GUIDE TO THE SUPPLY OF

GASES FOR USE IN FOODS

Doc 125/20
Revision of Doc 125/11

EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL

AVENUE DES L’ASTRONOMIE 30 • B – 1210 BRUSSELS

Tel: +32 2 217 70 98
E-mail: info@eiga.eu • Internet: www.eiga.eu
 Doc 125/20

GUIDE TO THE SUPPLY

OF GASES
FOR USE IN FOODS

Prepared by WG-8 Food Gases CO2

Disclaimer
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information contained in such publications were obtained from sources believed to be reliable and are based on technical
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While EIGA recommends reference to or use of its publications by its members, such reference to or use of EIGA's publications by
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Therefore, EIGA or its members make no guarantee of the results and assume no liability or responsibility in connection with the
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EIGA's publications are subject to periodic review and users are cautioned to obtain the latest edition.

 EIGA grants permission to reproduce this publication provided the Association is acknowledged as the source

EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL

Avenue de l’Astronomie 30 B 1210 Brussels Tel +32 2 217 70 98
E-mail: info@eiga.eu Internet: www.eiga.eu
EIGA DOC 125/20

Table of Contents
1 Introduction.................................................................................................................... 1
2 Scope and purpose......................................................................................................... 1
2.1 Scope..................................................................................................................... 1
2.2 Purpose.................................................................................................................. 2
3 Definitions ..................................................................................................................... 2
3.1 Publication terminology ............................................................................................. 2
3.2 Technical definitions ................................................................................................. 2
4 European food legislation................................................................................................. 4
4.1 Regulation (EC) No 178/2002 laying down the general principles and requirements of food
law, establishing the European Food Authority, and laying down procedures in matters of food
saf ety 5
4.2 Regulation (EC) No 1333/2008 on food additives .......................................................... 5
4.3 Regulation (EU) No 231/2012 laying down specific purity criteria on food additives other than
colours and sweeteners ...................................................................................................... 5
4.4 Regulation (EU) No 1169/2011 on the provision of food information to consumers.............. 5
4.5 Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs............................................ 6
4.6 Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with
f ood 6
5 General standards requirements ....................................................................................... 7
5.1 ISO 22000 / FSSC 22000 .......................................................................................... 7
5.2 Hazard analysis and critical control points .................................................................... 8
5.3 General food gases safety considerations .................................................................... 8
5.4 Traceability.............................................................................................................11
6 Bulk gas production, transport and storage........................................................................11
6.1 Introduction and scope .............................................................................................11
6.2 Production..............................................................................................................11
6.3 Transport and storage..............................................................................................12
6.4 Equipment requirements...........................................................................................13
7 Additives and ingredients gases supplied in cylinders and transportable containers .................14
7.1 Introduction and scope .............................................................................................14
7.2 Bulk additives and ingredients gases ..........................................................................14
7.3 Container requirements ............................................................................................14
7.4 Pre-f ill inspection.....................................................................................................15
7.5 Filling ....................................................................................................................16
7.6 Post-fill inspection ...................................................................................................16
7.7 Quality control and traceability ...................................................................................17
7.8 Delivery .................................................................................................................18
8 Dry ice production, storage and distribution .......................................................................18
8.1 Introduction and scope .............................................................................................18
8.2 Provisions applicable to foodstuffs .............................................................................18
8.3 Requirements for dry ice production premises..............................................................18
8.4 Production equipment requirements ...........................................................................19
8.5 Containers and transport ..........................................................................................19
8.6 Post-fill inspection dry ice containers ..........................................................................20
8.7 Personal hygiene ....................................................................................................20
8.8 Wrapping and packaging ..........................................................................................20
9 Onsite gas generators ....................................................................................................20
9.1 Introduction and scope .............................................................................................20
9.2 Requirements for food premises ................................................................................21
9.3 Equipment requirements...........................................................................................21
EIGA DOC 125/20

10 Ref erences................................................................................................................21
11 Additional ref erences ..................................................................................................22
Appendix 1 - Main articles describing labelling requirements of Regulation 1333/2008 on Food
Additive [2]..........................................................................................................................23
Appendix 2 - Hygiene Requirements to follow according to Regulation 852/2004 [7].......................25

Amendments to 125/11

Section Change
Editorial to align style with EIGA style manual
1 Update to Regulation numbers
2 Clarif ication on processing aids
3 New def initions added
4.2 Update to applicability from Regulation 1333/2008
4.2 Inf ormation transferred to appendix 1
4.4 New section on labelling
4.5 Inf ormation transferred to Appendix 2
4.6 Addition of CNR study information
5.1, 5.1.1, New sections
5.1.2
6.3 Changes to non-conforming product guidelines
7.2 Inf ormation added on labelling and marking
7.7 Changes to non-conforming product
8 Re-ordering of section and alignment with EIGA Doc 150

NOTE Technical changes from the previous edition are underlined

EIGA DOC 125/20

1 Introduction

The basis f or European food legislation is Regulation (EC) No 178/2002 laying down the general
principles and requirements of food law, establishing the European Food Safety Authority and laying
down procedures in matters of food safety [1].1 Current and proposed European legislation requires
that f oods, including gases supplied to the f ood industry as f ood additives and ingredients meet
increasingly rigorous standards to ensure food safety.

Gases are used f or a variety of purposes in the f ood industry as additives, processing aids and
ingredients. Particularly f or f ood additive and f ood ingredients, there are requirements regarding
labelling, purity and hygiene.

For gases used as processing aids in contact with food according to the Regulation (EC) No 1333/2008
on food additives Article 3 §2 b (iii), the purity of the gas should be in compliance with f ood additive
quality as required by the Regulation (EU) No 231/2012 laying down specifications for food additives,
in order to avoid that any residues or derivatives in the gas do not represent any health risk [2, 3].

The principal uses of gases in the food industry includes, but is not limited to:

• Additives:

o oxygen, nitrogen and carbon dioxide as modified atmosphere packaging gases;

o nitrogen and carbon dioxide as propellant gases for beverages;

o nitrous oxide as a propellant gas for cream; and

o sulphur dioxide as a preservative for specified foods.

• Processing aids:

o liquid nitrogen and liquid carbon dioxide for f reezing and chilling;

o carbon dioxide for super-critical extraction; and

o hydrogen for hydrogenation of fats.

• Ingredients:

o carbon dioxide for carbonated beverages.

This publication provides a summary of the relevant legislation together with advice as to how best to
meet their requirements.

2 Scope and purpose

2.1 Scope

This publication covers all stages of the supply chain including production, storage, re-packaging and
distribution of food gases to the final user (customer or consumer).

For this publication, food gases are gases in solid, liquid or gaseous form that are supplied to the food
industry and used as additives, processing aids or ingredients. For the applicability of requirements for
processing aids, see the definition of food gases. Food gases can be generated on site, delivered as
bulk liquid, compressed cylinder gases, or, in the case of carbon dioxide, as solid dry ice.

1
References are shown by bracketed numbers and are listed in order of appearance in the reference section.

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2.2 Purpose

The publication is intended to establish an awareness of the particular legislative requirements as they
apply to food gases and to offer advice as to how these requirements can be met. These requirements
cover legislation in the following areas:

• use of food gases including purity criteria;

• hygiene and food safety requirements including use of Hazard Analysis and Critical Control
Points (HACCP);

• labelling; and

• lot marking and traceability.

3 Definitions

For the purpose of this publication, the following definitions apply.

