SIST-TP CEN/TR 15623:2008

SLOVENSKI STANDARD
SIST-TP CEN/TR 15623:2008
01-april-2008
Stroji za predelavo hrane - Smernice - Materiali v stiku z živili
Food processing machinery - Route map - Materials for food area
Leitlinie - Materialien in Kontakt mit Nahrungsmitteln
Machines pour les produits alimentaires - Carte routière - Matériaux destinés à la zone
alimentaire
Ta slovenski standard je istoveten z: CEN/TR 15623:2008
ICS:
67.250 Materiali in predmeti v stiku z Materials and articles in
živili contact with foodstuffs
67.260 Tovarne in oprema za Plants and equipment for the
živilsko industrijo food industry
SIST-TP CEN/TR 15623:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 15623:2008

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SIST-TP CEN/TR 15623:2008
TECHNICAL REPORT
CEN/TR 15623
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
January 2008
ICS 67.260

English Version
Food processing machinery - Route map - Materials for food
area
Machines pour les produits alimentaires - Carte routière - Nahrungsmittelmaschinen - Leitlinie - Werkstoffe im
Matériaux destinés à la zone alimentaire Nahrungsmittelbereich
This Technical Report was approved by CEN on 16 June 2007. It has been drawn up by the Technical Committee CEN/TC 153.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15623:2008: E
worldwide for CEN national Members.

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Contents Page
Foreword.3
1 Scope.4
2 Terms and definitions .4
3 Selection method for the materials.4
3.1 Global consideration.4
3.2 Example list of considerations to be taken into account at each stage of the flow chart
(see Figure 2).5
4 Legal and normative references for materials.7
5 Migration test methods .11
Annex A (informative) Useful websites addresses .12
Bibliography .13

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Foreword
This document (CEN/TR 15623:2008) has been prepared by Technical Committee CEN/TC 153 “Machinery
intended for use with foodstuffs and feed”, the secretariat of which is held by DIN.
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1 Scope
This document gives guidance to machinery manufacturers for the selection of suitable materials which will be
used in the food area of machines intended for the production of food.
It provides a selection process, showing those matters that need to be taken into consideration and the
decisions that have to be made.
NOTE Be aware that references of this document can be amended, deleted or new references can become available.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
food
any product, ingredient or material intended to be orally consumed by human or animal
[EN 1672-2:2005, definition 3.1]
2.2
food area
machinery surfaces which are exposed to the food and from which the food or other materials can drain, drip,
diffuse or be drawn into (self returned) the food or food container
[EN 1672-2:2005, definition 3.4.1]
3 Selection method for the materials
3.1 Global consideration
3.1.1 Not only the production conditions shall be considered but for instance also environmental and
cleaning conditions, economical considerations, hygienic aspects will influence the choice of the materials see
Figures 1 and 2.

e. g. solidity threshold values, density, elastic module,
hardness

e. g. availability, costs, production cost

e. g. Ability of recycling, ability of re-use, waste products

e. g. allergenic effect, toxicity, mutagenicity,
teratogenicity

e. g. Corrosion resistance, surface condition, ability of
cleaning and disinfection

