Global Regulatory Update: Regulatory Issues in the Candle Industry

Transcription

1 Global Regulatory Update: Regulatory Issues in the Candle Industry Eileen Hedrick Corporate Vice President Regulatory Affairs & Fragrance Safety Belmay, Inc. Catherine Herman Vice President Regulatory Affairs & Fragrance Safety Belmay, Inc. Rob Harrington Director of Regulatory and Safety Blyth, Inc.

2 Canada Proposed Candle Regulations Mandatory safety/warning labeling Prohibition of lead wicks Prohibition against relighting candles May appear in the Canada Gazette I in fall of 2010 at the earliest Comment period Phase in stage (likely at least 180 days)

3 Proposed Warning Text WARNING: Never leave burning candles unattended. Do not place burning candles on or near anything that can catch fire. Keep burning candles out of the reach of children. AVERTISSEMENT : Ne jamais laisser de bougies allumées sans surveillance. Ne pas placer de bougies allumées sur une chose susceptible de prendre feu ou à proximité. Garder les bougies allumées hors de la portée des enfants. Or equivalent

4 Small Candle Warnings An exception is provided for small candles which requires only: WARNING: Never leave burning candles unattended. AVERTISSEMENT : Ne jamais laisser de bougies allumées sans surveillance.

5 Pictogram Option May use either ASTM 2058 pictograms or European Standard EN 15494:2007 pictograms OR

6 Additional Proposed Regulations Labels or tags must be Made of nonflammable material or Pass candle fire safety testing (ASTM or CEN Standard) or Must have instructions to remove label before use May be imported unlabeled/mislabeled if properly labeled prior to sale

7 Ingredient Labeling U.S./California Several proposed regulations are before the State of California and the U.S. Congress on mandatory labeling of consumer products Things are still in the negotiation stage Uncertainties in what/how/where consumer products must be labeled

8 California Labeling bill includes air care products, cleaners/polishes, car care products Must have an internet site that lists all substances in each product by a common name

9 U.S. Congress The labeling bill includes air fresheners, paints, cleaners, polishes, laundry, dishwashing, and adhesive products Fill disclosure of all ingredients on the label

10 ACME Fragranced Candle INGREDIENTS: PARAFFIN, AETATE C-10, C LINALOOL, METHYL DIHYDROJASMONATE, CINNAMYL ACETATE, METHYL IONONE GAMMA, TRIETHYL CITRATE, JAVANOL, ETHYL BENZOATE, METHYL-5-PHENYL PHENYL-2-HEXEN-2-AL ETHYL PYRAZINE-2, CUMINIC ALCOHOL, DIPROPYLENE GLYCOL TERPINENOL-4, DECYL ACETATE, SANDAL MYSORE CORE, ALDEHYDE C11 UNDECYLENIC, MANDARIN OIL, PYRAZINE CYCLOPENTA, ALPHA-IONONE CITRIC ACID, NERYL ACETATE, ESYL METHYL ETHER PARA, GERANIC ACID, TRIMETHYL PYRAZINE, SULFUROL, CEDARWOOD OIL TERPENES, PHENYLETHYL DIMETHYL CARBINOL, METHYL CYCLOPENTENOLONE, ALLYL HEXANOATE, LABDANUM RESINOIDE, EBANOL, ACETYL PROPIONYL, LIMONENE, E, TERPINEOL, ISOEUGENYL ACETATE, LINALYL FORMATE, HEXENAL TRANS-2, EUGENYL ACETATE, ALDEHYDE C18, CYMENE PARA, CINNAMIC ALD DIMETHYL ACETAL, BISABOLNE, CTRAL, CASSIA OIL, MALTOL, ACETYL PYRIDINE-2, FURFURALDEHYDE, 2-, 2, TOL PROPIONATE, GURJUN BALSAM OIL, TINUVIN 5060, VANILLIN, CINNAMON LEAF OIL, COUMARIN, LYRAL, ETHYL VANILLIN, CLOVE LEAF OIL, ANISYL ALDEHYDE, CEDRYL KETONE, PATCHOULI OIL, HELIOTROPIN, BENZYL BENZOATE, EUGENOL, METHYL CINNAMIC ALDEHYDE ALPHA, NUTMEG OIL, GERANIOL, BUTYL HYDROXYTOLUENE, LEMON OIL, ORANGE OIL TERPENE, ORANGE O OIL, LAVANDIN OIL, OCTALACTONE GAMMA, CEDRYL ACETATE, ETHYL MALTOL, BENZYL ACETATE CLARY SAGE OIL, ETHYL BUTYRATE, EXENOL CIS-3, METHYL DIANTILIS, JASMONYL, CITRONELLOL, BETA-IONONE, CALYPTOL, PHENYLETHYL ALCOHOL, GERANYL ACETATE, METHYL SALICYLATE, HEXENOL TRANS-2, DAMASCOL,4-,, HEXYL FORMATE, ISOEUGENYL METHYL ETHER, TAGETTE OIL, PEPPER OIL, STYRALYL ACETATE, CARYOPHYLENE DISTILLED, BLUE DYE 1, and A PARTRIDGE IN A PEAR TREE.

