regulation & safety in cosmeticssenior project specialist, emollients advisory committee garrett...

ConferenCe

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8 - 9 November 2017, Cologne, Germany

Michelle Thew Cruelty Free International, UKChief executive

ellen PfrommerBASF SE, GermanyHead of regulatory Affairs Cosmetics

Regulation & Safety in Cosmetics

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Meet our Speakers:Dr. Iris eschenbacherLa Prairie Group, SwitzerlandSafety Affairs & Compliance Specialist

ellen PfrommerBASF SE, Germany Head of regulatory Affairs Cosmetics

rajat narangRichards & Appleby, UKGlobal Head, Cosmetic regulatory & Compliance & nPD

Angela GuerraCOSMEWAX, Spain Product Safety & regulatory Affairs Director Member of registered european Toxicologists (erT)

Mick CooperPZ Cussons, UKProduct Safety executive

Signe WestermannLEO Pharma, DenmarkSenior Project Specialist, emollients

Advisory CommitteeGarrett MoranOriflame, IrelandDirector of regulatory & Product Safety

Dr. Peter freunschtUnilever, Germanyr&D Director Global Product Compliance, regulatory Affairs

rajat narangRichards & Appleby, UKGlobal Head, Cosmetic regulatory & Compliance & nPD

Mick CooperPZ Cussons, United KingdomProduct Safety executive

Michelle ThewCruelty Free International, UKChief executive

Pascale CochetExpanscience laboratoire, FranceHead of Cosmetic regulatory Affairs Department

Mercedes ViñasEuropean Chemicals Agency, FinlandHead of the Dossier Submission & PIC Unit | Directorate of registration

Claudio PariL'Oréal, FranceVP Safety regulatory Affairs APAC

Garrett MoranOriflame, IrelandDirector of regulatory & Product Safety

Jean-Marc ovigneL'Oréal Predictive Evaluation Center, FranceHead of r&D | Technology transfer and industrialization, episkin

Cuross Bakhtiar PhDHarley Street Cosmetic, UKCeo

TBCFieldfisher, Belgium

www.fleming.events tel.: +421 257 272 155 email: [email protected]

Event IntroductionThe cosmetics industry is facing many challenges in europe. The european cosmetics and toiletries market is growing as it constantly adapts to the needs of a changing world. According to Cosmetics europe, there are two most important challenges this industry is facing. first is the move to a more risk-based approach for the assessment of ingredients and products, rather than a hazard-based approach. Second is the key challenge of product preservation. As there are very few new preservatives allowed in the market, the industry anticipates a strong need to defend the existing ones and to adopt a more holistic approach to product preservation. * Source: premium beauty news

Key takeaways 2017 Stay up to date on comprehensive cosmetic

regulations & legislation in europe

Discuss product claims in the scope of international compliance

Combat globalization and develop a functional approach to streamline market entry

evaluate bio-performance and toxicology assessment methods about cosmetics and ingredients

Clearly outline the latest eU classification and procedures concerning CMr substances

Understand the complexity of preservative safety

navigation through fragrance safety assessments

find out alternatives to QrA methodology and evaluate new methodologies & regulations

Discuss how far we are in our understanding of endocrine disruptors

Learn about the determination of potency of skin sensitization

Job Title Breakdown 2016

Regional Breakdown 2016

10% Ceos & Partners

10% Heads

20% Directors

26% Managers

30% Technicians & Specialists

4% Pharmacists

34% france, Germany & Switzerland

18% UK & Ireland

12% Benelux

12% Asia

10% Scandinavia

14% others

… of regulatory affairs, dossier submission, cosmetovigiliance, product compliance & safety, quality assurance, applied research & toxicology

Media PartnersSilver Sponsor


DAY 1november 8th, 2017

8:30 Registration & morning coffee

9:00 Welcoming note from Fleming.

