Third Commission Directive of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (83/514/EEC)

EU Directive 1983/514 · Adopted 27 September 1983 · Extends to United Kingdom

Third Commission Directive

of 27 September 1983

on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products

(83/514/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products^f1, as last amended by Directive 83/341/EEC^f2, and in particular Article 8 (1) thereof,

Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of ensuring that the conditions laid down by Community provisions concerning the composition of cosmetic products are satisfied;

Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas two steps towards the attainment of this objective having already been taken through the definition of certain methods in Commission Directives 80/1335/EEC^f3 and 82/434/EEC^f4, the third step is to consist in the definition of methods for the determination of dichloromethane and 1,1,1-trichloroethane, the identification and determination of quinolin-8-ol and bis(8-hydroxyquino-linium) sulphate, the determination of ammonia, the identification and determination of nitromethane, the identification and determination of mercaptoacetic acid in hair-waving, hair-straightening and depilatory products, the identification and determination of hexachlorophene (INN), the tion of tosylchloramide sodium (INN), the determination of total fluorine in dental creams, the identification and determination of organomercury compounds, the determination of alkali and alkaline earth sulphides;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation of Directive 76/768/EEC to Technical Progress,

HAS ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1: OJ No L 262, 27. 9. 1976, p. 169.
f2: OJ No L 188, 13. 7. 1983, p. 15.
f3: OJ No L 383, 31. 12. 1980, p. 27.
f4: OJ No L 185, 30. 6. 1982, p. 1.

