Food Additives Regulations 2021. S.I. no. 66 of 2021

Extraordinary Federal Republic of Nigeria Official Gazette No. 134 Lagos—16th August, 2021 Vol. 108 Government Notice No. 108 The following is published as Supplement to this Gazette : S..I. No. Short Title Page 66 FoodAdditiviesRegulations,2021 ..0 . o.oo... .. B3081-3089 Printed and Published by The Federal Government Printer. Lagos. Nigeria FGP 155/092021/150 Annual Subscription from Ist January, 2021 is Local : N45.000.00 Overseas : N60.500.00 [Surface Mail] N75.000.00 [Second Class Air Mail]. Present issue N2.500 per copy. Subscribers who wish to obtain Gazette after Ist January should apply to the Federal Government Printer. Lagos for amended Subscriptions. B 3081 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT (CAP. N1 LEN), 2004 FOOD ADDITIVES REGULATIONS, 2021 ARRANGEMENT OF REGULATIONS Regulation : $2 ) 92 ) SA SN S An e e Bo ee Ge SO ) 90 Oy O r e : e t . Scope of application. Prohibition. Food additives. Labeling of synthetic colour and mixture of colours in food. Net weight. Name and Address of Manufacturer. Labelling information. Instructions on storage and use. Processing aids and carry-over of food additives. Conditions for a request to add to or change food additives. Restriction on sale of baby foods containing food additives. Conditions for allowing more than one preservative. Ionizing radiation. Offences and Penalties. Forfeiture after conviction. Revocation. Enforcement of these Regulations. Interpretation. Citation. S. I. No. 66 of 2021 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL ACT (CAP. N1 LEN), 2004 FOOD ADDITIVES REGULATIONS, 2021 [7th Day of July, 2021] In exercise of the powers conferred on it by sections 5 and 30 of the National Agency for Food and Drug Administration and Control Act (Cap. N1, LFN) 2004 and section 12 of the Food, Drug and Related Products (Registration, Etc.) Act (Cap. F33, LFN) 2004 and all other powers enabling it in that behalf, the Governing Council of the National Agency for Food and Drug Administration and Control with the approval of the Minister of Health makes the following Regulations— 1. These Regulations shall apply to— (a) food additives sold as either by wholesale, retail or any other means ; and (b) food processing aids. 2.—(1) A person shall not manufacture, import, export, distribute, advertise, display for sale or use food additives, except as prescribed by these Regulations. (2) Food additive shall be included in food in a quantity within the limits prescribed for such food and food additive in the National Standards for the particular food and Codex standards, where applicable and as prescribed by the Agency. (3) Where the limit prescribed for a food additive in the Codex Standard is stated to be “Good Manufacturing Practice”, the amount of the food additive added to a food in the manufacturing and processing, shall not exceed the amount required to accomplish the purpose for which that additive is required in that food. 3.—(1) Food additives shall not be described or presented on any label or in labelling— (a) in a manner, which is false, misleading or is likely to create an erroneous impression regarding its character in any respect ; or (b) by words, pictorials or other devices which refer to or are suggestive, either directly or indirectly of any other product with which such food additives might be confused, or in such a manner as to lead the purchaser or consumer to suppose that the food additive is connected with or derived from such other product. (2) Food additives with a shelf life not exceeding 18 months shall carry the date of minimum durability using words such as ‘will keep at least until......”. B 3083 Commence ment. Scope of application. Prohibition. Food additives. B 3084 Labelling of synthetic colour and mixture of colours in food. Net weight. Name and Address of Manufacturer, Labelling information. (3) The use of ‘for food use’ or a statement substantially similar to it shall appear in a prominent position on the label. 4, All synthetic colour or mixture of colours manufactured, imported, exported, distributed, advertised, displayed for sale, offered for sale or sold for use in food shall carry on its label the— (a) lot number of the mixture ; (6) words “food grade colour” ; and (c) common name of the individual colours (synthetic or inorganic) in the mixture. 5. Thenet content shall be declared in the metric units and this declaration shall be made in the following manner for— (a) liquid food additives ; by volume or weight ; (6) solid food additives other than those sold in tablet form ; by weight ; (c) semi-solid or viscous food additives ; either by weight or volume ; and (a) food additives sold in tablet form ; by weight together with the number of tablets in the package. 6.—(1) The name and address of the manufacturer, packer, distributor, importer or vendor of the food additive shall be declared on the product label. (2) The name and address of the Holder of Certificate of Registration shall be declared on the product label. (3) Where a food additive undergoes processing in second country, which changes its chemical or physical nature, the country in which the processing is performed shall be considered to be the country of origin for the purposes of labeling. 