Decree No. 409 / 2005 Coll.
Ordinance on sanitary requirements for products in direct contact with water and for water treatment
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Effective from 15.11.2005
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409
DECLARATION
of 30 September 2005
on hygiene requirements for products coming into direct contact with water and for water treatment
According to § 108 (1) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 320 / 2002 Coll., (hereinafter referred to as "the Act"), the Ministry of Health provides for the implementation of § 5 (1), (2), (5) to (9) of the Act:
Subject matter
(1) This Decree lays down health requirements for:
(a) the composition and labelling of products intended for direct contact with drinking or hot water or raw water (hereinafter referred to as "water") and the treatment of their surfaces;
(b) composition and labelling of a chemical or chemical mixture intended for drinking or hot water treatment (hereinafter referred to as "chemicals or chemical mixtures");
(c) the method of verifying that drinking or hot water is not adversely affected and the particulars of the record of its execution;
(d) water treatment technologies for the treatment of crude water and chemicals or chemical mixtures which may be used for the treatment of water.
(2) This decree does not apply to:
(a) packaging of bottled water, bottled water bottling equipment, heating, cooling or sealing equipment for bottled water; storage, cooling, heating or dipping equipment for the consumer, the food industry in the manufacture of foodstuffs or in joint dining facilities for the preparation of meals which are not permanently incorporated or connected to the internal tap;
(b) products for the medical equipment of buildings listed in Annex 2, Table 12, item 1, of the Specific Legislation (1).
Interpretation of terms
For the purposes of this decree:
(a) expert opinion - a set of activities aimed at expressing the conformity of the test result with the various technical requirements under this Decree;
(b) verification of the product test and formulation of the expert opinion by the testing laboratory;
(c) a verification record - a document issued by the test laboratory in the form of a test report, containing the test results and establishing compliance or non-compliance of the test results with the various technical requirements of this Decree;
(d) test - a set of professional activities consisting of one or more characteristics of the sample of the product concerned,
(e) test method - specified test procedure under this decree leading to the determination of the value of the observed characteristics of the sample of the product,
(f) testing laboratory - an authorised or accredited laboratory carrying out both a product test and a formulating expert opinion;
(g) the product - the finished article or part of the article produced which comes into contact with water; in particular, products used for the reception, collection, transport, treatment, distribution, collection and measurement of the supply of drinking, hot or raw water;
(h) a non-homogeneous product - a product for which the surface contact with water is made of one or more materials which differ from the materials forming the rest of the product and whose separate separate testing is not technically possible;
(i) test sample - product, product assembly or part of product taken for testing and complying with the test conditions;
(j) test water or treated test water - water complying with the technical requirements of this Regulation for carrying out the test;
(k) leaching - procedure for migration of constituents from the test sample using test water and specified conditions;
(l) leaching - test water after exposure to a test sample of leaching,
(m) migration - transfer of the substance or substances from the test sample of the product into the test water;
(n) the migration number - the number indicating the mass of the component (s) migrating from the test sample with a specified area in the specified volume of the test water, at a specified time and at a specified temperature;
(o) conversion factor - factor used to convert the migration number into a modified concentration taking into account the conditions of use of the product in construction;
(p) TOC - total organic carbon content,
q) CHSKMn - chemical oxygen consumption with manganese,
(r) short-term contact with water - a situation where, under normal conditions, the whole volume of water within the product is changed at least once within 24 hours or the product is not in contact with water for 24 hours; water fittings, assembly material, gaskets and water meters may be evaluated as short-term contact products. For the purposes of this Regulation, the following definitions apply:
(s) raw water - water taken from surface water sources or groundwater for treatment to drinking water and water during treatment;
(t) chemical and chemical mixtures - chemicals or chemical mixtures according to the directly applicable European Union regulation governing classification, labelling and packaging of substances and mixtures (4), in final form, intended for drinking or hot water treatment;
(u) shape - part of a pipe excluding tubes, allowing diverging, changing direction or diameter; includes flange pieces with neck and smooth end and neck movements,
v) fittings - a component enabling the flow and water pressure to be closed or controlled, such as closing fittings, regulating fittings, reduction valve, air-conditioning and air-conditioning valve, reversing valve and hydrant,
(w) plastics - organic macromolecular compounds obtained by polymerisation, polycondensation, polyation or other similar processes from molecules of lower molecular weight or by the chemical transformation of natural macromolecules; other substances may be added to these macromolecular compounds,
(x) good manufacturing practice - compliance with a set of sanitary, technical and technological procedures necessary to ensure the health, safety and functionality of products, taking into account their type, characteristics and destination.
