2017
NATIONAL REGULATOR FOR COMPULSORY SPECIFICATIONS ACT(Act No. 5 of 2008), AS AMENDED THROUGH THE LEGAL METROLOGYACT (Act No. 9 of 2014)
COMPULSORY SPECIFICATION FOR AQUACULTURED LIVE AND CHILLEDRAW BIVALVE MOLLUSCS (VC 9107).
Itis hereby made known under section 13(4) of the National Regulator forCompulsory Specifications Act, (Act 5 of 2008) as amended, that I, Dr RobDavies, Minister of Trade and Industry, on the recommendation of the NRCS,intends to declare the compulsory specification for aquacultured live and chilledraw bivalve molluscs as set out in the attached Schedule.
Any person, who wishes to comment on the intention to introduce the new theCompulsory Specification concerned, shall submit their comments, in writing, tothe Chief Executive Officer, National Regulator for Compulsory Specifications,Private Bag X 25, Brooklyn, 0075, on or before the date two (2) months after thepubs'on of this notice.figgis
Dr Rob Davi - s, MPMinister ofade and Industry
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DEPARTMENT OF TRADE AND INDUSTRY
NO. 1079   06 OCTOBER 20
17
1079  National R egulat or for Compulsory Specifications Act (5/2008): Compulsory Specification for Aquacultured Live and Chilled Raw Bivalve Molluscs (VC 9107)   411 64
Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 SCHEDULEVC 9107COMPULSORY SPECIFICATION FOR AQUACULTURED LIVE AND CHILLEDRAW BIVALVE MOLLUSCS
1SCOPE
1.1This Compulsory Specification applies to live and chilled raw aquaculturedbivalves molluscan shellfish either in the round or shucked and/ cleaned for directconsumption or further processing (hereinafter referred to as bivalves).Note:Fish Shops (over the counter sale shops),Hotels,BoardingHouses,Restaurants or Other Eating Houses, as well as entities where the core business arethe transportation of goods, are excluded from the scope of this CompulsorySpecification.
2DEFINITIONS2.1For the purposes of this Compulsory Specification the definitions in the latestedition of the SANS (South African National Standard) live and chilled raw bivalvesmolluscs: 2879 are applicable.2.2In addition, the following definitions shall apply:2.2.1applicant: a handler, processor, packer, transporter, importer or exporterapplying for approval of the product and /or facility /factory/establishment. The handler,processor, packer, transporter, importer or exporter shall be established within theRepublic of South Africa;2.2.2approval: confirmation by the NRCS that the product and /or facility /factory/establishment satisfies the requirements of this Compulsory Specification;2.2.3conformityofproduction:evidencethatthehandling,preparation,processing, packing, transportation, chilling, freezing, storage and quality of live andchilled raw bivalve molluscs as in the scope, and products derived therefrom producedfor sale continues to conform to the requirements of this Compulsory Specification;2.2.4DAFF: Department of Agriculture, Forestry and Fisheries;2.2.5facility /factory /establishment: South African based premises or processingfishing vessels where preparation and packing of live and chilled raw aquaculturedbivalve molluscs harvested according to the SAMSM &CP and are handled and treatedto prepare them for commercial purposes;
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 2.2.6 HACCP (Hazard Analysis Critical Control Point): a system which identifies,evaluates, and controls hazards that are significant to food safety;2.2.7NRCS: the National Regulator for Compulsory Specifications as established bythe National Regulator for Compulsory Specifications Act, 2008 (Act No. 5 of 2008);2.2.8official facility number /code: a unique identification number or code allocatedto a facility, factory or establishment by the NRCS.2.2.9 official sampling: sampling done by an official inspector as defined in andaccording to the SAMSM &CP;
2.2.10 product safety management system: a management system implementedby afacility/factory/establishment based on the principlesof HACCP asrecommended by the Codex Alimentarius Commission; and2.2.11 SAMSM&CP: the most recent edition of the South African Molluscan ShellfishMonitoring and Control Programme administered by DAFF.
