by Ms. Vidyottama Tripathi

Asstt. Director, EIC

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Regulations are the mandatory requirement imposed by importing country before its entry

Regulations are divided based on category of products 1. Products intended for human consumption (HC)

Stored at room temperature Stored under controlled temperature : chilled or

frozen2. Products intended for non-human consumption

Stored at room temperature Stored under controlled temperature : chilled or

frozen 3. Live animals, semen, ova, embryos

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1 Import in to border only possible if : the product comes from a country or a part of

country authorised to export this kind of product the product has been produced in an establishment

approved for export Detained , inspected and cleared .

2 Products not allowed for import Redispatch

same means of transport authorization of competent authorities of origin

Destruction : redispatch impossible time limit elapsed decision of the importer risk for health

.

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Serious risk for human or animal health• seizure of the consignment• information to all BIPs (RASFF)• RASFF notification : reinforced checks 10

consignments, 3 months• imports suspended if repeated infringments• specific decisions (lab. analyses)

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Proactive Anticipate

needs & comply ahead of time

Participate in developments (standards)

Anticipate requirements & leave particular markets

Reactive Wait for

imposition of requirements & then upgrade

Complain when stringent conditions applied

Wait for requirements and give up

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Comply

Voice

Exit

EXPORT QUALITY CONTROL – A EXPORT QUALITY CONTROL – A BACKGROUNDBACKGROUND

• GoI enacted the Export (QC&I) Act, 1963 – an umbrella Act governing quality of exports

• Powers of Central Government under the ActSpecify standards for export and type of QC & I Notify commodities for compulsory PSIEstablish or recognize Agencies for QC & I

• EIC set up to advise Government on measures for sound development of exports through QC & I and draw up progs for QC & inspection of commodities

• EIC operates certification through 5 EIAs at Mumbai, Kochi, Kolkata, Delhi and Chennai, 28 Sub Offices, Labs and other designated CABs

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Product Spectrum Mandatory export certification – 6 items (Marine,

meat , Egg, Dairy, Honey, Poultry Meat, Basmati Rice-authenticity)

Voluntary - notified (nearly 1000 commodities range from food, footwear, chemicals, st steel, electrical) & non- notified.

Total number of units approved-- B.Rice-06, Black Pepper-8,

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Systems of CertificationConsignment wise InspectionSystems approach

Systems Approach In- process Quality Control (IPQC)Self-Certification (SC) Food Safety Management Systems based

approach Basis of compliance

Primary responsibility on processor – develop & maintain systems

EIC to approve & ensure compliance

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Approval/renewal of units through a 2-level process (Conditional & final)

Compliance ensured through 3-tier surveillance system - Risk based monitoring

Implementing HACCP-based systems; aligned with Codex/EC requirements

Traceability & Primary production issues – addressing farms controls, upgrading landing centres, fishing boats, residue monitoring & control, awareness programmes

Testing as/ latest technology & systems reqts (Pesticide residues, antibiotic residues, heavy metals, microbiological parameters, water)

Complaint addressing system

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ECEC - Designated CA for marine products & - Designated CA for marine products & basmati rice; dialogue on for dairy, egg, poultry basmati rice; dialogue on for dairy, egg, poultry meat, honeymeat, honey

USA (USFDA)USA (USFDA) - recognized for Black Pepper – - recognized for Black Pepper – no detention if accompanied by EIC certificate; no detention if accompanied by EIC certificate; started dialogue for poultrystarted dialogue for poultry

SingaporeSingapore – MRA in area of food & agri, – MRA in area of food & agri, electrical & electronics, drugs, electrical & electronics, drugs, telecommunicationtelecommunication

Australia (AQIS)Australia (AQIS) - recognized for marine - recognized for marine products – seeking for dairy, spices, honey, etc products – seeking for dairy, spices, honey, etc

Sri Lanka (SLSI)Sri Lanka (SLSI) - recognized for >100 - recognized for >100 regulated prods (food, cement, regulated prods (food, cement, engineering/electrical, etc)engineering/electrical, etc) 11