General hygiene requirements for products in direct contact with water
(1) Products coming into direct contact with water 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 into water in quantities which might be dangerous to human health or cause undesirable changes in the composition of the water, or affect its sensory properties; they must not contain pathogenic micro-organisms, be a source of microbial or other water pollution and contain radioactive substances above the limits laid down by specific legislationm2).
(2) The effluent test carried out under the conditions and according to the procedures laid down in Annex No 1, the identified proportion of water pollution caused by the product in direct contact with water intended for permanent contact with drinking water may reach a maximum of 10% of the hygiene limit of the drinking water indicator as laid down in the specific legislature), with the exception of TOC, CHSKMn and mercury, where the proportion may reach a maximum of 20% and a maximum of 30% of the sanitary limit for CHSKMn and mercury, and the aluminium indicator for cement-based products where the proportion may reach the hygiene limit. The proportion is the contribution of the product to water pollution in the third leachate expressed as the concentration of the migrated component K72 or the contribution of the product to water pollution in the third leachate modified by the conversion factor in accordance with Annex 1, point 11, expressed as the modified concentration C3. For colour, odour and taste indicators, the hygiene limit laid down by the specific legislationm3 must be met).
(3) An exchange test carried out under the conditions and in accordance with the procedures laid down in Annex 1, found a share of water pollution caused by:
(a) a product in direct contact with water intended for short-term contact with drinking water;
(b) the product coming into direct contact with water, the area of which in contact with drinking water does not exceed 100 cm2 or the ratio of its area to the area of all other products (materials) in the water tower or in the water distribution network is less than 1: 1000 or less than 1: 100 for the internal tap; or
(c) a product coming into direct contact with water intended for direct contact with hot or rough water;
may reach the maximum hygiene limit of the drinking water indicator monitored, laid down by specific legislationm3). The proportion is the contribution of the product to water pollution in the third leachate expressed as the concentration of the migrated component K72 or the contribution of the product to water pollution in the third leachate modified by the conversion factor in accordance with Annex 1, point 11, expressed as the modified concentration C3. For colour, odour and taste indicators, the hygiene limit laid down by the specific legislationm3 must be met).
(4) The leaching shall identify the presence and concentration of ingredients that are characterised as a natural component or possibly impurity for the product under test and are at risk for the health of the population. The minimum scope of the monitored components per product circuit is given in Annex 1, point 15. The presence and concentration of other components shall be determined on the basis of the precise chemical composition of the product and the list of all chemicals used in the manufacture of the product submitted by the applicant for the exclusive test.
(5) The test laboratory shall take into account and recognise the results of the exclusive tests carried out in the test accredited laboratory of another Member State of the European Union, the European Economic Area or Turkey in the verification of the product and shall not carry out the determination of those ingredients for which it is evident from the submitted test report that the requirements of this Decree have been met when applying a comparable method of leaching with the conditions of the exclusive test set out in Annex 1.
