On 28 June 2017, the 3D food printing conference took place at the Brightland Campus in Venlo, the Netherlands. These are the slides on my presentation on the legal angle of this topic.
This document summarizes key information about organic certification standards and requirements. It discusses consumer expectations for organic products including being free from pesticides and synthetic chemicals. It also summarizes the Codex Alimentarius definition of organic as products produced according to organic standards and certified by an authorized body. The document outlines the growth of the organic marketplace in countries like the US. It then discusses the purpose of certification in providing customer assurance and government requirements. It provides examples of major government certification schemes and private certifiers. It also summarizes the requirements for an organic system plan including practices and procedures, substance use, recordkeeping, and management to prevent commingling.
Food Safety: Effective Product Recall - using global standardsShantalla
Presentation given to the Korean Food Safety Information Centre on how global standards and a standards based cloud service can enable effective product recall between trading parties and government regulators. Effectively reducing the time to complete a recall notification to all parties from days to minutes and reducing the negative impact on unnecessary food loss.
Vitafoods Europe 2015: Clearer labels for consumersAxon Lawyers
The document summarizes the key aspects of the EU Food Information for Consumers Regulation, which aims to modernize and clarify food labeling requirements for consumers. It overviews the scope of the regulation, mandatory food information that must be included like ingredients and country of origin, new legibility requirements, and the upcoming mandatory nutrition declaration. It concludes that the regulation will increase administrative burden for industry but is intended to better support consumer choice and rebuilt trust following food scandals.
Organic certification verifies that farms and handling facilities comply with USDA organic regulations to sell, label, and represent products as organic. Becoming certified is rigorous, requiring a detailed application outlining operations, inspections to ensure compliance, and records tracing ingredients to final products. The document proposes using blockchain technology to create proofs of organic certification records and documents to increase transparency and trust for consumers.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
The document summarizes new EU regulations on food labelling and advertising. Key points include:
- The Food Information for Consumers Regulation brings together rules on general and nutrition labelling into a single regulation.
- Mandatory labelling information such as ingredients, allergens, nutrition information, and country of origin/provenance will be extended and standardized.
- Front of package nutrition labelling options and guidelines are being considered to increase consistency and consumer understanding.
- Claims on food packages must be clear, substantiated, and pre-approved under new rules on nutrition and health claims.
Global food traceability market (tracking technologies) to reach $14.1 billio...Lita Person
The Food traceability (tracking technologies) market is growing at a healthy rate with increasing awareness about food safety among governments and consumers. Governments across the globe are making regulations to track food as it is directly concerned with consumer health.
Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
This document summarizes key information about organic certification standards and requirements. It discusses consumer expectations for organic products including being free from pesticides and synthetic chemicals. It also summarizes the Codex Alimentarius definition of organic as products produced according to organic standards and certified by an authorized body. The document outlines the growth of the organic marketplace in countries like the US. It then discusses the purpose of certification in providing customer assurance and government requirements. It provides examples of major government certification schemes and private certifiers. It also summarizes the requirements for an organic system plan including practices and procedures, substance use, recordkeeping, and management to prevent commingling.
Food Safety: Effective Product Recall - using global standardsShantalla
Presentation given to the Korean Food Safety Information Centre on how global standards and a standards based cloud service can enable effective product recall between trading parties and government regulators. Effectively reducing the time to complete a recall notification to all parties from days to minutes and reducing the negative impact on unnecessary food loss.
Vitafoods Europe 2015: Clearer labels for consumersAxon Lawyers
The document summarizes the key aspects of the EU Food Information for Consumers Regulation, which aims to modernize and clarify food labeling requirements for consumers. It overviews the scope of the regulation, mandatory food information that must be included like ingredients and country of origin, new legibility requirements, and the upcoming mandatory nutrition declaration. It concludes that the regulation will increase administrative burden for industry but is intended to better support consumer choice and rebuilt trust following food scandals.
Organic certification verifies that farms and handling facilities comply with USDA organic regulations to sell, label, and represent products as organic. Becoming certified is rigorous, requiring a detailed application outlining operations, inspections to ensure compliance, and records tracing ingredients to final products. The document proposes using blockchain technology to create proofs of organic certification records and documents to increase transparency and trust for consumers.
