Specification for Body Oils

KENYA STANDARD KS 1766: 2006

ICS 71.100.70

Specification for body oils

TECHNICAL COMMITTEE REPRESENTATION

The following organizations were represented on the Technical Committee:

Oasis Ltd.

Beiersdorf E.A. Ltd.

HACO Industries Ltd.

Interconsumer Products Ltd.

Rozeco Chemical Industries Ltd.

Ministry of Health

Government Chemist’s Department

Consumer Information Network

National Quality Control Laboratory

Kenyatta National Hospital — Dermatology Department

Kenya Industrial Research and Development Institute (KIRDI)

Jomo Kenyatta University of Agriculture and Technology — Chemistry Department

Kenya Bureau of Standards — Secretariat

REVISION OF KENYA STANDARDS

In order to keep abreast of progress in industry, Kenya Standards shall be regularly reviewed. Suggestions for improvements to published standards, addressed to the Managing Director, Kenya Bureau of Standards, are welcome.

Copyright: Users are reminded that by virtue of Section 6 of the Copyright Act, Cap. 130 of the Laws of Kenya, copyright subsists in all Kenya Standards and except as provided under Section 7 of this Act, no Kenya Standard produced by Kenya Bureau of Standards may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing from the Managing Director.

ISBN 9966-23-320-2

ICS 71.100.70

Specification for body oils

KENYA BUREAU OF STANDARDS (KEBS)

Head Office: P.O. Box 54974, Nairobi-00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031

E-Mail: , Web:http://www.kebs.org

Coast Region Lake Region Rift Valley Region

P.O. Box 99376, Mombasa-80100 P.O. Box 2949, Kisumu-40100 P.O. Box 2138, Nakuru-20100

Tel.: (+254 041) 229563, 230939/40 Tel.: (+254 057) 23549, 22396 Tel.: (+254 051) 210553, 210555

Fax: (+254 041) 229448 Fax: (+254 057) 21814

Foreword

This Kenya Standard was prepared by the Technical Committee on Cosmetics and Related Products, under the guidance of the Healthcare and Personal Safety Industry Standards Committee and it is in accordance with the procedures of the Bureau.

Body oils are based on refined vegetable oils, mineral oil, or a mixture of the two. They can be used for skin maintenance instead of the emulsion-based creams. One common marketed product is baby oil. Also, vegetable oils mixed in different proportions are commonly used for body massage.

This standard is aimed at ensuring that the oils offered for sale are of the proper quality.

It shall be the responsibility of the manufacturer to ensure the dermatological safety of the formulation before releasing the product for sale.

In the preparation of this standard, reference was made to the following publications:

76/768/EEC: EEC Cosmetics Directive.

AOAC Official methods of analysis, 2000 Edition, Volume 1, Chapter 15.

Acknowledgement is made for the assistance obtained from the above sources.

iii

KS 1766: 2006

Specification for body oils

1 Scope

This Kenya Standard prescribes the requirements and methods of test for body oils.

2 Application

2.1 This standard applies to all liquid oils based on refined vegetable oils, mineral oil or a mixture of the two, and meant for application on the skin. It shall also cater for mixtures of vegetable oils meant for skin application.

2.2 Baby oils and mixtures of essential oils are also covered by this standard. Pure essential oils are however covered in other standards (see Annex H).

2.3 This standard does not cover hair oils. These are covered in KS 602[1)].

2.4 Oils for which therapeutic claims are made are not covered by this standard. Such products shall be registered with the Ministry of Health.

3 Requirements

3.1 All vegetable oils and essential oils used shall comply with the relevant Kenya Standards (see Annex H).

3.2 If mineral oil is used, it shall comply with KS 796[2)].

3.3 When examined visually, the product shall be a clear oily liquid, free from sediments, suspended matter and separated water.

3.4 All added ingredients, e.g. dyes, colours, pigments and perfume shall comply with all parts of KS 1474[3)].

3.5 The oils shall be dermatologically safe, and shall not cause irritation or harm to the skin when used as intended by the manufacturer.

3.6 The oil shall not have any objectionable odour at room temperature.

3.7 The oil shall also conform to the requirements specified in Table1.

4 Packing

The product shall be packed in suitable containers.

5 Marking and labelling

The product shall conform to the labelling requirements outlined in KS 17074).

Table 1 — Requirements for body oils

SL No

/ Characteristic / Requirement / Test method
i) / Moisture content, % by mass, max. / 0.5 / KS 801:Part 2a)
ii) / Acid value, max. / 1.0 / KS 801:Part 4b)
iii) / Peroxide value, mg/1 000 g, max. / 7.5 / KS 801:Part 17c)
iv) / Rancidity / Shall be free from rancidity / KS 801:Part 19d)
v) / Lead, ppm, max. / 20 / Annex A
vi) / Arsenic, ppm, max. / 2 / Annex B
vii) / Mercury, ppm, max. / 2 / Annex C
viii) / Total viable count for aerobic mesophyllic micro-organisms
per g, max. / 100 / Annex D
ix) / Pseodomonas aeruginosa staphylococcus aureus a albicans / Not detectable in 0.5 g of cosmetic product / Annex E
x) / Thermal stability / To pass the test / Annex F
xi) / Total heavy metals, ppm, max. / 20 / Annex G
a) Oils for cosmetic industry — Methods of test — Determination of moisture content.
b) Micro-organisms shall include both pathogenic and non-pathogenic.
c) Determination of peroxide value.
d) Determination of rancidity.

