Clarifying cosmetics legislation

The Cosmetics Business Regulatory Summit 2016 addressed a broad range of global regulatory issues for beauty

The Cosmetics Business Regulatory Summit, the global platform for regulatory compliance, had its third edition at the Crowne Plaza in Brussels from 24-25 May. The conference gathered leading industry professionals from all over the world to learn and discuss the latest and emerging regulatory changes in the cosmetics industry.

What follows is part one of SPC Magazine's event synopsis.

Day one opened with a overview of recent regulatory developments in the European Union, presented by Annelie Struessmann from regulatory services company Conusbat. Struessmann first looked at the most recent updates to the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals, or REACH (EC 1907/2006). While animal testing on cosmetics and ingredients uniquely used in cosmetics is banned in the EU under the Cosmetics Regulation (EC 1223/2009), in 2014, the EU Commission in cooperation with the European Chemicals Agency (ECHA) clarified that the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH.

The latest validated alternatives to animal testing were likewise discussed during Streussmann’s comprehensive talk. She drew attention to “next generation” safety assessments, using data integration from cheminformatics, cell cultures, 3D tissues, genomics and exposure modelling to design an integrated testing strategy; a suggested, integrated approach on testing and assessment saw the adverse outcome pathway broken down into chemical structure and properties; molecular initiating event; cellular response; organ response; and organism response, with a ‘toolbox’ of available validated tests for each stage.

Other recent cosmetic-specific developments were the 9th revision of the Scientific Committee on Consumer Safety’s (SCCS) Guidance for the Testing of Cosmetic Ingredients from 29 Sept 2015 – with new requirements for the analysis of the batch composition of naturals, new interpretations of toxicological data for substances with a very low dermal availability and new data for nail polish exposure and powder inhalation – and the long-awaited, very recent acceptance of sunscreen active zinc oxide into Annex VI.

Streussmann then concentrated on horizontal legislation (applying across all industries) beginning with the Transatlantic Trade Investment Partnership (TTIP), which could result in more efficient testing and greater harmonisation of cosmetics regulation practices in Europe and the US. Also on the agenda were the Common Criteria for Claims (EU 655/2013) – here a report on the use of certain free-from and hypoallergenic claims is due for submission by the Commission to the European Parliament and Council – the Nagoya Protocol, which protects biodiversity and establishes access to genetic resources and the sharing of benefits arising from their use, and Europe’s Regulatory Fitness and Performance Program (REFIT), which exists to make EU law simpler and reduce regulatory costs. 

The presentation finished with Streussmann flagging up potential drivers for new legislation, primary among them being the prohibition of endocrine disrupting substances; voluntary action by the industry to reduce the use of plastic microbeads in anticipation of EU legislation; and the Multiannual Consumer Programme (EU 254/2014), designed to safeguard consumer interests and covering sustainability, internet sales, vulnerable (older) consumers, consumer rights and redress, and enhanced surveillance and enforcement.

Making cosmetics

The view for manufacturers was put forward by Jayn Sterland from Weleda UK and Alexandra Egan from Oriflame. In the context of creating a 100% natural cosmetic, Sterland discussed the respective responsibilities of Weleda UK’s regulatory affairs and scientific teams. The former, she said, covers compliance with EU law, all parts of the cosmetic product information file (PIF) excepting safety assessments, text on pack and advertising, certification and export documents, among others. The scientific team, meanwhile, is responsible for scientific support of products and raw materials, safety assessments for the PIF, answering internal and external queries, toxicological support of raw materials and plants, and the calculation of the NATRUE category.

Sterland then talked the audience through Weleda’s specific new product development (NPD) process, demonstrating how regulatory helps the company at each step. The NPD process is initiated with the selection of a claim, such as for post-menopausal skin. Then, having analysed the required herbal active, the brand must search for the best plant to meet this need.

“We don’t use the plant extract,” explains Sterland. “We use the entire essential oil from the plant. We may only be searching for four or five specific ingredients from that plant, but we understand that the 250 ingredients that they come with are really important.”

