Innovate to accumulate - the 2008 Colipa Scientific Forum

The 2008 Colipa Scientific Forum and General Assembly saw a plethora of speakers laying to rest many demons, reports Louise Prance

Cast against the backdrop of Switzerland’s Lake Lucerne, the 2008 Colipa’s general assembly, held from 14 to 16 May, was set to educate and inspire. This year’s agenda picked up where last year’s left off, with updated talks on topics that look set to be recurring issues for the industry.

ANIMAL ALTERNATIVES

Animal testing alternatives was a key issue, with the first address, Feasibility study for a Threshold of Sensitisation Concern (TSC) concept in risk assessment based on human data, delivered by David Keller from Henkel. Keller began by discussing Henkel’s new TSC concept and how it could reduce animal testing levels. Keller highlighted the similarities between the TSC concept and the established Threshold of Toxicological Concern (TTC) method. He explained that the TTC concepts establish human exposure thresholds for all chemicals “below which there is a very low probability of an appreciable risk to human health”. Meanwhile TSC looks at the “acceptable risk” for an unknown chemical regarding its ability to cause an allergic reaction in concentrations below a proposed threshold of sensitisation concern (TSC).

Keller discussed the differences found when assessing skin sensitisation using traditional test methods, such as the GMPT and Buehler-Test (guinea pigs) and the mouse lymph node assay (LLNA) methods, as opposed to the Human Repeated Insult Patch Tests (HRIPT). According to Keller, the guinea pig tests “do not generally include dose-response assessments and are therefore not designed for the assessment of potency”, while the LLNA tests do. HRIPT meanwhile are “used to confirm the absence of skin sensitisation”. Analysing the relevance of human testing for TSC, Keller explained that a TSC should be based on quantitative potency data which can be derived from human data as well as the more commonly used animal methods.

However, he was quick to highlight that hazard assessments should not be made on humans, therefore the current practice is to do a hazard assessment using an animal model (mostly LLNA) and then carry out a safety practice using the HRIPT method. Following comparisons on the human testing and animal methods, Keller discussed the meta-analysis carried out to test the TSC concept. He went on to look at the level of TSC-derived acceptable concentrations in cosmetic products as a result of these tests, finding that two analyses affirmed the principal applicability of the concept, but the weakness was still a limited set of available clinical data.

Concluding, Keller said: “a TSC may provide suitable threshold values for a risk-based assessment and limit further animal tests for cosmetics ingredients”. However, it was generally agreed that for this method to move forward, the database needs to be extended further and a general consensus for what is considered an “acceptable risk” needs to be found.

Pauline McNamee, principal scientist from Procter & Gamble and chairperson of PT-SCAAT for Eye Irritation, started the afternoon session with a talk on Non-animal alternatives to eye irritation testing: Has the science delivered? The overall programme portfolio created to work on these issues dealt with integrated research projects, method development/optimisation of existing models (a focus on Human Reconstructed Tissue (HRT) models) and partnership activities with external bodies such as ECVAM (European Centre for the Validation of Alternative Methods). The team took a three-tiered approach, extracting information from previous validation studies, taking research from mechanism workshops held previously and carrying out basic research in mechanistic work. Using these elements, all of which were based on mechanistic work and the cornea of the eye, a research programme was devised incorporating three projects. The aim was to have: “a better understanding of cellular and molecular mechanisms of chemically induced eye irritation, an identification of endpoints related to dynamics of injury and recovery, a lead to new, appropriate in vitro endpoints – which are more predictive of in vivo response of the human eye to irritants – and the development of prediction models for pre-validation of new and/or improved non-animal methods to proceed to formal validation”. The three projects included an in vitro corneal culture assay, cell culture models for ocular toxicity project and a genomics approach project (for which, due to the need to expand the project, a new proposal is under review). All three of the projects then moved onto the method development and optimisation stage, which McNamee stated would be a focus point of future effort. Data will be submitted to the Eye Irritation workshop planned for 2008’s Q3 where a panel of experts will address a series of questions and future portfolio challenges to deal with further issues. The two optimisation programmes (MatTek Epicolular and SkinEthic Human Corneal Epithelial model) carried out have had resulting data submitted to ECVAM in February this year for consideration for formal validation. The challenge now is to effectively combine assays into a battery approach with the use of analysis. However, McNamee stressed that no one in vitro test would ever fully replace the draize test.

