On 30 October 2013 amendments to the fruit juice and soft drink regulation and other foodstuff-related provisions (3rd amending order) was published in the Federal Law Gazette (BGBl I no. 64 of 30 October 2013, page 3889). This ordinance came into force on 31 October 2013 with immediate effect.
The 3rd amending ordinance did not only implement the fruit juice regulation 2012/12/EU into German Law, it also changed the manufacturing requirements for fruit juice and soft drinks and their labelling as well as the permitted and prohibited additions to fruit juices. The German Food Supplements Ordinance (NemV) and the Ordinance on dietetic foodstuffs (DiätVO) have been adapted to European requirements. The changes in the NemV made upon sanctions are however of particular practical relevance.
What are the future changes in the NemV?
Sec. 6 NemV, which contains provisions on administrative and criminal offences, is amended as follows:
- Violations of the notification duty stipulated in sec. 5 NemV will be punished with a fine of up to € 50,000 EUR (Sec. 6 para 3a NemV, Sec. 60 para. 2 no. 26 lit. a), para 5 no. 2 German Food and Feed Code (LFGB).
- Violations of the particular labelling requirements stipulated in Sec. 4 para 1 no. 1, 2, 4 and 5 respectively sec. 4 para 3 NemV may also be punished with a fine of up to € 20,000 (sec. 6 para 4 NemV iVm sec. 60 para 2 no. 26 lit. b), para 5 no. 3 LFGB)
- Violations of the advertising ban laid down in Sec. 4 para 4 NemV will be subject to a penalty (Sec. 6 para 2 NemV in conjunction with sec. 59 para 1 no. 21 lit. a) LFGB). Such violations could result in imprisonment for up to one year or a fine.
The stricter sanctioning is justified by the fact that a successful enforcement of the respective provisions through the Länder would otherwise not be possible. Enforcement experiences have demonstrated this (cf. draft of the 3rd amending regulation of 28 June 2013, page 26).
Moreover, an adjustment to European Law has been made by the following amending measures:
- The former annexes 1 and 2 NemV have been removed. Instead sec. 3, 4 NemV now refers to the respective material approvals in attachments I and II of the European directive in the current version of 5 December 2011, which were made in accordance with the regulation (EC) no. 1170/2009 and the regulation (EC) no. 1161/2011.
- With regard to measures determining the purity criteria for vitamin and mineral substances which may be used for the production of food supplements, it refers to the provisions of the regulation (EU) no. 231/2012 which are directly applicable.
- The transitional provisions (sec. 7 NemV) that are no longer necessary are deleted.
Back to the roots?
Until now, a violation of the notification duty was neither punished with a penalty nor with a fine. The threat of a prison sentence of up to one year or a fine (cf. Sec. 6 para 2 no. 2 of the draft of NemV) as intended in the draft of the NemV dated 13 May 2003 (BMVEL 312-818-1/0) in case of a violation of the notification duty was eventually not incorporated in the final version of the NemV.
Those who feared that the Federal Office for Consumer Protection and Food Safety (BVL) would properly examine the application documents and would inform the competent supervisory authorities accordingly in the event of suspected deviations from the valid legal provisions could therefore refrain from a notification without fearing any consequences at an enforcement level. This is now no longer possible.
What is to be done exactly?
According to Sec. 5 para 1 NemV, any manufacturer or importer wanting to launch a food supplement on the German market has to notify the BVL when the product is placed on the market for the first time. They must do this by submitting a sample of the product's labelling.
According to the legal definition in Art. 3 no. 8 regulation (EC) 178/2002, a food supplement is placed on the market (for the first time) when it is hold for the purpose of sale. This includes it being offered for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves. Internal transfer processes of a product or passing on an unfinished product that is not labelled accordingly for being passed onto the consumer through the contract manufacturer is not considered as a "first marketing". The same applies to so-called pre-marketing measures which only announce the imminent distribution of the product.
If the food supplement has previously been launched in a different member state of the EU, the notification must indicate the authority of the member state where the first notification was made, cf. Sec. 5 para 2 NemV, provided that the law of said member state provides for such a notification duty.
However, not all member states (eg Great Britain and the Netherlands) made use of the option provided for in article 10 of the Directive 2002/46/EC, i.e. a notification before an authority by submitting a sample of a label, which serves to ease the monitoring of market launches. For example, anyone who distributes a food supplement at first in Great Britain does not need to notify the BLV about such a first placing on the market.
On its website, the BVL provides a relevant form for such a notification. The person responsible for placing the product on the market can use this form, but is not obliged to do so. The wording of the law only requires a copy of the product label is submitted. Alternatively, the notification can be made easily and quickly via the BVL website. After completing the online form with a copy of the product label uploaded, the applicant will immediately receive an email confirming the notification, enabling the product to be distributed.
What happens in case of an absent notification?
As of 31 October 2013, anyone who does not give a notification, gives a wrong or incomplete notification or does not notify in time is committing an offence. But what happens in cases where no notification has been made to the BVL but the product was put on the market before 30 October 2013?
According to Sec. 3 Code of Administrative Offences (OWiG), which is based on the general legal principle in article 103 para 2 German Constitutional Law (GG) ("nullam poene sine lege"), an act can only be punished as an administrative offence if the possibility of a punishment was already determined by the law before the act has been committed.
