Requirements for the Safe Use of Fragrances in Cosmetics

A fragrance is a natural or artificial synthetic substance that has a smell or odor because of its specific functional group or specific chemical structure. It is used in small amounts in cosmetics, but it is an indispensable raw material of cosmetics. With the wide application of fragrances, security issues are also of concern.

IFRA Code of Practice

The International Fragrance Association (IFRA) was founded in 1973 and it is committed to promoting the safe use of fragrances. The safety evaluation results from the Research Institute for Fragrance Materials (RIFM) served as the benchmark of the code of practice (including IFRA standards). The management of fragrances for daily use mainly adopts a negative list and restriction list, which can be divided into prohibition standard, restriction standard, and quality standard.

The IFRA standard has been revised for 50 times so far, and the 50th revision was issued in June 2021 under which the use of menthol lactone (CAS 13341-72-5) as a flavor ingredient was prohibited. Except the prohibition of menthol lactone as a flavor, other information in the 50th revision is consistent with that in the 49th revision published on January 10, 2020. It is worth noting that the 49th revision introduced the revised methodology of Quantitative Risk Assessment for fragrance ingredients (QRA2) and the aggregate exposure model. This included the revision to the Safety Assessment Factor (SAF) and the use of the aggregate exposure model. Besides, in the 49th revision, the number of categories has changed from 11 categories for dermal sensitization Standards and 4 for systemic toxicity-based Standards to 12. The product categories in the 49th revision of the IFRA standard are summarized as follows:

Category	Product Type
1	Products applied to the lips
2	Products applied to the axillae
3	Products applied to the face/body using fingertips
4	Products related to fine fragrance
5	Products applied to the face and body using the hands (palms), primarily leave-on:
5A	Body lotion products applied to the body using the hands (palms), primarily leave-on
5B	Face moisturizer products applied to the face using the hands (palms), primarily leave-on
5C	Hand cream products applied to the hands using the hands (palms), primarily leave-on
5D	Baby Creams, baby Oils and baby talc
6	Products with oral and lip exposure
7	Products applied to the hair with some hand contact
7A	Rinse-off products applied to the hair with some hand contact
7B	Leave-on products applied to the hair with some hand contact
8	Products with significant anogenital exposure
9	Products with body and hand exposure, primarily rinse off
10	Household care products with mostly hand contact
10A	Household care excluding aerosol products (excluding aerosol/spray products)
10B	Household aerosol/spray products
11	Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate
11A	Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate without UV exposure
11B	Products with intended skin contact but minimal transfer of fragrance to skin from inert substrate with potential UV exposure
12	Products not intended for direct skin contact, minimal or insignificant transfer to skin

Requirements for Cosmetic Fragrance Allergen in EU

In the 7th amendment to the Cosmetics Directive (2003/15/EC) of March 2003, 26 fragrances that may lead to allergic reaction upon contact as identified by the by the European Scientific Committee for Cosmetics and Non-Food Products (SCCNFP, now known as SCCS) were added into Annex III (List of Restricted Substances for Cosmetics). In addition, when the concentration of leave-on products is higher than 0.001% and the concentration of rinse-off products is higher than 0.01%, the presence of these substances should be listed in the ingredient list on cosmetics labels. In November 2009, the European Commission formulated and published the European Cosmetics Regulation (2009/1223/EC) based on the European Cosmetics Directive, which still retained the requirements on the 26 allergens. Details are as follows:

Number	INCI Name	CAS Number
1	Amyl Cinnamal	122-40-7
2	Benzyl Alcohol	100-51-6
3	Cinnamyl Alcohol	104-54-1
4	Citral	5392-40-5
5	Eugenol	97-53-0
6	Hydroxycitronellal	107-75-5
7	Isoeugenol	97-54-1
8	Amylcinnamal Alcohol	101-85-9
9	Benzyl Salicylate	118-58-1
10	Cinnamal	104-55-2
11	Coumarin	91-64-5
12	Geraniol	106-24-1
13	Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde	31906-04-4
14	Anise Alcohol	105-13-5
15	Benzyl Cinnamate	103-41-3
16	Farnesol	4602-84-0
17	Butylphenyl Methylpropional	80-54-6
18	Linalool	78-70-6
19	Benzyl Benzoate	120-51-4
20	Citronellol	106-22-9
21	Hexyl Cinnamal	101-86-0
22	Limonene	5989-27-5
23	Methyl 2-Octynoate	111-12-6
24	Alpha-Isomethyl Ionone	127-51-5
25	Evernia Prunastri Extract	90028-68-5
26	Evernia Furfuracea Extract	90028-67-4

In November 2021, the European Commission issued Regulation (EU) 2020/1902, updating the Annex II, Annex III, and Annex V to the European Regulation (EC) No 1223/2009. Under the Regulation (EU) 2020/1902, Butylphenyl Methylpropional (CAS No. 80-54-6) was listed as a prohibited substance. The regulations have been implemented since March 1, 2022.

