Regulation 178 Flashcards
Hazard
‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;
traceability
‘traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;
Risk
‘risk’ means a function of the probability of an adverse
health effect and the severity of that effect, consequential to a hazard;
food
‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
Application 852
This Regulation shall apply to all stages of production, processing and distribution of food and to
exports, and without prejudice to more specific requirements relating to food hygiene.
Not apply 852
This Regulation shall not apply to:
(a) primary production for private domestic use;
(b) the domestic preparation, handling or storage of food for private domestic consumption;
(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;
(d) collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.
“food hygiene”
“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;
“contamination”
“contamination” means the presence or introduction of a hazard;
“processing”
“processing” means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes;
“unprocessed products”
“unprocessed products” means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed;
“processed products”
“processed products” means foodstuffs resulting from the processing of unprocessed products.
These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.
scope 853
They shall apply to unprocessed and processed products of animal origin.
scope 853
Unless expressly indicated to the contrary, this Regulation shall not apply to food containing
both products of plant origin and processed products of animal origin. However, processed
products of animal origin used to prepare such food shall be obtained and handled in accordance
with the requirements of this Regulation.
regulation 853 shall not apply
(a) primary production for private domestic use;
(b) the domestic preparation, handling or storage of food for private domestic consumption;
(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;
(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;
(e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.
853 scope
Unless expressly indicated to the contrary, this Regulation shall not apply to retail.
However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:
(i) the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply; or
(ii) the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised
and restricted activity.
10/2011
shall not apply to the following materials and articles which are placed on the EU market and are intended to be covered by other specific measures:
(a) ion exchange resins;
(b) rubber;
(c) silicones
10/2011
This Regulation shall be without prejudice to the EU or
national provisions applicable to printing inks, adhesives or coatings.
the value of migration shall be expressed in mg/kg applying a surface to volume ratio of 6 dm2 per kg of food.
(a) containers and other articles, containing or intended to contain, less than 500 millilitres or grams or more than 10 litres,
(b) materials and articles for which, due to their form it is impracticable to estimate the relationship between the surface area of such materials or articles and the quantity of food in contact therewith,
(c) sheets and films that are not yet in contact with food,
(d) sheets and films containing less than 500 millilitres or grams or more than 10 litres,
the value of migration shall be expressed in mg/kg applying the real surface to volume ratio in actual or foreseen use.
To check the compliance, the specific migration values shall be expressed in mg/kg applying the real surface to volume ratio in actual or foreseen use.
For materials and articles already in contact with food
verification of compliance with specific migration limits shall be carried out in accordance with the rules set out in Chapter 1 of Annex V.
For materials and articles not yet in contact with food
verification of compliance with specific migration limits shall be carried out in food or in food simulants set out in Annex III in accordance with the rules set out in Chapter 2, Section 2.1 of Annex V.
For materials and articles not yet in contact with food
verification of compliance with the overall migration limit shall be carried out in food simulants A, B, C, D1 and D2 as set out in Annex III in accordance with the rules set out in Chapter 3, Section 3.1 of Annex V.
For materials and articles not yet in contact with food
screening of compliance with the specific migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 2, Section 2.2 of Annex V. If a material or article fails to comply with the migration limits in the screening
approach a conclusion of non-compliance has to be confirmed by verification of compliance in accordance with paragraph 2.
For materials and articles not yet in contact with food
screening of compliance with the overall migration limit can be performed applying screening approaches in accordance with the rules set out in Chapter 3, Section 3.4 of Annex V. If a material or article fails to comply with the migration limit in the screening approach a conclusion of non-compliance has to be confirmed by
verification of compliance in accordance with aragraph 4.
ordem de importancia de 10/2011
The results of specific migration testing obtained in food shall prevail over the results obtained in food simulant.
The results of specific migration testing obtained in food simulant shall prevail over the results obtained by screening approaches
Before comparing specific and overall migration test results with the migration limits
the correction factors in Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.
Union list 10/2011
Only the substances included in the Union list of authorised substances (hereinafter referred to as the Union list) set out in Annex I may be intentionally used in the manufacture of plastic layers in plastic materials and articles.
simulantes
Ethanol 10 % (v/v) Food simulant A
Acetic acid 3 % (w/v) Food simulant B
Ethanol 20 % (v/v) Food simulant C
Ethanol 50 % (v/v) Food simulant D1
Vegetable oil (*) Food simulant D2
poly(2,6-diphenyl-p-phenylene oxide), particle size
60-80 mesh, pore size 200 nm Food simulant E
Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract
hydrophilic substances
Food simulant B shall be used for those
foods which have a pH below 4.5.
Food simulant C shall be used for
alcoholic foods with an alcohol content of up to 20 % and those foods which contain a relevant amount of organic ingredients that render the food more lipophilic.
Food simulants D1 and D2 are
assigned for foods that have a lipophilic character and are able to extract lipophilic substances.
Food simulant D1 shall be used for alcoholic foods with an alcohol content of above 20 % and for oil in water
emulsions.