As the obligation to make a notification on the marketing of a food supplement is based on the point of time when the product was "placed on the market for the first time", the amendment to the law does not affect those distributors who have placed a food supplement on the market before 30 October 2013 without having notified the BVL thereon. The "first marketing" is completed upon the first market launch of a product.
It is contested whether or not a change to a product being already on the market triggers a notification duty again. It cannot be taken from the wording of sec. 5 NemV whether changes to the formulation of food supplements that are already on the market are subject to a notification duty.
It is different, however, with cosmetic products or authorised medicinal products. Changes to their ingredients must always be communicated to the relevant authorities or are even subject to approval in the individual case (cf. article 13 para 7 Regulation (EU) no. 1223/2009 relating to cosmetic products and Sec. 29 et seq. German Drug Act (AMG) relating to medicinal products).
It is assumed that changes to the formulation that are, in general, not subject to labelling requirements, e.g. a mere exchange of a flavour or of an ingredient being only labelled with its class name, does not trigger a new notification duty. This also applies to changes in the format of dosage as such, e.g. capsule instead of tablets, unless this does not conflict with approval requirements necessary for the substances used (e.g. through a required exemption clause or a general ruling). The introduction of new packaging sizes is also not subject to the notification duty.
However, if the character of the product is substantially changed as a result of the changed formulation because of the following reasons, this might require a new notification before the BVL:
- valuable ingredients or substances are replaced, added or increased which do regularly affect the labelling of the product itself ; or
- a food supplement of the same composition having, for instance, a new flavour shall be distributed as a so-called "line extension" besides a product with an identical composition that has already been notified; or
- a change to the brand or trade name of the product; or
- a different distributor.
The issue discussed here has not yet been clarified by a court. If there is a sanction due to a missing and in the individual case unclear "new notification" of changes to the formulation, the principle "in dubio pro reo" may help the concerned distributor.
Consequences of an absent notification in view of Unfair Competition Law
Irrespective of that, there is now a risk that a violation of the notification duty will be prosecuted as violation of a market relevant provision under German Unfair competition law by competitors or competition associations. A potential complainant may gain knowledge on the lacking product notification by asserting claims for information against the BVL. The Consumer Information Act (VIG) gives every consumer in Germany the right to obtain such information with respect to foodstuff-related information of authorities (cf. sec.sec. 1, 2 VIG). The reasons for exemption or restriction laid down in sec. 3 VIG would not apply.
What happens in case of violations of labelling and advertising regulations?
The situation is different with respect to violations of labelling and advertising regulations which are sanctioned for the first time or are subject to stricter sanctions now. As far as they date back to the time before 31 October 2013, milder penalties or fines shall in general be applicable according to Sec. 2 German Penal Code (StGB), resp. Sec. 4 OWiG:
- Violations of labelling requirements which are not subject to sanctions according to sec. 4 para 2 no. 1, 2, 4, 5 and para. 3 clause 1 NemV remain unpunished;
- Violations of sec. 4 para 4 NemV are punished as administrative offence and not as a criminal offence.
The principle of non-retroactivity prohibits the subsequent intensification of a punishment.
The distributor of a food supplement benefits from this privilege only in the case of objections before authorities, but not in unfair competition proceedings. Violations of the labelling regulations are always relevant for the market since they regularly serve to advise and inform the consumers about food and health-related aspects of the foodstuff (cf. Federal Court of Justice, judgement dated 22 November 2012 - I ZR 72/11).
Do not forget
Please ensure that you do not forget to indicate the following information on pre-packed food supplements which are intended for the end consumer:
- The names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances;
- The portion of the product recommended for daily consumption;
- The warning "The stated recommended daily dose shall not be exceeded";
- A statement to the effect that food supplements should not be used as a substitute for a varied and balanced diet;
- The information that the products must be kept out of the reach of small children (cf. Sec. 4 para 2 NemV).
Please also ensure that you declare the amounts of the nutrients or other substances per portion of the product as recommended for daily consumption on the labelling by using the correct measurements also with regard to vitamins and minerals. The specifications shall also relate to the respective reference values (RDA) set out in the Annex to Directive 2008/100/EC (sec. 4 para 3 NemV). The substance and nutrient information must in general be based on a nutrition analysis of the manufacturer but may also take into account respective tolerances (cf. Guidelines of the commission for tolerances in the nutrition information, December 2012).
And finally, please do not advertise your product by stating that it is exactly what "the consumer needs to be optimally supplied" (cf. District Court of Munich I, judgement dated 16 November. 2006, docket no. 17 HK 0 20 917/04). This does not only constitute a punishable violation against sec. 4 para 4 NemV, but also a violation of the prohibition on misleading statements as set out in sec. 11 para 1 clause 2 no 2 LFGB.
Equally inadmissible in that context would be information on an insufficient nutrient intake by consumption of certain foods (e.g. fast food), cf. District Court of Munich I, judgement dated 11 February 2011 - 4 HKO 12374/09. Advertising slogans like "Ensure that you are never without your survival food under any circumstance" (cf. Court of Appeal Berlin, judgment dated 20 July 2013 - 5 U 177/08) would be also inadmissible. In contrast, highlight special situations in life in which the additional consumption of a food supplement is indicated to serve an increased need for nutrients or other substances of a nutritional value would be allowed.