Actives characterisation is used to discover which plants are highest in the extracts Weleda is looking for, she said, adding that the company also compares the potency of its extract with similar ingredients on the market. The next step is for the brand to look at the most natural place for this product to grow, be it through wild harvest, organic farmers, or farmers that might wish to convert to organic methods; Weleda also has 50 fairly traded partnerships with suppliers globally.

Lastly, the galenic formulation is created to ensure optimal active delivery, while packaging selection remains vital for the preservative-free brand. 

Sterland rounded off her presentation by raising a curious topic that Weleda, as a historic pharma company, has experienced first hand: the blurring of the lines between medicine and beauty as a result of regulation. This, she said, “is going to be the most fascinating area for the next ten years”. She explained that it is now so hard and so expensive to get certification for a pharmaceutical product, that a lot of companies who’d used to get a traditional licence for a medicine are now using cosmetics regulation instead and “dumbing down” a lot of the claims.

Raising a laugh from the audience, Oriflame’s Alexandra Egan opened with an infamous quote from former US Secretary of Defence Donald Rumsfeld on the topic of “known knowns”, or “things we know we know” – and a section of her talk focused on “known knowns” when operating in Russia and India.

But before analysing these markets, Egan explained how a company that operates globally and launches 450 new products a year across all cosmetics categories, from fine fragrance to supplements, can achieve global compliance for its products. 

While Oriflame adheres to “six pillars” of global compliance, namely legal compliance, truthfulness, evidential support, honesty, fairness and informed decision making, Egan admitted that sometimes things can get lost in translation. For example, the name of the brand’s Ecollagen Wrinkle Correcting Day Cream SPF 15 had to be changed to Ecollagen Day Cream SPF 15 in Indonesia for regulatory reasons, while the anti-ageing claim claim of adding ‘bounce’ – which works well in English-speaking countries – doesn’t have the same meaning in France, China or Indonesia – therefore ‘elasticity’ was used instead. 

Egan then provided a case study of Oriflame’s strategy when operating in Russia, its largest market. Russia has been a part of the Customs Union since 2010: a free trade zone shared with Kazakhstan, Belarus, Armenia and Kyrgyzstan.

The most recent piece of legislation relevant to the cosmetics industry is the Custom Union Technical Regulation on safety of perfumery and cosmetics 2011, a ‘cut and paste’ copy of the EU legislation but with some differences. The first of these, said Egan, is the categorisation of products, whereby “depending on the claim of the product – SPF, whitening, tanning – if the product contains nanomaterials, these types of products would require a pre-market registration, so a large dossier to support the products”. There is also a requirement to include an expiry date, unlike in Europe, where an expiry date is only necessary if a product’s shelf life is under 30 months. In addition, a conformity symbol is required.

She added that Russian legislation was currently undergoing some developments, with a 1st amendment clarifying chemical and mechanical peels due in 2017. A 2nd amendment is expected to include the addition of an Annex 13 covering claims management. This, said Egan, is “very reflective of claims management in the EU”, but, she added (drawing attention to another shot of Rumsfeld) it is still the “unknown” and requires clarifying.

Turning her attention to the mighty Indian market, Egan said the challenge here lies in the 1.2 billion population comprising many ethnicities, religions and languages. She provided an overview of the many different stakeholders providing legislation that impact on cosmetics, primarily the CDSCO, Department of Consumer Affairs, Bureau of Indian Standards and ASCI for advertising.

Providing particular confusion at present is a recent labelling requirement for vegetarian and non-vegetarian symbols for cosmetics. The cosmetics industry has taken this to the high court, but she noted that this has been repeatedly postponed. “What we’re really struggling to understand is Legal Metrology doesn’t have a definition for what veg or non-veg is for a cosmetic product; it’s slightly easier for food and there a definition does exist. But if it does become mandatory for cosmetics, the industry is going to have to find a way to quantify what is veg and non-veg.”

Natural standards

Following on from where Weleda’s Sterland left off, Mark Smith from NATRUE addressed both the positives and the negatives of ISO 16128 for natural and organic cosmetics, a guideline tabled by conventional industry for the creation of harmonised technical criteria. 

