Food Safety and Regulatory Compliance Services. Fraud Investigation & Dispute Services

Transcription

1 Food Safety and Regulatory Compliance Services Fraud Investigation & Dispute Services

2 Introduction Globally, governments have actively introduced regulatory standards and guidelines for the procurement, production and provision of safe and hygienic food. In India, historically the onus for safe and wholesome food for human consumption was on multiple ministries and departments. The Food Safety and Standards (FSS) Act, which contains science-based standards, was enacted in 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. The 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 Issues notifications with alerts on general awareness, issues and concerns related to food safety Mandates recalls Issues notices to food business operators (FBOs) to recall products that are contaminated, unsafe for human consumption, sub-standard or misbranded

3 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 products 2 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 Who are covered? Manufacturers Processors Repackers Relabellers Storage providers Transporters Distributors Importers and exporters Wholesalers and retailers Hotels, restaurants, canteens and catering services providers E-retailers Awareness training Food 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 Voluntary compliance programs: Schedule 4 compliance Audits Record-keeping Product compliance Recall or traceability plan Licensing or registration: Annual returns Renewals Modifications m/business/report/why-so-manyindian-food-product-exports-get-rejected/ htm Responsible business award 3

4 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 Contamination, temperature abuse, product spoilage etc. Packaging and labelling compliance 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

5 EY Food Safety and Regulatory Compliance Services Reviewing and providing assistance with regulatory compliance in India FSSAI regulations FSSAI licensing requirements Documentation and filing for proprietary food licenses Documentation for license Submission of annual returns Documentation for import clearance Food handling operations Preparation of FSMS plans and recall and traceability plans Preparation of standard operating procedures (SOPs) Vendor compliance 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 Others Working with companies on global food safety compliances 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 Assisting in obtaining voluntary certifications (Hazard Analysis Critical Control Point [HACCP], International Organization for Standardization [ISO] and Halal) 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. indialosesmoreyearstoillnessthanchinabrazil/702424/ Responsible business award 5

6 EY technology-enabled enterprise food safety systems 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: FSS standard product database Comprehensive list of additives Laboratory and COA parameters Integrated 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 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 Food Act Compliance tool 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 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.

7 Why EY Team experience Reviewed more than 5,000 products to assess compliance with various regulatory and legal metrology requirements 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 Provided trainings on food safety and regulatory compliance Process experience Establishing frameworks for food safety management Preparing SOPs for various sectors 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 People Food technologists for FSMS and regulatory compliance consultation services (FSSAI and CODEX) Nutritionists HACCP or ISO-certified auditors Certified food-safety trainers IT professionals Management professionals Sector/product experience Dairy Fruit and vegetables Confectionery Staples Bakery Meat and meat products Sea food Spices and condiments Beverages Savories and snacks Prepared foods Special ingredients Colors, flavors and other food additives Fats and oils Desserts and ice-creams Responsible business award 7

8 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 Fraud investigation Anti-Bribery and Anti-Corruption Compliance Services Dispute advisory services Competition and trade services Ethics and Integrity due diligence Third-party due diligence Whistle-blowing services Food Safety Compliance Supply chain compliance Forensic Technology and Discovery Services Computer forensics Forensic Data Analytics e-discovery Managed Document Review Software License Forensics Cybercrime Investigation Contact us Arpinder Singh Partner and National Leader arpinder.singh@in.ey.com Sandeep Baldava Partner sandeep.baldava@in.ey.com Vivek Aggarwal Partner vivek.aggarwal@in.ey.com Mukul Shrivastava Partner mukul.shrivastava@in.ey.com Anurag Kashyap Partner anurag.kashyap@in.ey.com Anil Kona Partner anil.kona@in.ey.com Rajiv Joshi Partner rajiv.joshi@in.ey.com Yogen Vaidya Partner yogen.vaidya@in.ey.com Dinesh Moudgil Partner dinesh.moudgil@in.ey.com Jagdeep Singh Partner jagdeep.singh@in.ey.com Amit Rahane Partner amit.rahane@in.ey.com Vinay Garodiya Executive Director vinay.garodiya@in.ey.com Raghu Guda Director raghu.guda@in.ey.com Ernst & Young LLP EY Assurance Tax Transactions Advisory 2016 Ernst & Young LLP. Published in India. All Rights Reserved.. EYIN ED None