Decree of the Ministry of Health No. 38 / 2001 Coll.
Decree of the Ministry of Health on sanitary requirements for products intended to come into contact with food and food
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Effective from 01.02.2001
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38
DECLARATION
Ministry of Health
of 19 January 2001
laying down health requirements for products intended to come into contact with foodstuffs and foodstuffs
According to Article 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws (hereinafter "the Act '), the Ministry of Health provides for the implementation of § 26 (1) (b) and (d) and paragraphs 2 and 3 of the Act:
GENERAL HYGIENIC REQUIREMENTS FOR PRODUCTS INTENDED FOR FOODSTUFFS AND FOOD
This decree implements the relevant provisions of the European Community1) and regulates the health requirements for materials and articles intended to come into contact with food (hereinafter referred to as "products intended to come into contact with food ') following the directly applicable regulations of the European Community1a).
Interpretation of certain terms
For the purposes of this decree:
1. by migration, the total weight of plastic constituents or plastic products released during the leaching test and under clearly defined conditions into the food or food simulant, per unit of plastic or plastic product area or per mass of food or food simulant used;
2. by specific migration of a substance from a product to a food or to a food or to a food simulant, unless otherwise specified;
3. by simulant food, a test solution of a well-defined composition and well-defined properties replacing a particular food or food group when verifying total or specific migration;
4. by a specific migration limit, the maximum authorised value of the specific migration of a substance from a product to a food or to a food or to a food simulant, unless otherwise specified;
5. short-term contact not exceeding 4 hours for beverages and foodstuffs of liquid consistency and 48 hours for foodstuffs of solid or pasty consistency;
6. fats other than fats whether or not oil, emulsion of water in fats and oils and foodstuffs for which the fat phase is self-separated;
7. An acid food with a pH of less than 4,5;
8. a highly acidic food with a pH of less than 3,7;
9. dry food which, by its appearance and characteristics, corresponds to that designation and in which the water content is such that it does not contribute to speeding up its deterioration or degradation of biological value;
10. use at "low temperatures" means the contact of material and food with a temperature below + 5 ° C;
11. use at "higher temperature" means the contact of material and food with a temperature above 45 ° C;
12. hot filling of the food contact with the material at 45 to 100 ° C, while the system is no longer heated;
13. cooking material the product used to prepare food or make food at temperatures above 90 ° C;
14. contact by boiling food and material with a temperature above 90 ° C;
15. The functional surface area of the product that comes into direct contact with food when the product is used normally;
16. the edge for drinking a 20 mm wide band along the upper edge of the filler products, which may come into contact with the mouth when drinking from such products;
17. the harmful effect of the effect resulting from a substantial reduction in the food's digestibility (e.g. from a chemical, pathogenic or other undesirable micro-organism, toxin, pests, domestic animals and other contaminants);
18. sensory analysis of the test of organoleptic properties of the product by sensory organs;
19. elastomers, complete spectrum of elastic polymers or polymers with rubber behaviour, unsystemically called: rubber, synthetic rubber or elastomers;
20. Rubber polymer which can be converted into rubber by vulcanisation;
21. Natural rubber rubber rubber obtained from latex of rubber plants (for example, Hevea Brasiliensis). The essence is cis- 1,4- polyisoprene, with a small amount of non-rubber additives;
22. synthetic rubber of rubber produced by polyreaction, mainly by polymerisation and co-polymerisation;
23. rubber soundproofed rubber mixture or rubber;
24. ceramic articles of articles made from a mixture of inorganic materials with a generally high content of clays or silicates to which a small quantity of organic substances may be added. These objects are first shaped and the shape thus obtained is permanently fixed by burning. Products may be glazed, emailed, or decorated, as appropriate;
25. An inorganic material produced by the complete melting of raw materials at high temperatures on a homogeneous liquid which is subsequently cooled to a liquid state without significant crystallization;
26. glass ceramics, inorganic material produced by the complete melting of raw materials at high temperatures on a homogeneous liquid, which is subsequently cooled to a solid state to form a certain proportion of crystals;
27th enamel glass, inorganic coating which is stretched to metal at temperatures above 500 ° C.
