Food Supplement Innovation

Size: px
Start display at page:

Download "Food Supplement Innovation"

Transcription

1 Swadlincote Site Food Supplement Innovation Nick Bennett RNutr. Food Matters Live, November /11/2014 Slide 1

2 Introduction Brunel Healthcare is the largest contract manufacturer of food supplements in the UK Supplying the majority of own label products to the mass market. We will briefly look at our steps to innovation. 2

3 Turning an idea into a finished product What is innovation? Building the supply chain Manufacture materials and formats Compliance opportunities and limitations Examples of innovative materials 3

4 Two sub categories: What is innovation? NPD - Working within the confines of existing regulations Incremental development Maximising benefits of existing claims Innovation developing new solutions to change the status quo. Research into new materials to win new claims Effectively promoting scientifically researched materials to communicate their benefits without claims. 4

5 Hurdles to launching new supplements Idea New function New material Dosage Manufacture Communication 5

6 How do we innovate? NPD Gap analysis Market review of successful products Maximising benefits of existing claims Innovation Search the globe Collaborate with raw material manufacturers to encourage new claims Identify scientifically researched materials to provide improved product benefits. By building the innovation supply chain 6

7 THE SUPPLY CHAIN 7

8 The supply chain Step 1 Generate idea and check its practicality Collaborate The idea 8

9 New function prove it! Novel food prove it is safe! The supply chain Step 2 Funding? Innovate UK (TSB)? Own the research or collaborate Investigate and research 9

10 The supply chain Step 3 Build the interest Secure the supply chain Test and present 10

11 The supply chain Step 4 Demonstrating a finished product always engages marketing more than just a concept. Small scale manufacture 11

12 The supply chain Step 5 Trials to prove safety, efficacy and possibly get a claim Larger scale trials with the backing of the supply chain 12

13 The supply chain Step 6 Get all the pieces of the supply chain in place Scale up manufacture 13

14 The supply chain Step 7 Packing, Warehousing and Distribution 14

15 The supply chain Step 8 Retail listings and sales through PR and promotion Engage with the consumer 15

16 Brunel Healthcare MANUFACTURING IN MORE DETAIL 16

17 Tablet Manufacturing DISPENSING GRANULATION BLENDING COMPRESSION COATING 3 Dispensing bays. 5 Granulation suites. 3 Fluid bed dryers. 2 Oven bed dryers. Drum Blending. Cone Blending. IBC Blending. 18 tablet compression machines. Variety of shapes and sizes available. 7 coating machines, including 3 dual sugar/film coaters. Purpose built 3,000m2 tablet facility fully operational since Installed tablet capacity for 3.5 billion tablets per annum. Expansion space available for a total capacity in excess of 6.5 billion tablets.

18 DISPENSING Capsule Manufacturing FILLING CHECKING BLENDING DRYING

19 Brunel Healthcare Packing Site Swadlincote Site Goods-in Goods-out

20 Brunel New Product Presentation COMPLIANCE 20

21 Manufacturing standards Food - HACCP, Safety, Allergen control, BRC Pharma MHRA, FDA, GMP, Positive release of all products Best of both - Stability, efficacy and safety. Compliant to highest standards.

22 Regulations Actives and Additives Novel? Claimable? Dose? Sustainable? Stable? Approved additive? E number compliant? Allergenic? Sustainable? 22

23 Trade Organisation Memberships European Federation of Associations of Health Product Manufacturers

24 INNOVATIONS NEW MATERIALS 24

25 Health Claims get over this barrier to advertise the products benefit. Beta glucan a natural extract from yeast which optimises the immune system. Intended claim Anti-pathogenic effect. Fruitflow a water soluble Tomato Concentrate, helps maintain normal platelet aggregation, which contributes to healthy blood flow 25

26 Conclusion. Truly innovative foods are rare. But, it can be done, it just requires upfront planning. Plan and work out the details, Build a supply chain! Comply with the regulations Overcome the hurdles and succeed! 26

27 Brunel New Product Presentation ANNEX 27

28 Legislation It is expected by the consumer and fundamental to good practice that all raw materials and products must: 1. Comply with all current European legislation applicable to food supplements. * 2. Not have been treated with irradiation of any kind nor come into contact with irradiated materials. 3. Not include ingredients that are genetically modified (GM) nor derived from GM organisms. 4. Comply with relevant purity standards where ingredients have an E number under EU food additive regulations. * this includes, but is not limited to the following regulations: 21/11/2014 Brunel Healthcare Presentation Department Author Slide 28

