SNUS and the GOTHIATEK STANDARD

Transcription

1 SNUS and the GOTHIATEK STANDARD Inger Wahlberg Consulting 1

2 SNUS 2

3 SNUS 3

4 Snus Swedish snus A moist to semi-moist oral tobacco product, traditionally produced and used in Sweden. Contains finely ground, mainly air-cured, tobaccos and is manufactured in a process comprising heattreatment. In 1988: 27% of men smoked daily; 17% daily snus users. In 2014: 10% of men smoked daily; 18% daily snus users. Banned in the EU in 1992; Sweden exempted 4

5 GOTHIATEK - PRELUDE 1971 Snus and chewing tobacco under the Swedish Food Act 1982 New manfacturing plant for snus (heat-treatment+ closed system) 1985 Vision: An Unobjectionable Snus (Agronomy, Chemistry, Toxicology, Human Health Studies; TSNA and B(a)P major issues); A program fortobacco Harm Reduction 1992 TPD 92/41/EEC Ban of snus in the EU; No distinction between smokeless tobacco types according to toxicity; Not possible to regulate according to toxicity 1980 and 1990s Extensive research programs: from seed to finished product, TSNA formation, nicotine uptake; development of methods for chemical analysis; quality assurance programs 5

6 FOOD REGULATION SNUS and the Swedish Food Act Consumer protection by product regulation Swedish Food Act (LIVSFS 1971:511): Snus and chewing tobacco are not food but are considered to be equivalent to food from a regulatory point of view. The current Swedish Food Act (LIVSFS 2012:6) includes general as well as specific requirements for snus and chewing tobacco, e.g.: Only food-allowed ingredients, additives and flavourings, packaging materials; water; food hygiene; hazard analysis; traceability Labelling on the consumer box/package Contaminants: Limits are set for lead (3 mg/kg) and the sum of the amounts of aflatoxin B1, B2, G1 and G2 (0.005 mg/kg) 6

7 GOTHIATEK 2001 Voluntary Quality (Assurance) Standard for Swedish Snus comprises A Manufacturing Standard Selection of raw material (tobacco, ingredients SM policy) Pasteurisation process, closed system A Constituent Standard Limits for constituents - SM Policy GRLs for pesticide residues SM policy A Consumer Information Standard Ingredients, food labelling style Best before date; storage conditions Website information (nicotine, sugar, research results, Commitment 7

8 GOTHIATEK 2001 Compound Nitrite Limit (50% water) < 3.5 mg/kg Compound Cadmium Limit (50% water) < 0.5 mg/kg TSNA < 5 mg/kg Lead < 1 mg/kg NDMA < 5 microgram/kg Arsenic < 0.25 mg/kg B(a)P < 10 microgram/kg Nickel < 2.25 mg/kg Pesticides According to the Swedish Match Pesticide Policy Chromium < 1.5 mg/kg 8

9 GOTHIATEK 2001 Selection of constituents Basis: Hoffmann, D. and Djordjevic, M.V Chemical Composition and Carcinogenicity of Smokeless Tobacco, Adv. Dent. Res. 11 (3): Restrictions: Several of the constituents listed in the above article are present in snus in amounts too low to be measurable using analytical methods available at that time. Justification: Most of the compounds included in the GOTHIATEK Product Standard are classified by IARC as Group 1 or 2 carcinogens 9

10 GOTHIATEK 2001 Limits The actual limits of the GOTHIATEK standard were set by taking into account both toxicity and natural levels of some of the trace components, e.g. metals, in tobacco. While TSNA are basically specific to tobacco, the remaining constituents of the Standard are also found in many foods. The GOTHIATEK standard for these non-tobacco specific compounds has limits, which are comparable with the levels found in many common food items. 10

11 AFTER 2001 ESTOC Regulatory Proposal (2006) is built on the GOTHIATEK Standard and the Swedish Food Act. In 2009: TOBREG The combined concentration of NNN+NNK in smokeless tobacco should be limited to 2 microgram/gram dry weight of tobacco. The concentration of B(a)P in smokeless tobacco should be limited to 5 ng/gram dry weight of tobacco. In 2012: Swedish Match announced that TSNA had been replaced by the sum of NNN+NNK (limit of 2 microgram/gram dry weight) and lowered the limit for B(a)P to 5 ng/gram dry weight in the GOTHIATEK Standard. In 2015: the Swedish Food Authorities proposed that limits for NNN+NNK (2 microgram/gram dry weight) and B(a)P (3 ng/gram) should be introduced for snus and chewing tobacco in the Swedish Food Act. In 2015: TOBREG proposed that levels of arsenic, cadmium and lead should be monitored in tobacco. 11