Import Regulations and Standards

An Expert's View about Agriculture and Animal Husbandry in Greece

Last updated: 15 Sep 2011

This report provides updated contact information for Greece and gives an overview of Greek food laws in the EU context.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Dat e: 8/9/2011 GAIN Report Number: GR1107 Greece Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: James Dever Prepared By: Ornella Bettini Report Highlights: This report provides updated contact information for Greece and gives an overview of Greek food laws in the EU context. Information on EU Member State specific requirements can be found in the FAIRS reports prepared by the Offices of Agricultural Affairs in the individual EU Member States: DISCLAIMER: This report was prepared by the Office of Agricultural Affairs of the USDA/Foreign Agricultural Service in Rome, Italy for U.S. exporters of domestic food and agricultural products. While every possible care was taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since its preparation, or because clear and consistent information about these policies was not available. It is highly recommended that U.S. exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. FINAL APPROVAL OF ANY PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY?S RULES AND REGULATIONS AS INTERPRETED BY BORDER OFFICALS AT THE TIME OF PRODUCT ENTRY. SECTION I: FOOD LAWS SECTION II: LABELING REQUIREMENTS SECTION III: PACKAGING & CONTAINER REQUIREMENTS SECTION IV: FOOD ADDITIVE REGULATIONS SECTION V: PESTICIDES & CONTAMINANTS SECTION VI: OTHER REGULATIONS & REQUIREMENTS SECTION VII: OTHER SPECIFIC STANDARDS SECTION VIII: COPYRIGHT AND/OR TRADEMARK LAWS SECTION IX: IMPORT PROCEDURES APPENDIX I: GOVERNMENT REGULATORY AGENCY CONTACTS APPENDIX II: OTHER IMPORT SPECIALIST CONTACTS Section I. Food Laws Greece?s food laws and regulations follow European Union (EU) rules to the extent that EU food laws have been harmonized. However, in cases in which the EU law may be incomplete or absent, the law of each Member State applies. One main principle of the single market concept is to ensure that all food products, whether produced in the EU or imported from a third country, can move freely throughout the EU if they comply with uniform requirements. In reality, certain directives allow Member States to make exceptions (i.e., in cases where a country can identify unique concerns about a product intended for import). Free movement can only be guaranteed when all aspects are covered by harmonized legislation (e.g., a foodstuff may comply with the general labeling directive but may carry a health claim for which harmonized rules do not yet exist). Imported products must meet existing Member State requirements in cases where EU regulatory harmonization is not yet complete. Greek authorities implement EU rules (directives and regulations) for food and agriculture through country specific laws and decrees. Current information on EU food import rules as well as general information on EU import duties and quotas can be found on the USEU website at In Greece, food safety is the primary responsibility of the Greek Ministry of Rural Development and Food in cooperation with the National Chemical Laboratory and the Ministry of Public Order. Occasionally, the Greek Ministry for Development and Commerce may play a role. Please note that imports of red meat, meat products, pet food, farmed and wild game meat, all dairy products, seafood, bovine embryos and semen, porcine and equine semen, and animal byproducts to the EU from the United States may originate only from EU approved U.S. establishments. Section II. Labeling Requirements A. General Requirements Food labeling and ingredient regulations for the most part have been harmonized within the EU. General provisions on the labeling, presentation and advertising of foodstuffs marketed in the EU are laid down in European Parliament and Council Directive No 2000/13/EC. It applies not only to foodstuffs intended for sale to the ultimate consumer but also for supply to restaurants, hospitals and other mass caterers. Nevertheless, Greece maintains specific labeling and ingredient rules for some food products that are described in detail in the Greek Food Code (hereafter referred to as the Food Code) published by the General State Chemical Laboratory (GSCL). There is no electronic version of the Food Code; a hard copy can be obtained in Greek from the GSCL. GSCL is the Greek agency responsible for document inspection upon arrival, labeling and product ingredient regulations, and the performance of laboratory tests to grant importation approval to foodstuffs subject to approval in cooperation with Greek Ministry of Agriculture Port Authorities. It is essential for U.S. exporters to work with a Greek agent who has a suitable background and is able to fulfill customs procedures involving more than two authorities. The current Food Code was published in 2003 and has been amended by a number of presidential decrees and ministerial decisions to incorporate new legislation. The Hellenic Food Control Agency (EFET) is responsible for enforcing the regulations and collecting samples from selling points to check compliance with food legislation, both to ensure food safety and protect consumer health in accordance with EU Directive 89/397. Locally produced and imported food items are regularly checked by random sampling to ensure the absence of prohibited ingredients and adherence to fair trading practices and consumer expectations, as product labels should not mislead or confuse the consumer. Labeling must not make false claims nor should any product present a risk to public health. Note that the standard U.S. label does not comply with EU labeling requirements ( U.S. food products can generally be uniformly packaged for sale in all EU Member States based on the condition that they conform to the national law set forth in at least one member state. Greek food regulations apply to both domestically produced and imported food products. Imported food and beverage products that comply with rules and regulations, as with any other product sold on the EU market, require no special permit nor are they subject to special rules or regulations regarding their commercialization in Greece. In special instances stricter controls may be required for a food product due to unique concerns (i.e. when certain food ingredients and/or supplements have to be approved). With the exception of food supplements, U.S. food products that conform to any individual EU member state?s rules and regulations may be transshipped and sold in any other EU member state. However, approval by the Hellenic Supreme Chemical Committee (HSCC) operating under the Greek General State Chemical Laboratory is needed when a food product does not correspond to Food Code specifications, in accordance with HSCC Decision 366/97, Official Journal of the Greek Republic 597/B/17.7.97, and in cases where preparation, processing, and packaging use one of the following: Additives such as antioxidants, colorants, emulsifiers, stabilizers, gelling agents and thickeners, flavorings, preservatives, sweeteners, and enzymes that are not listed in EU Regulations 94/34, 94/34, and 95/2; Materials and objects that will come into contact with foods, substances, or materials not included in the Food Code list of allowed materials; New techniques and technologies prohibited by the Food Code; Novel foods or new ingredients; Foods enriched with nutritional elements (vitamins, traces, aminoacids). Gaining HSCC approval