Code of Practice for the Manufacture, Packaging, Distribution and Sale of Salt in Ghana

Scientific Guideline template GCG comments No. 17 Indian Ocean Street, Nelson Mandela Avenue, Shiashie ● Greater Accra ● Ghana P. O. Box CT 2783, Accra ● GPS: GA-237-7316 ● (+233) 302 233200 / 235100 ● fda@fda.gov.gh © FDA-GHANA, 2023. Reproduction is authorized provided the source is acknowledged. FOOD AND DRUGS AUTHORITY Date published: 25 September 2023 FDA/FSC/COP - 01/01 Chief Executive Officer CODE OF PRACTICE FOR THE MANUFACTURE, PACKAGING, DISTRIBUTION AND SALE OF SALT IN GHANA Written by Food Safety and Consumer Education February 2023 Reviewed by Legal 11th May 2023 Start of public consultation 2nd June 2023 Final Quality Assurance Review 12th July 2023 Approved by CEO 24th July 2023 Date of coming into effect 01st August 2023 This guideline replaces ‘Code of Practices for Manufacture, Packaging, Distribution and Sale of Iodised Salt in Ghana, FDA/FID/CP-FOR/2013/02 mailto:fda@fda.gov.gh Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 2 of 14 DOCUMENT REVISION HISTORY Date of Revision Version Number Changes made and/or reasons for revision - 01 Initial issue 01st August 2023 02 Revised in line with current Ghana Standard specification for salt (GS) 154:2017, (GS) 152:2017, and (GS) 153:2017, Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 3 of 14 Code of Practice for the Manufacture, Packaging, Distribution and Sale of Salt in Ghana Table of Contents Document Revision History .............................................................................................. 2 Executive Summary ......................................................................................................... 4 1. Introduction .................................................................................................................. 5 1.1. Scope ........................................................................................................................ 5 2. Definitions And Abbreviations ...................................................................................... 6 2.1. Definitions ................................................................................................................. 6 2.2. Abbreviations ............................................................................................................ 7 3. Requirements ............................................................................................................... 8 3.1. General Requirements .............................................................................................. 8 3.2. Hygiene Requirements At Manufacturing Facilities ................................................... 8 3.3. Fortification of Salt .................................................................................................... 8 3.4. Packaging ................................................................................................................. 9 3.5. Labelling .................................................................................................................. 10 3.7. Industrial Salt .......................................................................................................... 11 3.8. Facility Licensing And Product Registration ............................................................ 11 4. Exemptions ................................................................................................................ 11 5. Penalties .................................................................................................................... 12 6. References ................................................................................................................. 14 Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 4 of 14 EXECUTIVE SUMMARY This Code of Practice, issued by the Food and Drugs Authority (FDA) in accordance with the Public Health Act (2012) Act 851, Part Seven, Sections 148, 107, 97, and 131, serves as a comprehensive regulatory framework for the entire salt value chain in Ghana. Its fundamental purpose is to guarantee the safety, and quality of salt. In essence, this Code plays a pivotal role in safeguarding the safety and quality of edible salt in Ghana. It not only protects consumers from potential contamination but also ensures availability of adequately iodised salt requisite for their overall well-being. Furthermore, it supports the elimination of iodine deficiency disorders and promotes optimal iodine nutrition throughout the population. The FDA, as the regulatory authority, is entrusted with enforcing this Code of Practice. Businesses failing to adhere to these regulations may face regulatory sanctions. