Regulatory matters important to indie beauty and wellness brands, brought to you by the Independent Beauty Association (IBA).
Regulatory and legislative activity can result in significant business impact within the cosmetic and personal care product industry. Compliance is not just a hurdle to be dealt with and forgotten. Non-compliance can be costly: consumer safety can be compromised and enforcement activity from regulators can directly impact the bottom line. The following is a roundup of some regulatory topics that could directly impact your business.
Whether or not all of these apply to you, that’s for you to determine (or we can help). However, we present them all because non-compliance can result in lost time and money. We put this information out as soon as we can so you have enough time to comply.
Federal Legislation
While nothing is certain in the early weeks of 2021 with respect to government, legislative activity, or seemingly anything happening in Washington, DC, many signs are pointing to new federal cosmetics regulations coming within the next year.
Are you ready? For those new to the industry or the industry’s legislative and regulatory side, the prospect of imminent new regulations may seem shockingly sudden. Still, the history of a new federal cosmetics bill has a long and complex timeline.
It appears that it will soon be time for the independent beauty industry to engage and make sure this important industry sector’s voices are heard and understood. IBA fully supports modernizing the existing federal cosmetic regulations to maintain the industry’s outstanding consumer safety records, reflecting the industry’s current innovation sophistication while allowing for the continuation of entrepreneurial success.
Brexit – UK Compliance in 2021 – Cosmetic Notification
The UK officially left the European Union on January 31, 2020. Since that date, an almost year-long transition period was in place to help allow time for implementation. However, the Brexit process was anything but smooth, and the overlap of the transition period with the global pandemic did not make things easier. While many companies wanted to get a head start on their cosmetic notifications during the transition period, the portal did not go live until January 1, 2021.
What products need to be notified? Cosmetic products sold to consumers in England, Scotland, and Wales must be notified via the Submit Cosmetic Product Notification Service. There is a separate process for Northern Ireland.
Who needs to submit the notifications? To sell cosmetic products in the UK in 2021, you must have a Responsible Person based in the UK, and the address of the UK RP must appear on the product labels by December 31, 2022. The UK RP should submit the notifications. The RP can be the manufacturer, importer, distributor (if the product is labeled as their own), or an authorized and appointed company or person.
Do existing products need to be notified? If your product is already sold in the UK and has already been notified to the EU Cosmetic Product Notification Portal before January 1, 2021, the UK is allowing until March 31, 2021, to submit your UK notifications.
What about new products? Any new cosmetic product you introduce to the UK market will need to be notified before the product is placed on the market.
ACTION: Confirm your company has both an EU and UK Responsible Person, if your products are sold in both markets. Confirm your products’ notification status with your EU and UK RPs (there should be no change to your EU notifications unless your RP was located in the UK prior to 2021; in that case, your products must be re-notified to the EU with an EU-based RP). Ensure label and packaging updates will meet the December 31, 2022, deadline.
Hand Sanitizer Should Not Look or Smell Edible
Hand sanitizers are playing an essential role for consumers and healthcare professionals during the COVID-19 pandemic. To benefit personal and public health, hand sanitizers must be widely available, safe, and effective.
FDA just released a Guidance document to help alert consumers and industry to the numerous instances of methanol contamination and what to do to help ensure that only safe product is placed on the market: Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19).
Methanol contamination from adulterated products can create significant risk, and there have been several hand sanitizer recalls in the US due to potentially lethal methanol contamination. This issue highlights the requirement that hand sanitizers must be produced according to drug GMPs, properly labeled, listed with the FDA, and appropriate caution taken concerning methanol contamination.
IBA requests that all points in the supply chain—suppliers, brands, manufacturers, and retailers—work together to support the FDA in ensuring product safety and preventing dangerous products from reaching consumers.
If manufactured or packaged improperly, non-compliant products can cause significant harm and be potentially lethal if accidentally ingested, particularly by children.
The industry cannot lose sight of the dangers that a scent and packaging could pose, even if the product is not intended to be used by children. A product that smells like cotton candy and has a picture of cotton candy on the label could undoubtedly be attractive to some small children.
In fact, fragrance may not be used for hand sanitizers produced under the Temporary Guidance issued by the FDA (except approved denaturants). Fragrance may only be included in products fully compliant with the OTC antibacterial monograph.
The use of flavors is inappropriate for hand sanitizers.
Also, warnings on labels and websites will not mitigate the risk for babies and small children who have not yet learned to read. Childproof packaging should be considered.
