Can One Formulation Match the Requirements of Multiple Markets?
By understanding the regulatory requirements of different countries, states or regions, it may be possible to formulate cosmetic products that can be sold in more than one market.
SGS experts Dr Martin Perry and Dr Roger Pengilly highlight the similarities and differences between Regulation (EC) No 1223/2009 and regulations for the US, Canada, Australia and ASEAN countries.
To qualify for distribution and sale in the European Union (EU), cosmetics must meet the requirements of Regulation (EC) No. 1223/2009 and be registered on the cosmetic product notification portal. In addition, a nominated responsible person within the EU should ensure that a product is safe and compliant. All products must have a cosmetic product safety report, which is compiled based on the results of stability, microbiological, preservative efficacy and heavy metal testing. Claims substantiation testing is also required, to verify any claims being made for a product. A product information file must be kept for each cosmetic product.
In The US
Cosmetic products in the US are subject to federal and state regulation. The US Food and Drug Administration (FDA) is the federal regulator and the two most important laws that apply to cosmetics at this level are:
- The Food, Drug and Cosmetic Act
- The Fair Packaging and Labeling Act
Some US states also have legislation that applies to cosmetic products.
While pre-market testing of cosmetic products is not required, the FDA does regulate the use of colors in cosmetics. In addition, some products are defined as both cosmetics and drugs and therefore have to meet requirements for both. These include:
- Antidandruff shampoo
- Toothpastes containing fluoride
- Moisturizers and makeup products that have a sun protection claim
Unlike the EU, sunscreen products are classed as over-the-counter drugs.
There are two proposed changes to federal legislation:
- The Microbead-Free Waters Act of 2015 – prohibiting the manufacture and introduction to the market of rinse-off products containing plastic microbeads. The intention is to phase out the manufacture of such products by July 1, 2017, prohibit sales by July 1, 2018 and, for non-prescription drugs that are rinse-off cosmetics, manufacture must cease by July 1, 2018 and they must be removed from sale by July 1, 2019
- The Cosmetic Modernization Amendments Bill of 2015 – will require cosmetic manufacturing establishments and cosmetic products to register with the FDA within 60 business days of the first sale of a product. Manufacturers would also submit a statement containing the brand names, cosmetic category, ingredients list and contact details
In the absence of federal legislation, some US states have their own requirements. Minnesota has banned formaldehyde and restricted the use of formaldehyde releasing preservatives in cosmetic products for children under eight years of age.
Washington State has adopted the Children’s Safe Product Act (CSPA – Chapter 70.240 RCW), which requires manufacturers of children’s products including personal care products sold in Washington State, to report to the state if their product contains a chemical of high concern (methylparaben, ethylparaben, propylparaben, butylparaben, and 1,4-dioxane).
California has enacted the Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, to protect the state’s citizens and drinking water from chemicals known to cause cancer, birth defects or other reproductive harm. In 2005, the State of California passed the California Safe Cosmetics Act that requires manufacturers of cosmetics to disclose to the state, any product that contains an ingredient that has been identified as causing cancer or reproductive toxicity. Some cosmetic products may contain impurities such as 1,4-dioxane, ethylene oxide, diethanolamine and lead, which are also on the proposition 65 list. The courts in California have determined whether these chemicals are permitted in cosmetic products sold within the State, and whether labeling is required to warn of their presence. The antiperspirants and deodorants regulation, commonly referred to as CARB, sets limits for volatile organic compounds contained within antiperspirant and deodorant products.
Regulated by the Food and Drugs Act and Cosmetic Regulations, cosmetic products sold in Canada must be labeled in accordance with:
- The Food and Drugs Act and the Cosmetic Regulations
- The Consumer Packaging and Labeling Act
- The Consumer Packaging and Labeling Regulations
- The Hazardous Products Act
- The Consumer Chemicals and Containers Regulations
With two official languages, products sold in Canada should be labeled in both French and English, with an exception for ingredient names. Manufacturers and importers must notify Health Canada within 10 days of selling a cosmetic product in Canada. Ingredients restricted or prohibited for use in cosmetics are listed on the cosmetic ingredient hotlist.
