EU Market Surveillance (Non-Food)

Market surveillance is designed to ensure that non-food products on the EU market do not endanger European consumers and workers. It seeks to ensure the protection of other public interests such as the environment, security and fairness in trade. It includes actions such as product withdrawals, recalls and the application of sanctions to stop the circulation of non-compliant products and/or bring them into compliance.

Market surveillance is said to be crucial for the smooth functioning of the Single Market. It helps protect:

  • consumers and workers against unsafe products and general non-compliance
  • businesses from unfair competition by those who ignore the rules.

EU Regulations

  • set out obligations for EU countries to carry out market surveillance and to prohibit or restrict the marketing of dangerous or non-compliant products
  • provide market surveillance authorities the powers to obtain all necessary documentation from manufacturers to evaluate product conformity, to enter manufacturers’ premises and take samples for testing, and in extreme cases to destroy products
  • include clear obligations for EU countries to ensure cooperation at national and international level.

Decision 768/2008/EC on a common framework for the marketing of products contains provisions on market surveillance, obligations of businesses, traceability and safeguard mechanisms. These provisions are being incorporated in sector specific legislation.

Directive 2001/95/EC (the General Product Safety Directive) contains additional market surveillance provisions, in particular for non-harmonised consumer products.

Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for performing the required conformity assessment procedure.

Organisation of Market Surveillance

Member States must organise and carry out market surveillance. Market surveillance must ensure that products covered by Community harmonisation legislation which are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in Community harmonisation legislation are withdrawn, prohibited or restricted and that the public, the Commission and the other Member States are informed accordingly.

Market surveillance authorities must perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they must take account of established principles of risk assessment, complaints and other information.

Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary.

Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities must take due account of such reports or certificates.

Market surveillance authorities must take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage. They must cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators.

Where the market surveillance authorities of one Member State decide to withdraw a product manufactured in another Member State, they must inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product.

Member States must ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on their market is prohibited, and that the Commission is informed without delay thereof.

Controls of products entering the Community market

The authorities of the Member States in charge of the control of products entering the Community market must have the powers and resources necessary for the proper performance of their tasks. They must carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the above principles, before those products are released for free circulation.

Where in a Member State more than one authority is responsible for market surveillance or external border controls, those authorities must cooperate with each other, by sharing information relevant to their functions and otherwise as appropriate.

The authorities in charge of external border controls must suspend release of a product for free circulation on the Community market when any of the following findings are made in the course of the checks:

  • the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest;
  • the product is not accompanied by the written or electronic documentation required by the relevant Community harmonisation legislation or is not marked in accordance with that legislation;
  • the CE marking has been affixed to the product in a false or misleading manner.

The authorities in charge of external border controls must immediately notify the market surveillance authorities of any such suspension.

In the case of perishable products, the authorities in charge of external border controls must, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products.

National measures

Where the market surveillance authorities find that a product presents a serious risk, they must take measures to prohibit that product from being placed on the market and must require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:

Where the market surveillance authorities find that a product does not comply with Community harmonisation legislation, they must take appropriate action, which may, if necessary, include prohibiting the product’s being placed on the market.

Where placing on the market is prohibited, the market surveillance authorities must require the authorities in charge of external border controls not to release the product for free circulation and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:

Where that product is subsequently declared for a customs procedure other than release for free circulation and provided that the market surveillance authorities do not object, the endorsements above must also be included, under the same conditions, on the documents used in connection with that procedure.

Product Safety

The safety of consumer products is assured by a wide range of sectorial legislation and is complemented by the Directive 2001/95/EC of the European Parliament and of the Council on the General Product Safety.

Under these legislations manufacturers and distributors are obliged to:

  • supply products that comply with the general safety requirements
  • inform consumers of risks that a product might pose and the precautions they should take
  • notify the appointed authorities in Member States if they discover that a product is dangerous and cooperate with them on the action taken to avoid the risks for consumers
  • Market surveillance and enforcement are carried out by the competent authorities appointed in the Member States with the support of certain mechanisms established at EU level.

The principal mechanism in Europe is the Rapid exchange of information between Member States and the European Commission on products causing serious risks, called RAPEX-System.

The General Product Safety Directive applies in a complementary way to products covered by specific sector legislation such as:

  • Cosmetics
  • Pharmaceuticals
  • Medicinal products for human use
  • Medicinal products for veterinary use
  • Industrial products (chemicals, medical devices, machinery, protective equipment, etc.)
  • Liability for defective products

Technical Standardisation

The main purpose of technical harmonisation within the EU is to remove technical barriers. The main elements are

  • the definition of general rules which are applicable to sectors or families of products (mandatory essential requirements), as well as types of hazard
  • the setting up of appropriate conformity assessment procedures
  • the introduction of European Conformity (CE) marking

New Approach Directives set down general health and safety requirements, as well as specifications for meeting these requirements.

Global Approach Directives lay down the guiding principles for Community policy on conformity assessment procedures (the system and responsibilities for testing and certification and, where applicable, accredited test laboratories).

Certain products are still covered by Old Approach Directives:

  • foodstuffs
  • motor vehicles
  • chemicals
  • cosmetics
  • detergents
  • biocides
  • pharmaceutical sectors

New approach principles

The harmonisation gives the essential product requirements when they are placed on the EU market (such as health, safety, consumer protection and environmental protection)The application of harmonised or other standards remains voluntary for manufacturers; however products manufactured in compliance with harmonised standards, benefit from a presumption of conformity with the corresponding essential requirements

Each Member State has designated bodies in charge of the conformity assessment procedures when a third party is required.

The Global approach establishes procedures to assess the conformity of products to requirements listed in the technical harmonisation directives.

Conformity assessment is either carried out by the manufacturer or third party and relates to the design phase of products, their production phase or both.

There are eight different procedures (modules) which cover the two phases in a variety of ways: internal control of production, full quality assurance, etc.

Council Resolution 90/C 10/01 sets up guiding principles for a reliable EU policy on conformity assessment, such as:

Generalised use of the European standards relating to quality assurance
Mutual recognition agreements between the EU and third countries, which have a similar level of technical development and approach on conformity assessment
The CE marking indicates that the product complies with the essential requirements of all applicable directives and experienced the appropriate conformity assessment procedure.

The CE marking:

  • consists of the “CE” marking and the identification number of the notified body involved in the production control phase when a third party is required
  • is affixed to the product, to its packaging or to the accompanying document
  • enables the product in question to be placed on the EU market

Manufacturers in third countries must appoint an authorised representative established in the EU to act on their behalf. They are responsible for designing and manufacturing a product in accordance with all applicable Directives and for performing the required conformity assessment procedure.

Customs authorities shall suspend the release of goods which may pose a serious risk to health or safety or which are not accompanied by the required documentation.

Packaging

Packaging marketed within the EU must comply with the general requirements which aim at protecting the environment, as well as with the specific provisions designed to prevent any risk to the health of consumers, for example:

Recycling materials, packaging waste prevention,
Size, nominal quantities and capacities,
Composition and constituents of materials intended to come into contact with foodstuffs

These types of products are affected by:

  • General requirements related to packaging and packaging waste, established in Directive 94/62/EC of the European Parliament and of the Council
  • Specific provisions related to package sizing, established in Council Directive 75/106/EEC and Council Directive 80/232/EEC
  • Specific rules on nominal quantities for prepacked products, established in Directive 2007/45/EC of the European Parliament and of the Council
  • Special rules for materials and articles intended to come into contact with foodstuffs, established in Regulation (EC) No 1935/2004 of the European Parliament and of the Council.

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