INTERNATIONAL ISO

STANDARD 21469

First edition
2006-02-15

Safety of machinery — Lubricants with

incidental product contact — Hygiene
requirements
Sécurité des machines — Lubrifiants en contact occasionnel avec des
produits — Exigences relatives à l'hygiène

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 21469:2006
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006

Reference number
ISO 21469:2006(E)

© ISO 2006
ISO 21469:2006(E)

PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 21469:2006
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006

© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [email protected]
Web www.iso.org
Published in Switzerland

ii © ISO 2006 – All rights reserved

 ISO 21469:2006(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 21469 was prepared by Technical Committee ISO/TC 199, Safety of machinery.

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 21469:2006
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006

© ISO 2006 – All rights reserved iii

ISO 21469:2006(E)

Introduction
During the production of foodstuffs, cosmetics, pharmaceutical, tobacco and animal feeding products —
including packaging in direct contact with the product — it is essential to avoid contamination with lubricants
from machine elements such as gears, bearings, hydraulics, pneumatics, compressors, slideways and chains.
In all cases where product and lubricant contact cannot be fully prevented, lubricants have to be used which
are acceptable for use should cross-contamination occur.

Up until 1998, the United States Department of Agriculture (USDA) issued the USDA H1 authorization for
lubricants, which met these requirements. Use of such lubricants gave users confidence that they were
complying with best practice in relation to their duty of care to the consumer. Following the end of the USDA
scheme, the need was recognized for an International Standard to be developed in this area.

The structure of safety standards in the field of machinery is as follows.

a) Type-A standards (basis standards) give basic concepts, principle for design, and general aspects that
can be applied to machinery.

b) Type-B standards (generic safety standards) deal with one or more safety aspect(s) or one or more
type(s) of safeguards that can be used across a wide range of machinery:

⎯
iTeh STANDARD PREVIEW
type-B1 standards on particular safety aspects (e.g. safety distances, surface temperature, noise);

⎯
(standards.iteh.ai)
type-B2 standards on safeguards (e.g. two-hands controls, interlocking devices, pressure-sensitive
devices, guards).
ISO 21469:2006
c)
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
Type-C standards (machinery safety standards) deal with detailed safety requirements for a particular
machine or group of machines.
4fdde924ce74/iso-21469-2006

This International Standard is a type-B standard as stated in ISO 12100-1.

When provisions of a type-C standard are different from those which are stated in type-A or type-B standards,
the provisions of the type-C standard take precedence over the provisions of the other standards for machines
that have been designed and built according to the provisions of the type-C standard.

iv © ISO 2006 – All rights reserved

INTERNATIONAL STANDARD ISO 21469:2006(E)

Safety of machinery — Lubricants with incidental product

contact — Hygiene requirements

1 Scope
This International Standard specifies hygiene requirements for the formulation, manufacture, use and handling
of lubricants which, during manufacture and processing, can come into incidental contact (e.g. through heat
transfer, load transmission, lubrication or the corrosion protection of machinery) with products and packaging
used in the food, food-processing, cosmetics, pharmaceutical, tobacco or animal-feeding-stuffs industries.
Included in this document are registration criteria that can be used to assess conformance with this
International standard for lubricants with incidental product contact (see Annex B). It is not applicable to
substances used as product additives or to those in direct product contact (see Annex A), but confines itself to
hygiene without addressing occupational health and safety matters. Nevertheless, it is considered essential
that where occupational health and safety is associated with the processes concerned it be considered along
with hygiene so that measures satisfying the needs of both can be taken.

2
iTeh STANDARD PREVIEW
Normative references
(standards.iteh.ai)
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies.ISO
For21469:2006
undated references, the latest edition of the referenced
document (including any amendments) applies.
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006
ISO 6743-99:2002, Lubricants, industrial oils and related products (class L) — Classification — Part 99:
General

ISO 6743 (all other parts), Lubricants, industrial oils and related products (class L) — Classification

ISO 12100-1:2003, Safety of machinery — Basic concepts, general principles for design — Part 1: Basic
terminology, methodology

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1
lubricant
substance capable of reducing friction, adhesion, heat and wear when introduced as a film between solid
surfaces

3.2
product
any substance intended to be applied or taken into humans or domestic animals, e.g. by ingestion, injection,
topical application, insertion

3.3
manufacture
obtainment, production, preparation and processing of lubricants and of products

© ISO 2006 – All rights reserved 1

ISO 21469:2006(E)

3.4
processing
unit operations such as weighing, measuring, filling and refilling, stamping, printing, packing, container filling,
container sealing/closure, cooling, storage and transportation of products

3.5
intended use
use of a lubricant in accordance with the instructions of the lubricant and machinery manufacturers in
consideration of the expected operating conditions including service life, chemical, thermal and mechanical
loads

3.6
incidental product contact
contact with product that is not intended but which is not preventable

4 List of hazards
The hygiene hazards that could possibly be associated with incidental product contact include the following:

a) biological factors, such as pathogens, spoilage micro-organisms or toxins;

b) chemical factors, such as toxic, carcinogenic or mutagenic substances;

c) physical factors, such as wear metals.

