Regulation 178 Flashcards Preview

Definitions food safety > Regulation 178 > Flashcards

Flashcards in Regulation 178 Deck (106)
Loading flashcards...
1

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;

2

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;

3

Risk

‘risk’ means a function of the probability of an adverse
health effect and the severity of that effect, consequential to a hazard;

4

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.

5

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.

6

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.

7

"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;

8

"contamination"

"contamination" means the presence or introduction of a hazard;

9

"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;

10

"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;

11

"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.

12

scope 853

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

13

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.

14

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.

15

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.

16

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

17

10/2011

This Regulation shall be without prejudice to the EU or
national provisions applicable to printing inks, adhesives or coatings.

18

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,

19

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.

20

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.

21

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.

22

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.

23

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.

24

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.

25

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

26

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.

27

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.

28

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

29

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

hydrophilic substances

30

Food simulant B shall be used for those

foods which have a pH below 4.5.