Requirements for the Use of Fragrance in Cosmetics in China

General requirements

According to Provisions on the Management of Cosmetic Registration and Filing Data, product formula flavor can be filled in two ways, and the dossier shall be submitted respectively:

• If only "flavor" is filled in the product formula table, there is no need to submit the type and content of specific flavor components; If the specific flavor components is listed in the product label, or the label of the original package of the imported product identifies the specific flavor components, then it shall be explained in the remarks column of the formula table;
• If "flavor" and specific flavor components are filled in the product formula table, the information on the types and contents of all components in the flavor issued by the manufacturer shall be submitted.

In April 2021, NMPA issued a notice on Technical Guidelines for Cosmetics Safety Assessment (2021) (Notice No. 51, 2021), which requires that cosmetics registrants and filers should carry out cosmetics safety assessment and submit product safety assessment materials based on the Technical Guidelines before they apply for filing of ordinary cosmetics or registration of special use cosmetics since 1 January 2022. In the appendix, when evaluating fragrances, for example, it shall be mentioned that they meet the requirements of IFRA, Fragrances for Daily Use (GB/T 22731-2017), or other certificates provided by the raw material supplier.

In April 2022, the FAQs issued by the National Institute for Food and Drug Control on the evaluation requirements of flavors once again pointed out that fragrances are raw materials, and the highest historical usage of fragrances in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) should not be used as evaluation evidence. The fragrances should be evaluated according to the principles and requirements of the Technical Guidelines for Cosmetics Safety Assessment or based on the documents certifying that the flavor used in the product complied with the IFRA code of practice or relevant national standards (fragrance) in China.

Trends in Children's Product Regulation

Considering the particularity of children users, the National Medical Products Administration released the Provisions on the Cosmetics Supervision and Administration Regulations of Children, in October 2021, which required that when it comes to children's cosmetics, the scientific nature and the necessity of ingredients used in the products, particularly fragrances, colorants, preservatives and surfactants, shall be evaluated from the perspective of safety, stability, function, compatibility, etc., and taking into consideration of children's physiological characteristics.

The Technical Guidelines for Children's Cosmetics released in 2022 (Draft for Comments) pointed out the compliance requirements for fragrance components in children's cosmetics:

• Use as few fragrances in children’s cosmetics. It is not recommended to use complex ingredients that may contain 26 allergenic components (note: same as those in the EU) as aromatic. Fragrances containing 26 allergenic components shall be adequately evaluated on its safety. The allergenic components shall be marked on labels to inform consumers if content of the allergenic component in a leave-on product is more than 0.001% or 0.01% in a rinse-off product.
• The flavor is a kind of raw materials, and the highest historical usage of fragrances in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) should not be used as evaluation evidence. The fragrances should be evaluated according to the principles and requirements of the Technical Guidelines for Cosmetics Safety Assessment or based on the documents certifying that the flavor used in the product complied with the IFRA code of practice or relevant national standards (fragrance) in China. If "flavor" and specific flavor components are filled in the product formula table, the information on the types and contents of all components in the flavor issued by the manufacturer shall be submitted. Each flavor component shall be assessed on its safety while fragrances/flavors containing the 26 allergenic components shall be utterly assessed.
• For flavors or fragrances containing 26 allergenic components, warning words should be printed on the labels according to the requirements of Section 3.2. “Containing allergenic components” shall be marked as guide language and name of the specific allergenic components shall be labeled as well.

Fragrance Compound (GB/T22731-2017)

Fragrance Compound (GB/T22731-2017) was revised in 2017, and has been implemented since February 1, 2018. It is a recommended standard. The standard stipulates the definition, requirements, test methods, inspection rules, marks, packaging, transportation, storage, and shelf life of daily flavors and it is applicable to analyze and evaluate the quality of various types of liquid daily flavor. The limit of spices in daily flavor and the maximum limit in 11 kinds of cosmetics and the forbidden substances in daily flavor were stipulated.

Fragrance Compound (GB/T22731-2017) requires manufacturers to ensure that their products meet the requirements of the standard, that each batch of products should be accompanied by a certificate of quality, and that customers should be informed in writing of the maximum amount of 11 categories of scented products or designated products.

At present, Flavors Fragrances and Cosmetics (SAC/TC257) has proposed to amend the Fragrance Compound (GB/T22731-2017) and plans to adopt the relevant content in the 49th revision of the IFRA standard.

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