SIST EN 1400-3:2003
(Main)Child use and care articles - Soothers for babies and young children - Part 3 : Chemical requirements and tests
Child use and care articles - Soothers for babies and young children - Part 3 : Chemical requirements and tests
This part of EN 1400 "Child use and care articles" specifies limits for the release of certain chemicals from materials to be used for the manufacture of soothers and products which resemble a soother.
It includes test methods for the chemical safety requirements specified.
This standard is applicable to products which resemble or function as a soother unless they are being marketed as medical devices.
This standard does not apply to products designed for specialist medical applications or use under medical supervision, e.g. those relating to Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (Annex A) to Part 1 of this standard.
NOTE It is recommended that soothers excluded from the scope of this European Standard should meet those requirements that can be applied.
The standard is not applicable to feeding teats.
Artikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Teil 3 : Chemische Anforderungen und Prüfungen
Dieser Teil von EN 1400, ?Schnuller für Säuglinge und Kleinkinder", legt Grenzwerte für die Abgabe bestimmter chemischer Stoffe aus Materialien fest, die für die Herstellung von Schnullern und von Produkten, die einem Schnuller ähnlich sind, verwendet werden.
Eingeschlossen sind Verfahren zur Prüfung der festgelegten Anforderungen an die chemische Sicherheit.
Die vorliegende Norm gilt für alle Produkte, die einem Schnuller ähnlich sind oder die als Schnuller dienen, ausgenommen solche, die zu medizinischen Zwecken abgegeben werden.
Diese Norm gilt nicht für Produkte für besondere medizinische Anwendungen oder den Einsatz unter medizinischer Aufsicht, z. B. beim Pierre-Robin-Syndrom oder bei Frühgeborenen. Diese Sonderfälle werden im informativen Anhang A zum Teil 1 dieser Norm beschrieben.
ANMERKUNG Es wird empfohlen, dass Schnuller, die vom Anwendungsbereich dieser Europäischen Norm ausgenommen sind, jene Anforderungen erfüllen sollten, die auf sie anwendbar sind.
Die Norm gilt nicht für Ernährungssauger ).
Articles de puériculture - Sucettes pour nourrissons et jeunes enfants - Partie 3: Exigences chimiques et essais
La présente partie de cette norme européenne spécifie les limites et les méthodes d'essai qui s'appliquent a la libération de certaines substances chimiques par les matériaux utilisés dans la fabrication des sucettes.
La présente Norme européenne est applicable aux produits qui ressemblent a une sucette ou qui fonctionnent de la meme façon, excepté ceux qui sont mis sur le marché en tant que dispositifs médicaux.
La présente Norme européenne n'est pas applicable aux produits destinés a des applications médicales spécialisées, tels que ceux destinés aux nourrissons prématurés ou présentant le Syndrome de Robin. Ces cas particuliers sont décrits dans une annexe informative (voir EN 1400 1:2002, Annexe A).
NOTE Il est recommandé que les sucettes exclues du domaine d'application de la présente Norme européenne satisfassent aux exigences qui leur sont applicables.
