Food Safety and Regulatory Compliance Services Fraud Investigation & Dispute Services
Introduction
• G ► lobally, governments have actively introduced regulatory standards and guidelines for the procurement, production and provision of safe and hygienic food. • I► n India, historically the onus for safe and wholesome food for human consumption was on multiple ministries and departments. • T ► he Food Safety and Standards (FSS) Act, which contains science-based standards, was enacted in 2006. The act consolidates previous acts and orders — which include the Prevention of Food Adulteration Act, 1954; Fruit Products Order, 1955; and Meat Food Products Order, 1973 — under one umbrella. • A ► statutory body, the Food Safety and Standards Authority of India (FSSAI), was established to enforce the provisions of the FSS Act. It regulates the manufacture, storage, distribution, sale and import of food and related products. • T ► he responsibility of implementing the FSS Act is on the Ministry of Health and Family Welfare.
Regulatory landscape : Food Safety and Standard Authority of India
Regulations
Enforces the provisions of the FSS Act
Advisories
Issues advisories on matters related to food and food supplements
Alerts
Mandates recalls
Issues notifications with alerts on general awareness, issues and concerns related to food safety
Issues notices to food business operators (FBOs) to recall products that are contaminated, unsafe for human consumption, sub-standard or misbranded
Applicability
What is covered? • Food • Beverages • Nutraceuticals • Food supplements • Foods for special dietary uses and special medical purpose • Ayurvedic products
Did you know? 2,570+ cases that violated the FSS Act identified in FY15–FY16 1 4,775+ violations detected of unsafe, substandard and misbranded products2 India ranked among the top three countries in terms of products rejected for import by the US Food and Drug Administration (US FDA) for mis-labelling and presence of allergens (as of quarter ending September 2016)3
Responsibilities of food business operators • Awareness training • F ► ood safety management system (FSMS) plan: A framework that empowers FBOs to exercise better control on all compliance aspects of the product life cycle and aid the business achieve self-compliance objectives, which are in accordance with the business plan
Who are covered?
• Voluntary compliance programs:
• Manufacturers►
• Schedule 4 compliance
• Processors►
• Audits
• Repackers
• Record-keeping
• Relabellers
• Product compliance
• Storage providers
• Recall or traceability plan
• Transporters
• Licensing or registration:
• Distributors
• Annual returns
• Importers and exporters
• Renewals
• Wholesalers and retailers
• Modifications
• Hotels, restaurants, canteens and catering services providers • E-retailers 1. http://www.fssai.gov.in/FoodSafetyinStates.aspx 2. https://www.accessdata.fda.gov/scripts/importrefusals
3. http://www.rediff.co m/business/report/why-so-many indian-food-product-exports-get-rejected/20160913.htm
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The food cycle
Key risks and compliance areas
From farm to fork • Raw material: local and foreign
• Pre-treatment
• Packaging and labelling
• Consumer: local and exports
• Transportation
• Sorting
• Storage
• Retail and e-tail
• Processing
• Advertisement • Research and development (R&D)
Product lifecycle Risk
Compliance
• Vendor and raw material non-compliance
• Vendor license and raw material standards
• Unsafe practices as well as unsafe foods: contaminants, microbes, pesticides, metals etc.
• Product and operational compliance, comprehensive FSMS and Schedule 4 audits
• Non-standard packaging, misbranding and labelling defects
• Packaging and labelling compliance
• Contamination, temperature abuse, product spoilage etc.
• Supply chain compliance
• Misleading advertisements
• Advertising compliance
• Misinformation to the consumer
• License and other regulatory compliance
• Novel or non-standardized products
• New product development assessment
EY Food Safety and Regulatory Compliance Services Reviewing and providing assistance with regulatory compliance in India FSSAI regulations
According to data released by the World Health Organization, India loses 27,316 healthy years per 1 lakh population per annum to illness and disability.4
• FSSAI licensing requirements • Documentation and filing for proprietary food licenses
Others
• Documentation for license
• Working with companies on global food safety compliances
• Submission of annual returns
• Assisting in aligning FSS regulatory compliance areas with international compliance requirements (Codex standards and legislations in the European Union [EU], the US, Australia, New Zealand, Bangladesh and Sri Lanka) through the EY Food Safety and Standards Lookup Plus tool
• Documentation for import clearance Food handling operations • Preparation of FSMS plans and recall and traceability plans • Preparation of standard operating procedures (SOPs)
• Assisting in obtaining voluntary certifications (Hazard Analysis Critical Control Point [HACCP], International Organization for Standardization [ISO] and Halal)
• Vendor compliance Product-related regulations • Product compliance and categorization • Alignment with proprietary food definitions • Appropriate additive categorization • Certificate of Analysis (COA) parameters • Labelling, packaging and legal metrology • Preparation of representations to FSSAI • Product approval documentation Conducting trainings, capacity building on FSSAI compliance Assisting in preparing representations or responses and collating documentation for responding to enforcement queries, as needed
4. http://www.financialexpress.com/archive/ indialosesmoreyearstoillnessthanchinabrazil/702424/
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EY technology-enabled enterprise food safety systems
Food Act Compliance tool
