General Product Safety

The European Communities (General Product Safety) Regulations give effect to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. The Regulations require that consumer products placed on the market are safe and obliges producers to place only safe products on the market.

The Regulations specify the duties of producers and distributors and make it an offence to place dangerous products on the market. The Competition and Consumer Protection The national regulator is given authority to ensure that products placed on the market are safe and that producers and distributors of such products comply with their obligations under the regulations and the Directive.

Interpretation.

A “consumer” means any natural person who, in respect of a product covered by the Directive, is acting for purposes which are outside his or her trade, business or profession.

A “producer” means—

  • the manufacturer of a product, when the manufacturer is established in the Community, and any other person presenting himself or herself as the manufacturer by affixing to the product his or her name, trademark or other distinctive mark, or the person who reconditions the product,
  • 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, or
  • other professionals in the supply chain, in so far as their activities may affect the safety properties of the product;

A distributor” means any professional in the supply chain whose activity does not affect the safety properties of a product;

A “product” means 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;

A “dangerous product” means any product which is not a safe product. A “safe product” means 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. A “serious risk” means any serious risk, including those the effects of which are not immediate, requiring rapid interventions by the national regulator.

Application

The Regulations apply to all products. They do not apply to a product subject to specific safety requirements imposed by EU legislation Where a product is subject to specific safety requirements imposed by such legislation, the general regulations apply only to the aspects and risks or categories of risk not covered by such regulation or legislation

The regulations do 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 of such product clearly informs the person to whom he or she supplies the product that such repair or reconditioning is necessary prior to use of the product.

Prohibition on placing dangerous products on the market

A producer must not place or attempt to place on the market a product unless it is a safe product. In determining the safety of a product, the following is taken into consideration:

  • the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
  • the effect on other products, where it is reasonably foreseeable that it will be used with other products;
  • 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; and
  • the categories of consumers at risk when using the product, in particular children and the elderly.

However, the feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk does not constitute grounds for considering a product to be dangerous.

A producer who contravenes the regulations is guilty of an offence.

Products deemed or presumed safe in certain circumstances

A product is deemed to be a safe product if it conforms with any specific rules of the law of the State, drawn up in conformity with the EU Treaty, laying down the health and safety requirements which the product must satisfy in order to be marketed.

A product is presumed safe as far as the risk and risk categories covered by the relevant Irish Standards are concerned when it conforms to voluntary Irish Standards transposing European standards, the references of which have been published by the The national regulator in the Official Journal of the European Communities in accordance with the Directive.

Where no specific rules as those above exist, or where no voluntary Irish Standard transposing European standards have been adopted, the conformity of a product to the general safety requirement is assessed by taking into account the following elements in particular, where they exist:

  • voluntary Irish Standards transposing relevant European standards;
  • other Irish Standard Specifications;
  • The national regulator recommendations setting guidelines on product safety assessment;
  • product safety codes of good practice in force in the sector concerned;
  • the state of the art and technology; and
  • reasonable consumer expectations concerning safety.

Notwithstanding the conformity of a product with the general safety requirements, the national regulator may take appropriate measures in accordance with the regulations to impose restrictions on its being placed on the market or to require its withdrawal from the market or its recall where there is evidence that, despite such conformity, the product is dangerous.

Duties of producers

A producer must, in relation to any product which he or she has placed on the market, provide consumers with all relevant information relating to the product to enable them to assess the risks inherent in the product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. The presence of a warning does not exempt any person from any obligations to comply with any other requirement of the regulations or the Directive.

A producer shall, in relation to any product which he or she has placed on the market, adopt measures commensurate with the characteristics of the product, to enable the producer be informed of the risks which the product might pose, or choose to take appropriate action, including, if necessary to avoid such risks, withdrawal of the product in question from the market, adequately and effectively warning consumers, or recall of the product from consumers. Recall shall take place as a last resort where other measures do not suffice to prevent the risks involved.

The measures above shall include, for example:

  • an indication, by means of the product or its packaging, of the identity and details of the producer and the product reference or, where applicable, the batch of products to which it belongs, except where not to give such indication is justified, and
  • in all cases where appropriate, the carrying out of sample testing of marketed products, investigating and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring.

Where the regulator  considers that a producer has not given relevant information to consumers or taken appropriate action in relation to above risks, he or she may by a direction to the producer require the producer to give to consumers such information or to take such action concerning the product, within such period as may be specified in the direction, as is specified in the direction. A producer who fails to comply with a direction under paragraph (5) is guilty of an offence.

Duties of distributors

A distributor must act with due care to ensure that any product he or she supplies is a safe product.  A distributor must not supply or attempt to supply a product which he or she knows, or it is reasonable to presume, on the basis of the information in his or her possession as a professional, that he or she should know is a dangerous product. A distributor who contravenes this requirement is guilty of an offence.

A distributor shall, in relation to any product placed on the market which he or she supplies, monitor the product with regard to product safety, and for this purpose, the distributor shall, in particular

  • inform the producer of the product, the regulator and consumers as to any defects in it or risks it may pose to consumers that he or she becomes aware of in relation to it,
  • keep and provide to the regulator the documentation necessary for tracing the origin of the product, and
  • cooperate in actions taken by the producer and the regulator to avoid any risk.

A distributor who, without reasonable excuse, fails to comply with these requirements is guilty of an offence.

Duty to inform The national regulator of risk

Where a producer of a product or a distributor of a product knows or, on the basis of information in his or her possession and as a professional, ought to know, that a product which he or she has placed on the market poses a risk to the consumer that is incompatible with the safety requirements of the regulations or of the Directive, the producer or distributor must immediately inform the regulator of the risk, in a form and under conditions (being defined and drawn up by the The national regulator) in accordance with Annex 1 to the Directive and published by the The national regulator, and giving details, in particular, of action to prevent risk to the consumer. In the event of serious risks, the information must include at least the following:

  • information enabling a precise identification of the product or batch of products in question,
  • a full description of the risk that the products in question present,
  • all available information relevant for tracing the product, and
  • a description of the action undertaken to prevent risks to consumers.

A producer of a product or a distributor of a product shall, on the request being made to him or her by the The national regulator, provide every reasonable assistance to the regulator to avoid the risks posed by any product which such producer or distributor supplies or has supplied.  A producer or distributor who, without reasonable cause, fails to comply with the above requirement or request is guilty of an offence.

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