Essential oils & Regulatory obligations
Essential oils & Regulatory obligations
jeudi 22 juin 2023
Regulatory speaking, what is an essential oil? According to the European Chemicals Agency (ECHA), “an essential oil is defined as a volatile part of a natural product, which can be obtained by distillation, steam distillation or expression in the case of citrus fruits. Essential oils are derived from various sections of plants and contain mostly volatile hydrocarbons. The oil is "essential" in the sense that it carries a distinctive scent, or essence of the plant.”
Under REACH (1907/2006) and CLP (1272/2008) regulations, essential oils are considered as substances. In application of article 3.1 of the REACH regulation and article 2.7 of the CLP regulation, a substance is “a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”.
There are 2 types of substances:
- “Well-defined substances” that include:
o Mono-constituent substances: substances in which one main constituent is present in a concentration ≥ 80% (w/w)
o Multi-constituent substances: substances in which more than one main constituent is present in a concentration ≥ 10% (w/w) and < 80% (w/w)
- UVCB substances (Unknown or Variable composition, Complex reaction products or Biological materials): a UVCB substance comprises various constituents, some of which may be unknown. The composition may vary or be difficult to predict.
Essential oils are complex natural substances most often identified as “UVCB sub-type 3, where the source is biological and the process is refinement” (according to the Guidance for identification and naming of substances under REACH and CLP).
Complex natural substances are characterized mainly by:
- Their botanical source,
- Their manufacturing process,
- Their chemical composition.
The chemical composition of complex natural substances is a key data to determine if they should be qualified as UVCB substances or mono-/multi-constituent.
According to the Guidance for identification and naming of substances under REACH and CLP, the following name should be used for the registration of complex natural substances:
- Mono-constituent substance: The name of the main constituent used present at a concentration ≥ 80%
- Multi-constituent substances: the words “reaction mass of” followed by the name of all the constituents present at a concentration ≥ 10%
- UVCB substances: the name is a combination of source and process starting by the source.
Meeting REACH and CLP requirements, yes, but not only.
The CLP Regulation does not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user (article 1 paragraph 5):
a) medicinal products as defined in Directive 2001/83/EC;
b) veterinary medicinal products as defined in Regulation 2019/6/EC;
c) cosmetic products as defined in Regulation 1223/2009/EC;
d) medical devices as defined in Regulation 2017/745/EC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;
e) food or feeding stuffs as defined in Regulation 178/2002/EC including when they are used:
i. as a food additive in foodstuffs within the scope of Regulation 1333/2008/CE;
ii. as a flavouring in foodstuffs within the scope of Regulation 1334/2008/EC and 872/2012/EC;
iii. as an additive in feeding stuffs within the scope of Regulation 1831/2003/EC;
iv. in animal nutrition within the scope of Regulation 767/2009/EC.
When an essential oil is sold as a substance to the consumer, the applicable regulations differ according to its use.
The various possible uses and applicable regulations for essential oils in their finished state are the following:
- Use as a cosmetic: essential oils, which qualify as (finished) cosmetic products under Regulation 1223/2009/EC, are not subject to the CLP regulation. However, they remain subject to REACH.
- Use as a medicinal product: essential oils qualifying as medicinal products under Regulation 2019/6/EC are exempt from registration under REACH and are not subject to the CLP regulation.
- Use as room fragrances: essential oils used as room fragrances are subject to the REACH and CLP regulations. In particular, they must be CLP-compliant in terms of packaging and container labeling.
- Use as a biocidal product: essential oils qualifying as biocidal active substances under Regulation 528/2012/EC are subject to the CLP Regulation and to the Biocidal Products Regulation 528/2012/EC, but are exempt from registration under REACH.
- Use as food or feeding stuffs: essential oils used as foodstuffs must comply with regulations 1334/2008/EC and 2015/2283/EC. The CLP and REACH regulations do not apply to them.
Essential oils sold as raw materials and essential oils not covered by any of the exemptions listed in Article 1 of the CLP regulation must be classified, labeled and packaged in accordance with the requirements of the CLP regulation.
When essential oils are sold as raw materials, they are also subject to registration and authorization procedures under REACH, with the exception of biocidal active substances.
Do essential oils marketed to the general public comply with REACH and CLP regulations?
Between November 2021 and March 2022, the Irish Health & Safety Authority (HSA) conducted a survey on fragrance reed diffusers and their refills, for the general public.
During this study, 20 companies and 71 products were inspected to assess their compliance with chemicals legislation.
87% of the products inspected did not comply with the requirements of the REACH and CLP regulations. Of these non-compliant products, 46% had to be withdrawn from the market due to incorrect or missing hazard labelling.
For example, in two reed diffusers, a substance called Lilial was found in concentrations of over 0.3%. Lilial is a reprotoxic substance whose use in mixtures intended for the general public is prohibited above this concentration. These diffusers have been withdrawn from the market.
Among non-compliant products:
- 44% of products have no or incorrect hazard labelling
- 48% of products did not display a hazard label on all layers of packaging.
The non-compliance of these products and their labeling leads to health hazards for consumers. In its 2021 annual report, the National Poisons Information Center (NPIC) focused on poisoning cases linked to essential oils and reed diffusers, which are likely to cause toxicity if ingested or exposed to the skin or eyes. NPIC reports:
- For essential oils
o 180 enquiries received
o 78% cases aged under 10 years
o 93% concerned accidental exposures
o 82% involved ingestion
o 28% cases were symptomatic
o The most common essential oils were eucalyptus oil, tea tree oil and lavender oil.
- Reed diffusers
o 134 enquiries received
o 95% cases aged under 10 years
o 100% concerned accidental exposure
o 89% involved ingestion
o 26% cases were symptomatic
In 2023, the HSA will continue to monitor the compliance of products containing essential oils. Inspectors are responsible for checking that labelling complies with the CLP regulation and that products have a safety data sheet in line with Annex II of the REACH regulation. On their radar: products containing carcinogens and products imported from countries outside the European Union.
You need help to bring your essential oils into compliance with REACH and CLP: contact our team!