Cosmetics Products: SVHCs in Supply Chain Worldwide

Many of us think that the cosmetics and personal care products are safe. In fact there are some products that do contain some hazardous chemicals, materials, or substances of very high concerns (SVHCs). In the U.S. these products are least regulated as compared to the countries in the European Union (EU).

For safe cosmetics, public health, environmental, and consumer groups are campaigning to eliminate or reduce these harmful chemicals from the cosmetics and personal care products.

Cosmetics products may contain some ingredients which are toxic and hazardous in form of nanomaterials that beautify faces, hairs, and other parts of the body. Majority of them are applied to the face and the body. These products contain mixtures of chemical compounds; some of them may be derived from natural sources such as coconut oil, or from synthetic or artificial man-made products.
Common cosmetics items are skin cleaners, lipstick, mascara, eye shadow, foundation, shampoo & conditioners, blush, nail polish, lipstick, fragrance (perfume & cologne), body lotion, deodorant, hairs styling as hair gel or spray, creams, sunscreens, and skin lighteners.

In the US, the Food and Drug Administration (FDA) regulates cosmetics. Pure soaps are not the product of cosmetics. Internationally, the European Union (EU) is one of the largest markets for cosmetic products in the world. Its regulation is considered to be one of the most stringent as compared to other nations. Some of the foreign brands are difficult to understand and explain the regulatory implications. It is somewhat complex.

Exporters must validate different steps before obtaining compliance. The verification of the formula is fundamental; it determines whether the cosmetic product is “importable” and therefore could be registered through the CPNP (Cosmetic Products Notification Portal). The appointment of a Responsible Person (RP) based in Europe is mandatory in order to be compliant and to fulfill the regulatory requirements. Cosmetic regulations 1223/2009 is updated approximately every 3 months.

It is important to understand the regulations and regularly check the labels and the formulas of the product in question.

Some of these chemicals may be allergens or irritants, cancer causing, developmental or reproductive toxicity, endocrines disruption, or any environmental concerns.

Some of the examples like DEA (diethanolamine), hydroquinone, formaldehyde, and carbon black as pigment should be looked with health concerns as in eyeliners, mascaras, and lipstick or coal tar in shampoos hair dying and lotions. Lead and heavy metals like arsenic, mercury in lipstick, eye liners and nail colors should be avoided.

It is an occupational safety and health concerns in the beauty parlors’, cosmetics hairs dressing & hair beautifying salons or studios in the long term.

Cosmetics Products & Nanomaterials

European Commission (EC)’s regulation # 223/2009, article 2 (1) (k), nanomaterials are defined as insoluble or bio-persistent and intentionally manufactured materials with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. Based on this definition, soluble or degradable/non-persistent nanomaterials like liposomes, emulsions, etc. are not considered within this classification.

According to article 16 of this regulation, the EC must be notified six months prior to any cosmetic product containing nano-materials being placed on the market. Furthermore, article 19:1 requires the nano-scale ingredients to be labeled (name of the ingredient, followed by ‘nano’ in brackets).
When nano-materials are approved to be used in cosmetic products, they should be listed in the appropriate annexes.

In this case, notification of nonmaterial under article 16 is not required since they have been approved in the positive lists.

Approved nanomaterials in cosmetic products

Titanium Dioxide

Titanium dioxide is allowed to be used in cosmetic products via Annex IV/143 as a colorant and Annex VI/27 as a UV filter. In July 2016, an additional entry Annex VI/27a authorized the application of titanium dioxide nano by maximum concentration of 25% in cosmetic products. This conclusion is only valid if there is no possibility of inhalation exposure for the finished products.

Hence, Titanium dioxide nano is not safe to be used in sprays, aerosols or any other products that may cause exposure to lungs. Furthermore, Titanium dioxide nano shall have further physiochemical characteristic as:

• purity ≥ 99%, rutile form, or rutile with up to 5% anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,
• median particle size based on number size distribution ≥ 30 nm,
• aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,
• coated with Silica, Hydrated Silica, Alumina, Aluminum Hydroxide, Aluminum Stearate, Stearic Acid,
• Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone;
• Photocatalytic activity ≤ 10% compared to corresponding non-coated or non-doped reference,
• nanoparticles shall be photos table in the final product.

There are still further ongoing discussions regarding Titanium dioxide being used in products with possible oral ingestion, like lipsticks. In case the nanomaterials are coated with manganese dioxide, the potential harmful effects of coating materials should be taken into account. Another new entry is in annex VI.

Zinc Oxide

Zinc oxide (nano)/30a by maximum concentration of 255 in the finished product. Like the other nanomaterials, in case of inhalation exposure, it is not considered a safe ingredient. In addition, there are certain criteria set in the regulation for Zinc oxide nano as:

• purity ≥ 96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like,
• star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1% in total,
• median diameter of the particle number size distribution D50 (50% of the number below this diameter) > 30 nm and D1 (1% below this size) > 20 nm,
• water solubility 97%
• Ash content ≤ 0,15%
• total sulphur ≤ 0,65%
• total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb
• dibenz(a,h)anthracene ≤ 5 ppb
• total As ≤ 3 ppm
• total Pb ≤ 10 ppm
• total Hg ≤ 1 ppm

In conclusion, it is important to note that risk assessment of nanomaterials is currently evolving. In particular, criteria like long-term stability of coating and possibility of oral ingestions are yet to be investigated. There are certain knowledge gaps in regard to potential penetration of nanoparticles through cuts and bruises, or long term application of nanomaterials. It is also important to state that Scientific Committee on Consumer Safety (SCCS) opinions for nanomaterials’ safety, environmental impact of nanomaterials have not been investigated and have yet to be considered.

Since the Regulation 1223/2009 on cosmetic products came into force in July 2013, a Responsible Person (RP) must be designated for each cosmetic product placed on the EU market.

The RP must be a legal or natural Person based in the European Union and has a key strategic role:

• Ensure the compliance of products placed on suppliers market
• Fulfill all obligations described in the regulations
• Cooperate as a single point of contact with competent regulatory authorities involved.

We see EU is more stringent than America and allows some of the chemicals that are banned in EU. Visit the webpage at: https://www.theguardian.com/us-news/2019/may/22/chemicals-in-cosmetics-us-restricted-eu. For further information on these issues, visit ECHA web page at: https://echa.europa.eu/ for further regulatory information.

References:

• European Chemical Agency, webpage at: https://echa.europa.eu/.
• Wikipedia Cosmetics webpage at: https://en.wikipedia.org/wiki/Cosmetics
• COMMISSION REGULATION (EU) 2016/1143 of 13 July 2016, webpage at: web page at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1143&from=EN
• Cosmetics Regulations No 1223/2009, webpage at; https://www.ecomundo.eu/en/blog/prohibited-ingredients-cosmetics-regulation
• REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, webpage at: https://ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/cosmetic_1223_2009_regulation_en.pdf

EC Regulation 1223/2009 on cosmetics, webpage at:

• https://en.wikipedia.org/wiki/EC_Regulation_1223/2009_on_cosmetics
• The EC Scientific Committee on Consumer Safety SCCS
• https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_224.pdf

 

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