MoCRA Update

On November 8, 2023, an FDA announcement was issued delaying enforcement of MoCRA Facility Registration and Product Listing requirements. Here’s what you should know.

What Changed?

The announced delay pertains only to the Facility Registration and Product Listing regulations described below. Compliance with all other statutory requirements by December 29, 2023 remains in effect. This includes but is not limited to safety substantiation, adverse event tracking and reporting, records access, and professional use labeling.

  • FDA will start enforcing the MoCRA Facility Registration and Product Listing requirements beginning July 1, 2024 instead of the statutory deadline of December 29, 2023. This additional six months gives the cosmetics industry additional time to comply.
  • FDA will not enforce the registration requirement only for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022 until July 1, 2024.
  • FDA will not enforce the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
  • FDA plans to open their portals for Cosmetic Facility Registration and Product Listings in early December 2023.

Who Is Affected?

The new timeline for enforcing Facility Registration impacts all global Manufacturers (not otherwise exempt) producing cosmetic products to be sold in the US market.

The new timeline for enforcing Product Listings requirements impacts all responsible persons (not otherwise exempt) who must complete listings for cosmetic products sold in the US market.

Where Can I Find Updated Regulatory Resources?

Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing

How Can Ithos Help?

Ithos Global can provide software solutions and personalized regulatory services to help organize your data and evaluate your overall MoCRA compliance. We can also complete MoCRA product listings on your behalf.

And to ensure ongoing MoCRA compliance, our software includes the product fields necessary to capture, store, and export the required information for your formulas.

Contact us to learn more!

The Scientific Advisory Group on Chemical Safety (SAG-CS) in the United Kingdom is considered the equivalent acting body of the Scientific Committee on Consumer Safety (SCCS) in Europe.  The SAG-CS has recently published three (3) final opinions on substances that will have an impact on cosmetic and personal care products.

Final Opinion on Formaldehyde Releasing Substances

The SAG-CS Final Opinion in general now offers the formal conclusion which is in line with the recent EU SCCS adopted advice formally published on May 7, 2021 regarding formaldehyde releasing substances.  As is similarly stated in the SCCS advice,  the SAG-CS members have concluded the previous threshold of 0.05% for labeling of formaldehyde releasing preservatives was insufficient to protect its consumers from contact dermatitis in persons with a formaldehyde allergy.  Final Conclusion:

Members were satisfied that there was sufficient evidence to form an opinion at this stage.

Members concluded that the current threshold of 0.05% for labeling formaldehyde releasing preservatives was insufficient to protect consumers.

Members agreed that a threshold for labeling formaldehyde releasing preservatives of 10 ppm (0.001%) would be adequate to protect consumers if used for leave-on products. Members agreed that such a level would likely be sufficiently protective for use in rinse-off products also.

For additional information about the Scientific Advisory’s Group’s opinion on Formaldehyde Releasing Substances, click to read the official publication.

Final Opinion on Methyl-N-methylanthranilate in Cosmetic Products

The SAG-CS Final Opinion in general now offers the formal conclusion which is in line with the recent EU SCCS opinion formally published on June 1, 2021 regarding Methyl-N-methylanthranilate in Cosmetic Products.  However, the EU SCCS opinion contains much stronger language in advising against the use of Methyl-N-methylanthranilate in sunscreen products and products marketed for exposure to natural/artificial UV light.  Whereas the SAG-CS Final Opinion notes members agreed that methyl-N-methylanthranilate presented a potential risk from phototoxic effects if used in sunscreen products and products marketed for exposure to natural/artificial UV light.  Final Conclusion:

Members were satisfied that there was sufficient evidence to form an opinion at this stage.

Members agreed that methyl-N-methylanthranilate presented a potential risk from phototoxic effects if used in sunscreen products and products marketed for exposure to natural/artificial UV light.

The members have only been able to evaluate limited genotoxicity data for methyl-Nmethylanthranilate. Considering the limited available data and evidence of low dermal absorption, methyl-N-methylanthranilate does not appear to present a cause for concern.

