updated-david-pickard-the-chinese-approach-to-authorising-feed-additives-david-pickard-read-only

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The Chinese Approach to Authorising Feed Additives

Management Forum, London, 8-9th December 2014

The Chinese Approach to

Authorising Feed Additives

David Pickard



Summary• The Chinese market

• The Regulatory Framework and Key Legislation

• Official Guidance

• Documentation Required

• Renewals and Change Control

• Some common questions

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THE CHINESE MARKET



Market Size – as meat production

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Market Size – no. feed mills and

feed/premix production

15518

10843

2005 2010

200 mT

60 mT

Feed Premix

No. of Feed Mills 12th 5-Year Development Plan: 2015 Target



Food Safety

Premier Li Keqiang - Head of the

National Food Safety

Commission, State Council,

P.R.C

Food Scandals

Deliberation and review

(5 years)

Food Safety Law 2009

"Food is essential, and safety

should be a top priority. Food

safety is closely related to

people's lives and health,

economic development and

social harmony. We must

create a food safety system of

self-disciplined food

companies with integrity,

effective government

supervision and broad public

support to improve overall

food safety.“

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IMPACT

Food Safety Value Chain “Farm to Fork”

Traceability

Controls on Feed

Additives

Antibiotic Growth

Promoters

National Standards

Harmonisation

Enhanced Monitoring

Controls on Production Processes�

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LEGISLATIONRegulatory Bodies

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Regulatory Bodies - Vertical

State Council of PRC

Ministry of Agriculture (MOA)

To research and

formulate the

development of rural

economies

National Health & Family Planning Commission

(NHFPC)

(Ministry of Health)

Food safety risk assessment and National food safety

standards; accreditation of test institutions

China Food and Drug Administration

(CFDA)

Food safety, drugs and cosmetics

State Administration for Industry and Commerce

(SAIC)

Guide the development of the advertising

industry and supervise adverting activities

General Administration of Quality Supervision, Inspection

and Quarantine (AQSIQ)

Management of import and export food safety

Local CIQ (China Inspection and

Quarantine)

Supervision of imports and exports



Regulatory Bodies - Horizontal

Source: Enting et al. 2010. The Animal Feed Chain in China.

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LEGISLATIONLegal Instruments



Legal Instruments

STATE COUNCIL of the Peoples Republic of China - DECREES

MINISTRY DECREES

MINISTRY NOTIFICATIONS, ANNOUNCEMENTS, &

DOCUMENTS

TECHNICAL STANDARDS

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STATE COUNCIL DECREES

• No 645 - 2013 – in force 2014 (originally

Decree 609)

– Feed and Feed Additive Administration Regulation

– substantially revised since first publication in

1999

• No 304

– Agricultural GMO Regulation



MOA DECREES• No 2 – Regulation on Feed and Feed Additive Importation

• No 3 - Production licences

• No 4 - Administrative measures new feed and feed additives

• No 5 - Product approval nos.

• No 8 - Administrative measures GMO safety assessment

• No 10 - Administrative measures GMO labelling

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MOA Notifications and

Announcements

• 193 - Substances prohibited for food animals (incl. vet drugs)

• 517 - Administrative licences

• 611 - Requirements for feed and feed additives to be officially

authorised

• 1173 - Feed materials catalogue

• 1519 - Substances prohibited in feed and water

• 1849 - Requirements for feed and feed additive production

establishments

• 1224 - Practice for safe use of feed additives

• 2045 - Feed Additive Catalogue (originally 1126)



Documents of General Office of MOA

• Guidance on stability studies for feed

additives

• Guidance on efficacy studies terrestrial

species

• Guidance on efficacy studies aquatic species

and major to minor species extrapolation

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Technical Standards

• GB 13078-2001 Hygiene Standards For Feeds

• GB 10648-2013 Feed labelling

• NY/T 1444-2007 General rules for microbial feed additives

• + > 400 others … including …



Standard No/s Title

GB/T 4789.3 Microbial Examination of Food Hygiene –

Coliforms

GB/T 4789.5 Microbial Examination of Food Hygiene – Shigella

GB/T 4789.10 Microbial Examination of Food Hygiene – Staph.

aureus

GB/T 10647 General terminology – Feed Industry

GB/T 13080/81/82 Determination of Pb/Hg/Cd in Feeds

(respectively)

GB/T 13091/92 Determination of Salmonella/Moulds in Feeds

(respectively)

GB 15193.1 Procedures for toxicological assessment of food

GB/T 17480 Determination of Aflatoxin B1 in Feeds -- ELISA

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LEGISLATIONDecree 645



Terminology (Art.2 Decree 645)

• Feed:– the product used as animal food after industrialized

processing and manufacturing, including single feed

additive premix, concentrate feed, complete feed and

supplementary feed.