(6) For the purposes of this Decree, the following additional hygiene limits for drinking water shall be laid down for the characteristics not covered by the Decree laying down sanitary requirements for drinking and hot water and the frequency and scope of the control of drinking water:
| a) ftaláty (DEPH) | 0,008 mg/l, |
| b) fenoly (těkající s vodní parou) | 0,05 mg/l, |
| c) baryum | 0,7 mg/l, |
| d) cín (anorganický) | 3,0 mg/l, |
| e) cín (tributylcínoxid) | 0,002 mg/l, |
| f) zinek | 3,0 mg/l, |
| g) sloučeniny s NH2 skupinou | 0,3 mg/l, |
| h) primární aromatické aminy | < 0,01 mg/l (mez detekce), |
| i) styren | 0,02 mg/l, |
| j) ethylbenzen | 0,02 mg/l, |
| k) xyleny | 0,2 mg/l, |
| l) toluen | 0,2 mg/l, |
| m) vanad | 0,05 mg/l, |
| n) kobalt | 0,01 mg/l. |
Requirements for analytical methods and testing of non-homogeneous products and products intended to come into contact with drinking and hot water
(1) When determining the concentration of the monitored indicators in the exclusions for comparison with the hygiene limits laid down in this Decree and the specific legislation3), only those methods which meet the requirements for the methods laid down in the separate legislation3) shall be used, with the exception of the limit of detection which must be at a maximum of 10% of the hygiene limit of the monitored indicators laid down in the separate legislation3) and which are sufficiently sensitive to the substances and to the interpretation of the results of the exclusive test resulting from Annex 1.
(2) Non-homogeneous products intended to come into contact with water shall be assessed as a whole in a state intended to be used for final use, only those surfaces of the product which come in direct contact with water being exposed to leaching.
(3) If the product is intended to come into contact with both drinking and hot water, the exclusive test shall be carried out in the test water at temperatures (23 ± 2) ° C and at the same time (60 ± 2) ° C. The exception is water batteries and water meters to be tested only at (23 ± 2) ° C.
Product designation
(1) Products intended to come into contact with water must be labelled when placed on the market:
(a) the business firm and the registered office of the manufacturer, distributor, authorised representative or importer, if it is a legal person, on behalf of, and where applicable, the name and surname and, where applicable, the supplement, and the place of business, if it is a natural person involved in the business,
(b) the words "for permanent contact with drinking water," "for short-term contact with drinking water," "for contact with hot water" or "for contact with raw water" in accordance with Article 3 (2) or (3); and
(c) a condition necessary to take account of the specific nature of the product and its use; the condition is, for example, a restriction on the use of the product on water of a particular composition pursuant to § 9.
(2) The marking referred to in paragraph 1 shall be made in such a way that the particulars given are clearly visible and easily legible,
(a) on the product or its packaging;
(b) on the label attached to the product or its packaging; or
(c) on the package leaflet with an unambiguous identification of the product.
(3) The particulars referred to in paragraph 1 (a) and (c) shall be marked on the packaging, tag, accompanying documentation or in the instructions for use.
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 in Article 3 of Regulation (EU) No 1935 / 2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80 / 590 / EEC and 89 / 109 / EEC may be used for colouring, printing and decoration of products.
(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, the printing may be in an interlayer but shall not penetrate areas which come into contact with water. However, products which have no visible surfaces not in contact with water may also be printed on areas in contact with water if the printing colours used comply with the requirements of § 3 (2) or (3) and § 7 (1), (3) and (4). 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) The following aromatic amines: 4-amino-biphenyl, benzidine, 4-chloro-o-toluidine, 2-naphthylamine, o-aminoazotoluene, 2-amino-4-nitrotoluene, p-chloro-aniline, 2,4-diamino-anisol, 4,4 '-diamino-diphenylmethane, 3,3' -dichlorobenzidine, p- keresidine, 4,4 '-dimethylenidine), 4,4' -dimethylbenzidine, 3,3 '-dimethoxybenzidine, 3,3' dimethyl-4,4 '-diamine diamine, p-keresidine, 4,4' -methylenesidine, 4,4 '-dianiline, 4,4' -dianiline, 4,4 '-thio-dianiline, o-toluidine, 2,4-toluenediaminylamine, 2,4,5-oxydiamethylamine, 2,4,5-oxylamine, 2o-oxylenylenylenylenylenesidine, 2o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-o-
(5) The soot used as an additive in water contact products must comply with the purity requirements of the specific legislation5).