Members considered methyl-N-methylanthranilate to be safe for use up to 0.1% for leave-on and 0.2% for rinse-off cosmetic products.

For additional information about the Scientific Advisory’s Group’s opinion on Methyl-N-methylanthranilate, click to read the official publication.

Final Opinion on HAA299 and HAA299 (nano) as UV Filters in Cosmetic Products

The SAG-CS Final Opinion in general now offers the formal conclusion which is in line with the recent EU SCCS opinion formally published on November 25, 2021 regarding HAA299 and HAA299 (nano) as UV Filters in Cosmetic Products.  The language within both opinions does vary, particularly as it relates to potential for inflammatory effects on the lungs.  The EU SCCS opinion does not recommend the use of HAA299 (nano) in applications that could lead to lung exposure through inhalation.  However, the SAG-CS Final Opinion makes clear HAA299 (nano & non nano) should not be used in sprays and/or aerosols, although it does not include cosmetic products in powder forms.  Final Conclusion:

Members were satisfied that there was sufficient evidence to form an opinion at this stage.

Overall, the group concluded that the use of HAA299 and HAA299 (nano) can be considered safe up to a level of 10%, excluding use in spray and/or aerosol products.

The group concluded that there are no safe usage levels for either HAA299 and HAA299 (nano) in spray or aerosolised products owing to potential effects on the lungs.

The group clarified that the concentration of HAA299 in either form (non-nano and nano), when used either individually or when used in combination, must not exceed a total concentration of 10%.

The group highlighted a lack of information and validation regarding the method available to determine the composition of products containing HAA299 and HAA299 (nano).

The group wished to document that their assessment of HAA299 (nano) pertains only to particles with a median particle size of >50 nm according to number evaluation or >100 nm according to volume evaluation.

For additional information about the Scientific Advisory’s Group’s opinion on HAA299 and HAA299 (nano) as UV filters, click to read the official publication.

The FDA has released two major updates in response to the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). In this article, we will discuss the implications of these changes and the next steps that companies in the cosmetic industry should take.

MoCRA Explained: Bringing US Cosmetic Regulation into the Modern Era

FDA VCRP

What is it?

According to an FDA constituent update released March 27, 2023, the FDA will no longer accept and/or process VCRP submissions (as of January 2023) and will no longer use the VCRP system. Compliance with MoCRA requires a mandatory reporting procedure, which the FDA will need to implement without the help of the VCRP’s existing platform. This is because the VCRP system does not include the necessary fields for MoCRA compliance.

What’s the impact?

The VCRP was not obligatory and did not serve as an authorization process, hence the information received through it did not offer a comprehensive understanding of cosmetics available in the US market. However, MoCRA necessitates specific companies to register their facilities and enlist their products with FDA, and due to the high volume of submissions expected, FDA is devising a new system to manage them. It is crucial to acknowledge that the data provided through the VCRP will not be migrated to the system under development for facility registrations and product listings mandated by MoCRA.

When is it happening?

The FDA stopped accepting VCRP submissions as of March 27th, 2023. The timeline for the launch of the new reporting system has not been announced yet, but the FDA assures that it will continue to post updates its forthcoming availability.” It is important to note that the compliance date for reporting will still be December 29th, 2023. The FDA is hopeful that the new reporting system will be online soon so that companies will have several months of lead time to complete their registrations before the compliance date.

What are the next steps?

Enforcement of MoCRA will require companies to register their manufacturing facilities and list their products with the FDA. Companies should gather all necessary formulation and manufacturing documentation to facilitate both registrations. Additionally, if any products have been previously notified with the VCRP, those products will need to be registered with the new reporting system, since information from the VCRP will not be transferred to the new reporting system. Companies should keep a close eye on FDA communications to ensure that they comply with upcoming timelines and release dates for the new reporting system.

For more information about the FDA’s decision to deactivate its VCRP system, click to read the official constituent update.

FDA Office of Regulatory Affairs (ORA) Restructuring Update

What is it?

