FOUNDATIONS OF FOOD

HYGIENE
5-pages report before the debate and the debate we present 5 slides
Exam = multiple choice w penalties
No essay questions.

LESSON 1. FOOD HYGIENE DEFINITION

1. FOOD HYGIENE CONCEPT

Regulation 852/2004; Article 2: ‘food hygiene’, hereinafter called ‘hygiene’, means

the measures and conditions necessary to control hazards and to ensure fitness for
human consumption of a foodstuff taking into account its intended use.

Codex Alimentarius: Food hygiene comprises conditions and measures necessary for
the production, processing, storage and distribution of food designed to ensure a safe,
sound, wholesome product fit for human consumption.

We are also including the food production: treat animals, feed etc. strict definition but in
practice we use in a broad terms of definitions.

Food fraud is a collective term used to refer the deliberate and intentional substitution,
addition, tampering, or misrepresentation of food, food ingredients, or food packaging;
or false or misleading statements made about a product, for economic gain. Intentional,
not complying w the law.

The 4 operational criteria for Food Fraud: KEY WORDS

- Violation of EU Food Law

- Intention

- Economic Gain

- Deception of Customers

Adulteration: Violation of legal quality and safety standard; Violation of labelling

regulation. Change any conditions, ingredient, component of food but can be produce
intentionally or not. Chemical reactions or microbiological reasons, and the products are
not safe to eat.
Intentional adulteration is for an economic point and hide something and its related to
fraud.

Food authenticity: Food is considered authentic or genuine if the product or its contents
correspond to the original condition and the information on the label. They are almost
always related to the origin of the products. (Synthetic honey)

A substitute: In the case of foods in which a component or ingredient that consumers

expect to be normally used or naturally present has been substituted with a different
component or ingredient. Any product that, without deceptive or fraudulent purposes
and with explicit declaration of the purpose pursued, intends to replace totally or
partially a component of a food. Authorized change and its not misleading the
consumers

Safe Food: Food with absence of potentially toxic substances and pathogenic
microorganisms. It is a requirement that must be met to be considered as safe.

Healthy food is any natural or prepared popularly believed to promote good health. A
colloquial term. Regulated by the European commission or asset by an organisation.

Food for consumer health (functional food) contains some type of chemical whose
ingestion has been proved to prevent certain chronic diseases.

2. FOOD EDIBILITY AND QUALITY.

Food: All the substances or products of any nature, solids or liquids, natural or
processed, which due to their characteristics, applications, components, preparation and
state of preservation, are susceptible of being usually or ideally used for any of the
following (Spanish Food Codex): (not a subjective term)

- For the normal human nutrition or as fruitive. (give us pleasure)

- As dietary products in special cases of human feeding. (Infants, elderly, etc)

Fruitive

- Foods are also evaluated based on their palatability "set of factors whereby a
food is desired or accepted".

- EFSA says that insects are food.

- This are therms that define not if the product is food, but as is the product is
acceptable.

EDIBLE (Features) ACCEPTABLE

 (Specifications)
Physical General aspect
Chemical Organoleptic
Biological Phycho-social
Structural Religious
Organoleptic Economic

Food quality: "set of properties or attributes inherent to a food in relation to their

presentation, hygiene, purity, composition, treatment and conservation, responsible
appreciate it as equal, better or worse than the rest of their group and conditions for their
edibility and acceptability" attributes that can make me choose between products.
Quality can include food hygiene.

- Nutritional quality: contribution of food to the supply of nutrients to the diet,

both qualitative and quantitative.

- Sensory Quality: those attributes of the food that are perceived by the senses and
that are related with the acceptability on the user.

- Hygienic-sanitary Quality: absence of potentially toxic substances and of

pathogenic microorganisms.

- Technological Quality: features of the food to be subject to different

technological processes.

- Economic Quality: relationship between its cost and the degree of acceptability.

- Stability Quality: suitability of the food allowing long commercial shelf-life

Food losses and food waste

ERS defines food losses as the amount of food available for human consumption, after
removing bones, pits, peels, and other nonedible parts, that is not consumed for any
reason. It includes moisture losses and cooking shrinkage, loss from moulds,
microorganisms, chemical deterioration or inadequate temperature control.

Food waste is a type of food loss, and examples include edible food discarded by
retailers due to colour or appearance and plate waste thrown away by consumers.

