Single market for goods New Legislative Framework
ATEX Directive: 94/9/EC
The ATEX Directive will be updated as part of the new legislative framework alignment. This is intended to bring together the different New Approach Directives so that they use common terms and also use the same conformity assessment process. There are also clearer requirements for manufacturers to co-operate with enforcement bodies to assist in preventing non-compliant products from reaching the market.
The result of this is that all certificates, instructions and declarations will require updating with the new Directive number. Certificates will also change from 'EC Type Examination' to 'EU Type Examination' Manufacturers are expected to have several years to implement the changes needed to documents and will be able to update certificates as they require modification, however, it is expected that the market will start to insist that certificates are updated.
The European Commission state – “Implementation still remains a work in progress because effective coordination and cooperation between national authorities require, to allow market surveillance and imports control make their effects felt, permanent and continuous work, much more than an action limited in time. Measures which have been and are currently being put in place are therefore established to manage the infrastructures and ensure cooperation over time”.
For more information refer to the Europa website:
Main elements of the changes
The proposal introduces harmonised definitions of terms which are commonly used throughout Union harmonisation legislation and should therefore be given a consistent meaning throughout that legislation.
Obligations of economic operators and traceability requirements
The proposal clarifies the obligations of manufacturers and authorised representatives and introduces obligations for importers and distributors. Importers must verify that the manufacturer has carried out the applicable conformity assessment procedure and has drawn up a technical documentation. They must also make sure with the manufacturer that this technical documentation can be made available to authorities upon request. Furthermore importers must verify that the products are correctly marked and accompanied by the required documents, instructions and safety information. They must keep a copy of the Declaration of Conformity and indicate their name and address on the product, or where this is not possible on the packaging or the accompanying documentation. Distributors must verify that the product bears the CE marking, the name of the manufacturer and of the importer, if relevant, and that it is accompanied by the required documentation and instructions. Importers and distributors must cooperate with market surveillance authorities and take appropriate actions when they have supplied non-compliant products.
Enhanced traceability obligations
These are introduced for all economic operators. Products have to bear the manufacturer’s name and address and a number allowing to identify and link the product to its technical documentation. When a product is imported the importer’s name and address must also be on the product. Furthermore every economic operator must be able to identify towards authorities the economic operator who has supplied him with a product or to whom he has supplied a product.
Compliance with harmonised standards provides a presumption of conformity with the essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation on European Standardisation that sets out a horizontal legal framework for European standardisation. The proposal for the Regulation contains inter alia provisions on standardisation requests from the Commission to the European Standardisation Organisations, on the procedure for objections to harmonised standards and on stakeholder participation in the standardisation process. Consequently the provisions of Directive 94/9/EC which cover the same aspects have been deleted in this proposal for reasons of legal certainty. The provisions conferring presumption of conformity to harmonised standards have been modified to clarify the extent of the presumption of conformity when standards only partially cover the essential requirements.
Conformity assessment and CE marking
Directive 94/9/EC has selected the appropriate conformity assessment procedures which have to apply in order to demonstrate that their products comply with the essential health and safety requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision. Sector specific elements of the procedures have been maintained. General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while the detailed provisions on the affixing of the CE marking and the specific marking of explosion protection to products have been inserted in this proposal.
The proposal reinforces the notification criteria for notified bodies. It clarifies that subsidiaries or subcontractors must also comply with the notification requirements. Specific requirements for notifying authorities are introduced, and the procedure for notification of notified bodies is revised. The competence of a notified body must be demonstrated by an accreditation certificate. Where accreditation has not been used to evaluate the competence of a notified body, the notification must comprise the documentation demonstrating how the competence of that body has been evaluated. Member States will have the possibility to object to a notification.
Market surveillance and the safeguard clause procedure
The proposal revises the existing safeguard clause procedure. It introduces a phase of information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant product is found. A real safeguard clause procedure leading to a Decision at Commission level on whether a measure is justified or not is only launched when another Member State objects to a measure taken against a product. Where there is no disagreement on the restrictive measure taken, all Member States must take the appropriate action on their territory.
Published in Valve User Magazine Issue 22
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