FIGURE 22.3 Structures of atranol and chloroatranol, most potent allergens in oakmoss and tree moss.
This also seems to be in line with the opinion of the SCCP (SCCP/00847/04) on atranol and chloroatranol present in natural extracts (e.g., oakmoss and tree moss extract) where both constituents were regarded as very potent allergens. Because chloroatranol was shown to cause elicitation of reactions by repeated open exposure at the ppm level (0.0005%) and at the ppb level on patch testing (50% elicit at 0.000015%), the SCCP concluded that "chloro-atranol and atranol should not be present in cosmetic products."
As a result, today the Fragrance Industry is producing oakmoss and tree moss with reduced levels of atranol and chloroatranol (i.e., oakmoss and tree moss absolutes treated for the selective removal of atranol and chloroatranol).
The authors concluded in their paper that the study again emphasizes the need for a "different look" on fragrances as contact allergens, which is a confirmation of previous findings (Schnuch et al., 2002). The authors propose a differentiated evaluation of ingredients of each group for overall evaluation, considering not only frequency of sensitization, but also the amount of exposure or use, as well as allergenic potency—also exposure to (highly) oxidized materials could be taken into account.
In particular, for Group I substances the authors agree that a regulation in terms of restrictions (or even ban) and labeling is needed, whereas for Group II substances labeling alone may be adequate enough for the purpose of prevention. But according to the authors, for some of the ingredients of Group III, neither restrictions nor labeling seems justified.
Thus, the authors express their opinion, justified by the findings of this study, that the Commission Decision on the labeling of all 26 "alleged allergens" should be revised.
The Fragrance Industry in turn has taken note of this study and comes to the same conclusion. Based on this, the Industry would now like to propose a pragmatic and different approach for the three Groups of "alleged fragrance ingredients": for example for Group III materials, Industry would advocate no labeling requirements and only restrictions where needed based on scientifically justified concern and for Group II and Group I materials, the Industry would propose appropriate and adequate measures based on scientific data. The Industry would like to avoid overregulation and overlabeling for alleged sensitizers.
Also the Commission took note of the publication of this study and as a consequence DG Enterprise sent a mandate to the SCCP with a request for an updated scientific opinion on the fragrance substances hydroxycitronellal (CAS 107-75-5), isoeugenol (CAS 97-54-1), and rf-limonene (CAS 5989-27-5).
Currently, the presence of hydroxycitronellal and isoeugenol needs to be labeled in the final cosmetic product according to Annex III, Part 1 of the Cosmetic Directive (Entries 72 and 73, respectively). However, in the future, restrictions to these fragrance ingredients may be proposed, because the Commission is considering a maximum concentration of 1.0% of hydroxycitronellal and of 0.02% of cis- and irans-isoeugenol (or their sum) in finished cosmetic products (except oral care products). DG Enterprise has asked SCCP its opinion whether they consider these concentrations to be safe for consumers when used in cosmetic products taking into account the scientific data provided. In fact such restrictions would be more in line with the self-regulating policy and principles of the Fragrance Industry, as applied through the IFRA CoP and its Standards, as explained above.
Regarding limonene, DG Enterprise has asked SCCP to re-evaluate the level of peroxides for the limonenes in cosmetic products. In parallel, the Fragrance Industry through the Research Institute for Fragrance Materials (RIFM) is conducting some local lymph node assay (LLNA) work on limonene and some other key materials for a better scientific substantiation of the maximum peroxide level. RIFM is planning to test limonene with different (low) levels of peroxide to determine the EC3 value (equivalent to the human NOEL). This is a project with the University of Goteburg, Sweden (Professor. A.-T. Karlberg). Some of the goals of this research are to investigate the fundamental scientific basis of the auto-oxidation of four important structurally related fragrance ingredients (e.g., limonene) and one essential oil; to look more closely at the sensitization potential of limonene (and hence to challenge the current sensitization hazard classification of R43 of limonene, which itself is not a sensitizer, and essential oils rich in limonene such as orange oil); and to challenge the sensitization hazard classification of other essential oils, containing another important fragrance ingredient, labeled as allergen, namely linalool. This is possible if it can be demonstrated that linalool oxidizes differently in an essential oil as compared to the pure compound.
