Simplyokcodeofpractice 1667402753548

Complete and reliable information about allergens in food
SimplyOK Code of Practice

European Allergen Information Certification Standard
Liability
Foundation SimplyOK publishes information and expresses opinions in good faith but accepts no liability for
any error or omission in any such information or opinion, including any information or opinion used in this
publication.
Whilst Foundation SimplyOK has endeavoured to ensure that the information in this publication is accurate, it
shall not be liable for any damages (including without limitation damages for pure economic loss or loss of
business or loss of profits or depletion of goodwill or otherwise in each case, whether direct, indirect or
consequential) or any claims for consequential compensation whatsoever (howsoever caused) arising in
contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise, in
connection with this publication or any information contained in it, or from any action or decision taken as a
result of reading this publication or any such information.
All warranties, conditions and other terms implied by statute or common law are, to the fullest extent
permitted by law, excluded.
Nothing excludes or limits the liability of Foundation SimplyOK for death or personal injury caused by its
negligence, for fraud or fraudulent misrepresentation or for any matter which it would be illegal for it to
exclude or attempt to exclude liability for.
Copyright
© Copyright 2021, Foundation SimplyOK
All rights reserved. No part of this publication may be reproduced and/or published in any form, by means of
printed matters, photocopy, microfilm, recording or any other method or technology, without written approval
by the copyright owner. Application for permission should be addressed to Foundation SimplyOK (contact
details below). Full acknowledgement of the author and source must be given.
No part of this publication may be translated without the written permission of the copyright owner.
The Foundation SimplyOK retains the ownership and the copyright and the license agreements for certification
bodies.
Due to the dynamic content of this document the user of this document should always verify if the correct
version is held. In all cases the English version of the SimplyOK certification scheme is leading.
Every effort has been made to ensure that the content of the SimplyOK certification scheme is accurate at the
time of printing. However, it may be subject to minor changes, and reference should be made to the SimplyOK
website (www.simplyok.eu), where changes will be published.
Foundation SimplyOK
Postbus 693
4200 AR Gorinchem
The Netherlands
tel: +31 (0)183 822 935
e-mail: info@simplyok.eu
Version 3.0 – September 2021 1

ACKNOWLEDGEMENTS
We are grateful to the members of the Board of Stakeholders.
Within the Board, the interests of all parties involved in the food supply chain and food allergy are represented.
Name Company
Erna Botjes Stichting Voedselallergie/ Dutch Food Allergy Organisation
Betty Groen Dutch Spices
Charlotte ter Haar Association of the Dutch Bakery and Confectionery Industry
Marloes Kneppers Federatie Nederlandse Levensmiddelen Industrie/
Esther Oldenhuis Federation for the Dutch Food and Grocery Industry
Nadine Kregting Jumbo Supermarkten
Johan Hulleman
Harold Oldenbeuving Marfo
Floris van Overveld NCV, The Dutch Coeliac Society
Evert van der Pest Schouten Certification
Remco Pieters Lloyd’s Register Nederland B.V.
Marjan van Ravenhorst Allergenen Consultancy B.V.
Bregje Kroeze-Krebbers
Ilse Roosenbrand Centraal Bureau Levensmiddelenhandel
Superunie
Ronald Siteur Albert Heijn
Jaco Vink Vinçotte Nederland B.V.
Sacha Visser Diëtistenpraktijk Andermaal
Thédor van der Vleuten
Wieke van der Vossen Voedingscentrum
Table 1 A not comprehensive list of the members of the Board of Stakeholders

SimplyOK Standard
Table of contents
1. Introduction.................................................................................................................................................... 5
1.1 General scope ...................................................................................................................................... 5
1.2 Goal ..................................................................................................................................................... 5
1.3 Certification process ............................................................................................................................ 5
1.4 Definitions ........................................................................................................................................... 6
2. Requirements on Allergen Management ....................................................................................................... 8
1.5 Basic requirements .............................................................................................................................. 8
1.6 Action levels ........................................................................................................................................ 8
1.7 Analysis and sampling procedures ...................................................................................................... 9
1.8 Free-from claims ............................................................................................................................... 10
1.8.1. Gluten-free .......................................................................................................................... 10
1.8.2. Lactose-free ......................................................................................................................... 10
1.9 Labelling and product specification................................................................................................... 10
1.10 Allergen management ....................................................................................................................... 11
1.10.1. Basic 1 – Correct and complete raw material information ................................................. 12
1.10.2. Basic 2 - Apply correct recipe .............................................................................................. 12
1.10.3. Basic 3 - Designing a correct packaging and other food information ................................. 13
1.10.4. Basic 4 – Preventing accidental exchange ........................................................................... 13
1.10.5. Basic 5 - Avoiding cross-contamination............................................................................... 14
3. Audit Protocol .............................................................................................................................................. 15
1.11 Private label owners .......................................................................................................................... 15
1.12 Head Office ........................................................................................................................................ 15
1.13 Scope of certification......................................................................................................................... 16
1.13.1. Exclusions from scope ......................................................................................................... 16
1.13.2. Extension to scope .............................................................................................................. 17
1.13.3. Reduction of the scope ....................................................................................................... 17
1.14 Type of audits .................................................................................................................................... 17
1.14.1. Initial certification audit (certification audit) ...................................................................... 17
1.14.2. Audit program ..................................................................................................................... 17
1.14.3. Surveillance audit ................................................................................................................ 17
1.14.4. Recertification audit ............................................................................................................ 17
1.14.5. Special (extra) audit............................................................................................................. 18
1.14.6. Follow up audit .................................................................................................................... 18
1.14.7. Extension audit .................................................................................................................... 18
1.14.8. Parallel audit ....................................................................................................................... 18
1.15 Certification cycle .............................................................................................................................. 18
1.16 Certification ....................................................................................................................................... 18
1.16.1. Certification date................................................................................................................. 18
1.16.2. Certificate expiry date ......................................................................................................... 18
1.17 Review and certification decision...................................................................................................... 18
1.18 Audit duration ................................................................................................................................... 19
1.18.1. On-site audit duration ......................................................................................................... 19
1.18.2. Audit time reduction in case of a combined audit .............................................................. 19
1.19 Reporting time................................................................................................................................... 20
1.20 Audit trail........................................................................................................................................... 20

1.21 Time in the production area .............................................................................................................. 20

1.22 Findings and closing non-conformities .............................................................................................. 20
1.23 Closing meeting ................................................................................................................................. 21
1.24 Closing non-conformities .................................................................................................................. 21
1.24.1. Minor non-conformity ......................................................................................................... 21
1.24.2. Major non-conformity ......................................................................................................... 21
1.24.3. Critical non-conformity ....................................................................................................... 22
1.25 Report ................................................................................................................................................ 22
4. Certification Bodies ...................................................................................................................................... 23
1.26 Selection of a Certification Body ....................................................................................................... 23
1.27 Food business operator / Certification Body Contractual Arrangements ......................................... 23
ANNEX 1 Use of VITAL® ......................................................................................................................................... 24
ANNEX 2 Determination of consumption size (reference amount) ...................................................................... 26
ANNEX 3 AOECS Standard Gluten-free ................................................................................................................. 28

1. Introduction
Food allergic consumers are confused that information on packaging about allergens is not consistent.
European labelling legislation requires ingredients used to be specified and emphasised in the ingredients
declaration. Nevertheless, this information is sometimes incorrect resulting in occasional allergic reactions and
many more recalls and allergy alerts.
Reliable information about the unintentional presence of allergens (also called cross contamination) is even
more difficult. There is no legal requirement for food suppliers to provide a precautionary allergen statement
(e.g., ‘may contain’). Consumers are confronted with a wide range of formats and styles to indicate the
possibility of allergen cross contamination. Some food business operators don’t use precautionary allergen
labelling (PAL) at all, even when a relevant level of allergen cross contamination is likely.
On the other hand, products with a warning will not always pose a potential risk to allergic consumers.
Finally, different food suppliers use PAL for different food allergens. This may range from a warning for a single
allergen (e.g., nuts /peanuts), or a selection of allergens, to all fourteen allergens, which have to be labelled as
allergens in Europe. This lead to a lack of clarity, which causes possible health risk to consumers.
There is a need for:
1. unambiguous, complete and reliable allergen information;
2. an objective method for assessing cross contamination risks;
These are the cornerstones of this SimplyOK Standard.
In this document allergens are being addressed as substances or products causing allergies
or intolerances as mentioned by European Regulation (EU) No 1169/2011 Annex II.
1.1 General scope

