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Priorities in Malaysia

  Yoke Fong Chong
   FMM MAFMAG
Technical Barriers to Trade
   Priorities in Malaysia
             Presented by:
           Chong Yoke Fong
 FEDERATION OF MALAYSIAN MANUFACTURERS
  MALAYSIAN FOOD MANUFACTURING GROUP
            (FMM MAFMAG)
About Malaysia
     •     Malaysia has an area of 329,758 square
           kilometers (127,320 square miles).

     •     Population - 29.2million

     •     Multiracial country - 58% Malays, 26%
           Chinese, 7% Indians, 9% other groups

     •     Inflation% (CPI) : 2.7%

     •     Per capita income : RM29,094 (USD9,508)

     •     GDP growth : 5.1% (2011)

         Natural resources: crude oil, natural gas, tin,
          timber, palm oil, rubber
Malaysia: Trade Stats
•   Total Trade in January 2012 – valued at RM105.4 billion, a growth of
    1.7% from 2011.
•   Trade surplus registered at RM8.8 billion
•   Malaysia’s major trade partners:
FMM Brief Background
                          FMM
• Established on 2nd July, 1968
• Companies from many Industry Sectors
• Membership categories: Ordinary, Affiliate, Association


                     FMM MAFMAG
• Established on 24th September, 1984

• Membership:
    Manufacturers and affiliates in the Food and Beverage
    Industry
• 68 companies to date
FMM MAFMAG Objectives
• Cohesive group to promote co-operation among
  food industries;
• Promote development of food industries by
  formulating recommendations on investment
  incentives, market protection and other
  measures;
• Channel of communication between food
  industries and government on relevant matters;
• Active participation in ASEAN and international
  activities e.g. ASEAN-ICC, Codex Committees.
Common Technical Trade Barriers
Common Technical Trade Barriers
 • Customs & Administrative Entry Procedures
    – Pre Market Product Registration
    – Importation of Flavours
    – Requirement of COA for Custom Clearance
 • Standards
    – Different Tolerance Limit for Nutrients
    – Different Contaminant Limits
    – Ever-changing & Stringent Microbiology & Contaminant
      Limits
 • Labelling
    – Local language requirement
    – Format of Nutrition Information Panel
    – Different nutrition reference values
Customs & Administrative
    Entry Procedures
Pre-Market Product Registration
                        • Multiple
                          registration
                          process
                        • Long
                          registration
                          lead time
                        • Restrictions
Pre-Market Product Registration
               •   Manufacturing Process Chart
               •   Certificate of Composition
 Multiple      •   Certificate of Origin
Registration   •   COA for Raw Materials
               •   Certificate of Compliance for Packaging
  Process      •   GMP / ISO Certificate
               •   HACCP Certificate
               •   Health Certificate
               •   Free Sales Certificate
               •   Sanitary & Phyto-Sanitary Certificate
               •   Certificate of Analysis
               •   Certificate of Keeping Quality
               •   FDA / ML Number
               •   Actual Label Sample
Pre-Market Product Registration
Long Registration Lead Time                 Some Restrictions…


                                     Product must be    Any changes, no
                                     in market within   matter how
                                     3 months of        small, needs P5
                                     BPOM approval.     re-registration.




                                                           Change of label
                                                           needs FDA
          Impact:                                          approval ….
                                                           Lead time…
          - Overly burdensome product registration
          requirements
          - Risk to intellectual property
Importation of Flavours
Malaysia MOH - Registration & Yearly Renewal
  •   Warranty Letter
  •   Free Sales Certification
  •   Health Certificate
  •   Ingredient breakdown of the flavour
  •   Absence/ presence of animal ingredient declaration
  •   Allergen declaration
                Impact:
                - Additional administrative work
Requirement of COA for Custom Clearance
                  Every shipment
              to be accompanied with
                COA for Every Batch                                              • Samples to 4 labs at
                 Analysis         Lab                  Method
                                                                          Cost   4 countries -
                                                                          (RM)
                                                                                 accreditation issue.
                Moisture        NQAC-NN              LI-20.014-2           20

                 Caffeine       Shah Alam          LI20.020-1/LC-UV        96
                                                                                 • Analytical cost
                   Ash          Shah Alam       LI00.565-4/Gravimetry      42    RM 1845 per batch.
               Salmonella       Shah Alam         LI00.713-4 LI00.746      80

