Federal Institute for Materials Research and Testing (BAM) Pyrotechnics Division 2.3 Explosives D Berlin Berlin,

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1 Federal Institute for Materials Research and Testing (BAM) Pyrotechnics Division 2.3 Explosives D Berlin Berlin, Pyrotechnic Articles Directive 2007/23/EC Information on the Conformity Assessment Procedure for Fireworks of Categories 1, 2, 3 and 4 and for Theatrical Pyrotechnic Articles of Categories T1 and T2 General information As the Directive 2007/23/EC on the placing on the market of pyrotechnic articles was published on May 23 rd of 2007 a new procedure for certifying pyrotechnic articles came into existence. Since October 2008 the BAM Federal Institute for Materials Research and Testing is a notified body for modules B, C, D, E, G, and H for this Directive, and BAM is entitled to conduct the conformity assessment procedure for fireworks of categories 1-4 and for theatrical pyrotechnic articles of categories T1-T2. During the transposition period (ending on 4 July 2010 for fireworks of categories 2 and 3 and ending on 4 July 2013 for fireworks of category 4 and theatrical pyrotechnic articles of categories T1 and T2) differing national regulations for the placing on the market may still exist. Since October 2009 the mentioned Directive is part of the German Explosives Act (called SprengG). German approvals, which have been issued before October 2009, remain valid in Germany until July 3 rd, Concerning such types of articles, where harmonised standards do not yet exist, the national test methods are applied to examine conformity with the requirements of the Directive. Where up to now for the purpose of national approvals some aspects had not been examined, which are however now demanded by the Directive, BAM will make use of suitable or adjusted test methods for this purpose. Current developments as present in the standardisation working groups of CEN will be taken into account. The following standards are applied by BAM: EN (F1-F3), EN (F4), and EN (T1-T2). Before attaching the CE-mark to the article, it is in addition necessary that the manufacturer selects a quality control module (as referred to in Art. 9 of the Directive) for manufactured products and that he lets a notified body inspect quality control. Selection of the quality control module is an indispensable part of the conformity assessment procedure. Costs Testing and other services of BAM are subject to payment which is charged according to the ordinance on fees to the Explosives Act in conjunction with the ordinance on fees of BAM. Time spent on testing and costs for materials will be charged in accordance with the legal prescriptions. The current hourly rate of the division 2.3 Explosives of BAM is 108. Flat rate agreements are beyond what BAM can offer. From the above information it is not possible to estimate actual costs. Therefore the following gives some indications on costs valid for Fireworks of categories 1, 2, 3, and 4 and for theatrical pyrotechnic articles of categories T1 and T2. The figures are based on a rough estimate and former certifications and are applicable where no extraordinary problems occur. In addition, general testing and auditing procedures are described. Information leaflet on pyrotechnic articles according to 2007/23/EC page 1 of 6

2 EC type-examination procedure (module B) Application An application for EC type-examination must include: the name, type and category of the pyrotechnic article, the name and address of the manufacturer, in case of a manufacturer not established in the Community, name and address of an importer; according to Art. 4 of the Directive the importer of the pyrotechnic article must either ensure that the manufacturer has fulfilled his obligations under the Directive, or must assume these obligations himself; where the importer assumes the obligations himself he must present an agreement by the manufacturer, a written declaration that the same application has not been lodged with any other notified body, a statement through which module the quality of the produced pyrotechnic article will be assured (also see below), Information on design, construction and characteristic properties, including detailed chemical composition (mass and percentage of substances used) and dimensions, Suitable instructions and, where necessary, markings in respect of safe handling, storage, use (including safety distances) and disposal in the official language or languages of the recipient Member State, Specification of all devices and accessories needed and operating instructions for safe functioning of the pyrotechnic article. Since March 2013, BAM offers the possibility to carry out EC type-examinations for fireworks of the categories F1-F4 directly in the P.R. China (Liuyang, Hunan). For the application it is suggested to use the standardised application form, which is published on the BAM website as well, and indicate the location of testing in case of fireworks (Germany or P.R. China). In order to perform the EC type-examination we will inform you separately about the number of pyrotechnic articles and the respective shipping address. Future testing effort taking into account recent standardisation work will be similar to former approval testing. Therefore costs can be estimated to range from 1000 to 2700 for each certified article. For theatrical pyrotechnic articles the examination effort will also not change very much and costs can be estimated to lie between 600 and The range of figures is related to the differing complexity of articles, e. g. comparing a sparkler and a 50-shot combination, and further linked to eventually required chemical analysis for forbidden substances. Fireworks of category 4 will usually lead to different efforts. On the one hand, dismantling is not mandatory and fewer articles are required for type testing. On the other hand, product families may be more comprehensive compared to F1-F3 and higher safety measures which have to be taken into account during testing and a larger number of staff may be required. Cost estimation is therefore less exact and the variety of category 4 articles is wider, as well. Even though dismantling is not mandatory during type tests, in some cases, however, it may be necessary in order to verify technical documentation with the actual article or to check for forbidden substances. This would increase the cost estimate. All given costs above are rough estimations based on our experiences in the recent past. They all are based on the hourly rate of 108 /hour and the respective working times. Fixed values of the final costs cannot be defined. BAM follows the harmonised procedures between the Notified Bodies under 2007/23/EC for the grouping of articles in product families. These procedures are published on the homepage of the European Commission: Information leaflet on pyrotechnic articles according to 2007/23/EC page 2 of 6

