Administrative Regulation on Packaged Drinking Water (Administrative Notice MCJ/No.007/07/2017)

MJNISTRY OF COMMERCE AND lNDUSTRY lr(~'PU81 \\>£RI A •le OF \ , ADMINISTRATIVE REGULATION PACKAGED DRINKING WATER ADMINISTRATIVE NOTICfl: MCI/NO.007/07/2017 J ULY 19, 2017 Administrati ve Notice MCI/No.007/07/20 17 Page 2 of 16 TABLE OF CONTENT 1.0 CENF.RAL RU I.E ....................... ........... ... .......... ............... ... .. .... ....... .......... 3 2.0 PURPOSE ..................................................................................................... 3 3.0 APPLICABILtl·v ........... .. ........... ..... ............. ......... .......... .. .... ........ ............. 3 4.0 DEFINITIONS .... ... ........ ............................ .............................. .................... 3 5.0 GENERAL, TECHNICAL AND AOMINISTRATLVE REQUIREMENTSS 5. 1 General Requircrnents .......................... ...... ...... ..... ....... .... ..... ............... .............. 5 5.2 Technical Requiren1cnts ..................................................................................... 5 5.3 Ad n1inistr ativc Requirements ...... . .................................. .. .............. .................... 7 ANNEX A ........... .............................................................. ... ................................ 10 Signat0rics' In i tials: ~ / / Adminis1ra1ivc Notice MCI/No.007/07/2017 Page 3 of 16 ADMINISTRATIVE '.'iOTICF.MCJ/NO.007/07/201 7 ADMINISTRATI VE REGU LATION ON PACKAGED DRINKING WATER 1.0 GENERAL RULE WH EREAS, Part II , Executive Branch generally; chapter 10, Genera l prov1s1ons; Section I 0.5 of Title 12 Liberia Code of Laws Revised (Executive Law); grants authority to the head of each ministry or independent agency in the Executive Branch, subject to the approval of the President, the power to prescribe regulations not inconsistent with the law of the operation of the ministry or agency, and the accomplishment of its lawful functions; WH EREAS, Chapter 29, Section 29.2(a) of the executi ve Law mentioned supra, grants the Minister of Commerce and Industry the power to regulate commodity and trade standards; 2.0 PURPOSE The purpose of this Regu lation is to regulate the eommerciali7.ation of packaged drinking water within the commerce of Liberia in order to ensure that the referenced product meets the required regulatory requirements and is safe and healthy for the consumers. 3.0 APPLICABILITY This regulation is applicable to all businesses, entities and establishments that arc engaged in the importation and/or production, storage and distribution of packaged drinking water for commercial purposes on the Liberian market. 4.0 DEFINITIONS "Ad vertisement" means any representation by any means for the purpose of promoting directly or indirectly the sale, distribution, or consumption of any food. "Authorized officer," means an officer appointed by the ministry or otherwise authorized to cany out duties under the provisions of th is Regulation. "Certificate of Analysis" or CoA- refers to an authenticated docun1ent that is generally issued by Qual ity Assurance that ascertains that a regulated product has met its product specification and quality. Signatories· ln i tials: .k-I I Administrative Notice MC!/No.007/07/20 17 Page 4 of 16 "Distribute" with respect to food means to exchange, transmi t, convey, consign, suppl y, deliver, trade, sell, or dispose of, whether or not for remuneration or other consideration. "Drinking wa ter systems" - Public or private systems providing the consumer with tap water safe and suitable for direc t consumption. "Establishment" - / y suitable building(s), area(s) or sun-otmdings in which water intended for bottling is collected, processed and bottled. "Food" - For the purposes of this Regulation, the term includes bottled/packaged drinking water. "Food handling" - / y operation pe11a111111g to collecting, processing, bottling, packing of bottles, storing, transpo11i ng. distributing and marketing of bottled drinking water. G round water - Waters sucb as spring water, artesian water, and well water originating from subsurface aq uifers. Ground waters. may be classified broadly as protected or unprotected water. Protected ground waters arc not directly influenced by surface water or the surface environment. "Good Manufacturing Practice" is a food quality system to ensure that products meet food safety, quality and legal requirements. Food quality controls are necessary to ensure that food supplies are safe, of good qua lity, and compliant to regulations of the Government. "Import" with respect to food means to bring into the country from another country for sale or distribution in Liberia. "Packaged drinking wa ter" - Water fi lled into hermetica lly sealed containers of various compositions, fom1s, and