iTeh STANDARD PREVIEW
NOTE It is recognized that in some countries there may be limits on the amount of lubricant that can come into
incidental product contact. (standards.iteh.ai)
ISO 21469:2006
5 Hygiene requirements
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006
5.1 Basic strategy for selection of hygiene measures by the manufacturer

The basic strategy for the selection by a manufacturer of hygiene measures for the design of incidental
product contact lubricants shall be in accordance with ISO 12100-1:2003, 5.1, including

a) identification of the product/process with which the lubricant is to be associated,

b) the hazards associated with the product(s) produced (see Clause 4),

c) the risk assessment associated with each hazard identified (see 5.2),

d) design methods which can eliminate hazards or reduce risks associated with those hazards (see 5.3),

e) means of verification of the effectiveness of the risk reduction method (see Clause 6), and

f) a description of residual risks and any additional precautions that are deemed necessary (see Clause 7).

NOTE Guidance on the process for selecting hygiene measures is also given, schematically, in ISO 14159.

2 © ISO 2006 – All rights reserved

 ISO 21469:2006(E)

5.2 Elements of manufacturer’s risk assessment

The following are representative of the range and types of factors that shall be considered as elements in the
risk assessment of a lubricant during its manufacture, handling, storage, use and replenishment:

a) contamination of the lubricant by the packaging material;

b) contamination of the lubricant with biological factors;

c) contamination of the lubricant by the product;

d) contamination of the lubricant with water;

e) the service age of the lubricant;

f) chemical/physical changes caused by temperature exposure, mechanical activity, oxidation and

degradation;

g) reasonable foreseeable misuse.

The outcome of the risk assessment should translate into corrective and preventative actions in accordance
with defined lubricant quality and usage criteria.

NOTE It is recognized that product contact can lead to changes in product aspect, taste, odour or texture.

5.3 Hygienic design iTeh STANDARD PREVIEW

5.3.1 Classification
(standards.iteh.ai)
Lubricants for incidental product contact areISO to be21469:2006
selected from ISO 6743-99:2002 according to the intended
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
application. They shall conform with the description given in the relevant other part of ISO 6743 and comply
with the related ISO specifications. 4fdde924ce74/iso-21469-2006

5.3.2 Cross-contamination

Lubricants shall be composed in such a way that if cross-contamination with the product occurs, residues in
the processed product are innocuous with respect to the health of the consumer, as well as taste and odour
and such that they do not have any other adverse influence on the product's intended use.

5.3.3 Composition

Lubricants shall meet the qualitative and compositional requirements if they consist only of substances
regarded as being safe for product, or incidental product, contact by governments or other recognized
international organizations. These substances should be included in listings published by government or
recognized international organizations (see Annex A), or which are authorized by them, for use in lubricants
with incidental product contact.

5.3.4 Good manufacturing practice

Manufacturers should exercise care in the manufacturing and packaging of lubricants in order to avoid
contamination such as that from lubricants not intended for incidental product contact.

© ISO 2006 – All rights reserved 3

ISO 21469:2006(E)

6 Manufacturer's compliance verification

The manufacturer shall verify the compliance of the lubricant with the requirements of this International
Standard by means of the following, as appropriate:

a) examination of the formulation and its ingredients;

b) assessment of procedures and practices used in the manufacturing process against defined quality
standards;

c) use of competent third parties providing independent inspection of, for example, the formulation and/or
manufacturing practices;

d) undertaking specific testing when available;

e) use of competent laboratories undertaking testing required for lubricant registration.

7 Information for use

Following hygienic design and manufacture, the hygienic use of the lubricant is dependent on the user taking
additional precautions, at the least those indicated by the manufacturer of the lubricant.

The manufacturer shall provide the user of the lubricant with the following:

a) iTeh STANDARD PREVIEW

clear and correct labelling, which shall include an indication of shelf life and the suitability for use as an
incidental food contact lubricant;
(standards.iteh.ai)
b) appropriate packaging adequately protecting the product from tampering, adulteration, transit, storage
and package deterioration; ISO 21469:2006
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
c) suitable storage requirements. 4fdde924ce74/iso-21469-2006

4 © ISO 2006 – All rights reserved

 ISO 21469:2006(E)

Annex A
(informative)

Acceptable substances for hygienic product contact

The following are examples of suitable national/international sources specifying acceptable substances.

⎯ Joint FAO/WHO Expert Committee on Food Additives (JECFA):

www.fao.org/es/esn/jecfa/database/cover.htm

⎯ Council Directive 95/2/EC of the 18th March 1995 on food additives other than colours and sweeteners.
Official Journal of the European Communities, No. L61/1

⎯ United States Code of Federal Regulations (CFR) 21, Part 178.3570, revised April 2002: Lubricants with
Incidental Food Contact [including references to other paragraphs of CFR1)]

iTeh STANDARD PREVIEW

(standards.iteh.ai)
ISO 21469:2006
https://standards.iteh.ai/catalog/standards/sist/a15e4338-0f58-4b1d-8c5d-
4fdde924ce74/iso-21469-2006

1) Able to be obtained from the US Government Printing Office Superintendent of Documents, Mail Stop: SSOP,
Washington, DC 20202 9328

© ISO 2006 – All rights reserved 5