title: A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.
abstract: The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike.
authors: Imperial Tobacco Limited, PO Box 244, Southville, Bristol BS99 7UJ, UK. steve.purkis@uk.imptob.com
authors: Stephen W
authors: SW
authors: Purkis
authors: Linda
authors: L
authors: Drake
authors: Michael
authors: M
authors: Meger
authors: Derek C
authors: DC
authors: Mariner
mesh_terms: D033161:Government Regulation; D019983:Guideline Adherence; D007753:Laboratories / Q000331:legislation & jurisprudence; D009538:Nicotine / Q000592:standards; D015588:Observer Variation; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D013638:Tars / Q000592:standards; D014028:Tobacco Smoke Pollution / Q000032:analysis* / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D006113:United Kingdom
chemical_list: D013638:Tars; D014028:Tobacco Smoke Pollution; C024746:tobacco tar; D009538:Nicotine