Legal Document
ARRANGEMENT OF SECTIONS
PRELIMINARY
Section
1. Short title
2. Interpretation
GENERAL PROVISIONS
3. Prohibition against sale of poisonous, unwholesome or adulterated food
4. Deception
5. Standards of foods
6. Prohibition against sale of food not of the nature, substance or quality demanded
7. Sale and preparation of food under insanitary conditions
8. Prohibited sale of drugs
9. Deception
10. Standards of drugs
11. Prohibition against sale of drugs not of the nature, substance or quality demanded
12. Sale and preparation of drugs under insanitary conditions
13. Prohibited sale of cosmetics
14. Standards of cosmetics
15. Sale and preparation of cosmetics under insanitary conditions
16. Prohibited sale of devices
17. Deception
Section
18. Standards of devices
19. Sale and preparation of devices under insanitary conditions
IMPORTATION AND WARRANTY
20. Importation
21. Warranty
ADMINISTRATION AND ENFORCEMENT
22. Food and Drugs Board
23. Regulations
24. Powers of authorised officers
25. Appointment and duties of public analyst
26. Power of Director of Medical Services
27. Duty of local authority to enforce Act
28. Power of Minister to obtain particulars of certain food or drug ingredients
LEGAL PROCEEDINGS
29. Power of court to order licence to be cancelled and articles to be disposed of
30. Prosecution
31. Penalties
32. Certificates of analysis and presumptions
33. Saving of other written laws
34. Minister's power to amend Schedule
SCHEDULE-Publications
CHAPTER 303
FOOD AND DRUGS
An Act to protect the public against health hazards and fraud in the sale and use of food, drugs, cosmetics and medical devices; and to provide for matters incidental thereto or connected therewith.
[1st December, 1972]
PRELIMINARY
1. This Act may be cited as the Food and Drugs Act.
2. In this Act, unless the context otherwise requires-
"advertisement" includes any representation by any means whatsoever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device;
"article" includes-
(a) any food, drug, cosmetic or device and any labelling or advertising materials in respect thereof; or
(b) anything used for the preparation, preservation, packing or storing of any food, drug, cosmetic or device;
"authorised officer" means a Medical Officer of Health, a Health Inspector, or any suitably qualified person authorised in writing by the Minister or by a local authority with the approval of the Minister for the purposes of this Act, and-
(a) for the purpose of taking of samples under sections twenty-four and twenty-six and sending them to a public analyst, and for receiving reports thereof under section twenty-five, includes a police officer of or above the rank of Assistant Inspector and an officer of the Department of Customs and Excise authorised in that behalf by the Controller of Customs and Excise;
(b) for the purpose of exercising control in respect of drugs, cosmetics or devices, includes an inspector as defined in the Dangerous Drugs Act; and
(c) for the purpose of any proceedings under section thirty, includes the principal officer as defined in the Local Government Act;
"Board" means the Food and Drugs Board established by section twenty-two;
"cosmetic" includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair, eyes, teeth or nails, and includes deodorants and perfumes;
"device" means any instrument, apparatus or contrivance, including components, parts and accessories thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in man or animal;
"drug" includes-
(a) any substance included in any publication mentioned in the Schedule; and
(b) any substance or mixture of substances prepared, sold or represented for use in-
(i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof, in man or animal; or
(ii) restoring, correcting or modifying organic functions in man or animal;
"food" includes any article manufactured, sold or represented for use as food or drink for human consumption, chewing gum, and any ingredient of such food, drink or chewing gum;
"Health Inspector" has the meaning assigned to it in the Public Health Act; Cap. 295
"insanitary conditions" means such conditions or circumstances as might cause contamination of a food, a drug or a cosmetic with dirt or filth or might render the same injurious or dangerous to health;
"label" includes any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to or included in, belonging to, or accompanying any food, drug, cosmetic or device;
"local authority" means-
(a) a municipal council; or
(b) a township council; or
(c) a rural council; or
"Medical Officer of Health" has the meaning assigned to it in the Public Health Act;
"municipal council", "District Council" and "township council" have the meanings assigned respectively thereto in section two of the Local Government Act;
"package" includes anything in which any food, drug, cosmetic or device is wholly or partly placed or packed, and includes any basket, pail, tray or receptacle of any kind, whether open or closed;
"premises" includes-
(a) any building or tent or other structures, permanent or otherwise, together with the land on which the same is situated and any adjoining land used in connection therewith, and includes any vehicle, conveyance or vessel; and
(b) for the purpose of section twenty-four, a reference to premises shall be deemed to include reference to any street, open space or place of public resort, bicycle or other vehicle used for the preparation,
preservation, packaging, storage or conveyance of any article;
"preparation" includes manufacture and any form of treatment, and "prepare" shall be construed accordingly;
"public analyst" means a person appointed by the Minister, or by a local authority with the approval of the Minister, to act as an analyst for the purposes of this Act;
"sell" includes offer, advertise, keep, expose, transmit, convey, deliver or prepare for sale or exchange, dispose of for any consideration whatsoever, or transmit, convey or deliver in pursuance of a sale, exchange or disposal as aforesaid;
"ship" includes any boat or craft;
"subordinate court" means a subordinate court constituted under the Subordinate Courts Act;
"substance" includes liquid and gas.
GENERAL PROVISIONS
3. Any person who sells any food that-
(a) has in or upon it any poisonous or harmful substance; or
(b) consists in whole or in part of any filthy, putrid, rotten, decomposed or diseased substance or foreign matter, or is otherwise unfit for human consumption; or
(c) is adulterated;
shall be guilty of an offence.
4. Any person who labels, packages, treats, processes, sells or advertises any food in a manner that is false, misleading or deceptive as regards its character, nature, value, substance, quality, composition, merit or safety, or in contravention of any regulations made under this Act, shall be guilty of an offence.
5. Where a standard has been prescribed for any food, any person who labels, packages, sells or advertises any food which does not comply with that standard, in such a manner that it is likely to be mistaken for food of the prescribed standard, shall be guilty of an offence.
6. Any person who sells to the prejudice of the purchaser any food which is not of the nature, or is not of the substance, or is not of the quality, of the article demanded by the purchaser, shall be guilty of an offence.
7. Any person who sells, prepares, packages or stores for sale any food under insanitary conditions shall be guilty of an offence.
8. Any person who sells any drug that-
(a) is adulterated; or
(b) consists in whole or in part of any filthy, putrid, rotten, decomposed or diseased substance or foreign matter;
shall be guilty of an offence.
9. Any person who labels, packages, treats, processes, sells or advertises any drug in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merit or safety, or in contravention of any regulations made under this Act, shall be guilty of an offence.
10. (1) Where a standard has been prescribed for a drug, any person who labels, packages, sells or advertises any substance in such a manner that it is likely to be mistaken for that drug shall be guilty of an offence unless the substance is the drug in question and complies with the prescribed standard.
(2) Where a standard has not been prescribed for a drug but a standard for the drug is contained in any of the publications specified in the Schedule, any person who labels,
packages, sells or advertises any other substance or article in such manner that it is likely to be mistaken for such drug shall be guilty of an offence.
(3) Any person who labels, packages, sells or advertises any drug for which no standard has been prescribed or for which no standard is contained in any of the publications specified in the Schedule, shall be guilty of an offence unless such drug-
(a) is in accordance with the professed standard under which it is labelled, packaged, sold or advertised; and
(b) does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or which is contained in any of the publications specified in the Schedule.
11. Any person who sells to the prejudice of the purchaser any drug which is not of the nature, or is not of the substance, or is not of the quality, of the article demanded by the purchaser, shall be guilty of an offence.
12. Any person who sells, prepares, packages or stores for sale any drug under insanitary conditions shall be guilty of an offence.
13. Any person who sells any cosmetic that-
(a) has in or upon it any substance that may cause injury to the health of the user when the cosmetic is used-
(i) according to the direction on the label of or accompanying such cosmetic; or
(ii) for such purposes and by such methods of use as are customary or usual therefor; or
(b) consists in whole or in part of any filthy, rotten, decomposed or diseased substance or of any injurious foreign matter; or
(c) was prepared, preserved, packed or stored under insanitary conditions; shall be guilty of an offence.
14. Where a standard has been prescribed for a cosmetic, any person who labels, packages, sells or advertises any article in such a manner that it is likely to be mistaken for a cosmetic of the prescribed standard shall be guilty of an offence unless the article complies with the prescribed standard.
15. Any person who sells, prepares, packages or stores for sale any cosmetic under insanitary conditions shall be guilty of an offence.
16. Any person who sells any device that, when used according to directions on the label or contained in a separate document delivered with the device or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof shall be guilty of an offence.
17. Any person who labels, packages, treats, processes, sells or advertises any device in a manner that is false, misleading or deceptive as regards its character, value, composition, merit or safety, or in contravention of any regulations made under this Act, shall be guilty of an offence.
18. Where a standard has been prescribed for a device, any person who labels, packages, sells or advertises any article in such a manner that it is likely to be mistaken for that device shall be guilty of an offence unless the article complies with the prescribed standard.
19. Any person who sells, prepares, packages, or stores for sale any device under insanitary conditions shall be guilty of an offence.
IMPORTATION AND WARRANTY
20. (1) Subject to the provisions of subsection (2), the importation of any article which does not comply with the provisions of this Act is hereby prohibited.
(2) Where an article sought to be imported into Zambia would, if sold in Zambia, constitute a contravention of this Act, the article may be imported into Zambia for the purposes of satisfactorily relabelling or reconditioning the same so that the provisions of this Act are complied with and, where such relabelling or reconditioning is not carried out within three months of the importation, such article shall be exported by the importer within a further period of one month or such other period as the Minister may determine and, where it is not so exported, it shall be forfeited and disposed of as the Minister may direct.
21. (1) No manufacturer or distributor of, or dealer in, any article shall sell such
article to any vendor unless he gives a warranty in writing in the prescribed form about the nature and quality of such article to the vendor.
(2) If any person contravenes the provisions of subsection (1) or gives a warranty which is false, he shall be guilty of an offence.
ADMINISTRATION AND ENFORCEMENT
22. (1) The Minister shall, as soon as may be after the commencement of this Act, constitute a Board called the Food and Drugs Board to advise the Minister on matters arising out of the administration of this Act and to carry out such other functions as may be assigned to it under this Act.
(2) The Board shall consist of the following members:
(a) the Permanent Secretary, Ministry of Health, ex officio, who shall be the chairman;
(b) the Secretary-General of the National Council for Scientific Research, ex officio;
(c) the Chief Health Inspector employed in the Ministry of Health, ex officio;
(d) the Chief Pharmacist employed in the Ministry of Health, ex officio;
(e) one public analyst nominated by the Minister;
(f) one member representing the National Food and Nutrition Commission established under section three of the National Food and Nutrition Commission Act, and nominated by the Commission;
(g) one member nominated by the Minister from amongst the Medical Officers of Health employed by local authorities;
(h) one member who is a person connected with or dealing in the food industry nominated by the Minister;
(i) one member nominated by the Minister from amongst persons who are members of the Pharmaceutical Society of Zambia; and
(j) one member of the Zambian Bureau of Standards Board nominated by the said Board
(3) A member of the Board who is not an ex officio member shall, unless his office becomes vacant earlier by resignation, death or otherwise, be entitled to hold office for three years and shall be eligible for renomination.
(4) The quorum of the Board shall be five.
(5) The Board may invite any person to attend any particular meeting for the purpose of assisting or advising the Board, but no such person shall have any right to vote at such meeting.
(6) The Board may appoint one or more committees of the Board consisting of such number of persons, whether members of the Board or not, as it may deem necessary to assist it in the exercise of its functions, provided that the Board shall not delegate any of the powers conferred upon it under this Act to any such committee.
(7) The Board may, subject to any written direction of the Minister, regulate its own procedure and the transactions of its business as well as the work and procedure of the committees appointed by it.
(8) The Minister may appoint a public officer as secretary to the Board, who shall be the Chief Executive Officer of the Board, and it shall be his duty to assist the Board in all respects and in such manner as the Board may from time to time require in the discharge of its functions and the carrying out of its activities under this Act.
23. (1) Subject to the provisions of subsection (2), the Minister may, after
consultation with the Board, by statutory instrument, make regulations-
(a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substance is present therein or has been added thereto or extracted or omitted therefrom;
(b) respecting-
(i) the labelling and packing and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices;
(ii) the size, dimensions and other specifications of packages of food, drugs, cosmetics and devices;
(iii) the sale or the conditions of sale of any food, drug, cosmetic or device; and
(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device, to prevent the consumer or purchaser thereof from being deceived or misled as to its quality, quantity, character, value, composition, effect, merit or safety or to prevent injury to the health of the consumer or purchaser;
(c) prescribing standards of composition, strength, potency, purity, quality or other property of any food, drug, cosmetic or device;
(d) respecting the importation or exportation of food, drugs, cosmetics and devices in order to ensure compliance with this Act;
(e) respecting the method of preparation, preserving, packing, storing, conveying and testing of any food, drug, cosmetic or device in the interests of, or for the prevention of injury to, the health of the consumer, user or purchaser;
(f) respecting the carriage of goods subject to the provisions of this Act, including the licensing of vehicles used in such carriage;
(g) requiring persons who sell food, drugs, cosmetics or devices to maintain such books and records as the Board considers necessary for the proper enforcement and administration of this Act;
(h) requiring manufacturers of any drugs to submit test portions of any batch of such drugs;
(i) providing for the analysis or examination of food, drugs, cosmetics or devices for the purposes of this Act or for any other purpose and prescribing a tariff of fees to be paid for such analysis and prescribing methods of analysis;
(j) providing for the taking of samples of any article for the purposes of this Act or for any other purposes;
(k) exempting any food, drug, cosmetic or device from all or any of the provisions of this Act and prescribing the conditions of such exemption; and
(l) prescribing anything which is to be or which may be prescribed under this Act.
(2) Where the Board deems it advisable that any regulations under subsection (1) should be published as a draft thereof with a view to inviting the comments of the public thereon, no such regulations shall be made unless a draft thereof has been published in the Gazette not less than fourteen days before the regulations are made.
(3) Where any regulations made under this Act or under the Public Health Act prohibit or restrict the addition of any ingredient or material to any food, the addition of such ingredient or material, if made in contravention of such regulations, shall, for the purposes of this Act, be deemed to render the food injurious to health.
(4) Where any regulations made under this Act or under the Public Health Act prescribe the composition of any article of food intended for sale, or prohibit or restrict the addition of any ingredient or material to any such article, the purchaser of such article shall, unless the contrary is proved, be deemed, for the purposes of this section, to have demanded an article complying with the provisions of such regulations as regards the presence or amount of any constituent, ingredient or material specified in the said regulations.
(5) The Minister may, by statutory instrument, after consultation with the Board, make regulations generally for carrying out any of the purposes or provisions of this Act.
24. (1) An authorised officer may, at any hour reasonable for the proper performance of his duty-
(a) enter any premises where he believes any article to which this Act applies is prepared, preserved, packaged, stored or conveyed, examine any such article and take samples thereof, and examine anything that he believes is used or capable of being used for such preparation, preservation, packaging, storing or conveying;
(b) stop or search or detain any aircraft, ship or vehicle in which he believes on reasonable grounds that any article subject to the provisions of this Act is being conveyed and examine any such article and take samples thereof for the purposes of this Act;
(c) open and examine any receptacle or package which he believes contains any article to which this Act applies;
(d) examine any books, documents or other records found in any premises mentioned in paragraph (a) that he believes contain any information relevant to the enforcement of this Act with respect to any article to which this Act applies and make copies thereof or take extracts therefrom; and
(e) seize and detain for such time as may be necessary any article by means of or in relation to which he believes any provision of this Act has been contravened.
(2) An authorised officer acting under this section shall, if so required, produce his authority.
(3) Any owner, occupier or person in charge of any premises entered by an authorised officer pursuant to subsection (1) (a), or any person found therein, who does not give to the authorised officer all reasonable assistance in his power and furnish him with such information as he may reasonably require, shall be guilty of an offence.
(4) Any person who obstructs or impedes any authorised officer in the course of his duties, or prevents or attempts to prevent the execution by the authorised officer of his duty under this Act, shall be guilty of an offence.
(5) Any person who knowingly makes any false or misleading statement, either verbally or in writing, to any authorised officer engaged in carrying out his duties under this Act shall be guilty of an offence.
(6) An authorised officer shall release any article seized by him under this Act when he is satisfied that all the provisions of this Act with respect thereto have been complied with.
(7) Where an authorised officer has seized an article under this Act and the owner thereof or the person in whose possession the article was at the time of seizure consents to the destruction thereof, the article may be destroyed or otherwise disposed of as the authorised officer may direct; if the owner or the person does not consent to the destruction of the article, the authorised officer may apply to a subordinate court for the destruction or disposal of such article and the subordinate court may make such order as it may deem fit.
(8) Where any article has been seized under the provisions of subsection (1) (e) and the owner thereof has been convicted of an offence under this Act, the article may be destroyed or otherwise disposed of as the court may direct.
(9) Any person who removes, alters or interferes in any way with any article seized under this Act, without the authority of an authorised officer, shall be guilty of an offence.
(10) Any article seized under this Act may, at the option of an authorised officer, be kept or stored in the premises where it was seized or may, at the direction of an authorised officer, be removed to any other proper place.
(11) An authorised officer may submit any article seized by him or any sample therefrom or any sample taken by him to a public analyst for analysis or examination.
25. (1) No person shall be appointed to be a public analyst for any area in which he is engaged directly or indirectly in any trade or business connected with the sale of food, drugs, cosmetics and devices.
(2) A public analyst shall as soon as practicable analyse or examine any sample sent to him in pursuance of this Act and shall give the authorised officer a certificate specifying the result of the analysis or examination, and such certificate shall be in such form as may be prescribed by the Minister on the advice of the Board.
26. The Director of Medical Services may, in relation to any matter appearing to him to affect the general interests of the consumer, direct a public officer to procure for analysis samples of any food, drug, device and cosmetic, and thereupon that officer shall have all the powers of an authorised officer under this Act, and this Act shall apply as if the officer were an authorised officer.
27. (1) It shall be the duty of every local authority to exercise such powers as are conferred upon it and in particular to direct its officers to procure samples for analysis.
(2) If the Minister is of the opinion that a local authority has failed to execute or enforce any of the provisions of this Act in relation to any article and that its failure affects the general interests of the consumer, the Minister may by order empower an officer to execute and enforce those provisions or to procure the execution and enforcement thereof in relation to any article mentioned in the order.
(3) The expenses incurred as a result of any order under subsection (2) shall be recoverable by the Minister from the local authority and the amount so recovered shall be treated as expenses incurred by the local authority under this Act.
28. (1) The Minister may direct any person who at the date of the direction or at any subsequent time carries on a business which includes the production, importation or use of any substances to which this Act applies to furnish to him, within such time as may be specified in such direction, such particulars, as may be so specified, of the composition and use of any such substance sold or for sale in the course of that business or used in the preparation of food or drugs.
(2) Without prejudice to the generality of subsection (1), a direction made thereunder may require the following particulars to be furnished in respect of any substance, that is to say:
(a) particulars of the composition and chemical formula of the substance;
(b) particulars of the manner in which the substance is used or proposed to be used in the preparation of food;
(c) particulars of any investigations carried out by or to the knowledge of the person carrying on the business in question, for the purpose of determining whether and to what extent the substance, or any product formed when the substance is used as aforesaid, is injurious to, or in any other way affects, health;
(d) particulars of any investigation, or inquiries carried out by or to the knowledge of the person carrying on the business in question, for the purpose of determining the cumulative effect on the health of a person consuming the substance in ordinary quantities.
(3) No particulars furnished in accordance with a direction under this section and no information relating to any individual business obtained by means of such particulars shall, without the previous consent in writing of the person carrying on the business in question, be disclosed by any person except in due discharge of his duties under this Act, and any person who discloses any such particulars or information in contravention of this subsection shall be guilty of an offence.
LEGAL PROCEEDINGS
29. (1) On the conviction of any person for any offence under this Act, the court may, in addition to any other penalty which it may lawfully impose, cancel any licence issued to such person under any written law.
(2) Where a person has been convicted of an offence under this Act, the court may order that any article by means of or in relation to which the offence was committed, or anything of a similar nature belonging to or in the possession of the convicted person or found with such article, be forfeited, and, upon such order being made, such articles and things may be disposed of as the court may direct.
30. (1) Where a public analyst, having analysed or examined any article to which this Act applies, has given his certificate and from that certificate it appears that an offence under this Act has been committed, an authorised officer may take proceedings under this Act before any subordinate court having jurisdiction in the place where the article sold was actually delivered to the purchaser or the sample thereof taken.
(2) In any proceedings under this Act, the contents of any package appearing to be intact and in the original state of packing by the manufacturer thereof, shall be deemed, unless the contrary is proved, to be an article of the description specified on the label.
31. (1) In any prosecution under this Act, the summons shall state the particulars of the offence or offences alleged and also the name of the prosecuting officer and shall not be made returnable before fourteen days from the date on which it is served.
(2) A person found guilty of an offence under this Act for which no special penalty is provided shall be liable on conviction-
(a) in the case of a first offence, to a fine not exceeding one thousand penalty
units or to imprisonment for a term not exceeding three months, or to both;
(b) in the case of a subsequent offence, to a fine not exceeding two thousand penalty units or to imprisonment for a term not exceeding six months, or to both;
(As amended by Act No. 13 of 1994)
32. In any proceedings under this Act- Certificates of analysis and presumptions
(a) a certificate of analysis purporting to be signed by a public analyst shall be accepted as prima facie evidence of the facts stated therein, provided that-
(i) the party against whom it is produced may require the attendance of the public analyst for the purposes of cross-examination; and
(ii) no such certificate of a public analyst shall be received in evidence unless the party intending to produce it has, before the trial, given the party against whom it is intended to be produced reasonable notice of such intention together with a copy of the certificate;
(b) evidence that the package contains any article to which this Act applies, bore a name, address or registered mark of the person by whom it was manufactured or packed shall be prima facie evidence that such article was manufactured or packed, as the case may be, by that person;
(c) any substance commonly used for human consumption shall, if sold or offered, exposed or kept for sale, be presumed, until the contrary is proved, to have been sold or, as the case may be, to have been or to be intended for sale for human consumption;
(d) any substance commonly used for human consumption which is found on premises used for the preparation, storage or sale of that substance, and any substance commonly used in the manufacture of products for human consumption which is found on premises used for the preparation, storage or sale of those products, shall be presumed, until the contrary is proved, to be intended for sale, or for manufacturing products for sale, for human consumption;
(e) any substance capable of being used in the composition or preparation of any substance commonly used for human consumption which is found on premises on which that substance is prepared shall, until the contrary is proved, be presumed to be intended for such use.
