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The State of Regulations in the European Union, Japan,
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Color Selection – Regulations 29
Table 2.7 Common US exempt color additives and their EU/Chinese and Japanese counterpart names.
United States (FDA 2018c)
European Union/China (European Commission 2009/NMPA 2015)
Japan
(MHLW 2003)a
Aluminum Powder 77000 Aluminum Powder
Carmine 75470 Carmine
Chromium Hydroxide Green 77289 Hydrated Chromium Oxide
Chromium Oxide Green 77288 Chromium Oxide Green
Ferric Ammonium Ferrocyanide 77510 Ferric Ammonium Ferrocyanide
Iron Oxides 77491 Red Oxide of Iron
Iron Oxides 77492 Yellow Oxide of Iron
Iron Oxides 77499 Black Oxide of Iron
Manganese Violet 77742 Manganese Violet
Titanium Dioxide 77891 Titanium Dioxide
Ultramarines 77007 Ultramarine
Zinc Oxide 77947 Zinc Oxide
aThese are the common reference names. Due to the major revision of the Japanese color regulations in 2004, these colorants are no longer officially regulated there.
obscure exempt colorants may not be on the positive list in all four markets.
Use Restrictions: All four markets restrict the use of some colors in cer- tain types of cosmetic and toiletry products but these are not uniform in all jurisdictions. For example, ferric ammonium ferrocyanide is limited to external use only in the United States, but no such restriction exists in the European Union/China.
Specifications: All four markets have chemical specifications for the color additives on their positive lists that may differ among them. An example is that D& C Yellow No. 10 and CI 47005 are both Quinoline Yellow, but the former is specified in the United States as composed of not less than 75%
of the monosodium salt and the latter in the European Union as not less than 80% of the disodium salt.
Precipitants: All four markets specify what precipitants are allowed for the manufacture of lakes. The United States has a general positive list, allowing any of the precipitants to be used with any of the primary colors. Although Japan does not have a general positive list, in the Japanese regulations, precipitants are specified for each of the colorants individually in the color additive positive list, divided into two categories.
The first contains the precipitants that are specified in the chemical
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Table 2.8 Approved cosmetic lake precipitants.
United States (FDA 2018e)
European Union/China (European Commission 2009/NMPA 2015)
Japan
(MHLW 2003)a
Sodium Sodium Sodium
Potassium Potassium Potassium
Aluminum Aluminum Aluminum
Barium Bariumb Barium
Calcium Calcium Calcium
Strontium Strontiumb Strontium
Zirconium Zirconiumb Zirconium
aNot all precipitants are permitted with all color additives.
bNot permitted with certain color additives.
definition of each colorant. The second contains the precipitants that are permitted for the manufacture of lakes. Again, this list is color additive specific. In the European Union/China, the innocuous metals approved in the United States and Japan are generally accepted, but some of these precipitants – zirconium, barium, and strontium – are restricted for use with certain colors. Table 2.8 provides a comparison among the regions of the approved precipitants for lakes.
The differences amongst the regulations in the four markets make devel- opment of cosmetic formulations very challenging. The major ones are:
Nomenclature: As described previously, the US system is an arbitrary one that does not relate to any other system. The Japanese system, likewise, is arbitrary. It provides for the use of a descriptive color name followed by a number (e.g., Red 201). The European Union/China system uses Color Index numbers to identify approved color additives. Examples of all these systems with regard to certifiable colorants can be found in Table 2.9.
Approved Color Additives: Even though all four markets have positive lists, the colorants that are permitted in each vary considerably. The pos- itive lists in the European Union/China and Japan each contain far more colorants than the FDA positive list, so formulators have more choice in creating a particular color shade if their product is to be sold in one of these markets.
Listing Status: The United States and the European Union/China have both provisional and permanent lists of approved color additives. As the names imply, the permanently listed color additives are those for which the regulatory bodies are satisfied that the colorants are safe for use in cosmetic
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Color Selection – Regulations 31
Table 2.9 Common US certifiable color additives and their EU/Chinese and Japanese counterpart names.
United States (FDA 2018d)
European Union/China (European Commission 2009/NMPA 2015)
Japan
(MHLW 2003)a
FD&C Red No. 40 Al Lake 16035 Not permitted
D&C Red No. 6 Ba Lake 15850 Not permitted
D&C Red No. 7 Ca Lake 15850 Red 202 Mixture
D&C Red No. 21 Al Lake 45380 Not permitted
D&C Red No. 22 Al Lake 45380 Red 230 (1) Lake
D&C Red No. 27 Al Lake 45410 Not permitted
D&C Red No. 28 Al Lake 45410 Red 104 (1) Lake
D&C Red No. 30 Al Lake 73360 Red 226 Mixture
D&C Red No. 30 73360 Red 226
D&C Red No. 31 Ca Lake 15800 Red 219
D&C Red No. 33 Al Lake 17200 Red 227 Lake
D&C Red No. 33 Zr Lake Not permitted Not permitted
D&C Red No. 34 Ca Lake 15880 Red 220 Mixture
D&C Red 36 12085 Red 228
D&C Orange No. 5 Al Lake 45370 Not permitted
FD&C Yellow No. 5 Al Lake 19140 Yellow 4 Lake
FD&C Yellow No. 6 Al Lake 15985 Yellow 5 Lake
D&C Yellow No. 10 Al Lake, primarily a monosulfonate
47005, a disulfonate; differs from D&C Yellow No. 10
Yellow 203 Lake
FD&C Blue No. 1 Al Lake 42090 Blue 1 Lake
D&C Black No. 2 77266 Carbon Black
aAluminum lakes of some color additives are not permitted.