11 Issues with the Bills Are candles air care products? List every ingredient? Impurities? Use of generic terms (fragrance, colors) What is the common name of a substance? Label vs. website disclosure? Trade secret protection? Sell through provision? Stay tuned..

12 U.S. Consumer Product Safety Improvement Act (CPSIA) of 2008 The U.S. Congress passed sweeping reforms of consumer product regulations Primary focus was children s s products but other product categories are effected Increases enforcement and recall authority, requires some product testing and certifications, substantially increases penalties and establishes a public database

13 CPSIA Requires a company that uses metal wicks to test and certify to their customers that the metal is less than 0.06% lead Certification must be provided my manufacturers to retailers or distributors Increases maximum penalties from $1.25 million to $15 million

14 CPSIA Public Database Consumers, physicians, public officials can submit reports of harm to the CPSC via internet or telephone on any consumer product Must provide details on the product, manufacturer and the harm caused Manufacturers are informed have a comment period to respond to allegations Publically searchable, reports not verified Concerns for reliability of information and how the data will be used

15 Product Recalls U.S. If a product contains a defect which creates a product hazard or a risk of serious injury or death Must IMMEDIATELY report to the CPSC Must include details of the product, defect, injuries, sales, dates etc

16 Product Recalls - Canada No mandatory recall process, all recalls are voluntary Products should be recalled if it is determined that a product is unsafe Recalls are company driven Health Canada should be informed when a safety related recall is initiated by a company Canadian recall guidance is found at: sc.gc.ca/cps-spc/advisories- avis/child-enfant/recalling enfant/recalling-guide rappel-eng.php eng.php

17 Canada Proposed Regulations Canada Consumer Product Safety Act (Bill C-6) was introduced in January 2009 Prohibited sale of dangerous products, mandated labeling and reporting requirements, authorized recall powers, increased monitary fines, required products meet established standards Bill did not pass Likely to be reintroduced in the near future

18 Europe The General Product Safety Directive, 2001/95/EC is the EU regulation governing consumer products Producers/distributors that become aware that a product poses risks to the consumer shall immediately inform the competent authorities of the Member States safety/rapex/contact_points.pdf

19 Europe The competent authorities of the member states alert the commission which in turn alerts the other EU states through a system called the Community Rapid Information System (RAPEX) RAPEX shares information on serious product safety issues and recalls RAPEX information and recalls are found at /rapex_archives_en.cfm

20 IMPLEMENTATION OF GHS

21 What are we going to cover? UN GHS Background US Status and Implementation of GHS Global Implementation of GHS (to date)

22 UN - GHS BACKGROUND

23 International Mandate from UN Conference on Environment and Development (UNCED) aka Earth Summit A A globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000

24 GHS What is it? GHS an acronym for Globally Harmonized System of Classification and Labeling of Chemicals A document (not a regulation or directive) Provides a logical and comprehensive approach to: Defining health, physical, and environmental hazards of chemicals Create a classification process using available data on chemicals Communicate hazard information & protective measures on labels & SDS s

25 GHS Guiding Principles Protection will not be reduced Based on intrinsic hazards of chemicals All types of chemicals will be covered All systems will have to be changed Involvement of all stakeholders should be ensured Comprehensibility must be addressed

26 Existing Systems Used to Develop GHS Included: UN Transport Recommendations U.S. Requirements for Workplace, Consumer, and Pesticides EU DSD/DPD Canadian Requirements for Workplace, Consumers, and Pesticides