3.1 Publication terminology

3.1.1 Shall

Indicates that the procedure is mandatory. It is used wherever the criterion for conformance to specific
recommendations allows no deviation.

3.1.2 Should

Indicates that a procedure is recommended.

3.1.3 May

Indicate that the procedure is optional.

3.1.4 Will

Is used only to indicate the future, not a degree of requirement.

3.1.5 Can

Indicates a possibility or ability.

3.2 Technical definitions

3.2.1 Batch

A discrete, defined quantity whose characteristics can be proven, f or example it can be a number of
cylinders f illed on the same manif old at the same time, an isolated bulk storage tank or tanker, or a
period of continuous production from an air separation unit.

3.2.2 Bulk

A large amount of gas transported, supplied, stored generally in liquid cryogenic f orm in a cryogenic
vessel.

3.2.3 Consumer

The person that eats or drinks the product and will not use the f ood as a part of any f ood business

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operation or activity as per Regulation (EC) No 178/2002 [1].

3.2.4 Container

General term used in f ood law to describe the item used for storage or transport of foodstuffs. Within
this publication the term container shall be used to describe any equipment used f or the storage or
transport of gases in either solid, liquid or gaseous f orm. Where appropriate, additional descriptions
common in the gases industry may be used such as cylinder, bundle, tank, dry ice container etc.

3.2.5 Cryogenic vessel

A thermally insulated vessel f or the transport and the storage of ref rigerated liquefied gases, often
ref erred to as a tank or mini-tank.

3.2.6 Customer

The legal entity that uses the food gases for further processing.

3.2.7 Cylinder

A transportable non-insulated pressure vessel f or storage and containment of gases at above

atmospheric pressure.

3.2.8 Food or foodstuff

Any substance or product, whether processed, partially processed or unprocessed, intended to be, or
reasonably expected to be, ingested by humans as per Regulation (EC) No 178/2002 [1].

3.2.9 Food additive

Any substance not normally consumed as a f ood in itself and not normally used as a characteristic
ingredient of f ood, whether or not it has nutritive value, the intentional addition of which to f ood for a
technological purpose in the manuf acture, processing, preparation, treatment, packaging, transport or
storage of such food results, or may reasonably be expected to result, in it or its by-products becoming
directly or indirectly a component of such foods as per Regulation (EC) No 1333/2008 [2]. Food additives
include packaging gases and propellants.

3.2.10 Food business

Any undertaking, whether for profit or not and whether public or private, carrying out any of the activities
related to any stage of production, processing and distribution of f ood as per Regulation (EC) No
178/2002 [1].

3.2.11 Food business operator

The natural or legal persons responsible for ensuring that the requirements of food law are met within
the f ood business under their control as per Regulation (EC) No 178/2002 [1].

3.2.12 Food gases

Gases in solid, liquid, gaseous form intended to be used as a food additive, processing aid or ingredient
however, processing aids are not subject to the same legal requirements as food. In this publication the
requirements for food gases are indicated with a “shall”, for processing aids it may be read as “should”
as the legal requirements do not apply to processing aids.

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3.2.13 Hazard analysis critical control points (HACCP)

A f ormal method to assess the food safety risks.

3.2.14 Ingredient

Any substance or product, including flavourings, food additives and food enzymes, and any constituent
of a compound ingredient, used in the manuf acture or preparation of a f ood and still present in the
f inished product, even if in an altered f orm. Residues shall not be considered as ingredients as per
Regulation (EU) No 1169/2011 on the provision of food information to consumers [4].

3.2.15 Non-conforming product

Product that does not meet the relevant company specifications or that has other unspecified impurities
which are suspected or known to be at levels that might, when used in contact with foods, be injurious
to health. Company specifications are assumed to exceed legislative specifications.

3.2.16 Packaging gases

Any gas, other than air, which is introduced into a container before, during or after the placing of a food
in that container as per Regulation (EC) No 1333/2008 [2].

3.2.17 Preservatives

Substances which prolong the shelf -life of f oods by protecting them against deterioration caused by
micro-organisms and/or which protect against growth of pathogenic micro-organisms as per Regulation
(EC) No 1333/2008 [2].

3.2.18 Processing aid

Any substance not consumed as a f ood by itself, intentionally used in the processing of raw materials,
f oods or their ingredients to fulfil a certain technological purpose during treatment or processing, and
which may result in the unintentional but technically unavoidable presence of residues of the substance
or its derivatives in the final product, provided that these residues do not present any health risk and do
not have any technological effect on the finished product as per Regulation (EC) No 1333/2008 [2].

3.2.19 Propellants

Any gas, other than air, which expels a foodstuff from a container as per Regulation (EC) No 1333/2008
[2].

3.2.20 Top filling

Filling without completely degassing a cylinder.

4 European food legislation

Food legislation is issued in the form of either Directives or Regulations.

Directives are legislative acts that sets out a goal that all EU countries shall achieve. However, it is up
to the individual countries how to devise their own laws to achieve these goals. This process can lead
to slight differences of interpretation between the member countries and how the directive is transposed.

Regulations on the other hand, are binding legislative acts that member countries shall apply in its
entirety and no modification is allowed. Theref ore, for example, Regulation (EC) No 178/2002 is legally
binding in all member states [1].

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4.1 Regulation (EC) No 178/2002 laying down the general principles and requirements of
food law, establishing the European Food Authority, and laying down procedures in
matters of food safety

Regulation (EC) No 178/2002 established the European Food Authority and stipulates general
principles of food law. It harmonises national requirements which, hitherto, had varied slightly between
countries [1].

This regulation gives a def inition of f ood that includes any substance that is intended to be, or is
reasonably expected to be, ingested by humans. The ref erence to 'reasonably expected' is formulated
to ensure that a substance that may be reasonably expected to f ind its way into the food supply chain
but may f ind its way into different industry sectors, is handled with the same care as a f ood until it is
clear it will not become a f ood. This implies that nitrogen, oxygen and carbon dioxide, etc. in the
production / distribution process shall be treated as if they are f oods until specifically designated
otherwise.

The regulation also confirms that food includes any substance intentionally incorporated into the food
during its manufacture preparation or treatment.

The regulation def ines traceability as the ability to trace and f ollow a f ood through all stages of
production, processing and distribution and requires food business operators to know from whom they
have received food and to whom they supply it. The principal purpose of the traceability requirement is
to enable ef ficient and rapid withdrawal f rom the market of any f ood that may be injurious to the
consumer’s health.

4.2 Regulation (EC) No 1333/2008 on food additives

Regulation (EC) No 1333/2008 def ines f ood additives and processing aids and states explicitly that it
does not apply to processing aids [2]. Annex I of this regulation defines 26 applications of which 3 are
relevant to gases: preservatives, propellants and packaging gases.

The requirements relating to applicable labelling obligations (articles 21, 22 and 23) are given for
inf ormation in Appendix 1. Additional information relating to batch / lot identification is found in Directive
2011/91/EU on indications or marks identifying the lot to which a foodstuff belongs, [5].

4.3 Regulation (EU) No 231/2012 laying down specific purity criteria on food additives other
than colours and sweeteners

Regulation (EU) No 231/2012 gives purity criteria f or f ood additives [3]. EIGA Doc 126 Minimum
Specifications for Food Gas Applications lists the gases which are food additives [6].

4.4 Regulation (EU) No 1169/2011 on the provision of food information to consumers

Regulation (EU) No 1169/2011 provides the rules of a common def inition of f ood inf ormation to
consumers, for them to make informed choices, particularly on the labelling of ingredients.

