43 Sustainable Fragrances
CLP proposed that essential oils, or “more than one constituent substances”, should be
classified as any chemical mixture according to their constituent parts, ignoring test results
for the complete essential oil as a substance used hitherto. This would have led to a number
of essential oils being classified CMR 1 and therefore a ban on use in cosmetics. In the
finally approved version of the CLP Regulation (EU) 2024/2865 this measure will not be
implemented, with a review after 6 years following the entry into force of the Regulation.
This alone does not resolve all the regulatory challenges around the use of natural complex
substances containing a CMR 1 substance in cosmetic products and there is a Commission
proposal to find a path to permit use. If approved, it would need to be allied to an opinion
from the Scientific Committee on Consumer Safety (SCCS) on the safe use in cosmetics of
the concerned substances before their incorporation in the relevant CPR annex.
Since the Cosmetic Products Regulation 2003/15/EC entered into force, 26 fragrance materials
considered skin allergens (Annex III) are listed on pack in Europe if present above a certain
level. Following a SCCS opinion in 2012 (SCCS/1459/11), Commission Regulation (EU)
2023/1545 of July 2023 sets out new obligations for the labelling of an additional list of 56 so
called “fragrance allergens”, which must be applied from July 2026. With the mechanics of
printing packaging and wanting to avoid eventual removal from shelf of mislabelled product
in due course, implementation has already begun. As the amount of text that can be printed
on pack is limited, one consequence of this legislation is that fragrances will be reformulated
to ensure a limited number of “allergens” need to be labelled. A network of dermatologists in
Germany, Switzerland and Austria -Information Network of Departments of Dermatology
(IVDK) – report that the existing practice of establishing and updating IFRA standards is
effective and is leading to a reduction in reaction frequencies to patch tests with two standard
sets of fragrance materials know as Fragrance Mix I and II [36] as shown in Figure 6. In the
time period of the review more than 100,000 patients were tested. It can be questioned if
additional labelling is really necessary or a case of over-regulation [37].
The industry is still waiting for the outcome from the ECHA led call for evidence in
late 2022 following a request from Denmark, France, Germany, and Ireland to interested
Figure 6. IDVK 2012-2022 Standardised reaction frequencies to fragrance mixes I and II. Reproduced with
permission from reference 36. © 2023 John Wiley &Sons A/S.

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.