From a regulatory standpoint natural and organic cosmetics are officially undefined, although, like any cosmetic, in Europe they fall under EC 1223/2009, while claims are regulated under EC 655/2013. As such, there has been a proliferation of voluntary standards, like NATRUE. Smith told the audience that part of NATRUE’s commitments involved participating in and contributing to EU regulatory decision making, as well as working as a liaison organisation for the development of the International Organization for Standardization's (ISO) natural and organic cosmetics standard.          

Exploring the differences between NATRUE’s criteria and that of ISO 16128, and where he felt the ISO standard fell short, Smith flagged the ISO’s acceptance of GM plant-derived materials in certain regions of the world under ISO Natural (for NATRUE GM plants are not considered natural anywhere) and the acceptance of ingredients of up to 49% petrochemical origin in ISO Derived Natural – again, for NATRUE, ingredients must always be of 100% natural origin. 

Moreover, whereas NATRUE has three certification levels that notify consumers as to whether a product is considered natural and/or organic, ISO offers only a framework to calculate the percentage content of natural, meaning the consumer only has a perception of natural and/or organic authenticity, but lacks notification.

Overall, Smith noted, “ISO 16128 represents an overall weak benchmark”, but it nevertheless remains highly important for NATRUE to be part of the Working Group ISO TC/217/WG4 in order to be aware of what criteria the guidelines will contain, to differentiate and to reveal the weaknesses to the end consumer, ensuring they “always have the right to know what they're getting and to be able to make informed decision making”.

Protect your property

What is intellectual property? Asked Rachel Best from Croda, before explaining the breakdown of IP into patents, trade marks, design IP and copyright, among others. Best’s talk looked primarily at patents, which secure exclusive monopoly rights for new and non-obvious inventions (including chemistry, formulation, use and process) for 20 years, but which are also expensive and include a drawn-out application process; and trade marks, which indicate the trade origin of a product and which can be registered indefinitely.

Best’s top tips when filing a patent included: not disclosing information before the patent is filed; ensuring you have freedom to operate, for example that your formulation patent doesn’t infringe on someone else’s earlier ingredient patent; remembering that the application will be published (in case you’re planning to include commercially sensitive material); making the patent as broad as you can; and taking into account which countries to file in, as there is no such thing as a global patent.

Consider, is something actually worth patenting? “Look at the long-term picture of a product lifetime,” she told delegates. “If you think it could be around for a long time, its worth it; if market technology will progress in next two years, it’s probably not.”

She also looked at infringement, noting that you can only infringe a granted patent, not a pending one, but that, once grated, the owner can take retrospective action. Infringement can be secondary in some countries, stinging importers and sellers, as well as makers. Exceptions, meanwhile, include use for research purposes where there are no commercial considerations – if you feel there is a strong need to use certain technology, the patent owner may be approached for a licence but a fee may be applicable.

A trade mark can be applied to anything that is capable of clearly indicating the trade origin of a product, be it a brand name, phrase, design (such as Coca-Cola’s bottle shape), or even a jingle (like Intel’s). A trade mark qualifies a generic noun and descriptive terms are not registrable. As with patent filing, freedom to operate should be assessed when selecting a trade mark and it is worth considering that infringement can be claimed retrospectively once registered.  

IP rights, Best concluded, are tricky to work with but are valuable assets nevertheless. 


Roundtable: Protecting the protectors
Day one featured a roundtable on the topic of preservatives involving Ray Boughton of Delphic HSE, Nadeem Butt from 3E Company and Schulke & Mayr’s Bernd Heinken.
“Across industry consumers are far more aware of what they buy and use,” said Butt, who added that because of this raised awareness there is greater need for transparency.
This led Heinken to ask, if marketing people are requesting free-from, what is left over? Removing ‘problem’ products from Annex V ingredients leaves very few alternatives, he demonstrated, before discussing hurdle technology, which utilises techniques such as pH, ether content, packaging, boosting agents, chelating agents etc to reduce a product’s susceptibility to contamination. 
Commenting on restrictions for propyl- and butyl-paraben, Boughton noted that there is a ‘data gap’ for what happens when humans metabolise parabens – a gap that cannot be filled as testing on humans is (of course) illegal.
He said that consumers needed a better appreciation of risk versus hazard. Crossing the road is a risk-based decision that people make on a daily basis, he told delegates, but when it comes to  chemicals “humans lose their ability to risk-process – to say to themselves that something is okay at this dose because of X-Y-Z”.
After a lengthy and lively debate from the floor, the general consensus was that the “education, education, education” of consumers by cosmetic scientists, and not just marketeers is essential if the industry is retain the ability to formulate cosmetics that are not at risk of microbial and fungal contamination.


