RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of December 30, 2014 No. 119

About approval of Sanitary standards and the rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff", the Hygienic standard rate "Maximum permissible amounts of the chemicals which are emitted from the materials contacting to foodstuff" and recognition No. 263 which voided resolutions of the Chief state health officer of the Republic of Belarus of December 26, 2005

Based on article 13 of the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population", paragraph two of subitem 8.32 of Item 8 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:

1. Approve enclosed:

Sanitary standards and rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff";

The hygienic standard rate "Maximum permissible amounts of the chemicals which are emitted from the materials contacting to foodstuff".

2. Declare invalid the resolution of the Chief state health officer of the Republic of Belarus of December 26, 2005 No. 263 "About modification and amendments in health regulations and regulations "Maximum permissible amounts of the chemicals which are emitted from the materials contacting to foodstuff" No. 13-3 of the Republic of Belarus 01.

3. This resolution becomes effective since December 31, 2014.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of December 30, 2014 No. 119

Sanitary standards and rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff"

Chapter 1. General provisions

1. These Sanitary standards and rules establish requirements to migration of the chemicals which are emitted from the materials (including products from them) contacting to foodstuff.

2. In these Sanitary standards and rules the main terms and their determinations in the values established by the Law of the Republic of Belarus of June 29, 2003 "About quality and safety of food staples and foodstuff for life and health of the person" are used (The national register of legal acts of the Republic of Belarus, 2003, No. 79, 2/966), the Law of the Republic of Belarus of January 7, 2012 "About sanitary and epidemiologic wellbeing of the population" (The national register of legal acts of the Republic of Belarus, 2012, No. 8, 2/1892), and also the following terms:

the admissible number of migration of chemicals measured in mg/l, mg/sq.dm (further - DKM);

the threshold limit values of chemicals in drinking water measured in mg/l (further - PDKV);

the maximum permissible average daily concentration of pollutants in atmospheric air of settlements measured in mg/m3 (further - Pdks.s.).

3. For the purposes of these Sanitary standards also governed the materials contacting to foodstuff, are subdivided into the following types:

polymeric materials and plastics on their basis;

paraffin and wax;

paper, cardboard, parchment, subparchment;

glass and products from glass;

pottery;

products from porcelain and faience;

the steel enameled ware;

ware with antiprigarny covering;

the varnished canning container;

filtering inorganic materials;

metals, alloys;

wood and products from it, corking cortical products.

4. These Sanitary standards and rules are obligatory for observance by state bodies, other organizations, physical persons, including individual entrepreneurs.

5. The state sanitary inspection behind respect for these Sanitary standards and rules is performed according to the legislation of the Republic of Belarus.

6. Perpetrators bear responsibility according to legal acts of the Republic of Belarus for violation of these Sanitary standards and rules.

Chapter 2. General requirements to the choice of controlled indicators in case of research of the materials contacting to foodstuff

7. The products made of polymeric and other materials, contacting to foodstuff and environments shall not:

allocate in contacting to them model and air circles of substance in quantities, unhealthy the person, exceeding the admissible number of migration, and also connection capable to cause cancerogenic, mutagen, embriotoksichny, teratogenny, allergenic and other remote effects;

have strongly expressed smell, change taste, color and smell of the foodstuff contacting to them.

8. The list of the model circles used in case of research of the materials contacting to foodstuff is given in appendix 1 to these Sanitary standards and rules.

9. Conditions of modeling of duration of contact and temperature conditions of contact of material with model circles are given in appendix 2 to these Sanitary standards and rules.

10. The materials contacting to foodstuff on hygienic indicators of safety shall correspond to the Hygienic standard rate "Maximum permissible amounts of the chemicals which are emitted from the materials contacting to foodstuff" (further - the Hygienic standard rate), approved by the resolution which approved these Sanitary standards and rules, to other sanitary standards and rules, hygienic standard rates establishing requirements to safety of the contacting materials.

11. DKM values are the main evaluation criteria when carrying out sanitary and chemical researches of the materials contacting to foodstuff which humidity exceeds 15%.

Determination of level of migration of chemicals in this case is carried out on the model circles imitating properties of expected range of foodstuff in case of the temperature and time modes, reproducing real service conditions of the researched materials.

12. Organoleptic indicators in case of research of the materials contacting to foodstuff and environments shall conform to the requirements specified in appendix 3 to these Sanitary standards and rules.

Intensity of smell of the contacting material higher than 1 point is not allowed.