33. The provisions of this Act shall be in addition to and not in derogation of the provisions of any other written law.
34. The Minister may, by statutory order, amend the Schedule.
(Sections 2 and 10)
PUBLICATIONS
The current editions of:
Name Abbreviation
Pharmacopoeia Internationalis (Ph.I.)
The British Pharmacopoeia (B.P.)
The Pharmacopoeia of the United States of America (U.S.P.)
Codex Francais (Codex)
The Canadian Formulary (C.F.)
The British Pharmaceutical Codex (B.P.C.)
The National Formulary (N.F.)
The British Veterinary Codex (B.Vet.C.)
FOOD AND DRUGS
SECTION 23-THE FOOD AND DRUGS (WARRANTY) REGULATIONS
Regulations by the Minister after consultation with the Food and Drugs Board
1. These Regulations may be cited as the Food and Drugs (Warranty Regulations).
2. No manufacturer or distributor of, or dealer in, any article shall sell such article to a vendor unless he gives to the vendor a warranty in a form set out in the Schedule and applicable to such sale.
SCHEDULE
(Regulation 2)
PRESCRIBED FORMS
THE FOOD AND DRUGS* REGULATIONS
ARRANGEMENT OF REGULATIONS
PRELIMINARY AND GENERAL
Regulation
1. Title and commencement
2. Interpretation
3. Application
4. Power to delegate
5. Copies of prescribed methods to be furnished
6. Reference by one name deemed reference by any other
7. Manner of designating lot or batch number
8. Language on label to include English
9. All information required on label to be prominently displayed and discernible
10. Jurisdiction of authorised officer
11. Authorised officer to have identification
12. Power to take photographs
13. Prohibition on selling to vendor without warranty
14. Formalities for taking sample by, and form of certificate of analysis or examination given by public analyst to, authorised officer
15. Interpretation of terms in Part II
16. Licence required for use of premises for sale or manufacture of food
17. Validity of permit or licence
18. Application for licence
19. Licence not to be granted except where facilities comply with regulations 410 to 422
20. Renewal or grant of licence may be refused
21. Licence not transferable
*The part of these Regulations dealing with Drugs, Cosmetics and Devices, other than Part I hereof, is to be published separately.
22. Composition of standardised food
23. Unstandardised food to contain only permitted additives and in quantities within prescribed limits
24. Use of additives not conforming to prescribed specifications prohibited in food
25. When food is adulterated
26. Exceptions to regulation 25
27. Restriction on sale of babies' food containing food additive
28. Package intended to hold food to be used for no other purpose
29. Package not intended to hold food not to be used to hold food
30. Prohibition from sale of unlabelled food
31. Declaration to be included in label
32. Label information not to be at bottom of container
33. Manner of displaying multi-worded common name and declaration of net contents
34. Waiver of declaration of net contents of certain packages
35. Position or size of letters of declaration of net contents not to apply on labels of certain foods
36. Label declaration to appear on inner and outer labels
37. Restriction on referring to this Act on label or in advertisement
38. In certain cases food may be sold unlabelled and label declaration dispensed with
39. Acceptable common names of certain foods for purpose of regulation 31 (b) (iv)
40. Label declaration not required to indicate presence of caramel as food colour in certain foods
41. Label declaration not required to indicate presence of added flavouring preparation in certain foods
42. Specific label requirement in prescribed standard for food also to be followed
43. Misleading description or presentation on label prohibited
44. Country of origin of food to be declared
FIRST SCHEDULE-Warranty and form of certificate of analysis or examination
PART I-Warranty
PART II-Form of Certificate of Analysis or Examination
SECOND SCHEDULE-Common names and acceptable common names of certain foods for purpose of regulation 31 (b) (iv)
PART I-Common names
Regulation
PART II-Acceptable common names of certain foods for purpose of regulation 31 (b) (iv)
THIRD SCHEDULE-Varieties of types of recognised cheese and their minimum milk fat contents on the dry basis
FOURTH SCHEDULE-Composition and quality factors of arachis oil
FIFTH SCHEDULE-Composition and quality factors of cottonseed oil
SIXTH SCHEDULE-Composition and quality factors of maize oil
SEVENTH SCHEDULE-Composition and quality factors of mustardseed oil
EIGHTH SCHEDULE-Composition and quality factors of olive oil
NINTH SCHEDULE-Composition and quality factors of rapeseed oil
TENTH SCHEDULE-Composition and quality factors of safflowerseed oil
ELEVENTH SCHEDULE-Composition and quality factors of sesameseed oil
TWELFTH SCHEDULE-Composition and quality factors of soya bean oil
THIRTEENTH SCHEDULE-Composition and quality factors of sunflowerseed oil
FOURTEENTH SCHEDULE-Composition and quality factors of refined oil
FIFTEENTH SCHEDULE-Composition and quality factors of lard
SIXTEENTH SCHEDULE-Composition and quality factors of edible tallow
SEVENTEENTH SCHEDULE-Use of and limits for food colours permitted in canned vegetables and canned fruits
PART I-Use of and limits for food colours permitted in canned vegetables
PART II-Use of and limits for food colours permitted in canned fruits
EIGHTEENTH SCHEDULE-Exemption limits for poisonous or harmful substances in food for sale
NINETEENTH SCHEDULE-Substances that may be used as food additives
Part I-Food additives that may be used as anticaking agents
Part II-Food additives that may be used as bleaching, maturing and dough
conditioning agents
Part III-Food additives that may be used as colouring agents
Part IV-Food additives that may be used as emulsifying, gelling, stabilising, and thickening agents
Part V-Food additives that may be used as food enzymes
Part VI-Food additives that may be used as firming agents
Part VII-Food additives that may be used as glazing and polishing agents
Part VIII-Miscellaneous food additives
Regulation
Part IX-Food additives that may be used as non-nutritive sweetening agents
Part X-Food additives that may be used as pH adjusting agents, acid-reacting materials and water correcting agents
Part XIA-Food additives that may be used as Class I Preservatives
B-Food additives that may be used as Class II Preservatives
C-Food additives that may be used as Class III Preservatives
D-Food additives that may be used as Class IV Preservatives
Part XII-Food additives that may be used as sequestering agents
Part XIII-Food additives that may be used as starch modifying agents
Part XIV-Food additives that may be used as yeast foods
TWENTIETH SCHEDULE-Reasonable daily intake for various foods
TWENTY-FIRST SCHEDULE-Foods to which vitamin mineral nutrient or amino acid may be added
TWENTY-SECOND SCHEDULE-Statutory instruments revoked
SECTION 23-FOOD AND DRUGS REGULATIONS
Regulations by the Minister after consultation with the Food and Drugs Board
PRELIMINARY AND GENERAL
1. (1) These Regulations may be cited as the Food and Drugs Regulations.
(2) These Regulations shall come into operation-
(a) except in respect of regulations 30 to 49 and regulation 299, on the expiration of a period of six months after the day on which they shall be published in the Gazette;
(b) in respect of regulations 30 to 49 and regulation 299, on the expiration of a period of twelve months after the day on which they shall be published in the Gazette.
2. In these Regulations, unless the context otherwise requires- Interpretation
"Act" means the Food and Drugs Act;
"cubic centimetre" and its abbreviation "cc", shall be deemed to be interchangeable with the term "millilitre" and its abbreviation "ml";
"inner label" means the label on or affixed to an immediate container of a food, drug, cosmetic or device;
"lot number" means any combination of letters, figures, or both, by which any food, drug or device can be traced in manufacture and identified in distribution;
"manufacturer" means a person who, under his own name, or under a trade, design or word mark, trade name or other name, word or mark controlled by him, sells a food, drug, cosmetic or device;
"outer label" means the label on or affixed to the outside of a package of food, drug, cosmetic or device;
"prescribed method" means a method of analysis or examination which shall be used as indicated.
3. These Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the article of food, drug, cosmetic or device to which they refer.
4. The Minister may, by writing under his hand, delegate his authority as he deems fit.
5. The Minister shall, upon request, furnish copies of prescribed methods.
6. Where a food, drug, cosmetic or device has more than one name, whether proper or common, a reference in these Regulations to the food, drug, cosmetic or device by any of its names is deemed to be a reference to the food, drug, cosmetic or device by all of its names.
7. When a lot or batch number is required by these Regulations to appear on any article, container, package or label it shall be preceded by one of the following designations:
(a) "lot number" or "batch number";
(b) "lot no." or "batch no.";
(c) "lot" or "batch";
8. (1) Any statement, information or declaration that is required by these Regulations to appear on the label of any food, drug, cosmetic or device, shall be in the English language.
(2) Any other language may be used in addition to English.
9. All information required by these Regulations to appear on a label of a food, drug, cosmetic or device shall be-
(a) clearly and prominently displayed on the label; and
(b) readily discernible to the purchaser, customer or recipient under the customary conditions of purchase or use.
10. Within limits specified by the Minister, the authority of an authorised officer extends to and includes the whole of Zambia.
11. Every authorised officer shall have a suitable identification to indicate that he has been appointed as an authorised officer.
12. An authorised officer may take photographs of such premises and such articles referred to in section twenty-four of the Act as may be relevant to the administration of the Act.
13. No manufacturer or distributor of, or dealer in, any article shall sell such article to a vendor unless he gives to the vendor a warranty in Form 1 or Form 2 in Part I of the First Schedule and applicable to such sale.
14. (1) When taking a sample pursuant to section twenty-four of the Act, an authorised officer shall-
(a) notify the owner thereof, or the person from whom the sample is obtained, of the fact that the sample is so taken and that, if he considers it necessary, he would submit the sample to a public analyst for analysis or examination;
(b) identify the entire quantity as the sample;
(c) seal the sample in such a manner that it cannot be opened without breaking the seal; and
(d) forward the sample to a public analyst for analysis or examination.
(2) A public analyst after analysis or examination of a sample sent to him shall give the authorised officer a certificate, specifying the result of analysis or examination, in a form in Part II of the First Schedule.
15. In this Part, unless the context otherwise requires-
"close proximity" means, with reference to the common name, immediately adjacent to the common name without any intervening, printed, written or graphic matter;
"common name" means, with reference to food, any name set out in column 2 of Part I of the Second Schedule and referred to in the regualation set out in column 3 opposite thereto or, if the name is not so set out, any name in English by which that food is generally known;
"component" means any substance which forms part of an ingredient;
"flavouring preparation" includes any food for which a standard is provided in regulations 219 to 243;
"food additive" means any substance, including any source of radiation, the use of which results, or may reasonably be expected to result in it, or its by products becoming a part of affecting the characteristics of a food, but does not include-
(a) any nutritive material that is used, recognised, or commonly sold as an article or ingredient of food;
(b) vitamins, mineral nutrients and amino acids;
(c) species, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives;
(d) pesticides;
(e) packaging materials and components thereof; and
(f) drugs in foods from animal sources;
"food colour" means those colours permitted for use in or upon food by regulation 116;
"gelling agent" includes any food for which a standard is provided in regulations 282 and 283;
"ingredient" means any substance, including a food additive, used in the manufacture or preparation of a food and present in the final product;
"per centum" means per centum by weight, unless otherwise stated, and may be symbolised as %;
"licence" means a licence granted under regulation 16;
"sugar" means sucrose;
"sweeteing agent" includes any food for which a standard is provided in regulations 337 to 343;
"unstandardised food" means any food for which a standard is not prescribed in this Part.
16. No person shall use any premises for sale or manufacture for sale of any food unless he shall first have obtained a licence from the local authority authorising him to use them in such a way:
Provided that this regulation shall not apply to the sale of liquor in any case in which the provisions of the Liquor Licensing Act do not apply.
17. (1) A licence may be issued for a period not exceeding one calendar year and no licence shall continue in force beyond the 31st December of the year in which it was issued.
(2) The permits, licences, or certificates of registration, if any, issued under the regulations revoked by these Regulations and which are in force at the time of the commencement of these Regulations shall be deemed licences issued under regulation 16 of these Regulations.
18. Any person desiring a licence shall send to the local authority a written application on a form to be obtained from the office of the local authority and shall furnish all the information required by such form.
19. No licence shall be granted unless the authorised officer is satisfied that the premises and manufacturing facilities in respect of which such licence is desired comply with regulations 410 to 422.
20. (1) The local authority may refuse to grant or renew any licence, or may grant such licence on such conditions as it may lay down.
(2) A breach of any condition attached to a licence shall be deemed to be a breach of these Regulations.
21. No licence shall be transforable from the premises in respect of which it is granted to any other premises.
22. Where a standard for a food is prescribed in this Part-
(a) the food shall contain only the ingredients included in the standard for that food;
(b) each ingredient shall be incorporated in the food in a quantity within any limits prescribed for that ingredient; and
(c) if the standard permits an ingredient to be used as a food additive for a specified purpose, that ingredient shall be a food set out in one of the Parts of the Nineteenth Schedule for use as an additive to that food for that purpose.
23. Where a standard for a food is not prescribed in this Part-
(a) the food shall not contain any food additives except food additives set out in a Part of the Nineteenth Schedule for use as additives to that food for the purpose set out, except in the case of Part VIII of the said Schedule, at the heading to that Part and in the case of Part VIII of the said Schedule, in the column marked "column 4" thereof;
(b) each such food additive shall be incorporated in the food in a quantity within any limits prescribed for that food and food additive in that Part.
24. Where an ingredient is permitted to be used as a food additive in or upon a food, no person shall use that food additive unless-
(a) where specifications are set out for that additive in this Part, it meets those specifications; and
(b) where no specifications are set out for that additive in this Part but specifications are set out for that additive in publication 1406, "Food Chemical Codex", published by the National Academy of Sciences Natural Research Council of the United States of America, it meets those specifications.
25. Subject to the provisions of regulation 26, a food is adulterated if any of the following substances or classes of substances are present therein or have been added thereto:
(a) mineral oil or paraffin wax or any preparation thereof;
(b) coumarin, an extract of tonka beans, the seed of Dipteryx odorate Willd. Or Dipteryx oppositifolia Willd,;
(c) non-nutritive sweetening agents other than saccharin or its salts;
(d) cottonseed flour that contains more than four hundred and fifty parts per million of free gossypol;
(e) fatty acids and their salts containing chicken-oedema factor or other toxic factors;
(f) dihydrosafrole;
(g) isosafrole;
(h) oil of American sassafras from Sassfras albidum (Nutt). Nees;
(i) oil of Brazilian sassafras from Octes Sp. H.B.K.;
(j) oil of camphor sassafras from Cinnamonum Camphorum Sieb;
(k) oil of micranthum from Cinnamomum micranthum Hayata;
(l) safrole; or
(m) oil, extract, root or Rhizome of calamus from Acorus calamus L.
26. Nothwithstanding anything contained in regulation 25-
(a) a food is not adulterated if it contains less than 0.3 per centum of mineral oil, if good manufacturing practices require the use of mineral oil;
(b) chewing gum is not adulterated by reason only that it contains a paraffin wax base;
(c) fresh fruits and vegetables, except turnips, are not adulterated if they are coated with less than 0.3 per centum of paraffin wax and petrolatum, if good manufacturing practices require the use of such coating; and
(d) turnips and cheese are not adulterated if they are coated with paraffin wax in accordance with good manufacturing practice.
27. (1) Subject to the other provisions of this regulation, no person shall sell a food that is represented as for use for babies if the food contains a food additive unless permission for such use has been granted by the Minister.
(2) Sub-regulation (1) shall not apply to-
(a) ascorbic acid used in dry cereals containing bannas; or
(b) soyabean lecithin in rice cereals represented as for use for babies.
28. A package intended, or customarily considered suitable, to hold food shall be used for no other purpose.
29. A package not intended, or not customarily considered suitable, to hold food shall not be used to hold food.
30. Subject to the other provisions of these Regulations, no person shall sell a food unless a label has been applied to that food.
31. (1) The label applied to a food shall carry-
(a) on the main panel-
(i) the brand or trade name, if any of the food;
(ii) the common name of the food; and
(iii) in close proximity to the common name, a correct declaration of the net contents in terms of weight, volume or number in accordance with the usual practice in describing the food;
(b) grouped together on any panel-
(i) a declaration by name of any Class II, Class III or Class IV Preservative in the food;
(ii) a declaration of any food colour added to the food;
(iii) a declaration of any artificial or imitation flavouring preparation added to a food other than a food listed in regulation 41;
(iv) in the case of a food consisting of more than one ingredient, unless specifically exempted by the Minister, a complete list of the ingredients by their acceptable common names in descending order of their proportions, unless the quantity of each ingredient is stated in terms of per centum or proportionate composition; and
(v) any other statement required by these Regulations to be declared, such as meaningful coding and date-marking referred to in regualtion 421 (4) (i) (i) and (ii);
(c) on any panel, the name and address of the manufacturer, packer, distributor, importer, exporter or vendor of the food.
(2) For the purposes of sub-regulation (1) (a) (ii) and (iii), the size of the letters used for the common name and in declaring the net contents shall be at least half of the size of the letters used for the brand or trade name.
(3) For the purpose of sub-regulation (1) (b) (iv), in the case of food consisting of more than one ingredient, the size of the letters used in the complete list shall be at least one quarter of the size of the letters used for the brand or trade name.
32. Notwithstanding anything contained in regulation 31, the information required by that regulation shall not be placed at the bottom of the container of any food or on a panel at the bottom thereof.
33. For the purposes of regulations 9 (a) and 31 (a)-
(a) a common name consisting of more than one word shall be deemed to be clearly and prominently displayed on the main panel of the label if each word, other than articles, conjunctions or prepositions, is in identical type and identically displayed as the brand or trade name; and
(b) a declaration of net contents, including each numeral in any indicated fraction, on a package of food shall be deemed to be clearly and prominently displayed thereon if it is in boldface type.
34. Notwithstanding anything contained in regulation 31 (a) (iii), a declaration of net contents on a package of food the weight of which, including the package, is less than 50 Grams, may be waived by the Minister.
35. Regulations 9 and 31 (a) (iii) shall not apply to the position or size of the letters
of the declaration of net contents on the label of-
(a) a package of food where the manner of declaration is described or prescribed by any other Act of Parliament or any regulation made thereunder;
(b) a food packed in glass containers on which the declaration of net contents appears in blown lettering;
(c) alcoholic beverages or soft drinks;
(d) margarine, shortening, lard and similar packaged food fats when packed in packages of 250 grams or multiples thereof;
(e) eggs packed in cartons.
36. Where inner and outer labels are employed on a package of food, all label declarations required by these Regulations shall appear on both the inner and outer labels.
37. No reference, direct or indirect, to this Act shall be made upon any label of, or in any advertisement for, a food unless the reference is a specific requirement of this Act.
38. Regulations 30 and 31 shall not apply to a food sold in bulk or packaged from bulk at the place where the food is retailed.
Provided that packages of such food may bear-
(i) the name of the food; and
(ii) the net contents of the package.
39. For the purpose of regulation 31 (b) (iv), a name set out in column 1 of Part II of the Second Schedule is an acceptable common name for the food set out in column 2 thereof relating to the same item.
40. Notwithstanding the provisions of regulation 31 (b) (ii), a label declaration is not required to indicate the presence of caramel as a food colour in-
(a) non-excisable fermented beverages;
(b) sauces;
(c) spirituous liquors;
(d) vinegar, except vinegar or blends containing spirit vinegar;
(e) wine;
(f) soft drinks.
41. A label declaration is not required to indicate the presence of added artificial or imitation flavouring preparation in liqueurs, alcoholic beverages and soft drinks.
42. Where a standard for a food is prescribed in this Part, any specific label requirement in the standard shall also be followed.
43. Food in a package shall not be described or presented on any label by words, pictures or other marks which, either directly or indirectly, refer to, or are suggestive of, any other product with which such food might be confused, or in such manner as to lead the purchaser or consumer to suppose that the food is connected with such other product.
44. (1) The country of origin of a food shall be declared. Country of origin of food to be declared
(2) When a food undergoes processing in a second country and changes its nature, the country in which the processing is performed shall, for the purposes of labelling, be considered to be the country or origin.
45. No person shall manufacture, produce, pack or sell any food which has been subjected or exposed to ionising radiation unless, upon application, the Minister approves the radiation of such food. Food which has thus been permitted to such subjection or exposure shall be so designated.
46. Grade designations used on the label shall be readily understandable and in no way misleading or deceptive.
47. (1) Subject to regulation 49, the main panel of the label applied to a food packaged in a disposable metal container designed to release pressurised contents by means of a manually operated valve that forms an integral part of the container shall prominently show-
(a) the signal word, "Caution"; and
(b) the nature of the primary hazard, such as "Container may explode if heated".
(2) One panel of the label applied to a food referred to in sub-regulation (1) shall show-
(a) the nature of the secondary hazard as "Contents under pressure"; and
(b) statements of precaution, such as "Do not place in hot water or near radiators, stoves or other sources of heat" and "Even when empty, do not puncture or incinerate container or store at temperatures above 50ºC".
(3) The requirements of sub-regulations (1) and (2) shall not apply where, in relation to a food, in the opinion of the Minister, the design of the container, the material used in its construction, or the incorporation of a safety device, eliminates the potential hazard therein.
48. (1) Subject to regulation 49, the main panel of the label applied to a food referred to in regulation 47 (1) shall, where it does not meet the flame projection test and the closed drum test, as determined by the prescribed method, prominently show-
(a) the applicable signal word, "Danger", "Warning" or "Caution"; and
(b) the nature of the primary hazard, as "Extremely Flammable".
(2) Where the flashpoint of the product is less than 65ºC, one panel of the label shall, in addition to the requirements of paragraphs (a) and (d) of sub-regulation (1), show the statement of precaution, such as "Keep away from open flame or spark".
49. Where the net contents of a container of a food, referred to in regulation 47 (1) or 48, do not exceed 50 grams, the label may, by waiver from the Minister, be required to show only the information described in paragraphs (a) and (b) of sub-regulation (1) of regulation 47 or paragraphs (a) and (b) of sub-regulation (1) of regulation 48, as the case may be.
Special Dietary Foods
50. Where a statement or claim implying a special dietary use is made on any label of, or in any advertisement for, a food the label shall carry a statement of the type of diet for which that food is recommended.
51. A food containing saccharin or its salt shall carry on the label a statement to the effect that it contains (naming the non-nutritive sweetener) a non-nutritive sweetener.
52. Special dietary foods recommended for carbohydrate or sugar-reduced diets shall be foods that contain not more than 50 per centum of the glycogenic carbohydrates normally present in foods of the same class.
53. For the purposes of these Regulations, a food may, if it contains not more than 0.25 per centum of glycogenic carbohydrates, be described as sugarless, sugar-free, low in carbohydrates or by any other appropriate synonymous terms.
54. Where a statement of claim relating to the carbohydrate, sugar or starch content is made on the label of, or in any advertisement for, a food, the label shall carry a statement, on a percentage basis, of the carbohydrate content.
55. Special dietary foods recommended for calorie-reduced diets shall be foods that contain not more than 50 per centum of the total calories normally present in foods of the same class.
56. For the purposes of these Regulations, a food may be described as low calorie
or by any other appropriate synonymous term if it contains not more than-
(a) 15 kilo calories per average serving; and
(b) 30 kilo calories in a reasonable daily intake.
57. Where a statement of claim relating to the calorie content is made on the label of, or in any advertisement for, a food, the label shall carry a statement of the calorie content in kilo calories per 100 grams.
58. For the purposes of these Regulations, a food may be described as-
(a) "low sodium", or by any other appropriate synonymous term, if it is a food which has been processed without the addition of sodium salts; and the sodium content of the food is not more than one-half of that of the comparable normal product as consumed; and it is not more than 120 milligrams per 100 grams of the final product as normally consumed;
(b) "very low sodium" or by any other appropriate synonymous term, if it is a food which has been processed without the addition of sodium salts; and the sodium content of the food is not more than one-half of the comparable normal product as consumed; and is not more than 40 milligrams per 100 grams of the final product as normally consumed.
59. Where a statement of claim relating to the sodium content is made on the label of, or in any advertisement for, a food, the label shall carry a declaration of the sodium content in milligrams per 100 grams.
60. No person shall sell a food containing a non-nutritive sweetening agent unless-
(a) that food meets the requirements for special dietary foods as prescribed in regulation 52 or 55; and
(b) the label carries a statement implying a special dietary use.
Alcoholic Beverages
61. The foods referred to in regulations 61 to 96 are included in the term "alcoholic beverages".
62. For the purposes of regulations 61 to 96, unless the context otherwise requires-
"absolute alcohol" means alcohol of a strength of 100 per centum;
"age" means the period during which an alcoholic beverage is kept under such conditions of storage as may be necessary to render it potable or to develop its characteristic flavour or bouquet;
"alcohol" means ethyl alcohol (ethanol);
"grain spirit" means an alcoholic distillate, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or by other enzyme and fermented by the action of yeast and from which all or nearly all of the naturally occurring substance other than alcohol and water have been removed;
"flavouring" means other domestic or imported spirit or wine customarily used, or permitted under the Customs and Excise Act;
"neutral spirit" means the alcoholic distillate obtained from the fermentation of carbohydrate materials and rectified at a strength of not less than 81.84 per centum of absolute alcohol; and
"small wood" means wood casks or barrels of not greater than 750 litres capacity.
63. Whisky shall be a potable alcoholic distillate, obtained from a mash of cereal grain or cereal grain products saccharified by the diastase of malt or other natural enzyme and fermented by the action of yeast and aged not less than three years, may contain a flavouring or caramel, and shall contain not less than 34.49 per centum of absolute alcohol.
64. (1) Subject to sub-regulation (2), no person shall make any claim with respect to the age of whisky other than for the period during which the whisky has been stored in small wood.
(2) Where whisky has been aged in small wood for at least three years, any period not exceeding six months during which that whisky was held in other containers may be claimed as age.
65. Malt whisky shall be whisky obtained by the pot-still distillation of a mash consisting substantially of barley malt fermented by the action of yeast or a mixture of such whiskies.
66. Grain whisky shall be whisky that has been distilled in such a manner as to retain some of the volatile congeneric substance produced during fermentation.
67. Scotch whisky shall be the whisky distilled in Scotland as Scotch whisky in accordance with the laws of the United Kingdom for consumption in that country.
68. Blened whisky shall be a potable alcoholic distillate obtained from a mash of cereal grain products saccharified by the diastase of malt or other natural enzyme and fermented by the action of yeast or a mixture of such distillate to which neutral spirit may be added, may contain a flavouring or caramel and shall contain not less than 34.49 per centum of absolute alcohol.
69. If neutral spirit is added in the manufacture of blended whisky, the label shall clearly and legibly bear the words "Blended with neutral spirit".
70. Rum shall be a potable alcoholic distillate obtained from sugarcane products fermented by the action of yeast or a mixture of yeast and other organisms, or a mixture of such distillates which has been aged and held for a period of not less than two years in small wood, may contain caramel, and be flavoured with fruit or other botanical substances or flavouring, and shall contain not less than 34.49 per centum of absolute alcohol.
71. Blended rum shall be a potable alcoholic distillate obtained from sugarcane products fermented by the action of yeast or a mixture of such distillates to which neutral spirit may be added, may contain caramel and be flavoured with fruit or other botanical substances or flavouring, and shall contain not less than 34.49 per centum of absolute alcohol.
72. If neutral spirit is added in the manufacture of blended rum, the label shall clearly and legibly bear the words "Blended with neutral spirit".
73. Gin shall be the product obtained by redistillation of suitable rectified grain spirit or other carbohydrate material with or over juniper berries, may contain other aromatic botanical substances, sugar and salt, and shall contain not less than 34.49 per centum of absolute alcohol.
74. Dry gin shall be the gin to which no sugar has been added. Standard for gin
75. No person shall make any claim with respect to the age of gin, but gin that has been held in suitable containers may bear a label declaration to that effect.
76. Blended gin shall be a potable alcoholic product obtained by the redistillation of suitable rectified grain spirit with or over juniper berries, may contain aromatic botanical substances, sugar and salt and to which neutral spirits may be added, and shall contain not less than 34.49 per centum of absolute alcohol.
77. If neutral spirit is added in the manufacture of blended gin, the label shall clearly and legibly bear the words "Blended with neutral spirits".
78. Brandy shall be a potable alcoholic distillate obtained by the distillation of wine in the manufacture of which no additional sugar has been used or a mixture of such distillates which has been aged and held for a period of not less than two years in small wood, may contain caramel, and be flavoured with fruit or other botanical substances or flavouring, and shall contain not less than 34.49 per centum of absolute alcohol.
79. No person shall make any claim with respect to the age of brandy other than for the period during which it has been held in small wood.
80. Cogna brandy or Cognac shall be brandy manufactured in the Cognac district of France in accordance with the laws of the French Republic for consumption in that country.
81. Armagnac brandy or Armagnac shall be brandy manufactured in the Armagnac district of France in accordance with the laws of the French Republic for consumption in that country.
82. Blended brandy shall be a potable alcoholic distillate obtained by the distillation of wine in the manufacture of which no additional sugar has been used, or a mixture of such distillates to which neutral spirit may be added, may contain caramel, and be flavoured with fruit or other botanical substances or flavouring, and shall contain not less than 34.49 per centum of absolute alcohol.
83. If neutral spirit is added in the manufacture of blended brandy, the label shall clearly and legibly bear the words "Blended with neutral spirit".
84. Fruit brandy or (naming the fruit) brandy shall be-
(a) a potable distillate obtained by the distillation of-
(i) fruit wine or a mixture of fruit wines;
(ii) a mixture of wine and fruit wine; or
(iii) fermented mash of sound ripe fruit or a mixture of fruits; or
(b) a mixture of such distillates as are referred to in paragraph (a) of this regulation.
85. Liqueurs and alcoholic cordials shall be the products obtained by the mixing or distillation of grain spirit, brandy or other distilled spirits with or over fruits, flowers, leaves or other botanical substances or their juices, or with extracts derived by infusion, percolation or maceration of such botanical substances, shall have added to them during the course of manufacture, sucrose or dextrose or both in an amount that is not less than 2.5 per centum of the finished product, shall contain not less than 23 per centum of absolute alcohol by volume, and may contain neutral or artificial flavouring preparations and colour.
86. Vodka shall be the potable alcoholic beverage obtained by the treatment of grain or other carbohydrate spirit with charcoal and shall contain not less than 34.49 per centum of absolute alcohol.
87. Blended vodka shall be the potable alcoholic beverage obtained by the treatment of grain or potable spirit with charcoal to which neutral spirit may be added, and shall contain not less than 34.49 per centum of absolute alcohol.
88. If neutral spirit is added to the manufacture of blended vodka, the label shall clearly and legibly bear the words "Blended with neutral spirit".
89. Wine shall be the product of alcoholic fermentation of the juices of grapes or other fruits, may have added to it yeast, concentrated grape juice, sugar, dextrose, or invert sugar, or aqueous solutions of any of the yeast foods, brandy or fruit spirit, carbon dioxide or oxygen, and may be treated, prior to filtration, with a strongly acid cation exchange resin in the sodium ion form or weak basic ion exchange resin in the hydroxyl form and, if food additives or food colours are used in the course of manufacture of wine, their use and limits shall conform to those specified in the Nineteenth Schedule.
90. No person shall sell wine that contains more than 0.35 per centum weight by volume of volatile acid calculated as acetic acid as determined by the prescribed method.
91. Cider shall be the product of the alcoholic fermentation of apple juice or of apple juice to which has been added not more than 10 per centum weight by volume of sugar, dextrose or invert sugar, shall contain not less than 2.5 per centum and not more than 13 per centum by volume of absolute alcohol; and 100 millilitres of it, measured at a temperature of 20ºC, shall-
(a) contain not less than 2 grams and not more than 12 grams of total acids and not more than 8 grams of sugar calculated as dextrose sugars; and
(b) yield not less than 0.2 gram and not more than 0.4 gram of ash.
92. No person shall sell cider that has more than 0.2 per centum weight by volume of volatile acidity calculated as acetic acid as determined by the prescribed method.
93. Perry shall be the product of alcoholic fermentation of pear juice or pear juice to which has been added not more than 10 per centum weight by volume of sugar, dextrose or invert sugar, shall contain not less than 2.5 per centum and not more than 13 per centum by volume of absolute alcohol; and 100 millilitres of it, measured at a temperature of 20ºC, shall-
(a) contain not less than 2 grams and not more than 12 grams of total solids and not more than 8 grams of sugar calculated as dextrose sugar; and
(b) yield not less than 0.2 gram and not more than 0.4 gram of ash.
94. Beer, ale, stout, porter, lager beer and black beer shall be that food produced as a result of alcoholic fermentation of an extract derived from barley malt or cereal grain or starch or saccharine matter and hop derivatives in potable water with other suitable ingredients in such a manner as to possess the aroma, taste, and character commonly attributed to the relevant food; and if food additives are used in the course of their manufacture, their use and limits shall conform to those specified in the Nineteenth Schedule, and they shall contain-
(a) absolute alcohol, not less than 3.2 per centum;
(b) total solids, not less than 3.5 per centum weight by volume; and
(c) total ash, not less than 0.12 per centum weight by volume.
95. Near beer shall be the beer that contains, notwithstanding regulation 94, not less than 0.96 and not more than 2.0 per centum of absolute alcohol; and, 100 millilitres of light beer measured at a temperature of 20ºC shall yield not less than 0.12 grams of total ash.
96. Opaque beer or chibuku shall mean the potable liquid derived by the fermentation of a mash of cereal grain or vegetables or grain or vegetable products with or without the addition of sucrose and containing the mash or the residue of the mash from which it is derived in such a manner as to possess the aroma, taste, and character attributed to it, and shall contain not less than 2 per centum and not more than 6 per centum of absolute alcohol.
Baking Powder
97. For, the purposes of regulation 98, "acid-reacting material" means one or any combinations of-
(a) lactic acid or its salts;
(b) tartaric acid or its salts;
(c) acid salts of phosphoric acid; and
(d) acid compounds of aluminium.
98. Baking powder shall be a combination of sodium or potassium bicarbonate with an acid-reacting material; may contain starch or other neutral material and an anti-caking agent, and shall yield not less than 10 per centum of its weight of carbon dioxide as determined by the prescribed method.
Cacao Products
99. The foods referred to in regulations 99 to 109 shall be derived from cacao beans and are included within the term cacao product.
100. Cacao beans or cocoa beans shall be the seeds of the cocoa tree (Theobroma cacao L.) which may or may not have been fermented.
101. Cacao nibs, cocoa nibs or cracked cocoa shall be the product obtained from cocoa beans which have been cleaned and freed from shells as thoroughly as is technically possible; and shall contain, calculated on the fat-free dry matter, not more than-
(a) 4 per centum of cocoa shell;
(b) 0.3 per centum of ash insoluble in hydrochloric acid; and
(c) 8.0 per centum of moisture.
102. Chocolate, bitter chocolate or chocolate liquor shall be the product obtained by grinding cacao nibs, to which cocoa butter may be added; and shall contain not less than 50 per centum of cocoa butter calculated on the dry matter.
103. Cacao products may be processed with hydroxides, carbonates or bicarbonates of ammonium, sodium or potassium or hydroxides or carbonates of magnesium.
104. No person shall sell a cacao product that is processed with hydroxides or carbonates of magnesium unless-
(a) the main panel of the label carries, immediately preceding or following the name of the cacao product and without intervening written, printed, or graphic matter, one of the following phrases: "Processed with Alkali";
"Processed with (naming the alkali)"; or "Alkali Treated"; and
(b) the total weight of such processing agents used with each one hundred parts by weight of cacao nibs used in the preparation of such cacao products shall not be greater in neutralising value, calculated from the respective combining weights of such processing agents, than the neutralising value of three parts by weight of anhydrous potassium carbonate.
105. The ash limits provided for cacao products in regulations 99 to 109 may be increased for cacao products processed with alkali as provided in regulation 104 by the amount of ash from the processing agent used.
106. Sweet chocolate or sweet chocolate coating shall be chocolate mixed with sugar or with a combination of not less than 75 per centum of sugar and not more than 25 per centum of dextrose; may contain cacao butter, spices, other flavouring material (see regulations 219 to 243) and not more than a total of 1.5 per centum of emulsifying agents in the finished product (see Part IV of the Nineteenth Schedule); and shall contain, on the dry, sugar-free and fat-free basis, no greater proportion of crude fibre, total ash, or ash insoluble in hydrochloric acid respectively than does chocolate on the dry, fat-free basis.
107. Milk chocolate, sweet milk chocolate, milk chocolate coating or sweet milk chocolate coating shall be the cacao product obtained from chocolate by grinding with sugar or with a combination of not less than 75 per centum of sugar and not more than 25 per centum of dextrose; may contain cacao butter, spices, other flavouring material (see regulations 219 to 243) and not more than a total of 1.5 per centum of emulsifying agents in the finished product (see Part IV of the Nineteenth Schedule); and shall contain, in the finished product, not less than 12.0 per centum of milk solids of which milk fat shall be not less than 3.65 per centum by weight in the finished product.
108. Cocoa or powdered cocoa shall be chocolate from which part of the cocoa and butter has been removed, may contain spices, flavouring materials (see regulations 219 to 243) and not more than a total of 1.5 per centum of emulsifying agents in the finished product (see Part IV of the Nineteenth Schedule), shall contain, on the dry, fat-free basis, no greater proportion of crude fibre, total ash or ash insoluble in hydrochloric acid, respectively, than does chocolate on the dry, fat-free basis, may be designated "Breakfast Cocoa", if it contains 20 per centum or more of cocoa butter, and shall be designated "Low Fat Cocoa" if it contains less than 8 per centum of cocoa butter.
109. Cacao butter or cocoa butter shall be the fat from sound cacao beans, obtained either before or after roasting, and free from foreign odour and taste, and shall have a refractive index, at 40ºC, of between 1.453 and 1.459, a saponification value of between 188 and 198, free fatty acids (expressed as per centum of oleic acid) to a maximum of 1.75, and iodine value (Wijs) of between 32 and 43.
Coffee and Chicory
110. Green coffee, raw coffee or unroasted coffee shall be the seed of all varieties of coffea Arabica L., Liberica Hiern, or C. Canephora and C. excelsa freed from most of its spermoderm.
111. Roasted coffee or coffee shall be roasted green coffee and shall have-
(a) not more than 5 per centum of total ash;
(b) not less than 3.4 ml and not more than 4.4 ml of N/10 acid as alkalinity of soluble ash per gram of dried roasted coffee;
(c) not less than 25 and not more than 32 per centum of aqueous extract by the prescribed method.
112. Soluble coffee shall be the free flowing soluble coffee powder derived by dehydration of aqueous extract of freshly roasted and ground coffee having the colour, taste and flavour characteristic of coffee, shall dissolve readily in boiling water with moderate stirring, and shall contain-
(a) not more than-
(i) 3.5 per centum of water;
(ii) 15 per centum of total ash;
(b) not less than 2.8 per centum of caffeine content.
113. (1) Coffee-chicory mixture or coffee mixed with chicory or coffee and chicory shall contain not less than 50 per centum of coffee.
(2) The expression "French coffee" may be used for the coffee-chicory mixture, if it is followed by the words "mixed with chicory".
114. For the purpose of regulation 113, chicory shall mean the roasted chicory powder obtained by roasting the cleaned and dried roots of Chicorium intybus Linn.
Food Colours
115. For the purposes of regulations 115 to 122, unless the context otherwise requires-
"diluent" means any substance suitable for human consumption other than a synthetic colour present in a colour mixture or preparation;
"dye" means the principal dye and associated subsidiary and isomeric dyes contained in a synthetic colour;
"mixture" means a mixture of two or more synthetic colours or a mixture of one or more diluents;
"preparation" means a preparation of one or more synthetic colours containing less than 3 per centum of dye and sold for household use;
"synthetic colour" means any organic colour, other than caramel, that is produced by chemical synthesis and has no counterpart in nature.
116. No person shall sell for use in or upon food any colour other than-
(a) natural colours, being alkanet, anatto, b-apo-8¢-carotenal, b carotene, beet red, chlorophyll, chlorophyll copper complex, cochineal, ethyl and methyl b-apo-8¢-caroteneates, orchil, paprika, riboflavin, saffron, sandalwood, sodium and potassium chlorophyllin copper, turmeric, xanthophyll capsanthin, lycopere flavoxanthin lutein cryptoxanthin nubixanthin violaxanthin rhodoxanthin cantnaxanthin or their colouring principles whether isolated from natural sources or produced synthetically, and caramel;
(b) inorganic colours, being charcoal, carbon black, iron oxide, titanium dioxide, metallic aluminium and metallic silver; and
(c) synthetic colours, being amaranth (colour index number 1971, 16185), brilliant blue FCF (colour index number 1971, 42090), erythrosine (colour index number 1971, 45430), fast green FCF (colour index number 1971, 42053), indanthrene blue RS (colour index number 1971, 69800), indigotine (colour index number 1971, 73015), patent blue V (colour index number 1971, 42051), ponceau 4R (colour index number 1971, 16255), quinoline yellow (colour index number 1971, 47005), sunset yellow FCF (colour index number 1971, 15985), tartrazine (colour index number 1971, 19140), wool green BS (colour index number 1971, 44090) and aluminium or calcium lakes of these colours, brilliant blue PN (colour index Number 28440), carmosine (colour index number 14720, curaumin (colour index number 75300 and red 2G colour index number 18050)
(As amended by S.I. No. 89 of 1988)
117. No person shall sell a food to which has been added any colour other than those mentioned in regulation 116 (a), (b) and (c).
118. No person shall sell a food, other than a synthetic colour or flavouring mixture preparation, that contains, when prepared for consumption according to label direction, more than-
(a) 300 parts per million of indigotine (colour index number 1971, 73015), tartrazine (colour index number 1971, 19140), sunset yellow FCF (colour index number 1971, 15985), or any combination of those colours;
(b) 100 parts per million of amaranth (colour index number 1971, 16185), brilliant blue FCF (colour index number 1971, 42090), erythrosine (colour index number 1971, 45430), fast green FCF (colour index number 1971, 42053), indanthrene blue RS (colour index number 1971, 69800), patent blue V (colour index number 1971, 42051), ponceau 4R (colour index number 1971, 16255), quinoline yellow (colour index number 1971, 47005), wool green BS (colour index number 1971, 44090); or
(c) 300 parts per million of any combination of the synthetic colours named in paragraphs (a) and (b) of this regulation and within the limits set by these paragraphs.
119. No person shall sell a food to which has been added more than 35 parts per million of b-apo-8¢-carotenal or ethyl or methyl b-apo-8¢-carotenoate.
120. No person shall sell a food colour for use in or upon food that contains more than-
(a) 3 parts per million of arsenic, calculated as arsenic, as determined by the prescribed method;
(b) 10 parts per million of lead, calculated as lead, as determined by the prescribed method; or
(c) except in the case of iron oxide and lakes, a total of 100 parts per million of iron and copper, calculated as iron and copper; and if other heavy metals are present, the colour shall be deemed to be adulterated.
121. No person shall sell a "synthetic colour" for use in or upon food unless the label carries-
(a) the common name of the synthetic colour;
(b) the lot number of the manufacture of the synthetic colour; and
(c) the words "Food Colour".
122. No person shall sell a mixture or preparation of food colour for use in or upon food, unless the label carries-
(a) the lot number of the mixture or preparation;
(b) the words "Food Colour"; and
(c) the common names of individual colours present in the mixture or preparation.
Spices, Dressing and Seasoning
123. Cloves, whole or ground, shall be the dried flower buds of Eugenia caryophyllata Thumb, and shall contain-
(a) not more than-
(i) 5.0 per centum of clove stems;
(ii) 8.0 per centum of total ash;
(iii) 0.5 per centum of ash insoluble in hydrochloric acid;
(iv) 10 per centum of crude fibre;
(b) not less than 15 per centum of volatile ether extract.
124. Ginger, whole or ground, shall be the washed and dried or decorticated and dried rhizome of Zingiber officinale Roscoe, and shall contain not more than 12 per centum of moisture, and, on the dry basis, not less than 11.4 per centum of cold water extractive as determined by the prescribed method, and 1.9 per centum of ash soluble in water, and may contain not more than 1.1 per centum of calcium, calculated as calcium oxide, 8 per centum of total ash, and 2.3 per centum of ash insoluble in hydrochloric acid.
125. Limed ginger or bleached ginger, whole or ground, shall be the ginger coated with calcium carbonate, and shall conform to the standards provided in regulation 126, except that it shall contain not more than 2.5 per centum of calcium, calculated as calcium oxide and not more than 12 per centum of total ash.
126. Allspice or pimento, whole or ground, shall be the whole berry Pimento dioica, L., Merrill and shall contain not more than 27.5 per centum of crude fibre, 4.5 per centum of total ash, and 0.4 per centum of ash insoluble in hydrochloric acid.
127. Cinnamon or cassia, whole or ground, shall be the dried bark or cultivated varieties of Cinnamomum zeylanicum Nees, or C. Cassia L., from which the outer layers may have been removed, and shall contain not more than 5 per centum of ash and not more than 2 per centum of total ash insoluble in hydrochloric acid.
