Bolton Consultancy Ltd

Proposed NEW General Product Safety Regulation

The European Commission published proposals in early 2013, to replace the General Product Safety Directive with a new regulation; the Consumer Product Safety Regulation (CPSR).   The current directive had to be implemented in each member state as local legislation - hence the UK Government for example enacted the General Product Safety Regulations 2005.   The proposed EU Regulation, when enacted, will apply in all member states directly; so removing the possibility of different interpretations in different states.   In addition to replacing the GPSD the Commission are proposing a new regulation, the Market Surveillance of Product Regulation (MSPR) which will replace market surveillance provisions contained within the GPSD (and a range of other instruments) with a unified approach to market surveillance across the EU.

Obligations under the proposed CPSR

For Economic Operators (EOs) across the EU, the proposed Regulation will not change existing obligations to ensure only safe product is placed on the market [Note: EOs include Manufacturers, Importers, Distributors, Agents and Retailers etc.]. It does however clarify the requirements for what EOs need to do related to product safety.   Most measures should already be in place in companies across the EU in order for them to demonstrate compliance with the current directive, but company procedures may need strengthening or streamlining.   Specific obligations fall on EOs depending on their role(s) in the supply chain but all must discharge due care in assuring that the safety and compliance of product is not compromised in storage, transport, distribution or any process they may apply, and not place on the market any product that does not conform.   The scope of the proposed CPSR still relates only to products which are not covered by other sector specific requirements and is intended to allow different product types to be treated with a more consistent approach.

The main requirements are outlined below:

Marking of Product

The product must carry several specific pieces of information; allowing for practicalities this can be on a label, the packaging or on accompanying documentation as follows:

Product identification needs to be sufficient to distinguish one product - should it present a risk - from otherwise similar products, allowing it to be traced through the supply chain and to the consumer.

Inclusion of Safety Instructions

Where a risk is present if the consumer fails to install, use or maintain a product as intended by the manufacturer, sufficient safety or user instructions must be provided.

Assessment of Risk

Within the limits of their role EOs must assess the risk associated with product and its compliance, or ensure such assessments have been carried out and adequately documented.

Keeping Records

EOs must retain records for ten years, depending on the role in the supply chain of:

Monitoring of Product Risk

Depending on their role EOs need to have procedures in place for monitoring product risk, both through the manufacturing process and after product has been placed on the market.   The areas covered specifically include:

Notification and Response to MSAs

If product is found to be unsafe EOs must notify the MSAs including all relevant technical information, corrective action taken and identify where they have made product available.   They must also inform their suppliers and distributors.

When requested by MSAs EOs must provide the identity of suppliers and distributors; and this needs to be possible for a period of ten years after the product has been received or placed on the market.

Procedures for Corrective Actions

EOs are required to immediately take corrective action if product is found to be unsafe or non conforming. Depending on their role this will require procedures for a company, in line with the severity of the risk, to:

Implications of the MSPR

MSPR places further obligations on EOs to provide documentation and information to MSAs both on request, and in a language that can be easily understood by them.   It is also significant that it urges MSAs to treat formal non compliance, that is where documentation or marking is wrong but the product is otherwise still safe, as though they were dealing with an unsafe product.

Further information

Bolton Consultancy Ltd provides assistance in the requirements and procedures needed for compliance with the general product safety requirement.   For further information on current product safety obligations or the proposed regulations please contact us.

The information contained in this note is believed to be accurate at the time of writing but is for information only and should not be relied upon. Reference should be made to the published standards or regulations.