National foreword

This British Standard is the UK implementation of EN 71‑18:2024.

The UK participation in its preparation was entrusted to Technical Committee CW/15, Safety of toys.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication has been prepared under a mandate given to the European Standards Organizations by the European Commission and the European Free Trade Association. It is intended to support requirements of the EU legislation detailed in the European Foreword. A European Annex, usually Annex ZA or ZZ, describes how this publication relates to that EU legislation.

For the Great Britain market (England, Scotland and Wales), if UK Government has designated this publication for conformity with UKCA marking (or similar) legislation, it may contain an additional National Annex. Where such a National Annex exists, it shows the correlation between this publication and the relevant UK legislation. If there is no National Annex of this kind, the relevant Annex ZA or ZZ in the body of the European text will indicate the relationship to UK regulation applicable in Great Britain. References to EU legislation may need to be read in accordance with the UK designation and the applicable UK law. Further information on designated standards can be found at www.bsigroup.com/standardsandregulation.

For the Northern Ireland market, UK law will continue to implement relevant EU law subject to periodic confirmation. Therefore Annex ZA/ZZ in the European text, and references to EU legislation, are still valid for this market.

UK Government is responsible for legislation. For information on legislation and policies relating to that legislation, consult the relevant pages of www.gov.uk.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2024.

This European Standard was approved by CEN on 1 December 2024.

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 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 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, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN 71‑18:2024) has been prepared by Technical Committee CEN/TC 52 “Safety of toys”, the secretariat of which is held by DS.

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 June 2025, and conflicting national standards shall be withdrawn at the latest by June 2025.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States.

For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document.

Additional information on the background and rationale for various requirements are given in Annex A.

This document constitutes the 18^th part of the EN 71 series of standards on safety of toys.

EN 71, Safety of toys, consists of the following parts:

Part 1: Mechanical and physical properties;
Part 2: Flammability;
Part 3: Migration of certain elements;
Part 4: Experimental sets for chemistry and related activities;
Part 5: Chemical toys (sets) other than experimental sets;
Part 7: Finger paints — Requirements and test methods;
Part 8: Activity toys for domestic use;
Part 10: Organic chemical compounds — Sample preparation and extraction;
Part 11: Organic chemical compounds — Methods of analysis;
Part 12: N-Nitrosamines and N-nitrosatable substances;
Part 13: Olfactory board games, cosmetic kits and gustative games;
Part 14: Trampolines for domestic use;
Part 15: Formamide in foam toy materials (content) (under development);
Part 16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials (under development);
Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials (under development);
Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials (this document);
Part 19: Migration of bisphenol A from toy materials;
Part 20: Microbiological safety of toys containing accessible aqueous media (under development).

It is up to the user of the standard to determine whether or not a toy is included in the scope of several of the above parts of the EN 71 series, and to apply each applicable standard accordingly. Normative references from one part of the EN 71 series to another, are therefore normally not provided in the individual parts.

NOTE 1 In addition to the above parts of EN 71, the following deliverables have been published:

— CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in theEN71series;

— the CEN/TR 15371 series, Safety of toys — Interpretations;

— CEN/TR 16918, Safety of toys — Children's mouthing behaviour in contact with toys;

— CEN/TR 17695, Safety of toys — Mechanical and physical properties — Guidance on categorisation of projectile toys withinEN71‑1;

— CEN/TS 17973, Safety of toys — Categorization of slime type materials; and

— CEN ISO/TR 8124‑8, Safety of toys — Part 8: Age determination — First age grade for the appropriate play of toys (ISO/TR 8124-8).

NOTE 2 Words in italics (apart from document titles) are defined in Clause 3 (Terms and definitions).

Any feedback and questions on this document should be directed to the users’ national standards body. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Introduction

According to article 46 of Directive 2009/48/EC on the safety of toys [1] the “Commission may adopt specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth”.

In May 2017, the European Commission amended Appendix C to Annex II to this Directive accordingly and adopted specific limit values for phenol in toys (see Commission Directive (EU) 2017/774 [2]). The limit values take into account the SCHER Opinion on “CEN's response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys” [3].

This document provides test methods to check compliance with these limit values.

WARNING — The application of the test method specified in this document can involve hazardous materials, operations and equipment. The document does not purport to address all of the safety or environmental problems associated with its use.

1 Scope

This document specifies requirements and test methods for determining the concentration of phenol in aqueous toy materials and for migration of phenol from polymeric toy materials. This document is applicable to toys intended for use by children under 36 months or other toys intended to be placed in the mouth.

NOTE The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on the Safety of Toys [4] provides guidelines to help on the classification of toys intended for children under 36 months of age or of 36 months and over.

2 Normative references

3 Terms and definitions

4 Requirements

5 Principle

5.1 Migration method

5.2 Extraction method

6 Reagents, standards and apparatus

6.1 Reagents

6.2 Standards

6.3 Apparatus

7 Sample preparation

7.1 Migration method

7.2 Extraction method

8 Method of analysis

8.1 General

8.2 Chromatographic conditions

8.3 Mass spectrometer settings

8.4 DAD and FLD detection

9 Method performance

9.1 Limit of quantification

9.2 Precision

10 Calculation of the result

10.1 Evaluating the concentration of phenol using LC-MS/MS

10.2 Evaluating the concentration of phenol using HPLC-DAD, HPLC-DAD/FLD and HPLC-FLD

10.3 Migration method

10.4 Extraction method

11 Test report

Bibliography

BS EN 71-18:2024

Safety of toys - Phenol in aqueous (content) and polymeric (migration) toy materials

Current

Published:

31 Dec 2024