The U.S. Food and Drug Administration (FDA) announced they have begun restructuring of its Human Foods Program and Office of Regulatory Affairs (ORA). Certain functions of the Office of Regulatory Affairs (ORA) and all functions of the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) will come together under the umbrella authority of its Human Foods Program. In addition, the FDA is announcing that this restructure will include moving cosmetics regulation and color certification functions out of the Center for Food Safety and Applied Nutrition  (CFSAN) and into the Office of the Chief Scientist. The FDA notes that the “proposed move will better align the expertise” of cosmetics experts and the agency’s Chief Scientist to work together as a body focused on “research, science, and innovation.” Additionally, this shift will better leverage the FDA’s expertise as it works to implement the Modernization of Cosmetic Regulation Act of 2022 (MoCRA).

What’s the impact?

The goal of this restructure is to “enhance coordination, prevention and response activities” within these departments. The vision for the restructuring is in part to improve the agency’s overall efficiency and effectiveness and in part to assign clear roles and responsibilities to the respective authorities.

This new model of restructuring aims to “enable ORA and program personnel to function as a multidisciplinary team” empowering them to make efficient, knowledgeable decisions. Its core activities of focus will include:

  • Setting the global standard in inspections
  • Investigations
  • Laboratory analysis
  • Import operations

When is it happening?

On February 28th, 2023, the FDA announced a proposal for the restructuring. The FDA is hoping to finalize this proposal in Fall of 2023. 

What are the next steps?

To finalize the proposal, a reorganization package will be created, comprising a new structure, a budget, and a staff mapping from the current to the new organization. Before sending it to Congress for a 30-day notification period, the package will be reviewed. During this time, Congress members may voice concerns that the FDA will need to address. After the notification period ends, the FDA will publish a Federal Register Notice and negotiate with affected staff unions before implementing the new proposal. Additional updates will be provided as work on this proposal continues to unfold.

For more information about the FDA’s restructuring of its Office of Regulatory Affairs, click to read the FDA’s full release.

In the past few years, the cosmetics industry has made efforts to address the global concerns of sustainability and corporate responsibility. In the spirit of corporate sustainability, the United Kingdom and European Union recently issued rulings to regulate deforestation practices used in cosmetics manufacturing and ingredient sourcing.

Here’s what you need to know about the recent rulings from the UK and EU:

United Kingdom

The United Kingdom took a major historical step towards the effort of preserving the environment when passing the Environment Act 2021 on November 9, 2021.  This new law includes significant provisions on the import and use of “Forest Risk Commodities” otherwise referred to as “FRC’s”.  FRCs and products derived from FRC’s that are imported and/or used in commercial manufacturing and distribution in the UK will most likely include palm oil, soya, cocoa, rubber, beef, and leather.  Although these commodities are considered priorities at the moment, the list is almost certain to be extended in the future.

Timing for when the obligations of the FRC Law will actually apply to industry will be set out in secondary legislation.  UK legislators will be introducing secondary legislation incrementally based on priority.  It should be noted that NGOs are applying pressure to ensure supply chains to be considered deforestation free with a phase target of 2023 to 2025.

Click to read more on the UK Environment Act 2021.

European Union

The Council of the European Union and the European Parliament completed negotiations on the latest version of the EU Deforestation-Free Supply Chain Regulation on December 6, 2022.  When the new rules enter into force, all relevant companies will have to conduct strict due diligence if they place on the EU market, or export from it: palm oil, cattle, soy, coffee, cocoa, timber and rubber as well as derived products (such as beef, furniture, or chocolate).

In an official press release from the European Commision, it was concluded that:

“Operators and traders will have to prove that the products are both deforestation-free (produced on land that was not subject to deforestation after 31 December 2020) and legal (compliant with all relevant applicable laws in force in the country of production).”

Business operators will be required to provide extensive information about the product’s origins, including the precise location(s) and general time of production. Products sourced from standard- or high-risk origins must comply with additional risk assessment and mitigation procedures.