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 5 of 14 1. INTRODUCTION In exercise of the powers conferred on the Food and Drugs Authority (FDA) by the Public Health Act (2012) Act 851, Part Seven, Sections 148, 131 and 107, this Code of Practice applies to the manufacture, packaging, storage, distribution, transportation and retail of iodised salt to facilitate adequate iodine nutrition leading to elimination of iodine deficiency disorders in Ghana. The purpose of this Code of Practice is to provide manufacturers/producers, importers, exporters, distributors, transporters, and retailers of iodised salt with the requirements of the FDA, and also provide a procedure to facilitate compliance to the Public Health Act, 2012 (Act 851) Part Seven, Section 107. 1.1. SCOPE The Code applies specifically to salt: a) For culinary use. b) For direct sale to the consumer. c) For manufacture of food and feed. d) As a carrier for food additives. e) Used for industrial purposes. And provides guidance to: a) Manufacturers/producers, importers, exporters, distributors, transporters and retailers of salt. b) Food product manufacturers and processors. c) Catering facilities i.e., food service establishments. The conditions in this Code is in addition to, and not in derogation of conditions in any other current standard for iodised salt. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 6 of 14 2. DEFINITIONS AND ABBREVIATIONS 2.1. DEFINITIONS For the purpose of this Code, the following definitions shall apply: Conveyance means any receptacle or vessel for transporting salt (i.e., food grade or industrial) from one place to another. Food grade salt refers to salt for human and animal consumption as distinguished from industrial salt. Fortificant refers to iodate either in the form of potassium, sodium or calcium salt or other approved micronutrients. Fortification refers to the addition of a fortificant to food grade salt to facilitate iodine nutrition in humans and animals. Industrial salt refers to salt used in the treatment, processing, and/or manufacture of non- food commercial products. Iodine deficiency disorders refers to all the consequences including inadequate production of thyroid hormone (hypothyroidism), perinatal mortality, mental and physical retardation and deafness resulting from inadequate intake of iodine in a population. Iodised salt refers to salt fortified with iodate. Manufacture refers to the operations involved in the production, preparation, processing, compounding, formulating, filling, refining transformation, packing, packaging, re- packaging and labelling of food. Salt is a crystalline product consisting predominantly of sodium chloride. It is obtained from the sea, from underground rock salt deposits or from natural brine/saline waters. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 7 of 14 2.2. ABBREVIATIONS GS – Ghana Standard ppm – Parts per million kg – Kilogramme LI – Legislative Instrument Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 8 of 14 3. REQUIREMENTS 3.1. GENERAL REQUIREMENTS 3.1.1. No person shall engage in the manufacture and/or storage of salt without a valid licence from the FDA. 3.1.2. No person shall manufacture, distribute, store and offer for sale food grade salt unless it is appropriately and adequately fortified in accordance with requirements in GS 154:2017 (Spices and Condiments – Specification for Salt Fortified with Iodine). 3.1.3. Iodised salt shall be produced and packaged under Good Manufacturing Practices (GMPs). 3.1.4. Iodised salt shall be stored, distributed, and retailed under Good Storage and Distribution Practices (GSDPs). 3.1.5. No person shall offer for sale packaged iodised salt unless it is registered by the FDA. 3.1.6. No person shall use food grade salt in food service unless it is adequately iodised. 3.1.7. Industrial salt shall not be transported, unless the entire consignment is covered by a valid permit issued by the FDA. 3.2. HYGIENE REQUIREMENTS AT MANUFACTURING FACILITIES 3.2.1. Manufacturing, packaging and storage of iodised salt shall be in accordance with hygiene requirements in the current codes of Good Manufacturing Practices. 