128. Ceylon cinnamon shall be the whole cinnamon obtained exclusively from Cinnamomum zeylanicum Nees.
129. Mace, whole or ground, shall be the dried arillus of Myristica fragrans Houttyn, and shall contain not more than 7.0 per centum of crude fibre, 3.0 per centum of total ash, and 0.5 per centum of ash insoluble in hydrochloric acid, 5.0 per centum of non-volatile ethyl ether extract obtained after extraction of mace using petroleum ether and 33 per centum of the sum of the non-volatile extracts using petroleum ether and ethyl ether.
130. Nutmeg, whole or ground, shall be the dried seed of Myristica fragrans Houttyn, may have a thin coating of lime, and shall contain-
(a) not less than 25 per centum of non-volatile ether extract;
(b) not more than-
(i) 5 per centum of total ash; and
(ii) 0.5 per centum of ash insoluble in hydrochloric acid.
131. Black pepper, whole or ground, shall be the dried, whole berry of Piper nigrum L., and shall contain not more than 8.0 per centum of total ash and not more than 1.4 per centum of ash insoluble in hydrochloric acid.
132. White pepper, whole or ground, shall be the dried mature berry of Piper nigrum L., from which the outer coating of pericarp has been removed, and shall contain not more than 6 per centum of crude fibre, 4 per centum of total ash, and 0.2 per centum of ash insoluble in hydrochloric acid.
133. Cayenne pepper or cayenne or chillies, whole or ground, shall be the dried, ripe fruit of Capsicum frutescens L., Capsicum baccatum L., Capsicum annum or other small-fruited species of Capsicum, and shall contain-
(a) not more than-
(i) 28 per centum of crude fibre;
(ii) 8 per centum of total ash; and
(iii) 1.25 per centum of ash insoluble in hydrochloric acid; and
(b) not less than 15 per centum of non-volatile ether extract.
134. Tumeric, whole or ground, shall be the dried rhizome of Curcuma longa L.
135. Sage, whole or ground, shall be the dried leaves of Slavia offinalis L., and shall contain not more than 12 per centum of stems (excluding peticles) and other foreign material.
136. Thyme, whole or ground, shall be the dried leaves and flowering tops of Thymus vulgaris L., and shall contain not more than 12.0 per centum of total ash and not more than 4.0 per centum of ash insoluble in hydrochloric acid.
137. Caraway seed shall be the dried fruit of Carum carvi L., and shall contain not more than 8 per centum of total ash and not more than 1.5 per centum of ash insoluble in hydrochloric acid.
138. Cardamom seed shall be the dried seed of Elettaria cardamomum L., and shall contain not more than 8 per centum of total ash and not more than 3 per centum of ash insoluble in hydrochloric acid.
139. Celery shall be the dried fruit of Apium graveolens L., and shall contain not more than 10 per centum of total ash and not more than 2.0 per centum of ash insoluble in hydrochloric acid.
140. Coriander seed shall be the dried fruit of Coriandrum Sativum L., and shall contain not more than 7.0 per centum of total ash and not more than 1.5 per centum of ash insoluble in hydrochloric acid.
141. Dill seed shall be the dried fruit of Anethum graveolens L., and shall contain not more than 10.0 per centum of total ash and not more than 3.0 per centum of ash insoluble in hydrochloric acid.
142. Mustard seed shall be the seed of Brassica Bois, B. hirta Moench, B. nigra (L) Kuch, B. Juncea (L) Czern, or seed of species closely related to B. nigra and B. Juncea, a shall contain not more than 1.5 per centum of ash insoluble in hydrochloric acid and not more than 8.0 per centum of total ash, on the oil-free basis.
143. Mustard, mustard flour or ground mustard, shall be the powder made from mustard seed with the hulls largely removed and from which a portion of the fixed oil may be removed, shall contain not more than 1.5 per centum of starch and, on the oil-free basis, not more than 8.0 per centum of total ash, and shall yield not less than 0.40 per centum of volatile mustard oil as determined by the prescribed method.
144. Marjoram, whole or ground, shall be the dried leaves of Majorana hortensis Moench, may contain a small proportion of the flowering tops of the marjoram plant, and shall contain not more than 10 per centum of stems and foreign material, 16 per centum of total ash, and 4.5 per centum of ash insoluble in hydrochloric acid.
145. Dried herbs, spices and curry powder shall be any combination of turmeric with spices and seasoning, shall contain not more than 5.0 per centum of salt and may contain up to 15 per centum of starch and farinacious matter.
146. Mayonnaise, mayonnaise dressing or mayonnaise salad dressing, shall be a combination of edible vegetable oil, whole egg or egg yolk in liquid, frozen or dried form and vinegar or lemon juice, may contain water, salt, a sweetening agent, spice or other seasoning (except turmeric or saffron), citric, tartaric or lactic acid, and a sequestering agent (see Part XII of the Nineteenth Schedule), and shall contain not less than 65 per centum of edible vegetable oil.
147. French dressing shall be a combination of edible vegetable oil and vinegar or lemon juice; may contain water, salt, a sweetening agent, spice, and tomato or other seasonings; and shall contain not less than 35 per centum of edible vegetable oil.
148. Salad dressing shall be a combination of edible vegetable oil, whole egg or egg yolk in liquid, frozen or dried form, vinegar or lemon juice, and cereal; may contain water, salt, a sweetening agent (see regulations 337 to 343), spice, or other seasoning, an emulsifying agent (see Part IV of the Nineteenth Schedule), citric, tartaric or lactic acid; and a sequestering agent (see Part XII of the Nineteenth Schedule); and shall contain not less than 35 per centum of edible vegetable oil.
Milk Products
149. The foods referred to in regulations 150 to 197 are included in the term "milk products".
150. For the purposes of regulations 174 to 187 "pasteurised source", when used in relation to cheese, means milk, skim milk, cream, reconstituted milk powder, or reconstituted skim milk powder, butter milk or a mixture thereof that has been pasteurised by being held at a temperature of not less than 63ºC for a period of not less than 30 minutes, or for a time and a temperature that is equivalent thereto in phosphatase destruction as determined by the prescribed method.
151. Except as provided in these Regulations, a milk product that contains a fat, other than milk fat, is adulterated.
152. (1) Milk or whole milk shall be the normal mammary secretion, free from colostrum and obtained from the mammary gland of the cow, genus Bos, and shall contain not less than 3.2 per centum of milk fat and 8.5 per centum of milk solids-not-fat.
(2) Normal mammary secretion obtained from other animals shall be designated, preceded by the origin from which such mammary secretion has been obtained; for example, "Goat milk", "Sheep milk", etc.
(As amended by S.I. No 38 of 1992)
153. Except as otherwise provided in these Regulations, the term, "pasteurised", when used in association with milk or milk products, shall be taken to refer to the process of heating all the milk-
(a) to a temperature of not less than 63ºC, and holding it at such a temperature for not less than 30 minutes and immediately thereafter reducing it to a temperature below 4ºC; or
(b) to a temperature of not less than 71.5ºC and retaining it at such a temperature for at least fifteen seconds or at any other approved time-temperature combination, and immediately thereafter reducing the milk to a temperature below 4ºC and conforming to the following standard:
(i) the standard plate count determined by the prescribed method shall be not more than 50,000 per millilitre;
(ii) the coliform count determined by the prescribed method shall be not more than 5 per millilitre and faecal coliform shall be nil per millitre;
(iii) the dye-reduction time determined by the methylene blue-keeping quality test by the prescribed method shall be not less than two hours; and
(iv) the phosphatase test determined by the prescribed method shall give a reading of not more than 10 micrograms of p-nitrophenol for one millilitre of milk.
154. Standardised milk means pasteurised milk or whole milk that has been standardised to a minimum of 3 per centum of milk fat by abstraction or addition of milk or by addition or substraction of skim milk.
155. Sterilised milk shall be milk which has been heat-treated and after packaging shall-
(a) satisfy the keeping quality tests by the prescribed method; and
(b) give no turbidity when subjected to the prescribed method.
156. (1) Ultra high temperature heat-treated milk (or UHT milk) shall be milk which has been subjected to a continuous flow heating process at a high temperature for a short time and which afterwards has been asepticaly packaged.
(2) The heat treatment shall be such that the milk shall-
(a) pass the keeping quality tests by the prescribed method;
(b) give turbidity when subjected to the prescribed method.
157. Skimmed milk or skim milk shall be milk from which all or most of the milk fat has been removed and which contains not more than 0.1 per centum of milk fat.
158. (1) Partly skimmed milk (partly skim milk or partially skim milk or partially skimmed milk) shall be milk from which part of the milk fat has been removed.
(2) No person shall sell partly skim milk unless the label thereof carries a statement of the percentage of milk fat contained therein.
159. Reconstituted milk (recombined milk) shall be the pasteurised homogenised product prepared from milk fat, non-fat-milk solids and water, with or without whole milk, may contain permitted stabilisers/emulsifiers (see Part IV of the Nineteenth Schedule), and shall have not less than 3.0 per centum of milk fat and not less than 8.5 per centum of milk solids-not-fat.
160. (1) Reconstituted milk product (recombined milk product) shall be the pasteurised homogenised milk product prepared from milk fat, non-fat milk solids, and water, with or without skim milk or whole milk; may contain permitted stabilisers/emulsifiers (see Part IV of the Nineteenth Schedule), and shall have not less than 2.0 per centum of milk fat and not less than 9.0 per centum of milk solids-not-fat.
(2) No person shall sell a reconstituted milk product unless the label thereof carries a statement of the percentage of milk fat and milk solids-not-fat.
161. (1) Evaporated milk (unsweetened condensed milk) shall be the liquid product obtained by the partial removal of water only from milk, shall have not less than 7.5 per centum of milk fat and not less than 17.5 per centum of milk solids-not-fat, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) When milk other than cow's milk is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin, for example "evaporated goat milk" or "evaporated cow and goat milk" or "evaporated goat and cow milk", depending upon the proportion of the milk contents, the one in larger proportion being indicated first.
162. (1) Evaporated skimmed milk (evaporated skim milk, unsweetened condensed skimmed milk) shall be the product obtained by the partial removal of water only from skimmed milk, shall have not less than 20 per centum of milk solids, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) When milk other than cow's milk is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin.
163. (1) Sweetened condensed milk (condensed milk) shall be the product obtained by the partial removal of water only from milk with the addition of sugars, shall have not less than 8 per centum of milk fat and not less than 20 per centum of milk solids-not-fat, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) When milk other than cow's milk is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin.
164. (1) Skimmed sweetened condensed milk (skim sweetened condensed milk) shall be the product obtained by the partial removal of water only from skimmed milk with the addition of sugars, shall have not less than 24 per centum of milk solids, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) When milk other than cow's milk is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin.
165. (1) Whole milk powder (dried full cream milk, full cream milk powder, dry whole milk, milk powder, dried milk, dry milk, powdered milk or powdered whole milk) shall be the product obtained by the removal of water only from milk, after adjusting of fat and milk solids, if necessary, shall have not less than 26 and not more than 40 per centum of milk fat and not more than 5 per centum of water, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule) and added vitamins.
(2) Permitted emulsifiers (see Part IV of the Nineteenth Schedule) may be used in the case of powders for instant use.
(3) When milk, other than cow's milk, is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin.
166. (1) Partially skimmed milk powder (partly skimmed dried milk, partially skim milk powder, partly skim dried milk) shall mean the product obtained by the removal of water from partly skimmed milk, shall have not less than 1.5 and not more than 26 per centum of milk fat and not more than 5.0 per centum of water, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) Permitted emulsifiers (see Part IV of the Nineteenth Schedule) may be used in the case of powders for instant use.
(3) When milk, other than cow's milk, is used for the manufacture of the product or any part thereof, it shall be so designated along with such origin.
167. (1) Skimmed milk powder (skim milk powder, skim-milk powder, dry skim milk, dry skimmilk, dry skimmed milk, powdered skim milk, or powdered skimmilk, non-fat dry milk, dried skim milk) shall be the product obtained by the removal of water from skimmed milk, and shall have not more than 1.5 per centum of milk fat and not more than 5.0 per centum of water, and may contain permitted stabilisers (see Part IV of the Nineteenth Schedule).
(2) Permitted emulsifiers (see Part IV of the Nineteenth Schedule) may be used in the case of powders for instant use.
(3) When milk other than cow's milk is used for the manufacture of the product or any part thereof it shall be so designated along with such origin.
168. (1) Flavoured milk shall be the pasteurised or sterilised liquid product made from milk, milk powder, milk fat, skim milk or skim milk powder, a flavouring preparation, and a sweetening agent; may contain a food colour (see Part III of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule) and salt; and shall contain not less than 3.0 per centum of milk fat.
(2) Flavoured milk shall be labelled (naming the flavour) milk.
169. Chocolate drink shall be the pasteurised or sterilised liquid product made from milk, skim milk, skim milk powder or milk fat, cocoa or chocolate, and a sweetening agent; may contain added lactose, a food colour (see Part III of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule) or salt; and shall contain not less than 2.0 per centum of milk fat.
170. Malted milk or malted milk powder shall be the product made by combining milk with the liquid separated from the mash of ground barely malt and meal, may have added to it, in such a manner as to secure the full enzyme action of the malt extract, salt and sodium carbonate or potassium carbonate, may have water removed from it, and shall then contain not less than 7.5 per centum of milk fat and not more than 3.5 per centum of water.
171. No person shall sell milk for manufacture into dairy products, if it contains more than 2,000,000 bacteria per millilitre or 2 milligrams of sediment for 450 millitres as determined by the prescribed method.
172. No manufacturer of dairy products shall purchase milk for manufacture into other dairy products if he has reason to believe it does not meet the requirements of regulation 171.
173. (1) Flavoured skim milk shall be the product made from skim milk or skim milk powder, a flavouring preparation, and a sweetening agent; may contain food colour (see Part III of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule), or salt; shall contain not more than 0.1 per centum of milk fat and not less than 8.0 per centum of milk solids-not-fat.
(2) Flavoured skim milk shall be labelled (naming the flavour) skim milk.
174. Cheese shall be the fresh or matured non-liquid product, obtained by draining after coagulation, of milk, cream, skimmed or partly skimmed milk, butter milk or a combination of some or all of these products; and may contain salt, seasoning, special flavouring materials, food colour, a firming agent and a Class III Preservative (see Part XIC of the Nineteenth Schedule).
175. The milk used in the manufacture of cheddar, colby, granular, Swiss and washed curd cheese may be treated with hydrogen peroxide in an amount not exceeding 500 parts per million and a suitable catalase preparation in such amount that the catalase added does not exceed 20 parts per million, if this treatment is carried out in a manner that does not alter the characteristics of the cheese.
176. (1) No person shall sell any cheese, except cheddar cheese weighing 5 kilogram or more, unless the label thereof carries a statement of the variety or type of cheese.
(2) No person shall sell cheese that is not made from a pasteurised source, unless it has been kept, held or stored at a temperature of 1.6ºC or more for 60 days or more from the date of the beginning of the manufacturing process.
177. Cheddar cheese shall be the cheese made from the matted and milled curd of milk by the cheddar process, or from milk by another procedure that produces a finished cheese having the same physical and chemical properties as the cheese produced by the cheddar process; and shall contain, on the dry basis, not less than 50 per centum of milk fat.
178. (1) The varieties or types of cheese listed in column 1 of the Third Schedule are those cheese recognised as belonging to those varieties or types, and shall contain, on the dry basis, not less than the percentage of milk fat set opposite thereto in column 2 of the said Schedule for that variety or type of cheese.
(2) Hard grating cheese shall contain not more than 34 per centum of moisture.
179. Skim milk cheese shall be the cheese, other than cottage cheese, that contains, on the dry basis, not more than 15 per centum of milk fat.
180. Cream cheese shall be the cheese made from milk to which cream has been added, with or without further processing; may contain not more than 0.5 per centum of stabilising agent (see Part IV of the Nineteenth Schedule); and shall contain not more than 55 per centum of moisture and, on the dry basis, not less than 65 per centum of milk fat.
181. Process cheese, processed cheese, emulsified cheese, process cheese spread, processed cheese spread, and when made from a cream cheese base, process cream cheese, processed cream cheese, process cream cheese spread or processed cream cheese spread, shall be the food produced by comminuting or mixing one or more lots of cheese into a homogenous mass with the aid of emulsifying agents and a sufficient degree of heat to bring about pasteurisation in the manner described in regulation 150; and may contain water, solids derived from milk, food colour, seasoning, fruit, vegetable, relish, condiment, pH adjusting agent (see Part X of the Nineteenth Schedule) and a Class III Preservative (see Part XIC of the Nineteenth Schedule):
Provided that the finished product shall contain-
(a) in the case of a product manufactured from a cream cheese base with or without seasoning or condiment-
(i) not more than 55 per centum of moisture; or
(ii) on the dry basis, not less than 65 per centum of milk fat;
(b) in the case of a product manufactured from any cheese named in column 1 of Part I or Part II of the Third Schedule-
(i) not more than 43 per centum of moisture; or
(ii) on the dry basis, not less than 48 per centum of milk fat;
(c) in the case of a product manufactured from any other cheese base-
(i) not more than 43 per centum of moisture; or
(ii) on the dry basis, not less than 45 per centum of milk fat.
182. For the purposes of regulation 181 and 184, "relish" means chives, dates, horseradish, olives, onions, pickles, pimentos and pineapple or any combination thereof.
183. Skim milk process cheese or skim processed cheese shall conform to the standard for process cheese except that it shall contain not more than 55 per centum of water and, on the dry basis, not more than 15 per centum of milk fat.
184. Cottage cheese shall be the product, in the form of discrete curd particles, prepared from skim milk, evaporated skim milk or skim milk powder and harmless acid-producing bacterial cultures; may contain milk, cream, milk powder, rennet salt, calcium chloride, added lactose, pH adjusting agents, stabilising agents (see Part IV of the Nineteenth Schedule), relish, fruits or vegetables; and shall contain not more than 80 per centum of moisture.
185. Creamed cottage cheese shall be the cottage cheese containing cream or a mixture of cream with milk or skim milk or both, in such a quantity that the final product shall contain not less than 4.0 per centum of milk fat, and not more than 80 per centum of moisture.
186. All dairy products used in the preparation of cottage cheese shall be from a pasteurised source.
187. No person shall sell cottage cheese or creamed cottage cheese that contains more than 10 coaglase positive staphylococci per gram or any faecal coliform per gram as determined by the prescribed method.
188. Butter shall be the fatty product derived exclusively from milk; may contain permitted food colours (see Part III of the Nineteenth Schedule), permitted neutralising salts for pH adjustment (see Part X of the Nineteenth Schedule) or harmless lactic acid producing bacterial cultures; and shall have not less than 80 per centum of milk fat, not more than 2.0 per centum of milk solids-not-fat, 3.0 per centum of salt and 16 per centum of water. When obtained wholly or partly from a milk origin other than a cow, butter shall be so designated along with such a word denoting the animal from which the milk has been derived.
189. Butter oil (ghee) shall be the product obtained exclusively from butter or cream and resulting from the removal of practically the entire water and solids-not-fat content, may contain Class IV Preservatives (antioxidants) (see Part XID of the Nineteenth Schedule), and shall have not less than 99.3 per centum of milk fat and not more than 0.5 per centum of water.
190. Cream shall be the pasteurised fatty liquid prepared from milk by separating the milk constituents in such a manner as to increase the milk fat content, shall contain not less than 35 per centum of milk fat, and not more than a total bacteria count of 100,000 per gram and not more than 10 coliform organisms per gram.
191. (1) Reduced cream shall be the cream with a content of less than 18 per centum of milk fat.
(2) The label of reduced cream may specify the percentage of the fat content in it.
192. (1) Ice cream shall be the pasteurised frozen food made from ice cream mix by freezing; may contain cocoa or chocolate syrup, fruit, nuts or confections; and shall contain not less than 36 per centum of solids; 10 per centum of milk fat, 171 grams of solids per litre, not more than a total bacteria count of 100,000 per gram and 10 coliform organisms per gram as determined by the prescribed method.
(2) For the purpose of regulation 192, "ice cream mix" shall be the unfrozen pasteurised combination of cream milk or other milk products and sweetened with sugar, invert sugar, honey, dextrose, glucose, corn syrup or corn syrup solids; and may contain egg, a flavouring preparation, cocoa or chocolate syrup, a food colour (see Part III of the Nineteenth Schedule), pH adjusting agents (see Part X of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule), and a sequestering agent and added lactose.
193. Dairy whip shall be the pasteurised frozen preparation of milk products and other food ingredients; may contain added food colour, pH adjusting agents, a stabilising agent and a sequestering agent (see Part XII of the Nineteenth Schedule); and shall contain not less than 10 per centum of milk solids-not-fat not more than a total bacteria count of 100,000 per gram and not more than 10 coliform organisms per gram.
194. Milk ice shall be the pasteurised frozen preparation of milk products and other food ingredients, may contain added food colour (see Part III of the Nineteenth Schedule), pH adjusting agents (see Part X of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule), and a sequestering agent (see Part XII of the Nineteenth Schedule); shall contain not less than 10 per centum of milk solids, not more than a total bacteria count of 100,000 per gram and not more than 10 coliform organisms per gram.
195. Ice confection shall be a pasteurised frozen preparation; may contain milk products or other food ingredients, added food colour, pH adjusting agents, a stabilising agent, and a sequestering agent (see Part XII of the Nineteenth Schedule); and shall contain not more than a total bacteria count of 100,000 per gram, and not more than 10 coliform organisms per gram.
196. Yoghurt shall be the coagulated pasteurised milk product obtained, by lactic acid fermentation through the action of Lactobacillus bulgaricus or Streptococcus thermophilus and, if desired, other suitable lactic acid producing cultures, from cream, concentrated or unconcentrated milk, partly skimmed milk or skimmed milk, with or without the addition of skimmed milk powder, concentrated whey, whey powder, cream, and sugars. Before lactic acid producing cultures are added, the mixture of dairy products to be so treated shall be pasteurised. Yoghurt may contain flavours, food colours (see Part III of the Nineteenth Schedule), stabilisers (see Part IV of the Nineteenth Schedule), pH adjusting agents (see Part X of the Nineteenth Schedule), and preservatives (see Part XI of the Nineteenth Schedule). It shall contain not less than 8.5 per centum of milk solids-not-fat and not less than 2.0 per centum of milk fat.
197. Non-fat-yoghurt shall be yoghurt but shall contain not more than 0.5 per centum of milk fat, and not less than 8.5 per centum of milk solids-not-fat.