Food waste is food loss at consumer and retail level. The producer level is food loss.

“Best before” and “Use by” dates on food packaging help us prevent food waste and
sabe money. Shelf life is optimized to reduce the food loss or stablish the correct shelf
life.
“Best before” (fecha de consumo preferente) indicates the date until when the food
retains its expected quality.

- Food is still safe to consume after the indicated “best before” day on the
condition that storage instructions are respected and packaging is not damaged,
but it might begin to lose its flavor and texture.

- You have to consume it the in the conditions of the producer.

- Appear on a wide range of refrigerated, frozen, dried, tinned and others.

- Once a food with this date has been opened, follow any instructions such as “eat
within three days of opening”, when applicable.

“Use by” (fecha de caducidad) indicates the date until when the food can be eaten
safely.

- Don´t use any food after expiration of this date.

- When you freeze the product you have to take into consideration the use by
because the product can change

- Appear on highly perishable food, such as fresh fish.

- Follow the storage instructions, if not the food will spoil quicker and you may
risk food poisoning.

- By freezing the food at home son after purchase, you can extend its life beyond
this date, if it is frozen properly.

- Once a food with this date is opened follow storage and use instructions, bearing
in mind that food should be consumed before the expiration of this date.

Araceli

CONTROL AND INSPECTION

- OFFICIAL CONTROL: for which the Public Administration is responsible.
- PRIVATE CONTROL: business or self-control, which is carried out by
institutions, business organizations, regulatory councils, associations of
scientists or consumers, as well as by the technical services of each company,
supervised or not by the official authorities
- CONTROL CONCERTED WITH THIRD PARTIES: whose capacity has been
officially recognized to them, for such function.
RISK: probability of harm or danger. Probability that this danger is and the seriousness
that this produces. Function of the probability of an adverse effect on health and the
severity of this effect, as a consequence of a danger or hazards in food.

DANGER: the agent that has the potential to cause damage. Biological, chemical or
physical agent or properties of a food, capable of causing a harmful effect on health.
LESSON 2. LOSS OF FOOD EDIBILITY

- PHYSICAL FACTORS: changes on organoleptic characteristics.

o Physiological changes: (example: period of spawning fish, fruit

ripening…)

o Pathological changes: appears in the meat, milk and eggs because of

animal diseases. (Example: mastitis, parasites…)

- CHEMISTRY AND BIOCHEMISTRY FACTORS

o Proteins denaturation: the destruction of the secondary and terciary

structures of proteins. The released peptide chains, kept intact its
covalent bonds, but they gather together in an disordered way. The
resulting proteins in this process present different physical properties
which will affect the texture and flavour of food. It is due to temperature,
strong acids, alkalis, ionizing radiation, pH, and the action on surface as
shaking.

o Rancidity of fats (by lipases & autooxidation): It is stimulated by

temperature, light, ionizing radiation, peroxides, lipolytic enzymes, ferric
organic catalysts (Hb) and metal catalysts (Fe, Cu, Zn). It is delayed by
refrigeration, opaque or colored containers, antioxidant and chelating
agent (sequestering of metals).

o Enzymatic & non-enzimatic browning: It is stimulated by hits, peeled,

chopped, crushed, freezing for enzimatic browning of vegetables; and
processing, storage and food liquids in the case of non-enzymatic
browning. It is delayed by refrigeration, opaque or colored containers,
antioxidant, chelatant, low pH, modified atmosphere (MAP), and
controlled heat treatment.

A non-desireable enzymatic browning reaction is involved in the

formation of brown spots on the peel of bananas.
Examples of non-beneficial enzymatic browning: Fresh fruit and
vegetables, including apples, potatoes, bananas and avocados;
polyphenols oxidases is the major reaction in the formation of Melanosis
in crustaceans such as shrimp. Examples of beneficial enzymatic
browning: Developing color and flavor in Coffee, Cocoa beans, and tea,
and developing color and flavor in dried fruit such as figs and raisins.

- MICROBIOLOGICAL FACTORS
 o Intrinsic factors: nutrients, pH and buffer capacity, potential redox,
water activity, antimicrobial constituents.
o Extrinsic or environmental factors: relative humidity, temperature,
gaseous atmosphere.
o Implicit to the microorganism: growth rate, synergism, antagonism,
between microorganisms.
o Processing or treatment: sliced, washed, packing, irradiation,
pasteurization, others.

