If you are looking to start a cosmetic business in the United Kingdom (England, Scotland, and Wales), it is essential that you comply with the relevant regulations. The UK Cosmetic Regulation was put in place to ensure that all cosmetic products sold in the UK are safe and fit for purpose. The Regulation is a set of rules and requirements that govern the safety, labelling, advertising, and distribution. It applies to all cosmetic products sold in the UK, whether manufactured within the country or imported from abroad. There is a separate process for placing cosmetic products on the market in Northern Ireland – following the EU Cosmetic Regulation. Other countries are making changes and updating regulations, just as the UK is.
Brazil Allows QR Codes
In addition to the resolution published on November 2020 requiring the ingredient list of cosmetic products placed on the Brazilian market to be labelled in Portuguese, the National Health Surveillance Agency (Anvisa) has just published a technical note specifying the rules applicable from November 2021.
Anvisa, the Brazilian agency responsible for overseeing the safety of drugs and cosmetics, has just published a technical note (Nota Técnica (NT) 5/2021 [1]) specifying the procedures for labelling in Portuguese the ingredients of perfumes and hygiene and cosmetic products sold in the country. The note complements the rules laid down in the resolution (RDC) 432/2020 of November 4, 2020, which provides that personal hygiene products, cosmetics and perfumes marketed in Brazil must be labelled with the list of their ingredients in Portuguese.
The labelling in Portuguese language of the full list of ingredients in cosmetics and perfumes sold will be mandatory in Brazil from November 1, 2023. However, the National Health Surveillance Agency (Anvisa) recently adopted new rules confirming brands will have the possibility to use a QR Code to make this information accessible to consumers. This clarification was made after a request from ABIHPEC – the Brazilian Association of the Personal Hygiene Products, Perfumes and Cosmetics Industry – which wanted to minimise the impact of this mandatory labelling in Portuguese, in particular for small-size products.
Anvisa thus adopted a new resolution (RDC n° 773/2023 of February 15, 2023) modifying an earlier resolution of March 24, 2022 (RDC n° 646/2022), which authorized online information. The latest text clearly states that the presentation in Portuguese of the detailed chemical composition of a hygiene, cosmetic or perfume product can be provided in digital format by reading – through a mobile device – a code permanently printed on the label (for example a QR Code).
According to ABIHPEC, ANVISA will also soon publish its own database of ingredients translated into Portuguese. Companies will have a period of 36 months to update the old labelling (in the event of a difference with the translation made available by Anvisa or in the event of an update of the list of ingredients published by the agency).
Canada
Health Canada is proposing amendments to the Cosmetic Regulations to introduce a requirement to disclose certain fragrance allergens on the product cosmetic label. In addition, Health Canada is proposing to amend the Regulations to enhance regulatory oversight for cosmetics.
The amended regulations would require the disclosure of certain fragrance allergens on cosmetics to inform consumers about the presence of these ingredients in the product, outside of the term “parfum”. This would allow consumers to avoid products containing fragrance allergens to which they may be sensitive. This initiative was identified as a commitment in the Minister of Health’s 2021 Mandate Letter. This regulatory initiative is a part of Health Canada’s Regulatory Stock Review Plan.
The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate with manufacturers and other stakeholders that certain ingredients may be prohibited or restricted for use in cosmetics. It consists of two distinct tables, one for ingredients identified as prohibited and another for those identified as restricted.
- Prohibited ingredients, including synonyms, salts and related compounds, should not be present in cosmetic products sold in Canada.
- Restricted ingredients are permitted only if the conditions of use and/or cautionary statement(s) are met as outlined. If the ingredient has a concentration restriction, the applicant is encouraged to provide the exact concentration used in the product at the time of notification, which will help expedite Health Canada’s processing of the Cosmetic Notification Form.
The Hotlist is a science-based document that is reviewed and updated when new scientific data becomes available. Last update to the Hotlist was in August 2022.
It is anticipated that the proposed amendments would increase consumer protection, specifically of vulnerable individuals who are sensitive to fragrance allergens, by requiring certain fragrance allergens to be disclosed on the label.
The cosmetic industry would be impacted by this proposal, as it would introduce label updates to many cosmetic products. Health Canada will determine an appropriate coming-into-force strategy and other solutions, such as a digital ingredient labelling option for products sold in small packages, to reduce the burden on industry. Other proposed amendments are expected to improve the department’s risk assessments and support current enforcement practices. These are anticipated to have minimal impact on industry.
United States
On December 29, 2022, U.S. President Biden signed into law the “Consolidated Appropriations Act, 2023,” which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant expansion of the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics since 1938. Over several decades, FDA has sought additional authority from Congress to regulate cosmetics; numerous bills were introduced, all of which failed to be enacted into law until MOCRA, which is the product of legislative efforts that FDA initiated, working with industry and Congress, more than 10 years ago.
