The IFRA 49th
Amendment is here!
After years of development, it replaces 2015 amendment... Lori H. Parker
After a multi-year process, the International Fragrance Association
(IFRA) has issued the 49th Amendment to its Code of
Practice. Due to the large number of standards, the development
of a new safety assessment process and the time needed to properly
test and validate, the 49th Amendment now officially replaces the
48th Amendment published in 2015.
The primary objective of the
global fragrance industry is to
ensure that all consumers can
have trust in the fragranced
products they buy and use. The
IFRA Code of Practice is the
managed compliance program
used by both fragrance ingredient
suppliers and fragrance oil manufacturers; at its core are the
IFRA Standards. IFRA’s aim is to deliver a high-quality product that
honors the goal of the Standards to protect consumers and the environment
while aiming to prevent unnecessary impacts on business.
The IFRA Standards are the “backbone” of the industry’s safety
program. With the new 49th Amendment, released in January 2020,
there are big changes in store for not only the broader fragrance
industry, but also for its customers and the companies that formulate
the fragranced products
we have all come to
know and trust. The 49th
Amendment integrates
updated data, new assessment
methodologies and
new product types into
the collective system. The standards are rigorous, comprehensive and
responsive. Based on solid scientific research, they reflect the work
of the Research Institute for Fragrance Materials (RIFM), setting
standards that are both familiar in their setup and also innovative in
their new approach by leveraging the Quantitative Risk Assessment
Model 2 (QRA2).
The Process
The IFRA standard-setting process begins with the collection of
data from the industry and customers on the exposure to fragrance
ingredients, including concentration levels in finished consumer
products as well as varieties and volumes of use. RIFM also uses the
chemical composition and the olfactory potential of the ingredient.
Next, RIFM prepares a safety dossier on the ingredient by combining
the exposure with the toxicological information. The dossier is sent
to an independent Blue-Ribbon expert panel to evaluate that the
reported use and exposure risk assessment is supported by the data.
If accepted, the dossier is used to set a standard for the risk management
and use of the ingredient and formatted to be consistent with
the code of practice accepted standard format. After a consultation
period with the stakeholder community, the standard is officially
published with the next Amendment.
RIFM currently has about 3,000 materials in scope, including
about 900 Natural Complex Substances (NCS). The most recent
Safety Assessment process has been published as “Criteria Document
II” in Food & Chemical Toxicology 82 (2015). It includes the substance
and endpoint-specific approach as well as the improvement of the
exposure information using the aggregate exposure model, which is
the basis of the QRA2.
The 49th Amendment covers 214 standards in total: 25 are new to
the 49th, 91 have been revised to meet new safety standards under the
QRA2, while the remaining 98 have been reformatted to address the
new product categories. There are three types of standards:
1. Prohibition–a ban on the use of the material
2. Restriction–a maximum concentration level based on the product
type
3. Specification–additional rules on use, such as origin or purity
criteria
The QRA2 is a new element to the 49th Amendment. Under this
model, dermal sensitization includes consideration for aggregate
exposure to an ingredient, involving such questions as:
• How many types of product is it in?
• How much is in each product?
• How often and how much of each product is used?
• What part of the body is it in contact with?
• Does it stay on the body or does it rinse off?
RIFM has also revised the Safety Assessment Factors (SAFs) to reflect
new data and computational models that have been developed. The
new model is based on data for the habits and practices collected
from more than 36,000 consumers in the European Union (EU) and
U.S. The expanded scope of the standards also addresses Systemic
Toxicity as detailed in the Criteria II document.
Phototoxicity
A final consideration is the topic of phototoxicity. Traditional
approaches to phototoxicity limited the scope of the restrictions
28 Spray July 2020
Senior Regulatory
Affairs Manager,
Arylessence, Inc.