1、February 2015Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 71.100.70; 07.100.99!%?c“2286429www.din.deDDIN EN ISO 17516Cosmetics Microbiology Microbiological limits (ISO 17516:2014);English version EN ISO 17516:2014,English translation of DIN EN ISO 17516:2015-02Kosmetische Mittel Mikrobiologie Mikrobiologische Grenzwerte (ISO 17516:2014);Englische Fassung
3、EN ISO 17516:2014,Englische bersetzung von DIN EN ISO 17516:2015-02Cosmtiques Microbiologie Limites microbiologiques (ISO 17516:2014);Version anglaise EN ISO 17516:2014,Traduction anglaise de DIN EN ISO 17516:2015-02www.beuth.deIn case of doubt, the German-language original shall be considered autho
4、ritative.Document comprises 13 pages01.15 DIN EN ISO 17516:2015-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17516:2014) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretaria
5、t: AFNOR, France). The responsible German body involved in its preparation was the DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-07-01 AA Kosmetische Mittel. The DIN Standards corresponding to the
6、International Standards referred to in this document are as follows: ISO 11930 DIN EN ISO 11930 ISO 16212 DIN EN ISO 16212 ISO 18415 DIN EN ISO 18415 ISO 18416 DIN EN ISO 18416 ISO 21148 DIN EN ISO 21148 ISO 21149 DIN EN ISO 21149 ISO 21150 DIN EN ISO 21150 ISO 22716 DIN EN ISO 22716 ISO 22717 DIN E
7、N ISO 22717 ISO 22718 DIN EN ISO 22718 ISO 29621 DIN EN ISO 29621 DIN EN ISO 17516:2015-02 3 National Annex NA (informative) Bibliography DIN EN ISO 11930, Cosmetics Microbiology Evaluation of the antimicrobial protection of a cosmetic product DIN EN ISO 16212, Cosmetics Microbiology Enumeration of
8、yeast and mould DIN EN ISO 18415, Cosmetics Microbiology Detection of specified and non-specified microorganisms DIN EN ISO 18416, Cosmetics Microbiology Detection of Candida albicans DIN EN ISO 21148, Cosmetics Microbiology General instructions for microbiological examination DIN EN ISO 21149, Cosm
9、etics Microbiology Enumeration and detection of aerobic mesophilic bacteria DIN EN ISO 21150, Cosmetics Microbiology Detection of Escherichia coli DIN EN ISO 22716, Cosmetics Good Manufacturing Practices (GMP) Guidelines on Good Manufac-turing Practices DIN EN ISO 22717, Cosmetics Microbiology Detec
10、tion of Pseudomonas aeruginosa DIN EN ISO 22718, Cosmetics Microbiology Detection of Staphylococcus aureus DIN EN ISO 29621, Cosmetics Microbiology Guidelines for the risk assessment and identification of microbiologically low-risk products DIN EN ISO 17516:2015-02 4 This page is intentionally blank
11、 EN ISO 17516October 2014 ICS 07.100.99; 71.100.99 English VersionCosmetics - Microbiology - Microbiological limits(ISO 17516:2014)Cosmtiques - Microbiologie - Limites microbiologiques (ISO 17516:2014) Kosmetische Mittel - Mikrobiologie - Mikrobiologische Grenzwerte (ISO 17516:2014) This European St
12、andard was approved by CEN on 9 August 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning
13、 such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its
14、 own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, German
15、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploi
16、tation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17516:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword . 3 Introduction . 4 1
17、Scope . 5 2 Terms and definitions 5 3 Principle 5 4 Microbiological limits for cosmetics 6 Annex A (normative) Flowchart for interpretation of test results . 7 Bibliography 8 2DIN EN ISO 17516:2015-02 EN ISO 17516:2014 (E) ForewordThis document (EN ISO 17516:2014) has been prepared by Technical Comm
18、ittee ISO/TC 217 in collaboration with Technical Committee CEN/TC 392 “Cosmetics” 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 April 2015, and conflic
19、ting national standards shall be withdrawn at the latest by April 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to t
20、he CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
21、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17516:2014 has been approved by CEN as EN ISO 17516:2014 without a
22、ny modification. “Cosmetics”3DIN EN ISO 17516:2015-02EN ISO 17516:2014 (E)IntroductionEvery cosmetic manufacturer has a responsibility relative to the microbiological safety and quality of its products to ensure that they have been produced under hygienic conditions. Cosmetic products are not expect
23、ed to be sterile. However they shall not contain excessive amounts of microorganisms nor specified microorganisms that have the potential to affect the product quality or consumer safety. Moreover, some cosmetic products which are considered to have low microbiological risk (see ISO 29621) may not n
24、eed to be subjected to routine microbiological testing and manufacturers can decide not to test if they can ensure products meet this standard.The manufacturer should follow the Good Manufacturing Practices described in ISO 22716 and take the necessary precautions to limit the introduction of microo
25、rganisms from raw materials, processing and packaging. When necessary, microbiological testing may be performed using ISO 21148, ISO 21149, ISO 16212, ISO 18415, ISO 18416, ISO 21150, ISO 22717, and ISO 22718.The objective of this International Standard is to develop acceptable quantitative and qual