3GENERAL ADMINISTRATIVE REQUIREMENTS
3.1All live and chilled raw aquacultured bivalve molluscs as per the scope of thisspecification, to be offered for sale, shall comply with the requirements of thisCompulsory Specification.3.2The facility /factory/establishment for the production of the product in theRepublic of South Africa shall be pre -approved by the NRCS for conformity ofproduction requirements as prescribed in Annex A - A.1.Such approval shall bereviewed annually or more frequently as may be determined by the NRCS.3.3The facility /factory /establishment as referenced in paragraph 3.2 above shallnot dispatch any product covered in the scope of this specification, without a validNRCS approvals certificate.3.4Application for approval of the product(s) shall be made to the NRCS for everyconsignment of the product covered by this specification which are imported into SouthAfrica in accordance with the requirements of Annex A - A.23.5Application for approval required for export or any other purposes as requiredby the applicant, shall be made in accordance with the requirements of Annex A - A.3.3.6The facility /factory /establishment shall provide the NRCS with evidence ofconformity of production on request.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 3.7The facility/factory /establishment shall inform the NRCS in writing of anychange in the process of production affecting any mandatory requirement of thisCompulsory Specification. In the event of such change /s the NRCS may at itsdiscretion, demand the submission of further evidence of conformity or a newapplication for approval.3.8The facility /factory/establishment shall immediately report to the NRCS inwriting any failure, of whatever nature, to conform to the requirements of thisCompulsory Specification.3.9A facility /factory /establishment which is suspended must re -apply to the NRCSin writing within three months of the date of suspension for a reassessment; otherwiseapproval for the establishment to operate in terms of this Compulsory Specification willbe withdrawn.3.10A facility/factory/establishment shall notify the NRCS, in writing, when itsoperation is closing down three (3) months before the effective date.3.11The testingof productagainsttherequirementsofthisCompulsorySpecification, shall be done by test facilities that are accredited to use the testmethods as referenced in the SAMSM &CP. In the case where there are no testfacilities available that are in compliance with the foregoing, the NRCS shall determinewhich test facilities can be used in terms of its conformity assessment policy.3.12The NRCS shall issue health guarantee certificates for export purposes, whererequired,in accordance with the requirements of the country of destination asprescribed in Annex B.3.13The NRCS may for the purposes of inspection and verification of products,sample products according to the regulatory risk based sampling plans.
4SPECIFIC REQUIREMENTS4.1The harvesting, handling, preparation, processing, packing, transportation,storage, chilling, quality of the products covered by this specification, the hygienerequirements for the product, as well as chemical contaminants, microbiologicalcontaminants, and marine biotoxins requirements of the product and the packingfacility employees requirements, shall comply with the requirements of the latestedition of SANS 2879.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 4.2The principles of HACCP, as recommended by the Codex AlimentariusCommission, shall as a minimum be used for the implementation of a product safetymanagement system.4.3All local live aquacultured bivalves molluscs for packing and /or processing shallbe obtained from a source that has a valid permit from DAFF to harvest or supply livebivalves molluscs.4.4Farms shall be evaluated and approved annually by DAFF as per therequirements of the SAMSM &CP and animal health guarantees shall be issued to theNRCS. Packers shall also be issued with permits on an annual basis by the DAFF,after official approval of the facility /factory /establishment by the NRCS.4.5Land -based wet storage facilities shall conduct monthly microbiological testingof the live aquacultured bivalves molluscs and water against the requirements of theSAMSM &CP.4.6All official sampling of live aquacultured bivalves molluscs and water shall takeplace according to the requirements of the SAMSM &CP.4.7No live aquacultured bivalves molluscs shall be harvested, packed or shippedfor the purpose of placing on the market for human consumption, when the live
bivalves molluscs does not meet the requirements of the SAMSM &CP or when the
farm is closed by DAFF.4.8In the event of an amendment or updating of the SANS standard referenced in4.1 above, the facility/ factory / establishment shall be in compliance with the amendedor updated requirements within six months of publication of the amended or updatedstandard.If evidence of compliance to such amendments or updates cannot beprovided, the approval of the facility/ factory establishment may be withdrawn.
