European General Product Safety Directive (2001/95/EC)

  • Date: April 26, 2011
  • Source: Admin
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This directive covers nearly all products sold in the European Union. In general, it places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product. It takes into account various characteristics including pack-aging/labeling, instructions for use and disposal, packaging, maintenance and more.

The directive requires "producers" to take appropriate action in the event of a product crisis, including:

  • notifying the appropriate competent authorities,
  • temporarily withdrawing the product from the marketplace,
  • warning consumers of a potential problem or, in severe cases,
  • recalling product already in the marketplace.

To aid the compliance effort, the EU has implemented a single rapid alert system called RAPEX for re-porting dangerous consumer products. It allows the rapid exchange of information among member countries. The original directive (92/59/EEC) was revised and replaced with (2001/95/EC) in December 2001. The new version went into effect in most countries in January 2004 (later for 10 new EU countries and on Oct 1, 2005 in the UK).


The Directive applies to the supply of all new and second hand products to consumers for personal use. It also applies to products that have migrated from professional to consumer user, either through the distribution of new products or resale of second-hand products.

Products include all goods placed on the market, including goods supplied during the provi-sion of a service. "Supply" includes selling, leasing, hiring, lending and part exchanging.

The Directive does not apply to products for use in the workplace by employees or for those which are to be exported outside the EU.

General safety requirement

The Directive imposes a general safety requirement on any product put on the market for con-sumers or likely to be used by them, including all products that provide a service. Second-hand products that have antique value or those that need to be repaired are not subject to this re-quirement.

A product is deemed safe once it conforms to the safety provisions provided in European legisla-tion. The product is also deemed safe if it complies with the European standard established ac-cording to the procedures in this Directive. The product's compliance is further determined ac-cording to the following:

  • the voluntary national standards, the Commission’s recommendations (setting out guidelines on the assessment of product safety);
  • the standards of the Member State in which the product is being marketed or sold;
  • the codes of good practice as regards health and safety;
  • the current state of the art;
  • the consumers' safety expectations.

Manufacturer and distributor obligations

Manufacturers must put on the market products which comply with the general safety requirement. In addition, they must:

provide consumers with the necessary information in order to assess a product's in-herent threat, particularly when this is not directly obvious;

take necessary measures to avoid such threats (e.g. withdraw products from the market, inform consumers, recall products which have already been supplied to consumers, etc.).

Distributors are also obliged to:

  • supply products that comply with the general safety requirement;
  • monitor the safety of products on the market;
  • provide the necessary documents ensuring that the products can be traced.

Member States' obligations

  • The Member States ensure that the manufacturers and the distributors comply with their obligations. They put in place structures which are responsible for:
  • monitoring product compliance with the safety requirement;
  • taking necessary measures as regards risk products and informing the Commission of the details.

Member States set out rules to punish offenders and ensure that consumers benefit from the system

The Commission's role :

The Commission defines the general safety requirements for the European standardization organisa-tions and publishes European standardization references in the Official Journal of the European Union. The Commission also manages the Rapid Information System RAPEX.

RAPEX system (rapid intervention where products pose a serious risk): This system is a means for rapidly exchanging information between the Member States and the Commission.

  • Member States identify products which pose a serious risk to health and safety.
  • They take rapid intervention measures to protect consumers.
  • They immediately inform the Commission via the RAPEX system.
  • They enable the distribution of dangerous products to be limited or prevented. (Food, pharmaceutical and medical products are governed by other intervention systems.)

The Commission implements rapid measures at European level when a certain product is found to pose a serious threat. These measures include:

  • imposing specific safety limitations;
  • prohibiting the use of certain substances; or
  • requiring manufacturers to affix warnings to their products.

The Commission is assisted by a Regulatory Committee on the Safety of Consumable Products when taking “emergency measures” and decisions on standardization.

The Commission is also assisted by an Advisory Committee on the Safety of Consumable Prod-ucts responsible for the other aspects of the Directive.


Information on the risks posed by the products must be provided to the public. Professional secrecy is limited to justified cases.


The Regulations are generally enforced in the United Kingdom by local authorities, primarily local Trad-ing Standards Authorities and Environmental Health Officers. For certain products, enforcement is un-dertaken by other authorities, such as VOSA for vehicles and MHRA for medical devices. There is also a provision, for the European Commission to impose a ban on a product without a member state's re-quest.


In the UK, the maximum penalty for the supply of non-compliant products is 12 months of imprisonment and/or a GBP 20,000 fine. More importantly, the regulations also give the authorities the power to force manufacturers to recall or replace a faulty product. Under the regulations, authorities are given the power to enter the premises, test products and seize records and products. The authorities have various measures available to them, such as,

  • Suspension Notices to suspend supply of a product until the results are collected.
  • Requirements to mark and warn, placing an obligation to add appropriate warnings etc.
  • Withdrawal Notices to prevent further supply of a product.
  • Recall Notices to recall products (which could include the disposal of the products by consumers)


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