requires an application. The procedure takes approximately 3 months for products already circulated in other EU member states, and 5 months for new products entering the EU. In compliance with EU Regulations 1829/2004 and 1830/2004, Greece requires all foods and feeds containing GMO ingredients, either detectable or non- detectable, to be labeled accordingly. Exporters are advised to have an experienced agent or joint venture partner - with suitable background, demonstrated experience, and extensive sales/services network - who can offer full support to the end-user. The Greek importer holds responsibility for the marketability of any imported product in Greece. The importer is also responsible for any violations of the Food Code and is liable for prosecution in the event of failure to observe food laws. All food products imported into Greece must comply with the Greek Food Code. Products not labeled with all information required by the Food Code cannot be sold on the Greek market. Greece requires that labels be in the Greek language. Multi-language and stick-on labels are acceptable. Sample-size products should bear the ?Not for Sale? indication. Labels, including attached pictures or symbols that refer to the product, must not deceive the consumer in regards to its characteristics. They should not attribute characteristics to the product which it does not have, present a common characteristic as unique, or attribute preventative or therapeutic properties to the product. Labels such as ?No colorants? and ?No preservatives? should only appear on products that do not contain such substances, either in raw form or included in the production process, manufacturing process, additions or residues. Labels should not indicate that the foodstuff has the capacity to prevent, treat, or cure human diseases. This rule does not apply to dietetic foods or natural mineral water. Food labeling and ingredient regulations have generally been harmonized within the EU, and Greek regulations are fully harmonized to-date. Harmonization is an ongoing process that differs in speed from member state to member state. EU regulations published in the Official EU Journal are immediately applicable. EU directives, on the other hand, take time to become national law through member-state parliaments, ministerial decisions, and/or presidential decrees. The European Parliament and Council Directive No 2000/13/EC contains general provisions on the labeling, presentation, and advertising of foodstuffs marketed in the EU. It applies to foodstuffs sold directly to the consumer as well as for supply to restaurants, hospitals, and other mass caterers. Greece sets its own national requirements when EU standards have not yet been established. In cases where the standard U.S. label fails to comply with member-state rules and regulations, a sticker must be placed on the packaging that contains a translation of the U.S. label in Greek as well as all mandatory EU information listed below. Although many international companies provide multi-language labels to ensure the possibility of sale throughout the European Union, the Greek language is rarely present. All food and beverage products imported into Greece (excluding food products transited through Greek soil) must provide the following information: a. Name of the product as commonly used in the trade. The name established by law or, if this is lacking, a brief description of the product. b. List of ingredients and food additives in descending order by weight. The following ingredients require a specific statement on the label: GMOs, packaging gases, sweeteners, aspartame, poly oils, quinine, caffeine, phytosterols, phyostanols, and licorice. c. Food allergen labeling rules were introduced by Directive 2003/89/EC that became effective on November 25, 2005. The following potential allergenic ingredients must be indicated on food labels: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk and dairy products (including lactose), nuts and nut products, sesame seeds, lupine and products thereof, mollusks and products thereof and sulphite at concentrations of at least 10 mg per kg or 10 mg/l, celery, and mustard. Allergen labeling also applies to alcoholic beverages. Guidelines for the implementation of the allergen labeling rules are available on the Commission?s website: d. Quantitative ingredient declaration (QUID). The quantity of certain ingredients or categories of ingredients is mandatory in the following cases: Where the ingredient or category of ingredients appears in the name under which the foodstuff is sold; Where the ingredients or category of ingredients is usually associated with that name by the consumer; Where the ingredient or category of ingredients is emphasized on the labeling in words, pictures or graphics; Where the ingredient or category of ingredients is essential to characterize a foodstuff and to distinguish it from similar products. The QUID declaration must be indicated in or immediately next to the name under which the product is sold, unless a list of ingredients is voluntarily indicated on the label in which case the quantity may appear in the list. The quantity of the ingredient, expressed as a percentage, must correspond to the quantity of the ingredient(s) actually used in the preparation of the product. e. Metric units for all measurements. The nominal net content or weight expressed in metric units: (weight in grams, liters, kilograms, centiliters, etc.). A small ?e? on the label may be used to guarantee that the actual content corresponds to the quantity indicated. f. Expiration date. Every package must have listed the minimum shelf-life period. Preferred language is: ?Best before end of DD/MM/YY?. It is also possible to state the time limit of consumption if the food is stored and prepared properly. g. Storage and usage conditions. Any special storage conditions or conditions of use should be stated. Instructions for use should be given as necessary. h. Alcoholic content. This is required for drinks with alcoholic content equal or greater than 1.2 percent alcohol in volume. i. Name or business name and address of manufacturer, packager, vendor, and importer established within the European Union. j. Country of origin. Particulars of the place of origin or provenance in case absence of such information might mislead the consumer. k. Lot Marking. Council Directive 89/396/EEC requires that foodstuffs carry a mark identifying the lot to which a foodstuff belongs. l. Instructions for intended use. m. Treatments undergone, with specific indications for irradiate or deep-frozen foods. n. The actual alcoholic strength for beverages containing more than 1.2 percent alcohol by volume. Additives - Annex II to the labeling directive lists the categories of additives, which must be designated by the name of their category followed by their specific name or EEC number. The categories are the following: color, preservative, anti-oxidant, emulsifier, thickener, gelling agent, stabilizer, flavor enhancer, acid, acidity regulator, anti-caking agent, modified starch, sweetener, raising agent, anti-foaming agent, glazing agent, emulsifying salts, flour treatment agent, firming agent, humectants, bulking agent, propellant gas. - Flavorings: Annex III to the labeling directive describes the way of designating flavorings in the list of ingredients. Quinine and Caffeine Commission Directive 2002/67/EC requires the compulsory labeling of quinine and caffeine used in the production or preparation of foodstuffs (usually tonic waters and energy drinks). Quinine