Electronic Cigarette Industry Trade Association
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What constitutes a package under the Regulations?
“For the purposes of the Regulations a “package” is defined as the combination of a product and the individual package in which it is packed when:
• it is placed in a package of whatever nature without the purchaser being present, and;
• the quantity cannot be altered without the package either being opened or undergoing a perceptible modification.
The Regulations apply this system to all packages intended for sale in constant nominal quantities which are between 5g or 5ml and 25kg or 25L, inclusive."
In distinguishing between the contents and the packaging, the approach of OIML (Organisation Internationale de Métrologie Legale or International Organisation of Legal Metrology) recommendation 87 is recommended. This classifies as packaging ‘everything that is intended to be left over after use of the product, except for items naturally in the product. ‘Use’ includes consumption or subjecting to a treatment. (See also CHAPTER 9 PACKAGING AND PACKAGING WASTE DIRECTIVE.)
The Directives set out three rules with which packers must comply:
• the actual contents of the packages should not be less, on average, than the nominal quantity;
• the proportion of packages which are short of the stated quantity by a defined amount (the “tolerable negative error” or TNE) should be less than a specified level; and
• no package should be short by more than twice the TNE.
The packers and importers checks need to be ‘sufficiently rigorous’ to ensure that the packages are packed to meet the three rules. (This includes filling bottles with liquid.) This implies that the system should be as efficient as a reference test (as defined in Schedule II of the Regulations) to control the average quantity and the proportion of packages with a deficiency of more than the TNE.
Fig.1 TNE for a range of nominal quantities
Where the TNE is calculated as a percentage of the nominal quantity, the amount must be rounded up to the nearest one tenth of a gram or millilitre.
• In order to demonstrate compliance with the three rules, packers are placed under a duty either to measure the content of each package or to check the contents by sampling. Where packers choose to measure each package, there is no requirement under the Regulations for records to be made.
• Where packers do not measure the contents of each package but choose to rely on sample checking to demonstrate compliance, the Regulations require records to be made of the results of this checking, which must include any corrections and adjustments made to the packing system. Records must be kept for a period of at least one year from the date on which the packages leave the packer’s premises, or until the date, if any, marked on the package which indicates by when the product ought to be consumed, whichever is shorter. As noted earlier, the system of sampling used must be sufficiently rigorous to ensure that the packages are packed in line with the three rules.
(Please see ANNEX X for the testing procedure for e-liquid batches for Weights & Measures compliance, and ANNEX XI for the Weights & Measures testing protocol.) All measurements and checks are required to be performed with equipment that is suitable for the purpose. (Please refer to ANNEX XII for the calibration procedure.)
• Packers and importers must ensure that packages are marked in such a way as to be indelible, easily legible and visible on the package in normal conditions of presentation (on the outside or inside if the packaging is transparent) with the following:
• the nominal quantity, expressed in litres, centilitres or millilitres for liquids or in kilograms or grams for other products
• The size of the marking should comply with the following table:
Figure 2 Sizes of marking for nominal quantities
• The nominal quantity must be shown in figures followed by the name or the symbol for the measurement unit involved.
• The nominal quantity must include any additional quantity to which any statement on the package refers. So if the package states that a quantity or percentage is provided “free” the nominal quantity must refer to the total quantity contained in the package including the “free” amount.
• The name and address of the packer or importer or of the person who arranged or the packer to make up the package in the UK, or a mark which enables the name and address of any of the foregoing to be identified.
It is recommended that the nominal quantity figure and words (or symbols) should be of the same point size to ensure legibility. (This is included in the samples for labelling requirements provided to ECITA members.)
Where a package contains liquid, its nominal quantity must be indicated by the volume at 20°C (room temperature).
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