Chapter IV, Article 4 describes the list of requested food information:

• name of the food;

• list of ingredients (with additive numbers in the cases of the food gases);

• quantity of ingredients;

• net quantity of the food;

• date of minimum durability;

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• name and address of the food business operator; and

• country of origin.

4.5 Regulation (EC) No 852/2004 on the Hygiene of Foodstuffs

Hygiene is defined as measures and conditions necessary to control hazards and to ensure f itness for
human consumption of a f oodstuff taking into account its intended use.

Primary responsibility f or hygiene rests with the f ood business operator and f ood business operators
shall ensure that all stages of production, processing and distribution of food under their control satisfy
the relevant hygiene requirements laid down in Regulation (EC) No 852/2004 [7].

Food business operators should establish and operate food safety programmes and procedures based
on HACCP principles.

The HACCP principles consist of the following:

(a) identifying the hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) identifying the critical control points at the step or steps at which control is essential to prevent
or eliminate a hazard or reduce it to acceptable levels;

(c) establishing critical limits at control points which separate acceptability f rom unacceptability
f or the prevention, elimination or reduction of identified hazards;

(d) establishing and implementing effective monitoring procedures at critical control points;

(e) establishing corrective action when monitoring indicates that a critical control point is not under
control;

(f ) establishing procedures, which shall be carried out regularly, to verif y that the measures
outlined in subparagraphs (a) to (e) are working effectively; and

(g) establishing documents commensurate with the nature and size of the f ood business top
demonstrate the effective application of the measures outlined in subparagraphs (a) to (f).

When any modification is made in the product or process, f ood business operators shall review the
procedure and make changes to it.

Member states shall encourage the development of national guides to good practice f or hygiene and
f or the application of HACCP which may be used voluntarily by food businesses.

Extracts of Regulation (EC) No 852/2004, where there is particular relevance to gas companies, are
given either in Appendix 2 or in f urther sections dealing with specific requirements [7].

4.6 Regulation (EC) No 1935/2004 on materials and articles intended to come into contact
with food

Regulation (EC) No 1935/2004 consolidates a large amount of earlier legislation on materials that come
into contact with f oods [8]. It requires that any packaging, wrapping or process equipment does not
transf er its constituents into the food and thereby adversely affect the food. It permits the use of active
f ood contact materials that may deliberately release or absorb substances into or f rom the food to
enhance its shelf life, this is not normally relevant to the gas industry. This regulation also covers food
contact areas of f ood processing machinery, such as f reezers. Eventually a positive list of authorised
f ood contact materials will be produced but, until then, in case of doubt, consult the supplier of the
material.

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In 2014, the Centre f or National Research (CNR) based in Italy, published the first study about the
migration process of potential metal contamination from carbon steel cylinders to food gases. The result
was no hazardous contamination in the food gases. Currently this study supports the authority request
about the compatibility of cylinders in contact with f ood gases, f or more inf ormation see Migration
processes of metal elements from carbon steel cylinders to food gases [9].

5 General standards requirements

European legislation demands that the saf ety of all f ood is assured by means of a HACCP risk
assessment procedure. This shall be part of a documented overall quality management system, for
example, ISO 22000, Food Safety Management, and the Global Food Safety Initiative (GFSI) scheme
FSSC 22000, Food Safety management systems, and ISO 9001, Quality Management System –
Requirements [10, 11, 12].

These standards address:

• premises design and cleanliness;

• raw material and supplier management;

• adherence to product specifications;

• equipment design;

• personal hygiene;

• training; and

• traceability and recall.

The production and supply of food gases is generally carried out in f ully enclosed pressurised equipment
f requently at very low temperatures. Theref ore, the possibility of physical, chemical or microbiological
contamination of the product is considerably reduced in comparison with traditional f oods. This
publication places emphasis on good manufacturing practices to maintain the integrity of the product
during all stages of the supply chain and highlights specific areas where particular care is required.

By their nature, gas production and distribution plants are not typical f ood premises and many of the
traditional food safety and hygiene controls will not be required. The HACCP shall determine the extent
of control required to ensure that appropriate standards of food hygiene are maintained.

5.1 ISO 22000 / FSSC 22000

ISO 22000 was developed using ISO 9001 approach, and tailors it to apply to food safety, incorporating
the widely used and proven HACCP principles and Good Manuf acturing Principles (addressed by
prerequisite programs in ISO 22000) [10, 12].

The standard contains requirements for food safety management systems processes and procedures,
and requires that the organisation implement prerequisite programmes and HACCP.

Unlike some of the other food safety management systems certification programmes (for example FSSC
22000 and SQF), ISO 22000 does not have specific requirements for prerequisite programmes (PRPs),
but requires that the organisation identifies and implements the appropriate programs [10, 11].

FSSC 22000 is a complete certification scheme for f ood and feed safety management systems, which
is in compliance with ISO 22000. The scheme provides a certif ication model that can be used in the
whole f ood supply chain. It covers sectors where such technical specifications f or sector PRPs have
been realised. FSSC 22000 follows the food chain category description for example ISO / TS 22002-1

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Prerequisite programmes on food safety — Part 1: Food manufacturing (f ood-grade gases f all into
Category K - Production of bio-chemical products) [13].

5.1.1 Food defence

Food def ence is an important element in protecting businesses and consumers f rom internal and
external threats. It encompasses a range of potential threats from relatively common tamper hoaxes to
less probable terrorist attacks. Many examples exist where products have been tampered with
deliberately and maliciously. Often supply chain or manufacturing threats can be mitigated to reduce a
wide range of threats, f or example, using locking lids can reduce a wide range of potential intentional
attacks. Food defence programs shall be developed to reduce the risks from both internal and external
threats in order to protect your facility and your customers.

FSSC 22000 includes clauses related to Food Def ence [11]. Although ISO 22002-1 Chapter 18
addresses this topic, it is now aligned with new GFSI requirements and taken to the management
system level, making it a part of the management responsibility process [13].

5.1.2 Food fraud

The relevance of food fraud has grown, not in the least f ollowing a number of food scandals that have
led to a reduction in consumer confidence in the food industry.

Although the driver of f ood fraud acts (cause) is often economic gain, it can nevertheless result in a food
saf ety risk. Such a risk is very often caused by negligence or lack of knowledge by f raudsters. Consumer
f ood fraud related risks can be:

(a) Direct food safety risks: the consumer is put at immediate risk (f or example addition of
melamine to milk powder that results in an acutely toxic exposure; hiding of substances
resulting in undeclared allergens);

(b) Indirect food safety risks: consumer is put at risk through long-term exposure (for example
high levels of heavy metals in f ood supplements causing harm, or lack of benefit, over a
longer period of time); or

(c) Technical food fraud risk: there is no direct or indirect f ood saf ety risk (f or example
misrepresentation of country-of-origin inf ormation). However, this indicates that material
traceability may have been compromised and the company no longer able to guarantee the
saf ety of their food products.

For f ood manufacturers, the economic impact can be high (for example recall, loss of sales, cost of re-
building reputation etc.), but also the consumer trust is important, not only for companies but for food
industry (sector) as a whole.

Following the GFSI benchmarking requirements, FSSC 22000 has introduced a chapter on food f raud
mitigation [11]. This has become mandatory for FSSC certification holders since January 1st, 2018 and
includes requirements f or a f ood f raud vulnerability assessment and a f ood f raud prevention plan
applicable to all products.

5.2 Hazard analysis and critical control points

Food gas businesses should implement and maintain a documented system of HACCP to ensure that
all potential risk of contamination of the product that could represent a hazard to f ood saf ety can be
identified and controlled. The system includes the seven principles of HACCP, see 4.5.

