gothiatek - coresta

Eng Eng Eng

GOTHIATEK®

The Quality Standard

Lindholm. J; Hedin. A; Back. S; Hassler. T; Rutqvist. L.E.

Swedish Match North Europe AB

Maria Skolgata 83, SE-11885 Stockholm, Sweden

[email protected]

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mailto:[email protected]

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Swedish Match strives to produce smokeless tobacco products using the best

manufacturing practices while maintaining the lowest possible level of harmful

constituents.

In 2001, Swedish Match introduced the GOTHIATEK® standard and logo as a

symbol of quality to assure consumers that each can of Snus meets these

requirements.

The GOTHIATEK® standard is not static, but continues to evolve as techniques

and processes are improved and more scientific data is made available.

GOTHIATEK® Quality Standard

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1800s

Invention of a heat treatment process for production of snus

1970s

Snus included in the Swedish Food Act 1971

Quality problems related to microbial activity and formation of nitrite in finished products

”Project Eternell”

1982

Production centralized to a new factory in Gothenburg

Production process re-engineered

Closed process blenders

Temperature during heat treatment increased

”Food-grade” production

1980s-1990s

Collaboration with toxicologists at the Swedish Food Authority and university-based scientists with expertise in agronomy

Several projects to lower levels of harmful constituents in snus (e.g. TSNAs and PAHs)

2001

Launch of the voluntary industrial standard GOTHIATEK®

Development of GOTHIATEK®

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The GOTHIATEK® quality standard remains voluntary

Basis for ESTOC’s proposal to DG SANCO 2006 for a smokeless tobacco product regulation within the European Union

WHO’s Advisory Committee on Tobacco Product Regulation (TobReg) suggested in 2009 a smokeless product regulation with MLs for TSNAs (NNN, NNK) and B(a)P

GOTHIATEK® standard

ESTOC: European Smokeless Tobacco Council

DG SANCO is the European Commission (EC) Directorate General for Health and Consumers

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GOTHIATEK® Standard Product Requirements 1. Maximum Levels on Constituents

2. Raw Material Requirements Tobacco

Ingredients

3. Manufacturing Requirements Standards and Regulation

Process

Hygienic conditions

Packaging

4. Product Information to Consumers

Website information

Consumer package labeling

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1. Maximum Allowable Levels - Constituents

GOTHIATEK® requires that finished products shall not exceed the maximum allowable levels of certain harmful constituents. These constituents originate from the environment or from the tobacco plant

GOTHIATEK® Standard Product Requirements

ppm: parts per million (corresponding to ug/g)

ppb: parts per billion (corresponding to ng/g) All values based on 50% moisture water or wet basis

*Lowered 2012

NP: Not Public

Constituent GOTHIATEK® Limit Internal Limits Mean Content 2013

NNN+NNK* (ppm) 1.0 NP 0.5

NDMA (ppb) 5 NP < 0.6

Nitrite ion (ppm) 3.5 NP 1.1

B(a)P* (ppb) 2.5 NP < 0.6

Arsenic (ppm) 0.25 NP < 0.1

Lead (ppm) 1.0 NP 0.2

Cadmium (ppm) 0.5 NP 0.3

Chromium (ppm) 1.5 NP 0.4

Nickel (ppm) 2.25 NP 0.8

Agrochemicals According to the Swedish Match Agrochemical Management

Program

NP Below SM internal limits

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1. Maximum Allowable Levels - Constituents

GOTHIATEK® requires that finished products shall not exceed the maximum allowable levels of certain harmful constituents. These constituents originate from the environment or from the tobacco plant


ppm: parts per million (corresponding to ug/g)

ppb: parts per billion (corresponding to ng/g) All values based on 50% moisture water or wet basis

*Lowered 2012

NP: Not Public

Constituent GOTHIATEK® Limit Internal Limits Mean Content 2013

NNN+NNK* (ppm) 1.0 NP 0.5

NDMA (ppb) 5 NP < 0.6

Nitrite ion (ppm) 3.5 NP 1.1

B(a)P* (ppb) 2.5 NP < 0.6

Arsenic (ppm) 0.25 NP < 0.1

Lead (ppm) 1.0 NP 0.2

Cadmium (ppm) 0.5 NP 0.3

Chromium (ppm) 1.5 NP 0.4

Nickel (ppm) 2.25 NP 0.8

Agrochemicals According to the Swedish Match Agrochemical Management

Program

NP Below SM internal limits

Compliance with WHO recommendations for Smokefree tobacco products (NNN + NNK: 2 μg/g dry weight and B(a)P: 5 ng/g dry weight)

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1. Maximum Allowable Levels – Crop Protection Agents (CPAs)

The Swedish Match GRL-list for snus cover 160 CPAs

‐ Used on tobacco in areas where SM buys tobacco ‐ Found in tobacco upon analysis ‐ Legislated on tobacco in countries of interest ‐ On CORESTA Guide No. 1 ‐ Updated annually