Formal adoption of the new law is expected sometime in the spring of 2023.  Once the Regulation is in force, operators and traders will have 18 months to implement the new rules.

Click to read the Commission’s final regulation on commodities and products associated with deforestation and forest degradation.

The FDA has issued a new ruling on CBD products in the ongoing pursuit to strike a balance between consumer demand and regulatory mechanisms that ensure public health and safety. Citing new findings from the public and a working group review of studies, the FDA has ruled that CBD products cannot be marketed as food additives or dietary supplements. 

Prior to this ruling, the FDA did not allow CBD or hemp derivatives to be used in food or dietary supplements. Therefore, this new ruling from the FDA reinforces the body’s original stance on the matter.

To achieve the ruling’s objectives, the FDA will work with Congress to establish new regulatory pathways, mitigating any associated risks or adverse events linked to CBD. One such regulatory pathway includes implementing a series of risk assessment and management tools. 

Some of the measures suggested, such as the printing of clear labels, are similar to the compliance processes cosmetics manufacturers take to meet new and emerging regulations. There is also the possibility of setting a minimum purchasing age of CBD products, which would implicate retailers and distributors as enforcers of the FDA’s ruling.

CBD in Cosmetics: Hype or Future of the Industry?

As of now, the FDA has yet to pass any legislation limiting the usage of CBD in cosmetics products. But with the landmark passing of MoCRA (the Modernization of Cosmetics Regulation Act) in December 2022, the FDA could be prompted to issue a new ruling on CBD in cosmetics.

In the past, the FDA has expressed concern with the fragmented nature of the growing CBD industry. Many of these concerns were expressed in warning letters sent to companies selling CBD products branded as alternative treatments to medical ailments. Because CBD products are largely sold in the digital marketplace with hundreds of small manufacturers selling their products online, the FDA has recognized a need to establish safety systems that consider the entire supply chain. 

The FDA has also led research efforts to learn more about how CBD affects aspects of human health. It is probably safe to assume that the FDA’s new ruling will continue to expand on these initiatives and incorporate them into new regulatory pathways.

In December 2022, the Consolidated Appropriations Act was signed into law, introducing the Modernization of Cosmetics Regulation Act (MoCRA). This is the first significant amendment to the Federal Food, Drug, and Cosmetic Act since 1938. MoCRA grants the FDA more authority to regulate the cosmetics market, moving the US model of self-regulation to align with international industry standards of cosmetic regulatory oversight.

On Tuesday, February 21, Ithos Global hosted a regulatory webinar dedicated to educating cosmetic industry professionals on how to achieve compliance according to MoCRA standards. Titled ‘MoCRA Explained: Bringing US Cosmetic Regulation into the Modern Era’, Bridget Salter, VP of Global Regulatory Affairs and Adrienne Gabriel, Senior Regulatory Specialist walked attendees through the changes expected to take place within the next few years and next steps on how to prepare.

Watch the Webinar: MoCRA Explained

We summarized the law’s major updates for you below. For more in-depth information and clear, easy-to-follow steps on how to prepare, we recommend watching ‘MoCRA Explained’ in full.

Adverse Event Recordkeeping and Serious Adverse Event Reporting

Cosmetics companies will be required to maintain records of all adverse events related to their products, and report serious adverse events to the FDA within 15 days. This update is designed to improve consumer safety and enable the FDA to take action against potentially harmful products.

Mandatory Facility Registration

Companies that manufacture, process, pack, or hold cosmetics will be required to register with the FDA. This will enable the FDA to monitor facilities and improve their ability to respond to safety concerns.

Mandatory Product Registration

Companies will be required to register their cosmetic products with the FDA, providing detailed information about their ingredients and labeling. This will allow the FDA to identify potentially hazardous products and take appropriate action.

GMP Adherence

Good Manufacturing Practices (GMP) adherence requires cosmetics companies to follow specific manufacturing processes and procedures to ensure the safety, quality, and consistency of their products. The FDA will propose regulations for GMP adherence by December 29, 2024.