6 Sampling

Representative samples shall be drawn for test from the market or anywhere else following the procedure outlined in KS 1668[5)]. The samples shall be declared as complying to the standard if they satisfy all the specified requirements.

7 Quality of reagents

Unless specified otherwise, analytical reagent grade chemicals and distilled or deionized water shall be used in tests. All calculations shall be carried out to 3 decimal places.

Annex A

(normative)

Determination of lead content in cosmetics by graphite furnace atomic absorption spectrophotometer (AAS)

A.1 Scope

This test method specifies an electrothermal atomization technique using graphite furnace AAS method for the determination of lead content of cosmetics.

A.2 Warning and safety

The acids used in the test are highly corrosive and should be handled with maximum care and where appropriate, use a fume hood during preparation of standards. Lead is very toxic/carcinogenic and must be handled with maximum care avoiding physical contact.

If spillage occurs, use adequate amounts of water and soap to wash off the spill.

A.3 Principle

Injecting of the prepared solution into a graphite furnace. Spectrometric measurements of the atomic absorption of the 228.8 spectral line emitted by lead hollow cathode lamp.

A.4 Materials

A.4.1 Reagents, chemicals and standards

A.4.1.1 Nitric acid, r about 1.4 g/mL.

A.4.1.2 Nitric acid (1+1) v/v

Mix 1 volume of concentrated HNO3 with 1 volume of distilled water.

A.4.1.3 Nitric acid (0.1 M)

Place 17 mL of concentrated acid in 100 mL volumetric flask then top to the mark with distilled water and mix.

A.4.1.4 Lead standard solution (1 000 ppm)

In 1-litre volumetric flask, dissolve 1.598 g of Pb (NO3)2 in minimum volume of 1 % v/v HNO3 and finally top the mark using 1 % HNO3.

NOTE Commercial grade standards can also be used when available.

A.4.1.5 Lead standard solution (100 ppb)

This shall be prepared freshly by serial dilution of the lead solution (A.4.1.4).

A.4.1.6 Purge gas argon

Sufficiently pure, free from water, oil and free from lead.

A.4.2 Apparatus and equipment

A.4.2.1 Atomic absorption spectrometer fitted with graphite furnace

The atomic absorption spectrometer used will be satisfactory if after optimization according to the manufacturer’s instructions and when in reasonable agreement with the values given by the manufacturer it meets the performance criteria as set out in the manual.

A.4.2.2 Lead hollow cathode lamp.

A.4.2.3 Ordinary laboratory apparatus.

NOTE All glassware shall first be washed in hydrochloric acid (r about 1.19 g/mL, diluted).

A.5 Performance

A.5.1 Sample preparation

Ignite 1 g of sample at 500 ± 2 °C to ash. Extract the lead from the ash with 20 mL of 2N HNO3, and repeat with 10 mL of 2N HNO3. Combine the extracts and dilute to 50 mL with 0.5 N HNO3.

A.5.2 Calibration

A.5.2.1 Preparation of calibration curve

A.5.2.1.1 Dilute the stock 100 ppb solution with 0.1 M HNO3 to obtain solutions with 10 ppb, 20 ppb, 40 ppb, 60 ppb, 80 ppb and 90 ppb of lead.

A.5.2.1.2 Inject 20 microlitres of each of the six solutions above in turns at the same rate starting from the lowest concentrated solution to the highest concentrated solution.

A.5.2.1.3 Record the corresponding absorbance values and plot the calibration curve.

A.5.3 Quality control checks

A.5.3.1 Duplicates

A.5.3.1.1 All samples shall be analyzed in duplicates and the stated acceptance criteria shall apply: The absolute difference between two independent test results obtained using the same procedure shall be not greater than 10 % of the arithmetic mean of the two results.

A.5.3.1.2 Spike distilled water with 10.0 ppb of lead and obtain the recovery percentage.

A.5.3.1.3 Recovery % ³ 96.

A.6 Procedure

A.6.1 Test portion

Use sample as prepared in (A.5.1).

A.6.2 Blank test

A.6.2.1 Run a parallel reagent blank determination replacing the test solution with distilled water.

A.6.2.2 Reagent blank should be £ 0.000 1 ppb of lead.

A.6.3 Instrumentation

A.6.3.1 Follow the manufacturer’s instructions for preparing the instrument for use.

A.6.3.2 Install the appropriate lamp and adjust the current to the recommended value.

A.6.3.3 Ensure that the autosampler pipette is correctly aligned and that the drain is available.

