Directive 94/9/EC: Guidelines on the application
10. DOCUMENTS OF CONFORMITY
10.1. Documents issued by the manufacturer
10.1.1. EC Declaration of Conformity
Once the manufacturer has undertaken the appropriate procedures to assure conformity with essential requirements of the Directive it is the responsibility of the manufacturer or his authorised representative established in the EU to affix the CE marking and to draw up a written EC declaration of conformity.
The manufacturer or his authorised representative established within the EU keeps a copy of this EC declaration of conformity for a period of ten years after the last equipment has been manufactured.
Where neither the manufacturer nor his authorised representative is established within the EU, the obligation to keep the copy of the EC declaration of conformity available is the responsibility of the person who places the product on the EU market.
In respect of the Notified Bodies possibly involved in the conformity assessment procedure the EC declaration of conformity must contain, where appropriate, the name, identification number and address of the Notified Body and the number of the EC-type-examination certificate. The name and address of a Notified Body involved in the production phase, where relevant, is not a mandatory requirement.
As far as assemblies of ATEX equipment are concerned, if an assembly is to be treated as a new item of ATEX equipment the EC declaration of conformity needs only to identify the unit and the related information. Details of the items of equipment making up the assembly will be included on the technical file. However, there is a duty on all those in the supply chain to pass on the relevant information relating to the items of equipment where these have been previously placed on the market accompanied by their own EC declaration of conformity and instructions.
Annex X.B of the Directive states what the EC declaration of conformity must contain. Further information can be found in section 5.4 of the "Blue Guide". As a general rule, the content of the EC declaration of conformity contains the following:
a) Name or identification mark and the address of the manufacturer or his authorised representative in the Community
Straightforward, noting that the name on the product places the named organisation in the position of manufacturer (or authorised representative)
b) A description of the equipment, etc.
A descriptive product designation e.g. Motor Control Unit Type ABC 123 and its intended use.
c) All relevant provisions fulfilled by the equipment, etc.
The marking included on the product e.g. Equipment Group II, category 2 G (IIB T4).
d) Where appropriate, the name, identification number and address of the Notified Body and the number of the EC-type examination certificate
Name and number of the Notified Body (or Bodies) conducting the EC-type examination.
e) Where appropriate, reference to the harmonized standards
f) Where appropriate, the standards and technical specifications used
The harmonised standards quoted in the technical documentation file should be listed here.
Other standards and technical specifications quoted in the technical documentation file should be listed here
g) Where appropriate, references to other Community Directives which have been applied
If this is a multi-directive declaration, it should already be clear from the heading which Directives the product conforms to.
h) Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer, etc.
he signatory needs to be a responsible officer of the manufacturer or of the authorised representative.
10.1.2. Written Attestation of Conformity for Components
The EC declaration of conformity should not be confused with the written attestation of conformity for components mentioned in Article 8(3) of Directive 94/9/EC. In addition to declaring the conformity of the components with the provisions of the Directive, the written attestation of conformity has to state the characteristics of the components and how the components are to be incorporated into equipment or protective systems to ensure that the finished equipment or protective system meets the applicable Essential Health and Safety Requirements of Directive 94/9/EC.
10.1.3. Documents accompanying the product
According to Articles 4(2) and 5(1) of Directive 94/9/EC and for the purposes of market surveillance the EC Declaration of Conformity / the written Attestation of Conformity must accompany the information given with each single product, or each batch of identical products delivered for the same end user.
The product is also accompanied by instructions for safe use (see EHSR 1.0.6 of Annex II to the ATEX Directive 94/9/EC). The manufacturer shall provide to the user written instructions that include the necessary information for repair, maintenance and/or overhaul of the equipment concerned. The manufacturer does not have to provide the full technical file.
The user takes into account the instructions issued by the manufacturer to carry out repair, maintenance and/or overhaul on the basis of the requirements of the applicable directives (as 2009/104/EC - Use of work equipment by workers at work and 1999/92/EC - Protection of workers potentially at risk from explosive atmospheres) and of relevant specific national legislation that regulates the repair, maintenance and overhaul of used equipment. The instructions must contain drawings and diagrams necessary for repair of the equipment. Applicable and technically accepted standards can also be used, for example EN 60079-19 - Explosive atmospheres - Equipment repair, overhaul and reclamation.
