44 JOURNAL OF COSMETIC SCIENCE
parties to submit information related to skin sensitising substances in consumer mixtures
“The information gathered will be used to assess the need for regulatory actions on skin
sensitisers in consumer mixtures.”
In 2023–24 the German Federal Institute for Risk Assessment (BfR) commissioned
an impact assessment on the introduction of a potential REACH restriction on skin
sensitising substances when used in consumer mixtures. Whilst this assessment concerns
many industrial sectors including detergents but not cosmetics, it illustrates the continuing
fixation of EU authorities on skin sensitisers as a major consumer issue.
In the USA, The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition
65) requires the State of California to publish a list of chemicals known to cause cancer
or reproductive toxicity, and to update the list at least annually (Health and Safety Code
Section 25249.8). As the list has been updated, materials used by the fragrance industry,
such as beta-myrcene, or present as impurities, like toluene, have been added to the list.
Whilst sometimes there is a safe harbour limit, this is not always the case, placing the
burden of responsibility on the final product manufacturer to determine the level at which
the warning statement “This product can expose you to chemicals including [name of one
or more chemicals], which is [are] known to the State of California to cause cancer [and]
[or] [birth defects or other reproductive harm]” can be avoided. Proposition 65 applies to
consumer products including cosmetic products distributed in California.
A number of U.S. States (Maine, Washington, Oregon, Vermont, Minnesota) have either
established a list of chemicals of concern or reporting requirements for chemicals of concern
for children’s health in Kids or Children’s Toys that extends to cosmetics marketed to
children. The chemicals of concern often include chemicals on the Prop 65 list, and typical
reporting limits are practical quantification limit (PQL), the lowest measurable amount,
for intentionally added, and 100ppm for not intentionally added. Oregan’s The Toxic Free
Kid’s Act (2015) has a phase out requirement for declared substances in children’s cosmetics
(e.g. toluene, di-ethyl phthalate).
ENVIROMENTAL SAFETY
Concerns about water pollution (or water quality) linked to fragrance ingredient production
are largely linked to naturals cultivation, the use of fertilizers and pesticides, and were
discussed above under water footprint.
The fate of fragrance ingredients in the environment, both natural and synthetic, is a key
concern. For many years biodegradation tests of fragrance ingredients attracted limited
attention, except for nitro-musks and polycyclic musks (PCMs), which are persistent and
were identified in breast milk in Europe and the USA [38, 39]. Because of health concerns
nitro-musks are widely banned, and the European detergents and cosmetics industries have
voluntarily reduced the use of PCMs to avoid environmental accumulation.
Three trends have changed the narrative:
As part of the REACH process more testing has been required leading to more
substances being classified Environmental Hazards.
With a focus on sustainability there is a renewed desire for biodegradable product
claims and standards like ecolabel integrate biodegradability restrictions, which in
turn increases attention on the biodegradability of the fragrance.
The link between biodegradability and pollution.
45 Sustainable Fragrances
Pre-REACH the requirement for data on the environmental fate of chemicals used by the
fragrance industry was limited and focused on new substances in Europe and substances
1000 lbs/y in the USA through the EPA High Production Volume Challenge Program
(HPV). A key objective of REACH was to fill data gaps to better understand the risks of
chemical spillage and contamination of wastewater. This additional testing has led to a
sharp increase in the number of substances classified H410-412, “very toxic/toxic/harmful
to aquatic life”, with more than a doubling of the substances in these categories from 2010
to 2023 as illustrated in Figure 7 below.
The latest CLP revision includes two new environmental hazard categories, Persistent,
Mobile, Toxic (PMT) and very Persistent, very Mobile (vPvM). The most severely classified
substances PBT (Persistent, Bioaccumulative, Toxic), vPvB, PMT, vPvM are seen in a
similar light to CMR 1 and ED 1 discussed above concerning “essential use” and SSbD.
Today only four fragrance industry used materials meet these criteria, and all are subject
to European bans as substances of very high concern: Karanal®, musk xylol, butylphenyl
methylpropional (commonly known as Lilal®) and Octitrizole (commonly known as
CYASORB® W-5411)
The biodegradability status of a material today falls into one of three categories, “readily”,
“inherently/ultimately” and “not biodegradable”. It may seem simple but in practice there
are nuances, especially around how natural extracts are considered [40].
There is some good news. The renewed focus on biodegradation has led to additional more
rigorous testing within the OECD guidelines leading to a number of substances being
reclassified more favourably.
It can be questioned whether there is room for an additional category between “inherently/
ultimately” and “not biodegradable”, for example for substances that are shown to be not
persistent or degrade abiotically, provided that the metabolites or transformation products can
be shown to be degradable. The extended test conditions in (EU) 2023/2055 for considering
whether a microparticle is biodegradable are perhaps a first step in this direction.
In the past, materials which were persistent but inert were considered acceptable. Today, with
zero pollution ambitions and less confidence in the notion of “inert”, persistent materials are
less accepted, and we can anticipate a gradual replacement in the coming years.
Figure 7. Percentage of chemical substances in the IFRA Labelling Manual classified H410-412.
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