The 40 key differences between US and EU cosmetics regulation and how MoCRA impacts this
Find out important and trending key differences between the US and EU regions when it comes to entering these markets for cosmetic product manufacturers.
By Alex van der Burgh
24 November 2023
The regulatory landscapes for cosmetic products in the EU and the USA are distinct in several ways. For manufacturers serving both markets, it can be tough navigating these regions.
That’s why we’ve put together the most important and trending key differences between the two when it comes to entering their markets for cosmetic product manufacturers.
USA legislation is currently at a turning point with MoCRA going into effect, so we’ll also highlight the impact of MoCRA on these key differences.
What is MoCRA and what’s the impact of it on the cosmetics regulation?
MoCRA stands for Modernization of Cosmetics Regulation Act. MoCRA is set to take full effect on December 29, 2023. This legislation is created for cosmetics manufacturers to ensure the safety of their products.
MoCRA grants the US Food and Drug Administration (FDA) greater control over standards and regulations of the cosmetics industry. Check out below what the differences are between the EU, USA, and USA MoCRA regulations.
The most important differences between US and EU cosmetics regulation
The European Union (EU) and the United States (USA) display key differences in their approaches to cosmetics regulation, stemming from variations in their legislative frameworks, historical perspectives, and regulatory philosophies. Looking into entering the EU or the USA as a cosmetics manufacturer? Here’s a full overview of the key (40!) differences within regulation. We’ll provide an explanation of the regulations applicable in each of these regions below.
1. Regulatory framework
Countries or locations around the world often have their own set of rules and laws that control cosmetics in particular.
USA: The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) are the primary laws, but there’s no overarching federal regulation specifically for cosmetics. The FDA oversees cosmetics, but pre-market approval is not mandatory. As a counterpart to the SCCS, the USA has the Cosmetic Ingredient Review (CIR), an expert panel originally established by the industry trade association (PCPC, formerly CTPA)
USA-MoCRA: MoCRA replaces the old legislation.
2. Responsible person
Every cosmetic product requires a ‘Reponsible Person’, this is the entity that is legally accountable for ensuring that a cosmetic product complies with the relevant legislation in the market where it is sold.
EU: Manufacturers outside the EU must appoint a Responsible Person within the EU to ensure compliance with regulations.
USA: There’s no equivalent “Responsible Person” requirement.
USA-MoCRA: There is now a requirement for a designated Responsible Person under MoCRA. This is defined as “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product”. Under MoCRA, the Responsible Person’s contact information includes a domestic address, a domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports relating to such cosmetic products.
3. Product registrations
Products may need to be notified or registered into a digital system for objectives such as cosmetovigilance. This also involves providing authorities and toxicology centers with information about product composition.
EU: Before launching a product, manufacturers must notify the European Commission through the Cosmetic Products Notification Portal (CPNP).
USA: There’s no mandatory federal-level product registration, but voluntary registration is available through the FDA’s Voluntary Cosmetic Registration Program (VCRP).
USA-MoCRA: The VCRP is terminated and replaced by a digital product listing platform comparable to the EU CPNP.
4. Ingredient restrictions
Some ingredients are more dangerous than others. As such, they must be limited with conditions like limiting their maximum use or only allowing their use in specified product categories, age groups, or rinse-off products. Other substances are simply too dangerous to be limited and are outright prohibited from usage.
USA: The FDA has prohibited or restricted fewer ingredients compared to the EU. Manufacturers are responsible for ensuring product safety, with no specific guidelines on how to do so.
5. Animal testing
In the past, a lot of cosmetic products have been tested on animals to demonstrate their safety before they could be used by consumers. Nowadays, more and more countries are banning the testing of cosmetic products and their ingredients on animals.
EU: The sale of cosmetics tested on animals has been banned for roughly two decades already.
USA: There’s no federal ban on animal testing, though some states have restrictions or bans in place.
6. Product claims
Products may carry specific marketing and efficacy claims such as ‘anti-aging’ or ‘wrinkle-reducing’. These claims may be subject to specific rules and laws, to prevent outrageous claims or unsubstantiated claims.
EU: Cosmetic claims must adhere to the EU’s “Common Criteria” which ensures claims are clear, truthful, and based on evidence.
USA: Claims must not be misleading, and the FDA can intervene if a product’s claims make it a drug under the FD&C Act.
Ingredients in the nano-spectrum with a certain size or length, also known as nanomaterials, have very special qualities due to their unique and small size. These qualities also make it more difficult to test for safety, therefore nanoparticles may require extra care before they can be utilized in cosmetics.
EU: Products containing nanomaterials must be explicitly notified to the European Commission.
USA: The FDA provides guidelines on nanomaterials but doesn’t have specific regulations or notification requirements for cosmetics containing them.