However, where necessary, the manufacturer can include in his documentation a statement that specific repair, maintenance and/or overhaul of the equipment shall only be conducted by the manufacturer himself, or by a repairer he has qualified or authorized.
With respect to assemblies, it is important to the safe installation, operation and maintenance of the assembled unit that all relevant information is passed to the end user. The manufacturer of the assembled unit should do this by including all related information in a package supplied to the end user
10.1.4. Retention of documentation - Quality assurance
According to Annex IV, paragraph 5 of the ATEX Directive 94/9/EC the manufacturer, or where relevant, the authorised representative or importer) shall, for a period ending at least 10 years after the last piece of equipment was manufactured, be able to make available to the national authorities:
- the documentation of the quality system;
- updating of the quality system;
- audit reports and certificates of the Notified Body.
Larger organisations have a certified quality management system according to the ISO 9000 standards. For these manufacturers it is recognised that it is difficult to keep all quality documents and all changes to the quality system for a such a long period. It is the opinion of the ATEX Standing Committee that the requirements in Annex IV, paragraph 5 of the ATEX Directive 94/9/EC are fulfilled if the manufacturer keeps at the disposal of the national authorities at least the actual quality management system documents + the following documents which have to be kept for a period ending at least 10 years after the last piece of equipment was manufactured:
- audit reports and certificates of the ISO 9000 certifier. This will be one or two audit reports per year that include the actual state at that moment of the quality system with changes;
- audit reports and notifications of the Notified Body that issued the Production Quality Assurance Notification.
The above consideration is against the background that this documentation shall always be sufficient so as to enable surveillance authorities to determine that the relevant conformity assessment procedure(s) was / were applied in a satisfactory manner and that the relevant obligations of the ATEX Directive 94/9/EC were fulfilled.
10.1.5. Acceptance of test results of manufacturers by a notified body
Test reports can be a part of the technical documentation the manufacturer has to present to the notified body and the latter may take them into consideration appropriately.
Concerning safety relevant aspects in connection with Annex III (EC-type examination) and Annexes V (Product verification) and IX (Unit verification) to directive 94/9/EC, a notified body's independent and transparent intervention vis-à-vis the client and all interested parties (e.g. Member States, European Commission, manufacturers, notified bodies) is required legally. Therefore a notified body only may accept test reports of manufacturers under certain conditions. The requirements included in the standard EN ISO/IEC 17025:2005 "General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)" shall be used as basis for acceptance of test results.
The notified body has to state the acceptance of test results in his test report.
In any case the notified body remains fully responsible for accepted test results and for the EC-Type Examination Certificate (Annex III) or Certificate of Conformity (Annexes V and IX) based on them.
10.2. Documents issued by the Notified Body
The Notified Body issues the following documents according to the provisions of the relevant conformity assessment procedures:
- EC type examination certificate;
- product and production quality assurance notification;
- conformity to type notification;
- product verification, certificate of conformity;
- unit verification, certificate of conformity.
These documents need not accompany the product.
It is not possible to issue an EC-Type Examination Certificate for products of category 2 nonelectrical equipment and of category 3, as mentioned in Article 8(1)(b)(ii) and 8(1)(c). Further, it is also not permissible to list such goods on an EC-Type examination certificate issued for goods of categories other than these. This is because an EC-Type examination certificate is an attestation that the goods listed on it have undergone the necessary conformity assessment procedures that result in the issuing of an EC-Type examination certificate; it is not necessary for such goods to undergo such conformity assessment procedures.
Where a single item is covered by more than one Category, it may be permissible to issue an EC-Type Examination certificate. Under such circumstances, these items need to comply with the highest applicable conformity assessment requirements (see section 8.1). If this requirement results in an EC-Type Examination certificate being issued, these goods are permitted to be listed on an EC-Type Examination certificate.