Cosmetic products are regulated as industrial chemicals under Australia’s Industrial Chemicals (Notification and Assessment) Act 1989. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) assesses the risk of industrial chemicals. Importers and manufacturers of cosmetic products must register with NICNAS.
The Cosmetics Standard 2007 regulates antibacterial products, antidandruff products, dental and oral care products, and some sunscreen products. At the same time, all ingredients used in cosmetics must appear on the Australian Inventory of Chemical Substances (AICS), with the exception of extracted natural substances. Ingredients not listed on AICS are deemed to be new, and companies must submit a notification to NICNAS to obtain a certificate or permit for use. Additionally, cosmetics should be labeled in accordance with the Trade Practices (Consumer Product Information Standards (Cosmetics) Regulations 1991.
Australian regulators place sunscreen products into two categories:
- Cosmetic sunscreens – products whose primary function is not to provide protection from the sun, but which do contain an ingredient with sunscreen properties. These are regulated by NICNAS as cosmetics
- Therapeutic sunscreens – specifically, sunscreens used for protection from ultra violet (UV) radiation with a sun protection factor (SPF) of four or more, insect repellents with a SPF of four or more, and moisturizers with a SPF greater than 15. These are regulated by Australia’s Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990
In ASEAN countries
ASEAN countries (Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) have common regulatory requirements for cosmetics, including:
- The company or person responsible for placing a cosmetic on the market must notify the regulatory authority in each country before the product is placed on the market
- Product notifications can only be made by individuals or companies who are registered to do business in that country
- Product registration is valid for five years
- The company or person responsible for placing the product on the market must ensure that the product complies with the ASEAN cosmetics directive, and will not cause harm to human health when the product is used under normal and foreseeable use.
In all countries, the regulatory authority’s post-market monitoring and surveillance verify compliance with the cosmetic directive.
The ASEAN cosmetic directive contains lists of substances that are not permitted in cosmetics; substances that are restricted; colorants; preservatives and permitted sunscreen filters.
Formulating For Different Markets
With all the regulatory information and expertise available, it is worth considering the destination markets that a product could be sold into and formulating it accordingly.
For example, when formulating products destined for the US, the demands of federal and state legislation should be considered. Will the product be sold in all 50 states? Does Proposition 65 apply? Also, some ingredients, such as cocamide DEA, which are permitted in the European Union are prohibited in California.
When targeting the US and EU, color becomes all-important. In the US all colors used in cosmetics must comply with FDA requirements, so both Regulation (EC) No. 1223/2009 and the FDA’s requirements must be met.
Sunscreens too are treated differently in the US, to the above-mentioned markets. In the US, sunscreens are over the counter drugs. The number of sunscreens permitted in the US is fewer than in the EU, and some of the sunscreens permitted in Europe are not permitted in the US.
In Canada, fatty acid ethanolamines are permitted for use in cosmetics. Formaldehyde is permitted for use in nail hardeners, oral cosmetics and non oral cosmetics. This is similar to how Regulation (EC) No 1223/2009 permits the use of formaldehyde in the EU. However, since January 1, 2016, formaldehyde has been classified as Carc. 1B and Mut. 2 by European Commission Regulation (EU) No 655/2014, and may affect whether formaldehyde is permitted to be used in cosmetic products in the EU.
Also in Canada, the use of ethoxylated ingredients is permitted, providing the 1,4- dioxane concentration is low, and the presence of heavy metals in cosmetics is permitted, providing they are at levels that are technically unavoidable. Guidance published by Health Canada states that heavy metal impurities are deemed to be technically avoidable when they exceed 10 ppm for lead, 3 ppm for arsenic, 3 ppm for cadmium, 3 ppm for mercury, and 5 ppm for antimony.
Regulation (EC) No 1223/2009 requires that a cosmetic product safety report is written for every cosmetic product that is placed on the market within the European Union. It would be worth considering writing a toxicological risk assessment for products that are being sold outside the European Union as part of due diligence.
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For further information, please contact:Martin Perry and Roger Pengilly
Cosmetic Safety Assessors
SGS United Kingdom Limited
t: +44 1274 303080