8. Safety assessment
Cosmetics, like all other products on the market, must be safe to use. A safety assessmentis used to demonstrate safety. This evaluation is typically written in a report by a specific person.
EU: A Cosmetic Product Safety Report (CPSR) is mandatory before placing a product on the market. The CPSR must be made by a safety assessor, a person who has received years and years of specific education and training.
USA: Safety assessments are the responsibility of the manufacturer, and there’s no mandated format or report submission.
USA-MoCRA: The Responsible Person shall ensure and maintain the safety assessment of a cosmetic product.
9. Product recall
A product recall is typically done when a cosmetic product is found to be unsafe for use due to factors such as contamination, formulation issues, adverse reactions reported by consumers, or any other reason that poses a risk to consumer health.
EU: If a product is found non-compliant, the Responsible Person or distributor might need to undertake corrective actions, which can include a product recall.
USA: The FDA can request a recall but cannot mandate it. It’s up to the manufacturer or distributor to initiate a recall.
USA-MoCRA: FDA now has a mandate to issue a mandatory recall.
Cosmetic items include labeling on their package, which includes all of the words, photos, and pictograms. This labeling informs the end user about the product’s usage directions, ingredients, expiration date, and nominal contents.
EU: Labeling requirements are stringent, including the need to list ingredients in descending order of weight and to display any potential allergens.
USA: Labeling requirements are also strict but differ in specifics. For instance, color additives must be approved by the FDA, and the ingredient list should use the nomenclature from the International Nomenclature of Cosmetic Ingredients (INCI).
USA-MoCRA: Additional labeling requirements include the contact information of the Responsible Person (address, phone number / electronic contact information), the declaration of fragrance allergens (similar to EU regulation), and whether the product is for professional use.
11. Definition of cosmetics
Basically, everybody uses cosmetic products. However, the definition of what a cosmetic product is varies per region.
EU: The definition is broad, covering any ‘substance or mixture’ intended to be ‘applied externally to the human body or hair or external genitals, or inside the oral cavity’ with a cosmetic function (cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors).
USA: The FD&C Act defines cosmetics by their intended use, such as “articles intended to be rubbed, poured, sprinkled, or sprayed on or otherwise applied to the human body.
USA-MoCRA: A cosmetic product is a “preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
Depending on the region, sunscreen products may be classified as cosmetics or as a different product category.
EU: Classified as cosmetics.
USA: Classified as over-the-counter (OTC) drugs.
13. Color additives
Not only is the use of specific colorants regional. Furthermore, the process by which colorants are approved varies.
EU: A positive list of approved colorants exists called Annex IV of EC 1223/2009. These colorants are included in this positive list by the EU Commission through legislative changes.
USA: Color additives must be FDA-approved before use (often recognizable by their name ‘FD&C ….’), some even requiring a per-batch approval
14. GMP (Good Manufacturing Practices)
Cosmetic products need to be manufactured in a repeatable manner and under clean circumstances (you don’t want any dust or microbes in your cream….YUCK!). This is called Good Manufacturing Practices. There are international standards for this like ISO 22716 or pharmaceutical GMP.
EU: Compliance with GMP is mandatory.
USA: GMP guidelines are provided, but adherence is not strictly enforced for cosmetics.
USA-MoCRA: Mandatory GMP compliance. Facilities need to register every 2 years
15. Product claims substantiation
You cannot ‘simply’ claim whatever you want on your product artwork; instead, you must demonstrate that your product works. Thus, if you claim that your product is ‘anti-wrinkle,’ you may need to do some testing to confirm it really is.
EU: Requires robust evidence, often involving clinical trials. It does depend on the type and ‘severity’ of the claim, for instance, sunscreen protection factors (SPF) need a lot of testing while a claim such as ‘feels good’ may only need a questionnaire sent out to a few consumers
USA: While evidence is required, the depth and type of evidence might differ.
16. Fragrance allergens
Consumers may be allergic to certain fragrance allergens. To inform consumers, some regions require extra fragrance allergen labeling on the product packaging.
EU: Specific fragrance allergens must be declared on the label if the concentration of these substances is above 0.01% for leave-on products or 0.001% for rinse-off products.
USA: No specific requirement for individual fragrance allergen declaration.
Parabens are preservatives that have a negative reputation since some of them are not harmful to human health. Others are entirely safe to use under certain conditions, however, these conditions vary by region.
EU: Some parabens are banned, and others have concentration restrictions.
USA: No specific bans, but they must be listed if used.
18. Hair Dyes
Hair dyes are a category of cosmetic products that are subject to regulatory oversight in many countries. The regulation of hair dyes typically involves ensuring the safety of the ingredients used, proper labeling, and adherence to specific requirements to protect consumer health.