5.3 General food gases safety considerations

Regulation 852/2004 sets out twelve chapters for consideration when reviewing the controls needed to
maintain f ood hygiene [6]:

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Chapter 1 Premises

Chapter 2 Rooms where foodstuffs are processed

Chapter 3 Temporary or movable premises

Chapter 4 Transport

Chapter 5 Equipment

Chapter 6 Food Waste

Chapter 7 Water Supply

Chapter 8 Personal Hygiene

Chapter 9 Provisions Applicable to Foodstuffs

Chapter 10 Provisions applicable to the Wrapping and Packaging of Foodstuffs

Chapter 11 Heat Treatment

Chapter 12 Training

General guidance is set out below and only where relevant is f urther information given in the sections
of the guide specific to bulk gases, cylinder gases, dry ice and on-site supply. Matters relating to
transport and equipment are covered elsewhere in this publication.

5.3.1 Premises and rooms where foodstuffs are processed

Since the production and distribution of gases f or use in the f ood industry does not expose the gases
to the environment or to the personnel carrying out the work, many of the practices used in typical food
premises are inappropriate.

Premises should be designed and constructed to ensure that cleaning and maintenance operations can
be carried out effectively to minimise the risk of contaminating product.

Appropriate documented arrangements are required for the control of pests within the premises.

Individual cases can require a f ormal risk analysis where particular circumstances or adverse
environmental conditions apply, for example dry ice see Section 8.

For installations on customer sites, the gas supplier, in conjunction with the customer, should agree the
identification of a suitable location on the f ood premises f or the sitting of product storage and vehicle
of f-loading area. The customer is responsible for ensuring that the location meets the requirements for
f ood safety and is also responsible f or the upkeep of f ood hygiene standards around the storage tank
and associated equipment.

5.3.2 Temporary and removable premises

There are no relevant applications in the food gases industry.

5.3.3 Food waste

Food waste can be defined as either non-conforming product or product of uncertain quality f or which
documented handling procedures should be in place.

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5.3.4 Water supply

A HACCP study should identify where water is used in the process together with any associated hazards
and necessary controls. Where the water comes into contact with the gas, then it is necessary to specify
potable water or alternative control measures to prevent contamination of the product.

5.3.5 Personal hygiene

With the exception of dry ice, there is no physical contact between the gases supplied and the personnel
employed in their manuf acture or distribution. Theref ore, the personal hygiene controls that would be
necessary in a high-risk environment are not required. However, good personal hygiene practices
should be encouraged, especially during maintenance activities of components and other items that will
be in direct contact with the food gas.

Companies shall have a system in place to deal with health and sickness reporting of personnel involved
in the manuf acture and distribution of food gases.

5.3.6 Provisions applicable to foodstuffs

This chapter ref ers predominantly to perishable f oodstuffs and to f oodstuffs that may be subject to
microbiological degradation and, as such, has little relevance to f ood gases. However, consideration
needs to be made to potential contamination of incoming raw materials.

5.3.7 Provisions applicable to the wrapping and packaging of foodstuffs

Wrapping is def ined as the placing of a f oodstuff in a container in direct contact with the foodstuff
concerned, and the wrapper or container itself.

Packaging is defined as the placing of one or more wrapped foodstuffs in a second container, and the
latter container itself.

This chapter theref ore requires that wrapping and packing such as cylinders, tanks and dry-ice
containers shall not contaminate the gas therein. Nor shall the filling / transfilling process contaminate
the gas.

5.3.8 Heat treatment

This is not relevant to the food gas industry.

5.3.9 Training

All personnel contributing to the quality and integrity of products used in f ood should undergo relevant
f ood safety awareness training.

The level of training in food hygiene, hazard analysis and control given to personnel employed on food
gas production and supply shall be appropriate to their activities and commensurate with the ability of
their particular job function to impact on food safety.

Basic level training for appropriate personnel shall include personal hygiene standards such as the
reporting of illness, awareness of potential food hazards associated with the business (such as visible
damage / contamination to cylinders or potential contamination in bulk equipment due to inappropriate
maintenance procedures) and awareness of pest control requirements.

Training records should be maintained for all personnel.

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5.3.10 Labelling

In addition to hygiene considerations described above, it is also essential that f ood gases are labelled
in accordance with the relevant legislation, see 4.4.

5.3.11 Purity criteria

Purity criteria exist f or all gases when used as f ood additives. These set maximum levels f or certain
specific impurities, see Section 4. There is also a responsibility on behalf of the supplier to consider the
potential for other non-specified impurities and their effect on food safety. See EIGA Doc 126 Minimum
Specification for Food as Applications for further information [6].

5.4 Traceability

The general requirement of the traceability legislation is that the f ood business operator shall have
systems and procedures in place to:

• identify from whom they receive product;

• identify to whom they supply product; and

• allow this information to be made available to the competent authorities on demand.

This requirement emphasises the need for a batch marking system to be in place (see Section 4).

If a f ood business operator has reason to suspect that a f ood which it has produced, imported or
distributed is non-conforming product then the f ood business operator shall take steps to withdraw the
f oodstuff from the market and inform the competent authorities of this. The authorities may then decide
if any f urther action needs to be taken.

A mock traceability exercise at intervals is recommended to evaluate the speed at which product can
be withdrawn f rom the market. It is also beneficial to check that product can be traced f rom suppliers
through to dispatch.

6 Bulk gas production, transport and storage

6.1 Introduction and scope

This section provides specific guidelines on the production of gases suitable for use in f ood and their
distribution via bulk road tanker, as either a pressurised cryogenic liquid or as a pressurised gas, into
bulk storage. From storage the gas may be used either by f ood producers or by gas suppliers f or the
production of other gas products, for example filling into gas cylinders or production of dry ice.

6.2 Production

The bulk gas production process will be dependent on the particular product, but stages will typically
involve f eed gas intake (air in the case of oxygen, nitrogen or argon production), pre-treatment,
purif ication, liquefaction and production site storage.

Bulk gas production is carried out in closed, pressurised equipment often operating for extended periods
of time. This ensures that the risk of environmental contamination of the product is negligible.

EIGA provides information for producers and distributors of bulk carbon dioxide for food and beverage
use in EIGA Doc 68 Prevention of Carbon Dioxide Backfeed Contamination and EIGA Doc 70 Carbon
Dioxide Food and Beverages Grade, Source Qualification, Quality Standards and Verification [14, 15].

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EIGA DOC 125/20

6.3 Transport and storage

6.3.1 Prevention of cross contamination

Food gas businesses shall consider the use of appropriate precautions to ensure that the correct
product is delivered into the correct delivery point.

Vessels for transport and storage shall be allocated to a single product. These vessels should be fitted
with couplings specific to the type of gas being transported. The gas supplier can also consider the
installation of alternative means to ensure that cross-contamination does not occur, f or example
procedural control.

6.3.2 Gas service conversions

In the event of the need f or conversion of vessels f rom one gas service to another, documented
procedures shall be established and implemented to ensure that the gas in the vessel, after the change
of service, is suitable for food use. Procedures shall include control measures such as:

• analytical checks for all possible contaminants; and

• purging with an appropriate food gas to achieve required purity.

NOTE Containers are typically purged by pressurising and de-pressurising a specified number of times to remove
residual gases in order to achieve a specified purity.

