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Produto: Diversos (Agosto/2012)
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Informações:
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Temas Horizontais:
Embalagens
Diretiva 2007/45/EC: Diretiva 2007/45/EC - estabelece as regras relativas às quantidades nominais dos produtos pré-embalados, revoga as Diretivas 75/106/CEE e 80/232/CEE e altera a Diretiva 76/211/CEE.
Resumo das legislações sobre embalagens
Sistema Ponto Verde
Este sistema representa todos os tipos de atividades envolvidas na chamada cadeia de embalagens e cobre, sobretudo, 6 materiais específicos de embalagens: papel/cartão, vidro, plástico, aço, alumínio e madeira.
A sociedade Ponto Verde possui a seguinte base legal:
Decreto-Lei nº 366-A/97
Portaria nº29-B/98
Decreto-lei nº 162/2000
Outros links importantes sobre o Ponto Verde:
Site Oficial do Packaging Recovering Organisation Europe
Produtos Específicos:
1- Aparelho Médico
Os dispositivos médicos estão cobertos, respectivamente, pelas Directiva 93/42/CEE - Dispositivos Médicos (dental cements and fillings), e Directiva 2003/32/CE - Dispositivos médicos que incorporam/usam substâncias de origem animal.
A avaliação da conformidade é feita pelos Organismos Notificados (designação, competência e monitorização descritas/reguladas nas Directivas).
Chama-se atenção para o fato de, no mercado Comunitário, surgical catgut não se encontrar disponível. Um Estado Membro introduziu uma cláusula de salvaguarda (Artigo 8, Directiva 93/42/EEC), outros introduziram o Princípio de Precaução (Special Health Monitoring Measures, Article 14b Directive 93/42/EEC, emendada através da Directiva 98/79/EC).
No seguimento destes procedimentos, e de forma VOLUNTÁRIA, todos os fabricantes/distribuidores retiraram esses produtos do mercado Europeu.
É claro que, para este tipo de produtos, existem alternativas involvendo um grau de risco muito menor.
A política da União Europeia é a de promover um alto nível de protecção da saúde e se a sua intervenção fosse requerida (em alternativa à voluntaridade verificada), em concerto com os Estados Membros, seria possível, de forma obrigatória, retirar esses produtos do mercado.
2- Instrumentos de Medição
http://ec.europa.eu/enterprise/prepack/ms_inst/index_measin_en.htm
3- Isqueiros
Cigarette lighters and other lighters are covered by the General
Safety of Products Directive 2001/95/CE (Directive 2001/95/CE ).
4- Manômetro
Manometers - by their very purpose - are pressure equipment. If they are exposed to a pressure above 0,5 bar, they are in principle (i.e. subject to the exclusions listed in the text of the Directive) covered by the Pressure Equipment Directive. You can find more information on the Pressure Equipment Directive at the Commission website under the Address:
http://ec.europa.eu/enterprise/pressure_equipment/ped/index_en.html
5- Material de laboratório de polipropileno
A Directiva 98/79 alterada pelos documentos que trata de dispositivos médicos para análse também aborda os requisitos técnicos dos materiais de laboratório elaborados de poli- e polipropileno.
6- Materiais de construção e Segurança em construção
Technical standards for Construction Products
The placing on the European Union (EU) market of construction products is subject to Directive 89/106/EEC (OJ L-40 11/02/1989), which does not lay down the essential requirements regarding the products themselves, but the construction works in which these products are to be incorporated. Essential requirements for works are developed and translated into technical specifications by means of interpretative documents.
Scope of application
The Directive applies to construction products, meaning any product which is produced with a view to permanent incorporation into construction works, including both buildings and civil engineering works.
Essential requirements and interpretative documents
Essential requirements do not refer to construction products but to construction works in which these products are to be incorporated. Construction products must be suitable for works which satisfy, for an economically reasonable working life, the essential requirements set out in Annex I to the Directive, which refer to mechanical resistance, stability, safety in case of fire, hygiene, health and the environment.
Interpretative documents serve as a bridge between the essential requirements and the technical specifications. They harmonise the terminology and the technical bases, indicating classes for each requirement and methods of correlating these classes with the technical specifications. The classification of requirements into product classes is designed to take into account the differences of geographical position, climate and way of life which exist in the various Member States. A list of the interpretative documents under this Directive can be found at:
http://www.europa.eu.int/comm/enterprise/construction/internal/intdoc/intdoc.htm
Harmonised standards
The technical specifications to meet the above essential requirements are not described in the Directive, which allows manufacturers, or their representatives, to fulfil the essential requirements by any appropriate means. However, the following types of specifications provide a presumption of conformity to the essential requirements they implement:
(a) Harmonised standards
Harmonised standards are technical specifications that would enable to meet the essential requirements. Products manufactured according to these harmonised standards benefit from a presumption of compliance with the essential requirements.