1. A food production process that is certified against the SimplyOK standard ensures that labeling of products
meet the regulatory requirements and provides unambiguous, complete and reliable allergen information
regarding ingredients and cross contamination.
2. Information regarding cross contamination is an addition to legally required emphasizing of allergens in

the list of ingredients.
3. Every food business operator that produces packed food products, ingredients and semi-finished products
intended for consumers (for human consumption), wholesale and for further processing in the production
chain can be certified according to this Standard. All products from a production site are included, as the
entire production process is audited.
4. The production process as well as the branding, labelling and/or information process regarding the
products will be assessed.
5. Non-prepacked products or foods which are packed on the sales premises at the consumer’s request or
prepacked for direct sale are not covered by the certification standard. Medical diet products and Infant,
Follow on and Toddler nutrition (IFT) are also outside the scope.
6. Products with ‘free from…[name of the allergen]’ claims, with the exception of legally determined claims
such as ‘gluten-free’ and ‘lactose-free’, are not covered by this Standard (see paragraph 1.8).
1.2 Goal
This document describes the requirements that shall be met by food business operators (organizations).
1.3 Certification process

1. The European Allergen Information Standard (SimplyOK of Practice. Hereafter: The Standard) is a
management system certification scheme. A food business operator that has selected a SimplyOK
approved certification body will be audited by a qualified auditor. Certification bodies accredited according
to ISO 17065 or ISO 17021-1 with ISO 22000 in their scope of accreditation can be accepted by the
Foundation SimplyOK and provide the certification services.

2. An audit takes approximately one to two man-days on-site, depending on the size and complexity of the
manufacturing plant (see paragraph 1.18).
3. Prior to the audit, the (certified) food business operator shall provide all relevant information to the
certification body to determine the audit time and for the auditor to prepare the audit schedule.
1.4 Definitions
Action level Action Levels are the concentrations (of protein) which define the labelling outcomes
for each concentration of cross contact allergen in a VITAL risk assessment. They are
determined using the Reference Dose and the Reference Amount.
• Action Level 1: Low concentration of the relevant allergen under evaluation, low
chance of adverse reaction and no precautionary allergen labelling statement
required.
• Action Level 2: Significant concentration of relevant allergen under evaluation,
significant chance of adverse reaction and a precautionary allergen labelling
statement is required.
The corresponding formula is:
Action level transition point (mg total protein of allergenic food/ kg product= ppm):
Reference dose (mg) x 1000/ consumption size (g)
Brand A logo and/ or (business) name, placed on food products.
Brand owner The food business operator under whose brand the food is marketed. This could be a
brand of the manufacturer or a private label owner. The brand owner is legally
responsible for the food information according to REGULATION (EU) No 1169/2011
article 8.
Bulk products Products not intended for presentation to consumers but sold to mass caterers or
marketed at a stage prior to sale to the final consumer (ingredients for further
processing).
Consumption size The maximum consumption amount of a food for each eating occasion (= period of
(reference amount) approx. ½ hour ) in the event of normal use. VITAL® is a risk assessment employing a
well-founded worst-case approach. The consumption size to be determined is
therefore generally not equal to the portion/ serving size on the nutrition information
panel. The Reference Amount should never be less than the serving size.
Cross A residue or other trace amount of a food allergen that is unintentionally
contamination incorporated into another food. Cross contact sources can be from
ingredients, raw materials, personnel, inadequate cleaning of equipment,
or concurrent and/or co-located processes.
Food business Food business operator: Legal representative or organization responsible for ensuring
operator that the requirements of food law are met within the food business under their
control.
Manufacturer A food business operator that produces product on site from raw materials and/or
components and packs the product into a prepacked food or supplies bulk products
intended for food service or further processing. Some, but not all, production or
packaging processes can be outsourced.
A (co)packer that packs product into prepacked food from bulk-supplied material can
also be classed as a manufacturer.
Outsourced If an intermediate production process or step in the manufacturing or packing of a
processing, product is completed at another food business operator. Packaging processes which
(sub)contracted or do not affect the product itself or the product information/ labelling are excluded.
co-manufacturing
Precautionary A voluntary statement listing all allergens that can be present because of
Allergen cross contact and at Action Level 2.
Labelling (PAL)

Private label owner A brand owner who is not the manufacturer or producer but a retailer or supplier
who gets its goods made by a outsourced processing, (sub)contracted or co-
manufacturing.
Particulate For the purpose of the VITAL risk assessment, separate and distinct particle of
material (e.g., sesame seeds, slivered nuts, grated cheese) which either
• does not mix homogeneously with other parts of the food; or
• may consist of, or are likely to aggregate into an entity which contains a level
equal to or greater than the relevant Reference Dose (see also ‘Readily
Dispersible Form’)
Readily dispersible A powder or liquid in homogenous form that is easily distributed throughout a food
form product e.g., milk powder, soy flour. A readily dispersible cross contact allergen which
is considered homogeneously distributed in the final product (see also ‘Particulate’).
Reference dose The milligram protein level (total protein from an allergenic food) below
which only the most sensitive (1% eg. ED01) of individuals in the allergic population
are likely to experience an adverse reaction. If reactions to unlabelled
allergens do occur from exposure below the Reference Dose they will be
mild and transient, requiring no emergency medical intervention.
Choice of ED01 and other assumptions are based on advice of VITAL Scientific Expert
Panel (VSEP) of Allergen Bureau. Local authorities may use different assumptions,
leading to other values.
Validation (in accordance with the Codex Alimentarius) is the process of obtaining evidence that
a control measure, if properly implemented, is capable of controlling a particular
hazard to the specified level.
Verification (in accordance with the Codex Alimentarius, and in addition to monitoring) is the
application of methods, procedures, tests, and evaluations to determine whether a
control measure is or has been operating as intended.

2. Requirements on Allergen Management

1.5 Basic requirements
The food business operator shall meet basic food safety criteria, including a functioning HACCP system and a
prerequisite program. Therefore, a valid, GFSI recognized food safety certificate issued by an accredited
certification body shall be present. The food safety management system (FSMS) shall include specific aspects
where allergen control is incorporated.
1.6 Action levels

Products shall meet the legal requirements and action levels where applicable. For allergens, according to
Regulation (EU) No 1169/2011, for which no thresholds have been adopted yet, the most recent reference
doses provided by the VITAL® system of the Allergen Bureau are valid. For allergens that are not included in
this system, the allergen with the lowest reference dose shall be used in the framework The Standard. In the
VITAL®3.0 the lowest reference dose is for walnut.
Allergen (all proteins from Reference dose Source

source) (total protein of allergenic
food at one eating occasion)
Cereals containing gluten 0,7 mg VITAL®3.0 (based on wheat), with a
maximum action level up to 20 ppm
(Commission Implementing Regulation
(EU) No 828/2014)
Crustaceans 25 mg VITAL®3.0
Egg 0,2 mg VITAL®3.0
Fish 1,3 mg VITAL®3.0 (based on finfish)
Peanut 0,2 mg VITAL®3.0
Soy 0,5mg VITAL®3.0
Milk* 0,2 mg VITAL®3.0
Nuts subgroup 1 (almonds, 0,1 mg VITAL®3.0
Brazil nuts, hazelnuts,
macadamia nuts)
Nuts subgroup 2 (cashews/ 0,05 mg VITAL®3.0
pistachio nuts)
Nuts subgroup 3 (walnuts/ 0,03 mg VITAL®3.0
pecan nuts)
Celery 0,05 mg VITAL®3.0
Mustard 0,05 mg VITAL®3.0
Sesame 0,1 mg VITAL®3.0
Sulphur dioxide and sulphites No reference dose, but a According to (EU) 1169/2011
static action level of 10 ppm
Lupin 2,6 mg VITAL®3.0
Molluscs 0,03 mg VITAL®3.0 (based on walnut)
Table 2 Reference dose
* Lactose is a milk sugar, not a milk protein. Lactose does not trigger a food allergic reaction, but it may cause
food intolerance reactions. Lactose is not subject to a VITAL risk assessment, nor to Precautionary Allergen
Labelling (PAL).
1. VITAL®3.0 action levels are calculated by the food business operator, according to previous mentioned
formula and expressed in mg total protein of allergenic food/ kg product, see Annex 1 for more
information regarding the VITAL® Program.

