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Prepare for new US cosmetics regulation - MoCRA

On 29 December 2022, the US President signed into law the Consolidated Appropriations Act 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a long-awaited reform of the US cosmetics regulation.

MoCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This new Act requires FDA to establish new regulations for cosmetic products in the USA. It will affect all cosmetic companies that manufacture and distribute cosmetics in the USA. Some new requirements will already come into force at the end of this year.

Below is a summary of the most important changes under MoCRA:

Mandatory FDA registration for cosmetic facilities

Mandatory product listings for cosmetics sold in the USA

Mandatory compliance with Good Manufacturing Practices (GMPs=, which will be issued by the FDA)

Mandatory reporting of serious adverse events to the FDA

Mandatory declaration of fragrance allergens on the labels

New mandatory recall authority for the FDA

Mandatory safety substantiation and record keeping

New regulations on talc, asbestos and PFAS, which will be issued by the FDA

Animal testing will be phased out

New labelling requirements for professional use products

The FDA has not yet established the regulations required under MoCRA but CE.way is following new updates and will inform our clients when FDA issues the additional guidelines.

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Responsible person (RP) is defined as "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act."

The RP will be responsible for:

  • Product listing

  • Adverse advents reporting

  • Safety substantiation

  • Disclosure of fragrance allergens

  • Fragrance records access

  • Labelling

  • Record-keeping

Responsible person can also be a third-party US company.

The term "facility" includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. Based on that, certain establishments are excluded from this term, such as beauty shops/salons, retailers, pharmacies, hospitals, hotels, etc. It does not affect facilities that label or re-label products only, package or repackage only or hold or distribute only.

The mandatory registration affects all existing facilities, domestic and foreign. Foreign facilities require a U.S. agent (US based contact has to be provided). It has to be a physical address and not a P.O. box.

The following information will have to be included:

  • Facility name and address

  • USA agent (for foreign entities)

  • Facility registration number

  • All brand names produced at the facility

  • Product category

  • Responsible person for each product produced at the facility

MoCRA exempts certain small businesses from GMP, facility registration and product listing. Small businesses are defined as businesses with average gross annual sales in the USA for previous 3-year period of less than $1,000,000 (adjusted for inflation). However, this exemption does not apply for facilities of products that:

  • Come into contact with mucus membrane of the eyes

  • Are injected (e.g. tattoos)

  • Are intended for internal use (e.g. mouthwash)

  • Alter appearance for more than 24 hours under the usual conditions of use

Exemptions also apply to certain facilities that are subject to requirements for devices and drugs.

Mandatory facility registration is required by 29 December 2023. Registrations have to be renewed every two years.

Following the deadline, new businesses will have 60 days after beginning manufacturing to register with the FDA.

All products introduced into the US Market by US or foreign brand.

Product listing have to be done by legal US entity. Foreign entities have to use a USA Agent to do the listing. Product listing will be done using FDA online program, which has not been released yet.

The following information will have to be included:

  • facility registration number

  • name and contact number of the responsible person

  • name of the product

  • cosmetic category of the product

  • list of ingredients (including allergens and colors)

  • product listing number (if previously assigned)

Each product will be assigned a listing number.

Mandatory product listings have to be done by 29 December 2023. These listings have to be updated every year.

New products must be registered within 120 days of introduction into interstate commerce.

Yes. MoCRA allows flexible listings, which means that multiple cosmetic products with identical formulations, or formulations that differ only in color, fragrance or flavor, or quantity of contents, may be grouped under the same listing.

FDA has stopped accepting submissions for the VCRP as they are preparing to launch a new program, which will be used for facility registration and product listings mandated by MoCRA. Furthermore, they confirmed that VCRP registrations will not be transferred to the new program.

Product labels must include:

  • US address

  • US phone number or electronic contact information, which is required as a way to contact the RP in case of any adverse events

  • Fragrance allergens, if they are present in the cosmetic product (FDA will determine which substances are considered allergens)

Label for professional use products must comply with the labelling requirements for cosmetic products and they have to include a statement that the product should be used only by professionals.

Labelling for professional use products has to be updated by the end of this year.

The responsible contact information and fragrance allergens have to be listed on product labels by the end of next year.

We are monitoring the updates surrounding MoCRA and will be providing our clients with all the information so they can prepare for the upcoming deadlines. We will be able to inform you about our scope of services related to MoCRA when everything related to MoCRA is clarified by the FDA.

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To be determined when everything related to MoCRA is clarified by the FDA. Would you like to be notified as soon as additional information becomes available? Contact us!

And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland

Alpure

We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA

IBP

We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece

Funkitup

It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA

Nuvision

CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA

Eufora

This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA

SBBM

CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA

Inverness

Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA

NCLA

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