Regulation 178

Question 1

Hazard

Answer 1

‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect;

Question 2

traceability

Answer 2

‘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;

Question 3

Risk

Answer 3

‘risk’ means a function of the probability of an adverse

health effect and the severity of that effect, consequential to a hazard;

Question 4

food

Answer 4

‘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.

Question 5

Application 852

Answer 5

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.

Question 6

Not apply 852

Answer 6

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.

Question 7

“food hygiene”

Answer 7

“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;

Question 8

“contamination”

Answer 8

“contamination” means the presence or introduction of a hazard;

Question 9

“processing”

Answer 9

“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;

Question 10

“unprocessed products”

Answer 10

“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;

Question 11

“processed products”

Answer 11

“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.

Question 12

scope 853

Answer 12

They shall apply to unprocessed and processed products of animal origin.

Question 13

scope 853

Answer 13

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.

Question 14

regulation 853 shall not apply

Answer 14

(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.

Question 15

853 scope

Answer 15

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.

Question 16

10/2011

Answer 16

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

Question 17

10/2011

Answer 17

This Regulation shall be without prejudice to the EU or

national provisions applicable to printing inks, adhesives or coatings.

Question 18

the value of migration shall be expressed in mg/kg applying a surface to volume ratio of 6 dm2 per kg of food.

Answer 18

(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,

Question 19

the value of migration shall be expressed in mg/kg applying the real surface to volume ratio in actual or foreseen use.

Answer 19

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.

Question 20

For materials and articles already in contact with food

Answer 20

verification of compliance with specific migration limits shall be carried out in accordance with the rules set out in Chapter 1 of Annex V.

Question 21

For materials and articles not yet in contact with food

Answer 21

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.

Question 22

For materials and articles not yet in contact with food

Answer 22

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.

Question 23

For materials and articles not yet in contact with food

Answer 23

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.

Question 24

For materials and articles not yet in contact with food

Answer 24

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.

Question 25

ordem de importancia de 10/2011

Answer 25

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

Question 26

Before comparing specific and overall migration test results with the migration limits

Answer 26

the correction factors in Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.

Question 27

Union list 10/2011

Answer 27

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.

Question 28

simulantes

Answer 28

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

Question 29

Food simulants A, B and C are assigned for foods that have a hydrophilic character and are able to extract

Answer 29

hydrophilic substances

Question 30

Food simulant B shall be used for those

Answer 30

foods which have a pH below 4.5.

Question 31

Food simulant C shall be used for

Answer 31

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.

Question 32

Food simulants D1 and D2 are

Answer 32

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.

Question 33

Food simulant E is assigned for

Answer 33

testing specific migration into dry foods.

Question 34

To demonstrate compliance with the overall migration limit for all type of foods

Answer 34

testing in distilled water or water of equivalent quality or food simulant A and food simulant B and simulant D2 shall be performed

Question 35

To demonstrate compliance with the overall migration limit for all types of food except for acidic foods

Answer 35

testing in distilled water or water of equivalent quality or food simulant A and food simulant D2 shall be performed.

Question 36

To demonstrate compliance with the overall migration limit for all aqueous and alcoholic foods and milk products

Answer 36

testing in food simulant D1 shall be performed.

Question 37

To demonstrate compliance with the overall migration limit for all aqueous, acidic and alcoholic foods and milk products

Answer 37

testing in food simulant D1 and food simulant B shall be performed

Question 38

To demonstrate compliance with the overall migration limit for all aqueous foods and alcoholic foods up to an alcohol content of 20 %

Answer 38

testing in food simulant C shall be performed.

Question 39

To demonstrate compliance with the overall migration limit for all aqueous and acidic foods and alcoholic foods up to an alcohol content of 20 %

Answer 39

testing in food simulant C and food simulant B shall be performed.

Question 40

Testing for 10 days at 20 °C

Answer 40

shall cover all storage times at frozen condition

Question 41

Testing for 10 days at 40 °C

Answer 41

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

Question 42

Testing for 10 days at 50 °C

Answer 42

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.

Question 43

Testing for 10 days at 60 °C

Answer 43

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.

Question 44

For storage at room temperature

Answer 44

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.

Question 45

If a material or article is intended for different applications covering different combinations of contact time and temperature

Answer 45

the testing should be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.

Question 46

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,

Answer 46

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.