Vitafoods B2C communication in the funtional food Axon Lawyers
1) The document discusses the legal framework for health, nutrition, and medical claims regarding functional foods and nutraceuticals in B2C communication in the EU.
2) It outlines the differences between nutrition claims, health claims, and medical claims and the conditions for using each type of claim. Nutrition claims relate to nutrient content while health claims relate the relationship between a food and health. Medical claims are not allowed for foods.
3) The document also discusses requirements for food information to consumers regarding ingredients, legibility, and nutrition declarations according to the Food Information to Consumers Regulation.
The document summarizes new EU regulations on food labelling and advertising. Key points include:
- The Food Information for Consumers Regulation brings together rules on general and nutrition labelling into a single regulation.
- Mandatory labelling information such as ingredients, allergens, nutrition information, and country of origin/provenance will be extended and standardized.
- Front of package nutrition labelling options and guidelines are being considered to increase consistency and consumer understanding.
- Claims on food packages must be clear, substantiated, and pre-approved under new rules on nutrition and health claims.
Global food traceability market (tracking technologies) to reach $14.1 billio...Lita Person
The Food traceability (tracking technologies) market is growing at a healthy rate with increasing awareness about food safety among governments and consumers. Governments across the globe are making regulations to track food as it is directly concerned with consumer health.
Vitafoods eu clinical trials regulationAxon Lawyers
The document discusses the key changes to the legal framework for clinical trials in the EU under the new Clinical Trials Regulation, including streamlined application procedures, a single submission process, increased transparency requirements, and clarification around what products are considered medicinal products versus food or dietary supplements.
The document discusses several food recalls due to potential health risks from pathogens like Salmonella and Listeria. It also summarizes lessons from a recall of hydrolyzed vegetable protein (HVP) due to Salmonella contamination, including the importance of having a recall plan, validating processes to eliminate pathogens, and ensuring facilities meet regulatory standards for sanitation and maintenance. Finally, it addresses the increased demands on the food industry for food safety, traceability, and compliance in the current regulatory environment.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
This document discusses EU and national legislation related to eco-farming and organic products. It begins by outlining key EU regulations on organic production, labeling, animal health and welfare, and environmental protection. It then provides details on national legislation in Bulgaria, Greece, Slovenia, and Turkey, including major organic agricultural products in each country. The document emphasizes that legislation plays an important role in ensuring fair competition and consumer confidence in organic markets across Europe.
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and European citizens' negative perceptions of the technique.
A Closer Look At Brazil’s New Serialization RegulationShari Popovich
Brazil has gone through several attempts at defining its pharmaceutical serialization and traceability regulation. The newest version of the law requires ANVISA to develop new regulations, which should result in a more attainable architecture.
In this webinar, Dirk Rodgers, Regulatory Strategist at Systech International, will review the features of the new law and the recent draft of regulations from ANVISA. He will also give his quarterly overview of regulatory developments around the rest of the world.
The document summarizes the current status and future changes to novel food regulations in the EU. It discusses the four categories of novel foods, the authorization procedures, examples of novel foods that have received authorization, and how specific novel foods like algae, insects and duckweed are currently treated. It notes that the new regulations will centralize the authorization process and create a simplified procedure for traditional foods, while introducing provisions around nanomaterials and cloned animals.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
This guidance document provides information to food businesses on making appropriate "free-from" allergen claims for food products. It covers considerations for both prepacked and non-prepacked foods. A "free-from" claim should only be made if a rigorous risk assessment of ingredients, manufacturing processes, and environment has been conducted to substantiate the absence of the specified allergen. It also requires effective communication of the claim to consumers through labeling or other practices for non-prepacked foods. The guidance aims to ensure consistent application of "free-from" claims across the food industry to make labeling clear for those with allergies or intolerances.
The EU Regulation on food information to consumers consolidates and updates existing legislation on food labelling and nutrition labelling. Key provisions include mandatory nutrition declarations and clearer allergen labelling. It aims to harmonize rules and ensure consumers receive essential information to make informed choices while facilitating the EU internal market. National measures allow member states to require non-prepacked food businesses to provide allergen information.