1Article 1
2Article 2
3Article 3
Signature
Annex: DETERMINATION OF DICHLOROMETHANE AND 1,1,1-TRICHLOROETHANE
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
5.4Division 5.4
PROCEDURE
6.1Division 6.1
6.2Pressurized sample: use the sampling method described in the sampling chapter, but with the following refinements:
CHROMATOGRAPHIC CONDITIONS
7.1Precolumn
7.2Column
7.3As examples the following columns yield the results sought:
8MIXTURE FOR ESTABLISHING THE RESPONSE FACTORS
CALCULATIONS
9.1Calculating a response factor of a substance ‘p’ relative to a substance ‘a’ selected as an internal standard
9.2Calculate the % (m/m) of dichloromethane and 1,1,1-trichloroethane present in the sample to be analyzed
10REPEATABILITY
IDENTIFICATION AND DETERMINATION OF QUINOLIN-8-OL AND BIS(8-HYDROXYQUINOLINIUM) SULPHATE
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
PRINCIPLE
3.1Identification
3.2Determination
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
4.7Division 4.7
4.8Division 4.8
4.9Division 4.9
4.10Division 4.10
4.11Division 4.11
4.12Division 4.12
4.130,1 hydrochloric acid.
4.15Division 4.15
4.15.1Division 4.15.1
4.15.2Division 4.15.2
4.16Fehling's solution
4.17Eluting solvents for thin-layer chromatography
4.18Division 4.18
4.19Division 4.19
4.20Division 4.20
4.21Division 4.21
4.22Buffer solution, pH 7
4.23Prepared thin-layer plates
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
5.4Division 5.4
5.5Division 5.5
5.6Division 5.6
5.7Division 5.7
5.8Division 5.8
5.9Division 5.9
5.10Division 5.10
5.11Division 5.11
5.12Division 5.12
PROCEDURE
Identification
Liquid samples
6.1.1.1Division 6.1.1.1
6.1.1.2Division 6.1.1.2
6.1.1.3Division 6.1.1.3
6.1.1.4Division 6.1.1.4
Solid samples or creams
6.1.2.1Division 6.1.2.1
6.1.2.2Division 6.1.2.2
Determination
Liquid samples
6.2.1.1Division 6.2.1.1
6.2.1.2Division 6.2.1.2
6.2.1.3Division 6.2.1.3
6.2.1.4Division 6.2.1.4
Solid samples or creams
6.2.2.1Division 6.2.2.1
6.2.2.2Division 6.2.2.2
6.2.2.3In the case of emulsions that impede further treatment, mix 0,500 g of the sample with 2 g of Celite 545 (4.14) to form a freely flowing powder. Transfer the mixture in small portions into a glass chromatography column (5.12).
6.2.2.4Division 6.2.2.4
6.2.2.5Division 6.2.2.5
6.2.2.6Division 6.2.2.6
7STANDARD CURVE
CALCULATION
8.1Liquid samples
8.2Solid samples or creams
9REPEATABILITY
DETERMINATION OF AMMONIA
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
4.7Division 4.7
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
5.4Division 5.4
5.5Division 5.5
PROCEDURE
6.1Division 6.1
6.2Division 6.2
6.3Division 6.3
6.4Division 6.4
6.5Division 6.5
6.6Division 6.6
6.7Division 6.7
Division
CALCULATIONS
7.1Calculation in the case of back titration
7.2Calculation in the case of direct potentiometric titration
8REPEATABILIT Y
IDENTIFICATION AND DETERMINATION OF NITROMETHANE
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
IDENTIFICATION
4.1Reagents
4.1.1Division 4.1.1
4.1.2Folin's reagent
4.2Procedure
DETERMINATION
5.1Reagents
5.1.1Division 5.1.1
5.1.2Division 5.1.2
5.1.3Division 5.1.3
5.1.4Division 5.1.4
5.1.5Chloroform reference solution
5.1.62,4-dimethylheptane reference solution
Apparatus
5.2.1Division 5.2.1
5.2.2Division 5.2.2
5.2.3Division 5.2.3
Procedure
5.3.1Preparation of the sample
5.3.2Preparation of the standard
Gas chromatographic conditions
5.3.3.1Column
5.3.3.2Detector
5.3.3.3Temperature conditions
5.3.3.4Suitable gas supplies
CALCULATIONS
6.1Response factor of nitromethane, calculated with reference to the internal standard used
6.2Concentration of nkromethane in the sample
7REPEATABILITY
IDENTIFICATION AND DETERMINATION OF MERCAPTOACETIC ACID IN HAIR-WAVING, HAIR-STRAIGHTENING AND DEPILATORY PRODUCTS
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
IDENTIFICATION
Identification by spot tests
4.1.1Reagents
4.1.1.1Division 4.1.1.1
