2014 has seen a raft of changes to EU product safety legislation and more are on the horizon. In this article we provide an update on the following:
- In March 2014 the European Commission (the "Commission") published 9 new Directives relating to the safety of products across a variety of industry sectors continuing the process of aligning pre-existing legislation to the new framework on sectoral product harmonisation in order to ensure greater consistency of the rules across Europe.
- Less progress was made on the proposals to revise the scope of the general product safety and market surveillance rules, but it is hoped that the presentation of new evidence on the controversial country of origin requirement in early 2015 will encourage the Commission and the European Parliament ("EP") to reach a compromise. That aside, the proposals maintain most of the existing product safety requirements, but also impose stricter documentation and notification obligations.
Proposal for a Consumer Product Safety Regulation ("CPSR")
The key points of the CPSR, as currently drafted, are as follows:
- The proposed CPSR would replace the General Product Safety Directive (2001/95/EC) ("GPSD").
- Like the GPSD, the CPSR would cover all non-food manufactured consumer products with the exception of a specific list of excluded products, such as medicines and antiques. The range of products covered by the proposal is extended beyond the scope of the GPSD to include products which consumers are exposed to in the course of services provided to them, but which consumers do not actually use themselves, e.g. teeth whitening products and sun beds as used by service providers on consumers.
- The CPSR aims to improve product traceability and associated documentation by requiring all products covered by it to be marked with a batch and lot number, the identity of the manufacturer and importer and, for the first time, the product's place of origin.
- The proposal involves using the non-preferential origin provisions in the EU Customs Code to determine the country of origin, the complexity of which will undoubtedly add to the burden on manufacturers should this provision survive the legislative process.
- Other obligations imposed on economic operators by the CPSR include a requirement for manufacturers to draw up technical documentation for their products, which includes undertaking risk analysis and risk management by showing what standards have been applied, what testing methods have been used and what the results were.
- Economic operators are obliged to take corrective measures if they have reason to believe that the product they have made available is not safe or not in conformity with the legislation. Corrective measures include withdrawing a product from the supply chain or recalling it from end users, even for formal non-conformities, such as having no signature on the CE form.
Proposal for a Market Surveillance of Products Regulation ("MSR")
A new MSR is planned to bring together the market surveillance rules currently found in Regulation 765/2008, the GPSD, and sector-specific pieces of EU legislation.
The aim of the MSR is to simplify the current regime and improve cross-border cooperation between Member States by codifying the powers of the market surveillance authorities into one regulation. It will increase the obligations on the authorities by setting out what checks should be made on products and the procedure they should follow in order to ensure surveillance is effective. For example, authorities will be able to act by blocking imports or ordering sales to be stopped, even where a product does not present a health and safety risk. Even formal non-conformities such as a failure to state the country of origin will require rectification, and if rectification is not possible, withdrawal from distribution channels may be necessary.
A new overarching guiding body of Member States' market surveillance authorities (the European Market Surveillance Forum) is proposed to coordinate information exchange, organise joint market surveillance and joint testing, and to establish best practice. The Information and Communication System for Market Surveillance will also be extended to all Member States. Finally, the RAPEX system will be moved from the GPSD to the MSR, and it is thought that the website may be used to report allrisk types and levels rather than just significant risks to health and safety.
The result of these changes is that economic operators will likely notice an increase in market surveillance activities, including spot checks of products on shelves and at external borders.
The EP and the Commission have so far failed to reach common ground during their negotiations of the proposals, with the new country of origin requirement proving to be the main sticking point.
The disagreement reportedly stems from the fact that northern Member States (including the UK and Germany) consider the requirement to be overly burdensome for economic operators and disadvantageous to imported products which, as a result of global supply chains, are often made in non-European jurisdictions. Other Member States argue that mandatory marking of origin will have a positive effect on consumer protection.
With the aim of progressing negotiations, the EP has invited the Commission to present further information and evidence on the benefits of the proposed mandatory marking of origin. The Commission is gathering evidence to present a technical study at the beginning of 2015. The current drafts of the CPSR and the MSR can be found here and here respectively.
The "Alignment Package" to the "New Legislative Framework" ("NFL")
The package of measures known as the NFL was adopted by Council Regulation 765/2008 in July 2008. This was complemented by Council Decision 768/2008/EC (on a common framework for the marketing of products) which sets out reference provisions and general principles to be incorporated into future product harmonisation legislation. Together, the statutory instruments form a consistent legal framework for the marketing of products.
With a view to bringing product harmonisation legislation into line with the NFL, the Commission adopted a package of proposals to accelerate the alignment of nine Directives, which would not have been revised in the near future, to Decision 768/2008 (the "Alignment Package"). The objective of the Alignment Package is to ensure better product safety by clarifying definitions, obligations of economic operators, traceability requirements, conformity assessment bodies and procedures, and CE marking.
Whilst the Pyrotechnic Articles Directive was aligned in 2013, on 29 March 2014 the following eight Directives were published in the Official Journal:
- Directive 2014/35/EU on the marketing of electrical equipment designed for use within certain voltage limits (known at the Low Voltage Directive);
- Directive 2014/30/EU on the harmonisation of the laws of Member States relating to electromagnetic compatibility (recast);
- Directive 2014/34/EU on the harmonisation of the laws of Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (known as the WMC Directive);
- Directive 2014/33/EU on the harmonisation of the laws of Member States relating to lifts and safety components for lifts;
- Directive 2014/29/EU on the harmonisation of the laws of Member States relating to the making available of simple pressure vessels
- Directive 2014/32/EU on the harmonisation of the laws of Member States relating to the making available on the market of measuring instruments (recast);
- Directive 2014/31/EU on the harmonisation of the laws of Member States relating to the making available on the market of non-automatic weighing instruments; and
- Directive 2014/28/EU on the harmonisation of the laws of Member States relating to the making available on the market and supervision of explosives for civil uses (recast).
Whilst there is still disagreement over the country of origin requirement, the legislative timetable for when the CPSR and MSR will come into force remains unconfirmed. What is clear is that changes to the product safety rules remain a priority for the Commission. Manufacturers should be mindful that when a resolution is reached many of them will have to implement new technical information gathering and traceability requirements, which will require serious consideration.