Italy – Italy – fish & fishery productsfish & fishery products Japan – Japan – recognized EIC certification for recognized EIC certification for

poultry products wef 13 October 2005poultry products wef 13 October 2005 Turkey – Turkey – recognized EIA health certificates recognized EIA health certificates

for all food items, stainless steel utensils & for all food items, stainless steel utensils & packaging material for foodspackaging material for foods

S.Korea (KFDA)S.Korea (KFDA)- recognised for food/ - recognised for food/ agriculture prodsagriculture prods

ChinaChina – Agreement on Iron ore signed on 21 – Agreement on Iron ore signed on 21 November 2006November 2006

Nepal – Nepal – all agriculture & food productsall agriculture & food products Russia – Recognized for Marine Products

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A general obligation of operator to monitor food safety of product & process (Article 3 of reg (EC) no. 852/2004

General Hygienic provision of primary production (Article 4.1 of part A of Annex I to Reg (EC) no. 852/2004

Detailed reqm after primary production (Article 4.2 of and Annex II to Reg (EC) no. 854/2004

Microbiological criteria as per article 4.3of 852/2004 and commission regulation 2073/2005

Procedures to be based on HACCP Principles (Article 5 of reg 852/2004

Registration of establishment (Article 6 of regulation (EC 852/2004

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Health Requirements Contaminants eg in basmati rice- 5&10

ug/kg MRLs for pesticide residue (in basmati

rice-carbendazim, benomyl, cyfluthrin, thiophanate-methyl

Use of Food Additives Food Irradiation Products specific requirements Non GMO certificate

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Vide EC Regulation NO. 799/2011 of 9 August 2011

Curry leaves – due to pesticides residue problem 10% physical checks

Chillies & spices- due to aflatoxin problem 50% physical checks . For Sudan dyes- 10%

Ground nuts- due to aflatoxin problem 20% physical checks

Fresh okra- due to pesticides residue problem 10% physical checks

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Foodstuffs concerned It listed MRLs for 1270 pesticides for products intended for

human or animal consumption listed in Annex I. not subject to the set limits if they are intended for sowing

or planting or export outside the European Union. Default limit and specific limits MRL in foodstuffs- 0.01 mg/kg. This general limit is

applicable ‘by default’, i.e. in all cases where an MRL has not been specifically set for a product or product type.

specific MRLs listed in Annex II are higher than the default limit.

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In some cases, provisional MRLs -listed in Annex III, in particular be set in the following cases:

for honey and herbal infusions; in certain exceptional circumstances of contamination by

plant protection products; for national MRLs which have not yet been harmonised; where new products are listed in Annex I and a Member

State requests it, in order to have enough time for a comprehensive scientific assessment and provided that no risk to the consumer has been detected.

Products which do not comply with the fixed limits may not be diluted except in the case of certain processed and/or composite products listed by the Commission (Annex VI).

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Maximum Residue Limits (MRLs) of Agricultural Chemicals in Foods

Foods in which any agricultural chemical residues (including pesticides, feed additives, and veterinary drugs) are found in excess of the level shall not be produced, imported, processed, used, cooked, or stored for sale, or sold, provided, (Summary of Article 11, Paragraph 3 of the Food Sanitation Law) Uniform Limit: 0.01 ppm

The level determined by the Minister of Health, Labour and Welfare(MHLW Notification No. 497, 2005)

List: Total – 65 substances having no potential to cause damage to human health and specified so by the Minister of Health, Labour and Welfare.

(MHLW Notification No.498, 2005)

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Maximum Limits of Pesticide Residue in Agricultural and Food Products Part 1 — UAEs GSO 382/1994 and Maximum Limits of Pesticide Residue in Agricultural and Food Products Part 2 — UAEs GSO 383/1994. Countries included in the GCC are: Saudi Arabia, United Arab Emirates, Kuwait, Bahrain, Oman and Qatar. If an MRL is ‘not set’, generally, the GCC will use the Codex MRL.

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All foods imported into the U.S. must meet the same requirements as those produced domestically.

In the U.S., food safety is a shared responsibility with several departments of the United States government sharing jurisdiction over ensuring the safety of the American food supply.

Agencies involved include:

1. The Food and Drug Administration as FDA - regulates both domestic and imported foods, except meat, poultry and processed eggs, and has primary responsibility for enforcing food safety laws including food import and export regulations.