- CULINARY LOSS: frying, baking, grilling, smoking and roasting. Most high
temperature processes produce son undesirable compounds.

o Undesirable compounds:

 During cooking, nitrosamines are produced from nitrites and

secondary amines, in some smoked, grilled or fried foods, such as
charred meat.

 Acrylamide and heterocyclic amines, (formed by Maillard

Reaction) as well as furan, polycyclic aromatic hydrocarbons, and
chloropropanols/esters.

 Furan: is a volatile chemical that tends to evaporate quickly, if

cannot escape (e.g. in sealed cans or jars), it remains present in
the food for some time.

 Polycyclic Aromatic Hydrocarbons (PAHs) are produced when

any incomplete combustion occurs, from grilling roasting and
frying, but also smoking and drying. Most PAHs are not
carcinogenic, although a few are (such as pyrene and
benzo(a)pyrene).

 Chloropropanols/esters have also been linked with the thermal

treatment of processed food products.

 Nevertheless, most food processing contaminants can be reduced

by modifying cooking times/temperaturas or by the inclusión of
certain additives while not cooking food can lead to higher health
risks, due to microbial contamination.
LESSON 3. FOOD HYGIENE REGULATION

- Regulation or statutory bodies: FAO/OMS, European Comission, European

council, Codex Alimentarius Comission, Food Drug Administration.
- Advisory bodies: EFSA, AECOSAN, Comisión Interministerial para la
Ordenación Alimentaria (CIOA). Providing scientific advice to make the law but
they don’t make the law. La CIOA they try to coordinate between the
communities.

Codex alimentarius is a reference, standard stated by the codex, but is not mandatory
although the ue relies on it to make their regulations.

HYGIENE PACKAGE

Harmonize and increase the efficiency of food control:

- REGULATION (EC) 852/2004 on the hygiene of foodstuffs. Most important

- REGULATION (EC) 853/2004 laying down specific hygiene rules for food of
animal origin.

- REGULATION (EC) 854/2004 laying down specific rules for the organisation
of official controls on products of animal origin intended for human
consumption. (Derogated) specific regulation, with official controls in the
products of animal origin.

- REGULATION (EC) No 882/2004 on official controls performed to ensure the

verification of compliance with feed and food law, animal health and animal
welfare regulations.

The new hygiene rules take into account of the following principles: EXAM

- Primary responsibility for food safety borne by the food business operator. Not
the inspectors.

- Food safety ensured throughout the food chain, starting with primary
production. Must be ensure though the food chain.

- General implementation of procedures based on the Hazard Analysis and

Critical Control Points Principles (HACCP). A special system by the
regulators for the producer to implement in the food industries. knowledge
 - Application of basic common hygiene requirements, further specified for certain
categories of food. Sometimes HACCP it’s not necessary, smaller.

- Registration or approval for certain food premises.

- Development of guidelines for good practice in hygiene or for the application of

HACCP principles as a valuable instrument to aid food business operators at all
levels of the food chain to comply with the new rules.

- Flexibility provided for food produced in remote areas (high mountains,

remote islands) and for traditional production and methods. Flexibility can
be derogated exemption or adapt the regulation. Also, we can exclude (in a
national level you modify the scope from European level to national level) some
activities. At national level: we need to be transparent, and subsidiary principle,
in their own countries.

FOOD REGULATION

- Goal: protect consumer health.

- Food law: set of legislative principles and rules that food sector should comply;
and all those aspects related with them.

- Food regulation: It refers to the set of food normative regulations of mandatory

compliance, and recognized officially by legislative provision published in:

o Official Journal of the European Union.

o Official Journal of Spanish National Office (BOE)

o Official Journal of Spanish Autonomous Communities

o Provincial Journals

o Other international regulations

Organizations regulating and harmonizing all aspects of hygiene, inspection and

control food through guidelines or codes of good practice (origin of food
regulations):

- United Nations Organization for Food and Agriculture

improve "food security" with the regulation and harmonization of food safety
legislation.
 - World Health Organization improve public health by developing programs to
control and eliminate diseases.

Food security exists when all people, always, have physical, social and economic
Access to sufficient, safe and nutritious food which meets their dietary needs and
food preferences for an active and healthy life.

