Decree of the Ministry of Health No. 37 / 2001 Coll.
Decree of the Ministry of Health on sanitary requirements for products in direct contact with water and for water treatment
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37
DECLARATION
Ministry of Health
of 8 January 2001
on sanitary requirements for products coming into direct contact with water and for water treatment
According to Section 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws (hereinafter referred to as "the Act"), the Ministry of Health provides for the implementation of Sections 4 (5) and 5 (1), (2) and (5) of the Act:
Basic provisions
(1) Sanitary requirements are laid down for the composition, marking and treatment of the surface of products intended for direct contact with drinking water or raw water from which drinking water is obtained and for the composition and labelling of the chemical or chemical preparation intended for the treatment of crude water by drinking water (hereinafter referred to as "chemical"), for the implementation and evaluation of the exclusive test and the necessity of the record of its execution, for the water treatment of raw water, for the application for authorisation of other water treatment and for the authorisation of a derogation or modification of the surface of the product intended for direct contact with drinking or crude water (hereinafter referred to as "water"). "
(2) This Decree does not apply to packaging of packed infant, table, drinking and natural mineral waters for which specific legislation applies. 1)
(3) Without prejudice to the requirements laid down for chemicals by specific legislation. (2)
For the purposes of this decree:
(a) a test of a technical operation consisting of the determination of one or more characteristics of the product;
(b) the test method specified in the technical procedure for carrying out the test or test;
(c) a test record of a document stating the results and other information relating to the test;
(d) testing laboratory by the laboratory which carries out the tests;
(e) a product manufactured in its finished form which comes into contact with water or a component of the article manufactured;
(f) a composite product of a product for which the surface in contact with water is of material different from materials forming the rest of the product,
(g) a sample of the product or part of the product submitted for testing for suitability for use in contact with water intended for human consumption (in some cases the sample may represent more than one specimen of the product),
(h) testing water specifically identified (specified) migration water;
(i) extraction (leaching) procedure for the separation of components from the sample using test water and specified (specified) conditions;
(j) by extraction (by leaching) of test water after exposure to the sample;
(k) migration of a sample substance or substances into test water;
(l) the migration number of the mass of the component (s) migrating from the sample with a specified area in the test water, at a specified time and at a specified temperature;
(m) TOC total organic carbon content.
General hygiene requirements for products in direct contact with water
(To implement § 4 (5) and § 5 (1) and (2) of the Act)
(1) Products coming into direct contact with water are, in particular, products used for the reception, collection, transport, treatment, collection and measurement of the supply of drinking or raw water. These products must be manufactured in accordance with good manufacturing practice in such a way that, under normal and foreseeable conditions of use, their constituents are not transferred to water in quantities which might be dangerous to human health or cause undesirable changes in the composition of drinking water, or affect its sensory properties; shall not contain pathogenic micro-organisms, be a source of microbial or other contamination of water and contain radioactive substances above the limits laid down in specific legislation.3) Good manufacturing practice is compliance with a set of hygienic, technical and technological procedures and standards necessary to ensure the health, safety and functionality of products, taking into account their nature, characteristics and determination.4)
(2) Water contact products must comply with the limits of the exclusive tests carried out under the conditions and in accordance with the procedures laid down in Annex 1. The exclusion test determined by the contribution to water pollution caused by the product in direct contact with water intended for permanent contact with water shall not exceed 10 per cent of the sanitary limit of the drinking water indicator monitored, as laid down in the specific legislation.5) The exclusion test determined by the test determined by the contribution to water pollution caused by:
(a) a product coming into direct contact with water intended for short-term contact with drinking water, i.e. a period not exceeding 24 hours;
(b) a product in direct contact with water, the surface of which does not exceed 100 cm2 in contact with drinking water;
(c) a product coming into direct contact with water intended for contact with hot and hot commercial water;
shall not exceed the hygiene limit of the drinking water indicator monitored provided for in the specific legislation. 5)
(3) The leaching shall identify the concentration or presence of ingredients that are characteristic of the natural component or possibly impurity for the product tested and are at risk for the health of the population.