3.3. FORTIFICATION OF SALT The under listed requirements apply specifically to fortification of food grade salt with iodate: 3.3.1. Harvested salt shall be adequately dried under hygienic conditions prior to fortification to ensure maximum moisture content of 5% by mass for unrefined salt and 1% by mass for refined salt after iodisation, as per Spices and Condiments – Specifications Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 9 of 14 for Unrefined Edible Salt (GS 152: 2017) and Spices and Condiments – Specifications for Refined Edible Salt (GS 153:2017) respectively. 3.3.2. Locally produced salt shall be fortified with potassium, calcium or sodium iodate only. Minimum inclusion level of the fortificant shall be 50 ppm at the manufacturing point and 25 ppm at retail, as per the GS 154:2017. 3.3.3. Imported salt shall be fortified with potassium, calcium or sodium iodate or iodide. Minimum inclusion level of the fortificant shall be 50 ppm on receipt in the country. 3.3.4. The method of fortification shall be wet or dry mixing. 3.3.5. Where the wet mixing method is used, potable water shall be used for dilution of the fortificant. Where the dry mixing method is used, an approved anticaking agent shall be used to facilitate uniform mixing (list of approved anticaking agents at annex A). 3.3.6. The salt and fortificant shall be thoroughly mixed to ensure uniform distribution. Mixing process and implements used shall not present hazards to the final product i.e. iodised salt. 3.3.7. Other than approved fortificants (e.g. iodine and iron), iodised salt shall not contain extraneous matter or adulterants. 3.3.8. The level of iodine in batches of iodised salt shall be checked after manufacturing to ensure adequate iodisation. 3.3.9. Iodised salt shall be packaged using the designated primary packaging materials and sealed immediately. 3.4. PACKAGING 3.4.1. Iodised salt shall be packaged in a manner that prevents microbial, chemical and physical contamination during storage, transportation and retail. 3.4.2. Iodised salt shall be packed into air tight bags or containers fabricated of either: 3.4.2.1. High density polyethylene (HDPE) or 3.4.2.2. Laminated or non-laminated polypropylene. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 10 of 14 Alternatively, it shall be packed into jute bags lined with low density polyethylene (LDPE). 3.4.3. Retail units shall be packaged in maximum 1 kg airtight bags or containers. 3.4.4. Materials previously used for packaging non-food items (e.g. cement, household chemicals and agrochemicals) shall not be re-used for iodised salt. 3.5. LABELLING In addition to the General Labelling Requirements for Pre-packaged foods (FDA/FER/RQT– 04) and General Labelling Rules, 1992 (L.I. 1541), the following shall apply specifically to labelling of iodised salt: 3.5.1. Name of the product shall have "iodised salt" in close proximity to the brand name. 3.5.2. The term "dendritic" shall only be included in the name or declared on the label, if the brine was treated with ferrocyanide salt(s) during the crystallization process. The concentration of ferrocyanide salt added shall not exceed 14 ppm. 3.5.3. The logo for iodised salt (specified at annex B), shall be displayed visibly on the label. 3.5.4. Storage condition shall be indicated visibly on the label i.e., store in cool and dry place, away from direct sunlight. 3.6. TRANSPORT, DISTRIBUTION AND SALE OF IODISED SALT 3.6.1. Iodised salt in transit and retail shall not be exposed to rain, excessive humidity, or direct sunlight. 3.6.2. Conveyance for transporting iodised salt shall be adequate for the intended purpose and fabricated of non-toxic materials. Fabrication of the conveyance shall permit easy and thorough cleaning. 3.6.3. Conveyance shall be thoroughly cleaned and sanitised prior to use and maintained regularly. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 11 of 14 3.7. INDUSTRIAL SALT The under listed requirements apply specifically to industrial salt: 3.7.1. Industrial salt shall be visibly labelled, and label shall bear a visible caution statement, i.e., “INDUSTRIAL SALT – NOT FOR HUMAN AND ANIMAL CONSUMPTION”. 3.7.2. Industrial salt shall be stored and displayed separately from salt intended for human or animal consumption. 3.7.3. Iodised salt shall be segregated from industrial salt and transported in separate conveyances. 3.7.4. Industrial salt in transit shall be accompanied by a valid permit from the FDA. 3.8. FACILITY LICENSING AND PRODUCT REGISTRATION 3.8.1. Salt manufacturing facility shall be licenced in accordance with requirements in the Guidelines for Licensing of Food Manufacturing Facility, FDA/FED/GL-REG/2020/01. 3.8.2. Salt storage facility shall be licenced in accordance with requirements in the Guidelines for Licensing of Food Storage Facility, FDA/FID/CP/-DFW/20202/02. 