and caffeine must be mentioned in the ingredients list, preceded by the term "flavoring". Beverages containing more than 150 mg of caffeine per liter will have to be labeled with "high caffeine content" followed by the caffeine content expressed in mg/100 ml. Phytosterols & Phytostanols Commission Regulation 608/2004 lays down labeling requirements for foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and phytostanol esters (used to reduce cholesterol levels). For labeling purposes, they must be designated respectively by the terms ?plant sterols?, ?plant sterol esters?, ?plant stanols? and ?plant stanol esters?. Warnings on Labels Commission Directive 2008/5/EC establishes a list of foodstuffs that require a warning on the label: foodstuffs whose durability has been extended by means of packaging gases; foodstuffs containing (a) sweetener(s); foodstuffs containing added sugar(s) and sweetener(s); foodstuffs containing aspartame; foodstuffs containing more than 10% added polyols; confectionery or beverages containing liquorices. As of July 20, 2010, Regulation 1333/2008 requires foodstuffs containing the food colors sunset yellow (E110), quinoline yellow (E104), carmoisine (E122), allura red (E129) and ponceau 4R (E124) to be labeled ?may have an adverse effect on activity and attention in children?. Food placed on the market or labeled before July 20, 2010, which do not comply with this provision may be marketed until their date of minimum durability or use-by-date. Any non-edible parts of a packaging system that consumers could mistake for food must be labeled with the words ?DO NOT EAT? and where technically possible carry the warning symbol established by Annex I of Regulation 450/2009. Language Requirements As a general rule, labeling has to be in a language easily understood by consumers. However, as an exception to the general rule, it also is allowed to use: - Another language, provided if can easily be understood by consumers. - Other means depicting the content (e.g. pictures). Multi-language labeling is allowed throughout the EU. For Greece, the language requirement requires that the label also be in Greek. Labeling of Genetically Modified Foods Section VII of this report is entirely dedicated to the regulatory review and commercialization of genetically modified foods in the EU and provides information on EU labeling requirements for genetically modified foods and their derivatives. All foods and ingredients that are produced in whole or in part from genetically modified organisms should indicate this on their labels. The same rules apply to flavors and additives. For detailed information see Section VII. B. Medical / Health / Nutrition Claims Medical claims that expressly or implicitly affirm or suggest that a food product has a healing (curative) or preventive effect are prohibited in the EU/Greek labeling directive. Only rather bland references that the product has general beneficial effects are allowed as long as these are not misleading to consumers. U.S. exporters of ?health? foods, weight loss/diet foods, baby foods and vitamins should work closely with a Greek importer, since Greek labeling laws regarding health claims can be particularly stringent. Greek legislation sets forth orders, obligations and criminal sanctions for violations. On July 1, 2007, a new EU regulation on nutrition and health claims entered into force. Regulation 1924/2006 sets EU-wide conditions for the use of nutrition claims such as ?low fat? or ?high in vitamin C? and health claims such as ?helps lower cholesterol.? The regulation applies to any food or drink product produced for human consumption that is marketed in the EU. Once the nutrient profiles, based on scientific evaluations by the European Food Safety Authority (EFSA) have been set, there will be another two-year period before the nutrient profiles begin to apply to allow food operators time to comply with the new rules. Nutrition claims can fail one criterion (i.e., if only one nutrient (salt, sugar or fat) exceeds the limit of the profile) still be made provided the high level of that particular nutrient is clearly marked on the label. For example, a yogurt can make a low-fat claim even if it has high sugar content but only if the label clearly states ?high sugar content?. Health claims cannot fail any criteria. Regulation 353/2008 as amended by Commission Regulation 1169/2009 sets out implementing rules for applications for the authorization of health claims as provided for in Article 15 of Regulation 1924/2006. A guidance document on how companies can apply for health claim authorizations can be downloaded from EFSA?s website at: Trademarks and brand names that suggest health and/or nutritional benefits but do not comply with the new rules must be entirely removed from the EU market by January 19, 2022. C. Nutritional Value Labeling Ordinance Nutrition labeling is not mandatory in the EU unless a nutrition claim is made on the label or in advertising messages. Nutrition labeling rules are laid down in Council Directive 90/496/EEC. The presence of a U.S. nutritional label (Nutrition Facts) may be considered to be equivalent to a nutritional claim and consequently its presence on the label requires drawing up the nutritional table according to European (and thus, Greek) standards as well. To avoid this problem, many U.S. products place their Greek language label over the portion of the U.S. label containing nutritional information. The energy value and the proportion of nutrients must be declared in specific units per 100 grams or per 100 milliliters. Information on vitamins and minerals must be expressed as a percentage of the recommended daily allowance (RDA). The information on the label must be presented in tabular form with the numbers aligned or if space does not permit, in linear form in a language easily understood by the purchaser. Commission Directive 2008/100/EC update the list of vitamins and minerals and their Recommended Daily Allowances (RDAs) and provide an EU definition of ?fiber?. The conditions for the use of nutrition claims such as ?source of fiber? or ?high fiber? are laid down in Regulation 1924/2006 (see nutrition and health claims). Nutrition labeling is usually optional in Greece and other EU countries, but it is compulsory if the label, advertising, or any other presentation contains a nutritional claim (see "Related Acts" in: The EU Nutritional Value Labeling Directive 90/496/EEC establishes rules for the separate labeling of the caloric and nutritional values of foods. This directive concerns nutrition labeling of foodstuffs for final consumers and for mass caterers (restaurants, hospitals, canteens, etc.). Though not mandatory for all foods, it requires additional information for products with labels that emphasize a particularly low caloric content or a particularly high nutritional value. The directive does not apply to food supplements, natural mineral water, or other waters intended for human consumption. Greek consumers and nutritional NGOs emphasize common problems with regulations, including their sometimes ?optional nature,? widespread lack of nutritional knowledge and healthy diet awareness, confusion created by misleading labels, multilingual label descriptions, lack of enforcement, and the widespread lack of nutritional information in the Greek language. The European Food Information Council (EUFIC) and EUFIC Greece provide additional information and reading on nutritional labeling developments in the EU (EUFIC Europe:; in the Greek language: There is also helpful