Why fragrances

1
Why fragrances?

2
What is a fragrance?

• Fragrances are complex mixtures of natural and
  synthetic materials. Natural ingredients are
  derived from roots, seeds, bark, flowers etc.
  Synthetic ingredients are manufactured through
  chemical processes.

3
Benefits of fragrance

• They are safe for consumers and the environment
• Aromatherapeutic
• relaxing, increase efficiency and alertness,
  raise test scores, shed weight, project an image,
  inspire confidence, to name a few.
• Cover/mask an off base note or other offensive
  odors

4
Safety Guarantee

• Fragrance materials are used in a variety of
  consumer products including
• perfumes, creams, lotions, detergents, personal
  products, household products
• It is essential to minimize potential skin
  disorders linked to fragrances
• This is accomplished through the publication of
  worldwide industry safety standards (IFRA Code of
  Practice)
• The fragrance industry has maintained a strict
  system of safety assurance for more than 30 years

5
The Structure of the Safety Sector of the
Fragrance Industry

• RIFM
• RIFM Expert Panel (REXPAN)
• IFRA
• National/Regional Associations
• Member companies

6
Research Institute for Fragrance Materials (RIFM)

• Located in NJ, chartered in 1966 as a nonprofit
  international organization
• Primary objectives
• gather and analyze scientific data from the
  industry and open literature
• engage in evaluation and testing of fragrance
  ingredients
• review and evaluate the standards and methods
  employed by the industry for testing on a
  continuous basis
• Comprehensive research and testing program
  including
• fragrance allergy
• respiratory safety
• human health and environmental methodology
• group safety evaluations
• use level support
• Publishes results, findings, and conclusions in
  peer-reviewed and accredited scientific journals

7
RIFM Expert Panel (REXPAN)

• Consists of
• independent toxicologists, academic
  dermatologists, pharmacologists, and
  environmental scientists
• No commercial ties to the industry
• REXPAN conclusions form the basis for standards
  issued by IFRA
• Receives safety dossiers for fragrance raw
  materials from RIFM for evaluation

8
REXPAN Conclusions

• After REXPANs review of the safety dossier they
  communicate with RIFM one of the following
• Recommend no action or standard required
• Recommend no action to an existing standard
  (mandatory 5 year review of all materials with a
  published standard in place)

9
REXPAN Conclusions (cont.)

• Determined effect to be the critical effect
  (i.e., sensitization) which is detected through
  an induction (primary prevention) assay
• Decision based on an effect level/no effect level
  of x
• Using an uncertainty factor of y

10
REXPAN Conclusions (cont.)

• If no changes recommended, suggests shortened
  review cycle
• Based on the fact that effect (such as
  irritation) is easily detected and is considered
  to be self-limiting
• Date

11
International Fragrance Association (IFRA)

• Founded in 1973
• Publishes and distributes the IFRA Code of
  Practice (industry safety standards)
• Standards are based on scientific principles with
  primary aims to protect the consumer and the
  environment

12
IFRA Commitment

• IFRA its national associations and their
  member companies are committed to providing
  products that are safe for use to the consumer
  and to the environment

13
International Fragrance Association (IFRA)
Standard Practice

• Three IFRA Scientific Committee meetings per year
• Request to RIFM safety evaluations
• Current use conditions
• Usually skin sensitization

14
IFRA Standard Practice (cont.)

• REXPAN review
• Human Repeated Insult Patch Test (HRIPT)
• Phased approach to panelist exposure
• No-effect level (NoEL)

15
IFRA Standard Practice (cont.)

• REXPAN conclusion
• Draft IFRA standard
• Consultation phase
• Final Standard language and rationale
• Adoption/communication

16
Elaboration of an IFRA Safety Standard

• WHAT?
• Drafting safety dossier ? ? ?
• Evaluation ? ? ?
• Drafting standard ? ? ?
• Consultation ? ? ?
• Final Wording ? ? ?
• Communication to membership ? ?