13. Change of one of organoleptic indicators of extracts (smell it is higher than 1 point, foreign smack, availability of dregs, deposit, change of color of extract) is not allowed.

14. Quantitative content in model circles of the identified substances shall not exceed the DKM values established for them. Are guided by PDKV values in that case when for the identified substance DKM value is not established.

15. When carrying out sanitary and chemical researches of the materials contacting to dry foodstuff which humidity does not exceed 15% determination of the emitted chemicals carry out in the air circle, in case of the temperature and time modes reflecting real service conditions of the researched materials. Values Pdks.s. are criteria by which estimate the established migration level at air.

16. On extent of impact on human body hazardous substances subdivide into four classes of danger: 1 class - substances extremely dangerous, the 2nd class - substances highly dangerous, 3rd class - substances moderately dangerous, the 4th class - substances a little dangerous.

Classes of danger of chemicals are specified in the Hygienic standard rate in case of their content in water and in air.

17. In case of assessment of the materials and products contacting to products of baby food, migration of the chemicals belonging to 1 and 2 classes of danger is not allowed.

Chapter 3. General requirements to the combined, composition and new material types, contacting to foodstuff

18. When carrying out sanitary and chemical researches of the combined materials consisting of two and more layers, controlled indicators are determined, first of all, by material of the layer contacting to foodstuff and the following layer behind it.

If these layers of pronitsayema migration sanitarily of significant ingredients from deep layers is also possible, then sanitary and chemical researches and the subsequent layers are conducted.

19. In case of sanitary and chemical research of composition materials, glues, plastisols, sealants, coverings on the basis of pitches of different type and other similar objects controlled indicators are determined proceeding from the main component (pitch type), the used solvents and additives.

20. The new material types contacting to foodstuff in addition to sanitary and chemical researches of migration of chemicals shall pass toxicological assessment with reference to danger class (including biotesting methods).

21. In case of absence in these Sanitary standards and rules of data on the material (materials) used (used) for production of object of research, controlled sanitary and chemical indicators are determined proceeding from the chemical nature of material, conditions of its synthesis, its prescription structure.

Appendix 1

to Sanitary standards and the rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff"

The list of the model circles used in case of research of the materials contacting with food produktami1

The name of food products material is intended for contact with which	The model circles imitating food products
Meat and fish fresh	The distilled water,  % 0,3 solution dairy kisloty2
Meat and fish salty and kopchenye4	The distilled water, 5 % solution of table salt
Milk, lactic products and dairy konservy4	The distilled water,  % 3,0 solution dairy kisloty2
Sausage boiled; konservy4: meat, fish 3, vegetable; vegetables marinated and fermented, tomato paste, etc.	The distilled water, 2 % the solution of acetic acid containing 2 % of table salt; not refined sunflower maslo5
Fruit, berries, fruit and vegetable juice, canned food fruit and berry, soft drinks, pivo4	The distilled water, 2 % solution of lemon acid
Alcoholic beverages, vina4	The distilled water, 20 % solution of ethyl alcohol, 2 % solution of lemon acid
Vodka, konyaki4	The distilled water, 40 % solution of ethyl alcohol
Alcohol food, liqueurs, rom4	The distilled water, 96 % solution of ethyl alcohol
Ready dishes and hot drinks (tea, coffee, milk, broth , etc.)	The distilled water, 1 % solution of acetic acid

 

______________________________

1 The materials used in the conditions other than stated are processed in case of the maximum approach to the operation modes with some aggravation.

2 In case of research of products from the plastic containing nitrogen and aldehydes as the model circle use 3 % solution of lemon acid instead of lactic acid.

3 In case of research of the products intended for fish canned food in own juice as the model circle only the distilled water is used.

4 For determination of lead and cadmium from products from glass, ceramics, porcelain and faience as the model circle use 4 % solution of acetic acid.

5 In case of research of products from polymeric materials and plastics on their basis change of acid number (only for the model circle – crude sunflower oil) – no more 0,1 MGKON/g of discrepancy of parallels in comparison with single test is in addition determined.

 

Appendix 2

to Sanitary standards and the rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff"

Modeling of duration of contact of material with model circles

Duration of contact of material with model circles is established depending on its service conditions with some aggravation:

if time of expected contact of food products with material does not exceed 10 minutes, exposure in case of research - 2 hours;

if time of contact of food products with material does not exceed 2 hours, exposure in case of research - 1 days;

if time of contact of food products with material constitutes from 2 to 48 hours, exposure in case of research - 3 days;

if time of contact of food products with material over 2 days, exposure in case of research - 10 days.