3 Supervising of quality control modules Contract on assessment of quality control modules The contract on assessment of quality control in accordance with one of the modules (see Art. 9 of the Directive) is the pre-requisite for periodic inspection visits and negotiates rights and duties between applicant and the notified body. Usually the contractual agreement will apply to a range of, or perhaps to all, products of the manufacturer, where the list of products under supervision is placed in an Annex to the contract. Conclusion of the contract leads to singular costs of approximately Technical audits modules D and E Assessment of quality control in accordance with modules D and E requires an inspection at the manufacturer's site and the site, where the end product tests are carried out. Typically the effort ranges from 2 to 4 days depending on number or size of production lines or sites. At the end of the inspection an abbreviated report is issued. Further on a full audit report is drafted in German language (and English, if wanted). Total costs will depend on the audit extent, i. e. whether one or several product families, or one or several production lines are inspected. Expenses for travelling and overnight stays have to be reimbursed as well. Follow-up audits will be held every 2 to 3 years. Shorter inspection intervals are possible under certain circumstances. During re-inspections usually only parts of the quality management system are inspected which leads to lower costs as compared with an initial audit. Module D: Production quality assurance BAM procedure An audit according to module D cannot comprise all generic types of the respective categories, if the company does not have type tested articles of all possible generic types, due to significantly differing production lines of the generic types and articles. BAM applies the following procedure: Definition of scope of audit (categories, generic types and articles) between company and BAM, Review of quality management handbook (QMH) on a document level; before and during audit, QMH should be based on ISO 9001 in general (or other applicable system standards), QMH shall comprise all relevant production steps (such as incoming goods inspections, traceability of initial substances, raw materials, chemicals, intermediate products, in-process inspections etc.) and the necessary test requirements with regard to final article inspection and testing, Number of auditors typically 2 (due to reasons of impartiality and complexity with regard to technical and organisational/legal questions), Check of incoming goods inspections, Check of traceability of initial substances and intermediate products, Check of in-process inspections, Check of sampling abilities (e.g. deviation from ISO possible after adjustment with BAM), Check of final end product testing abilities on test site, Check of nonconformity assessments carried out by the company and procedure on how to handle nonconforming articles/lots, BAM provides a written abridged audit report at the last day of audit, Information leaflet on pyrotechnic articles according to 2007/23/EC page 3 of 6

4 BAM draws up an audit report (incl. actions during audit, observations, and requirements) after the audit according to 2007/23/EC, Annex II, No. 3, 4.3, BAM audits company periodically (typically 2 years, e.g. based on the performance of previous audits, market surveillance etc.) BAM gives out certificate (with a defined time of validity aligned to the expected periodicity of audit and information on the respective categories and generic types and articles included) after the fulfilment of all requirements, if applicable Module E: Product quality assurance -BAM procedure An audit according to module E can comprise all generic types of the respective categories, even if the company does not have type tested articles of all possible generic types, since the batch testing abilities of the respective generic types are checked. BAM applies the following procedure: Definition of scope of audit (categories, generic types) between company and BAM, Review of the QMH on a document level; before and during audit, QMH should be based on ISO 9001 in general (or other applicable system standards) and shall comprise all batch test requirements with regard to final article inspection and testing according to the relevant pyrotechnic article standards (e.g. chapter 10 of EN ), Number of auditors typically 2 (due to reasons of impartiality and complexity with regard to technical and organisational/legal questions), Check of final end product testing abilities according to batch test criteria (e.g. chapter 10 of EN ) on test site, Check of sampling abilities (e.g. according to ISO ), Check of nonconformity assessments carried out by the company and procedure on how to handle nonconforming articles/lots, BAM provides a written abridged audit report at the last day of audit, BAM draws up an audit report (incl. actions during audit, observations, and requirements) after the audit according to 2007/23/EC, Annex II, No. 4, 4.3, BAM audits company periodically (typically 2 years, in dependence on the performance of previous audits, market surveillance etc.), BAM gives out certificate (with a defined time of validity aligned to the expected periodicity of audit and information on the respective categories and generic types included) after the fulfilment of all requirements, if applicable. With regard to Module E only, the following major quality management requirements are significant to BAM: Batch test reports for the pyrotechnic articles in accordance with the respective standards, including all relevant nonconformity assessments for the batch tested items (depending on lot size), List of all necessary test equipments in accordance with the respective standards (incl. proof of calibrations, responsibilities and frequencies of calibrations), Responsibilities in batch testing and assessments must be clearly documented, Procedure on how to handle nonconforming lots and clearance of a conforming lot must described in detail, List of generic types that are involved or envisaged in the future, Standard operation procedures that describe the relevant batch tests in detail (e.g. how an effect height/radial effect distance is measured etc.), Description of how long the test reports are archived and data back-up, Description of sampling procedure of articles before batch testing (e.g. according to the relevant standards such as ISO2859-1, EN , and EN ), Information leaflet on pyrotechnic articles according to 2007/23/EC page 4 of 6