capacities that is safe and su itable for direct consumption without necessary fu rther treatment. Packaged drinking water is considered a food. The terms "drinking" and "potable" arc used interchangeably in relation to water. "Package" means anything in which any food is partially or wholly covered, wrapped, attached, enclosed, contained. or packed. "Person" means any individual, licensee, business, corporation, firm, partnership proprietorship, organization, agency, association, facility, or other entity. "Premises" means any bui lding, stall , tent, can, or any other structure, whether fixed, temporary, or mobile, together with the land on which it is situated and any adjoining land used in connection with it, and includes any vehicle, vessel, or aircraft. "Quality Control" refers to a system of maintaining standards in manufactured products by testing a sa1nple of the output aga inst the specification. Signatories· Initi als: - ~ / Administrative Notice MCI/No.007/07/20 17 Page 5 of 16 "Regulatory requirements" means the provisions of al l applicable laws, regulations, decrees, and other govcmmcnt enactments relating to food quality and safety, nutrition, hygiene, and any other aspect of food regulat ion or control. "Sell" with respect to food means to offer, expose, or prepare for sale, trade, or exchange, transmit, convey, consign, supply, deliver, distribute, or dispose of for human or animal consumption for any consideration. /\ II words and terms not defined herein shall be given their plain and customary meaning and shall be interpreted in accordance with the context in which they appear. "Verification" refers to the inspection processes that verify compliance with the mandatory food fo1tification standards. 5.0 GENERAL, TECHNICAL AND ADMINISTRATI VE REQUIREMENTS 5.1 General Requirements The Ministry of Commerce and Industry (hereafter "MoCI") shall take the measures necessa1y to ensure that packaged drinking water traded or intended to be traded within the commerce of Liberia for human consumption is wholesome, clean, heathy and safe for consumers. Therefore, entities, businesses and establishments which are engaged or shall be engaged in such commercial activities of impo1tation, production, distribution and se lling of packaged drinking water intended shall be under obligation to be in compliance with requirements at every stage of their business activities. The MoCI shall ensure that duly registered Liberian businesses be granted the recognition to trade packaged drinking water after meeting all initial requirements and wh ile at the same time shal l enforce compliance in an ongoing manner through a stringent monitoring of product, processing, packaging, storing, transporting, distributing, product and sale of products in accordance with defined protocols. 5.2 Technical Requirements 5.2.1 Initial Requirements All packaged drinking water products shall initially meet the chemical, physical, and microbiological standards presented in Annex A of this Regulation as requirement for gaining access to local markets. Therefore; a) Importers sha ll be expected to submit Certi ficates of Analysis (CoA) of product from an ISO accredited testing laboratory in count1y of origin (importing country) along with required samples for verification; b) local businc. ses including producers of packaged water for commercial purposes sha ll submit required sample of initial finished product for Signatories· Initials: h / Administrat ive Notice MCI/No.007/07/2017 Page 6 of I 6 verification against quali ty standards. In addition, the sample shall be accompanied with evidence of an approved source of raw water preferably a val id hydrologica l test report showing that the packaged drinking water is from an approved source. Production site shall be subjected to initial inspection to verify status of compl iance to elements of GMP guidelines. 5.2.2 Quality Assurance and Quality Control of Package Water for Commercial Purpose All importers or local producers of packaged water shall take the responsibility of putting into place appropriate measures of ensuring quality control of their products. They shall establish procedures and carry out activities of qua li ty assurance in accordance with requirements prescribed in regulations to ensure that their processes and procedures meet CODEX Code of hygienic practice for bottled/packaged drinking waters (other than natural mine ra l waters) CAC/RCP 48-200 I. Therefore, in addition; a) Importers shall submit Certificate of Analysis (CoA) of consignments of packaged water and/or ensure requir,ed samples are submitted on a regular basis (at least on a quarterly basis) for on-going quality verification of their product; b) Packaged water producers shall ensure that their production process, including transport, packaging, and storage, shall