28. plastics, organic macromolecular compounds, obtained by polymerisation, polycondensation, polyation or other similar processes of molecules with lower molecular weight or chemical transformation of natural macromolecules. Additional substances or materials listed in Annex 3 to this Decree may be added to these macromolecular compounds under the terms of this Decree,
29. by the addition of a polymer, a substance which is physically dispersed in polymers without significantly affecting the structure of the polymer and is added for reasons of influence on the processing properties or for the purpose of modifying the performance of the polymer,
30. good manufacturing practice, a set of measures in place and maintained which guarantee the management of production processes and reproducible quality of products with the required characteristics,
31. Multilayer or plastic article material or plastic article consisting of two or more layers of materials each consisting solely of plastic and which are joined together by adhesives or otherwise,
32. a plastic barrier which consists of one or more layers of plastic and ensures that the final product complies with the requirements of this Decree and the directly applicable European Commonwealth Regulation (1b),
33. non-fat foods for which Annex 4 to this Decree provides for simulants other than simulant D for migration testing.
Requirements for the composition of food contact products
(1) Products intended to come into contact with foodstuffs must comply with the requirements of the directly applicable Regulation of the European Communities (1b), the hygiene requirements and the limits laid down in this Decree and, depending on the nature of the product, the requirements for the protection of human health from the risks which may arise from oral contact with products, in accordance with the requirements laid down in Section 15 (a) and Annex 9.
(2) The hygiene requirements and limits for products intended to come into contact with foodstuffs must be verified under the conditions and under the rules laid down in this Decree and the directly applicable regulation of the European Communities (1c).
(3) Only natural materials, such as cork or wood of non-toxic wood, with a smooth uncracked surface, may be used in the manufacture of food contact products. Such materials shall not show signs of pest infestation or micro-organisms, in particular microscopic fibrous sponges.
(4) Plastic materials and articles, varnishes, coatings and surface-treated products as well as adhesives containing or made from one or more of the following substances:
(a) 2,2bis [4- (2,3-epoxypropoxy) phenyl] propane and certain derivatives thereof,
b) bis (2,3-epoxypropyl) ether and certain derivatives thereof,
c. Neolac-glycidyl ethers and certain derivatives thereof
it shall comply with the requirements of the directly applicable Regulation of the European Communities (1d).
(5) The requirements referred to in paragraph 4 shall not apply to containers and storage tanks with a capacity of more than 10 000 litres as well as to their pipes and pipes connected thereto, which are treated with high load coating.
Verification of compliance with hygiene requirements
(1) Validated analytical methods complying with the requirements of the directly applicable legislation of the European Communities (1c) or with the rules and conditions laid down in Annexes 1 to 14 thereto are used to verify the hygiene requirements laid down by this Decree. Where the method is not so modified, a method with adequate characteristics may be used, taking into account the relevant hygiene limit laid down in this Decree.
(2) Products intended to come into contact with food produced by a combination of several types of materials are evaluated as a whole, the main focus being on material that comes into direct contact with food.
Construction of food contact products
(1) Products intended to come into contact with food must be designed, with a view to their use, so as to allow proper cleaning, sterilisation and, where appropriate, disinfection before each contact with food and to withstand cleaning, disinfection and sterilisation agents and procedures throughout their life. It shall have functional and mechanical characteristics corresponding to the intended use.
(2) The surfaces, coatings, or decor of the products must be non-breakable, resistant to cracking, deburring, sandblasting and abrasion. It must resist food, food raw materials and substances.
(3) Products intended to come into contact with foodstuffs intended for re-use must comply with the hygiene requirements laid down in this Decree even if re-use. These products shall not be used on a temporary basis for non-food goods.
(4) Products intended to come into contact with foodstuffs which are not intended for re-use cannot be re-used in food production and in the putting into circulation of foodstuffs for the original or other food purposes.
Dyeing, printing and decoration of food contact products
(1) Only dyes and pigments which are firmly anchored in the products and comply with the purity requirements laid down in Annex 1 may be used for colouring, printing and decoration of food contact products.
(2) Products intended to come into contact with foodstuffs may only be printed on areas which do not come into contact with foodstuffs. For products made up of several layers, printing may be in the interlayer. Printing shall not penetrate or be printed on areas which come into contact with food. The discolourants must be completely removed.
(3) Colouring and printing of products intended to come into contact with food shall not be used on the basis of antimony, arsenic, hexavalent chromium, cadmium, lead, mercury and selenium compounds.
(4) For colouring and printing of food-contact products, azo dyes and diazodyes (for example, diarylpigments) may be used only on condition that, during all stages of the technological process of manufacture and processing of the products and in other correct and foreseeable use, the temperature at which the dye is decomposed to form carcinogenic aromatic amines is not exceeded.
(5) The soot used as an additive in food contact products must comply with the purity requirements of Annex 1.
(6) The provisions of paragraphs 1 to 3 shall not apply to burnt decoration of silicate products which must comply with the hygiene requirements of Section 19.
Fillers for food contact products
(1) Substances based on antimony, arsenic, hexavalent chromium, cadmium, lead, mercury and selenium compounds shall not be used as fillers for food contact products.
