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.
1, Mons Calpe
This release was published on openPR.
Permanent link to this press release:
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release Formulating Cosmetics For Multiple Markets here
News-ID: 371311 • Views: 774
More Releases from SGS
SGS Expands Furniture Services to Assist Vietnam’s Growing Furniture Export In …
SGS has responded to Vietnam’s recent 7.9% growth in gross domestic product and the opportunities for international trade this presents to the furniture industry, with an expansion in capabilities. Despite a long history of domestic furniture manufacturing, there has only been a single recognizable furniture industry for about 20 years. It has now grown into the second largest exporter of furniture in the Asia-Pacific region, and fifth in the world.
New York State Assembly Approves ‘Harper’s Law’ to Improve Safety in Cloth …
The New York State Assembly has passed ‘Harper’s Law’, a law requiring retailers to only sell clothing storage units that comply with industry recognized standard ASTM F2057. Passed on May 30. 2019, ‘Harper’s Law’ is named after Harper Fried, a three-year-old who died in 2016 as a result of a clothing storage unit tip-over incident. ASTM F2057 “Standard Safety Specification for Clothing Storage Units” is a voluntary US standard, originally
EU Updates Rules for Persistent Organic Compounds with Recast POPs Regulation
On June 25, 2019, the European Union (EU) published Regulation (EU) 2019/1021, recasting the EU’s Persistent Organic Pollutants (POPs) Regulation. The original POPs Regulation - Regulation (EC) No 850/2004 – has been amended several times, making recasting a necessity to preserve clarity as new amendments are introduced. POPs are organic compounds that threaten both the environment and human health. Exposures to these compounds can lead to bio-accumulation in the fatty
EU Adds Over 200 Prohibited Substances n Cosmetics Regulation Update
On May 22, 2019, the European Commission amended Cosmetics Regulation (EC) No. 1223/2009 by updating Annexes II, III and V. The new regulation, (EU) 2019/831, updated the annexes in regard to substances classified as carcinogenic, mutagenic and reprotoxic (CMR) – categories 1A, 1B or 2 under Regulation (EC) No. 1272/2008 as at December 1, 2018. The amendments include the inclusion of over 200 entries to Annex II for prohibited substances, and
More Releases for Regulation
Tech Regulation Segments, Size, Trends and Opportunities
The Latest Research Report Tech Regulation – Thematic Research provides information on pricing, market analysis, shares, forecast, and company profiles for key industry participants. – MarketResearchReports.biz The international legal system, based on separate national sovereignties, is struggling with its task of providing a framework for internet governance, given the cross-border flows of online services. Yet a raft of online abuses culminating with the Facebook / Cambridge Analytica scandal is likely to
Palau Welcomes the Future of Shipping Regulation
Port State Control could be about to change and move away from black, grey and white performance lists as pressure grows to concentrate more on targeted inspections of under-performing ships, a potential move welcomed by Palau International Ship Registry (PISR). Panos Kirnidis, CEO of PISR has responded positively to the recent workshops held at the IMO headquarters in London in October that has suggested a range of proposals and recommendations centred
Update on the New EU Medical Device Regulation and In Vitro Diagnostic Regulatio …
Eudamed, the European Database on Medical Devices, has published a timetable for the expected completion of legislation towards an amended Medical Device Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR). According to the timetable, an official version of the new MDR and IVDR will probably be published in May 2017. As part of this process, Eur-lex released the final draft of the amended MDR and IVDR on February 22, 2017.
EU REACH Regulation Tightens Lead Restrictions
The European Union (EU) has expanded the scope of restriction of lead to articles or accessible parts of articles for the general public if children can place such articles or components in the mouth. The enforcement date will be June 1, 2016. Amendments to EU REACH to Protect Young Children In October 2014 information was released that the European Commission (EC) had notified the World Trade Organization (WTO) of a proposal (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-17814-eu-notifies-wto-draft-regulation-restriction-lead-reach-a4-en-14.pdf)
Ecuador Proposes Regulation on Textile Labeling
This technical regulation establishes requirements for the labeling of apparel, home textiles and clothing accessories marketed in Ecuador, whether locally manufactured or imported, in order to prevent deceptive practices or to deceive consumers. The information presented on labels must be expressed in Spanish (other languages without prejudice can also be present). The required information must be permanently labeled and must be visible, indelible and easily accessible to the consumer. The
Really simple light regulation and control
New JENCOLOR semiconductor sensors for measuring tasks in the areas of analysis, color and light Jena (Germany) 22 January 2013 - MAZeT GmbH - a leading provider of Electronic Design and Manufacturing Services - presents new JENCOLOR products for measuring tasks in the fields of colorimetry and LED light. The new products include the MTCSiCF color sensor for photometry and colorimetry, the MCDC04 sensor signal amplifier with an I²C interface and