Your SlideShare is downloading. ×
0
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Food Labeling as a market access tool
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Food Labeling as a market access tool

1,852

Published on

Food labelling regulation (FLR) is designed to protect the economic expectations of both consumers and the food industry. …

Food labelling regulation (FLR) is designed to protect the economic expectations of both consumers and the food industry.
Since compliance with food labelling requirements is necessary to market the product, FLRs have a straight impact on international trade and they may pose obstacles to international trade;
Within the World Trade Organization (WTO), traditional trade barriers such as tariffs are steadily being reduced, while food safety standards, regulations related to traceability, product certification, environmental standards and other regulations are increasing in scope and significance as international trade in food opens up.
The presentation addresses an introduction to the International Rules on Trade in Foods (SPS and TBT agreements) and some highlights on major changes in FLRs.
A final section puts en eye on the Chinese, Japanese and US food regulations with special regards to import-process

Published in: Education, Technology, Business
0 Comments
2 Likes
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
1,852
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
0
Comments
0
Likes
2
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  1. Food labelling asa market access tool: Methodology Daniele Pisanello -Food Lawyer- Parma, 5 luglio 2012 www.lexalimentaria.eu www.lexalimentraia.eu
  2. Few words about the SpeakerDaniele Pisanello is a 10-year experienced food lawyer Current position • Founder and owner of LEX ALIMENTARIA STUDIO LEGALE (www.lexalimentaria.eu, offices in Bologna and Lecce; desks in Istanbul, Turkey, and Jakarta, Indonesia) • Board Member at Food Ingredient and Health Research Institute (FIHRI), a no profit US organization involved in food safety and risk communication • Author for ItaliaOggi and EU Food Law Weekly • Lecturer at: University of Bari – Veterinary Faculty and School of Law Our Legal Services: • Marketing standards for foodstuffs • Food regulatory compliance • Labelling and consumer Protection • Sanctions and Orders by Official Controls • Contracts and Liabilities • Administrative and Trade Law 2 Avv. Daniele Pisanello
  3. 1 Food Labelling Regulations: an international outlook2 Major recent changes in FLRs3 A compliance-oriented approach4 Enforcing guidelines - Country reports 3 Avv. Daniele Pisanello
  4. Food labelling: an introductionAccordingly to Codex Alimentarius’ Standard “Labelling of Prepackaged Foods”(CODEX STAN 1-1985) “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of food. “Labelling” includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal. 4 Avv. Daniele Pisanello
  5. Food labelling regulation (FLR) is designed to protect the economicexpectations of both consumers and the food industrySince compliance with food labelling requirements is necessary to marketthe product, FLRs have a straight impact on international trade and they maypose obstacles to international trade;Within the World Trade Organization (WTO), traditional trade barriers suchas tariffs are steadily being reduced, while food safety standards, regulationsrelated to traceability, product certification, environmental standards andother regulations are increasing in scope and significance as internationaltrade in food opens up. International Rules on Trade in Foods Some highlights on major changes in FLRs 5 Avv. Daniele Pisanello
  6. International Rules on Trade in FoodsWTO Agreements affecting Trade in Commodities and Processed Foods GATT (General Agreement on Tariffs and Trade) Agreement on Agriculture Agreement on Sanitary and Phytosanitary Measures Agreement on Technical Barriers to Trade 6 Avv. Daniele Pisanello
  7. The Agreement on Sanitary and Phytosanitary MeasuresThe two-fold objective of the SPS Agreement is: To recognize the sovereign right of WTO Members to provide the level of health protection they deem appropriate; and To ensure that SPS measures do not represent unnecessary, arbitrary, scientifically unjustifiable, or disguised restrictions on international trade. 7 Avv. Daniele Pisanello
  8. The Agreement on Sanitary and Phytosanitary Measures (cont.)The scope of application of the Agreement (Article 1.1): It applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade; Such measures shall be developed and applied in accordance with the provisions of this Agreement (if they are not, a complaint can be field through the Dispute Settlement Mechanism under the WTO Framework). 8 Avv. Daniele Pisanello
  9. The Agreement on Sanitary and Phytosanitary Measures (cont.)To fall under SPS Agreement’s provisions, a measure must: Have the subjective intent to protect human, animal or plant life or health; Aim to protect against either food-borne risks or against pest or disease related risks; “Directly or indirectly affect international trade.”A non-exhaustive list of SPS measures is provided in Annex A of the SPS Agreement: Additives in food or drink; Contaminants in food or drink; Certification: food safety, animal or plant health; Processing methods with implications for food safety; Other sanitary requirements for imports; Labeling requirements directly related to food safety and others. 9 Avv. Daniele Pisanello