If any of the below conditions are not met, the product will be considered misbranded, adulterated, and/or an illegal, unapproved new drug. The sale of an illegal drug product is not just a regulatory concern resulting in FDA enforcement action, warning letters, and the threat of seizure, but can cascade to insurance issues and significant business and PR problems. Most importantly, non-compliant products can be harmful to the consumer.
ACTION: Take particular care during the product development process to make sure scents and packaging do not make hand sanitizers appealing for children or encourage ingestion.
Another Retailer Requirement List
In addition to federal and state regulatory requirements, cosmetics and personal care product companies must also be aware of the constantly changing landscape of retailer requirements in order to successfully get products to market. FabFitFun has recently joined the ranks of retailers with customized requirements for products available through their organization.
ACTION: Alert your product development team and formulators as early as possible when considering new retailers/distribution channels to account for specific retailer formulation requirements. The FabFitFun Standard can be found here, which lists ingredients that products must exclude as soon as Spring 2021.
Prop 65 – Activity to Watch
The California Office of Environmental Health Hazard Assessment (OEHHA) is proposing rulemaking that would limit the use of short-form versions of the safe-harbor warning. OEHHA believes there has been “widespread use of short-form warnings in ways that were not intended and do not further the purposes of Proposition 65.” Why does this matter? Many cosmetic and personal care products do not require Prop 65 warnings, but with the listing of THC (with no safe-harbor limit, not even for CBD cosmetics), this could be an important development.
ACTION: Consult with subject-matter experts and your legal counsel to review California Prop 65 compliance specific to your company’s product assortment, especially if you are or are thinking about selling CBD cosmetics.
Sunscreen Ban Reminders
Hawaii: Stakeholders in the sunscreen category should be reminded that Hawaii passed a bill on July 6, 2018, banning the sale and distribution of sunscreens containing octinoxate and oxybenzone. The ban went into effect on January 1, 2021.
ACTION: Brands with sunscreen products using these ingredients should confirm that they are set up to accommodate this state law.
Effective Date and Limits:
January 1, 2021 – Prohibited without a Prescription
Key West, Florida: The Key West City Commission voted to ban the sale of sunscreens containing octinoxate and oxybenzone within the city, intending that the ban would be going into effect in January 2021. However, legislative activity at the state level disrupted those plans. The Florida governor signed a bill preventing local governments from regulating over-the-counter drugs, which of course includes sunscreens.
ACTION: None. The Key West ban has been blocked, and the effective date no longer applies.
EU: Future Ingredient Bans and Restrictions
The European Commission has notified the World Trade Organization of its intention to restrict dihydroxyacetone and ban deoxyarbutin. These EU Regulation changes are not final but are likely to pass in the first half of 2021.
Dihydroxyacetone is found in self-tanning products and hair dye products.
Proposed EU limits:
We should expect a transition period to allow companies to bring their products into compliance, but the amount of time that will be allotted for products to comply has not yet been determined.
Deoxyarbutin is a skin-bleaching agent that results in the release of hydroquinone. The EC is recommending a ban on this substance in cosmetic products. There will likely be no transition period to phase out impacted products.
ACTION: Review your EU product formulas to identify any products currently including these ingredients to plan for reformulation or phaseout.
Don’t Get Behind on Reformulation Projects for Upcoming 1,4-Dioxane Limits in NY
At the end of 2019, New York passed a bill setting strict limits on trace contaminant content of 1,4-Dioxane in cosmetic and personal care products. 1,4-Dioxane is a contaminant found in ethoxylated surfactants, meaning shampoos, cleansers, and body washes are likely product categories possibly impacted by this regulation.
According to the FDA, impacted ingredients include certain detergents, foaming agents, emulsifiers, and solvents identifiable by the prefix, word, or syllables “PEG,” “Polyethylene,” “Polyethylene glycol,” “”Polyexyethylene,” “-eth-,” or “-oxynol-.”
When does this go into effect? Effective dates and limits:
ACTION: There is still time to prepare for the first effective date, but brands cannot delay reformulation efforts.
New Labeling Requirement for Brazil
A new resolution (Resolution 432/2020) will require INCI and Portuguese ingredient lists on labeling cosmetics, personal care products, and fragrances as of November 5, 2021, in Brazil. Products manufactured before this date will be exempt from this new requirement.
ACTION: Review product labels for Brazil and begin implementing updates to comply with the new requirement by the effective date.
