One gram of chocolate can amount to millions in the annual bottom line. The German calibration authorities illustrate this with a model calculation: If a factory produces 2.5 million bars a day for 200 days a year and each 100-gram bar is one gram short, the shortfall amounts to a merchandise value of 7.45 million euros, assuming a retail price of 1.49 euros. For filling plants, this presents a two-sided challenge: They must comply with the prescribed fill quantities while also wanting to avoid unnecessary overfilling.
The Prepackaged Goods Regulation specifies which deviations are permitted and how businesses must monitor their fill quantities. At ESSMANN | Scales & Automation , we support you in selecting and operating the right weighing technology. This article explains the most important requirements for prepackaged goods with nominal fill quantities ranging from 5 g or 5 ml to 10 kg or 10 l and addresses key special cases.
What does the Prepackaged Goods Regulation cover?
The Prepackaged Goods Ordinance (FPackV) of November 18, 2020, has been in effect since December 1, 2020, and has completely replaced the old Prepackaged Goods Ordinance from 1981. It specifies the requirements of the Measurement and Calibration Act (MessEG) regarding prepackaged goods. You may also come across the abbreviations FPVO and FertigPackV in common usage; the official abbreviation is FPackV.
According to the German Prepackaged Goods Act (MessEG), a prepackaged item is any package that is filled and sealed in the absence of the purchaser and whose contents can only be altered by opening the package or making a noticeable change to it. The FPackV applies to prepackaged goods with both equal and unequal nominal fill quantities, to measuring containers, and to other sales units. Special regulations apply to larger packages. Prepackaged foodstuffs weighing more than 10 kg or 10 l are also covered: Section 16 of the FPackV refers, among other things, to the filling quantity requirements of Section 34. The scope of application for larger packages is therefore not limited to goods such as coal, paint, or fertilizer.
For food products, the EU Food Information Regulation also applies . Directive 76/211/EEC forms the European basis for the harmonized rules governing prepackaged goods with the same nominal quantity.
How much can be missing from a prepackaged item?
The FPackV operates on the principle of the mean value and two tolerance limits. For prepackages with the same nominal fill quantity, three rules generally apply at the time of manufacture (Section 9 FPackV):
- The average value determined in accordance with the prescribed test procedure must not be less than the nominal fill quantity.
- No more than 2% of the packages may exceed the permissible negative deviation (TU).
- No package may exceed the maximum negative deviation specified in § 9, paragraph 4.
For prepackages manufactured outside the EU, § 9(2) specifies, by way of exception, the date of placing on the market.
| Nominal capacity in g or ml | Permissible Negative Deviation TU | Maximum negative deviation for a single package |
|---|---|---|
| 5 to 50 | 9 % | 18% |
| 50 to 100 | 4.5 g/mL | 9 g/mL |
| 100 to 200 | 4.5% | 9 % |
| 200 to 300 | 9 g/mL | 18 g/mL |
| 300 to 500 | 3 % | 6% |
| 500 to 1,000 | 15 g/mL | 30 g/mL |
| 1,000 to 10,000 | 1.5% | 3 % |
Deviations calculated from percentages must be rounded up separately for both columns of the table to 0.1 g and 0.1 ml, respectively. Source: § 9, paras. 3 and 4, FPackV.
An example from the calibration authorities illustrates this: For a nominal fill quantity of 250 g, the average must be at least 250 g. Individual packages may contain up to 9 g less, but no more than 2% (up to 18 g) less. No single package may weigh less than 232 g. The 2% requirement cannot be directly applied to any arbitrarily small sample. Recognized statistical methods are required for sampling. The official test plans are set forth in Annex 3 of the FPackV.
The average-value rule protects consumers as a whole and ensures fair competition. The tolerance limits prevent individual customers from receiving a package that is significantly underfilled. For prepackaged goods with varying nominal fill quantities—such as prepackaged cheese or fresh meat with individual weights—fixed tolerance limits between 1 g and 10 g apply (Section 32 of the Prepackaged Goods Regulation (FPackV)).
For filling, this means: The smaller the variation in your system, the closer you can set the average value to the nominal fill quantity. If your variation is significant, you’ll have to overfill to ensure compliance with the 2% rule. This overfilling is money down the drain, disappearing into packages month after month.
What does the ℮ on the packaging mean?
The small ℮ next to the fill quantity is a voluntary declaration by the manufacturer. It confirms that the manufacturer complies with regulations regarding fill quantity, labeling, as well as inspection and documentation. The symbol has nothing to do with “weighing in,” even though this interpretation persists.
The ℮ symbol facilitates distribution within the EU because no deviating national quantity control rules may be required for the harmonized requirements. Regulatory inspections remain possible, including within the distribution chain. The symbol is intended for specified nominal quantities ranging from 5 g or 5 ml to 10 kg or 10 l. It must be at least 3 mm high and appear in the same field of view as the nominal quantity indication (Section 11 FPackV).
