Which are the competent authorities for food & beverage?
In Greece, several ministries are in charge of food issues, namely the Ministry of Rural Development & Food, the Ministry of Health, and the Ministry of Economy & Development.
However, food safety and consumer protection is the primary responsibility of the Food Control Authority (“ΕΦΕΤ”), which is supervised by the Ministry of Rural Development & Food and appointed as the contact point for the European food authorities and the Codex Alimentarius Commission.
Sanitary inspections are mainly carried out by the Regional Hygiene Control Directorates.
Another important authority is the General State Chemical Laboratory (Γ.Χ.Κ.), established in 1929 within the Ministry of Finance, with a wide spectrum of activities, such as conducting samplings and laboratory tests on various food including alcohol drinks, granting approvals for new, functional food products and offering technical-scientific support to other authorities.
Moreover, the Supreme Chemical Council (A.X.Σ.), аn organ of the General State Chemical Laboratory, carries out a significant legislative work on issues of food composition and food distribution.
Worth mentioning is finally the National Organization for Medicines (“ΕΟΦ”), which is exclusively competent for food supplements and dietetic foods.
By which legislation are the food hygiene requirements stipulated?
Like in other EU countries, food hygiene is also in Greece a domain primarily regulated through binding, directly applicable EU norms, namely the EU Regulations 178/2002, 852/2004, 853/2004, 854/2004 and 882/2004.
National regulatory acts, such as the Ministerial Decision 15523/2006 and the Presidential Decree 79/2007, the latter one referring to specific hygiene rules for food products of animal origin, focus essentially on administrative, procedural issues resulting from the implementation of aforesaid EU norms, with particular regard to the registration and approval requirement for food business operators establishing activities in Greece.
On national regulatory level, food hygiene requirements are notably stipulated in the new Sanitary Regulation Υ1γ/Γ.Π/οικ.47829/2017. By establishing a partially revised classification, this Regulation applies to the following categories of food business operators:
Category I: Manufacturers and/or packagers of foodstuffs & beverages distributing directly or not directly their products to the consumers, such as catering companies, manufacturers of bottled water, ice, soft drinks and juices, companies producing material and articles coming into contact with food, bakery and bake-off facilities
Category II: Distributors (storage – wholesale of foodstuffs & beverages including cash & carry shops conducting wholesale as main activity) and transporters (vehicles transporting foodstuffs & beverages)
Category III: Food & Beverage Retailers (all types of retail stores including supermarkets, automatic preparation and dispensing machines, sale via e-commerce, sale on cars, kiosks, flea markets)
Category IV: Mass catering companies, such as fast food stores, restaurants, cafes, bars, entertainment centers, canteens, but also hygiene relevant service providers (hairdressers, gyms, etc.)
National guides to good practice drawn up for every single food business sector and officially approved by the competent authority (ΕΦΕΤ or the Ministry of Rural Development & Food) deserve consideration in order to safely comply with the hygiene requirements. This refers especially to food hygiene aspects that are not explicitly or specifically regulated.
Finally, significant is the new institutional framework for the exercise of business activities that was introduced by the Law 4442/2016. Pursuant to this Law, which is being implemented by the Ministerial Decision οικ. 32790/392/Φ.15/2017 on the simplification of licensing procedures for food & beverage manufacturing and other related activities, and by the Ministerial Decision οικ. 16228/2017 on the simplification of administrative procedures for the notification of hygiene relevant activities, a quite large spectrum of food business operations, especially those covered by the above Sanitary Regulation, shall be simply notified to the competent local authority in a quick-standardized transparent way and with no previous hygiene control of the installations concerned. Official hygiene controls will be carried out afterwards.
What requirements for the labeling of food products are to be considered?
In Greece, food labeling provisions are, to a great part, harmonized with EU law, especially in line with the prescriptions of Regulation (EC) 1169/2011, which is, anyway, directly applicable from December 13, 2014. By the Decision of the Supreme Chemical Council 97/2017, the general labeling stipulations in Art. 11 Food Code were fully adjusted to the prescriptions of the above Regulation.
Greece maintains though for a number of products, such as meat and dairy products, fish, honey, fruits & vegetables, bakery products, beer and legumes, specific labeling requirements. The respective stipulations in Food Code and ΔΙ.Ε.Π.Π.Υ. rules are applicable under the condition that they comply with the Regulation (EC) 1169/2011.
However, the Bakery Law 3526/2007 contains labeling provisions that are incompatible with EU law, especially the Regulation (EC) 1169/2011. This concerns, in particular, the obligation laid down by the aforesaid Greek law to indicate all required information on the packaging of bake-off products, although such products do not actually fall under the legal definition of “prepacked food” pursuant to Art. 1 par. 2 item e of the above Regulation.
The use of Greek language is obligatory with regard to the mandatory labeling indications; multi-language labeling is permitted.
How nutrition and health claims are currently regulated?