  10. The Agreement on Sanitary and Phytosanitary Measures (cont.)Basic Rights and Obligations: WTO Members have the right to adopt appropriate SPS measures that they consider necessary to protect health, provided that they are consistent with the provisions of the SPS Agreement.Standard based on Science: Although WTO Members do have a certain degree of flexibility with regard to SPS measures, Article 2 of the SPS Agreement provides that measures not based on scientific principles are not valid within the terms of the agreement. 10 Avv. Daniele Pisanello
  11. The Agreement on Sanitary and Phytosanitary Measures (cont.)The SPS Agreement recognises three international standard-setting bodies: CODEX ALIMENTARIUS COMMISSION INTERNATIONAL OFFICE OF THE EPIZOOTICS SECRETARIAT OF THE INTERNATIONAL PLANT PROTECTION CONVENTION 11 Avv. Daniele Pisanello
  12. Codex and Labelling RegulationsGeneral Guidelines on Claims (CAC/GL 1-1979 , rev. 1991)Guidelines on Nutrition Labelling (CAC/GL 2-1985 , rev. 2011)Guidelines for the Production, Processing, Labelling and Marketing of OrganicallyProduced Foods (CAC/GL 32-1999, rev. 2010)General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985 , rev.2010)General Standard for the Labelling of Food Additives when sold as such (CODEX STAN107-1981, rev. 1981)General Standard for the Labelling of and Claims for Prepackaged Foods for SpecialDietary Uses (CODEX STAN 146-1985, rev. 1985)Standard for Labelling of and Claims for Foods for Special Medical Purposes (CODEXSTAN 180-1991, rev. 1991) 12 Avv. Daniele Pisanello
  13. The WTO Agreement on Technical Barriers to TradeThe WTO Agreement on Technical Barriers to Trade General Objective of the TBT Agreement The right of WTO Members to adopt Technical Recognizes Regulations, Standards and Conformity Assessment Procedures But, at the Ensures that such measures do not create same time unnecessary obstacles to trade 13 Avv. Daniele Pisanello
  14. What a TBT measure deal with?TBT measures typically deal with: Labeling of composition or quality of food, drink and drugs; Quality requirements for fresh food; Volume, shape and appearance of packaging; Testing vehicles and accessories; Regulations for ships and ship equipment; Safety regulations for toys and others. 14 Avv. Daniele Pisanello
  15. Objectives of TBT AgreementThe WTO Agreement on Technical Barriers to Trade (TBT) seeks to assure that: mandatory product regulations, voluntary product standards, and conformity assessment procedures (procedures designed to test a product’s conformity with mandatory regulations or voluntary standards)do not become unnecessary obstacles to international trade and are not employed toobstruct trade. 15 Avv. Daniele Pisanello
  16. Technical RegulationTechnical Regulation: “Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.” • Examples of technical regulations: a) A law stating that all product packaging must be recyclable b) A law stating that only refrigerators that are one meter high can be sold in State X c) A regulation establishing compulsory particulars for food labelling 16 Avv. Daniele Pisanello
  17. Standards and Conformity AssessmentStandard: Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. • Examples of Standards: a) A guideline defining what products can display a “recyclable symbol” is a standard (provided that products that do not bear the symbol may still be sold). b) A government guideline saying that all eggs weighing 62 grams or more are entitled to be labelled “Grade A” is a standard (provided that eggs weighing less may still be sold).Conformity Assessment Procedure: “Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.” 17 Avv. Daniele Pisanello
  18. Private standardsPrivate standards: role and differences in respects to mandatoryrequirements: Requirements of private standards are often stricter than the law (for example, in terms of MRLs) Compliance with private standards is not required by law but by private contracts with, for example, retailers Third country suppliers often think they are mandatory by lawExamples for widely accepted standards in the European market British Retailer Consortium BRC, EUREPGAP 18 Avv. Daniele Pisanello
  19. Private Standards and WTO lawThe taking up of consumer concerns about animal welfare, environmental,occupational health and safety and consumer safety aspects of foods, forexample, in private voluntary standards is a phenomenon that largely post-dates the negotiation of the SPS and TBT Agreements. The possible application of the SPS Agreement to the development of private voluntary standards or conformity assessment against such standards was never anticipated. The TBT Agreement, on the other hand, deals not only with the development and implementation (including “conformity assessment”) of mandatory technical regulations by governments but also, explicitly, with private activities to develop and adopt standards and to conduct conformity assessment. 19 Avv. Daniele Pisanello