6.3.3 Hygiene controls and product integrity

Hoses and piping used f or bulk supply should be stored in clean environments and capped if necessary.
Each f ood gases business should have in place procedures that shall ensure that the integrity of the
product is maintained throughout the transfer process. The risk of vessels becoming contaminated
during delivery is controlled by means of engineering and / or procedural arrangements. These should
be clearly documented as part of the HACCP.

Controls may include:

• hoses protected from ingress of contamination, for example use of end caps;

• purging prior to delivery; and

• common good handling and housekeeping practices such as not dragging hose ends on the
ground.

For the reasons given in the introduction to this section, vessels used for the transport of foodstuffs can
also be used for transporting products of at least the same quality to a non-food application.

All vessels used f or the distribution of bulk f ood gases shall be designated as being suitable for food
use. Particular attention should be paid to vessels undergoing intrusive maintenance. Procedures
should be established to ensure the cleanliness of such tanks and equipment prior to their return to
service.

6.3.4 Control of non-conforming product and traceability

Procedures shall be in place to avoid releasing non-conforming products. Where non-conformance

occurs (or is suspected to occur) at any point in the supply chain, the following procedures apply.

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EIGA DOC 125/20

6.3.4.1 Bulk storage

Saf ely empty and vent the storage tank then purge back to service. (Analyse vessel contents prior to
placing back in service).

6.3.4.2 Delivery vessel (detected after filling)

• Quarantine the vessel.

• Saf ely empty and vent the vessel then purge back to service.

• Analyse vessel contents prior to placing back in service.

6.3.4.3 Suspected non-conforming product at a food customer after delivery

• Trace all other deliveries to food customers of potentially defective product, (including third party
collections).

• If deliveries have been made to other food customers, inform the relevant government agency
if impurities are suspected or known to be at levels that might, when used in contact with foods,
be injurious to health.

• Conf irm the source and supplier of the defective product.

• Quarantine and analyse the contents of vessels suspected of carrying non-conforming product.
If this analysis shows conformity, inform the customer and no further action is required.

• If analysis confirms non-conformity, the customer shall be informed. Safely empty and vent
customer storage. Investigate and complete corrective actions in accordance with f ood safety
management system.

6.4 Equipment requirements

6.4.1 Design

Production plant and equipment used for producing more than one product shall be designed to ensure
no cross-product contamination can occur.

The equipment used to manuf acture and store f ood gases, is designed to operate as a closed,
pressurised system for continuous operation over many years, thus retaining its commissioning state of
cleanliness.

Equipment should be selected and maintained so that it does not introduce f ood safety hazards, for
example consideration should be given to eliminating or minimising the need for physical entry into the
system. When it is necessary to break in to the system f or maintenance or inspection, documented
procedures should be in place to ensure equipment is clean and shall not compromise product integrity
when returned to service.

Validation of cleanliness may involve product analysis to ensure that f oreseeable contaminants
introduced during the maintenance procedures have been removed and that the product in final storage
meets the required specification.

6.4.2 Materials of construction

Materials of construction shall be compatible with both the product and the manufacturing process and
shall not introduce contaminants that would present a risk to food safety according to Regulation (EC)
No 1935/2004 [8].

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EIGA DOC 125/20

Formalised systems should be in place to ensure that materials in contact with the f ood gases are
suitable for the purpose and that when equipment is newly installed or transferred f rom one surface to
another, cleanliness is assured and maintained.

Formal change control systems should ensure that, whenever modifications are made to plant and / or
equipment, consideration is given to their impact on food safety. Where appropriate, it may be necessary
to review and revise the HACCP study.

If a vessel becomes inadvertently depressurised, then it shall be quarantined and considered unfit for
f ood service until designated “suitable for use in food” in accordance with documented re-commissioning
procedures.

7 Additives and ingredients gases supplied in cylinders and transportable containers

7.1 Introduction and scope

This section provides specific guidelines on the process of f illing containers such as cylinders and
transportable containers f or the supply of gases to the f ood industry. Container specification, valves
specification, pref illing inspections, f illing procedures, post f illing inspections, quality control and
traceability are within the scope of this section of the publication.

The overall process of container filling f or additives and ingredients gases shall be the subject of a
f ormalised HACCP review. Particular attention should be paid to the identification and control of
potential hazards resulting f rom cross contamination with other products, shutdown / start-up and
intrusive maintenance. The HACCP shall also take into account the possibility of contamination being
introduced at customer sites.

7.2 Bulk additives and ingredients gases

The supply of bulk gases for container filling shall be in accordance with the requirements of recognised
f ood gas product quality standards.

Bulk gas documentation shall clearly indicate which gases are suitable for use in food, including:

• batch or lot numbers (for example in the delivery paper); and

• labelling shall comply with the labelling requirements including the requirement for a best before
date (typically three to five years from the date of loading transport tank or in accordance with
local regulation).

7.3 Container requirements

Containers shall be regularly inspected to ensure their condition to remain acceptable for use with food.
Records of container inspections and any remedial actions should be maintained.

Materials of construction shall be compatible with both the product and the manufacturing process and
shall not introduce contaminants that would present a risk to food safety according to Regulation (EC)
No 1935/2004 [8].

Formalised systems should be in place specifying containers and valves and to ensure that when
containers are transf erred f rom one service to another, or new containers are stored or installed,
cleanliness is assured and / or maintained.

Formal change control systems should ensure that whenever modifications are made to plant and/or
containers consideration is given to their impact on food safety.

7.3.1 Containers

If a container becomes depressurised, then it shall be quarantined and considered unfit for food service

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EIGA DOC 125/20

until designated suitable for use in food in accordance with documented re-commissioning procedures.

Bef ore containers are introduced into gas service, unless they are new and previously specified as being
suitable f or f ood service, they shall be de-valved and, if possible, internally inspected in accordance
with the appropriate documented procedure, cleaned as necessary and fitted with the appropriate valve.

When containers are subjected to their periodic inspection and test, they shall be in accordance with
documented procedures. If water is used, it shall be either drinking water or of such a quality that
possible internal contamination of the container is avoided. The containers shall be dried internally prior
to f illing.

7.3.2 Valves

Valves used f or gas applications f ollow international design codes. Valves f itted to cylinders for food
use should be of the residual pressure type incorporating a non-return valve (RPV). For additional
guidance refer to EIGA Doc 64, Use of residual pressure valves [16].

Where an RPV is not employed, an equivalent level of protection as provided by an RPV shall be
incorporated in the pre-fill procedure for container and/or the design of the customer installation.

7.4 Pre-fill inspection

ISO 24431 Gas cylinders. Seamless, welded and composite cylinders for compressed and liquefied
gases (excluding acetylene). Inspection at time of filling [17] is applicable, but additional requirements
apply to additives and ingredients gases.

Bef ore filling containers for gases, a pre-fill inspection shall be carried out.

The inspection shall include, but is not limited to, the following:

• The external condition shall be checked to ensure that the container is f ree f rom damage or
excessive corrosion and that it is suitably clean prior to filling. Previous batch labels should be
removed or rendered illegible.

• Liquef ied gases cylinders fitted with a dip-tube shall be clearly marked.

• The specific functions of valves on containers should be clearly identifiable.

• The valves shall be inspected and shall be f ree f rom any external contamination or damage
bef ore filling commences.

• The containers shall be within their due date for inspection and re-test.

• The compatibility of the containers and their valves with their intended gas fill shall be checked.

• The saf e f illing pressure of containers shall be established f or the gas service and checked
against the intended filling pressure.