information in a recent study entitled, ?Results of a Pan-European Consumer Research on In-Store Behavior, Understanding and Use of Nutrition Information on Food Labels, and Nutrition Knowledge? ( When nutritional labeling is required, nutritional values must be presented or advertised (according to EU Directive 90/496) in order to prevent misleading information on labels. Nutritional information, if cited, must provide information from Groups 1 or 2 in the following order: Group 1 Group 2 Energy value Energy value Amount of proteins Amount of proteins Carbohydrates Carbohydrates Fats Sugar Fat Saturates Fibre Sod ium Nutritional claims related to sugars, saturated fatty acids, fibre, or nitrates must include Group 2 information. Nutritional labeling may include quantities of: Starch; Polyalcohol; Hydrocarbons; Fats; Cholesterol; Vitamins; Inorganic acids. Energy and nutrient content information is numerical and should be in specific units per 100 grams or 100 milliliters. Units used in the label are: Energy: Kj and Kcal; Proteins, hydrocarbons, fasts, fibre, sodium: grams; Cholesterol: milligrams. Vitamins and inorganic acids may also state the recommended daily intake. When nutritional labeling is required, it must also be presented in Greek. Information should be in tabular form with properly aligned numbers, but a linear form is acceptable if space is insufficient for a table. A product may be labeled as ?low in hydrocarbons and/or sugars? if the absorbable carbohydrate content is less than 0.25 percent. A product may be labeled as ?reduced calorie? if the calories are reduced by at least 30 percent compared with the original foodstuff. This category covers products such as ?light,? ?line,? or ?slim.? A product may be labeled as ?low in calorie? if a single intake yields a maximum of 15 calories to the body and 30 calories per daily intake. D. Product-Specific Labeling For a number of products, specific labeling requirements have been established in addition to the general requirements described above. These include: genetically modified foods novel foods fortified foods foodstuffs for particular nutritional uses including dietetic and baby/infant foods beef wine spirit drinks olive oil organic foods cocoa and chocolate products, sugars, honey, fruit juices and similar products, preserved milk coffee extracts and chicory extracts, fruit jam, jellies, marmalades and chestnut puree fresh fruits and vegetables meat, poultry, eggs, dairy products, spreadable fats seafood pet food E. Country of Origin Labeling In the EU, country of origin labeling is mandatory for beef and veal, fruit and vegetables, eggs, poultry meat, wine, honey, olive oil, aquaculture products and for organic products carrying the EU logo. For other products, the indication of the place of origin or provenance is mandatory only if the omission of such information might mislead the consumer. F. Health Claims The European Parliament and the Council on Nutrition and Health Claims Made on Foods re-published Regulation 1924/2006 in its corrected form on 18 January 2007 (OJ No. L12, 18.1.2007, p.3), and it entered into force on 1 July 2007. It sets EU-wide conditions for the use of nutrition claims such as ?low fat? or ?high in vitamin C? and health claims such as ?helps lower cholesterol.? The regulation applies to any food or drink product produced for human consumption and marketed in the EU. Only foods that fit a certain nutrient profile (below certain salt, sugar, and/or fat levels) are allowed to carry claims. Food labels can only contain nutrition and health claims if they are included in one of the EU positive lists. Food products carrying claims must comply with the provisions of the nutritional labeling directive 90/496/EC. Regulation 1924/2006, as all EU regulations, is directly applicable in Greece as in all member states. EFET has put in place the necessary enforcement provisions. EU Regulation 353/2008, ?Implementation Measures of Reg. 1924/2006,? establishes current implementation rules for applications to authorize health claims as provided in article 15 of Reg. 1924/2006. Amendments N.107/2008 and 109/2008 of the 1924/2006 contain other relevant provisions (See: U.S. firms exporting food items to Greece have the responsibility to: follow U.S. laws and regulations; follow the EU Regulations in effect; work closely with Greek importers who are familiar with labeling regulations and laws in effect. The competent authority for health claims in Greece is the National Pharmaceuticals Organization (EOF) operating under the Ministry of Health. Disease risk reduction claims and claims referring to the health and development of children will require authorization on a case-by-case basis, following the submission of a scientific dossier to EFSA. A simplified authorization procedure has been established for health claims based on new scientific data. Regulation 353/2008 sets rules for applications to authorize health claims as provided in Article 15 of Regulation 1924/2006 (see also USEU Report No E48055, page 2). Section III. Packaging and Container Requirements A. Consumer Packaging Ordinance and Laws on Weight and Measures Council Directive 76/211/EEC (amended by Commission Directive 78/891/EEC) specifies the maximum tolerable error between the actual content and the quantity indicated on the label of prepackaged products. New Directive 2007/45/EC abolishes regulations on mandatory pack sizes at both EU and national levels. The Directive frees sizes for all prepackaged products except wine and spirits, coffee and white sugar. Member States in which mandatory nominal quantities are prescribed for milk, butter, dried pasta and coffee may maintain their restrictive rules until October 2012. The rules for white sugar may be maintained until October 2013. Mandatory nominal quantities for wines and spirits are set out in the Annex to Directive 2007/45/EC. B. Materials in Contact with Foodstuffs Regulations for materials in contact with food are EU-harmonized (see European Parliament and Council Regulation 1935/2004 specifies the main requirements for materials that come into contact with foodstuffs, including active and intelligent packaging. This regulation entered into force on November 16, 2004 (except for the provisions on traceability which went into effect on October 27, 2006) and repeals and replaces Directives 80/590/EEC and 89/109/EEC. It also sets out labeling and traceability requirements and the procedure for the authorization of substances through the European Food Safety Authority (EFSA). C. Packaging Disposal Regulations Greek legislation is fully harmonized with existing EU legislation concerning food-contact materials and substances. In addition, Greece has implemented national provisions for the following materials: dyes and pigments for plastics in contact with food (HSCC decision No. 358/95 & 1028/96, Greek Food Code, Art. 26a); coatings (HSCC decision No. 446/98, Greek Food Code, Article 28); paper and board (HSCC decision No. 478/2004, Greek Food Code, Article 24); metals and alloys (HSCC decision No. 232/98, Greek Food Code, Article 22); cans (HSCC decision No. 232/98, Greek Food Code, Article 22). The table below provides an overview of the EU legislation on food contact materials and implementation in Greece. Materials/Substances EU legislation Greek implementation All food contact materials Regulation (EC) 1935/2004 Automatically applicable* Ceramics Directive 84/500/EC HSCC Decision No 159/86 Regenerated cellulose film Directive 93/10/EC HSCC Decision No 240/95 Plastics Directive 