5MARKINGSThe products covered in this specification shall be marked in accordance with therequirements of the latest edition of SANS 2879 as applicable and as per the labellingrequirements promulgated in terms of the Foodstuffs Cosmetics and Disinfectants Act
(Act 54 of 1972) as amended or in compliance with the labelling requirements of thecountry to which it must be exported. In terms of South African produced products theofficial facility/ factory / establishment number issued by the NRCS in accordance withsection A 1.4 of this Compulsory Specification shall be included.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 A.1APPLICATION FOR APPROVAL OF THE FACILITY AND PRODUCT IN THEREPUBLIC OF SOUTH AFRICAANNEX A
(Normative)
The applicant shall apply in writing to the NRCS for approval of the facility. Approval ofa facility shall be valid for a maximum period of one (1) year. The applicant shallreapply for approval annually. The application shall be accompanied by the following:A.1.1Details of the facility for which approval is sought;A.1.2 Documentation and records insupportof an effectiveproduct safetymanagement system. For new facilities, provisional approval may be given for a periodof three months in order to generate the required documentation and records;A.1.3Information required by the NRCS for the measures taken by the applicant toensure ongoing conformity with the requirements of this Compulsory Specification; andA1.4The NRCS shall issue an official facility number /code on approval of the facility.
A.2APPLICATION FOR APPROVAL OF IMPORTED PRODUCTSThe applicant shall apply to the nearest NRCS regional office for approval of theproduct(s). The applicant shall notify the NRCS at least 10 working days prior to thedate on which approval is needed. The application shall be accompanied by thefollowing:A.2.1Applicants shall supply details of the products per consignment for whichapproval is sought by providing the following information:a)The applicable permits as required by DAFF;(b)Importers shall supply a health guarantee certificate (Annex C) containingevidence that imported products originate from a facility approved for export inthe country of origin per consignment for which approval is sought. The NRCSmay also request that specific testing be performed;Details of the importer, product, bill of entry, quantity, number of product andbatch code(s), code list or bill of lading;d)The date and place where it will be available for inspection;e)Name and contact details of a contact person;
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 f)The number(s) of the bill(s) of entry and the date authorized by custom officials;andThe voyage number of the cargo carrier (vessel, aircraft or registration number
A.2.3 The NRCS may for the purposes of inspection and verification of products,sample products according to the regulatory risk based sampling plans.A.3APPLICATION FOR APPROVAL OF EXPORT OF PRODUCTSThe applicant shall apply to the nearest NRCS regional office for approval of the
product(s). The application shall be submitted at least one (1) working day prior to thedate on which it is needed. The application shall be accompanied by the following:A.3.1Where applicants require official approval for export or any other purposes,applicants shall supply details of products per consignment for which approval issought by providing information with regards to the type of approval required (e.g.certificate of compliance, health guarantee to a particular country or other specificcertification for official purposes).A.3.2 The applicable permits as required by DAFF;
A.3.3Detailsof the markings as required by clause 5 of this CompulsorySpecification used on the packed product(s);A.3.4 Where required by the NRCS, guarantees that the product(s) complies with theprescribed testing requirements outlined inthe Compulsory Specifications andreferenced standards. The NRCS may also request that specific testing required bythe importing country be performed;A.3.5 Any reasonable additional information to clarify the application as requested bythe NRCS; andA.3.6 The NRCS may for the purposes of inspection and verification of products,sample products according to the regulatory risk based sampling plans.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 A.4GRANTING OF APPROVALA.4.1The NRCS shall issue an approvals document, as is applicable for the facility/factoryestablishment, imported products or products destined for export, to theapplicant when all the requirements of this Compulsory Specification have been met.A.4.2 The NRCS shall assign a unique number to each approvals document.A.4.3 An approvals document shall be the sole proof of approval by the NRCS.
