Use of CE Marking and Market Surveillance

Regulation 765/2008 which came into force last January 2010 treats various issues including:

• Requirements for accreditation bodies and the accreditation framework;
• Market Surveillance framework;
• Use of the CE mark
• Controls on products entering the EU including the prohibition of entry into the market of dangerous products.

The criteria relating to Market Surveillance and use of the CE mark as far as Products that fall within the remit of the Malta Standards Authority are effectively already in force as they are already implied from the existing CE marking legislation.  The intention of the regulation is to clarify these criteria and ensure their implementation at a European level.

Use of the CE mark:

Article 30 of Regulation 765/2008 mandates that:

1. The CE mark can only be affixed by the manufacturer or the authorized representative;

2. The CE mark can only be affixed to products that are covered by the applicable legislation ;

3. The CE mark shall not be affixed to products which are not covered by any directives listed in point 2 above;

4. The CE mark is a declaration by the manufacturer that he has complied with the requirements of the applicable Directive(s) (listed in point 2 above) ;

5.  The affixing of marks that may be mistaken for the CE mark are prohibited;

6. Other markings may not impair the visibility of the CE mark.

Market Surveillance framework

Market surveillance would now be harmonized as a result of this regulation. Amongst others the following which are part of MSA's remit as far as the Product Safety Act is concerned (in relation to products covered by harmonized EU legislation) are addressed:

1. Complaints by all users related to product safety or non-compliance with product related legislation should be followed;

2. Monitor accidents which are caused by products;

3. Market Surveillance programs are to be drawn;

4. Users are to be alerted on dangerous products;

5. Cooperation with economic operators;

6. Periodic assessment of market surveillance activities;

7. Banning of dangerous products even if the effect is not immediate;

8. Exercise the principle of proportionality;

9. Measures taken against a product are communicated to the relevant economic operator;

10. The economic operator is informed on the remedies available;

11. Give the economic operator the opportunity to be heard;

12. Allow the economic operator to take effective action;

13. Enhance exchange of information on non-compliant products between member states;

The above applies both to products intended for consumers and products intended to be used by non-consumers.

The text of the regulation 765/2008/EC may be found at: http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/

Kindly contact Ing Joseph Micallef on 23952221 or if you require further information by 2 August 2010.