What are the obligations of manufacturers and fillers?
Anyone who manufactures, imports, or places on the market prepackaged goods of the same nominal quantity labeled by weight or volume must ensure that the required measurements or checks are performed during filling and that the results are recorded (Section 41 FPackV). The following applies:
- Measurement methods: generally accepted measurement methods or recognized statistical principles.
- Measuring instrument: suitable for the intended purpose and compliant with the Measurement and Calibration Act, as specified in detail in Annex 7 of the FPackV.
- Records: traceable by batch, including all results of the measurements or inspections actually performed, whether electronic or handwritten. The calibration authorities specify that the records must include, among other things, the product, nominal fill quantity, batch, tare, and measuring instrument used.
- Retention: at least until the next prepackaged goods inspection by the authorities.
If another company fills the packages for you, you may request and submit their records. For packages produced primarily by hand that do not bear the ℮ symbol, the authority may grant exemptions upon request (Section 41(5) FPackV).
An automatic checkweigher can inspect all packages and reject non-compliant ones. Alternatively, regular spot checks based on recognized statistical principles are possible. The inspection plan must ensure compliance with both the specified mean value and the limits for individual packages. The results of the measurements or inspections performed must be documented.
For prepackages with the same nominal fill quantity ranging from 5 g or 5 ml to 10 kg or 10 l, additional scales used exclusively for filling do not generally need to be calibrated. The required filling quantity control using suitable measuring instruments that comply with calibration regulations remains mandatory. If an integrated scale is to simultaneously perform the statutory measurement or control function, both the device and the procedure must meet the applicable requirements.
Which checkweighers comply with the FPackV?
Appendix 7 of the FPackV specifies which measuring instruments are suitable for checking fill quantities. Basic requirement: They must be conformity-assessed or calibrated. In addition, there are two requirements that must be met together.
First, the scale’s margin of error must not exceed one-fifth of the permissible negative deviation. Second, there are minimum requirements regarding accuracy class and calibration value.
Non-automatic scales (plus/minus scales, checkweighers for random sampling) must meet at least accuracy class III. The calibration value e must not exceed:
| Nominal capacity in g or ml | Maximum permissible calibration value e in g |
|---|---|
| 5 to less than 10 | 0,1 |
| 10 to less than 25 | 0,2 |
| 25 to less than 150 | 0,5 |
| 150 to less than 350 | 1 |
| 350 to less than 1,750 | 2 |
| 1,750 to less than 3,500 | 5 |
| 3,500 to less than 7,000 | 10 |
| 7,000 to less than 25,000 | 20 |
| 25,000 to less than 50,000 | 50 |
| 50,000 to less than 100,000 | 100 |
| 100,000 to less than 600,000 | 200 |
| 600,000 to 1,500,000 | 500 |
Automatic checkweighers (in-line checkweighers) must meet at least accuracy class XIII(1). A separate calibration value table applies to them:
| Nominal capacity in g or ml | Maximum permissible calibration value e in g |
|---|---|
| 5 to less than 20 | 0,1 |
| 20 to less than 50 | 0,2 |
| 50 to less than 175 | 0,5 |
| 175 to less than 500 | 1 |
| 500 to less than 5,000 | 2 |
| 5,000 to less than 10,000 | 5 |
| 10,000 to less than 15,000 | 10 |
| 15,000 to less than 50,000 | 20 |
| 50,000 to 100,000 | 50 |
Source of both tables: Appendix 7, No. 1 of the FPackV.
Here’s a calculation example: Your smallest nominal fill quantity is 75 g. A non-automatic checkweigher therefore requires a calibration value of no more than 0.5 g. The permissible negative deviation is 4.5 g, so the scale’s permissible error limit must not exceed 4.5 g / 5 = 0.9 g. The smallest nominal fill quantity that you check on the scale is always the determining factor.
One detail that saves money during the planning phase: Additional equipment that records and evaluates measurement values during the production of prepackaged goods is exempt from the requirements of the Measurement and Calibration Act (Annex 7, No. 3, FPackV). The scale must be calibrated, but the connected statistical software does not need to be.
For baked goods produced primarily by hand without prepackaging and for prepackaged foods intended for immediate sale, calibrated commercial scales are sufficient (Annex 7, No. 2, FPackV).
How do I find the right checkweigher?
Four steps from the package to the scale:
- Determine the smallest nominal fill quantity. This determines the maximum permissible calibration value based on the table above.
- Check the calibration status. The scale must be labeled as “calibratable” or “calibrated at the factory” and must have at least accuracy class III. Non-calibratable checkweighers are not eligible for FPackV compliance checks, even if they have a limit value function.
- Take a close look at multi-range scales. Each weighing range has its own calibration value. The range in which your package is actually weighed is the decisive factor.