4.1.1.2Division 4.1.1.2
Procedure
4.1.2.1Identification of mercaptoacetic acid by means of a colour reaction with lead di(acetate)
4.1.2.2Characterization of inorganic sulphides by the formulation of hydrogen sulphide on acidification
4.1.2.3Characterization of sulphites by the formation of sulphur dioxide upon acidification
Identification by thin-layer chromatography
4.2.1Reagents
4.2.1.1Division 4.2.1.1
4.2.1.2Division 4.2.1.2
4.2.1.3Division 4.2.1.3
4.2.1.4Division 4.2.1.4
4.2.1.5Division 4.2.1.5
4.2.1.6Division 4.2.1.6
4.2.1.7Division 4.2.1.7
4.2.1.8Division 4.2.1.8
4.2.1.9Division 4.2.1.9
4.2.1.10Division 4.2.1.10
4.2.1.11Division 4.2.1.11
4.2.1.12Division 4.2.1.12
4.2.1.13Division 4.2.1.13
4.2.1.14Division 4.2.1.14
4.2.1.15Division 4.2.1.15
Eluting solvents
4.2.1.16.1Division 4.2.1.16.1
4.2.1.16.2Division 4.2.1.16.2
Detection reagents
4.2.1.17.1Division 4.2.1.17.1
4.2.1.17.2Bromine solution 5 % (m/v):
4.2.1.17.3Fluorescein solution, 0,1 % (m/v):
4.2.1.17.4Division 4.2.1.17.4
Reference solutions
4.2.1.18.1Division 4.2.1.18.1
4.2.1.18.2Division 4.2.1.18.2
4.2.1.18.3Division 4.2.1.18.3
4.2.1.18.4Division 4.2.1.18.4
4.2.1.18.5Division 4.2.1.18.5
4.2.2Apparatus
Procedure
4.2.3.1Treatment of samples
4.2.3.2Elution
4.2.3.3Detection
4.2.3.4Interpretation
5DETERMINATION (see NB)
lodometry
5.1.1Principle
5.1.2Reagents
Division
5.1.3Apparatus
5.1.4Procedure
5.1.5Calculation
5.1.6Remarks
Gas chromatograyhy
5.2.1Principle
5.2.2Reagents
5.2.2.1Division 5.2.2.1
5.2.2.2Division 5.2.2.2
5.2.2.3Division 5.2.2.3
5.2.2.4Division 5.2.2.4
5.2.2.5Division 5.2.2.5
5.2.2.6Acetate buffer solution (pH 5):
5.2.2.7Division 5.2.2.7
5.2.2.8Division 5.2.2.8
5.2.2.9Division 5.2.2.9
5.2.2.10Division 5.2.2.10
5.2.2.11Division 5.2.2.11
5.2.2.12Diazomethane solution prepared from iV-methyl-AT-nitrosotoluen-4-sulfonamide (Fieser, Reagents for Organic Synthesis (Wiley), 1967)
Apparatus
5.2.3.1Division 5.2.3.1
5.2.3.2Division 5.2.3.2
5.2.3.3Division 5.2.3.3
5.2.4Preparation of the sample
5.2.5Methylation
5.2.5.1Methylation in situ
5.2.5.2Methylation with the previously prepared diazomethane solution
5.2.6Preparation of the standard
Gas chromatographic conditions
5.2.7.1Column
5.2.7.2Packing
5.2.7.3Detector
5.2.7.4Gas supplies
5.2.7.5Temperature conditions
5.2.7.6Recorder chart speed
5.2.7.7Quantity injected
5.2.7.8The conditions of chromatography are given as a guide. They permit the achievement of a resolution ‘R’ equal to, or better than, 1,5, where:
Calculations
5.2.8.1Coefficient of proportionality for mercaptoacetic acid
5.2.8.2Concentration of mercaptoacetic acid present in the sample
6REPEATABILITY
IDENTIFICATION AND DETERMINATION OF HEXACHLOROPHENE
IDENTIFICATION
1SCOPE AND FIELD OF APPLICATION
2PRINCIPLE
3REAGENTS
3.1Division 3.1
3.2Division 3.2
3.3Division 3.3
3.4Division 3.4
3.5Visualizing agent I:
3.6Visualizing agent II:
3.7Reference solution:
APPARATUS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
PREPARATION OF THE TEST SAMPLE
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
5.4Division 5.4
5.5Division 5.5
5.6Division 5.6
PROCEDURE
6.1Division 6.1
6.2Division 6.2
6.3Division 6.3
6.4Division 6.4
6.5Visualization
6.5.1Division 6.5.1
6.5.2Division 6.5.2
INTERPRETATION
7.1Visualizing agent I (3.5):
7.2Visualizing agent II (3.6):
DETERMINATION
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
4.7Division 4.7
4.8Division 4.8
4.9Division 4.9
4.10Division 4.10
4.11Division 4.11
4.12Division 4.12
4.13Division 4.13
4.14Division 4.14
4.15Division 4.15
4.16Division 4.16
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
PROCEDURE
6.1Preparation of the standard solution
6.1.1Division 6.1.1
6.1.2Division 6.1.2
6.2Preparation of the sample
6.3Methylation of the sample
6.4Methylation of the standard
7GAS CHROMATOGRAPHY
CALCULATION
8.1Proportionality coefficient of hexachlorophene
8.2The amount of hexachlorophene in the sample