Surface treatment of products
(1) The surface treatment of products, in particular paint, tinting or coating of plastics, must be continuous, uniformly executed, with a minimum quantity of microscopic pores and well-adhering to the product and must protect the area in contact with drinking water safely during the life of the equipment. 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) Only products in direct contact with water may be used in accordance with this Decree to adjust the surface of products in direct contact with water.
(a) metal or alloy metallization under the conditions set out in Section 9;
(b) tinting of the surfaces of the products, provided that the tin used does not contain more than 0,01% lead, 0,01% arsenic, 0,01% bismuth, 0,01% antimony, 0,01% cadmium, 0,01% chromium and 0,01% nickel; that the product complies with the requirements of § 3 (2) or (3) (a) to (c) and that the tin layer is ≥ 1 μm (in the case of chemical tinting) and ≥ 4 μm (in the case of heat tinting);
(c) coverage of the surface with titanium nitride or zirconium oxide;
(d) chroming,
(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 meeting the requirements of § 3 (2) or 3 (a) to (c) and § 7; or
(h) cementation (covering the surface of mortar based on sand and cement) meeting the requirements of § 3 (2) or (3) (a) to (c).
Articles of metal materials
(1) The requirements for the production of products of metal materials coming into direct contact with water fulfil the following metals and alloys for each product type:
(a) stainless steel (stainless steel): 1.4401 (X5CrNiMo17-12-2), 1.4404 (X2CrNiMo17-12-2), 1.4571 (X6CrNiMo17-12-2), 1.4521 (X2CrMoTi18-2), 1.4462 (X2CrNiMon22-5-3), 1.4301 (X5CrNi18-10), 1.4307 (X2CrNi18-10), 1.4510 (X3CrTi17), 1.4520 (X2CrTi17), 1.4539 (X1NiCrMoCu25-20-5),
(b) silver, gold, platinum, iridium, rhodium, titanium and their reciprocal alloys;
(c) copper containing at least 99,90% Cu + Ag and phosphorus (P) in the range of 0,015 - 0,040%. Copper products may be used only if the distributed water has a stable pH of 6,5 to 9,5 and is not otherwise aggressive - it must meet at least the acid neutralising capacity of KNK4,5 ≥ 1,0 mmol / l, CO2 (total) ≤ 44 mg / l; evidence is provided of a statistical evaluation of the relevant network site in the form of data minimum, maximum, average, of at least six analyses, evenly distributed in one year or of a water quality protocol from an individual source,
(d) copper alloys, namely brass and zinc-resistant brass, such as CuZn39Pb3 (CW614N), CuZn40Pb2 (CW617N), CuZn36Pb2As (CW602N), not containing more than 2,2% lead and 0,1% arsenic; also bronze such as CuSn10-C (CC480K), CuSn3Zn8Pb5-C (CC490K), CuSn5Zn5Pb5-C (CC491K), not containing more than 3,0% lead and 0,6% nickel but which can be used only for the production of fittings and fittings,
(e) zinc alloys, unless they contain more than 0,01% arsenic, 0,01% antimony, 0,005% beryllium, 0,01% bismuth, 5% chromium, 0,01% cadmium, 2,5% copper, 1% nickel, 0,25% lead, 5% aluminium, other elements individually up to 0,1%, but cumulatively up to 0,8%; magnesium, calcium, silicon, titanium, silver, gold, iridium and rhodium may be present without limitation of quantities.
(2) Products complying with the conditions referred to in paragraph 1 need not be subject to an exclusive test. The manufacturer, importer or distributor of these products shall have a chemical composition verification in the form of a test report issued by the testing laboratory.
(3) In the case of higher content of substances in the products referred to in paragraph 1 or other composition of the product, compliance with the requirements set out in § 3 (2) or (3) shall be decisive. The test water referred to in Annex 1 (3) (b) or the modified test water referred to in Annex 1 (3) (c) may be used for the exclusive test. In the case of use of only modified test water, such a product may be placed on the market only if the requirements set out in Paragraph 3 (2) or (3) are met, indicating the restrictive conditions referred to in paragraph 4.