2002/72/EC HSCC Decision No 58/2002 Recycled plastic materials Regulation (EC) 282/2008 Automatically applicable* Plasticizers in gaskets & lids Regulation (EC) 372/2007 Automatically applicable* Vinyl Chloride monometer Directive 78/142/EC HSCC Decision No 1976/85 N-nitrosamines and N-nitrosatable Directive 93/11/EC HSCC Decision No 598/94 BADGE, NOGE, BFDGE Regulation 1895/2005 Automatically applicable* D. Phytosanitary Requirements Health Requirements for Plant Products Greece complies fully with the EC?s plant health regime as established by Council Directive 2000/29/EC (as amended by Council Directive 2002/89/EC of 28 November 2002) on ?Protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community.? Detailed information on the EU?s phytosanitary policies, certification, and controls are provided in: Council Directives 2000/29/EC & 2002/89/EC were adopted by GOG with Presidential Decree No. 365/2002 and other associated presidential decrees, ministerial decisions and joint ministerial decisions (JMDs). Presidential Decree No. 84 harmonizes Greek national legislation with EU Commission Directive 2004/103/EC on identity and plant health, including inspection of plants, plant products, or other objects as listed in Part B of Annex V to Council Directive 2000/29/EC. Inspections may be carried out at a place other than the point of entry into the Community, and the legislation specifies conditions related to these checks. All plant products must be accompanied by a U.S. Department of Agriculture phytosanitary certificate or PPQ577, issued by an official APHIS (Animal and Plant Health Inspection Service) inspector. Presidential Decree No. 42 which entered into force on January 1, 2005 determines the models of official phytosanitary certificates or phytosanitary certificates for re-export accompanying plants, plant products, or other objects from third countries. The decree, in compliance with European Community Directive No. 2004/105/EC, determines the models of official phytosanitary certificates or phytosanitary certificates for re-export accompanying plants, plant products, or other objects from third countries, listed in Presidential Order No. 365/2002 (which refers to Council Directive 2000/29/EC). The Hellenic authorities shall accept certificates issued in accordance with the models as specified in Annex I and II (Model Phytosanitary Certificate and Model Phytosanitary Certificate for Re-export) until 31 December 2009. The competent authority for phytosanitary law enforcement is the GOG Ministry of Rural Development and Food (for specific info visit IPP website at: Section IV. Food Additives Regulations A. Food Additives and Flavorings Food additive use is fully harmonized within the EU (see The Greek food additive sector is governed by Council Directive 89/107/EEC which provides for the establishment of EU harmonized positive lists ?lists of what is permitted? of a wide range of food additives. All food additives not included in the positive lists are prohibited, except for new food additives that receive a temporary two-year authorization by Member States. Most food additives may be used only in limited quantities in certain foodstuffs. Food additives for which no quantitative limits have been established (maximum level established at ?quantum satis?) must be used according to good manufacturing practice. This means using only as much as necessary to achieve the desired technological effect. Processing aids and flavorings fall outside of the scope of this directive. An important difference from U.S. legislation is the use of flour bleaching agents: chlorine, bromides and peroxides that are not allowed in the EU. Regulation 1333/2008 on food additives brings the current miscellaneous additives directive and the directives on colors and sweeteners into one regulation and become applicable as of January 20, 2010, except for the transitional provisions. It provides for the establishment of an EU positive list, conditions of use and rules on the labeling of additives sold as such. Regulation 1333/2008 also provides for an evaluation program, set up by Commission Regulation 257/2010, for food additives permitted before January 2009. Those food additives shall be subject to a new risk assessment carried out by EFSA and the re-evaluation of approved food additives shall be completed by the end of : 2015 for food colors (currently listed in Directive 94/36/EC); 2018 for all additives other than colors and sweeteners (currently in Directive 95/2/EC); 2020 for all sweeteners (currently listed Directive 94/35/EC). Annex I of Regulation 1333/2008 lists the approved food additives for which the re-evaluation by EFSA was already completed at the time of adoption of Regulation 257/2010. Foods containing any of the six food colors Quinoline Yellow (E104), Sunset Yellow (E110), Ponceau 4R (E124), Tartrazine (E102), Azorubine/Carmoisine (E122) and Allura Red AC (E129), will have to be labeled with the phrase, ?may have an adverse effect on activity and attention in children? (Annex V to Regulation 1333/200). Annex II to the labeling directive lists the categories of additives, which must be designated by the name of their category followed by their specific name or EEC number. The categories are the following: color, preservative, anti-oxidant, emulsifier, thickener, gelling agent, stabilizer, flavor enhancer, acid, acidity regulator, anti-caking agent, modified starch, sweetener, raising agent, anti-foaming agent, glazing agent, emulsifying salts, flour treatment agent, firming agent, bulking agent, and propellant gas. Annex III to the labeling directive describes the way of designating flavorings in the list of ingredients. The presence of sweeteners/aspartame/polyols and licorice requires standardized statements on the label; packaging gases are not considered as additive but also require a standardized statement (Commission Directive 2008/5/EC). The lists of authorized food additives and their conditions for use are published in three directives: 1) European Parliament and Council Directive 94/35/EC on sweeteners for use in foodstuffs. The annex to this directive lists maximum usable doses for sweeteners in selected foodstuffs. 2) European Parliament and Council Directive 94/36/EC on colors for use in foodstuffs. Annex I: list of permitted food colors. Only substances listed in this annex may be used; Annex II: foodstuffs that may not contain added colors; Annex III: foodstuffs to which only certain permitted colors may be added; Annex IV: colors permitted for certain uses only; Annex V: colors permitted in general and the conditions of use therefore. 