|
It has already been three and a half years since the major change in assessment, publication and reporting of IFRA Standards has occurred. With the publication of IFRA’s 40th Amendment in May 2006 came a required overhaul of regulatory systems for reviewing, greater project specificity for end product identification, and training for more than just the Regulatory and Perfumery departments.
The driving force was the implementation of RIFM’s QRA approach for risk assessment of fragrance ingredients. From a scientific point of view, the QRA methodology provides a significant advancement warranting praise. From every other angle, well, ouch! For those who thought IFRA compliance was a difficult and daunting task pre-40th Amendment, you can now look back and say “I remember when……” reliving memories of a more simplistic approach consisting of “leave-on, rinse-off and non-skin” contact reviews and reporting.
Hopefully the 11 categories (with sub-classes) replacing the initial three (leave-on, rinse-off and non-skin contact) is not news to you. Do keep in mind this categorization is a dynamic list. As we have already seen, with new data the number of categories or classes can increase, application types can change location and new products need categorization. Specific details regarding the QRA approach and existing categories can be found in the QRA INFORMATIONAL BOOKLET VERSION 4.1 from RIFM’s website. Within this you can find numerous additional links and reference documents: http://www.rifm.org/doc/IFRA%20RIFM%20QRA%20Information%20booklet%20V4%201_July%202009_1.pdf
In addition to the obvious features of IFRA Standards, there are other IFRA compliance requirements which could be easily neglected. Below are some important reminders which necessitate repeating:
1. Standards for fragrance raw materials are classified as Prohibited, Restricted and/or having a Specification requirement. Restricted designates that there are maximum allowable use levels imposed on the material. This parameter is typically the main focus for IFRA traditional compliance. Prohibited materials had previously been segregated in a separate region of the IFRA Standards labeled “Other Materials” enabling them to be easily overlooked and forgotten. They have finally been given the attention they warrant. They have joined the rank of the other materials appearing directly within the Standards. These Prohibited materials should be revisited for reviewed. The Specification Standards are unique for their management requires knowledge of processing and/or quality control details. Materials designated as having a Specification Standard should be reviewed with the Supply Chain at Purchasing and supplier level to ensure proper qualities are available.
2. Contributions from additional sources must be accounted for (unless otherwise noted). The TOTAL concentration of a restricted material should be used when evaluating a fragrance formulation. This requires the summation to include all direct and indirect (e.g., a component of naturals or synthetic ingredient) contributions. For indirect contributions, go to the IFRA Website within the IFRA Standards section: http://ifraorg.org/Home/Code,+Standards+Compliance/IFRA+Standards/page.aspx/56
There is a “Quick Link” to Annex 1. This Annex provides values to use in place of missing analytical / supplier details for materials which may be present from additional, indirect sources.
3. If a material does not have an IFRA Standard this does not mean you can use it without restraint, nor does it mean you must absolutely avoid it. Usage of a “new” fragrance ingredient requires significant and appropriate safety evaluation. The IFRA Code of Practice, Appendix 5, provides guidance for the Safety Evaluation of Fragrance Materials. (REXPAN = RIFM’s Expert Panel)
4. Finally, you should also be aware that IFRA has an official Compliance Program which was also launched in May 2006. Full implementation began a year later. With this program, specific product types are randomly evaluated for the presence of IFRA Prohibited materials. Restricted materials will follow suit. Full details of this program are also found on IFRA’s website: http://ifraorg.org/Home/Code,+Standards+Compliance/Compliance-Program/page.aspx/57
Remember, we are a self-regulating industry. These proactive measures help us to maintain this status.
If you have any questions/comments/concerns regarding this or other Regulatory issues, please contact me at
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
. It is my intent to select a topic of interest each month to include on the ASP website. Pressing issues will be included as deemed necessary.
Have a Happy & Healthy Holiday Season!
Written by Stephanie Blakely, Regulatory Consultant, for The American Society of Perfumers Website (December 16, 2009). |
