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Monday, June 27, 2011

IFRA 46th Amendment is Out

The International Fragrance Association (IFRA) has officially issued the 46th Amendment to the IFRA Code of Practice as part of the industry's ongoing safety program*.
There are six new restrictive Standards based on the Quantitative Risk Assessment (QRA)** and one new Standard prohibiting the use of 2,4-Octadienal.
IFRA has also withdrawn the Standard for Vanillin, which was first put in place with the 44th Amendment. This Standard was put on hold on 1st December, 2009, has now been officially withdrawn. Following the Vanillin Standard's notification additional information was submitted, which allowed for a re-evaluation of the material. After further additional testing and a critical evaluation of all available data today, IFRA has decided to withdraw the Standard and not set a revised Standard.
IFRA has also updated various guidance documents as part of the 46th Amendment.

  • QRA Information Booklet Version 6.0 Final 2011 (including guidance on classes for IFRA Certificates)
  • Annex 1 to the IFRA Standards which has been updated with contributions from other sources for o-Methoxycinnamaldehyde and Safranal
  • Index (list of all IFRA Standards)
  • Standard Operating Procedures (SOP) for the implementation of IFRA Standards

All the new Standards and related guidance documents are freely available on the IFRA website: http://www.ifraorg.org
1.    Six new Standards, based on the QRA
CAS             Name                                      Status
                                                            
    7492-44-6     alpha-Butylcinnamaldehyde                   
    39189-74-7    2-Heptylidene cyclopentan-1-one                  NEW
    1504-74-1     o-Methoxycinnamaldehyde                       RESTRICTED
    68922-13-4    3-Methyl-2-(pentyloxy)cyclopent-2-en-1-one      (QRA)
    13257-44-8    2-Nonyn-1-al dimethyl acetal
    13144-88-2    1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)
                  ethan-1-one


2.    One new Standard prohibiting the use of 2,4-Octadienal
2,4-Octadienal has been reviewed by the RIFM Expert Panel and, due to lack of adequate data (Dermal DNA Adduct study), it was concluded that it should not be used as or in fragrance ingredients in whatever application until additional data is available and considered sufficient to support its use. The presence of a structural alert as defined in the Human Health Criteria Document justifies this ban which already concerns several materials of the same structural family.
CAS           Name                     Status

    30361-28-5    2,4-Octadienal            PROHIBITED

How the whole thing works, for those who missed our previous posts on the subject of perfumery ingredients restrictions:
The fragrance industry's safety program is founded on testing fragrance materials and either establishing 'Safe Use Levels', or prohibiting their use, based on studying their potential effects on people and the environment. Currently the safety program contains 186 'Standards', which restrict, or prohibit, the use of selected fragrance materials.
To ensure that the fragrance industry adheres to its safety standards the International Fragrance
Association (IFRA) has a Compliance Program. Every year 50 products from a selection of 450, gathered from stores in 10 different countries, are tested. If a product does not comply with its Code of Practice and Standards, IFRA works with the manufacturer to ensure compliance.
The IFRA Code of Practice is a comprehensive document that supports the IFRA commitment to provide products that are safe for use by the consumer and to the environment.
The Code of Practice applies to the manufacture and handling of all fragrance materials, for all types of applications and contains the full set of IFRA Standards. Abiding by the IFRA Code of Practice is a prerequisite for all fragrance supplier companies that are members of IFRA (either directly or through national associations). The majority of client companies (including producers of toiletries and household products) expect their fragrances to comply with IFRA Standards as set out in the Code.
The IFRA Code of Practice is distributed worldwide and is in the hands of all member associations and their member companies, in addition to governmental regulatory bodies and many other stakeholders. It is also available to all on our website: http://www.ifraorg.org

**Quantitative Risk Assessment (QRA)
In 2005 IFRA introduced a new Quantitative Risk Assessment or QRA approach to restrict fragrance materials that have a potential to induce contact sensitization. This new approach is a much more refined approach for evaluating sensitizing materials, and so provides more precise guidance on use levels of materials depending on the situation and the product in which they are used; ultimately it should better protect the consumer from becoming sensitized to a specific material.

SOURCE: The International Fragrance Association (IFRA), Brussels 27th June 2011

2 comments:

  1. Anonymous18:16

    So this is good news about vanillin? I'd love to hear someone's analysis. Also, o-Methoxycinnamaldehyde? Isn't this the antiinflamitory, antioxidant, etc., etc., found naturally in cinnamon? How is it proposed to be restricted and is this news? Just curious ...

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  2. It is good news on vanillin. It had escaped with the previous installment, but this assures us that things won't go astray in that regard at least.
    Yeah,methoxycinnamaldehyde is common. But spicy notes are demonised, it seems, taking in mind previous ones. Cinnamon has rather sensitising qualities on skin (a simple experiment with oil will convince you) so I guess that if the ingredient is used in research in that context, it might skew the proportions of the "demonising". They do apply quite a lot and on quite sensitive areas of the lab rats (on the ears etc) and such....

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