European Voice Conference « Chemicals and consumers: a question of confidence » Dr. Matthias Vey International Fragranc

1. European Voice Conference« Chemicals and consumers: a question of confidence » Dr. Matthias VeyInternational Fragrance Association Tuesday December 4, 2007 Renaissance Hotel Brussels, Belgium

2. Preparing for REACH A Whiff of Danger: Synthetic MusksMay Encourage Toxic Bioaccumulation  Environmental Health Pespectives – January 2005 Common household fragrances may be harming aquatic wildlife, study finds Stanford New Service – October 2004 Environment group raises stink over perfumes Agence France Presse – 10 February 2005 Valentine perfume 'can make you sick' The Guardian – 11 February 2005 Study on Air Fresheners - BEUC Hits Back BEUC Press Release – February 2005 Greenpeace Study Critical of Some Fragrances Women’s Wear Daily – 14 February 2005 Phthalates and Artificial Musks in Perfumes – R&I-A R 2005/011 TNO-Report – Greenpeace – January 2005 MY TOXIC VALENTINE: GREENPEACE FINSD SUSPECT CHEMICALS IN PERFUMES

3. Growth of the Scare Industry Toxic bathroom Excessive public campaigns: • Lead to increasing consumer mistrust. • Result even in loss of materials that have been declared safe by numerous scientific institutions – like DEP (Diethyl phthalate), sacrificed by the industry due to pressure by the misinformed consumer, scared by non-differentiating ‘phthalate’ campaigns • Become worse by advances in analytical chemistry (Relevance of finding 0.000000000001% of a material in blood, mothers’ milk or the environment?). • May result in regulatory activities that tend to be based on hazard identification instead of risk assessments - potentially leading to unnecessary constraints – danger of misusing the precautionary principle Toxic Valentine Air fresheners cause a stink

4. Where is this leading to ?

5. Synthetic versus NaturalA twisted debate • Chemo phobia fuelled by certain interest groups leads to strange consumer expectations: Natural is generally regarded safe –chemically derived (synthetic) as unsafe • Naturals are per se neither more safe or less safe than synthetic materials – a number of very potent toxins are naturally derived (think about the fugu in Japan) – one of the strongest fragrance sensitizers is a natural extract

6. Vanilla Flower Many chemicals used in modern perfumery were developed between: 1850 and 1910. Many chemicals (so called ‘aroma chemicals’ are derived from the study of natural products. One example is vanillin: Naturals Fresh Vanilla pods Synthetics Dried Vanilla pods

7. Role of (Aroma) Chemicals RECONSTITUTION ORIGINALITY Lily of the Valley SUBSTITUTION ECOLOGY Musk deer, an endangered species

8. Synthetic versus NaturalA twisted debate • If our industry wanted to provide fragrances only consisting of natural materials (like e.g. rose oil), they would be prohibitive for most of the consumers due to the price – but would they be more safe? • Basis for a decisions about the safety of an ingredient (synthetic as well as natural) is a sufficient set of data that allows a safety (risk) assessment

9. Who cares about fragrance safety!? Industry self-discipline versus regulation? to ensure the safe use of fragrance ingredients / fragrance compounds Stakeholders involved:Sensitive points: Regulators, Media, Adequate Science NGO’s, Dermatologists Compliance - Control Consumers, Distributors Sufficient independence more… The fragrance industry has a research program in place since more than 40 years and maintains a global regulatory system with the objective of protecting consumer health and the environment since 1973 IFRA Self-regulation is: fast, global and independent!

10. REXPAN – Independent Panel of Experts Hachiro Tagami, MD Tohoku Univ. School of Medicine, Sendai, Japan Jon M. Hanifin, MD Oregon Health Sciences Univ. I. Glenn Sipes, PhD. (Chair) University of Arizona Donald V. Belsito, M.D.Univ. of Missouri David R. Bickers, MD Columbia University, NY Adrianne E. Rogers, MD Boston Univ. School of Medicine Prof. Magnus BruzeMalmo University Hospital, Sweden Prof. Peter CalowRoskilde University, Denmark Prof. Dr. Helmut A. Greim Neuherberg Institut für Toxikologie Munich, Germany Jean-Hilaire Saurat, MD Universitaire de Geneve, Switzerland

11. Fragrance Industry Safety Program Build on two pillars: • RIFM : Research Institute for Fragrance Materials RIFM and its Expert Panel REXPAN are responsible for safety testing and risk assessmentwww.rifm.org • IFRA : International Fragrance Association IFRA is responsible for the risk managementvia theIFRA Code of Practice and ‘Standards’ for safe use of fragrance ingredients www.ifraorg.org

12. Perfumers dispose of approximately 2000 ingredients both natural and synthetic, with which to create fragrances.

13. Complexity of the fragrance The formula used in the manufacturing plant First level Full composition Natural Synthetic Natural Base Natural Natural Synthetic Natural 100to 800 ingredients Synthetic Synthetic Synthetic Synthetic Base Natural Base Synthetic The formula used for the risk assessment, labelling, etc

14. DOWNSTREAM USE OF FRAGRANCE SUBSTANCES

15. Globally Harmonised System • The basis for setting classification and labelling has been harmonised to follow the UN GHS criteria • The GHS system is made up of building blocks and allows countries / regions to pick and chose – local systems with different regulatory basis will result  Different hazard information for workers in different regions of the world • Some countries (e.g. Japan) consider a risk based approach for consumer product labelling under the roof of the GHS, others do not  Different hazard information / warning statements on the same consumer product in different regions of the world Globally Harmonised System?

16. Thank you very much for your attention Avenue des Arts 6, B 1210 Bruxelles, Phone: +32 2 214 2062, Email: mvey@ifraorg.org

17. Sensitisation to the Fragrance Mix I IVDK 2007 Basis: Schnuch et al Contact Dermatitis, 50: 65-76 (2004)

18. IFRA Standards Recognition • IFRA Standards are the only globally acceptedrisk management system for fragrance ingredients and receive high reputation from customer and authority point of view. • Since 1990 the Brazilian regulation recognizes the self-regulation of the industry by official adoption of the IFRA Standards • IFRA Standards are about to be introduced in the European Cosmetics law (IFRA prohibited already included, IFRA restricted in the process). • The ASEAN Cosmetics Directive foresees a requirement for proving IFRA compliance.