Goods Safety and Surveillance

Uniform conditions for the marketing of safe products in the EU (conformity marking)

Decision No 768/2008/EC — a common framework for the marketing of products in the EU sets out common principles and procedures which EU legislation must follow when harmonising conditions for marketing products in the EU and the European Economic Area (EEA). It includes reference requirements to be incorporated whenever product legislation is revised. As such, it is a template for future product harmonisation legislation.
It lays down rules for CE marking.

KEY POINTS

—It provides clear definitions for relevant terms, such as ‘manufacturer’, ‘placing on the market’, ‘recall’ or ‘withdrawal’ of products.
—Clear divisions of responsibility are set for manufacturers, importers and distributors along the product chain.
—Manufacturers must ensure their products comply with the relevant legislation and follow the appropriate conformity assessment* procedure. They must place the CE marking on the product once compliance is demonstrated.
—Importers must make sure the manufacturer has complied with the appropriate conformity assessment procedure and the product is accompanied by the necessary documentation and CE marking.
—Distributors must act with due care and verify the product has the necessary documentation and CE marking.
—A common set of different conformity assessment procedures, known as modules, is provided. Legislators must choose which one is the most appropriate depending on the risk a product might present.
—Uniform rules are laid down for designating and supervising notified bodies which carry out the conformity assessments on the basis of EU legislation. The rules lay down their responsibilities when third-party product conformity assessments (i.e. certification of conformity by an independent body) are required.
—Market surveillance rules deal with products which present a health or safety risk or do not comply with the relevant legislation.

KEY TERMS

CE marking: this indicates that a product meets the applicable health, safety and environmental requirements and has undergone the relevant conformity assessment procedure.

Conformity assessment: the process confirming that a product satisfies the necessary process, service, system, person or body requirements.

ACT

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

Accreditation and market surveillance

Regulation (EC) No 765/2008 — setting out the requirements for accreditation and market surveillance relating to the marketing of products

It lays down common rules for accrediting bodies that ensure non-food products in the European Union (EU) conform to certain requirements.
It establishes a surveillance system to guarantee a high level of safety of those products and in general their compliance with applicable requirements.
It also sets rules in regard to controls on imports from outside the EU; and establishes the general principles for CE marking*.

KEY POINTS

National accreditation bodies

EU countries must:
appoint a single not-for-profit national accreditation organisation;
ensure the organisation has sufficient finance and staff to carry out its duties;
monitor the organisation to ensure it fulfils the requirements given;
communicate the relevant details to the European Commission which draws up a publicly available list of the various national organisations.

National accreditation bodies must:
determine whether individual conformity assessment organisations* are competent to do their work and monitor their performance;
restrict, suspend or withdraw accreditation certificates for assessment organisations that become unable to carry out their duties;
be objective and impartial with efficient management and appropriate internal controls in place;
agree to peer evaluation;
inform other national accreditation bodies of their conformity assessment activities;
make regularly publicly available information on their work.

The European co-operation for Accreditation (EA) manages the peer evaluations to ensure the quality of the services the national accreditation bodies provide.
EU market surveillance and import controls

EU countries must:
organise and carry out market surveillance to ensure the safety of products;
withdraw, restrict or ban products that could damage the health or safety of users and immediately inform the Commission of the action they have taken;
establish procedures for handling and dealing with complaints;
ensure national market surveillance authorities are appointed and provided with sufficient resources to carry out their tasks;
ensure national market surveillance authorities cooperate and exchange information with each other;
establish rules on penalties, which may include criminal sanctions, for serious breaches of the law.
Market surveillance authorities must:
carry out appropriate checks on a sufficient scale, taking account of risk assessments, complaints and other information;
alert users in their own country of any dangers they discover;
inform the EU’s rapid information system (RAPEX) of any serious risks;
exchange information on product compliance via a common EU database;
cooperate with authorities in other EU countries.
National customs authorities may prevent an imported product from being sold in the EU if they believe it poses a serious risk to health, safety, the environment or any other public interest.
CE marking may only be attached to a product by a manufacturer or someone mandated to operate on their behalf, provided it satisfies all the conformity standards.

BACKGROUND

It has applied since 1 January 2010.Accreditation is part of an overall system that includes conformity assessment and market surveillance. Provisions in the regulation for the latter complement those set out in other pieces of EU legislation.
CE marking: a marking manufacturers use to indicate the item meets EU legal conformity standards.Conformity assessment body: a body that performs activities which include calibration, testing, certification and inspection.