5 Important ISO 9001-aspects like: internal audits, customer complaints handling, supplier evaluation etc., QMH must have date / version numbers and a revision service to keep the documents up-to-date. This list has no claim to completeness, other aspects will be considered, as well. Technical audit module H (for fireworks of the category 4 only) In case module H is to be applied the notified body is not involved in type examination of the pyrotechnic articles. It remains the obligation of the manufacturer to develop under his quality management system only such articles, which are in conformity with the requirements of the Directive. During a technical audit for module H it will be necessary to inspect the quality management system with respect to product development, production, and testing. All three aspects will have to be considered for different product families separately, if the case. The manufacturer must, further on, periodically provide to the notified body all records related to quality control (for details see Annex II of the Directive). Supervision of quality control with module H covers a much larger extent of aspects than compared with the other modules, leading to higher costs. Travel expenses and overnight stays have to be paid in addition, as in other cases. Costs to be expected can be estimated more accurately when detailed data on the number and type of products and the production facilities are communicated. An audit according to module H cannot comprise all generic types of the respective categories, if the company does not have type tested articles of all possible generic types, due to significantly differing production lines of the generic types and articles. BAM applies the following procedure: Definition of scope of audit (generic types, subtypes and articles) between company and BAM, Review of the QMH on a document level; before and during audit, QMH should be based on ISO 9001 and ISO in general, QMH shall comprise the design phase, all relevant production steps (such as incoming goods inspections, traceability of initial substances, raw materials, chemicals, intermediate products, in-process inspections etc.) and the necessary test requirements with regard to final article inspection and testing, Number of auditors typically 2 (due to reasons of impartiality and complexity with regard to technical and organisational/legal questions), Check of design phase, Check of the ability to perform type tests (e.g. thermal and mechanical conditionings etc.), usually according to the standard EN 16261, Check of incoming goods inspections, Check of traceability of initial substances and intermediate products, Check of in-process inspections, Check of sampling abilities (e.g. deviation from ISO possible after adjustment with BAM), Check of final end product testing abilities on test site, Check of nonconformity assessments carried out by the company and procedure on how to handle nonconforming articles/lots, BAM provides a written abridged audit report at the last day of audit, BAM draws up an audit report (incl. actions during audit, observations, and requirements) after the audit according to 2007/23/EC, Annex II, No. 6, 4.3), BAM audits company periodically (typically 2 years, e.g. based on the performance of previous audits, market surveillance etc.) Information leaflet on pyrotechnic articles according to 2007/23/EC page 5 of 6

6 BAM gives out certificate (with a defined time of validity aligned to the expected periodicity of audit and information on the respective categories and generic types and articles included) after the fulfilment of all requirements, if applicable BAM procedure for issuing the registration number: Company hands over the type test report, BAM carries out ESR assessment and issues the assessment report incl. the registration number and all relevant certificate related documents. Further information The Implementation Guide published by the European Commission describing rights and duties of the manufacturer and/or the authorised importer is available at the web-location: Certificates are usually issued in German language or partly bilingual (German and English). The English translation is, however, unofficial and in case of discrepancies between the German certificate and its translation, only the German version is legally binding. In the case a certificate is issued, you will receive the certificate attesting conformity with the requirements of the directive, the two annexes (identification, suitable instructions), a test report including technical annex, and an assessment report. According to the 1 st Ordinance to the Explosives Act requires article 6 (4), pyrotechnic articles must be announced by the manufacturer or importer before the first-time use within the scope of the German Explosives Act to BAM. All suitable instructions according to Annex I no. 3. h) of 2007/23/EC must be sent along with the application. After checking of the application on a document level (no physical tests) and a positive assessment by BAM, an Identification number is issued and published on the corresponding BAM website. This number has to be placed in the German user instructions, except for fireworks of the categories F1 and F4. The additional costs depend on the quality of the submitted certificate related documents and usually range between 100 and 300. In case of further questions please address these to: Lutz Kurth Pyrotechnics Division 2.3 Explosives Tel: lutz.kurth@bam.de Dr. Christian Lohrer Standardisation of Explosives Division 2.3 Explosives Tel: christian.lohrer@bam.de Information leaflet on pyrotechnic articles according to 2007/23/EC page 6 of 6

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