REACH FOR THE STARS

The second half of the day revolved largely around technical and regulatory issues, specifically the chemical registration REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). Since the inception of REACH, the legislation has caused concern amongst manufacturers and ingredient suppliers. Many have been preparing themselves to cope with the inevitable monetary and time costs. Time is up however and manufacturers are now required to begin pre-registering, with the online database closing on 1 December this year. Manuela Coroama, issue manager for Colipa, presented a talk on the final countdown to pre-registration under REACH: Last minute tips, giving an insight into the process of the new legislation. Kicking off, Coroama first drove home what actually had to be done to meet requirements. She emphasised that all potential registrants (manufacturers or importers of phase-in substances including representatives of non-EU manufacturers) must go through the preliminary stage in order to complete the final registration process. This allows the registrant to avoid discontinuity of supply. Any substance in a quantity of over one tonne per year must be registered and downstream users are also required to pre-register any substances that are imported from suppliers outside of the EU. Despite there being a restriction on email pre-registrations, there are a few ways to register, such as the REACH IT portal (ECHA), and substances can be registered singly or in bulk at no cost. A unique pre-registration number is then issued for each substance, which manufacturers can request from suppliers as proof that the substances they purchase have gone through the necessary registration process.

The European Commission is taking no prisoners, with any substances not registered in the allotted time having to be withdrawn from market (with the exception of substances under one tonne, or that have been manufactured or imported for the first time after the deadline). Following the deadline, the ECHA will publish the list of substances that have been pre-registered and allow downstream users to express an interest in a substance. However, pre-registration does not equal a commitment to final registration and the substance provider does not have to follow up if manufacturing or importation stops, or the quantity drops beneath a tonne before the deadline.

Despite spelling out the process in detail, Coroama did acknowledge that there is still concern in the industry, with a general worry regarding the lack of awareness amongst suppliers.

However, downstream users were urged to maintain as much contact with their suppliers as possible and, if it is found that they are not intending to register an alternative source of supply, this needs to be sought from that point onwards.

REGULATION REVISION

Sticking to wider EU concerns, Claudio Pari of Colipa’s steering group, CosReg, took to the floor to discuss the future of the EU cosmetics legislation. Pari explained the reason behind the recent European Commission proposal for a Cosmetics Regulation, which has been created to replace the Cosmetics Directive that currently governs the industry. The new regulation has been developed in a bid to forge better communication between companies and authorities and to streamline 30 years of European legislation into one single format. Many of the key structures of the original directive will remain, however many areas have been brought under scrutiny for revision. These include sets of definitions, substance definition (including the controversial CMRs) and the Cosmetic Product Safety Report. Due to the directive being a “patchwork of national legislation”, as opposed to the updated regulation being directly applicable to all 27 EU member states, the EC hopes that the regulation will result in a higher lever of consumer protection and also the EU having a smoother function as a single market.

OVERSEAS INSIGHTS

News from overseas came from Jay Ansell of the Personal Care Products Council (formerly the CTFA), who explained the agenda behind the CTFA’s new name.

Originating as the Manufacturing Perfumers’ Association in 1894, Ansell explained that members felt that the name ‘The Cosmetics, Toiletry and Fragrance Association’ was outdated. Meanwhile, the new name (PCPC) more broadly “represents the association’s growing and diverse membership”. Ansell also touched upon the success of the association’s Cosmetics Ingredients Review and its enhancement, which has received government (FDA) co-operation.