(To implement Article 5 (2) of the Act)
(1) The verification of the hygiene limits laid down in this Decree and in specific legislation5) shall be carried out according to the standard methods which refer to the methods contained in the relevant Czech technical standard, the result of which is to be proven to be the result required. If the standard methods are not so specified or cannot be used for objective reasons, another appropriate method may be used to demonstrate the limit of retention, accuracy and reproducibility of the test result. The determination of monomer vinyl chloride in polyvinyl chloride products and its copolymers or in the leaching from these products shall be carried out in accordance with a specific regulatory provision (1).
(2) Material-diverse products intended to come into contact with drinking water are assessed as a whole, the exclusive test being carried out on those parts of the product which come into direct contact with water.
(To implement § 5 (1) of the Act)
(1) Water contact products which are not yet in contact with water when placed on the market must be labelled
(a) the commercial name and registered office of the manufacturer or importer, if it is a legal person and the place of permanent residence and registered trade name, if it is a natural person;
(b) by expressing its determination by the words "for permanent contact with drinking water," "for short-term contact with drinking water" or "for contact with hot (hot) commercial water" in accordance with § 3 (2) (a) to (c), and
(c) the conditions necessary to take account of the specific nature of the product and its use.
(2) The particulars referred to in paragraph 1 must be indicated in such a way that they are clearly visible, easily legible and unremovable,
(a) on the product or its packaging; or
(b) on the label affixed to the product or its packaging.
(3) The packaging of the chemical shall bear the particulars referred to in paragraph 1 (b) and (c). This is without prejudice to the designation of a chemical specified by specific legislation2.
The application under Article 5 (5) of the Law on the authorisation of the content of substances in products intended to come into contact with water and not covered by this Decree shall contain:
(a) the trade name and registered office of the manufacturer, for foreign products, the trade name and registered office of the manufacturer and of the importer; if it is a product composed of several materials from different manufacturers, also the commercial name and registered office of suppliers of these components,
(b) product type designation, chemicals, their trade name, chemical composition, structural formula and purity data according to the relevant Czech technical standard;
(c) a brief description of the production technology, including all raw materials and additives used in the manufacture;
(d) data on the concentration of the required substance in the finished product and justification for the technical necessity of its use;
(e) known data on breakdown products resulting from the proposed substance in the manufacture, processing, possibly ageing of material or arising as products of interaction in these processes;
(f) details of the intended use of the product,
(g) data on the resistance and suitability of the product or additives according to the proposed method of use;
(h) data on the leaching of individual substances (additives) from the product, indicating the composition of the product tested, as well as the conditions of testing, modelling the intended use and toxicity data;
(i) methods for determining the proposed additives, their impurities and, where appropriate, the products of interaction and breakdown;
(j) the available foreign documentation as to whether the product or the proposed ingredient has been authorised in other countries;
(k) samples in quantities according to the nature of the product and the method of use.
Hygienic requirements for individual materials and their coating
(To implement § 5 (1) of the Act)
Colouring, printing and decoration
(1) Only dyes and pigments which will be firmly incorporated in the products and comply with the purity requirements laid down by the specific legislation.6)
(2) Water contact products may only be printed on areas which do not come into contact with water. For products made up of several layers, printing may be in the interlayer. However, it must not penetrate areas that come into contact with water. The paint solvers shall be perfectly ventilated.
(3) Dyes based on antimony, arsenic, hexavalent chromium, cadmium, lead, mercury and selenium compounds may not be used for colouring and printing water contact products.
(4) For dyeing and printing of water-contact products, azo dyes and diazobarvives (for example, diarylpigments) may be used only on condition that, during all stages of the technological process of manufacture, processing and other correct and foreseeable use, the temperature at which the dye is decomposed is not exceeded.