27 A Brief Timeline 1992 an international mandate adopted at the UN Conference on Environment & Development (UNCED) 1999 scope is expanded to include transport of DG 2002 implementation plan encouraged countries to implement GHS ASAP fully operational by 2008 World Summit on Sustainable Development (WSSD) st edition of the GHS published (affectionately referred to as The Purple Book ) 2009 US-OSHA publishes NPRM - GHS

28 Is it necessary to harmonize? Global chemical business - >$1.7 trillion/yr US $450 billion/exports >$80 billion/yr Sector-specific regulations i.e.: transport, workplace, and consumer products; etc.

29 GHS One system to cover all.. Using the same criteria World-wide Protect potentially exposed Workers Consumers Emergency responders Public

30 An example of the difference between country/classification

31 As you can see DOT Flammable = F Combustible = F WHMIS EU Division 2 Flammable = F Division 3 Combustible = F Extremely/highly/flammable = 0 131F OSHA HCS Flammable = F Combustible = F

32 What does this mean Flammable liquids covered by most existing systems The same product can be hazardous or non-hazardous, depending where you are different labels/sds SDS s required The Goal GHS will resolve this as all will use the same criteria to classify chemical

33 How will GHS help? GHS Category 1 Criteria (flash point) <23C (73F) BP</=35C (95F) GHS Category 2 <23C (73F) BP>35C (95F) GHS Category 3 GHS Category 4 >/=23C (73F) and </=60C (140F) >60C (140F) and </=93C (200F)

34 GHS 3 major hazard groups Physical hazards Health hazards Environmental hazards Within each hazard group classes/categories Each class/categories = building block Select correct building block and apply corresponding GHS rules for classification/labels

35 GHS Health Hazard Categories Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicology Target organs SE Target organs RE Aspiration toxicity

36 Physical Hazards Categories Explosives Flammable gases Flammable aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self-reactive substances Pyrophoric liquids Pyrophoric solids Self-heating substances Oxidizing liquids Oxidizing solids Organic peroxides Corrosive to metals Contact with water emit flammable gases

37 Environmental Hazards Categories Hazardous to the Aquatic Environment Acute aquatic toxicity Chronic aquatic toxicity Bioaccumulation potential Rapid degradability

38 All Chemicals in the Workplace must be Classified Once classified, specific signal words, hazard statements and symbols/pictograms are required for each hazard class and category These elements must appear on the label

39 Pictograms Examples not all cat. have symbols

40 Hazard Statements Prescribed for each classification, for example: GHS Class ATO 1,2 ATO 3 ATO 4 ATO 5 GHS HS Text fatal if swallowed toxic if swallowed harmful if swallowed may be harmful if swallowed

41 2 Signal Words Danger and Warning Danger most serious Warning less serious Must appear on MSDS and label

42 UN - GHS US Status & Implementation of GHS

43 What s s OSHA Up To? September 30, 2009 OSHA released NPRM to modify the existing Hazard Communication Standard (29 CFR ) to incorporate GHS ~90 day comment period 12/30/09 Currently reviewing comments (700 received) Final rule expected 18 months (minimum) after the NPRM ~March 2011 NPRM based on Revision 3 of the UN GHS

44 What s s changing? All provisions of GHS adopted except: Acutely toxic oral, dermal, inhalation where LD50 = mg/kg Skin corrosion/irritation Cat. 3 causes mild skin irritation Aspiration hazard Cat.2 maybe harmful if swallowed and enters lungs All Hazardous to the Environment categories (EPA)

45 What s s outside scope of GHS but retained or added by OSHA? OSHA term - unclassified hazards Combustible dust Cryogenic materials Simple asphyxiant (new)

46 What else? Material Safety Data Sheet/MSDS = Safety Data Sheet/SDS 16 point MSDS allowed but not enforcing sections Currently 90 days to update information on label/msds for downstream users proposed to be lifted

47 Implementation 2 year transition period for training 3 years for manufacturers, importers, distributers Full compliance by 2014

48 Global Implementation of GHS Finally!

49 The following countries have implemented GHS or are in the process of implementation Australia China Hong Kong India Indonesia Japan Korea Malaysia New Zealand Philippines Singapore Taiwan Vietnam EU Russia South Africa Brazil Mexico Canada USA