The GRLs for Snus are lower than for tobacco

1. If an ADI-value (Acceptable Daily Intake) exists for the CPA, the maximum load from the intake of 25 g / dayi of snus containing SM GRL amounts of the CPA may not exceed 2.5 % of the ADI-value

2. The load from 25 g / day of snus containing GRL amounts of the CPA is compared to the total load from vegetables containing MRL (Maximum Residue Level) amount. The ratio should not exceed 2.5 %

3. If a legislated MRL on tobacco products exists for the CPA in any country and it is lower than calculated as above, the lower value will be used as GRL for snus

4. If the CORESTA GRLs are lower SM will use the CORESTA value for tobacco recalculated for snus

SM test in raw tobacco and in snus for a scope of more than 350 CPAs

iby a 70 kg person


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Tobacco

EWS

Tobacco

Packing samples

Tobacco

Blend

Product

”Fresh”

Product

”Stored”

1. Maximum Allowable Levels - Products

Snus

Chemical Control of Products – At production line

Every production batch

(1) pH, (2) Moisture, (3) Water activity, (4) Bacteria

Chemical Control of Products – Four times a year

All products manufactured by Swedish Match

Sampling at the production line

Stored in refrigerator, analysed within 3 weeks

Shelf-life; Products stored in room temperature and refrigerator and analysed at the end of ”Best before date”

Analytes: GothiaTek Constituents, Mycotoxins, Humectants, Nicotine, Bacteria, pH, Moisture, Ammonia, Aldehydes, Water, Acrylamide, Ethanol, Ethylcarbamate, Water activity

Analytes on selected products: HPHC 37 list

Action plan for every deviation from Internal Limits – continuous improvement

Analytical methods

Accreditation consistent with ISO/IEC 17025:2005

Reports

Swedish Match Quality Forum

Authorities

Web page www.svensktsnus.se

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TSNA B(a)P

1. Maximum Allowable Levels – Consumer protection To continuously reduce or eliminate harmful constituents in Swedish snus and to increase the knowledge about

Swedish Match snus products and its impact on users health.

Conduct research and development work directed at continuous improvement of products.

Cooperate with authorities so that regulations shall be based on all available knowledge.

Average levels in Swedish snus manufactured by Swedish Match AB 1990-2014


1 9 9 0 1 9 9 4 1 9 9 8 2 0 0 2 2 0 0 6 2 0 1 0 2 0 1 4

0

5

1 0

1 5

2 0

2 5

E tta n L ö s

G e n e ra l L ö s

G ro v L ö s

TS

NA

[p

pm

]

1 9 9 6 1 9 9 8 2 0 0 0 2 0 0 2 2 0 0 4 2 0 0 6 2 0 0 8 2 0 1 0 2 0 1 2 2 0 1 4

0

5

1 0

1 5

2 0

2 5

3 0 G e n e ra l L ö s

E tta n L ö s

G ro v L ö s

Ba

P [

pp

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TSNA B(a)P

1. Maximum Allowable Levels – Consumer protection To continuously reduce or eliminate harmful constituents in Swedish snus and to increase the knowledge about

Swedish Match snus products and its impact on users health.





1 9 9 0 1 9 9 4 1 9 9 8 2 0 0 2 2 0 0 6 2 0 1 0 2 0 1 4

0

5

1 0

1 5

2 0

2 5

E tta n L ö s

G e n e ra l L ö s

G ro v L ö s

TS

NA

[p

pm

]

1 9 9 6 1 9 9 8 2 0 0 0 2 0 0 2 2 0 0 4 2 0 0 6 2 0 0 8 2 0 1 0 2 0 1 2 2 0 1 4

0

5

1 0

1 5

2 0

2 5

3 0 G e n e ra l L ö s

E tta n L ö s

G ro v L ö s

Ba

P [

pp

b]

Swedish Snus products meet WHO recommendation

for smokefree tobacco products

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LEAD CADMIUM

1. Maximum Allowable Levels – Consumer protection (count´d) To continuously reduce or eliminate potential toxicants in Swedish snus and to increase the

knowledge about Swedish Match snus products and its impact on users health.