(5) The soot used as an additive in water contact products must comply with the purity requirements of the specific legislation.6)
(1) The coating (in particular paint, tinting, coating of plastics) must be continuous, uniformly applied, with a minimum quantity of microscopic pores and well attached to the product. During use of the water contact product, the surface treatment shall not be peeled off under the prescribed conditions of use and shall have apparent striations, cracks, blisters or other breaches.
(2) For the treatment of the surfaces of products in contact with water, the provisions of this Decree may be applied:
(a) metal or alloy metallization under the conditions set out in Section 9;
(b) tinting of the surface of products coming into short-term contact with water pursuant to Article 3 (2), provided that the tin used does not contain more than 1% lead, 0,05% arsenic, 0,1% vismuth and 0,05% antimony,
(c) coverage of the surface with titanium nitride or zirconium oxide;
(d) chromium and nickel for products intended for short-term contact with water as referred to in Article 3 (2);
(e) plastics complying with the hygiene requirements laid down in Section 10;
(f) rubber and elastomers complying with the hygiene requirements of Section 11;
(g) coatings complying with the requirements of Sections 3 (2) and 7; and
(h) cementation (covering the surface of mortars based on sand and cement) meeting the requirements of § 3 (2).
(3) The surface treatment of products for contact with water by means of coatings must comply with the requirements of the special legislation1) and must be burned or hardened in such a way that the stripping from the coating to the distilled water complies with the requirements of § 3 (2).
(4) For surface treatment of water-contact products, the following technological processes are permitted, after which residues of used equipment, solutions and baths must be removed from the surface of the products:
(a) sandblasting and blasting;
(b) grinding,
(c) grinding,
(d) polishing and brushing,
(e) de-lubricating by organic or alkaline means, followed by de-lubrication from the surface;
(f) pickling;
(g) anodic or alkaline or double chromate passivity.
(1) Only metals and alloys meeting the following hygiene requirements may be used for the manufacture of products of metal materials coming into direct contact with water:
(a) stainless steel containing not more than 21,0% by weight of chromium, nickel, 2,2% manganese, 0,1% lead and 0,05% cadmium,
(b) cast iron of different types of steel and iron alloy; where they are easily subjected to corrosion, they shall be provided with appropriate coating according to § 8;
(c) non-ferrous alloys of different elements, if they contain not more than the following element mass concentrations: 0,01% arsenic, 0,005% beryllium, 5% chromium, 0,01% cadmium, 2,5% copper, 2% nickel, 0,5% zinc, 0,5% lead, 5% aluminium, other elements individually up to 0,1% but cumulatively up to 0,8%. These alloys may contain magnesium, calcium, silicon, titanium, silver, gold, iridium and rhodium without limitation of quantities,
(d) silver, gold, platinum, iridium, rhodium, titanium and their alloys,
(e) copper and its alloys (brass, bronze), unless they contain more than 1% lead, 0,01% arsenic and 0,1% antimony by weight. These products must not be used when the distributed water does not have a stable pH of 6,5 - 9,5 and is otherwise aggressive (must meet at least the acid neutralising capacity of KNK8,2 ≤ 1,0 mmol / l, CO2 ≤ 44 mg / l),
(f) zinc, unless it contains a quantity of other ingredients (elements) than those referred to in (c).
(2) 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.
(1) Only monomers and other starting substances and additives listed in the list of monomers and other starting substances of a specific legislation may be used for the manufacture of plastics and products from water contact with water, (1) except for acrylamide and epichlorohydrin content where a maximum of 0,001 mg / kg is required in the product, and vinyl chloride, where a maximum of 0,005 mg / kg is required in the product. In the case of higher levels of scheduled substances in the product, compliance with the requirements set out in § 3 (2) is decisive.
(2) Organic macromolecular compounds obtained by polymerisation, polycondensation, polyation or other similar processes from molecules of lower molecular weight or chemical transformation of natural macromolecules shall be regarded as plastics. Silicones and similar macromolecular compounds are also regarded as plastics. Additional substances may be added to these macromolecular compounds.