9:05 Opening remarks from the chair & Delegate get-together

Comprehensive regulations in Europe

9:15 Opening discussion | Comprehensive cosmetic regulations in Europe

•Identify the challenges of the regulatory landscape in europe

9:35 Strategic claims management | Effective compliance and product communication

•Discuss product claims in the scope of the international compliance which surrounds claim substantiation and labeling

•Identify how far companies can go with the product claims based on a single ingredient

•explore best practices | How to make a strong claim without testing a finished product

•Standardize claims processes | What and how companies can claim

•Discover guidelines on certain claims used e.g. hypoallergenic

Angela Guerra, COSMEWAX, Spain Product Safety & Regulatory Affairs DirectorMember of Registered European Toxicologists (ERT)

10:05 Cosmetic regulation and perfect compliance determination

•Bringing effective compliance to life•Leave no avenue unexplored: how to align

product claims and compliance•Understand the value of claims for effective

compliance

Signe Westermann, LEO Pharma, DenmarkSenior Project Specialist, Emollients

10:35 Stay tuned | REACH deadline 2018 is approaching

•Last call | Less than 1 year until the final phase-in registration in May 2018

•Discuss the regulatory risks that the reACH deadline 2018 poses to cosmetic ingredients and raw materials

•How to re-verify the supply chain to have continuous access to the substance

•Changes in data sharing | extended Data Sheet updates

•Learn how SMe’s can implement a strategy to ensure continued reACH compliance

Mercedes Viñas, European Chemicals Agency, Finland, Head of the Dossier Submission & PIC Unit | Directorate of Registration

11:05 Morning coffee& networking

11:30 Natural ingredients from point of view of a safety officer

•natural ingredients are complex mixtures and very often used in cosmetic products.

•And a cosmetic product made available on the market shall be safe for human health.

•This proof is to be provided with a Safety Dossier for cosmetic products - which is mandatory.

•The presentation would like to give you an insight into the various possibilities of evaluating such challenges.

Dr. Iris Eschenbacher, La Prairie Group, Switzerland, Safety Affairs & Compliance Specialist

12:00 Determination of packaging impurity gap

•Discuss the determination of impurity gap coming from the primary packaging

•Is packaging a new “cosmetic ingredient”? •Learn how to deal with the lack of information

from packaging suppliers and the impurity in the final product

12:30 Break-out session


13:00 Lunch

Cosmetic compliance in other regions

14:00 Stay up to date on the latest legislation changes in the China & ASEAN region

•outline ongoing changes in in China’s regulation•Identify new legislation concerning animal testing

and how it can influence cosmetic business •Analyze what will make products compliant with

Chinese and global requirements early on•Learn about action steps when placing your

product in the ASeAn region

Claudio Pari, L'Oréal, France VP Safety Regulatory Affairs APAC

14:30 Combat globalization | Develop a functional approach to streamline market entry

•find ways to make your product compliant globally

•Identify action steps for product globalization | Is global product compliance possible?

•Learn how to deal with market-specific product regulations and packaging legal tests

Rajat Narang, Richards & Appleby, UK, Global Head, Cosmetic Regulatory & Compliance & NPD

15:00 Audience-Driven Discussion | Determination of Brexit’s effects in 2017 | Perceived concerns vs. reality

•Determine the effect of Brexit on UK firms in terms of Cosmetic Product regulation (eC) 1223/2009 | reACH regulation (eC) 1907/2006 | CLP regulation (eC) 1272/2008 of substances & mixtures

•Identify practical consequences of Brexit for eU companies | Discuss how Brexit will impact eU laws

•Build action steps for how companies can prepare for the real consequences of Brexit

15:45 Closing remarks from the chair

16:00 Speakers and delegates are cordially invited to attend a Networking Cocktail


application Use sli.do live application for Q&A, Polls and Slides at our events

Ask questions

Vote in polls

See the up–to–date agenda

View slides in real time and download them

Discuss topics via the interactive wall

network with other delegates on-line

I would like to thank advisors and speakers for the cooperation on creating the program, for their expertise, time and support. I am looking forward to meeting you all in Cologne.

Barbora Karasova, Event ProducerT: +421 257 272 235E: [email protected]


http://www.sli.do/


8:30 Registration & morning coffee

9:00 Welcoming note from Fleming.