7.—(1) Every information on the label of food additives shall be in compliance with the Agency’s Pre-packaged Food Labelling Regulations of the Agency. (2) Notwithstanding the provisions of sub-regulation (1) of this regulation, the language used for the declaration of the information on the product label shall be in English language. (3) Where the language on the original label is not English, a supplementary label containing the mandatory information in English language may be used instead of re-labeling. (4) This supplementary label shall be attached on the primary packaging in a manner that it will not be easily removed or damaged. (5) Where food additives label is to be re-packaged, mandatory information provided shall be fully and accurately reflected as in the original label. (6) The name of each food additive shall be specific and not generic and shall indicate the true nature of the food additive. (7) Where a name has been established for a food additive in a list of additives as may be accepted by the Agency, that name shall be used in relation to the food additives. In other cases, the common or usual name shall be listed or where none exists, an appropriate descriptive name shall be used. (8) Where two or more food additives are present, their names shall be listed in the order of the proportion by weight which each additive bear to the total contents of the container, the food additive present in the greatest proportion by weight being listed first. (9) Where one or more of the food additives is subject to a quantitative limitation in a food in which the food additive is to be used, the quantity or proportion of that additive and adequate instruction to enable the compliance with the limitation shall be stated and if food ingredients are part of the preparation, they shall be declared in the list of ingredients in descending order of proportion. (10) Where two or more food additives in the same functional class are present in a product, satisfactory documented evidence of safety of the combination shall be provided to the Agency. (11) In the case of mixtures of flavourings, the name of each flavouring present in the mixture need not be given but the generic expression of ‘flavour’ or ‘flavouring’ may be used together with a true indication of the flavour. (12) The expression ‘flavour’ or ‘flavouring’ may be qualified by the words ‘natural’, ‘nature-identical’, ‘artificial’ or a combination of these words, as appropriate. (13) The provision in sub-regulation 12 of this regulation, does not apply to flavour modifiers, but applies to ‘herbs’ and ‘spices’ of which generic expressions may be used. 8. Adequate information shall be given about the manner in which the food additive is to be kept and is to be used in food. 9.—(1) For a food additive carried over into a food in significant quantity or in an amount sufficient to perform a technological function in that food as a result of the use of raw materials or other ingredients in which the additive was used, it shall be included in the lists of ingredients. (2) For a food additive carried over into foods at a level less than that required to achieve a technological function, processing aids are exempted from declaration in the list of ingredients. B 3085 Instructions on storage and use. Processing aids and carry-over of food additives. B 3086 Conditions for a request to add to or change food additives. Restriction on sale of baby foods containing food additives. Conditions for allowing more than one preservative. lonizing radiation. Offences and Penalties. 10. A person who wish to request for food additive to be added to or a change to be made to a food product, shall submit such request to the Agency ina form, manner and content satisfactory to the Agency, which shall include— (a) adescription of the food additive including its chemical name and the name under which it is proposed to be sold, method of its manufacture, chemical and physical properties, composition and specifications ; (b) a statement of the amount of the food additive for use and the purpose for which it is proposed to be used, together with all directions, recommendations and suggestions for use ; (c) where necessary, in the opinion of the Agency, an acceptable method of analysis suitable for regulatory purposes that shall determine the amount of food additive in any substance arising from the use of the food additive ; (d) data establishing that the food additive shall have the intended physical or other technical effect ; (e) detailed reports of test method to establish the safety of the food additive under the conditions of use recommended ; (f) data to indicate the residues that may remain in or on the finished food, when the food additive is used in accordance with good manufacturing practice ; (g) aproposed maximum limit for residues of the food additive in or on the finished food ; (A) specimen of the labeling proposed for the food additive ; and (‘) asample of the food additive in the form in which it is proposed to be used in foods and on request, a sample of food containing the food additives. 