1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12689:1998 The Euro
2、pean Standard EN 12689:1998 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Guidance on assessment of the purity, biological activity and stability of micro-organism based productsBS EN 12689:1998 This Br
3、itish Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 December 1998 BSI 1998 ISBN 0 580 30181 8 Amendments issued since publication Amd. No. Date Text affe
4、cted National foreword This British Standard is the English language version of EN 12689:1998. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible Europea
5、n committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cros
6、s-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electroni
7、c Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This docume
8、nt comprises a front cover, an inside front cover, the EN title page, pages 2 to 7 and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploita
9、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 12689:1998 E EUROPEAN STANDARD EN 12689 NORME EUROPE ENNE EUROPA ISCHE NORM July 1998 ICS 07.080; 07.100.01 Descriptors: biotechnology, genetics, modified organisms, accident prevention, environmental protecti
10、on, purity, stability, microbiology, bioassay English version Biotechnology Guidance on assessment of the purity, biological activity and stability of micro-organism based products Biotechnologie Guide pour le valuation de la purete , lactivite biologique et la stabilite des produits a base de micro
11、-organismes Biotechnik Leitfaden zur Bewertung der Reinheit, biologischen Aktivita t und Stabilita t von Produkten, die auf Mikroorganismen basieren This European Standard was approved by CEN on 1 July 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate th
12、e conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in
13、 three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies o
14、f Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12689:1998 BSI 1998 Foreword This European Standard has been prepared by Technical Committee CEN/
15、TC 233, Biotechnology, the Secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 1999, and conflicting national standards shall be withdrawn at the latest
16、by January 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Eu
17、ropean Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Definitions 3 3 General considerati
18、ons 4 4 Validity of purity assessment 4 5 Validity of biological activity assessment of product 5 6 Validity of stability assessment 6 Annex A (informative) Bibliography 7Page 3 EN 12689:1998 BSI 1998 Introduction Micro-organism based products (MBPs), such as fertilizer, growth promoter, pest and we
19、ed control agents, silage additive, probiotic for feedstuff additives, bioremediation agents and biodegradation agents are used in the environment. MBPs can contain one or more micro-organism strains including genetically modified micro-organisms (GMMs). Purity, biological activity and stability of
20、the micro-organisms present are considered to be the technical specifications for evaluating MBP quality. NOTE During the development of a MBP that contains genetically modified micro-organisms, attention is drawn to national and European (see annex A 5, 6, 12) regulations, and related European Stan
21、dards (see annex A 7, 8, 9, 10, 11) concerning the handling of genetically modified micro-organisms in contained or released conditions. A large variety of MBPs exists and the choice of methods applied to assess technical specifications depends primarily on the characteristics of the microbial compo
22、nent of the product such as taxonomy, genotype, metabolism, growth environment, doubling time. 1 Scope This European Standard gives guidance on the assessment of technical specifications of micro-organism based products (MBPs) for product quality evaluation. It is also applicable for purposes of pro
23、duct registration. NOTE 1 In this European Standard, the technical specifications are considered to be purity, biological activity and stability of the micro-organism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical s
24、pecifications. This European Standard only applies to the microbial components of a MBP as a whole and does not apply to any type of molecular components purified from the micro-organism. This European Standard applies to MBPs specifically manufactured to be used in agriculture and in the environmen
25、t. This European Standard does not apply to MBPs used either in food industry, for veterinary use or for human health. NOTE 2 This European Standard can be used by the manufacturer of MBPs or anyone interested in the evaluation of product quality. NOTE 3 Due to rapid evolution in this field, it is r
26、ecommended that the user should consult existing applicable national, European and international standards. NOTE 4 Technical specification assessment is consistent with the need for protection of human health, animal and environmental safety. 2 Definitions For the purposes of this standard, the foll
27、owing definitions apply: 2.1 analyte substance sought or determined 2.2 biocontaminant undesired micro-organism 2.3 biological activity of product intended performance of micro-organism based products as related to the use 2.4 control preparation of known characteristics used to standardize an analy
28、sis 2.5 microbial component desired micro-organism or mixture of desired micro-organisms 2.6 micro-organism any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material EN 1619 NOTE For the purposes of this standard, the term micro-organism covers
29、the term biological agent, according to Directive 90/679/EEC: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites which may be able to provoke any infection, allergy or toxicity. 2.7 micro-organism based product (MBP) product whose efficacy is
30、 dependent upon its microbial component 2.8 product purity content of the microbial component in the micro-organism based product NOTE Depending of the type of micro-organism based product, product purity can be expressed as one or more of the following: a) proportion of microbial component to total