• Feed additive: – the small or trace amount of substance added during the

processing, manufacturing and use of feed, including

nutritional feed additive and general feed additive

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Terminology (Art. 49 Decree 645 )• Raw material refers to substances which are not feed

additives and are used to produce feed, coming from animals,

plants, microbes or mineral sources.

• Single feed refers to feed composed of ingredients coming

from only one kind of animal, plant, microbe or mineral.

• Feed additive premix refers to feed mainly composed of at

least two nutritional feed additives which are mixed with

carriers or diluents in a specified ratio, including complex

premix, trace mineral premix and vitamin premix (incl. rates

min. 0.5% and max. 10% w/w)



Terminology (Art. 49 Decree 645 )

• Concentrated feed refers to feed composed of protein, minerals and feed additives in a specified ratio.

• Complete feed refers to feed designed to meet the total nutritional requirements of animals and comprising specified raw materials and feed additives in a specified ratio.

• Supplementary concentrate refers to feed designed to improve herbivore’s nutrition, comprising specified feed materials and feed additives in a specified ratio.

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Terminology (Art. 49 Decree 645)

• Nutritional feed additive refers to the small or trace

amount of substances added for nutritional purposes,

including feed-grade amino acids, vitamins, minerals,

enzymes, non-protein nitrogen (NPN), etc.

• Ordinary feed additive refers to the small or trace

amount of substances blended in feed to ensure or

improve feed quality and utilisation.



Decree 645 – Scope

• Chap. 1 – General Provisions

– Art. 1-6 – General but incl. 2 important definitions

(mentioned)

• Chap. 2 – Verification and Registration

– Art. 7 – 13 – Frames the regulatory process and

covers post-authorisation monitoring, imports and

data confidentiality.

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Chapter 3 – Production Operation and Use

• Art. 14 – 19 – Requirements for establishments; incl. some feed hygiene and QC elements

• Art. 20 – 24 – labelling and packaging

• Art. 25 – 26 – use (farmers and State controls)

• Art. 27 - 28 – withdrawal (if additive proves harmful)

• Art. 29 – 30 – defines illegal activities

• Art. 31 – 34– authority responsibilities



Chapters 4 & 5 – Legal Responsibilities (4)

& Supplementary Provisions (5)

• Art. 35 – 48

– Offences under the act

• Art. 49

– Definitions

• Art. 50 – 51

– Administrative

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LEGISLATIONMOA Decrees



MOA Decree No. 2 Regulation on Feed

and Feed Additive Import Registration

• Art. 3 - 4

– Requirement to file an application via a China based agent

• Art. 5

– Product must comply with law in Country of Origin and China

• Art. 6 – 7

– Application documents required (in English and Chinese)

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• Art. 8

– Sample requirements

• Art. 9 - 12

– MOA commitment – review within 10 days

– Verification testing – complete within 3 months

– Appeals (15 working days to file)

– License issued within 10 days





• Art. 13 – special circumstances (treated as new

additive)

– Additive approved in C of O but not China

– Application to expand scope of use

– Active ingredient content is below the safety level (?)

– Significant change in processing methods

– Certificate granted but additive not produced within 3

years

– Other situations (safety / quality risks)



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• Art.14 - Licence validity – 5 yrs

• Art. 15 - 16

– Provisions for renewals (including circumstances where a new sample is required)

• Art. 17 – 19 - Change control

• Art. 20 - Confidentiality (on request)

• Art. 21 – 22 – requirements for a sales agent

• Art. 23 – packaging and labelling

• Art. 24 – 25 Revocation

• Art. 26 – 27 – Inspection and sampling (at provincial level)

• Art. 28 – 30 - Offences



Positive ListsFeed Additives

(non-medicinal)

Feed Materials

(Single Feeds Product

Directory)