11. A person shall not manufacture, import, export distribute, advertise, display for sale or sell a food that is presented for use by babies, if the food contains food additives, unless permission for such use has been granted by the Agency. 12. Where more than one preservative is used in a food, the sum of the ratios of the quantities of each preservative present in the product to the quantities permitted in the product shall be as prescribed by the Agency. 13. Food additives which have been treated with ionizing radiation shall be so designated and incompliance with the Food Irradiation Regulations of the Agency. 14.—(1) A person who contravenes any of the provisions of these Regulations commits an offence and liable on conviction, inthe case of — (a) an individual, to imprisonment for a term not exceeding | year or to a fine not exceeding N800,000.00 or to both ; and (b) a body corporate, to a fine not exceeding N5,000,000.00. (2) Where an offence under these Regulations is committed by a body corporate, firm or other association of individuals, a— (a) director, manager, secretary or other similar officer of the body corporate ; (b) partner or officer of the firm ; (c) trustee of the body concerned ; (d) person concerned in the management of the affairs of the association ; or (e) person who purports to act in a capacity referred to in paragraphs (a) to (d) of this sub-regulation, is liable to be proceeded against and punished for the offence in the same manner as if the person committed the offence, unless the person proves that the act or omission constituting the offence took place without his knowledge, consent or connivance. 15. A person convicted of an offence under these Regulations shall forfeit to the Federal Government— (a) any asset or property constituting proceeds derived from or obtained, directly or indirectly, as a result of the offence ; and (5) any of the person’s property or instrumentalities used in any manner to commit or to facilitate the commission of the offence. 16.—(1) The Food Additives Regulations 2005 is revoked. (2) The revocation of the Regulations specified in sub-regulation (1) of this regulation shall not affect anything done or purported to be done under the revoked Regulations. 17. The Agency shall be responsible for the enforcement of these Regulations. 18. In these Regulations— “Agency” means National Agency for Food and Drug Administration and Control ; “Container” means any form of packaging of food additives for sale as a single item, whether by completely or partially enclosing the food additives, and includes wrappers ; B 3087 Forfeiture after conviction. Revocation. Enforcement of these Regulations. Interpretation. Citation. B 3088 “Flavour modifier” means a flavouring substance with modifying properties that changes individual orangoleptic characteristic of a food product but does not produce and overall enhancement of all the sensorial properties ; “Container” means any form of packaging of food for sale as a single item whether by completely or partially enclosing the food and includes wrappers, but does not include leaves traditionally used as food wrappers. A container may enclose several units or types of packages when such is offered to the consumer ; “Contaminant” means any substance not intentionally added to food, which is present in such food as a result of the production,(including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination ; “Food additive” means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological(including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or maybe reasonably expected to result,directly or indirectly, in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods, reference to food addition shall include food processing Aids and the term does not include contaminants, or substances added to food for maintaining or improving nutritional qualities, or sodium chloride ; “Food” means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes water and other drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs ; “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to a package or container of food ; “Labeling” includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including promoting its sale or disposal ; “Proceeds” means any property derived or obtained, directly or indirectly, through the commission of the offence ; “Processing aid” means a substance or material not including apparatus or utensils and not consumed as a food ingredient by itself, intentionally B 3089 used in the processing of raw materials, foods or its ingredients to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product ; “Retail” means any sale to a person buying otherwise than for the purpose of resale but does not include a sale to caterers for the purposes of their catering business or a sale to manufacturers for the purposes of their manufacturing business ; and ° “Synthetic colour” means any organic colour, other than caramel, that is produced by chemical synthesis and has no counterpart in nature. 19. These Regulation shall be cited as the Food Additives Citation. Regulations, 2021. Mabe at Abuja this 7th day of July, 2021 Dr. OsaGie E. EHANIRE, MD, FWACS Honourable Minister of Health