(2) Only substances which comply with the purity requirements set out in Annex 1 may be used as fillers for food contact products.
HYGIENE REQUIREMENTS FOR INDIVIDUAL MATERIALS, NOT MADE OF PRODUCTS INTENDED FOR FOOD STYLE
REQUIREMENTS FOR PLASTIC PRODUCTS
(1) Plastic shall not be considered
(a) coated or unvarnished cellophane,
(b) elastomers and materials based on natural and / or synthetic rubber;
(c) paper and paperboard, whether or not modified with plastics;
(d) surface treatment obtained
1. paraffin wax, including synthetic paraffin wax or microcrystalline wax,
2. mixtures of the abovementioned waxes or their mixtures with plastics,
e. Ion exchange resins;
(f) silicones.
(2) The requirements set out in paragraphs 11 to 14 apply to products intended to come into contact with food and to parts thereof consisting exclusively of plastics, or consisting of two or more layers, each consisting exclusively of plastics, layers or surfaces of plastics, consisting of sealing rings of lids which together consist of two or more layers of different types of materials. They do not apply to products consisting of two or more layers, one or more of which does not consist exclusively of plastics, even if the layer intended for direct contact with foodstuffs is made of plastic. Such products shall be evaluated in accordance with Article 4 (2).
(3) By way of derogation from paragraph 2, in the case of a layer which is not in direct contact with foodstuffs and which separates the functional barrier from the food, it shall be possible, where the final material or article complies with the specifications and migration limits laid down in the following decree:
(a) not comply with the restrictions and specifications laid down in this Decree;
(b) have been manufactured using substances other than those listed in Annex 3 to this Decree.
(4) The migration of substances referred to in paragraph 3 (b) into a food or food simulant determined by an analytical method meeting the requirements of the directly applicable European Community2) must not exceed 0,01 mg / kg. This limit must always be expressed as concentration in food or simulants. It shall apply to a group of compounds which are structurally and toxicologically related, in particular isomers or compounds with the same functional group, and shall include any unwanted transfer of the imprint.
(5) The substance referred to in paragraph 3 (b) must not belong to either of the following categories:
(a) substances classified as having been proven or are considered to be carcinogenic, mutagenic or toxic to reproduction in accordance with specific legislation (2a); or
(b) substances classified as carcinogenic, mutagenic or toxic to reproduction in accordance with the specific legislation2a.
(1) Only monomers, starting substances and additives listed in the list of substances in Annex 3 may be used for the manufacture of plastics and plastic products intended to come into contact with food, while respecting the restrictions and specifications laid down.
(2) The general specifications concerning plastic products and their materials are set out in Appendix II, Part A of Annex 3. Further specifications concerning certain substances included in the positive lists of Annex 3 are set out in Appendix II, Part B to this Annex. The formalities for the declaration on the basis of Article 2b), which is attached to plastic materials and articles, are set out in Annex 3 to this decree.
(3) The lists of substances set out in Annex 3 to this Decree do not include:
(a) monomers and other starting substances and additives used in the manufacture of:
1. surface coatings of resins or polymers in liquid, powder or dispersed form, such as varnishes and coatings;
2. epoxy resins,
3. adhesive and adhesive coatings;
4. printing inks; or
(b) dyes,
(c) solvents.
(1) Where additives authorised as food additives or flavourings under specific legislation3 are used in the manufacture of plastic products intended to come into contact with foodstuffs, these substances may not be released into foodstuffs,
(a) in quantities having a technological function in finished foodstuffs;
(b) in which they are authorised as food additives or flavourings, in quantities exceeding the limits laid down under the specific legislation or restrictions provided for in Article 11; compliance with this provision shall be assessed according to a restriction which is stricter;
(c) in which they are not authorised as food additives or flavourings in quantities exceeding the limits laid down in Article 11.
(1) The additives listed in Annex 3 to this Decree, which are to be used in the manufacture of plastic layers and surfaces in lids, shall comply with the restrictions and specifications concerning their use in accordance with this Annex.
(2) For the use of additives which behave exclusively as polymerisation aids and which are not intended to remain in the finished product (PPA), for the manufacture of plastic layers and surfaces listed in Annex 3 to this Regulation, the restrictions and specifications set out in this Annex shall apply.
(1) Plastics and plastic products shall not release their constituents into foodstuffs in quantities exceeding 60 milligrams of ingredients released per kilogram of food or food simulant (hereinafter referred to as "total migration limit").
