The personal care product sector has an increasingly complex and global supply chain. And, as a result, international technical standards are growing in utility and importance.
Where suppliers and retailers follow international standards to guide their operations and products, there will be fewer nasty surprises in orders and purchases.
Moreover, standards are constantly under development, in consultation with the industries that they serve. And regional bodies such as the European Committee for Standardization (CEN – Comité Européen de Normalisation) and ANSI (American National Standards Institute), for instance, often dovetail standards with those of the International Organization for Standardization (ISO), based in Geneva, Switzerland.
ISO has a wide range of standards. Accreditation can be a significant marketing bonus for packaging and ingredient suppliers, especially in emerging markets. It can also help brands with marketing, of course, especially those that seek to demonstrate their products’ safety and sustainability.
Standards focus on product and packaging design; manufacture and use of machinery; testing; and associated business standards, such as environmental controls, use of IT and effective human resources. These standards are developed by technical committees charged with producing standards for a focused area of an industry, along with linked sub-committees and working groups.
The technical committee on cosmetics ISO/TC 217 is the key ISO body for the beauty sector. This year, it released a new standard helping brands and manufacturers evaluate the antimicrobial protection of a cosmetic product: ISO 11930:2019.
Last year, it released guidelines on the stability testing of cosmetic products: ISO/TR 18811:2018. And, in 2017, it released five standards helping manufacturers and brands deal with technical issues posed by microbiology.
Looking ahead, the committee’s experts are going to be busy. They are developing seven standards on sun protection products that range from water resistance (and testing that quality) to lab test (in vitro) assessments of sun protection factors (SPF), as well as testing product efficacy via diffuse reflectance spectroscopy methods, plus in vivo assessments of UVA protection and SPF.
Other ISO standards under development include microbiological testing of impregnated or coated products (wipes and masks); measurement of traces of heavy metals in cosmetics; and two standards on testing for mercury in beauty products.
The strategic business plan of the committee sets out its goals clearly: “Today, the personal care products industry has evolved into a truly international business delivering safe, high quality products to consumers around the world. To create the new tools, standards and approaches needed to operate in this global environment it is important… to harmonise methods, agree on common approaches to assure quality, and to facilitate a common language for the exchange of information.”
The most influential national standards body is the US’s ANSI, whose guidance often inspires ISO standards
Noting that industry technical requirements are becoming tougher and regulators are demanding more information about residues, stability and toxicology, international standards will not only help companies deal with these issues, they will reduce technical barriers in cross-border trade that keeps growing.
One regulatory issue that the committee business plan says it wants to help the beauty industry grapple with is how products might be considered as cosmetics in one jurisdiction and as pharmaceuticals in the other.
Like many other ISO technical committees, ISO/TC 217 has working groups that provide detailed analysis on special subjects – in this case on microbiological standards and limits; analytical methods; terminology; and sun protection test methods.
Interestingly, its secretariat is based at the Institute of Standards and Industrial Research of Iran. It has 40 participating countries, represented by national standards organisations, including some key personal care product manufacturing countries: Britain, France, Germany, Japan, South Korea and the US.
The CEN’s role
ISO standards are supposed to dovetail with regional and national standards. The most prominent regional body is Europe’s CEN, which writes guidance for 33 countries comprising most European countries, bar the former USSR states (the three Baltic States – Estonia, Latvia and Lithuania – being the exception).
CEN member countries are bound to implement CEN standards as their own national standard. It goes about developing standards in a similar way to ISO. The organisation’s work is steered by the CEN Technical Board; in addition, it has technical committees, subcommittees and working groups.
That said, here the technical committees are more likely to be involved in the nitty-gritty of standard development. They are made up of national standards organisation representatives and try to reach a consensus on what should be included in these European standards.
CEN technical committee CEN/TC 92 on cosmetics has approved or published 24 standards. Of these, 18 incorporate guidance from related ISO standards. But there are six that are CEN’s own – all on analytical methods.
These are designed to help companies assess zinc pyrithione, piroctone olamine and climbazole in anti-dandruff products, for instance, and measure the presence of 12 phthalates in cosmetic samples.
A who’s who of European national standards bodies
As for upcoming CEN standards now under development, all are linked to ISO standards (or draft standards), for instance on measuring SPF and UVA in sun protection products and assessing the presence of heavy metals in cosmetics.
CEN and ISO’s work is acknowledged by national standards organisations in Europe, and often woven into their guidance, with national standards work also feeding up into the European and global standards organisations.
In the UK, for instance, the national standards body BSI (the British Standards Institution) develops standards, which may also aid ISO and CEN standard development.
A good example here is BS EN 16956:2017 on cosmetics analytical methods, describing the HPLC/UV method for assessing hydroquinone, ethers of hydroquinone and corticosteroids in skin whitening cosmetic products. Another is BS EN ISO 29621:2017, guidelines for the risk assessment and identification of microbiologically low-risk cosmetic products.
