BS PD ISO TS 210-2014 Essential oils General rules for packaging conditioning and storage《香精油 包装、状态调节和储存的一般规则》.pdf

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1、BSI Standards Publication PD ISO/TS 210:2014 Essential oils General rules for packaging, conditioning and storagePD ISO/TS 210:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TS 210:2014. It supersedes PD ISO/TR 210:1999 which is withdrawn. The UK pa

2、rticipation in its preparation was entrusted to Technical Committee AW/54, Essential oils. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible

3、 for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 85572 6 ICS 71.100.60 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standa

4、rds Policy and Strategy Committee on 30 June 2014. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dPD ISO/TS 210:2014 ISO 2014 Essential oils General rules for packaging, conditioning and storage Huiles essentielles Rgles gnrales demballage, de conditionnement et de stocka

5、ge TECHNICAL SPECIFICATION ISO/TS 210 First edition 2014-06-01 Reference number ISO/TS 210:2014(E)PD ISO/TS 210:2014ISO/TS 210:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced o

6、r utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO c

7、opyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandPD ISO/TS 210:2014ISO/TS 210:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv 1 Scope . 1 2 Composition of the containers .

8、 1 2.1 Materials for containers intended for containing essential oils for food use . 1 2.2 Materials for containers intended for containing essential oils for pharmaceutical use . 4 2.3 Materials for containers intended for containing essential oils for perfumery and cosmetic use 4 2.4 Materials fo

9、r containers intended for containing reference samples or test samples of essential oils 5 2.5 Materials for containers intended for containing essential oils used as industrial raw materials 5 3 Pigments or colourings 18. 5 4 Characteristics for containers intended for containing essential oils .5

10、4.1 Types 5 4.2 Capacity . 6 4.3 Closures . 6 4.4 External solderings . 6 5 Conditioning and storage 6 5.1 Conditioning 6 5.2 Storage . 6 5.3 Special cases 7 Bibliography 8PD ISO/TS 210:2014ISO/TS 210:2014(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation

11、 of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee.

12、International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and thos

13、e intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (s

14、ee www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the doc

15、ument will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms a

16、nd expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 54, Essential oils. This first

17、 edition of ISO/TS 210 cancels and replaces ISO/TR 210:1999 which has been technically revised.iv ISO 2014 All rights reservedPD ISO/TS 210:2014TECHNICAL SPECIFICATION ISO/TS 210:2014(E) Essential oils General rules for packaging, conditioning and storage 1 Scope This Technical Specification describ

18、es the specifications to be met by the containers intended for containing essential oils, as well as recommendations relating to their conditioning and storage. Essential oils are used for different purposes: food use; pharmaceutical use; perfumery and cosmetic use; reference samples or test samples

19、; industrial raw materials. According to the use of the essential oils, it is necessary to use appropriate containers which also meet the requirements of national, European, or international regulations. This Technical Specification describes the materials to be used for the containers intended for

20、containing essential oils, depending on the uses listed above. It also gives some general rules and recommendations relating to the properties of these containers and their conditioning and storage. NOTE The information given in this Technical Specification does not substitute for the regulations in

21、 force in the different countries. 2 Composition of the containers Essential oils shall be packed in containers which, by their nature, do not cause alteration of the product and which protect it against any external attack. Generally, the container materials shall be inert towards the packed produc

22、t so as to prevent any simultaneous damage of the product and of the material. 2.1 Materials for containers intended for containing essential oils for food use 2.1.1 Glass 1 Type III glass (soda-calcic glass, according to Pharmacopoeia standards), is advisable as it permits to keep the organoleptic

23、properties of the essential oils. Tinted antiactinic glass is always advisable. 2.1.2 Metals and alloys 2.1.2.1 Stainless steel 2 These materials shall contain at least 13 % of chromium. They also may contain nickel and manganese. ISO 2014 All rights reserved 1PD ISO/TS 210:2014ISO/TS 210:2014(E) Fu

24、rthermore, one or more of the following elements in Table 1 may be included, with the following limit for each of them. Table 1 Tantalum 1 % max. Niobium 1 % max. Zirconium 1 % max. Molybdenum 4 % max. Titanium 4 % max. Aluminium 4 % max. Copper 4 % max. 2.1.2.2 Aluminium and aluminium alloys 345 2.

25、1.2.2.1 Aluminium shall be at least 99 % pure The total content of impurities shall not exceed 1 %, and they are limited as shown in Table 2. Table 2 Iron + Silicon Lower than 1 % Titanium 0,15 % max. Chromium, Zinc, Copper, Manganese, Magnesium, Nickel, Tin 0,1 % max (for each of these elements) Le

26、ad, Thallium, Beryllium, and each of the other pre- sent impurities 0,05 % max (for each of these elements Copper Between 0,10 % (m/m) and 0,20 % (m/m), on condition that the chromium and manganese contents are less than 0,05 % (m/m) 2.1.2.2.2 In the aluminium alloys, the percentage (m/m) of the ele

27、ments which may be added or which are present as impurities, shall not exceed the following values in Table 3. Table 3 Silicon 13,5 % max. Magnesium 11 % max. Manganese 4 % max. Nickel 3 % max. Iron 2 % max. Copper 0,6 % max. Antimony 0,4 % max. Chromium 0,35 % max. Titanium 0,3 % max. Zirconium 0,3

28、 % max. Zinc 0,25 % max Strontium 0,2 % max.2 ISO 2014 All rights reservedPD ISO/TS 210:2014ISO/TS 210:2014(E) Tin 0,1 % max. Arsenic, Tantalum, Beryllium, Thallium, Lead, and each of the other impurities present. 0,05 % max, with a total to 0,15 % The anodization of aluminium or aluminium alloy mat