Fats and Oils
198. Vegetable oils shall be derived from the botanical source after which they are named and indicated under the regulations for individual oils. They shall be free from foreign and rancid odour and taste. An addition of certain colours in oils (see regulations 115 to 122) is permitted for the purpose of standardising colours, as long as the added colours do not deceive or mislead the consumer by concealing damage or inferiority or by making the product appear to be more than its actual value. Natural flavours and their identical synthetic equivalents, except those which are known to represent a toxic hazard, and other approved synthetic flavours are permitted for the purpose of restoring natural flavours lost in processing or for the purpose of standardising flavours, so long as the added flavours do not deceive or mislead the consumer by concealing damage or inferiority or by making the product appear to be more than its actual value. Vegetable oils may contain permitted Class IV Preservatives (see Part XID of the Nineteenth Schedule), an antifoaming agent (see Part VIII of the Nineteenth Schedule), and crystallisation inhibitor (see Part VIII of the Nineteenth Schedule):
Provided that vegetable oils shall not contain any food additives or food colour when sold as virgin oils.
199. Animal fats shall be the fats obtained entirely from animals healthy at the time of slaughter and fit for human consumption as certified by a competent authority. They may contain a Class IV Preservative (see Part XID of the Nineteenth Schedule).
200. Refined oil or fat shall be the product that has been subjected to a process of purification and neutralisation and may be, depending upon the virgin oils, subjected to a process of de-colourisation, deodourisation and winterisation.
201. Arachis oil (peanut oil, groundnut oil) shall be derived from groundnuts (the seeds of Arachis hypogaea L.), and shall have the composition and quality factors set out in the Fourth Schedule.
202. Cottonseed oil shall be derived from the seeds of various cultivated species of Gossypium, and shall have the composition and quality factors set out in the Fifth Schedule.
203. Maize oil shall be derived from maize germ (the embryo of Zea Mays L.), and shall have the composition and quality factors set out in the Sixth Schedule.
204. Mustardseed oil shall be derived from the seeds of the white mustard (Sinapis alba L. synonym: Brassica hirta, Moench), the brown mustard (Brassica juncea (L.) Czern. and Coss), and the black mustard (Brassica nigra (L.) Koch), and shall have the composition and quality factors set out in the Seventh Schedule.
205. Olive oil shall be the oil obtained from the fruit of the olive tree (Olea europaea L.), and shall have the composition and quality factors set out in the Eighth Schedule.
206. Rapeseed oil (turnip rape oil, colza oil, ravision oil, sarson oil, toria oil) shall be derived from the seeds of Brassica campetris L., Brassica napus L., and Brassica tournefortti Gouan, and shall have the composition and quality factors set out in the Ninth Schedule.
207. Safflowerseed oil (safflower oil, carthamus oil, kurdee oil) shall be derived from safflower seeds (the seeds of Carthamus tinctorius L.), and shall have the composition and quality factors set out in the Tenth Schedule.
208. Sesameseed oil (sesame oil, gingelly oil, bene oil, benne oil, till oil, tillie oil) shall be derived from sesame seeds (the seeds of Sesamum indicum L.), and shall have the composition and quality factors set out in the Eleventh Schedule.
209. Soya bean oil (soybean oil) shall be derived from soya beans (the seeds of Glycine max L., Merr), and shall have the composition and quality factors set out in the Twelfth Schedule.
210. Sunflowerseed oil (sunflower oil) shall be derived from sunflower seeds (the seeds of Helianthus annus L.), and shall have the composition and quality factors set out in the Thirteenth Schedule.
211. Refined oil or a mixture of refined oils, shall have the composition and quality factors set out in the Fourteenth Schedule.
212. If a refined oil is obtained from a single oil, it shall, in addition to the trade name, if any, be so stated on the label; for example, "Refined sunflowerseed oil"; and if it is entirely constituted of vegetable oils, a declaration that it is "a vegetable oil product" shall be suitably made on the label.
213. No person shall sell a mixture of animal fat and vegetable fat unless the label of that mixture carries the declaration "Contains animal fat."
214. Lard shall be the fat rendered from fresh, clean, sound fatty tissues from swine (Sus scrofa). The tissue shall not include bones, detached skin, head skin, ears, tails, organs, windpipes, large blood vessels, scrap fat, skimmings, settlings, pressings and the like, and shall reasonably be free from muscle tissues, and blood. Lard shall have its characteristic odour and taste and be free from foreign odours and tastes and, when subjected to processing may, as long as it is so declared on the label in a descending order of proportion, contain refined lard, lard stearine and hydrogenated lard, and shall have the composition and quality factors set out in the Fifteenth Schedule.
215. Edible tallow (dripping) shall be the product obtained by rendering the clean, sound, fatty tissues (including trimming and cutting fats), attendant muscles and bones of bovine animals (Bos taurus) or sheep (Ovis aries). It shall have its characteristic odour and taste, and be free from foreign odour and tastes. It shall have the composition and quality factors set out in the Sixteenth Schedule.
216. Shortening, other than butter or lard, shall be the food prepared from fats, oils or a combination of fats and oils; may be processed by hydrogenation; and may contain a Class IV Preservative (see Part XID of the Nineteenth Schedule), an anti-foaming agent (see Part VIII of the Nineteenth Schedule), stearly, monoglycaridyl citrate and other emulsifying agents (see Part IV of the Nineteenth Schedule), the use and limits of all of which shall be as prescribed in their respective schedules.
217. Margarine shall mean the food generally known as margarine, being an emulsion of edible oils and fats, with water or skimmed milk or other substances with or without the addition of colouring matter capable of being used for the same purpose as butter. It may contain preservatives (see Part XI of the Nineteenth Schedule) and emulsifying agents (see part IV of the Nineteenth Schedule); and shall contain not less
than 80 per centum of fat, not more than 10 per centum of milk fat, not more than 16 per centum of water, not less than 2 per centum of sesame oil or, alternatively, 0.1 per centum of potato, wheat or corn starch, not less than 26 and not more than 33 international units per gram of vitamin A when determined by the prescribed method, and not less than 3 and not more than 4 international units of vitamin D per gram when determined by the prescribed method.
218. The label of the container in which margarine is packed shall, on the principal display panel, legibly and very conspicuously bear the word, 'MARGARINE'.
Flavouring Preparations
219. (Naming the flavour) extract or (naming the flavour) essence shall be a solution in ethyl alcohol, glycerol, propylene glycol or any combination of these, of sapid or odorous principles, or both, derived from the plant after which the flavouring extract or essence is named, and may contain water, a sweetening agent (see regulations 337 to 343), food colour (see Part III of the Nineteenth Schedule), and a Class II Preservative or a Class IV Preservative (see Parts XIB and XID of the Nineteenth Schedule).
220. Artificial (naming the flavour) extract, artificial (naming the flavour) essence, imitation (naming the flavour) extract or imitation (naming the flavour) essence, shall be a flavouring extract or essence except that the flavouring principles shall be derived in whole, or in part, from sources other than the aromatic plant after which it is named; and if such extract or essence is defined in these Regulations, the flavouring strength of the artificial or imitation extract or essence shall be not less than that of the extract or essence.
221. (Naming the flavour) flavour shall be a preparation, other than a flavouring preparation described in regulation 219, of sapid or odorous principles or both, derived from the aromatic plant after which the flavour is named; may contain a sweetening agent (see regulations 337 to 343), food colour (see Part III of the Nineteenth Schedule), Class II Preservative (see Part XIB of the Nineteenth Schedule), Class IV Preservative (see Part XID of the Nineteenth Schedule), a stabilising agent (see Part IV of the Nineteenth Schedule), an emulsifying agent (see Part IV of the Nineteenth Schedule), or a density adjusting agent (see Part VIII of the Nineteenth Schedule); and may have added to it water, ethyl alcohol, glycerol, propylene glycol and edible vegetable oil.
222. Artificial (naming the flavour) flavour or imitation (naming the flavour) flavour, shall be a flavour, except that the flavouring principles may be derived in whole or in part from sources other than the aromatic plant after which it is named; and if such a flavour is defined in these Regulations, the flavouring strength of the artificial or imitation flavour shall be not less than that of the flavour.
223. Notwithstanding regulations 219 and 221, a (naming the fruit) extract naturally fortified, (naming the fruit) essence naturally fortified or (naming the fruit) flavour naturally fortified shall be an extract, essence or flavour derived from the named fruit to which other natural extractives have been added, and 51 per centum of the flavouring strength shall be derived from the named fruit.
224. On any label of or in any advertisement for any artificial or imitation flavouring preparation the word "artificial" or "imitation" shall be an integral part of the name of such flavouring preparation and in identical type, and identically displayed, with such name.
225. Almond essence, almond extract or almond flavour shall be the essence, extract or flavour derived from the kernels of the bitter almond, apricot or peach, and shall contain not less than 1.0 per centum by volume of volatile oil, and not more than one part per million of hydrocyanic acid.
226. Anise essence, anise extract or anise flavour shall be the essence, extract or flavour derived from natural or terpeneless oil of anise, and shall correspond, in flavouring strength, to an alcoholic solution containing not less than 3.0 per centum by volume of oil of anise, the volatile oil obtained from the fruit of Pimpinella anisum L., or Illicium verum Hook.
227. Celery seed essence, celery seed extract or celery seed flavour shall be the essence, extract or flavour derived from celery seed, or oil of celery seed, or terpeneless oil of celery seed, and shall correspond, in flavouring strength, to an alcoholic solution containing not less than 0.3 per centum by volume of volatile oil of celery seed.
228. Cassia essence, cassia extract, cassia cinnamon essence, cassia cinnamon extract, cassia flavour or cassia cinnamon flavour shall be the essence, extract or flavour derived from natural or terpeneless oil, obtained from leaves and twigs of Cinnamomum cassia L., containing not less than 80 per centum of cinnamic aldehyde, and shall correspond, in flavouring strength, to an alcoholic solution containing not less than 2.0 per centum by volume of volatile oil of cassia cinnamon.
229. Ceylon cinnamon essence, Ceylon cinnamon extract or Ceylon cinnamon flavour shall be the essence, extract or flavour derived from the volatile oil obtained from the bark of Cinnamomum zeylanicum Nees, and shall contain not less than 2.0 per centum by volume of oil of Ceylon cinnamon and 65.0 per centum of cinnamic aldehyde and not more than 10.0 per centum of eugenol.
230. Clove essence, clove extract or clove flavour shall be the essence, extract or flavour derived from the volatile oil obtained from clove buds, and shall contain not less than 2.0 per centum by volume of oil of clove.
231. Ginger essence, ginger extract or ginger flavour shall be the essence, extract or flavour derived from ginger, and shall contain, in 100 millilitres, the alcohol-soluble matter from not less than 20 grams of ginger.
232. Lemon essence, lemon extract or lemon flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of lemon or from lemon peel, and shall contain not less than 0.2 per centum of citral derived from oil of lemon.
233. Nutmeg essence, nutmeg extract or nutmeg flavour shall be the essence, extract or flavour prepared from natural or terpeneless oil of nutmeg, and shall correspond, in flavouring strength, to an alcoholic solution containing not less than 2.0 per centum by volume of oil of nutmeg.
234. Orange essence, orange extract or orange flavour shall be the essence, extract or flavour prepared from sweet orange peel, oil or sweet orange or terpeneless oil of sweet orange, and shall correspond, in flavouring strength, to an alcoholic solution containing 5.0 per centum by volume of oil of sweet orange, the volatile oil obtained from the fresh peel of Citrus aurantium L., that shall have an optical rotation, at a temperature of 25ºC, of not less than +95º, using a tube 100 millimetres in length.
235. Peppermint essence, peppermint extract or peppermint flavour shall be the essence, extract or flavour prepared from peppermint or oil of peppermint, obtained from the leaves and flowering tops of Mentha piperita L., or of Mentha arvensis De. C., var. piperascens Holmes, and shall correspond, in flavouring strength, to an alcoholic solution of not less than 3 per centum by volume of oil of peppermint, containing not less than 50 per centum of free and combined menthol.
236. Rose essence, rose extract or rose flavour shall be the essence, extract or flavour prepared from the volatile oil obtained from the petals of rose and shall contain not less than 0.4 per centum by volume of attar of rose.
237. Savory essence, savory extract or savory flavour shall be the essence, extract or flavour prepared from savory or oil of savory, and shall contain not less than 0.35 per centum by volume of oil of savory.
238. Spearmint essence, spearmint extract or spearmint flavour shall be the essence, extract or flavour prepared from spearmint or from oil of spearmint, obtained from the leaves and flowering tops of Mentha spicata L., and Mentha cardiaca, and shall contain not less than 3.0 per centum by volume of oil of spearmint.
239. Sweet basil essence, sweet basil extract or sweet basil flavour shall be the essence, extract or flavour prepared from sweet basil or from oil of sweet basil, obtained from the leaves and tops of Ocymum basilicum L., and shall contain not less than 0.1 per centum by volume of oil of sweet basil.
240. Sweet marjoram essence, sweet marjoram extract or sweet marjoram flavour or marjoram flavour shall be the essence, extract or flavour prepared from marjoram or from oil of marjoram, and shall contain not less than 1.0 per centum by volume of oil of marjoram.
241. Thyme essence, thyme extract or thyme flavour shall be the essence, extract or flavour prepared from thyme or from oil of thyme, and shall contain not less than 0.2 per centum by volume of oil of thyme.
242. Vanilla essence, vanilla extract or vanilla flavour shall be the essence, extract or flavour prepared from the vanilla bean, the dried, cured fruit of Vanilla planifolia Andrews, or Vanilla tahitensis J. W. Moore, shall contain, in 100 millilitres, regardless of the method of extraction, at least the quantity of soluble substances in their natural proportions that are extractable by the prescribed method from not less than 10 grams of vanilla beans, where such beans contain 25 per centum or less of moisture, and not less than 7.5 grams of vanilla beans, on the moisture-free basis, where such beans contain more than 25 per centum of moisture; and shall, notwithstanding regulations 219 and 221, contain no added colour.
243. Wintergreen essence, wintergreen extract or wintergreen flavour shall be the essence, extract or flavour prepared from oil of wintergreen, the volatile oil distilled from the leaves of Gaultheria procumbens L., or from Betula lenta L., and shall contain not less than 3.0 per centum by volume of oil of wintergreen.
Fruits, Vegetables, and their Products
244. For the purposes of regulations 245 to 281, unless the context otherwise requires-
"acid ingredient" means citric, malic, tartaric or lactic acid; lemon or lime juice; or vinegar;
"fruit juice" means the unfermented liquid expressed from sound, ripe, fresh fruit, and includes any such liquid that is heat-treated and chilled;
"sweetening ingredient" means sugar, invert sugar, dextrose, in dry or liquid form, or a combination of not less than 75 per centum of sugar, invert sugar or dextrose and not more than 25 per centum of liquid glucose, calculated on the dry basis.
245. Canned (naming the vegetable) shall be the product obtained by heat processing in an appropriate manner before or after being sealed in a container so as to prevent spoilage of the named fresh vegetable after it has been properly prepared, and it may contain sugar, invert sugar or dextrose, in a dry or liquid form, salt, a firming agent (see Part VI of the Nineteenth Schedule), if declared by name on the label, and other suitable ingredients which are not food additives, or food colours as specified in the Nineteenth Schedule or, if the ingredients are food additives, their use shall conform to the limits specified in the Nineteenth Schedule and, if they are food colours, their use and limits shall be as prescribed in Part I of the Seventeenth Schedule.
246. Frozen (naming the vegetable) shall be the product obtained by freezing the named fresh vegetable after it has been properly prepared and subjected to a blanching treatment and may contain added sugar, suitable flavourings and salt, if such addition is declared on the label.
247. Canned tomatoes shall be the product prepared from washed ripened tomatoes conforming to the characteristics of the fruit of Lycopersicum esculentum P. Mill, of red or reddish varieties (cultivars) which are clean, substantially sound and packed with or without a suitable liquid packing medium (other than added water) and spice or other seasoning ingredients appropriate to the product and processed by heat, in an appropriate manner, before or after being sealed in a container, so as to prevent spoilage. The tomatoes shall have had the stems and calices removed and, except where the internal core is insignificant as to texture and appearance, have been cored, and may contain sugar, invert sugar or dextrose, in a dry form, salt, a firming agent, namely, calcium chloride or other suitable calcium salts (see Part VI of the Nineteenth Schedule), and citric, acetic, lactic, malic or tartaric acid, and shall contain not less than 50 per centum of drained tomatoes as determined by the prescribed method.
248. The label of canned tomatoes shall carry a declaration of added salt and firming agent, and the name of added ingredients, such as citric or acetic acid, sugar, invert sugar, dextrose, etc.
249. Tomato juice shall be the pasteurised liquid containing a substantial portion of fine tomato pulp, extracted from sound, ripe, whole tomatoes from which all stems and skins, seeds or other coarse or hard objectionable portions have been removed, and may contain salt, and shall contain not less than 6 per centum of tomato solids, determined by the refractometer at 20ºC, uncorrected for acidity and read as degree brix on the International Sucrose Scale.
250. The label for tomato juice shall carry a declaration of added salt.
251. Tomato paste shall be the product made by evaporating a portion of the water from tomato juice obtained from sound tomato trimmings, may contain salt and Class II Preservatives (see Part XIB of the Nineteenth Schedule), and shall contain not less than 24 per centum of tomato solids as determined by the prescribed method.
252. Concentrated tomato paste shall be the tomato paste containing not less than 32 per centum of tomato solids as determined by the prescribed method.
(As amended by S.I. No 38 of 1992)
253. Tomato pulp (tomato puree) shall be the heat-processed product made from concentrated tomato juice from whole, ripe tomatoes or sound tomato trimmings, and may contain salt and a Class II Preservative (see Part XIB of the Nineteenth Schedule). It shall contain not less than 8 per centum and not more than 24 per centum of tomato solids.
254. The label for tomato paste, tomato pulp, tomato puree or concentrated tomato paste, shall carry a declaration of added salt.
255. Tomato catsup, cutsup, ketchup, tomato relish or tomato sauce or products whose common names are variants of the word catsup shall be the heat-processed product made from the juice of red-ripe tomatoes or sound tomato trimmings from which skins and seeds have been removed; shall contain vinegar, salt and seasoning; sugar, invert sugar, glucose or dextrose, in a dry or liquid form; and not less than 6 per centum of tomato solids; and may contain a Class II Preservative (see Part XIB of the Nineteenth Schedule), and a food colour (see Part III of the Nineteenth Schedule).
256. Where tomato trimmings or tomato products made from tomato trimmings are used in the manufacture of a catsup, the label shall carry a declaration of the use of such materials.
257. No person shall sell canned tomatoes, tomato juice or a vegetable juice that contains mould filaments in more than 25 per centum of the microscopic fields when examined by the prescribed method.
258. No person shall sell tomato puree, tomato paste, tomato pulp or tomato catsup that contains mould filaments in more than 50 per centum of the microscopic fields when examined by the prescribed method.
259. Pickles or relishes shall be the product prepared from vegetables or fruit with salt and vinegar, and may contain spices, seasonings, sugar, invert sugar, dextrose or glucose, in a dry or liquid form, a food colour (see Part III of the Nineteenth Schedule), a Class II Preservative (see Part XIB of the Nineteenth Schedule), a firming agent (see Part VI of the Nineteenth Schedule), polyoxythylene (20) sorbitan monooleate in an amount not exceeding 0.05 per centum, lactic acid, vegetable oils, and in the case of relishes and mustard pickles, an approved thickening agent (see Part IV of the Nineteenth Schedule).
260. Canned (naming the fruit) shall be the product obtained from the named fresh fruit after it has been properly prepared and subsequently processed by heat in an appropriate manner, before or after being sealed in a container, so as to prevent spoilage, and may contain sugar, invert sugar, dextrose or glucose, in a dry or liquid form, and food additives whose use and limits shall conform to those specified in the Nineteenth Schedule and, if they are food colours, their use and limits shall be as prescribed in Part II of the Seventeenth Schedule.
261. Frozen (naming the fruit) shall be the product obtained by freezing the named fresh fruit after it has been properly prepared, and may contain sugar, invert sugar, dextrose or glucose, in a dry or liquid form, ascorbic acid, to prevent discolouration, and in the case of frozen sliced apples, a firming agent (see Part VI of the Nineteenth Schedule), and sulphurous acid.
262. The label of canned or frozen fruit packed in syrup shall be so declared.
263. The label of frozen fruit packed in sugar, invert sugar, dextrose or glucose, in a dry form, shall carry a declaration of each sweetening ingredient added.
264. The label of frozen fruit containing added ascorbic acid shall carry the statement "Contains ascorbic acid to prevent discolouration".
265. The label of canned or frozen fruit shall carry a declaration of any food additives.
266. (Naming the fruit) juice shall be the juice obtained from the named fruit and may contain sugar, invert sugar or dextrose, in a dry form, and a Class II Preservative (see Part XIB of the Nineteenth Schedule).
267. Notwithstanding regulation 266, the fruit juice prepared from any fruit named in any regulations 268 to 274 shall conform to the standard prescribed for that fruit juice in that regulation.
268. Apple juice shall be the fruit juice obtained from apples, may contain a Class II Preservative (see Part XIB of the Nineteenth Schedule) and ascorbic acid, shall havenot less than 10 per centum of soluble solids as determined by the refractometer at 20ºC and read as degrees brix on the international sucrose scales, and not exceeding 0.4 gram per kilogram of volatile acid expressed as acetic acid.
269. Grape juice shall be the fruit juice obtained from grapes, may contain citric acid, sugar, invert sugar or dextrose in a dry form, a Class II Preservative (see Part XIB of the Nineteenth Schedule), and ascorbic acid, shall have not less than 15 per centum of soluble solids as determined by the refractometer at 20ºC and read as degrees brix on the international sucrose scales, and not exceeding 0.4 gram per kilogram of volatile acid expressed as acetic acid.
270. Grapefruit juice shall be the fruit juice obtained from grapefruit, may contain sugar, invert sugar or dextrose in a dry form and a Class II Preservative (see Part XIB of the Nineteenth Schedule), and shall contain, exclusive of added sweetening agents, not less than 9 per centum of soluble solids as determined by the refractometer at 20ºC and read as degrees brix on the international sucrose scales.
271. Lemon juice shall be the fruit juice prepared from lemons, shall contain not less than 6 per centum of soluble lemon solids as determined by the refractometer at 20ºC and read as degrees brix on the international sucrose scales, and the total titratable acidity of lemon juice shall be not less than 4.5 per centum expressed as anhydrous citric acid.
