Guidance On Essential-Oil Identification Under REACH Is 'First Step' – IFRA

Essential oils, even when derived from the same plant, can vary significantly in composition, which poses challenges for registrants under the EU's REACH law. European trade groups' substance-identification guidance released in August provides direction to essential-oil and other "natural complex substance" producers, following meetings last year between industry stakeholders and EU regulatory authorities.

Recent guidance from the European Federation of Essential Oils and International Fragrance Association provides direction for identifying, registering and labeling essential oils under European chemical regulations, while offering insight into the challenges the variable substances pose for producers.

Released in August, the guidelines address "substance identification and sameness of natural complex substances (NCS)" under the EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling and Packaging (CLP) regulations.

Developed in close cooperation with the European Chemicals Agency, the resource complements ECHA's own guidance for identification and naming of substances in compliance with the regulations.

Under REACH, registrants must provide information that is "sufficient to enable each substance to be identified" and observe rules for identifying and naming substances in safety data sheets. The CLP regulation imposes similar requirements for labeling substances and mixtures containing them.

NCS are generally considered by ECHA as Substances of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB), as opposed to "well-defined substances," which can be mono-constituent substances (those in which one constituent is present at a concentration of at least 80%) or multi-constituent substances (those consisting of several main constituents present at levels generally above or equal to 10% and below 80%).

However, ECHA notes in its guidance that borderline cases will present, and it is the registrant's responsibility to identify its substance in the most appropriate way.

EFEO and IFRA's guidelines attempt to steer NCS registrants in the right direction, depending on various factors.

Characterization and Registration of NCS

"In principle, the key parameters to characterize NCS," according to the EFEO/IFRA guidelines, are:

• Botanical source (family, genus, species, as well as the part of the plant used for the extraction, as appropriate)
• Manufacturing Process (e.g., extraction process; the fractionation, purification or concentration process; "or other processes that influence the composition")
• Chemical composition

Chemical composition will dictate whether the NCS is most appropriately registered under REACH as UVCB sub-type 3 or as a mono- or multi-constituent substance, the trade groups note.

Essential oils are among the most common NCS, according to the industry guidelines, and many essential-oil producers are subject to REACH registration for the first time under the May 31, 2018 deadline for low-volume manufacturers and importers of chemicals.

Last year, IFRA and essential-oil producers met with ECHA and European Commission representatives, including at a workshop held in April 2014, to discuss questions and concerns about REACH registration requirements and classification/labeling requirements for the aromatic substances (Also see "Essential Oil Producers Making Progress Toward REACH 2018 Deadline" - HBW Insight, 17 Dec, 2014.).

Essential-oil industry stakeholders stressed that their substances are not standard chemicals, as they are "produced outdoors in nature and therefore their properties and composition depend on many different naturally occurring factors."

EFEO and IFRA note in their guidance that the region in which plants are grown, annual variations in climate within a given region and the part of the plant used as source material can cause NCS from the same botanical genus and species to have different chemical compositions.

Differences in processing methodologies – in terms of drying, cutting, extraction, distillation, fractionation and other steps – also can yield variances, the organizations note.

These realities make for a level of unpredictability that is not faced by registrants of mono- and multi-constituent substances, according to the guidance.

In a Sept. 2 email, an IFRA rep said the substance-identification guidance is "the first step" toward addressing challenges faced by essential-oil producers subject to the 2018 REACH deadline.

The essential-oils industry now is focused on how ecotoxicological data should be provided under REACH, which requires information on aquatic toxicity, impact on invertebrates and aquatic plants and degradation in the environment, among other concerns.

Stakeholders also are keeping an eye on EC efforts to reduce costs for small enterprises. Reportedly, the EC has drafted a proposal for an "implementing act" to more clearly define "fair, transparent and non-discriminatory" data cost-sharing within REACH Substance Information Exchange Forums.

Generally, the IFRA spokesperson said the group is "very pleased with the excellent dialogue throughout the supply chain from farmers to end users, including the authorities," regarding the pathway to regulatory compliance for essential oils and other NCS.

Guidance Tackles Various NCS Registration Scenarios

The trade groups note that composition complexity for NCS can range from simple (with only a few constituents) to very complex (in excess of 100 constituents), and their characterization will be affected accordingly.

While ECHA generally classifies NCS as "UCVB sub-type 3," certain NCS' chemical composition could qualify them for registration as mono- or multi-constituent substances under European chemical regulations, the associations say.

"Characterization of NCS (as UVCB, mono- or multi-constituent substance) will influence the registration of NCS under REACH, and more specifically (i) the "qualities" of NCS that can be registered in a single registration dossier, and (ii) the data that shall be relevant for such registration."

To complicate matters further, the groups note that NCS can be eligible for exemption from REACH registration if they meet certain conditions as substances that occur in nature that are not chemically modified and do not pose specified hazards.

Generally, companies' registration and labeling requirements for NCS must be determined on a case-by-case basis. EFEO and IFRA include an extensive Q&A portion in the guidance to address questions that producers might have relative to their particular situation.

Questions include:

• Can different "qualities" of one NCS be covered in one UVCB registration dossier?
• How can one determine that the qualities of one NCS are similar in composition?
• How can one determine that two NCS have the same botanical source?
• Can a single UVCB registration be made for two or more NCS with a similar composition, but obtained from different botanical sources?
• Can a single UVCB registration be made for NCS from the same botanical source but with different composition due to the use of different parts of the same plant (e.g. the peel and the leaves and twigs of the same botanical species)?

There are 17 questions in total, plus various examples, including how specific substances should be registered under defined scenarios.

The EU's REACH program launched in June 2007 with staggered deadlines for phase-in chemicals registration, based on risk and tonnage. The 2018 deadline is for chemicals produced or imported at 1 ton to 100 tons annually (Also see "ECHA Launches REACH 2018 Web Portal For Low-Tonnage Registrants" - HBW Insight, 20 Oct, 2014.).

The CLP regulation came into force in January 2009, aligning European law with the United Nation’s Globally Harmonized System for Classification and Labeling of Chemicals, which specifies information that should be included on labels of hazardous chemicals and in safety data sheets.