PDF EU Food safety law and national law

Master Degree in Veterinary Medicine Curricular unit: Food Safety & Hygiene Applicable national and European legislation related to Food Safety and Hygiene Ana Rita de Sá Henriques, DVM, PGCert, MSc, PhD [email protected] www.egasmoniz.com/pt...

Master Degree in Veterinary Medicine Curricular unit: Food Safety & Hygiene Applicable national and European legislation related to Food Safety and Hygiene Ana Rita de Sá Henriques, DVM, PGCert, MSc, PhD [email protected] www.egasmoniz.com/pt For teaching purposes only  Lesson syllabus Applicable national and European legislation related to Food Safety and Hygiene - Food scares, scandals and crisis in Europe - Principles of EU food safety legislation - Food business operators responsibilities - Competent authorities and involved institutions - Trends in the EU food law Ana Rita de Sá Henriques For teaching purposes only  Food scares, scandals and crisis in Europe European Union´s agri-food sector emerged deeply traumatised from the 1990s A series of crises resulted in a breakdown of consumer confidence in public authorities, industry and science For teaching purposes only  Rapeseed oil scandal Spain, 1981 Toxic oil syndrome (TOS) Rapeseed oil contaminated with aniline, to resemble olive oil 20,000 cases of a new illness (TOS) with chronic and lifelong sequelae Over 1,600 deaths Ana Rita de Sá Henriques For teaching purposes only  Bovine Spongiform Encephalopathy 1990-1997: BSE and Creuztfeldt-Jakob human variant WHO reported 224 cases of human variant Creutzfeldt- Jakob disease from October 1996 to March 2011, mainly in Great Britain Ana Rita de Sá Henriques For teaching purposes only Ana Rita de Sá Henriques For teaching purposes only  Dioxins crisis Belgium, 1996-1998 Detection of dioxins in poultry products and poultry feed, due to the contamination of animal feed with industrial oil residues, most likely due to the consecutive transport without proper disinfection of the same truck container Dioxins are persistent carcinogenic substances that can contaminate the downstream of the food chain continuum Consumption of eggs and chicken meat suffered a huge drop Other cases that followed: lard in Belgium in 2006, mozzarella cheese in Italy in 2008, pork in Ireland in 2008 Ana Rita de Sá Henriques For teaching purposes only Ana Rita de Sá Henriques For teaching purposes only  Embargo of the main importers of EU foodstuffs: USA, Russia, Asian markets - Following BSE crisis, importers embargoed European beef - Lack of traceability systems in Europe makes it impossible to trace products (such as processed beef) Ana Rita de Sá Henriques For teaching purposes only These events lead to a sense of urgency to take protective measures, pushing food safety to the top of the EU political agenda Ana Rita de Sá Henriques For teaching purposes only Green paper on the General Principles of Food Law published in 1997 to settle the future development of EU food lawFor teaching purposes only Ana Rita de Sá Henriques  Embargo from the main importers Protests by producers - “Dioxin scandal is another example of Europe's failure to protect its food supply and as an opportunity to tout the U.S.A. science-based system as the only rational alternative”. - “The level of opposition and distrust in parts of Europe comes in part from the lack of faith in the EU to assure the safety of their food. They have no independent regulatory agencies like the FDA, USDA or EPA." Dan Glickman, USA delegate, 1999 Ana Chairman of theRita de Sá World Henriques Food Conference, Rome For teaching purposes only  White Paper on Food Safety A new vision on EU Food Law (2000): - need for a Food Authority in the EU - a real farm to fork approach to food safety regulation in the EU EU political priority in 2000: Restore and maintain consumer confidence reaching the highest level of food safety For teaching purposes only White Paper on Food Safety Based on worldwide trade and legislation: - Codex Alimentarius - Sanitary and Phytosanitary measures (SPS) ageement of the World Trade Organization (WTO) The White paper included 84 action points to be further developed in the EU law For teaching purposes only  EU General Food Law Also known as the General Food Law, Reg. 178/2002 considers 3 main elements: 1. lays down the general principles of EU food law 2. creates the European Food Safety Authority (EFSA) 3. establishes a Rapid Alert System for the notification of direct or indirect risks to human health related to food or feed (RASFF), including procedures for dealing with food safety emergencies and crises For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council General principles of EU food law to be enforced by all EU Member States: 1. Protection of public health, including plant health, and animal health and welfare 2. Use of Risk Analysis and independent scientific advice for decision-making 3. Precautionary principle application 4. Traceabilty 5. Transparency in communication 6. Clearly defined responsibilities for all those involved in the food-chain continuum, including food business operators, authorities, and consumers 7. Strict controls and regular checks in the food-chain continuum 8. Training and education Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council 1. Food and feed business operators (FBO’s) responsabilities -Do not place on the market unsafe food/feed -Traceability (“one step forward, one step back” approach) -Regular controls in their production (HACCP) -Withdrawal/ recall of non-compliant products -Immediate alert of competent authorities of unsafe food/feed FBO’s have the primary responsibility for the safety of the food and feed placed on the market! Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council 2. Traceability The ability to track any: - food and feed - food-producing animal - substance through all stages of production, processing and distribution Reg. 178/2002 Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council 3. Decisions based on Risk Analysis RISK ANALYSIS Risk Risk Risk Assessment Management Communication Importance of: - independent and sound scientific advice in the decison-making process - clear and unambiguous communication by the appropriate parties – Authorities Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council 4. Precautionary principle - Precautionary principle application by decision-makers - Use of precautionary measures when scientific evidence about an environmental or human/ animal health hazard is uncertain: - withdrawal - recall Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No 178/2002 of the European Parliament and of the Council 5. Transparency, training and education Systematic analysis of the impact of legislative proposals through public consultation Public access to all food safety related studies “Better Training for Safer Food” - training programme for officials of national authorities involved in official controls in the EU Ana Rita de Sá Henriques For teaching purposes only EU General Food Law (2002) Reg. 178/2002 Ana Rita de Sá Henriques For teaching purposes only  EU legal acts Binding legislative acts directly applicable in all EU member-states Regulations Must be applied in its entirity across the EU Legislative act that sets a goal (guidelines) for all EU member-states to achieve Directive Each member-state needs to transform the guidelines into national laws with space for adaptation Only binding to those to whom it is addressed Decisions Directly applicable Recommendations Not binding, suggest a line of action without imposing obligation Ana Rita de Sá Henriques For teaching purposes only  “Hygiene pack” (2004) Reg. 853/2004 Reg. 852/2004 on hygiene rules for foods on the hygiene of from animal origin foodstuffs Reg. 178/2002 Reg. 854/2004 Directive 2004/41/EC on food hygiene and health on official controls of products of conditions for the animal origin intended for production and placing on human consumption the market of certain Directive 2002/99/EC products of animal origin on animal health rules governing intended for human the production, processing, consumption distribution and introduction of products of animal origin for human consumption Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No. 852/2004 of the European Parliament and of the Council Considers common principles for the hygienic production of all foods and sets general hygiene requirements applicable to all FBO’s: - “Farm to fork” approach (all stages of food production, transport and distribution) - Involvement of primary producers (records) - HACCP-based control (except primary production) - FBO’s approval by food/ health authorities (registration) - FBO’s responsabilities - Adoption of national codes of practice (GHP/ GMP) - Lays down important definitions: food hygiene; contamination; potable water; food wrapping and packaging; processed products.... Yet, it does not cover nutrition, composition Ana Rita de Sáand food quality issues For teaching purposes only Henriques  Regulation (EC) No. 852/2004 of the European Parliament and of the Council CHAPTER I General dispositions CHAPTER II Obligations of food business operators General obligations General and specific hygiene requirements Hazard analysis and control of critical points Official controls, registration and approval of establishments CHAPTER III Codes of Good Practice CHAPTER IV Imports and exports CHAPTER V Final provisions It also inlcudes 12 Annexes: GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS TRANSPORT WATER TRAINING...... Ana Rita de Sá Henriques For teaching purposes only  Regulation (EC) No. 853/2004 of the European Parliament and of the Council Hygiene rules for foods from animal origin: - Specific hygiene rules applicable to foods of animal origin (specific hazards, rules and controls to be applied in addition to those of Reg. 852/2004) - Traceability: FBO’s must apply an identification mark to foods of animal origin under their control Annex I – Definitions 1. Meat; 2. Live bivalve molluscs; 3. Fishery products; 4. Milk; 5. Eggs; 6. Frog legs and snails; 7. Processed prodcuts; 8. Other definitions Annex II – Requirements concerning several products of animal origin Annex III – Special requirements concerning several products of animal origin Meat of domestic ungulates; Meat from poultry and lagomorphs; Meat of farmed game; Wild game meat;.... Raw milk, colostrum, dairy products.... Eggs and egg products; Gelatine; Collagen..... Ana Rita de Sá Henriques For teaching purposes only  “Hygiene pack” evolution Reg. 852/2004, Reg. 853/2004, and Reg. 854/2004 have since been amended and supplemented Reg. 854/2004 was completely replaced by updated comprehensive official controls contained in Reg. 2017/625 Ana Rita de Sá Henriques For teaching purposes only EU Food law – official controls for authorities Reg. (EC) No 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products