European Union: European Commission Solidifies Reform To The Product Safety Regime

Last Updated: 25 April 2014
Article by Lukas Rootman

Summary and implications

The European Commission (the Commission) has published its proposals to revise the rules for the safety of consumer products marketed in the European Union (EU). To the extent that this removes uncertainty and promotes a more evolved regulatory regime in line with other regulated spheres, it can only be seen as good news for manufacturers and suppliers.

The prior three years of debate have culminated in the proposals which seek to bring the legislation in line with the "New Legislative Framework" agreed in 2008. For businesses in the consumer product supply chain, the reform package, once adopted, will have significant practical implications for manufacturers, distributers and sellers of products.

The new measures include, for example, the prospect of greater scrutiny and regulatory intervention when unsafe products are placed on the market and significant new labelling and documentation obligations. 

Product safety and technical document retention, including risk assessment

The proposed General Product Safety Regulation will be directly applicable and enforceable in every member state of the EU. It will encapsulate the current legislation in product safety within EU Directives and will include additional wider and more onerous obligations. An exception is where there are specific safety requirements such as the Toy Safety Directive or the Personal Protective Equipment Directive where these product specific requirements will remain.

Manufacturers will have to provide technical documents about the product, which include, in particular, a risk assessment and solutions to show mitigation or elimination of risks. This requirement will add to compliance costs and will need to be managed with care by all product manufacturers.

All economic operators (which includes manufacturers, own branders (a person who places a product on the market under his own name or trade mark), authorised representatives, importers and distributors) must be able to identify the economic operator that previously handled the product, and to whom they supplied the product, up to 10 years later.


One of the key issues addressed by new Regulations is the concept of traceability of potentially dangerous products, as the Commission put it, to "reflect the challenges of a globalised market". There are significantly enhanced labelling requirements, including the labelling of all products with country of origin, the manufacturer and importer, type, batch and serial numbers.

Where products are likely to pose a serious risk to consumer health and safety, the Commission can require operators to put in place an electronic traceability system.

Duties down the chain

The proposed changes prescribe more explicit obligations on parties in the supply chain to take responsibility for the safety of products they are handling. Each economic operator below the manufacturer in the supply chain will be expected to ensure that the economic operator above them has complied with certain key duties, in particular:

  • There are explicit obligations on importers to ensure that the manufacturer has complied with its obligations on labelling for manufacturer's identity and product identification, and has produced technical documents for the product.
  • A distributor (including wholesalers and retailers) must verify that the manufacturer and the importer have complied with their obligations on labelling for identity and product identification, and that the product is accompanied by consumer instructions and safety information in the appropriate language as produced by the manufacturer or importer.

This is in line with the intention of the Commission to ensure that information about potentially dangerous products is quickly disseminated among the enforcement authorities.

Market surveillance regulation

The current rules on market surveillance are spread across the current legislation on Consumer Product Safety, creating uncertainties for both economic operators and national authorities. The proposed Regulation on market surveillance of products will enhance and strengthen co-operation and exchange of information between national authorities, and with those outside the EU.

A further key development relates to the concept of "risk" in the Regulation: it does not apply only in the context of the health and safety of consumers. It will set out powers and responsibilities for authorities to deal with any "product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, consumer protection, the environment and public security...". Where a product presents a risk (a widely defined concept), economic operators must take corrective action, ranging from affixing warning labels to product recalls.


Member states would be free to determine national penalties for infringements by the relevant economic operator, despite the fact that the proposed EU Regulations will be directly applicable. Penalties must be calculated with reference to the size of the offending economic operator.

There are more explicit, and expanded obligations on national authorities to investigate and exchange information on product risks, including obligations to share information with authorities outside the EU, even if information is confidential to the business. There are also more explicit powers for national authorities to require manufacturers, importers and distributors to undertake recalls, and for the authorities to carry out recalls and other activities at the expense of the business.

The regime has been expressed to be a zero tolerance for formal breaches of labelling and documentation requirements.


The Commission asserts that the key to effective protection of consumers and the prevention of other risks is to ensure that the authorities have both the power and the obligation to enforce the regulations for which they are responsible.

In the case of harmonised products, an economic operator's non-compliance with labelling obligations, incomplete technical documents or failure to produce a technical document, will trigger action by national authorities. Such non-compliance will be considered sufficient reason for national authorities to decide that the product may present a risk and to require the economic operator to rectify the non-compliance, regardless of whether a risk assessment shows that the product does, in fact, present a risk. The product would be withdrawn from the market if the economic operator failed to rectify the non-compliance. The changes will result in increased costs for businesses and potentially greater risks in the event that unrecognised issues arise.

The reform package is now being considered by the European Parliament and Council of the EU. Depending on the outcome of that, the expected date for the new legislation to come into force is 2015. Companies should begin to plan now for the changes that they will need to make and budget for any extra costs that they may incur.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions