EN 14350-2 PDF

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EN E May EN A1 E. DIN EN EN Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February , and conflicting national standards shall be withdrawn at the latest by February Some of the provisions have been taken from other existing national and European Standards and for these provisions the Technical Committee has relied on previous validation. It is not permitted to claim compliance with individual parts of this document.

Any claim relates to all published parts. This document does not purport to address all the safety problems associated with its use. It is the responsibility of the user of this document to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to its use. It is recommended that manufacturers and suppliers operate to EN ISO [7] standard for quality management systems. The current Directive provides in its annexes an outline method of analysis that has been published as EN A limit for the release of 2-mercaptobenzothiazole MBT has been specified in the standard.

The Scientific Committee for Food has concluded that the limit does not constitute a health hazard. The limit for release of MBT will be reconsidered in light of future studies and recommendations. A limit for the release of 2,2-bis 4-hydroxyphenyl propane [Bisphenol A] BPA has been specified in the standard. The limit for release of BPA will be reconsidered in light of future studies and recommendations.

At the time of preparing this document a final decision was awaited. This document will be reviewed in the light of that decision. The Technical Committee has considered the issues relating to phthalate plasticiser migration from child use and care articles not intended to be placed in the mouth. Recognising the inadequacies of the only currently validated static test method for plasticiser migration from PVC [8], the Committee has developed an improved test to provide migration data under more realistic dynamic conditions of exposure.

However, the Technical Committee will consider the official European method prior to its application to drinking equipment; such child use and care articles may require additional or alternative measures due to the mode of usage of drinking equipment and their potentially longer periods of exposure to babies and young children. After this consideration, an amendment to this document may be made. Formaldehyde, caprolactam and colorants have each been considered by the Technical Committee.

They will be reconsidered when further information becomes available. For similar reasons, latex protein allergy risk has also not been included in this document. There is an extremely low incidence of latex protein allergy amongst babies and young children.

Nevertheless, provision for information for drinking equipment containing natural rubber latex has been made in Part 1 of this document. The issue of potential sensitisation and allergic reaction from rubber products will be reconsidered when further information becomes available.

Re-usable feeding teats and drinking accessories; Re-usable feeding bottles and drinking cups; Single-use feeding bottles, feeding teats, feeding bags and drinking accessories, which do not contain fluid when purchased. It includes test methods for the chemical safety requirements specified. It does not apply to drinking equipment designed for medical applications or for use under medical supervision. This document is not applicable to soothers.

For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document including any amendments applies.

EN , Safety of toys — Part 3: Migration of certain elements. EN , Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers. Chemicals other than those mentioned in this document may be used where toxicological evidence, either on the original chemical or any reaction product, is available to demonstrate that no unacceptable risk will be posed when they are used in drinking equipment and an appropriate analytical test procedure for determining migration levels exists.

When drinking equipment contain components manufactured from different material s , or in different colours, all components shall be tested individually. Decorations shall be considered to be part s of the material s on which they are printed. The limits have been set based on the limit of detection for each element using commonly available analytical techniques. NOTE This is to remove the surface coating arising from the manufacturing processes and ensure that the materials used are stable in boiling water.

Soluble elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium are extracted from the individual components of the drinking equipment that are accessible to the child. Conditions that simulate contact with stomach acid shall be used. The concentrations of the soluble elements are described quantitatively. Membrane filter with a pore size of 0,45? EN E 5. Distilled water. Selection of test portions Test portions shall be taken from each individual component of the drinking equipment that is accessible to the child.

Components that are joined together shall be separated and tested as separate items. Heating of the materials, whilst separating components and during cutting into pieces, shall be avoided. Feeding teats shall be cut length-wise only once. All other components shall be cut, as far as is possible, into pieces of length 4 mm to 6 mm and width not exceeding 6 mm. Agitate the container in the water bath 5.

Immediately after standing, separate the solids from the solution by membrane filtration 5. The use of centrifugation shall be reported. NOTE The detection limit of a method is deemed to be 3 times the standard deviation of the blank value measured by the laboratory carrying out the analysis.

MBT is identified and determined by High Performance Liquid Chromatography HPLC and ultra violet UV detection at a specific wavelength, either by direct injection of the aqueous migration liquid, or in a concentrated solution. The identification is confirmed by comparing the UV-spectrum of the sample peak produced by a diode array detector with the spectrum of the peak of an authentic MBT-sample.

Blosczyk and H. Domling [9] and G. Blosczyk [10]. The method is also used for the qualitative and quantitative determination of the antioxidants 2,6-bis 1,1-dimethylethyl methyl-phenol Antioxidant BHT and 2,2'-methylenebis 6- 1,1-dimethylethyl methylphenol Antioxidant The identification is confirmed by comparing the UV-spectra of the sample peaks produced by a diode array detector with the spectra of the peaks of authentic substances. For unknown samples a further identification step by thin layer chromatography TLC or gas liquid chromatography GLC is recommended.

Acetonitrile HPLC grade. Dichloromethane Residue analysis grade. Anhydrous sodium sulphate. Reagents: standard solutions Standard MBT solution. Prepare six standard solutions containing for example 1,0 mg, 2,0 mg, 5,0 mg, 10,0 mg, 15,0 mg and 20,0 mg MBT 5.

EN E Prepare a solution of the two antioxidants containing 30? The number of parts shall be defined by the size of the neck of a ml flask. The area of the sample shall be the sum of the areas of the inner and outer surfaces. NOTE 1 Cutting into two pieces is usually sufficient for a feeding teat. NOTE 2 To aid measurement of area, cut the elastomeric or thermoplastic part into several pieces and draw around them on millimetre paper. Count the number of squares within each line and add the number together.

After removing the solid parts, shake the aqueous migration liquid with two 50 ml aliquots of dichloromethane 5. The combined organic phases are dried over anhydrous sodium sulphate 5.

The residue is then re-dissolved in 5 ml of acetonitrile 5. NOTE Concentration columns may be used to replace shaking with dichloromethane. Inject the test solution 5. Use the calibration curve to determine the MBT-content of the test solution, either manually or with data-handling software. The calibration curve should be rectilinear and the correlation coefficient 0, or better.

It is recommended that the test be carried out at least in duplicate. Inject the sample solution 5. If the peak areas of the antioxidants in the test solution are greater than the standard peak areas, prepare and obtain chromatograms of additional standard solutions in order to create a calibration curve over the region of interest. Obtain the amounts of migrated antioxidants from the calibration curve. However, in comparison with the gas chromatographic method, the HPLC method has the advantage that BPA can be determined directly in the migrate without pre-concentration and derivatisation.

Analytical balance with sensitivity of 0, g. Micro syringes: 10? Methanol HPLC grade. Reagents: standard solutions Stock standard solution of BPA in methanol at defined concentration of approx. Weigh to the nearest 0,1 mg approx. Dissolve the BPA in methanol 5. Calculate the concentration in? Repeat the procedure to obtain a second stock solution.

NOTE weeks.


BS EN 14350-2:2004

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