EU Commission revises 700 Old Approach directives and 27 New approach Directives
The Package of measures known as the “New legislative framework” was published in the Official Journal on 13 August 2008. The measures are designed to help the internal market for goods work better and to strengthen and modernize the conditions for placing a wide range of industrial products on the EU market.
The target of the New Legislative Framework is:
- Improve market surveillance rules to better protect consumers and professionals from unsafe products
- Boost the quality of the conformity assessment of products
- Clarify the meaning of CE marking
- Define roles of economic operators
The New Legislative framework is composed by Regulation 764/2008 on national technical rules (New Mutual Recognition Regulation), Regulation 765/2008 on requirements for accreditation and market surveillance and Decision 768/2008/EC on a Common Framework for the marketing of products.
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Regulations |
Decision |
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| Applicable 1 January 2010 | Basis for future legislation |
For Which Products?
- All products covered by Community harmonization legislation
- “Product” means: substance, preparation or good produced through a manufacturing process
- …unless specific provisions already exist
- Excluded: food, feed, living plants and animals, products of human origin.
What changed?
Here is the summary of the changes these documents provide:
- Stricter safety rules for all consumer products and for specific product groups (toys, electrical appliances, etc.).
- Clearer definitions and obligations for different economic operators: manufacturers, authorized representatives, importers and distributors.
- Better identification & traceability throughout the supply chain.
- Establishment of a general framework for market surveillance of products.
- Identification of requirements for Conformity Assessment Bodies.
- More flexibility to restrict dangerous products across the EU in a timely and consistent manner and control on products coming from 3rd countries.
Obligations of the economic operators:
- Manufacturer having detailed knowledge of the design and production process, the manufacturer is best placed to carry out the complete conformity assessment procedure. Conformity assessment should therefore remain the obligation of the manufacturer alone.
Obligations of the manufacturer include:
- Drawing up the required technical documentation and carry out the conformity assessment procedure
- Drawing up the EC Declaration of conformity and affixing the CE Marking
- Keep the technical documentation available to competent authorities
- Ensure incidents follow-up and cooperate with competent Authorities on market surveillance activities.
2. Authorized Representative’s obligations:
- Keep the EC Declaration of Conformity and the technical documentation at the disposal of national surveillance authorities.
- Provide the Competent Authority with all the information and documentation to demonstrate the conformity of a products.
- Cooperate with the Competent Authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.
- Importers and Distributor’s obligations:
- Importers and Distributors shall only place compliant products on the Community market.
- Ensure the appropriate conformity assessment has been carried out before placing the product on the market.
- They should be involver in market surveillance:
i. Provide information to Competent Authorities
ii. Investigate complaints and follow-up on incidents
iii. Take the necessary corrective measure in case of non conform product placed on the market
New Legislative Package overview
| Legislative Text | Scope | Role of the E.A.R |
| Regulation 764/2008 | Default application When no specific sectorial legislation applicable |
Counterpart of CA decision for manufacturer established outside the EU |
| Regulation 765/2008 | Default application When no specific sectorial legislation applicable |
Act on behalf of the manufacturer in relation to specified tasks |
| Decision 768/2008 | Horizontal framework for sectorial products harmonization legislation | Gather and keep technical documentation and interact with CA |
The proposed legislation dictates actions against businesses that ignore the rules in a way which will be taken consistently in all EU countries. If manufacturers will know the same rules apply everywhere, they will be more likely to comply but also, more likely to expand their activities in other European countries.
Importers and Non-EU manufacturers will need to come together to allow all economic operators to maintain their scope of activities and their operations in Europe – this, with the support of a neutral party, such as an Authorized Representative.
To know more about the proposed package on general product safety, contact us.