DOCUMENTS

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17)

Successive amendments to Directive 2001/95/EC have been incorporated into the original document. This consolidated version is of documentary value only.

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128)

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, pp. 21-29)

Market surveillance and compliance of products

Regulation (EU) 2019/1020 — market surveillance and compliance of products aims to improve how the free movement of goods principle works by strengthening market surveillance* of products covered by EU hamonisation legislation. This must ensure a high level of protection of health and safety, in general and in the workplace, and protect consumers, the environment, public security and other public interest.

It lays down rules and procedures for economic operators* and establishes a system for their cooperation with supervisory authorities.
It establishes controls on products imported into the EU.

It deletes and replaces Articles 15 to 29 of Regulation (EC) No 765/2008 (see summary on Accreditation and market surveillance) and amends Directive 2004/42/EC and Regulation (EU) No 305/2011 (see summary on Construction products).

It applies from 16 July 2021. However, Articles 29, 30, 31, 32, 33 (on the EU Product Compliance Network) and 36 (on financing activities) apply from 1 January 2021.

KEY POINTS

The regulation applies to products:

covered by EU harmonisation legislation (and set out in Annex I);
imported into the EU which are not subject to specific legislation.

Certain products may not be offered for sale to EU consumers without an economic operator established in the EU:

who keeps EU conformity and performance declarations and makes these and the technical documentation available to authorities when asked;
who informs the authorities when they consider a product poses a risk;
who cooperates with the authorities, when asked, by taking immediate corrective action — from remedying the fault to recall or destroying the item — if a product is considered non-compliant, and helps to eliminate or mitigate risks;
whose name and contact details are on the product, packaging or accompanying document.

Market surveillance authorities:

carry out effective surveillance of products sold online and offline;
perform appropriate documentary, physical and laboratory checks on products, taking into account possible hazards;
act when a product, properly installed, maintained and used for its intended purpose:
could damage users’ health and safety,
does not conform to EU legislation;
ensure economic operators take corrective action when instructed and act when they fail to do so;
establish procedures to follow up complaints and reports and to verify economic operators have taken corrective action;
apply a high level of transparency and make available to the public any information they consider relevant to protect end users’ interests;
provide economic operators with grounds for their decisions to give them an opportunity to respond;
notify the European Commission and the other EU countries immediately of any measures they take if these could have an impact in other EU countries;
may ask colleagues elsewhere in the EU to help with investigations and enforcement and participate in peer reviews to improve the system’s overall efficiency;

have powers to:
start investigations on their own initiative,
require economic operators to provide relevant documents, data and information on supply chains, distribution networks, product models and ownership of websites,
carry out unannounced onsite inspections and physical checks,
enter any premises, land or means of transport an economic operator uses,
acquire product samples without revealing their identity,
instruct economic operators to take measures to end non-compliance or eliminate risk,
prohibit or restrict availability of a product and order it be withdrawn or recalled,
insist in case of serious risk that product content is removed from a website or require it be accompanied by a warning,
adopt measures, including penalties, against economic operators that fail to act.

EU countries:

designate one or more authorities with the powers of market surveillance, investigation and enforcement;
appoint a single liaison office to represent the surveillance authorities and communicate the country’s national strategy;
ensure the authorities and office have sufficient budgetary and other resources;
may authorise surveillance authorities to reclaim from an economic operator all the costs they incur when pursuing non-compliance cases;
draw up an overarching national market surveillance strategy every 4 years from 16 July 2022 to promote a consistent, comprehensive and integrated approach to market surveillance — this must include:

data on non-compliant products,
priority areas for enforcing the EU legislation,
enforcement activities to reduce non-compliance,
assessment of cooperation between authorities in other EU countries;
provide economic operators, at their request and free of charge, information on national implementation of EU product harmonisation legislation;
introduce effective, proportionate and dissuasive penalties and notify these to the Commission by 16 October 2021.

The Commission:

ensures the Your Europe portal provides users with easy online access to information about the EU’s product requirements, rights, obligations and rules;
adopts implementing acts;
assists the EU Product Compliance Network (see below) in all its activities;
maintains a computer system to store and process all the data collected;
reports to the European Parliament, the Council and the European Economic and Social Committee by 31 December 2026, and every 5 years thereafter, on the regulation’s implementation.
Specific rules apply to imported products:

EU countries designate authorities with the necessary powers to check imports;
market surveillance authorities provide them with information on products and economic operators where a high risk of non-compliance has been identified;
authorities may impound a product if the necessary documentation is absent or there are concerns it presents a serious health, safety, environmental or public interest risk, and only release it when certain conditions are met.