  20. At the national level there is no apparent legal impediment to prevent buyers fromdefining and applying specific technical requirements to the products that theypurchase; and in the case of food wholesalers and retailers there are many goodreasons why the application of such requirements is justified in order to managebusiness risksWhile private voluntary standards may in many instances provide a stimulus toimproved production practices and performance in exporting countries, andpotentially give a competitive advantage to complying producers, they may also actas significant barriers to market access for some industries in some countries –especially least developed countries. There may also be a proportionately greaterdisadvantage to smaller-scale producersThese barriers to trade are associated with a number of factors including up-frontcapital costs, initial and on-going costs of third-party certification, higher operatingcosts for producers, and reduced profit margins. 20 Avv. Daniele Pisanello
  21. Notwithstanding that the TBT Agreement specifically addresses private standard-setting and conformity assessment activities, there remain difficulties in the path ofits effective application in this sphere. Members are obliged to take such reasonable measures as may be available to them to ensure compliance by non-governmental organisations with the provisions of Article 2 of the Agreement, but there is again the issue of the scope of “ reasonable measures”. Many developing countries believe that eco-labelling requirements that relate to matters other than attributes incorporated into products (e.g. pesticide residues) are proscribed under WTO rules; other Members do not agree. Lack of significant case law prevent the understanding of the applicability of the TBT Agreement to voluntary standards that are not product-related. 21 Avv. Daniele Pisanello
  22. 2 Major recent changes in FLRs 22 Avv. Daniele Pisanello
  23. Changing Patterns in the field of FLRs in a Year and half Within 1/1/2011 to 1/06/2012 , 158 TBT measures have been notified as regards processed foods Czech Ukraine: 1 EC: 6 Republic: 1 South Korea: 6 Canada: 1 Japan: 3 Kuwait: 40 Chinese US: 3 Tapei: 4Mexico: 40 Indonesia: 4Guatemala: 4 Kenya: 3El Salvador: 7 Costa Rica: 3 Brasil: 1 UAE: 15 Bahrain: 29 Chile: 15 South Africa: 10 Qatar: 3 Oman: 7 Australia: 1 Paraguay: 2 Saudi Arabia: 1 23 Avv. Daniele Pisanello
  24. Rapid Changes in FLRs around the world: issues from the last 12 months ISRAEL.: proposal KUWAIT: mandatory CZECH REP.: additional requirements for new labelling standard specifies for the labelling of milled cereal requirements for requirements for low products, pasta, bakery products and honey starch macaroni for confectionery products, and doughs special dietary uses intended for the final consumer. JAPAN: revisions to the "Labelling Standard for Liquors Made from Organic Agricultural Products and Others"COLOMBIA:TechnicalRegulation FORfoodscontaining CHINA: technical andtrans and/or labelling requirementssaturated fats" for distilled spirits and their integrated alcoholicCHILE: optimize beveragesthe Nutritional SOUTH AFRICA: INDONESIA:Labelling of Regulations relating to Guidelines for TheFood; the use of Sweeteners Inclusion of Nutrition in Foodstuffs and Facts on Food Label related matters 24 Avv. Daniele Pisanello
  25. Different FLRs: the trans fatty acids caseTrans fatty acids are substances posing growing health concerns as they increase risk ofcoronary heart disease. Several countries and regions in North America, South America, and Asia have established mandatory transfatty acid labelling as one of the nutrients in the nutrition labelling regulations. Some other National Authority addressed specific guidelines as regards daily intake or national labelling scheme to be adopted on a voluntary basis (Japan)Developing labelling systems of transfatty acids is a top priority in several countries. 25 Avv. Daniele Pisanello
  26. Nutrition Declaration and trans fatty acids: strong CANADA As of December eterogenity SOUTH KOREA 2005, nutrition As of 2006, JAPAN SWITZERLAND UE labelling including nutrition labelling is Nutrition labelling is As of April 2008, Up to 13 December transfatty acids is mandatory. voluntary transfatty acids in 2016 Nutrition mandatory. As of December oils and fats must labelling is not mandatory 2007, transfatty not exceed 2% of acid labelling is TAIWAN oil or fat. mandatory. As of 2002, nutrition labelling isUS mandatory.As of 1994, nutrition As oflabelling is January2008,mandatory. transfatty acidAs of January 2006, CUBA labelling istrans fatty acid nutrition mandatory.labelling is labellingmandatory. mandatory ISRAEL HONG KONG Transfatty acid nutrition As of July 2010, labelling is labelling nutrition labellingPARAGUAY voluntary mandatory, including transfattyAs of August 2006, BRAZIL Transfatty acid acids is mandatory.nutrition labelling As of 2001, labelling isincluding transfatty nutrition voluntary MALAYSIA CHINAacids is mandatory. labelling is nutrition nutrition labelling mandatory.CHILE labelling mandatory, Transfatty As of AugustAs of November 2006, mandatory, acid labelling is 2006,transfatty INDIAnutrition labelling Transfatty acid mandatory on January acid labelling nutritionincluding transfatty labelling is 1, 2013 is mandatory. labellingacids is mandatory voluntary URUGUAY mandatory, ARGENTINA AUSTRALIA NEW ZELAND As of August 2006, Transfatty acid As of August 2006, nutrition labelling nutrition labelling nutrition labelling labelling is nutrition labelling mandatory, Transfatty mandatory, Transfatty including transfatty voluntary including transfatty acids acid labelling is acid labelling is acids is mandatory voluntary voluntary is mandatory Based upon Japanese Consumer Affairs Agency, Regulatory trends of Nutrition labelling and transfatty Avv. Daniele Pisanello 26 acid labelling October, 2010, up-to-dated by D.Pisanello