The EU Regulation 1924/2006 on nutrition and health claims made on foods brought significant changes into the Greek regulatory system and the corresponding practice of Greek authorities. Before 1 July 2007 when this Regulation entered into force, nutrition claims were allowed only to a quite limited extent, and any reference to health promoting effects of food was strictly prohibited.
Consequently, several regulatory restrictions as previously stipulated in Art 10 of the Food Code were repealed. As explicitly prescribed in this article, the formulation of nutrition and health claims on food is exclusively governed by the aforesaid EU Regulation.
Nutrition claims may now refer also to other substances than the nutrients listed in Directive 90/496/EEC, but their handling shall fully correspond to the conditions of use set out in the above EU Regulation. Some of previously permissible nutrition claims (for example “cholesterol-free” or “free of hydrogenated fat”) are, therefore, not any more allowed.
The most important impact of the EU Regulation 1924/2006 to the Greek law was the legalization of “health-related claims” and “reduction of disease risk claims” under the strict conditions defined in this Regulation, which requires the adoption or authorization of such claims by the European Commission.
In principle, it remains prohibited to indicate on a label or to advertise that foodstuffs have the capacity to prevent, treat, or cure human diseases.
What is the standing of food ingredient regulations?
As for the use of additives, flavorings and enzymes in food the EU Regulations 1331/2008, 1332/2008, 1333/2008 and 1334/2008 are directly applicable and explicitly referred to in several relevant provisions of Food Code.
National-specific ingredient rules for certain food products are stipulated in the Food Code. Such rules shall not apply to those foodstuffs which have a non-complying composition but are legally produced or marketed in another EU country or in a country that is contracting party to the EEA Agreement.
In respect to the setting of maximum residue levels for veterinary medicinal products, pesticides and certain contaminants in foodstuffs, Greece has implemented all relevant EU Regulations. Besides, the Food Code contains several provisions on this topic for single food products and food ingredients.
Especially regarding GMO’s?
Until now, the Greek authorities have adopted an absolutely negative attitude towards genetically modified food. This attitude, which is not expected to change in the future, explains the factual irrelevance of authorization procedures stipulated by the EU Regulation 1829/2003 and the Directive 2001/18/EC. The Ministry of Rural Development & Food and its directorates in charge of implementing the aforesaid legal acts play a mere advisory role with respect to application procedures initiated in other EU countries.
What should one basically know about the import of food products from third countries?
Such products, as well as food ingredients and package materials, must comply with the prescriptions of the Food Code and other relevant national regulatory acts that are in force
for similar products of Greek origin.
In principle, food products containing edible raw materials that pursuant to the standards of the Food Code are to be considered safe, or foodstuffs processed with allowed technologies can be freely traded.
What kind of food has to undergo pre-marketing-authorization in Greece?
Besides novel food and novel food ingredients falling under the specific stipulations of EU Regulation 2283/2015, “normal food enriched with nutrients such as vitamins, minerals, amino acids etc.”, which is the most common method of producing functional food, has to undergo pre-marketing authorization (approval) by the Supreme Chemical Council, pursuant to Art 5 par. 1 of the Food Code. The same approval requirement is stipulated also by article 3 par. 11 of the Food Code that refers to any permissible “fortification of normal food and drinks with vitamins”.
The approval of Supreme Chemical Council is required even for fortified food legally produced and/or marketed in another EU member state, as well as for food enriched only with those vitamins and minerals listed in Annexes I and II of the EU Regulation 1925/2006. Due to the fact that specific maximum limits for the addition of vitamins and minerals to normal food have not been uniformly stipulated on Community level yet, the Supreme Chemical Council continues to enjoy substantial discretion in valuating and defining such limits. Moreover, Art. 3 par. 11 of the Food Code stipulates additionally that, should an amount of
each added vitamin lead under normal conditions of daily consumption to exceeding 50% of RDA, without been over the corresponding therapeutic dosage, the consensual opinion of ΕΟΦ is required before marketing the product concerned.
For which kind of fortified normal food is though pre-marketing-authorization not required?
The approval requirement does not, however, apply to those products that as to their composition(type and content of ingredients) are to be considered of the same kind such as the products already approved by the Supreme Chemical Council. The decisions of Council by which the marketing of concrete food products has been permitted are given by Art 5 par. 2 of the Food Code the sense of a general act that becomes automatically effective to all similar products. Thus, such products may be legally marketed without any approval and any prior notification.
Does the Food Code or another regulatory act define substances permitted for food fortification?
Apart from the application of EU Regulation 1925/2006, on this topic there are a few provisions in Food Code, which explicitly allow the fortification of specific foodstuffs, such as culinary fats, spreadable fats and fish preparations, with certain vitamins and minerals to a certain maximum amount.
The addition of other (than vitamins and minerals) substances with a particular nutritional or physiological effect, such as plant extracts and other bioactive substances, to normal food is currently not regulated by a specific national law or by-law, especially in the form of positive or negative lists, and must be evaluated by the Council on a case by case basis.
In general, the use of bioactive substances, such as amino acids, flavonoids, herbal extracts, in normal food is considered by the Greek authorities with high reservation.