              Staph. aureus     Shah Alam             LI00.750-4           32    •10 days Release
              Total Alfatoxin   Weiding                LI12.503            473   Time.
                                                 LI-00.848-1 / ICP-MS
                   Tin          Singapore                                  325
                                                   (single elements)
              Total Arsenic     Singapore
                                                LI-00.848-1 / ICP-MS (5
                                                                                 •Warehouse cost
                  Lead          Singapore                                  425
                 Mercury        Singapore
                                                       elements)                 RM 2K/MT product.
                 Copper         Shah Alam       LI-SGRL-99.110 / ICP-MS    75
                   Zinc         Shah Alam       LI-SGRL-99.110 / ICP-MS    75    •Huge resources.
               Courier Cost      FEDEX                                     202
                                        Total                             1845
Requirement of COA for Custom Clearance




                   Impact:
                   - Cost, duplication of certification,
                   resources
 Certificate for
Non-Genetically                                            Starlink Certificate
   Modified                                                    (Chemistry
  Organism                                                    Department,
                                                                Malaysia)
Standards
Different Tolerance Limit for Nutrients
      Country        Tolerance Limit for
                   fortified nutrient (of
                      declared value)

      Malaysia           Min 80%
                                            Impact:
                                            Declared value of
                                            a fortified nutrient
                                            is different for a
      Thailand          Min 100%
                                            same product
                                            recipe

     Indonesia          Min 100%



     Philippines         Min 80%
Different Tolerance Limit for Nutrients
 Country       Tolerance Limit for
                                                                   Sodium (mg/100g)
                 Sodium of the
                 declared value
                                                       Declared Value
                                     Selling Country                     Min          Max
                                                         (mg/100g)
  Malaysia         Max 120%
                                        Malaysia            120            -          144

  Thailand         Min 100%
                                        Thailand            100          100           -

 Indonesia         Max 120%            Indonesia            120            -          144

                                       Philippines          120           96
 Philippines        Min 80%
                                     Operating norms tighten to 100 – 144 mg/100g in order
                                                to meet all market requirements
Sodium -
Desired or Undesired Nutrient?            Illustration of a product with sodium declaration
Different Contaminant Limits
                  Vietnam        Thailand           Malaysia           Indonesia

         Tin          40              250                 50                 152

       Arsenic       0.1                2                 0.1                0.38
                         Impact:
                         - Restriction to cross border trade
        Lead         0.02            1             0.2                       1.14

      Mercury        0.05              0.5               0.05                0.05

       Copper         5                 20                 -                  5

         Zinc          -              100                   -                 -

Contaminant or Nutrient?    Heavy Metal Limits (in ppm) for Infant Cereals
Ever-changing & Stringent Microbiology &
         Chemical Contaminant Limits
                                                                    Limits                Updated 25 Mar
CONTAMINANTS       PARAMETER                       Unit                                                             Remarks
                                                                                               2011
                                                             Old              2010             NEW
                                                                    2                                         Old:unit = col/ml.
                   Total Plate Counts (TPC)                1 x 10               10       < 10 colony/ 0.1ml
Microbiologicals                                                                                              New:unit = col/0.1 ml
                   MPN coliform                     /ml      <3                  -               -
                   S. Aureus                        /ml      0                   -               -

                   APM E. Coli
                                 Impact:
                   Clostridium Perfringens          /ml      0                   -               -
                                                                                              < 3 /g
                   Salmonella sp.
                   Yeast & Mould
                                 - Disruption to operation                                 Negative /25g
                                                                                          1x102 colony/g

Heavy Metals       Arsenic (As)                    ppm       0.1               0.1*             0.1*
                   Cadmium (Cd)                    ppm                          0.2              0.2
                   Mercury (Hg)                    ppm                         0.03             0.03
                   Tin (Sn)                        ppm     250 (tin)         250 (tin)        250 (tin)
                                                             40                 40               40
                   Lead (Pb)                       ppm       0.2              0.02*            0.02*
                   Copper (Cu)                     ppm       2.0                 -                -
                   Zinc (Zn)                       ppm       5.0                 -                -