Food simulant D2 shall be used for foods which contain free fats at the surface.
Food simulant E is assigned for
testing specific migration into dry foods.
To demonstrate compliance with the overall migration limit for all type of foods
testing in distilled water or water of equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed
To demonstrate compliance with the overall migration limit for all types of food except for acidic foods
testing in distilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products
testing in food simulant D1 shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk products
testing in food simulant D1 and food simulant B shall be performed
To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol content of 20 %
testing in food simulant C shall be performed.
To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 %
testing in food simulant C and food simulant B shall be performed.
Testing for 10 days at 20 °C
shall cover all storage times at frozen condition
Testing for 10 days at 40 °C
shall cover all storage times at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minute
Testing for 10 days at 50 °C
shall cover all storage time at refrigerated and frozen conditions including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes and storage times of up to 6 months at room temperature.
Testing for 10 days at 60 °C
shall cover long term storage above 6 months at room temperature and below including heating up to 70 °C for up to 2 hours, or heating up to 100 °C for up to 15 minutes.
For storage at room temperature
testing time can be reduced to 10 days at 40 °C if there is scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.
If a material or article is intended for different applications covering different combinations of contact time and temperature
the testing should be restricted to the test conditions which are recognised to be the most severe on the
basis of scientific evidence.
If the material or article is intended for a food contact application where it is successively subject to a combination of two or more times and temperatures,
the migration test shall be carried out subjecting the test specimen successively to all the applicable worst foreseeable conditions appropriate to the sample, using the same portion of food simulant.
To screen if a material or article complies with the migration limits
any of the following approaches can be applied which are considered more severe than the verification method described in section 2.1. Verification method time-temperature
Residual content
Migration modelling
Food simulant substitutes
When applying the maximum levels set out in the Annex to foodstuffs
taken into account if are dried, diluted, processed or composed of more than one ingredient
Nitratos
espinafres frescos 2500-3000 ppm
espinafres congelados 2000
Alface 2000-4000
Cereais processados para infants 200
Aflatoxinas
B1
Soma (B1 B2 G1 G2) =2xB1
M1- leite
Frutos secos e nozes e cereais para consumo direto 2ppb
Para preparar 5-8 ppb
Especiarias 5 ppb
Baby food 0,1 ppb
Leite 0,05 ppbOchratoxin A
geral 2-5ppb
vinho 2
uvas secas e coffe 10ppb
Baby foods 0,5
Patulina
Sumos de maça 50ppb
Produtos de maça sólidos 25ppb
Produtos para criança 10ppb
Deoxynivalenol
cereais nao processados 1250-1750 ppb
pasta e cereais 500-750 ppb
para criança 200ppb
Zearalenone (
cereais e pão 50ppb
crianças 20ppb
Fumonisins
Milho 400ppb
Milho crianças 200ppb
Lead
leite e produtos para criança 0,02ppm
sumos de fruta 0,05ppm
outros 0,1-0,5ppm
Cadmium
todos 0,05-0,2 ppm
bivalves, polvos 1ppm
Mercury
Peixe 0,5-1 ppm
Tin
Canned beverages 100 ppm
Canned foods 200 ppm
Crianças 50 ppm
3-monochloropropane-1,2-diol (3-MCPD)
proteina vegetal molho de soja 20ppb
Dioxins and PCBs
carne 1-3 pg/g fat leite 3 ovos 3 oleos vegetais 0,75 oleos marinho 2
Polycyclic aromatic hydrocarbons
Benzo(a)pyrene
carnes 2-5 ppb
pescados 5-10 ppb
crianças 1 ppb
‘principal field of vision’
means the field of vision of a
package which is most likely to be seen at first glance by the consumer at the time of purchase and that enables the consumer to immediately identify a product in terms of its character or nature and, if applicable, its brand name. If a package has several identical principal fields of vision, the principal field of vision is the one chosen by the food business operator;
‘primary ingredient’
means an ingredient or ingredients of a food that represent more than 50 % of that food or which are usually associated with the name of the food by the consumer and for which in most cases a quantitative indication is required
‘date of minimum durability of a food’
means the date until which the food retains its specific properties when properly stored;
‘nutrient’
means protein, carbohydrate, fat, fibre, sodium,
vitamins and minerals
‘prepacked food’
means any single item for presentation as such to the final consumer and to mass caterers, consisting of a food and the packaging into which it was put before being offered for sale, whether such packaging encloses the food completely or only partially, but in any event in such a way that the contents cannot be altered without opening or changing the packaging; ‘prepacked food’ does not cover foods packed on the sales premises at the consumer’s request or prepacked for direct sale;
‘ingredient’
means any substance or product, including flavourings, food additives and food enzymes, and any constituent of a compound ingredient, used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form; residues shall not be considered as ‘ingredients’;
‘compound ingredient’
means an ingredient that is itself the product of more than one ingredient
‘field of vision’
means all the surfaces of a package that can be read from a single viewing point
‘use by’ date.