- Consider documentation. A data interface (RS-232, USB, or Ethernet) eliminates the need for manual transcription and makes the records required under § 41 FPackV significantly less prone to errors.
You can find suitable models in the ESSMANN Scales Shop under “Checkweighers,” where you can filter by calibration value. For very small nominal fill quantities that require a calibration value of 0.1 g or 0.2 g, it’s worth taking a look at the precision scales. Not sure which scale is right for your production line? Our shop team is available to assist you at +49 (0)40 / 84 000 410.
Does this also apply to checkweighers that are already in use?
A transition period applies to certain existing devices through December 31, 2031. This applies only if the devices were already being used for inspection purposes prior to December 31, 2021, in accordance with Section 27 or Section 31 of the former Prepackaged Goods Ordinance. The year of manufacture or date of purchase alone is not sufficient. These devices must meet the requirements of the new Annex 7 only as of January 1, 2032. The regular calibration requirements remain in effect. Therefore, check early on whether your scales can take advantage of the transitional provision and whether adjustments or replacements will be necessary.
How often must checkweighers be calibrated?
The calibration interval is governed by the Measurement and Calibration Ordinance, not by the FPackV:
- Non-automatic scales with a maximum capacity of less than 3,000 kg: 2 years (standard period under § 34 MessEV).
- Automatic checkweighers and sorting scales: 1 year (Annex 7 of the MessEV).
The calibration period ends at the close of the calendar year. Damaged calibration seals or unauthorized tampering will terminate the period early. In individual cases, the specific device and its intended use determine the exact duration of the calibration period.
Plan maintenance, required calibrations, and verification well in advance, and coordinate the schedules accordingly. ESSMANN supports you with maintenance, preparation, and assistance during the verification process. The verification itself is performed by the responsible authority.
Who conducts inspections, and what are the penalties for violations?
The state metrology authorities conduct random inspections at manufacturers, importers, and retailers (Section 40 FPackV). They weigh random samples according to a specified statistical testing plan and review your inspection records. Violations may be punished as administrative offenses subject to fines. As part of market surveillance, the authorities may also order the withdrawal or recall of products.
Frequently Asked Questions About the Prepackaged Goods Ordinance
What is the difference between FPVO, FertigPackV, and FPackV?
There is no difference in substance. All three refer to the Prepackaged Goods Ordinance. The official abbreviation for the version in effect since December 1, 2020, is FPackV.
To which package sizes does the FPackV apply?
The central filling quantity regulations apply to prepackages with the same nominal filling quantity ranging from 5 g or 5 ml to 10 kg or 10 l. Beyond that, they apply only to certain goods such as coal, varnishes, paints, and fertilizers.
Does a checkweigher have to be calibrated in accordance with the FPackV?
Yes. It must undergo a conformity assessment or be calibrated and meet the requirements of Annex 7 regarding accuracy class, calibration value, and maximum permissible error. For devices that were already in use before December 31, 2021, a transition period applies until December 31, 2031.
What calibration value does my checkweigher need?
That depends on the smallest nominal fill quantity you are checking. For 75 g, the maximum is 0.5 g for non-automatic scales; for 250 g, the maximum is 1 g. The complete table can be found in Appendix 7 of the FPackV.
Is the ℮ symbol required?
No. It is optional. Those who display it declare compliance with the requirements regarding fill levels, labeling, and documentation and may distribute the product throughout the EU without further national testing.
Does the statistical software for the checkweigher need to be calibrated?
No. According to Annex 7, No. 3 of the FPackV, auxiliary devices for recording and evaluating measurement values are exempt from the Measurement and Calibration Act. The checkweigher itself must meet the requirements.
How long do I have to keep the audit records?
At least until the next inspection of prepackaged goods by the competent calibration authority.
Does my filling machine need to be calibrated?
No, for prepackaged items with a nominal fill quantity ranging from 5 g to 10 kg, provided you verify the fill quantity using a suitable, conformity-assessed, or calibrated checkweigher. For packages weighing more than 10 kg, the filling equipment is exempt from the calibration requirement only if a suitable scale is installed downstream or if the filling is subject to statistical control (Section 34(5) FPackV).
Do I need a calibrated scale for packages with varying weights?
Yes. Anyone who produces prepackaged goods with varying nominal quantities—such as cheese or meat with the individual weight printed on the package—must use calibrated scales. Automatic labeling scales used for this purpose must be calibrated annually.
One Gram Under Control
By monitoring the variation and average weight of your fillings, you can reduce unnecessary overfilling and reliably comply with the prescribed fill quantities. This requires a checkweigher suitable for the intended package sizes, traceable records, and a valid calibration status.
Not sure whether your checkweighers meet the requirements of Annex 7 or whether you can take advantage of the transitional provision? Talk to ESSMANN | Waagen & Automation about your package sizes, scales, and processes so that every single gram in your production remains under control.