• The f unctionality of the RPV, where f itted, shall be checked. For containers not fitted with an
RPV, a check of the residual pressure shall be made. Where the residual pressure is zero or
very low, procedures shall be established to ensure that the containers are f ree from
contamination and appropriate control should be employed such as purging or internal
inspection before filling.

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EIGA DOC 125/20

7.5 Filling

7.5.1 General

During any f illing process the container valve shall be checked for leakage, paying particular attention
to glands. After the f illing process is complete and the container disconnected, ensure that no gas is
escaping through the valve.

Dedicated filling equipment for additives and ingredients gases is not necessary.

All f illing processes shall be formally documented.

7.5.2 Specific requirements for filling containers – liquefied gases

Liquif ied gases, cylinders shall be vented to be liquid free prior to filling. A check shall be carried out to
ensure that this is the case before a cylinder is f illed, for example tare weight check. No filling shall be
carried out until any discrepancy has been investigated and resolved. Under no circumstances shall
any container used for drinks dispense gas be top filled.

NOTE Venting residual pressure prior to filling is good practice, but vacuum is not necessary. For more
information see EIGA Doc 83, Recommendation for safe filling of CO2 cylinders and bundles [18].

NOTE Liquefied gas cylinders (particularly carbon dioxide) become cold during filling and it is therefore
recommended that all labelling be completed prior to filling – see 7.6 for details.

7.5.3 Specific requirements for filling – compressed gases

Due to the potential f or contaminated gas being returned f rom the customer, consideration shall be
given to appropriate methods for preserving product integrity such as:

• f itting an RPV;

• purging cylinders, which do not have an RPV fitted; and

• complete emptying of the cylinder of any residual compressed gases.

During f illing a check should be made that the cylinders are becoming warm. A cold cylinder can indicate
a blocked valve that should then be investigated.

If supplied to the consumer, the package shall carry the expiry date.

7.5.4 Specific requirements for filling – cryogenic vessels

Cryogenic vessels may be filled by weight, level indicator or by filling to the full trycock (overfill indicator).

Ensure that the correct product is filled into the vessel. This can be achieved by the f itting of gas specific
couplings or similar protective devices. A system shall be in place to prevent change of service of the
vessel without formal authorisation, and to ensure that labelling and product identification operations
are complete before filling with the new product.

If the previous vessel content cannot be verified, then the vessel shall be quarantined and its contents
shall be analysed against the relevant product specification prior to supply.

7.6 Post-fill inspection

Containers should be checked for product leakage, correct labelling and product identification. Checks
include:

16
EIGA DOC 125/20

• batch or lot labels shall are f itted to the containers

• labelling complies with the labelling requirements including the requirement for a best before
date (this should be three years from the date of filling);

• the containers are of acceptable finish externally;

• containers ready for dispatch should be stored in such a way as to prevent any accumulation
of debris that may provide a refuge for pests; and

• container valve outlets are plugged or capped after quality control checks have been carried
out.

The containers may then be released for dispatch to the customer.

7.7 Quality control and traceability

To comply with the traceability requirements, all records should be kept for the time of durability of the
product plus one year.

Where a product may be suspected or proven to not meeting the requirements f or use in f ood, the
procedures shall conform to the guidance in Regulation (EC) No 178/2002 [1]. The procedures below
should be followed.

7.7.1 Suspected non-conforming product in bulk tank at filling depot

• Inf orm production and distribution management – and then treat as if it were non-conforming
bulk product in a customer tank.

• Do not use to fill food grade cylinders.

7.7.2 Suspected non-conforming product in cylinder before delivery

• Quarantine the batch.

• Analyse / vent as necessary.

• If any of the batches have been delivered, proceed in accordance with 7.7.3.

7.7.3 Suspected non-conforming product delivered

• Receive notification from customer.

• Obtain as much information from the customer to establish if it is a gas supply problem and not
a customer’s internal problem.

• Establish filling depot and batch number of the suspected product.

• Identif y all other customers for that batch.

• Make no f urther deliveries of that batch.

• Inf orm customers who have already received some of this batch.

• Inf orm the relevant food standards authority if impurities are suspected or known to be at levels
that might, when used in contact with foods, be injurious to health.

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EIGA DOC 125/20

7.8 Delivery

Appropriate information including the safety data sheet shall be supplied when any product is delivered
f or the f irst time to any user. Customer risk assessments should identify suitable locations for gas
cylinders following any legal requirements of gas association guidance.

Labelling shall distinguish clearly between food and industrial cylinder gases.

8 Dry ice production, storage and distribution

EIGA Doc 150, Guidelines for Safe and Hygienic Handling of Dry Ice, covers in detail the production,
storage and distribution of dry ice [19]. The inf ormation below contains a brief summary of requirements,
however ref erence should be made EIGA Doc 150 for more information [19].

8.1 Introduction and scope

Dry ice is carbon dioxide in its solid f orm, produced by expanding pressurised liquid carbon dioxide to
atmospheric pressure.

The product is supplied as either blocks, slices or in pellet f orm and is generally packed into plastic,
paper or composite bags that are stored and transported in insulated containers. Some products
(particularly pellets) may also be supplied loose, in containers, with no wrapping. In the gases industry,
dry ice is the only solid product and, unlike other f ood gas products, is not kept in a pressurised or
closed system. It therefore requires specific attention to food hygiene and training requirements.

The requirements for dry ice as specified below are exclusively for the use of it as food additive or food
ingredient and not applicable for food processing aid.

8.2 Provisions applicable to foodstuffs

Dry ice shall be made only from liquid carbon dioxide that is certified as being suitable for use in foods.
Incoming supplies and storage should be subject to a recognised, documented quality system, such as
ISO 9001 [12].

HACCP analysis of the entire supply chain including the supply and storage of bulk liquid carbon dioxide,
the dry ice manufacturing facility and transport arrangements to the point-of-sale shall be carried out.

Hazardous materials such as lubricants, hydraulic fluid and cleaning chemicals etc. shall be stored
separately from dry ice products. They shall not be kept in production areas and shall be clearly labelled.
Such products shall only be brought into production areas when necessary and shall be removed again
into safe storage as soon as possible.

Dry ice shall be traceable to a registered premises and batch / lot. The system shall enable suppliers of
dry ice to identify suspect products in case of customer complaint or quality f ailure in order to recall
af f ected products. These procedures should be part of the overall quality system, see Section 5.

8.3 Requirements for dry ice production premises

The f ollowing good manufacturing principles shall be applied:

• The f loors, walls and ceilings of production premises shall be designed in a way to avoid all
contamination and f acilitate cleaning. The room where the dry ice presses, the sawing /
ref orming and other packing processes are located, shall be separated f rom the other f actory
and storages areas.

• Wood should be kept out of the production area.

• The lighting equipment above open containers and other uncovered production equipment shall
be protected in case of breakage of glass and particles. In general, glass shall be kept out of

18
EIGA DOC 125/20

the production area or protected to prevent to fall in the containers.

• The toilet areas shall be clean and separated from the production area. The doors shall close
automatically. There shall be suf ficient wash basins with cleaning material, hot and cold running
water, and hygienic hand drying. Notices shall be visible encouraging workers to wash their
hands.

• Adequate ventilation should be provided and precautions taken to prevent ingress of dust,
odours and pests. The drains and water evacuation systems shall be correctly installed and
maintained.

• The production and packaging operation shall be carried out under hygienic conditions. The
use of disposable packaging is pref erred including the use of plastic liners f or bulk dry ice
containers.

• A pest control system is necessary. Regular checks shall be made. Checks shall be recorded.

