ASSIGNMENT SSK 3203

(CHEMICAL ANALYSIS)

Prepared by ;

Siti Farhanah Mohd NasirDX091681KKJ04790126-14-5504

10000-50000

Application of Chemical Analysis/ Analytical Chemistry in the

Cosmetics Industry

The definition of Cosmetic Product

• any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs),

• or with teeth and mucous membranes of the oral cavity,

• with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them in good condition

The Cosmetic Industry

The Cosmetic Industry

The Cosmetic Industry

The Cosmetic Industry

The Analysis of Body & Skin Care Products

• Body Scrub

• Body Firming Lotion

• Body Cellulite Gel

Problem Definition of Body Scrub, Body Firming Lotion and Body Cellulite Gel

Dealing with Cosmetic Regulation Before the cosmetic products are put in the market, the industry has

to comply with the Cosmetic Regulation by notifying the regulatory authority.

The notification is to ensure that their products do not cause any damage to human health and to establish the product information file (PIF). The PIF is a file consisting of the qualitative and quantitative composition of the product (name and percentage of the ingredients), raw materials specifications, and manufacturing method as in Good Manufacturing Practice (GMP) Guidelines (4), assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure.

It should also include data on the undesirable effects on human health resulting from the use of the product, supporting data for claimed benefits (efficacy assessment), certificate of analysis to check the ingredients and microbiological control.

Dealing with Cosmetic Regulation

In general, requirements of the Cosmetic Regulation will cover physical-chemical properties, safety, microbiology and efficacy, whereas the halal compliance will include the safety, microbiology, efficacy, alcohol and animal origin ingredients detection.

Problem Definition of Cosmetic Products Analysis

1. Toxic Metals Contaminant Analysis such as Lead (Pb), Arsenic (As) and Mercury (Hg)

2. Physical-Chemical Analysis such as the pH, viscosity and color

3. Microbiological Analysis of bacteria and other microorganisms

4. Skin Irritation Analysis5.

Problem Definition of Cosmetic Products Analysis

Toxic Metals Contaminant

Problem Definition of Cosmetic Products Analysis

Toxic metals can be found in moisturizer, lotion, sun block, sunscreen, mascara, eye shadow, rouge, face powder, lipstick, and theatrical and clown makeup.

Health effects may include nausea, cramps, vomiting, skin rash, joint and bone pain, mouth sores, cancer, stillbirths, genetic damage, immune dysfunction, brain and learning disorders, and impulsive and violent behavior.

Problem Definition of Cosmetic Products Analysis

Physical-ChemicalpHSkin has a different pH and to avoid and treat dry skin, it is

important to make sure that the body and skin care products range have the proper pH balance.

The pH of normal skin ranges from 4 to 6.5, which is slightly acidic.

Alkaline stronger than pH 8 is very irritating to the skin and, unfortunately, the majority of body and skin care products range are far too alkaline. Most skin care soaps have a pH factor of 9 to 11.

Problem Definition of Cosmetic Products Analysis

Physical-ChemicalViscosity ( in the term of Cosmetic Viscosity Science) Viscosity is a measure of a fluid’s internal friction (resistance to flow) when one layer of fluid is forced to move in over another layer. Viscosity measurements are commonly used on release specifications for

raw materials and cosmetic formulations because these types measurements are quick

and easy to take. Viscosity measurements are a key part of creating almost any cosmetic product. By considering all of these factors, high quality products.

Problem Definition of Cosmetic Products Analysis

Physical-ChemicalColor The reading of color measurement on finish product is important to detect the color changes when a stability test is applied to the product.

Sampling Technique(s) of Cosmetic Products

SAMPLING PROCEDURE1. Cosmetic products shall be sampled in their original

containers and forwarded to the analytical laboratory unopened.

2. For cosmetic products which are placed on the market in bulk or retailed in a container different from the original manufacturer’s pack, appropriate instructions for sampling at the point of use or sale should be issued.

3. The number of basic samples required for the preparation of the laboratory sample shall be determined by the analytical method and the number of analyses to be performed by each laboratory.