Figure 1 — Schematic approach to the choice of materials
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Figure 2 — Flow chart for the choice of materials
3.1.2 Materials shall be suitable for intended use.
Surfaces of materials and coatings shall be durable, cleanable and where required capable of being
disinfected, without breaks, resistant to cracking, chipping, flaking and abrasion and prevent penetration of
unwanted matter under intended use.
NOTE This subclause corresponds to 5.2.1 of EN 1672-2:2005.
3.1.3 In addition to the general requirements (see 3.1.2), under intended conditions of use, the materials
shall be:
 corrosion resistant;
 non toxic;
 non absorbent (except when technically or functionally unavoidable).
The materials shall:
 not transfer undesirable odours, colours or taint to the food;
 not contribute either to the contamination of food or have any adverse influence on the food.
NOTE This subclause corresponds to 5.2.2 of EN 1672-2:2005.
3.2 Example list of considerations to be taken into account at each stage of the flow chart
(see Figure 2)
a) Consider the nature of the food and physical environmental conditions:
 description of the food coming into contact with the surface in the food area:
• type of food (vinegar, salted products, fruit juice, sausage, presence of abrasives particles,
stones of fruits, tough powder, etc.);
• type of additives (citric acid, acetic acid, colorants, etc.);
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 composition of the elements in contact:
• pH of the food product;
• combined with high level of salt, with high temperature;
• quality of water (TH, CaCO , Fe, Cl, etc.);
3
• presence of pieces of food, flour, etc;
 description of the cleaning and disinfecting products:
• composition of the cleaning and disinfecting agents;
• parameters during cleaning and disinfecting (time, concentration and pH, temperature, flow rate,
etc;
 temperature:
• during production time;
• during cleaning time;
 humidity of the environment.
b) Consider the conditions of production, cleaning, disinfection and/or sterilisation:
 conditions of circulation, agitation (speed, turbulence);
 thermal stress (hot, cold, cycling);
 pressure stress;
 radiation (Ultra Violet, Infra Red, etc.);
 mechanical erosion (mixing, scraping);
 chemical corrosion;
 condensation.
c) Consider the material:
 type of materials (metals, alloys, plastics, rubbers, etc.);
 structure and composition;
 corrosion (galvanic, pitting, stress, etc.);
 state of the material at the delivery (relief treatment, temper, etc.);
 surface treatment (mechanical, electrolytic, thermal, coating, etc.);
 stress zone (welding area, deflection, etc.).
d) Consider the need for testing (corrosion tests, qualification of thermal or chemical treatment, mechanical
properties, cleanability, etc.).
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4 Legal and normative references for materials
The Regulation (EC) No. 1935/2004 entry into force on 6 December 2004 (20 days after publication) and
27 October 2006 in the case of article 17 on traceability requirements. This regulation repeals directives
80/590/EEC and 89/109/EEC. Also the Regulation 2023/2006 is published. The main content is defined below.
The recourse to regulations as a legal instrument for execution provisions, in place of specific execution
provisions, will allow provisions to be applied in a uniform manner throughout the European Union.
A regulation need not be transcribed into national law for it to become applicable.
The inclusion of “active and intelligent materials and articles”.
The procedure for the authorisation of new substances and for their addition to an existing positive list is
detailed. Request is to be submitted to the relevant national authority which informs and forwards the
application to the European Food Safety Authority (EFSA instituted by regulation EC no. 178/2002). EFSA
informs the other member states and the Commission, checks the validity of the dossier and must issue an
opinion within six months (possibly 6 months more with justification). It should also be noted that there will be
general access to applications except for parts which are clearly marked as and accepted as being
confidential (Article 20 of the Regulation).
NOTE Guidance on the administrative and technical data required and on the format for formal submissions is
available on the EFSA website address (see Annex A).
Requirements for establishing systems for good manufacturing practices (GMP) are introduced for materials
intended to come into contact with food.
st
NOTE Regulation 2023/2006 applies from 1 August 2008.
Traceability requirements for materials and articles intended to come into contact with food are provided in
article 17 (see also consideration 18).
Specific safeguarding measures for materials and articles intended to come into contact with food are
provided in article 18. These may be taken by a member state, should circumstances so require it, in the
event of a risk to human health.
Reference laboratories: A community reference laboratory and several national reference laboratories shall be
designated according to article 24 (see also consideration 23).
New materials that may be subject to specific directives: In addition to “active and intelligent materials and
articles”, there are plans to add two additional groups of materials, these being ion exchange resins and glues.
Annex 1 of the regulation 1935/2004 gives a list of groups of materials for which specific measures may be
adopted, such as (see article 5 of the regulation for the complete list of the "Specific measures for groups of
materials and articles"):
a. a list of substances authorised for use in the manufacturing;
b. purity standards for substances referred to in (1);
c. limits on the migration of certain constituents;
d. global limit of migration, etc.
The elements of this list are indicated below in the Table 1.
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Table 1
Groups of materials Legal references Standards references Other references
Materials in contact with
Regulation 1935/2004
All materials – food – EHEDG document
Regulation 2023/2006
32.
Active and intelligent
No specific Directive - -
materials and articles
Adhesives No specific Directive - -
 Directive 84/500/EEC
 Directive
1)
Ceramics - -
2005/31/EC
 Directive 69/493/EEC
(Crystal glass)
Cork No specific Directive - Resolution AP (2004) 2
 Resolution AP (2004)
4
Rubbers Directive 93/11/EEC –
 Policy statement
concerning rubber
products
Guidelines on lead
Directive 69/493/EEC
Glass – leaching from glass
2)
(Crystal glass)
tableware into foodstuffs
Ion-exchange resins No specific Directive – Resolution AP (2004) 3
Policy statement –
Metals and alloys –
– – Guidelines on metals and
General
alloys
 EN 573-3
Metals and alloys – Guidelines on metals and
Aluminium and aluminium No specific Directive alloys used as food
 EN 601
alloys contact materials
 EN 602
 EN 10333
 EN 10334
Metals and alloys – Steels No specific Directive –
 EN 10335
 EN 14392:2007