(4) The following products may only be used if the drinking water distributed:
(a) it has a stable pH of between 7,0 and 9,5 (evidence of the quality of water from the supplied area or individual source); and
(b) is not otherwise aggressive against the product as specified by the manufacturer.
(5) Cast iron, steel other than stainless steel and iron alloy shall be provided with an appropriate coating to prevent corrosion in accordance with § 8 complying with the requirements of § 3 (2) or (3).
(6) The surface of products coming into direct contact with water shall be free of macroscopic damage: cracks, spots, apparent creases, signs of corrosion, frakking, pressed objects, crevices, tubes, shingles or sharp overforms. Only a degree of deformation of metal products which does not adversely affect their function is permitted.
Plastic articles
Only monomers and other starting substances and additives listed in the list of monomers and other starting substances referred to in Article 11 of Commission Regulation (EU) No 10 / 2011 of 14 January 2011 on plastic materials and articles intended to come into contact with foodstuffs, as amended, may be used for the manufacture of plastics and products for contact with water.
Articles of rubber and elastomers
Products of rubber and elastomers intended to come into contact with water shall comply with the requirements of § 3 (2) or 3. In the case of seals with a total surface area of less than 100 cm2, products corresponding to categories I to III may also be used for contact with water under Sections 15 and 16 of the Specific Legislation (5).
Water pipes and water pipes, with an inner lining on the ground based on cement
(1) The water pipes up to and including DN 300, which have been equipped with an internal cement-based bedding on the site, may only be put into service after seven days in contact with drinking water which has been changed at least three times after a minimum stagnation of 24 hours and after at least 24 hours in the pipeline stagnation of drinking water by testing that the quality of that water is equivalent to drinking water (3), by performing an analysis of that water within the range of the cut-off analysis referred to in Annex 5 to the specific legislation3) and by establishing the aluminium concentration value.
(2) A water pipeline of a greater diameter than DN 300, which has been fitted on-site with an inner lining based on cement, may be put into service only after it has been verified by the test that the quality of drinking water after 24 hours of stagnation corresponds to drinking water (3), by performing an analysis of that water in the range of shortened analysis referred to in Annex 5 to the specific legislation3) and by establishing the value of aluminium concentration.
(3) A new or reconstructed water that has the surfaces of walls in contact with drinking water from concrete or covered with cement-based bedding may be put into service only after its walls have been sufficiently rinsed with drinking water, and after at least 24 hours of stagnation of drinking water in the water, it has been verified by a test that the quality of that water corresponds to drinking water (3) by performing a water analysis in the range of the cut-off analysis referred to in Annex 5 to the specific legislation3) and by establishing the value of aluminium concentration.
Chemical substances and chemical mixtures for the treatment of drinking water or hot water
(1) Chemicals or chemical mixtures intended for the treatment of drinking or hot water shall not exceed the detection limit of the method set out in Annex 6 (1). B Specific legislation3), contain no foreign substances of the type pesticides, polyaromatic hydrocarbons or cyanides which are not naturally part of the starting raw material or are not derived from the raw material during the manufacture of the chemical or chemical mixture. Chemicals or chemical mixtures shall no longer contain pathogenic micro-organisms, be a source of microbial or other contamination of water and contain radioactive substances above the limits laid down by specific legislationm2). The purity and safety requirements for essential chemicals or chemical mixtures used to adjust drinking or hot water are set out in Annex 2.
(2) For the application of other chemicals or chemical mixtures for the treatment of water for which the manufacturer, seller, authorised representative or importer has obtained the approval of the public health authority pursuant to Article 5 (5) and (6) of the Act, the conditions set out in Annex 3 shall be complied with. The same conditions apply to non-natural additives of chemicals or chemical mixtures listed in Annex 2.
(3) The effectiveness of disinfectant and algicide chemicals or chemical mixtures (6) intended for drinking or hot water treatment shall be verified in accordance with the procedure set out in Annex 4.
