17 June sees day one of the Cosmetics Business Regulatory Summit held in Brussels, Belgium – LIVE UPDATES
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Day one of the Cosmetics Business Regulatory Summit has begun with Professor Philippe Masson – Chairman of the EVIC International Group and Manager of EVIC France Laboratories – opening proceedings with his keynote speech providing solutions for distributing cosmetics and toiletries on a global scale
With the space and time between locations becoming smaller as communications and technology increase worldwide, it continues to get easier to sell products to the far corners of the world; but when a product is made in one country and sold in or bought online from a variety of locations, at which point do the various global regulations become relevant for the product? Masson showed that compliance needs to be taken into account based on the consumers and governing body in each region the product could be purchased, even through online platforms.
Roman Mokry from the European Commission then provided an overview of the Common Criteria for the EU Cosmetics Regulation which is based on the six areas: Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed Decision Making.
Steven Hanft then provided a view from his privately-owned company, CONUSBAT, about the hard work SMEs go through for compliance. He went through the issues that changes of regulation and directives have on all sizes of companies, especially with the complexity of REACH. The talk covered: The EU’s SME definition and resulting staffing in companies; compliance activities in focus; cost implications from defined compliance steps; and observations on disadvantages and gains for SMEs.
Florian Schellauf from Cosmetics Europe has taken the Summit through the organisation's basis and drivers for providing Regulation and submitting amendments. Schellauf provided an overview of the impending amendment to the EU Cosmetics Regulation which could cover revision of the general safety directive, internet sales regulation, roles and responsibilities (e.g. for independent Responsible Persons), adjustment of nano material requirements, CPNP notification, improvement of CMR exemption process and more. However, Schellauf gave a blow to the wishful view for the future of cosmetics regulation stating that 'global regulatory harmonisation is a utopia.' He believed that compatibility is the way to go instead.
The final talk of the morning came from Sharon Blinkoff from Edwards Wildman Palmer LLP providing a comprehensive view of the fragmented US market. Blinkoff believes that the industry will always have an issue with wanting to compartmentalise and box claims with certain tests and compliance regulation but with a constantly innovating industry, we will always find it difficult to do this; thus, the regulators and manufacturing companies alike must be aware of this and embrace it.
LUNCH – Day one
Debra Rebourn from dR Cosmetic Regulations started the afternoon's session by highlighting the differences in regulation around the world with examples from the US, Canada, Australia, China, Japan and South Korea. Redbourn said how one global formulation and pack is almost impossible, as countries have different definitions and categories of cosmetics, drugs and in-between. The consultant said how companies increasingly need to consider not only the ingredients regulated under the cosmetics legislation, but also chemical and environmental legislation too.
The roundtable debate focussed on the statement: “Sun protection labelling should be taken out of the laboratory and into consumer reality”. Led by chairman Dr Jack Ferguson, the panel consisting of Redbourn, Blinkoff and Dr Marc Pissavini from Coty-Lancaster Group discussed the possibility of changing the marketing direction and technical testing methods for producing sun protection products so that this sector was more relevant to the consumer. The panel took continuous questions and responses from the audience over the hour and a half debate coming to the conclusion that sun protection product must, at the very least, start in the laboratory for its information as sold to the consumer because of the baseline comparative system that it provides across the board. However, the sector and solutions are always imperfect and in need of continuous re-evaluation as the consumer application will always also be imperfect. The panel advised that the engagement and education of sun protection product must start before the purchase of the product is made
Ric Williams took to the floor with a whirlwind tour of the regulatory differences and specific notifications in the Asia Pacific region including eight main markets: Australia, New Zealand, China, Japan, Korea, Taiwan, India, and ASEAN Countries. Apart from the differences in population and wealth, Williams highlighted how each of these eight regions have different regulations mainly caused by which government department administers the regulations; he stated in general that it would be fair to say that a product that is approved by one may not be approved by another.
Finishing the first day of lively debate and in-depth information for cosmetics regulation around the world was Catherine Renard from Quatre S Cosmetics. Renard talked about 'Living with the Regulation from a SME perspective providing a practical view point from an SME company. Her presentation provided an insight into the weight of the change from the Directive to Regulation for an SME and what they learned from their experience; this highlighted the issues today for SME companies within the EU that are not technical issues to overcome but are economical ones. Renard showed how the interpretation of the EU regulation with various languages barriers had a costly impact on packaging and time consuming impacts for the completion of PIFs.
The Summit then adjourned for a cocktail reception providing a more relaxed networking and debating environment to continue the day's hot topics.
Day two of the Summit started with Vera Rogiers, Head of the Department of Toxicology at Vrije Universiteit Brussel, bringing the audience's attendance to the basis of manufacturing by asking 'how safe is safe enough?'. Rogiers highlighted the principals surrounding why safety regulations are implemented and how they should be adhered to, both for raw ingredient supply and end product manufacturing, while noting the unique obligations that the EU Cosmetics Regulation requires when compiling the Product Information File (PIF).