A.5WITHDRAWAL OF APPROVALA.5.1Any approval granted in respect of the product or the facility/ factory /establishment pursuant to this Compulsory Specification may be withdrawn at any timewithoutpriornotice,ifcompliance with the requirements of this CompulsorySpecification has not been maintained.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 ANNEX B(Normative)
B.1HEALTH GUARANTEES FOR EXPORTB.1.1The NRCS may provide health guarantees to authorities in countries to whichproducts are exported at the request of exporters, if products have been handled,prepared, processed, packed, transported, refrigerated, stored, and quality are inaccordance with the requirements of this Compulsory Specification and /or therequirements of the country of destination. In terms of requirements, all sections of thehandling and processing chain are to be in compliance and, where appropriate,random samples may be taken for inspection and verification purposes.B.1.2Health guarantees shall only be issued for product from approved facility!factories / establishments requiring such guarantees.B.1.3 As required, finally prepared product/s shall be monitored on the basis ofrandom testing and surveillance programmes.B.1.4For the issuing of health guarantees, it is required that for every consignment:a)The product originates from facility/ factories / establishments approved by theNRCS in terms of the requirements of this Compulsory Specification;b)All products and product codes are reflected in the request for export; andc)The product covered by such a guarantee is fully traceable to its origin as perthe movement document issued by DAFF.B.1.5 No health guarantees will be issued for foreign product where the anatomicalwholeness has not been changed in South Africa.
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 Number of Packages /UnitsANNEX CC.iHEALTH GUARANTEES FOR IMPORTED FISH AND FISHERYPRODUCTS AND CANNED MEAT PRODUCTS REGULATED UNDER THENRCS(ON AUTHORITY'S OFFICIAL LETTERHEAD) Reference no.Country of dispatch:Competent Authority:Inspection Authority:
I.Identification of productsTrue description of product:-Scientific name--Presentation of product and type oftreatment-Batch Identification Marks /Code /sType and Manner of Packaging:.............
Temperature:ChilledFrozenAmbient
H.Origin of Products
Piacedispatch:
III,Destination of products:
Country of destination:
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 Port of entry..Transport details' .....Sea Freight / Air freight /OtherContainer number / Flight detailsSeal number/ air waybill numberConsignor name andaddress'...
Consignee name and address:IV.Health attestationThe official inspector hereby certifies that:
1.The fish and fishery products and canned meat products specified above, have beenfarmed (where applicable), processed, packed and stored in a facility /ies approved by theCompetent Authority.2.The fish and fishery products and canned meat products comply /ies with the particularCODEX Standard for the specific product/s or where there is no such Standard, with theCompulsory Specifications/Technical Regulations legislated by the Republic of South Africain terms of The National Regulator For Compulsory Specifications Act (Act No.5 of 2008)and contained and referenced in the Compulsory Specification.3The processing plant and where applicable, aquaculture farms specified above, is /are
subject to regular inspection /audit by the Competent Authority in that country to ensurethat production, processing practices and food safety systems are in compliance withrequirements of the most updated versions of the general CODEX Principles for FoodHygiene and HACCP (CAC /RCP- 1969) as well as with CODEX Code of Practice forFishery Products (CAC /RCP 52 -2003) and any animal health requirements to be controlledin terms of OIE Directives.4All products imported into the Republic of South Africa in terms of this Regulation shallcomply with marking requirements as prescribed by the relevant national legislations.5The products above:5.1are free from microorganisms or substances originating from microorganisms in amountsas prescribed by relevant national legislation;5.2shall not contain any other substances in amounts that may present a hazard to humanhealth in accordance with relevant national legislation.
Signed at
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Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998 This gazette is also available free online at www.gpwonline.co.za106  No. 411 64 GOVERNMENT G AZETTE, 6 OCTOBER 2017
Reproduced by Sabinet Online in terms of Government Printer’s Copyri ght Authority No. 10505 dated 02 February 1998