  27. Trans Fatty Acids in European Countries AUSTRIA (2009) Regulation of the FederalDENMARK (2002) Minister of Health on the transOrder on the content of fatty acid content of foodstuffstrans fatty acids in oils and (Trans Fatty Acids Regulation)fats etc. (Bekendtgørelseom indhold af The Regulation applies to fatstransfedtsyrer i olier og and oils as well as otherfedtstoffer m.v.) foodstuffs containing fats and oils either as an ingredient or asOrder applies to oils and a consequence of theirfats, including emulsions production process. BUT it doeswith fat as the continuous not apply to trans fatty acidsphase which, either alone which occur naturally in fats ofor as part of processed animal origin.foodstuffs, are intended, or It is prohibited to produce orare likely, to be consumed market foodstuffs with a transby humans. fatty acid content exceeding 2gBUT it does not apply to per 100g of total fat content.trans fatty acids whichoccur naturally in fats ofanimal origin.It is prohibited to sell theoils and fats to consumersif they contain the transfatty acids higher than 1gram per 100 grams of oilor fat, cf. 27 Avv. Daniele Pisanello
  28. 3 A compliance-oriented approach 28 Avv. Daniele Pisanello
  29. Compliance with Law is the result of a process Consistency with Food Law requires a process to be designed, enforced and implemented • So long as we have to deal with a process, the binding requirements addressed can be explained by a process flow chart 1. Defining the Targets 2. Cost-Benefit Assessment 3. Setting Guidelines 4. Actions and Monitoring 29 Avv. Daniele Pisanello
  30. Defining the targetsDefining the framework (actors, requirements, trends …) Policy makers Legal Framework Customs and Executive bodies Official control on Regulatory Authorities imports Trade Inspections Authorities Certification issuing Bodies Public Affairs & communication Importers Agents Clients Consumer Embassy & Media 30 Avv. Daniele Pisanello
  31. Defining Requirements Defining critical points Does the product comply with all Safety requirements? Does the product comply with YES NO Food Labelling requirements? Actions in order to reduce trade Does the product comply with contract’s requirements? barriers risks YES NOContinual Improvement Quality management Fair and less risky trading 31 Avv. Daniele Pisanello
  32. Safety requirements: a not exhaustive list ofSafety Requirements(not exhaustive lists of) FOOD HYGIENE REQUIREMENTS Product origins from approved Countries and Establishments Hygiene Related Obligations GMP, HACCP, other safety procedures FOOD SAFETY REQUIREMENTS Maximum Residue Level for certain substances Additives, flavours, enzymes Materials and articles in contact with food Permitted substances Ad hoc authorization / approval TRACEABILITY AND SAFETY MANAGEMENT Traceability Risk Management tools 32 Avv. Daniele Pisanello
  33. Consumer’s protection related concerns: a not exhaustive list Labelling (labelling, presentation & advertising) MANDATORY LABELLING OF PREPACKAGED FOODSGENERAL ADDITIONAL MANDATORY LABELING REQUIREMENTS OPTIONAL LABELLING PRESENTATION OF MANDATORY REQUIR.PRODUCT LAW 33 Avv. Daniele Pisanello
  34. Consumer’s protection related concerns: a not exhaustive list Labelling The name of the food (labelling, presentation & advertising) List of ingredients MANDATORY LABELLING OF Processing aids and PREPACKAGED FOODS carry-over of food additivesGENERAL ADDITIONAL MANDATORY Net contents and LABELING REQUIREMENTS drained weight OPTIONAL LABELLING Name and address PRESENTATION OF Country of origin MANDATORY REQUIR. Lot identification Date marking andPRODUCT LAW storage instructions Instructions for use Nutrition Facts 34 Avv. Daniele Pisanello
  35. Consumer’s protection related concerns: a not exhaustive listLabelling(labelling, presentation & Quantitative ingredients declarationadvertising) Irradiated foods MANDATORY LABELLING OF PREPACKAGED FOODS Warning on specific aspectGENERAL ADDITIONAL MANDATORY LABELING REQUIREMENTS Allergen related warnings OPTIONAL LABELLING Warning on the presence/absence of PRESENTATION OF some substances MANDATORY REQUIR. High in caffeine content Declaration that it is completely free of pork products or their derivatives Pregnant women and other categories of vulnerable consumers Avv. Daniele Pisanello
  36. Consumer’s protection related concerns: a not exhaustive listLabelling(labelling, presentation &advertising) MANDATORY LABELLING OF PREPACKAGED FOODSGENERAL ADDITIONAL MANDATORY Nutrition Claims LABELING REQUIREMENTS Health Claims OPTIONAL LABELLING Organic Product PRESENTATION OF MANDATORY REQUIR. Other process-related claims Environmental related claim Social responsibility 36 Avv. Daniele Pisanello
  37. Consumer’s protection related concerns: a not exhaustive listLabelling(labelling, presentation &advertising) MANDATORY LABELLING OF PREPACKAGED FOODSGENERAL ADDITIONAL MANDATORY LABELING REQUIREMENTS OPTIONAL LABELLING Minimum fonts’ size PRESENTATION OF Languages MANDATORY REQUIR. Mislabelling Displaying mandatory requirements 37 Avv. Daniele Pisanello
  38. Setting GuidelinesWhat is the appropriate procedure to manage the process ? The FIVE LATIN Q rule: Usually, it is up to importers to guarantee products’ legal QUI consistency with Importing WHO must guarantee the country’s laws. This compliance with FLRs obligation may be transfered to manufacture by contract QUID Compliance with WHAT (laws & contracts) Manufactures obligation QUOMODO must be defined as regards How, by which means, advices, legal requirements the resources product must be consistent with. They may depends on QUONIAM product’s end use, intended Timing use and other elements QUIA which should be drafted in the Contract Main goals to reach 38 Avv. Daniele Pisanello
