The New EU Commission Proposal’s on Novel Foods Regulation (2013)

Note material contained publication freely quoted reprinted acknowledgement requested, reference document number. copy publication quotation reprint UNCTAD Secretariat, : Palais de Nations, 1211, Geneva 10, Switzerland. designations employed presentation material imply expression position whatsoever part United Nations Secretariat legal status country, territory, city area, authorities, delimitations frontiers boundaries, economic system degree development. UNCTAD/DITC/TED/2014/2 UNITED NATIONS PUBLICATION Copyright © United Nations, 2014 rights reserved Acknowledgements publication prepared David Vivas Eugui, Legal Officer Trade, Environment, Climate Change Sustainable Development Brach, DITC, UNCTAD. document benefited substantive comments Vanesa Ingar (Ministry Environment Peru), Bonapas Onguglo (UNCTAD Secretariat), Lorena Jaramillo (UNCTAD Secretariat), Katie Beckett (PhytoTrade Africa), Eugune James, (Grenoble Graduate School Business). desktop formatting Rafe Dent. UNCTAD gratefully acknowledges support Swiss State Secretariat Economic Affairs (SECO) publication BioTrade Programme. publication, “ EU Commission Proposal’ Foods Regulation (2013): Preliminary Overview Perspective Biodiversity-based Traditional Products”, product BioTrade Initiative, part Division International Trade Goods Services Commodities (DITC). part larger effort UNCTAD analyse trade-related issues importance developing countries. Guillermo Valles Director Division International Trade Goods Services, Commodities. iii Contents Note ........................................................................................................................................................... ii Acknowledgements..................................................................................................................................... ii Acronyms ................................................................................................................................................... iv Executive Summary ................................................................................................................................ 1 . IntroductIon ................................................................................................... 1 II. Scope baSIc defInItIonS ........................................................................... 2 III. SpecIfIc propoSed procedureS tradItIonal foodS thIrd countrIeS ........................................................................................................ 5 IV. labellIng requIrementS ................................................................................. 6 . releVant tranSItIonal ruleS propoSal .............................. 7 VI. potentIal ImplIcatIonS natIonal bIotrade programmeS organIzatIonS ................................................................................................. 7 VII. recommendatIonS ................................................................................ 7 Notes ......................................................................................................................................................... 9 References ................................................................................................................................................. 9 iv eu commISSIon propoSal’ noVel foodS regulatIon (2013) Acronyms EC European Commission EPAs Economic Partnerships Agreements EU European Union ESFA Europeans Food Safety Authority GMOs Genetically Modified Organisms IGOs International Governmental Organisations SCFCAH Standing Committee Food Chain Animal Health SPS Sanitary Phytosanitary NFR EU regulation foods UNCTAD United Nations Conference Trade Development WTO World Trade Organisation 1prelImInary oVerVIew perSpectIVe bIodIVerSIty-baSed tradItIonal foodS . IntroductIon EU Commission published proposal amend foods regulation (draft law). EU draft regulation1 aims ensuring food safety, protecting public health securing effective functioning internal EU market food. adopted EU Parliament Council, substitute existing regulation2 (EC) . 258/97 foods3. proposed regulation seeks introduce simpler, clearer efficient procedures commercial authorization foods EU market. proposed procedures centralized Community level4, ESFA (Europeans Food Safety Authority) EU members introduce comments objections ap- plication market authorization. existing EU regulation foods (NFR) significantly criticized 15 years diverse set stakeholders applying market safety standards evaluations biodiversity-based prod- ucts traditional foods commensurate level risk posed products impeding access EU market. oc- curred product question long - torical record traditional safe countries. standards contained EU’ NFR meant designed regulate entry products derived transgenic technologies geneti- cally