Food security is more general, a broad term, affordable and feed with this food

Food safety we are referring to one specific thing in the food, and its included in
food security

Codex Alimentarius Commission (1962): subsidiary body of the FAO/WHO joint

programme on food standards, develops Codex Alimentarius.

European Council (1949): multidisciplinary body which has, among its objectives, to
improve public health and the hygiene of foodstuffs.

European Commission (2009): program of harmonization of regulations among its

States Members in the field of foodstuffs.

World Trade Organisation: in their general principles: the international trade of food
should respect the principle that all consumers have the right to safe, healthy and
genuine food and to be protected from dishonest commercial practices. Avoid technical
restrictions, because it unifies the regulation. It’s an agreement, a rule for the countries
belonging to the organisation.

Comisión Interministerial para la Ordenación Alimentaria (CIOA): collegiate body

to coordinate and harmonize national food law regulation.

The Spanish Agency for Consumer Affairs, Food Safety and Nutrition
(AECOSAN) incorporates and carries out, within the framework of the General State
Administration, functions relating to the promotion and fostering of consumer and user
rights regarding goods and services, as well as food safety and healthy eating.

- To promote and foster consumer and user rights, both in terms of product safety
and of their economic interests.

- To promote food safety by offering guarantees and objective information to

consumers and economic agents in the Spanish agrofood sector.

- To plan, coordinate and develop strategies and lines of action that foster
information, education and health promotion in the area of nutrition, and
particularly in the prevention of obesity.
The Scientific committee is a risk assessment board in charge of providing AECOSAN
with scientific opinion, defining the research framework to accomplish its role and
coordinating expert groups carrying out risk assessments within the agency remits. This
is made up of two sections: Food Safety and Nutrition; and Consumption.

They are in charge of communication the alerts, the risk, etc. to the consumers and to
the different regions. Also, the industries can contact aecosan to ask for any doubt.

The reports are published in the magazine of scientific committee in aecosan.

Technical Health Regulations/Reglamentaciones Técnico Sanitarias (RTS):

horizontal legislative provisions (Royal Decrees) on technical, health and commercial
aspects of a specific food sector (elaborated by the CIOA)

Standards of quality/Normas de Calidad (NC): vertical detailed provisions on

agricultural, livestock or fishery product regarding conditions and characteristics for
appropriate marketing in the domestic market

Types of European standards:

- Regulations have binding legal force throughout every Member State and enter
into force on a set date in all the Member States.
(Example: Food Information to Consumers Regulation 1169/2011) .

- Directives lay down certain results that must be achieved but each Member
State is free to decide how to transpose directives into national laws.
(Example: Directive 2002/46 on the approximation of the laws of the Member
States relating to food supplements).

- Decisions are EU laws relating to specific cases and directed to individual or

several Member States, companies or private individuals. They are binding upon
those to whom they are directed.
(Example: Commission Implementing Decision 2016/1189 authorizing UV-
treated milk as a novel food (see Article 3)).

- Recommendations differ from regulations, directives and decisions, in that they

are not binding. A recommendation allows the institutions to make their views
known and to suggest a line of action without imposing any legal obligation on
those to whom it is addressed. (Example: Infant and young child feeding:
standard recommendations for the European Union).

- An opinion is an instrument that allows the institutions to make a statement in a

non- binding fashion, in other words without imposing any legal obligation on
 those to whom it is addressed. An opinion is not binding. It can be issued by the
main EU institutions. (Example: EFSA draft opinion on the risks from BPA).

General Sanitary Register of food companies and food/Registro General Sanitario de

Empresas alimentarias y alimentos

• What is the RGSEAA?

• What does the food company registration number mean?

• Which companies must register in the national RGSEAA?

• Which establishments should register in regional registers?

LESSON 4: NATURAL TOXINS

“Natural toxins are chemicals that are naturally produced by living organisms. These
toxins are not harmful to the organisms themselves, but they may be toxic to humans,
when eaten.”

Classification of natural toxins on the basis of the way of action:

As Anti-nutrient substances of natural origin are classified according to the type of

nutrients that they interfere with:

•Chemicals affecting the digestive or metabolic use of protein (enzyme

inhibitors) (amylase inhibitors)

•Chemicals that interfere with the assimilation of minerals (phytic acid)

•Chemicals that inactivate or increase the requirement for vitamins (thiaminase)

I.- Intrinsic components of plant foods

 II.- Intrinsic components present in foods of animal origin.