EU: Certain hair dye substances require additional safety evidence.
USA: Hair dyes have been a source of controversy, but no specific bans exist.
19. Voluntary standards
As a cosmetic company, you may often seek to go the extra mile by meeting additional standards. Whether your aim is to achieve a higher quality level for marketing objectives or to meet specific standards required by your consumer group.
EU: ISO standards are often referenced.
USA: Industry-led initiatives, like those from the Personal Care Products Council (PCPC), often guide manufacturers.
20. Reporting adverse effects
Cosmetic products should be safe for normal use. If a product, when used as directed, causes an undesirable effect, the company responsible for the product must take action, especially if the effect is serious. The process of monitoring complaints related to cosmetic products is known as cosmetovigilance. In the case of a serious adverse effect, some regions require the responsible company to report it to the authorities.
EU: Mandatory for serious undesirable effects.
USA: Voluntary, but the FDA monitors and can take action.
USA-MoCRA: The introduction of the definition of an adverse event is as follows: ‘Any health-related event associated with the use of a cosmetic product that is adverse.’ A serious adverse event is defined as ‘an adverse event that results in or requires the medical prevention of death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, or significant disfigurement.’ Additionally, MoCRA mandates the reporting of serious adverse events within 15 business days.
21. Organic and natural claims
While cosmetic products must be safe, many brands also emphasize the importance of their products being organic or natural. However, it’s not simply a matter of labeling a product as ‘natural’; you must substantiate this claim. There may be specific rules or guidelines on how to do so.
EU: Several bodies certify organic and natural cosmetics, like ECOCERT, COSMOS, and NATRUE.
USA: No official standard for “natural” in cosmetics; USDA-certified organic claims.
22. Product shelf life
Since cosmetic products don’t last forever, it may be mandatory to mention the shelf-life on the product packaging.
EU: “Best before” date (hourglass symbol) or Period After Opening (PAO) is required.
USA: No specific requirement unless stability testing suggests it.
23. Microbead usage
Microplastics, such as microbeads, are a prominent concern across various product categories, including cosmetics. These tiny particles find their way into sewage and river water, ultimately reaching the oceans, where they pose a threat to marine creatures—and, potentially, to us through consumption.
EU: The Industry already started phasing out microbeads in rinse-off products years ago. Now they’re fully banned in cosmetic products as of 2023
USA: Microbeads are banned from rinse-off cosmetics due to environmental concerns.
24. Product packaging
The regulation of product packaging, particularly the artwork (symbols, images, and words), varies across different regions worldwide.
EU: Emphasis on being as transparent as possible to let the consumer make an informed decision.
USA: Regulations focus more on typography and correct labeling element placement than sustainability.
25. Children’s cosmetics
Cosmetics are used by old and young alike. The way kids’ cosmetics are assessed does differ between regions.
EU: Specific safety considerations apply.
USA: No distinct category, but safety is paramount.
26. Borderline products
Cosmetic products often bear a resemblance to other products and may even share similar functions. Depending on the region, a product can be classified as both a cosmetic and another category, or it must be mutually exclusive, meaning it can only fall under the cosmetic category or another specific category.
EU: Cosmetics are mutually exclusive with other product categories, including medical devices, drugs, and biocides. The categorization is largely determined by the claims, wordings, and positioning of the product
USA: Cosmetics may overlap with drugs (sunscreens) and OTC products.
27. Import procedures
When importing products, some regions require a company to be legally responsible for the compliance and safety of the product.
EU: Requires a Responsible Person within the EU.
USA: Importers must adhere to FDA regulations, but no “Responsible Person” is needed.
USA-MoCRA: Introduction of the Responsible Person, who must ensure that the cosmetic product is compliant and safe. Responsible Person does not have to be present in the USA.
28. Post-market surveillance
The responsibility of a cosmetic brand doesn’t end when the product is sold to the consumer. It is equally crucial for brands to monitor products and potential undesirable health effects throughout the entire product lifecycle. This process, involving the monitoring and response to customer health complaints, is also known as cosmetovigilance.
EU: Continuous monitoring is expected.
USA: The FDA monitors but relies on voluntary reporting.
USA-MoCRA: mandatory cosmetovigilance and record keeping
29. Product categories
Numerous subcategories exist within cosmetics, including personal care, beauty, make-up, and overlapping with other product categories such as cosmeceuticals. The question arises as to whether these subcategories have ‘real’ (read: legal) definitions.
EU: Categories like “cosmeceuticals” aren’t legally recognized.
USA: “Cosmeceuticals” aren’t officially recognized but are widely marketed.
30. Data protection
Collecting consumer data accelerates the marketing and selling of cosmetics to consumers. However, it’s important to note that not all data may be collected and stored, as some regions have stringent rules in place to protect consumer data.
