General Product Safety (GPSD)
European General Product Safety Directive (GPSD)
European Directive GPSD 2001/95/EC
The European Directive GPSD 2001/95/EC regulates the basic requirements that all products must comply with in terms of safety and health in Europe and for the entire European Economic Area (EEA). All products must meet all requirements established by law before being introduced to the market, marketed or used.
The purpose of this Directive is for manufacturers and importers to design and manufacture their products taking into account all relevant safety aspects, in particular consumer categories that may be particularly vulnerable to the risks presented by products such as children and old people. The manufacturer or importer that markets products in the European Union guarantees that they meet all requirements established by law for safety, health and the environment regulated by this Directive and all others that may be applicable as the case may be.
Compliance with this Directive DOES NOT imply the right to stamp products with CE Mark Logotype since there are specific Directives that regulate specifically its implementation according to type of product and its application scope.
Brief
1. The purpose of this Directive is to ensure that products placed on the market are safe.
2. This Directive shall apply to all the products defined in Article 2 (a). Each of its provisions shall apply in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned. Where products are subject to specific safety requirements imposed by Community legislation, this Directive shall apply only to the aspects and risks or categories of risks not covered by those requirements.
This means that:
(a) Articles 2(b) and (c), 3 and 4 shall not apply to those products insofar as concerns the risks or categories of risks covered by the specific legislation;
(b) Articles 5 to 18 shall apply except where there are specific provisions governing the aspects covered by the said Articles with the same objective.
For the purposes of this Directive:
(a) ‘product’ shall mean any product
— including in the context of providing a service
— which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned.
This definition shall not apply to second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect;
(b) ‘safe product’ shall mean any product which, under normal or reasonably foreseeable conditions of use including duration and, where applicable, putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons, taking into account the following points in particular:
(i) the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
(ii) the effect on other products, where it is reasonably foreseeable that it will be used with other products;
(iii) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;
(iv) the categories of consumers at risk when using the product, in particular children and the elderly.
The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be ‘dangerous’; (
c) ‘dangerous product’ shall mean any product which does not meet the definition of ‘safe product’ in (b);
(d) ‘serious risk’ shall mean any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities;
(e) ‘producer’ shall mean:
(i) the manufacturer of the product, when he is established in the Community, and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark, or the person who reconditions the product;
(ii) the manufacturer’s representative, when the manufacturer is not established in the Community or, if there is no representative established in the Community, the importer of the product;
(iii) other professionals in the supply chain, insofar as their activities may affect the safety properties of a product;
(f) ‘distributor’ shall mean any professional in the supply chain whose activity does not affect the safety properties of a product;
(g) ‘recall’ shall mean any measure aimed at achieving the return of a dangerous product that has already been supplied or made available to consumers by the producer or distributor; (h) ‘withdrawal’ shall mean any measure aimed at preventing the distribution, display and offer of a product dangerous to the consumer.
General safety requirement, conformity assessment criteria and European standards
Article 3
1. Producers shall be obliged to place only safe products on the market.
2. A product shall be deemed safe, as far as the aspects covered by the relevant national legislation are concerned, when, in the absence ofspecific Community provisions governing the safety of the product in question, it conforms to the specific rules of national law of the Member State in whose territory the product is marketed, such rules being drawn up in conformity with the Treaty, and in particular Articles 28 and 30 thereof, and laying down the health and safety requirements which the product must satisfy in order to be marketed.
A product shall be presumed safe as far as the risks and risk categories covered by relevant national standards are concerned when it conforms to voluntary national standards transposing European standards, the references of which have been published by the Commission in the Official Journal of the European Communities in accordance with Article 4. The Member States shall publish the references of such national standards.
3. In circumstances other than those referred to in paragraph 2, the conformity of a product to the general safety requirement shall be assessed by taking into account the following elements in particular, where they exist:
(a) voluntary national standards transposing relevant European standards other than those referred to in paragraph 2;
(b) the standards drawn up in the Member State in which the product is marketed;
(c) Commission recommendations setting guidelines on product safety assessment;
(d) product safety codes of good practice in force in the sector concerned;
(e) the state of the art and technology;
(f) reasonable consumer expectations concerning safety.
4. Conformity of a product with the criteria designed to ensure the general safety requirement, in particular the provisions mentioned in paragraphs 2 or 3, shall not bar the competent authorities of the Member States from taking appropriate measures to impose restrictions on its being placed on the market or to require its withdrawal from the market or recall where there is evidence that, despite such conformity, it is dangerous.
- No Modifications -
¿Need assessment to guarantee the Safety of your Products?
Sherpa Product Certification provides complete certification or concrete assistance at any stage and throughout the process of certification or CE Marking for all kind of Products covered by the European Directive 2001/95/EC, Our intervention will summarize and delimit the legal framework that applies to your products, facilitating the identification and understanding of requirements and the development of processes to fulfill them.
How Sherpa Product Certification can help?
- Classify the product and determine the legal framework applicable in each case.
- Identify essential requirements in specific Directives by product.
- Identify, acquire, adapt to the design and carry out tests on products according to Harmonized European and Regulatory Standards.
- Check and manage the intervention of an Accredited Body (Notified Body).
- Evaluate the Product’s Conformity Evaluation according to the mandate established in the Directive.
- Prepare and maintain the technical documentation.
- Write the Declaration of Conformity and carry out the CE Marking.
How can we Help you?
- Complete European Certification and CE Marking for your products
- Complete assessment for manufacturers, importers or exporters regarding product legislation
- General inquiries about CE Marking
- Product analysis & classification in accordance with its applicable normative scheme and region
- Determine which regulations and directives apply to a product at an specific region
- Customs Tariff analysis for products and materials.
- Perform product conformity test according EN, ISO, IEC among others
- Product Market Access complete assistance
- Determine corrections and authenticity about specific Product Certifications.
- Determine manufacturer's, importer's and distributores responsabilities regarding product legislation.
- European Authorised Representative Services
- Write and validate product's Tecnical Documentation and Declaration of Conformity
- Perform Risk Analysis
- Packaging and labeling verification according to its applicable normative
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- +34 649 574 811
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- +34 649 574 811
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ABOUT SHERPA
Sherpa Product Certification is formed by a group of engineers who are experts in regulation and standardization of products, materials and industrial processes at an international level. Our essence as Sherpas is to help our clients to create lasting value in their business and meet their professional needs. If you need help in the procedures of a certificate or simply need specific information about our services, we are happy to help you. Hire a Sherpa in your company and forget about legislation and documentation of your products. Our Sherpas certification experts report quickly and efficiently to the needs of our clients when we are most needed.