Formulating Cosmetics For Multiple MarketsWith all the regulatory information and expertise available, it’s worth considering the destination markets where you want to sell a product as the basis for the formulation you use.
For example, when formulating products destined for the US market, you should consider the demands of federal and state legislation – in as many states as you want to sell into. If California is one of them, you need to know if Proposition 65 (which protects the state's drinking water sources from being contaminated) applies. You’ll also have to ascertain whether your product includes certain ingredients – e.g. cocamide DEA – that are permitted in the European Union (EU) yet prohibited in California.
When targeting both the US and EU, color is also an important factor. In the US, all colors used in cosmetics must comply with the requirements of the US Food and Drug Administration (FDA) and in EU states, Regulation (EC) No. 1223/2009 is applicable.
SGS experts Dr Martin Perry and Dr Roger Pengilly have considered Regulation (EC) No 1223/2009 and the regulations for the US, Canada, Australia and ASEAN countries. Below, they highlight the similarities and differences between them.
Cosmetics must meet the requirements of Regulation (EC) No. 1223/2009, and be registered on the cosmetic product notification portal, to qualify for distribution and sale in the European Union (EU). 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, based on the test results for stability, microbiology, preservative efficacy, and heavy metals. To verify any claims being made for a product, substantiation testing is also required. A product information file must be kept for each cosmetic product.
In the US
Cosmetic products in the US are subject to federal regulation and, in some cases, state regulation too. The US Food and Drug Administration (FDA) is the federal regulator and the two most important laws that apply to cosmetics at this national level are:
• The Food, Drug and Cosmetic Act
• The Fair Packaging and Labeling Act
While pre-market testing of cosmetic products is not required, the FDA does regulate the use of colors in cosmetics. If a product is defined as both a cosmetic and a drug, it must meet the requirements for both. Products falling under this dual categorization include:
• Anti-dandruff shampoo
• Toothpastes containing fluoride
• Moisturizers and makeup products that have a sun protection claim
In the US, unlike the EU, sunscreen products are classed as 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.
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
Since Canada has two official languages, products sold should be labeled in both French and English (although ingredient names are an exception). Manufacturers and importers should check the cosmetic ingredients hotlist to find which are restricted or prohibited for use in cosmetics. They must also notify Health Canada within 10 days of selling a cosmetic product in the country.
There are some interesting differences in regulation – and, therefore, formulation – between Canada and the EU. For example, in Canada, fatty acid ethanolamines are permitted for use in cosmetics, while formaldehyde is permitted for use in nail hardeners, oral cosmetics and non-oral cosmetics. Regulation (EC) No 1223/2009 also permits the use of formaldehyde in the EU, although – since January 1, 2016 – it has been classified as Carc. 1B and Mut. 2 by European Commission Regulation (EU) No 655/2014. This may affect whether formaldehyde is permitted for use in cosmetic products in the EU.
Also in Canada, the use of ethoxylated ingredients is permitted, providing the 1,4- dioxane concentration is low. Additionally, the presence of heavy metals in cosmetics is permitted, providing they are at levels that are technically unavoidable. According to Health Canada, heavy metal impurities are deemed technically avoidable when they exceed 10 parts per million (ppm) for lead, 3 ppm for arsenic, 3 ppm for cadmium, 3 ppm for mercury, and 5 ppm for antimony.
Cosmetic products are regulated as industrial chemicals under Australia’s Industrial Chemicals (Notification and Assessment) Act 1989. Importers and manufacturers of cosmetic products must register with NICNAS, the National Industrial Chemicals Notification and Assessment Scheme, which assesses the risk of industrial chemicals.
The Cosmetics Standard 2007 regulates dental and oral care products, anti-bacterial products, anti-dandruff products, and some sunscreen products. What’s more, all ingredients used in cosmetics – with the exception of extracted natural substances – must appear on the Australian Inventory of Chemical Substances (AICS). 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, labeling of cosmetics should comply with the Trade Practices (Consumer Product Information Standards (Cosmetics) Regulations 1991.
The regulators in Australia put sunscreen products into two categories:
• Cosmetic sunscreens – where the primary function is not to provide protection from the sun, although an ingredient with sunscreen properties is included. Product matching these criteria are regulated by NICNAS as cosmetics
• Therapeutic sunscreens – specifically, sunscreens used for protection from ultra violet (UV) radiationwith a sun protection factor (SPF) of four or more. This category also includes insect repellents with a SPF of four or more, and moisturizers with a SPF greater than 15. These are all regulated by Australia’s Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990
In ASEAN countries
The Association of Southeast Asian Nations (ASEAN) comprises Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. These members 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 launch
• Only those individuals or companies who are registered to do business in a country can perform product notifications there
• Each product registration is valid for five years
• The company or person responsible for placing the product on the market must ensure that it complies with the ASEAN cosmetics directive. This contains lists of substances that are not permitted in cosmetics; substances that are restricted; colorants; preservatives and permitted sunscreen filters.
• They company or person responsible must also be certain that the product, causes no harm to human health when used under normal and foreseeable circumstances
In all countries, the regulatory authority constantly monitors the market to verify compliance with the cosmetic directive.
To potentially reduce the number of formulations you create, we suggest using Regulation (EC) No 1223/2009 as a starting point. This requires that a cosmetic product safety report is written for every cosmetic product on sale within the EU – very likely to be a target market for you. So, for each product that you want to sell outside the EU, it will only take a similar effort to write a toxicological risk assessment as part of your due diligence. This could help form the basis of future formulations for all markets.
For further information on complying with the global regulations affecting the cosmetics market, and on toxicology and other testing, please contact:
Cosmetic Safety Assessors
SGS United Kingdom Limited
t: +44 1274 303080
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.
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