2. A VITAL risk assessment shall be performed (see Annex 1):

a. For each product or group of similar products, the consumption size and corresponding action level
shall be determined.
b. The total cross contamination from raw materials and own process shall be calculated and
summarized.
c. The nature of contamination (particulate or homogeneous) is taken into account.
d. The total cross contamination shall be compared with the action levels.
3. All reasonable efforts shall be taken to prevent or reduce cross contamination.
4. Only in cases where cross contamination occurs, and cannot be reasonably wise prevented, and if it is
exceeding the VITAL® action level a precautionary allergen statement shall be used.
1.7 Analysis and sampling procedures
Allergen management depends on a number of factors outlined in this Standard.

1. Allergen analysis helps and supports understanding of the allergen management capability and control but
should never be regarded as the sole tool sufficient for allergen management neither should it be used as a
positive release system without control of raw materials and the production process.
2. VITAL® action levels can and shall not be used for rinse water or swab samples as no food is tested (sample
unit cm² instead of kg).
3. Analytical results could lead in many ways to wrong conclusions due to false positive or negative results,
wrong target proteins, comparison of different units or sampling issues. Analytical techniques should
therefore be carefully chosen and applied.
4. Testing is performed by a laboratory that is accredited by the National Accreditation Body in accordance
with standard ISO 17025. When possible methods are included in the scope of accreditation.
5. Used techniques shall be demonstratable suitable for their purpose in terms of sensitivity and specificity.
Positive and negative controls are strongly recommended to demonstrate fit for purpose.
6. A risk-based validation- relevant to the site, production equipment and process, and product - shall be
conducted. This cleaning validation shall be performed in worst-case scenarios where the highest amount
of allergen protein can contaminate non-allergen containing product. Preferably quantitative methods for
detecting allergens shall be used for validation purposes.
7. A risk-based verification program- relevant to the site, production equipment and process, and product -
shall be present. Rapid tests and visual inspection can be used for verification purposes.
8. In case of free-from claims, such as ‘gluten-free’ or ‘lactose-free’, testing of products covered by claim is
conducted at least once a year.
9. In case of testing gluten-free products to confirm the claim ‘gluten-free’ the analytical method shall be an
R5 sandwich ELISA (Mendez method), unless testing hydrolysed gluten, where a modification of the R5
ELISA (competitive ELISA) is required.
10. In case of testing lactose-free products, derived from milk, to confirm the claim ‘lactose-free’ the analytical
method shall be based on techniques where other carbohydrates will not influence the results. Techniques
like HPAEC-PAD or HPLC are preferred Enzymatic methods shall be adjusted for milk-based products
where lactase has been used to convert lactose into galactose and glucose.

1.8 Free-from claims

This Standard aims unambiguous, complete and reliable allergen information and is not addressing ‘free-from’
products, with the exception of legally allowed claims such as ‘gluten-free’ and ‘lactose-free’.
Allergen free claims stating that the food product is free from allergen(s) and/or that allergen(s) are not
present, in any amount in the food product (including unintentionally cross contact) are not allowed by
SimplyOK. Examples of free claims are e.g., ‘milk free’, ‘wheat free’ and ‘egg free’. These example claims are
not allowed to be used by a SimplyOK certified organization.
VITAL® is not applicable to such products and therefore not covered by means of this Standard.
1.8.1. Gluten-free
The claim ‘gluten-free’ is regulated by Commission Implementing Regulation (EU) No 828/2014, containing
harmonized legal requirements on the information to consumers, associated limits and the use of oats.
The statement ‘gluten-free’ may only be used where the food as sold to the final consumer contains no more
than 20 mg/kg of gluten. The statement ‘very low gluten’ may only be used where the food, consisting of or
containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have
been specially processed to reduce the gluten content, contains no more than 100 mg/kg of gluten in the food
as sold to the final consumer.
For the purpose of this Standard, for addressing the use of a cross contact statement only in absence of a
‘gluten-free claim’, the VITAL® action limits (cut off at a maximum action level of 20 ppm) for cereals containing
gluten are applicable.
1.8.2. Lactose-free
1. The claim ‘lactose-free’ is regulated by Commission delegated Regulation (EU) 2016/127 as regards the
specific compositional and information requirements for infant formula and follow-on formula and as
regards requirements on information relating to infant and young child feeding. Additionally some
Member-States have laid down national requirements for regular products sold as ‘lactose-free’.
2. Until European legislation for regular ‘lactose-free’ products has been established the following
requirements are applicable by means of this Standard:
a. The statement ‘lactose-free’ may only be made where the product as sold to the final consumer
contains no more than 100 mg/kg of lactose.
b. When the statement ‘lactose free’ is used for products manufactured from milk, it shall be
accompanied by the statement ‘not suitable for persons/ infants with milk allergy’, which shall be
indicated with the same font size and prominence as the statement ‘lactose free’ and in close
proximity to it.
c. When the statement ‘lactose free’ is used for products manufactured from enzymatic treated milk, it
shall be accompanied by the statement ‘not suitable for persons/ infants with galactosemia’, which
shall be indicated with the same font size and prominence as the statement ‘lactose free’ and in close
proximity to it.
1.9 Labelling and product specification

Allergen information is communicated by different means in the value chain, such as a label, product
specification, databases, customer questionnaires or websites. For the purpose of this Standard all are referred
as ‘labelling’.
1. Labelling of allergens is to be divided in a legally required ingredient list where the name of the allergen
shall be emphasized and the precautionary allergen labelling which is provided on a voluntary basis.
2. The organization shall establish, implement and maintain a review process for product specifications to
ensure continued compliance with food safety, legal and customer requirements.
3. For product specifications provided to food business operators, instead of applying VITAL® action levels
also quantitative information of cross contact can be provided. Levels of identified cross contamination for

each allergen could be communicated instead of indicating a probability, so each purchaser can make up
their own VITAL® risk assessment.
4. Cross contamination of allergens shall be clearly labelled only when cross contamination occurs, cannot
reasonable be prevented and exceeds the VITAL® action level. This precautionary allergen statement shall
be specific for the allergens concerned and not be used for any allergen in combination with a ‘–free-from’
claim for the allergen involved. E.g., a gluten-free product cannot bear a warning for possible presence of
gluten.
A lactose-free product, however, can have a warning for milk because of the different type of reactions
involved, see above.
5. A precautionary allergen statement shall be specific (e.g. almond instead of nuts) and provided in closest
proximity to and same field of vision as the list of ingredients in the same font size.
1.10 Allergen management

1. The food business operator shall have a written food allergen policy1 and documented procedures for
allergen management and conforms to its stated policy.
2. Management shall define, document and communicate its allergen policy.
3. Management shall ensure that the allergen policy:

a) is appropriate to the role of the organization in the food chain,
b) conforms with both statutory and regulatory requirements and with mutually agreed food safety
requirements of customers,
c) is communicated, implemented and maintained at all levels of the organization,
d) is reviewed for continued suitability,
e) adequately addresses communication,
f) is supported by measurable objectives, and
g) is incorporated in the certified FSMS.
4. The allergen management defined in the FSMS shall include dedicated allergen:
- Risk assessment, based on HACCP principles and VITAL®,
- Procedures, work instructions and registration forms,
- Internal audits,
- Training programs,
- Rules for visitors and external service providers,
- Supplier assessment,
- Cleaning Schedules,
- Waste management,
- Corrective actions and recalls,
- Complaints,
- Tracking of legislative and allergen management developments,
- Job descriptions, duties, responsibilities and competencies
5. Personnel, including temporary staff, shall be trained in allergen management and shall be aware of the
consequences of food allergies and the impact of allergen management on their work.
1
overall intentions and direction of an organization related to allergen management as formally expressed by
top management

A good allergen management system shall provide the necessary allergen information to enable the allergic
customer to make a well-considered product choice.
A certified allergen management system is based on five basics:
1. Correct and complete raw material information
2. Apply correct recipe
3. Designing a correct packaging and other food information
4. Preventing accidental exchange of raw materials, semi-finished products or labels
5. Preventing cross contamination
This will be assured by:

1.10.1. Basic 1 – Correct and complete raw material information
1. Information regarding the legal allergens shall be present for all raw materials and processing aids. When
direct product contact cannot be excluded this also applies to lubricants and packaging material.
2. The specification shall include information regarding cross-contamination at the production site.
3. Product information shall be obtained from the last manufacturer or packer, also in case of buying raw
materials from agents or brokers.
4. Specifications shall be reviewed and approved. If necessary, an audit at the producer site shall be carried
out.
5. Approved specifications shall be present before (test) productions are carried out.
6. Specifications shall be checked for accuracy at least annually.
7. An overview of allergen containing materials handled on site shall be present.
1.10.2. Basic 2 - Apply correct recipe

1. The list of ingredients shall match with the used ingredients according to the product recipe and raw
material information.
2. Prior to production, presence of allergens in test productions and associated operations (cleaning,
planning, etc.) shall be discussed with all relevant operators and staff.
3. All used materials such as raw materials, rework and packaging materials shall be listed in the product
recipe / production order.
4. A product in which a different product is reworked, shall contain at least all the same ingredients and
allergens as the product that is to be reworked. In case of rework, a rework matrix shall be present.
5. Proper product separation during a product change in production shall be assured through adhering to the
emptying time of transport systems and pipes. Automatic product feed shall be stopped timely.
6. Recipe changes are communicated to all relevant operators and staff.
7. When raw materials and / or recipes are modified, the consequential changes for the ingredients and
allergens for the product and other products shall be considered.
8. Adjusted labels shall be used from the moment changes to raw materials or a modified recipe are actually
being used in production.

1.10.3. Basic 3 - Designing a correct packaging and other food information

1. For each product a label and / or product specification shall be available.
2. The product specification and label shall include information regarding all legal allergens according to the
recipe (intentionally present).
3. The product specification and label shall include information regarding unavoidable cross-contamination
(precautionary allergen statement) for allergens that possess a risk for food allergic consumers according
to a VITAL® risk assessment (see paragraph 2.2 and Annex 1). No allergens shall be excluded.
4. Any additional allergen information shall not be misleading or confusing.
5. The list of ingredients, including allergenic ingredients, shall be based on the recipe and raw material
information.
6. All pre-printed packaging materials (listing ingredients and allergen information) shall be approved. This is
also applicable for private label products.
7. All pre-printed packaging shall be provided with a number for identification purposes, including a version
designation.
8. Rejected or expired versions of pre-printed packaging materials shall be identified, removed or destroyed
to prevent unauthorized use.
9. An overview of approved packaging materials/ label information shall be present.
10. In case ingredients and allergen information is printed, the data shall be pre-checked for accuracy and be
approved.
11. Data for printers shall be managed and backed up in a controlled way.
12. Pre-printed packing material shall be stored in a controlled way.
13. An overview of places where product information is stored, such as external databases, customer service
department, websites, brochures, etc., shall be maintained when applicable.
14. When food information is provided in ways other than mentioned on the label or specification, such as
through completing customer questionnaires, only allergen information in accordance with the
specification shall be given. Information on allergens that are not included in the system can only be
provided if similar information about all used raw materials is known.
1.10.4. Basic 4 – Preventing accidental exchange

When raw materials, semi-finished products or labels are accidently exchanging the information on the pack
will not match the content. In order to avoid substitution, identification is crucial.
1. At all times it must be clear which product is present in a transport or storage unit.
2. Also packing material shall be properly being identified.
3. All raw materials and incoming goods shall be checked and recorded to make sure the correct products
and packaging are being supplied.
4. Received products and packaging materials shall be clearly identified immediately upon receipt with a
unambiguous and unique identification, preferably by a batch- and article number.

5. All products, such as raw materials, weighed raw materials, semi-finished products, non-labelled finished
products, blocked products and rework – shall carry a sign visibly showing the allergenic status.
6. All products and packaging material shall be identifiable at every stage of the process.
7. Only a limited working stock of pre-printed packaging materials or labels shall be available in the packaging
area.
8. In case of off-line coding documented checks shall be performed to assure the correct printed materials
are used.
9. At every product change over and, in case of pre-printed packaging material, also any label or film role
exchange, shall be verified that the correct label / foil is used and shall be recorded.
10. Automated processes (valve circuits, silo emptying, dosages) shall be secured so that no product can be
processed unintentionally.
1.10.5. Basic 5 - Avoiding cross-contamination

Due to cross-contamination of allergens, allergenic ingredients are unintentionally in products where they do
not belong. A not labelled allergen is a risk for food allergic consumer.
1. The cleanliness of transportation units shall be verified on receipt.
2. Allergen containing products shall be handled and stored in such a way cross contamination of other
products shall be prevented.
3. Contamination of packaged product and packaging during storage shall be prevented.
4. Sampling procedures shall not lead to cross contamination.
5. Dust formation shall be prevented when weighing ingredients. Also, appropriate measures shall be taken
to prevent cross contamination through the usage of scoops, knives or other materials.
6. Materials used for internal transport shall be cleaned after each use or should be dedicated to certain
products to prevent cross contamination.
7. Where necessary, reserved, (colour) marked materials / equipment shall be used for products that contain
allergens.
8. Waste or rejected product and their disposal shall not contaminate other products.
9. In case of flexible deployment of staff on different lines, adequate precautions shall be taken, such as
washing hands or clothing and shoes exchange in between switching product lines.
10. Technical work shall not lead to cross contamination.
11. When necessary either through physical segregation of production processes or through planning in
combination with cleaning, cross contamination shall be prevented. In the latter case, a clear written
planning system shall be present.
12. The preferred method for removing allergens is wet cleaning. In case this is not feasible, a combination of
physical removing product residues and flushing shall be applied.
13. Cleaning methods shall be documented and validated.

14. Cleaning procedures and cleaning areas shall not lead to cross contamination.
15. A risk assessment is performed for foods brought onto site by staff, visitors, contractors and for catering
purposes. Appropriate measures are taken when necessary.
16. A production location shall be designed to facilitate good cleaning and avoid cross-contamination.
General attention points, but where extra caution is needed when allergens are being processed, are:
a. Placement of operations or equipment above each other.
b. Closely spaced production lines
c. Preventing dust formation and air transport.
d. Flexible equipment that is used depending on the product in the production process such as loose
hoses, check scales or slicing machines.
e. Possibilities to disassemble equipment for better access.
f. Filters in which products may remain.
g. Processes where commonly used mediums as brine baths, cooling water or cooking oil are used.
h. Contamination of general used provisions such as ice water, CIP liquids or (compressed) air.
i. Placement of exhaust systems should not be vertically over open product due to possible relapse of
product from the system.
j. Entrances from employee facilities (canteens) to production areas shall have designated areas in
which hands shall be washed and when necessary clothing shall be exchanged.
k. Food and beverages shall not be brought in facility through a production area.
3. Audit Protocol
All food business operators who produce packed food products, ingredients and semi-finished products
intended both for consumers and/or for further processing in the food production chain can be certified
against this Standard, see also paragraph 1.1).
Conformance by food business operators to the requirements of the SimplyOK standard and its suitability for
the awarding of a certificate shall be assessed by an independent SimplyOK licensed certification body.
1.11 Private label owners

Private label owners play an important role in food production chain and allergen labelling. A private label
owner has as owner of the brand a legal liability for the product label. The food business operator has, being
the manufacturer of the product, the responsibility to provide the correct information to the private label
owner to determine the product information on the label. A food business operator could produce food
products for multiple private label owners.
Foundation SimplyOK can establish specific additional requirements regarding for auditing and/or certification
of private label owners such as retailers.
1.12 Head Office

A head office separate from the production location(s) can control functions pertinent to certification of the
allergen management system. Functions controlled by a head office may be e.g.:
- Procurement policy;
- Human resource management;
- The approval of suppliers;
- Product labels;
- Overall responsibility for the group allergen management system.
1. Functions of the allergen management system pertinent to the certification and controlled by a head office
are always audited on-site at the manufacturing site.
The auditor sets the conditions and there shall be local access at the audited production site to required
files, records and any other evidential material.

