41 Sustainable Fragrances
The Lacey Act (16 U.S.C. 3371-3378), first enacted in 1900 and significantly amended in
1981, is the United States’ oldest wildlife protection statute. The Act combats trafficking
in illegally taken wildlife, fish, or plants. The Food, Conservation and Energy Act of 2008,
amended the Lacey Act by expanding its protection to a broader range of plants and plant
products (Section 8204, Prevention of Illegal Logging Practices). Under the statute, plant,
and plant products covered by the Lacey Act cannot be imported into the U.S. without
an import declaration. Concerning the fragrance industry, in 2021 the essential oils of
sandalwood, rosewood and cedarwood were included (Phase VI) and from end 2024, vetiver
and potentially other essential oils are included (Phase VII).
HUMAN SAFETY
The safety use of fragrance ingredients is managed through the IFRA standards, which
considersing human exposure to a substance with a given hazard level to establish safe
limits by product categoryization [32]. IFRA provides guidance to its members on the
appropriate Hazard classification to apply to substances via the annually updated Labelling
Manual [33]. Concerning the hazard classification of fragrance ingredients, a period of
significant change is underway with potentially significant consequences for the industry.
The key changes are:
(i) More and more substances classified H317 and self-classified or officially classified
CMR 1 and 2 – CMR stands for Carcinogenic, Mutagenic and Reprotoxic.
(ii) The introduction in the latest CLP of a new hazard category, Endocrine disrupter (ED),
1 and 2.
(iii) The assessment of natural substances under CLP.
(iv) EU focus on skin sensitisers.
Taking the topics in turn, pre-REACH (the Regulation on the registration, evaluation,
authorisation and restriction of chemicals), testing of substances was largely focused on
high volume and new substances. Following the REACH legislation (“no data, no market”),
the European Chemicals Agency (ECHA) has required more data in general for chemicals
including fragrance ingredients, but now specifically on the large number of lower volume
substances used by the fragrance industry. In very crude terms, the implementation
timeframe for REACH registration was 2010 for 1,000 T/y, 2013 for 100 T/y and 2018
for 1-100 T/y. A key objective of REACH was to fill data gaps to better protect workers
with massive exposure to undiluted chemicals during their working hours. This has led to
a sharp increase in the number of substances classified H317 “may cause an allergic skin
reaction”, as shown in Figure 5 below for the more than 1,500 chemical substances in the
Labelling Manual. It can be anticipated that for H317 the future will now be more stable.
Concerning substances classified as CMR there has been a similar tendency. Historically
there were few, and the industry legislation and functioning were organised around the
few exceptions CMR 1s cannot be used in cosmetics (safrole being the exception at very
low dose as a natural constituent) and for CMR 2s an expert opinion was sought from
the competent authorities to establish safe levels of use case by case, a process typically
taking years. Following the precautionary principle ECHA tends to propose a more severe
classification if in doubt and invite the registrant to conduct additional testing to show
the contrary. Given the expense and uncertainty of the final outcome, many registrants
accept the severe classification. With a rise in substances proposed for CMR 1 and CMR 2

42 JOURNAL OF COSMETIC SCIENCE
classifications, there is a risk that there will be an effective ban on many suspected CMRs.
Within the CSS framework grouping of substances to allow read across has been promoted
to accelerate the review of substances by the authorities. This could further exacerbate the
situation as associated structures to the suspected CMRs can also be tagged.
One element of the revised CLP is the establishment of a new hazard classification, ED,
which could be related to human safety or the environment. For substances, if relevant,
labelling will be mandatory in 2025–26, and for mixtures in 2026–28 depending on
when they are first placed on the market. It is too early to know the impact this measure
will have. One substance that has frequently been cited as a suspected ED is butylated
hydroxytoluene (BHT) which has recently been further restricted by UK authorities [34] to
apply from 2025. BHT is also a substance under evaluation for endocrine disruption under
EU legislation [35].
It should be noted that substances classified CMR 1 and ED 1 should be substituted
under the “essential use” concept. Equally they would not pass the current European
Assessment framework for “Safe and Sustainable by Design” (SSbD) under test in 2024
this is positioned as a voluntary framework for “frontrunners” to promote Innovation
(Commission Recommendation (EU) 2022/2510).
Amongst the substances being self or officially classified CMR 1 and 2 are components of
naturals, for example p-cymene (proposed CMR 1). The initial proposal for updating 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 with 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 decision
now needs to be allied to an opinion from the Scientific Committee on Consumer Safety
(SCCS) on safe level of use of the concerned substances, and will no doubt also be addressed
in the revised CPR.
Amongst the substances being self or officially classified CMR 1 and 2 are components
of naturals, for example p-cymene (proposed CMR 1). The initial proposal for updating
Figure 5. Percentage of chemical substances in the IFRA Labelling Manual classified H317.