The Quandary. Next Generation Preservatives: International Regulatory Status

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1 Next Generation Preservatives: International Regulatory Status Janet Winter Blaschke International Cosmetics & Regulatory Specialists, LLC (US) International Cosmetics & Chemical Services Ltd (UK) The Quandary Continual safety questions on preservatives used for years Positively-listed, approved preservatives continue to be called into question Few, if any, being approved to replace them Significant net loss of choices Worldwide formula is almost a fantasy 1

2 International Challenges Microbial Limits TPC G+ G- Molds, yeasts Specific organisms Test Methodologies Vary per country, even by product category Particular concerns in Asia Informal limits Those pesky ingredient challenges 2

3 Parabens- throwing the baby out with the bath water Lightning rod for NGOs Public opinion first, science second Concerns about overall estrogenic activity Specific concerns about their use on products intended for small children Example: Parabens in the EU Ester Current EU Reg CIR review SCCS Opinion (proposed) Existing EU Regulation SCCP Opinion Methylparaben 0.4%/0.8% all esters Same Same Propylparaben 0.4%/0.8% all esters Same 0.14% max; * Ethylparaben 0.4%/0.8% all esters Same Same Butylparaben 0.4%/0.8% all esters Same 0.14% max* Isobutylparaben & Isopropylparaben 0.4%/0.8% all esters Same To be removed Benzylparaben Not listed Same To be removed Pentylparaben Not listed Not listed To be removed Phenylparaben Not listed Not listed To be removed *not to be used in leave-on products intended to be used on nappy area of children under three years of age; 0.14% max of the sum of Propyl- and Butylparaben. (proposed) 3

4 Chemicals legislation: Quaternium-15 Listed in the EU under Annex VI since 1976 Separate legislation CLP - Classification of chemicals EU-wide Chemicals legislation Not Cosmetics legislation Still applicable First instance, more to come Options/restrictions based on regulations Combinations needed Broad Spectrum preservatives limited Regulatory restrictions by level Regulatory restrictions per application type Negative lists Restricted lists Positive lists 4

5 Replacements Development time Costs Uncertain regulatory approval Ingredients with multiple functionsregulatory status? Rationale for the presence of the ingredient Specified purpose in the product 5

6 Possible options P-anisic acid Enzyme Systems Caprylyl Glycol Ethylhexylglycerin Undecylenolglycerin Pentylene Glycol 1,2-Hexanediol Other possible options Glyceryl Caprate Glyceryl Caprylate Glyceryl Laurate Levulinic Acid Phospholipids Polylysine Silver citrate 6

7 Extracts Essential Oils Curry Leaf Oil Cinnamon Leaf Oil Orange Oil Lemon Grass Oil Sesame Oil Clove Bud Oil Honeysuckle Flower Extract Willow Bark Extract Extracts Honeysuckle Flower Extract Willow Bark Extract Cost Important Issues to Consider Effective levels Cost Interference with formula stability Performance Physical/organoleptic characteristics Allergenic potential 7

8 Public perception Sound bites trump good science Industry must be vigilant Upper management should be aware of decisions based on perception NGO level of understanding Ultimately- does the consumer want Increased cost Contaminated products Free From Claims Now not allowed on Cosmetics If ingredients are legally permitted, they cannot be singled out and made to appear negative May be helpful in slowing ingredient hysteria 8

9 Some good fortune. Biocidal Products Regulation (BPR) Many products subjected to approval Approval at the EU level- ECHA Standard cosmetic products containing Biocides are exempted May be some positive fallout Previous approval was at EU Member State level Now approval at EU level May give more evidence for approval 9

10 Next steps Find ingredients used for other purposes that also have anti-microbial properties Continue to assure that products are safe Continue to provide information available to the consumer Our action items Industry needs focused efforts- multiple countries/agencies reviewing the same ingredients ISOs- scientists working together ICCR- Industry and government side by side 10

11 Information from Industry Other newer concerns Additional countries and trade groups adopting or recognizing the EU lists Other countries chemical regulations (e.g., K-REACH) China Korea 11

12 Solutions More and more creativity from Microbiologists and Formulators A level-headed approach by Upper Management Responsible ingredient marketing Responsible defense by cosmetic companies Conclusion Cooperation between formulators and microbiologists is essential now (innovation is not a hobby, but a fact of life) Follow breaking developments Support CIR and trade associations, submit valuable data, consumer info International Cooperation is critical- we sink or swim together NO Free from or comparative claims vs. other products 12

13 Thank you. Janet Winter Blaschke International Cosmetics (US and UK) 13