Document ID: EPA-HQ-OPP-2010-1046-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-11-22T05:00Z

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 Fragrance Ingredient List (FIL).

Should be submitted to the Inert Ingredient Assessment Branch of the Registration Division.

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 FIL.  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 fragrance companies

8. Clarify the frequency and timing of publication of future revisions to the FIL.

 
It has 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 comments of IRG)
1. An annual submission of composition data makes sense for an annual EPA audit.

OPP agrees.

2.  Requirement for "annual self-certification" of a supplier's "fragrances" should be deleted.

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 portion of the new fragrances" - IRG 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.
It has 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 every 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 be provided 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.