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Produto: Madeira

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The main purpose of technical harmonisation within the EU is to remove technical barriers which may result from diverging technical standards in the Member States.

New approach Directives vs. Old Approach Directives

Council Resolution of 7 May 1985 (OJ C-136 04/06/1985) laid down a new approach to technical harmonisation and standards, which limits public intervention to what is essential and leave business and industry the greatest possible choice on how to comply with the essential requirements.

The main idea is to establish general rules (essential requirements) which are applicable to sectors or families of products, as well as types of hazard. This avoids the lengthy decision-making procedures which, in the past, established technical harmonisation through very technical and detailed product-specific directives which were difficult to implement (Old Approach Directives).

New approach principles:
The legislative harmonisation (directives) is limited to the essential requirements that products must meet when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)
The technical specifications of products meeting the essential requirements may be laid down in harmonised standards drawn up by three independent standardisation bodies: European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (CENELEC) and European Telecommunications Standards Institute (ETSI)
The application of harmonised or other standards remains voluntary for manufacturers, but products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements
Each Member State has designated notified bodies in charge of the conformity assessment procedures when a third party is required
Conformity assessment procedure

EU legislation establishes a range of procedures for assessing the conformity of products to the essential requirements laid down by the technical harmonisation directives.

Conformity assessment is either carried out by the manufacturer or a by a third party (notified body) and relates to the design phase of products, their production phase or both.

There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production; full quality assurance, etc.

Council Resolution of 21 December 1989 (OJ C-010 16/01/1990) sets up guiding principles for a reliable EU policy on conformity assessment, such as:

Generalised use of the European standards relating to quality assurance
Mutual recognition agreements between the EU and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment
The CE conformity marking

As a general rule, all New Approach directives provide for the affixing of the CE marking, which indicates that the product complies with the essential requirements of all applicable directives and that has been subject to the corresponding conformity assessment procedure.

It has a single form consisting of the CE mark and of the identification number of the notified body involved in the production control phase when a third party is required
It is affixed to the product itself, to its packaging or to the accompanying document;
It enables the product in question to be placed on the EU market.
Market surveillance

Each Member State establishes the authorities responsible for checking that products placed on the market meet the requirements and that the affixing and use of the CE marking is correct. Surveillance may consist in documentary checks and/or physical inspections.

Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for carrying out the required conformity assessment procedure.

Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or are not accompanied by the required documentation.

12. Packaging

Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers.

Hence, these type of products are affected by:

General requirements related to packaging and packaging waste, laid down in Directive 94/62/EC (OJ L-365 31/12/1994);
Specific provisions related to package sizing, established in Directives 75/106/EEC (OJ L-42 15/02/1975) and 80/232/EEC (OJ L-51 25/02/1980);
Special rules for materials and articles intended to come into contact with foodstuffs, covered by Regulation (EC) 1935/2004 (OJ L-338 13/11/2004).
Besides these mandatory provisions, imports into the European Union (EU) of packaging made of wood and other plant products may be subject to phytosanitary measures established by Directive 2000/29/EC (OJ L-169 10/07/2000).

13. Labelling

1. Labelling requirements

In view of consumers protection only products which comply with the EU labelling requirements may be marketed within the EU.

The EU legislation establishes mandatory labelling standards for specific sectors, such as foodstuffs, household appliances, footwear, textiles, etc.

Further information:

http://europa.eu.int/scadplus/leg/en/s16400.htm

2. EU Eco-label

The EU Eco-label or Flower logo is a voluntary scheme that may be awarded to products which contribute significantly to improvements in relation to key environmental aspects and provide simple and accurate guidance to consumers on the environmental impact of products.

Eco-label criteria are specifically established according to different product groups (e.g. textiles, footwear, cleaning products, household appliances, paper products...).

The Flower logo can be displayed as a marketing tool to show consumers that product has a superior environmental quality compared with other products in the same group.

Manufacturers, importers, service providers, traders or retailers may apply for the Eco-label to the competent body of the Member State in which the product has been placed on the market. The application must include all relevant documentation.

The basic rules for Eco-labelling are established in Regulation (EC) No 1980/2000 (OJ L-237 21/09/2000).

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