modified organisms (GMOs) natural products. concerns reached level World Trade Organisation’ (WTO) Sanitary Phytosanitary (SPS) Committee submission Peru 2011. submission Peru acknowledges impor- tance consumer protection health, significant marketing biodiversity-based products EU 1997, long history safe human - sumption countries origin, products treated foods subject stringent safety risk assessment requirements.5 requirements odds obligations WTO SPS Agreement6 require Members ensure sanitary phytosanitary measures trade-restrictive required achieve level protection. level risk assessment food regu- lation commensurate level risk posed biodiversity-based traditional products. Biodiversity-based traditional products risk health GMOs bio- technology-derived products - sumed safely local populations long period time country origin. biodiversity-based traditional products produced inputs foods defined foods food ingredients consumed significant degree EU entry force current foods regulation (15 1997). executIVe Summary EU Commission published proposal amend foods regulation December 2013. proposal reforming current EU foods regulation (1997). seeks ad- dress issues related scope regulation biotechnological developments cloning, importantly respond concerns barriers faced traditional foods exports developing countries. EU Commission proposal (2013) simplified faster proce- dure market authorization traditional foods countries. proposal address concerns expressed biodiversity-rich countries BioTrade organizations 15 years, clear step direction. instance, suggests commensu- rate process marketing approval traditional foods biodiversity-based products current status quo 1997 EU food regulation. preliminary overview process suggested proposal implications presented paper. 2 eu commISSIon propoSal’ noVel foodS regulatIon (2013): nature existed humans appeared planet. , GMOs biotechnology-derived products subject significant alterations genetic / chemical structure consumed released nature , effects human health living environ- ment . , Peru, EU NFR placing heavy burden local producers hindering export potential biodiversity-based products food consumption camu camu yacon. drafted EU NFR affect commercial viability products, inconsistent efforts promote sustainable biodiversity incentives crops shifting fight illegal drug trafficking. - mission, Peru requested exclusion traditional products history safe consumption country origin scope EU NFR. illustration burdens costs obtaining market approval foods EU case baobab fruit pulp. approval processes fruit pulp cost region EUR 250 thousand EUR 350 thousand institutions PhyoTrade Africa support UNCTAD.7 costs filing request EU involve finite figure, costs continue approval follow- work required revisions. process takes years final approval. - plexity length process related costs set high regulatory bar biodiversity-based products, applications small medium-sized producer organizations. reflected fact handful ap- plications biodiversity-based traditional prod- ucts EU NFR.8 Examples biodiversity-based traditional foods approved EU NFR include Morinda citrofilia leaves, Tahitian noni juice powder (products derived Morinda citrofilia plant)9 , baobab fruit pulp, chia seeds oil, Allanblackia seed oil.10 inchi virgin oil (Plukenetia volubilis) benefited positive option substantial equivalence assessment flaxseed linseed oil food safety authority Ireland.11 number biodiversity-based traditional foods applications food approval contrasts 130 applications products derived biotechnological methods including transgenic . paper seeks outline introduce key - pects proposed regulation, EU COM (2013) 894 FINAL, published 18 December 2013. note seeks identify main implications BioTrade activities12. understood proposal reform accommodate trade traditional foods, successful minimum years EU regulation. EU regulation, proposal approved EU Parliament Council. regard, proposal positive political signal draft law, stable policy change stage. II. Scope baSIc defInItIonS proposal, basic definition “ foods” remains unchanged. definition includes food13 human consumption significant degree EU 15 1997.14 date considered arbitrary affects biodiversity products unknown date EU market. important note EU food regulation apply products food, cosmetic medicinal . , biodiversity-based product exported imported cosmetic authorized food consumption. key definitions proposal determine products subject special procedural treatment NFR. definitions include () traditional foods coun- , () primary production, () history safe country () experience continuous 25 years customary diet large part population country. terms defined important impacts potential implemen- tation future NFR regulation; terms “tra- ditional food processed products” “ large part population”. terms legal development order provide certainty. proposal introduces definition “tradi- tional food countries”. included purpose providing separate track facili- tated procedure products. definition essential understand products facilitated track avoid complex safety risk assessments applicable foods. 