2. Where any part of the audit is made by electronic means or where the site to be audited is virtual, the
certification body shall ensure that personnel conduct such activities with appropriate competence. The
evidence obtained during such an audit shall be sufficient to enable the auditor to take an informed
decision on the conformity of the requirement in question.
Non-conformities (findings) raised against functions controlled by the head office have an impact on the
manufacturing site and have consequences for the certificate of the manufacturing site. The
manufacturing site is responsible for resolving the non-conformities that were raised against functions
controlled by the head office.
1.13 Scope of certification

1. The scope of the audit shall be agreed between the food business operator and the certification body in
advance of the audit. An example of a description of the scope statement- but needs to be amended when
necessary- is: The manufacturing of [list products and brands] in accordance with the SimplyOK
certification scheme and intended for [mention markets and/or target groups]. The auditor shall verify the
wording of the scope statement during the site audit.
2. The audit shall include all applicable requirements of the Standard and all processes covered by the scope
of certification. The audit scope and any permitted exclusions (See exclusions from the scope) shall be
clearly defined both on the audit report and any certificate issued.
The description of product groups, brands and type of pack within the scope shall enable a recipient of the
report or certificate to clearly identify if products supplied are covered by the scope. This may include a
description of processing activities undertaken at the site, which are within the scope of the standard,
where this adds clarity for the user of the report or certificate.
3. The audit, report and certificate shall be site specific but may include storage facilities under the control of
the site management. In all cases these activities shall be included within the audit and certificate or
specifically excluded.
1.13.1. Exclusions from scope

The achievement of the certification criteria relies on clear commitment from the site management to adopt
the best practice principles out lined within the Standard and to the development of a food safety culture
within the business. As a result, the exclusion of products from the scope of certification shall only be accepted
by exception and shall be verified during the audit.
1. The exclusion from the scope of certification of processes, sectors, products produced at a site to be
certificated will only be acceptable where the excluded processes, sectors, products or services shall not
have an negative influence on the allergen safety of the end products and:
- the excluded products are produced in a dedicated area of the factory; and,
- the excluded products shall be clearly differentiated from product within the scope
2. Where exclusions are requested these shall be agreed with the certification body in advance of the audit.
Exclusions shall be clearly stated on the audit report and certificate and the justification for any exclusions
from scope shall be justified in the audit report.
3. Products purchased for resale by a site cannot be included within the scope of the certificate.
4. The certification of products must include audit of the entire process from raw material to end product
dispatch. It is not possible to exclude either parts of the process undertaken at the site or parts of the
Standard. Where exclusions are accepted the auditor shall assess any risks presented by excluded areas or
products e.g., the introduction of allergens.
5. Brand/private labels from a private label owner, as client of the organization and legally responsible for the
label, that fail to meet the labelling requirements shall be excluded from the scope of certification.

1.13.2. Extension to scope

Once certification has been granted, any additional significant products manufactured, or processes
undertaken by the site, which are required to be included in the scope of certification, shall be communicated
to the certification body. The certification body shall assess the significance of the new products or processes
and decide whether to conduct a site visit to examine the aspects of the required extension to scope. The
current certificate will be superseded by any new certificate issued using the same expiry date as detailed on
the original certificate.
1.13.3. Reduction of the scope

Once certification has been granted the scope of certification shall (temporary) be reduced by the certification
body when a private label owner, as client of the organization and legally responsible for the label, has
persistently or seriously failed to meet the labelling requirements. The brand/ private labels that do not meet
the requirements shall be excluded from the scope of certification.
The current certificate will be superseded by any new certificate issued using the same expiry date as detailed
on the original certificate and containing the reduced scope of certification excluding the brand/ description of
the private labels that do not meet the requirements.
1.14 Type of audits

1.14.1. Initial certification audit (certification audit)
An initial audit is a first audit against the Standard. During the audit, all requirements shall be assessed by the
auditor. The audit includes the documentation, procedures and all production processes for the products
within de scope of certification.
The initial auditing for certification is always carried out at the manufacturing site of the applicant food
business operator and is conducted in two separate stages:
1. During the stage 1 the five basics of the allergen management system and the VITAL®3.0 Program shall be
verified. The objective of this audit is to assess the preparedness of the applicant organization to proceed
to the stage 2 audit.
2. During the Stage 2 audit the implementation of the allergen management system is assessed.
The objective of this audit is to assess the effectiveness of the allergen management system.
Typically at least 40% of the total on-site audit time is allocated to the stage 1 audit and the remaining 60%
is allocated to the stage 2 audit.
1.14.2. Audit program

An audit program for the full certification cycle shall be developed to clearly identify the audit activity/activities
required to demonstrate that the client’s management system fulfils the requirements. The audit program for
the certification cycle shall cover the all requirements of the Standard.
The audit program for the initial certification shall include a two-stage initial audit, surveillance audits in the
first and second years following the certification decision, and a recertification audit in the third year prior to
expiration of certification. The determination of the audit program and any subsequent adjustments shall
consider the size of the client, the scope and complexity of its management system, products and processes as
well as demonstrated level of management system effectiveness and the results of any previous audits.
1.14.3. Surveillance audit

Surveillance audit is carried out on-site audits to determine that the certified allergen management system
continues to fulfil the requirements of the Standard. Surveillance audits shall be conducted annually but within
the calendar year.
Particular attention is paid to the non-conformities identified during the previous audit, as well as to the
effectiveness and implementation of corrective actions and preventive measures laid down in the companies
corrective action plan.
1.14.4. Recertification audit

The goal of the recertification (renewal) audit is to re-issue the certificate for a new three-year cycle. During
the on-site audit, all criteria shall be assessed by the auditor. The renewal audit is conducted to assess

continued fulfilment of all requirements and is a full audit. Particular attention is paid to the non-conformities
identified during the previous audit, as well as to the effectiveness and implementation of corrective actions
and preventive measures laid down in the companies corrective action plan.
1.14.5. Special (extra) audit

In special circumstances the certification body can decide to perform an extra audit (extension or follow-up
audit) in case of significant changes at the certified food business operator or in case of many non-
conformities, at the discretion of the certification body.
1.14.6. Follow up audit

A follow-up audit could be performed to close non-conformities that were raised during the previous audit. The
goal of this audit is to verify the implementation and effectiveness of actions taken to correct all non-
conformities. The follow-up audit shall be performed within a four weeks after the last day of the stage 2 audit
or within 6 weeks after the last day of the surveillance or recertification audit.
1.14.7. Extension audit

An extension audit is performed when the certified food business operator wants to extend the scope of
certification with new products and/or processes which introduce significant new allergens and/or
contamination risks. A new certificate will be issued including the new scope of certification. The certificate
expiry date will be the same as detailed on the original certificate.
1.14.8. Parallel audit

A parallel audit is an unannounced audit performed by an auditor who is appointed by the Board of the
SimplyOK foundation.
The parallel audit is conducted unannounced (max. 48 hours notified in advance) and to assess continued
fulfilment of all requirements and covers all the requirements of the standard. Particular attention is paid to
the non-conformities identified during the previous audit conducted by the certification body, as well as to the
effectiveness and implementation of corrective actions and preventive measures laid down in the companies
corrective action plan.
1.15 Certification cycle

The validity of the SimplyOK certificate is three years. The certificate expires three years after the date of the
certification decision. Surveillance audits shall be conducted annually, within the calendar year, in the
intermediate period. The recertification audit has to take place in time to ensure that recertification is granted
prior to the expiry date of the certificate.
1.16 Certification
1.16.1. Certification date
The certification date is the date of the certification decision by the certification body.
The certification decision shall be made within 8 weeks after the last day of the certification audit or the
recertification audit. The certificate shall be issued within 4 weeks after the certification decision.
1.16.2. Certificate expiry date

The certificate expires three years after the date of the certification decision.
1.17 Review and certification decision

The certification body shall conduct a technical review all audits prior to making a decision for granting
certification, continuing certification, expanding or reducing the scope of certification, renewing, suspending or
restoring, or withdrawing of certification, including, that;
1. the information provided by the audit team is sufficient with respect to the certification requirements and
the scope for certification;
2. for any critical nonconformity, it has corrective actions during a follow-up audit;
3. for any major nonconformities, it has reviewed, accepted and verified the correction and corrective
actions;

4. for any minor nonconformities it has reviewed and accepted the client’s plan for correction and corrective
action.
Following each technical review, certification bodies shall make a certification decision based on the audit
report recommendation.
The certification body shall ensure that the persons or committees that conduct the review and/or make the
decisions for granting or refusing certification, continuing certification, expanding or reducing the scope of
certification, suspending or restoring certification, withdrawing certification or renewing certification are
different from those who carried out the audits. The individual(s) appointed to conduct the review and/ or
certification decision shall have appropriate competence.
1.18 Audit duration

The on-site audit duration depends on the size and the complexity of the food business operator:
Audit days Product groups*
FTE** 1 2-3 4-5
<50 0.75 1 1.5
50 – 100 1 1.5 1.5
100 – 300 1.5 1.5 2
>300 1.5 2 2.5
Table 3 Minimum on-site audit time (except for stage 1 initial audit, see below) The audit time is expressed in man-days
(FTE). One man-day (FTE) is 8 hours and does not include travel time and/ or lunch.
* A product group is a group of final products with similar ingredients/allergens, produced at the same
equipment/processes, with the same contamination risks to be managed.
** The number of employees expressed as the number of full-time employees (FTE).
1.18.1. On-site audit duration

1. Table 3 is a guide for certification bodies to calculate the minimum on-site audit duration. The audit
duration is shown in Table 3, is additional to the time needed for the food safety management system
audit. The time for audit preparation and audit reporting is not included in the calculated audit duration.
2. It is the responsibility of the certification body to calculate an appropriate audit time.