The impact of hazard classification (e.g., R43 Risk Phrase) of fragrance ingredients on the classification of essential oils containing them will be discussed in more detail in the section on Hazard Classification and Labeling.
The impact of allergen labeling requirements on essential oils is very important and a different approach of the regulators toward labeling based on the new scientific data available could be very high. If for example no further labeling requirements would apply to Group III materials (which include the following six naturally occurring substances: benzyl alcohol, linalool, benzyl salicylate, rf-limonene, anisyl alcohol, and benzyl benzoate), the number of affected natural raw materials (extract and essential oils) would be reduced from about 180 to only 80 extracts/essential oils that would need to be taken into account for labeling purposes (see Annex 22.2 to this chapter), according to the EFFA CoP. This would also have a favorable impact on the analytical burden: much less essential oils would have to be analyzed for the presence and concentration of the allergens; also the number of target analytes (allergens) would be reduced from 16 to 10 naturally occurring ones.
The issue on allergen labeling can also have detrimental business impact as some customers (clients) of the fragrance industry (being the cosmetic and detergent industry) are requesting fragrances (i.e., perfume mixtures and preparations) that are "allergen-free." This would mean that the suppliers of essential oils would need to produce "allergen-free" essential oils and extracts, that is, natural materials that do not contain any of the 16 naturally occurring "alleged allergens." This is of course practically impossible. Moreover, generally producing extracts and essential oils without or even with reduced levels of the 16 naturally occurring "allergens" (which are very important fragrance constituents by themselves), for example, by selectively removing them, would have a very high and negative impact on the organoleptic and sensory properties of the essential oils and hence on the fine fragrances and perfumes containing them. As mentioned above, only in particular cases (e.g., for oakmoss and tree moss extracts, which are of high importance to the perfumer but also very potent allergens) the Industry is successfully producing new qualities with reduced levels of allergens (in casu atranol and chlorotranol) to reduce the sensitization potential of the mosses. It is worthwhile to mention here that a considerable number of IFRA Standards (IFRA prohibited materials) are part of the Cosmetics Directive (banned materials under Annex II of the Cosmetics Directive).
22.2.5 First Amendment of the Detergent Regulation and Allergen Labeling
In line with the 7th Amendment of the Cosmetic Directive 76/768/EEC as just discussed above in the previous paragraph, the first amendment of the Detergent Regulation (from June 2006) makes the labeling of the 26 alleged "allergenic" materials mandatory: the presence of these materials above the given threshold has to be declared irrespective of the way they are added (as such or as being part of "complex ingredients" such as essential oils).
This first amendment is the Commission Regulation (EC) No. 907/2006 (20/06/06) amending Regulation (EC) No. 648/2004 on detergents. The recital (whereas) (4) of this regulation states the following:
(4) There is a requirement to declare allergenic fragrances if they are added in the form of pure substances. However there is no requirement to declare them if they are added as constituents of complex ingredients such as essential oils or perfumes. To ensure better transparency to the consumer, allergenic fragrances in detergents should be declared irrespective of the way they are added to the detergent.
The threshold for labeling is defined as 0.01% by weight (100 ppm), according to the adaptation of Annex VII (for labeling and ingredient data sheet) as follows:
If added at concentrations exceeding 0.01% by weight, the allergenic fragrances that appear on the list of substances in Annex III, Part 1 to Directive 76/768/EEC, as a result of its amendment by Directive 2003/15/EC of the European Parliament and of the Council to include the allergenic perfume ingredients from the list first established by the Scientific Committee on Cosmetics and Non-food Products (SCCNFP) in its opinion SCCNFP/0017/98, shall be listed using the nomenclature of that Directive, as shall any other allergenic fragrances that are subsequently added to Annex III, Part 1 to Directive 76/768/EEC by adaptation of that Annex to technical progress.
