Fragrance Regulations and Requirements: What You Need to Know
Major Updates: Modernization of Cosmetic Regulations Act (MoCRA)
In early 2011, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law, launching the biggest overhaul of federal food regulations in the US since the 1930s. More than a decade later, on December 29, 2022, his former Vice President Joe Biden ratified the Modernization of Cosmetic Regulations Act (MoCRA). Like FSMA, this was the first major regulatory act to address cosmetic safety since the 1930s. Many of the elements of MoCRA are similar to those in FSMA but adopted for cosmetic consumer protection.
Like FSMA, MoCRA aims to take a more proactive approach to consumer safety as well as providing the FDA with more authority. Companies that manufacture or pack cosmetics marketed in the US, as well as distributors whose name appears on the label of the cosmetic, must comply with MoCRA. The act requires that both domestic and foreign cosmetic companies register their facilities with the FDA and renew registrations biennially. Additionally, a full list of the cosmetic products from each registered company and the ingredients for those products must be provided to FDA. Registered firms will be subject to FDA inspections, and all cosmetics in the US must be made under the appropriate GMP rules as defined by the FDA.
To help prevent adverse reactions to cosmetics, firms that produce or market cosmetics must ensure they are safe. The cosmetic firm must evaluate the product, base their studies on scientific methods, and maintain relevant safety data. The Act does not require animal testing; however, it encourages companies to find alternatives. Furthermore, any cosmetic allergen must be listed on the label. The ACT also mandates the FDA address some specific material concerns. Specifically, providing a standardized test for asbestos in talc-containing cosmetics and assessing the safety of PFAS.
If any harmful health effects are discovered, the cosmetic company must report those health events to the FDA. Upon request, cosmetic firms must provide any records to the FDA, and the firm must recall products harmful to consumers. Harmful health effects that could result in a recall include failing to list allergens on the cosmetic label. Under MoCRA, the FDA has the authority to initiate a recall, and the public must be informed.
Fortunately, the implementation dates are staggered to allow the industry to adopt the new requirements. The deadline for facility registration and providing product and ingredient listings is December 29, 2023. Requirements on recalls must also be in place by the end of the year (December 29), including the authority for the FDA to initiate recalls. The GMP requirements are not yet finalized, and the FDA has until December 29, 2024, to issue its cosmetic GMP rules. Firms will then have 1 year (until December 29, 2025) to have their GMP programs in place.
The FDA has until June 29, 2024, to propose fragrance allergens for the mandatory allergen labeling rule. During this process, the FDA must factor in scientific data, including that which was used to determine the EU cosmetic allergens (Regulation (EC) No 1223/2009. It is probable that the list of US allergens will closely resemble those that are already required in the EU. Once the proposed allergens are published, there will be a public comment period. Afterward, the final rule will be effective in 180 days. Similarly, the talc test standard must be published by December 29, 2023, and after a public comment period, the final rule will come into effect 180 days later. With the complexities of assessing PFAS safety, however, the safety report on PFAS is not required to be published until December 29, 2025.
Fragrance Allergens: Updated EU Allergen List and Labeling Requirements
As stated above, US fragrance allergens must consider published data establishing EU cosmetic allergens. Although the EU cosmetic regulation establishing allergens was published in 2009 there were ongoing concerns about the potential allergenic activity of many cosmetic ingredients not identified in the regulation. As a result, the European Commission Scientific Committee on Consumer Safety (SCCS) issued an opinion on fragrance allergens in cosmetic products in 2012. This report identified dozens more potential fragrance allergens, including products with known skin sensitivity in humans as well as materials with sensitivity concerns in animals. The European Commission completed analysis of this data and additional inputs after over 10 years of review and published a major update to the EU allergen list in July 2023.
Under the new update, the number of fragrance allergens in the EU more than tripled, from 26 to 82. The updated list of allergens includes 28 natural extracts and 54 individual chemicals. It also clarifies the natural extracts by citing the source scientific name as well as the common name. EU rules require cosmetic manufacturers to indicate on their product labels which fragrance allergens are present if the allergen concentration is greater than 0.001% for leave-on products or greater than 0.01% for rinse-off products. In order to support the industry transition to the new requirements, firms marketing cosmetic products in the EU have 3 years (until July 31, 2026) until they must list the additional allergens on new cosmetic products and 5 years (until July 31, 2028) for products marketed in the EU prior to July 31, 2023.
Although no longer a member of the EU, the UK generally follows EU requirements. As such, they will likely adopt the updated fragrance allergens. Additionally, the UK is calling for data on nanomaterial safety in cosmetics. The UK authorities are asking for safety data on most nanoparticles by December 22, 2023, with the exception of silica nanoparticles where the deadline for submission of safety data is June 27, 2025.
International Standards: IFRA's Role in Fragrance Safety and Ingredient Transparency
MoCRA and the EU regulations stipulate requirements for marketing cosmetics in specific regions, but with the modern global marketplace, many firms also adhere to international guidelines. IFRA, the International Fragrance Association, is the largest and most respected global organization providing guidance on the safety of fragrances. The primary tool leveraged by IFRA to provide cosmetic firm information on fragrance ingredient safety is the IFRA standard. In the standard, IFRA identifies prohibited ingredients; those materials that should not be used in cosmetics. The standard designates restricted materials that should only be used in cosmetics under certain conditions. Fragrances generally accepted for use in cosmetics without restriction are designated as specified and should only be used in formulations if they meet the IFRA specification. On June 30, 2023, IFRA released their 51st amendment to their standard. This amendment revises 12 existing standards, identifies one new prohibited material, and adds 48 new restricted materials. The amendment also provides clarification to help cosmetic firms apply the standard. IFRA recommends that firms adopt changes to prohibited materials by August 20, 2023, for new products and July 30, 2024, for existing products. For the changes to restricted materials, IFRA recommends adopting the new amendment by March 30, 2024, for new products and October 30, 2025, for existing products.
Summary
A major new US regulation and a signification change to EU 2023 saw a new emphasis on fragrance safety and ingredient transparency. Like major updates to the food laws a decade earlier, the changes in the US and EU will have an ongoing impact on the fragrance industry for years to come. It is expected that these changes will be reflected around the globe in both regulations and consumer expectations. With the increasing global demand for cosmetics and fragrances, both suppliers and manufacturers must continue to update and adapt to changing regulatory requirements and industry expectations to deliver safe products.
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