9:05 Opening remarks from the chair

Exploring the landscape of safety assessments and standards for cosmetic ingredients

9:15 Safety assessments of CMR substances

•Clearly outline the last eU classification and procedures on CMr substances

•Understand the important actions to make sure your product does not contain illegal ingredients after the reACH deadline 2018

•Identify action steps to make the product compliant | When companies need to act

9:45 Navigating through fragrance safety assessments

•Determine the practical safety assessments and best practices of fragrance ingredients

•Deeper understanding of the QrA2 model/IfrA 49•Discuss possible alternatives to QrA

methodology and evaluate the developments in new safety methodologies

•Stay compliant with the new regulation coming into force by the end of 2017

•evaluate the most recent update on allergens labeling

Mick Cooper, PZ Cussons, United KingdomProduct Safety Executive

10:15 Morning coffee& networking

10:45 Understanding the complexity of preservative safety

•Develop a flexible strategy for choosing the right preserver for the product

•Learn to navigate through the minefield of ingredient safety

•Discuss whether shrinking the pool of preservatives is increasing the likelihood that companies will lose due to bigger exposure to the remaining preservatives

TBC, Fieldfisher, Belgium

11:15 Reporting of serious undesirable effects

•Identify the requirements for effective reporting of undesirable effects

•Learn to communicate consumers reports within the company

•Understand how and what the company should report to relevant institutions & bodies

Signe Westermann, LEO Pharma, DenmarkSenior Project Specialist, Emollients

Dr. Iris Eschenbacher, La Prairie Group, Switzerland, Safety Affairs & Compliance Specialist

11:45 Lunch

Toxicology in cosmetics

13:00 How far are we in our understanding of endocrine disruptors?

•evaluate the most recent update on the classification of endocrine disruptors

•Discuss how to classify chemicals according to whether or not they are endocrine disruptors

•Discuss how to deal with “suspected” or “potential” endocrine disruptors



13:30 Determination of skin sensitization potency

•Development of in vitro methods to address skin sensitization

•Analyze the evaluation assessment methods of sensitizer potency

•Learn about validated methods of determining and what confidence/information they provide in this respect

•find out the procedures and effective alternatives of the best tests and methods

•Learn to combine different tools to perform non-animal testing based on skin sensitization assessment methods |

•outline how to evaluate results from various tests

14:00 Understanding of Microplastics and Microbeads

•Where does marine litter come from and how do cosmetic products contribute to marine litter

•Microbeads versus microplastics•Legislation (ban) on microbeads and how plastic

microbeads can be replaced

Ellen Pfrommer, BASF SE, Germany Head of Regulatory Affairs Cosmetics

Alternatives to Testing on Animals

14:30 How quickly are the animal testing rules changing

•following the european ban on animal testing for cosmetics, legislative changes have been implemented or discussed in most major countries, China, Brazil, Korea and russia

•How quickly is change coming, and how does it vary from country to country?

•How far will chemical programmes like reACH affect the position?

•What can consumers reasonably expect?

Michelle Thew, Cruelty Free International, UKChief Executive

15:00 Exploring alternative testing methods

•Learn about validated in vitro reconstructed tissue models and methods for cosmetics safety evaluation

•Learn about non validated in vitro reconstructed skin models and their use for safety and efficacy cosmetics evaluation

•Have a preview on the latest reconstructed models developed at ePISKIn

Jean-Marc Ovigne, L'Oréal Predictive Evaluation Center, France, Head of R&D | Technology transfer and industrialization, Episkin

15:30 DISCUSSION: Science misinterpretations & media impact on cosmetic safety perceptions & consumer behavior

•Discuss how to deal with a strong media impact on consumers

•Is the education of media and society about cosmetic ingredients an answer? Is media interested in being educated?

•Determine possible strategies how to avoid misinterpretations of negative impact of ingredients

•Should cosmetic companies hold and stand together for the ingredients?

16:00 Sharing of key learnings | Opening opportunities for cosmetic regulatory and safety assessment

•Post-conference sharing of key takeaways •Addressing emerging challenges of cosmetic

safety & regulation in the future

16:15 Closing remarks from the chair & Fleming.

16:30 Farewell coffee and networking


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Regulation & Safety in Cosmetics 8 - 9 november 2017, Cologne, Germany

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regulation & safety in cosmeticssenior project specialist, emollients advisory committee garrett...

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