Fragrance Allergen Labeling

The FDA estimates that by the end of 2024, cosmetics companies will be required to label fragrance allergens on their products. This will help consumers with allergies or sensitivities avoid potentially harmful products.

Safety Substantiation

Cosmetics companies will be required to have evidence supporting the safety of their products. This update will ensure that cosmetics are safe for use and reduce the risk of harm to consumers. The FDA estimates that this requirement will be effective by the end of 2023.

Fragrance Ingredient Disclosure

The FDA will assess the safety of PFAs (per- and polyfluoroalkyl substances) and test methods for Talc, in order to improve consumer safety.

These updates will have a significant impact on the cosmetics industry, as companies will need to prepare for these changes and potentially update current practices to achieve compliance. The FDA will have increased authority to regulate the market, and failure to comply could result in significant financial penalties and damage to a company’s reputation.

Ithos Global can provide the necessary resources and support to help companies achieve compliance and stay ahead of the game. Our team of regulatory experts can assist with product registration, label and formula review, and GMP compliance. We can also provide access to our proprietary database of global regulations, allowing companies to stay up-to-date with the latest regulatory requirements and changes. View our guide to learn more about how you can start preparing for these upcoming changes.

Attention packaging manufacturers! The Washington State Plastic Producer Registration for 2023 is now open and must be completed on or before April 1st, 2023.

As a reminder, producers of plastic personal care packaging sold in Washington must register with Washington’s Department of Ecology. 

The Producer is the person or entity who has the final authority on decisions about the container in which a covered product is offered as a finished retail product.  

The Brand Owner is assumed to be the producer of the product unless evidence showing otherwise is provided. 

de Minimis Producer is a producer whose plastic product generates less than $1 million each year in revenue in Washington or generates less than one ton of containers in Washington,

To register, the producer must first sign up for a SecureAccess Washington (SAW) account, add the Waste Reduction Portal to their account, and submit the plastic producer registration by providing the following information:

  • Employer Identification Number (EIN)
  • Producer Contact Information
    • Billing Contact (Required)
    • Responsible Official (Optional)
  • Brand names the plastic product is sold under 
  • Revenue of the plastic packaging from the previous year sold in Washington
    • Exact amount is not needed but rather whether the revenue of plastic product generated was above or below $1 million
  • Total resin amount from the previous year sold in Washington
    • This includes virgin, post-consumer and post industrial plastic
    • If the amount for Washington is unknown, producers can input their total resin amount for the US and the system will convert this number for Washington based on Washington’s population

De minimis producers are not required to register but encouraged to show compliance with the upcoming PCR requirements. 

In addition to the registration, all producers must pay an annual fee which is determined using the following calculation: Program Administration Fee = Ecology Workload Cost x [(Individual Producer Resin pounds)/ (Washington Resin Total pounds)]. The resin pounds represent the total non-de minimis plastic resin weight submitted during registration for all plastic product categories.

The detailed registration steps and link to the SAW portal can be found on the Washington’s Department of Ecology website.

Ithos Information Network Flagging More “No-No” Ingredients

We share a cautionary tale about unapproved color additives and how they can prevent your product from being sold at retailers and online marketplaces. Brands are increasingly turning to the Ithos Information Network to navigate new ingredient rules and gather documentation regarding colorants in eye shadow, lip products, hair color, bronzers, lotions and more.

In the United States, color additives are a main focus of regulation, subject to a strict approval process under the Federal Food, Drug and Cosmetic Act. However, more brands are facing new scrutiny from retailers and websites who are adopting their own, stricter safe ingredient standards to meet customer demand. They have names like “no-no,” “never,” “made without,” “clean” or “dirty” ingredient lists.

We recently helped a brand that made an agreement to sell on a major cosmetics website, only to learn a few ingredients across its entire product portfolio were not permitted. While some products could be sold, they could not offer their entire colorant product line.

Working with the Ithos Information Network, they were able to gather additional documentation to show the actual regulatory status of a particular additive to be sold.  In another case, the IIN identified alternative ingredients that would make the product permissible to sell. When a formula is run through the Ithos Information Network, it immediately flags any ingredient that is not permitted for that product, not only in the United States but across jurisdictions around the world.