9REPEATABILITY
(CHLORAMINE-T)
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
Development solvent
4.6.1Division 4.6.1
4.6.2Division 4.6.2
4.7Division 4.7
4.8Division 4.8
4.9Division 4.9
4.10Division 4.10
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
PROCEDURE
6.1Hydrolysis
Extraction
6.2.1Division 6.2.1
6.2.2Division 6.2.2
Thin-layer chromatography
6.3.1Spot 20 μl of the ethanolic residue (6.2) on to a thin-layer chromatography plate (4.7).
6.3.2Division 6.3.2
6.3.3Division 6.3.3
6.4Measurement
6.5Plotting the calibration curves
7NOTE
8CALCULATION
9REPEATABILITY
DETERMINATION OF TOTAL FLUORINE IN DENTAL CREAMS
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
Fluorine standard solutions
4.7.1Division 4.7.1
4.7.2Division 4.7.2
4.8Internal standard solution
4.9Chlorotriethylsilane/internal standard solution
4.10Division 4.10
4.11Division 4.11
APPARATUS
5.1Division 5.1
5.2Division 5.2
5.3Division 5.3
5.4Division 5.4
5.5Division 5.5
5.6Division 5.6
5.7Division 5.7
5.8Division 5.8
PROCEDURE
Sample analysis
6.1.1Division 6.1.1
6.1.2Division 6.1.2
6.1.3Division 6.1.3
6.1.4Division 6.1.4
6.1.5Division 6.1.5
6.1.6Division 6.1.6
Centrifuge 10 minutes at such a speed as to produce a clear separation of the phases, uncap the tube, withdraw the organic layer and inject 3 μl of the organic phase on to the column of the gas chromatograph (5.2).
Remark:
6.1.8Division 6.1.8
6.1.9Division 6.1.9
Chromatographic conditions
6.2.1Column: stainless steel.
Calibration graph
6.3.1Division 6.3.1
6.3.2Division 6.3.2
6.3.3Division 6.3.3
6.3.4Division 6.3.4
6.3.5Division 6.3.5
7CALCULATION
8REPEATABILITY
IDENTIFICATION AND DETERMINATION OF ORGANOMERCURY COMPOUNDS
SCOPE AND FIELD OF APPLICATION
IDENTIFICATION
1PRINCIPLE
2REAGENTS
2.1Division 2.1
2.2Division 2.2
2.3Division 2.3
2.4Division 2.4
2.5Division 2.5
2.6Standard solution, 0,001 % in water of:
2.7Division 2.7
2.8Division 2.8
APPARATUS
3.1Division 3.1
3.2Division 3.2
3.3Division 3.3
PROCEDURE
Extraction
4.1.1Division 4.1.1
4.1.2Division 4.1.2
4.1.3Division 4.1.3
4.1.4Division 4.1.4
4.1.5Division 4.1.5
4.1.6Division 4.1.6
Separatum and identification
4.2.1Division 4.2.1
4.2.2Place the plate in the solvent (2.5) and allow the latter to rise 150 mm. The organomercury compounds appear as coloured spots whose colour is stable, provided the plate is covered by a glass plate immediately the solvent evaporates.
DETERMINATION
1DEFINITION
2PRINCIPLE
3REAGENTS
3.1Division 3.1
3.2Division 3.2
3.3Division 3.3
3.4Division 3.4
3.5Division 3.5
3.6Division 3.6
3.7Division 3.7
3.8Division 3.8
3.9Division 3.9
APPARATUS
4.1Division 4.1
4.2Division 4.2
5PROCEDURE
Breakdown
5.1.1Division 5.1.1
5.1.2Division 5.1.2
5.1.3Division 5.1.3
5.1.4Division 5.1.4
5.1.5Division 5.1.5
5.1.6Division 5.1.6
Determination
5.2.1Division 5.2.1
5.2.2Division 5.2.2
6CALCULATION
NOTES
7.1Division 7.1
7.2Division 7.2
8REPEATIBILITY
DETERMINATION OF ALKALI AND ALKALINE EARTH SULPHIDES
1SCOPE AND FIELD OF APPLICATION
2DEFINITION
3PRINCIPLE
4REAGENTS
4.1Division 4.1
4.2Division 4.2
4.3Division 4.3
4.4Division 4.4
4.5Division 4.5
4.6Division 4.6
4.7Division 4.7
4.8Division 4.8
4.9Division 4.9
APPARATUS
5.1Usual laboratory equipment.
PROCEDURE
Entrainment of the sulphides
6.1.1Division 6.1.1
6.1.2Division 6.1.2
Fit a dropping funnel, the dip tube and the outlet tube on to the round-bottom flask (5.2). Connect the outlet tube to the conical flasks (5.3) set up in series by means of PVC tubing.
Division
6.1.4Division 6.1.4
6.1.5Division 6.1.5
6.1.6Division 6.1.6
6.1.7Division 6.1.7
6.1.8Division 6.1.8
Titration
6.2.1Division 6.2.1
6.2.2Division 6.2.2
6.2.3Division 6.2.3
6.2.4Division 6.2.4
6.2.5Division 6.2.5
7CALCULATON
8REPEATABILITY

Third Commission Directive of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (83/514/EEC)

Annotations to the whole text

Footnotes

Contents