INNOVATIVE IDEAS

Day two was more future focused, with Colipa making the Importance of innovation for the cosmetics industry feature of the day. First up was Francoise Le Bail, deputy director general DG Enterprise & Industry and former European Commission spokesperson, who spoke about Innovation as a driver of sustainability. Drawing influence from global European affairs, Le Bail discussed how innovation was key to the success of the Lisbon Strategy – a ten-year development plan implemented in Portugal in 2000 with a view to making the EU the most successful knowledge-based economy in the world in relation to sustainable economic growth, jobs and environmental awareness. It was suggested that despite the EU still being behind the US with regard to innovation performance, the gap has narrowed significantly between 2003 and 2007. “The 2007 European Innovation scoreboard shows that the gap in overall innovation performance between the EU and US continues for the fifth year in a row to narrow. Yet we have to pursue our efforts since the part of high-tech products in our exports is still lower than those of our competitors,” Le Bail said. Making the case for the EU to act now to become leaders in the industries of the future, Le Bail emphasised the need to build up R&D and innovation sustainability. Relating this to the cosmetics market, she suggested that to remain the world leader in C&T manufacturing and exportation, the European cosmetics industry “needs a favourable business climate and the right framework conditions for innovation”. Heeding this, an Innovation Policy has been developed that aims to allow access for more R&D funding whilst giving way to increasing demand for innovative goods and services. The policy, Putting knowledge into practice: A broad-based innovation strategy for Europe, comprises nine priorities to act upon. These include intellectual property rights, standardisation in innovation, public procurement in support of innovation, joint technology initiatives (JTIs), lead markets, European institute of technology (EIT), clusters, innovation in services and risk capital markets.

The flagship proposal was the lead market initiative, which aims at “fostering the emergence of markets that depend on innovation, have high economic and societal value, and where European companies have the potential to become world leaders”. Six markets were identified for initial focus: electronic health, protective textiles, sustainable construction, recycling, bio-based products and renewable energy.

One key element in driving forward innovation in the cosmetics industry reverts back to the simplification of the cosmetics directive as previously mentioned by Pari.

SIMPLY SIMPLIFY

Le Bail was keen to highlight four elements of the revision that she felt were of the highest importance.

The first was amending the numerous texts linked to the directive into a single piece of legislation. Next was regarding the underdeveloped requirements of the cosmetics safety report. Le Bail stated that the concept of the legislation is currently very focused on ingredient by ingredient. “The challenge lies in developing the right requirements for such a safety assessment, they have to be ambitious yet proportionate,” she said. “They must not drive small companies out of their business and they must not re-introduce animal testing through the back door”. The third aspect was regarding CMR substances and the complexities surrounding them being banned completely in all cosmetic products. Finally, it was agreed that certain elements of the directive, such as the

rules on animal testing, should not be changed. “I can assure you that the topic of animal testing is being discussed at the highest levels with our trading partners. Essentially, we have to ensure that alternative methods – once validated – are accepted by regulators worldwide. This reduces not only impacts on trade, but also the animals used.”

However, as any manufacturer knows, adhering to the legal framework is just one part of ensuring consumer loyalty to a brand. Phillip Sheppard from AIM (Association des Industries de Marque, the European Brands Association that represents European FMCG manufacturers), gave pointers on creating trust in brands in an environment of competition.

He said: “Goods must deliver the message and there are six key messages that will provide good consumer benefits from brands.” These messages are value, choice, convenience, relevance, reassurance and satisfaction.

“Innovation lies at the heart of the ability of manufacturers to deliver these six messages,” Sheppard added. “The innovation policy is not only about research and development. To be successful, a new product must also be brought to market. Branding and marketing are crucial stages in the innovation process.” Relating this to the five other messages, Sheppard emphasised how each individual message played an integral part in delivering a reliable and successful brand to the consumer. AIM has recently launched two new initiatives. The first focusing on the health and well-being of the consumer, and the second relating to sustainable consumption and production.

The EU cosmetics industry is heading for a shake up and has the innovative tactics up its sleeve to deliver such. But there are hurdles, such as the implementation of new legislation and scientific and technical issues which will continually need addressing. However, what the Colipa Scientific Forum and General Assembly proved was that the industry is ready and willing with the manpower and, perhaps more importantly, the dedication to focus on forging a more co-operative and coherent C&T market, one that rivals that of any other competing industry in the world.