Conformity Assessments

Transcription

1 Industry support for effective compliance BTHA Toy Safety Directive Guidance 2009/48/EC Conformity Assessments 8

2 Primary Authority Assurance Milton Keynes Council (MKC) has assured this BTHA guidance as Primary Authority advice The level of assurance that this document can give individual members is detailed below: 1 BTHA Coordinated Primary Authority Partnership British Toy and Hobby Association members who are included within the 'regulatory group', as decided by the BTHA, will be able to legally rely on primary authority advice issued by Milton Keynes Council via BTHA. This primary authority advice will be tailored to the collective needs and circumstances of the businesses that will be eligible to receive it. Any proposed enforcement action in the UK against any of the BTHA members within the 'regulatory group' that is inconstant with this BTHA primary authority assured advice, will be "directed against". This means that Milton Keynes Primary Authority may direct an enforcing authority not to take proposed enforcement action (thereby blocking the enforcement action) where such action is inconsistent with primary authority advice. Full members of the BTHA are all invited to join the primary authority 'regulatory group' but can opt out of the scheme if they choose to. 2 Direct Primary Authority Partnerships British Toy and Hobby Association members who are part of the 'regulatory group' under the coordinated primary authority arrangement with Milton Keynes Council can also have direct Primary Authority Partnership with Milton Keynes Council or another local authority of their choice. BTHA members who are included in the coordinated primary authority scheme, and who also have a direct Primary Authority Partnership, are able to enjoy the benefits of legally relying on the BTHA primary authority assured advice and can also obtain other primary authority assured advice tailored to their individual business needs and circumstances. They will have control over any questions and requests for advice at their own cost. 3 No Primary Authority Partnership British Toy and Hobby Association full members can choose to opt out of being a member of the scheme by confirming annually or contacting admin@btha.co.uk at any time. In some cases these companies may not have a Primary Authority Partnership with Milton Keynes Council or any other Council. Such members can use the guidance with the knowledge that it is BTHA assured guidance, however, as the members are not in the Primary Authority Partnership they cannot legally rely on this guidance. Further details regarding the BTHA Primary Authority agreements can be obtained from the BTHA.

3 BTHA Toy Safety Directive Guidance 2009/48/EC Contents 1. Obligations of Economic Operators 2. Introduction 3. Overview 4. How to use this guide 5. The Conformity Assessment 6. Table explanation 1

4 1. Obligations of Economic Operators Obligation Manufacturer Importer Distributor Authorised Representative Carry out the Conformity Assessment A4(2) A19 Obligated A6(2) Ensure it s done No obligation No obligation See separate BTHA guidance on the Obligations of Economic Operators which should be read first. 2. Introduction The Toy Safety Directive (2009/48/EC) (TSD) was adopted by the European Parliament on 18 December 2008 and the final text was formally adopted and published in the Official Journal of the European Union (OJ) on 30 June From this date, the overall timetable for the implementation of the subject material covered by this guidance document was from 20 July The Directive came into force in two stages; on 20 July 2011, and for the Chemical requirements on 20 July Article 4 of the revised Toy Safety Directive specifies the following obligation for Manufacturers for Conformity Assessments: Manufacturers shall... carry out or have carried out the applicable Conformity Assessment procedure in accordance with Article 19. This document provides an interpretation of this obligation. It is based on the current understanding of the Directive and may be subject to change as more information is published by the EU Commission and UK enforcement authorities. 3. Overview 2 A Conformity Assessment is defined as the process of demonstrating whether or not specified requirements relating to a product, process, service, system, person or body have been fulfilled. The Conformity Assessment described by the Toy Safety Directive is required in order to demonstrate that the toy complies with: The Essential Safety Requirements specified in Article 10 and The Particular Safety Requirements specified in Annex II. A Conformity Assessment is required for all toys before they are placed on the market. Conformity Assessments are distinct from Safety Assessments. Safety Assessments are intended to identify potential hazards that a toy may possess and the potential exposure to those hazards. Conformity Assessments are intended to identify the means by which Economic Operators demonstrate that the toy is in conformity with the requirements of the Toy Safety Directive. A Conformity Assessment therefore will depend on Manufacturers having carried out a Safety Assessment including the analysis of hazards and their associated risks and whether or not they are addressed by Harmonised Standards. If companies do not have the necessary expertise to conduct a Conformity Assessment, a third party expert may be needed. 4. How to use this guide There are two ways of carrying out a Conformity Assessment. Table 1 can be used to decide which method of carrying out the Conformity Assessment is required for the toy in question. Each question asked on table 1 has explanatory text shown in section The Conformity Assessment Article 10 of the Toy Safety Directive provides Essential Safety Requirements with which a toy must comply. Particular Safety Requirements for certain toys are also provided in Annex II. The requirements include those covering mechanical and physical, flammability, chemical, electrical, hygiene and radioactive aspects of a toy. A Conformity Assessment must demonstrate that the toy conforms to all of these requirements. The Manufacturer may achieve this by (a) self-assessment (which may involve laboratory testing) or (b) third party assessment (which must involve a Notified Body). Table 1 can be used to determine which method is required.