be conducted under such conditions and controls as far as necessary to minimize the potential for microbiological contamination of the finished products including the formation of toxic by-products (pa11icularly bromatcs) and the presence of residues of water treatment chemicals in amounts that raise hea lth concerns. Therefore, it shall be expected that packaged water producers estab li shed and conduct regular internal quality control measures as far as possib ility exist to ascertain product qualiry status; c) Producers of packaged drinking water sha ll also ensure that their processes meet requirements of GMP and food safety management principles as outlined in ISO 2200 as far as possible in an ongoing process. This shall include the development and maintain a Hazard Analysis and Critical Control Point (H/\CCP) program and the establi shment of a food management system. The processes and products shall be subject to announced and unannounced inspections and audits in an ongoing basis. Appropriate documents and records shal l be made ava ilable to MoCr inspection staff upon request from time to time in order to verify compliance; d) Producers of packaged drinking water sha ll address vendor programs and materi als management issues that affect the safety and security of packaged water products. ln add ition. the producers sha ll document other safety security measures, including but not limited to those addressing Signatories' Initials: ~ / / Ad ministra tive Not ice MCI/No.007/07/2017 Page 7 of 16 safety and security of buildings, employees, materials, transportation, and products. 5.2.3 Packaging All packaged drinking water shall be packaged in a manner that protects and preserves composition, qua lity, purity, hygiene, and safety of the product from harmfi.tl contamination. Packaged drinking water shall be packaged in accordance with CODEX /\ LIM ENTARI US prescri bed req ui re ments in ANNEX A of th is Regu lation. 5.3 Administrative Requirements 5.3. 1 Monitorin g MoCI sha ll take all measures neccssa1y to ensure that regu lar monitoring of the quality of water intended for human consumption is carrie.d out, in order to check that the water availab le to consumers meets the requirements of this regulation. Authorized officers/ inspectors shall have the authority to conduct surveillance, inspections and investigations to determine the effectiveness of this regulation and level of compliance with regulatory requiremen'ts; a) Surveillance: Market urveillance program sha ll be conducted on packaged drinking water product at regular time interval for ensuring that product quali ty characteristics in order to determined compliance. b) Inspections: The premises and operations of al I im porters and producers of packaged drinking water shat l be subject to periodic inspection and monitoring. c) investigations: Any premises where packaged drinking water is produced, received, stored, distributed, or so ld by any person or business entity, shall be subject to an investigation whenever an authorized officer has a reasonable basis to question compliance with regulatory requirements of activities, operations, or of food therein. 5.3.2 Enforcement MoCI shall ensure that any failure to meet the requirements set in accordance with this regulation shall be immediately investigated in order to identify the cause and shall ensure that the necessary remedial actions are taken as soon as possible to restore packaged drink ing water quality and shat l give priori ty to enforcement action. The following shall be carried out; a) Prohibition: In the case that fa ilure of pack ing drinking water product quality shall present critical danger to consumers' health, MoCI shall ensure that identified product is prohi bited or its use restricted or such S igna to ries' In itials: ~ / Administrative Notice MCI/No.007/07/2017 Page 8 of 16 other action is taken as is necessary to protect human health. ln such cases consumers sha ll be informed promptly thereof and given the necessary advice. b) Civil E nforcement: The MoCl shall take a civil administrative enforcement action or may commence a civil action in a cou11 of competent jurisdiction against any person responsible for the importation, manufacture, packaging, labe lling, storage, distribution , sale of packaged drinking water found, pursuant to this Regulation , not to be or have been in substantial compliance with al l provisions of applicable regulatory requirements. Penalties authorized by this Section may be imposed for each substantial violation of regulatory requirements: • • • May impose of an appropriate civil fine 1n accordance with Fees and Fines regime of MoCl; Issuance of an order to cease and desist from any activity that does not comply with regulatory requirements; Adverse publicity of unfavorable inspection, investigation