La présente norme ne s'applique pas aux tétines de biberons. )
Izdelki za otroke - Dude za dojenčke in malčke - 3. del: Kemijske zahteve in preskusi
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Child use and care articles - Soothers for babies and young children - Part 3 : Chemical requirements and testsSUHVNXVLArticles de puériculture - Sucettes pour nourrissons et jeunes enfants - Partie 3: Exigences chimiques et essaisArtikel für Säuglinge und Kleinkinder - Schnuller für Säuglinge und Kleinkinder - Teil 3 : Chemische Anforderungen und PrüfungenTa slovenski standard je istoveten z:EN 1400-3:2002SIST EN 1400-3:2003en97.190ICS:SLOVENSKI
STANDARDSIST EN 1400-3:200301-maj-2003
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 1400-3September 2002ICS 97.190English versionChild use and care articles - Soothers for babies and youngchildren - Part 3 : Chemical requirements and testsArticles de puériculture - Sucettes pour nourrissons etjeunes enfants - Partie 3: Exigences chimiques et essaisArtikel für Säuglinge und Kleinkinder - Schnuller fürSäuglinge und Kleinkinder - Teil 3 : ChemischeAnforderungen und PrüfungenThis European Standard was approved by CEN on 28 July 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1400-3:2002 E
EN 1400-3:2002 (E)2ContentspageForeword.3Introduction.41Scope.52Normative references.53Terms and definitions.54Chemical requirements.64.1General.64.2Chemical properties.64.3Requirements by material.64.4Migration of certain elements.74.5N-Nitrosamines and N-Nitrosatable substances release.74.6Mercaptobenzothiazole (MBT) release.84.7Antioxidants release.84.8Volatile compounds content.85Test methods.85.1Sample preparation.85.2Determination of the migration of certain elements.95.3Determination of N-Nitrosamines and N-Nitrosatable substances release.105.4Determination of 2-Mercaptobenzothiazole (MBT) and antioxidants release.105.5Determination of volatile compounds content.12Annex A (informative)
A suitable HPLC apparatus, method and precision data for determination of 2-Mercaptobenzothiazole (MBT) and/or antioxidants.13Bibliography.15
EN 1400-3:2002 (E)3ForewordThis document EN 1400-2:2002 has been prepared by Technical Committee CEN/TC 252 "Child use and carearticles", 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 orby endorsement, at the latest by March 2003, and conflicting national standards shall be withdrawn at the latest byMarch 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association.This European Standard 1400 “Child use and care articles” consists of the following parts:— Part 1: General safety requirements and product information— Part 2: Mechanical requirements and tests— Part 3: Chemical requirements and testsThis part of this European Standard contains one annex:- annex A (informative) A suitable HPLC apparatus, method and precision data for determination of 2-Mercaptobenzothiazole (MBT) and/or antioxidantsAccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 1400-3:2002 (E)4IntroductionElastomeric and rubber teats are regulated by the Commission Directive 93/11/EEC concerning the release ofN-Nitrosamine and N-Nitrosatable substances from elastomer or rubber teats and soothers. The current Directiveprovides in its annexes an outline method of analysis which, has been published as EN 12868.A limit for the release of 2-mercaptobenzothiazole (MBT) has been specified in the standard. This limit significantlyreduces the level of this substance potentially released from soothers. The Scientific Committee for Food hasconcluded that the limit does not constitute a health hazard. The limit for the release of MBT will be reconsidered inlight of future studies and recommendations.It is noted that all plastic components are regulated by the Commission Directive 90/128/EEC.Commission Decision 198/815/EC with its subsequent extensions has adopted temporary measures prohibiting theplacing on the market of toys and childcare articles intended to be placed in the mouth by children under threeyears of age. The prohibition relates to such products made of soft PVC containing one or more of the substancesdi-iso-nonyl phthalate (DINP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate(DIDP), di-n-octyl phthalate (DNOP), and butylbenzyl phthalate (BBP). At the time of preparing this standard a finaldecision was awaited. This standard will be reviewed in the light of that decision.Formaldehyde, caprolactam and colourants have each been considered by the Technical Committee. They havenot been included in the standard at this stage because of the lack of either adequate information for making asatisfactory potential risk assessment, or validated test methods for the determination of their migration levels fromrelevant products. They will be reconsidered when further information becomes available.For similar reasons, latex protein allergy risk has also not been included in this standard. There is an extremely lowincidence of latex protein allergy amongst babies and young children. Nevertheless, provision for packaginginformation for soothers containing natural rubber has been made in Part 1 of this standard. The issue of potentialsensitisation and allergic reaction from rubber products will be re-considered when further information becomesavailable.