29、erials and objects complying with the provisions of Article 2 and 3 of Reference 3 shall be only carried out in a diluted bath of the following acids or their mixtures: sulfuric acid; sulfomaleic acid; sulfosalicilic acid; oxalic acid; phosphoric acid. The anodic layer may be coloured by pigments or

30、 colourings, provided that they are authorized by the regulations in force in the countries concerning the materials and products in contact with food. (See Clause 3). A compulsory final filling operation is applied with the exception of the aluminium or aluminium alloy materials and products anodiz

31、ed in a phosphoric medium or covered by coating, in conformity with the Article 4 of Reference 3. This operation shall be carried out with distilled or demineralized water containing either 8 g/l of nickel acetate and 1 g/l of cobalt acetate or one of these two salts at the maximum concentrations in

32、dicated. All the technical conditions and particularly the temperature and the standing time shall be chosen in such a way that, at the end of the operation, the oxide layer formed during the anodization process, loses its absorption power due to its natural porosity, and acquires optimum inertness.

33、 2.1.2.3 Tin 67 This material shall contain at least 97 % of tin, determined as metastannic acid, and not more than 0,5 % of lead or 300 mg/kg of arsenic. 2.1.2.4 Copper, zinc, galvanized iron 6 Except during the distillation process, direct contact between the essential oil and these materials is f

34、orbidden. 2.1.3 Polymers: plastics and varnishes Compatibility tests between the container and the content shall be carried out before using these materials. The authorized global migration limit is established by the national or international regulations in force in the countries, 91011121314and, d

35、epending on the case, is 60 mg/kg or 10 mg/dm 2(according to the shape or dimensions of the container). Only those substances listed in the national or international regulations, 16which also include migration limits for some of these substances 1517are authorized as components of plastics materials

36、. 2.1.4 C er amic, vitrified, enamelled mat erials, used for int ernal c oating These materials shall not release lead and cadmium in larger quantities than those laid down by the national or international regulations in force in the countries. 8Table 3 ISO 2014 All rights reserved 3PD ISO/TS 210:20

37、14ISO/TS 210:2014(E) 2.2 Materials for containers intended for containing essential oils for pharmaceutical use No material or substance placed in contact with an essential oil for pharmaceutical use shall perceptibly adulterate its composition or modify its activity. All packaging shall have a Lice

38、nsing Approval delivered by the relevant authorities. NOTE This authorization forms a part of the Licensing Pharmaceutical dossier. Depending on the country, the regulations applicable to containers and packaging differ, but generally refer to general principles of Pharmacopoeia (European, 1American

39、, 21or Japanese, 22etc.), which specify, among other things, that a study relating to the possible interaction between the container and the product should be undertaken in each case where a hazard may appear, and national standards or regulations if there is no specific or relevant Pharmacopoeia mo

40、nograph. 2.2.1 Glass The glass used is of type III and shall comply with the Pharmacopoeia standards concerning its hydrolytic resistance. Tinted antiactinic glass is advisable in all cases. 2.2.2 Metals and alloys These materials shall have the same properties and stresses as those described throug

41、hout 2.1.2. 2.2.3 Plastics materials These materials are generally described in the Pharmacopoeia monographs. They are submitted to various analyses and tests, which comprise in particular an identification, a determination of certain substances such as antioxidant monomer residues, anti-UVs, stabil

42、izers, catalyst residues, heavy metals, or aromatic diamines, and a control of water or solvent extraction, etc. 2.2.4 C er amic, vitrified, enamelled mat erials, used for int ernal c oatings Varnished, enamelled, vitrified, ceramic coatings shall meet the same constraints as the materials used for

43、food essential oils, as described in paragraph 2.1.4. 2.3 Materials for containers intended for containing essential oils for perfumery and cosmetic use All the previously listed materials (see 2.1 and 2.2) may be used, on condition that they do not alter the composition of the essential oil or its

44、organoleptic properties: appearance, colour, odour, etc. Because they are oxidation catalysts, copper and iron are not advisable. Plastics materials intended for this use shall be submitted to prior testing, concerning their carbon dioxide, oxygen, steam, fragrances, etc., permeability, and the agei

45、ng of the packed product.4 ISO 2014 All rights reservedPD ISO/TS 210:2014ISO/TS 210:2014(E) 2.4 Materials for containers intended for containing reference samples or test samples of essential oils The only advisable material is tinted antiactinic glass. 2.5 Materials for containers intended for cont

46、aining essential oils used as industrial raw materials Tinted antiactinic glass is advisable, but all the materials quoted in 2.1 to 2.4 may also be used. 3 Pigments or colourings 18 If containers intended for containing essentials oils for food use (2.1) or pharmaceutical use (2.2) are coloured, th

47、e pigments or colourings used shall comply with the regulations in force, similar to those of the additives of plastics. They shall have a high level of purity and the maximum content in mineral elements is shown in Table 4. Table 4 Antimony 0,05 % Arsenic 0,01 % Barium 0,01 % Cadmium 0,01 % Chromiu

48、m 0,1 % Lead 0,01 % Mercury 0,005 % Selenium 0,01 % One method of analysis of benzo-3,4 pyrene is given in Reference 19. 4 Characteristics for containers intended for containing essential oils 4.1 Types The containers intended for containing essential oils differ in shape, nature, and capacity. They

49、 shall be appropriate for their use (following the recommendations relating to the materials given in Clause 2). The most frequently used types of container are the following: flasks; cans; barrels; drums; tanks. Drums of capacity equal to or greater than 200 l shall be provided with hoops or with moulded ribs. ISO 2014 All rights reserved 5PD ISO/TS 210:2014ISO/TS 210:2014(E) 4.2 Capacity The capacity of the containers used differs according t