THE GENERAL PRODUCT SAFETY DIRECTIVE
Directive 2001/95/EC (19) on general product safety (GPSD) is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by sector-specific EU harmonisation legislation. The GPSD also complements the provisions of sector legislation in some aspects. The key provision of the GPSD is that producers are obliged to place on the market only products which are safe (20). The GPSD also provides for market surveillance provisions aimed at guaranteeing a high level of consumer health and safety protection.
The GPSD has set up the Rapid Alert System which is used for dangerous non-food products (RAPEX, Rapid Alert System) between Member States and the Commission. The Rapid Alert System ensures that the relevant authorities are rapidly informed of dangerous products. Subject to certain conditions, Rapid Alert System notifications can also be exchanged with non-EU countries. In the case of serious product risks to the health and safety of consumers in various Member States, the GPSD provides for the possibility for the Commission to take temporary Decisions on Union-wide measures, so-called ‘emergency measures’. Under certain conditions, the Commission may adopt a formal Decision (valid for 1 year, but renewable for the same period) requiring the Member States to restrict or prevent the marketing of a product posing a serious risk to the health and safety of consumers. The Rapid Alert System has been subsequently extended by Regulation (EC) No 765/2008 to apply to all harmonised industrial products irrespective of the final user (i.e. professional products) and to products posing risks to other protected interests than health and safety, for example risks to the environment.
Inspection and Product certification
Inspection and product certification can be considered similar and there is some overlapping in the definitions. They both go beyond simple testing by including tasks related to the ability to assess test results and decide on conformity. They pursue the same goal (i.e. the assessment of the conformity of a product) in slightly different ways.
Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements of the applicable legislation, and, in some cases, the manufacturer may benefit from a simplified conformity assessment procedure (in many instances the manufacturer's declaration of conformity, made more easily acceptable to public authorities by the existence of the product liability legislation.
Certification Marks: Assurance of quality
Product certification necessitates giving assurance that a product conforms to specified requirements such as regulations, standards or other technical specifications. A product certification system can include, e.g. type testing or examination, testing or inspection of every product or of a particular product, batch testing or inspection, design appraisal, which could be coupled with production surveillance or assessment and surveillance of the manufacturer's quality system.
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
There are two main benefits CE marking brings to businesses and consumers within the EEA:
- Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.
- Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.
CE marking is a part of the EU’s harmonization legislation, which is mainly managed by Directorate-General for Internal market, Industry, Entrepreneurship and SMEs. The CE marking for Restriction of Hazardous Substances is managed by Directorate-General for Environment. Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide.
EU declaration of conformity
The manufacturer or the authorised representative established within the Union must draw up and sign an EU declaration of conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation. The EU declaration of conformity must contain all relevant information to identify the Union harmonisation legislation according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other technical specifications. A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU declaration of conformity. The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity.
WHY DOES TRACEABILITY MATTER?
Traceability is the ability to trace the history of the product.
From a regulator's perspective, traceability matters because it enables effective enforcement through market surveillance via corrective measures including withdrawals and recalls. It enables unsafe or non-compliant products to be traced up the distribution chain and identifies roles and responsibilities of the economic operator throughout the chain. Traceability enables market surveillance authorities to trace products up to the factory gate and from factory to the end- user in certain cases.
From a manufacturer's perspective traceability matters because it enables effective control of the production process and suppliers before the marketing of the products, and control of their distribution chain after the placing of the product on the market. In case of non-compliance, manufacturers are able to reduce the impact of recalls or withdrawals depending on the detail of their traceability system.
The manufacturer must draw up a technical documentation. The technical documentation is intended to provide information on the design, manufacture and operation of the product.
Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants). The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location (203).
The technical documentation must be kept for 10 years from the date of placing the product on the market, unless the applicable Union harmonisation legislation expressly provides for any other duration (204). This is the responsibility of the manufacturer or the authorised representative established within the Union. Since the concept of ‘placing on the market’ refers to each individual product, the time period needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market.
The contents of the technical documentation are laid down, in each Union harmonisation act, in accordance with the products concerned. As a rule, the documentation has to include a description of the product and of its intended use and cover the design, manufacture and operation of the product. The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards. The requirements in Annex II to Decision No 768/2008/EC refer to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation legislation. Furthermore, the requirement for an ‘adequate analysis and assessment of the risk(s)’ requires the manufacturer to first identify all possible risks of the product and determine the essential requirements applicable. This analysis has to be documented and included in the technical documentation. In addition, the manufacturer needs to document the assessment of how he is addressing the risks identified to ensure that the product complies with the applicable essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all applicable essential requirements, then also the way applicable essential requirements not covered by it are dealt with should be documented in the technical documentation.