  39. Setting GuidelinesWhat is the appropriate procedure to manage the process ? The FIVE LATIN Q rule: Compliance with applicable requirements should be QUI assessed: due to changes in WHO must guarantee the FLRs and taking into complaince with FLRs account several legal QUID implications, a (well-done) Compliance with WHAT (laws & legal advice is highly contracts) recommended QUOMODO How, by which means, advices, resources QUONIAM Timing QUIA Main goals to reach 39 Avv. Daniele Pisanello
  40. Setting GuidelinesWhat is the appropriate procedure to manage the process ? The FIVE LATIN Q rule: Generally speaking, food QUI imports must be consistent with WHO must guarantee the applicable legal requirements at complaince with FLRs the time of Custom clearance, but this is not a uniform rule: QUID China’s current regulation Compliance with WHAT (laws & requires the imports to comply contracts) with GB7718 – “2004 General Rules of Prepackaged Food QUOMODO Labeling”) and other more How, by which means, advices, specific legal act at the time of resources cargo’s arrival. Japan: under Japanese Law, QUONIAM Labeling is required at the Timing point of sales from importer to other businesses in the QUIA domestic market. Main goals to reach 40 Avv. Daniele Pisanello
  41. 4 Enforcing guidelines - Country reports 41 Avv. Daniele Pisanello
  42. Enforcing Guidelines 42 Avv. Daniele Pisanello
  43. China – defining the targetsOn May 13 2011, Chinas Ministry of Health published on its web site National FoodSafety Standard on General Rules for the Labeling of Prepackaged Foods to beadopted on April 20, 2012. These Rules prescribe the basic requirements for the labeling of pre-packaged foods. They apply to the labeling of all pre-packaged foods • directly or • indirectly offered to consumers. 43 Avv. Daniele Pisanello
  44. China – defining the actors (public affairs)The Competent Authority in the field of export control is the General Administrationof Quality Supervision, Inspection and Quarantine (AQSIQ) AQSIQ is a ministerial-level department under the State Council of the Peoples Republic of China that is in charge of national quality, metrology, entry-exit commodity inspection, entry-exit health quarantine, entry-exit animal and plant quarantine, import-export food safety and accreditation, standardization, as well as administrative law enforcement. AQSIQ directly administers provincial Entry-Exit Inspection and Quarantine Bureaus and Bureaus of Quality and Technical Supervision. 44 Avv. Daniele Pisanello
  45. CHINA – Basic requirementsApplicable requirements depends on direct or indirect destination to the consumer; Where food is intended to final consumer, basic legal requirements are as below: • Label must be clear, prominent, indelible and readily legible by customers in purchase. • easily understood by the public, precise and supported by scientific evidence. Any indications, which are superstitious, pornographic, debasing other products, or unscientific, shall be prohibited. • true and accurate, and shall not be described or presented in a manner that is false, misleading or deceptive; or is likely to create an erroneous impression by means of different word size or color contrast. • It is prohibited to use words, pictorial or other devices which refer to or are suggestive either directly or indirectly, of any other product with which such food or its certain property might be confused. • It is forbidden to declare or imply contents with effect of prevention and curing of diseases, and non-health care 45 Avv. Daniele Pisanello
  46. CHINA – Language and fonts requirementsLanguage requirements Language: label must be in normal Chinese characters (except registered trademark). Languages of minority ethnic groups may also be used at the same time, but the size of words shall not be larger than the corresponding Chinese characters. Foreign languages are also allowed in addition to Chinese characters provided that they are not larger than the corresponding Chinese characters (except for registered trademarks).Fonts requirements If surfaces area of a package (container) of prepackaged food is more than 35 cm2: the minimum size of the words, symbols and numerals in the mandatory labeling information shall not be less than 1.8 mm in height • Note: Reg. EU no 1169/2011 will requires1,2 mm; 46 Avv. Daniele Pisanello
  47. CHINA: labelling particularsLabeling of prepackaged food for direct delivery to consumers shall include name of foods, * list of ingredients, net weight and configuration, * name of the food, address and contact information of manufacturers and/or distributors, date of manufacture and date of minimum durability, conditions for the storage, * food production license number, code of the product standard and Nutrition declaration (as from January 2013) other contents needed to be labeled. 47 Avv. Daniele Pisanello
  48. The new mandatory nutrition declaration in ChinaThe mandatory labelling contents are energy and core nutrients: protein, fat, carbohydrate andSodiumNutrition information contains the name, content and NRV (%) of each nutritional component.The presentation order of the names of nutritional components is shown below. When any oneof the nutritional components is lacking, the next one simply moves upwards. Energy Protein Fat • -- Saturated fat (fatty acid) • -- Monounsaturated fat (fatty acid) • -- Polyunsaturated fat (fatty acid) • -- Trans fat (fatty acid) Cholesterol Carbohydrate • -- Sugar (lactose a) Dietary fibre (or monomer component b) • -- Soluble dietary fibre • -- Insoluble dietary fibre Sodium 48 Avv. Daniele Pisanello