(2) In the following cases, a limit of 10 milligrams of total migration per decimeter of the surface of the material or product may be applied:
(a) containers or products which resemble containers and which can be filled, with a capacity of less than 500 milliliters or more than 10 litres;
(b) plates, film or other products which cannot be filled or for which the ratio between the surface area of the product and the quantity of food in contact with it cannot be estimated.
(3) In the case of plastic products intended to come into contact with foods intended for infants and young children under special legislation (4) or already in contact with such foodstuffs, the limit on total migration shall always be 60 milligrams per kilogram of food or food simulant.
(1) The migration size of each component from plastic materials and products must not exceed the specific migration limits or other restrictions specified in the list of substances.
(2) The specific migration limits specified in the list of substances in Annex 3 are expressed in mg.kg-1 on the weight of the food or food simulant.
(3) In the following cases the limits of specific migration are expressed in mg.dm-2:
(a) containers or products which resemble containers or which can be filled, with a capacity of less than 500 milliliters or more than 10 litres;
(b) plates, film or other products which cannot be filled and for which the ratio between the surface area of the product and the quantity of food in contact with it cannot be established.
(4) In cases where the limits specified in Annex 3 are expressed in mg.kg-1, they may be converted into mg.dm-2. by dividing by conventional conversion factor 6.
(5) Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Annex 4.
(6) Verification of compliance with specific migration limits shall not be compulsory if it can be demonstrated that compliance with the total migration limit will not exceed the specific migration limits.
(7) Verification of compliance with the specific migration limits referred to in paragraph 5 shall not be compulsory if it can be demonstrated that, even if the residual substance is fully migrated in the product, the specific migration limits are not exceeded.
(8) Verification of compliance with the specific migration limits may be carried out by establishing the quantity of the substance in the final material or product, provided that the relationship between that quantity and the value of the specific migration of the substance has been established by sufficient experiments or using generally accepted diffusion models based on scientific evidence. To demonstrate non-conformity of the material or product, confirmation of the determined migration value by experimental testing is required.
(9) For substances listed in Annex 3 to this Decree, in the Incomplete List of Additives that may be used for the production of plastics, Section B thereof, when verifying the conformity of their migration with the specific migration limits in simulant D or in the test medium of replacement migration tests, the procedure set out in Annex 4 to this Decree shall be followed.
(1) The content of monomer vinyl chloride in polyvinyl chloride products and its copolymers must not exceed one milligram per kilogram of the final product (1 mg of monomer vinyl chloride per kg of product).
(2) The method for determining the level of monomer vinyl chloride in polyvinyl chloride products and its copolymers is set out in Annex 5.
(3) Products made from polyvinyl chloride and its copolymers must not pass to foods or to foods of monomer vinyl chloride in quantities that would be detectable by the analytical method set out in Annex 6.
(4) Monomer vinyl chloride released from products into food is determined in the food by the method set out in Annex 6. Where this determination cannot be carried out for technical reasons, a determination may be made in food simulants.
REQUIREMENTS FOR ELASTHOMERS AND MATERIALS PRODUCTS BASED ON NATURAL AND SYNTETIC CAUCHES
According to the method of use, products made of elastomers and materials based on natural and synthetic rubber are classified in categories I to V:
(a) category I which includes products for health-intensive applications (for example, baby mammals, sows and other products put into the mouth of children or which are expected to be in contact with children's diet);
(b) category II which includes products for which the time of contact with foodstuffs is expected to exceed 24 hours (e.g. storage tanks, large-area seals, gaskets for containers, glasses),
(c) category III which includes products for which the period of contact with foodstuffs is expected to exceed 10 minutes but not more than 24 hours (e.g. food transport hoses),
(d) category IV which includes products for which the time of contact with foodstuffs is expected to be no more than 10 minutes (for example, parts of milking equipment, sealing of dairy machinery, cylinder covers and conveyor belts for foods with fat on the surface, gloves used in the processing of foodstuffs),
(e) category V which includes products for which a short period or minimum area of contact with foodstuffs is foreseen and which cannot be included in categories II to IV (for example, cylinder covers and conveyor belts, pump seals, day seals and canning covers).
(1) For products of categories I and II, only the substances listed in Part A of Annex No 7 may be used. For products of categories III to V, the substances listed in Parts A and B of Annex No 7 may be used.
(2) Products of elastomers and materials based on natural and synthetic rubber must comply with the hygiene requirements set out in point 9 of Annex No 7.
(3) Baby mammals and statuettes put into the mouth by children or intended to be in contact with children's food must not contain inorganic and organic pigments, dyes and fillers.
REQUIREMENTS FOR ARTICLES OF METAL MATERIALS
(1) Metals, alloys and solders listed in Annex 8 may be used for the manufacture of metal products.
