to products applied to the body areas reasonably expected to be
exposed to sunlight. The 49th Amendment introduced a restriction
level to some rinse-off products, which has led to a significant
change in the rationale to attribute phototoxicity considerations
to the finished consumer product. Going forward, new product
categories will now have phototoxicity restrictions.
Ultimately, the goal is to prevent induction of allergic sensitization
to fragrance ingredients. To this end, new conclusions
were drawn. When a limit for skin sensitization is introduced,
the QRA2-derived level will be compared to levels derived from a
systemic toxicity point assessment in which the lower limit becomes
the restriction in the standard.
Additional information on the QRA2 can be found under
“Discussions” at the International Dialogue for the Evaluation of
Allergens (IDEA) website located at ideaproject.info
New Categories & Products
New categories and products have been categorized in the chart
below:
Products with potential or intended for ingestion have received
additional policy clarification in the 49th Amendment. Consumer
products with a potential risk of ingestion, such as oral care or lip
products (Categories 1 and 6), are in the scope of the IFRA standards
as they are not designed to be ingested. Even so, accidental
ingestion—even minor amounts—can still occur.
However, IFRA is clear that the safety of fragrance ingredients or
mixtures within products intended for ingestion (e.g. ingestible perfumes,
fragrances for odorizing potable water, cleaning
products intended for food contact are outside the
scope of current risk assessments and management
practices. It is the responsibility of the manufacturer
to assess the safe usage of these products based on
the specific use conditions and legal requirements applicable
to the country/region. IFRA cannot incorporate
products intended to be ingested into the IFRA
product categorization scheme.
Timeline
What is the implementation timeline for the 49th
Amendment? Short answer: It’s longer than previous
Amendments. The IFRA 49th Amendment was officially
released on Jan. 10, 2020. Fragrance companies
had been given seven months to implement, which includes
the time needed to update IT systems, exchange
information within the industry on purchased bases
and ingredients and to exchange information with
customers about the 49th Amendment. However, on
April 2, 2020, IFRA issued a three-month extended
implementation timeline because of the COVID-19
pandemic crisis. Therefore, fragrance companies now
have 10 months from Jan. 10, 2020 to implement.
Beginning Nov. 10, 2020, a request or brief for a
fragrance will be considered a new creation (extended
from Aug. 10, 2020). These new creations must meet
the 49th Amendment by May 10, 2021 (extended
from Feb. 10, 2021). In addition, existing fragrances—
those developed before Nov. 10—must be brought
into compliance by May 10, 2022 (extended from
Jan. 10, 2022).
July 2020 Spray 29
Category Product type Phototoxicity
considerations
1 Products applied to the lips Applicable (leave-on)
2 Products applied to the axillae Applicable (leave-on)
3 Products applied to the face/body using fingertips Applicable (leave-on)
4 Products related to fine fragrance Applicable (leave-on)
5
5A Body lotion products applied to the body using
the hands (palms), primarily leave-on Applicable (leave-on)
5B Face moisturizer products applied to the face using
the hands (palms), primarily leave-on Applicable (leave-on)
5C Hand cream products applied to the hands using
the hands (palms), primarily leave-on Applicable (leave-on)
5D Baby Creams, baby oils, and baby talc Applicable (leave-on)
6 Products with oral and lip exposure Applicable (leave-on)
7
7A Rinse-off products applied to the hair with
some hand contact Applicable (rinse-off)
7B Leave-on products applied to the hair with
some hand contact Applicable (leave-on)
8 Products with significant anogenital exposure Applicable (leave-on)
9 Products with body and hand exposure,
primarily rinse-off Applicable (rinse-off)
10
10A Household care excluding aerosol products
(excluding aerosol/spray products) Applicable (rinse-off)
10B Household aerosol/spray products Applicable (leave-on)
11
11A Products with intended skin contact but minimal Not applicable
transfer of fragrance to skin from inert substrate (leave-on without
without UV exposure UV exposure)
11B Products with intended skin contact but minimal
transfer of fragrance to skin from inert substrate
with potential UV exposure Applicable (leave-on)
12 Products not intended for direct skin contact, Not applicable
minimal or insignificant transfer to skin (non-skin contact)