The document outlines guidelines for food recalls in Hong Kong, including the roles and responsibilities of government and industry. Legislation empowers the government to order recalls to protect public health. When a recall is initiated, companies must immediately notify the government and provide details. Recalls aim to remove potentially hazardous foods from sale and consumption. Companies are responsible for recovery and proper disposal of recalled products, while keeping records and reporting to assess the recall's effectiveness. Cooperation between government and industry is key to quickly removing dangerous products from the market.
Dr. Lisa Becton - Pork Industry Antibiotics UpdateJohn Blue
Pork Industry Antibiotics Update - Dr. Lisa Becton, National Pork Board, from the 2016 Iowa Pork Congress, January 27-28, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2016-iowa-pork-congress
The document discusses Vietnam's current food safety management system and laws/regulations. It notes that while Vietnam has established a basic legislative framework around food safety, including ordinances on food hygiene, animal health, and plant health, food standards are still lacking and food inspection capabilities are weak. Specifically, there are only around 150 food inspectors for over 446,000 food enterprises. It concludes that Vietnam needs to develop a more comprehensive food law, expand food standards, and strengthen the food safety inspection system by improving human resources, skills, and facilities.
Presented at Michigan State University's WorldTAP International Short Course in Food Safety on July 31, 2009. (http://foodsafetyknowledgenetwork.org/worldtap/foodsafety09)
How can CBD still be applied in food products after the most recent change in the Novel Food Catalogue, according to which CDB foods are, in principle, Novel Foods?
One of the results of the recently approved EU Falsified Medicines Directive imposes the application of a Unique Product Identifier and a Tamper Evidence Feature. This is only the top of the iceberg. It is not just printing a code and adding a label on a box, it means Authentication Data Flow, design the proper IT architecture, learn a new way of handling the products with a precise deadline: February 2019.
From this date all prescription products (with some exceptions)
must be serialized and data must be loaded into the EU hub.
Sharp can support you, thanks to 8 years of experience, 2 billions of sales units serialized to date, 4 plants already serializing for USA (US Drug Quality Security Act enforced from 27th November 2017), China, Brazil, South Corea.
Novel foods and animal cloning era 5 may 2014Axon Lawyers
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and citizens' negative perceptions of the technique.
The document discusses several food recalls due to potential health risks from pathogens like Salmonella and Listeria. It also summarizes lessons from a recall of hydrolyzed vegetable protein (HVP) due to Salmonella contamination, including the importance of having a recall plan, validating processes to eliminate pathogens, and ensuring facilities meet regulatory standards for sanitation and maintenance. Finally, it addresses the increased demands on the food industry for food safety, traceability, and compliance in the current regulatory environment.
Vitafoods marketing functional food to childrenAxon Lawyers
The document discusses marketing functional foods to children in the EU. It outlines WHO recommendations to reduce marketing of unhealthy foods to children. In the EU, health claims must meet strict criteria and not mislead consumers. National self-regulatory bodies in countries like the Netherlands set rules for food advertising to children, generally prohibiting advertising of foods high in fat, sugar, or salt for children under 12. Effectiveness of self-regulation is debated as some find additional restrictions are still needed.
This document discusses EU and national legislation related to eco-farming and organic products. It begins by outlining key EU regulations on organic production, labeling, animal health and welfare, and environmental protection. It then provides details on national legislation in Bulgaria, Greece, Slovenia, and Turkey, including major organic agricultural products in each country. The document emphasizes that legislation plays an important role in ensuring fair competition and consumer confidence in organic markets across Europe.
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and European citizens' negative perceptions of the technique.
A Closer Look At Brazil’s New Serialization RegulationShari Popovich
Brazil has gone through several attempts at defining its pharmaceutical serialization and traceability regulation. The newest version of the law requires ANVISA to develop new regulations, which should result in a more attainable architecture.
In this webinar, Dirk Rodgers, Regulatory Strategist at Systech International, will review the features of the new law and the recent draft of regulations from ANVISA. He will also give his quarterly overview of regulatory developments around the rest of the world.