3.8.3. Locally produced packaged food grade salt shall be registered in accordance with the Requirements for Registration of Locally Manufactured Pre-Packaged Foods, FDA/FER/RQT-01. 3.8.4. Imported food-grade salt shall be registered in accordance with the Requirements for registration of imported pre-packaged foods, FDA/FER/RQT-02. 4. EXEMPTIONS The requirements of this Code does not apply to salt as a by-product of chemical reactions. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 12 of 14 5. PENALTIES The FDA will impose appropriate regulatory sanctions on entities and/or individuals who fail to adhere to the requirements in this Code of Practice. Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 13 of 14 ANNEX A Examples of approved anticaking agents/fillers: • Carbonates (Calcium and / or Magnesium) • Tri-calcium Phosphate • Calcium Alumina • Calcium, Magnesium, Sodium • Magnesium oxide • Sodium Ferrocyanide ANNEX B Figure 1 Logo of iodised salt Code Of Practice For The Manufacture, Packaging, Distribution, And Sale Of Salt In Ghana FDA/FSC/COP - 01/02 Page 14 of 14 6. REFERENCES 1. Ghana Standard Authority (2017). Ghana Standard (GS) 154:2017, Spices and Condiments – Specification for Salt Fortified with Iodine. 2. Ghana Standards Authority (2017). Ghana Standard (GS) 152:2017, Specification for unrefined common salt. 3. Ghana Standards Authority (2017). Ghana Standard (GS) 153:2017, Specification for refined common salt. DOCUMENT REVISION HISTORY EXECUTIVE SUMMARY 1. INTRODUCTION 1.1. SCOPE 2. DEFINITIONS AND ABBREVIATIONS 2.1. DEFINITIONS For the purpose of this Code, the following definitions shall apply: Conveyance means any receptacle or vessel for transporting salt (i.e., food grade or industrial) from one place to another. Food grade salt refers to salt for human and animal consumption as distinguished from industrial salt. Fortificant refers to iodate either in the form of potassium, sodium or calcium salt or other approved micronutrients. Fortification refers to the addition of a fortificant to food grade salt to facilitate iodine nutrition in humans and animals. Industrial salt refers to salt used in the treatment, processing, and/or manufacture of non-food commercial products. Iodine deficiency disorders refers to all the consequences including inadequate production of thyroid hormone (hypothyroidism), perinatal mortality, mental and physical retardation and deafness resulting from inadequate intake of iodine in a population. Iodised salt refers to salt fortified with iodate. Manufacture refers to the operations involved in the production, preparation, processing, compounding, formulating, filling, refining transformation, packing, packaging, re-packaging and labelling of food. 2.2. ABBREVIATIONS 3. REQUIREMENTS 3.1. GENERAL REQUIREMENTS 3.1.1. No person shall engage in the manufacture and/or storage of salt without a valid licence from the FDA. 3.1.2. No person shall manufacture, distribute, store and offer for sale food grade salt unless it is appropriately and adequately fortified in accordance with requirements in GS 154:2017 (Spices and Condiments – Specification for Salt Fortified with... 3.1.3. Iodised salt shall be produced and packaged under Good Manufacturing Practices (GMPs). 3.1.4. Iodised salt shall be stored, distributed, and retailed under Good Storage and Distribution Practices (GSDPs). 3.1.5. No person shall offer for sale packaged iodised salt unless it is registered by the FDA. 3.1.6. No person shall use food grade salt in food service unless it is adequately iodised. 3.1.7. Industrial salt shall not be transported, unless the entire consignment is covered by a valid permit issued by the FDA. 3.2. HYGIENE REQUIREMENTS AT MANUFACTURING FACILITIES 3.2.1. Manufacturing, packaging and storage of iodised salt shall be in accordance with hygiene requirements in the current codes of Good Manufacturing Practices. 3.3. FORTIFICATION OF SALT The under listed requirements apply specifically to fortification of food grade salt with iodate: 3.3.1. Harvested salt shall be adequately dried under hygienic conditions prior to fortification to ensure maximum moisture content of 5% by mass for unrefined salt and 1% by mass for refined salt after iodisation, as per Spices and Condiments – Spec... 3.3.2. Locally produced salt shall be fortified with potassium, calcium or sodium iodate only. Minimum inclusion level of the fortificant shall be 50 ppm at the manufacturing point and 25 ppm at retail, as per the GS 154:2017. 