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 

1. An annual submission of composition data 

makes sense for an annual EPA audit.

OPP agrees.
comments of IRG)

2. Requirement for “annual selfcertification” 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 (selfcertification 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.