29 Regulations and Best practice Good Manufacturing Practices - EEC Guide Volume IV Good Warehousing Practices - PQG Monograph Good Laboratory Practices - EEC Guide Volume IV Food Safety Act 1990 Weights and Measures Act 1985 EC Regulation 258/97 on Novel Foods EC Regulation 1169/2011 on the provision of food information to consumers EC Regulation 1924/2006 on Nutrition and Health Claims EC Directive 89/396/EC Indications or Marks Identifying the Lot to which a Foodstuff Belongs EC Regulation 178/2002/EC General Principles and Requirements of Food Law EC Directive 2002/46 EC Approximation of the Laws of the Member States relating to Food Supplements EC Regulation 1924/2006/EC Nutrition & Health Claims made on Foods EC Regulation 1129/2011 and 1130/2011 for food additives and associated purity criteria 231/2012 EC Regulation 1881/2006/EC Setting Maximum Levels for Certain Contaminants in Foodstuffs (including limits on Heavy Metals in Food Supplements) EC Regulation 396/2005/EC Maximum Residue Levels of Pesticides in or on Food or Feed of Plant and Animal Origin EC Regulation 999/2001/EC Prevention, Control and Eradication of Certain Transmissible Spongiform Encephalopathies EC Regulation 1829/2003 and 1830/2003/EC Genetically Modified Feed and Food EC Directive 1999/2/EC Foods and Food Ingredients Treated with Ionising Radiation EC Regulation 1935/2004/EC Materials and Articles Intended to come into Contact with Food IADSA / EHPM / FSE / CRN Quality Guide 21/11/2014 Brunel Healthcare Presentation Department Author Slide 29

Food supplement manufacture

Food supplement manufacture Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1 Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine

More information

Declaration for Enzymes for use in Oenological Practices

Declaration for Enzymes for use in Oenological Practices Declaration for Enzymes for use in Oenological Practices 25 March 2015 Food Fit for Human Consumption We hereby confirm that all raw materials used in the production of aforementioned products have a purity

More information

15 years of the European Union s Food Supplement Directive

15 years of the European Union s Food Supplement Directive 15 years of the European Union s Food Supplement Directive Food Supplements Directive (46/2002) Recital 3 An adequate and varied diet could, under normal circumstances, provide all necessary nutrients

More information

IPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope

IPEC Europe Suggested Alternative (if none then original text is clear and needs no alteration) Purpose and Scope IPEC Europe Observations and Recommendations on Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human

More information

Nutritional Information and the Food Information Regulations John Stewart

Nutritional Information and the Food Information Regulations John Stewart Nutritional Information and the Food Information Regulations 2014 John Stewart What are we going to cover? Enforcement responsibilities The importance of food labelling compliance The benefits of working

More information

Savesta Herbals is engaged in manufacturing

Savesta Herbals is engaged in manufacturing Savesta Herbals is engaged in manufacturing standardized herbal extracts that synergistically combine the ancient wisdom of Ayurveda with the modern production and QC methods. Our state-of- the- art production

More information

Final Rule for Preventive Controls for Animal Food

Final Rule for Preventive Controls for Animal Food Final Rule for Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Background Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food

More information

Ornsurang Teerawat

Ornsurang Teerawat ASEAN TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS REGULATORY AND HARMONIZATION UPDATE Ornsurang Teerawat 21.10.2014 \ http://trainstudenytp.wordpress.com ACCSQ (ASEAN Consultative Committee for Standard

More information

Product Information Sheet MALTOSWEET

Product Information Sheet MALTOSWEET Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet RESISTAMYL

Product Information Sheet RESISTAMYL Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet MERIZET

Product Information Sheet MERIZET Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet REZISTA DF

Product Information Sheet REZISTA DF Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Health Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product

Health Products Regulatory Authority IPAR. Public Assessment Report for a. Traditional Herbal Medicinal Product IPAR Public Assessment Report for a Traditional Herbal Medicinal Product for Human Use Ginkgo-Biloba Pharma Nord film-coated tablets Ginkgo dry extract TR 1242/1/1 TR holder Pharma Nord ApS March 2018