Sampling Technique(s) of Cosmetic Products

SAMPLE IDENTIFICATION1. Samples shall be both sealed where taken and identified, in

accordance with the rules in force in the relevant Member State.2. Each basic sample taken shall be labelled with the following

information:— name of the cosmetic product,— date, time and place of sampling,— name of the person responsible for taking the sample, — name of the inspectorate.3. A report on the sampling shall be drawn up in accordance with the rules in force in the relevant Member State.

Sampling Technique(s) of Cosmetic Products

STORAGE OF SAMPLES

1. Basic samples must be stored in accordance with the manufacturer’s instructions appearing on the label if any.

2. Unless other conditions are specified, laboratory samples shall be stored in the dark at between 10 and 25 °C.

3. Basic samples must not be opened until the analysis is about to begin.

Sample Preparation & Measurement Technique

Toxic Metals Contaminant Analysis

A) For lead and arsenic determination

1. The sample (5 - 10 g) is dried on slow heat on sand bath.

2. Then ashed at 450°C for 4 hr.3. A 10 ml of 10% nitric acid was

added to the sample, filtered.4. Finally, the lead and arsenic

content was determined using Perkin Elmer ICP-OES instrument.

Perkin Elmer ICP-OES instrument Model : PE AAnalyst 300 Optima Inductive Couple Plasma-Optical Emission Spectrometer

Sample Preparation & Measurement Technique

Toxic Metals Contaminant Analysis

B) For mercury determination1. The sample (0.5 g) was added with 10

ml 4:1 sulphuric acid solution and left overnight.

2. Then 5 ml of hydrogen peroxide was added drop-wise, followed by digestion in a water-bath shaker for 2 hr at 70°C.

3. Cooled and added with 20 ml 5% nitric acid. T

4. The solution was mixed thoroughly, homogenized and filtered.

5. Then, the determination of the mercury content carried out by

AAS-FIAS spectrometer instrument.

Perkin Elmer AAS-FIAS instrument Model : PE Optima 4300DV Atomic Absorption Spectrometer- Flow Injection Atomic Spectrometer

Sample Preparation & Measurement Technique

Physical-Chemical Analysis such as the pH, viscosity and color

1. The pH value of the cosmetic products was detected by a Mettler Toledo pH meter (S20 + Crison).

Sample Preparation & Measurement Technique

2. Determination of viscosity was carried out using a Brookfield Viscometer (DV-II + Pro) applying spindle number S25 at 12 rpm speed.

Sample Preparation & Measurement Technique

3. Color was determined using a Chroma meter (Minolta CR-300) and reported using ‘L’, ‘a’, ‘b’ system.

Results/Data Analysis• Table 1: Heavy metals contaminants of cosmetic products

*Note: ASEAN Cosmetic Specification Limit for lead (Pb) is 20 mgkg-1, arsenic (As) is 1 mgkg-1 and mercury (Hg) is 5 mgkg-1.

CosmeticProducts 

Lead (Pb) (mgkg-1)

Arsenic (As)

(mgkg-1)

Mercury (Hg) (mgkg-1)

 

Body scrub 0.006 0.004 0.1

Body firming lotion 

0.006 0.004 0.1

Body cellulite gel 

0.006 0.004 0.1

Results/Data Analysis

Table 2: Color, pH and viscosity of cosmetic products

  CosmeticProducts Results

 

Company Specification 

Remark

Cosmetic ProductSamples

Color pH Viscosity(cps) pH Viscosity(cps)  

Body scrub 90.31 5.62 63120 5.0-6.5 10000-50000 complied

Body firming lotion

 

32.49 5.03 8958 5.0-6.5 5000-10000 complied

Body cellulite gel 

26.27 5.04 6999 5.0-6.5 5000-10000 complied

Discussion

Toxic metals contaminants1. The toxic metals of primary toxicological concern in cosmetics are lead,

arsenic, mercury, cadmium and antimony.