26、itative limits for cosmetic finished products.4DIN EN ISO 17516:2015-02 EN ISO 17516:2014 (E) 1 ScopeThis International Standard is applicable for all cosmetics and assists interested parties in the assessment of the microbiological quality of the products. Microbiological testing does not need to b
27、e performed on those products considered to be microbiologically low risk (see ISO 29621).2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1productportion of an identified cosmetic product received in the laboratory for testing2.2aerobic mesophili
28、c microorganismsmesophilic bacteria, yeast and mould growing aerobically under the conditions specified in ISO 21149 and ISO 162122.3specified microorganismaerobic mesophilic bacteria or yeast that is undesirable in a cosmetic product because it can cause skin or eye infection or is an indication of
29、 hygienic failureSOURCE: ISO 18415:2007, definition 3.6 modified terminology has changed.2.3.1Escherichia coligram-negative rod, motile, smooth coloniesSOURCE: ISO 21150:2006, definition 3.62.3.2Pseudomonas aeruginosagram-negative rod, motile; smooth colonies pigmented brown or greenishSOURCE: ISO 2
30、2717:2006, definition 3.62.3.3Staphylococcus aureusgram-positive cocci, mainly joined in grape-like clusters, smooth colonies generally pigmented in yellowSOURCE: ISO 22718:2006, definition 3.62.3.4Candida albicansyeast that forms white to beige, creamy and convex colonies on the surface of a select
31、ive mediumSOURCE: ISO 18416:2007, definition 3.63 PrincipleCosmetics, the raw materials of which they are composed and the conditions under which they are manufactured are not required to be sterile. However the microorganisms present in a product should not 5DIN EN ISO 17516:2015-02EN ISO 17516:201
32、4 (E)have an adverse effect on consumer safety or product quality during intended or foreseeable use. Therefore, quantitative and/or qualitative microbiological limits are established for finished cosmetic products.Less than or equal to 1 103CFU per gram or ml of product is considered as an acceptab
33、le number for topical applications. However, it is considered that particular attention should be paid to cosmetics specifically intended for use in the eye area, for children under three years of age and on mucous membranes where less than or equal to 1 102CFU per gram or ml of product is considere
34、d acceptable. In addition, interpretation of out of limit results shall consider the inherent variability of the plate count method (see Table 1).Additionally it is expected that product shall be free from E. coli, S. aureus, P. aeruginosa and C. albicans in 1 g or 1 ml of product.This International
35、 Standard sets microbiological limits for cosmetics. When necessary, International standard test methods (see Annex A) should be used to assess compliance.4 Microbiological limits for cosmeticsTo ensure the quality of the product and consumer safety it is crucial that the number of non-specified mic
36、roorganisms recovered from the product remains stable or declines over the product life. The presence of non-specified microorganisms shall not be considered as objectionable, provided that they do not have the ability to grow in the product. This can be based on a risk assessment that includes pres
37、ervation efficacy studies (e.g. ISO 11930) or by the demonstration that the product cannot support microbial growth (ISO 29621).Based on these considerations the following microbiological limits mentioned in Table 1 shall apply.Table 1 Microbiological limits for cosmeticsTypes of microorganismsProdu
38、cts specifically intended for children under three years of age, the eye area or the mucous membranesOther productsTotal Aerobic Mesophilic Microor-ganisms (Bacteria plus yeast and mould) 1 102CFU per g or mla 1 103CFU per g or mlbEscherichia coli Absence in 1 g or 1 ml Absence in 1 g or 1 mlPseudom
39、onas aeruginosa Absence in 1 g or 1 ml Absence in 1 g or 1 mlStaphyloccocus aureus Absence in 1 g or 1 ml Absence in 1 g or 1 mlCandida albicans Absence in 1 g or 1 ml Absence in 1 g or 1 mlDue to inherent variability of the plate count method, according to USP Chapter 61 or EP Chapter 2.6.12, Inter
40、pretation of results, results considered out of limit ifa 200 CFU/g or ml,b 2 000 CFU/g or ml.NOTE When colonies of bacteria are detected on Sabouraud Dextrose agar, Sabouraud Dextrose agar containing antibiotics may be used.6DIN EN ISO 17516:2015-02 EN ISO 17516:2014 (E) Annex A (normative) Flowcha
41、rt for interpretation of test resultsDetection ofmicroorganisms?Productspecig976ically intended for Children under 3 years of age, the eye area or mucous membranes?Microbial examination of nonsterile products: microbial enumeration tests Microbial examination of nonsterile products: acceptance crite
42、ria for pharmaceutical preparations and substances for pharmaceutical use24 Andean Community: “Resolution 1418 Adiciones a la resolucion 797 Lmites de conteni-do microbiologico de productos cosmeticos”: Gaceta oficial del acuerdo de Cartagena Ao XXVIII Numro 1953 13 June 201125 Mercosul/GM/RES. N 51
43、/98- parmetros de controle microbiologico para produtos de hygiene pessoal, cosmeticos e perfumes8DIN EN ISO 17516:2015-02 EN ISO 17516:2014 (E) 26 MCCA (Guatemala, El Salvador, Nicaragua, Honduras et Costa Rica): Reglamento tcnico Centroamericano RTCA 71.03.45:07 Productos cosmeticos. Verificacion de la calidad27 Microbiology Guidelines CTFA 20079DIN EN ISO 17516:2015-02EN ISO 17516:2014 (E)