Water
(1) The technological process of water treatment must correspond to the quality of the treated water and must not cause 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) The introduction of a new water treatment technology shall not lead directly or indirectly to deterioration of the existing chemical, physical or microbiological quality of the water and its organoleptic properties. An increase of more than 10% in the initial concentration of chemical indicators is considered to be worsening if 50% of the hygiene limit laid down by the specific legislationm3 is exceeded). Technology reducing the content of dissolved substances or calcium and magnesium content may only be used when the content of calcium and magnesium in water is higher than the recommended value laid down in a separate legislation3) and when the water after treatment does not have a content of these elements lower than the lower limit of the recommended value and the content of dissolved substances is not less than 150 mg / l. Where an increase in the concentration of a chemical indicator is an integral part of a technology intended to reduce the concentration of another undesirable drinking water component, the public health authority shall assess the acceptability of the proposed technology on the basis of a health risk assessment and taking into account other available technologies.
(3) Depending on the quality of the raw water in a particular site, the treatment process, as verified by a test of the correctness of that water, supported by a laboratory, semi-operational or operational test, the duration of which must be demonstrated by the required water treatment efficiency, shall be applied. The following technological procedures may be used for water treatment:
(a) the removal of organisms on micro-nets;
(b) aeration of water;
(c) filtration on suitable material;
(d) water stabilization by means of water filtration through limestone or other deacidification material or by the dosing of lime or, where appropriate, by the dosing of carbon dioxide;
(e) one or two-stage de-irradiation and de-manganese treatment,
(f) one-stage separation, in particular by filtration through a layer of granular material;
(g) two-stage separation by classifying the first separation step before filtration with a layer of granular material;
(h) membrane separation subject to compliance with the requirements referred to in paragraph 2;
(i) adsorption on powdered or granulated activated charcoal and other sorption materials;
(j) oxidation of inorganic constituents using chlorine, sodium hypochlorite, calcium hypochlorite, chloride oxide, potassium peroxide, hydrogen peroxide or ozone;
(k) oxidation of organic compounds using ozone, potassium peroxide or their combinations in advanced oxidation processes with hydrogen peroxide, Fenton reagent, catalysts or UV radiation; these processes must be followed by the absorption of oxidising products on activated charcoal or slow biological filtration to maintain the biological stability of the water,
(l) slow biological filtration;
(m) pH adjustment,
(n) disinfection of water using chlorine, sodium hypochlorite, calcium hypochlorite, chloride oxide, chloramine or ozone;
(o) irradiation by ultraviolet radiation with a wavelength of 250-270 nm and a minimum dose of 400 J / m2 at the full volume of water, with 85% of the radiation output being at the wavelength of 253,7 nm for a monochromatic low-pressure lamp, or a wavelength between 200-400 nm and a minimum dose of 400 J / m2 for a polychromatic medium-pressure lamp, and subject to the other conditions laid down in the CSN 75 505050-3 Economics for water disinfection in water-based plants - Part 3: UV-radiation disinfection,
(p) ion exchange adjustment; or
(q) anti-corrosion protection by dosing of corrosion inhibitors, subject to compliance with the requirements set out in Part F of Annex 2.
(5) In addition to the technological procedures referred to in paragraph 3, magnetic and electromagnetic water treatment may also be used for the treatment of hot water, but not drinking water.
Record of verification
(1) A test laboratory conducting the test and formulating a technical opinion shall issue a verification record of its findings indicating whether the product characteristics, chemical properties or chemical mixtures or water-based technologies set out in the test comply with the requirements of the law and this Decree. The record shall consist of two parts:
(a) information on the test, including the test result, the name of the test report; the name and address of the laboratory conducting the test and formulating the expert opinion, unambiguous identification of the protocol on each of its pages; the name, address of the customer, the address of the manufacturer and the country of origin or the authorised representative, or, where applicable, the address of the seller or importer; the commercial name of the product, its description and type designation; materials used to complete the product, including its manufacturer; the framework chemical composition of the product; the declared use of the product, in particular for short-term contact with drinking water, for contact with hot water; method of sampling and identification of samples taken; a description of the test sample and, where appropriate, the test assembly; identification and description of the test method; indication of the test result; indication of uncertainty of determination; the name, function and signature of the responsible person for carrying out the test. Annex 1 sets out the technical details; and
(b) expert opinions and a statement of compliance or non-compliance of the test result with the various technical requirements under the law and this decree; In addition, the expert opinion shall list any supporting documents used to formulate the opinion; evaluation of test results; an indication of the value requirement and the identification of the Regulation setting out the requirements; indication of the restrictive conditions of interpretation and of the compliance or non-compliance expressed; an indication of the outcome of the investigation - an indication of the conformity or non-compliance of the characteristics of the products established by the examination with the requirements for these characteristics under the law and the Decree; the name, function and signature of the person responsible for interpreting and establishing compliance.
