EU Industry Guidance Supports Essential Oil Eco-Assessment
This article was originally published in The Rose Sheet
Executive Summary
While no “definitive methodology” for assessing environmental risks associated with essential oils and other natural complex substances, the new guidance should help steer producers and cosmetic manufacturers in their efforts to compile and assess data for compliance with the EU’s REACH and CLP regs.
The complexity of essential oils, which can vary widely in composition depending on a host of factors, poses regulatory challenges for producers and personal-care product manufacturers in the EU, and ultimately environmental risk assessment must be conducted on a case-by-case basis, European trade groups say.
In light of that reality, recently released guidance from the European Federation of Essential Oils and International Fragrance Association is just that, a useful tool to help steer industry players in their efforts to compile and assess environmental data on essential oils in order to comply with the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals and Classification, Labeling and Packaging regs.
While essential oil producers and affected product manufacturers still have their work cut out for them, the EFEO/IFRA Guidelines on the Environmental Assessment of Natural Complex Substances (NCS) represent significant progress achieved over years of collaboration between industry and European regulatory authorities to overcome compliance obstacles (Also see "Essential Oil Producers Making Progress Toward REACH 2018 Deadline" - HBW Insight, 17 Dec, 2014.).
This EFEO/IFRA guidance complements a separate guidance issued in August 2015 on “substance identification and sameness of natural complex substances,” which NCS registrants should consult first, the trade groups say.
Essential oils, among the most common NCS, are the volatile components of plants that carry their distinctive scents, making them vital to the production of perfumes and fragranced products.
The European Commission underscores the complexity of essential oils in a June 27 release, noting that “factors such as the region of growth, the climate within the region, the part of the plant used as source material and the process applied lead to natural variations in their chemical composition.”
According to the EC, “their complexity varies widely from simple substances with only few constituents to very complex ones with more than 100 constituents.”
As such, there is no one-size-fits-all approach to essential oil identification, characterization and risk analysis.
The EFEO/IFRA guidance generally echoes those observations and notes that “constituents of an NCS may exhibit different physico-chemical properties that are relevant for their environmental assessment (e.g. water solubility, volatility, lipophilicity and ability to adsorb onto particles and surfaces), but also for their classification and labelling,” representing challenges for companies working to fulfill regulatory obligations.
Under REACH, registrants must assess their substances’ environmental fate and ecotoxicological properties, including impact on fish and algae, as well as their degradability.
For substances manufactured or imported in volumes of 10 tons or more, predicted no effect concentrations (PNECs) and (very) Persistent, (very) Bioaccumulative and/or Toxic (PBT/vPvB) assessments are required as part of their chemical safety assessments, according to the trade groups.
Their guidance spells out the environmental regulatory requirements in greater detail and presents concepts and approaches that can be used to meet those requirements, from data generation and collection to assessment and risk characterization.
EFEO and IFRA note, however, that “no definitive methodology for an NCS risk assessment has been presented here,” as the complexity of essential oils requires evaluation on a case-by-case basis.
“The three different approaches presented here (and various combinations of these approaches) can result in several differing PECs [Predicted Environmental Concentrations] and PNECs. The registrant needs to provide justification as to the appropriateness of their decisions for deriving the reported PEC and PNEC, and why they are sufficiently conservative,” the groups say.
REACH 2018 Deadline Creeps Closer
The EFEO/IFRA guidance complements a separate guidance the industry associations issued in August 2015 on “substance identification and sameness of natural complex substances,” which essential oil registrants should consult first, the trade groups say (Also see "Guidance On Essential-Oil Identification Under REACH Is 'First Step' – IFRA" - HBW Insight, 3 Sep, 2015.).
Proper identification and characterization of NCS is necessary for companies to determine the specific tonnage band relevant to them and the type of data they need to produce, they note.
The European Chemicals Agency, which oversees REACH, also has developed NCS guidance documents. According to EFEO and IFRA, those resources are currently being updated, so stakeholders should refer to ECHA’s website for new iterations potentially on the horizon.
ECHA and the EC have been working to raise awareness and prompt companies to get organized with co-registrants so they can prepare their technical dossiers and chemical safety reports for submission to ECHA.
The majority of essential-oil producers are subject to REACH requirements for the first time under its May 31, 2018 deadline for phase-in substances produced or imported at volumes between 1 ton and 100 tons annually.
At the same time, enterprises in the essential oils business must comply with the European CLP regulation, which entered into force in January 2009, mandating that hazards associated with chemicals be identified, communicated to users via labeling and controlled through safe packaging.
Both regulations affect entities throughout the supply chain, with implications for manufacturers, importers and downstream users.