of analysis results; and • Business Registration suspension, cancellation or revocation. Signatories' Initials : ~ / / Adminis1ra1ivc No1icc MCI o.007/07/20 17 Page 9 of 16 EFFECT I VE DATE This regulation shall take immedia te effect upon signing and publication. CLLR. FEDERICK CHERUE MINISTER/ATTORN ERY GENERAL R.L. MINISTRY OF .JUST ICE APPROVED BY: MRS. ELLEN JOHi\SON SIRLEAF PRESIDENT RE PUBLIC OF LIBERIA Signatories' Initials: k I I Admin istrative Notice MCI/No.007/07/2017 Page 10 of 16 ANNEX A GENERAL STANDARD FOR PACKAGED DRI NKING WATERS (Other tha n Natural Mineral Waters) CODEX STANDARD 227-2001 I. SCOPE This Standard applies to waters for drinking purposes other than Natural Mineral Waters, as defined in the Revised Codex Standard CODEX ST AN l 08-1981, that are pre-packaged/bottled' and are suitable for human consumption. 2. DESCRIPTION 2.1 Packaged Waters "Packaged waters". other than natural mineral waters, arc waters for human consumption and may contain minerals, natura ll y occurring or intentionally added; may conta in carbon dioxide, naturally occurring or intentionally added; but shall not contain sugars, sweeteners, flavourings or other foodstuffs. 2.1.1 Waters Defined by Origin " Waters defined by origin", whether they come from the underground or from the surface, defined under the present standard share the following characteristics: a) they originate from specific environmental resources without passing through a community water system; b) precautions have been taken within the vulnerabil ity perimeters to avoid any pollution of, or external influence on, the chemical, microbiological and physical qualities of water at origin; c) collecting conditions wh ich guarantee the original microbiological purity and essential clements of their chemical make-up at origin; d) from the microbiological standpoint, are constantly fit for human consumption at their source and arc kept in that state with particular hygien ic precautions unti l and whi le packaging in accordance with provisions of secti ons 3 and 4; e) are not subject to any modification or treatment other than those permitted under Section 3. 1. I. Signatories' lni1ials: k. / / Administrative Notice MCI o.007/07/20 I 7 Page I I of 16 2.J .2 Prepared Waters "Prepared waters" are waters that do not comply with all the provisions set fo r waters defined by origin under subsection 2.1. 1. They may originate from any type of water supply. 3.0 ESSENTJAL COM POSITION AND Q UALITY FACTORS 3.J Modifications And Handling Of Packaged Waters 3.1.1 Permitted Physicochemical Modifications And Antimicrobial Treatments For The Waters Defined By Origin Waters defined by origin must not, prior to packaging, be modified or subject to treatments other than those described in the subsections below with the provision that these modifications or treatments and the processcs2. used to achieve them do not change the essential physicochcmical characteristics nor compromise the chemical, radiological and microbiological safety of these waters when packaged: 3.1.1.I Selective Treatments That Modify The Original Composition: • Reduction and/or elimination of dissolved gases (and resulting possible change in pH); • Addition of carbon diox ide (and resulting change in pH) or re-incorporation of the original carbon dioxide present at emergence; • Reduction and/or elimination of unstable constituents such as iron, manganese, sulphur (as s0 ors- ) compounds and carbonates in excess, under normal conditions of temperature and pressure, of the calco-carbonate equi librium; • Addition of air, oxygen or ozone on condition that the concentration of by-products resulting frorn the ozone treatment is below the tolerance established under section 3.2. 1; • Decrease and/or increase in temperature; • Reduction and/or separation of elements originally present in excess of maximum concentrations or of maximum levels o f radioactivity set according to section 3.2.1. 1 As defined in Codex General Standard /or the labelling of Pre-packaged Foods: "pre-packaged foods to be offered as such to consumer or fo r catering purposes". 2 These processes include the techniques listed in Section 4. 1 of the Code of Hygienic Practice/or Bo/lied/Packaged Drinking Waters (Other Than Natural Mineral Water~) Signatories· Initials: k 1 I Administrative Notice MCl/No.007/07/20 17 Page 12 of 16 with the proviso that such techniques comply with the provisions outli ned in Section 3.2.1 of the present standard . 2 Codex Standard 227-200 I 3.1.1.2 Antimicrobial T reatm ents For T he Waters Defined By Orig in Antimicrobial treatments may be used singly or in combination solely in order to conserve the original microbio logica l fitness fo r human consumption, original purity and safety of waters defined by origin. 3. 