The metal cans varnished fill with the model circle, hermetically roll up, autoclave within hour and leave at the room temperature for 10 days.

The materials contacting to the food products which are subject to sterilization fill with model circles, hermetically close and autoclave in case of 121 °C within 2 hours, and then leave for 10 days at the room temperature.

Metal cans, uncovered it is delicious (if banks in use fill in with the product which underwent heat treatment and further cooled to room temperature), fill with the model circle, hermetically rolled up and left at the room temperature for 10 days.

Temperature condition in case of research of the materials contacting to foodstuff

The materials intended for contact:

with food products in case of ambient temperature, fill in with model circles of room temperature and maintain during the specified time;

with hot food products, fill in with the model circles heated to 80 °C and then maintain at the room temperature during the specified time;

with the food products packaged hot (melted butter, firm and processed cheeses, etc.), fill in with the model circles heated to 80 °C and then maintain at the room temperature during the specified time.

Baking dishes of bread, ham, etc. fill in with the boiling model solutions, close cover and boil within 30 minutes.

Appendix 3

to Sanitary standards and the rules "Requirements to Migration of the Chemicals Which Are Emitted from the Materials Contacting to Foodstuff"

Table 1

Mark assessment of intensity of smell

Intensity of smell	Characteristic	Manifestation of smell
0	Any smell	Lack of notable smell
1	Very weak	The smell which is usually not noticed, but found by the experienced taster
2	Weak	The smell found by the inexperienced taster if to pay its attention to it
3	Noticeable	The smell which is easily noticed and capable to cause disapproving response
4	Clear	The smell attracting attention, defiant negative response
5	Very strong	Smell so strong that causes unpleasant feeling

 

Table 2

Organoleptic indicators of water extracts in case of research of the materials contacting to foodstuff with humidity more than 15%

Controlled indicators	Standard rate
Began to smell (points)	No more than 1
Smack	It is not allowed
Dregs	It is not allowed
Deposit	It is not allowed

 

Note. The insignificant coloring of water extract when modeling corking cortical products and products from wood which is not worsening organoleptic properties is allowed.

 

Table 3

Organoleptic indicators of sorbent in case of research of the materials contacting to foodstuff with humidity no more than 15%

Controlled indicators	Standard rate
Sorbent smell (points)	It is not allowed
Taste of sorbent	It is not allowed
Color of sorbent	It is not allowed

 

Note. As sorbent apply foodstuff (bread, cookies, flour, oil, etc.), proceeding from material service conditions.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of December 30, 2014 No. 119

The hygienic standard rate "Maximum permissible amounts of the chemicals which are emitted from the materials contacting to foodstuff"

Table 1

Hygienic indicators and standard rates of the substances which are emitted from the materials, products contacting to foodstuff

Name of material, product	Controlled indicators	DKM, mg/dm3	PDKV, mg/dm3	Danger class	Pdks.s., mg/m3	Danger class
1	2	3	4	5	6	7
1. Polymeric materials and plastics on their basis
1.1. Polyethylene (low and high pressure), polypropylene, propylene copolymers with ethylene, polybutylene, polyisobutylene, the combined materials on the basis of polyolefins	Formaldehyde	0,100	–	2	0,003 *	2
	Ethyl aldehyde	–	0,200	4	0,010	3
	Ethyl acetate	0,100	–	2	0,100	4
	Hexane	0,100	–	4	–	–
	Geptan	0,100	–	4	–	–
	hexen	–	–	–	0,085	3
	Gepten	–	–	–	0,065	3
	Acetone	0,100	–	3	0,350	4
	Alcohols:
	methyl	0,200	–	2	0,500	3
	propyl	0,100	–	4	0,300	3
	isopropyl	0,100	–	4	0,600	3
	butyl	0,500	–	2	0,100	3
	isobutyl	0,500	–	2	0,100	4
1.2. Polystyrene plastics:
1.2.1. polystyrene block, shock-resistant	Styrene	0,010	–	2	0,002	2
	Alcohols:
	methyl	0,200	–	2	0,500	3
	butyl	0,500	–	2	0,100	3
	Formaldehyde	0,100	–	2	0,003 *	2
	Benzene	–	0,010	2	0,100	2
	Toluene	–	0,500	4	0,600	3
	Ethyl benzene	–	0,010	4	0,020	3

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