50 Implementation Dates Vary Different compliance dates for substances/mixtures Run parallel systems

51 Summary The concept of GHS was born in 1992 at the Earth Summit It provides a framework for countries without chemical safety regulations to develop one It provides the tools needed to revise existing chemical safety regulations It provides a prescribed system to classify and label hazardous chemicals which is intended to be implemented by all users

52 The End Thank you! Eileen Hedrick Corporate Vice President Regulatory Affairs and Fragrance Safety Belmay, Inc

53 Research Institute for Fragrance Materials, Inc. (RIFM) What is RIFM? RIFM is THE International Scientific Authority for the Safe Use of Fragrance Materials

54 RIFM What does RIFM do? RIFM s s purpose is to gather and analyze scientific data, engage in testing and evaluation, distribute information, cooperate with official agencies and to encourage uniform safety standards related to the use of fragrance ingredients. What doesn t RIFM do? RIFM does NOT establish ingredient standards

55 IFRA 45 th Amendment

56 RIFM Expert Panel An independent* & internationally respected Panel of Experts comprised of: Dermatologists Pathologists Toxicologists Environmental Scientists *having no ties to the fragrance industry

57 RIFM Expert Panel (REXPAN) Advises RIFM on its strategic approach, reviews protocols and evaluates all scientific findings. The conclusions of the Expert Panel form the basis for the Standards set by the International Fragrance Association (IFRA).

58 International Fragrance Association (IFRA) IFRA is the GLOBAL representative body of the fragrance industry. What is the Main Purpose of IFRA? To ensure the safety of the consumer and the environment through a dedicated science program.

59 Fragrance Safety Standards The Fragrance Industry is self regulated. Self-regulation enables the IFRA standards to be adopted very rapidly by fragrance houses worldwide and by the industry as a whole.

60 Hazard / Risk / Exposure What is Hazard? Hazard is the harm that something can cause. The harm may be physical injury, damage to health, property and/or the environment. What is Risk? Risk is the likelihood that a hazardous material will cause harm to people, property or the environment. What is Exposure? Exposure is the extent to which people or objects are subjected to the hazard. it can be influenced by factors such as the length or duration of exposure (short versus long), how much exposure (high concentration versus low) and/or the route of exposure (inhalation versus skin contact versus ingestion).

61 Quantitative Risk Assessment (QRA) This new methodology is a major improvement improvement over former risk assessment practices because it specifically addresses the elements of exposure based risk assessment that are unique to the induction of dermal sensitization. The QRA addresses the protection of human health and is specifically aimed at ideally eliminating the acquisition of dermal sensitization of fragrance ingredients under conditions of use. QRA was introduced with the 40 th Amendment to the IFRA Code of Practice.

62 IFRA Categories Prior to the QRA approach there were two product categories: Skin Contact Non-skin Contact Under previous risk management strategies used by IFRA each specific fragrance raw material identified as an allergen was limited to the same concentration across all skin contact product types. This is no longer considered sufficient. With QRA there are now 11 Categories and a total of 23 Classes

63 IFRA Categories/Classes/Groupings The IFRA QRA approach for fragrance ingredients uses multiple product categories for the implementation of IFRA Standards. This is achieved by grouping consumer product types according to key parameters identified within the QRA approach. These parameters are Sensitization Assessment Factors (SAFs) and consumer product exposure, which when combined, lead to similar acceptable use levels of a fragrance ingredient.

64 Category 11 Non-Skin / Incidental Skin Contact Due to the expected insignificant skin exposure from products grouped in this Category the risk of induction of dermal sensitization through the normal formulation and use of such products is considered negligible. As such, the concentration of fragrance ingredient is not restricted in the finished product.

65 Category 11 Non-Skin / Incidental Skin Contact Air Fresheners of all types Animal Sprays Candles Cat litter Deodorizers/Maskers (e.g. fabric drying machine deodorizers, carpet powders) Floor wax Fragranced lamp ring Fuels Insecticides (e.g. mosquito coil, paper, electrical, for clothing) Joss Sticks or Incense Sticks Machine Dishwash Detergent and Deodorizers Machine Only Laundry Detergent (e.g. liquitabs) Odored Distilled Water Paints Plastic articles (excluding toys) Reed diffusers Scratch and sniff Scent pack Shoe Polishes Toilet Blocks Treated Textiles (e.g. starch sprays, fabric treated with fragrances after wash, etc.)