1.2 Ph ysical And C hemica l M odifications And Antimicrobial Treatments For Prepared Waters Prepared waters can be subjected to any microbial treatments and any treatments that modi fy the physical and chemical characteristics of the original water on condition that such treatments result in prepared waters that comply with all provisions of section 3.2 and 4 regarding the chemical, microbiological and radiological safety requirements for pre-packaged waters. 3.2 C hemica l And Radiological Quality Of Packaged Waters 3.2.1 Health- Related Limits For C hemical Ai1d Radiologica l Substances No packaged water shall contain substances or emit radioactivity in quantities that may be injurious to hea lth. To this effect, all packaged water shall comply with the health-related requirements of the most recent "Guidelines .f<>r Drinking Water Quality" published by the World Health Organization. 3.2.2 Addition Of M inerals Any addition of minerals to water before packaging must comply with the provisions outl ined in the present standard and, where applicable, with the provisions in the Codex General Standard for Food Additives (CODEX STAN 192- 1995) and/or the Codex General Principles for the Addition of Essential N111rie111s to Foods (CAC/GL 9-1987). 4.0 HYGIENE 4.1 Code Of Practi ce It is recommended that all waters covered by the prov1s1ons of this standard be collected, transported, stored, and if applicable treated, and packaged in accordance with the Recommended lntemational Code of Practice - General Principles of Food I lygiene (CAC/RCP 1- 1991 ) and in accordance with the Code of Hygienic Practice for Bottled/Packaged Drinking Warers (other than Natural Mineral Waters) (CAC/RCP 48-200 I). Signatories' Initi als: bi}- / / Administrat ive Notice MCI/No.007/07/2017 Page 13 of 16 4.2 Approval And Inspection Of T he Source For Waters Defin ed By Origin Initial approval or inspection of the source of waters defined by origin should be based upon appropriate scicnti fie study adapted to the type of resource (hydrogeology, hydrology, etc.) and based on field survey of the source and of the recharge zone that sha ll demonstrate the safety of the source, the facilities and collection operations. The initial in. pcction of the source must be confirmed on a regu lar basis by periodic monitoring of the essent ial constituents, temperature, flow (in the case of natural springs) and tbe chemical and radiological factors specified under section 3.2.1 and the microbiological standards established in conformity with the latest "Guidelines for Drinking Water Quality" published by the World Hea lth Organization. The results of source inspection should be made avai lable to the impot1ing country upon request. 5.0 LABELL[NG REQU IREMENTS In addition to the Codex Ge11eral Standard.for the Labelling of Pre-packaged Foods (CODEX STAN 1-1985), the following provisions shal I apply: 5.1 Name Of The Product Countries may select appropriate names for products, to be specified in nationa l legislation, that reflect local consumer expectations arising from cultural and traditiona l practices. 3 Codex Standard 227-200 I However, in establishing such labelling requirements, consideration should be given to ensuring that any product complying with this standard may be represented in a way that reflects its classification within the standard and that consumers are not misled. 5. 1.1 The name of the product shall be as follows, depending on its classification in accordance with Section 2.1. 5.1. 1. 1 Waters Defined By Origin Any appropriate name ( or names) in the case of waters that comply with the criteria described under section 2.1.1 and that meet additional criteria established by each country including restricting the name of such water to ce11ain names or only one name. ln the case of blend or mixtures of waters from different environment resources, each resource shal l be labe lled. Only waters defined by origin, in accordance with the present standard , can be represented by names that rerer to the origin or give an i1npression of specific origin. The names used or chosen by the countries, in accordance with the present standard, to represent prepared waters cannot apply to waters defined by origin and vice versa. Signatories' Initials: ~ / / Administrative Notice MCI I o.007/07/20 I 7 Page 14 of 16 When applicable, the additional criteria estab li shed by the countries fo r the definition of the chosen names cannot contravene the provisions of the present standard . 