EU: GDPR affects consumer data collection and marketing.
USA: No federal equivalent to GDPR, but state laws like California’s CCPA exist.
31. Product dossiers
Keeping information on the product in one centralized place ensures transparency and traceability regarding the origins and make-up (hah!) of the product. Some regions mandate such a central collection of product information.
USA-MoCRA: Mandatory record keeping, at least of the safety substantiation of the product. MoCRA has not (yet) introduced the concept of the PIF, but from an efficiency standpoint it may be wise to already have a centralized information system in place for your products.
32. Notification of new ingredients
When utilizing novel ingredients, some countries require the registration of these substances before they can be used.
EU: New ingredients don’t require notification, except for nanomaterials. Nanomaterials have to be assessed by the Scientific Committee on Consumer Safety (SCCS). Notify novel nanomaterials via the CPNP
USA: No mandatory notification for new cosmetic ingredients.
33. Cruelty-free claims
While many countries have implemented strict bans on animal testing for cosmetics, some regions are still lagging behind. In these areas, claims such as ‘cruelty-free’ may emerge to inform consumers that these cosmetics are not tested on animals.
EU: Animal testing ban may seem to support cruelty-free claims, but since it is a regulatory requirement anyway, this may conflict with cosmetic claims regulations EC 655/2013.
USA: No federal ban, but cruelty-free claims are popular.
34. Homeopathic products
Homeopathic products fall into a category that may sometimes seem to overlap with cosmetics, as some of these products are applied in the same manner as cosmetics.
EU: Regulated differently across member states, most often not as cosmetics.
USA: Regulated as drugs, not cosmetics.
35. Safety assessor qualifications
Cosmetic products must be safe (obviously!). However, the question arises: who checks the safety of cosmetics? In some countries, there are obligatory requirements regarding the person who performs these safety assessments.
EU: Specific qualifications and expertise are required.
USA: No specific qualifications outlined.
36. Trade secrets
There is a definite trade-off between trade secrets and transparency to consumers. Interestingly enough, this balance varies between countries, with some placing more emphasis on trade secrets (protecting the industry) and others on transparency (protecting consumers).
EU: Ingredient disclosure is mandatory since safety takes precedence. The only exception to this rule is for fragrances, which can be labeled as ‘parfum’ or ‘aroma.’ However, it is mandatory to declare specific fragrance allergens regulated by Annex III of the EU cosmetic regulation.
USA: Trade secret ingredients can be labeled as “and other ingredients.”
USA-MoCRA: Mandatory declaration of specific fragrance allergens, comparable with EU
A rapid mindset shift is occurring right now, moving from consumerism to a heightened concern for the environment. This shift is particularly evident in the cosmetic industry, especially concerning the materials used in packaging.
EU: Emphasis on eco-design and recyclability.
USA: Guidelines exist, but not as stringent.
38. Online sales
With globalization and internet selling, it has become increasingly easy to sell products online to various countries. However, does online selling differ significantly from selling through brick-and-mortar stores when it comes to cosmetic regulations?
EU: Products must still comply with all cosmetic regulations. Since cosmetics are regulated at the EU level, the free-trade principle applies to these products rather than national laws.
USA: Compliance with federal laws is required, but state laws can vary.
39. Product sampling
When testing new prototypes or marketing a product, cosmetic brands may give away product samples and freebies, often in smaller (one-time-use) packaging. However, do these samples have to comply with the same rules?
EU: Samples must meet the same regulations as full-sized products. But you don’t need to indicate the nominal content on the labeling for samples.
USA: Same as the EU, but labeling requirements might differ.
40. Use of CBD
Cannabidiol-containing products have become increasingly popular in recent years. CBD tea, pills, and cosmetic creams may all contain CBD. But what does the legislation say about this?
EU: Regulations vary by country, but there’s a general move towards acceptance with conditions. It is currently under further investigation by the European Commission Working Group on Cosmetics.
USA: The FDA hasn’t approved CBD in cosmetics, but it’s widely used and state regulations vary.
What you should do as a manufacturer supplying products to the EU and USA regions
These key differences underscore the importance of having a thorough understanding of regulatory landscapes when introducing cosmetic products in different markets.
As a manufacturer, it is crucial not only to be aware of these differences but also to have the ability to address these challenges proactively. Every aspect of product manufacturing should incorporate these regional differences, including product development, raw material sourcing, and the compliance workflow itself.
How SkinConsult can assist with market entry in the USA and EU
Address these differences ahead of time. We’re here to support and can point out regulatory specifics per region. Forget about heavily investing in your own regional regulatory teams. Save valuable resources to ramp-up time that can be better focused on getting your products to market faster. At SkinConsult we help you with a super fast service, so you can safely market your products and never compromise on quality.
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