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Table 2.13 Universally acceptable color additives.
United States (FDA 2018a)
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and was updated again in 2021. This is a list of existing cosmetic ingredients that have already been used in cosmetic products in China. Any substances not listed in the IECIC are regulated as new cosmetic ingredients that must be approved by the CFDA prior to being used in cosmetic products in China.
Please note that in 2018, the CFDA was merged into the State Admin- istration for Market Surveillance (SAMR), and its name was changed to the National Medical Products Administration (NMPA).
United States
There is a potential change involving lakes in the United States. All of the lakes, with the exception of FD&C Red No. 40, are still provisionally listed. In the mid-1990s, the FDA published its draft regulations for lakes, which con- tained one revision that would have a dramatic impact on the color points and economics of the D&C lakes, but would not affect the FD&C ones. This provision would require that all D&C lakes be made from previously certi- fied straight color. Currently, most of the D&C lakes can be made in situ, which means that the dye can be made and then precipitated as a pigment all in one step. If the change were to be made, the straight color would have to be made and certified, then returned to the production vessel, redissolved, and laked. This would cause the color point to change slightly and double the manufacturing cost for lakes. After receiving numerous objections from color additive and cosmetic manufacturers, the FDA fell silent on the draft regulations, and they have never been subsequently promulgated. However, this situation is like a dormant volcano; one doesn’t expect it to erupt any- time soon, but the potential is always there.
Another regulatory action affecting a cosmetic pigment is the State of California’s classification of Titanium Dioxide as an inhalation carcinogen under Proposition 65 (OEHHA 2011). Details follow the discussion of EU activities regarding Titanium Dioxide.
European Union
In 2009, the European Union developed a new regulatory document titled Regulation (EC) No. 1223/2009 of the European Parliament and of the Coun- cil of 30 November 2009 on Cosmetic Products(European Commission 2009).
The regulation came into force in July 2013. From the color perspective, Annex IV contains a list of colorants allowed in cosmetic products. The list contains substance identification including the Color Index number,
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as well as the conditions for use (e.g., the product type and maximum concentration in ready-for-use preparations, if applicable.) There are also purity criteria inserted for some colorants. For those colorants which were already approved as food colors, the purity criteria are the same as set out in Commission Directive 95/45/EC, which lays down specific purity criteria concerning colors for use in foodstuffs (European Commission 2009).
Titanium Dioxide
Titanium Dioxide is one of the most widely used pigments in cosmetics because of its unique technical properties and the fact that it is universally permitted. However, in recent years, there have been some growing con- cerns with regard to the safe use of this pigment in cosmetics, particularly in powder form, in which various risk assessments and analytical analyses have been conducted. As a result, there have been some regulatory updates on Titanium Dioxide in the European Union and United States. These are worth mentioning briefly in this chapter, considering its importance in the cosmetics world.
CMR Classification (Category 2 by Inhalation): As per Commission Regulation (EU) 2020/217, Titanium Dioxide (in powder form containing 1% or more of particles with aerodynamic diameter of≤ 10μm) will be classified as a CMR category 2 substance (by inhalation) from October 1, 2021 (European Commission 2019). Following this classification, an opin- ion from the Scientific Committee on Consumer Safety (SCCS) would be required to determine whether Titanium Dioxide is still safe enough to be used in cosmetic products. In October 2020, an SCCS opinion on Tita- nium Dioxide was adopted, in which Titanium Dioxide was considered to be safe for general consumers when used in face products in powder form up to a maximum concentration of 25% and in hair products in aerosol dispenser (spray) form up to a maximum concentration of 1.4% (European Commission 2020). The use of pigmentary Titanium Dioxide as a colorant in accordance with Annex IV to Regulation (EC) No 1223/2009 should also be allowed, with specific use restrictions being added to Annex III (List of Restricted Substances) as a result of this SCCS opinion.
E171 Specification Update: Apart from its use in cosmetics, Titanium Dioxide has also historically been used as a food additive in accordance with the EU E171 specification. There is a recent update to the E171 spec- ification as a result of the EFSA Scientific Opinion (European Food Safety Authority 2019), which was adopted in June 2019 (European Commission
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2019). According to Annex IV of Regulation (EC) No 1223/2009, the Titanium Dioxide entry includes a dynamic reference to the E171 purity criteria outlined in Commission Regulation (EU) No 231/2012 of Regula- tion (EC) No 1333/2008 (European Commission 2009). Consequently, the proposed E171 specification amendment may also have an impact on the cosmetics industry for its use as a colorant. However, it has to be noted that the proposed E171 specification is based on the EFSA assessment and opinion on Titanium Dioxide as a food additive, and not as a cosmetic colorant; thus, the outcome of the modification on the use of Titanium Dioxide in cosmetics is being reviewed. The cosmetic industry, through multiple channels, is in discussion to address this topic, in order to ensure continued compliance of all Titanium Dioxide-containing ingredients in cosmetic applications.
Particle Size: The current definition of a “nanomaterial” as per Regula- tion (EC) No 1223/2009 (European Commission 2009) is not consistent with that of Commission Recommendation (2011/696/EU) (European Commission 2011), which creates room for interpretation. Further clar- ification with regard to the definition and measurement methodology is required to avoid confusion and inconsistency. With the evolution of analytical techniques and sample preparation methods in recent years, the particle size of some cosmetic pigments has been under increasing scrutiny, including that of Titanium Dioxide. The use of Titanium Dioxide in nano form is permitted as a UV-filter in sunscreen products, provided that it meets the conditions set out as per Commission Regulation (EU) 2016/1143 (European Commission 2016). However, the nano form of Titanium Dioxide is currently not authorized as a colorant according to Annex IV to Regulation (EC) No 1223/2009 (European Commission 2009).
United States (Continued)
California Proposition 65: In 2011, the California Office of Environ- mental Health Hazard Assessment (OEHHA) added Titanium Dioxide (airborne, unbound particles of respirable size) to the list of chemicals known to the State of California to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing, however, does not cover Titanium Dioxide when it remains bound within a product matrix (OEHHA 2011). It is worth pointing out that the use of Titanium Dioxide pigments, which are defined as “unbound particles of respirable size,” in cosmetic formulations does not necessarily
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equate to their being unbound in the final cosmetic products exposed to consumers. The businesses involved in the manufacture of final products are responsible for conducting risk and exposure assessments to deter- mine whether a Proposition 65 labelling is required on the packaging of products supplied to California. While the regulatory situation portrayed here is accurate at the time of writing, regulations change on a regular basis. Therefore, the information presented here may have been revised by the various regulatory bodies in the intervening time between this writing and your reading.