**FRN for the Pilot Fragrance Notification Program: Response to Comments**

**September 14 , 2011** 

Submitter Comments/Recommendations OPP Response

IFRA 1. Clarify that submission of fragrance

composition data is not necessary if certification requirements are met.

2. Require the resubmission of certifications only when there are changes to an individual fragrance formulation.

3. Edit Attachments I & II as suggested above. Done.

4. Establish the requirements for submission of information regarding an ingredient proposed for addition to the F ragrance Ingredient L ist (FIL)

. Should be submitted to the Inert In gredient Assessment Branch of the R e gistration D ivision

.

5. Add all ingredients on the existing inert lists (food & nonfood) to the FIL. There are many ingredients on the inert list and most are not appropriate for inclusion on the FI L. Those for consideration are done on a case by case basis. 6. Remove an ingredient from the FIL upon notification that IFRA has instituted a Standard banning that ingredient. This should be submitted to the Inert Ingredient Assessment Branch. Once notification is received that concurs about the ingredient, it will be promptly removed. 7. Give registrants and fragrance suppliers adequate time to reformulate a fragrance after an ingredient has been removed from the FIL. Registrants and fr agrance

c ompanies

8. Clarify the frequency and timing of publication of future revisions to the FIL. Ithas not been determined. However, it might be quarterly or twice a year depending whether or not there are new fragrances to add to the list.

IRG (ACC, Clorox, P&G and Reckett Benckiser support the 1. An annual submission of composition data

ma kes sense for an annual EPA audit. OPP agrees.comments of IRG) 2. Requirement for “annual self

certification” of a supplier’s “fragrances” should be del eted. OPP agrees that annual certification is not needed since the fragrance supplier is certifying with each notification that all components in the fragrance are listed in the FIL. 3.#9 every 6 months to provide “fragrance composition” seems at odds with an annual “self certification” OPP agrees with once a year submissions. However, each fragrance supplier must e

- submit (once a year) full composition of each fragrance that the company has submitted through notification.

4. #10 talks about the OPP audit (requests for composition data for a po rtion of the new fragrances”

- IR G thinks they understand the intent, but wouldn’t the composition data already be required by #9?

EPA should clarify that no additional “requirements for composition data” beyond those normally required, are intended. The process calls for a yearly audit. Thus, the information is needed only when we perform our audit. A yearly submission will require fewer resources. We have never had to disclose the identity of a fragrance due to health concerns.

Recket Benckiser (IRG also supports this) Eligibility of fragrance actions involving

aerosol antimicrobial products. Ithas been long standing policy that any change to an antimicrobial aerosol formulation could affect the efficacy. If companies have data to prove otherwise, the data needs to be submitted to EPA for evaluation. If the data support the claim that fragrance changes do not affect the efficacy of an aerosol product, then the Agency will revise this process and allow aerosol products to make fragrance changes via notification.

P&G 1.Deletion of eligibility item # 8 (self

certification requirement eve ry year) OPP agrees to deletion of item # 8. 2. Twice a year requirement to contact the fragrance supplier to ensure that the fragrance composition is submitted in the Agency. OPP agrees that the identity of the components in a given fragrance needs to b e prov ided only once a year

.3.#10 Auditing of the program would be done yearly by OPP. It’s not clear how this audit program will differ from the submission of the fragrance disclosures to EPA cited from item 9. Please clarify. The process calls for a yearly audit. Thus, the information is needed only when we perform our audit. A yearly submission will require fewer resources. We have never had to disclose the identity of a fragrance due to health concerns.