The document summarizes the current status and future changes to novel food regulations in the EU. It discusses the four categories of novel foods, the authorization procedures, examples of novel foods that have received authorization, and how specific novel foods like algae, insects and duckweed are currently treated. It notes that the new regulations will centralize the authorization process and create a simplified procedure for traditional foods, while introducing provisions around nanomaterials and cloned animals.
The long awaited new novel food regulation has finally made its very welcome arrival to update and streamline the approach to gaining approval for new food and food ingredients in the EU. It’s main benefits are to clarify the scope and definitions, to introduce a centralised procedure and to introduce a notification process for “traditional foods from third countries”. Whilst it also introduces a generic “Union List”, it also allows proprietary submissions in some cases. Although the actual legal enactment is not until January 2018, there is so much to do in the meantime. January 2016 webinar now available on demand: http://www.intertek.com/knowledge-education/new-novel-food-regulation-transition-begins/
This guidance document provides information to food businesses on making appropriate "free-from" allergen claims for food products. It covers considerations for both prepacked and non-prepacked foods. A "free-from" claim should only be made if a rigorous risk assessment of ingredients, manufacturing processes, and environment has been conducted to substantiate the absence of the specified allergen. It also requires effective communication of the claim to consumers through labeling or other practices for non-prepacked foods. The guidance aims to ensure consistent application of "free-from" claims across the food industry to make labeling clear for those with allergies or intolerances.
The EU Regulation on food information to consumers consolidates and updates existing legislation on food labelling and nutrition labelling. Key provisions include mandatory nutrition declarations and clearer allergen labelling. It aims to harmonize rules and ensure consumers receive essential information to make informed choices while facilitating the EU internal market. National measures allow member states to require non-prepacked food businesses to provide allergen information.
The document outlines guidelines for food recalls in Hong Kong, including the roles and responsibilities of government and industry. Legislation empowers the government to order recalls to protect public health. When a recall is initiated, companies must immediately notify the government and provide details. Recalls aim to remove potentially hazardous foods from sale and consumption. Companies are responsible for recovery and proper disposal of recalled products, while keeping records and reporting to assess the recall's effectiveness. Cooperation between government and industry is key to quickly removing dangerous products from the market.
Dr. Lisa Becton - Pork Industry Antibiotics UpdateJohn Blue
Pork Industry Antibiotics Update - Dr. Lisa Becton, National Pork Board, from the 2016 Iowa Pork Congress, January 27-28, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2016-iowa-pork-congress
The document discusses Vietnam's current food safety management system and laws/regulations. It notes that while Vietnam has established a basic legislative framework around food safety, including ordinances on food hygiene, animal health, and plant health, food standards are still lacking and food inspection capabilities are weak. Specifically, there are only around 150 food inspectors for over 446,000 food enterprises. It concludes that Vietnam needs to develop a more comprehensive food law, expand food standards, and strengthen the food safety inspection system by improving human resources, skills, and facilities.
Presented at Michigan State University's WorldTAP International Short Course in Food Safety on July 31, 2009. (http://foodsafetyknowledgenetwork.org/worldtap/foodsafety09)
How can CBD still be applied in food products after the most recent change in the Novel Food Catalogue, according to which CDB foods are, in principle, Novel Foods?
One of the results of the recently approved EU Falsified Medicines Directive imposes the application of a Unique Product Identifier and a Tamper Evidence Feature. This is only the top of the iceberg. It is not just printing a code and adding a label on a box, it means Authentication Data Flow, design the proper IT architecture, learn a new way of handling the products with a precise deadline: February 2019.
From this date all prescription products (with some exceptions)
must be serialized and data must be loaded into the EU hub.
Sharp can support you, thanks to 8 years of experience, 2 billions of sales units serialized to date, 4 plants already serializing for USA (US Drug Quality Security Act enforced from 27th November 2017), China, Brazil, South Corea.
Novel foods and animal cloning era 5 may 2014Axon Lawyers
The document discusses the European Commission's proposals on regulating novel foods and food from cloned animals. It provides an overview of the current Novel Foods Regulation and proposes amendments, including establishing three new categories of novel foods and centralizing the authorization process. For food from cloned animals, the proposals result in a temporary ban on imports and sales due to concerns about animal welfare, low cloning efficiency, and citizens' negative perceptions of the technique.