MOA Announcement No 2045 1773

Publication Date 2013 2012

Implementation Date 2014 2013

Published By MOA

ImpactIllegal to produce, trade and, use

additives/materials not listed

New entries Following validation by MOA

NB:

1. All ingredients in a product should be in one or both of the two lists

2. If a feed additive contains several ingredients then it would be assessed as “a

whole”

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“Categories” of Feed Additive

• Amino acids their salts and analogues

• Vitamins, provitamins, chemically well-defined substances having a similar effect

• Minerals and their complexes/chelates

• Enzymes

• Live micro-organisms

• Non-protein nitrogen sources

• Antioxidants

• Preservatives and acidity regulators

• Colouring agents

• Flavourings and appetising substances

• Binders, anti-caking, stabilising and, emulsifying substances

• Polysaccharides and oligosaccharides

• Others



Listed in 2 Appendices …

Appendix I

• Additives currently in production and use (for

which an authorisation is required to import)

Appendix II

• Additives which are currently within the trial

commercial use period (5-yr brand specific)

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Flavours – a new special case

• June 2014 MOA notice to provincial feed management offices to standardise the management of feed flavours

• Flavours = feed additive mixture for improving palatability and increasing consumption; can be mixed with other additives (e.g. antioxidants) which affect the efficacy or maintain the stability of the flavouring product.

• Producers need:

– Production License

– Approval under Decree 645.

• There are some other “interesting” provisions ….



Flavours – the interesting provisions

• Applications on a “one product – one approval” basis (not like the EU ...) though there may be scope for one application to cover several “similar” products

• Flavours will probably be categorized by flavour “type” (e.g. condiment, sweetener, aroma)

• (Data requirement (efficacy) – cumulative effect of individual components)

• (Products will be identified as “feed flavouring substance” on the product licence)

• (Labelling of individual flavour components is not required) (cf EU Reg. 1831/2003).

• Approved feed flavouring agents (i.e. food flavouring agents) must be in accordance with the Hygienic Standards for Use of Food Additives (GB 2760)

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GUIDANCE



Official Guidance

• There is an official English guideline for registration of imported feed additives dated 2000, 2004 and 2014

• There are also the following “internal” (i.e. Chinese “unpublished”) guidance documents:– Guidance for stability testing of feed additives

– Guidance on tolerance and efficacy studies (terrestrial target animals)

– Guidance on tolerance and efficacy studies in aquatic target animals, tolerance in aquatic animals and extrapolation of data from major to minor species

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Stability Study Guidance

• Not published

• Typical (e.g. VICH Guideline) approach seems

acceptable



Tolerance Study Guidance• Not published

• Objective: to determine short-term toxicity and

safety margin

• Test animals: the target species

• Experimental groups: control/use-level/multi-fold

use level groups

• Replicates required: 6

Species No. per rep Min. duration (days)

Pigs 1 28

Cattle and sheep 1 28

Poultry 10 28

Fish ? 28

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Efficacy Study Guidance

• Not published

• Purpose: to demonstrate efficacy at the lowest proposed dose

• Species: all target species and categories

Species Dose

Titrations

Reps No. per rep Duration

(days)

Pigs 5 6 6 ?

Cattle and sheep 4 15 1 ?

Poultry 5 6 15 ?

Fish 5(?) ? ? ?



Guidance –Extrapolation Major-Minor

Species

• Not published

• Extrapolation is permitted if major and minor species are physiologically similar

• Extrapolation can only be considered when the additive is already authorised for the major species

• Major species are

– Pigs, laying hens, broilers, cattle for fattening, turkeys, dairy cattle, sheep for fattening

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APPLICATIONS AND DOSSIERS



Before you start…

• Is your product registered, produced, authorised (and used?) in the country of origin?

– If yes – proceed to registration (you will have to provide evidence of registration)

– If no - an application for registration in China cannot be made (Article 5 of Decree No. 2)

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Process

Your product is already on the approved list …

Prepare the Dossier

Preliminary review

Quality Test

Application Approved and License issued

Your product is not yet on the approved list

Prepare the Dossier

Preliminary review

Efficacy and Safety Tests target Category and Species

Evaluation of Efficacy and Safety results

Application Approved and License issued

Type 1. Type 2.



