Table 222

List B (SCCNFP/0017/98)—11 Less Frequently Reported Allergens (CAS No.)

Anisyl alcohol (105-13-5) Benzyl benzoate (120-51-4)

Benzyl cinnamate (103-41-3) CitroneUol (106-22-9)

Farnesol (4602-84-0) Hexyl cinnamaldehyde (101-86-0)

Lilial (80-54-6) rf-Limonene (5989-27-5)

Linalool (78-70-6) Methyl heptine carbonate (111-12-6)

3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one (=alpha-iso-methylionone) (127-51-5)

Note: Substances highlighted in bold are naturally occurring fragrance materials and the other substances are synthetic fragrance ingredients that are not known to occur in nature.

Additionally, as mentioned above, also two natural ingredients, oakmoss and tree moss extracts, were addressed in a separate SCCNFP opinion (adopted during the 14th plenary meeting of October 24, 2000).

These two natural mosses are identified as follows: oakmoss extracts derived from the lichen, Evernia prunastri (L.) Arch. (Usneaceae), growing primarily on oak trees, and tree moss extracts derived from a mixture of lichens, mainly Evernia furfuracea (L.) Arch. (Usneaceae) growing on Pinus species.

Oakmoss extract has CAS no. 90028-68-5 and EINECS no. 289-861-3.

Tree moss extract has CAS no. 90028-67-4 and EINECS no. 289-860-8.

The term "labeling" comes from the EU Commission (DG Enterprise) and whether a fragrance ingredient should be labeled or not is a Risk Manager's decision. In its memorandum of 2001 (SCCNFP/0450/01), the SCCNFP (being the Risk Assessor) clearly states that "because of the lack of dose/elicitation data for these substances, the SCCNFP has been unable to provide recommendations on levels above which the information to the consumer would be necessary." Nevertheless, SCCNFP mentions in its memorandum that it is "aware that for practical risk management reasons there is a need for threshold levels for the provision of information." There is a proposal that for leave-on products, this threshold level should be 10 ppm in the finished cosmetic product, whereas for rinse-off products, the SCCNFP would consider a working level 10 times higher than that recommended for leave-on products to be reasonable, being 100 ppm.

22.2.2 Cosmetic Directive and its Seventh Amendment

The EU Commission has implemented the above-mentioned SCCNFP opinions in the 7th Amendment of the Cosmetic Directive 76/768/EC (2003/15/EC) by adding the following restrictions [limitations and requirements (for labeling)] to 26 fragrance substances in Annex III, Part 1: "The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products."

However, no further restrictions (such as maximum authorized concentrations in the finished cosmetic products), except the labeling requirements were introduced at that time.

This means that the presence of any of the 26 alleged allergens (sensitizers) must be indicated (labeled) in the list of ingredients on the packaging of the finished cosmetic products when its concentration exceeds 10 ppm (leave-on products) or 100 ppm (rinse-off products), according to Art. 6.1(g) of the Cosmetic Directive, 7th Amendment.

However, it is important to note here that the Fragrance Industry is self-regulating by issuing the International Fragrance Association Code of Practice (IFRA CoP), which is published by the IFRA. This CoP consists of Standards (the so-called IFRA Standards) for the fragrance ingredients with certain restrictions/limitations and in some cases bans to which the International Fragrance Industry should comply. The last amendment of the IFRA CoP is the 44th Amendment. The IFRA CoP and its 44th Amendment and the IFRA Standards can be found on the homepage of the International Fragrance Association: www.ifraorg.org.

22.2.3 Impact on Extracts and Essential Oils and Aromatic Natural Raw Materials

The mandatory labeling requirement for the 26 alleged allergens is irrespective of the source of the allergen or the way by which it has been introduced in the final cosmetic product. In other words, 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 extracts and essential oils). This means that the use of essential oils containing them in formulations may lead to the presence of such allergens and the labeling requirement will apply.

Sixteen of the 24 alleged allergenic substances are naturally occurring (see substances indicated in bold in Tables 22.1 and 22.2), the other eight substances are synthetic fragrance ingredients that do not occur in nature as far as known.

The structures of the 16 naturally occurring allergenic substances are depicted in Figures 22.1 and 22.2.

The remaining two alleged allergens are aromatic natural raw materials by themselves: oakmoss (E. prunastri) and tree moss (E. furfuracea).

According to the current knowledge of the F&F Industry, these 16 allergens occur in about 180 natural raw materials (extracts and essential oils) (EFFA CoP, 2007).

A list of aromatic natural raw materials containing any of the 16 naturally occurring sensitizers and their presence (if >0.1%) or concentration can be found in Annex 22.1 to this chapter—this is based on earlier internal communication (2004) of the F&F industries related to a former version of the EFFA CoP.

One of the key challenges for the Fragrance Industry is the analysis and identification of the 16 naturally occurring allergens in the natural raw materials (extracts and essential oils) and fragrance compounds (mixtures and preparations). To address this work, the Fragrance Industry has established an Analytical Working Group of IFRA where methods of analysis are developed. A recommended method of analysis for gas chromatography-mass spectrometry (GC-MS) quantification of suspected allergens in fragrance compounds has been published by this group in 2003 (Chaintreau et al., 2003). Some further work on the investigation of the GC-MS determination of allergens (GC-MS quantification of allergens in fragrances and data treatment strategies and method performances) was published more recently by the same group (Chaintreau et al., 2007).

Eugenol c/t-Isoeugenol Benzyl salicylate Coumarin

FIGURE 22.1 Structures of the 16 naturally occurring alleged allergenic substances (part 1).

Eugenol c/t-Isoeugenol Benzyl salicylate Coumarin

FIGURE 22.1 Structures of the 16 naturally occurring alleged allergenic substances (part 1).

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