MOCRA will require cosmetics to comply with various new requirements, including: Good Manufacturing Practice (GMP), safety substantiation, adverse event reporting, registration and listing with FDA, mandatory recall authority for FDA, additional labelling, and various recordkeeping requirements. MOCRA requires FDA to establish through regulations requirements for GMP, fragrance allergen labelling, and methods to test for asbestos in talc-containing cosmetic products. The new legislation also provides for pre-emption of certain State requirements for cosmetics but will generally not pre-empt product liability litigation under State causes of action pertaining to cosmetics with regard to any standard, rule, requirement, regulation or adverse event report. However, the law includes exemptions from GMP and registration/listing requirements for qualifying small businesses,
It will likely take FDA several years to implement and enforce the new law, for several reasons. First, the effective date for the provisions necessary to enforce the new requirements is deferred for one year (two years for certain labelling requirements). Second, the GMP requirements will likely not come into effect for several years because they will require a rulemaking proceeding that will be technical and complicated by numerous constraints on the authority granted to FDA. And third, the legislation does not come with any additional user fee funding, which will limit FDA’s ability to develop the regulations and guidance documents that will be necessary for implementation. Although MOCRA includes authorization of appropriations for cosmetic regulation, MOCRA does not include any actual appropriations, which FDA will need to obtain through the annual appropriations process to expand FDA’s cosmetic program and fund MOCRA implementation. Obtaining new funds for FDA regulation in a divided Congress will not be easy.
China
On May 31, 2021, China’s National Medical Products Association (NMPA) released the Measures for the Administration of Cosmetic Labeling (the “Measures”), which describe how cosmetics companies should label their products. The new labelling requirements follow a comprehensive series of new regulations governing the cosmetics industry in China, which took effect on January 1, 2021. The Measures act in accordance with this broader regulatory framework and will come into force on May 1, 2022. Cosmetics provided to consumers in the form of free trial, gift, and via coupons or vouchers that can be redeemed are also subject to the Measure.
China’s lucrative cosmetics industry hit RMB 340 billion (US$53 billion) in sales last year, and is set to become the world’s largest market in the coming years. This growth, however, has led to a number of cosmetics products featuring claims that may mislead consumers about their efficacy, contents, and health benefits. Accordingly, the Measures establish clearer labelling requirements to ensure transparency about the products consumers purchase and use.
Per Article 3, the Measures apply to words, symbols, numbers, patterns, and other markings on the packages of cosmetics products and their containers used to identify basic information and safety warnings.
Article 6 of the Measures stipulates that cosmetics must have labels using standard simplified Chinese characters. Labels may include other characters and symbols, but must have a corresponding explanation in Chinese characters. Likewise, if the Chinese label is affixed on top of another one, such as in a foreign language, the Chinese label must correspond to the original. The font size of the Chinese characters on the label must be at least as large as the font size of other characters, except for registered trademarks, which can be larger.
In terms of naming, Article 8 states that cosmetic product names generally consist of a brand name, a generic name, and an attribute name. Brand names cannot include references to effects or raw materials that the product does not actually possess; generic names must be accurate and can include raw materials (for example, daily face moisturizer); and attribute names should indicate the physical property or form of the product (for example, cream, powder, serum, etc.).
The Chinese name itself, according to Article 9, should be displayed in a prominent position, and should not include non-Chinese characters (except for registered trademarks), numbers, and symbols. Besides the Measure’s naming requirements, companies must abide by China’s broader company and brand naming regulations.
The Measures also provide detailed guidance to the display of each items. For example, the ingredients shall be listed in descending order of their content unless the ingredient is of less than 0.1 percent (W/W) in the product formula. If the formula filling is made in the form of compound or mixed raw materials, the content of each component in the formula shall be taken as the basis for sorting the content of the components and judging whether it is trace component.
The Measures include a number of provisions to prevent companies from displaying misleading information.
Article 19 bars the use of the following features:
- Medical terms, medical celebrities, or implication of medical effects
- False, exaggerated, or misleading information
- Trademarks, symbols, design features, etc. that imply medical effects
- Terms not widely accepted by the scientific/medical community
- Fabricated information or disparaging language about other products
- Fictitious or unverifiable data, survey results, quotes, etc.
- Implying another function by describing the function of raw materials used in the product
- Labels, awards, certifications, etc. that have not been confirmed by industry authorities
- The names and images of state and public institutions
- Guarantees of safety and efficacy
- Vulgar and/or superstitious content
- Other content prohibited by relevant laws
Besides labelling rules, China’s regulations for the cosmetics industry are particularly demanding by international standards, including controversial animal testing requirements. Foreign investors in the industry should therefore undertake a comprehensive regulatory review to ensure a seamless entry into the market. The introduction of more stringent cosmetic labelling requirements reflects an effort to better regulate the industry. Further, the increasing penetration of e-commerce platforms has enabled the cosmetic market’s rapid growth, but also increased opportunities for third party sellers to sell poorly regulated products or those meant for overseas markets.