It is important to know that in the US, the Food and Drug Administration (FDA)requires every batch of colorant be approved before you can add it to your product. In some cases, colorants are permitted for certain products, but not others. And in other scenarios, the FDA requires additional certification to permit a colorant to be used.

While it is up to your manufacturer to follow these rules, if you are using a third-party vendor, it is a good idea to verify how they are managing the process. From hair dye to eye shadow palettes, know the colorants being used and the related regulations – before spending time and money on packaging and marketing.

 Ithos Information Network Launches New Artwork Review Workflow

 Whether using the Ithos Information Network’s Formul8 feature for actual formulation, or screening  ingredient lists for verification, the IIN ensures you can access the right documentation for that jurisdiction or purpose. It also provides peace of mind that your brand won’t find itself on the latest “no-no” list.

 Schedule a demo to see how the Ithos Information Network can flag ingredients and create more compliant products from the start.

Three Key Changes Impact English and French Trademarks

By Adrienne Gabriel, Ithos Regulatory Team

Whether you’re currently selling in Québec, Canada or planning to expand there, new French translation requirements for products sold there now far exceed rules for the rest of the country, especially regarding trademarks. 

Last Spring, Bill 96 or the “Act respecting French, the official and common language of Québec” made several important  changes, including: 

  • All label copy must appear in both French and English, with the French being of equal or greater prominence, regardless of trademark.  

  • Trademarks must be registered. Pending registrations are no longer permitted. For an English trademark to appear on product labeling, the registration process must be complete. 

  • An English trademark cannot have a corresponding French version registered in Canada, otherwise both must appear on product labeling.

  • If an English registered trademark contains generic or descriptive words, they must also appear in French on product labeling.

  • The new rules affect products being sold in Québec beginning June 1st, 2025.

Health Canada Submits Self-Care Framework Draft Regulations

Ithos is recommending that brands review both current and future product portfolios, applying for necessary trademarks as soon as possible. In the past, delays with the Canadian Intellectual Property Office had taken up to three years for trademark approval.

Brands should also know the new bill not only impacts product labeling, but it affects other areas such as employment documents, contracts, and public signage. Given the bill’s complexity and new translation requirements, Ithos continues to monitor industry opposition and will alert customers of any reversals or changes in policy.  

If you need help with your current product labeling or have questions about the impact of the new rule on your business, contact Ithos today.

EU Lowers Threshold for Labeling Formaldehyde Releasers in Cosmetics

The EU is lowering the threshold for labeling when formaldehyde releasers are present  in cosmetics. The October 6, 2022 amendment of the European Cosmetics Regulation 1223/2009 drops the previous level of 0.05% (500 ppm) to 0.001% (10 ppm). This applies to the total formaldehyde released, regardless of whether a product contains one or more formaldehyde releasers.

While formaldehyde is rarely used in today’s cosmetic formulas, preservatives that release the chemical as an impurity in the presence of water are still common in many cosmetic products such as shampoos and creams, as well as topical medications and household cleaners.

All finished products containing substances which are listed in the Annex and which release formaldehyde must now be labeled with the warning “releases formaldehyde,” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm).

Updated to reflect this change, the Ithos Information Network allows brands to quickly evaluate ingredient lists across their portfolio to determine which products are impacted by the new EU policy.

Whether leave-on or rinse-off, any product with releasers must include the specific label “contains formaldehyde.” According to the amendment, products not meeting the new limits may not be placed on the market after July 31, 2024. Further, non-compliant products must not be available for sale after July 31, 2026.

Common ingredients that may be affected by the change include:

In addition, Quaternium-15 is a formaldehyde releaser, now prohibited.

FDA Publishes Information on Formaldehyde Risks in Hair Smoothing Products

Concerned about how this change will affect your products? Contact us for a demo that shows how the Ithos Information Network can keep you up to date on changing regulations.  

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