3prelImInary oVerVIew perSpectIVe bIodIVerSIty-baSed tradItIonal foodS UNCTAD institution put differential treatment “traditional foods” “traditional safe ”15 suitable standard assessing risks products. “Traditional foods countries” means food, derived primary production, history safe country.16 Primary produc- tion defined production, rearing growing primary products including harvesting, milking farmed animal production prior slaughter.17 includes hunting, fishing harvesting wild products flora fauna. definition excludes processed products scope regulation. opens important question processed products derived approved -approved foods. case processed products food ingredients approved, logic commercialization subject food regula- tion risks assessed - ditions set. case -approved ingredients, question remains open. , argued risk processed foods foods primary production manufacturing process eliminate components potential safety toxicity concern (.. oil nut retained proteins allergenic effects filtered extracted).18 Clear answers status “traditional food processed products” purposes future NFR order generate certainty exporters importers avoid creation additional unnecessary barriers processed foods countries. “ history safe country” means safety food question confirmed compositional data experience - tinued 25 years customary diet large part population country.19 “Compositional data20 relevant databases” tend include information nutritional components food, toxicological, intake levels allergenic analysis, depending country. “traditional foods countries” subjected systematic nutri- tional toxicological / allergenic assessments accordance modern scientific standards. , due long history , customary preparation methods absence evidence harm, generally regarded safe eat.21 “Experience continuous 25 years customary diet large part population country” points safe experience generation. period 25 years usu- ally considered good benchmark safety risk. , condition product part “customary diet large part population” raise problems authorization biodiversity-based products. defi- nition large part population means. defined 50 cent total population, significant share population risk assessment purposes. cases biodiversity-based products widely consumed, cases intake occurred region. true common ecosystem areas people eat . , , product reached na- tional markets traditional consumption remain traditional regional context. approach large part population reduces perception risk, modification fu- ture regulation cover “region” facilitate approval entry volume region- ally BioTrade products (.. products Amazon basin Namibian desert reached national markets regions South America Southern Africa, ). definition traditional foods countries introduces set cumulative requirements scientific data experience consideration defining product subject fast-track procedure safe food assessment. important support role national food sanitary authorities coun- provide scientific evidence support applications food operations, export- ers importers making application. significant weight recorded experience safe absence negative incident country evidence-gathering easier. support evidence-gathering require inter- institutional coordination capacity-building sanitary authorities potential applicants understand requirements EU regu- lation preparation compositional data evidence safe . 4 eu commISSIon propoSal’ noVel foodS regulatIon (2013): Figure1. Proposed EU Traditional Food Approval Process (2013) Submission notification EU Commission business operator Commission forwards notification Members States EFSA Members States EFSA 4 months submit reasoned safety objections objection: Commission authorise placing product EU market list authorised products updated Objection: application based notification documented data related reasoned objections EFSA adopt opinion 6 months. require additional information applicant. Opinion forwarded Commission Members 3 months date publication ESFA' opinion, Commission prepare draft implementing act authorise placing product EU market EU Commission assisted SCFCAH deliver opinion EU internal rules procedures Committee delivers positive opinion: Adoption Commission implementing draft act Committee delivers negative opinion: adoption opinion delivered, Commission adopt draft implementing act. 5prelImInary oVerVIew perSpectIVe bIodIVerSIty-baSed tradItIonal foodS III. SpecIfIc propoSed procedureS tradItIonal foodS thIrd countrIeS Procedural rules steps significantly simplified proposal. main features proposed procedures : • central procedure EU community level. initiated notification business operation seeking place food ingredient EU market