and toiletry products. The provisionally listed color additives are those for which some safety studies remain pending or the results of such tests are under review. The Japanese regulations have only a permanent list of color additives.
Lake Definition: The EU/Chinese and Japanese regulations use the clas- sical chemical definition of a lake as described earlier in this chapter. That is, a lake is a pigment that is produced by absorbing a water-soluble dye on to an insoluble, inorganic substrate. The US definition differs considerably;
while the US regulations embrace the classical definition, they also define a lake as any color additive, dye, or pigment that is extended (reduced) with one of the 10 approved substrates. This difference leads to a considerable amount of confusion. Some important colorants, particularly the reduced toners, which are considered lakes under the US regulations, would appear to not be permitted as lakes under the Japanese ones. But, since they are
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not true chemical lakes, they are permitted for use in Japan. Two major examples of this anomaly are D&C Red No. 7 Ca Lake and D&C Red 30 Al Lake.
Specifications: Specifications, like the colorants on the positive lists, are not the same for all four markets. The major differences are found in the chemical purity and allowable level of contaminants.
Certification: Only the United States has a mechanism for testing and subsequent certification of each batch of synthetic organic colors for cos- metics. Japan does have a batch certification program for food colors. The US certification process is administered by the FDA. All cosmetic products destined for sale in the United States must use certified color additives.
Substrates: The United States is the only market that has a positive list for substrates. In the European Union/China and Japan, any chemical that is used as a substrate in the manufacture of a cosmetic color must be accept- able as a cosmetic ingredient in that market. The European Union does not have a positive list for all cosmetic ingredients, but it does have prohibited and restricted lists, like China and Japan. Table 2.10 lists the substrates that are permitted in the United States along with their status in the European Union/China and Japan.
Use Restrictions: While all four markets have use restrictions, these restrictions vary amongst them. The most notable difference is that the US regulations permit only some synthetic organic colorants to be used in eye makeup, while many more of these types of colorants are permitted for this use in both the European Union/China and Japan. Table 2.11 lists the most commonly used US color additives along with their corresponding use restrictions in all four markets.
Quantity Restrictions: The United States and the European Union/China each have restrictions on the quantity of certain colors permitted for use in cosmetic products, but these restrictions differ between the two markets.
The United States does not list specific quantity limits on all colors. As mentioned earlier, for those that do not have a specific amount listed, the regulations will state that the color “shall be used in amounts consistent with good manufacturing practice (GMP).” Japan does not have any quantity restrictions. Similarly, the EU/Chinese regulations do not list specific use amounts for every color. But, unlike with the United States, there is not a similar GMP quantity use clause. And while Japan, again, does not have quantity restrictions per se, it must be noted that there are commonly accepted use levels in the Japanese market. Table 2.12 lists the quantity restrictions placed on some commonly used US color additives.
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Color Selection – Regulations 33
Table 2.10 Substrates approved in the United States and their EU/Chinese and Japanese statuses.
United States (FDA 2018e)
European Union/China (European Commission 2009/NMPA 2015)
Japan (MHLW 2003)
Barium sulfate No restrictions No restrictions
Gloss white No restrictions No restrictions
Talc No restrictions No restrictions
Zinc oxide No restrictions No restrictions
Titanium dioxide No restrictions No restrictions
Clay No restrictions No restrictions
Aluminum hydrate No restrictions No restrictions
Aluminum benzoate No restrictions No restrictions Calcium carbonate No restrictions No restrictions
Rosin No restrictions No restrictions
To demonstrate how the differences in the global color regulations can make formulating cosmetic products a challenge, look back at Table 2.9. This shows the most common certifiable colorants used in the US market, along with their regulatory status in the European Union/China and Japan. If a colorant is approved for use in the European Union or Japan, its name in that market is shown. As can be seen, several important colors, the most notable of which is D&C Red No. 6 Ba Lake – the major yellow shade certifiable red used in US formulations – are not permitted for use in Japan.
Fortunately for the sanity of the cosmetic chemist, there are some other colorants on the US list that are acceptable in Japan. To replace D&C Red No. 6 Ba Lake, the formulator can use the primary color, D&C Red No. 6, in its place. Although some of these colors have not been widely used in the past, their use has become more prevalent as cosmetic companies seek to develop universally acceptable formulations. Table 2.13 includes these col- orants in a more complete list of color additives that are permitted in all four markets.