272. Lime juice or lime fruit juice shall be the fruit juice obtained from limes, may contain sugar, invert sugar or dextrose in a dry form and a Class II Preservative (see Part XIB of the Nineteenth Schedule), shall contain, exclusive of added sweetening agents, soluble solid contents of not less than 6.0 per centum as determined by the refractometer at 20ºC and read as degrees brix on the international sucrose scales, and the total titratable acidity of lime juice shall be not less than 4.5 per centum expressed as anhydrous citric acid.
273. Orange juice shall be the fruit juice obtained from oranges; shall contain, exclusive of added sweetening agents, not less than 10 per centum of soluble solids as determined by the refractometer at 20ºC on the international sucrose scales; may contain sugar, invert sugar or dextrose, in a dry form, and a Class II Preservative (see Part XIB of the Nineteenth Schedule); have the pulp and natural orange oil content adjusted in accordance with good manufacturing practice; and may have added the natural orange juice flavour lost during processing.
274. Pineapple juice shall be the fruit juice obtained from pineapple; may contain sugar, invert sugar or dextrose, in a dry form, a Class II Preservative (see Part XIB of the Nineteenth Schedule), and ascorbic acid; and shall contain, exclusive of sweetening agents, not less than 10 per centum of soluble solids as determined by the refractometer at 20ºC on the international sucrose scales.
275. Carbonated (naming the fruit) juice or sparkling (naming the fruit) juice shall be the named fruit juice impregnated with carbon dioxide under pressure and shall contain a minimum of 3.0 per centum of the fruit obtained from the named fruit.
(As amended by S.I. No 40 of 1992)
276. Concentrated (naming the fruit) juice shall be fruit juice that has been concentrated to at least one-half its original volume by the removal of water, and may contain ascorbic acid, food colour (see Part III of the Nineteenth Schedule), sugar, invert sugar or dextrose, in a dry form, and a Class II Preservative (see Part XIB of the Nineteenth Schedule).
277. (1) (Naming the fruit) jam shall be the product obtained by processing fruit, fruit pulp, or canned fruit, by boiling to a suitable consistency with water and a sweetening ingredient; shall contain not less than 40 per centum of the named fruit and 65 per centum of water soluble solids as estimated by the refractometer; and may contain such amount of added pectin, or acid ingredients, as reasonably compensates for any deficiency in the natural pectin content or acidity of the named fruit, a Class II Preservative (see Part XIB of the Nineteenth Schedule) and an antifoaming agent (see Part VIII of the Nineteenth Schedule).
(2) In this regulation, "fruit" includes ginger, rhubarb and marrow.
278. (Naming the citrus fruit) marmalade shall be the product obtained by processing a combination of peel, pulp or juice of the named citrus fruit by boiling with water and a sweetening ingredient, shall contain not less than 65 per centum of water soluble solids as estimated by the refractometer, and may contain such amount of acid ingredients as reasonably compensates for any deficiency in the natural acidity of the named citrus fruit, a pH adjusting agent (see Part X of the Nineteenth Schedule), an antifoaming agent (see Part VIII of the Nineteenth Schedule), and pectin.
279. (Naming the fruit) jelly shall be the gelatinous food, free of seeds and pulp, made from the named fruit, the juice of the named fruit or a concentrate of the juice of the named fruit, which has been boiled with water and a sweetening ingredient; shall contain not less than 65 per centum of water soluble solids as estimated by the refractometer; and may contain such amount of added pectin, or acid ingredients as reasonably compensates for any deficiency of the natural pectin content or acidity of the named fruit, a pH adjusting agent (see Part X of the Nineteenth Schedule), and an antifoaming agent (see Part VIII of the Nineteenth Schedule).
280. Lemon curd shall be the product manufactured by boiling together, cornflour or wheat flour, margarine or butter, egg, citric acid, oil of lemon, food colour (see Part III of the Nineteenth Schedule) and water, and shall contain not less than 65 per centum of soluble solids.
281. Mincemeat shall be the product manufactured by mixing together, without heating, apples, dried fruits, mixed peel, sugar, suet, acetic acid, flavouring preparations and salt, and shall contain not less than 65 per centum of soluble solids.
Gelling Agents
282. Gelatin or edible gelatin shall be the protein produced by partial hydrolysis of collagen in skin, tendons, ligaments and bones of animals; may contain sulphurous acid or its salts; shall dissolve completely in warm water to get a clear translucent colloidal solution which sets to a jelly when cooled to and maintained at 15.5º for two hours; and shall contain, on the dry basis, not more than 2.0 per centum of total ash, less than 10,000 total plate count per gram and a nil coliform count in 1.0 gram.
283. Agar or agar-agar shall be the dried, purified, mucilaginous food obtained by aqueous extraction of seaweeds of the species Gelidium, shall contain, on the dry basis, not more than 7.0 per centum of total ash and 1.0 per centum of ash insoluble in hydrochloric acid and shall yield, with water, a practically colourless and tasteless solution.
Grain and Bakery Products
284. Flour shall be the food prepared by the grinding of cleaned milling grades of wheat, and bolting through cloth having openings not larger than those of woven nylon or wire cloth having an aperture of 180 microns, and free from bran coat and germ to such an extent that it does not exceed 1.20 per centum of ash, calculated on a moisture-free basis. It shall have not more than 15.0 per centum of moisture, and may contain malted wheat flour, malted barley flour in an amount not exceeding 1.0 per centum of the weight of the flour, and food additives the use and limits of which shall conform to those specified in regulations 325 to 334.
285. Enriched flour shall be the flour to which has been added thiamine, riboflavin, nicotinic acid and iron in a harmless carrier and in such amounts that one kilogram of enriched flour shall contain not less than 4.5 milligrams and not more than 5.5 milligrams of thiamine, not less than 2.7 milligrams and not more than 3.3 milligrams of riboflavin, not less than 35.5 milligrams and not more than 44.4 milligrams of nicotinic acid or niacinamide, not less than 28.9 milligrams and not more than 36.7 milligrams of iron, and may contain calcium carbonate in an amount that will provide in one kilogram of enriched flour not less than 1,111 milligrams and not more than 1,444 milligrams of calcium.
286. Whole wheat meal (whole wheat flour) shall be the food prepared by the grinding and bolting of cleaned, milling grades of wheat from which a part of the outer bran or epidermis layer may have been separated; shall contain the natural constituents of the wheat berry to the extent of not less than 95 per centum of the total weight of the wheat from which it is milled, have not less than 1.25 per centum and not more than 2.25 per centum of ash, calculated on a moisture-free basis, and not more than 15.0 per centum of moisture and such a degree of fineness that not less than 90 per centum of it bolts freely through a 2,380 micron sieve, and less than 50 per centum of it through an 840 micron sieve, and may contain malted wheat flour, malted barley flour in an amount not exceeding 1.0 per per centum of the flour, and food additives the use and limits of which shall conform to those specified in regulations 325 to 334.
287. Crushed wheat shall be the food prepared by so crushing clean wheat that 40 per centum or more of it passes through a 2,380 micron sieve and less than 50 per centum of it through an 840 micron sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered, and shall have not less than 1.25 per centum and not more than 2.25 per centum of ash, calculated on a moisture-free basis. It shall have not more than 15.5 per centum of moisture.
288. Cracked wheat shall be the food prepared by so cracking or cutting cleaned wheat into angular fragments that not less than 90 per centum of it passes through a
2,380 micron sieve and not more than 20 per centum of it through an 840 micron sieve, the proportions of the natural constituents of such wheat, other than moisture, remaining unaltered and shall have not less than 1.25 per centum and not more than 2.25 per centum of ash, calculated on a moisture-free basis. It shall have not more than 15.5 per centum of moisture.
289. Self-raising flour shall be an intimate mixture of flour and sodium bicarbonate and one or more of the acid reacting substances, namely, monocalcium phosphate, sodium acid pyrophosphate, or sodium aluminium phosphate, may be seasoned with common salt, and shall evolve not less than 0.4 per centum of carbon dioxide when tested by the prescribed method.
290. Maize roller meal (mealie meal) shall be the product obtained by grinding and bolting cleaned milling grades of maize such that not less than 95 per centum of it passes through a mesh of 800 microns aperture, and shall have not more than 15.0 per centum of moisture, not more than 4.5 per centum of maize oil, not more than 2.0 per centum of crude fibre, not more than 1.5 per centum of total ash, not more than 0.3 per centum of ash insoluble in hydrochloric acid and not more than 0.1 per centum alcoholic acid expressed as sulphuric acid.
(As amended by S.I. Nos. 37 and 93 of 1992)
291. Maize breakfast food (degerminated maize meal) shall be the product obtained by grinding and bolting cleaned milling grades of degerminated maize from which a portion of the bran and germ has been removed and not less than 95 per centum of which passes through a wire mesh sieve of 800 microns aperture, and shall have not more than 15.0 per centum of moisture, not more than 3.0 per centum of maize oil, not more than 1.5 per centum of crude fibre, not more than 1.0 per centum of total ash, not more than 0.2 per centum of ash insoluble in hydrochloric acid and not more than 0.1 per centum alcoholic acid expressed as sulphuric acid.
(As amended by S.I. Nos. 39 and 93 of 1992)
292. Maize flour shall be the product obtained by grinding and bolting cleaned milling grades of maize such that not less than 95 per centum of it passes through a wire mesh of 180 microns aperture, and shall have not more than 15.0 per centum of moisture, not more than 3.0 per centum of maize oil, not more than 1.0 per centum of crude fibre, not more than 1.0 per centum of total ash and not more than 0.2 per centum of ash insoluble in hydrochloric acid.
293. Maize rice shall be the product obtained by grinding and bolting cleaned milling grades of maize such that not less than 95 per centum of it passes through a mesh of 2,380 microns and not more than 10 per centum of it passes through a mesh of 1,800 microns, and shall have not more than 15.0 per centum of moisture, not more than 1.5 per centum of maize oil, not more than 1.0 per centum of crude fibre, not more than 1.0 per centum of total ash, and not more than 0.2 per centum of ash insoluble in hydrochloric acid; and the main panel of the label shall carry the words, "an entirely maize product".
294. Maize samp shall be the product obtained by degerminating cleaned milling grades of maize and removal of bran and germ such that not more than 10 per centum of it passes through a mesh of 2,380 microns and shall have not more than 15.0 per centum of moisture, not more than 2.0 per centum of maize oil, not more than 1.0 per centum of crude fibre, not more than 0.5 per centum of total ash, and not more than 0.1 per centum of acid insoluble ash.
295. Rice shall be the dehulled, or dehulled and polished seed of the rice plant (Oryz sativa), and may contain glucose.
296. Bread or white bread shall be the food made by baking a yeast-leavened dough prepared with flour and water; and may contain salt, shortening, lard, butter or margarine, milk or milk product, whole egg, egg-white, egg-yolk (fresh, dried or frozen), a sweetening agent, malt syrup, malt extract or malt flour, inactive dried yeast of the genus Saccharomyces cerevisiae in an amount not greater than 2 parts by weight for each 100 parts of flour used, oatmeal, maize flour, cassava flour, potato flour, rice flour, soya-bean flour, barley flour, vegetable flours, maize starch, cassava starch, potato starch, wheat starch, any of which may be wholly or partially dextrinised, in an amount not greater than 5 parts by weight of all such additions for each 100 parts of flour, vinegar, acetic acid or citric acid, a Class III Preservative (see Part XIC of the Nineteenth Schedule), and food additives (see the Nineteenth Schedule) the use and limits of which shall conform to those specified in regulations 325 to 334.
297. Enriched bread or enriched white bread shall be the bread baked from a yeast leavened dough, and shall contain, for each 100 parts of flour used, not less than 2 parts by weight of skim milk solids, or 4 parts by weight of dried whey powder, and in each kilogram, not less than 2.4 milligrams and not more than 5.3 milligrams of thiamine, not less than 1.8 milligrams and not more than 4.0 milligrams of riboflavin, not less than 22.2 milligrams and not more than 33.3 milligrams of nicotinic acid or niacinamide, and not less than 18.0 milligrams and not more than 27.7 milligrams of iron.
298. Brown bread shall be the bread made by the use of whole wheat meal and bran and which has acquired a brown colour.
299. (1) Bread for sale shall be wrapped, and bakery product for sale shall be contained, in such a manner as to be adequately protected from contamination. Wrapping material or container which is not clean or which is liable to contaminate the bread or bakery product and, in particular (without prejudice to the generality of the foregoing), any printed material, other than printed material designed exclusively for wrapping or containing food, shall not be used for wrapping bread or containing any such bakery product.
(2) For the purpose of this regulation, "adequate" shall have the meaning assigned thereto in regulation 410.
300. For the purposes of regulations 301 to 323, unless the context otherwise requires-
"animal" means any animal used as food, but does not include marine and fresh water animals or poultry;
"filler" means-
(a) flour or meal prepared from grain, wheat tube or soyabeans, including soya protein isolates;
(b) bread, biscuits, or bakery products, but not those containing or made with a legume;
(c) milk powder, skim milk powder, buttermilk powder, whey powder or caseinates (potassium. sodium or calcium);
"lean meat content" means the total weight of lean meat free from visible fat, when raw or after curing or after any other similar processing, contained in any canned meat product expressed as a percentage of the total weight of that product;
"meat content" means the total weight of meat, when raw or after curing or after any other similar processing, contained in any canned meat product expressed as a percentage of the total weight of that product.
301. Meat shall be the edible part of the skeletal muscle of an animal that was healthy at the time of slaughter, and may contain an accompanying and overlaying fat together with portions of skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and are not separated from it in the process of dressing but, subject to regulation 320, does not include muscle found in the lip, snout, scalp or ear.
302. Meat by-product shall be any edible part of an animal, other than meat, that has been derived from one or more animals that were healthy at the time of slaughter.
303. Meats, meat by-products or preparations thereof are adulterated if any of the following substances or class of substances are present therein or have been added thereto:
(a) preservatives, other than those provided for in regulations 300 to 323; and
(b) colours, other than those provided for in regulations 300 to 323.
304. Prepared meat or prepared meat by-product shall be meat or meat by-product respectively, whether comminuted or not, to which has been added any other ingredient permitted by these Regulations, or which has been preserved, canned or cooked and, in the case of prepared hams, may contain shoulders, butts, picnics, and backs, and gelatin and, in the case of partially defatted pork fatty tissues, or partially defatted beef fatty tissues and a Class IV Preservative (see Part XID of the Nineteenth Schedule).
305. A food that consists wholly or in part of a meat by-product or a prepared meat by-product shall be labelled with the words, "meat by-product", or with the name of the meat by-product.
306. Pumping pickel, cover pickle and dry cure employed in the curing of preserved meat or preserved meat by-product may contain preservatives as prescribed in Part XI of the Nineteenth Schedule, citric acid, sodium citrate or vinegar, dextrose or glucose, salt, spices or seasoning, sodium bicarbonate or sodium hydroxide, in the case of pumping pickle for cured pork and beef cuts, such disodium phosphate, monosodium
phosphate, sodium hexametaphosphate, sodium tripolyphosphate, tetrasodium pyrophosphate and sodium acid pyrophosphate, as shall result in the finished product contain-ing not more than 3,000 milligrams per kilogram expressed as P2O5, in the case of pumping pickle for cured beef briskets, enzymes, and in the case of dry cure, an anticaking agent (see Part I of the Nineteenth Schedule) or a humectant (see Part VIII of the Nineteenth Schedule).
307. No person shall sell as food a dead animal or any part thereof.
308. No person shall sell as food, meat, meat by-products, prepara.tions containing meat or meat derivatives obtained, prepared or manufactured from a dead animal.
309. For the purposes of regulations 307 and 308, "dead animal" means a dead animal that was not killed for the purpose of food in accordance with the commonly accepted practice of killing animals for the purpose of food, or was affected with disease at the time it was killed and which disease, in the opinion of veterinarians, renders it unfit for use as meat.
310. Subject to the provision of regulation 311, no person shall sell a meat, meat by-product or any preparation thereof packed in a hermetically sealed container unless it has been heat-processed, after or at the time of sealing, at a temperature and for a time sufficient to prevent the survival of any pathogenic micro-organism.
311. Notwithstanding regulation 310, meat, meat by-product or any preparation thereof, packed in a hermetically sealed container that has not been processed as required by regulation 310, may be sold if it has been stored continuously under refrigeration at a temperature lower than 4ºC the label thereof carrying a statement on the main panel to the effect that the product is perishable and that it shall be kept refrigerated at a temperature lower than 4ºC; or has been maintained continuously in the frozen state, the label thereof carrying a statement on the main panel to the effect that the product is perishable and that it shall be kept frozen; or contains preservatives as specified in Part XI of the Nineteenth Schedule, has been heat-processed, after or at the time of sealing, at a temperature and for a time sufficient to prevent the formation of any bacterial toxins; or has been subjected to a dehydration procedure in accordance with good manufacturing practice; or has a pH of 4.4 or less.
312. Minced beef or ground beef shall be comminuted beef meat and shall contain not more than 20 per centum of fat:
Provided that where the produce is represented by any means whatsoever as being lean, it shall contain not more than 10 per centum of fat.
313. No person shall sell prepared meat or prepared meat by-product, except black pudding, and white pudding, that contains more than that amount of filler, meat binder or other ingredient, that is represented by 4 per centum of reducing sugars, calculated as dextrose, as determined by the prescribed method, or 60 per centum of moisture where such prepared meat or prepared meat by-product contains filler.
314. Preserved meat or preserved meat by-product shall be cooked or uncooked meat or meat by-product that is salted, pickled, corned, cured or smoked; may be glazed and may contain a Class I Preservative (see Part XIA of the Nineteenth Schedule), dextrose, glucose or sugar, spices and seasonings, vinegar, or smoke flavouring or artificial smoke flavouring, in which case the main panel of the label shall carry, immediately preceding or following the common name, the statement, "Smoke Flavouring Added", or "Artificial Smoke Flavouring Added", as the case may be.
315. Sausage or sausage meat shall be the fresh or preserved comminuted meat to which has been added salt, a Class I Preservative (see Part XIA of the Nineteenth Schedule), and spices (see regulations 325 to 334); may be enclosed in a casing, dipped in vinegar, smoked or cooked; and may contain animal fat, filler, beef tripe, liver, fresh blood from meat cattle, sugar, dextrose or glucose, other seasonings, harmless Lacto bacilli cultures, lactic acid starter culture, Pediococcus cerevisiae, meat binder, blood plasma or, in the case of preserved comminuted meat, smoke flavouring or artificial smoke flavouring, in which case the main panel of the label shall carry, immediately preceding or following the common name, the statement, "Smoke Flavouring Added" or, "Artificial Smoke Flavouring Added", as the case may be; or, if cooked, glucona delta lactone, partially defatted beef fatty tissue, and a dried skim milk product, obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding 3 per centum of the finished food or, in the case of a dry sausage or dry sausage meat, glucone delta lactone; and shall contain not less than 65 per centum of meat and, in a case of a product sold as fresh sausage, not more than 40 per centum of fat as determined by the prescribed method.
316. Potted meat, meat paste or meat spread shall be the comminuted and cooked or preserved meat, and may contain meat, binder, salt, sugar, dextrose, glucose, spices, other seasonings or a gelling agent and shall contain not less than 65 per centum of meat.
317. Potted meat by-product, meat by-product paste or meat by-product spread shall be the food consisting, wholly or in part, of meat by-products, and shall otherwise conform to the standard prescribed for potted meat.
318. Meat loaf, meat roll, meat lunch or luncheon meat shall be the comminuted and cooked, or preserved meat, pressed into shape and may contain a dried skim milk product obtained from skim milk by the reduction of its calcium content and a corresponding increase in its sodium content, in an amount not exceeding 3 per centum of the finished food, filler, meat binder, salt, sugar, dextrose, glucone delta lactone, glucose, spices, other seasonings, milk, eggs, a gelling agent and partially defatted beef fatty tissue or partially defatted pork fatty tissue; it shall contain not less than 65 per centum of meat.
319. Meat by-product loaf or meat and meat by-product loaf shall be the food consisting, wholly or in part, of meat by-product, and shall otherwise conform to the standard prescribed for meat loaf.
320. (1) Headcheese shall be the comminuted, cooked preserved meat, shall not contain less than 65 per centum of head meat, and may contain scalp, snout, lip and ear, beef tripe, salt, spices, seasonings and an added gelling agent.
(2) For the purpose of this regulation, scalp, snout, lip or ear shall, notwithstanding regulation 301, be deemed head meat.
321. Brawn shall be headcheese, except that it need not contain 50 per centum of head meat.
322. The label of prepared meat by-product, to which a gelling agent has been added as permitted by these Regulations, shall carry a declaration of the presence of the added gelling agent, or the word, "jellied", as an integral part of the name of the food.
323. Edible bone meal or edible bone flour shall be the food prepared by grinding dry, defatted bones obtained from animals, healthy at the time of slaughter, and shall contain not less than 85 per centum of ash, not more than a total micro-organism count of 1,000 per gram and no Escherichia coli as determined by the prescribed method.
Poisonous Substances in Food
324. Except as provided in these Regulations, a food named in Part I or Part II of the Eighteenth Schedule, and which contains in or upon it any or all of the poisonous or harmful substances listed in amounts not exceeding the quantities stated in the said Schedule and in parts per million for that food and no other poisonous or harmful substance, is hereby exempted from the provision of paragraph (a) of section three of the Act.
Food Additives
325. In regulations 326 to 334, unless the context otherwise requires-
"soft drinks" means any of the foods included in regulations 385 to 388, including a beverage base, beverage mix and beverage concentrate. In the case of a beverage base, beverage mix and beverage concentrate, the maximum levels of food additives permitted shall be for the finished drink.
326. No person shall sell any substance or mixture of substances for use as a food additive unless the label carries a quantitative statement of the amount of each additive present, or carries a complete list of the food additives present in descending order of their proportions, including directions for their use which, if followed, shall produce a food that shall not contain such additives in excess of the maximum levels of use prescribed by these Regulations.
327. A request that a food additive be added to, or a change made in, the Nineteenth Schedule shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include-
(a) a description 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 and, where that information is not available, a detailed explanation;
(b) a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use;
(c) where necessary, in the opinion of the Minister, an acceptable method of analysis suitable for regulatory purposes that shall determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food;
(d) data establishing that the food additive shall have the intended physical or other technical effect;
(e) detailed reports of tests made 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 upon the finished food when the food additive is used in accordance with good manufacturing practice;
(g) a proposed maximum limit for residues of the food additive in or upon the finished food;
(h) specimens of the labelling proposed for the food additive; and
(i) a sample of the food additive in the form in which it is proposed to be used in foods, a sample of the active ingredient and, on request, a sample of food containing the food additives.