More information

Final Rules Preventive Controls for Human Food Preventive Controls for Animal Food

Final Rules Preventive Controls for Human Food Preventive Controls for Animal Food Final Rules Preventive Controls for Human Food Preventive Controls for Animal Food http://www.fda.gov/fsma THE FUTURE IS NOW 1 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive

More information

Partner with the Global Leader in Drug Delivery Systems

Partner with the Global Leader in Drug Delivery Systems 3M DRUG DELIVERY SYSTEMS Partner with the Global Leader in Drug Delivery Systems Loughborough, United Kingdom Manufacturing Facility Experts at Commercializing Innovation 3M: Transforming New Ideas into

More information

Product Information Sheet CLARIA Elite

Product Information Sheet CLARIA Elite Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

COMMISSION REGULATION (EU) / of XXX. establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food

COMMISSION REGULATION (EU) / of XXX. establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food EUROPEAN COMMISSION Brussels, XXX SANTE/11059/2016 Rev. 2 (POOL/E2/2016/11059/11059R2- EN.doc) D048379/05 [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX establishing mitigation measures and benchmark

More information

COMMISSION REGULATION (EU) / of XXX. establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food

COMMISSION REGULATION (EU) / of XXX. establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food EUROPEAN COMMISSION Brussels, XXX SANTE/11059/2016 Rev. 2 (POOL/E2/2016/11059/11059R2- EN.doc) D048379/05 [ ](2017) XXX draft COMMISSION REGULATION (EU) / of XXX establishing mitigation measures and benchmark

More information

Public Assessment Report Scientific discussion. Ginsana, soft capsule. Asp.no.:

Public Assessment Report Scientific discussion. Ginsana, soft capsule. Asp.no.: Läkemedelsverket 2014-04-15 Public Assessment Report Scientific discussion Ginsana, soft capsule (Panax ginseng C.A. Meyer, radix, standardised dry extract G115 Pharmaton (0.9-3.9:1, 40% ethanol)) Asp.no.:

More information

Technical requirements Nutrition products

Technical requirements Nutrition products Technical requirements Nutrition products Anna Kistauri Medicines and Nutrition Centre UNICEF Supply Division Nutrition Supplier Meeting 11 September 2013 Copenhagen Nutrition Unit Anthropometrics Supplementary

More information

Product Information Sheet

Product Information Sheet Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet REZISTA HV

Product Information Sheet REZISTA HV Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Emanuela Turla Scientific Officer Nutrition Unit - EFSA

Emanuela Turla Scientific Officer Nutrition Unit - EFSA EFSA s role, experiences with the evaluation of the applications for authorisation of Novel Food or notification of Traditional Food from the third country Emanuela Turla Scientific Officer Nutrition Unit

More information

FOOD LAW AND THE TORTILLAS EU. 1

FOOD LAW AND THE TORTILLAS EU.  1 FOOD LAW AND THE TORTILLAS EU www.ainia.es 1 EU LEGISLATION CONSIDER SEVERAL POINTS AROUND THE TORTILLAS : Main aspects about food safety and higiene regulation Food labelling and consumer information

More information

Product Information Sheet CLARIA Bliss

Product Information Sheet CLARIA Bliss Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

FOOD AND DRUGS AUTHORITY (FDA) GHANA

FOOD AND DRUGS AUTHORITY (FDA) GHANA REGULATION OF HERBAL MEDICINE IN GHANA FOOD AND DRUGS AUTHORITY (FDA) GHANA 1 PRESENTATION OUTLINE Background Mandate Functions General overview Regulation of Herbal Medicine Cooperation in the ECOWAS

More information

Regulatory framework

Regulatory framework Regulatory framework Status and future changes for sports nutrition Nick Morgan, Performance Director, Glanbia Performance NutritionMember of ESSNA Food Matters Live 2014 19 th November - ExCeL, London

More information

Dr. Tipvon Parinyasiri

Dr. Tipvon Parinyasiri Dr. Tipvon Parinyasiri Director, Bureau of Food Thai Food and Drug Administration 28 January 2014, Faculty of Medicine Guideline Content of Presentation Roles and Responsibility of Thai FDA From Research