As a final note on regulations, the current official publications of the US FDA, the European Union, China, and Japan must be consulted before using any color additives in a cosmetic or toiletry product. While the regu- latory situation portrayed here is accurate at the time of writing, regulations change on a regular basis. So, the information presented here may have been revised by the various regulatory bodies in the intervening time between this writing and your reading.
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Table2.11UScertifiedcoloradditives:cosmeticuserestrictions. ColoradditiveUnitedStates (FDA2018d)EuropeanUnion/China (EuropeanCommission 2009/NMPA2015)
Japan (MHLW2003) FD&CRedNo.40AlLakeNorestrictionsNorestrictionsNotpermitted D&CRedNo.6BaLakeNotforuseintheareaoftheeyeNorestrictionsNotpermitted D&CRedNo.7CaLakeNotforuseintheareaoftheeyeNorestrictionsRed202asamixture D&CRedNo.21AlLakeNotforuseintheareaoftheeyeNorestrictionsNotpermitted D&CRedNo.22AlLakeNotforuseintheareaoftheeyeNorestrictionsRed230(1)Lake D&CRedNo.27AlLakeNotforuseintheareaoftheeyeNorestrictionsNotpermitted D&CRedNo.28AlLakeNotforuseintheareaoftheeyeNorestrictionsRed104(1)Lake D&CRedNo.30AlLakeNotforuseintheareaoftheeyeNorestrictionsRed226asamixture D&CRedNo.30NotforuseintheareaoftheeyeNorestrictionsNorestrictions D&CRedNo.31CaLakeExternalonlyExternalonlyNailandhairuseonly D&CRedNo.33AlLakeNotforuseintheareaoftheeyeNorestrictionsNorestrictions D&CRedNo.33ZrLakeNotforuseintheareaoftheeyeNotpermittedNotpermitted D&CRedNo.34CaLakeExternalonlyNorestrictionsNorestrictions D&CRed36NotforuseintheareaoftheeyeNorestrictionsNorestrictions D&COrangeNo.5AlLakeNotforuseintheareaoftheeyeNorestrictionsNotpermitted FD&CYellowNo.5AlLakeNorestrictionsNorestrictionsNorestrictions FD&CYellowNo.6AlLakeNotforuseintheareaoftheeyeNorestrictionsNorestrictions D&CYellowNo.10AlLakeNotforuseintheareaoftheeyeNorestrictionsas CI47005Norestrictions FD&CBlueNo.1AlLakeNorestrictionsNorestrictionsNorestrictions D&CBlackNo.2Permitteduseslisted;mostcolor cosmeticsNorestrictionsNorestrictions;under industrystandard
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Table2.12UScertifiedcoloradditives:cosmeticquantityrestrictions. ColoradditiveUnitedStates (FDA2018d)EuropeanUnion/China (EuropeanCommission 2009/NMPA2015)
Japan (MHLW2003) FD&CRedNo.40AlLakeConsistentwithGMPamountsNorestrictionsNotpermitted D&CRedNo.6BaLakeConsistentwithGMPamountsNorestrictionsNotpermitted D&CRedNo.7CaLakeConsistentwithGMPamountsNorestrictionsN/Aa D&CRedNo.21AlLakeConsistentwithGMPamountsNorestrictionsNotpermitted D&CRedNo.22AlLakeConsistentwithGMPamountsNorestrictionsN/A D&CRedNo.27AlLakeConsistentwithGMPamountsNorestrictionsNotpermitted D&CRedNo.28AlLakeConsistentwithGMPamountsNorestrictionsN/A D&CRedNo.30AlLakeConsistentwithGMPamountsNorestrictionsN/A D&CRedNo.30ConsistentwithGMPamountsNorestrictionsN/A D&CRedNo.31CaLakeConsistentwithGMPamountsNorestrictionsN/A D&CRedNo.33AlLakeMaximum3%inlipsticksNorestrictionsN/A D&CRedNo.33ZrLakeMaximum3%inlipsticksNotpermittedNotpermitted D&CRedNo.34CaLakeConsistentwithGMPamountsNorestrictionsN/A D&CRed36Maximum3%inlipsticksMaximum3%infinishedproductN/A D&COrangeNo.5AlLakeMaximum5%inlipsticksNorestrictionsNotpermitted FD&CYellowNo.5AlLakeConsistentwithGMPamountsNorestrictionsN/A FD&CYellowNo.6AlLakeConsistentwithGMPamountsNorestrictionsN/A D&CYellowNo.10AlLakeConsistentwithGMPamountsNorestrictionsasCI47005N/A FD&CBlueNo.1AlLakeConsistentwithGMPamountsNorestrictionsN/A D&CBlackNo.2ConsistentwithGMPamountsNorestrictionsN/A aNotapplicable,asJapandoesnothavequantitylimitations.
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Table 2.13 Universally acceptable color additives.
United States (FDA 2018a)