2. However, the Malaysian Cosmetic Guidelines and the ASEAN Cosmetic Directive impose heavy metal specification of cosmetic with the maximum limit of lead 20 mgkg-1, arsenic 5 mgkg-1 and mercury 1 mgkg-1. Cadmium and antimony are not being regulated.

3. Table 1 showed the results of the toxic metal analysis (lead, arsenic and mercury) on cosmetic products were complied with the ASEAN specification.

4. The detection of lead, arsenic and mercury level for all cosmetic products analyzed were 0.006, 0.004 and 0.1 mgkg-1, respectively.

5. The results were well below the maximum limit allowed under the regulation. Therefore, the products are safe and not cause harmful effect to consumer.

Discussion

Physical-Chemical Determination pH

1. The pH, viscosity and color measurements are important components of physical-chemical properties that determine the specification of a finished product and also raw materials.

2. Results of pH measurement for the cosmetic products (body scrub, body firming lotion and body cellulite gel) were within the optimal range of pH 5.0 to 6.5 (Table 2).

3. The pH results complied with the company specification requirements. This range of pH is suitable for the skin as the pH of the healthy skin is 5.5.

4. Measurement of pH can reflect the stability of a product because they are indicative of chemical be monitored by measuring the pH. It is assumed that cosmetic products at the skin pH range are more compatible with the body.

5. Furthermore, pH measurement can provide information about the quality of the product and gives clues as to the functionality reactions taking place. For example, compounds such as esters may hydrolyze and release free acid that could produce adverse effects. Such chemical changes can of the product. Some materials will function differently as the pH changes.

DiscussionPhysical-Chemical Determination

Viscosity

1. The results of viscosity of the cosmetic products were within the range of the company specification (Table 2).

2. Only the body scrub was highly viscous (63120 cps) as it was a paste and therefore it was thicker.

3. Viscosity is another revealing parameter commonly used to evaluate the quality of finished products. It determines the proper consistency and can indicate product stability.

4. Viscosity measurement is also an indicator of the thickness and flow properties of the products.

DiscussionPhysical-Chemical Determination

Color

1. The color measurement of the cosmetic products was undertaken using the ‘L’, ‘a’, ‘b’ system, with only ‘L’ values presented (Table 2).

2. The color of the finished product was recorded to detect the change of color when the product is undergoing stability test.

3. In general, the company will set allowable maximum color difference after stability test and usually it did not exceed 3-5 ‘L’ units.

4. The small color difference change implied that longer storage times and moderate increases in temperature only slightly affected the color.

Conclusion

Cosmetic analysis is an important component inconforming to the requirements of halal and quality without violating the regulatory compliance. Physical - chemical test are important in maintaining the stability of products, whereas toxic metals and skin irritation are for safety of consumers. The microbiological analysis is for both stability and safety of consumers. Safe products are the basic requirement of regulatory, halal and quality control parameters in producing cosmetic products. All cosmetic products shall use safe ingredients, manufacture under GMP and undergo adequate safety assessment for the finished products to comply with regulatory requirement, halal and quality control before they could be released to the

market. 

References1. National Pharmaceutical Control Bureau (2009) Guidelines for Control of Cosmetics Products in

Malaysia, Ministry of Health, Malaysia.2. Malaysian Journal of Chemistry, 2009, Vol. 11, No. 1,081 – 0873. Health Canada, Consumer Product Safety, Draft Guidance on Heavy Metal Impurities in Cosmetics

at http://www.hc-sc.gc.ca/cps-spc/legislation/consultation/_cosmet/metal-metaux-consult-eng.php 4. Fitsugar, 10 Toxic Cosmetic Ingredients to Avoid http://www.fitsugar.com/tag/toxic+ingredientsat 5. Ayurvedic Herbal Cure Blog at

http://ayurvedic-herbal-cure.blogspot.com/2010_04_01_archive.html

6. Why pH is important -- skin, products, acids, etc., a must-read for acne sufferers, at http://www.acne.org/messageboard/pH-important-skin-p-t144725.html

7. Viscosity Tips for Cosmetic Products at http://chemistscorner.com/viscosity-tips-for-cosmetic-products/