported within 15 business days of the incidence. Additionally, adverse event reports must include a copy of the cosmetics product label. Furthermore, for 1 year after the initial submission, new medical information related to the initial report has to be submitted. It is the responsibility of the responsible person to file these reports. Additionally, they must maintain proper records of the adverse events.

5. Adverse event recordkeeping

As per MoCRA guidelines, the responsible person is required to maintain records of any and all adverse events. Furthermore, these records must be made available in case the cosmetics product poses a potential threat to public health. During inspections, the FDA can request copies of adverse event report records. Records of all adverse events should be maintained for a period of 6 years. However, small businesses can maintain the records for a period of 3 year. 

6. Voluntary product recall

The MoCRA responsible person is required to carry out voluntary product recalls, if required. If the FDA authorities consider a cosmetic product adulterated or misbranded and can cause serious harm to the public, they can demand a recall.  Then, they will contact the responsible person and give them the opportunity to cease production of the product. Additionally, the responsible person will have to order a voluntary recall.  However, if the responsible person does not choose to voluntarily recall the product, the FDA will issue a mandatory recall. Then, the responsible person will have no choice but to recall the products.

As per guidelines, a cosmetic product will be considered “adulterated” if: 

• The product has been manufactured in conditions that do not meet cosmetics good manufacturing practise guidelines.
• Its container is composed of any poisonous substance that may render the contents injurious to health.  
• It contains any poisonous substance that may render it injurious for its intended use.
• It consists in whole or in part any putrid or decomposed component   
• It contains a colour additive that is considered unsafe or has not been approved.
• It has been prepared, packed or, stored, under unsanitary conditions, thereby making it contaminated.

As per guidelines, a cosmetic product will be considered “misbranded” if: 

• It has misleading packaging 
• There is a lack of required information on the label
• Its product labelling is false or misleading 
• There is improper packaging of the product
• There is improper labelling of the colour additives used in the product

What is the difference between the FDA and EU responsible person?

Similar to FDA, EU regulations also have requirements of a responsible person for companies marketing their cosmetics products in EU. However, the EU definition and obligations of a responsible person are slightly different from those of FDA. As per EU definition, the responsible person is “a legal or natural person” located in the EU responsible for assuring the regulatory compliance of domestic, imported, and exported products. They have the responsibility of informing authorities of the potential risks associated with using the product. Moreover, as opposed to FDA responsible person, the EU responsible person has to be located within the EU. 

In this blog, we have detailed the roles and obligations of the MoCRA responsible person. Navigating the MoCRA guidelines can be overwhelming. For MoCRA regulatory compliance, you can always depend on Pharmadocx Consultants’ team of seasoned experts. Simply call/Whatsapp on 9996859227 or drop an email at [email protected] and we will be more than happy to help you.