• WHO?
• RIFM
• REXPAN
• IFRA Scientific Committee (SC)
• IFRA Members Assns.
• Client industry
• IFRA SC
• REXPAN
• IFRA Secretariat

17
IFRA Standards Compliance!

• All major international and national fragrance
  manufacturers are members of IFRA through
  membership in their national associations
• The Fragrance Materials Association of the United
  States, located in Washington, D.C., is our
  national association

18
IFRA Standards Compliance!

• All members of IFRA obey the IFRA Code of
  Practice
• Standards are binding for all members of the
  association
• Mandatory compliance with the IFRA Code of
  Practice is conditional for membership

19
Summary

• The IFRA Code of Practice is comprehensive
• Applies to the manufacture and handling of all
  fragrance materials for all type of products
• Formulates the basic principles which are
  standards of good operating procedures by the
  fragrance industry

20
What does it take to get a sample of the door?

• Government Regulations
• IFRA Code of Practice and Standards
• RIFM What is it? The RIFM database
• Customer requirements
• Formula review
• The paperwork
• Tying it all together.

21
Government regulatory compliance - Federal

• EPA
• Storm water regulations
• Clean air regulations
• SARA 313
• OSHA
• Hazard Communication Standard
• PPE Standard
• Forklift Standard
• VOC regulations
• Shipping DOT, IATA, IMCO
• DEA
• BATF

22
Government regulatory compliance State and local

• NY - DEC
• California Proposition 65
• Massachusetts RTK
• NJ RTK
• California consumer products VOC regulation
• Cal-OSHA

23
Government regulatory compliance - International

• EU Dangerous Preparations Directive
• EU Cosmetic Regulation
• Germany WGK regulations
• Canada WHMIS
• UK CHIPS
• Australia TGA
• Japan Cosmetic regulation
• Korea labeling regulations

24
How do you become aware / comply to all of these
regulations???

• It aint easy!!!!
• Association memberships
• Committee memberships
• Networking
• Lots of reading
• Lots more reading.

25
Important!

• Recordkeeping keep accurate records of all
  training, filings, course records, customer
  communication, documents
• Work efficiently, work safely!

26
Customer requirements

• Examples
• Compliance to VOC regulations
• Compliance to EU cosmetic allergens regulations
• No polycyclic musks
• No nitromusks
• No alkylphenol ethoxylates
• No phthalates

27
Customer requirements (cont.)

• Paperwork examples
• IFRA Certification
• MSDS
• Product specifications
• Compliance to customer requirements certification
• Customer specific forms and spreadsheets

28
Formula review what do you have to know?

• Does the formula comply with the current IFRA
  Code of Practice
• Does the formula comply with specific customer
  requirements?
• Does the formula comply with government
  requirements in the states/countries where it
  will be marketed?

29
REACH An EU Regulation that will change the
global marketplace!

• Expected entry into force Spring 2007
• Burdensome producers and importers of chemicals
  (and products that contain chemicals) that are
  manufactured or imported into the EU in
  quantities gt1 metric ton (approx. 30,000
  substances) to register these substances with a
  central EU Chemicals agency and provide extensive
  information on their properties, uses, and
  handling

30
REACH NOT RISK-BASED

• REACH is based on hazard not risk!
• A good science-based risk-based approach would be
  more workable because it would target chemicals
  that pose significant risks to human health or
  the environment

31
Enormous Scope

• REACH impacts chemicals and articles containing
  chemicals
• Impact US goods exported to Europe, including
  electronics, textiles, cars, and FRAGRANCES!!!
• US exports to Europe were gt200 billion in 2005

32
Overly Expansive NOT Workable!

• Not focused on substances that pose the highest
  risk
• Costly
• Burdensome
• Complex
• Adversely impact innovation

33
Non-EU Countries Voice Serious Concerns..

• Ambassadors from US, South Africa, South Korea,
  India, Japan, Israel, Brazil, Mexico, Malaysia,
  Singapore, Thailand
• EU response not encouraging
• The more regulationss unnecessary costs exceed
  its benefits, the greater the negative impacts on
  investment, innovation, job creation, and
  economic growth

34
Why fragrances?

• Why not?

35
References

• Research Institute for Fragrance Materials
  www.rifm.org
• International Fragrance Association
  www.ifraorg.org
• Fragrance Materials Association of the United
  States www.fmafragrance.org

36
Acknowledgements

• Thank you to Dr. Anne Marie Api, RIFM Scientific
  Director, for her contributions to this
  presentation
• amapi_at_rifm.org

37
Contact Information

• Eileen Hedrick
• Corporate Vice President
• Regulatory Affairs and Fragrance Safety
• BELMAY, INC.
• 200 Corporate Blvd. South
• Yonkers, NY 10701
• eileenh_at_belmay.com
• 914-750-9141