More information

Safety Assessment of Yestimun Beta-Glucans

Safety Assessment of Yestimun Beta-Glucans Safety Assessment of Yestimun Beta-Glucans Name of Applicant: Leiber GmbH, Bramsche, Germany Contact person(s): Marion Hartong Novel Food Classification: Article 1.2(d) Introduction An application for

More information

Shawn Stevens Food Industry Consultant and Lawyer

Shawn Stevens Food Industry Consultant and Lawyer Shawn Stevens Food Industry Consultant and Lawyer stevens@foodindustrycounsel.com 920.698.2561 COMPLYING WITH FSMA S PREVENTIVE CONTROL RULE AS A SMALL BUSINESS COMPLYING WITH FSMA S PREVENTIVE CONTROL

More information

Guidance for Handling and Labeling

Guidance for Handling and Labeling ECOCERT ICO Page 1/7 This guideline does not replace the current Regulation. It provides some explanations on main requirements for organic handling and labeling. To understand the complete organic requirements,

More information

Product Information Sheet TASTEVA Stevia Sweetener

Product Information Sheet TASTEVA Stevia Sweetener Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet

Product Information Sheet Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Product Information Sheet SODA-LO EXTRA FINE IODIZED

Product Information Sheet SODA-LO EXTRA FINE IODIZED Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

Delegations will find attached document D048379/05.

Delegations will find attached document D048379/05. Council of the European Union Brussels, 17 August 2017 (OR. en) 11651/17 AGRILEG 150 DENLEG 63 COVER NOTE From: European Commission date of receipt: 24 July 2017 To: No. Cion doc.: D048379/05 Subject:

More information

Food Commissaries under FSMA and the US FDA model Food Code

Food Commissaries under FSMA and the US FDA model Food Code Food Commissaries under FSMA and the US FDA model Food Code Introduction A food commissary is a facility or operation that procures and/or produces foods intended for distribution. A retail or foodservice

More information

Commodity Code: Data Sheet Version: 1.6 Valid from (production date):

Commodity Code: Data Sheet Version: 1.6 Valid from (production date): Product Description Ready-to-use neutral glaze for making mirrors on bavarois. Usage Information Usage rate / recipe Ready to use product. Do not add water. Application / Method Stir gently with a spatula

More information

Challenges of Incorporating Functional Ingredients into Foods - An NPD and Analytical Perspective

Challenges of Incorporating Functional Ingredients into Foods - An NPD and Analytical Perspective Challenges of Incorporating Functional Ingredients into Foods - An NPD and Analytical Perspective Jane Staniforth & Robert Griffiths Customer Focused, Science Driven, Results Led Overview Introduction

More information

Quality Certification in Italy and in the Mediterranean countries: a way for accessing foreign markets. Davide Pierleoni

Quality Certification in Italy and in the Mediterranean countries: a way for accessing foreign markets. Davide Pierleoni Quality Certification in Italy and in the Mediterranean countries: a way for accessing foreign markets Davide Pierleoni Vice President Istituto Mediterraneo di Certificazione srl Presentation of IMC IMC

More information

Allergens Assessing risk and mapping your facility

Allergens Assessing risk and mapping your facility Allergens Assessing risk and mapping your facility Evaluate and mitigate your allergen risks Allergen mapping is a part of allergen risk assessment and is an effective tool to identify and track allergens

More information

Product Information Sheet SODA-LO EXTRA FINE

Product Information Sheet SODA-LO EXTRA FINE Contents: 1. Supplier Information 2. Emergency Contacts 3. Product Information 4. Regulatory Status 5. Ingredient Statement 6. Quality Documents 7. Kosher/Halal Status 8. Allergen Status 9. Sulfur Dioxide

More information

MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA

MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA MEDICNES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL PRODUCTS IN THE GAMBIA Document No.: MCA/HMPG/17/12/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017 Version

More information

Product Data Sheet Hemp Oil 3% CBD. 1. General information. Best before: 06 / Product information: Appearance Ingredients CBD oil

Product Data Sheet Hemp Oil 3% CBD. 1. General information. Best before: 06 / Product information: Appearance Ingredients CBD oil 1. General information 1.1 Product information: Appearance Ingredients CBD oil : CBD Oil in Glass bottle 10ml with dropper : Hemp extract and organic olive oil 1.2 Ingredients CBD Oil : Hemp extract :

More information

Leader in custom manufacturing. for the pharmaceutical and nutraceutical industries.