EY Food Safety and Standards Lookup tool The EY Food Safety and Standards Lookup tool is a digitized format of the FSS Act, regulations and periodic updates on regulatory-related information. This e-book empowers FBOs with an interactive searching facility to obtain all the information pertaining to a given FSS standard product along with the latest up-to-date advisories and notifications for proactive decision-making and course correction. The main features of the tool include: • F ► SS standard product database • C ► omprehensive list of additives • L ► aboratory and COA parameters • I► ntegrated search feature on product or related keywords
EY Food Safety and Standards Lookup Plus tool • The EY Food Safety and Standards Lookup Plus tool is a digitized format of four different standards: Codex, US FDA and legislations in Australia and New Zealand (AUSNZ) and the EU • It compiles the respective country-specific regulatory information with useful insights for international clients looking to bridge the compliance gaps of products
The Food Act Compliance tool is a digitized alternative for FBOs to perform periodic internal audits with customized compliance checklists and convert into an FSMS specific for FBO premises and operations using hand-held devices. It has a built-in audit module generated based on the daily compliance checklists to assist FBOs identify the conformances and non-conformances, and be prepared for regulatory inspections. The tool also has additional features with management dashboards using data updated periodically. • Compliance audit checklists • Regulator inspection-ready compliance scorecards • Decentralized data - gathering • Evidence database • SOPs and regulatory references • Dashboards
Other IT solutions • Data analytical services specific to the food industry • Supply chain validation software for fast-moving consumer goods (FMCG) products
• The interactive search facility provides timely results of all the relevant information with useful insights. This can help clients in import-export businesses bridge the compliance gaps of products that are imported or exported. • Codex standards • US FDA Code of Federal Regulations (CFR) for products • EU regulations • AUSNZ standards code • Integrated search feature on product or related keywords
How can you benefit? • Create a culture of compliance around food safety within the organization • Identify food safety risks in the company’s operations • Have a competitive edge with a food safety management plan that addresses compliance aspects along the product life cycle • Comply with international and national regulations around food safety • Educate employees with respect to food safety requirements and repercussions of non-compliance • Increase stakeholder confidence — customers, regulators and investors • Mitigate the probability of product approval rejections or recalls • Stay updated with changing food safety regulatory requirements With increased scrutiny by regulators and rapid consumer empowerment, food businesses are required to invest in food safety compliance systems to establish credibility and trust.
Why EY
Team experience
Process experience
• Reviewed more than 5,000 products to assess compliance with various regulatory and legal metrology requirements
• Establishing frameworks for food safety management • Preparing SOPs for various sectors
• Conducted facility reviews at manufacturing units, restaurants and quick service restaurant chains to assess compliance • Conducted investigations into food fraud and potential non-compliance with Indian and global food safety standards
• Assisting in the collation of keywords for e-commerce validation engines • Creating repositories of materials related to compliance • Conducting training and capacity-building • Working with companies for global food safety and regulatory compliance
• Provided trainings on food safety and regulatory compliance
People
Sector/product experience
• Food technologists for FSMS and regulatory compliance consultation services (FSSAI and CODEX)
• Dairy
• Savories and snacks
• Nutritionists
• Fruit and vegetables
• Prepared foods
• Confectionery
• Special ingredients
• Staples • Bakery
• Colors, flavors and other food additives
• Meat and meat products
• Fats and oils
• Sea food
• Desserts and ice-creams
• HACCP or ISO-certified auditors • Certified food-safety trainers • IT professionals • Management professionals
• Spices and condiments • Beverages
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EY Fraud Investigation & Dispute Services
Dealing with complex issues of fraud, regulatory compliance and business disputes can detract from efforts to succeed. Better management of fraud risk and compliance exposure is a critical business priority — no matter the industry sector. With more than 4,500 fraud investigation and dispute professionals around the world, we assemble the right multidisciplinary and culturally aligned team to work with you and your legal advisors. We work to give you the benefit of our broad sector experience, our deep subject-matter knowledge and the latest insights from our work worldwide. • Anti-fraud and fraud risk assessment
• Food Safety Compliance
• Fraud investigation
• Supply chain compliance
• Anti-Bribery and Anti-Corruption Compliance Services
• Forensic Technology and Discovery Services
• Dispute advisory services
• Computer forensics
• Competition and trade services
• Forensic Data Analytics
• Ethics and Integrity due diligence
• e-Discovery
• Third-party due diligence
• Managed Document Review
• Whistle-blowing services
• Software License Forensics • Cybercrime Investigation
Contact us Arpinder Singh
Partner and National Leader
+ 91 22 6192 0160
[email protected]
Sandeep Baldava
Partner
+ 91 40 6736 2121
[email protected]
Vivek Aggarwal
Partner
+ 91 12 4464 4551
[email protected]
Mukul Shrivastava
Partner
+ 91 22 6192 2777
[email protected]
Anurag Kashyap
Partner
+ 91 22 6192 0373
[email protected]
Anil Kona
Partner
+91 80 6727 3300
[email protected]
Rajiv Joshi
Partner
+91 22 6192 1569
[email protected]
Yogen Vaidya
Partner
+91 22 6192 2264
[email protected]
Dinesh Moudgil
Partner
+91 22 6192 0584
[email protected]
Jagdeep Singh
Partner
+91 80 6727 5300
[email protected]
Amit Rahane
Partner
+91 22 6192 3774
[email protected]
Vinay Garodiya
Executive Director
+91 22 6192 2164
[email protected]
Raghu Guda
Director
+91 40 6736 2204
[email protected]
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