SGS Helps Manufacturers Access International Cosmetic Markets

Manufacturers of cosmetic products need to consider how their product will be defined by the target market. While it may be characterized as a cosmetic product in one market, it may be considered a drug or interface in another. This is because applicable legislation and consumer perception can be complex and difficult to interpret. How a product will be categorized can have important repercussions, for example labeling, in relation to consumer acceptance and regulatory compliance.

SGS advises manufacturers to consider their products from three distinct angles:
• Definition
• Consumer perception
• Active Ingredients

This approach will help stakeholders in most cases but, as complexity is a byword in cosmetic product legislation, it will also lead to products that exist on the margins being difficult to categorize – borderline products.

The first consideration for any manufacturer must be the regulatory definition. The European Union (EU), for example, defines ‘cosmetic product’, according to Article 2(1) of (EC) 1223/2009 Cosmetic Regulation, as:

“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors”

This cosmetic definition defines its scope by looking at its state, application area, and intended function but not all definitions work in the same way. For example:
• False eyelashes – as appearance changers, they should be considered cosmetic products but their categorization actually relies upon the definition of cosmetic:
o EU: not cosmetics as definition only considers ‘substance and mixture’
o USA: Food and Drug Administration (FDA) considers false eyelashes, eyelash extensions, and their adhesives, to be cosmetic products. The Federal Food, Drug and Cosmetic (FD&C) Act defines cosmetics as, “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance”
• Wet razors - not cosmetics in the EU unless they have a chemical strip that slowly releases a substance or mixture that brings a cosmetic effect – e.g. a moisturizer
• Hand sanitizers – may be classified as medicinal products if they protect the skin against infection:
o EU: any substance or mixture with properties for treating or preventing disease in humans; or being used in or administered to human beings, either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to assist in the making a medical diagnosis, falls under the scope of a medicinal product. If the hand sanitizer claims antiseptic or antibacterial properties, it will probably fall under the scope for biocidal products, meaning it should follow the biocide directive
o USA: the definition is different because ‘drug’ is defined as - ‘articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...and articles (other than food) intended to affect the structure or any function of the body of man or other animals’. Hand sanitizer is therefore considered an over-the-counter (OTC) drug and does not require a doctor's prescription
• Nasal sprays – not considered cosmetic products in the EU because the definition of cosmetics does not cover the nasal cavity, only the external parts of the human body and teeth/mucous membrane in the oral cavity

After looking at the definition, the manufacturer should then consider the consumer’s perception of the product. If the consumer may think the cosmetic product has a function other than purely cosmetic, either through the use of print, images, illustrations, or package design, then it may have consequences concerning marketability. In the EU, products may not comply with the Cosmetic Products Regulation (EC) 1223/2009 and the requirements of Directive 87/357/EEC if they appear to be other than they are and endanger the health or safety of consumer. Therefore, a bathing product, for example, must take the right characteristic form, color, etc. and cannot be made to look like a foodstuff.

Finally, the manufacturer should consider the active ingredients in the product, as classification as a drug or medicinal product often relates to this aspect of the formulation. Borderline products include:
• Toothpastes – normally a cosmetic product except when it contains an active ingredient like fluoride at an active level. Because this prevents dental decay, it is not a cosmetic. In the US, it will probably be an OTC
• Sunscreen products:
o EU: falls under the scope of cosmetics, as defined in (EC) 1223/2009 Cosmetic Regulation
o USA: OTC drug product, with permitted active ingredients for sunscreen function defined in 21 CFR Part 352 (subpart B). This applies whether the product is purely a sunscreen, or has sunscreen as a secondary function
o Australia: only products having primary cosmetic function and secondary sunscreen function, but under certain conditions, are classified as a cosmetic product and are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

Borderline products provide a useful way to understand the difficulties concerning classifying and bringing cosmetic products to the marketplace. If the manufacturer or supplier does not consider these factors, or seek professional assistance, there is a possibility they will send a product to market that is incorrectly labeled and does not have the correct safety requirements applied. If this happens, it will result in an expensive product recall, reformulation and extended time-to-market delays.

SGS Cosmetics & Personal Care Testing Services
SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. A global network of state of the art laboratories offer custom-made solutions for chemical, biophysical, microbiological, stability and biological aspects. Learn more about SGS’s Cosmetics & Personal Care Testing Services. (www.sgs.com/en/consumer-goods-retail/cosmetics-personal-care-and-household/cosmetics-and-personal-care/testing)

For more information on how SGS can assist with understanding international personal care product regulations, contact:

Queenie Tse
Consumer and Retail
Cosmetics, Personal Care and Household (CPCH)
Tel: +852 2765 3672 ext. 1672
mail: crs.media@sgs.com
Website: www.sgs.com/cpch

About SGS
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 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.

1, Mons Calpe
Chitcombe Road
Broad Oak
Rye
East Sussex
TN31 6EU

This release was published on openPR.