Regulation No. 40 of the Minister of Economic Affairs concerning Tolerable Errors in Actual Contents of Prepackages, and Checking of Prepackages

Tolerable Errors in Actual Contents of Prepackages, and Checking of Prepackages1 Regulation No. 40 of the Minister of Economic Affairs of 29 November 2000 (RTL2 2000, 124, 1981), entered into force 1 January 2002, amended by the following Regulation: 11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054. The Regulation is established on the basis of subsections 12 (1) and (3) of the Metrology Act (RT3 I 1994, 71, 1224; 2000, 71, 442; 2002, 61, 375; 63, 387). § 1. Definitions (1) The main terms relating to the field of metrology are used in this Regulation according the Estonian standard EVS 758:1998 “Metrology. Terms and Definitions”. (2) Special terms are used as follows: 1) “net contents” or “actual contents” means the actual quantity of a product contained in one prepackage expressed in units of weight or volume; (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) 2) “nominal quantity” means the quantity of a product contained in a prepackage expressed in units of weight or volume as indicated on the packaging by the producer or importer; (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) 3) “negative error in actual contents” means the quantity of a product by which the actual contents of a prepackage is less than the nominal quantity indicated on the packaging; 4) “prepackages of equal nominal quantity” means prepackages of the same type and of an equal nominal quantity; 5) “multipack” means an additional package for grouping prepackages of the same type, which is used in order to protect the prepackages or facilitate handling thereof and which can be removed without affecting the properties of the products; 6) “handling (process of handling)” means all procedures relating to the manufacture, packaging, storage and transportation of and performance of transactions (including import) with prepackages; 7) “handler” means the person who organises or is responsible for handling; 8) “conformity” means the conformity of a prepackage with the requirements provided for in the Metrology Act and the implementing legislation thereof. § 2. General provisions (1) This Regulation establishes tolerable errors in the actual contents of prepackages handled in the territory of the Republic of Estonia, and the procedure for checking prepackages. (2) This Regulation applies to prepackages of equal nominal quantity, the nominal quantity of which is expressed in units of weight or volume and is not less than 5 g or 5 ml and not more than 10 kg or 10 l (inclusive), respectively. (3) Handlers and supervisory officials shall use verified measuring instruments for checking the actual contents of prepackages. (4) In all operations for checking prepackages the nominal quantity of which is expressed in units of volume, the value employed for the actual contents shall be measured at or corrected to a temperature of +20 °C, whatever the temperature at which packaging is carried out. This rule shall not apply to prepackages of frozen products, the nominal quantity of which is expressed in units of volume. (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) § 3. Obligations and liability of handlers (1) A handler is liable for the conformity of the prepackages handled thereby with the requirements of this Regulation and the requirements for permissible nominal quantities of prepackages and for the marking of prepackages. (2) A handler shall consistently and regularly check the actual contents of prepackages during the process of handling. (3) If a manufacturer of prepackages submits documentary proof to the importer of the prepackages that the actual contents of the prepackages of the corresponding lot is in conformity with the requirements set out in § 6 of this Regulation, the importer of the prepackages may organise the checking of such prepackages during further handling according to the quality system established and documented by the importer. (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) (4) A handler is required to document the results of all checks of actual contents and preserve such results for at least two years after the performance of the checks. (5) If the management of a process of handling prepackages is certified by an accredited certification body, state supervisory officials may consider this to be sufficient to prove the conformity of the prepackages and the process of handling the prepackages. (6) Regardless of whether the previous prerequisite is complied with, a handler of prepackages is required to provide a state supervisory official with the prepackages necessary to conduct measurement checks (hereinafter sampling). § 4. Supervision (1) State supervision over compliance with legislation establishing requirements for prepackages shall be exercised by the Technical Inspectorate and the officials thereof who are authorised to exercise supervision (hereinafter supervisory officials). (2) Supervisory officials have the right to check prepackages at any stage in the process of handling. (3) A supervisory official checking prepackages during the process of handling shall present the verification marks and/or verification certificate of the measuring instruments used in the supervisory operations to the handler. A supervisory official organising sampling (see subsection 5 (4)) shall ascertain whether the measuring instruments used by the competent measuring laboratory, i.e. the independent third party (hereinafter measuring laboratory), have been verified. (4) A supervisory official shall draw the prepackages necessary for measurement checks from the batch at random and shall prepare a sampling report. (5) A report shall be prepared in two identical copies of which one shall be given to the handler and the other shall remain with the supervisory official. (6) A sampling report shall contain the following information: 1) the date, time and place of sampling; 2) a notation indicating that the representative of the handler has ascertained that the measuring instruments used in the supervisory proceedings bear verification marks; 3) the details of the person responsible for the conformity of the prepackages; 4) the time of manufacture of the prepackages and, in the case of