  49. The name of the foodThe name of the food must indicate the true nature of food and it must be borne in theprominent place of the label Where a name or several names have been established in respect of a certain food under a national, trade, or local standard, one of these names or an equivalent name shall be selected for use. In the absence of any such name, either a common or usual name which is not misleading or confusing to the consumer shall be used. A coined, fanciful, transliterated, brand name, folk name or trade mark may be also used provided it in the same display panel one of the trade names as ruled by Law (previous points) Particular in regard to the true nature, physical condition of the food, or method of preparation of the food are mandatory, as necessary to avoid misleading or confusing the consumer; for example • dried, • concentrated, • reconstituted, • smoked, • fried, • powdery, • granular 49 Avv. Daniele Pisanello
  50. List of ingredientsThe list of ingredients must declare all ingredients in descending order of theirweights added in the process of manufacture or preparation of the food; those ingredients constituting less than 2% of the food may not be listed in descending order; Ingredients other than additives must be named according to rules on “name of foods” • Special rules apply to listing of additives. Compound ingredient: where an ingredient is itself the product of two or more ingredients (except compound food additives), such a compound ingredient may be declared, as such, in the list of ingredients, provided that it is immediately accompanied by a list, in brackets, of its primary ingredients in descending order of proportion. • Where a compound ingredient (for which a name has been established in a national, trade or provincial standard) constitutes less than 25% of the food, its primary ingredients need not be declared. The processing aids need not be indicated. 50 Avv. Daniele Pisanello
  51. Food AdditivesOn May 13, 2011, the Ministry of Health of the Peoples Republic of China (MOH)published a new food additive standard, entitled "Food Safety National Standards -Standards for Use of Food Additives (GB 2760-2011)," which became effective onJune 20, 2011, and replaces GB 2760-2007 ("Hygienic Standards for Use of FoodAdditives"). GB 2760-2011 provides for the use of • food additives, • processing aids, • flavors, and • gum bases in foods which are categorized into 16 groups. A significant change is that the new Standard details both the applicable principles and requirements for the use of processing aids and flavors in food. GB 2760-2011 has also removed those food additives and processing aids that are either no longer in use, or have been deemed not "technically necessary" (e.g., benzoyl peroxide, calcium peroxide, formaldehyde, etc.). 51 Avv. Daniele Pisanello
  52. Scope of Use and Level of Use of Food AdditivesThe new GB 2760-2011 has incorporated expanded uses and use levels for certainfood additives. For instance, changes to the scope of use and level of use have been added to over 40 food additives listed at Table A.1. • For example, food additive tea polyphenol (TP) now has additional 8 types of food added to its scope of use, including Cooked Nuts and Seeds (limited to fried nuts and seeds), Oil Fried Flour Product, and etc. Moreover, the use requirements of certain food additives are also revised, including changes in the maximum level of use and/or additional use requirements. • "sorbic acid, potassium sorbate" (maximum level increased in egg products) • "erythrosine, erythrosine aluminum lake“: new calculation reference, stating that "calculation is to be based on the amount of erythosine"。 。 52 Avv. Daniele Pisanello
  53. Labelling food additivesThe names of food additives shall be declared in general names in accordance with GB 2760.Two form to food additive declaration: Declare the specific names of all food additives in descending order of proportion; example: • Ingredient: water, whole milk powder, pouring cream, vegetable oil, chocolate (cocoa mass, sugar, cocoa fat, lecithin, PGPR, food flavor and lemon yellow), glucose syrup, propylene glycol ester of fatty acid, carrageenan, guar gum, annatto, malto dextrin and food aroma; Declare the class names and international code of all food additives in descending order of proportion; example • Ingredient: water, whole milk powder, pouring cream, vegetable oil, chocolate (cocoa mass, sugar, cocoa fat, emulsifier (322,476),food flavor, colorant (102)), , glucose syrup, emulsifier (477), thickener (407,412), colorant (160b) malto dextrin and food aroma. Declare the class names and specific names of all food additives in descending order of proportion • Ingredient: water, whole milk powder, pouring cream, vegetable oil, chocolate (cocoa mass, sugar, cocoa fat, emulsifier (ecithin, PGPR),food flavor, colorant , (lemon yellow)), glucose syrup, emulsifier (propylene glycol ester of fatty acid), thickener (407,412), colorant (carrageenan and guar gum), colorant(annatto), malto dextrin and food aroma. 53 Avv. Daniele Pisanello