The BSI also has technical committees that develop its standards. Its relationship with CEN will not change if Brexit goes ahead, because the CEN is not a EU body.
The German Institute for Standardization (Deutsches Institut für Normung – DIN) also works to the classic technical committee model, with national experts developing standards.
NA 057-07-01 AA, its cosmetics committee, is its key beauty body – an example of its work is a standard on cosmetics microbiological limits. Its sub-committee NA 057-07-01-04 AK on natural and organic cosmetics is one subsidiary organisation charged with developing specialist guidance.
In France, the standards body is AFNOR: the Association Française de Normalisation. Here the specialist cosmetics committee is AFNOR/S91K. It is currently developing standards on assessing SPF protection in cosmetic products; assessing microbiological elements within beauty masks; and water resistance in sun protection products.
The Asia perspective
National standards bodies outside of Europe can have less influence on the international personal care product sector, although organisations from key industrial centres such as the Japanese Standards Association are important players.
The Japanese Standards Association has a relatively limited set of national standards for personal care products and broadly accepts standards that have already been applied in other jurisdictions.
JIS K 3301 covers toilet soaps; JIS K 3302 is applied to bar-type laundry soaps; and JIS K 3303 is for powder laundry soaps, says Moriyasu Morohashi, a spokesman for the association. JIS K 3304, meanwhile, covers test methods for soaps, and JIS S 9623 is for medical wigs and accessories.
“JIS S 9623 was our latest standard and was released in 2015,” Morohashi says. “Usually, draft standards are drawn up by organisations with a stake in the industry,” such as cosmetics companies, research institutes, consumer groups and universities.
“Typically, a technical committee will have between ten and 20 experts, and they deliberate with our assistance, using existing international standards as a yardstick but also taking into consideration test data and so on,” he says.
Even when an existing international standard is available, a new Japanese standard can take as much as a year to release, while Morohashi admits “if we have to start from scratch, if experiments and research data are required, then it can take three years or more”.
In another important beauty manufacturing country, South Korea, national standards (the Korean Industrial Standards – KS) are developed by the Korean Agency for Technology and Standards (KATS).
KS are officially optional – although they may be quoted in regulation and are usually required in public procurement. There are Product KS (related to improvement, measurement or quality of a product); Procedure KS (related to the testing, analysis, inspection or measurement processes required); and Horizontal KS (related to terminology, technical characteristics, unit and numerical progression).
Cosmetics standards are included under the system’s chemistry category. The most recently added cosmetics standard (December 2018) advises on using liquid chromatography (LC/UV) methods for identifying and measuring 22 organic UV filters in cosmetic products.
The development of new KS involves KATS writing a standard basic plan or by industry players submitting proposals to KATS. They are then opened for public consultation under the KATS’s Korea Industrial Standards Commission.
An approved proposal is made into a draft standard by KATS and is then approved as a new KS. Any KS is automatically reviewed at least every five years.
In Southeast Asia, the Association of Southeast Asian Nations (ASEAN) has agreed to harmonise the national standards followed by its ten member states with international standards, creating specialist sectoral bodies to undertake this work.
The ASEAN cosmetics committee (ACC) is the body working on this file for the beauty sector. It already has nine standards, for instance evaluating antimicrobial protection of a cosmetic product (ACM 008); determining the presence of heavy metals in cosmetic products (ACM 005); assessing the presence of aerobic bacteria, yeast and mould present in cosmetic products; and more.
Almost certainly, the most influential national standards body, however, is the US’s ANSI, whose guidance often inspires ISO standards.
It is, however, organised differently from ISO and CEN. It does not assign such an important role for permanent subject-based technical committees. It follows a looser structure, with standards being developed by around 200 accredited standards framers, representing organisations from the private and public sectors.
These groups work together to develop American National Standards (ANS) and Voluntary National Standards, as well as international standards; their work is carefully screened via a network of cross-industry committees and forums before being published.
This system has produced a wide range of American – and international – standards guiding the beauty sector. One key accredited standard framer in the US is ASTM International (formerly the American Society for Testing and Materials).
This year, ASTM International has released ASTM E640-06(2019), a standard test method for assessing preservatives in water-containing cosmetics. Last year, it released ASTM E1327-07(2018), a standard test method for evaluation of antimicrobial handwash formulations.
Other examples include ASTM E2049-12, a standard guide for evaluation of fragrance/odours for shampoos and hair conditioners.
Taken together, the world’s standards organisations offer a collective database of good practice and expertise that no effective personal care product company can afford to ignore.
To find out the latest on cosmetics compliance and standards, register to attend the 2019 Cosmetics Business Regulatory Summit today.