Yearbook 2013/2014 - ehedg

18 Legal requirements for hygienic design in Europe
EU Regulation 1935/2004 on materials and articles
intended to come into contact with food covers the following
equipment: processing machinery and filling equipment, and
kitchen equipment, containers, and packaging materials. The
regulation specifically requires that food-contact materials
and equipment comply with the following:
• No human health hazards
• No indefensible modification of food composition
• No detraction from organoleptic food properties
• No misdirection of customers
• Use of ‘for food contact’ or the symbol (Figure 2). (This
symbol is only needed, if there is no instruction manual
and if it is not obvious that this is for food contact).
• Traceability on all manufacturing and distribution steps
EU Regulation 2023/2006 of 22 December 2006 on good manufacturing
practice (GMP) for materials and articles intended to come
into contact with food requires that the following must be set up and
installed for all producers of materials intended to come into contact
with food and are covered by EU Regulation 1935/2004:
• Quality assurance system
• Quality control system
• Documentation
According to Article 2 of EC 2023/2006: “This regulation shall
apply to all sectors and all stages of manufacture, processing
and distribution of materials and articles, up to but excluding
the production of starting substances.” This means that,
for example, all producers of plastic materials must have a
quality system that includes the required documentation if
they produce materials intended to come in food contact.
Depending on the risk assessment, this documentation must
be more or less detailed, corresponding to the known or
potential risk.
To prevent consumers from absorbing toxic substances
that may leach from plastics that come into contact with
foods, the European Commission has issued EU Regulation
10/2011 on plastic materials and articles intended to come
into contact with food. Rubber and silicone materials are not
covered by this regulation. Since there is nothing specific
for seals in Europe, the US Food and Drug Administration
(FDA) Code of Federal Regulations (CFR) 21 is commonly
used in Europe.
Food safety is the core interest of the European Commission.
EC Directive 2006/42/EC, or the Machinery Directive, which
came into force at the end of 2009, sets up the essential
requirements for machinery. All machines brought to the
European market must fulfil these requirements. The CE
mark, which identifies industrial equipment as in compliance
with all the of safety requirements established by the
European Union must appear on each unit (Figure 1).
Annex I of the Machinery Directive describes in detail what
has to be taken into consideration to build safe machines.
Of particular interest to the food industry is Chapter 2.1 of
Annex I, entitled ‘Foodstuffs machinery and machinery for
cosmetics or pharmaceutical products.’ This chapter not only
takes into consideration potentially hazardous situations
for equipment operators and the environment in which the
machine is used, but it is the only chapter in this directive
that refers to the potential hazards for the consumer of the
product produced on these machines. Essentially, this means
that mistakes caused by neglecting these requirements can
have a strong impact on public health.
The Machinery Directive states that all surfaces (with the exception
of disposable parts), including joining areas that come into product
contact must:
• Be smooth, without ridges or crevices
• Reduce projections, edges and recesses to a minimum
• Be easily cleaned and disinfected
• Inside surfaces must have curves of a radius sufficient
to allow sufficient cleaning
From a hygienic design perspective, the following re quirements
are particularly noteworthy:
• It must be possible for liquids, gases and aerosols
deriving from products and from cleaning, disinfecting
and rinsing fluids to be completely discharged from the
machinery.
• Machinery must be designed and constructed in such
a way as to prevent any substances or living creatures,
in particular insects, from entering, or any organic
matter from accumulating.
• Machinery must be designed and constructed in such
a way that no ancillary substances that are hazardous
to health, including the lubricants used, can come into
contact with products.
Figure 2. EU food contact symbol used for marking materials
intended to come into contact with food in the European Union as
defined in EU Regulation 1935/2004.
For food processing machines, so-called “C-Standards”
also are provided in some detail, including how the design
of the machine (e.g., the roughness of the surfaces)
should be addressed in machines used in contact with
specific products. The standards EN ISO 14159, “Safety
of machinery - Hygiene requirements for the design of
machinery” and EN 1672-2, “Food processing machinery -
Basic concepts - Part 2: Hygiene requirements” describe the
aim of the Directive through examples.
In addition to these standards, the European Hygienic
Engineering & Design Group (EHEDG) Guideline 8 criteria
and the EHEDG Guideline 13, Hygienic design of equipment
for open processing, offer additional guidance. The content