General Product Safety Directive

Table of Contents


Scope

The General Product Safety Directive is a "horizontal" directive applying to all those products addressed to general consumers which do not have more specific EU legislation setting out safety requirements.


The Directive: GPSD 2001/95/EC

Directive 2001/95/EC became fully applicable on the 15th of January 2014. Objective of the Directive is to ensure that products placed on the European market are safe (Art. 1 par.1). Accordingly, the GPSD aims at protecting consumers from unsafe products.

The safety essential requirements must be ensured for products to be lawfully placed in the European Economic Area.

Art. 2 GPSD defines a safe product as "any product which, under normal

or reasonably foreseeable conditions of use [..], 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 safety evaluation must be performed concerning the relevant product and the below must be taken into account:

  • "the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance,
  • the effect on 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,
  • the categories of consumers at risk when using the product, in particular children and the elderly.” (Art. 2 par.B).

Under certain conditions, if a product is deemed to be unsafe, the European Commission can ban the marketing of it, recall it from customers and withdraw it from the market.

EU Member State enforce the GPSD requirements and are entitled to request all necessary information to the involved parties and take samples and perform safety checks of any product on the EU market.

The directive provides an alert system, the RAPEX system, which ensures the exchange of information about risk assessments, dangerous products and scientific development amongst other aspects necessary for control of safety of products.


Compliance

Manufacturers need to determine the applicable standards for the product, at European, and/or international and/or national level, and then identify the appropriate conformity assessment module according to the product characteristics. The technical documentation to be compiled per product type should include the following:

  • Safety Evaluation and Risk Assessment Report,
  • Complete (exhaustive) list of standards your product is currently complying with (EN, international or nationals),
  • Declaration of Conformity of the product,
  • Quality Management System in place or ISO Certificate,
  • Instructions of Use including any relevant warning concerning the correct use of the product and explanation of any possible risks your product expose the end user to,
  • Labeling: labels should clearly mention both manufacturer's name and complete details (address, tel., fax, email address) and the "European Authorized Representative" complete details (name, address, email address),
  • Vigilance & Traceability activities such as tracking any compliants reported by the users.

Authorized Representative

Non-EU Manufacturers are strongly encouraged to appoint a professional European Authorized Representative so as to be informed of all the necessary documentation, applicable standards in relation to their products and any change in the applicable requirements.

At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:

  • Keeping the Declaration of Conformity and the technical documentation available to the national market surveillance authorities at all times and for 10 years after the product has been placed on the market,
  • Accommodate any reasoned requests from the national Competent Authorities relating the documentation or conformity of the product,
  • Cooperate with the national Competent Authorities regarding and actions to be taken to eliminate and risks related to the product for which they are responsible under the EAR written mandate.

The Authorized Representative should be clearly identified on the packaging to ensure efficient communication between end-users, Competent Authorities, economic operators with regard to the product(s) compliance.


Post-Market Surveillance

It is the responsibility of the manufacturer  to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves.

Post-Marketing surveillance activities include, but are not limited to:

  • Staying up-to-date on new requirements or legislative changes,
  • Continual updating of the technical file as modifications are made to the product,
  • Reporting of any incidents related to the product use,
  • Removal of non-compliant batches from EU economics operators and end-user,
  • Keeping technical file available for 10 years after the last batch entered the EU market.

Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.


Risks of Non-Compliance

Non-compliant products enter the EU Market everyday - whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.

Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.

In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX,
  • Warehousing Fees,
  • Requested Withdrawal,
  • Mandated Withdrawal,
  • Product Recall (from end-users and/or the market),
  • Complete ban on marketing of the product,
  • Destruction of the product,
  • Fines,
  • Revocation of the CE Marking.

The professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.


Need more information regarding the General Product Safety Directive? Contact us now!

Get in touch