The document provides information on recent updates to the EU Falsified Medicines Directive and its requirements for safety features on medication packaging to help prevent falsified medicines. It discusses the growing problem of falsified medicines in Europe, the goals of the Falsified Medicines Directive to strengthen regulation of the pharmaceutical supply chain, and the delegated regulation outlining technical specifications for unique identifiers and anti-tampering devices that must be implemented by February 2019. It also addresses the roles and responsibilities of various stakeholders including marketing authorization holders, manufacturers, wholesalers, pharmacies and regulatory authorities in complying with the new regulations.
-Bio-Medical Waste
-Contents:
-Evolution of Bio-Medical Waste in India
-Biomedical Waste
-Need of Rules for Bio-Medical Waste
-Present Scenario in India
-Disease Caused by Improper Disposal of Waste
-BMW(H&M) 1998
-Major Differences between BMW 1998 and BMW 2016
-BMW (H&M) 2016
-Conclusion
Evolution of Bio-Medical Waste Management Rules in India:
-First Bio-Medical Rules were notified by the Govt. of India, erstwhile
MOEF on 20th July 1998.
-Modification in the next following years (2000, 2003 and 2011)
-BMW rules 2011 remained as the draft
-MOEFCC in March 2016 has amended the BMWM rules.
-BMW Management 2016 was released on 27 March 2016
Bio-Medical Waste:
means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals
or research activities pertaining thereto
or in the production or testing of biological or in health camps, including the categories mentioned in Schedule I appended to these rules;
TGA presentation: Advertising therapeutic goods to consumers - Complying with...TGA Australia
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods, including an exploration of key concepts, such as why advertising is regulated, the definition of ‘advertise’, food-medicine and cosmetic-medicine interface issues, prohibited representations and restricted representations.
IMPACT OF REGULATIONS ON MEDICAL DEVICES IN CONTEXT OF INNOVATIONSJAYA PRAKASH VELUCHURI
The document discusses the impact of regulations on innovation in the medical devices sector. It provides background on regulations in the United States and European Union, which classify devices based on risk and require clinical trials and quality standards. Regulations influence the entire innovation cycle from design to post-market surveillance. While regulations aim to ensure safety, they can also introduce barriers and uncertainty that slow innovation. Emerging technologies like nanomaterials and 3D bioprinting further complicate classification and evaluation. The document argues for collaboration between developers and regulators to streamline processes while encouraging innovation and access to new treatments.
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This document provides an overview of regulations for nutraceuticals and functional foods in India. It discusses key terms like nutraceuticals and functional foods. It outlines the history and timeline of food regulations in India, describing various national laws established. It explains the Food Safety and Standard Act of 2006, which aims to establish a single reference point for all food safety matters. The document also discusses licensing and registration requirements for nutraceuticals under FSSAI, labeling requirements, and the regulatory requirements for entering the Indian nutraceutical market.
TGA presentation: Update on recent activitiesTGA Australia
This document provides an update on recent activities and ongoing reforms from the Scientific Evaluation Branch of the Therapeutic Goods Administration of Australia. It discusses implemented reforms such as streamlined variations for prescription medicines, utilizing evaluation reports from comparable overseas regulators, and biological and biosimilar medicines naming. Upcoming reforms addressed include improved labeling of neuromuscular blocking agents and regulation of fecal microbiota transplantation material. Approval times for different categories of medicines over the past years are also presented.
This document summarizes a project called The Food Safety Market (TheFSM) which aims to create a transparent, data-powered certification ecosystem for a safe food supply chain by digitalizing agriculture. TheFSM is a 36-month, €4.8 million project involving 11 partners from 9 EU countries and 2 non-EU countries testing a digital platform and tools through 10 pilots across 10 countries. The platform will allow producers, inspectors, and buyers to securely exchange certification data while respecting data ownership. This will help address issues in the food industry like food waste, safety, recalls, and sustainability.
