This section describes the rules for hazard classification and labeling of F&F substances and preparations, including natural raw materials, such as extracts and essential oils, containing hazardous constituents, according to the EU regulations.
For trade of F&F (including pure substances and mixtures or preparations thereof and natural raw materials) within the European Union, certain rules apply within the European Industry which are established by the European Flavour and Fragrance Association Code of Practice (EFFA CoP). The following general considerations are taken over from the Introductory note to the EFFA CoP, which is published yearly on the EFFA website: www.effa.be. It should be noted that the most recent version of the EFFA CoP (version of 2009) for the first time also takes into account the Globally Harmonized System of Classification and Labeling of Chemicals (UN-GHS). This GHS has now also been implemented in the EU with the Publication of the EU-GHS Regulation (so-called "CLP Regulation": Classification, Labelling and Packaging of substances and mixtures) [Regulation (EC) No. 1336/2008, OJ L 354, 31.12.2008, p. 60]. It has entered into force on 20 January 2009 and the current Directive 67/548/EEC (DSD) and Directive 1999/45/EC (DPD) shall be repealed with effect from 1 June 2015. However, Annex I of the DSD has already been repealed and transferred into Annex VI of the EU-CLP Regulation, with exception of the last two technical adaptations (ATP 30 and ATP 31) to the DSD.
However, the following section on classification on labeling is still based on the currently applicable DSD and DPD.
Within the European Union, substances and preparations have to be classified and, if dangerous according to criteria laid down in the regulations, have to be labeled according to certain rules. The classification and labeling of substances are either prescribed in Annex I to the Dangerous Substances Directive 67/548/EEC (DSD) or have to be done by the supplier using the criteria of Annex VI of this Directive. For preparations, like F&F compounds, it is done according to the Dangerous Preparations Directive 1999/45/EC (DPD).
Several substances of interest to the fragrance and flavor industry are mentioned in Annex I of the DSD. They are included in the respective attachments to the EFFA CoP with their Annex I number next to their CAS and EU numbers. The label mentioned in the attachment has to be used in the MS of the European Union.
Special emphasis is put on Classification of aspiration hazard (Xn; R65) of both substances that can easily reach the lungs upon ingestion and cause lung damage (substances with low viscosity and low surface tension) and mixtures/preparations with a high hydrocarbon (HC) content and low kinematic viscosity that will pose the same hazard.
Based on measurement results for a number of natural raw materials (e.g., extracts and essential oils) with HC contents between 10% and 90+% and on similar measurements of some F&F compounds, a dedicated Working Group of the F&F Industry has come to the conclusion that in practice, substances and preparations containing more than 10% of HC(s) fall within the criteria for viscosity and surface tension.
Therefore, the European F&F Industry through its EFFA CoP recommends
• To determine the HC content of substances (supplier information, analysis) and preparations (including extracts and essential oils) (calculation) and to classify as Xn; R65 if more than 10% HC is present.
• That nonclassification should only be possible if viscosity and/or surface tension measurement results are available for a specific substance or preparation (including extracts and essential oils).
In addition, classification and labeling of skin sensitizers is addressed in the CoP: the issue on skin sensitization (and labeling of the alleged allergens for the purpose of the Cosmetic Directive, 7th Amendment) has been in depth discussed in the first section. However, it should be noted here that classification of substances and essential oils or extracts as sensitizers (R43) has nothing to do with the requirement to label the 26 alleged allergens on the final cosmetic products according to the Cosmetic Directive (7th Amendment).
Following the EFFA CoP, skin sensitizers are labeled Xi, R43. According to the CoP, it is recommended to use the administrative limit concentration of 1% when classifying preparations (including extracts and essential oils) containing them in all cases, unless a different threshold is laid down in Annex I to the DSD.
In the EFFA CoP, special attention is paid to the hazard classification and labeling of natural raw materials, referred to as "natural complex substances" (NCSs) in the CoP. The terminology Natural
Complex Substance is used because in some cases the natural raw material (the complex) is regarded as a single substance, rather than a complex mixture.
NCSs (e.g., essential oils, and extracts from botanical and animal sources) require special procedures due to the fact that they might have quite different chemical compositions (and therefore hazard classifications) under the same designation. This may occur even when this differentiates between species, cultivars and chemotypes and different production procedures (e.g., absolutes, resinoids, and distilled oils).
There are two ways of classifying and labeling NCSs such as extracts and essential oils: either based on the data known and available on the natural raw material as such (NCS is regarded as a single "substance") or based on the hazardous constituents they are composed of (NCS is regarded as a complex mixture).
In the first case, an NCS may be classified on the basis of the data obtained by testing the NCS. The test results of an NCS, even if containing classified constituents, are evaluated in accordance with the DSD. The health and environmental hazard classifications derived following this approach are quality dependent, which is also indicated in the EFFA CoP.
In the second case, for grades of NCSs and for endpoints for which reliable test data are lacking, the EU's Labelling Guide (Annex VI to the DSD) incorporates a requirement introduced by Commission Directive 93/21/EEC, whereby the hazard classification of complex substances shall be evaluated on the basis of levels of their known chemical constituents. Where knowledge about constituents exists, for example, on substances limited as per Annex II of Directive 88/388/EC (the so-called biologically active substances—see above) or on substances with sensitizing, toxic, harmful, corrosive, and environmentally hazardous properties, the classification and labeling of these NCSs according to the requirements of the European Union should follow the rules for preparations (= mixtures) as prescribed by the DPD.
One dedicated section of the EFFA CoP also provides a list with the composition of the NCSs (extracts, essential oils, concretes, absolutes, etc.) in terms of the presence (content in %) of hazardous constituents and HCs in the NCSs that have to be taken into account for the classification and labeling of the NCSs or a preparation containing these NCSs, based on the DPD.
F&F compounds that are preparations (i.e., compounded mixtures, formulations, or compositions) should be classified and labeled according to the EU's DPD 1999/45/EC and its articles 6 and 7.
In practice, test data on the flavor or fragrance compounds (preparations) are not available or collected. Therefore the classification of these preparations should be based on the chemical composition and should include the contributions of hazardous substances present as constituents in the NCSs present in the formulation. This is another reason why the composition of the NCSs in terms of presence of the hazardous constituents is also part of the EFFA CoP.
Examples of important constituents to take into account for classification:
- Sensitizers (R43) ^ NCSs (essential oils and extracts) to be classified as R43 if the content (%) of the sensitizer (if one) or the content of their sum (if more than one) is greater than or equal to 1%.
- CMRs (carcinogenic, mutagenic, and reprotoxic materials: R45; R46; R68) ^ NCSs to be classified as CMR if the content of the CMR substance(s) is greater than or equal to 0.1%.
The final classification and labeling of an essential oil can be totally different depending on the approach used for the classification, either based on data on the essential oil as such (the first case described above) or based on the hazardous constituents in the essential oil (the second case described above). This is illustrated below with two examples: orange oil, containing mainly limonene [which is classified as both a sensitizer (R43) and very toxic for the environment (R50/53)], and nutmeg oil, containing safrole which is a CMR (T; R45-22-68).
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