Leader in custom manufacturing. for the pharmaceutical and nutraceutical industries. Leader in custom manufacturing for the pharmaceutical and nutraceutical industries. Since its inception in April 1994, Viva Pharmaceutical Inc. has built a reputation as a leading manufacturer committed

More information

Technical Transfer- A tablet process transfer case study. Presented by Jonathan King 4 July, 2016

Technical Transfer- A tablet process transfer case study. Presented by Jonathan King 4 July, 2016 Technical Transfer- A tablet process transfer case study Presented by Jonathan King 4 July, 2016 What is a technical transfer? Technical transfer is about enabling someone else to do what you are able

More information

Product Code: DexMono001 Raw Material Full Name: Dextrose Monohydrate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Alpha-D-Glucose

Product Code: DexMono001 Raw Material Full Name: Dextrose Monohydrate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Alpha-D-Glucose Product Code: DexMono001 Raw Material Full Name: Dextrose Monohydrate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Alpha-D-Glucose Monohydrate Limit/Range/Specification: Dextrose Content

More information

Preventing contamination from food packaging and other food contact materials

Preventing contamination from food packaging and other food contact materials Preventing contamination from food packaging and other food contact materials Teagasc Food Packaging seminar for SMEs 29 November 2012 Dr Bernard Hegarty bhegarty@fsai.ie Overview Contamination - How packaging

More information

Version: 2016:1 September 22, CKB Nude (hereafter referred to as the paperboard)

Version: 2016:1 September 22, CKB Nude (hereafter referred to as the paperboard) Certificate Version: 2016:1 September 22, 2016 Declaration of Compliance CKB Nude Trade name Product description Grammage Fiber source Bleaching Production site Producer CKB Nude (hereafter referred to

More information

(Text with EEA relevance)

(Text with EEA relevance) 29.6.2013 Official Journal of the European Union L 181/35 REGULATION (EU) No 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 June 2013 on food intended for infants and young children, food

More information

Proposed FDA Food Safety Modernization Act:

Proposed FDA Food Safety Modernization Act: Proposed FDA Food Safety Modernization Act: Its impact on distillers production and sales Paula Emberland Business Analyst History of the FDA 1862 Beginning of Bureau of Chemistry 1927 Bureau of Chemistry

More information

COMMISSION REGULATION (EU)

COMMISSION REGULATION (EU) 11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council

More information

Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs Information for Manufacturers/Processors

Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs Information for Manufacturers/Processors ISSUE NO. 1 OCTOBER 2011 This factsheet outlines the main issues to be considered by manufacturers/processors to ensure compliance with Regulation (EC) No 2073/2005. It should be read in conjunction with

More information

FoodDrinkEurope Position on GLP studies

FoodDrinkEurope Position on GLP studies FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?

More information

Checklist of issues to be considered by food business operators when implementing Commission Regulation (EC) No 2073/2005

Checklist of issues to be considered by food business operators when implementing Commission Regulation (EC) No 2073/2005 Checklist of issues to be considered by food business operators when implementing Commission Regulation 1. General requirements 2. Sampling foodstuffs and testing against the relevant criteria 2.1 Validation

More information

Frequently Asked Questions by HPs to NCs

Frequently Asked Questions by HPs to NCs Frequently Asked Questions by HPs to NCs 1. What is the advantage of working with a distribution company instead of the manufacturer? As a distribution company, we are able to choose different manufacturers

More information

(OJ L 276, , p. 40)

(OJ L 276, , p. 40) 1990L0496 EN 11.12.2008 004.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE of 24 September 1990 on nutrition

More information

IMPORTANT DISCLAIMER. Note

IMPORTANT DISCLAIMER. Note yn EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL June 2012 DRAFT GUIDANCE DOCUMENT FOR COMPETENT AUTHORITIES FOR THE CONTROL OF COMPLIANCE WITH EU LEGISLATION ON: Regulation (EU) No 1169/2011

More information

EUROPEAN UNION. Strasbourg, 12 June 2013 (OR. en) PE-CONS 34/ /0156 (COD) LEX 1348 DENLEG 53 AGRI 342 SAN 183 CODEC 1237

