Change of EC-Type Approval Certificates from the "old" to the "new" Machinery Directive 2006/EC/42

From December 29, 2009 on the currently valid European Machinery Directive 98/37/EC will be replaced by the Directive 2006/EC/42.

With this Directive changes will be effective and will have an influence on existing EC-Type Approval Certificates, which have been issued in the past for safety components as listed in Annex IVB of Directive 98/37/EC.

The business area Automation, Software and Information Technology (ASI) of TÜV Rheinland Industrie Service GmbH is accredited as Test Laboratory for the following safety components of Annex IVB.

• Electro-sensitive devices designed specifically to detect persons in order to ensure their safety,
• Logic units which ensure the safety functions of two-hand control devices,
• Automatic moveable screens to protect the presses with manual loading or unloading.

The type of safety components, for which in the future an EC-Type Approval Certificate will be issued after a successful EC-Type examination, has been increased. The new Machinery Directive lists the following safety components in annex IV for which a special admission procedure is required and for which our business unit ASI is also accredited as Test Laboratory:

• Protective devices designed to detect the presence of persons,
• Power-operated interlocking moveable guards designed to be used as safeguards in machinery with manual loading or unloading,
• Logic units to ensure safety functions.

The scope of accreditation according to the Directive 98/37/EC is included to the new Directive 2006/EC/42; meaning safety components, which according to the "old" MD required a EC-Type Approval Certificate, also need to have a corresponding certificate according to the "new" MD. The existing  EC-Type Approval Certificates have to be updated for the new MD accordingly.

Further changes in the new MD have the following effects on the certification:

• The validity of the EC-Type Approval Certificate is limited to 5 years. After expiration of the 5 years, a renewal of the validity can be done, provided that no changes of the product have been made regarding the tested model and that the standards taken as basis for testing have not been changed in the meantime. Should this not be the case, a re-examination of the product has to be performed before a renewal of the certificate can be done.

• The manufacturer is obliged to build his product always according to the technical state-of-the-art which is defined by the current valid standards. Accordingly, every change of the product and every amendment in the standards leads to a re-examination and a re-issue of the EC-Type Approval Certificate.

Due to the reason that there is no transition period from the old to the new MD during which both Directives are valid, the following procedures within the business area ASI of TÜV Rheinland have been established, which assure that every manufacturer of safety components, who possesses a EC-Type Approval Certificate from TÜV Rheinland, will obtain a valid certificate according to the new MD by December 29, 2009 at the latest.

1. Every holder of an EC-Type Approval Certificate will receive by June 2009 a list of all EC-Type Approval Certificates for safety components which have been issued for him by TÜV Rheinland in the past.
   
   
2. The holder sends us a list of the products back, for which a new EC-Type Approval Certificate according to the new MD shall be issued. An official application for each product has to be done.
   
   
3. Alternatively the new EC-Type Approval Certificate can be issued already now (prior to December 29, 2009) or on December 29, 2009.
   
   In the first case, the EC-Type Approval Certificate contains the confirmation that the product meets "the requirements according to Annex I of Directive 98/37/EC of the European Parliament and the Council of 22 June 1998 on the approximation of the laws of the member states relating to machinery as well as of the Directive 2006/42/EC of 17 May 2006 on machinery and amending Directive 95/16/EC(recast)".
   In the second case it will be confirmed on the EC-Type Approval Certificate that the product meets "the requirements according to Annex I of Directive 2006/42/EC dated May 17, 2006 on machines".
   
   
   
4. Prerequisite for the issue of a new EC-Type Approval Certificate is that the product (safety component) has been tested according to relevant presently valid product standards (latest versions) and according to the new harmonized Standards for Functional Safety of Machines (EN ISO 13849-1 and/or EN 62061). Should these examinations not be available, supplementary or re-examinations have to be carried out before the certificate can be issued acc. to the new MD.

As these prerequisites for many of the older products are often not fulfilled the owner of the certificate or manufacturer of the product should contact our Test Institute at TÜV Rheinland in due time in order that the supplementary or re-examinations can already be carried out now and soonest. This is in order to avoid the risk that the new issue of EC-Type Approval Certificate until December 29, 2009 cannot be done because of missing prerequisites and he has no valid EC-Type Approval Certificate for his product from this date.

Contact and further Information

Dipl.-Ing. Stephan Häb

Tel.: + 49 - 221 - 806 1822