5.1.1.2 Prepared waters Any appropriate name ( or names) to designate prepared waters described under section 2.1.2 and that meet additional criteria established by each country includ ing restricting the name of such water to cc11ain names or on ly one name. 5.1.2 Carbonation 5.1.2.1 The following respective declarations should appear on the label 111 accordance with the fo l lowing criteria: In the case of ground waters defined by origin, "naturally carbonated" or "naturally sparkling" if, after packaging, carbon dioxide spontaneously and visibly is given off under normal conditions of temperature and pressure and the carbon dioxide originates from the source at emergence and is present at the same level as was present originally at emergence, with a possible re-incorporation of gas from the same source, taking into consideration a technical tol~rancc of ± 20%. In the case of ground waters defined by origin , ''.fhrt[/ied with carbon dioxide" if, after packaging, carbon dioxide spontaneously and visibly is given off under nom1al conditions of temperature and pressure and the carbon dioxide originates from the source at emergence but is present at a level at least 20% higher than the quantity present originally at ernergence, with a possible re-incorporation of gas from the same source. Jn the case of all waters, "carbonated" or "sparkling" if, after packaging, carbon dioxide spontaneously and visibly is given off under no1111al conditions of temperature and pressure and the ca rbon dioxide does not entirely originate from the same source as that of the water at emergence. 5. 1.2.2 Words such as "11011-carbonated" or "non sparkling" or "still" may apply if, after packaging, there is no visible and spontaneous release of carbon dioxide under normal conditions of temperature and pressure when the packaged is opened. 5.2 Additio nal labelling requirements 5.2.1 Chemica l composition The tota l dissolved solid content of packaged waters may be declared on the principal display panel. With regard to waters defined by origin, the chemical composition that confers the characteristi cs to the product may also be declared on the label. Signatories· Initials : /Jt>: / / Administrative Not ice MCI/No.007/07/2017 Page 15 of 16 5.2.2 Geogra phic Location Where requ ired by the authorities having jurisd iction , the precise geographic location of the specific environmental resource and/or the source of a water defined by origin must be declared in the manner prescribed in the app licable legislation. 5.2.3 Prepared Water From A W ater D istribution System When prepared water is supplied by a public or private tap water distribution system and subsequently packaged/bottled, but has not undergone further treatment that would modify its origina l composition or to which carbon dioxide or fluoride have been added, the wording "From a public or private distribution system" must appear on the label along with the name of the product on the principal display panel. 4 Codex Standard 227-200 I 5.2.4 Treatments ' Where required by the authorities having jurisdiction, if a packaged/bottled water has been modified by a permitted treatment before packaging, the modification or the result of the treatment must be declared on the label in a manner prescribed in the ' applicable legislation. 5.3 Labelling Prohibitions 5.3.1 No claims concerning medicinal (preventive, alleviative or curative) effects shall be made in respect of the properties of the product covered by this standard. Clai ms of other benefic ial effects related to the health of the consumer shall not be made unless true and not misleading. 5.3.2 The name of the locality, hamlet or specified place may not form part of the trade name unless it refers to a water defined by orig in collected at the place designated by that trade name. 5.3.3 The use of any statement or of any pictorial device which may create confusion in the mind of the public or in any way mislead the public about the nature, origin, composition and properties of packaged waters put on sale is prohibited. 6.0 METHODS Of ANALYSrs AND SAMPLING See relevant Codex texts on methods of ana lysis and sampling. W.H.0 . DRINKING WAT ER ST A~ DAROS PA RAi\lETF.R Aluminium Arsenic Barium UNIT mg A 1/1 mg As/I mg Ba/I LIM IT 0.2 0.05 0.05 S ignalorics' Initials: - ~ / / Administrative Notice MCI/No.007/07/2017 13cryllium Cadmium Calcium Chromium Copper Iron Total Lead M agnesium Manganese Mercury Selenium Sodium Z inc Chlorides Cyan ide Fluorides Nitrates N itr ites Sulphates Sulphides TOT/\ L "drins" TOTAL "ddt" Hydrocarbons A nionic Detergents pH Total dissolved so lids Total hardness Alkalinity M ICRORIOLOGICAL PARAMETERS Total Bacteria Coliform E. Coli Salmonella ug = microgram or ppb mg= mill igram or ppm ug Bd l ug ('ti/I mg Ca/I mg Cr/I mg Cu/I mg Fe/I mg Pb/I mg Mg/I mg Mn/ I ug I lg/I mg Sc/I mg Na/I mg Zn/I mg Cl/I mg Cn/1 mg f-/ 1 mg Oi l ,mg N Oi/1 mg SO4'1 mg ll!S/1 ug/1 ug/1 mg/I mg/I mg/I mg/I mg/I Count/ml Count/l00ml Count/ l 00ml Count/I 00ml Page 16 of 16 0.2 5.0 200.0 0.05 1.0 0.3 0.01 150.0 0.1 1.0 0.01 200.0 5.0 250.0 0. 1 1.5 10.0 400.0 0 0,03 1.0 0.1 0 9.2 1500 500 500 100 0 0 0 Signatories· Initials: ~ / /