Coturnism: illness featuring muscle tenderness and rhabdomyolysis (muscle cell

breakdown) after consuming quail (Coturnix coturnix, from which the name
derives) that have fed on poisonous plants. For wild animals.

SEAFOOD BIOTOXINS

Ichthyotoxicosis: Clinical syndromes caused by toxins present in fish and fish

muscle, that can be produced by the fish itself or my algae that are ingested by
the fish.

CIGUATERA FOOD POISONING: Clinical syndrome caused by eating

fish contaminated with ciguatoxins (CTXs) produced by the
dinoflagellate species Gambierdiscus (algae). The number of people
suffering of the disease annually was estimated from 10,000-50,000 to
50.000-500.000 individuals, but true incidence is difficult to know due to
under ascertainment and under reporting.

80% of gp cases are not reported, underdeveloped countries, homemade

remedies, countries do not report it.

Ciguatoxins are a heat-stabile toxin. Characterized mainly by

neurological, gastrointestinal, and, in the most severe cases,
cardiovascular disorders (6–10) Toxicological effects of ciguatoxins are
attributed to the toxins’ modulating effect on Na+ channels, which result
in increased membrane depolarization. The most known are lipophilic,
but there are also Water-soluble toxins, such as maitotoxin, coexist with
ciguatoxins in G. toxicus.

Change in the distribution of the disease, global warming and importing

cases. Mainly in tropical to template regions, also with the global
importations, contaminated fish to Spain.

Mitilotoxicosis: Clinical syndromes caused by toxins present in shellfish

(Molusk).
 Saxitoxins and other related toxins: proliferations of algea

 Ficotoxins, produced by algae, and accumulate by mollusks. For

example: “Paralytic shellfish poisoning”,

 Red tides

 La saxitoxina is a complex alkaloid (heterocyclic guanidines): very sever

symptoms, source of intoxications but not if you swim, only if you eat an
infected fish, not fishing. 21 types

 Goniautoxins: analogue to saxitoxin

 Thermostable and nearly insoluble in water

 Severe neurotoxic effect: From mild, severe to death.

Biogenic amines

Fish microbiota

➢ Scombroids (tuna) with poor storage practices

➢ Histamine (hypertensive: increase of preasure)

(most common) / tyamine (hypotensive)

➢ Thermostable, not removed by treatment. Fish must be maintained at a temperature

approaching melting ice to avoid the growth of spoilage and histamine producing
bacteria and maintain the cold chain.

➢ Gastro-intestinal, neurological and skin symptoms, common outbreak and common

and mild symptoms.
 SECTION II: PROCESS HYGIENE

LESSON 1: Approaches for Food Safety management

Historical remark “The 1993 Jack-in-the-Box outbreak caused by Escherichia coli

O157:H7, the United States began to look for a more robust regulatory food safety
system than previously employed.” “In the same time frame in the United Kingdom, an
outbreak of Bovine Spongiform Encephalopathy (BSE) eroded public trust in the food
safety systems of Western Europe”.

Managing of food hygiene and safety.

Driving factors
A high level of protection of human life and health should be assured in the pursuit of
Community policies (Regulation 178/2002). Oldest regulation (basis for other
regulation, responsibility for food and feed companies)

The operators of food and feed companies should ensure at all steps of the production,
transformation and distribution under their control that food and feed meet the
requirements of the legislation relevant to the effects of their activities

White Paper on Food and Feed, principles of food control (Libro blanco)

Disadvantages for the retrospective system us that the sample is destructive, we don’t
check step by step.

Remove the hazard if you have it a preventive system. But it doesn’t means you don’t
have to analyse the final product. Its what we do right now.

Driving factors: complexity and interconnection

• Globalized market

• Novel food and new ways of consumption

• Complex formulas and processes

• Automatization and high speed of processes

Risk management tools

One Health approach that would match the complex, adaptive problems of food safety
with shared, adaptive, and holistic problem solving that considers the entire food
system.
Health of everyone, animals, plants, food, environment, etc. affect the health of humans,
also can affect the food. We need to understand this connection. Consider health as a
whole.

Risk management scheme

The establish a public health goal, number of cases of an illness. And they implement
all the measures no to reach the number. The prevent system is not in the hands of the
government but in the industries, the translate or communicate the information by
HACCP and the GHP/GMP or SOP.