8.4 Production equipment requirements

The extruders, saws or presses used for the production of dry ice, shall be inspected regularly to make
sure there is no contamination from the equipment or from lubricant

Food grade lubricants shall be used wherever there is a risk that lubricants could come into contact with
the product.

Chutes, conveyors, weighing systems and packaging equipment shall be regularly inspected and
cleaned.

Pressure washers using a detergent are adequate for cleaning equipment. Only suitable quality water
should be used for cleaning purposes.

Equipment shall be constructed of materials that are easily cleanable, resistant to corrosion, non-toxic
and capable of withstanding contact with dry ice at a temperature of –78.4 °C. Stainless steel and some
non-f errous alloys or plastic materials have been found to be acceptable.

Equipment should be designed and manufactured to avoid dirt traps etc. Surfaces shall be smooth and
f ree f rom pits, crevices and chips.

Consideration should be given to exposed sections of the production line to prevent airborne
contamination / foreign bodies whilst allowing easy access for maintenance and cleaning.

8.5 Containers and transport

Dry ice containers shall be constructed of easily cleanable and maintainable materials f or example
stainless steel, f ibreglass and epoxy, plastic or non-f errous alloys. The use of disposable plastic
container liners should be considered, especially f or "loose" product, which has no primary wrapping.
Ref erence should be made to the wrapping and packaging requirements of Regulation (EC) No
852/2004 [7].

Containers (f ull or empty) should be kept closed, whenever possible, and always kept closed if stored
outside in the open air. The use of closed vehicles for road transport is recommended to keep the
containers clean and dry, see EIGA SL 09, Safe Transport of Dry Ice [20].

Dry ice containers shall be inspected and in a clean state before each use. Only suitable quality water
shall be used. Pressure washers using a detergent are adequate for cleaning containers. Because the
dry ice can be used in direct contact with f ood stuff, all cleaning agents and water shall be suitable for
use in f ood industry. The cleaning area shall be separated from the production area. Containers should
be identifiable, f or example, by a number and the inspection / maintenance program should be
documented and recorded.

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EIGA DOC 125/20

Containers shall not be used f or non-f oodstuffs where this poses a risk of contamination. Adequate
cleaning shall be carried out if containers have been used for other foodstuffs before use for dry ice.

The transport of dry ice containers to the customer is pref erably carried out using closed vehicles
provided with ventilation to prevent the build-up of carbon dioxide.

8.6 Post-fill inspection dry ice containers

Containers f or dry ice f or use in f ood processes shall be segregated f rom those containing non-food
grade dry ice. Containers f or use in f ood processes should be checked for damage, correct labelling
and product identification. Checks include:

• batch or lot labels shall be fitted to the containers;

• labelling shall comply with the labelling requirements including, for food additive application, the
requirement f or a best before date, this should be three years from the date of filling;

• the containers shall be of acceptable finish externally; and

• containers ready for dispatch should be stored in such a way as to prevent any accumulation of
debris that may provide a refuge for pests.

8.7 Personal hygiene

During the production of dry ice there can be manual handling of the product. Theref ore, good personal
hygiene practices are required covering such items as health status, illness and injuries, personal
cleanliness, eating and jewellery. Other good hygiene practices include:

• operators shall be removed from the production area, if scabs and wounds cannot be covered;

• wearing of clean and proper protective clothing for all personnel working in the production area
is necessary, documented hygiene procedures should be established and implemented;

• use of tobacco in any form is strictly forbidden; and

• eating and drinking in the work area is strictly forbidden.

8.8 Wrapping and packaging

Wrapping for use with dry ice shall be made from food compatible materials, which are suitable for use
at low temperature (down to –78.4 °C). This includes plastic bags, plastic f ilm, paper and composite
materials including container liners (if used). See Regulation (EC) No 1935/2004 [8].

All wrapping materials for use with dry ice shall be transported and stored in suitable conditions to
prevent any risk of contamination.

Material, scrap and waste shall be correctly stored separated f rom the production area and well
identified.

Finished product shall be stored in a separate area and clearly identified. The use of seals / anti-
tampering devices is recommended.

9 Onsite gas generators

9.1 Introduction and scope

This section provides specific guidelines for onsite generators.

An onsite generator produces gas for use directly at the location where the equipment is installed without

20
EIGA DOC 125/20

the need of transport. The equipment usually supplies the gas to a distribution pipe work system but on
large installations there can be intermediate storage tanks.

Onsite gas generators range in size f rom gas flows of a f ew litres per minute up to a f ew tonnes per
hour.

Typical gases produced by onsite generators are:

• nitrogen (gaseous or liquid) from air;

• oxygen from air; or

• hydrogen from electrolysis of water.

The most common onsite generators are non-cryogenic systems f or producing a mixture of gases
(typically nitrogen and oxygen) with a variation of content of the different gases.

Onsite generators shall be designed to produce gases suitable f or the intended applications. This
includes the requirements f or use in f oods. See EIGA Doc 194 Design and Operation of On-Site
Nitrogen Generators for Food Use [21].

9.2 Requirements for food premises

The on-site gas generators shall be installed in locations that are suitable for the purpose. In particular
where air is the f eedstock f or the onsite generator, the air intake shall be free f rom certain contaminants.
For example, waste solvents and boiler / engine exhausts shall not be adjacent to the air intake to a
plant.

On-site generators are pressurised systems and thus have a level of good protection f rom the
environment provided that appropriate hygiene controls are in place for maintenance operations.

The operator where the on-site generator is installed is responsible for the upkeep of f ood hygiene
standards around the equipment.

Requirements f or items such as temperature / humidity / power supply shall be specified by the
manuf acturer of the on-site generator.

There shall be access to the on-site generator to allow for maintenance operations.

9.3 Equipment requirements

The equipment shall be designed to produce gas that complies with the requirements f or use in foods.
It is normal f or on-site generators to be designed as a standard product that shall produce gas of a
consistent quality provided that it is installed and maintained according to formal written procedures.

Consequently, the design process shall include validation of the design to prove the capability of the
equipment.

Any requirement to control and track the quality of the produced gas may require the installation of on-
site analytical equipment. There may be additional requirements such as flow and pressure alarms. The
materials of construction shall be compatible with foods and the environment.

The equipment shall be designed to give adequate protection from contamination of the environment.
On-site generators can be located outdoors in some circumstances and thus consideration shall be
given to appropriate enclosures according to established international standards.

10 References

Unless otherwise stated the latest edition shall apply.

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EIGA DOC 125/20

[1] Regulation (EC) No 178/2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in matters of food
safety, www.europa.eu.

[2] Regulation (EC) No 1333/2008 on food additives, www.europa.eu.

[3] Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and
III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council Text with EEA
relevance, www.europa.eu.

[4] Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011
on the provision of food information to consumers, www.europa.eu.

[5] Directive 2011/91/EU on indications or marks identifying the lot to which a foodstuff belongs,
www.europa.eu.

[6] EIGA Doc 126, Minimum Specifications for Food Gas Applications, www.eiga.eu.

[7] Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on
the hygiene of foodstuffs, www.europa.eu.

[8] Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004
on materials and articles intended to come into contact with food, www.europa.eu.

[9] Migration Processes of Metal Elements from Carbon Steel Cylinders to Food Gases, National
Research Council, Istituto Geochimica e Georisorse, Florence, Italy (CNR-IGG), Packing
Technology and Science, Volume 27, Issue 10, February 2014, www.onlinelibrary.wiley.com.