DOCUMENTS

Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, pp. 1-44)

Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, pp. 5-43)

Successive amendments to Regulation (EU) No 305/2011 have been incorporated into the original text. This consolidated version is of documentary value only.

Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, pp. 87-96)

Product Safety — EU Rapid Information System (RAPEX) Guidelines

Implementing Decision (EU) 2019/417 — guidelines for the management of the European Union Rapid Information System ‘RAPEX’ This implementing decision sets out guidelines for the management of the EU Rapid Information System (RAPEX) on product safety and its notification system, set up by Directive 2001/95/EC, the General Product Safety Directive (GPSD).

This implementing decision seeks in particular to update the scope of the system integrating certain aspects of Regulation (EC) No 765/2008 on the market surveillance of harmonised products, as well as to reference to new tools developed in recent years for the proper functioning of RAPEX (wiki, interface between RAPEX and ICSMS, the Information and Communication System on Market Surveillance platform set up under Regulation (EC) No 765/2008) and establish risk assessment methods and, in particular, criteria for identifying serious risks.
It repeals Decision 2010/15/EU.

Scope

These guidelines cover 2 sets of products:

products covered by the GPSD;
products covered by Regulation (EC) No 765/2008 on the accreditation and market surveillance of non-food products.This implies the inclusion of professional products and the extension of the risks to other risks than those for the health and safety of consumers, e.g. environmental risks.

The decision does not cover the following:

food and feed and other products covered by Regulation (EC) No 178/2002;
medicinal products covered by Directive 2001/83/EC (EU rules on the authorisation, import and production of medicines for humans) and Directive 2001/82/EC (EU rules on the authorisation, import and production of veterinary medicines);
medical devices covered by Regulation (EU) 2017/745;
active implantable medical devices covered by Directive 90/385/EEC;
second-hand products, antiques, or products to be repaired or reconditioned prior to use;
equipment used by professional service providers to supply a service.

RAPEX

RAPEX was set up for the rapid exchange of information between EU countries and the European Commission on products posing a serious risk to the health and safety of consumers. Its main features are that it:

prevents and restricts the supply of dangerous products;
monitors the effectiveness and consistency of market surveillance and enforcement activities;
identifies needs and provides a basis for action at EU level; and
ensures consistent enforcement of the EU product safety requirements.

Risk

Before an authority of an EU country decides to submit a RAPEX notification, it assesses whether the product to be notified poses a risk to the health and safety of consumers or, in the case of products covered by Regulation (EC) No 765/2008, a serious risk to the health, safety or, for example, security or the environment, of the end-users, and thus whether one of the RAPEX notification criteria is met.
Risk assessment guidelines and case studies are included in an appendix to the decision.

Action notified through RAPEX

Action to prevent or restrict sales can be taken, in relation to products posing a risk, either voluntarily by manufacturers or distributors, or ordered by an authority of an EU country. Measures include, albeit not exclusively:

marking a product with warnings about risks;
making the marketing of a product subject to conditions;
warning consumers and end-users of risks;
temporary ban on the product’s supply or display;
ban on the marketing of a product;
withdrawal of a product from the market;
recall of a product from consumers;
destruction of a withdrawn or recalled product.

Notifications

Participation in RAPEX is mandatory for EU countries, who must notify the Commission where the following 4 criteria are met for a product:

the product falls under the scope of application of the GPSD or under the scope of application of Regulation (EC) No 765/2008;
it is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use (‘preventive and restrictive measures’);
it poses a risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end-users;
it cannot be ruled out that the effect of the serious risk to the health and safety of consumers or, in case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end-users, goes beyond the territory of the notifying EU country.

Additional provisions for notifications covered by the decision include:

streamlining the processes for notification;
setting out the notification criteria;
defining the content of notifications;
establishing follow-up requirements for EU countries;
describing how notifications and their follow-up are handled by the Commission;
setting deadlines for the various types of action taken under the notification mechanisms;
setting out the practical and technical arrangements needed at Commission and national level for the notification mechanisms to be employed effectively and efficiently.

It has applied since 12 November 2018.

DOCUMENTS

Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, pp. 121-187)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-17)

Successive amendments to Directive 2001/95/EC have been incorporated into the original document. This consolidated version is of documentary value only.