Applicant SubmitsDocumentsNational Feed Industry Office(NFIO) notifiesacceptance within 15 daysAssessment (officially 3months can be longerAre documentsqualified? NoInstruction to submitsamples for testingTesting(Fee required)3 MonthsPass/FailSecond TestPass/FailAuthorisation Refused TestReport NFIO submits applicationto MOA for approvalLicence issued(fee required)Fail

YesPassPassFail

Process Timeline for

Feed Additives Not

Requiring Technical

(Safety and Efficacy)

Evaluation

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Applicant SubmitsDocumentsNational Feed Industry Office(NFIO) notifiesacceptance within 15 daysAssessment (officially 3months can be longerAre documentsqualified? NoInstruction to submitsamples for testingTesting(Fee required)6 MonthsPass/FailSecond TestPass/FailAuthorisation Refused TestReport NFIO submits applicationto MOA for approvalLicence issued(fee required)Fail

YesPassPassFail

Process Timeline for

Feed Additives

Requiring Technical

Evaluation



DATA REQUIREMENTS

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Identity, Manufacturing and Analytical Methods• Details of origin

• Composition and confirmation of identity studies

• Purity data

• Physicochemical properties

• Production processes, flow chart, description, key technical parameters

• Stability test reports

• Quality standards – tests and analytical methods (validated) (Incl. purity and proximate analysis data)

• Methods of analysis premix and feed – if a maximum inclusion level is indicated

• Label and Trademark

• Mode of use



Additional Requirements for Viable

Microorganisms (NY/T 1444-2007

• Strain details

– Systematic naming, certificates of deposition, molecular micro

• Description of biological characteristics

– Isolation and screening, Gram +/-, colony morphology, sugar fermentation and biochemical reactions (as per Bergey’s Manual)

– Serology (if considered relevant – agglutination tests)

– Description of metabolites (e.g. lactic acid, enzymes etc)

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Purity (as per Technical Standards)

Analyte Limit

Aflatoxin B1 (µg/kg) Max. 10.0

As (total mg/kg) Max. 2.0

Pb (total mg/kg) Max. 5.0

Hg (total mg/kg) Max. 0.1

Cd (total mg/kg) Max. 0.5

“Other” microorganisms (%) Max. 1.0

Coliforms (CFU/g) Max. 1.0E+5

Moulds (CFU/g) <2.0E+7

Salmonella (CFU/g) Absent

Pathogens (i.e. enteros and pathogenic cocci) Absent



Safety

• Free from transferable antibiotic resistance traits; no toxin production

• Production processes shall be non-polluting

• Qualitative tests for safety shall include the antibiotic resistance test

• Toxicological assessment

• Toxicological studies required for new strains (GB-15193.1)

• Genetic stability

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Test Methods

• Enumeration method (scientific basis required

for the test …)

• Method for determining content (%) of

“other” microorganisms:“Other” (%) = “Other” / (Effective viable count of target + “Other”) x 100



Efficacy & Target Animal Safety

• In vivo efficacy studies which must be

conducted by the institutions designated by

the MOA and in accordance with the technical

guidance

• Target animal safety studies which must be

conducted by the institutions designated by

the MOA and in accordance with the technical

guidance

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Consumer Safety

• Toxicology safety evaluation report (use JECFA

for e.g. if possible – otherwise must be GLP)

• Metabolism and residues studies

• Human health impact analysis



Worker Safety

• Information on worker safety and MSDS

Environmental Safety

• An assessment of the impact of the product

on the environment

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Documentation

• Application form

• Power of Attorney

• Copy of company registration

• Production approval certificate for country of origin

• Registration certificates for country of origin

• Technical documentation

• Original label and sample Chinese label (as per labelling standard)



• Efficacy and safety study reports (from

Chinese MOA)

• Samples:

– 3 consecutive batches; 2 samples per batch not

less than 5 times the required quantity (per Tonne

feed)

– Chemical standards if relevant

– Getting samples into China for testing can be

problematic …

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Post-market Monitoring

• New products are under supervision for 5

years

• MOA will require reports on quality and safety

from the applicant



Renewals

• Renewals are required every 5 years and the application for renewal must be made at least 6 months before expiry