(2) A test laboratory carrying out the test and formulating a technical opinion may issue, at the request of the customer, a short test report on its findings, in addition to the verification record referred to in paragraph 1, containing at least:
(a) the name of the test report;
(b) the name and address of the laboratory conducting the examination and formulating the expert opinion;
(c) a clear identification of the protocol on each of its pages;
(d) the name, address of the customer, the address of the manufacturer and the country of origin or the authorised representative, or the address of the seller or importer,
(e) the trade name of the product, its brief description and type designation; declared use of the product (e.g. for short-term contact with drinking water, for contact with hot water),
(f) a reference to the non-abridged protocol referred to in paragraph 1;
(g) indication of the restrictive conditions of interpretation and of the compliance or non-compliance expressed;
(h) an indication of the outcome of the investigation and an indication of the conformity or non-compliance of the characteristics of the products established by the examination with the requirements for these characteristics under the law and the Decree;
(i) the name, function and signature of the person responsible for carrying out the test, interpretation and determination of compliance.
Repeal
Decree No. 37 / 2001 Coll., on sanitary requirements for products coming into direct contact with water and for water treatment is hereby repealed.
Efficacy
This Decree shall take effect on 15 November 2005.
Minister:
Doc. MUDr. Emmer, CSc.
Příloha č. 1
Annex No 1 to Decree No 409 / 2005 Coll.
Exhaust 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 (e.g. fittings), gaskets, coatings, coatings, membranes and others.
2. The principle of the exclusive test - after pre-cleaning of the test sample precisely determined in accordance with the procedure laid down in paragraph 8, the surface of the test sample coming into direct contact with water shall be brought into contact with the test water during three consecutive time intervals:
(a) the test sample of the product intended to come into contact with drinking water shall be tested in steps of three consecutive 72 hours at test water temperature (23 ± 2) ° C;
(b) a test sample of the product intended to come into contact with hot water shall be tested in steps of three consecutive 24-hour intervals at a test water temperature (60 ± 2) ° C.
Chemical analyses shall be carried out from the leases (extracts) of each time interval separately and the concentration values of the indicators monitored shall be determined.
3. Reagents used:
(a) fresh water from the tap or other water meeting the following requirements - drinking water3) with a free chlorine content of less than 0,2 mg / l and a calcium content of more than 30 mg / l and magnesium greater than 10 mg / l; it is used to verify the functioning of the drinking water treatment plant at the point of consumption. For pre-cleaning of the test samples referred to in point 8, fresh water from the tap with lower calcium and magnesium content may also be used,
(b) test water - chlorine-free water, with a condensation of less than 2 mS / m and a TOC content of less than (0,2 ± 0,1) mg / l expressed as carbon, prepared by means of reverse osmosis, deionisation or distillation followed by carbon filtration; is used to perform the exclusive tests,
(c) treated test water - test water according to subparagraph (b) with addition of 50 mg NaCl, 50 mg Na2SO4 and 37 mg Ca (OH) 2 per litre of test water / solution is acidified by bubbling carbon dioxide to a pH of less than 5 and then treated by bubbling air purified through an appropriate filter containing substances that are the subject of an exclusive pH test (7,5 ± 0,1) /; it is used to perform restricted tests for selected metal products with limited use (e.g. copper products);
d) comparison water for sensory evaluation - water which is described by the test panel as completely free of smell and taste and which is used in sensory assessment of drinking water. The comparative water may be water of water, bottled drinking, spring or infant water, possibly packaged natural mineral water with low mineral content or prepared according to Annex D in ČSN EN 1622: 2007,
(e) carbonate solution - test water containing (222 ± 2) mg calcium chloride anhydrous and (336 ± 2) mg sodium bicarbonate per litre of test water; The pH value shall be adjusted to 7,4 ± 0,1 by bubbling air and / or CO2 according to EN 14944-1; it is used to simulate the ageing of cement-based products.