2. The Centers for Disease Control and Prevention as CDCP - works closely with state and local public health epidemiologists and laboratories to identify Illnesses and clusters of illnesses that may be foodborne.

3. The U.S. Department of Agriculture as USDA -has several agencies that carry out a wide range of programs that may play a role in assuring food safety by establishing the safety of imported fruits and vegetables.

4. The U.S. Environmental Protection Agency as EPA - regulates pesticides and assures drinking water meets standards for health.

5. The U.S. Customs Service - serves as the point of entry for products imported into the U.S.

APHIS Import Authorization SystemUSDA through the Animal Plant Health and

Inspection Service (APHIS) requires permits for certain fresh fruits and

vegetables that are imported from any foreign country.

Entry requirements can be obtained from the Import Authorization System

available on USDA’s website http://www.aphis.usda.gov/oa/new/at.html..

Recognized that: access to nutritionally adequate and safe

food is a right of each individual, Food regulations… should fully take

international standards of the Codex Alimentarius

Latin term for “ Food Law” or“Food Code”

FAO in 1961 and WHO 1963 passed Resolution to establish the Codex Alimentarius Commission,

Responsible for Joint FAO/WHO Food Standard Program.

Under the Export (QC&I) Act 1963Gazette notification S.O. no. 1025 and 1026 dated 19 April 1980 published by

Ministry of Commerce and Civil supplies notification• EIAs established under section seven of the Act were also authorized Gazette

notification S.O. no. 823(E) and 824(E) dated 30 Sept. 1980.• Subsequently above notification superseded by Gazette notification S.O. no.

2538 and 2539 dated 14th Sept. 1990 • To further smoothen the trade, the above notification superseded by SO67E &

SO68E dated 23 January 2003 which is now titled as The Export of Basmati Rice (Q/C,& Inspection) Rules 2003 dated 23/01/2003 is in force.

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Basmati Rice means “Basmati raw milled rice, raw parboiled rice, husk and unpolished (brown) basmati rice, parboiled brown basmati rice grown in indo-gangetic plains having. exceptional grain length which increases substantially on cooking. The cooked grain has high integrity* and distinctive aroma, taste and

mouth feelis a traditional or an evolved variety.

*The state of being whole or unified

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• “Brown Rice” means where husk is removed leaving bran intact on the grain.

• “Brown Rice Parboiled” means rice grain obtained when paddy is parboiled and

husked or shelled .

• “Raw Milled Rice” means rice grains obtained after the process of shelling and milling

of paddy resulting in removal of bran from brown rice.

• “Raw Parboiled Rice” means rice grains obtained when paddy is parboiled, husked and

milled resulting in removal of bran from brown parboiled rice.

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The inspection of Basmati Rice shall be carried out to ascertain that the same conforms to the standard specification recognized under section 6 of the Act.

Consignment Wise Inspection (CWI) system

Processing/ milling unit approval under In Process Quality Control system (IPQC).

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An exporter intend to export shall prepare the consignment of Basmati Rice in a manner that the same can form any of three grade i.e. Special, A or B prescribed in the notification and packed in new gunny bags with the following information.

Name and address of the exporter Name of the product Variety & grade Lot no. Gross weight and net weight. Product of India Shipping mark

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Notice of Intimation:

The exporter shall submit the following at the nearest office of EIA

Intimation for inspection in duplicate Invoice copy Purchase order Inspection fee @ 0.4% of fob

Place of Inspection

The inspection shall be carried out at the premises where the consignment is offered.

Exporter shall provide the adequate facilities for inspection.

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SAMPLING PROCEDUREMake homogeneous composite sample weighing about 3.5 Kgs.

divide the composite sample into 5 final samples 2 weighing 1 kg and rest 3 weighing 500 gms.

pack the final sample in a cloth bag with identification mark, which shall contain intimation no. , date of inspection, lot no., product, variety, grade, name designation and signature of the inspecting officer.

seal the samples with lead seal using pliers.

hand over one sealed sample to the exporter under proper acknowledgement

bring back the other sealed samples and hand over to the controlling officer.

prepare a Field Inspection Report (FIR) in respect of each consignment on completion of inspection.

