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23/12/2014
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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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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 Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
THE CHINESE MARKET
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Market Size – as meat production
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
LEGISLATIONRegulatory Bodies
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Regulatory Bodies - Horizontal
Source: Enting et al. 2010. The Animal Feed Chain in China.
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
LEGISLATIONLegal Instruments
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Legal Instruments
STATE COUNCIL of the Peoples Republic of China - DECREES
MINISTRY DECREES
MINISTRY NOTIFICATIONS, ANNOUNCEMENTS, &
DOCUMENTS
TECHNICAL STANDARDS
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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)
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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 …
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
LEGISLATIONDecree 645
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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)
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
LEGISLATIONMOA Decrees
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
• 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
MOA Decree No. 2 Regulation on Feed
and Feed Additive Import Registration
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
• 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)
MOA Decree No. 2 Regulation on Feed
and Feed Additive Import Registration
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
• 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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
“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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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 ….
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
GUIDANCE
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Stability Study Guidance
• Not published
• Typical (e.g. VICH Guideline) approach seems
acceptable
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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(?) ? ? ?
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
APPLICATIONS AND DOSSIERS
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
DATA REQUIREMENTS
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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)
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
• 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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Post-market Monitoring
• New products are under supervision for 5
years
• MOA will require reports on quality and safety
from the applicant
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Fees
• Fees can vary depending on whether
difficulties in registration are encountered
• The Official fee is approx. $3-4k
• Agency fees typically > $10,000
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Change Control
MAKE THE RELEVANT APPLICATIONS
BEFOREYOU MAKE THE CHANGES
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Documents Required for Alterations
• Application Form
• Power of Attorney (Chinese agent)
• Original license
• Details of the change and “supporting
documentation”
• Decision within 10-days
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
Finally!
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
SOME COMMON QUESTIONS
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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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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The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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.
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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 Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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
The Chinese Approach to Authorising Feed Additives
Management Forum, London, 8-9th December 2014
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