Mycotoxin          Aflatoxin M1                    ppb                         0.5              0.5



                   * based on ready to consumed products
Labelling
Labelling
– local languages, different NIP format & NRV




                Impact:
                - No shared packaging
                - Not being able to maximise
                economies of scale




Thailand         Malaysia          Indonesia   Philippines
           One recipe, 4 different labels
Opportunities?
Harmonisation

1. Harmonised system for Product
   Registration, Import & Export Certification

2. Uniform standard of Food Safety &
   Nutrition limits across Asean aligned to
   international standards

3. A uniform standard on Labelling
Industry’s Role
1. Active interaction between industry associations
   across Asia

2. Share experiences of trade and regulatory
   priorities

3. Seek appropriate platform to shape Asia
   regulatory landscape
Thank You
Priorities in Malaysia 2012

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Priorities in Malaysia 2012

  • 1.
  • 2. Priorities in Malaysia Yoke Fong Chong FMM MAFMAG
  • 3. Technical Barriers to Trade Priorities in Malaysia Presented by: Chong Yoke Fong FEDERATION OF MALAYSIAN MANUFACTURERS MALAYSIAN FOOD MANUFACTURING GROUP (FMM MAFMAG)
  • 4. About Malaysia • Malaysia has an area of 329,758 square kilometers (127,320 square miles). • Population - 29.2million • Multiracial country - 58% Malays, 26% Chinese, 7% Indians, 9% other groups • Inflation% (CPI) : 2.7% • Per capita income : RM29,094 (USD9,508) • GDP growth : 5.1% (2011) Natural resources: crude oil, natural gas, tin, timber, palm oil, rubber
  • 5. Malaysia: Trade Stats • Total Trade in January 2012 – valued at RM105.4 billion, a growth of 1.7% from 2011. • Trade surplus registered at RM8.8 billion • Malaysia’s major trade partners:
  • 6. FMM Brief Background FMM • Established on 2nd July, 1968 • Companies from many Industry Sectors • Membership categories: Ordinary, Affiliate, Association FMM MAFMAG • Established on 24th September, 1984 • Membership: Manufacturers and affiliates in the Food and Beverage Industry • 68 companies to date
  • 7. FMM MAFMAG Objectives • Cohesive group to promote co-operation among food industries; • Promote development of food industries by formulating recommendations on investment incentives, market protection and other measures; • Channel of communication between food industries and government on relevant matters; • Active participation in ASEAN and international activities e.g. ASEAN-ICC, Codex Committees.
  • 9. Common Technical Trade Barriers • Customs & Administrative Entry Procedures – Pre Market Product Registration – Importation of Flavours – Requirement of COA for Custom Clearance • Standards – Different Tolerance Limit for Nutrients – Different Contaminant Limits – Ever-changing & Stringent Microbiology & Contaminant Limits • Labelling – Local language requirement – Format of Nutrition Information Panel – Different nutrition reference values
  • 10. Customs & Administrative Entry Procedures
  • 11. Pre-Market Product Registration • Multiple registration process • Long registration lead time • Restrictions
  • 12. Pre-Market Product Registration • Manufacturing Process Chart • Certificate of Composition Multiple • Certificate of Origin Registration • COA for Raw Materials • Certificate of Compliance for Packaging Process • GMP / ISO Certificate • HACCP Certificate • Health Certificate • Free Sales Certificate • Sanitary & Phyto-Sanitary Certificate • Certificate of Analysis • Certificate of Keeping Quality • FDA / ML Number • Actual Label Sample
  • 13. Pre-Market Product Registration Long Registration Lead Time Some Restrictions… Product must be Any changes, no in market within matter how 3 months of small, needs P5 BPOM approval. re-registration. Change of label needs FDA Impact: approval …. Lead time… - Overly burdensome product registration requirements - Risk to intellectual property