328. The Minister shall inform in writing the person filing the submission of his decision to approve the request for the addition to or change in the Nineteenth Schedule.
329. More than one Class II Preservative shall be allowed:
Provided that the sum of the ratios of the quantities of each preservative present in the product to the quantities permitted under this regulation shall not exceed unity.
330. Notwithstanding the other provisions of these Regulations, paragraph (c) of regulation 22 and paragraph (a) of regulation 23 shall not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives.
331. No person shall sell a food containing a food additive except as provided for in regulations 22 and 23.
332. In respect of regulations 284 to 299 and Part XIV of the Nineteenth Schedule, ammonium chloride, ammonium sulphate, calcium carbonate, calcium lactate, diammonium phosphate, dicalcium phosphate, monoammonium phosphate or any combination thereof shall be used in an amount not greater than 0.25 part by weight of all such additives for each 100 parts of flour.
333. In respect of regulations 284 to 299 and Part II of the Nineteenth Schedule,
potassium bromate, calcium peroxide, ammonium persulphate, potassium persulphate or any combination thereof, shall be used in an amount not greater than 0.01 part by weight of all such additives for each 100 parts of flour.
334. No person shall sell any substance as a food additive unless the food additive is listed in one or more of the Parts in the Nineteenth Schedule.
Salt
335. Salt shall be the crystalline sodium chloride, and shall contain not less than 97.0 per centum of sodium chloride on a moisture-free basis, not more than 0.2 per centum of matter insoluble in water, and one part of potassium iodide per 20,000 parts of salt.
336. Table salt shall be the fine grained refined crystalline salt with the addition of harmless anticaking agents (see Part I of the Nineteenth Schedule) to secure free running properties.
Sweetening Agents
337. White sugar shall be the purified and crystallised sucrose and shall have a polarisation of not less than 99.7º S.
338. Icing sugar shall be the finely pulverised white sugar with or without the addition of an anticaking agent. It may contain not more than 5 per centum of starch, if no other anticaking agent is used. If an anticaking agent is used, its use and limits shall conform to those specified in Part I of the Nineteenth Schedule. It may contain not more than 20 parts per million of residual sulphur dioxide from the white sugar used.
339. Brown sugar, yellow sugar, or golden sugar shall be the food obtained from the syrups originating in the sugar refining process. It shall contain not more than 4.5 per centum of moisture, not more than 3.5 per centum of sulphated ash, and not less than 90 per centum of sugar and invert sugar.
340. Refined sugar syrup, refiners' syrup or golden syrup shall be the food made from the syrup originating in the sugar refining process, and partly hydrolysed and shall contain not more than 35 per centum of moisture, and not more than 2.5 per centum of sulphated ash.
341. Dextrose or dextrose monohydrate, for the purposes of regulations 15 to 421, shall be the food chemically known as dextrose or d-glucose or dextrose monohydrate, and shall contain not less than 90 per centum of total solids and not more than 0.25 per centum of sulphated ash.
342. Glucose syrup or liquid glucose shall be the purified concentrated aqueous solution of nutritive saccharides obtained from starch, may contain sulphurous acid or its salt (see Part XIB of the Nineteenth Schedule), and shall contain not less than 70 per centum of total solids, not more than 1.0 per centum of total ash and not less than 20 per centum of reducing sugars calculated as d-glucose on a dry basis.
343. Honey shall be the sweet substance produced by honey bees from the nectar of blossoms or from secretions, or on living parts, of plants, which they collect, transform and combine with specific substances, and store in honey combs; and shall contain not more than 21 per centum of moisture, not more than 10 per centum of sucrose, and not less than 60 per centum of invert sugar.
Vinegar
344. Vinegar shall be the liquid obtained by the acetous fermentation of an alcoholic liquid, and 100 millititres of it, measured at 20ºC, shall contain not less than 4.0 grams of acetic acid.
345. If any reference is made by any statement, mark, or device, on the label, or in any advertisement, for a vinegar, to the strength of the vinegar, the label shall carry a statement of the strength of the vinegar declared as per centum of acetic acid.
346. Wine vinegar shall be the vinegar made from wine and may contain caramel.
347. Spirit vinegar, alcohol vinegar, white vinegar or grain vinegar shall be the vinegar made from diluted distilled alcohol.
348. Malt vinegar shall be the vinegar made by the alcoholic and subsequent acetous fermentations, without distillation, of an infusion of barley malt or cereals whose starch has been converted by malt, may contain caramel, and shall contain, in 100 millilitres, measured at 20ºC, not less than 1.8 grams of solids, and not less than 0.2 gram of ash.
349. Cider vinegar or apple vinegar shall be the vinegar made from the liquid expressed from apples, and may contain caramel.
350. Imitation vinegar means the product prepared by diluting acetic acid, conforming to British pharmacopoeia, with water, shall contain not less than 4.0 grams of acetic acid per 100 millilitres measured at 20ºC, and may contain caramel.
351. Imitation vinegar shall be distinctly labelled.
"IMITATION-PREPARED FROM ACETIC ACID".
Tea
352. Tea shall be the dried leaves and buds and tender stems of species of the camellia genus produced by acceptable process.
353. Black tea (generally known as tea) shall be the tea derived exclusively and produced by acceptable process, from the leaves, buds and tender stems of species of the camellia genus known to be suitable for making tea, and includes all types of tea, except green tea and instant tea, and shall have-
(a) a minimum of 32 per centum of water extract;
(b) between 4 and 8 per centum of total ash;
(c) a maximum of 1.0 per centum of acid insoluble ash;
(d) a minimum of 45.0 per centum of water soluble ash as per centum of total ash;
(e) between 1.2 and 2.6 per centum of alkalinity of water-soluble ash (as KOH);
(f) a maximum of 17 per centum of crude fibre.
354. Green tea shall be the tea derived exclusively and produced by acceptable process, from the leaves, buds and tender stems of species of the camellia genus known to be suitable for making tea, and shall contain not more than 5.0 per centum of moisture.
Marine and Fresh Water Animal Products
355. The foods referred to in regulations 356 to 367 are included in the term marine and fresh water animal products.
356. In regulations 355 to 367, unless the context otherwise requires- Interpretation
"filler" shall have the meaning assigned thereto in regulation 300;
"marine and fresh water animal" includes-
(a) fish;
(b) crustaceans, molluses, other marine invertebrates; and
(c) marine mammals.
357. Fish shall be the clean, whole or dressed edible portion of fish, with or without salt or seasoning, and may contain food additives as permitted in the Nineteenth Schedule.
358. For the purposes of regulations 359, 360, 361, 363 and 364, meat shall be the clean, dressed flesh of crustanceans, molluses, other marine invertebrates, and marine mammals, whether comminuted or not, with or without salt or seasoning, and may contain food additives as permitted in the Nineteenth Schedule.
359. Fish and meat products or preparations thereof are adulterated if any of the following substances or any substance in one of the following classes is present therein or has been added thereto:
(a) preservatives, other than those provided for in regulations 356 to 365, except-
(i) sorbic acid or its salts in dried fish that has been smoked or salted, and in cold-processed, smoked and salted fish paste; and
(ii) benzoic acid or its salts, methyl-p-hydroxy benzoate, propyl-p-hydroxy benzoate in marinated or similar cold-processed, packaged fish and meat products; and
(b) food colour, except as provided for in regulations 356 to 365.
360. Prepared fish or prepared meat shall be the whole or comminuted food prepared from fresh or preserved fish or meat, respectively, may be canned, retorted or cooked, and may-
(a) in the case of lobster paste or fish roe, contain food colour (see Part III of the Nineteenth Schedule);
(b) in the case of canned shellfish, canned spring mackerel and frozen cooked shrimp, or prawn, contain citric acid or lemon juice;
(c) in the case of fish paste, contain filler, fish binder or monoglyceride;
(d) in the case of canned sea foods, excepting tuna, contain sodium hexametaphosphate and sodium acid pyrophosphate;
(e) in the case of canned salmon, lobster, crabmeat and shrimp or prawn, contain calcium disodium ethylenediaminetertraacetate (EDTA) and aluminium sulphate, if such addition is declared on the label;
(f) in the case of canned cod livers, canned sardines or canned kippered snacks, contain liquid smoke flavour, if such addition is declared on the main panel of the label;
(g) contain edible oil, vegetable broth and tomato sauce or puree, if such addition is declared by name on the label;
(h) contain a gelling agent, if the label carries the word, "jellied", as an integral part of the name;
(i) contain salt;
(j) in the case of cooked canned clams, contain calcium disodium ethylenediaminertertaacetate (EDTA), if such addition is declared on the label.
361. Fish binder, for use in or upon prepared fish or prepared meat, shall be filler with any combination of salt, sugar, dextrose, spices and other seasonings.
362. No person shall sell filler or a fish binder, represented either by label or in any advertisement, as for use in fish products, unless the label carries adequate directions for use in accordance with the limits provided in regulation 363.
363. No person shall sell prepared fish or prepared meat that contains more than that amount of filler, fish binder or other ingredients that is represented by 4 per centum of reducing sugars, calculated as dextrose, as determined by the prescribed method.
364. Preserved fish or preserved meat shall be the cooked or uncooked fish or meat that is dried, salted, pickled, cured or smoked, and may contain Class I Preservatives, dextrose, glucose, spices, sugar and vinegar; and dried fish that has been smoked or salted, and cold-processed smoked and salted fish paste, may contain sorbic acid or its salts; and smoked fish may contain food colour (see Part III of the Nineteenth Schedule); and packaged fish and meat products that are marinated or otherwise cold-processed may contain sandalwood, benzoic acid or its salts, methyl-p-hydroxy benzoate and propyl-p-hydroxy benzoate.
365. Finnan haddie, when canned, shall be the preserved fish made from smoked haddock.
366. Notwithstanding regulation 363, lobster paste shall not contain more than 2 per centum of filler or fish binder.
367. No person shall sell smoked fish or a smoked fish product packed in a container that has been sealed to exclude air, unless it has been heat-processed after sealing to destroy all spores of the species Clostridium botulinum or it contains not less than 6 per centum of salt, as determined by the prescribed method.
Poultry, Poultry Meat, their Preparations and Products
368. For the purpose of regulation 377, "filler" shall have the meaning assigned thereto in regulation 300.
369. Poultry shall be any bird that is commonly used as food. Standard for poultry
370. Poultry meat shall be the clean, dressed flesh, exclusive of the giblets, of eviscerated poultry that is healthy at the time of slaughter.
371. Poultry meat by-product shall be the clean parts of poultry other than poultry meat commonly used as food, and includes the giblets and skin, but excludes the oesophagus, feet and head.
372. Giblets shall be the heart, without the pericardial sac, liver, from which the bile sac (gall bladder) has been removed, and gizzard, from which the lining and contents have been removed, of poultry.
373. Poultry meat, poultry meat by-product or preparation thereof is adulterated if any of the following substances or any substance in the following classes is present therein or had been added thereto:
(a) any organ or portion of poultry that is not commonly sold as food;
(b) preservatives, other than those provided for in regulations 368 to 384;
(c) colour, other than caramel.
374. Prepared poultry meat or prepared poultry meat by-product shall be the poultry meat or poultry meat by-product, whether comminuted or not, that has been preserved, canned or cooked.
375. A food that consists wholly or in part of a poultry meat by-product or a prepared poultry meat by-product shall carry on the label the words "poultry meat by-product" or the name of the poultry meat by-product.
376. No person shall sell, for consumption as food, poultry to which has been administered any preparation having oestrogenic activity, or any residue of poultry meat or poultry meat by-product that contains any residues of exogenous substances.
377. No person shall sell a prepared poultry meat or a prepared poultry meat by-product that contains more than that amount of filler or other ingredient that is represented by 4.0 per centum of reducing sugars, calculated as dextrose, as determined by the prescribed method, or 60 per centum of moisture where such prepared poultry meat or prepared poultry meat by-product contains filler.
378. Preserved poultry meat or preserved poultry meat by-product shall be the cooked or uncooked poultry meat or poultry meat by-product that is cured or smoked and may contain Class I Preservatives (see Part XIA of the Nineteenth Schedule), dextrose, glucose, spices, sugar and vinegar.
379. Canned (naming the poultry) shall be prepared from poultry meat, and may contain those bones or pieces attached to the portion of the poultry meat that is being canned, broth, salt, seasoning, gelling agents, and not more than 5 per centum of added fat.
380. Broth that is used in canned (naming the poultry) for the purpose of regulation 379 shall be the liquid in which the poultry has been cooked.
381. Canned (naming the poultry) containing gelling agent shall, as an integral part of the name of the food, carry on the label a declaration of added gelling agent or the word "Jellied".
382. Boneless (naming the poultry) shall be the canned poultry meat from which the bones and skin have been removed and shall contain not less than 50 per centum of the named poultry meat, as determined by the prescribed method, and may contain broth having a specific gravity of not less than 1.000 at a temperature of 50ºC.
383. Liquid, dried or frozen whole egg, egg-yolk, egg-white, egg-albumen, or a mixture of these, shall be the egg products obtained by removing the shell of wholesome fresh eggs or wholesome stored eggs and processing them, and may contain salt, sugar and stabilising agents (see Part IV of the Nineteenth Schedule); in the case of dried whole egg, egg-yolk, egg-white and egg-albumen, 2 per centum of anticaking agent (see Part I of the Nineteenth Schedule); and in the case of liquid, dried or frozen egg-whites, a whipping agent (see Part VIII of the Nineteenth Schedule).
384. No person shall sell any egg product or liquid egg for use as food unless it is free from Salmonella bacteria, as determined by the prescribed method.
Soft Drinks
385. The foods referred to in regulations 386 to 388 are included in the term "soft drinks".
386. Soft drinks are the class of beverages made by absorbing carbon dioxide in potable water with or without various added substances. The amount of carbon dioxide used shall not be less than that which shall be absorbed by the beverage at a pressure of one atmosphere and at a temperature of 15.6ºC. It shall contain either no alcohol or only such ethyl alcohol (ethanol), not in excess of 0.5 per centum of the finished beverage, as is contributed by a flavouring ingredient used.
387. (1) A soft drink may contain optional ingredients, but if any such ingredient is a food additive, a food colour or a flavouring preparation as defined in regulation 15, it shall be used only in conformity with regulations 325 to 334, 115 to 122 and 219 to 243, respectively.
(2) The optional ingredients that may be used in soft drinks in such proportions as are reasonably requied to accomplish their intended effects are-
(a) nutritive sweeteners consisting of the dry or liquid form of sugar, invert sugar, dextrose, fructose, glucose syrup, sorbitol, or any combination of them;
(b) flavouring preparations permitted in soft drinks and conforming to regulations 219 to 243;
(c) food colours permitted in soft drinks and found in regulations 115 to 122 and Part III of the Nineteenth Schedule;
(d) one or more of the food additives for soft drinks found in Part X of the Nineteenth Schedule;
(e) one or more of the food additives for soft drinks found in Part IV of the Nineteenth Schedule, and when one or more of these food additives are used, dioctyl sodium sulfosuccinate, complying with Part VIII of the Nineteenth Schedule, may be used;
(f) one or more of the food additives for soft drinks found in Part VIII of the Nineteenth Schedule;
(g) quinine, as a flavouring preparation in an amount not to exceed 83 parts per million by weight of the finished soft drink in which case the label shall bear a prominent declaration to the effect that it contains quinine;
(h) one or more of the food additives for soft drinks found in Parts XIA to XID of the Nineteenth Schedule;
(i) in the case of canned carbonated soft drinks, stannous chloride, in a quantity not to exceed 11 parts per million calculated as tin (Sn), with or without one or more of the other chemical preservatives permitted in sub-regulation 2 (h) of this regulation.
388. (1) (a)The name of the soft drink for which this standard is established, which is neither flavoured nor sweetened, is "soda water", "club soda", or "soda".
(b) The name of each soft drink containing flavouring ingredients as provided in regulation 387 is " soda" or " soda water" or " carbonated beverage" or " soft drink", the blank being filled in with the word that designates the characteristing flavour of the soft drink; for example, "grape soda".
(c) If the soft drink is one generally designated by a particular common name, for example, ginger ale, root beer, or sparkling water, that name may be used in lieu of the name prescribed by this regulation.
(2) For the purposes of this regulation, a proprietary name that is commonly used by the public as the designation of a particular kind of soft drink may likewise be used in lieu of the name prescribed in this regulation.
Vitamins, Mineral Nutrients and Amino Acids in Food
389. For the purposes of regulations 390 to 409, unless the context otherwise requires-
"advertise" means to advertise to the general public;
"mineral nutrient" means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:
(a) calcium;
(b) phosphorus;
(c) iron;
(d) sodium;
(e) potassium;
(f) iodine;
(g) zinc;
(h) copper;
(i) magnesium; and
(j) manganese;
"reasonable daily intake", in respect of a food named in column 1 of the Twentieth Schedule, means the amount of that food set out opposite thereto in column 2 of that Schedule;
"testimonial", with respect to a food that is represented as containing a vitamin, mineral nutrient or an amino acid, means any pictorial, written or oral representation as to the result that is, has been or may be, produced by the addition to a person's diet of that vitamin, mineral nutrient, or amino acid, as the case may be;
"vitamin" means any of the following vitamins or their synonymous names:
(a) vitamin A (including retinol and retinol derivatives, excluding carotenes);
(b) vitamin B1 or thiamine;
(c) vitamin B2 or riboflavine;
(d) nicotinic acid or nicotinamide;
(e) vitamin B6 or pyridoxine;
(f) folic acid;
(g) d-pantothenic acid;
(h) biotin;
(i) vitamin B12 or cyanocobalamine;
(j) vitamin C or l-ascorbic acid;
(k) vitamin D;
(l) vitamin E;
(m) vitamin K1;
(n) any salt or derivative of a vitamin listed in paragraphs (a) to (m) of this regulation.
390. Regulations 389 to 406 shall apply only to a food that is represented as containing a vitamin, mineral nutrient or an amino acid for use in human nutrition.
391. Any statement, in an advertisement for, or on a label of, a food for sale, relating to or based on the vitamin content of that food, not conforming to regulations 392 to 396, shall be deemed to contravene section four of the Act.
392. Where the amount of a vitamin referred to in this regulation that is contained in a food is not less than the amount mentioned in paragraph (b) of regulation 393 in respect of that vitamin, a person may, in advertising that food or on a label of that food, state-
(a) in the case of vitamin C, that it is a factor in the normal development and maintenance of bones, cartilage, teeth and gums;
(b) in the case of vitamin D, that it is a factor in the normal development and maintenance of bones and teeth, especially in infancy and childhood; and
(c) in the case of any of the vitamins listed in paragraph (b) of regulation 393, that it is a factor in the maintenance of good health.
393. A person may, in advertising a food to which no vitamin has been added or on a label of such food, state-
(a) that the food is "a good source" or "a good dietary source" of any of the vitamins referred to in paragraph (a) of this regulation, if a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(i) in the case of vitamin A, 600 International Units;
(ii) in the case of vitamin B1, 0.25 milligram;
(iii) in the case of vitamin B2, 0.4 milligram;
(iv) in the case of nicotinic acid, 2.5 milligrams; and
(v) in the case of vitamin C, 7.5 milligrams; or
(b) that the food is an "excellent source" or "an excellent dietary source" of any of the vitamins referred to in this regulation, if a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(i) in the case of vitamin A, 1,200 International Units;
(ii) in the case of vitamin B1, 0.45 milligrams;
(iii) in the case of vitamin B2, 0.75 milligram;
(iv) in the case of nicotinic acid, 4.5 milligrams;
(v) in the case of vitamin C, 15 milligrams; and
(vi) in the case of vitamin D, 300 International Units.
394. A person may, in advertising a food to which a vitamin has been added or on a label of such a food, state that the food contains the added vitamin and the amount of the added vitamin that is contained in a specified quantity of the food.
395. No person shall sell a food to which a vitamin has been added unless the amount of the vitamin present in the food is expressed on the label of the food-
(a) in the case of vitamin A, vitamin D or vitamin E, in International Units per one hundred grams or millilitres of the food; and
(b) in the case of vitamin B1, vitamin B2, nicotinic acid, vitamin B6, d-pantothenic acid, folic acid, biotin, vitamin B12, vitamin C or vitamin K1, in milligrams per one hundred grams or millilitres of the food;
together with the name of the vitamin.
396. Where a food sale to which no vitamin has been added is represented as being solely for use in the feeding of children under two years of age, a person may state, on the label of the food, the amount of any of the vitamins referred to in this regulation and that are present in the food, if a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than-
(a) in the case of vitamin A, 600 International Units;
(b) in the case of vitamin B1, 0.25 milligram;
(c) in the case of vitamin B2, 0.4 milligram;
(d) in the case of nicotinic acid, 2.5 milligrams;
(e) in the case of vitamin B6, 0.25 milligram; and
(f) in the case of vitamin C, 7.5 milligrams.
397. Subject to regulation 398, no person shall sell a food to which any of the vitamins referred to in this regulation have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(a) in the case of vitamin A, 1,600 International Units;
(b) in the case of vitamin B1, 0.6 milligram;
(c) in the case of vitamin B2, 1.0 milligram;
(d) in the case of nicotinic acid, 6 milligrams;
(e) in the case of vitamin C, 20 milligrams; and
(f) in the case of vitamin D, 300 International Units.
398. Where a food to which a vitamin has been added is represented as being solely for use in the feeding of children under two years of age, no person shall sell such food unless a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than-
(a) in the case of vitamin A, 1,000 International Units;
(b) in the case of vitamin B1, 0.4 milligram;
(c) in the case of vitamin B2, 0.6 milligram;
(d) in the case of nicotinic acid, 4 milligrams;
(e) in the case of vitamin B6, 0.6 milligram;
(f) in the case of vitamin C, 20 milligrams;
(g) in the case of vitamin D, 300 International Units; and
(h) in the case of vitamin E, 5 International Units.
399. No person shall sell a food to which any of the vitamins referred to in this regulation have been added if a reasonable daily intake of that food by a person would result in the daily intake by such a person of more than-
(a) in the case of vitamin A, 2,500 International Units;
(b) in the case of vitamin B1, 2 milligrams;
(c) in the case of vitamin B2, 3 milligrams;
(d) in the case of nicotinic acid, 20 milligrams;
(e) in the case of vitamin B6, 1.5 milligrams;
(f) in the case of vitamin C, 60 milligrams;
(g) in the case of vitamin D, 400 International Units; and
(h) in the case of vitamin E, 15 International Units.
400. Any statement in advertising a food that is represented as containing a vitamin or on a label of such food, which-
(a) gives any assurance or guarantee of any kind with respect to the result that may be, has been or will be, obtained by the addition of the vitamin to a person's diet; or
(b) refers to, reproduces or quotes, any testimonial;
shall be deemed to contravene section four of the Act.