Program prerequisites or
hygiene programs: the base of the pyramid and then go to the top (HACCP).

They are a set of recommendations; measures you have to apply to ensure food safety.
LESSON III: FOOD CONTACT MATERIALS

METALS

 The main issue, in the past, was lead migration from solderings used to seal cans
and in the inside layers.
 Different technological alternatives have greatly reduced lead migration.
 Testing is getting complex due to the coatings on the surfaces. The most used
simulant is 3 % acetic acid.
 Still, problematic, due to direct contact with metal surface. New alternatives
have to be validated.
 Migration from coating resins: epoxy resins –PVC and additives from plastics
(corrosion inhibitor, pH modifiers, antioxidant and biocides)
 Low migration rate.

PLASTIC MATERIALS
A plastic material is made up of primarily of one or more polymers. The polymers can
be forming a more (crystalline) or less (amosphous) organized networks.

Additives are formulated in plastics at very low amounts to:

 -enhance polymerization
 -Molding
 -reduce degradation
 They are not inert materials.

Other compounds in plastic material can be rest from productions (residues of

monomers and oligomers)

TYPES OF PLASTIC MATHERIALS

Homopolymers: macromolecules made up of the repetition of a single type of

monomeric unit.

Copolymers: macromolecules made up of the repetition of a two or more types of

monomeric units

Mixture of polymers: consisting of the mixture of two o more polymers, homo or co

polymers.

Polyesters:

• Thermoset polyester based on styrene

 • 1000-1500 mg/kg volatiles in plastic

They provide substances to the food when heated (monomer, oligomer, residues from
the polimerization process, transformed or modifiers (additives))

ADDITIVES

 Plasticizers (softeners) are compounds added to plastic materials to make them

soft.
 Nowadays, PVC is still the most widely used plastic, containing softeners
 Soft PVC can contain up to 50 % plasticizer

- Antioxidants such as butylated hydroxyanisole (BHA) and butylated

hydroxytoluene
- Flame-retarding compounds (halogenated-chlorinated and brominated,
hydrocarbons, organophosphate esters)
- Plasticizers such as esters of dicarboxylic acids, polyesters of adipic acid and
glycols (polymeric softeners)
- Epoxidated soybean oil (ESBO; acts as softener, heat stabilizer, lubricating
mould substances

PVC

PVC a synthetic resin made from

the polymerization of vinyl
chloride.

Many products made up of PVC

was found to contain high
concentration of monomers of vinyl
chloride:

• In 1973, it was found that alcoholic beverages in PVC bottles could contain up to 0.2-
0.5 mg of vinyl chloride per litre.

• Later, butter /margarine and vegetable oils presented levels of 50 mg and 15 mg per
Kg, respectively.

• A 13-week study on rats clearly showed that vinyl chloride at a dose of 30 mg /kg BW
was toxic (carcinogenic). We have the migration and the monomers, that has health
effects. We have to make sure we have low level of the monomer to plastic.

Public health Issues

Legislation and industrial efforts to set limits for monomer residues have achieved to
gradually reduce monomer leakages. PVC from the milking machine, contamination in
an early step of the production.
DEHA (di-(2 ethylhexyl) adipate) and DEHP (di-(2-ethylhexyl) phthalate) are Softener
for PVC films

DEHP and milk from cow to mouth:

- -Use for softening tubes in milking machines

- -Danish legislation against the use of these tubes in 1989
- -Control by FDA in milk marketed for consumption (low exposure)
- -Commission Directive 2007/19/EC→ Specific Migration Limit (SML) of
1.5mg/kg

We must establish some control limits. Migration limits (softeners): monomers,

additives, colorants and impurities are the most migration components to control.

Migration of DEHA (and DEHP) is an increasing problem due to the use of softened
plastic container and wrappings.

SML are established.

Alternatives using polymeric softeners (polysters of adipic acid and glycols and ESBO).

ESBO also migrates, elastic wrappings contain up 11% ESBO; PVC seals in bottle
closures can reach up to 34 % ESBO and weaning food bottles can have between 0.5
and 51 mg/kg. Plastic substitute but is still migrating.

