The European Green Deal [1] has set the European Union (EU) on course to become a sustainable climate neutral and circular economy by 2050. One of the pillars of the Green Deal known as the Chemicals Strategy for Sustainability (CSS, adopted in October 2020) [2] aims to better protect human health and the environment as part of an ambitious approach to tackle pollution from all sources and move towards a toxic-free environment. In other words, the CSS aims to protect citizens and the environment from the most hazardous chemicals and to boost innovation by promoting the use of safer and more sustainable chemicals.
The EU already has comprehensive and protective regulatory frameworks in place addressing the production and use of chemical substances and their potential impact on human health and the environment, notably under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (2006) [3] and the Classification, Labelling and Packaging (CLP) Regulation (2008) [4] which is the EU implementation of the Globally Harmonised System (GHS) for classification, labelling, and packaging of chemical substances and mixtures.
The new regulations and directives resulting from the Green Deal and the CSS will, in a first phase, involve revision of both the REACH and CLP Regulations and may create unintended but potentially catastrophic consequences for the production, trade, and use of essential oils (EOs) and related natural plant extracts such as concretes, absolutes, and oleoresins. Collectively, such materials are often referred to as Natural Complex Substances (NCSs).
While the ultimate goals of the new regulations and directives are well-intended and generally supported by IFEAT, as well as other affiliated industry Associations, full implementation of the CSS carries at least four immediate and serious threats for the EO and NCS sector [5]:
- Regulation of EOs would be based on a hazard determination of individual constituents as opposed to an evaluation of the toxicology of the substance as a whole.
- The creation of five new hazard classes within the CLP may lead to a ban on many EOs.
- Replacement of current risk-based safety assessments to hazard-based assessments.
- Increase in REACH dossier requirements, especially for small volume materials, will cause extreme hardship to SMEs (small and medium-sized enterprises).
Further explanations are provided in the annexes below.
IFEAT has embarked on a campaign to address these potential legislative perils to our industry and is working with the European Federation of Essential Oils (EFEO) as well as other associations including IFRA, IOFI, and RIFM (including their respective regional members such as FCA, FEMA, EFFA, etc.) to coordinate advocacy efforts, communications, and outreach initiatives with EU competent authorities. IFEAT is also in contact with other regional and national authority institutions to mitigate threats on essential oils and other naturals from the proposed revisions. These initiatives cross the breadth of several areas: direct lobbying efforts along with other public and strategic communication measures are involved, as we promote positive aspects of the essential oil industry including socio-economic and product benefit considerations (sensory, health related, etc.) across the EU and beyond.
Annexes – European Green Deal poses an existential threat to Essential Oils
As described in the accompanying communication document, full implementation of the EU Chemicals Strategy for Sustainability (CSS) [2] carries at least four serious and immediate threats for essential oils (EOs) and Natural Complex Substances (NCSs), indeed potentially threatening the very existence of many. These are explained further below.
Annexe 1 – Further details on immediate topics of concern
(1) Essential oils (EOs) would be categorised as MOCS (more than one constituent substances) under REACH [3] and CLP [4] and thereby regulated based on the toxicology properties of their individual constituents as opposed to evaluated as a whole substance (full oil). EOs containing components such as methyl eugenol (rose oil) and gamma-terpinene (cumin, ginger, lemon, cloves, coriander), for example, or indeed other individual components considered hazardous under CLP may be banned even if the toxicology concern generated by individual components may be scientifically shown to be absent in the full oil. This would be further aggravated by the consequences of point (2) below.
(2) Some five new hazard classes have been added to CLP during the recent revision process, potentially affecting several EOs and NCSs. These are listed below:
- ED: endocrine disruptors
- PBT: persistent bioaccumulative and toxic: these substances are harmful chemicals that do not break down easily in the environment and are especially hazardous for human health and ecosystems
- vPvB: substances that are very persistent and very bioaccumulative
- PMT: persistent, mobile, and toxic
- vPvM: very persistent, very mobile
The CLP revision was published on 19th December 2022 and was submitted to the European Parliament for further consultation in January 2023. EU Commission Delegated Regulation (EU) 2023/707 introducing new hazard classes to the CLP was then published on 31st March 2023 in the EU Official Journal and became effective on 20th April 2023. As a result of these new hazard classes and evaluation of the individual components of EOs as described in point (1), there is high probability that EOs and NCSs become so-called substances of very high concern (SVHCs) under REACH and could be banned because they contain constituents considered harmful for the environment and/or human health.
