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Analytical Methods used for Market Enforcement and Surveillance in the Netherlands

Analytical Methods used for Market Enforcement and Surveillance in the Netherlands. Trend. Emphasis falls on product information enforcement (PIF) and less on product examination. However…. Product examination is still necessary to check at random if the system works well. And….

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Analytical Methods used for Market Enforcement and Surveillance in the Netherlands

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  1. Analytical Methods used for Market Enforcement and Surveillance in the Netherlands

  2. Trend • Emphasis falls on product information enforcement (PIF) and less on product examination TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  3. However… • Product examination is still necessary to check at random if the system works well TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  4. And… • Product examination is necessary to discover trends and to initiate product file inspections TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  5. Laboratory • Accreditation ISO/IEC 17025:2005 • Chemical and Microbiological team (22 fte) • 2006: 5300 analyses, 2200 for cosmetics (650 samples tattoo excluded) • 2007: 4200 analyses, 1900 for cosmetics (500 samples tattoo excluded) • VIDAS and Anoxomat • Pathogen laboratory and own preparation of culture media • HPLC (12), GC (5), GC-MS (4), LC-MS, UPLC-MS-MS, ICP-MS, FTIR, NIR and XRF TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  6. Microbiological Methods • Total Count • Moulds • Challenge tests • Entero’s • Pseudomonas • S. Aureus TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  7. Challenge test • Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans, Aspergillus niger • Test on germ free • Addition to product of different cultures of micro-organisms, yeast and moulds • After 1 week determination of Total Count • Addition to product of different cultures of micro-organisms, yeast and moulds • After 1 week determination of Total Count • Repeat the procedure until no growth is detected or until maximal 4 weeks after second addition • Determination of log reduction TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  8. Challenge test TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  9. Chemical Methods (1) • Vitamin A, D and E • Hydrogen peroxide in tooth whiteners • Local anaesthetics (benzocain, procain, lidocain, tetracoin, bupivacain) in creams • Formaldehyde • Hydroquinone • Nitrosamines in shampoo • Benzisotiazolinone, chloromethylisothiazolinone and methylisothiazolinone • Corticosteroids • Mercury in soap bars • Iodopropylbutylcarbamate (IPBC) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  10. Chemical Methods (2) • Benzoylperoxide in nail products • Thioglycolic acid in hair wave products • Oxidative hair dyes • Primary aromatic amines in tattoo • Allergens in perfumes • Dibutylphthalate and toluene in nail lacquers • Parabens, phenoxyethanol, benzoic acid, sorbic acid and salicylic acid • Bronopol, Bronidox and methyldibromoglutaronitril • UV filters • Ad hoc methods TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  11. Survey Nitrosamines (2004-2007) SB-Aq 150x4.6 mm, 5 µm Flow 1,0 ml/min Mobile phase acetic acid (1%) and acetonitril (Gradient) sample extracted with SPE or LLE TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  12. Survey Nitrosamines (2004-2007) NDELA detected: 2004: 18% of the samples (n=137) 2005: 19% of the samples (n=181) 2006: 5% of the samples (n=394) 2007: 4% of the samples (n=668) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  13. Survey Child Cosmetics (2005-2006) • Babies/pre-scholars (355 samples) and children > 3 years (400 samples) • Preservatives (parabens, BIT, MI, CMI, Formaldehyde) • Fluoride • UV filters • Heavy metals • Total Count • Challenge test TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  14. Survey Child Cosmetics (2005-2006) • Parabens most used preservatives possibly in combination with phenoxyethanol • Presence of benzisotiazolinone (4 out of 137) • Sodium salt most used form of fluoride • Presence of NDELA (3 out of 40) • Ethylhexylmethoxycinnamate, benzophenone-4/5, BMDBM and octocrylene most used UV filters in products for children <3 years • BMDBM and ethylhexylmethoxycinnamate most used UV filters in products for children >3 years • Presence of Lead (8%) and Cadmium (2%) (59 samples) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  15. Survey Child Cosmetics (2005-2006) • Total Count >10 CFU/g is 5% for products for children <3 years (262 samples) • Total Count >10 CFU/g is 8% for products for children >3 years (223 samples) • Challenge test for products for children <3 years were qualified as weak or unsatisfactory (27%) and at least 2-times unsatisfactory (4%) • Challenge test for products for children >3 years were qualified as weak or unsatisfactory (45%) and at least 2-times unsatisfactory (6%) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  16. Survey allergens (2006-2007) CPWax 52CB 50m*0.25mm*0.20µm sample diluted with acetone TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  17. Survey allergens (2006-2007) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  18. TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  19. Survey allergens (2006-2007) TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  20. Survey Microbiological State (2006) • 1070 products on water base • Total Count using Trypton Soya Agar (3 days at 30°C) • Moulds using Mout Agar (5 days at 25 °C) • Challenge test TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  21. Survey Microbiological State (2006) • Total Count >15 CFU/g : 4% • Total Count >1000 CFU/g: 1% • Non-compliance challenge test: 30% • Shampoo higher Total Count • Sun care products and creams/ointments score less in challenge test • In most cases the preservative system is not adequate for protection against infection of moulds TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  22. PAO symbol (2007) • Statutory requirement for products with shelf life >30 months • Creams without dispenser system • Once a week “finger-test” • Three weekly microbiological analysis (Total Count and Moulds) • Proceed as long as the product is run out or the PAO date is passed • No results yet TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

  23. Conclusion Product examination is still necessary to guarantee the safety of use of cosmetics by consumers. TAIEX Seminar EU Cosmetics Legislation Zagreb Author | BSc. Durk J. Schakel

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