4. Laboratory equipment:
(a) laboratory glass suitable for chemical tests, including trace analysis, for microbiological tests and for the determination of odour and taste;
(b) containers, tanks, stoppers and couplings shall be made of material which is stable during the test, such as glass, PET, PTFE or stainless steel;
(c) equipment capable of providing the required test temperature for leaching at (23 ± 2) ° C or (60 ± 2) ° C for the duration of the test without changing the volume of the test water or treated test water.
5. Preparation of test samples and testing requirements:
(a) the test samples shall be prepared in such a way that the test water (point 3 (b) or (c)) is exposed only to a surface intended to come into contact with water. For completely homogeneous test samples, the entire test sample may be exposed to test water, including surfaces not intended for direct contact with water,
(b) the test samples of cement-based products must be prepared in the form of beams (40 x 40 x 160 mm) and kept in the manner specified in ČSN EN 196-1 Methods of testing of cement - Part 1: Determination of strength; the maximum ageing time, unless the manufacturer determines a shorter ageing period, shall be 28 days, of which the test samples shall be stored in a carbonate solution for the last 8 days; the storage in the carbonation solution does not apply to test samples of material of the management type (scrapings, torcretes) for which the manufacturer assumes a shorter period between application and putting into service. After this period it is necessary to immediately start pre-cleaning and testing the samples; Test samples of cement-based smelting materials shall be prepared by applying the smelting material to the beams prepared according to the CSN EN 196-1 or with sand matted glass or compact cast plates of smelting material. The additives in cement-based products shall be tested by comparing the concentration of the determined constituents from reference samples prepared according to EN 196-1 with the concentration of the determined constituents from the same prepared samples to which the additive has been added,
(c) test samples of adhesives and solders for pipe coupling shall not be tested separately but after application according to instructions for use; The test samples shall be prepared in such a way that two pieces (or more pieces) of tube are glued together by means of a coupling (fittings) of the same material and the test sample thus prepared is filled with the test water after pre-cleaning in accordance with paragraph 8 and the inner part of the test sample is filled (the column of water in the tube must reach a maximum of 5 cm on each side of the outer joints); the diameter of the tubes used shall be chosen in such a way that the ratio S: V is as close as possible to 1 cm2 / 1 cm3; the distance of the individual connections on the test sample shall be not more than 5 cm; the number of connections shall be used for the test to achieve an appropriate volume of test fluid for determining all the indicators monitored; the results of the concentration values of the monitored parameters set out in the 3rd leaching shall be compared with those of the same leaching of the reference test sample, which is part of the same tube without applied adhesive (solder); the volume of water for both types of test samples shall be the same;
(d) test samples of coatings or coatings shall be prepared by painting or applying the coating or coating to stainless steel plates or sand-matted glass, as specified by the manufacturer; Industrial coating or coating of pipes, including cement-based coatings, shall be tested in accordance with point 7 (d) or (e);
(e) test samples of filter fabrics and membranes shall contain all the materials used for the finished product;
(f) test samples of non-homogeneous or surface-treated products shall have the same composition as finished products; the samples shall be tested in such a way that the test water / point 3 (b) / only the test samples of those parts of the products the surface of which comes into direct contact with the water are exposed;
(g) if there is no procedure for a specific type of product or if for technical reasons the test sample cannot be tested under the above conditions, derogations from the test procedure are possible; These exceptions shall be duly justified and indicated in the test report.
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Regulation Information
| Citation | Decree No. 409 / 2005 Coll., on sanitary requirements for products in direct contact with water and for water treatment |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 17.10.2005 |
|---|---|
| Effective from | 15.11.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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