There are a number of requirements, principles and commitments concerning standardisation, such as the participation of all interested parties (for example manufacturers, including SMEs, consumer associations, environmental stakeholders and trade unions), the role of public authorities, the quality of standards and a uniform transposition of European standards throughout the Union by national standardisation bodies. To safeguard impartiality and avoid conflicts of interest it is important to make a clear distinction between conformity assessment performed by notified bodies prior to placing products on the market and market surveillance. This information includes in particular the reference number and the title in all official languages of the EU. the development of the conformity assessment instruments made necessary by the implementation of the various Union harmonisation acts, both New Approach and Old Approach. Union harmonisation legislation providing in general for CE marking may exclude the application of the CE marking on certain products. However, the manufacturer is free to apply other quality system models than those based on EN ISO 9001 for the purpose of complying with these modules. Such cases include: the harmonised standard in question has been withdrawn by the relevant ESO without any intention to adopt a revised harmonised standard; the national standards transposing the harmonised standard are not available or valid as national standards anymore. In principle, occasional supplies by charities or hobbyists should not be considered as taking place in a business related context. establish an encyclopaedia of EU market surveillance intelligence. The economic operator directly concerned by the Decision may also challenge it on the basis of article 263 TFEU. THE APPLICATION OF SAFEGUARD MECHANISMS STEP BY STEP. The notification of a notified body is sent by the notifying authority to the Commission and the other Member States via NANDO the electronic notification tool developed and managed by the Commission where a list of all notified bodies can be found. Regulation (EC) No 765/2008 aims to ensure that accreditation serves the public interest. This is to ensure that the product complies with the essential or other legal requirements at the moment of first use within the Union(143). ISO/IEC 17050-1:2004 - Conformity assessment Supplier's declaration The bodies designated under MRAs figure in a dedicated part of NANDO. the application of harmonised or other standards remains voluntary, and the manufacturer can always apply other technical specifications to meet the requirements (but will carry the burden of demonstrating that these technical specifications answer the needs of the essential requirements, more often than not, through a process involving a third party conformity assessment body). They may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary. It is the ultimate goal for a harmonised standard and the end of the process which started when the relevant Commission request was issued. In addition to controlling the conformity of the product with the formal requirements, the distributor must: initiate corrective measures where there is suspicion of a non-conformity(139); assist market surveillance authorities in identifying the manufacturer or importer responsible for the product; upon a reasoned request(140) from a competent authority, cooperate with that authority and provide it with all the information and documentation necessary to demonstrate the conformity of a product(141); on request by market surveillance authorities, identify any economic operator who has supplied them and to whom they have supplied the product. The European Commission has the responsibility to facilitate the exchange of information between national authorities (in relation to their national market surveillance programmes, their risk assessment methodologies, etc.) This means that the national accreditation body may operate from within a ministry, be a governmental agency or be organised as a private company. Luxottica has adopted both a Code of Conduct and a Code of Ethics, with which employees, business partners and suppliers are expected to comply. (34) If objections are raised, the safeguard mechanism will apply. The role of harmonised standards and the responsibilities of the European standardisation organisations are now defined in Regulation (EU) No 1025/2012 together with relevant Union harmonisation legislation. According to Article 21 of the Regulation, the measures adopted by market surveillance authorities have to be proportionate and communicated to the relevant economic operator without delay. Distributors must be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. (146)Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L178, 17.7.2000, p.1). The distribution conditions (for example transport or storage) may have an impact on maintaining the compliance with the provisions of the applicable Union harmonisation legislation. (34)Directive 1999/44/EC on certain aspects of the sale of consumer goods and associated guarantees (OJ L171, 7.7.1999, p. The standstill period is 12 months in the presence of a proposal for a Union harmonisation act in the area in question. REGULATING THE FREE MOVEMENT OF GOODS. The level of the sanctions is determined at national level. The Regulation does not prescribe the legal form a national accreditation body should take. The customs authorities have not been notified of any action taken by the market surveillance authorities. However, despite the MRA, there is no customs union between the EU and Switzerland. It must also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits). If the Union harmonisation legislation covers putting into service, the natural or legal person who puts the product into service has the same responsibilities as a manufacturer who places a product on the market. However, the standstill period does not apply where a Member State is obliged to introduce technical regulations urgently to protect public health or safety, animals or plants. the legislator has already given the political acceptance to the harmonised standards to be developed and published within the legal framework given in Regulation (EU) No 1025/2012. The importer is a natural or legal person established in the Union who places a product from a third country on the EU market. There is a grey zone between correct and incorrect maintenance and use, and it can be considered that, to a certain extent, products should be safe, even if maintained and used for their intended purpose in an incorrect way that can reasonably be expected. Definition of a harmonised standard. 1. For placing on the market and putting into service, see Sections 2.3 and 2.5. In practice, it should be considered as sufficient when the manufacturer or the authorised representative has been provided with an opportunity to react. The Directive does not cover the destruction of the defective product itself and, therefore, there is no obligation to compensate for it under the Directive on product liability. Equally, importers who have reason to believe that a product which they have placed on the market is not in conformity with the Union harmonisation legislation applicable, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. (205)See the Directives relating to simple pressure vessels, machinery (for module B), non-automatic weighing instruments, active implantable medical devices, gas appliances, telecommunications terminal equipment, medical devices, potentially explosive atmospheres, lifts (for modules B, C, D, G, H), pressure equipment, in vitro diagnostic medical devices, and radio and telecommunications terminal equipment. They also need appropriate human and financial resources. More profound checks may be however necessary to verify the conformity of the product, for example regarding the correct application of the conformity assessment procedure, the compliance with the applicable essential requirements, and the contents of the EU declaration of conformity. (189)The Member States Committee under Regulation (EU) No 1025/2012 and, if provided for, the sectoral Committee. Under certain Union harmonisation acts, the manufacturer may be required to perform sample testing at the end of the production chain or of already marketed products in view of offering additional protection to consumers or other end-users(110) After the assessment, the authority must immediately inform the Commission, and the other Member States, of the incidents for which relevant measures have been taken or are contemplated. Thus, a transfer of a product is considered to have taken place, for instance, in the circumstances of sale, loan, hire(48), leasing and gift. In such a case he could be entitled to claim damages under the jurisdiction of the Member State which initiated the procedure and accordingly the Commission, at the end of a safeguard clause procedure, where the national measure is considered as non-justified. (138)Article R5(2), 2nd paragraph, of Annex I to Decision No 768/2008/EC. The primary task of a notified body is to provide conformity assessment services on the conditions set out in the applicable Union harmonisation legislation. The idea is to minimise the burden on manufacturers to the extent possible. Do you want to help improving EUR-Lex ? In these situations several identification numbers follow the CE marking. Hence in 1989 and 1990 the Council adopted a Resolution on the Global Approach and Decision 90/683/EEC (updated and replaced by Decision 93/465/EEC)(13) laying down the general guidelines and detailed procedures for conformity assessment. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B). Furthermore, when non-compliant or unsafe products are found in the internal market, it is often extremely difficult to identify how they entered the EU. (217)See for example recital 22 of Directive 2014/35/EU, or the similar recital 24 of Directive 2014/34/EU. A product is placed on the market when it is made available for the first time on the Union market. The aim of the peer evaluation system is to ensure consistency and equivalence of accreditation practices across Europe so that the wider market place, including the national public authorities(254), mutually recognise the services delivered by those bodies that have successfully passed the peer evaluation, and therefore accept the accreditation certificates and the attestations issued by the conformity assessment bodies accredited by them.
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declaration of conformity luxottica