5 Table 1. Conformity Assessment method determination a Are there any relevant safety aspects of the toy that are not covered by the Harmonised Standards that have not been addressed by the Safety Assessment? YES NO b Are there standards or parts of standards that are applicable that have not been applied to the toy? YES NO c Are the applicable Harmonised Standards published with restrictions? YES 3 NO d Are there aspects of nature, design, construction or purpose of the toy that may require third party verification? YES NO e Selfverification Module A Third party verification Module B + C

6 6. Table explanation a. Are there any relevant safety aspects of the toy that are not covered by the Harmonised Standards that have not been addressed by the Safety Assessment? The Safety Assessment process identifies any hazards and the associated risks present in the toy. It also enables the Manufacturer to discover whether or not the hazards are addressed by Harmonised Standards and how they should be managed. See separate BTHA Guidance concerning Safety Assessments. If there are safety issues/hazards that are not covered by compliance to Harmonised Standards or if the Manufacturer cannot satisfy himself that they are in compliance with Essential Safety Requirements in Article 10 and with the Particular Safety Requirements for certain toys in Annex II of the Directive, using the Harmonised Standards, third party verification is required (see section e). b. Are there standards or parts of standards that are applicable that have not been applied to the toy? If there are standards or parts of standard that are applicable to the toy that have not been applied then third party verification may be required, e.g. where there is a clause that is applicable to a product but that does not adequately address the risk. c. Are the applicable Harmonised Standards published with restrictions? 4 Standards may sometimes be referenced by the EU with restrictions. Restrictions may also be applied retrospectively if an EU Member State or the EU Commission considers that a Harmonised Standard does not entirely satisfy the safety requirements of the Toy Safety Directive. If a standard is referenced with such a restriction for any aspect that is applicable to the toy in question, then third party verification is required. At the time of writing none of the standards harmonised under the Toy Safety Directive have been published with restrictions. Manufacturers that are using Harmonised Standards to demonstrate conformity should ensure that the standards applied do not have restrictions. d. Are there aspects of nature, design, construction or purpose of the toy that may require third party verification? Some toys may require third party verification if they include aspects that lead the Manufacturer to believe that the Harmonised Standards may not address a safety aspect in full, e.g. those that are innovative, use unusual materials, have atypical age grades etc. e. Verification/Modules The procedures that Manufacturers use to demonstrate conformity are defined in modules These are described in Decision No 768/2008/EC. Different modules apply to the various CE marking directives. However the Toy Safety Directive makes reference to Modules A, B and C. Self-verification (Module A) Manufacturers must put in place an internal production procedure in accordance with Module A of Annex II to Decision No. 768/2008/EC. Module A does not require the involvement of a Notified Body. Module A describes the following obligations. Conformity to Harmonised Standards Manufacturers must ensure that their toy complies with: The Essential Safety Requirements (TSD Article 10) and

7 The Particular Safety Requirements (TSD Annex II). One way of achieving this is to demonstrate compliance with the relevant Harmonised Standards. The assessment/verification can either be carried out by the Manufacturer himself or by a third party (a test laboratory for example) or a combination of the two. It is often assumed that a third party testing organisation must be used to assess a toy against the Harmonised Standards. This is not the case. If conformity with any of the requirements of the Harmonised Standards can be demonstrated easily, perhaps without the use of specialised equipment, then a Manufacturer may carry out the assessment for himself. Sometimes a combination of third party and in-house assessments may be appropriate. Unfortunately some toy safety standards are open to interpretation. In-house tests and assessment should only be carried out by those with a full knowledge and understanding of the standards and their proper interpretation. Third party testing organisations accredited specifically for the toy safety tests required should be aware of the proper interpretations and can usually be relied upon. Third party test organisations can be commissioned to provide test results, it is ultimately the responsibility of the Manufacturer to demonstrate compliance. Many Manufacturers and their customers prefer the reassurance provided by third party test certificates/reports and incorporate them within their technical files. It is important to note, however, that this is not a requirement of the Toy Safety Directive. Technical Documentation All relevant information demonstrating conformity should be maintained in the Technical Documentation for a toy together with the Declaration of Conformity. See separate BTHA guide concerning Technical Documentation. Application of CE mark Once the Manufacturer has demonstrated conformity, he must apply the CE mark as required by the relevant Directives. 5 Manufacturing (Conformity of Series Production) Manufacturers must have documented procedures to ensure that on-going production continues to conform with the requirements of the Directive. See separate BTHA guide concerning Conformity of Series Production. Third party verification (Module B & Module C) Module B EC-Type examination of the design is covered by Module B of Annex II to Decision No. 768/2008/EC. EC-Type examination cannot be carried out by the Manufacturer. It must be carried out by a Notified Body. Notified Bodies are usually testing organisations appointed by the EU to do this work. More details on notified bodies can be found here: A Manufacturer may submit the toy or a model of the toy, together with supporting Technical Documentation, to a Notified Body for the EC-Type examination. The Notified Body assesses the toy and verifies that the design meets the Essential Safety Requirements and other relevant safety requirements of the Toy Safety Directive. If the toy is in conformity the Notified Body will issue an EC-Type examination certificate. The Notified Body is certifying that the toy complies with the Toy Safety Directive itself unlike simple third party testing in which the laboratory provides test results using the Harmonised Standards. For this reason EC-Type examination can be more involved, costly and it is closely controlled. If, for example, a model of a toy fails to comply with the requirements of the Directive, the Notified Body is required to report that fact to the EU Commission and other Notified Bodies. Module C If a toy has undergone an EC-Type examination, the Manufacturer must also comply with Module C. Module C requires that the Manufacturer ensures that the toys in question are in conformity with the model that was subjected to EC-Type examination.

8 Manufacturers must also ensure manufactured toys are in conformity with the requirements of the Toy Safety Directive. Unlike Module B above, Module C can be done by the Manufacturer and does not require the involvement of a Notified Body. It should be noted however that a Notified Body may specify production control requirements that must be followed. Application of CE Mark Once a Manufacturer has demonstrated conformity, they must apply the CE mark as required by the relevant Directives. Technical Documentation Documentation demonstrating conformity should be held in the Technical Documentation together with the Declaration of Conformity. See separate BTHA guide concerning Technical Documentation. 6

9 Industry support for effective compliance