66 IFRA 45 th Amendment Three new Standards, based on the QRA Dimethylcyclohex-3-ene-1-carbaldehyde (mixed isomers) Vertocitral Triplal / Cyclal / Cyclal C Agrumen Aldehyde Tricyclal Cyclovertal alpha-methyl-1,3-benzodioxole-5-propionaldehyde Helional / Tropional Phenylbutanal Trifernal

67 IFRA 45 th Amendment - continued One revised Standard on Verbena absolute (Lippia citriodora) CAS No , based on the QRA One revised Standard - 2,2-Dimethyl-3-(3-tolyl)propan-1-ol (Majantol) with specifications regarding presence of organochlorides One new Standard on Musk ketone with specifications regarding presence of Musk xylene Musk ketone can contain traces of musk xylene, which has been prohibited as part of the 44 th Amendment. It has therefore been decided to set a specification Standard, asking that the level of musk xylene in musk ketone be kept below 0.1%, which is consistent with current IFRA policy regarding the presence of trace substances in fragrance materials.

68 IFRA 45 th Amendment - continued One new Standard prohibiting the use of Quinoline (CAS No ) The material has been officially classified CMR II (GHS CMR 1B) and had only minor reported use. Future Amendments to the IFRA Code of Practice (beyond 2010): Beyond 2009, future Amendments to the IFRA Code of Practice will include new IFRA Standards (where none previously existed) on fragrance ingredients from the RIFM Database and will also include those existing IFRA Standards based on the QRA approach that are scheduled for their 5-year review or for which significant new data are available

69 RIFM CANDLE STUDY The aim of the study was to investigate the dermal exposure to fragrance materials from scented candles, whether occurring intentionally or unintentionally. A simple hand wipe sampling and analysis procedure was used to determine the human dermal exposure to three fragrance materials (Cinnamic aldehyde, d Limonene d and Eugenol) commonly used in candles. Pillar scented candles (3 in diameter x 6 6 in height) containing 5% fragrance mixture were used.

70 Hand Transfer 10 subjects washed their hands with non-fragranced soap & tap water, rinsed well and dried their hands with paper towels. They then grasped a new candle one at a time in each hand, and held the candles for ~20 seconds. The hands of the subjects were then wiped with dressing sponges containing isopropyl alcohol. This procedure was repeated 4 additional times for a total of 5 exposures. After each exposure, palms were wiped with the dressing sponges containing IPA and the samples were analyzed

71 Results In all subjects the residue of d Limonene d transferred to the hands from the candles was below the limit of quantification. The residue of Cinnamic aldehyde and Eugenol transferred to the hands was consistent from subject to subject and from round to round and was considered to be minimal. Based upon this study it was apparent that exposure to fragrance materials tested during short-term term consumer handling of scented candles does not pose a significant human dermal sensitization risk.

72 No-Observed Effect-Level Using RIFM (NOELs), a significant safety factor exists between the measured exposure concentration for human skin contact from scented candles and the NOEL for the induction of dermal sensitization in humans for all three fragrance materials.

73 IFRA Compliance Program The IFRA Compliance Program was voluntarily created to ensure that fragranced consumer products are in strict compliance to the IFRA Code of Practice and ensuing ingredient standards. It involves the analysis of a variety of consumer products for the presence of fragrance ingredients regulated by IFRA Standards. In order to assure confidentiality and impartiality this is accomplished through the use of an independent laboratory. The fourth cycle of the IFRA Compliance Program covering the period May 2009 to April 2010,found no IFRA banned substances in any of the selected products*. A test sample of fifty fragranced products, chosen at random from a selection of 450 marketed products from ten different countries, found that all fragrance formulations were compliant with the IFRA Code of Practice. (*FF, body care, household)

74 RIFM / IFRA Alliance The RIFM/IFRA alliance allows for coordination of information & action from the scientific body to the advocacy needs of our industry. This alliance promotes industry expertise in fragrance safety based on sound science. Communicates informed scientific data to official agencies and other interested parties.