Humane Society International's Policy Director, Emily McIvor, aptly followed this talk on toxicity and safety assessment in the EU – where animal testing is banned - by showing how the momentum of this movement is sweeping across the globe. McIvor highlighted how anti animal testing organisations understand that the EU ban has different impacts on different sectors, on large vs. small companies and on companies operating from different parts of the world both financially and in their manufacturing methodologies; however, she believes these pressures will never justify the use of animals in toxicity testing for the purpose of developing new cosmetics ingredients, and that all companies and organisations should assist in easing those pressures for all.
Ellen Pfrommer from BASF gave her presentation on the key challenges for producing cosmetic ingredients and how the ingredient supplier can help the cosmetic company to become compliant in an regulatory-obsessed era in the C&T industry. This includes requirements regarding chemical law registrations and also data on ingredients needed in the Product Information File. The Responsible Care approach of Ingredient Suppliers goes beyond mere legal compliance and leads to activities such as the Global Product Strategy (GPS) summaries. Pfrommer continued from McIvor's previous talk by showing how the commitment to animal welfare has resulted in an increase of available alternative test methods although there is still a long way to go until replacement methods are available for all relevant toxicological endpoints.
Claudia de Lucca Mano, a lawyer based in Sao Paulo Brazil, took to the stage with South American flair to clear the air of uncertainty that tends to surround the launch of products into an emerging global market – in this case, the burgeoning Brazilian market. de Lucca Mano's overview highlighted existing regulatory frameworks for cosmetics products and ingredients covering: company licensing, concepts and basic guidelines for cosmetics. She also looked at cosmetic product classification in the Brazilian market for the regulations that come into play in this region in terms of the degree of risk and clearance procedure within ANVISA including the necessary notification or registration, ingredients listings (Mercosur), labelling, new sunscreen regulation(Mercosur) and advertising.
Annelie Struessmann concluded the morning's proceedings with her talk focussing on the regulatory environment for cosmetics in the Eurozone detailing the various regulatory frameworks and branches applicable to the products. Struessmann showed, for the various stages of product development, when a defined regulatory framework has to be considered and its provisions have to be implemented into the developmental process. The presentation also showed the differences in requirements between imported products and products manufactured in the Eurozone, concluding that the environment is transparent, if demanding, and when compliance with EU regulation is achieved, it provides a strong basis to broach regulatory hurdles for many other worldwide markets for the products.
LUNCH – Day two
The second roundtable debate of the Summit discussed the statement: “Testing protocols should favour multinationals rather than balancing the marketability of products across the board”. The session was chaired by Jeffrey A. Quill – Director of Technical Applications, Q-Lab Corporation USA with panellists Ferguson, Williams and Pfrommer. The general belief of the panellists was that testing protocols didn't favour multinationals across the board because the availability of all tests, especially safety, is quite level across the field. However, it was brought to light that in providing an extended range of products with different fragrances or a slight change in formula, where a specific testing protocol would be needed for each SKU, this would be an area where multinationals would have an edge in resources to put towards further testing. Furthermore, the marketing of more exaggerated or extended on-pack claims would be a higher barrier to entry for the SMEs as the testing for wrinkle claims or bespoke tests for non-prevalently-used claims are higher in cost due to the length of time and the more resources it takes to test for this claim on each product. On the other side, it was stated that multinationals are using consumer trials more in recent time, tests that are cheaper to implement than clinical trials, and that this would actually lower the barrier for SMEs to enter the market and be comparative with the larger companies. The topic brought examples and questions from the SME and multinational delegates who have been through these practices in reality and asked the panel to consider the various in-situ examples against their standpoints. Debates such as these help bring to light the realities of the cosmetics industry with authorities and consultants present, who produce and police the regulations, in order to continue to allow all types of cosmetic companies to have their opinion heard when future regulatory amendments are being considered.
Alan Ritchie from Caleb Management Services took to the stage with a concluding take-home mantra that 'managing the media can be harder than adhering to regulatory due diligence'. His talk covered general safety issues experienced through the EU Cosmetics Regulation before moving onto the impact of the REACH initiative highlighting that new data developed for REACH could raise safety concerns for use in cosmetics. He briefly mentioned the animal testing argument before drawing to a climax on how the media handle substances that come under a cloud and whether this is based on accurate science or a desire to sell papers with SLS as his example – the Media influence regulations and regulations influence media, a chicken and egg situation that can become embattled. When a substance does become embattled industry groups and task forces can be brought in to manage this; however, stakeholder dialogue is critical he reminded the audience.
The final presentation at the Cosmetics Business Regulatory Summit 2014 was delivered by Sandra Ferretti, the Chief Compliance Officer at Obelis s.a.. A year on from the implementation of the EU Cosmetics Regulation, Ferretti provided an insight into the questions, problems and solutions that have arisen over the year in regards to: Responsible Person, Safety Assessor, documentation availability, CPNP, GMP, animal testing, serious undesirable effects and online sales regulations. Ferretti concluded that a the Regulation needs clearer rules to some extent, an increased awareness on safety among compliance operators and users of cosmetics and that many requirements need harmonisation, standardisation and guidance on practical implementation to better the current guidelines and obligations.