(1) According to the method of use, rubber and elastomer products intended to come into contact with water are to be classified in categories II and III in accordance with Section 14 of the Specific Legislation. 1) Category II includes products for which the time of contact with water is expected to exceed 24 hours (e.g. storage tanks, large-area seals, gaskets for containers). Category III includes products for which contact with water is expected in the short term (e.g. hoses for transport) or meet the requirements set out in § 3 (2) (b) and (c).
(2) For water contact products of categories II and III only substances listed in the specific legislation.1) may be used, 7)
(3) Products of categories II and III intended to come into contact with water must comply with the hygiene requirements laid down in a specific legislation. 8)
Chemicals used in the water industry
(To implement § 4 (5) of the Act)
(1) The health and purity requirements for essential chemicals used for the treatment of drinking water and in water are contained in Annexes 2 and 3.
(2) For the application of other chemicals and water treatment products for which the manufacturer or importer has received the approval of the public health authority pursuant to Article 5 (5) of the Act, the conditions set out in Annex 4 shall be complied with.
(1) The technological process of water treatment must be consistent with the quality of the source and must not be the cause of the introduction of foreign harmful substances into drinking water. They must respect the natural composition of water as much as possible and maintain the biological value of drinking water.
(2) Depending on the quality of the raw water, an appropriate adjustment procedure, as verified on a specific site, should be applied. The following technological procedures may be used for water treatment:
(a) mechanical aeration of water;
(b) sand filtration, marble filtration or deacidification;
(c) one or two-stage separation and de-manganation of water;
d) single-stage (coagulation filtration)
(e) two-stage treatment by scanning;
(f) adsorption to powdered or granulated activated charcoal;
(g) oxidation of inorganic (exceptionally organic) constituents using chlorine, hypochlorite, chloride oxide, potassium permanganate and ozone;
(h) slow biological filtration;
(i) pH adjustment;
(j) disinfection of water using chlorine, sodium hypochlorite, chloride oxide and ozone;
k) irradiation by ultraviolet radiation with a wavelength of 250 - 270 nm and a dose of 250 - 300 Jm2.
(3) In the event that a person referred to in Article 3 (2) of the Act intends to use other technologies than those referred to in paragraph 2 of that Act, the public health authority shall submit a request containing:
(a) a description of the technology under consideration, including the equipment and chemicals used;
(b) proof that the equipment or chemicals used comply with the requirements of this Decree;
(c) justification for the use of this technology;
(d) proof that the hygiene requirements laid down in the specific legislation are met. 5)
Efficacy
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No 1 to Decree No 37 / 2001 Coll.
Slug test
1. This Annex specifies the procedure for determining the migration of substances from industrially manufactured or used products coming into direct contact with water such as pipes, small assembly materials (fittings), gaskets, coatings, coatings, membranes and others.
2. Principle of the exclusion test; after a specified pre-cleaning procedure, the surface of the test sample is exposed to the test water during three consecutive periods:
(a) the cold water product sample shall be tested in steps of three consecutive 72 hours at 23 ° C;
(b) a sample of a product intended to come into contact with hot or hot water shall be tested in steps of three consecutive 24-hour intervals at 60 ° C (hot water) or 85 ° C (hot water).
The analyses shall be carried out from extracts of each time interval separately and the values of the migration number shall be calculated.