[10] ISO 22000, Food Safety Management Systems – Requirements for any Organization in the Food
Chain, www.iso.org.

[11] FSSC 22000, The Foundation Food Safety System Certification, www.fssc22000.com.

[12] ISO 9001, Quality Management Systems – Fundamentals and Vocabulary, www.iso.org.

[13] ISO 22002-1, Prerequisite programmes on food safety — Part 1: Food manufacturing,
www.iso.org.

[14] EIGA Docs 68, Prevention of Carbon Dioxide Backfeed Contamination, www.eiga.eu.

[15] EIGA Doc 70, Carbon Dioxide Food and Beverages Grade, Source Qualification, Quality Standards
and Verification, www.eiga.eu

[16] EIGA Doc 64, Use of Residual Pressure Valves, www.eiga.eu.

[17] EN ISO 24431, Gas cylinders. Seamless, welded and composite cylinders for compressed and
liquefied gases (excluding acetylene). Inspection at time of filling, www.iso.org.

[18] EIGA Doc 83, Recommendations for safe filling of CO2 cylinders and bundles, www.eiga.eu.

[19] EIGA Doc 150, Guidelines for Safe and Hygienic Handling of Dry Ice, www.eiga.eu.

[20] EIGA SL 09, Safe Transport of Dry Ice, www.eiga.eu.

[21] EIGA Doc 194, Design and Operation of On-Site Nitrogen Generators for Food Use, www.eiga.eu.

11 Additional references

https://ec.europa.eu/food/safety/biosafety/food_hygiene/guidence_en

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EIGA DOC 125/20

Appendix 1 - Main articles describing labelling requirements of Regulation

1333/2008 on Food Additive [2]

Article 21: Labelling of food additives not intended for sale to the final consumer

1. Food additives not intended for sale to the final consumer, whether sold singly or mixed with each other
and/or with food ingredients, as defined in Article 6(4) of Directive 2000/13/EC,[4] may only be marketed
with the labelling provided for in Article 22 of this Regulation, which must be easily visible, clearly legible
and indelible. The information shall be in a language easily understandable to purchasers.

2. Within its own territory, the Member State in which the product is marketed may, in accordance with the
Treaty, stipulate that the information provided for in Article 22 shall be given in one or more of the official
languages of the Community, to be determined by that Member State. This shall not preclude such
information from being indicated in several languages.

Article 22: General labelling requirements for food additives not intended for sale to the final
consumer

1. Where food additives not intended for sale to the final consumer are sold singly or mixed with each
other and/or other food ingredients and/or with other substances added to them, their packaging or
containers shall bear the following information:

(a) the name and/or E-number laid down in this Regulation in respect of each food additive or a sales
description which includes the name and/or E-number of each food additive;
(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its
intended food use;
(c) if necessary, the special conditions of storage and/or use;
(d) a mark identifying the batch or lot;
(e) instructions for use, if the omission thereof would preclude appropriate use of the food additive;
(f) the name or business name and address of the manufacturer,
(g) an indication of the maximum quantity of each component or group of components subject to
quantitative limitation in food and/or appropriate information in clear and easily understandable terms
enabling the purchaser to comply with this Regulation or other relevant Community law; where the
same limit on quantity applies to a group of components used singly or in combination, the combined
percentage maybe given as a single figure; the limit on quantity shall be expressed either numerically
or by the quantum satis principle;
(h) the net quantity;
(i) the date of minimum durability or use-by-date;
(j) where relevant, information on a food additive or other substances referred to in this Article and
listed in Annex IIIa to Directive 2000/13/EC [4] as regards the indication of the ingredients present in
foodstuffs.

2. Where food additives are sold mixed with each other and/or with other food ingredients, their packaging
or containers shall bear a list of all ingredients in descending order of their percentage by weight of the
total.

3. Where substances (including food additives or other food ingredients) are added to food additives to
facilitate their storage, sale, standardisation, dilution or dissolution, their packaging or containers shall
bear a list of all such substances in descending order of their percentage by weight of the total.

4. By way of derogation from paragraphs 1, 2 and 3, the information required in paragraph 1 points (e) to
(g) and in paragraphs2 and 3 may appear merely on the documents relating to the consignment which are
to be supplied with or prior to the delivery, provided that the indication ‘not for retail sale’ appears on an
easily visible part of the packaging or container of the production question.

5. By way of derogation from paragraphs 1, 2 and 3, where food additives are supplied in tankers, all of
the information may appear merely on the accompanying documents relating to the consignment which
are to be supplied with the delivery.

Article 23: Labelling of food additives intended for sale to the final consumer

If the additive is intended for sale to the ultimate consumer, the following information above shall be on

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the packaging

(a) the name and E-number laid down in this Regulation in respect of each food additive or a sales
description which includes the name and E-number of each food additive;
(b) the statement ‘for food’ or the statement ‘restricted use in food’ or a more specific reference to its
intended food use.

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Appendix 2 - Hygiene Requirements to follow according to Regulation 852/2004

[7]

I. General requirements for food premises

II. Specific requirements in rooms where foodstuffs are prepared, treated or processed

III. Requirements for movable and/or temporary premises

IV. Transport

1. Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained
in good repair and condition to protect foodstuffs from contamination and are, where necessary, to
be designed and constructed to permit adequate cleaning and/or disinfection.
2. Receptacles in vehicles and/or containers are not be used for transporting anything other than
foodstuffs where this may result in contamination of foodstuffs.
3. Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or
for transporting different foodstuffs at the same time, there is, where necessary, to be effective
separation of products.
4. Bulk foodstuffs in liquid, granulate or powder form shall be transported in receptacles and/or
containers/tankers reserved for the transport of foodstuffs. Such containers are to be marked in a
clearly visible and indelible fashion, in one or more Community languages, to show that they are
used for the transport of foodstuffs, or are to be marked 'for foodstuffs only'.
5. Where conveyances and/or containers have been used for transporting anything other than foodstuffs
or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the
risk of contamination.
6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimize the
risk of contamination.
7. Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable
of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored.

V. Equipment requirements

“All articles, fittings and equipment with which food comes into contact are to:
• be effectively cleaned and, where necessary, disinfected, Cleaning and disinfection are to take
place at a frequency sufficient to avoid the risk of contamination;
• be so constructed, be of such materials and be kept in such good order, repair and condition as to
minimize any risk of contamination of the food;
• with the exception of non-returnable containers and packaging, be so constructed, be of such
materials and be kept in such good order, repair and condition as to enable them to be kept clean
and, where necessary, to be disinfected; and
• be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding
area.”

VI. Food waste

VII. Water supply

VIII. Personal hygiene

IX. Provisions applicable to foodstuffs

X. Provisions applicable to the wrapping and packaging of foodstuffs

“Material used for wrapping and packaging is not to be a source of contamination.”

“Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary,
to disinfect.”

XI. Heat Treatment

XII. Training

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“Food business operators shall ensure that food handlers are supervised and instructed and/or trained
in food hygiene matters commensurate with their work activity.”
Every food business operator shall notify the appropriate competent authority of each establishment
under its control that carries out any of the stages of production, processing and distribution of food, with
a view to the registration of each establishment. This information shall be kept up-to date.
Indirectly these hygiene requirements bring processing aids within the scope of the food legislation.
Hitherto processing aids were not classified as foods and were subject to very little legislation, but the
hygiene requirements of Regulation 852/2004 [7] require that risk of contamination of foods from any
source shall be assessed. As contamination is possible from processing aids, then they themselves have
to be treated in a similar way to foods.

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