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1. The document discusses the legal frameworks governing functional foods and medical foods in the EU and Netherlands. It outlines key definitions and requirements for these categories of foods.
2. For medical foods, regulations establish composition standards and require they are only used under medical supervision. Claims on medical foods are limited mainly to general nutrition functions. Food information regulations also apply.
3. Functional foods have no single regulatory definition and are subject to various laws depending on their attributes. Nutrition and health claims may be used if scientific evidence and conditions of use are met. The food information regulation introduces new labeling requirements.
Presentation: Recall of Therapeutic GoodsTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
This document outlines the requirements for commercializing and ensuring quality in biomedical wearable and implantable devices. It discusses the markets and applications for these devices, including diagnosing and treating patients. Regulatory requirements for devices approved by the FDA and EU are also covered, including classification, quality system regulations, and labeling. The document addresses new product development processes, intellectual property, reimbursement, and preclinical testing requirements.
Food Safety Standards and Certifications.pptxmulkiabdiadan
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Food Safety Standards and Certifications.pptxmulkiabdiadan
This document discusses various food safety standards and certifications. It begins by introducing the importance of following food safety standards in the food industry to protect workers and customers. It then discusses some key global food safety standards and certifications, including the Food Safety Modernization Act (FSMA) in the USA, European Food Safety Authority (EFSA) standards in the EU, Food Standards Agency standards in the UK, Australian food safety standards, and WHO food safety standards. The document also provides details on several prominent private food safety certifications, such as Global Food Safety Initiative (GFSI), Safe Quality Food (SQF), British Retail Consortium (BRC), International Food Safety (IFS), ISO 22000, HACCP,
The document provides summaries of regulatory updates from 2015, including:
- New and revised FDA, Eudralex, WHO, and Indian Gazette guidelines.
- ICH announced organizational changes to become more globally inclusive.
- FDA released a new method validation guideline for biologics and updated requirements for quality metrics reporting.
- Eudralex provided new guidance on excipient GMP and prevention of cross-contamination in facilities and production.
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This document summarizes occupational health and safety issues and developments in India. It outlines the large workforce in India that faces serious health and safety hazards from exposure to toxic chemicals during manufacturing. While laws have been passed to address these issues, there remains a lack of trained environmental health and safety professionals and infrastructure. Efforts are being made through collaboration between Indian universities and organizations like the University of Cincinnati to establish occupational health education programs and strengthen safety regulations and enforcement. However, challenges remain in fully implementing prevention and control measures, especially in small industries.
Regulatory procedures for obtaining marketing authorization of medicines in the European Union are described. There are several types of authorization procedures including the centralised procedure, mutual recognition procedure, and decentralized procedure. Conditional approval may be granted if the risk-benefit balance is positive, comprehensive data will likely be provided, and unmet medical needs will be fulfilled. Accelerated assessment can be requested for products that are major therapeutic innovations or of major public health interest. Compassionate use programs make products available for named patients or cohorts when a product has not yet received full authorization.
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The presentation deals with the concept of Right to Default Bail laid down under Section 167 of the Code of Criminal Procedure 1973 and Section 187 of Bharatiya Nagarik Suraksha Sanhita 2023.
1. LEGAL FRAMEWORK
3-D FOOD PRINTING
3 D Food Printing Conference
Venlo, NL, 28 June 2017
Karin Verzijden
www.axonlawyers.com
2. Agenda
• Current and potential applications of 3 D food printing
• Legal positions & liabilities various parties involved
• Legal qualification of printed food & implications
• Legal requirements for marketing printed food
2
3. Applications 3 D printed food
Current applications
• mainly “fun products”
Future applications
• are expected to include mass production consumer products and house
appliances (cf. home breweries)
• are likely to extend to care setting (cf. medtech) for preventing
malnutrition, addressing swallowing issues and enabling personalized
approach
6. Liabilities parties involved (1)
Manufacturer food printer
• Food printer must comply with EU Machinery Directive 2006/42 and
national implementing legislation.
• “Machinery”: assembly fitted with a drive system, consisting of linked
components, at least one of which moves, joined together for specific
application.
• Machinery should conform to essential health and safety requirements
re. design and construction.
