Pre-packaged packaging regulations: Conformity to nominal content requirements

The Control of Pre-Packaged Packaging

With the increasing development of large-scale distribution, pre-packaged packaging is becoming increasingly important. In light of this, the European Community legislator, and subsequently the legislators of various Member States, deemed it necessary to impose certain rules on manufacturing companies, the pre-packaged packaging regulations.

Below, we provide a general overview of the relevant regulations currently in force. These regulations also apply fully to cosmetic products, regulated by Cosmetics Regulation 1223/2009. A key aspect to consider is what is described below regarding the nominal content of these products. For further insight on the requirements applicable to cosmetics packaging, read our blog article on packaging regulations in Europe. 

What Is Pre-Packaged?

Pre-packaging refers to both the product itself and the individual packaging in which the product is pre-packaged.

A product is pre-packaged when:

• it is contained in packaging of any kind
• it is closed in the absence of the buyer
• it is prepared in such a way that the quantity of the product contained in it has a fixed value, ensuring it is always the same.
• the quantity contained cannot be changed without opening or clearly altering the packaging itself

Any self-destructing closure system when opening the casing or container can be considered a valid alternative to sealing. We find many examples of pre-packaged packaging in our daily lives: from detergent to tins of tuna, from toothpaste to make-up, from butter to yogurt, from wine bottles to paint, etc.

Pre-Packaged or Pre-Packed Product?

The characteristics listed above lead us to conclude that, for example, packages of fresh fruit or vegetables sold in many commercial establishments cannot be classified as pre-packaged packaging. In this case, we are referring more accurately to a pre-packed product, which is weighed in the absence of the buyer and has a variable net weight for each product (meaning each package of the same product will have a different weight).

The product is placed in packaging or a package that wraps it, either partially or entirely, but is not hermetically sealed or sealed. The so-called pre-packed product is prepared and packaged in the absence of the buyer, but its net weight is not fixed or regulated, and the packaging is often not destroyed when the package is opened.

Who Must Comply With This Policy?

The metrological rules on pre-packaged packaging apply to products intended for sale to the final consumer. Therefore, it does not apply to pre-packaged packaging intended for professional use only. Some measures also determine the scope of the relevant provisions on the basis of the quantity (indicated in units of mass or volume) of the contents.

For example, the legislation on EEC-type pre-packaging containing liquid foodstuffs applies to packages containing volumes not exceeding 10 litres.

The sector’s legislation is divided into two main groups:

• Community legislation, implemented in national law with a specific series of measures.

In turn, this group is divided into two distinct series, concerning, respectively:

○ Liquid foodstuffs

○ All other types of products (whether solid, liquid or otherwise, including cosmetic products)

• national legislation, very similar in content and procedures to the Community legislation, but unlike the latter, it is aimed only at products intended for the national market.

Objectives of the rules laid down:

• With regard to EU-derived legislation: to guarantee the free movement of products within the territory of the European Community, establishing a series of common requirements and standards and the related control methods;
• Guarantee the protection of consumers in the context of transactions carried out by means of quantitative determinations carried out in the absence of the same, through a system of procedures and controls aimed at ensuring the compliance, within certain tolerances, of the actual content of pre-packaged packaging with that declared;
• At the same time, to ensure market transparency in this area.

The legislation establishes a series of principles and requirements, which are essentially the same across all the above-mentioned groups of standards. These principles ensure that pre-packaged packaging can be considered compliant with the relevant legal provisions, particularly concerning the conformity of the actual content with the nominal content.

One of the reasons for introducing mandatory nominal quantities for pre-packaging was to allow consumers to compare the prices of products of the same type but from different manufacturers or brands. With the liberalisation of product ranges, legislators needed to provide consumers with new tools for immediate price comparison.

This context led to the obligation to indicate the price per unit of measurement (€/kg, €/l, €/m, etc.), alongside the selling price of the individual pre-packaged food and non-food packaging. This obligation also extends to catalogues and all forms of advertising.

Terminology and Tolerances 

Terminology

• nominal content (by mass or volume) of a pre-package: the content indicated on the packaging, corresponding to the quantity of product it is considered to contain.
• actual content: the quantity, in terms of mass or volume, of the product that it actually contains.

Note: For products whose quantity is expressed in units of volume, the value of the actual contents considered in control operations is based on the reference temperature of 20 degrees Celsius, regardless of the temperature at which the filling or control was performed. This provision does not apply to frozen products whose quantity is expressed in units of volume.

• batch: a batch is defined as “all pre-packed packages of the same nominal quantity, of the same model and of the same manufacture, filled in the same place” (generally assumed to be equal to the maximum hourly production of the filling chain);
• minimum tolerated content: this is the value obtained by subtracting the corresponding maximum tolerated error, provided for by the regulations, from the nominal quantity of a pre-packaged package;
• Defective pre-packaging: the individual items in the batch whose actual content is less than the minimum tolerated content.

Tolerances

The nominal content indicated on the pre-packaged packaging must correspond to the actual content, within the tolerances established by the aforementioned regulations for the individual product categories, based on the following criteria:

• compliance with the tolerance values set by the legislation is determined not only with reference to the single pre-packaged package, but to the entire production batch;
• The actual content of pre-packaging must not be less, on average, than the nominal quantity. Therefore, it is not sufficient for any difference in the individual pre-packaged package to fall within the allowed tolerance. The differences, when referring to a specific production batch, must be distributed in a balanced manner around the nominal quantity value. For example, if one item in the batch has a shortfall, there must be another item in the same batch with a similar excess, so that the average value, calculated across all items in the lot, is not less than the nominal quantity.
• based on the number of batches, the number of any defective pre-packaged packages (see above) must not exceed the values set by the regulations (so-called acceptance/rejection criteria);
• None of the defective pre-packages may have one less error (difference between nominal quantity and actual content), greater than twice the permissible tolerance (such products are considered non-marketable).