In the case of foods which, from a microbiological point
of view, are highly perishable and are therefore likely after a short period to constitute an immediate danger to human health, the date of minimum durability shall be replaced by used by date
Food shall be deemed to be unsafe if it is considered to be:
(a) injurious to health;
(b) unfit for human consumption.
food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay
package<10cm2
nome
alergéneos
quantidade líquida
data de durabilidade
package<25cm2
nome alergéneos quantidade líquida data de durabilidade lista de ingredientes condições especiais de armazenamento e/ou uso nome do business food operator instruções de uso- se necessário
package<80cm2
nome alergéneos quantidade líquida data de durabilidade lista de ingredientes condições especiais de armazenamento e/ou uso nome do business food operator instruções de uso- se necessário informação nutricional Tamanho x 0,9mm
package>80cm2
nome alergéneos quantidade líquida data de durabilidade lista de ingredientes condições especiais de armazenamento e/ou uso nome do business food operator instruções de uso- se necessário informação nutricional Tamanho x 1,2 mm
Declaração nutricional obrigatório
a) energy value; and
(b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt.
Declaração nutricional facultativo
a) mono-unsaturates;
(b) polyunsaturates;
(c) polyols;
(d) starch;
(e) fibre;
(f) any of the vitamins or minerals listed in point 1 of Part A of Annex XIII, and present in significant amounts as defined in point 2 of Part A of Annex XIII.
‘claim’
means any message or representation, which is not
mandatory under Community or national legislation,
including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics;
‘nutrient’
means protein, carbohydrate, fat, fibre, sodium,
vitamins and minerals
listed in the Annex to Directive 90/496/EEC, and substances which belong to or are componentsbof one of those categories;
‘other substance’
means a substance other than a nutrientthat has a nutritional or physiological effect;
‘nutrition claim’ energy
a) the energy (calorific value) it
(i) provides,
(ii) provides at a reduced or increased rate, or
(iii) does not provide; and/or
‘nutrition claim’nutrients
the nutrients or other substances it
(i) contains,
(ii) contains in reduced or increased proportions, or
(iii) does not contain;
‘health claim’ others
means any claim that states, suggests or implies
that a relationship exists between a food category, a food or one of its constituents and health;
‘reduction of disease risk claim’ health claim
means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease;
CCP – Critical Control Point
A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Contamination IFS
Introduction or occurrence of a contaminant in food or food environment. Contamination does include: physical, chemical, biological contamination. Contamination can also mean correlation of packages among themselves.
Correction IFS
Action to eliminate a detected non-conformity or deviation
Corrective action
Action to eliminate the cause of a detected non-conformity, deviation or other undesirable situation
CP – Control point
Identified by the hazard analysis as essential in order to control the likelihood of introducing or proliferation of food safety hazard in the product and / or the environment. A CP can be considered as an OPRP (Operational Prerequisite Program), as defined in ISO 22000.
Deviation
Non-compliance with a requirement but there is no impact on food safety related to products and processes. In the IFS, deviations are requirements scored with a B, C or D and KO requirements scored with a B.
Food fraud
The deliberate and intentional substitution, mislabelling, adulteration or counterfeiting of food, raw materials, ingredients or packaging placed upon the market for economic gain. This definition also applies to outsourced processes
Food defense
The protection of food products fromintentionalcontamination or adulteration by biological, chemical, physical, or radiological agents for the purpose of causing harm.
Formula
Exhaustive description of quantity and quality of raw materials to be used to process the products, as required in customer specifications. Formula can also include technological parameters and specific “know-how” on the process.
Hazard analysis IFS
The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.
Hazard IFS
A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect
Monitoring
The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.
Non-conformity
Non-fulfilment of a specified requirement. Non-conformity can be given in non-respect of legislation, law, food safety, internal dysfunctions and customer issues. In the IFS, de- fined non-conformities are Majors and KO’s scored with a D.
Pasteurisation IFS
Process applied to a product with the objective of minimising possible health hazards arising from pathogenic micro- organisms associated with the product (e.g. milk, creams, ice cream, eggs, fruit juices, fermented products, soups, other beverages etc.) which is con sistent with minimal chemical, physical and organoleptic changes in the product
Product recall
Any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor.
Product withdrawal
Any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer.
Risk IFS
A function of the probability of an adverse health effect and the severity of that effect consequential to (a) hazard(s) in food
Seasonal products
Products which are processed at a specific time in the year, or processes which are used at a specific time in the year, for getting new / different products than those processed all year long.
Sterilisation ifs
Process applied to a product in final packaging (e.g. milk, fermented products, soups, beverages etc.) with the objective of producing commercially sterile products, with an extended (long) shelf life under ambient temperature. The main concern is inactivation of the most heat resistant pathogenic spore, namely C. botulinum
Validation
Confirmation through the provision of objective
evidences that the requirements for the specific intended use or application have been fulfilled.
Verification
Confirmation through the provision of objective evidences that specified requirements have been fulfilled