time. mentioned , space reasoned objections comments ESFA members States ( months), decision approval EU level. National procedures duplica- tions phased . notifications applications approval - mitted EU Commission. • time foreseen commercial autho- rization procedure 18 months, time takes today. significant improvement compared time needed fulfil procedure current NFR, usu- ally years . change direct impact level administrative burden cost. • safety risk management assessment traditional foods countries based history safe created. pur- pose, applicant jointly demonstrate safe based compositional data experience continued safe 25 years customary diet large part population country. procedure starts notification busi- ness operator interested placing traditional food product country EU mar- ket. notification EU Commission minimum, description traditional food, composition, coun- origin ( ), documented evidence data demonstrating history safe (nutritional, toxicological allergenic) condition labelling (amounts warnings).22 proposal data docu- mentation submitted support application foods subject test data protection ( impossibility data parties authorizations authorization originator data), apply traditional foods countries. regard, notifica- tion/application traditional foods considered “generic” notification/application. exporter/importer benefit rely original data enjoy original marketing authorization exporting/importing product.23 positive feature system product authorized, open competition EU market business operators producers countries export file notification/application market authorization. notification , Commission forwards notification members States EFSA.24 Members States EFSA months submit reasoned safety objections based scientific evidence.25 reasoned objections notification , Commission authorize placing product EU market EU list authorized products updated.26 case, process ends product quickly EU market. phase biggest advantage proposed process. basically sets positive semi- automatic response notification traditional foods line NFR regulation fulfils basic requirements objection EU member ESFA. objections, track process. Objection include heath / ethical concerns. case, submit application based notification documented scientific data respond- ing reasoned objections comments submit- ted.27 information forwarded members ESFA. Based application, EFSA adopt opinion months.28 EFSA require ad- ditional information applicant.29 period opinion extended additional information required.30 applicant submit additional information applicant considers .31 opinion , ESFA Commission members publish . months date publication ESFA opinion, Commission prepare draft implementing act authorize, authorize, placing product market.32 6 eu commISSIon propoSal’ noVel foodS regulatIon (2013): Commission, assisted Standing Committee Food Chain Animal Health33 (SCFCAH), deliver opinion EU internal rules procedures (.. voting) light EU Regulation 182/2011. Committee delivers positive opin- ion, Commission adopt implementing draft act.34 negative opinion delivered Committee, draft implementing act ad- opted.35 Committee give opin- ion. situation Commission adopt draft implementing act.36 ease understanding, simplified overview process presented figure 1. IV. labellIng requIrementS Today, foods subject general - quirements EU Directive 2000/13/EC States related labelling, presentation advertising foodstuffs.37 regard, labels food, ingredients, quantities, special storage conditions, conditions , place origin manufacturer.38 applies current NFR proposal. NFR proposal additional la- belling requirements39 fulfilled, food allowed entry EU market, Food Regulation (1997) EU Commission Proposal (2013) Level phases harmonized procedure mix EU national level phases inter- act process. initial national phase assessment EU level, case safety objections national authorities. process EU level final decision publication product finally approved. centralized authorization system EU level. Members EFSA provide reasoned objections. Market ap- proval EU Commission, EU Parliament EU Council depending case ( figure 1) effect EU members. Coverage traditional foods . . Special simple procedures tradi- tional foods , simplified procedures EU member national competent authority considers food question substantially equivalent existing food food ingredient. , objec- tions ESFA EU members. case, process semi-automatic. proposed process puts burden presentation reasoned objec- tions ESFA EU members. Length procedures years. 