Which sort of fortified food was approved by the Supreme Chemical Council until now?
The approvals granted since 1997 by the Council refer mostly to vitamin and mineral substances that are meanwhile permitted to be added to food in accordance with the EU Regulation 1925/2006. The Council generally ruled that certain vitamins and minerals may be added to milk and sips based on milk proteins, to flour, to bakery and confectionary products, several cereal products and breakfast cereals, as well as to desserts and caramels.
Furthermore, the Council approved alcohol free drinks containing plant extracts such as guarana extract with caffeine, cannabis extract and black tee extract. Taurine, glucuronolactone, caffeine, and the plant Panax ginseng were accepted as co-ingredients of energy drinks as well. With regard to probiotics it is finally to mention the marketing-permission of powder sip based on milk with Bifidus culture.
What are the requirements for the approval procedure?
The application for getting a marketing approval by the Supreme Chemical Council must be submitted to the Department B’ – Foods, Water and Environment of General Chemical State Laboratory, which is in charge of working out a proposal to the Council, and be accompanied by several documents containing especially reliable information on product safety. The “good history” of product concerned is namely of crucial importance for achieving the approval by the Council.
Further, it is to mention that the documents stating the analytical data of final product and the detailed methods of control shall bear the signature of a chemist or chemical engineer or another scientist who is officially authorized to conduct and sign a chemical or biological analysis.
Which procedure shall be initiated in order to legally market food supplements and dietetic products in Greece?
Pursuant to national regulatory acts implementing the respective EU Directives, every person placing food supplements or dietetic products (PARNUTS) on the Greek market shall immediately notify the National Organization for Medicines (ΕΟΦ) of that placing, i.e. this authority is to be notified the latest upon starting selling the product in Greece. As regards food intended for use in energy-restricted diets for weight reduction, the notification may be made within a period of 3 months from the moment of first placing the product on the market.
The notification requires, by filling in a standard application form, the submission of several data depending on product category and the product itself. A notification fee is to be paid as well. The notification application shall be electronically submitted to the competent department of ΕΟΦ.
As for food supplements, conducting the notification procedure is a rather simple issue in case the product is already marketed in other EU countries and contains only vitamins and minerals listed in Annexes I and II of the Food Supplement Directive 2002/46/EC. In such case, the notification merely includes the trade name of product concerned, the data of applicant and manufacturer, a description of product package, the Greek label of product and a proof of legally marketing the product in another EU country. But in case the product contains other (than the aforesaid vitamins and minerals) substances with nutritional or physiological effect, the notification shall include more information, such as quality and quantity composition of product, analytical data of product, appropriateness evidence for the nutritional purpose of product, specification of raw materials.
Are there any restrictions regarding the selling points of such products?
Actually not.
Food intended for use in energy-restricted diets for weight reduction may be legally sold in pharmacies, in specialty stores or in grocery stores with specialty departments.
Food for special medical purposes may be marketed in other stores than pharmacies, and not only for use in hospitals.
The sales monopoly of pharmacies was eliminated for food on infant formulae and food supplements as well. The latter ones may be sold in stores legally dealing with standardized (prepacked) food, as well as via e-commerce organized by such stores.
What should one know about the permissible composition of food supplements pursuant to the Greek legal standards?
Initially by the Joint Ministerial Decision (JMD) Y1/Γ.Π. 127962/2004 and now by the JMD Γ5α/53625/2017 being in force since 21.09.2017, Greece entirely adopted the positive lists of vitamins, minerals and their compounds as earlier and currently stipulated in Annexes I and II of the Food Supplement Directive 2002/46/EC. Maximum limits for vitamins and minerals used in food supplements are not (any more) defined on national regulatory level, but only minimum amounts at 15% of RDA in full accordance with Annex XIII of the EU Regulation 1169/2011.
Regarding “other substances” that may be used for the manufacture of food supplements, there is no specific regulation in the above new JMD or another legal act. ΕΟΦ is quite reserved towards food supplements containing “other substances“. Such reservation results often in denying the product marketability, although the product at issue is legally produced and/or marketed as food supplement in other EU countries. This refers especially to substances that are deemed to induce a pharmacological action leading to the conclusion that the product concerned shall be categorized as medicine.
In case of (allegedly) infringing food regulations, what are the possible sanctions and available options of defense?
The manufacture and marketing of food against the prescriptions of European and national legislation is considered in Greece as a serious infringement of law.
Besides criminal law consequences against any responsible individuals, such infringement may result in administrative fines that are precisely prescribed in Art. 23 Law 4235/2014 for each kind of infringement and in general range from € 300 up to € 60,000 depending finally on the frequency and gravity of offence at issue as well as on its impacts on public health and consumer interests. In quite serious cases the administrative fine may amount up to € 500,000.
In addition, the competent authority can revoke temporarily or definitely, partially or wholly the operating license of the infringing company. Especially in emergency cases referring to risks arising for the public health, the authorities may also order the immediate withdrawal of unsafe food product from the market and the confiscation of quantities concerned.