401. Any statement, in an advertisement for or on a label of a food for sale, relating to or based on the mineral nutrient content of that food, not conforming to regulations 402 to 407, shall be deemed to contravene section four of the Act.
402. Where the amount of a mineral nutrient referred to in this regulation and that is contained in a food is not less than the amount mentioned in paragraph (b) of regulation 403 in respect of that mineral nutrient, a person may, in advertising that food or on a label of that food, state-
(a) in the case of calcium or phosphorus, that it is a factor in the normal development and maintenance of bones and teeth, especially in infancy and childhood;
(b) in the case of iron, that it is a factor in the prevention of anaemia due to iron deficiency; and
(c) in the case of calcium, phosphorus or iron, that it is a factor in the maintenance of good health.
403. A person may, in advertising a food to which no mineral nutrient has been added or on a label of such food, state-
(a) that the food is "a good source" or "a good dietary source" of any of the mineral nutrients referred to in this regulation, if a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(i) in the case of calcium, 150 milligrams;
(ii) in the case of phosphorus, 150 milligrams; and
(iii) in the case of iron, 2 milligrams;
(b) that the food is "an excellent source" or "an excellent dietary source" of any of the nutrients referred to in this regulation, if a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(i) in the case of calcium, 300 milligrams;
(ii) in the case of phosphorus, 300 milligrams; and
(iii) in the case of iron, 4 milligrams.
404. A person may, in advertising a food to which a mineral nutrient has been added or on a label of such food, state-
(a) that the food contains the added mineral nutrient; and
(b) the amount of the added mineral nutrient that is contained in a specified quantity of the food.
405. No person shall sell any food, other than salt for table or general household use, to which a mineral nutrient has been added, unless the amount of the mineral nutrient present in the food is expressed on the label of the food-
(a) by using the name for that mineral nutrient; and
(b) in milligrams per one hundred grams or millilitres of the food.
406. Where a food for sale to which no mineral nutrient has been added is represented as being solely for use in the feeding of children under two years of age, a person may state on the label of the food the amount of any of the mineral nutrients referred to in this regulation and that are present in the food, if a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than-
(a) in the case of calcium, 150 milligrams;
(b) in the case of phosphorus, 150 milligrams;
(c) in the case of iron, 2 milligrams; and
(d) in the case of iodine, 0.05 milligram.
407. Any statement in advertising a food that is represented as containing a mineral nutrient or on a label of such food, which-
(a) gives any assurance or guarantee of any kind with respect to the result that may be, has been or will be, obtained by the addition of the mineral nutrient to a person's diet; or
(b) refers to, reproduces or quotes, any testimonial;
shall be deemed to contravene section four of the Act.
408. No person shall sell a food to which any of the mineral nutrients referred to in this regulation has been added, unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than-
(a) in the case of calcium, 300 milligrams;
(b) in the case of phosphorus, 300 milligrams;
(c) in the case of iron, 4 milligrams; and
(d) in the case of iodine, 0.10 milligram.
409. No person shall sell a food to which a vitamin, mineral nutrient or an amino acid has been added, unless the food is listed in column 1 of the Twenty-first Schedule and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite thereto in column 2 of the said Schedule.
Food Hygiene
410. For the purpose of regulations 411 to 422, unless the context otherwise requires-
"adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice;
"plant" means building or part thereof used for or in connection with the manufacturing, processing, handling, packaging, labelling, storing, selling or transporting of food;
"sanitise" means to adequately treat surface by a process that is effective in destroying vegetative cells of pathogenic bacteria and in substantially reducing other micro-organisms; such treatment shall not adversely affect food product and shall be safe for the consumer.
411. Growing and harvesting operations shall be of a clean and sanitary nature, including, but not limited to, the following:
(a) unfit raw materials shall be segregated out during harvesting and disposed of in such a place and in such a manner that they cannot contaminate food and water supplies or other crops;
(b) harvesting containers shall not constitute a source of contamination to raw materials; and containers which are re-used shall be of such material and construction as shall facilitate thorough cleaning.
412. (1) The grounds in or adjacent to a food plant under the control of the operator shall be free from conditions which may result in the contamination of food and shall include, but are not limited to, the following:
(a) improperly stored equipment, litter, waste and refuse within the immediate vicinity of the buildings, structures, or conveyances that may constitute an attractant, breeding place, or harbourage for rodents, insects, and other pests;
(b) inadequately drained areas that may contribute contamination to food produce through seepage or food-borne filth and provide a breeding place for insects or micro-organisms.
(2) If the grounds about a food plant are bordered by grounds not under the operator's control of the kind described in paragraphs (a) and (b) of sub-regulation (1) of this regulation, care shall be exercised in the plant by inspection, extermination, or other means to effect seclusion of pests, dirt, and other filth that may be a source of food contamination.
413. (1) All plant construction and structure shall be suitable in size, construction and design to facilitate maintenance and hygienic food operation.
(2) The plant and facilities shall provide-
(a) sufficient space for such placement of equipment and storage of materials as is necessary for sanitary operations, production and transporation of food;
(b) separation, by partition, location, or other effective means, for those operations which may cause contamination of food or food contact surfaces with undesirable micro-organisms, chemicals, filth, or other extraneous material;
(c) adequate dressing and locker rooms, not being any part used for storing or handling food, where persons working in the plant may store or change clothes, and shall include, if not provided separately, resting facilities;
(d) adequate lighting to hand-washing areas, dressing and locker rooms and toilet and to all areas where food or food ingredients are examined, processed or stored and where equipment and utensils are cleaned;
(e) adequate ventilation or control equipment to minimise odours and noxious fumes or vapours (including steam), particularly in areas where they may contaminate food, so, however, that such ventilation or control equipment shall not create a condition that may contribute to food contamination by air-borne contaminations;
(f) where necessary, effective screening or other protection against birds, animals and vermin (including, but not limited to, insects and rodents).
414. (1) Floors, walls, and ceilings in the plant shall be of such construction as to be adequately cleanable and shall be kept clean and in good repair.
(2) Fixtures, ducts and pipes shall not be so suspended over areas where drip or condensate may contaminate foods, raw materials or food-contact surfaces.
(3) Aisles or working spaces between equipment, and between equipment and walls, shall be unobstructed and of a sufficient width to permit employees to perform their duties without contamination of food or food-contact surfaces with clothing or personal contact.
(4) Light bulbs, fixtures, skylights or other glass suspended over exposed food in any step of preparation shall be of the safety type or otherwise protected to prevent food contamination in case of breakage.
415. (1) All plants, equipment and utensils shall be-
(a) suitable for their intended use;
(b) so designed and of such material and workmanship as to be adequately cleanable; and
(c) properly maintained.
(2) Food contact surfaces shall be-
(a) smooth and free from pits, crevices and loose scale;
(b) non-toxic;
(c) unaffected by food products;
(d) capable of withstanding repeated exposure to normal cleaning and sanitising; and
(e) non-absorbent, unless the nature of a particular and otherwise acceptable process renders the use of a surface, such as wood, necessary.
(3) The design, construction, and use of such equipment and utensils referred to in sub-regulation (1), shall preclude the adulteration of food with lubricant, fuel, metal fragments, contaminated water, or any other contaminants.
(4) All equipment shall be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.
416. (1) Areas, other than those in a caravan or market stall, where food is manufactured, processed, handled, packaged, labelled or stored for sale, shall be provided with adequate sanitary convenience including, but not limited to, the provision of adequate water supply, drainage, plumbing, hand-washing, rubbish-storage and offal disposal facilities.
(2) The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate quality. Running water at a suitable temperature and under pressure as needed shall be provided in all areas where the processing of food, the cleaning of equipment, utensils, or containers, and the employee sanitary conveniences require.
(3) The drainage of effluents shall be made through an adequate sewerage system or disposed of through other adequate and approved means.
(4) The plumbing shall be of such adequate a size and design and so adequately installed and maintained as to-
(a) carry sufficient quantities of water to required locations;
(b) properly convey sewage and liquid disposal waste;
(c) constitute no source of contamination to ingredient foods, food products, water supplies, equipment, or utensils;
(d) provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or liquid waste on the floor.
(5) The sanitary convenience, with adequate toilet and associated hand-washing facilities, shall be provided for use by employees; and where persons of both sexes are or are intended to be employed, the conveniences shall afford proper, separate accommodation for each sex. The conveniences shall be maintained in a sanitary
condition and kept in good repair. Doors to toilet rooms shall be self-closing and shall not open directly into areas where food is exposed to airborne contamination, except where alternate means have been taken to prevent such contamination (such as double doors, positive air-flow systems, etc.). Signs shall be posted directing employees to wash their hands with cleaning soap or detergents after toilet.
(6) Adequate and convenient installation for hand-washing and, where appropriate, hand-sanitising shall be provided at each location where good hygienic practices require employees to wash or sanitise and dry their hands. Such installations shall be furnished with running water at a suitable temperature for hand-washing, effective hand-cleaning and sanitising preparations (including nail brushes), hygienic towel service or suitable drying devices, and, where appropriate, easily cleanable waste receptables.
(7) Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimise the development of odour, prevent waste from becoming an attractant and
harbourage or breeding place for vermin, and prevent contamination of food, food-contact surfaces, ground surfaces, and water supplies.
417. Buildings, fixtures, and other physical facilities of the plant shall be kept in good repair and shall be maintained in a hygienic condition. Cleaning operations shall be conducted in such a manner as to minimise the danger of contamination of food and food-contact surfaces. Supplies employed in cleaning and sanitising procedures shall be free from significant microbiological contamination and shall be safe and effective for their intended uses. Only such toxic materials as are required to maintain sanitary conditions, for use in laboratory testing procedures, for plant and equipment maintenance and operation, or in manufacturing or processing operations, shall be used or stored in the plant. These materials shall be identified and used only in such manner and under such conditions as shall be safe for their intended uses.
418. No animals or birds, other than those essential as raw materials, shall, subject to the provisions of regulation 50 of the Public Health (Meat, Abattoir and Butcheries) Regulations, be allowed in any food plant. Effective measures shall be taken to exclude pests from food areas and to protect against the contamination of foods in or
on the premises by animals and vermin (including, but not limited to, rodents and insects). The use of pesticides shall be permitted only under such precautions and restrictions as shall prevent the contamination of food or packaging materials.
419. (1) All utensils and product-contact surfaces or equipment shall be cleaned as frequently as necessary to prevent contamination of food and food products.
(2) Non-product-contact surfaces of equipment shall be cleaned as frequently as necessary to minimise accumulation of food particles, dust, dirt, and other debris.
(3) Single-service articles (such as utensils intended for one-time use, paper cups, paper towels, etc.) shall be stored in appropriate containers and handled, dispensed, used, and disposed of in a manner that prevents contamination of food or food-contact surfaces.
(4) Where necessary, to prevent the introduction of undesirable microbiological organisms into food products, all utensils and product-contact surfaces of equipment used in the facilities shall be cleaned and sanitised prior to such use and following any
interruption during which such utensils and contact surfaces may have become contaminated.
(5) Where such equipment and utensils are used in a continuous production operation, the contact surface of such equipment and utensils shall be cleaned and sanitised on a predetermined schedule using adequate methods for cleaning and sanitising.
(6) Sanitising agents shall be effective and safe under conditions for use.
(7) Any procedure, machine, or device may be acceptable for cleaning and sanitising equipment and utensils if it is established that such procedure, machine, or device shall routinely render equipment and utensils clean and provide adequate sanitising treatment.
420. Cleaned and sanitised portable equipment and utensils with product-contact surfaces shall be stored in such a location and manner that product-contact surfaces are protected from splash, dust, and other contamination.
421. (1) All operations in the receiving, inspecting, handling, segregating, preparing, processing, packaging, storing and transporting of food shall be conducted in such a manner and environment as not to expose the food to risk of contamination from dust, dirt or any other material objectionable to the processed product.
(2) Overall sanitation of the plant shall be under the supervision of an individual assigned responsibility for this function.
(3) All reasonable precautions shall be taken to ensure that production procedures shall not contribute to contamination, such as filth, harmful chemicals, undesirable micro-organisms, or any other material objectionable to the processed product.
(4) The precautions referred to in sub-regulation (3) shall include the following:
(a) (i) raw materials and ingredients shall be inspected and segregated as necessary to ensure that they are clean, wholesome, and fit for processing into food. and shall be stored under conditions that shall protect against contamination and minimise deterioration;
(ii) raw materials shall be washed or cleaned as required to remove soil or other contamination;
(iii) water used for washing, rinsing, or conveying of food products shall be of adequate quality, and shall not be re-used for washing, rinsing, or conveying products in a manner that may result in contamination of food products;
(b) containers and carriers of raw ingredients shall be inspected on receipt to ensure that their condition cannot contribute to the contamination or deterioration of the products;
(c) when ice is used in contact with food products, it shall be made from potable water of adequate quality and shall be manufactured, handled, stored and transported, so as to protect it from contamination;
(d) food-processing areas and equipment used for processing food shall not be used for processing animal feed or inedible products unless there is no reasonable possibility of contamination of the human food;
(e) (i) processing equipment shall be maintained in a sanitary condition through frequent cleaning, including sanitising, where indicated;
(ii) in so far as necessary, equipment shall be taken apart for thorough cleaning and sanitising, where indicated;
(f) all food processing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimise the potential for undesirable bacterial or other micro-biological growth, toxin formation, or deterioration or contamination of the processed product or ingredients and this may require careful monitoring of such physical factors as time, temperature, humidity, pressure, flow-rate and such processing operations as freezing, dehydration, heat-processing and refrigeration as to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors shall not contribute to the decomposition or contamination of the processed products;
(g) chemical, micro-biological, or extraneous materialtesting procedures shall be utilised where necessary to identify sanitation failures or food contamination; and all foods and ingredients that have become contaminated shall be rejected or adequately treated or processed to eliminate the contamination where this may be properly accomplished;
(h) packaging processes and materials shall not transmit contaminants or substances objectionable to the products, and shall provide adequate protection from contamination;
(i) (i) meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity shall be utilised to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use;
(ii) specific products, as may be specified by the Minister, shall bear prominently a date-marking, showing the last day, month and year (for instance, 1 May 76 or 1.5.76) the product may be sold;
(j) storage and transportation of finished products shall be under such conditions as shall prevent contamination, including development of pathogenic or toxigenic micro-organisms or of both, and shall protect against undesirable deterioration of the product and the container.
422. Management shall take all reasonable measures and precautions to ensure-
(a) disease control, so that-
(i) no person affected by disease in a communicable form or while a carrier of such a disease, or affected with boils, sores, infected wounds, or micro-biological contamination, shall work in a food plant in any capacity in which there is a reasonable possibility of food ingredients becoming contaminated by such person or the disease being transmitted by such person to other individuals;
(ii) thorough medical examinations shall be made on individuals prior to their employment and at regular intervals of not more than six months while they are employed in the manner referred to in sub-paragraph (i) of paragraph (a) of this regulation;
(b) cleanliness, so that all persons while working in direct contact with food preparations, food ingredients, or surfaces or coming into contact therewith shall-
(i) wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty, to the extent necessary to prevent contamination of food products;
(ii) wash their hands thoroughly (and sanitise them, if necessary, to prevent contamination by undesirable micro-organisms) in an adequate hand-washing installation before starting work, after each absence from a work station, and at any other time when the hands may have become soiled or contaminated;
(iii) remove all insecure jewellery and, during periods where food is manipulated by hand, any jewellery, from the hands that cannot be adequately sanitised;
(iv) if gloves are used in food handling, maintain them in an intact, clean, and sanitary condition; and such gloves shall be of an impermeable material, except where their usage would be inappropriate or incompatible with work involved;
(v) as is necessary for the area of operation, wear effective hair restraints, such as hair nets, head-bands or caps;
(vi) refrain from storing clothing or other personal belongings, or from eating food or from drinking beverages, in areas where food is, or food ingredients are, exposed or in areas used for washing equipment or utensils;
(vii) take any other necessary precautions to prevent contamination of foods with micro-organisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals and medicaments;
(viii) refrain from smoking, snuffing, chewing or using tobacco in any form in areas where food is, or food ingredients are, exposed or in areas used for washing equipment or utensils;
(c) education and training, so that-
(i) personnel responsible for identifying sanitation failures or food contamination shall have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food;
(ii) food handlers and supervisors shall receive appropriate training in proper food-handling techniques and food-protection principles and shall be cognisant of the danger of poor personal hygiene and insanitary practices:
(iii) copies of regulations 410 to 422 so prominently displayed in appropriate places in a food plant;
(d) supervision, so that-
(i) responsibility for ensuring compliance by all personnel with all the requirements of regulations 411 to 422 shall be clearly assigned to competent supervisory personnel;
(ii) without prejudice to the generality of the foregoing, food handlers and supervisors, whilst engaged as such, shall ensure and take such special precautions as shall reasonably be necessary, to protect the food from risk of contamination.
Miscellaneous
423. Regulation 50 of the Public Health (Infectious Diseases) Regulations, of the Public Health Act, Cap. 295, in Volume 17 of the Laws, and the Statutory Instruments set out in the Twenty-second Schedule hereto are hereby revoked.
(Regulations 13 and 14)
WARRANTY AND FORM OF CERTIFICATE OF ANALYSIS OR EXAMINATION
PART I
(Regulation 13)
Warranty for a single transaction
PART II
(Regulation 14)
Form of Certificate of Analysis or Examination
(Regulations 15 and 39)
COMMON NAMES, AND ACCEPTABLE COMMON NAMES OF CERTAIN FOODS FOR PURPOSE OF REGULATION 31 (b) (iv)
PART I
(Regulaton 15)
PART II
(Regulation 39)
Acceptable Common Names of certain Foods for the purpose of regulation (b) (iv)
(Regulation 178)
VARIETIES OR TYPES OF RECOGNISED CHEESE AND THEIR MINIMUM MILK FAT CONTENTS ON THE DRY BASIS
(Regulation 201)
COMPOSITION AND QUALITY FACTORS OF ARACHIS OIL
(Regulation 202)
COMPOSITION AND QUALITY FACTORS OF COTTONSEED OIL
(Regulation 203)
COMPOSITION AND QUALITY FACTORS OF MAIZE OIL
(Regulation 204)
COMPOSITION AND QUALITY FACTORS OF MUSTARD SEED OIL
(Regulation 205)
COMPOSITION AND QUALITY FACTORS OF OLIVE OIL
(Regulation 206)
COMPOSITION AND QUALITY FACTORS OF RAPESEED OIL
(Regulation 207)
COMPOSITION AND QUALITY FACTORS OF SAFFLOWERSEED OIL
(Regulation 208)
COMPOSITION AND QUALITY FACTORS OF SESAMESEED OIL
(Regulation 209)
COMPOSITION AND QUALITY FACTORS OF SOYA BEAN OIL
(Regulation 210)
COMPOSITION AND QUALITY FACTORS OF SUNFLOWERSEED OIL
(Regulation 211)
COMPOSITION AND QUALITY FACTORS OF REFINED OIL
(Regulation 214)
COMPOSITION AND QUALITY FACTORS OF LARD
(Regulation 215)
COMPOSITION AND QUALITY FACTORS OF EDIBLE TALLOW
(Regulations 245 and 260)
USE OF AND LIMITS FOR FOOD COLOURS PERMITTED IN CANNED
VEGETABLES AND CANNED FRUITS
PART I
(Regulation 245)
Use of and Limits for Food Colours Permitted in Canned Vegetables
PART II
(Regulation 260)
Use of and Limits for Food Colours Permitted in Canned Fruits
(Regulation 324)
EXEMPTION LIMITS FOR POISONOUS OR HARMFUL SUBSTANCES IN FOOD FOR SALE
Part I
Part II
*Also includes practical residue limits occurring in foods not necessarily due to application to protect food against pest attack.
*Also includes practical residue limits occurring in foods not necessarily due to application to protect food against pest attack.
**Including its metabolite 2,3-dihydro-2,2-dimethyl-3-hydroxy-7-benzofuranyl N methylcarbamate.
*Also includes practical residue limits occurring in foods not necessarily due to application to protect food against pest attack.
*Also includes practical residue limits occurring in foods not necessarily due to application to protect food against pest attack
NINETEENTH SCHEDULE
(Regulation 334)
SUBSTANCES THAT MAY BE USED AS FOOD ADDITIVES
PART I
Food Additives that may be Used as Anticaking Agents
(Regulation 389)
REASONABLE DAILY INTAKE FOR VARIOUS FOODS
Column 1
Name and Description
(Regulation 409)
FOODS TO WHICH A VITAMIN, MINERAL NUTRIENT OR AMINO ACID MA
(Regulation 423)
STATUTORY INSTRUMENTS REVOKED
SECTION 23-THE POISONOUS SUBSTANCES IN FOOD REGULATIONS
Regulations by the Minister
1. These Regulations may be cited as the Poisonous Substances in Food Regulations.
2. In these Regulations unless the context otherwise requires-
"Act" means the Food and Drugs Act.
3. Except as provided in these Regulations, a food named in Part I or Part II of the Schedule hereto which contains in or upon it-
(a) any or all of the poisonous or harmful substances listed in amounts not exceeding the quantities stated therein in parts per million (p.p.m.) for that food; and
(b) no other poisonous or harmful substance;
is hereby exempted from the provision of paragraph (a) of section three of the Act.
SCHEDULE
Part I
SECTION 23-THE FOOD AND DRUGS (FOOD IN AIRTIGHT CONTAINERS) REGULATIONS
Regulations by the Minister
1. These Regulations may be cited as the Food and Drugs (Food in Air tight Containers) Regulations, and shall come into operation on the 7th day of February, 1992.
2. No person shall sell or shall prepare, keep, transmit or expose for sale, without reasonable excuse, any articles of food which is packed in an airtight receptacle if such receptacle:
(a) is blown to such a degree that:
(i) there is bulging of the flat or concave sides or ends; or
(ii) gas escapes from it on puncturing; or
(b) is extensively rusted; or
(c) is damaged so that it is not airtight; or
(d) shows evidence of having been punctured and the puncture is re-sealed.
SECTION 23-THE FOOD AND DRUGS (TARIFF OF FEES)
REGULATIONS
Regulations by the Minister
1. These Regulations may be cited as the Food and Drugs (Tariff of Fees) Regulations.
2. There shall be paid, the tariff of fees set out in the Schedule for the analysis, examination and certification of food, drugs and cosmetics conducted by the Public Analyst.
3. Without prejudice to the generality of regulation 2, such tariff of fees shall not be paid for samples submitted by authorised officers.
SCHEDULE
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