Excerpt from Directive 76/211/EEC on pre-packaging tolerances:

Manufacturers’ Obligations Regarding Compliance With Packaging Legislation

The manufacturer’s obligations to comply with the requirements of the legislation are:

• The manufacturer, i.e. the importer of pre-packaged packaging, must first check whether the product of interest is among those for which mandatory size ranges are provided for by the legislation, and comply with the permitted values.
• The manufacturer himself must therefore ensure that the actual content of the same corresponds to the nominal quantity, within tolerances and according to the criteria provided. To this end, the legislation provides that the actual content must be measured or controlled, under the responsibility of the individual or Company in charge of the filling of the product  (in the case of pre-packaged packaging from countries outside the European Community).
• Instead of the importer measuring or checking the content, he can demonstrate that he has all the necessary guarantees to ensure the conformity of the pre-packaging (e.g. he can produce documentation relating to checks carried out at the manufacturer’s premises in the country of origin).
• The measurement or control must be carried out (in terms of mass or volume) by means of a legal measuring instrument (i.e. subject to periodic verification by a special certifying body).

In practice, you operate in compliance with the legislation if:

• the actual quantity is measured manually, at the time of filling each individual pre-packaged package, with a legal instrument (first and periodic metric verification); This method is obviously applicable only in the case of production in small quantities, usually of an artisanal nature.
• For pre-packaging that follows national legislation, the relevant standards also specify the characteristics (minimum division) of the weighing instruments used for control purposes, and also provide for the possible obligation for the manufacturer, in relation to the characteristics of the filling instrument, to include a checkweigher in the packaging chain.
• The manufacturer/importer must record the results of the checks carried out, keeping and making available the relevant documents, to certify that the checks themselves and the related corrections or adjustments have been carried out correctly.

Correct Metrological Inscriptions

The manufacturer must observe certain rules regarding the metrological inscriptions to be shown on pre-packaged packaging:

• an indication of their mass or volume, expressed in kilograms or grams and in litres, centilitres or millilitres, respectively; the numerical value must be followed by the symbol of the unit of measurement used or its full name, in accordance with the relevant requirements;
• The figures for these inscriptions shall be as follows, in relation to the nominal quantity of the content:
  ○ for a nominal quantity of up to 50 grams or millilitres the minimum height is 2 millimetres,
  ○ over 50 and up to and including 200 is 3mm,
  ○ over 200 and up to and including 1000 is 4mm,
  ○ over 1000 is 6mm;

• the inscriptions relating to the nominal quantity of the pre-packaged packaging must be indelible, clearly legible, and visible under typical conditions of presentation. They must also be placed in the same field of vision as the product name.
• It is forbidden to accompany the inscription on the nominal quantity with any indication of inaccuracies or ambiguities, such as “about” or other similar terms.

Pre-packaged packaging must bear a mark or inscription that allows for the identification of the person who carried out or caused the filling to be carried out. In the case of pre-packaged packaging from third countries, the importer established in the national territory or the European Community must be identified.

The Symbol “e”

The estimated sign, e, also referred to as the e-mark or quantité estimée (estimated quantity) can be found on most prepacked products in the European Union (EU). Its use indicates that the prepackage fulfils EU Directive 76/211/EC, which specifies the maximum permitted tolerances in package content.

1. The symbol “e” must correspond exactly to the one indicated in the Directive

2. The symbol “e” must not alter the characteristics of the packaging and those of the packaged product;

3. The symbol “e” must have a minimum height of 3 mm;

4. The symbol “e” must be placed in the same field of view as the nominal quantity indication;

5. The affixing of markings that could cause confusion on the market with the mark “e” is prohibited.

General rules:

1. All mandatory particulars must be indelibly affixed.

2. All mandatory information must be clearly legible.

3. All mandatory particulars must be visible under the usual conditions of presentation of the pre-packaging.

4. Additional metrological indications are prohibited.

Surveillance

The Metric Service is responsible for monitoring the production and importing companies:

• the actual quantities contained in the individual pre-packages
• on the relevant inscriptions
• statistical sampling records
• on the instruments used for the control of pre-packaged packaging

Legislation

On the basis of the principle of the elimination of obstacles to the free movement of goods within the Community, the European Economic Community (now the European Community) has established unambiguous metrological standards to be applied in the production and marketing of pre-packaged packaging, namely:

• the establishment of a common mark for pre-packaged packaging (the above-mentioned estimated symbol)
• the definition of common filling tolerances (lower maximum tolerated errors), which only function of the nominal filling quantities
• the definition of standardized metrological inscriptions that can be understood in all countries of the European Community
• the formalisation of standard control methods applicable in all Member States, so as to ensure, in conjunction with the previous point, fair competition between the various economic operators within the Union

These directives have been transposed into the various national laws of the Member States by means of various transposition measures.

National Legislation

National manufacturers of pre-packaging that market their products exclusively on the national territory can – as an alternative to EC provisions – apply the national reference legislation on pre-packaging. In this case, however, they cannot apply the CE conformity mark (“e”).

Free Samples

All products given free of charge or free samples are fully subject to the provisions of Article 19 of the Cosmetics Regulation 1223/2009, with the sole exception of the indication of the content, which may not be indicated even if equal to or greater than 5 g or 5 ml. On the other hand, free samples are excluded, as products not intended for sale, from all obligations arising from the rules on pre-packaging.

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Are you still unsure about how to correctly label your product with regard to nominal content? Or you don’t know if the checks you are carrying out internally are sufficient, especially in the case of inspection? Contact us, and our team will help you understand all the aspects you need to take into account.