  54. Quantitative labeling of the ingredientsQuantitative labeling of the ingredients Where the labeling of a food places special emphasis on the presence of or adding one or more valuable and/or characterizing ingredients or components, the percentage of the emphasized ingredients added at the time of manufacture or the content of the emphasized components shall be declared. Where the labeling of a food places special emphasis on the low content of one or more ingredients or components, the percentage of the emphasized ingredient or component in the final product shall be declared. A reference in the name of a food to a particular ingredient or component shall not of itself constitute the placing of special emphasis. 54 Avv. Daniele Pisanello
  55. Net Weight and ConfigurationNet Weight and Configuration The net weight declaration shall be expressed using net weight, numerals and the official unit of measurement. (Refer to appendix C for declared form) The minimum font size of net weight declaration are set by the following table 55 Avv. Daniele Pisanello
  56. Japanese FLRs: an introductionRecently some specific administrative functions have been transferred from Ministry ofHealth, Labor and Welfare to the Consumer Affairs Agency.In September 2009, the new Consumer Affairs Agency issued the “Guidance for Food Labeling based on Ordinance for Enforcement of the Food Sanitation Act” and the paper “On Labeling of Milk and Milk Products based on Ministerial Ordinance on Milk and Milk products Concerning Compositional Standards, etc.” (“On New Labeling based on the Food Sanitation Act,” CAA Notification Label No. 8, September 17, 2009). 56 Avv. Daniele Pisanello
  57. Japanese FLR: basic requirementsMain legal requirements are address by the Food Sanitation Act and Ordinance forEnforcement of the Food Sanitation Act (Labeling). Specific requirements are provided for • Milk and Milk Products • mineral water, • tinned foods, • frozen foods, • raw fish, • irradiated foods, • oysters, • allergy-related products, • GM foods, and • Food for Specified Health Uses (FOSHU) / Food with Nutrient Function Claims (FNFC) 57 Avv. Daniele Pisanello
  58. Mandatory particulars for consumer direct selling of containers or packages ofprocessed foods other than those for institutional use: (1) Name; (2) Names of ingredients; (3) Net contents; (4) Best before; (5) Storage instruction; and (6) Name or trade name and address of manufacturer, etc.It is to be noted that foods other than imports must bear the place of origins ofingredients. Imported foods must only indicated the country of origin on the labelsThose foods whose total surface of the container or package is no more than 30cm2are exempted from the obligation to indicate: names of ingredients; best before oruse-by date; storage instructions, and place of origin of ingredient 58 Avv. Daniele Pisanello
  59. Name of foodThe name must be labeled with a generic name expressing the product content. Some foods are regulated by regulatory acts 59 Avv. Daniele Pisanello
  60. 60 Avv. Daniele Pisanello
  61. 61 Avv. Daniele Pisanello
  62. 62 Avv. Daniele Pisanello
  63. Listing ingredientsNames of ingredients (other than food additives) must be labeled with the mostgeneric names in the descending order by weight.Compound ingredients: Labeling of ingredients made from no less than twoingredients (hereafter must follow as provided below: i) The name of the mentioned compound ingredient followed by its component ingredients with the most generic names in parentheses in the descending order by weight in the mentioned compound ingredient. • Where the compound ingredient consists of no less than three ingredients, the ingredients consisting less than 5% by the total weight of the mentioned compound ingredient may be labeled as “others”. ii) The names of ingredients of the mentioned compound ingredient may be omitted, if the weight of the compound ingredient in the total ingredients of the product is less than 5% or the names of ingredients are easily identified from the name of the compound ingredient.Specific provision for naming of some ingredients: see table 63 Avv. Daniele Pisanello
  64. 64 Avv. Daniele Pisanello
  65. Warning on allergensAccordingly to Japanese FLRs, criteria for the labeling of food or food additives madefrom specified raw materials are as follows: (1) Labeling of foods made from “specified raw materials”: seven kinds of food/ingredients which have been designated to have links to food allergies in reference to the incidence and the severity of allergic reactions caused thereby: • prawn, crab, wheat, buckwheat, eggs, milk, and peanuts; A processed food containing any specified raw material shall carry a label stating that it contains them. • Foods, which contain additives derived from specified raw materials, shall carry a label, indicating that they contain these additives and that these additives are derived from specified raw materials. (2) Labeling of foods made from materials similar to specified raw materials : abalone, cuttlefish, salted salmon roe, oranges, kiwi fruit, beef, walnuts, salmon, mackerel, soybeans, chicken, banana, pork, matsutake mushroom, peaches, yams, apples and gelatin have also been found through experience and scientific studies to contain allergic substances. • It is recommended that processed foods, which contain these foods as raw materials, should indicate on their label that such foods are contained 65 Avv. Daniele Pisanello therein as raw materials as far as possible.