Deviations of the calculated minimum audit time need to be justified by the certification body.
3. The minimum on-site audit duration shown in Table 3 is the audit time for the initial stage 2 certification
audit, the surveillance audit and the recertification audit.
4. The audit duration for a stage 1 initial audit shall be 60% of the audit time in Table 3, with a minimum of
0.5 man-days.
1.18.2. Audit time reduction in case of a combined audit

To determine the audit time for a combined audit covering the SimplyOK standard and GFSI recognized
standards, the Certification Body shall:
a) calculate the required on-site audit time for each management system standard separately (applying all
relevant factors provided for by the relevant application documents and/or scheme rules for each
standard;
b) calculate the starting point T for the on-site duration of the audit of the combined standards by adding the
sum of the individual parts (e.g., T = A + B + C);
c) adjust the starting point figure by taking into account factors that may reduce the on-site audit time
required for the audit. The reduction shall not be 10% from the starting point T.

The factors for reduction shall include but are not limited to:
• The extent to which the organization’s management system is integrated;
• The ability of the organization’s personnel to respond to questions concerning more than one
management systems standard; and
• The availability of auditor(s) competent to audit more than one management system
standard/specification.
1.19 Reporting time

The minimum audit reporting time shall be at least 2 hours. The audit reporting time shall be allocated to the
auditor who is responsible for drafting the audit report and is additional to the calculated on-site audit
duration.
1.20 Audit trail

A minimum of five product labels in total shall be selected by the auditor. At least one label per product group.
The selected labels shall assessed during the on-site audit by the auditor. The assessment is done by
conducting a tracking and tracing investigation for the selected product labels:
a) Used raw materials shall be checked against the recipe and ingredient list on the label and other means of
product information.
b) Any absence of cross contamination statement has to checked against the results of the VITAL® risk
assessment.
The result of this assessment shall be included and detailed in the audit report
1.21 Time in the production area

An important part of allergen management takes place during processing. Therefore, it is important to spend
enough on-site audit time in the production area (shopfloor). 50% of the on-site audit shall be allocated to
audit activities of the audit team in the production area. Audits shall be undertaken when products covered by
the scope of certification are being manufactured.
NOTE: Cleaning activities are also seen as operational processes.
1.22 Findings and closing non-conformities

Conformity is the situation where there is full compliance with the requirement of the standard. A non-
conformity is a finding where there is no compliance with a requirement of the standard.
Non-conformities should be classified as:

Minor A minor non-conformity is a small deviation of a requirement of the standard. A minor is
appropriate where the non-conformity does not lead to doubts as to whether the product
meets the allergen information.
Major A major non-conformity is a substantial failure to meet the requirements of the standard. A
major is appropriate where the requirement has not been implemented, or only a limited part
has been implemented. Or when precautionary labelling is used without underpinning
evidence from a VITAL® risk assessment.
Critical A critical non-conformity is:
1. a severe food safety risk where one or more allergenic ingredients are not mentioned in
the ingredient list;
2. a not labelled significant cross-contamination. A risk assessment performed by an expert,
to be appointed by secretariat of the SimplyOK Foundation, can be necessary to
determine the actual risk to consumers;
3. Fraud. Intention misleading allergen information on the label.

When the auditor has determined a critical non-conformity the following actions need to be carried out:
- The audit shall be stopped, a new audit must be carried out.
- Root cause analysis has to be performed by the food business operator.
- Legal actions, such as informing the national government, has to performed by the food business
operator.
- The certification body suspends the certificate within 3 working days after terminating the audit. The
maximum suspension period is six months. If the shortcomings are not resolved within six months the
certificate will be revoked by the certification body.
1.23 Closing meeting

During the closing meeting the auditor presents the audit findings and will discuss all non-conformities. A
written overview of the non-conformities will be documented by the auditor at the closing meeting.
1.24 Closing non-conformities

1.24.1. Minor non-conformity
Certification is only possible where all minor non-conformities are closed by the auditor.
To close a minor non-conformity an action plan shall be drawn up and implemented by the food business
operator. The action plan shall include: root cause analysis, (temporary) corrections, corrective actions,
responsible person and date of implementation. This corrective action plan shall be part of the audit report.
The corrective action plan and objective evidence shall be forwarded to the auditor within 4 weeks after the
last day of the audit. The auditor will decide within 6 weeks after the last day of the audit, on the acceptance of
the corrective action plan.
- Objective evidence
To prove whether the corrective action plan is implemented, the food business operator shall present
objective evidence to the auditor. This evidence can exist of a photo, document, form with
registrations, procedure, etc.
- Assessment by the auditor
To finalize the audit report, the auditor shall assess the corrective action plan and the objective
evidence. The auditor closes the non-conformity within 6 weeks after the last day of the audit, in the
case the implementation of the corrective action plan is found to be valid and accepted.
The auditor can decide to assess the implementation of the corrective action plan by a follow-up audit
on site. The follow-up audit has to be performed within 30 working days after receiving the corrective
action plan by the auditor. The decision on the closure of the minor nonconformity shall be taken
within 10 days after the last day of the follow-up audit.
A major nonconformity is raised in the event of non-completion of the approved corrective action plan or when
the minor nonconformity cannot be closed during the next scheduled audit by verifying the agreed corrective
auction.
1.24.2. Major non-conformity

Certification and continuation of the certificate is only possible when all the major non-conformities are closed
by the auditor.
To close a major non-conformity a corrective action shall be drawn up and implemented by the food business
operator. The corrective action is supported by a corrective action plan including: root cause analysis,
corrective actions, responsible person and date of implementation. This corrective action plan is part of the
audit report. The corrective action plan and objective evidence shall be forwarded to the auditor within one
week after the last day of the audit. The auditor will decide within two weeks of the last day of the audit on the
acceptance of the corrective action(s).


To finalize the audit report, the auditor assesses the corrective action and the objective evidence. The
auditor closes the non-conformity by assessing the implementation of the corrective action during a
follow-up audit on site. The follow up audit shall be conducted within 14 days after acceptance of the
corrective action by the auditor.
A critical nonconformity is raised in the event of non-completion of the approved corrective action
plan and/or corrective action.
1.24.3. Critical non-conformity

The certificate is suspended immediately when a critical is raised during the on-site audit and confirmed by the
auditor during the closing meeting of the audit. The CB shall verify the suspension in writing within 3 days after
the last day of the audit. The organization shall be suspended for a maximum period of six (6) moths. Failure to
lift the suspension within this timeframe will automatically result in withdrawal of the certificate.
The suspension can only be lifted when the critical non-conformity is closed by the auditor during a follow-up
audit were all the criteria shall be assessed (a full audit). To close a critical non-conformity a corrective action
shall be drawn up and implemented by the food business operator. The corrective action is supported by a
corrective action plan including: root cause analysis, impact analysis, corrective actions, responsible person,
date of implementation. This corrective action plan is part of the audit report. The corrective action and
objective evidence shall be forwarded to the auditor.
To lift the suspension, the auditor assesses the corrective action and the objective evidence during an
on-site certification audit. The audit shall be conducted after the corrective action plan is accepted by
the auditor and the corrective actions are implemented.
1.25 Report
The audit report shall reflect the content of the audit and present detailed information about:
- Organization information
- Scope of certification:
- Clear description of products under the scope
- If any, exclusions from the scope
- Overview of outsourced processes
- Overview of present allergens in products
- Overview of free-from claims
- Summary of finding of each paragraph from chapter 2
- Overview of non-conformities
- Corrective action plan by the organization + auditor assessment result
- Certification status
The report shall be written in English. A template report is available.
Within 2 weeks after the last day of the audit the food business operator receives a preliminary report to check
organization information and audit details. The preliminary report contains an overview of non-conformities
identified during the audit.
Within 6 weeks after the last day of the audit the food business operator receives the final audit report from
the certification body. The secretariat of the SimplyOK foundation receives a copy of the final report within 8
weeks after the last day of the audit.