EN 1400-3:2002 (E)51 ScopeThis part of this European Standard specifies limits and test methods for the release of certain chemicals frommaterials used for the manufacture of soothers.This European Standard is applicable to products that resemble or function as a soother unless they are beingmarketed as medical devices.This European Standard does not apply to products designed for specialist medical applications, e.g. those relatingto Pierre-Robin Syndrome or premature babies. These special cases are described in an informative annex (seeEN 1400-1:2002, annex A).NOTEIt is recommended that soothers excluded from the scope of this European Standard should meet thoserequirements that can be applied.The standard is not applicable to feeding teats.12 Normative referencesThis European Standard incorporates, by dated or undated references, provisions from other publications. Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).EN 71-3, Safety of toys - Part 3: Migration of certain elements.EN 12868, Child use and care articles - Methods for determining the release of N-Nitrosamines and N-Nitrosatablesubstances from elastomer or rubber teats and soothers.EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987).3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1sootherarticle intended for satisfying the non-nutritive sucking need of childrenNOTESoothers are also known as pacifiers or babies' dummies.3.2teatflexible nipple which is the part of the soother designed to be placed in the mouth3.3shieldstructure positioned at the rear of the teat to reduce the likelihood of the soother being drawn entirely into thechild's mouth
1 A standard for safety requirements and test methods for drinking equipment is in preparation.
EN 1400-3:2002 (E)63.4ring or knobstructure positioned adjacent to or on the shield to facilitate handling of the sootherNOTEThe ring, knob or cover can be integral with the shield or plug or it can be a separate component that is attached tothe shield or plug.3.5plugdevice located within the neck of the teat that secures the teat to the shield3.6coverdevice that prevents open access to the plug3.7ventilation holesholes in the shield of a soother which provide an air passage through which a child can breath, should the sootherbecome accidentally lodged in the mouth. The holes also reduce the risk of the soother being sucked into thepharynx through the generation of negative pressure4 Chemical requirements4.1 GeneralMaterials used for manufacturing soothers shall be subjected to the sample preparation as specified in 5.1 and thetests listed in Table 1.NOTE 1Additional information for the finished product can be obtained from Directive 90/128/EEC [1] and the Commissionof the European Communities [2]NOTE 2It is recommended that manufacturers and suppliers operate to EN ISO 9001 [3] for quality management.4.2 Chemical propertiesThe vulcanising agents (e.g. MBT) and antioxidants mentioned below do not represent a definitive list. Chemicalsother than those mentioned in this standard can be used where toxicological evidence, either on the originalchemical or any reaction product, is available to demonstrate that no unacceptable risk is posed when they areused in soothers and an appropriate analytical test procedure for determining migration levels exists.4.3 Requirements by materialMaterials used in the manufacture of components of soothers shall be subjected to the tests marked with an x inTable 1.
EN 1400-3:2002 (E)7Table 1 — Tests to be carried out on materialsMaterialTestsMigration ofcertainelements(see 5.2)N-Nitrosamines andN-Nitrosatablesubstances release(see 5.3)MBT release(see 5.4)Anti-oxidantsrelease(see 5.4)Volatilecompoundscontent(see 5.5)VulcanizedrubberxxxxSilicone rubberxxxThermoplasticelastomers (TPEs)xxThermoplasticsx4.4 Migration of certain elementsWhen tested in accordance with 5.2 the migration of elements from all material(s) used in the manufacture ofsoothers shall not exceed the limits given in Table 2.When soothers contain components manufactured from different material(s), or in different colours, all componentsshall be tested individually. Decorations shall be considered to be part(s) of the material(s) on which they areprinted.Table 2 — Limits of element migration from soothersElementLimit(mg/kg)Antimony, SbArsenic, AsBarium, BaCadmium, CdLead, PbChromium, CrMercury, HgSelenium, Se151010020251010100NOTEThe analytical method specified in EN 71-3 has beenapplied in this standard to soothers. The limits set account forthe prolonged sucking of a teat in the mouth.4.5 N-Nitrosamines and N-Nitrosatable substances releaseWhen tested in accordance with 5.3, the total N-Nitrosamines and N-Nitrosatables release of any elastomer orrubber component shall not exceed the limits given in Table 3.
EN 1400-3:2002 (E)8Table 3 — N-Nitrosamines and N-Nitrosatable substances release and tolerancesSubstanceLimitmg/kgTolerancemg/kgN-Nitrosamines0,010,01N-Nitrosatables0,10,14.6 Mercaptobenzothiazole (MBT) releaseWhen elas
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