Directive 93/11/EEC, published by the European Parliament and of the Council, is a regulatory body concerning the release of N-nitrosamines and N-nitrosable substances from elastomer or rubber pacifiers. This directive is a specific directive within the meaning of its relevant article 89/109/EEC and deals with the release of N-nitrosamines and substances convertible to N-nitrosamines from pacifiers made of elastomer or rubber.
Soothers and pacifiers referred to in this directive must not pass any N-nitrosamine and N-nitrosable substance into the release test liquid (saliva test solution) under the conditions specified in the annex to the directive, which can be determined by an accurate method conforming to the specified criteria.
In the annex to this directive, the limits for parts of pacifiers made of elastomer or rubber are set as follows:
European Union countries have to put into effect the necessary legal regulations to comply with this directive. Member states must allow the trade and use of pacifiers that comply with this directive and prohibit the trade and use of pacifiers that do not comply with this directive.
To obtain the release test liquid (saliva test solution), 4,2 g of sodium bicarbonate, 0,5 g of sodium chloride, 0,2 g of potassium carbonate and 30,0 mg of sodium nitrite are dissolved in one liter of distilled water or water of equivalent quality. The pH of the solution should be 9. Samples of material obtained from the appropriate number of teats or teats are immersed in the test-releasing liquid for 40 hours at a temperature of 2 plus/minus 24 degrees.
The release of N-nitrosamines is determined in a non-residual divisor of each solution prepared according to the annex to the directive. N-nitrosamines are removed from the residue-free partition with nitrosamine-free dichloromethane and detected by gas chromatography.
The release of n- nitrosable substances is determined in a different residue of each solution prepared according to the annex to the directive. Nitrosable substances are converted to nitrosamines by acidifying the residue with hydrochloric acid. The nitrosamines are then extracted from the solution with dichloromethane and detected by gas chromatography.
Our organization, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, also provides the necessary testing services within the scope of the 93/11/EEC directive with its trained and expert staff and advanced technological equipment.
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