3) European Parliament and Council Directive 95/2/EC, as amended, the so-called miscellaneous additives directive on food additives other than colors and sweeteners. Annex I: list of food additives permitted for use in foodstuffs (excl. those listed in Annex II) following the "quantum satis" principle; Annex II: list of foodstuffs in which only a limited number of additives of Annex I may be used. These include cocoa and chocolate products, fruit juices and nectars, jam and jelly, dehydrated milk and cream, fruits and vegetables, rice, oils and fats, certain cheeses, minced meat, bread and pasta, wines and beer; Annex III: list of conditionally permitted preservatives and antioxidants; Annex IV: list of other permitted additives; Annex V: list of permitted carriers and carrier solvents; Annex VI: list of additives permitted in foods for infants and young children. These lists can be downloaded from the following web page: Greece has implemented the EU legislation on additives and flavorings in food into its national legislation. Greek competent authorities are the National Chemical Laboratory (NCL) and accredited laboratories for testing (only in the public sector and state universities); the Ministry of Public Health, the Ministry of Rural Development and Food, and the National Agency for Food Control (EFET). B. Flavorings Regulation 1334/2008 on flavorings and certain food ingredients with flavoring properties sets specific rules for the use of the term ?natural?. The register of all flavoring substances, as last amended by Commission Decision 2009/163/EC, authorized in the EU is being reviewed before inclusion in Annex I of the new Regulation as the community list of authorized substances. A Community procedure for the safety assessment and the authorization of smoke flavorings intended for use in or on foods is established in Regulation 2065/2003. C. Enzymes Regulation 1332/2008 on food enzymes introduces harmonized rules for their scientific evaluation and authorization in the EU and establishes labeling requirements. Until the adoption of an EU positive list of authorized enzymes, the existing national provisions on the marketing of food enzymes will continue to apply. Section V. Pesticides and Contaminants Current EU pesticide legislation has not been fully harmonized within member states. Regulation 1107/2009 sets out new rules for the authorization of plant protection products (PPPs) and replaces Directive 91/414/EEC. It entered into force at the end of December 2009 and became fully applicable June 14, 2011. This Regulation establishes a list of approved active substances. Only PPPs containing active substances included in the list may be authorized for use in the EU. Member States can approve PPPs containing the active substances. According to the new Regulation, the EU is divided in three different zones. Once a Member State approves the PPP, it can be mutually recognized and thus authorized within the same EU zone as set out in Annex I of the Regulation. MRLs: Regulation 396/2005 Since September 2008, all MRLs in the EU have been harmonized by Regulation 396/2005 on food or feed of plant and animal origin. Pesticide MRLs for processed or composite products are based on the MRLs of the raw agricultural ingredients. Harmonized sampling methods are established for the official control of residues in and on products of plant and animal origin by Commission Directive 2002/63/EC. Commission Regulation 915/2010 requires Member States to take and analyze samples for product and pesticide residue combinations in food of plant and animal origin. Annex I to the Regulation sets out the pesticide and product combinations to be monitored. Annex II sets out the number of samples that need to be taken for each combination. The Member States must submit results of the sample tests to the EU by 31 August 2012, 2013 and 2014 for samples tested in 2011, 2012 and 2013 respectively. The competent authority on controls and tests for MRLs (maximum residue levels) in Greece is the Ministry of Rural Development and Food through its laboratories and regional control centers (known as KEPYELS). Further reading on MRL developments in the EU is provided at: Maximum Levels EU wide harmonized maximum levels for contaminants are set in the Annex of Commission Regulation 1881/2006. The Annex to Regulation 1881/2006 includes maximum levels for: nitrates in lettuce, spinach and infant food (section 1); mycotoxins (section 2); aflatoxins in nuts, dried fruit, cereals, maize, spices, milk and infant food; ochratoxin A in cereals, cereal products, dried vine fruit, roasted coffee, soluble coffee, wine, grape juice, spices, infant; food and licorice; patulin in fruit juices, spirit drinks, solid apple products, apple juice and infant food; deoxynivalenol in cereals, cereal products, maize, pasta and infant food; zearelenone en cereals, cereal products, maize, refined maize oil, bread and small bakery wares and infant food; fumonisins in maize and maize based products; T-2 and HT-2 toxin in cereals and cereal products; heavy metals (section 3); lead in milk, infant food, meat, offal, seafood, vegetables, fruit, wine and food supplements; cadmium in meat, seafood, cereals, soybeans, vegetables, fruit, fungi and food supplements; mercury in seafood and food supplements; tin in canned foods, canned beverages and canned baby foods; 3-MCPD in vegetable protein and soy sauce (section 4); dioxin and PCBs in meat, liver, fishery products, milk, eggs and oils & fats (section 5); polycyclic aromatic hydrocarbons (PAH) in oils & fats, infant foods, (smoked) meat, fish and infant food (section 6). Import Conditions for U.S. Almonds In September 2007, the EU implemented special import conditions which called for mandatory testing of U.S. almonds imported into the EU. USDA and the California almond industry have developed a ?Voluntary Aflatoxin Sampling Plan (VASP)? comparable to the EU sampling procedures so that almonds can be uniformly tested before they are shipped to the EU. Per Commission Regulation 1152/2009, these procedures are considered to provide sufficient assurances which means that almonds shipped under VASP are subject to random controls. Almonds not controlled under VASP continue to be subject to 100 percent border controls. The Regulation covers almonds in shell or shelled, roasted almonds and mixtures of nuts or dried fruits containing almonds, and foodstuffs containing a significant amount of almonds (at least 20 percent). Regulation 1152/2009 also introduces the use of a Common Entry Document (CED). Importers have to provide prior notification to the competent authorities at the designated port of entry for the goods covered by the regulation at least 1 working day prior to the arrival of the goods, using the CED. The CED was published as Annex II to Regulation 669/2009. Provisions for methods of sampling and analysis for the official control of mycotoxins including aflatoxins are laid down in Commission Regulation 401/2006. Residues in Animals and Animal Product The monitoring of residues in animals and animal products is addressed separately in Council Directive 96/23/EC. This directive includes the monitoring of the pesticide residues as well as residues of veterinary drugs and a wide range of other contaminants and undesired substances such as residues of growth promotants. The prohibition of the use of hormones in meat production is addressed in Council Directive 96/22/EEC (amended by Directive 2008/97/EC). Section VI. Other Regulations and Requirements A. Product Inspection and Registration Member States are responsible for carrying out inspections on a regular basis and in cases where non-compliance is suspected. Products can be checked at import or at all further stages of marketing. Infringements of EU food and feed legislation are reported through the Rapid Alert System on Food and Feeds (RASFF). The rapid alert system is a network of Member State authorities managed by the European Commission. The weekly reports of the notifications under the rapid alert are available on the European Commission?s website ( The information published on the website is limited to the notifying country, the reason for notifying and the country of origin. Repeated non-compliance may lead to suspension of imports or special import conditions for products from the third country concerned, applicable on the entire EU territory. The criteria for laboratories conducting food controls have been EU harmonized but it is the responsibility