4. Certification Bodies
1.26 Selection of a Certification Body
The food business operator must select a certification body from the list of SimplyOK standard. SimplyOK
cannot advise on the selection of a specific certification body, but the SimplyOK website lists approved
certification bodies. Visit www.simplyok.eu.
1.27 Food business operator / Certification Body Contractual Arrangements

A contract shall exist between the food business operator and the certification body, detailing the scope of the
audit and the reporting requirements. This contract will be formulated by the certification body.

ANNEX 1 Use of VITAL®

More information regarding the VITAL® Program can be obtained from https://allergenbureau.net/
1. The most recent reference doses, see Table 2 of this Standard or updates from Allergen Bureau, shall be
used. For allergens for which insufficient data is available to derive an reference dose the lowest reference
dose (walnut) is used.
2. The use of VITAL® Online or Allergen Risk calculator tool is recommended but calculations can also
performed by other means. These calculations have to be validated.
3. VITAL® risk assessments are performed to determine if a precautionary allergen statement is necessary or
not. VITAL® provides scientifically proven safe levels for consumers with a food allergy.
To prevent unnecessary warnings only cross contamination which exceed the determined safe level –
action level – has to be labelled.
4. VITAL® action levels are not meant to be used to determine if an ingredient has to be listed in the
ingredient list. In case an allergen is present in food as an ingredient, additive, processing aid, or a
component of any of these, then legislation (Regulation (EU) No 1169/2011) applies.
5. A VITAL® risk assessment of cross contamination consists of two parts:

1. Cross contact of raw materials (from food chain) and
2. The production process of the food business operator
For the calculation of total cross contact allergen in finished product, sum the concentration of cross
contact allergen protein from raw ingredients and processing.
6. A VITAL® risk assessment shall be performed for all allergens (see Table 2) to determine if the action levels
are met. The risks are determined for each process step /production line. Subsequently, based on the
processing diagram, the risks of each process step are summed for each product or group of similar
products.
7. It may be appropriate to apply a dehydration or hydration factor to take into account the effect of losing
water through the cooking process (e.g., baking bread) or adding water (a concentrated gravy or soup
premix which will be diluted prior to consumption).
8. An appropriate consumption size, also called reference amount, shall be determined (see Annex 2), where
the possibility of deviation in consumption is taken into account. These considerations shall be
documented.
9. An action level transition point shall be calculated for each product(group) based on an appropriate
consumption size by entering the chosen amount into VITAL® Online or other calculator. The calculated
total cross contact allergen of mg protein of allergenic source/ kg food has to be compared with the action
level transition point.
10. VITAL® calculations shall be performed for each product, or product group when products are made under
similar circumstances and have similar consumption sizes. When performing a calculation for a product
group always the worst case has to be calculated, e.g. product change over where the previous product
has the maximum allergenic protein amount. Or the maximum percentage of an ingredient in all product
formulas when calculating on raw materials. When the worst case approach results in concentrations
above the action level, calculations product-by-product shall be made.
11. After review for opportunities to reduce or eliminate cross contact from the product and where they
cannot be eliminated, cross contact allergens should be labelled as specified by the appropriate Action
Level:

Action Level 1 – precautionary cross contact statement is not required for the relevant allergen
Action Level 2 – precautionary cross contact labelling statement is required for the relevant allergen.
12. The calculation shall be validated. Analysis of allergens can be used to validate the calculation.
13. In case no other allergens then those intentionally added possess a risk on cross contamination, no
calculation has to be performed.

ANNEX 2 Determination of consumption size (reference amount)
Introduction
When using VITAL®, the consumption size for consumer products needs to be determined in order to calculate
the action level of allergens. This Annex can be used to determine the consumption size in a consistent way.
The definition of consumption size is listed in paragraph 1.4.
Portion and serving size

The consumption size, as a maximum amount of food, differs in most cases from the serving or portion size a
food, but is never less than the declared serving size for nutritional values. The portion size can only be applied
as the consumption size for products that are offered to the consumer as single portions, such as airline meals.
Deviation/inaccuracy of calculation
A deviation of 10% is allowed in relation to the determination methods described below. The difference in the
outcomes of action levels is minimal, and mainly falls within the analytical measurement inaccuracy. For higher
consumption amounts (and thus lower action levels) this effect is even smaller, and the differences are less
relevant. For example, for a consumption of 100 grams, the action level for hazelnuts is 1 ppm. For 110 gram
this is 0.8 ppm. This difference is not measurable.
Working method
There are various ways of determining an appropriate consumption size for consumer products. It is important
that the consumption size is determined in a well-substantiated manner. This must be based on the maximum
amount of a product that will be eaten at one ‘eating occasion’, within realistic limits. A number of methods
are explained below.
Option 1 - Database
There are special databases for determining the maximum consumption per eating occasion, such as the TNO
database. It may also be that (sectoral) organizations have established a standard consumption size per
product or product group.
Option 2 - National food consumption surveys

Food consumption surveys are carried out in many different countries.
A number of issues are important when using food consumption surveys in order to obtain reliable data:
1. Use the data from the ‘eating days’. and take into account that products can be eaten more than once a
day. The likelihood of this is especially high when the median (the amount that the people eat) and the P95
differ greatly. Make an estimate per ‘eating occasion’.
2. Use data from a representative (age) category. So, for special products intended for children, use the
consumption data of children.
3. Find the correct product or its equivalent. Do not select a too large product group, where other products
are also included in the consumption data. For example, the total group ‘potato products’ is too broad for
a product such as mashed potato powder.
4. Only use data based on sufficient users of the product in question. The total number of people in a survey
is often large, but the number of actual users of a product can be very small. Alternatively, select a broader
product group.
5. The consumption amounts vary per person. The use of P75-95 as maximum consumption within realistic
limits is recommended.
6. Source from the latest available Food Consumption Survey data.
7. The consumption amount should be appropriate for the target market.

Option 3 Recent scientific data

Food consumption data can also be acquired from the latest scientific, such as by Blom et al. 2019
(https://doi.org/10.1016/j.fct.2019.01.025) and Birot et al. 2018 (https://doi.org/10.1016/j.fct.2018.05.042),,
who suggest to use P75 on an eating occasion.
Option 4 - Own determination

When research is carried out about consumption of a product, this data can also be used. In that case, make an
estimate of the consumption, with written substantiation.
Ingredients intended for further processing (e.g. bulk products).

1. Action Level calculations are only relevant for products which are intended for presentation to consumers.
Action Level calculations cannot be made for bulk products (i.e. products intended for food service or
further processing prior to presentation to a consumer) because a Reference Amounts cannot be
accurately determined for such products.
2. For bulk products, supply your customer with the following information about cross contact allergens:
• the presence of any particulate cross contact allergen
• the total concentration of any homogeneously present cross contact allergens.

ANNEX 3 AOECS Standard Gluten-free

Aspects to the production and labelling of gluten-free products are covered in the Standard.
Some extra requirements are applicable to fulfil also to the benchmark of the AOECS Standard of Gluten-free
products. The AOECS Standard for Gluten-Free Foods 2016 applies to food and drinks to meet the special
dietary needs of people intolerant to gluten and is the basis for licensing the crossed-grain symbol by the
national coeliac organization.
License
The Crossed Grain symbol is a registered trademark (at European Union and national level) of the AOECS itself,
and many national coeliac societies who are members of the AOECS. The Crossed Grain symbol can only be
used under license; therefore, organizations wishing to use the symbol must contact their national society.
Where licensed, the symbol may be used on packaging, promotional materials, websites, signage and
corporate literature directly related to the licensed products.
An audit against this Standard is one of the steps that must be completed by food manufacturers and private
label owners prior to obtaining a license to use the Crossed Grain symbol.
Traded products shall be gluten-free certified, where the certificate will be sent to national coeliac society to
obtain a license.
Specific remarks regarding to the symbol:

• The registration number shall be clearly displayed underneath the Symbol and consist of the country
code – company code – product number.
• For gluten-free foods containing oats either as an ingredient, or pure oats, the word “OATS” shall be
clearly displayed underneath the Symbol before the registration number to make consumers aware
that most, but not all, people who are intolerant to gluten may consume these products.
When a gluten-free product is contaminated with gluten above 20 mg/kg gluten, the organization shall also
inform the national coeliac society which issued the license for use of the Crossed Grain symbol.
Specific remarks regarding gluten-free claims:

Allowed statements on the absence or reduced presence of gluten in food, according to COMMISSION
IMPLEMENTING REGULATION (EU) No 828/2014 are:
• The statement ‘gluten-free’ may only be made where the food as sold to the final consumer contains
no more than 20 mg/kg of gluten.
• The food information may be accompanied by the statements ‘suitable for people intolerant to
gluten’, ‘suitable for coeliacs’, ‘specifically formulated for people intolerant to gluten’ or ‘specifically
formulated for coeliacs’.
However, the legal statement ‘very low gluten’ is not allowed according this Standard.
Gluten-free foods and drinks:

a) consisting of, or made only from, one or more ingredients which do not contain wheat (i.e. all Triticum
species, such as durum wheat, spelt, and khorasan wheat, which is also marketed under different trademarks
such as KAMUT), rye, barley, oats* or their crossbred varieties, and the gluten level does not exceed 20 mg/ kg
in total, based on the food as sold or distributed to the consumer.
and/or
b) consisting of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat, spelt, and
khorasan wheat, which is also marketed under different trademarks such as KAMUT) rye, barley, oats* or their
crossbred varieties, which have been specially processed to remove gluten, and the gluten level does not
exceed 20 mg/ kg in total. Or where gluten-containing ingredients substituted with other ingredients which are
naturally free of gluten.
Gluten: is defined as a protein fraction from wheat, rye, barley, oats* or their crossbred varieties and
derivatives thereof, to which some persons are intolerant and that is insoluble in water and 0,5 M sodium
chloride solution.

* oats: Most people with intolerance to gluten can include oats in their diet without adverse effect on their
health. However, a major concern is the contamination of oats with wheat, rye or barley that can occur during
grain harvesting, transport, storage and processing.
Oats are allowed in a food presented as gluten-free or very low gluten, according to COMMISSION
IMPLEMENTING REGULATION (EU) No 828/2014. This ingredient must have been specially produced, prepared
and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the
gluten content of such oats cannot exceed the corresponding threshold.
Prolamins: are defined as the fraction from gluten that can be extracted by 40 - 70 % of ethanol. The prolamin
from wheat is gliadin, from rye is secalin, from barley hordein and from oats avenin. The prolamin content of
gluten is generally taken as 50 %.
Additional requirements
1. Audits must be performed when gluten-free production is taking place.
2. When the organization uses the Crossed Grain symbol, the auditor will select a product bearing this
symbol. Where the site is not licensed or does not use the symbol, an alternative gluten-free product shall
be selected.
3. The analytical method to be used is the R5-sandwich-ELISA (Mendez-method)*, which has been endorsed
by the Codex Committee on Methods of Analysis and Sampling as a Type 1 method. This method detects
the prolamins from wheat, rye and barley in unprocessed and heat-processed products. For unprocessed
products like flours, the Ethanol extraction can be used, however, for heat-processed products the
‘Cocktail’ extraction shall be used. For calibration the gliadin reference material from the Working Group
on Prolamin Analysis and Toxicity (PWG-gliadin) must always be used.
4. For the detection of fermented of partially hydrolyzed gluten like beer, syrups or sourdough the R5-
competitive-ELISA shall be applied. The R5-sandwich-ELISA is not applicable for products consisting of, or
containing, fermented or partially hydrolyzed gluten.
5. For a rapid in-house control of raw materials and surfaces, as well as to check the effectiveness of cleaning
procedures in production equipment, the lateral flow test based also on the R5-antibody can be used.
When lateral flow is used for testing products instead of surfaces, the method shall be validated for the
matrix. Special attention is needed for extraction of heat-treated products. In case of a positive result on
products the gluten concentration shall be determined by ELISA.
6. The detection limit has to be appropriate according to the state of the art and the technical standard. It
should be 10 mg gluten/kg or below.
7. The organization shall undertake a documented risk assessment regarding gluten contamination in
ingredients. The risk level of raw materials should be assigned according to:
• the food safety management system of the supplier (for example if the supplier manufactures
only gluten-free raw materials or both gluten-free and gluten-containing raw materials)
• the type/kind of raw materials.
8. For high-risk raw materials (flours, starches and starch products, cereals and pseudo-cereals, extruded
and/or malted cereals, oats) shall either be:
• Purchased from a gluten-free certificated supplier .
• Supplied with a certificate of analysis that is specific to the consignment
• Tested for gluten prior to use of the ingredient.
Appropriate analytical methods are being used as defined (Testing and analytical methods).
9. For low-risk ingredients it shall be guaranteed by the producer or supplier that these ingredients are
gluten-free and are not subject to cross-contamination with gluten throughout production or
transportation. This is supported by the necessary associated documentation.

10. Raw materials used in the production of gluten-free products shall not contain gluten above the
corresponding threshold unless derived from a gluten-containing grain (for example, barley malt extract or
wheat starch) which may contain gluten above the corresponding threshold providing the final product
contains less than this limit.
11. In case of subcontracting or outsourced processes this shall be performed by gluten-free certified
organizations.
* In the collaborative study for approval of the Codex Method the R5-antibody was used with the R5 ELISA
RIDASCREEN® Gliadin R7001 test kit from R-Biopharm. If test kits from other producers based on the R5
antibody, but with extraction solutions other than the ‘Cocktail’ are used, it is recommended to compare the
results with the RIDASCREEN® Gliadin.

Simplyokcodeofpractice 1667402753548

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Simplyokcodeofpractice 1667402753548

Uploaded by

Copyright:

Available Formats

Complete and reliable information about allergens in food

SimplyOK Code of Practice

Version 3.0 – September 2021 1

Version 3.0 – September 2021 2

Version 3.0 – September 2021 3

1.21 Time in the production area .............................................................................................................. 20

Version 3.0 – September 2021 4

1.1 General scope

2. Information regarding cross contamination is an addition to legally required emphasizing of allergens in

1.3 Certification process

Version 3.0 – September 2021 5

Version 3.0 – September 2021 6

Version 3.0 – September 2021 7

2. Requirements on Allergen Management

1.6 Action levels

Allergen (all proteins from Reference dose Source

Version 3.0 – September 2021 8

2. A VITAL risk assessment shall be performed (see Annex 1):

3. All reasonable efforts shall be taken to prevent or reduce cross contamination.

1.7 Analysis and sampling procedures

Allergen management depends on a number of factors outlined in this Standard.

Version 3.0 – September 2021 9

1.8 Free-from claims

1.9 Labelling and product specification

Version 3.0 – September 2021 10

1.10 Allergen management

2. Management shall define, document and communicate its allergen policy.

3. Management shall ensure that the allergen policy:

Version 3.0 – September 2021 11

This will be assured by:

6. Specifications shall be checked for accuracy at least annually.

7. An overview of allergen containing materials handled on site shall be present.

1.10.2. Basic 2 - Apply correct recipe

6. Recipe changes are communicated to all relevant operators and staff.

Version 3.0 – September 2021 12

1.10.3. Basic 3 - Designing a correct packaging and other food information

4. Any additional allergen information shall not be misleading or confusing.

9. An overview of approved packaging materials/ label information shall be present.

12. Pre-printed packing material shall be stored in a controlled way.

1.10.4. Basic 4 – Preventing accidental exchange

2. Also packing material shall be properly being identified.

Version 3.0 – September 2021 13

1.10.5. Basic 5 - Avoiding cross-contamination

1. The cleanliness of transportation units shall be verified on receipt.

3. Contamination of packaged product and packaging during storage shall be prevented.

4. Sampling procedures shall not lead to cross contamination.

10. Technical work shall not lead to cross contamination.

13. Cleaning methods shall be documented and validated.

Version 3.0 – September 2021 14

1.11 Private label owners

1.12 Head Office

Version 3.0 – September 2021 15

1.13 Scope of certification

1.13.1. Exclusions from scope

Version 3.0 – September 2021 16

1.13.2. Extension to scope

1.13.3. Reduction of the scope

1.14 Type of audits

1.14.2. Audit program

1.14.3. Surveillance audit

1.14.4. Recertification audit

Version 3.0 – September 2021 17

1.14.5. Special (extra) audit