EUROPEAN UNION. Strasbourg, 12 June 2013 (OR. en) PE-CONS 34/ /0156 (COD) LEX 1348 DENLEG 53 AGRI 342 SAN 183 CODEC 1237 EUROPEAN UNION THE EUROPEAN PARLIAMT THE COUNCIL Strasbourg, 12 June 2013 (OR. en) 2011/0156 (COD) LE 1348 PE-CONS 34/13 DLEG 53 AGRI 342 SAN 183 CODEC 1237 REGULATION OF THE EUROPEAN PARLIAMT AND OF THE

More information

(Text with EEA relevance)

(Text with EEA relevance) L 138/92 COMMISSION REGULATION (EU) 2017/893 of 24 May 2017 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Annexes X, XIV and XV to Commission

More information

Council of the European Union Brussels, 12 November 2015 (OR. en)

Council of the European Union Brussels, 12 November 2015 (OR. en) Council of the European Union Brussels, 12 November 2015 (OR. en) 14050/15 AGRILEG 222 DENLEG 147 VETER 102 COVER NOTE From: European Commission date of receipt: 12 November 2015 To: No. Cion doc.: D039258/04

More information

Our proposal relies in the development and implementation of effective technology innovations in the world of Omega 3 fatty acids.

Our proposal relies in the development and implementation of effective technology innovations in the world of Omega 3 fatty acids. BEST QUALITY Our state-of-the-art facility, strategic location and strong R&D orientation allow us to take the purity and quality of our Omega 3 concentrates to the next level. APPLIED INNOVATION Our proposal

More information

(Text with EEA relevance)

(Text with EEA relevance) 13.8.2018 EN L 204/41 COMMISSION IMPLEMENTING REGULATION (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food under Regulation (EU) 2015/2283

More information

GUIDE TO REGISTER HOMEOPATHIC PRODUCTS FOR VETERINARY USE

GUIDE TO REGISTER HOMEOPATHIC PRODUCTS FOR VETERINARY USE CAMEVET PROCEEDINGS II REVIEW DATE in BRAZIL: HOMEOPATHIC COMMISSION - SINDAN August 18, 2016 GUIDE TO REGISTER HOMEOPATHIC PRODUCTS FOR VETERINARY USE SÃO PAULO, BRAZIL August 2016 Page 2 of 9 GUIDE TO

More information

Importing pre-packaged foods

Importing pre-packaged foods Importing pre-packaged foods Information for those who wish to import pre-packa Starting your business This brochure provides important information for those who wish to import and sell pre-packaged foods

More information

Sweetpotato puree - specification

Sweetpotato puree - specification KENYA STANDARD ICS Sweetpotato puree - specification KES 2018 First Edition KENYA STANDARD ICS TECHNICAL COMMITTEE REPRESENTATION The following organizations were represented on the Technical Committee:

More information

67 Years of Leadership in Pharmacy. A Journey of Continuous Improvement

67 Years of Leadership in Pharmacy. A Journey of Continuous Improvement 67 Years of Leadership in Pharmacy A Journey of Continuous Improvement September 2012 GALENIKA A.D. IS The only Serbian state-owned pharmaceutical company Manufacturer of generic drugs its manufacturing

More information

Overview of Dietary Supplement GMP Inspection Trends Quality Session 6

Overview of Dietary Supplement GMP Inspection Trends Quality Session 6 Overview of Dietary Supplement GMP Inspection Trends Quality Session 6 Presented by: Dean R. Cirotta, MBA President & Chief Operating Officer EAS Consulting Group, LLC 1700 Diagonal Road, Suite 750 Alexandria,

More information

FOOD ACT No.26 OF 1980

FOOD ACT No.26 OF 1980 FOOD ACT No.26 OF 1980 REGULATIONS made by the Minister of Health in consultation with the Food Advisory Committee under section 32 of the Food Act No. 26 of 1980. Colombo 15 th November, 2005 Nimal Siripala

More information

Recommendations for Regulators Cannabis Operations

Recommendations for Regulators Cannabis Operations Recommendations for Regulators Cannabis Operations Developed by: Cannabis Committee American Herbal Products Association 8630 Fenton Street, Suite 918 Silver Spring, MD 20910 www.ahpa.org This document