3. Reagents used:
(a) tap water - water with a free chlorine content of less than 0,2 ± 0,005 mg / l;
(b) test water - chlorine-free water, with a conductivity of less than 2mS / m and a TOC content of less than 0,2 ± 0,1 ppm C, prepared by means of reverse osmosis, deionisation or distillation followed by carbon filtration;
(c) chlorinated test water - test water according to (b) containing 1 ± 0,2 mg / l of active chlorine;
(d) hydrochloric acid, concentrated (30%), purity p.a.,
(e) a solution of hydrochloric acid, prepared by slow addition of 500 ml of hydrochloric acid as described in (d) to 500 ml of test water as specified in (b);
(f) nitric acid, concentrated (65%), purity p.a.,
(g) a nitric acid solution, prepared by slow addition of 500 ml of nitric acid according to (f) to 500 ml of test water according to (b);
(h) sulphuric acid, concentrated (98%), purity p.a.,
(i) chromic acid, purity p.a. (5%) or prepared by dissolving 50 g of chromium oxide per litre of sulphuric acid as specified in (h);
Note: Chromium acid presents a storage hazard. It may tear open the closed container by releasing carbon dioxide. It's a powerful oxygenant, and it can give potentially explosive reactions with oxygenable substances. It can ignite in contact with acetone or alcohols. In heat, it decomposes as the formation of pungent smoke and irritating fumes
(j) sodium hypochlorite, prepared from a commercial solution of sodium hypochlorite (NaOCl) with a known concentration of around 0,1% free chlorine,
Note: The sodium hypochlorite solution is not stable and is therefore prepared on the day of use.
4. Laboratory equipment:
(a) laboratory glass treated with either hydrochloric acid solution (point 4 (e), nitric acid (point 4 (g)), or chromium acid (point 4 (i)) and thoroughly rinsed with test water (point 4 (b)),
(b) stainless steel and glass plates, used to test coatings or materials intended to protect surfaces, are cleaned by washing in biodegradable laboratory detergent, followed by rinsing in hydrochloric acid solution (point 4 (e) or nitric acid solution (point 4 (g)), and finally rinsed with test water (point 4 (b)). The plates shall be drained and dried in a hot air dryer,
(c) containers, tanks, stoppers and couplings shall be made of material which is stable during the test, such as glass, PET, PTFE or stainless steel;
Note: PET and PTFE materials are only used in the case of a small water contact surface.
(d) equipment capable of providing the required temperature for extraction at 23 ± 2 ° C, 60 ± 2 ° C and 85 ± 2 ° C.
5. Preparation of samples and testing requirements:
(a) the samples shall be prepared in such a way that the test water (point 4 (b) or (c) is exposed only to a surface intended to contact drinking water. In the case of homogeneous materials, the entire sample may be exposed to test water, including surfaces not intended for drinking water contact;
(b) if there is no procedure for a specific type of product or if, for technical reasons, the sample cannot be tested under those conditions, derogations from the test procedure are possible. These exceptions shall be duly justified and indicated in the test record.
6. Transport and storage of samples:
(a) if samples have to be stored, stainless steel containers, tissue paper, glass or other materials which do not affect the migration test are used. Storage takes place in the absence of light, at 21 ± 4 ° C, except where the supplier of the samples provides other instructions for storage, i.e. maintaining the conditions to which the product is exposed in practice,
(b) storage containers or pockets shall not be closed, dusting powder shall not be used and cleaning shall only be carried out when this procedure is part of the usual production procedures;
(c) before use, stainless steel containers, glass and other storage material, if possible, shall be washed with biodegradable detergent or hydrogen peroxide (3% V / V; analytical quality), rinsed with hydrochloric acid solution (point 4 (e) or nitric acid solution (point 4 (g) and finally with test water (point 4 (b).
7. Determination of surface ratio to sample volume:
(a) the area of the test surface of the sample to be exposed to the test water shall be about 1: 1 (1 cm2 / 1 cm3), but shall not be less than 1: 2 (0,5 cm2 / 1 cm3). The size of the sample area and the resulting volume of test water shall be chosen in such a way as to meet the requirements for the quantity of leaching required for analysis;
(b) if the sample does not have a smooth surface or the shape of the sample is such that an accurate surface calculation cannot be made, the estimated surface area of the sample shall be used, but in this case the length and width shall be recorded, together with a sufficiently detailed description of the product (s) in order to prepare further samples within ± 10% of the surface area of the original sample;
(c) migration from home installation and supply line (pipes with diameter ≤ 80 mm) shall be determined using samples of a length which provides sufficient volume of leaching (extract) for analysis. Fill with test water (point 4 (b) or (c) and close with a stopper at both ends (point 5 (c)). In some cases it is acceptable to expose the entire surface area of the samples to test water (point 4 (b) or (c)), i.e. also surfaces not intended for contact with water;
(d) migration from the supply and long-distance pipelines (pipes with a diameter of > 80 mm), unless available as small-diameter pipes, is measured by immersing segments into the test water (point 4 (b) or (c) in glass containers (point 5 (c));
Note: If it is not possible to submerge samples of the entire pipe, then the sample can be tested according to alternative test arrangements.
