Reauthorisation of Amino Acids in Europe Ruud Bremmers, director of Regal B.V.

Transcription

1 Reauthorisation of Amino Acids in Europe Ruud Bremmers, director of B.V.

2 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

3 Development issues of a new Screening on possible effect/lab phase product New product Identity of the product Safety Test efficacy animal phase Production

4 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

5 Re-evaluation of additives Same regulations as for new authorisation!

6 Dossier Identity Safety Efficacy

7 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

8 Safety: case by case approach Of the additive for target species Risks to the consumer Risks to the user/worker Risks to the environment

9 Efficacy Studies? literature animal studies

10 Procedure

11 Procedure

12 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

13 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.

14 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

15 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

16 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 reevaluation EC has not authorised all lysine products under reauthorisation, however individual products have been approved

17 What happens with the rest? Generic or Authorisation holder? Withdrawal from market Transitional measures

18 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

19 Critical factors in amino acid registration The strain that is used for fermentation? QPS or not? Purity? Sensitivity towards antibiotics? GMO?

20 Critical factors in amino acid registration In case of GMO: Information on the genetic modification Antibiotic resistance? Plasmids? Residues in the additive?

21 Costs for studies Analyses on batches, impurities, product characteristics Strain Stability Homogeneity Strain Costs: 30-60k EURL: 6 k

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