In this article, we bring you the key aspects of the Modernization of Cosmetics Regulation Act or MOCRA which independent and small cosmetics manufacturers should be aware of.
MOCRA sets new requirements which certain “facilities” as well as “responsible persons” engaged in cosmetic procedures must comply with. As defined by MOCRA, a facility is one that mass produces cosmetics for production in the United States. However, establishments that only label, relabel, package, repackage, store and/or distribute cosmetics are not included. A responsible person is described as the person who packages, produces and distributes a cosmetic product, often including the person’s name on it. Cosmetic products can include professional salon products, personal and intimate care products. By adhering to MOCRA, the public would be more confident with the safety of cosmetics.
Several features of MOCRA are comparable to EU cosmetics rules, including the requirement to name a "responsible person" (often the manufacturer). It also emphasizes on guaranteeing the conformity of each cosmetic product created. In short, the law:
1. Requires mandatory reporting by manufacturers of serious adverse health events caused by cosmetic products.
2. Requires the Food and Drug Administration (FDA) to establish Good Manufacturing Practices that all manufacturers will be required to follow.
3. Requires cosmetic facilities to register with the FDA, and provide a list of products and product ingredients, including ingredients in fragrance and flavors, to the agency.
4. Requires manufacturers to keep records that show safety substantiation of a product.
5. Requires labelling of fragrance allergens for all cosmetics and labelling of ingredients in professional use only products used by salon workers.
6. Allows the FDA to request records related to a product’s safety substantiation and ingredients if there are concerns a product may be misbranded or adulterated.
7. Gives the FDA the authority to request a mandatory recall of products that are misbranded and/or adulterated.
8. Exempts small business from having to meet the requirements of the law.
9. Preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting or safety substantiation.
10. Requires the FDA to establish a standardized testing method for detecting asbestos in talc-containing products.
11. Requires the FDA to assess the use and safety of PFAS chemicals in cosmetics.
FDA registration
Manufacturers of cosmetics who sell their products in the US are now required to register with the FDA, by 29 December 2023, which is within a year after the approval of MOCRA, whether they are headquartered domestically or abroad. The responsible person must also register every cosmetic made, along with its components and manufacturing facility, with the FDA. Depending on whether the cosmetic product entered the market before or after MOCRA became legislation, there are different registration deadlines. If the products are commercialized after the enactment of MOCRA, the product listing must be submitted by the manufacturer no later than 120 days after marketing. Once listed, information about the cosmetic product must be updated yearly. New businesses must register with the FDA within 60 days after starting on their manufacturing operations, should they miss the registration deadline. In addition, these registrations must be updated every other year, and inform the FDA within 60 days as well.
Keeping a record of adverse reactions
Upon receiving the reports of adverse events from the consumer, the manufacturer should present them to the FDA no later than 15 days. Firms must now comply with the rule by keeping records of unfavorable events for a minimal of six years, or just three years in the case of small businesses. This aligns the FDA's demands with comparable demands it places on producers of over-the-counter medicines and dietary supplements. Additionally, the concept of what kind of an unfavorable reaction is expanded.
Proof of a cosmetic's security
One of the most crucial changes to be aware of is this one. The FDA now mandates and establishes standards for "sufficient substantiation" of a cosmetic product's safety. Once more, the responsible person is required to offer this proof and keep track of product safety. This is no longer voluntary to do. This modification most closely aligns US standards with EU cosmetic legislation, which calls for the responsible party to have product safety evaluations completed and to upload the results to the EU's cosmetic product notification portal (CPNP).
Disclosure of fragrance allergens on cosmetic product labels
For cosmetics items sold in the US, the FDA has highly rigorous labelling regulations. The MOCRA has recently expanded this need to call out each fragrance allergen in a cosmetic on the label. A list of prevalent allergens that can be found in cosmetics products has been collated by the FDA. These allergens are identified to cause the most allergic reactions upon the use of cosmetic products. Such allergens include Benzyl alcohol, Citral, Geraniol and Tree moss extract, which is similar to the 26 allergens listed in Annex III of the European Union Cosmetics Directive. The identified allergens may be expanded to 80 possible allergens in the future.
GMP specifications
The FDA will be developing several requirements for producers so as to ensure their compliance with good manufacturing procedures in accordance with the US and international criteria. In order to include different types and sizes of facilities to ensure that they follow the mandatory guidelines, these requirements must consider the scope and size of businesses. Products that do not obey the guidelines are considered adulterated, under the FDCA. However, businesses which do not produce cosmetics, or those with average gross annual sales totals that are less than $1 million over the previous three-year period, are not required to follow the GMP requirements and will not be subjected to the good manufacturing practices regulations.
Recalls of products
A recall is an act of removing or rectifying products that breach the laws by the FDA. Such products include products that are misbranded or adulterated, and those that pose health risks to consumers. With the importance of public health and well-being in mind, manufacturers recall these products to reduce the risk of injuries. On the other hand, MOCRA has now permitted the FDA to release a recall order to manufacturers if they do not recall dangerous products. A press release is necessary to inform the public and the FDA website should be updated with an image of the product as well. In addition, FDA can also suspend a facility if products manufactured by them pose danger to the health of the public. The affected facility will no longer be able to commercialize any products until its registration is replaced. However, the FDA must provide a notice together with an unofficial hearing within 10 days after the order has been issued, to justify the order. Recent years have seen a number of high-profile product recalls, with Johnson & Johnson Baby Powder (talc) being the most prominent.
Conclusion
In conclusion, MOCRA ensures for the safety of cosmetic products by establishing new requirements for companies or manufacturers to adhere to. These include FDA registration and listing, reporting of adverse events, GMP as well as the recalling of products. By following the guidelines, it accounts for the security of products and facilities, as they are examined and would be eliminated if they do not meet the criteria. This not only reduces the risk of potential health hazards, but it also builds the confidence and trust of consumers towards these products, allowing for a positive business to consumer relationship.
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