Chalk & cheese

Dr Theresa Callaghan of Callaghan Consulting International demonstrated why honest and relevant finished product claims should be the concern of suppliers as well as their customers.

The cosmetics industry hasn’t fared very well regarding the credibility of claims with the customer. This, said Callaghan, is in part the result of a disconnect between the “chalk and cheese” combination of R&D teams, who transform science into reality, and marketing, who transform science into dreams and don’t let facts get in the way of a good story.

To be legal, claims must be truthful, based on the perception of the average end user and be supported by fair and honest evidence – this will result in informed decision making and ultimately a satisfied consumer, she said.

One particular problem surrounds suppliers’ customers making finished product claims by copying and pasting relevant ingredient properties provided by the supplier. In both EU and US law, a claim extrapolating data must take into account the interactions between the active ingredient/s and the structural formula, so writing ‘contains moisturising aloe vera’ on the pack is illegal if the product itself has no moisturising effect.

Callaghan provided historic examples of where finished product manufacturers had gotten ingredient-derived claims very wrong.

Claims legislation is as important to all suppliers as it is to their customers, she concluded, reaffirming that “honesty, integrity and relevance are paramount” when making a cosmetic claim.

US rules

Sharon Blinkoff from Locke Lord LLP kept delegates up to date with major developments stateside over the past 18 months, with a specific focus on two bills which in differing ways could dramatically amend the way cosmetics are regulated in the US. The first of these is the Feinstein and Collins bill of 20 April 2015, which Blinkoff said would significantly increase the regulatory compliance burden on both manufacturers and distributors (defined under the bill as ‘responsible parties’), as well as brand owners.

The Feinstein Bill would put excess pressure of the industry, Blinkoff warned, noting that it would impose new requirements on warehouses, which would need to be registered with the US Food and Drug Administration (FDA) every three years; increase the FDA’s authority over cosmetics (with the right to cancel a formula or facility registration on ten days’ notice among a roster of enhanced authority); and result in annual fees on the industry of US$20.6m, subject to escalation.

In addition – and particularly worryingly for the cosmetics business – activists will get an equal position on the Cosmetics Advisory Board, and therefore equal input on the list of ingredients to be reviewed as industry.

The Feinstein Bill, said Blinkoff, grew from industry desire for uniformity, whereby businesses were willing to enhance the FDA’s authority to avoid more state statutes regulating cosmetic products, such as Prop 65 (California’s Safe Drinking Water and Toxic Enforcement Act). While the Feinstein Bill might provide some (if limited) relief from such statutes, “it’s gone way overboard”, Blinkoff warned.

The second of these bills – the 18 November 2015 Cosmetic Modernisation Act of 2015 introduced by Pete Sessions into Congress – also seeks to cede control for the regulation of cosmetics to the FDA so as not to leave states with the authority to regulate in the health and safety area; cosmetic products would no longer be subject to Prop 65 or the California Safe Cosmetic Act, for example. It also clarifies that cosmetics will not be considered drugs based upon moisturisation-type claims and corrects a mistake made in the colour additives segment by not letting marketers lawfully market products that are a combination of approved colours.

Blinkoff’s talk also covered the latest cosmetics-related developments from the FDA, the Federal Trade Commission (FTC – responsible for regulating cosmetic claims in the US), and certain state and local laws. She noted that her views were strictly her own and did not reflect those of her law firm.

Coverage of the Cosmetics Business Regulatory Summit 2016 will continue online, and in the July and August issues of SPC.

For more information visit: www.regulatorysummit.com or contact: +44(0)207 193 1285.

Featured Companies

Delphic HSE Solutions (more information, website)
Croda (more information, website)

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