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Certification of Inspection

If sample is found conforming to the specification, certificate of inspection with 45 days validity from the date of completion of inspection

If sample does not conform to the specification, EIA shall issue a rejection letter stating reason of rejection.

extension of 15 days validity

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The unit having all requisite facilities may submit an application in a prescribed proforma to the nearest EIA office along with following documents.

Application Layout plan of the unit. Legal identity of the unit. List of machineries and equipments. List of qualified technical staff.

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Application found complete in all respect, EIA shall depute an officer to conduct survey of the unit.

On the basis of survey report if the unit is found to be meeting the norms, Inter Departmental panel (IDP )shall be arranged.

IDP shall be constituted from the following departments.• Agricultural Products Export Development Authority. (APEDA)• Indian Agriculture Research Institute (IARI)• Food Corporation of India (FCI)• Joint Commissioner (SRR), Ministry of Consumer Affairs, GOI• Deputy Director, EIA (Convener) Minimum quorum -3

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◦ If the unit is recommended by IDP and its recommendation is accepted, the following actions are taken Allot an approval number which shall be unique for each unit-

BR-04-001 Issue a letter of approval to the unit with a copy to EIC.

◦ EIC shall issue Certificate of Approval to all approved unit in prescribed format.

◦ Validity of the approval granted to the unit for a period of 2 years.

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Surveillance of the approved unit

3 tier surveillance system

I Monitoring visit : • Frequency of Monitoring visit shall be carried out once in three months.

• The monitoring officer at the level of field officer verify the following

Raw material, process and product control, Storage and transportation controlHygiene and sanitation controlVerification of laboratory equipments and test recordsDocuments and records.

Monitoring officer shall also draw one sample from

consignment available for export and send the same to EIA

laboratory for testing as per notified std.

In case of any failure of sample tested, all the subsequent

consignments to be checked till such time three

consecutive consignments are found conforming to notified

std. 43

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Surveillance of the Approved Unit

Supervisory visit

Frequency- once in 6 months.Performance of laboratory equipments and testing Documents as per prescribed format

Corporate audit

Frequency -once in a yearExamination of records of processor maintained by the agency like visit report, laboratory report etc.Visit by audit team at least 10% of the units.Audit team comprises of at least two officers from EIC/EIA.

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Renewal of approval

apply at least 60 days before expiry of earlier approval.

Approval may be renewed on the basis of assessment conducted by IDP

Approval of renewal is valid for a period of 2 years.

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Certification

The IPQC unit shall issue certificate of inspection themselves

Before issuing certificate of inspection, processor shall ensure that the product conforms to the specification recognized by GOI/EIC

Shall be issued by authorized official not below the rank of head of quality control department.

Every certificate issued shall bear a distinct serial number which never be repeated and date of issue.

The certificate shall be neatly typed. If any correction, the same must be counter signed by the certifying officer.

Validity of certificate is 45 days from the date of issue.

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Norms of approval of IPQC unit of Basmati Rice

•Surrounding and constructions.•Raw material control•Process control•General sanitation with in the plant•Product control•Pest control •Equipment and meteorological control•Personnel hygiene•Packing•Transportation

Levels Permitted in food: PFA USFDA

EU A.Total: 30µg/kg 20µg/kg 10µg/kg A. B-1 : 1000µg/kg 5µg/kg µg/kg

Methods of Analysis: Analytical: TLC, HPLC

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Consignment wise inspection Sample from each consignment drawn and

tested IPQC system : One sample in a month

drawn and tested from IPQC unit

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(EC 1881/2006) setting maximum levels for certain contaminants in foodstuffs regards aflatoxins followed

Sampling method are followed as per (EC) Regulation No. 401/2006 for Alfatoxin

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•Ministry of agriculture has received complaints regarding presence of khapra beetle in the rice being exported to U.S.A.

• A series of meeting pertaining to same, have taken place between EIA/EIC, Agricultural and processed food products export development authority(APEDA), Directorate of plant protection, quarintine and warehouse(DPPQS), Ministry of agriculture. •As a results of this all establishment intending ot export ot USA need prior approval

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Detentions of Indian Consignments in USA

Sl No

Alert No.