of each Member State to designate laboratories authorized to perform analyses (Council Directives 89/397/EEC and 93/99/EEC). Specific detailed inspection requirements exist for animal products (Directive 97/78/EC). Inspections are carried out under the supervision of a veterinarian at a limited list of ports and border inspection posts (BIP?s ? Border Inspection Post.) In Greece, random checks are performed at import or at later stages of trading by Min Ag authorities at points of entry and EFET when they enter the distribution channel. Foodstuffs entering Greece for the first time are inspected to gain approval. The ingredient list that must accompany the product determines its clearance and what duties are imposed. The application for approval must include a statement indicating the name of the product, type of packaging, processing method, the exact composition of the product, and food safety control methods used. If all are in compliance with the Greek Food Code, the product is granted clearance. The clearance procedure costs about ?200 and is handled by a freelance customs agent hired by the importer. Products using allowed additives not included in the catalogue, non-approved packaging material, new technologies during processing, novel foods in accordance with HSCC Decision 366/97, and foodstuffs enriched with nutritional elements must obtain approval from the HSCC in order to be commercialized in Greece. The cost of this procedure is about ?450. The procedure takes 5 months for products new to EU countries and 3 months or less for products already commercialized in other EU member states. Specific agricultural and food products which are subject to inspection and to Greek trade restrictions include: Poultry, Meat, Fish, Dairy, and Egg: Products of third country origin must originate from plants included in the EU approved plant list. Proper public health certificate models cited in relevant EU regulations for importation and/or transiting through Greek soil must accompany all meat products signed by FSIS inspectors. Specific detailed inspection requirements exist for all animal products (Directive 97/78/EC). Inspections are carried out under the supervision of customs veterinarians at Greek ports of entry and border inspection posts (BIPs). Enriched/Bleached Flour: Greek regulations prohibit the import of any products made or including enriched/bleached flour. Nuts & Dried Fruit: Imported nuts and dried fruit are subject to a random aflatoxin test at entry stage or at selling points. At port, usually one out of ten containers is sampled to be tested for aflatoxin. Aflatoxin content certificates are required by Greek Authorities to accompany nuts and specific dried fruit (i.e. prunes) issued by accredited laboratories in the country of origin. Greek port authorities are authorized to repeat sampling and testing upon arrival. Consignments found to contain aflatoxins in excess are rejected. If the shipment is not returned to the country of origin or sent to an EU-approved re- processing facility elsewhere in the EU within 60 days, it is confiscated and discarded. Row Nuts: APHIS phytosanitary certificates for row nuts imported into Greece are required in accordance with EU legislation in effect. Wine-specific Import Requirements: Third-country (i.e. U.S.) wines imported into the European Community member states must be accompanied by simplified export certificate or VI1 document until such wine is put into free circulation. Further information on EU import regulations for wine can also be found in the wine section of the U.S. Mission to the European Union: An import declaration is required for goods from third countries such as the U.S. When goods are imported into Greece, it is the responsibility of the importer or his authorized agent (on Greek soil) to declare them to customs. A Single Administrative Document or SAD is used for this purpose. That is the approved form for the import declaration process. Further information on the SAD can be found in: The importer, or his local representative, must also request a health inspection by submitting an application to the port authorities according to the product (Greek Ministry Ag agronomists, veterinarians, and National Chemical Laboratory staff when sampling and testing becomes necessary), together with the documents related to the consignment. The release of goods from customs can only be carried out after that a favorable result of the inspection is reflected in the corresponding certificate. Goods are released from customs for ?free circulation? or ?transiting? when documents have been filed and payment of tariff duties has been completed if necessary. After paying the value added tax (VAT) and any other applicable excise duty, goods are also released for consumption and ready to be marketed. All plant and food samples, organic products, novel foods, and functional food items must undergo all phyto, hygiene, or labeling requirements. U.S. firms are advised to contact the Greek Ministry of Rural Development and Food - Phytosanitary Division and/or National Chemical Laboratory (NCL) prior to any shipment of samples. Authorization must be obtained from the Greek Ministry of Agriculture. For additional information please refer to: For detailed information on certification requirements to import into the EU, see USEU?s guide at: B. Certification and Documentation Requirements Detailed information on certification is also available on the website: http://www.fas.usda/posthome/useu/Certification_Guide.html. The following is a list of procedures and documents that are needed for importing into Greece. However, due to frequent changes in regulations, U.S. exporters are advised to cooperate closely with their importers and local customs agents for more detailed information. Food and agricultural products destined for the Greek market require an import license issued by the competent Greek authority (either Ministry of Rural Development and Food or Ministry of Commerce according to the type of product). Expiration of licenses varies in validity; Bill of Lading and/or Airway Bill; Commercial invoice: it must include all agreed costs plus insurance and shipping; A harmonized number is recommended; Certificate of origin or invoice declaration where the application for a preferential tariff treatment is requested. Please note that under EU regulations, certificates of origin may be required for certain goods, including goods subject to surveillance and/or quota requirements. The local importer and/or trade representative should be contacted for further information prior to issuance; Packing list (not mandatory, but may facilitate clearance of goods); Pro-Forma invoice; Certificate of insurance; An authorization or certificate of authenticity where a favorable EU tariff treatment is requested; A certificate of authenticity for all alcoholic beverages; APHIS phytosanitary certificate and/or FSIS public health certificate when applicable. Importers and/or potential Greek importers must register with the local Chamber of Commerce in their town or prefecture. C. AGRIM Certificates CAP (Common Agricultural Policy) import licenses are required for wine imported from third-countries (U.S. included) into any member state in the EU. Such import licenses, often referred to as AGRIM certificates, are issued in Greece by the OPEKEPE (GOG?s Payment and Control Agency for Guidance and Guarantee Community Aid), under the Ministry of Rural Development and Food. D. Health Certificates for Plant Products Phytosanitary certificates are required