(3) The EU intends to move from risk-based safety assessment (risk = hazard + exposure levels) to assessments based on hazard alone. i.e., the principle of “safe for its intended use” concept would no longer be recognized, a concept well accepted and recognised for flavour materials under the FEMA GRAS process. This implies that if one constituent present in an EO or NCS is deemed hazardous, then the whole oil would be classified as hazardous. Under the pending revision of REACH, this may result in a restriction or outright ban on the use of the EO or the NCSs either as itself or as an ingredient in consumer end use products within the EU.
In February 2023, the Fragrance Creators Association (FCA) published a white paper on the Importance of Comprehensive Assessments in Evaluating Fragrance Ingredients including scientific information contributed by the Research Institute for Fragrance Materials (RIFM). The paper was developed to clearly explain why risk assessment accounting for both hazard and exposure is the appropriate approach for evaluating the safety of fragrance ingredients and, further, that “grouping” of structurally similar chemicals is a complicated process that must be scientifically validated. In other words, the white paper highlights the potential impacts on the fragrance industry of chemical classification based on a hazard approach that includes the potential for broad chemical grouping and identifies science-based advocacy messaging that can be used to educate regulators on why this approach is inappropriate for fragrance ingredients including EOs and NCSs [6].
(4) The revision of REACH under the CSS will impose dossier requirements for materials in the 1-10 MT/year category to adopt the same documentation and testing requirements as for products in the 10-100 MT/year band. This represents a terrible burden for SMEs. Recall that 85% of the current EO and NCS registrations under REACH are in the 1-10 MT/year volume band [5]. In addition, new tests for endocrine disruption and other novel hazard classes under CLP mentioned above would be required for the 1-10 MT/year volume band (and upwards). Such requirements could translate into additional costs of between EUR 100k to 400k per substance [5].
Annexe 2 – Timeline
- Revision of CLP
- Delegated Act
- Scrutiny of Parliament and Council: February–May 2023
- Publication in the Official Journal: June 2023
- Entry into force: July 2023
- Time of application: + 24/42 months (substances) and 36/60 months (mixtures)
- Guidance document adopted by ECHA: June 2024.
- Ordinary Legislative Procedure (including MOCS)
- Delegated Act
- Start formal procedure at Parliament and Council level: February – March 2023
- Parliamentary process: March – October 2023
- Negotiations Council-Parliament: November 2023 – February 2024 (at the earliest)
- Final agreement March – April 2024 (before European elections)
- Revision of REACH
- Postponed to end of 2023
- REACH Revisions finalised by European Commission: December 2023
- REACH Revisions adopted by European Parliament; expected December 2024
The Presidency of the Council of the European Union is currently held by Sweden (from 1st January to 30th June 2023) and will be held by Spain from 1st July to 31st December 2023.
Annexe 3 – Abbreviations
- CLP – Classification, Labelling and Packaging Legislation
- CSS – Chemicals Strategy for Sustainability
- ECHA – European Chemicals Agency
- EFEO – European Federation of Essential Oils
- EFFA – European Flavour Association
- EO – Essential Oils
- EU – European Union
- FCA – Fragrance Creators Association
- FEMA – Flavor and Extract Manufacturers Association of the United States
- IOFI – International Organisation of the Flavor Industry
- IFRA – International Fragrance Association
- MOCS – More than One Constituent Substances
- NCS – Natural Complex Substance
- REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals Legislation
- RIFM – Research Institute for Fragrance Materials
- SME – Small and Medium Enterprises
- SVHC – Substances of Very High Concern
Annexe 4 – References
[1] EU Strategy & Policy – Green Deal https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal_en
[2] EU Chemicals Strategy for Sustainability Towards a Toxic-Free Environment https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf
[3] EU REACH Regulation: https://echa.europa.eu/regulations/reach/legislation
[4] EU CLP Regulation: https://echa.europa.eu/de/regulations/clp/legislation
[5] European Green Deal, through CSS, threatens the existence of Essential Oils, by Laure Moutet (EFEO Board Member), EFEO Newsletter 05/2022. For EFFEO newsletters visit: https://efeo.eu/publications/newsletters/
[6] The Importance of Comprehensive Assessments in Evaluating Fragrance Ingredients