This text for Annex VII is written in such a way to ensure that the presence of the 26 alleged fragrance materials above the given threshold has to be declared irrespective of the way they are added (i.e., as such or as being part of "complex ingredients" such as essential oils).
In that way according to the first amendment of the Detergent Regulation, the same rules apply for detergents as for cosmetic end products for the requirements of allergen labeling.
22.3 CURRENT FLAVOURING DIRECTIVE AND FUTURE FLAVOURING REGULATION: IMPACT ON ESSENTIAL OILS
In the European Union for flavorings, the current Flavouring Directive 88/388/EC still applies. This is the Council Directive of June 22, 1988, on the approximation of the laws of the MS relating to flavorings for use in foodstuffs and to source materials for their production, as published in the Official Journal on 15/07/88 (OJ L 184, p. 61). It has been amended once by the Commission Directive 91/71/EEC of 16/01/91 (OJ L 42, p. 25, 15/02/91). As this is a Directive, it is up to the EU MS to take the necessary measures to ensure that flavorings may not be marketed or used if they do not comply with the rules laid down in this Directive, as stated in Art. 3 of this Directive.
However since recent years (around 2002) a Proposal for a new Regulation of the European Parliament and of the Council on flavorings and certain food ingredients with flavoring properties for use in and on foods is under discussion. The last version of the Commission Proposal that was the basis for further discussions and Amendments from EU Parliament was issued in July 2006. As many essential oils and extracts either contain flavoring substances or are regarded as "food ingredients with flavoring properties," this new Flavouring Regulation will have an impact on essential oils and their use as flavoring ingredients for food products. Extracts and essential oils contain certain constituents (substances) that according to this regulation "should not be added as such to food" or to which maximum levels apply. They are often referred to as "biologically active substances" or "active principles." Especially the application of maximum levels of these substances will have an impact on how and when extracts, essential oils but also herbs and spices may or can be applied to food. Also the definitions for "natural" have drastically changed. The difference between the current Directive 88/388/EC and the future Flavour Regulation will be outlined in the next paragraphs.
22.3.1 Current Flavouring Directive 88/388/EC
18.104.22.168 Maximum Levels of "Biologically Active Substances"
In the current Flavouring Directive 88/388/EC, Annex II sets maximum levels (limits) for certain substances obtained from flavorings and other food ingredients with flavoring properties in foodstuffs as consumed in which flavorings have been used. Art. 4 (c) stipulates that
(c) the use of flavourings and of other food ingredients with flavouring properties does not result in the presence of substances listed in Annex II in quantities greater than those specified therein.
The limits apply to Foodstuffs and Beverages (mg/kg) — exceptions apply: for example, alcoholic beverages and confectionaries. In Table 22.4, the maximum levels (without the exceptions) for these substances for foodstuffs in general and beverages are given. A more detailed table (with all the exceptions) is given in Annex 22.3 to this chapter.
This means that for essential oils, extracts, complex mixtures containing these "biologically active substances" (e.g., nutmeg, cinnamon, peppermint, and sage oils) and when added to food and flavorings, maximum levels apply. The same applies to herbs and spices containing these "biologically active substances" as herbs and spices are also "food ingredients with flavoring properties."
22.214.171.124 Definition of "Natural"
Also important is how the current Flavouring Directive addresses "naturalness" of flavors and how "natural" is defined for the purpose of labeling. This is stipulated by Art. 9a.2 (amending the original Art. 9.2 of 88/388/EC by 91/71/EEC):
2. the word 'natural', or any other word having substantially the same meaning, may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1 (2) (b) (i) and/or flavouring preparations as defined in Article 1 (2) (c). If the sales description of the flavourings contains a reference to a foodstuff or a flavouring source, the word 'natural' or any other word having substantially the same meaning, may not be used unless the flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.
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