(e) samples of multi-component products shall have the same composition as finished products. The samples shall be tested in such a way that the test water (point 4 (b) or (c) is exposed only to the surface intended to contact drinking water;
(f) migration from paints is determined by immersion of wafers (e.g. stainless steel wafers or sand matted glass, coated with test paint) in test water (point 4 (b) or (c). The plates shall be prepared and coated using a standard industrial procedure (the obligation of the manufacturer requesting medical evaluation). The coating plates shall be tested in containers (point 5 (c) which are fully filled with test water (point 4 (b) or (c)) and closed with a lid. Industrial paints shall be tested according to (c);
(g) samples of filter fabrics and membranes shall contain all the materials used for the finished product.
8. Preparation of samples:
(a) Static water exposure
The test sample of material intended to come into contact with drinking water shall be immersed in water and left to stand for 24 ± 0,5 hours at 23 ± 2 ° C. Samples of materials intended to come into contact with hot or hot water shall be immersed in water and left to stand at 60 ± 2 ° C and 85 ± 2 ° C respectively. Then the water is removed and replaced by fresh water from the tap, tempered to the test temperature, and left to stand for 16 ± 0,5 hours at the test temperature.
In all cases, water is then removed and the sample is washed as follows.
(b) Preliminary flushing
All samples shall be rinsed with water (point 4 (a) for 60 ± 10 min under a steady current of 5 ± 2 cm / s and then rinsed with test water (point 4 (b) or (c) for at least 2 minutes
Note: If it is not possible to perform the test procedures in the laboratory without interruption for time reasons, work may be interrupted during the sample preparation procedure. However, migration intervals must follow each other and without interruption.
9. Test procedure:
(a) each test shall be performed in duplicate, i.e. in parallel with two identical test pieces. Extraction shall be carried out immediately after prior treatment of the samples by immersing the surface of the drinking water (or whole samples) in the test water. It shall be extracted three consecutive times, for 72 hours in respect of a product intended to come into contact with cold water or for 24 hours if the product tested is intended to come into contact with hot or hot water. Test temperatures must be observed. After the first and second exposure periods (72 or 24 h), all leaching (extract) is always drained and immediately replaced by the same volume of fresh test water. The analysis shall be performed from extracts of each exposure period separately. The specific conditions for exposure to different products are described in point 8;
(b) the vessels or tanks in which the exposure is carried out shall be closed so as to avoid leakage of volatile substances or contamination of the leaching. Extraction shall be carried out either at 23 ± 2 ° C (cold water contact materials), 60 ± 2 ° C (hot water contact materials) or 85 ° C ± 2 ° C (hot water contact materials).
10. Analysis:
(a) the required chemical analysis, in relation to the composition of the test material, shall be carried out using appropriate analytical methods. Determination of Kn (= concentration of monitored substances) shall be carried out at the end of each leaching period;
(b) the control test shall be carried out at the same time as each sample tested, using the same test conditions (test water, test temperature, extraction time, stoppers, etc.) as described in point 9 but excluding the sample of the test material. It is determined at the end of each extraction period K 0; n (n is the serial number of the extraction period) of each specified ingredient (or interfering substance) with the required accuracy. If any result of the control tests is greater than the relevant lowest concentration of the monitored substance (a value between the detection limit and the concentration not to be exceeded for drinking water), then the source of contamination must be determined, removed and the whole procedure repeated;
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Regulation Information
| Citation | Decree of the Ministry of Health No. 37 / 2001 Coll., on sanitary requirements for products coming into direct contact with water and for water treatment |
|---|---|
| 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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