More information

MHRA Anti-counterfeiting Strategy and Supply Chain Guidance

MHRA Anti-counterfeiting Strategy and Supply Chain Guidance Safeguarding public health MHRA Anti-counterfeiting Strategy and Supply Chain Guidance PQG Annual Meeting for QPs 24 Mar 2010 Nimo Ahmed Head of Intelligence Medicines and Healthcare products Regulatory

More information

COMMISSION DELEGATED REGULATION (EU).../... of XXX

COMMISSION DELEGATED REGULATION (EU).../... of XXX EUROPEAN COMMISSION Brussels, XXX SANTE/10355/2015 (POOL/E4/2015/10355/10355-EN. doc) [...1(2015) XXX draft COMMISSION DELEGATED REGULATION (EU).../... of XXX supplementmg Regulation (EU) No 609/2013 of

More information

Quality, Safety and Sourcing in Unlicensed Medicines

Quality, Safety and Sourcing in Unlicensed Medicines Quality, Safety and Sourcing in Unlicensed Medicines with Andrew Trouton Managing Director, UL Medicines Agenda Welcome What is an unlicensed medicine? When should you consider using an unlicensed medicine?

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX Ref. Ares(2016)6396619-14/11/2016 EUROPEAN COMMISSION Brussels, XXX SANTE/10539/2016 CIS Rev. 3 (POOL/G4/2016/10539/10539R4-EN CIS.doc) [ ](2016) XXX draft COMMISSION REGULATION (EU) / of XXX amending

More information

HISTORY, CAPACITY AND POSITION

HISTORY, CAPACITY AND POSITION HISTORY, CAPACITY AND POSITION A high level presentation for SAPRAA April 2017 History Founded in 1976, the HPA has efficiently supported, promoted and protected the CAMs industry for 40 years. The HPA

More information

Food Safety Monitoring System in the EU: Labelling and Traceability

Food Safety Monitoring System in the EU: Labelling and Traceability Food Safety Monitoring System in the EU: Labelling and Traceability Dr John Ryder FAO, Dhaka, Bangladesh A COUPLE OF FACTS USD billion 60 Top Importers and Exporters in 2010, 2011 & 2012 * includes intra-eu

More information

Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference

Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference Alignment of FSMA with Existing Food Safety Programs International Citrus & Beverage Conference Donald Kautter US Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food

More information

(Text with EEA relevance) (OJ L 141, , p. 3)

(Text with EEA relevance) (OJ L 141, , p. 3) 02009L0032 EN 09.11.2016 002.001 1 This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions

More information

The Regulation of Herbal Medicines in Europe

The Regulation of Herbal Medicines in Europe The Regulation of Herbal Medicines in Europe Chantel Henderson Avena Consultants Ltd, 6 Melville Terrace, Edinburgh, Scotland EH9 3BN Manuscript received : 16.05.2014 Manuscript accepted: 18.06.2014 The

More information

NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS

NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS NUTRILO YOUR COMPETENT PARTNER IN DIETARY SUPPLEMENTS Growing expertise in healthy dietary supplements At the mouth of the River Elbe, at the edge of the Lower Saxony Wadden Sea National Park, Nutrilo

More information

Safety Assessment of Botanicals and Botanical Preparations. Dr. Balasubramanian

Safety Assessment of Botanicals and Botanical Preparations. Dr. Balasubramanian Safety Assessment of Botanicals and Botanical Preparations Dr. Balasubramanian Introduction Plant materials and extracts (botanicals) form a major component in indigenous peoples traditional ingredients

More information

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 28.7.2006 COM(2006) 425 final 2006/0144 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food enzymes and amending Council

More information

Continuous & Continued Process Verification. Presented by Eoin Hanley 4 July, 2016

Continuous & Continued Process Verification. Presented by Eoin Hanley 4 July, 2016 Continuous & Continued Process Verification Presented by Eoin Hanley 4 July, 2016 This session will cover Quick recap on PV Lifecycle stages & Annex 15 Continued (Onoing) Process Verification Continuous

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX EUROPEAN COMMISSION Brussels, XXX SANTE/131/2015 CIS REV2 (POOL/G4/2015/131/131-EN CIS.doc) [ ](2015) XXX draft COMMISSION REGULATION (EU) / of XXX amending Annex III and Annex IV to Regulation (EC) No

More information

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Quick Facts Retailers that mix and prepare e-liquids or create or modify vaporizers