A.6.3.4 Select the sample tray type installed.

A.6.3.5 Ensure that the graphite tube is in good condition and correctly aligned.

A.6.3.6 Switch on the cooling system, turn on the purge gas and finally start the instrument software.

A.6.3.7 Select the relevant method and then condition the tube.

A.6.4 Instrument conditions

The following conditions shall be used for the furnace during analysis of lead:

A.6.4.1 Wavelength: 283.3

A.6.4.2 Slit: 0.7

A.6.4.3 Atomization site: pyro/platform

Table A.1 — Furnace conditions for lead

Step / Temperature, 0C / Ramp time
(seconds) / Hold time
(seconds) / Internal gas flow (L/min) /

Gas type

1) Drying / 120 / 10 / 60 / 250 / Normal
2) Pretreatment / 700 / 1 / 30 / 250 / ,,
3) Cooling / 20 / 1 / 15 / 250 / ,,
4) Atomization / 1 800 / 0 / 5 / 0 / ,,
5) Cleanout / 2 600 / 1 / 5 / 250 / ,,

A.6.5 Spectrometric measurements

A.6.5.1 Inject into the flame the calibration standards, the blank solution and the test solution.

A.6.5.2 Record the absorbance reading.

A.6.5.3 If the absorbance of the sample in greater than the highest calibration standard, dilute the test solution appropriately using 0.1 M HNO3 for lead then measure the absorbance.

A.6.5.4 Inject the calibration solutions in ascending order.

NOTE The calibration curve shall only be acceptable for analysis when the correlation coefficient r ³ 0.99.

A.7 Expression of results

A.7.1 Method of calculation

The lead content of the sample expressed in mg/L of product is equal to:

[ (C1 - C2) *V ] / M0

where

C1 = lead content of test solution expressed in mg/L read from calibration curve;

C2 = lead content of blank solution expressed in mg/L read from calibration curve;

M0 = grams of sample taken for analyze (5 g); and

V = volume of sample taken for analyze (100 mL).

NOTE If the test solution was diluted, then the dilution factor shall be taken into consideration in calculation.

A.7.2 Expression of results

Report results of manganese content in mg/L as Pb in the sample into two decimal points.

A.8 Method validation

A.8.1 Method validation data

Table A.2 — Method validation data

Element /

Linearity

LOQ ppb

LOD ppb

Pb / r ³ 0.99 / 32.356 / 3.804

A.8.2 Precision: Repeatability

The absolute difference between two independent test results obtained using the same method on identical test material in the same laboratory by the same operator using the same equipment within a short interval of time should not be greater than 10 % of the arithmetic mean of the two results.

A.8.3 Working range — Pb 10-100 ppb.

A.8.4 Reporting limits — Pb 30 ppb.

Annex B

(normative)

Test for arsenic using atomic absorption spectrophotometer (AAS)

B.1 Scope

This method describes the determination of arsenic in roll-on deodorants and antiperspirants.

B.2 Reagents

B.2.1 0.15 mol/L (@ 1.5 % v/v) hydrochloric acid

Carefully add 15 mL concentrated HCl to deionized water and make up to 1 L.

B.2.2 0.25 mol/L (@ 1 % w/v) NaOH solution

Carefully dissolve 10 g sodium hydroxide flakes in deionized water and make up to 1 L.

B.2.3 0.8 mol/L (@ 3 % w/v) NaBH4 solution

Dissolve 3 g sodium tetrahydroborate in 1 % NaOH solution and make up to 100 mL with 1 % NaOH solution.

B.3 Stock solution

The stock solution contains 1 000 mg/L As. The use of commercially available concentrated calibration solutions for AAS is recommended.

WARNING Arsenic solutions are toxic.

B.4 Calibration solution: 1 mg As/L (in 1.5 % HCl)

B.4.1 Aliquots for calibration: 10, 25, 50 mL

B.4.2 Corresponding to: 10, 25, 50 ng As

B.4.3 Diluent: 1.5 % (v/v) hydrochloric acid

B.4.4 Calibration volume: 10 mL

B.5 Reductant solution: 3 % NaBH4 in 1 % NaOH solution.

B.6 Oxidation state

The hydride is generated much more slowly from As(V) than from As(III). To prevent interferences, As(V) must be prereduced to As(III) prior to the determination.

Prereduction can be performed with KI in semiconcentrated (5 mol/L) HCl solution or, preferably, with

L-cysteine

B.7 Prereduction

B.7.1 KI solution

Dissolve 3 g KI and 5 g L (+)- ascorbic acid in 100 mL water. Prepare fresh daily. Add 1 mL of the KI solution per 10 mL of the sample solution in 5 mol/L HCl and stand for 30 min.

Or,

B.7.2 L-cysteine solution

Dissolve 5 g L-cysteine in 100 mL 0.5 mol/L HCl. This solution is stable for at least a month. Add 2 mL of the L-cysteine solution per 10 mL of the sample solution and stand for 30 min.