Key legislative issues covered at The Cosmetics Business Regulatory Summit
This article discusses fragrance allergen labelling laws in Europe, light stability testing of finished products and the enforcement of regulations in an online age.
‘Fragrance allergens: regulation to application and beyond’ was delivered by Graham Ellis, Head of Global Toxicology at Givaudan International.
The 2003 EU Cosmetic Directive listed 26 fragrance materials as allergens, however following a public consultation of recommendations laid out by the SCCS in 2012 and a public consultation in 2014, the list under the Cosmetics Regulation will rise to 82.
These would have to be declared on labelling when used above 10/100ppm in a finished product. In addition, nine substances will need to be managed through quantitive risk assessment, while the use of HICC and (chloro)atranol (used in many famous fragrances) above trace levels will be banned. According to Ellis, these modifications to Annex III of the Cosmetics Regulation will likely come into force in the second half of next year.
Natural products will be particularly hard hit – 28 of the 82 are naturals and examples of naturals very highly used in fragrances, such as lemon oil, lavender oil, rose oil and citronella, which themselves contain substances classed as allergens.
“When you move from 26 materials to 82 that represents quite a challenge,” Ellis understated, adding that more than 95% of fragrances would be affected by labelling changes, or reformulation if they chose to go in that direction instead. Some brands’ signature fragrances could also be impacted. “The olfactive impact is massive.”
Ellis said it was up to brands to decide whether they wanted to keep allergens in their formulation and declare them on their labelling, or whether to opt for ‘clean labelling’, whereby moving materials such as cinnamon or patchouli, would make it impossible to keep the same fragrance.
Ellis finished with an overview of the IDEA project, the International Dialogue for the Evolution of Allergens, a multi-stakeholder approach intended to encourage open dialogue to develop definitions and effective risk-based strategies.
There is little point in assessing the safety of a formulation if you plan to pop it into potentially hazardous packaging. Rounding off the morning session of day one was Q-Lab’s Jeffrey A Quill, who addressed this exact issue, asking: what level of testing should be assumed for the packaging of your product? Specifically, Quill discussed light stability-testing of cosmetics and personal care products with the aim of protecting products and companies’ reputations, bearing in mind that formulations can be affected by UVB rays even when indoors and not exposed to sunlight.
Quill looked at the common areas that clients should specify when commissioning such tests on behalf of clients, from variations in the UV ‘cut-on’ wavelength of optical filters of the same class (daylight filters, window glass, etc) but from different makers to the type of Black Panel used to control temperature (insulated or uninsulated) via the method of irradiance control used on the Xenon Arc lamp.
He outlined best practices for brands, stating: “Make sure you have outdoor natural exposure data, test until failure and not to a pre determined time – and identify where failure mode takes place – and use a control material of known durability.”
While it is not mandatory to test the light stability of a finished product in its pack, Quill ended with: “Perhaps there should be an industry standard for assessing light stability for cosmetics.”
The Cosmetics Business Regulatory Summit took place in Brussels, 19-20 May 2015
The internet age has changed the rules of retailing; at present it counts for 3.5% of total retailing and it is not even close to reaching its full potential. But with great potential gain comes an equal level of potential danger. After all, what is the point of selecting an RP, adhering to GMP, or navigating the myriad regulatory rules for each locality if online retail can blow the whole system wide open?
Andreea Pantazi of the European Commission’s Directorate General for Enterprise and Industry told the audience that e-commerce has certainly made classic regulatory enforcement a great deal more complicated. Products offered for sale online to EU consumers are considered as being placed on the Union market, regardless of where the web shop is located. However problems arise because transfer frequently occurs directly between the web shop and the consumer, without any known responsible economic operator within the EU to be held accountable – in this instance the customer could receive a non-compliant product directly to their home. Sometimes a web shop uses a fulfilment house, which takes care of storing goods, receiving orders, packaging and shipping goods to customers. However, Pantazi stressed that the roles and responsibilities of fulfilment services providers under Union harmonisation legislation are still unclear, and a fulfilment house cannot necessarily be held accountable in the role of a traditional distributor.
“Enforcement activities for products sold online still takes place in a fragmented, uncoordinated and incidental manner,” she said. “There is no coordinated approach to validating products which are sold online.”
It was certainly a subject that fired-up attendees with one member of the audience branding the percentage of unregulated and potentially unsafe products available in Europe online as “an emergency”.
However, Pantazi reassured delegates that the EC DG is implementing a multi-annual action plan for the surveillance of products in the EU to study the ways in which e-shops selling consumer products operate, produce guidance for national market surveillance authorities to enforce rules for products online, collect information on online enforcement activities and to inform consumers.
In the first of the Question Time discussions on day two, Jack Ferguson of Skinnovation fielded queries about claims and what has to be considered to comply. The first question was a long and multi-level one: The US does not permit claims that refer to collagen and elastin because they are considered structural claims and therefore drugs; whereas in the EU claims such as ‘boosts collagen’ and ‘promotes elastin’ are widely used. Can these be substantiated under the Common Criteria for Claims, and would the Advertising Standards Authority in the UK accept that data can be provided to support their use on cosmetic products? And how much can ingredient information be used to support product attributes?
Before getting to grips with the answer, Ferguson provided a background overview of the EU Common Criteria for the justification of cosmetic claims, a document which (as of last year) forms part of the Cosmetics Regulation. In the past, he said, cosmetic claims in terms of the Cosmetic Directive were directly related to pack claims. However, under the Regulation, it now relates to all types of claims – on pack, advertising or via any type of medium.“Much of the issues about cosmetic claims stems from the cosmetic definition of the market in which you are working,” Ferguson noted.
“If the definition, such as the FDA’s, is quite clear that it shouldn't have any effect other than just cleansing and perfuming then anything that seems to affect the skin structure is crossing the boundary very quickly, whereas in Europe you can have a secondary effect and that means there is an area of interpretation.”Commenting specifically on collagen and elastin claims, Ferguson said: “We can use these claims in Europe but in the US it clearly goes into the definition of a drug. In Europe there is more of a lack of clarity – but because it can be used I don’t think we can assume that it should be used.”As for the extent to which ingredient information can be used to support product claims, Ferguson explained: “You cannot necessarily say that the product has the attribute of the ingredient: that you have X ingredient and the ingredient does Y and therefore the product does Y. The ingredient would have to be used at a certain level, not deactivated by the formula etc. Equally the product might do Y even if ingredient X does not.”
Also answering delegate questions was Helioscreen’s Sébastian Miksa. Rather amusingly, Miksa was asked: ‘With regulatory compliance in mind during NPD, at what point do you inform the boss that this idea is not going to work?’
He pinpointed key hurdles at each stage of the development process at which point it might be wise to undergo a re-evaluation. These were: during pre-conception, regulations according to country, patents etc; during development, screening tests (stability, challenge, sun protection, toxicology, content container and sensorially tests); at the commercialisation stage, events surrounding marketing and commercialisation, for example a regions’ rules regarding on pack information.
The two-day Cosmetics Business Regulatory Summit (CBRS) took place at the Radisson Blu Royal Hotel in Brussels from 19-20 May 2015. Legislative issues faced by the global beauty and personal care industry were front and centre.