reauthorisation of amino acids in europe...status amino acids regulation 1831/2003 offered companies...
TRANSCRIPT
Regal
Reauthorisation of
Amino Acids
in Europe
Ruud Bremmers, director of Regal B.V.
Regal
Topics
Basic regulations registration
Required kind of information for a registration
Procedures
Status of amino acids
Examples threonine, tryptophan, lysine
Critical factors in registration
Costs for registration
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Development issues of a new
product
Screening on possible effect/lab phase
Identity of the product
Test efficacy
animal phase
Safety
Production
New product
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European Union
Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of
22 September 2003 on additives for use in
animal nutrition
Commission Regulation (EC) No. 429/2008
EFSA guidances
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Re-evaluation of additives
Same regulations as for new authorisation!
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Dossier
Identity
Safety
Efficacy
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Identity of the additive
1. Identity of the additive
2. Characterisation of the active substance(s)
3. Manufacturing process
4. Physical-chemical and technological properties
5. Conditions of use
6. Methods of analyses
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Safety: case by case
approach Of the additive for target species
Risks to the consumer
Risks to the user/worker
Risks to the environment
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Efficacy
Studies?
– literature
– animal studies
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Procedure
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Procedure
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Status amino acids
Regulation 1831/2003 offered companies to submit dossiers for amino acids, before the end of 2010
These products were subject to re-registration and can stay on the market until decision on authorisation is made
Products submitted after 2010 are considered “new” applications
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Status amino acids
During the period of re-registration of a type of
amino acid, there is a general allowance to sell this
amino acid (not bound to the producing organims)
When all applications of a specific amino acid are
finished, the general allowance will finish and
only the authorisations of amino acids for which a
dossier was submitted may be marketed.
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Status threonine
Applications done by Ajinomoto, Evonik, Meihua, Global BioChem, Star Lake, ADM, Zhejiang Guoguan, CJ, Evonik Degussa
EFSA has finalised opinions Sept 2015-May 2016, but not for all
EC authorised July 2016
Transitional measures
New applications pending
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Status tryptophan Applications done by Ajinomoto, Meihua, Dear
Garden Biotech, CJ, Evonik. New applications by Global BioTech, Feedway
EFSA has finalised opinions on applications for re-evaluation 2014-March 2017
EC has authorised in May 2017 (not all)
Transitional measures
New applications pending
Regal
Status lysine Applications done by Global Biotech, Ajinomoto, Helm,
Meihua, Agroferm, ADM, SA Bioproducts, CJ, Evonik,
Paik Kwang, VitaLys
New application by Feedway
EFSA has finalised opinions on applications for re-
evaluation
EC has not authorised all lysine products under re-
authorisation, however individual products have been
approved
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What happens with the rest?
Generic or Authorisation holder?
Withdrawal from market
Transitional measures
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Critical factors in amino acid
registration Micro-organism used in the fermentation to produce
the amino acid, ...
Does product contains fermentation residues or other impurities?
Details of the strain and method of manufacturing can be asked to keep confidential
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Critical factors in amino acid
registration The strain that is used for fermentation?
QPS or not?
Purity ?
Sensitivity towards antibiotics?
GMO?
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Critical factors in amino acid
registration In case of GMO:
Information on the genetic modification
Antibiotic resistance?
Plasmids?
Residues in the additive?
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Costs for studies
Analyses on batches, impurities, product characteristics
Strain
Stability
Homogeneity
Strain
Costs: 30-60k€
EURL: 6 k€