3.3.3. Imported salt shall be fortified with potassium, calcium or sodium iodate or iodide. Minimum inclusion level of the fortificant shall be 50 ppm on receipt in the country. 3.3.4. The method of fortification shall be wet or dry mixing. 3.3.5. Where the wet mixing method is used, potable water shall be used for dilution of the fortificant. Where the dry mixing method is used, an approved anticaking agent shall be used to facilitate uniform mixing (list of approved anticaking agents ... 3.3.6. The salt and fortificant shall be thoroughly mixed to ensure uniform distribution. Mixing process and implements used shall not present hazards to the final product i.e. iodised salt. 3.3.7. Other than approved fortificants (e.g. iodine and iron), iodised salt shall not contain extraneous matter or adulterants. 3.3.8. The level of iodine in batches of iodised salt shall be checked after manufacturing to ensure adequate iodisation. 3.3.9. Iodised salt shall be packaged using the designated primary packaging materials and sealed immediately. 3.4. PACKAGING 3.4.1. Iodised salt shall be packaged in a manner that prevents microbial, chemical and physical contamination during storage, transportation and retail. 3.4.2. Iodised salt shall be packed into air tight bags or containers fabricated of either: 3.4.2.1. High density polyethylene (HDPE) or 3.4.2.2. Laminated or non-laminated polypropylene. Alternatively, it shall be packed into jute bags lined with low density polyethylene (LDPE). 3.4.3. Retail units shall be packaged in maximum 1 kg airtight bags or containers. 3.4.4. Materials previously used for packaging non-food items (e.g. cement, household chemicals and agrochemicals) shall not be re-used for iodised salt. 3.5. LABELLING In addition to the General Labelling Requirements for Pre-packaged foods (FDA/FER/RQT– 04) and General Labelling Rules, 1992 (L.I. 1541), the following shall apply specifically to labelling of iodised salt: 3.5.1. Name of the product shall have "iodised salt" in close proximity to the brand name. 3.5.2. The term "dendritic" shall only be included in the name or declared on the label, if the brine was treated with ferrocyanide salt(s) during the crystallization process. The concentration of ferrocyanide salt added shall not exceed 14 ppm. 3.5.3. The logo for iodised salt (specified at annex B), shall be displayed visibly on the label. 3.5.4. Storage condition shall be indicated visibly on the label i.e., store in cool and dry place, away from direct sunlight. 3.6. TRANSPORT, DISTRIBUTION AND SALE OF IODISED SALT 3.6.1. Iodised salt in transit and retail shall not be exposed to rain, excessive humidity, or direct sunlight. 3.6.2. Conveyance for transporting iodised salt shall be adequate for the intended purpose and fabricated of non-toxic materials. Fabrication of the conveyance shall permit easy and thorough cleaning. 3.6.3. Conveyance shall be thoroughly cleaned and sanitised prior to use and maintained regularly. 3.7. INDUSTRIAL SALT The under listed requirements apply specifically to industrial salt: 3.7.1. Industrial salt shall be visibly labelled, and label shall bear a visible caution statement, i.e., “INDUSTRIAL SALT – NOT FOR HUMAN AND ANIMAL CONSUMPTION”. 3.7.2. Industrial salt shall be stored and displayed separately from salt intended for human or animal consumption. 3.7.3. Iodised salt shall be segregated from industrial salt and transported in separate conveyances. 3.7.4. Industrial salt in transit shall be accompanied by a valid permit from the FDA. 3.8. FACILITY LICENSING AND PRODUCT REGISTRATION 3.8.1. Salt manufacturing facility shall be licenced in accordance with requirements in the Guidelines for Licensing of Food Manufacturing Facility, FDA/FED/GL-REG/2020/01. 3.8.2. Salt storage facility shall be licenced in accordance with requirements in the Guidelines for Licensing of Food Storage Facility, FDA/FID/CP/-DFW/20202/02. 3.8.3. Locally produced packaged food grade salt shall be registered in accordance with the Requirements for Registration of Locally Manufactured Pre-Packaged Foods, FDA/FER/RQT-01. 3.8.4. Imported food-grade salt shall be registered in accordance with the Requirements for registration of imported pre-packaged foods, FDA/FER/RQT-02. 4. EXEMPTIONS The requirements of this Code does not apply to salt as a by-product of chemical reactions. 5. PENALTIES The FDA will impose appropriate regulatory sanctions on entities and/or individuals who fail to adhere to the requirements in this Code of Practice. ANNEX A 6. REFERENCES