Cosmetics testingCosmetics testingCosmetics testing

Applicable legislation

The legal authority that regulates cosmetics in the USA is the US Food and Drug Administration (FDA). To sell cosmetics in the USA, you must consider federal cosmetics regulations, which apply to all US States. Two main federal legal frameworks applicable to cosmetic products in the USA are:

Federal Food, Drug and Cosmetic Act (FD&C Act)

Fair Packaging and Labelling Act (FPLA).

Additionally, it is important to be aware that there are also many state provisions, which also have to be taken into account, such as California Proposition 65 (Prop 65).

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 is the biggest amendment of the Food, Drug and Cosmetics Act since 1938. This new legislation will affect all cosmetic companies that manufacture and distribute cosmetics in the USA.

The key changes introduced by MoCRA:

Mandatory FDA registration for cosmetic facilities, both domestic and international.

Mandatory product listings for cosmetics sold in the USA.

Compliance with Good Manufacturing Practices (GMPs; will be issued by the FDA).

Declaration of fragrance allergens on labels

Labelling requirements for professional-use products.

Labelling of RP contact information

Record-keeping, including safety substantiation and adverse events documentation.

Reporting of adverse events to the FDA.

Mandatory recall authority for the FDA.

New regulations on talc, asbestos, and PFAS (will be published by the FDA).

Phasing out animal testing.

What type of products are cosmetics?

Cosmetics products are defined by the FD&C Act as: “Articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap” (FD&C Act, sec. 201[i]).

Additionally, MoCRA defines the term cosmetic product as: "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product." (MoCRA, sec. 604 (2))

It is important to note, however, that products intended for therapeutic use (products used to treat or prevent diseases or those that affect the structure or function of the body) are classified as drugs or medical devices, even if they also affect appearance. Certain personal care products are also regulated as food supplements, consumer products or over-the-counter (OTC) drugs.

Claims made regarding a certain product can often determine how the product is going to be classified.

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Responsible person and product listing

MoCRA sets out the requirement for a Responsible Person (RP), which has to be designated for each cosmetic product placed on the US market. The RP is defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label.

Cosmetic products placed on the market in the USA have to be listed to the FDA. This has to be done by the responsible person via electronic submission portal Cosmetics Direct. Existing products have to be listed by December 29, 2023. New products must be listed within 120 days of marketing such products in interstate commerce. Product listings have to be updated annually.

Facility registration and US agent

Cosmetic facilities that are involved in the manufacturing or processing of cosmetic products distributed in the US have to be registered to the FDA. This has to be done via electronic submission portal Cosmetics Direct. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

Foreign facilities require a US agent, who will handle the facility registration and provide a contact point for the FDA in case of any enquiries. Existing facilities have to be registered by December 29, 2023. New facilities have to register within 60 days of first manufacturing or processing. Registrations have to be renewed every two years.

Safety substantiation

Cosmetic companies are responsible for selling safe and properly labelled products. Products must be safe when consumers use them according to directions on the labelling, or in the customary or expected way. It is the responsibility of the RP to ensure and maintain records of safety substantiation of their cosmetic products.

Under MoCRA, products require an adequate substantiated of safety, which is further defined as “tests, studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a product is safe.” (MoCRA, Sec. 608(c)(1)). However, the legislation does not provide a specific set of tests or documents to demonstrate the safety of individual products or ingredients. It is up to the cosmetic's manufacturers to determine how they will prove the safety of their products.

Cosmetic products must also comply with the ingredient restrictions, prohibitions, and colour additive requirements.Colour additives, except for coal tar hair dyes, require FDA approval before they can be used in cosmetics. Failure to meet US colour additive requirements can result in a cosmetic to be adulterated. Colour additives may be used only for the intended uses for which they were approved for.

Under MoCRA, the FDA has to publish a proposed rule for testing methods for detecting and identifying asbestos in talc-containing products by December 29, 2023, and the final rule no later than 180 days after the close of the public comment period. Furthermore, they have to publish a report on the use and safety of PFAS in cosmetics by December 29, 2025.


Under MoCRA, all cosmetic products placed on the US market must comply with Good Manufacturing Practices (GMP), which must be published by the FDA by December 29, 2025.


Labelling, including cosmetic product claims, is a very important part of ensuring compliance with the relevant legislation. Products that are improperly labelled, deceptively packaged or otherwise misbranded are prohibited and can be removed from the market.

MoCRA sets out some new labelling requirements, which include:

US address, US phone number or electronic contact information, which is required as a means to contact the Responsible Person in case of any adverse events.

Fragrance allergens, if present in the cosmetic product (the FDA has to propose a rule on allergen labelling by June 2024 and finalize the rule no later than 180 days after the close of the public comment period)

Additionally, it requires professional-use products to comply with the general labelling requirements for cosmetic products and to include a statement indicating that the product should be used only by professionals.

FDA authority over cosmetics

MOCRA expands the FDA authority over cosmetics. In case of adulterated or misbranded products, or risk of serious adverse health consequences, the FDA can:

Inspect the product safety dossier;

Inspect facilities to check compliance with GMP;

Request cosmetic companies to provide ingredients details of the formulation, fragrances, or flavors;

Require cosmetic companies to recall the product voluntarily. If the manufacturer does not comply, the FDA can impose a mandatory withdrawal;

Suspend the facility registration.

It is the responsibility of the RP to record and report adverse events, maintain product safety dossier and communicate with the FDA in case of inspections or any enquiries about the products.

For more information about new requirements under MoCRA, please check our FAQ.






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Services offered

US agent service

US RP support service

Product classification & formula compliance review

Labelling review

Product listings & facility registrations

Safety evaluation of products

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


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


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


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


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


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

James, USA


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


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

Mike, USA


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



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