Harmonised standards are developed by the European Standardisation bodies: CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These bodies are independent organisations whose mission is to develop respectively voluntary technical and electrotechnical standards, in order to promote free trade in the single European Market. The standards are published in the Official Journal of the European Communities and transposed into national legislation in the form of national standards with identical characteristics.
A list of approved harmonised standards can be found at:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/construc.html
(b) European technical approvals
The European Organisation of Technical Approvals (EOTA) draws up technical approvals guidelines (ETAG) for some sectors. A list of endorsed ETAGs can be found at:
http://www.eota.be/html/endorsed.htm
For products which strongly deviate from the European or national standards manufacturers or their representatives can request an approval body, member of EOTA, to certificate a European Technical Approval (ETA) according to the assessment principles set out in the relevant ETA guideline. In product areas where technical approval guidelines do not exist, the approval could also be awarded subject to the agreement of all EOTA bodies and the European Commission.
A list of issued ETAs can be found at:
http://www.eota.be/html/etawhoutetag.htm
(c) National technical standards
In the absence of harmonised standards and European technical approvals, national technical specifications may be recognized as providing a suitable basis for a presumption that the essential requirements are met. This standards have to be notified to and accepted by the European Commission and the other Member States.
Compliance attestation
Compliance attestation procedures are specified in ETAGs and Commission Decisions either by product, by product family or by horizontal subjects (like dangerous substances or fire resistance of certain products). The degree of involvement in these procedures of the manufacturer depends on the affected product: from a mere declaration of conformity by the manufacturer (with or without the intervention of a notified body), to a full conformity certification of the product by a notified body.
Notified bodies are organisations designated by each Member State and notified to the Commission and the other Member States, that are in charge of assesing manufaturer's conformity to the esssential requirements when a third party is required.
A list of Decisions relating to attestation of compliance can be found at:
http://europa.eu.int/comm/enterprise/construction/internal/cpdcomp/declist.htm
CE marking
Manufacturers, or their representatives established in the EU, must attest, either on the basis of their own resources or through a notified body, that their products comply with the requirements of the relevant technical specifications in order to convey the CE marking and be placed on the market anywhere within the European Union.
Market surveillance
Products which have been declared to comply with the Directive but which do not satisfy the essential requirements and therefore pose a health and safety threat may be temporarily withdrawn from the market by the Member States. Where non-compliance is attributable to the technical specifications, to their application or to omissions, the Commission decides, after consulting the Standing Committee on Construction, whether the European or national technical specification should or should not continue to enjoy presumption of conformity.
Legislation
Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (OJ L-40 11/02/1989)
Other information sources
European Commission - DG Enterprise and Industry:
http://europa.eu.int/comm/enterprise/construction/index_en.htm
7- Termômetros e Pirômetros
With reference to your request for information please note that there are no specific European technical standards for thermometers and pyrometers for use in civil aircraft.
In general, all equipment installed on an aircraft must be based on the following rules:
- it must either be installed by the Type Certificate holder of the aircraft,
- or it is based on a Supplemantal Type Certification (STC),
- or it is only a minor change,
- or it is a standard part.
If the part or appliance has an ETSO standard (European Technical Standard Order), this can be used to support the approval of the equipment.
In the European Union, the EASA (European Aviation Safety Agency) is responsible for the airworthiness and environmental certification of all aeronautical products, parts, and appliances designed, manufactured, maintained or used by persons under the regulatory oversight of EU Member States. This also includes all post-certification activities, such as the approval of changes to, and repairs of, aeronautical products and their components, as well as the issuing of airworthiness directives to correct any potentially unsafe situation.
All type-certificates are therefore now issued by the European Aviation Safety Agency, and are valid throughout the European Union (Website of the EASA: www.easa.eu.int).
Temas que geraram esta página:
- Aparelho médico
- Instrumento de medição
- Isqueiros
- Manômetro
- Material de laboratório de polipropileno
- Materiais de construção e Segurança em construção
- Termômetros e pirômetros
Utilize a base de informações do Ponto Focal para saber novas notificações e inscreva-se no Alerta Exportador.
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