1 9 9 0 1 9 9 4 1 9 9 8 2 0 0 2 2 0 0 6 2 0 1 0 2 0 1 4

0 .0

0 .5

1 .0

1 .5

2 .0

2 .5

G e n e ra l L ö s

E tta n L ö s

G ro v L ö s

Le

ad

[p

pm

]

1 9 9 0 1 9 9 4 1 9 9 8 2 0 0 2 2 0 0 6 2 0 1 0 2 0 1 4

0 .0

0 .5

1 .0

1 .5

2 .0

2 .5

G e n e ra l L ö s

E tta n L ö s

G ro v L ö s

Ca

dm

ium

[p

pm

]

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Requirement of Laboratory Performing Testing

Accredited according to ISO/IEC 17025:2005

Accredited by Nationally or

Internationally Accreditation Body

GOTHIATEK® analysis Accredited

Analytical Techniques including:

HPLC, UPLC-MS/MS

GC, GC-MS/MS

ICP-MS

Regular External Audit

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GOTHIATEK® Standard – Raw Material Requirements

2. Raw Materials - Tobacco

The GOTHIATEK® standard requires:

• Tobacco is selected to ensure that Swedish Match’s internal limits for harmful

constituents are met for each individual product.

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GOTHIATEK® Standard - Raw Material Requirements

Snus

Early warning samples (EWS)

Sampling at farmers/dealers

Internal limits for tobacco depending on growing areas

Analytes: TSNA, Nitrite/Nitrate, Alkaloids, Sugars, (Metals, GMO, B(a)P, Agrochemicals, Mycotoxins)

Packing samples

Sampling in the packing factory (packed samples)

Internal limits for tobacco depending on growing areas

Data collection for computerized blending at manufacture

Analytes: TSNA, Nitrite/Nitrate, Alkaloids, Metals, Aldehydes, Sugars, Mycotoxins, Agrochemicals, B(a)P, Chlorides, GMO

Tobacco blends

Every production batch

Sampling at storage after milling and blending of the tobacco

Internal limits for finished products

Analytes: TSNA, Nitrite/Nitrate, Nicotine, Metals, Aldehydes, Sugars, Mycotoxins B(a)P, Chlorides, GMO, pH

2. Maximum Allowable Levels - Tobacco Tobacco

EWS

Tobacco

Packing samples

Tobacco

Blend

Product

”Fresh”

Product

”Stored” 2014

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GOTHIATEK® Standard – Raw Material Requirements

2. Raw Materials – Ingredients The GOTHIATEK® standard requires:

• All ingredients must be approved according to the rules and regulations that apply in those

countries where Swedish Match conducts business.

• Snus product ingredients shall be publicly available.

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GOTHIATEK® Standard – Manufacturing Requirements

3. Manufacturing – Standards and regulation


• Manufacturing process must comply with Swedish law on food production, and Tobacco Acts in those countries

where Swedish Match conducts business

• Meets the requirements of quality standard ISO 9001:2000

• Meets the environmental standard ISO 14001:1996

Snus is equated with food products in the Swedish Food Products Act and the National Food Agency (“NFA”) applies certain EU food definitions and regulations to snus as well

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3. Manufacturing – Process


• The product must be heat treated to ensure that the majority of the natural microbial flora of the tobacco is

rendered harmless.

• The heat treatment process is performed in a closed system in order to prevent contamination from the

environment.


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3. Manufacturing – Hygienic conditions


• All open handling, such as filling of product into cans, must be performed in premises that satisfy national

sanitation requirements for food facilities.

• Process and packaging equipment must be cleaned and monitored according to a defined schedule.


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3. Manufacturing - Packaging


• Materials used in packaging must be approved for food packaging.

• Packages must be checked for cleanliness and hygiene standards according to a strict schedule.


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4. Consumer Information - Website

The GOTHIATEK® standard requires that the following information is available

on the website (unless prohibited by national legislation): Content of GOTHIATEK® compounds

Research reports

Composite list (flavours etc.)

Website information; www.svensktsnus.se; www.swedishmatch.com

24 februari 2014 21

GOTHIATEK® Standard - Consumer Information

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http://www.svensktsnus.se/

http://www.swedishmatch.com/

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4. Consumer Information - Website

The GOTHIATEK® standard requires that the concentration of the following components in each

specific finished product shall be publicly available (unless prohibited by national legislation):

Water

Nicotine

pH

Sodium chloride

Sodium carbonate

Humectants

Flavours

The concentrations shall be based on the finished product.


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4. Consumer Information - Consumer package labeling

The GOTHIATEK® standard requires that the following information is available

on the consumer package (unless prohibited by national legislation):

Ingredients in food labeling style

Shelf life, production date, best before date

Warning labels

Traceability codes

Storage recommendation

Nicotine content


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http://www.mynewsdesk.com/se/swedishmatch/images/general-i-ny-minidosa-74452

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An “ISO type” version of GOTHIATEK® has recently been developed in collaboration with the

Swedish Standardization Institute (SIS).

Work in progress to update the maximum permitted levels of harmful constituents in the

GOTHIATEK® standard.

Work in progress to include other suspected harmful constituents in the GOTHIATEK®

standard.

Improve the Consumer Product Information and presenting the levels of GOTHIATEK®

compounds for each brand.

GOTHIATEK® Standard – Future Updates consistent with continuous improvement

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Thanks for your attention

www.svensktsnus.se

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