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1. ISO 9001:2000 Quality standard 2. ISO 14001:1996 Environmental standard3. ISO/IEC 17025: 2006 Testing Laboratory Accreditation4. GOTHIATEK® Swedish Match proprietary snus quality standard
Four standards define the content of our Standard Operating Procedures
• Introduced in year 2000- Based on consumer care, quality and openess
• Applicable to all Swedish Matchsnus products
• Strives to- Produce the best products- Use the best manufacturing practices- Maintaining the lowest possible level of undesirable constituents
• Written up in 2014 as a consolidated standard in collaborationwith SIS, Swedish Standards Institute
• Dynamic and continues to evolve- As techniques and processes are improved- As more scientific data is made available
GOTHIATEK® Swedish Match Snus Quality Standard
1. Maximum Allowable LevelsNNN, NNK, B(a)P, Cd, As….
2. Declaration of ContentsAll ingredients are made publicly available
3. Declaration of Certain ComponentsNicotine, salt, water, humectants….
4. Manufacturing RequirementsSwedish food production standard and beyond
5. Raw MaterialsTobacco sourced to ensure maximum levels are achieved, no GMO..
6. IngredientsAn internal policy that each ingredient, including each substance in a complex flavor, must adhere to
7. PackagingFood grade and beyond
8. ProcessHeat treatment in closed systems, screening…
9. SanitationMeeting food grade production, cleaning to a strict regime
GOTHIATEK® requirements
Maximum Allowable Levels – Tobacco
GOTHIATEK® Product requirements
TobaccoEWS
Tobacco Packing samples
Tobacco Blend
Product”Fresh”
Product”Stored”
Maximum Allowable Levels
GOTHIATEK® Product requirements
All values based on 50% moisture water or wet basis
‘ *Lowered 2012‘**Comparable to the CORESTA Guide N° 1 for Agrochemicals GRLs in tobacco.
ppm: parts per million (corresponding to ug/g)ppb: parts per billion (corresponding to ng/g)
Component Gothiatek limit Mean contentNNN+NNK (ppm) 1 0,4NDMA (ppb) 5 less than 0,3Nitrite (ppm) 3,5 1B(a)P* 2,5 0,4Arsenic (ppm) 0,25 less than 0,05Lead (ppm) 1 0,1Cadmium (ppm) 0,5 0,2Chromium (ppm) 1,5 0,3Nickel (ppm) 2,25 0,7
AgrochemicalsAccordning to
SM policy
7
TSNA levels of different Smokeless Tobacco Products
1. Figures taken from Stansfill et al “Global surveillance of oral tobacco products: total nicotine unionized, nicotine and tobacco-specific N-nitrosamines”,
9
HPHCs: levels in Snus - TSNA
0
1
2
3
4
5
6
7
8
9
10
2002n=90
2003n=88
2004n=87
2005n=97
2006n=105
2007n=111
2008n=166
2009n=174
2010n=198
2011n=270
[µg/
g]
NNN, NNK and Total TSNA
NNN
NNK
TSNA
Figure 3-22. Average Content of TSNAs (NNN, NNK, and Total TSNAs) based on dry weight in All SnusProducts Included in Swedish Match’s Chemical Quality Program From 2002-2011 (the number of tested products (n) and 95% confidence intervals are indicated
These data cover all the products on the market in Sweden, Norway and USA, and were representative on the market
The GothiaTek limits for Total TSNAwere 10 ppm until 2012 (today NNN+NNK: 2 ppm = WHO TobReg)
HPHCs: Levels of NNN, NNK and Total TSNA in Swedish Match Snusproducts and proposed MRTP snus products
10
Average Content of TSNAs (NNN, NNK, and Total TSNAs) based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95%
Conclusion: There are no significantly differences in Nitrosamine levels between the historical Snus products compared to the proposed MRTP Snus products
The GothiaTek limits for Total TSNAwere 10 ppm until 2012 (today NNN+NNK: 2 ppm)
0
0.5
1
1.5
2
2.5
3
3.5
2002n=90
2002n=13
2003n=88
2003n=12
2004n=87
2004n=13
2005n=97
2005n=12
2006n=105
2006n=10
2007n=111
2007n=11
2008n=166
2008n=15
2009n=174
2009n=19
2010n=198
2010n=20
2011n=270
2011n=39
NNN
NNK
TSNA
NNN SM brand US market
NNK SM brand US market
TSNA SM brand US market
11
HPHCs: levels in Snus – B(a)P
0
2
4
6
8
10
12
14
16
18
20
2002n=91
2003n=62
2004n=87
2005n=97
2006n=105
2007n=111
2008n=126
2009n=131
2010n=198
2011n=268
[ng/
g]
B(a)P
Figure 3-23. The Average Content of B(a)P, based on dry weight, in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 (the number of tested products (n) and 95% confidence intervals are indicated)
Sun-cured, Dark air-cured and Flue-cured tobacco are used for Snus (no Dark fired-cured tobacco).