Migration of low-molecular-weight additives from rubber products

- 2-mercaptobenzothiazol (MBT) used for latex: Residues can be found in

feeding-bottles and dummies.
- MBT seems to play a major role in the development of allergy to latex
- A limit of 8 mg/Kg MBT is established as SML for rubber (CEN)

Legal concepts

11) ‘overall migration limit’ (OML) means the maximum permitted amount of non-
volatile substances released from a material or article into food simulants;

(12) ‘food simulant’ means a test medium imitating food; in its behaviour the food
simulant mimics migration from food contact materials;

(13) ‘specific migration limit’ (SML) means the maximum permitted amount of a given
substance released from a material or article into food or food simulants;

(14) ‘total specific migration limit’ (SML(T)) means the maximum permitted sum of
particular substances released in food or food simulants expressed as total of moiety of
the substances indicated; more than one specific substance for the limit (proportions)

Bisphenol A (BPA)
A monomer used in the most common type of polycarbonate plastic, which is clear and
shatter-proof.

BPA can act as oestrogen. Low-dose effects of BPA in rodents. Endocrine disrupter

Controversy: Several Risk assessment, Reviews (EFSA, 2006). In April 2008, US

National Toxicology Program (NTP):neural and behavioral effects in fetus, infant and
child at current exposure levels. Endocrine disruptor, hormones function.

- Study by EFSA of the elimination process and differences between Adults and
infants.
- EFSA Panel of Food Additives flavourings, Processing Aids and Material in
contact with FOOD (AFC) established TDI of 0.05 mg/kg.
- EFSA is not prohibiting the use of bisphenol A

European legislation

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.

Regulation (EC) No. 2023/2006 of 22 December 2006 on good manufacturing practice

for materials and articles intended to come into contact with food.

- ❑ containers for transporting food

- ❑ machinery to process food
- ❑ packaging materials
- ❑ kitchenware and tableware

Require that materials are:

1. General “inertness” of material;

2. Not release their constituents into food at levels harmful to human health or
change food composition, taste and odour in an unacceptable way
3. Rules for Active and intelligent materials: Active and intelligent materials
extend the shelflife by maintaining or improving the condition of packaged food,
by releasing or absorbing substances to or from the food or its surrounding
environment.
- Framework for additional EU measures for specific materials (e.g. for
plastics)
- Procedure to perform safety assessments of substances used to
manufacture FCMs involving the European Food Safety Authority
- Labelling and Symbols for labelling food contact materials.
- For compliance documentation and traceability
 - Indicate expiry of food through release of colourchange-provoking
substances subject to duration and temperature of storage (TTI).

Comission Regulation EU no 10/2011

To ensure the safety, quality and compliance of plastic materials, adequate data on the
composition of (intermediate) materials has to be communicated via the manufacturing
chain, up to but not including the retail stage. For this purpose, a 'Declaration of
Compliance' (DoC) needs to be provided.

It is something declarating that the plastic is safe in terms of compositions. Mandatory

in all steps before retailing. Everything has to be register.

Annex IV

- Testing for specific migration of materials and articles already in contact

with food
- Testing for specific migration of materials and articles not yet in contact
with food
- Testing for overall migration
- Correction factors applied when comparing migration test results with
migration limits.

Plastic plate

- Food simulants
- Materials and articles intended for contact with all types of food shall be
tested with food simulant A, B and D2.
- OM conditions: inmers the plate in a solution simultant of the food, and afer
the 2 hours you analise the simulant.
- OM3 (2 hours at 70 °C) the conditions you must test.
- SM conditions, in which is the conditions you have to do the testing.
- Testing for 2 hours at 70 °C.
- Testing plates by article filling method or by total immersion method; if V
plate < 0,5L, results of specific migration should use the relation of
6dm2/1kg of food. Apply the correction factor when we inmerse the plate.
There are guidelines provided by the European commission, and some labs that that
these procedures that are very diverse

Regulation (EC) No. 2023/2006 (general regulations, how to do the plastic plate)

ensures that the manufacturing process is well controlled so that the specifications for
FCMs remain in conformity with the legislation:

 premises fit for purpose and staff awareness of critical production stages.
 documented quality assurance and quality control systems.
 selection of suitable starting materials for the manufacturing process with a view
to the safety and inertness of the final articles. There is another regulation for
starting materials (companies that make the plastic have to have the plastic
already certificated, safe in terms of impurities).
 Good manufacturing rules apply to all stages in the manufacturing chain of food
contact materials, although the production of starting materials is covered by
other legislation.