Bundesanstalt für Materialforschung und -prüfung (BAM) Pyrotechnics Division 2.3 Explosives D -12200 Berlin Berlin, 2015-09-04 Pyrotechnic Articles Directive 2013/29/EU Information on the Conformity Assessment Procedures for Fireworks of Categories F1-F4 and for Theatrical Pyrotechnic Articles of Categories T1 and T2 General information The Bundesanstalt für Materialforschung und prüfung (BAM) is a notified body under the Directive 2013/29/EU for all applicable modules B, C2, D, E, G, and H. BAM is entitled to conduct the conformity assessment procedures for fireworks of the categories F1-F4 and for theatrical pyrotechnic articles of the categories T1-T2. Within the conformity assessment procedures, the latest versions of the applicable standard series are the preferred testing and assessment principles: EN 15947 (F1-F3), EN 16261 (F4), and EN 16256 (T1-T2). 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 the categories F1-F4 and for theatrical pyrotechnic articles of the categories T1-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. EU-type examination procedure (module B) Application An application for EU-type examination must include (refer to 2013/29/EU Annex II, Module B no. 3): (a) the name and address of the manufacturer; (b) a written declaration that the same application has not been lodged with any other notified body; (c) the technical documentation. The technical documentation shall make it possible to assess the pyrotechnic article s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture Information leaflet on pyrotechnic articles according to 2013/29/EU page 1 of 6
and operation of the pyrotechnic article. The technical documentation shall contain, wherever applicable, at least the following elements: (i) a general description of the pyrotechnic article; (ii) conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.; (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the pyrotechnic article; (iv) a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements of this Directive including a list of other relevant technical specifications applied. In the case of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; (v) results of design calculations made, examinations carried out, etc.; (vi) test reports; (d) the specimens representative of the production envisaged. BAM may request further specimens if needed for carrying out the test programme; (e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. NOTE: BAM offers the possibility to carry out EU-type examinations for articles of the categories F1- F4 and T1-T2 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 (Germany or P.R. China). In order to perform the EU-type examination we will inform you separately about the number of pyrotechnic articles and the respective shipping address. The actual tests in this case are carried out by the audited company International Quality Assurance BV (Int l QA) - Liuyang Representative Office under strict surveillance of BAM personnel. Costs can be estimated to range from 1000 to 2700 for each certified article. The range of figures is related to the differing complexity of articles, e. g. comparing a sparkler and a 50-shot combination, the number of family variants (if any) and is 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 personnel 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 2013/29/EU for the: Information leaflet on pyrotechnic articles according to 2013/29/EU page 2 of 6
grouping of articles in product families, guidance for conformity assessment procedures, and contents of certificates documentation and technical data sheets. These procedures are published on the homepage of the European Commission: http://ec.europa.eu/enterprise/sectors/chemicals/documents/specific-chemicals/pyrotechnicarticles/index_en.htm Supervision 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. 17 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 either placed in an Annex to the contract or is part of the quality management handbook. Conclusion of the contract leads to singular costs of approximately 100-450. 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 a draft report is issued. Further on an official audit report is issued in German or English language. 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 for two auditors from BAM have to be reimbursed, as well. Follow-up audits will typically be held every 2 years. Other inspection intervals are possible under certain circumstances. During re-inspections only relevant parts of the quality system are inspected which leads to lower costs as compared with an initial audit. Module D: Production quality assurance BAM procedure 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, inprocess 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, Information leaflet on pyrotechnic articles according to 2013/29/EU page 3 of 6
Check of sampling abilities (e.g. deviation from ISO 2859-1 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 draft audit report at the last day of audit, BAM draws up an audit report (incl. actions during audit, observations, and requirements), 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 15947-5), 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 15947-5) on test site, Check of sampling abilities (e.g. according to ISO 2859-1), Check of nonconformity assessments carried out by the company and procedure on how to handle nonconforming articles/lots, BAM provides a written draft audit report at the last day of audit, BAM draws up an audit report (incl. actions during audit, observations, and requirements), 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 system requirements are significant to BAM: Information leaflet on pyrotechnic articles according to 2013/29/EU page 4 of 6
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 or the applicable category standards), 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 upto-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 17025 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, Information leaflet on pyrotechnic articles according to 2013/29/EU page 5 of 6
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 2859-1 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 draft audit report at the last day of audit, BAM draws up an audit report (incl. actions during audit, observations, and requirements), 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 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 Certificates are usually issued in German or English 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. In case of further questions please address these to: Lutz Kurth Pyrotechnics Division 2.3 Explosives Tel: 030-8104-1234 email: lutz.kurth@bam.de Dr. Christian Lohrer Standardisation of Explosives Division 2.3 Explosives Tel: 030-8104-3249 email: christian.lohrer@bam.de Information leaflet on pyrotechnic articles according to 2013/29/EU page 6 of 6