Question 47

To screen if a material or article complies with the migration limits

Answer 47

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

Question 48

When applying the maximum levels set out in the Annex to foodstuffs

Answer 48

taken into account if are dried, diluted, processed or composed of more than one ingredient

Question 49

Nitratos

Answer 49

espinafres frescos 2500-3000 ppm espinafres congelados 2000 Alface 2000-4000 Cereais processados para infants 200

Question 50

Aflatoxinas B1 Soma (B1 B2 G1 G2) =2xB1 M1- leite

Answer 50

``` 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 ppb ```

Question 51

Ochratoxin A

Answer 51

geral 2-5ppb vinho 2 uvas secas e coffe 10ppb Baby foods 0,5

Question 52

Patulina

Answer 52

Sumos de maça 50ppb Produtos de maça sólidos 25ppb Produtos para criança 10ppb

Question 53

Deoxynivalenol

Answer 53

cereais nao processados 1250-1750 ppb pasta e cereais 500-750 ppb para criança 200ppb

Question 54

Zearalenone (

Answer 54

cereais e pão 50ppb | crianças 20ppb

Question 55

Fumonisins

Answer 55

Milho 400ppb | Milho crianças 200ppb

Question 56

Lead

Answer 56

leite e produtos para criança 0,02ppm sumos de fruta 0,05ppm outros 0,1-0,5ppm

Question 57

Cadmium

Answer 57

todos 0,05-0,2 ppm | bivalves, polvos 1ppm

Question 58

Mercury

Answer 58

Peixe 0,5-1 ppm

Question 59

Tin

Answer 59

Canned beverages 100 ppm Canned foods 200 ppm Crianças 50 ppm

Question 60

3-monochloropropane-1,2-diol (3-MCPD)

Answer 60

proteina vegetal molho de soja 20ppb

Question 61

Dioxins and PCBs

Answer 61

``` carne 1-3 pg/g fat leite 3 ovos 3 oleos vegetais 0,75 oleos marinho 2 ```

Question 62

Polycyclic aromatic hydrocarbons | Benzo(a)pyrene

Answer 62

carnes 2-5 ppb pescados 5-10 ppb crianças 1 ppb

Question 63

‘principal field of vision’

Answer 63

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;

Question 64

‘primary ingredient’

Answer 64

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

Question 65

‘date of minimum durability of a food’

Answer 65

means the date until which the food retains its specific properties when properly stored;

Question 66

‘nutrient’

Answer 66

means protein, carbohydrate, fat, fibre, sodium, | vitamins and minerals

Question 67

‘prepacked food’

Answer 67

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;

Question 68

‘ingredient’

Answer 68

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’;

Question 69

‘compound ingredient’

Answer 69

means an ingredient that is itself the product of more than one ingredient

Question 70

‘field of vision’

Answer 70

means all the surfaces of a package that can be read from a single viewing point

Question 71

‘use by’ date.

Answer 71

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

Question 72

Food shall be deemed to be unsafe if it is considered to be:

Answer 72

(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

Question 73

package<10cm2

Answer 73

nome alergéneos quantidade líquida data de durabilidade

Question 74

package<25cm2

Answer 74

``` 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 ```

Question 75

package<80cm2

Answer 75

``` 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 ```

Question 76

package>80cm2

Answer 76

``` 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 ```

Question 77

Declaração nutricional obrigatório

Answer 77

a) energy value; and | (b) the amounts of fat, saturates, carbohydrate, sugars, protein and salt.

Question 78

Declaração nutricional facultativo

Answer 78

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.

Question 79

‘claim’

Answer 79

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;

Question 80

‘nutrient’

Answer 80

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;

Question 81

‘other substance’

Answer 81

means a substance other than a nutrientthat has a nutritional or physiological effect;

Question 82

‘nutrition claim’ energy

Answer 82

a) the energy (calorific value) it (i) provides, (ii) provides at a reduced or increased rate, or (iii) does not provide; and/or

Question 83

‘nutrition claim’nutrients

Answer 83

the nutrients or other substances it (i) contains, (ii) contains in reduced or increased proportions, or (iii) does not contain;

Question 84

‘health claim’ others

Answer 84

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;

Question 85

‘reduction of disease risk claim’ health claim

Answer 85

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;

Question 86

CCP – Critical Control Point

Answer 86

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.

Question 87

Contamination IFS

Answer 87

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.

Question 88

Correction IFS

Answer 88

Action to eliminate a detected non-conformity or deviation

Question 89

Corrective action

Answer 89

Action to eliminate the cause of a detected non-conformity, deviation or other undesirable situation

Question 90

CP – Control point

Answer 90

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.

Question 91

Deviation

Answer 91

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.

Question 92

Food fraud

Answer 92

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

Question 93

Food defense

Answer 93

The protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents for the purpose of causing harm.

Question 94

Formula

Answer 94

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.

Question 95

Hazard analysis IFS

Answer 95

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.

Question 96

Hazard IFS

Answer 96

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect

Question 97

Monitoring

Answer 97

The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

Question 98

Non-conformity

Answer 98

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.

Question 99

Pasteurisation IFS

Answer 99

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

Question 100

Product recall

Answer 100

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.

Question 101

Product withdrawal

Answer 101

Any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer.

Question 102

Risk IFS

Answer 102

A function of the probability of an adverse health effect and the severity of that effect consequential to (a) hazard(s) in food

Question 103

Seasonal products

Answer 103

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.

Question 104

Sterilisation ifs

Answer 104

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

Question 105

Validation

Answer 105

Confirmation through the provision of objective | evidences that the requirements for the specific intended use or application have been fulfilled.

Question 106

Verification

Answer 106

Confirmation through the provision of objective evidences that specified requirements have been fulfilled