Product Problem No. of Rejections

Duration

1 IA0201 Basmati Rice

Filth 25 out of 34 1/12/86 to 31/05/87

2 IA0305 Papad and Wafers

Filth/ Pesticide 14 out of 47 March to Sept. ‘91

3 IA1609 Frozen King Fish

Decomposition 4 10-24 Feb. ‘89

4 IA1623 Lobster --do-- 14 out of 32 1/10/82 to 31/03/83

5 IA1635 Shrimps Salmonella/Decomposition

10 out of 11 April to Sept. ‘94

15 out of 18 Dec.’93 to Sept.’94

6 IA2502 Mushrooms

Adulteration due to toxic subs

-- --

7 IA2802 Black Pepper

Filth 20 out of 60 1/12/86 to31/05/87(April 1988- Recog.

EIC’s Cert.)

8 IA2803 Sesame Seeds

Filth 9 28 Feb. to 5 April, 1989 52

Reason for Alert:From December 1, 1986, through May 31, 1987, 25 of 34 shipments of Basmati rice from India (73%) were detained for filth (rodent, insect, bird, extraneous materials). Of the 25 detentions, 12 were for rodent filth or rodent and insect filth, 12 were for insect filth or insect filth and extraneous materials, and 1 for insect and bird filth..

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From December 1, 1986, through May 31, 1987, 20 out of 60 shipments of black pepper (peppercorns) that were sampled, or 33 percent, were detained for filth.

The 20 detentions represented 11 different shippers. These findings resulted in black pepper from India being placed under automatic detention in July 1987.

In April 1988, a certification program introduced Under this program the EIC is sample and test each lot of black pepper

exported to the United states; only permit those lots that comply with FDA's requirements for Salmonella,

filth, mold and foreign matter to be exported to the United States; Because of the apparently successful certification program initiated by the

EIC Government of India, detention without physical examination of Indian black pepper shipments will not be invoked when such shipments are accompanied by certificates.

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GOI SO 245 dated 7th March, 1988   GOI SO 1311 dated 22nd April, 1991  

I. Insect filth and mould in Pepper One percent or more by weight

I. Mammalian matter in Pepper One mg. Or more per pound

I. Foreign matter in Pepper One percent or more by weight

I. Insect filth in Ground Pepper 475 or more insect fragments per 50 gm

I. Rodent filth in Ground Pepper 2 or more rodent hair fragments per 50 gm.

I. Salmonella Negative

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Name of spice

Whole insect count

Bycount/lb

ExcretaMammalian

By Mg/lb

Excreta other

By Mg/lb

Moldy and/or Insect

infested

% By Wgt

ExtraneousForeign matter

% ByWgt

BlackPepper 2 1 3 5.0 1.00

WhitePepper 2 1 1 1 0.5 0

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Defect Action level

a. Pepper Whole  

(I) Insect filth and/or mold Average of 1 % or more of berries by weight are insect infested and or moldly

(2) Mammalian excreta Average of 1 mg or more of mammalian excreta per pound

(3) Foreign matter Average of 1 % or more pickings and sifting by weight.

(4) Microbial contamination Presence of Salmonella not allowed

b. Ground Pepper  

(1) Insect filth 475 or more insect fragments per 50gm

(2) Rodent filth 2 or more rodent hairfragments per 50 gm

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Pesticide Tolerance Limit

Dieldrin 0.05 ppm

BHC 0.05 ppm

Chlordane 0.1 ppm

Heptachlor 0.0 I ppm

Malathion 0.1 ppm

Parathion 0.3 ppm

Aflatoxin  

BI 2 ppb (Maximum)

B I + B2 + G I + G2 4 ppb (Maximum )

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All consignment to be detained (including whole peppercorns, ground, crushed, etc) from India not accompanied by a certificate from the Indian EIC. EIC certificates should contain the following information:

Lot identification number; Number and size of containers in the lot; Analytical methodology used to determine levels of

adulterants/ contaminants; Analytical results of tests for Salmonella, filth, mold and

foreign matter; Date of certificate; and Name and stamp or seal of authorizing official.

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