31、 viable micro-organisms; b) a specified level of biocontaminants; c) identity of the microbial component to strains. 2.9 product stability preservation of biological activity and/or purity over time and under defined conditions 2.10 reference data documentation of the characterization of micro-organ
32、ism including any methods which are state-of-artPage 4 EN 12689:1998 BSI 1998 3 General considerations 3.1 Assessment protocol The assessment of technical specifications should be consistent with the intended use of the product. This assessment refers only to the microbial component or the biologica
33、l activity of the products. Identification of the microbial component should be provided by the manufacturer to the user. The manufacturer can use a wide range of procedures to characterize the microbial component, depending on the characteristics of the micro-organism(s). The manufacturer should pr
34、ocess the microbial component in such a way that its identity is ensured in the end product. NOTE Attention is drawn to EN 1619 regarding the strain conservation of micro-organisms. Validity of assessment of technical specifications is assured when specific criteria and factors are considered. The t
35、echnical specifications should be assessed using appropriate methods, depending on: the micro-organism contained in the MBP; the purpose and design of the assessment. The method of assessment should be provided by the manufacturer. These methods should be used as the basis of the evaluation of produ
36、ct quality. Regardless of the applied method, the following criteria should be considered to assure the validity of the assessment of product purity, biological activity of the product, and product stability (see clauses 4, 5 and 6). Considerations for the assessment protocol to assess the technical
37、 specifications of a MBP should start with the definition and the statement of the objectives of the analysis, either product purity, biological activity of the product or product stability, followed by the design and documentation of an appropriate test method. The major steps of the assessment pro
38、tocol are: a) design and review of the assessment protocol (see 3.2); b) execution of the assessment protocol (see 3.3); c) record keeping (see 3.4). 3.2 Design and review of the assessment protocol The design of the assessment protocol should be documented and reviewed for validity according the cr
39、iteria in clauses 4, 5 and 6. The assessment protocol should include procedures for sampling and pre-treatment of samples. The assessment of technical specifications is carried out on product samples as prepared for use. The sampling should be consistent with the type of applied statistical analysis
40、. The type of applied statistical analysis should provide representative data concerning production. NOTE Sampling methods and sample pre-treatment methods described by national and international standards for the type of product to be tested should be used. Degradation and contamination of the MBP
41、microbial component should be minimized during storage and transportation of samples. Conditions of storage and transportation of MBP samples, such as temperature, humidity and light, should be as close as possible to those of the storage of the whole product. Pre-treatment of samples is usually nec
42、essary for the isolation of the microbial component of the MBP . Pre-treatment of samples is carried out after collection and storage if required. The choice of a pre-treatment procedure depends on: the nature and composition of the MBPs (e.g. liquid or solid samples); the applied method to assess p
43、roduct purity, biological activity of the product and product stability. Pre-treatment can alter the number and activity of the microbial component of the MBPs. Therefore, it is essential that the pre-treatment procedure should be validated before being incorporated into assessment protocols. 3.3 Ex
44、ecution of assessment protocol The assessment protocol should be carried out in accordance with the design as follows: collect samples and assay; identify and label samples; store the samples under conditions which minimize degradation of the analyte; pre-treat the samples; collect raw data and obta
45、in results; record any deviation from the assessment protocol. 3.4 Record keeping A record should be kept of all aspects of the assessment protocol. This should not be considered an exhaustive list and should include: identification of the test as foreseen by the assessment protocol; person performi
46、ng the test; date of the test; method chosen for technical specification assessment; origin, storage and transportation of samples; number and size (weight and/or volume) of samples tested; controls used; deviation from the protocol; interpretation of the results. 4 Validity of purity assessment 4.1
47、 General Purity assessment provides preliminary data on biological activity and dosage of the product. A large variety of MBPs exists and many methods are available to assess purity. For any type of product the validity of purity assessment depends on the criteria and factors given in 4.2 to 4.5.Pag
48、e 5 EN 12689:1998 BSI 1998 4.2 Identification of the microbial component Purity is expressed by quantitative data based on the evidence of the identity of the microbial component. Therefore, identity is the primary factor to be confirmed to validate purity assessment. NOTE Identification methods des
49、cribed by national and international standards for the type(s) of micro-organism to be identified should be used. Identity can be expressed as the degree of morphological or genetic similarity of the micro-organism contained in the MBP to the reference strain(s). Identity can be determined from the analysis of factors related to the activity of the micro-organisms. Methods applied to identify the microbial component such as serological, genetic and physiological analysis or isolation by
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