  66. Nutrition labellingNutrition labelling is voluntary in Japan. Only Special diet food and foods for infant and babies are required to declare their nutrient components and weight; Nutrition information shall be provided in accordance with Nutrition Labelling Standards under the Health Promotion Act if • nutrient declaration, • nutrient content claim such as a) “X free”, b) “X% reduced,” and/or c) nutrient function claim is made on the label of foods offered for sale 66 Avv. Daniele Pisanello
  67. Importing into the United States - A Guide for CommercialImporters (U.S. Customs and Border Protection) 67 Avv. Daniele Pisanello
  68. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Agricultural Commodities as Cheese, Milk, and Dairy Products. • Cheese and cheese products are subject to requirements of the Food and Drug Administration and the Department of Agriculture (USDA). Most importations of cheese require an import license and are subject to quotas administered by the Department of Agriculture, Foreign Agricultural Service. • The importation of milk and cream is subject to requirements of the Food, Drug and Cosmetic Act and the Import Milk Act. These products may be imported only by holders of permits from Food and Drug Administration, Department of Health and Human Services and the Department of Agriculture. 68 Avv. Daniele Pisanello
  69. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Fruits, Vegetables, and Nuts. Certain agricultural commodities, including Fresh tomatoes, Oranges, Grapefruit, Irish potatoes, Cucumbers, Eggplants, Dry onions, Avocados, Mangoes, Limes, Processed dates, Prunes, Walnuts and filberts Raisins, Olives in tins, Green peppers, must meet United States import requirements relating to grade, size, quality, and maturity • These commodities are inspected; an inspection certificate must be issued by USDA’s Food Safety and Inspection Service to indicate import compliance. 69 Avv. Daniele Pisanello
  70. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Livestock and Animals. • Inspection and quarantine requirements of the Animal and Plant Health Inspection Service (APHIS) must be met for the importation of ruminants, Swine, Horses, avian species, animal by-products (untanned hides, wool, hair, bones, bone, meal, blood meal, animal casings, glands, organs, extracts, or secretions of ruminants and swine (if animal by-products for food, drugs, or cosmetics, they are also regulated by the Food and Drug Administration), Animal germ-plasm, including embryos and semen; and Hay and straw. • A permit for importation must be obtained from APHIS before shipping from the country of origin. • In addition, a veterinary health certificate must accompany all animal imports. 70 Avv. Daniele Pisanello
  71. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection (CBP) andother agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and Drug Administration shouldbe forwarded to the nearest FDA district office; in other instances Department of Agriculturemay be involved. Meat, Poultry and Egg Products. • Country of origin must be listed as authorized exporting country • All commercial shipments of meat and meat food products (derived from cattle, sheep, swine, goats, and horses) are subject to USDA regulations and must be inspected by the Food Safety and Inspection Service (FSIS). Special procedures for Meat products from other sources (including, but not limited to wild game). • Inspection certificates from the country of origin must accompany all imported meat, poultry, and egg products. These certificates must indicate the: • Product name, • Establishment number, • Country of origin, • Name and address of the manufacturer or distributor, • Quantity and weight of contents, • List of ingredients, • Species of animals from which the product was derived, 71 Avv. Daniele Pisanello • Identification marks.
  72. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Foods, Drugs, Cosmetics, And Medical Devices • The importation into the United States of food, drugs, devices, and cosmetics is governed by provisions of a) The Public Health Security and Bio-Terrorism Preparedness and Response Act of 2002, or BTA; and b) the Federal Food, Drug, and Cosmetic Act; 72 Avv. Daniele Pisanello
  73. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Foods, Drugs, Cosmetics, And Medical Devices • BTA applies to all food imported or offered for import into the US, both for human and animal consumption, is subject to the requirements of this Act. • The BTA’s key elements require that manufacturers and shippers register the facilities from which they export food and food products to the U.S. with the Food and Drug Administration. • Manufacturers and shippers must also provide the FDA with prior notification (PN) for any food shipment covered by BTA regulations. Failure to provide the PN will result in refusal of the food importation, which could cause the shipment to be: • Held at the port of arrival, • Moved to secured storage pending compliance with PN requirements, • Exported, or • Destroyed. 73 Avv. Daniele Pisanello
  74. Import procedure to US: some food-related focusImporting food to US requires the importers to contact Customs Border’s Protection(CBP) and other agencies when questions arise about particular commodities.For example, questions about products regulated by the Food and DrugAdministration should be forwarded to the nearest FDA district office; in otherinstances Department of Agriculture may be involved. Foods, Drugs, Cosmetics, And Medical Devices • As ruled by provisions of the Federal Food, Drug, and Cosmetic Act, it is prohibited any importation of articles that are adulterated or misbranded and products that are defective, unsafe, filthy, or produced under unsanitary conditions. • The term misbranded includes statements, designs, or pictures in labeling that are false or misleading or that fail to provide the information required in labeling. • Imported products regulated by the FDA are subject to inspection at the time of entry. • Shipments inconsistent are subject to refusal; these shipments must be brought into compliance, destroyed, or re-exported. 74 Avv. Daniele Pisanello
  75. Thank you for your attention www.lexalimentaria.euSediTaviano (Lecce), via Principe Umberto 2, Bologna, via D’Azeglio 27tel./fax: (+39) 0833 91 47 27 40123 Bologna (BO), Italycell.: (+39) 349 58 49 718 Tel.: +39 0516486188email: info@lexalimentaria.eu email: info@lexalimentaria.eu 75 Avv. Daniele Pisanello

×