  • 14. Importation of Flavours Malaysia MOH - Registration & Yearly Renewal • Warranty Letter • Free Sales Certification • Health Certificate • Ingredient breakdown of the flavour • Absence/ presence of animal ingredient declaration • Allergen declaration Impact: - Additional administrative work
  • 15. Requirement of COA for Custom Clearance Every shipment to be accompanied with COA for Every Batch • Samples to 4 labs at Analysis Lab Method Cost 4 countries - (RM) accreditation issue. Moisture NQAC-NN LI-20.014-2 20 Caffeine Shah Alam LI20.020-1/LC-UV 96 • Analytical cost Ash Shah Alam LI00.565-4/Gravimetry 42 RM 1845 per batch. Salmonella Shah Alam LI00.713-4 LI00.746 80 Staph. aureus Shah Alam LI00.750-4 32 •10 days Release Total Alfatoxin Weiding LI12.503 473 Time. LI-00.848-1 / ICP-MS Tin Singapore 325 (single elements) Total Arsenic Singapore LI-00.848-1 / ICP-MS (5 •Warehouse cost Lead Singapore 425 Mercury Singapore elements) RM 2K/MT product. Copper Shah Alam LI-SGRL-99.110 / ICP-MS 75 Zinc Shah Alam LI-SGRL-99.110 / ICP-MS 75 •Huge resources. Courier Cost FEDEX 202 Total 1845
  • 16. Requirement of COA for Custom Clearance Impact: - Cost, duplication of certification, resources Certificate for Non-Genetically Starlink Certificate Modified (Chemistry Organism Department, Malaysia)
  • 18. Different Tolerance Limit for Nutrients Country Tolerance Limit for fortified nutrient (of declared value) Malaysia Min 80% Impact: Declared value of a fortified nutrient is different for a Thailand Min 100% same product recipe Indonesia Min 100% Philippines Min 80%
  • 19. Different Tolerance Limit for Nutrients Country Tolerance Limit for Sodium (mg/100g) Sodium of the declared value Declared Value Selling Country Min Max (mg/100g) Malaysia Max 120% Malaysia 120 - 144 Thailand Min 100% Thailand 100 100 - Indonesia Max 120% Indonesia 120 - 144 Philippines 120 96 Philippines Min 80% Operating norms tighten to 100 – 144 mg/100g in order to meet all market requirements Sodium - Desired or Undesired Nutrient? Illustration of a product with sodium declaration
  • 20. Different Contaminant Limits Vietnam Thailand Malaysia Indonesia Tin 40 250 50 152 Arsenic 0.1 2 0.1 0.38 Impact: - Restriction to cross border trade Lead 0.02 1 0.2 1.14 Mercury 0.05 0.5 0.05 0.05 Copper 5 20 - 5 Zinc - 100 - - Contaminant or Nutrient? Heavy Metal Limits (in ppm) for Infant Cereals
  • 21. Ever-changing & Stringent Microbiology & Chemical Contaminant Limits Limits Updated 25 Mar CONTAMINANTS PARAMETER Unit Remarks 2011 Old 2010 NEW 2 Old:unit = col/ml. Total Plate Counts (TPC) 1 x 10 10 < 10 colony/ 0.1ml Microbiologicals New:unit = col/0.1 ml MPN coliform /ml <3 - - S. Aureus /ml 0 - - APM E. Coli Impact: Clostridium Perfringens /ml 0 - - < 3 /g Salmonella sp. Yeast & Mould - Disruption to operation Negative /25g 1x102 colony/g Heavy Metals Arsenic (As) ppm 0.1 0.1* 0.1* Cadmium (Cd) ppm 0.2 0.2 Mercury (Hg) ppm 0.03 0.03 Tin (Sn) ppm 250 (tin) 250 (tin) 250 (tin) 40 40 40 Lead (Pb) ppm 0.2 0.02* 0.02* Copper (Cu) ppm 2.0 - - Zinc (Zn) ppm 5.0 - - Mycotoxin Aflatoxin M1 ppb 0.5 0.5 * based on ready to consumed products
  • 23. Labelling – local languages, different NIP format & NRV Impact: - No shared packaging - Not being able to maximise economies of scale Thailand Malaysia Indonesia Philippines One recipe, 4 different labels
  • 25. Harmonisation 1. Harmonised system for Product Registration, Import & Export Certification 2. Uniform standard of Food Safety & Nutrition limits across Asean aligned to international standards 3. A uniform standard on Labelling
  • 26. Industry’s Role 1. Active interaction between industry associations across Asia 2. Share experiences of trade and regulatory priorities 3. Seek appropriate platform to shape Asia regulatory landscape