A typical example of this is found in the semiconductor fabrication industry where a high vacuum pump is used to extract hydrogen but cannot meet the physical clearances necessary to justify Category 2. Category 3 is adequate for the process as the pump is normally filled with pure hydrogen at low pressure, so there is no ignition risk except during the very brief transitions between operation and non-operation.
In this case, it is only the electrical part that is truly subject to EC-Type Examination but it is already established that a mechanical part can be considered along with the electrical part if they are integral with each other, rather than a mere assembly.
In such cases, it is not unreasonable to mention such items in the same set of documentation i.e. the goods have an EC-Type examination certificate issued for them.
However, where the goods are discrete items e.g. two different type categories of a hand-held radio, one of which is Category 2 and the other Category 3, a single EC-Type examination certificate should never be issued; the Category 3 goods should be listed on a separate document that in no way implied it was an EC-Type examination certificate. The same should be true for components of items.
However, the voluntary issue of a certificate for goods that are not permitted to be listed on an EC-Type Examination certificate is possible. The certification body may not give an indication on the certificate that it is a notified body because it would not be acting in that capacity. Therefore, the number of the notified body must not be affixed. Further, it is not permissible to affix the CE marking to such certificates. There is no objection for the hexagon (Ex mark) to be used or to make reference to the directive 94/9/EC.
Provision of evaluation and test results with EC-Type ExaminationCertificates: although being a separate document, the report describing how the equipment fulfils the Essential Health and Safety Requirements of the Directive is considered to be integral to the provision of a certificate. Evaluation and test results supporting the decision to issue a EC-Type Examination Certificate should accompany the certificate from the Notified Body to the manufacturer.
10.3. EC Type Examination Certificate and the responsibilities of stakeholders
A Type Examination Certificate attests that a specimen (including instructions, as appropriate) representative of the production envisaged by the manufacturer fulfils the relevant applicable provisions of the Directive, in particular the Essential Health and Safety Requirements (EHSRs).
The question arises as to the actions that need to be taken when the "generally acknowledged state of the art" has developed. It is clear that the original specifications applied may continue to show fulfilment of the EHSRs and the Type Examination Certificate then remains valid.
However, over time the "generally acknowledged state of the art" can develop substantively such that the specifications originally applied no longer ensure the type examined complies with the EHSRs. It should be noted that the question of whether there has been substantive development of the state of the art is not left to discretionary interpretation by the Notified Body, but has equally to be generally acknowledged by the technical community of the stakeholders. The publication of a revised harmonised standard would be one way to recognise a development in the state of the art: in this case, the responsible European Standardisation Organisation (ESO) shall determine whether the state of the art concerning the EHSRs has changed, and if so, in what respects. The ESO shall indicate this in the foreword of each standard.
In such cases, if the specifications and evaluation criteria originally applied to a product no longer ensure that it complies with the latest state of the art, the Type Examination Certificate is no longer valid and further action is required. Given reasonable transition periods and knowledge of current developments, it is expected that the manufacturer will have sufficient time to contact a Notified Body to undertake the necessary re-evaluation so that there is a smooth transition from one set of applied specifications to another. Notified Bodies, who are expected to maintain a good knowledge of developments in the state of the art, should make arrangements to alert the holders of their EC-Type Examination Certificates to the revision of harmonised standards.
It should be noted, however, that the issuing of a new Type Examination Certificate will have no retroactive effect and, therefore, will not affect products placed on the market and/or put into service whilst the manufacturer was in possession, where appropriate, of a valid Certificate.
It should also be re-affirmed that the overall responsibility for compliance of the product rests with the manufacturer who, where required, must ensure that a valid Certificate is in his possession, as well as that all relevant conformity documents correspond to the current state of the art. In parallel, the Notified Body must provide all the relevant information for the manufacturer in order to ensure that the existing Certificate is correct in its evaluation that the type continues to meet the EHSRs.
See Annex IV paragraph 1, Annex V. paragraph 2, Annex VI paragraph 1, Annex VII paragraph 1, Annex VIII paragraph 1, Annex IX paragraph 1 of the Directive.