18 months. Data exclusivity . , notifications applica- tions commercial authorization traditional foods. Opportunity objections , national assessments. . Opportunity provide additional evidence support application Silent, required. , respond objections. Type evidence support safe traditional foods Scientific evidence gener- ally recognized based opinion delivered competent national food assessment authority. Evidence based compositional data experience continued safe 25 years customary diet large part population country. Labelling requirements current NFR proposal regulated general labelling rules. Additional labelling needed cases. Table : Comparative features current NFR (1997) EU Commission Proposal (2013) 7prelImInary oVerVIew perSpectIVe bIodIVerSIty-baSed tradItIonal foodS order inform consumer : • specification food; • conditions order avoid adverse ef- fects specific groups population, - ceeding intake levels risks case exercise consumption; • specific characteristic food property, composition, nutritional nutritional effects intended food, renders food longer equivalent existing food implications health spe- cific groups population. . releVant tranSItIonal ruleS propoSal proposal includes transitional period clause request placing food EU market submitted member State (meaning national phase current NFR procedure), (EC) . 285/97, final decision , considered application regulation.40 clause facilitate assess- ment relevant applications decided date entry force regulation. VI. potentIal ImplIcatIonS natIonal bIotrade programmeS organIzatIonS EU food regulation examples -tariff measure af- fecting entry biodiversity-based traditional products EU market. current proposal clearer simpler approval pro- cedure traditional foods current regula- tion. responds, extent, concerns raised developing countries, international governmental organizations (IGOs) civil society actors scope, burdensome nature, long procedures lack special treatment tradition- al biodiversity-based products current EU NFR (1997). reach level ambition sought Peru 2011 submission WTO SPS Committee traditional products history safe consumption country origin excluded application scope EU NFR. , significant improvements. significant improvements EU proposal include common EU procedure NF approval, separate fast-track procedure tradi- tional foods, shorter time periods, semi-automatic approval process objections comments, fact comments rea- soned based scientific evidence, fact composite data complemented supported history safe country origin, - application data protection rules, opportu- nity revise application respond objection comments . main limitations proposal : () obtain approval () case objection EU Member States, application, opinion examination procedures ESFA EU’ SCFCAH apply, making process longer. lacks clarity relation treatment traditional food processed products scope terms “customary diet large part population”. table compares main features cur- rent regulation proposal. VII. recommendatIonS potential recommendations national BioTrade programmes BioTrade organizations involved interested making notifications/applications foods include : 1. Prepare revised list priority BioTrade products needing NFR approval EU market; 2. Undertake assessments capacity national BioTrade programmes organizations fulfil EU proposal light priority list products, previous experience national systems evaluation safe . advisable include assessments availability systematic scientific compositional / consumption data, experience tradi- tional safe accepted proposal. National sanitary authorities involved assessments order views evaluate level capacity submit / support notifications/applications priority list products potential “substantial equivalence” existing food prod- ucts. Capacity-building include advice pre- 8 eu commISSIon propoSal’ noVel foodS regulatIon (2013): pare notifications/applications priority products light safe light EU standards order reduce risk opposition rejection. UNCTAD BioTrade partner organizations significant role strengthening capacities. 3. Identify options requesting modifications adjustments EU proposal submitted EU Commission Parliament. relevant definition safe order include consumption part “customary diet large part popu- lation region countries country”. applies clarification coverage rules applicable “traditional pro- cessed food”, proposal creates additional uncertainty barriers. collective exer- cise BioTrade Congress, jointly analy- sis -tariff measures. exercise providing support current EU Commission proposal adjustments adoption Parliament Council fast-tracked. UNCTAD BioTrade partners organisations relevant exercise. Modification enable -cost applications procedures small-scale producers. 4. Require technical cooperation plan develop- ing countries countries economic partnerships agreements (EPAs) pref- erential free trade agreements (.. EU–Colombia, EU–Peru, EU–South Africa) implement current future foods regulation. form technical financial - port prepare notifications applications gather relevant data. include support create improve safe data databases, safety risk monitoring systems imple- mentation safety measures sanitary authori- ties country origin. 