by Greek authorities for all imported plants and plant products in compliance with EU?s Plant Health Directive 2000/29/EC of 8 May 2000 (with the incorporated amendments to date). Imports of fresh fruits, vegetables, and unprocessed nuts must be accompanied by a USDA/APHIS phytosanitary certificate. The certificate is used to certify that the commodities have been inspected and that they comply with the importing country?s phytosanitary regulations. Wheat of U.S. Origin: Milling wheat, feed wheat, and wheat seed for planting are checked for Karnal bunt contamination by the Greek phytosanitary authorities, and must be 100 percent-free (Tilletia indica Mitra, the fungus responsible for Karnal bunt disease of wheat is currently recognized as a quarantine pest by both the EU and EPPO - European Plant Protection Organization). The last U.S. wheat shipment to Greece took place in 1997. Imports stopped after a rejection of a shipment of 3,000 MT of U.S. wheat due to false-positive findings by Greek inspectors (Greek testing methods for Karnal bunt disease in U.S. wheat have served as a de facto ban on imports and transshipment of wheat for over a decade due to a high incidence of false-positive results). The case is still in Greek courts after the importer pressed charges against the Greek. This fact has discouraged Greek grain importers from buying U.S. milling wheat for twelve years while similar Canadian wheat is still purchased. The competent authority for the adoption and implementation of EU legislation is the Phytosanitary Division of the Greek Ministry of Rural Development and Food. Information on specific subjects pertaining to phytosanitary regulations and controls for specific plants and plant products is also provided by EPPO, the European Plant Protection Organization ( EPPO is an intergovernmental organization responsible for European cooperation in plant health. E. Health Certificates for Animal Products Fresh meat must fulfill the animal health requirements laid down in Council Directive 2002/99/EC which superseded the former Directive 72/462/EC from the 1st of January 2005 and contains many of the same principles. All U.S. products imported into Greece and/or transited through Greece must be accompanied by the proper veterinary certificates (models of which are provided in relevant EU legislation document annexes). Greece fully implements EU-harmonized health certificates which are mandatory for meat, poultry, dairy, eggs, gelatin and seafood. Products destined for the Greek market must originate in EU-approved slaughtering and processing facilities in the United States. U.S. agencies, including FSIS, APHIS, AMS, and FDA, are involved in the establishment listing process. Establishments are subject to occasional EU audits after listing. Exporters should be aware that getting a plant listed can take several months. Actually, the following food products must come from an EU-approved establishment: red meat, meat products, farmed and wild game meat, ratites, animal casings, milk and milk products, fish and fishery products, and gelatin. Relevant EU regulations, document requirements, and guidance for imports of aquaculture products, game meat, meat products, dairy products, poultry meat, other products of animal origin, and personal imports into the EU are provided in the EU?s website cited above. Export Requirements for the European Union are provided by FSIS at:, with indications for the most recent revision to these requirements (see also: In the past few years, numerous misunderstandings between Greek veterinary authorities and U.S. meat importers in Greece and in neighboring Balkan countries were recorded, particularly for transiting products to these countries. Most problems had to do with wrong certificate models accompanying the products, use of old certificates instead of renewed EU certificate models, misinterpretations of current legislation by Greek customs veterinarians, mislabeling of cartoon boxes, etc. F. Health Certificates for Processed Foods Greece imports a large amount of processed food products, trading with countries all over the world in an increasing diversity of food products. It strictly implements all EU food legislation in effect. In order to export products to the EU, third-countries and food processing companies must meet the requirements of the basic legal framework. The European Union?s food legislation is built around high food safety standards which serve to protect the health of consumers. For import of foods of animal origin, additional requirements are set out in specific legislation. The requirements are mainly related to food safety and consumer health in avoiding the transmission of diseases to the public. They apply to all stages of the production process. Greece fully implements EU Regulation No. 852/2004 on hygiene of foodstuffs. All animal products imported into the EU, and therefore also Greece, need animal or public health certification (see relevant sections above). For processed foods containing animal product, the situation is more complicated because there is no legislation specifying the percentage of dairy, egg, red meat, or poultry meat that a foodstuff must contain to necessitate certification. As such, it is best to check the documentation requirements with the importer. In principle, products containing any amount of red meat or poultry meat must be certified. Certification of products containing egg products or dairy products depends on the composition of the product. Generally, any foodstuff containing more than 50 percent egg/dairy products will need the corresponding certificate. Prior to importation of any new processed food items into Greece, importers must contact the Food Chemistry Division in the NCL where instructions are provided for necessary actions. Usually, more documentation, food samples, and additional information must be submitted. Occasionally (on a random basis and/or after a complaint is filed by individuals or Consumer NGOs), EFET proceeds with sample inspections checking for mislabeled food items or for those carrying hidden ingredients. Section VII. Other Specific Standards A. Genetically Modified Food and Feed Labeling regulations for GM food products are established by EU Regulation 1829/2003 (articles 12-13). These rules apply to products that have undergone varying degrees of processing. The regulation does not require labeling of food products that are not food ingredients, such as processing aids (i.e. rennet in cheese production, yeast in wine production). Meat, milk or eggs obtained from animals fed with GM feed or treated with GM medicinal products do not require GM labeling. The traceability rules require all business operators to transmit and retain information on GM products in order to identify both the supplier and the buyer of the GM product. All food products containing or consisting of GMOs, produced from GMOs or containing ingredients produced from GMOs must be labeled even if they no longer contain detectable traces of GMOs. The allowable adventitious presence level for EU-approved varieties of GMOs is set at 0.9 percent. Above this level all products must be labeled. For GM varieties that received a positive EU risk assessment but are not yet formally approved, the adventitious presence level is set at 0.5 percent. A list of these varieties is available at The wording to be used on GM food labels is as follows: - Where the food consists of more than on
Posted: 14 September 2011, last updated 15 September 2011

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