(2) The surface treatment of metal products shall comply with the hygiene requirements set out in Section 20.
(3) The external and internal surface of metal products shall be clean, smooth, without macroscopic cracks, stains, apparent striations, signs of corrosion, frakking, moulded articles, dent, nozzles, sharps or sharp overforms. Only a degree of deformation of metal products which does not adversely affect their function is permitted.
(4) The inner surface of metal products, including the inner coating, shall not contain solder drops or other metal residues and their alloys, or gaskets, except in the case of reeling cans.
REQUIREMENTS FOR SILICATORY MATERIALS PRODUCTS
(1) For the manufacture of glass tableware and glass packaging, the use of glass of the water resistance class I to IV is permitted, provided that, during the normal and foreseeable use of the product, compliance with Section 3 (1) is guaranteed. Only colourless glass of water resistance class I is permitted to be used for the manufacture of child suction bottles.
(2) In the manufacture of glass products, other than child suction bottles, the following substances may be used to treat the external surface:
(a) tin compounds (for treating glass at the hot end);
(b) titanium (when plated with titanium),
(c) Vaseline oil;
(d) fatty acid methyl esters of C12-C18 from natural oils and fats, approved types of polypropylene oil, polyethylene and polyethylene waxes, oleic acid (for treatment at the cold end of the production line).
(1) The limits on the migration of lead and cadmium from glass, glass ceramics, ceramics, porcelain and enamelled surface products are set out in Section 1 of Annex 9.
(2) Verification of the migration of lead and cadmium is carried out under the conditions and using the analytical method set out in Section 2 of Annex 9 or according to the standardised method. Annex 9 also provides for the particulars of the written declaration to be used to equip ceramic products.
(3) Silicate products are divided into the following categories for the purpose of verifying the limit of lead and cadmium migration:
(a) category 1 which includes products which cannot be filled or which may be filled but whose internal depth measured from the deepest point to the horizontal plane passing through the upper edge does not exceed 25 mm;
(b) category 2 which includes products which may be filled;
(c) category 3 which includes products intended for heating in the preparation of meals and beverages and packaging and storage containers having an internal volume greater than 3 litres.
(4) For a silicate product consisting of a container fitted with a lid of the same material, the limits on the migration of lead and cadmium relating to the container itself shall not be exceeded, the container and the inner surface of the lid being tested separately and under the same test conditions. The sum of these two determined values of lead and cadmium migration shall be extended to the surface area of the container or to its volume.
REQUIREMENTS FOR THE SUPPORT OF PRODUCTS INTENDED FOR FOODSTUFFS
(1) Surface treatment (in particular by coating, tinting, coating of plastics, glazing, enamelling) must be continuous, uniformly applied, with a minimum quantity of microscopic pores, well attached to the product. During use of the food contact product, the surface treatment must not be peeled off, have obvious striations, cracks, blisters or other infringements under the prescribed conditions of use. If the surface of sea products is present, there shall be no infected areas.
(2) The list of permitted materials and technologies for surface treatment of food contact products is set out in Annex 10.
(3) The coating of the products must be made from the substances listed in Annex 11.
(4) The non-silicate and non-metallic coating of products intended to come into contact with food must comply with the hygiene requirements set out in point 7 of Annex No 11.
(5) For the manufacture of metal products intended to come into contact with food, double-sided oil from natural oils and fats and polypropylene oil is permitted. The quantity of lubricant on one side may not exceed 0,25 g.dm-2
(6) For the production of metal products intended to come into contact with food, the passivity of tin sheets in a bath containing chromate or double chromate is permitted. The rest of the passive bath must be removed from the sheet by proper washing.
REQUIREMENTS FOR PAPER, CARTONE AND PAPER PRODUCTS
(1) Only materials made from raw materials, ingredients, aids and other substances listed and authorised in Annex 12 may be used for the manufacture of products of paper and paperboard, including their compensating forms.
(2) Paper packaging materials may have a maximum moisture content of 8%.
(3) The re-use of paper packages for the direct packaging of foodstuffs is not allowed.
(1) Paper, paperboard and paperboard treated with plastics, where foodstuffs come into direct contact with only a polymer substance which creates a perfect barrier to the transfer of foreign substances from paper, paperboard and paperboard to the surface of foodstuffs, shall be assessed in accordance with the conditions laid down in Article 4 (2).
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Regulation Information
| Citation | Decree of the Ministry of Health No. 38 / 2001 Coll., on sanitary requirements for products intended to come into contact with food and food |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.02.2001 |
|---|---|
| Effective from | 01.02.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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