1) Second modification of the directive 84/500/EC planned to establish stricter migration limits on lead and cadmium and
to extend its scope to glass and enamelled articles.
2) In fact, this directive does not relate to the food aspects of crystal glass, but solely to the designations authorised
depending on the composition.
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Table 1 (continued)
Groups of materials Legal references Standards references Other references
 EN 10020
 EN 10028-7
 EN 10088-1
 EN 10088-2
 EN 10088-3
 EN 10095
 EN 10151
 EN 10213-4
 EN 10216-5
There is no directive
 EN 10217-7
Metals and alloys –
which deals with migration –
Stainless steels
 EN 10222-5
test for metals and alloys.
 EN 10217-7
 EN 10222-5
 EN 10250-4
 EN 10263-5
 EN 10264-4
 EN 10270-3
 EN 10272
 EN 10283
 prEN 10296-2
 Resolution AP
(version 2, 13-04-
2005) on paper and
board materials and
Paper and board – –
articles
 Policy statement
(2004)
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Table 1 (continued)
Groups of materials Legal references Standards references Other references
 Directive 2002/72/EC
(Lists of usable
monomers, migration
limits, list of additives)
 Directive 2004/1/EC
 Directive 2004/19/EC
 Directive 2005/79/EC
 Directive 2007/19/EC
 Directive 82/711/EEC
(migration test)
 Directive 93/8/EEC
 Directive 97/48/EC
 Resolution AP (89) 1
 Directive 85/572/EEC
3)
–
Plastics  Resolution AP (92) 2
(list of simulant)
 Directive 2002/16/EC
– Epoxy (BADGE,
BFDGE, NOGE)
 Directive 2004/13/EC
 Directive 78/142/EEC
(vinyl chloride
monomer)
 Directive 80/766/EEC
(vinyl chloride
monomer)
 Directive 81/432/EEC
(vinyl chloride
monomer)
Printing inks – – Resolution AP (2005) 2

3) Regulations for plastic materials do not apply to materials or articles comprised of two or more layers, when at least
one of these layers contains a material other than plastic. These are based on a positive list principle (monomers and
other authorised starting compounds), which sets global migration limits and, for certain monomers, a specific migration
limit or maximum quantity of the residual substance. Draft amendment dated 20/2/2003 already ready.
A new regulation is currently being drafted to replace all the directives on plastics: Directive 2002/72/EC and its
amendments (2004/1, 2004/19, 2005/79, 2007/19). The regulation will also replace the directive 82/711 and its two
amendments, 93/8/EEC and 97/48/EC, as well as the three directives on vinyl chloride monomer: 78/142/EEC,
80/766/EEC and 81/432/EEC (see the chapter on tests methods).
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Table 1 (continued)
Groups of materials Legal references Standards references Other references
 Directive 93/10/EEC
(regenerated
4)
cellulose)
Regenerated cellulose – –
 Directive 93/111/EC
(Amendment 1)
 Directive 2004/14/EC
(Amendment 2)
Silicones No specific directive – Resolution AP (2004) 5
textiles – – –
Framework Resolution
AP (2004) 1
Varnishes and coatings – –
Policy statement
concerning coatings
waxes – – –
wood – – –

5 Migration test methods
The migration test shall consider the application of the materials. The time of contact between material and
food product could not be compared between a package and a machine. Moreover certain machines process
tons of products per hours, so the migration is highly diluted.

4) Future modifications to directive 93/10/EEC should enable compatibility with recycling laws to be attained. The
previous directive 83/229/EEC relating to materials and articles made from regenerated cellulose film and its modifications
(directives 86/388/EEC and 92/15/EEC) have been repealed by directive 93/10/EEC.
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Annex A
(informative)

Useful websites addresses
 Council of Europe: http://www.coe.int/soc-sp
 EFSA: http://www.efsa.eu.int/science/afc/afc_guidance/722_en.html
 EHEDG: http://www.ehedg.org/
 European Commission: http://europa.eu.int
 European Parliament: http://www.europarl.eu.int/


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Bibliography
[1] Regulation (EC) 1935/2004 of the European Parliament and of the Council of 27 October 2004 relating to
materials and articles intended to come into contact with food, and repealing Directives 80/590/EEC and
89/109/EEC
[2] Commission regulation 2023/2006 of 22 December 2006 on good manufacturing practice for materials
and articles intended to come into contact with food
[3] Directive 98/37/EC of
...