imported prepackages, the date of importation; 5) the nominal quantity of the prepackages; 6) the number of prepackages taken for sampling; 7) the number of multipacks/packages opened for sampling; 8) the cost of the prepackages taken for sampling, as declared by the handler; 9) the name, signature and identification (personal identification code, requisite information from his or her official identification, etc.) of the representative of the handler; 10) the name, signature and valid means of identification (the number of his or her official identification, etc.) of the state supervisory official. (7) A supervisory official shall inform the handler of the results of the checks in writing within two weeks after the moment of sampling. § 5. Checking of actual contents in course of supervisory proceedings (1) In checking the actual contents of prepackages, supervisory officials shall use the methods for statistical checking provided for in §§ 7 to 11 of this Regulation. (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) (2) A supervisory official shall attach a corresponding sticker to all multipacks from which prepackages have been taken for sampling. (3) A sticker shall contain the following information: 1) printed text “Kinnispakkide täitekoguse kontrollimine” [Checking of actual contents of prepackages]; 2) printed text “Tehnilise Järelevalve Inspektsioon” [Technical Inspectorate]; 3) a printed space for the date, to be filled in by the supervisory official on the date of sampling; 4) the name and signature of the supervisory official. (4) If a supervisory official decides that, in order to check the conformity of prepackages, the prepackages need to be measured at a competent measuring laboratory, i.e. an independent third party (hereinafter measuring laboratory), the supervisory official shall organise the delivery (transportation) of the prepackages taken for sampling from the handler to the measuring laboratory. (5) In order to determine and, during transportation, preserve the initial condition of prepackages taken for measurement checks, the supervisory official shall place the prepackages in a container or package in the presence of the representative of the handler and shall seal the container or package with a sticker specified in subsection (3). (6) The marking shall be affixed to the container or package such that it cannot be removed without damaging the marking. (7) The shape and material of a container or package used for transporting prepackages shall preclude any substantial changes from occurring in the condition of the prepackages between the moment of taking the samples and their arrival at the measuring laboratory. “Substantial change in condition” means such damage to a prepackage which directly affects the actual contents of the prepackage. Scratches on the surface of the package, dents, loose labels, etc. shall not be considered substantial changes in condition. (8) Prepackages taken by a supervisory official for measurement checks shall be delivered (transported) from the handler to the measuring laboratory not later than within twenty-four hours as of the time of sampling. (9) A supervisory official shall ensure that the prepackages are preserved under normal conditions until the delivery thereof to the measuring laboratory. (10) After the report documenting the delivery of prepackages has been signed, the measuring laboratory shall ensure that the prepackages are preserved under conditions which do not affect the subsequent measurement procedures. (11) The situation and operations specified in subsections (4)–(9) shall be documented by corresponding entries in the sampling reports. § 6. Tolerable errors in actual contents of prepackages (1) The average actual contents of prepackages of equal nominal quantity shall be greater than or equal to the nominal quantity. (2) The actual contents of a prepackage may be less than the nominal contents only if this is caused by fluctuations in the packaging process. The variable T is the tolerable negative error in the actual contents of a prepackage and the corresponding values are given in Table 1. (3) The proportion of prepackages having a negative error in actual contents greater than T shall be sufficiently small for batches of prepackages to satisfy the requirements specified in §§ 10 and 11 of this Regulation. (4) The negative error in actual contents shall in no case exceed 2 × T. No prepackage having a negative error in actual contents greater than 2 × T shall be marked with the CE marking. Table 1 Tolerable negative error in actual contents of prepackages Nominal quantity Qn, g or ml T % of Qn g or ml 5 to 50 9 – 50 to 100 – 4,5 100 to 200 4,5 – 200 to 300 – 9 300 to 500 3 – 500 to 1000 – 15 1000 to 10 000 (inclusive) 1,5 – (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) Note. When using the second column of the table for determining the tolerable negative error in the actual contents, the resulting value shall be rounded up to the nearest one tenth of a gram or millilitre. § 7. Ensuring statistical reliability (1) Upon checking the actual contents of prepackages, the uncertainty of measurement results shall be less than 0.2 × T, where T is the tolerable negative error in actual contents according to Table 1. (2) The actual contents of prepackages shall be checked using the statistical method specified below or a method of at least the same level of reliability. (3) A statistical test shall be used to check whether a batch of prepackages of equal nominal quantity complies with the requirements specified in § 6 of this Regulation for the actual contents of one prepackage and the average actual contents of the batch. § 8. Object of statistical test (1) The object of a statistical test – a batch of prepackages of equal nominal quantity – shall be determined for each statistical test. The batch size for one statistical test shall not exceed 10 000 prepackages. Note. 1) A batch may, for example, consist of the hourly output of a production line, of the prepackages of the same type currently in the warehouse, etc. 2) If a batch of prepackages which is the object of a statistical test consists of less than 100 prepackages, all of them shall be subject to the test and, if it is possible to check the actual contents without opening the prepackages, the test