9prelImInary oVerVIew perSpectIVe bIodIVerSIty-baSed tradItIonal foodS References EC Commission (2013). Proposal Regulation European Parliament Council Foods. (EC) COM (2013) 894 FINAL, 18 December 2013. EU Commission (2013). Food: Commission tables proposals animal food. Press release, 18 December, 2013. EU Directive 2000/13/EC approximation laws Member States relating labelling, presentation advertising foodstuffs. Official Journal 109 , 06/05/2000. EU Regulation 258/97 European Parliament Council 27 January 1997 foods food ingredients. Official Journal European Union, L043, 14 February 1997. EU Regulation 178/2002 European Parliament Council 28 January 2002 laying general principles requirements food law, establishing European Food Safety Authority laying procedures matters food safety. Official Journal European Communities 01 February 2002. 31/1. Peru (2011). Communication EU Regulation 258/97 European Parliament Council foods. WTO document /SPS/GEN/1087 7 June 2011. UNCTAD (2009). Definitions, concepts history safe assessments. Issue paper concerned proposed amendments EU Food Regulation (EC) 258/97, reference traditional foods developing countries. UNCTAD/DITC/BCC/2009/5. EU Regulation 182/2011 European Parliament Council laying rules general principles mechanisms control Member States Commission’ exercise implement- ing powers 16 February 2011. Official Journal European Union, L5513, 28 February 2011. Notes 1 Proposal Regulation European Parliament Council Foods COM (2013) 894 FINAL 18 December 2013. older elaborated proposal sought improve original EU food regulation number COM (2007) 872 Final 14 January 2008. 2 EU regulation direct effect EU market. superiority vis-à-vis national law applied tribunals national legislative executive action. 3 EC Regulation 258/97 European Parliament Council 27 January 1997 foods food ingredients. Official Journal 043, 14/02/1997. http://eur-lex.europa.eu/LexUriServ/ LexUriServ.douri=CELEX:31997R0258:en:HTML. 4 centralised procedure involves Member States approval related traditional food country (notification phase). applications traditional foods countries EFSA evaluate safety (section Chapter III NF proposal, 2013). 5 Communication Peru EU Regulation 258/97 European Parliament Council foods. WTO document /SPS/GEN/1087 7 June 2011. 6 Articles 2.2, 5.1, 5.4 5.6 WTO SPS Agreement. 7 interview Katie Becket, Phytotrade Africa. 8 Applications Regulation (EC) . 285/97 EU Parliament Council, http://ec.europa. eu/food/food/biotechnology/novelfood/app_list_en.pdf (accessed 14 March 2014). 9 leaves, juice powder received applications applicants. sets products derivatives granted market authorizations EU level 2000, 2003 2004. 10 http://ec.europa.eu/food/food/biotechnology/novelfood/authorisations_en.htm. 11 http://www.fsai./uploadedFiles/Science_and_Health/Novel_Foods/Notifications/%20Inchi%20oil%20 SE%20opinion.pdf. 12 http://www.BioTrade.org/aboutINTRO.asp. 13 definitions food, food business operation risk relevant definitions, EU Regulation 178/2002, laying general principles requirements food law, establishing European Food Safety Authority laying procedures matters food safety. 14 Article 2.2, COM (2013) 894 FINAL. 15 UNCTAD (2009). Definitions, concepts history safe assessments. Issue paper proposed amendments EU Food Regulation (EC) 258/97, reference traditional foods developing countries. UNCTAD/DITC/BCC/2009/5. 10 eu commISSIon propoSal’ noVel foodS regulatIon (2013): 16 Article 2.2 ) ), COM (2013) 894 FINAL. 17 Article 3.17 EU Regulation 178/2002 European Parliament Council 28 January 2002 laying general principles requirements food law, establishing European Food Safety Authority laying procedures matters food safety. Official Journal European Communities 01 February 2002. 31/1. 18 UNCTAD (2009). 19 Article 1.2 () (), COM (2013) 894 FINAL. 20 includes detailed sets information nutritionally important components foods values energy nutrients including protein, carbohydrates, fat, vitamins minerals, important food components. include effects humans intended food . 21 UNCTAD (2009). 22 Article 13, COM (2013) 894 FINAL. 23 Article 24.3, COM (2013) 894 FINAL. 24 Article 14.1 3 COM (2013) 894 FINAL. 25 Article 14.2, COM (2013) 894 FINAL. 26 Article 14.4, COM (2013) 894 FINAL. 27 Art. 15, COM (2013) 894 FINAL. 28 Art. 16.1, COM (2013) 894 FINAL. 29 Art. 16.4, COM (2013) 894 FINAL. 30 Art. 16.5, COM (2013) 894 FINAL. 31 Art. 16.6, COM (2013) 894 FINAL. 32 Art. 17.1, COM (2013) 894 FINAL. 33 Art. 27.1 27.3 COM (2013) 894 FINAL. 34 Art. 5.1 5.2 EU Regulation 182/2011 16 February 2011. 35 Art. 5.3 EU Regulation 182/2011. 36 Ibid. 37 EU Commission (2013). Press release “Food: Commission tables proposals animal food”. 18 December, 2013. 38 Article 3 EU Directive 2000/13/EC approximation laws Member States relating labelling, presentation advertising foodstuffs. Official Journal 109, 06/05/2000. 39 Art. Art. 8 COM (2013) 894 FINAL. 40 Art. 29.1. COM (2013) 894 FINAL.