The GothiaTek limits for B(a)Pwere 20 ppb until 2012 (today: 5 ppb = WHO TobReg)
These data cover all the products on the market in Sweden, Norway and USA, and were representative on the market
12
HPHCs: Levels of B(a)P in Swedish Match Snus products and proposed MRTP snus products
Average Content of B(a)P based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95%
Conclusion: There are no significantly differences in B(a)P levels between the historical Snus products compared to the proposed MRTP Snus products
The GothiaTek limits for B(a)Pwere 20 ppb until 2012 (today: 5 ppb)
13
HPHCs: Levels of Nitrit in Swedish Match Snus products and proposed MRTP snus products
Conclusion: There are no significantly differences in Nitritlevels between the historical Snus products compared to the proposed MRTP Snus products
Average Content of Nitrite based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95% )
14
HPHCs: Levels of Metals in Swedish Match Snus products and proposed MRTP snus products
Conclusion: There are no significantly differences in Metal levels between the historical Snus products compared to the proposed MRTP Snus products
Average Content of Nitrite based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95% )
15
HPHCs: Levels of NDMA (Nitrosdimethylamine) in Swedish Match Snusproducts and proposed MRTP snus products
Average Content of NDMA based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95% )
Conclusion: There are no significantly differences in NDMA levels between the historical Snus products compared to the proposed MRTP Snus products
16
HPHCs: Levels of Nicotine in Swedish Match Snus products and proposed MRTP snus products
Average Content of Nicotine based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95% )
Conclusion: There are no significantly differences in Nicotine levels between the historical Snus products compared to the proposed MRTP Snus products
17
pH in Swedish Match Snus products and proposed MRTP snusproducts
Average pH level based on dry weight in All Snus Products Included in Swedish Match’s Chemical Quality Program From 2002-2011 versus the product in the MRTP application (the number of tested products (n) and 95% )
Conclusion: There are no significantly differences in Nicotine levels between the historical Snus products compared to the proposed MRTP Snus products
18
Product Stability
Year Product TSNAµg/g
General Loose (SKU 4852) 3 w 14 w
2007 Batch 724002 1.5 1.32008 Batch 823159 1.1 1.22009 Batch 923002 1.2 1.02010 Batch 021003 0.9 0.86
2011 Batch 124002 1.2 1.0General Portion Original Large (SKU
4880)3 w 20 w
2007 Batch 753002 1.7 1.42008 Batch 811113 1.3 1.62009 Batch 912001 1.5 1.42010 Batch 034003 1.1 1.2
2011 Batch 152006 1.6 1.3
General Portion White Large (SKU 4881) 3 w 20 w
2007 Batch 7A2003 1.4 1.22008 Batch 7A1187 1.2 1.32009 Batch 9A2001 1.7 1.82010 Batch 0B1002 1.3 1.3
2011 Batch 112002 1.5 1.4
Table 3-43. Analytical Results From the Years 2007 to 2011 Showing the Content of TSNA in Snus Products Stored in Refrigerator for 3 Weeks and at Ambient Room Temperature and Relative Humidity Until Best Before Date (values of TSNA are given as dry weight)
Conclusion: Shelf-life studies of Swedish Match snus products stored at ambient room temperature have not shown any increase of nitrosamines levels.
19
Product stability
TSNA* µg/g
Product, SKU 3 w14 w
Refr Room
General Loose, 4852 1.0 0.98 0.95
Product, SKU 3 w30 w
Refr Room
General Dry Mint Portion Original Mini, 4800
1.6 1.6 1.8
Product, SKU 3 w20 w
Refr Room
General Portion Original Large, 4880
1.4 1.2 1.2
General Classic Blend Portion White Large, 4878
1.5 1.3 1.2
General Mint Portion White Large, 4352
1.2 1.2 1.1
General Nordic Mint Portion White Large, 4876
1.5 1.4 1.3
General Portion White Large, 4881
1.3 1.1 1.0
General Wintergreen Portion White Large, 4882
1.2 1.5 1.2
Table 3-45. Analytical Results From the Year 2012 Showing the Content of TSNA for Products Marketed in the US, Stored Both in Refrigerator and at Ambient Room Temperature and Relative Humidity Until Best Before Date (values of TSNA, are given as dry weight)
Conclusion: Shelf-life studies of Swedish Match snus products stored at refrigerator and ambient room temperature have not shown any increase of nitrosamines levels nor any other GothiaTek constituents.
The levels of TSNAs in Swedish Match snus products have also been monitored in comprehensive shelf-life studies at ambient temperature (20 °C / 68 °F) and as well as in elevated ambient temperature (27 °C / 80.6 ° F ), the results showed no increase in nitrosamines