More information

WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS

WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS WHITE PAPER ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS SEPTEMBER 23, 2009 COUNCIL OF THE CONVENTION SECTION ON THE QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS INTRODUCTION The 1994 Dietary Supplement

More information

QUALITY OF HERBAL MEDICINAL PRODUCTS: PRESENT REQUIREMENTS

QUALITY OF HERBAL MEDICINAL PRODUCTS: PRESENT REQUIREMENTS QUALITY OF HERBAL MEDICINAL PRODUCTS: PRESENT REQUIREMENTS Phytopharm 2015 Bonn, 21 24 July 2015 1 Dr. Barbara Steinhoff Bundesverband der Arzneimittel-Hersteller CONTENTS Production of herbal starting

More information

Health Authority Abu Dhabi. Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number:

Health Authority Abu Dhabi. Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number: Health Authority Abu Dhabi Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number: PPR/DMP/DR/P0001 Version 0.9 Approval Date: August 2007 Effective Date: August 2007 Last

More information

The Safety and Effectiveness of Dietary Supplements

The Safety and Effectiveness of Dietary Supplements Assignment 4 The Safety and Effectiveness of Dietary Supplements In Depth: Supplements Supplements, according to the FDA, are a product containing ingredients like vitamins, minerals, herms, amino acids,

More information

AKA Good Manufacturing Practice (GMP) Certification Program

AKA Good Manufacturing Practice (GMP) Certification Program AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements

More information

Version: 2015:2 March 2, All used pulps are elementary chlorine free (ECF-pulps) Production site

Version: 2015:2 March 2, All used pulps are elementary chlorine free (ECF-pulps) Production site Certificate Version: 2015:2 March 2, 2015 Declaration of Compliance CKB Trade name CKB (hereafter referred to as the paperboard) Product description Paperboard Grammage Ranges between 175 g/m 2 to 380

More information

Explanatory Memorandum to the Food Labelling (Declaration of Allergens) (Wales) Regulations 2008

Explanatory Memorandum to the Food Labelling (Declaration of Allergens) (Wales) Regulations 2008 Explanatory Memorandum to the Food Labelling (Declaration of Allergens) (Wales) Regulations 2008 This Explanatory Memorandum has been prepared by the Food Standards Agency Wales and is laid before the

More information

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014 Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role

More information

Certifications & Approvals

Certifications & Approvals Certifications & Approvals Summary Food contact approvals. RoHS and WEEE European directives. UL/CSA. Packaging regulations. Other regulations. Where to find the ARMOR certificates. Certifications & Approvals

More information

Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings

Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings Version 2 Updated on 29/11/2011 Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings Valid as of: 11 September 2011 Disclaimer: This

More information

FDA Food Contact Fundamentals

FDA Food Contact Fundamentals FDA Food Contact Fundamentals Deborah Attwood 2017 SPE International Polyolefins Conference March 1, 2017 Legal Highlights for Food 1906: Pure Food and Drug Act 1938: Federal Food, Drug and Cosmetic Act

More information

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents 1989L0107 EN 10.09.1994 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE of 21December 1988 on the approximation

More information

Food Information Regulation

Food Information Regulation Food Information Regulation Deirdre Kennedy Food Safety Authority of Ireland Full title Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of

More information

COMMISSION STAFF WORKING DOCUMENT

COMMISSION STAFF WORKING DOCUMENT EUROPEAN COMMISSION Brussels, 25.3.2015 SWD(2015) 79 final COMMISSION STAFF WORKING DOCUMENT ILLUSTRATIVE GUIDANCE ON IMPORT/TRANSIT CONDITIONS AND CONTROLS OF CERTAIN COMPOSITE PRODUCTS, AND PRODUCTS

More information

ResistAid supports immune systems naturally

ResistAid supports immune systems naturally ResistAid supports immune systems naturally Presentation Outline What is ResistAid? Lonza s ResistAid Production Quality & Safety Health Benefits Summary What is ResistAid? ResistAid is a natural immune

More information

Excipient Risk Assessment

Excipient Risk Assessment Excipient Risk Assessment Richard O Sullivan- GMP Inspector GMP Conference 7 February 2017 Dublin Content Background 1 Guidance 2 HPRA Expectations 3 07/02/2017 2 Excipient Risk Assessment-Why? 07/02/2017

More information