• Requirements are:– Copy of original registration licence

– Renewal application form

– Power of Attorney

– Product Approval Documents

– Quality standard, test methods and Certificates of Analysis

– Copy of the label

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Fees

• Fees can vary depending on whether

difficulties in registration are encountered

• The Official fee is approx. $3-4k

• Agency fees typically > $10,000



Change Control

MAKE THE RELEVANT APPLICATIONS

BEFOREYOU MAKE THE CHANGES

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Change Control – Major Changes

• The following changes (within license validity

period) require that the product be re-registered:

– Change in location of manufacturing process

– Changes in product composition

– Changes to manufacturing process

– Changes to the conditions of use

NB If the product no longer remains authorised in the

country of origin the Chinese registration must lapse.



Change Control – Minor Changes

• The following changes (within license validity

period) require an application for license

alteration:

– Change of Chinese or English product name

– Change of applicant name

– Change of manufacturing facility name

– Change of the name of the manufacturing location

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Documents Required for Alterations

• Application Form

• Power of Attorney (Chinese agent)

• Original license

• Details of the change and “supporting

documentation”

• Decision within 10-days



Other Considerations• Within 6 months of issue of the licence you must:

– Establish a company in China to sell the product or

– Appoint a qualified sales agent

• You must sell some product within 3 years of obtaining the licence

• You must not sell direct

• You must report any change in sales agent to the MOA within 1 month of the change

• If safety concerns subsequently arise the registration will be revoked

• If the country of origin revokes that authorisation you must inform the MOA which will revoke the licence

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Market Monitoring

• The Chinese MOA conducts regular (and

irregular) inspection and testing (against the

registered quality standards)

• Results are published and companies with a

bad record may be publicly identified



Penalties• If you submit false information you cannot

make import submissions for 12 months

• If your licence was found to be gained through submission of false information …

– your licence will be revoked

– Your sales agent will be fined RMB 50k – 100k

– You will not be allowed to file any further applications for 3 years

– Licenses for other products may also be revoked

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Finally!



SOME COMMON QUESTIONS

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Q: Can mixtures be considered a “sole

ingredient”?

A: Not generally …

Q: Are authorisations “brand specific”?

A: Only if the additive is new (i.e. new to the list)

for the first 5 years (the “supervision period”)

Q: Are special requirements in place for GMOs?

A: Yes – like the EU – prior approval is required

before a feed additive application is made.



Q: Are there any special chemical labelling provisions?

A: Chemical labelling regulations don’t apply to feed but if special handling is needed it will be noted in the licence.

Q: Are submissions required for a Chinese company different from those required for a foreign company?

A: No.

Q: Are requirements for pets the same as for food animals?

A: Yes

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Q: Are requirements for major vs. minor species

different?

A: Yes (though minor species are not well-defined);

some extrapolation is allowed though.

Q: Can the claim or function for a feed change the

regulatory category?

A: Yes.

Q: Can feed ingredients be used to prevent

coccidiosis or histomoniasis?

A: They would need to be in the approved list and

would need to be registered as medicines.



Q: Can claims for production efficiency (growth,

milk yield etc) be associated with feed

ingredients?

A: Yes.

Q: Can feed ingredients be used to maintain feed

Salmonella negative?

A: Yes.

Q: Can feed ingredients be prebiotics or probiotics?

A: Yes – as feed additives.

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Q: Are there any special provisions for use of feed

additives in drinking water?

A: No. There is however a list of prohibited substances

in drinking water.

Q: Does the MOA need to visit a foreign manufacturers

facility for registration or afterwards?

A: It has the right to but will normally only visit if there

are quality concerns.

Q: Are there special requirements for feed additives

produced by GMO but not containing GMO residues?

A: Yes – a GMO safety certificate is required.



Summary• The Chinese market

• The Regulatory Framework and Key Legislation

• Official Guidance

• Documentation Required

• Renewals and Change Control

• Some common questions

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Acknowledgement

I’d like to thank Jeff Wang of China Agrotech Company

Ltd. for his invaluable contribution to the content of

this presentation.

www.agrotech.com.cn



Thank you!

Are there any questions?

updated-david-pickard-the-chinese-approach-to-authorising-feed-additives-david-pickard-read-only

Documents

chinese approach

feed mills

chinese market

overall food safety

years food safety law

mt feed premix

animal feed chain

c food scandals deliberation