• Before placing on the market, manufacturer should assess conformity to
safety standards > CE mark
• Enforcement by national MS authorities
7. Liabilities parties involved (2)
Raw materials supplier
• Raw materials = ingredients = food stuffs >
General Food Law Regulation 2002/178 and its national
implementations (NL: Commodities Act / Warenwet)
• Food: every substance intended to be ingested by humans
• Basic requirement: food safety!
• Food safety is responsibility of so-called Food Business Operator
(FBO): any person or entity active in the production / processing /
distribution of foodstuffs
• Traceability requirement: identification of FBO one level up, one
level down.
• ISO 22000: self-regulatory standards applied by food industry
8. Liabilities parties involved (3)
Consumer
• Consumer takes role of producer > ”prosumer”
• Home appliances: in case of safety or quality issues, consumer has
claim against printer manufacturer and supplier of raw materials >
what is his own share of responsibility?
• Care setting: hospital / elderly home takes on responsibilities of food
manufacturer > What share of responsibilities when when patients
experience problems with 3 D printed food?
• In both settings, clear contractual arrangements are required for all
conceivable safety and quality issues.
9. Status of printed food (1)
Potential Novel Food
• 3 D printed food may qualify as a Novel Food under the Novel Foods
Regulation 2283/2015.
• Novel Foods are foods that prior to 1997 did not form part of the regular
diet within the EU.
• Current NF Regulation contains 10 product categories, including the
new production process:
• Little is yet know about the effects of the 3D production process on the
food > any safety issues?
10. Status of printed food (2)
Implications of NF status
• If and when 3D printed food qualifies as Novel Food > prior marketing
authorization will be required.
• FBO involved needs to prepare application dossier for Commission >
competent authorities MS.
• EFSA will be asked for safety opinion if a MS has reasonable safety
concerns.
• Advantage of new NF Regulation: general authorizations.
Consumer setting: authorization requirement not likely to apply.
Care setting: hospitals are recommended to take NF requirements
seriously.
11. Marketing requirements (1)
3D printed food could be used for personalized nutrition:
• Fortified foods: Regulation 1925/2006
• Food supplements: Directive 2002/42 and national implementing
legislation (MS have some liberty to set national rules)
e.g. level of Vit. D should not exceed 4.5 microgram per 100 Kcal foodstuff
• Medical foods: Regulations 609/2013 and 2016/128
• Infant formula: Regulations 609/2013 and 2016/127
These are highly regulated foods for vulnerable groups > should meet strict
compositional criteria
12. Marketing requirements (2)
Labelling requirements & claims
• Raw materials to be used as ingredients for 3D printing should contain
clear instructions for use > Food Information Regulation 1169/2011.
• If any nutrition or health claims are made re. those ingredients > relate
to the foodstuff as prepared > Health Claim Regulation 1924/2006.
e.g. high in fibers > requires 6 g fibers / 100 g food product
e.g. high protein > requires that 20 % of the energy of the food is provided
by protein
• No health claims may be made re. medical foods > Regulation
2016/128.
13. Conclusions
• 3D printed food is obtained by using a technology relatively new in the
food supply.
• Such new technology presents new challenges for defining the
responsibilities of the stakeholders involved and its end user.
• 3D printed may qualify as Novel Food > prior market authorisation
required for professional trade in such products.
14. Axon Lawyers
14
• Amsterdam based law firm with international focus
• Fully dedicated to life sciences, focus on food business
• Assisting high tech companies marketing innovative food products
• Founder of European Alliance of Life Sciences Law Firms
• Reporting current food law developments at blog FoodHealthLegal
Editor's Notes
Annex I, par. 2.1 contains specific health and safety requirements for foodstuff machinery:
smooth surface of parts in contact with foodstuffs
those parts should be easily cleaned and desinfected
Substances and living creatures should be prevented from entering
Substances hazardous for health (lubricants) should be prevented from entering into contact with foodstuffs
NB processing aids = non-food, but also subject to safety requirements.
Examples of NF: high pressurized yoghurt (…)
Check Health Claim Regulation mbt
Artikel Vo 2016/128 verbiedt gebruik claims voor medische voeding.