A team from Portugal, Ferreira et al., recently published an article in Beauty productsreview of the current international regulatory framework for cosmetic products, including laws and regulations in the US, EU, Canada, Brazil, China and Japan.
Although some of the frameworks are similar across markets, there are notable differences and disconnects.
“Rather than asking if global harmonization is possible, the question could be ‘Is it necessary?'”Ferreira et al. said. “The legislative measures of the six regions considered in this work are in fact different, affecting international trade, among other issues.”
Ferreira et al. noted that the industry has been able to navigate the regulations in many ways, but improvements can be made.
Here are five areas of regulatory disconnect noted in their review.
Definition and categorization of products
Generally, in all regions, cosmetics are classified by “product functions, parts of the body where it is applied, mode of application, indication for use, claims and consumer perspectives”.
Disconnects tend to occur in the way categorizations are applied. For example, while cosmetics must belong to one category in the EU, they can belong to several categories in the United States and must comply with the regulations for each of them.
In the United States and Canada, some products fall into the category of drugs or somewhere between cosmetics and drugs, such as over-the-counter and natural health products.
China and Brazil also have many more specific categories, as well as more general categories like other regions.
Consumer safety assessment is a priority in practiced pre-market approval.
While the EU has a detailed and specific premarket approval process, the US only requires approval for colorants for specific uses. Canada places the onus of safety on the manufacturer and requires that a product be notified to Health Canada.
In China, only specific types of cosmetics need to be approved, and registration also depends on the type of product in Brazil.
Japan requires companies to obtain two types of licenses, a cosmetics manufacturing license and a cosmetics marketing license, dictating that standards of quality practices and vigilance must be met.
Ferreira et al. said ingredient regulations follow a similar pattern across the six markets, listing good and bad ingredients, with the main difference being the ingredients on these lists. They give the following examples:
- Unlike the EU, the US and Canada only have negative lists, in part because some of the products on the EU’s positive list are not regulated as cosmetics in North America.
- The EU bans over 1,400 hazardous chemicals in cosmetics while the US bans less than 20 chemicals.
- The EU has over 25 ingredients approved for use as sunscreens, while the US has only 2 fully approved ingredients and 12 tentatively approved ingredients, provided additional safety data is provided.
The EU uses a scientific committee to analyze the risks or ingredients, adding and removing ingredients from negative, restriction and prohibition lists, and positive lists for colorants, UV filters and preservatives.
While Brazil and China use a similar model to the EU, the US and Canada have lists of controlled cosmetic ingredients, although they are much less comprehensive than in the EU.
Packaging and Claims
Generally speaking, labeling requirements between the six regions are quite similar, although in the US there are specific requirements for certain ingredients, such as SPF, and EU regulations have requirements. regarding security guarantees.
Where there is more variation is in the regulation of claims. EU law states that advertising, marketing and communication around a product cannot make or imply claims or features that a product does not have.
Ferreira et al. While the EU and Japan, which have a list of 56 acceptable efficacy claims, have extensive consumer protections, other regions like the US, Canada, and Brazil do not have such lists. or guidelines, simply requiring claims to be truthful and not misleading.
They also say that because none of the six regions covered in the report has a body that approves claims, non-compliance is possible in all markets.
“One of the most common nonconformities is a drug claim on a cosmetic product,”the researchers said. “This happens because it is sometimes difficult to determine what type of claims are appropriate for cosmetics, rather than drugs, because some cosmetic products can alter the function of the body.”
One of the biggest disconnects between markets is the use of animal testing. While consumers are more aware of the issues with animal testing and some regions are codifying bans on the practice, other regions still use it widely.
The EU had largely banned animal testing and related marketing of finished products and ingredients, the US and Brazil have states banning animal testing, and Japan is phasing out animal testing.
Canada does not prohibit animal testing. Although a bill was introduced in their legislature in 2015, it has yet to pass.
In China, animal testing is still required for cosmetic registration, although Ferreira et al. said the country is working to bring its regulations in line with other regions.
Author: M. Ferreira et al
Cosmetics 2022, 9(4), 72; https://doi.org/10.3390/cosmetics9040072
Title: Overview of cosmetics regulatory frameworks around the world