shall be 100%. (2) A sufficient number of prepackages (hereinafter sample or batch subject to checking) shall be drawn at random from a batch of prepackages which is the object of a statistical test according to the plan for the test used so that, if necessary, double checking can be carried out. (3) A batch subject to checking shall be chosen before the start of measuring operations. New prepackages shall not be chosen at the same time as measurements are being performed. § 9. Rules for statistical tests (1) During a test, the fact whether the prepackages in the sample comply with the requirements specified in § 6 of this Regulation for the actual contents of one prepackage and the average actual contents of the batch shall be determined. A batch of prepackages shall be considered acceptable for the purposes of the test if the batch complies with the requirements for both the actual contents of single prepackages and the average actual contents. (2) Prepackages having a negative error in actual contents greater than T, where T is the tolerable negative error in the actual contents of a prepackage according to Table 1, shall be considered unacceptable. (3) The negative error in the actual contents of any prepackage checked shall not exceed the limit of 2 × T. § 10. Checking of actual contents of single prepackages (1) The actual contents of a prepackage may be checked by leaving the package unopened (double statistical test) or by destroying the package (single statistical test). (2) If actual contents is measured without opening the prepackage, the standard plan for a double statistical test as specified in Table 2 shall be used. Table 2 Standard plan for double statistical test Number of prepackages subject to testing Test level Sample at corresponding test level Sample subject to testing Number of defective prepackages Acceptance criterion Rejection criterion 100 to 500 1. 30 30 1 3 2. 30 60 4 5 501 to 3200 1. 50 50 2 5 2. 50 100 6 7 More than 3201 1. 80 80 3 7 2. 80 160 8 9 (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) (3) Depending on the results of the first part of a double statistical test: 1) if the number of defective prepackages is equal to or less than the acceptance criterion for the first test level as indicated in Table 2, the batch of prepackages subject to testing shall be considered to be in compliance with the requirements specified in subsection 6 (2) of this Regulation; 2) if the number of defective prepackages is equal to or greater than the rejection criterion for the first test level as indicated in Table 2, the batch of prepackages subject to testing shall be considered not to be in compliance with the requirements specified in subsection 6 (2) of this Regulation; in both cases, the second part of the test shall not be carried out; 3) if the number of defective prepackages lies between the acceptance criterion and the rejection criterion, the second part of the test shall be carried out; the number of defective prepackages found in the second part of test shall be added to the number of defective prepackages found in the first part of the test. If the aggregate number of defective prepackages is equal to or less than the acceptance criterion for the second test level as indicated in Table 2, the batch of prepackages subject to testing shall be considered to be in compliance with the requirements specified in subsection 6 (2) of this Regulation. If the aggregate number of defective prepackages is equal to or greater than the rejection criterion established for the same test level, the batch of prepackages subject to testing shall be considered not to be in compliance with the requirements specified in subsection 6 (2) of this Regulation. (4) If it is necessary to destroy (open) prepackages to measure the actual contents, the standard plan for a single statistical test specified in Table 3 shall be used. A batch of prepackages subject to a test shall be considered to be in compliance with the requirements specified in subsection 6 (2) of this Regulation if the number of unacceptable prepackages in the sample does not exceed the acceptance criterion. Table 3 Standard plan for single statistical test Number of prepackages subject to testing Sample Acceptance criterion 100 or more 20 1 (5) For batches of less than 100 prepackages, the checks shall be 100%. A batch of prepackages subject to testing shall be considered to be in compliance with the requirements specified in subsection 6 (2) of this Regulation if the number of unacceptable prepackages does not exceed the acceptance criterion specified in Table 4. Table 4 Permitted number of defective prepackages in small lots Number of prepackages subject to testing Acceptance criterion 1 to 10 0 11 to 50 1 51 to 99 2 § 11. Checking of average actual contents of batch of prepackages (1) In checking the average actual contents of a batch of prepackages, the level of reliability of the statistical test shall be taken into account. (2) A batch of prepackages meets the requirements specified in subsection 6 (1) of this Regulation if the mean value of the actual contents of the sample meets the acceptance criterion specified in Table 5 or 6, respectively. Table 5 Non-destructive test Number of prepackages subject to testing Sample Criteria Acceptance Rejection 100 to 500 (inclusive) 30 x == Qn – 0.503s x >= Qn – 0.503s > 500 50 x == Qn – 0.379s x >= Qn – 0.379s Table 6 Number of prepackages subject to testing Sample Criteria Acceptance Rejection >= 100 20 x == Qn – 0.640s x >= Qn – 0.640s where i = n sum Xi X = i = 1 n is the mean value of the actual contents of the batch where (11.06.2003 entered into force 23.06.2003 - RTL 2003, 72, 1054) is the estimated value of the standard deviation of the measurement results, n is the number of prepackages in the sample; Qn is the nominal quantity of the prepackages of the same type which are the object of the test. § 12. Entry into force of Regulation This Regulation enters into force on 1 January 2002. 1 The amended texts of Directives 75/106/EEC (OJ L 042, 15.02.1975, p. 1), 76/211/EEC (OJ L 046, 21.02.1976, p. 1) 80/232/EEC (OJ L 051, 25.02.1980, p. 1) and of the Council of the European Community have been taken into account. 2 RTL = Riigi Teataja Lisa = Appendix to the State Gazette 3 RT = Riigi Teataja = State Gazette