Ana Rita de Sá Henriques For teaching purposes only  EU Food law – other important regulations Reg. (EC) No 2073/2005 on microbiological criteria for foodstuffs - Food safety criteria (guidance on acceptability of foodstuffs and their manufacturing processes) & Process hygiene criteria (indicate correct functioning of production process) Reg. (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs - Nitrate, Mycotoxins, Metals, 3- monochloropropane-1,2-diol (3-MCPD), Dioxins and PCBs, Polycyclic aromatic hydrocarbons Reg. (EC) No 1169/2011 on the provision of food information to consumers: food labelling, substances or products causing allergies or intolerances Ana Rita de Sá Henriques For teaching purposes only Chronology of selected Regulations publication (van der Meulen, 2013) Ana Rita de Sá Henriques For teaching purposes only  May 2022 Hygiene of 2008: 2009 2021 Foodstuffs 1019/2008 219/2009 2021/382 Regulation Derogation – 852/2004 Oils and fats 2016: 2019: Regulation 2016/238 2019/978 579/2014 Microbiological 2013: Criteria 2007: 2010: 2011: 2014: 2017: 2019: 2020: 209/2013 Regulation 1441/2007 365/2010 1086/2011 217/2014 2017/1495 2019/229 2020/205 1019/2013 2073/2005 Acrylamide (Mitigation and benchmark levels) Regulation 2017/2158 Specific Rules – 2014: 2005: 2006: 2009: 2011: 2017: 2021: Food of Animal 1662/2006 2007: 2008: 2010: 2012: 2013: 218/2014 2016: 2019: 2020: 2074/2005 219/2009 150/2011 2017/1978 2021/1374 Origin 2076/2005 1791/2006 1243/2007 1020/2008 1161/2009 558/2010 1276/2011 16/2012 786/2013 633/2014 2016/355 2017/1981 2019/1243 2020/2192 2021/1756 Regulation 1137/2014 853/2004 Trichinella in Trichinella in Meat Regula- 2006: 2007: 2011: 2014: Meat 2020: 2021: tion 1665/2006 1245/2007 1109/2011 216/2014 Regulation 2020/1478 2021/519 2075/2005 1114/2014 2015/1375 2019: Implementing 2006: 2007: 2008: 2011: 2012: 2014: 2015: 2017: 2019/627 Measures Reg. 1664/2006 1244/2006 1022/2008 15/2011 1012/2012 218/2014 2015/2295 2017/1973 2019/628 2074/2005 1250/2008 809/2011 2017/1980 2019/1139 Control of 2014: Products of 2004: 2005: 2006: 2008: 2009 2010: 2011: 2013: 2015: 2017: 218/2014 Animal Origin 2074/2005 1663/2006 151/2011 882/2004 1021/2008 219/2009 505/2010 517/2013 219/2014 2015/2295 2017/1979 2076/2005 1791/2006 739/2011 Regulation 633/2014 854/2004 Repealed by Regulation 2017/625 Dec from 14 December 2019 2019 EU Food Hygiene – Developments since 2004 Regulations Repealed Repealed KEY : in force Amendments Regulations Amendments Source: Reading University, 2022 Ana Rita de Sá Henriques For teaching purposes only ABC of the food law: Authorities, Businesses (FBO’s) and Consumers Ana Rita de Sá Henriques ForVan teaching purposes der Meulen, 2013 only  EU food safety law and national law EU food law was (and still is) revolutionary and forced all Member States to change the way they manage food safety: - adopting new legal documents (Regulations and Directives) and adapting each Member State national laws - National food laws still exist, being specific and supplementary to the EU food law that is binding for Member States Ana Rita de Sá Henriques For teaching purposes only  EU food safety law and national law Applicable food safety law in small Catering industries and Restaurants in Portugal? Reg. 852/2004 Specific national Law i.e. Decreto-lei 10/2015 Ana Rita de Sá Henriques For teaching purposes only International organizations involved Ana Rita de Sá Henriques For teaching purposes only European organizations involved Ana Rita de Sá Henriques For teaching purposes only  Portuguese Authorities involved Official Laboratories Local Authorities (city halls) Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Fight against animal diseases and plant pests Animal welfare Sustainable food system with food waste and loss reduction Food fraud prevention Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Fight against animal diseases and plant pests - Implementation of programes tackling eradication, control and surveillance of animal diseases (African swine fever, bovine tuberculosis, rabies, and salmonellosis) - Survey and fight against plant pests (such as Xylella fastidiosa, one of the most dangerous plant pests in the world) Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Animal welfare: - Assess the welfare level of animals and its improvement through standards - EU Reference Centre for Animal Welfare: promoting an enhanced dialogue on animal welfare issues among competent authorities, businesses, civil society and scientists Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Sustainable EU food system - Integrating sustainability into all food-related policies, including: - “sustainability labelling” of food products - minimum criteria for sustainable public procurement of food - governance and monitoring Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Avoiding food wastage: strategies for a more efficient food chain in the EU European Parliament Resolution 2011/2175 - 50% of the edible food (≈ 89 million tons) are wasted in the EU - European Parliament proposes to reduce edible food waste by half until 2025 Ana Rita de Sá Henriques For teaching purposes only  EU food law trends Food fraud prevention: -improving the traceability control system -combating fraudulent food practices Ana Rita de Sá Henriques For teaching purposes only Thank you for your attention! [email protected] Ana Rita de Sá Henriques For teaching purposes only