Consumer product safety reforms a step closer in Europe – Productwise | Popgen Tech
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The ‘final’ text of the new European General Product Safety[{” attribute=””>Regulation is now available. This is the text of the provisional agreement reached between the European Commission, Parliament and Council during the last round of trilogue discussions. Whilst there are still a few hurdles to clear before this becomes law, and it’s possible there could still be some changes to the text, this is largely expected to represent what the final legislation should look like. Further detail is set-out below, however in short, this matters because we now know it will introduce:
- a new reporting obligation across the EU to report “without delay” “accidents caused by a product” where the incident has resulted in “death or “serious adverse effects on health or safety”.
- the creation of an independent obligation on online marketplaces to report any accident caused by a product“resulting in serious risk to or actual damage of the health or safety of a consumer”. This obligation, which appears to be broader than reporting the obligation on manufacturers, will give rise to significant challenges and concerns for product manufacturers.
- new requirements for product recalls,
- new obligations to undertake risk assessments prior to placing products in the market
- new requirements for online offers, and
- new documentation and labelling requirements for non-harmonised products (i.e. non CE marked products) and
- the possibility of class actions being brought for breaches of the GPSR.
It provides for an 18 month transition period. On current timings, it could be fully in force by Q4 2024.
Here are the highlights.
What is it?
The proposed General Product Safety Regulation (GPSR) was published by the European Commission in June 2021 to repeal and replace the existing General Product Safety Directive 2001/95/EC (GPSD). The legislative proposal has been working its way through the European ordinary legislative procedure. Provisional agreement on the text was reached during interinstitutional trilogue negotiations between the Commission, Parliament and Council during the final round that took place on 28-29 November 2022. We’ve been waiting for the text to be published and it’s just landed.
These reforms are the culmination of a long period of consideration and debate about this in Europe. The existing GPSD is around 20 years old, and reform has been under consideration for some 10 years after a failed attempt in 2013.
Why does it matter?
The GPSR represents a substantial update from the current rules. Some of the key changes include under the GPSR include:
- Introduces a new accident reporting obligation in the EU:
- the new rules, if passed, would introduce a mandatory obligation on a manufacturer to notify the authorities via Safety Gate if there is “an accident caused by a product”. A threshold to trigger the reporting obligation has been added into the provisional agreement by the co-legislators as “occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on their health and safety, permanent or temporary, including injuries, other damages to the body, illnesses and chronic health effects”. The Commission’s original legislative proposal did not include a threshold – so this is a welcome outcome.
- the time limit to file a report would be “without undue delay from the moment [the manufacturer] know about the accident”. This has changed from “two working days” under the Commission’s original proposal.
- where the manufacturer is not established in the EU, the ‘responsible person’ in the EU who has knowledge of the accident must ensure that a report is made.
- a separate obligation on online marketplaces to report without undue delay any accident of which they are informed “resulting in serious risk to or actual harm to the health or safety of a consumer caused by a product made available on their marketplace” to report was added in the preliminary agreement.
- Introduces additional factors to consider in an assessment of whether a product is safe:
- such as the different impact on health and safety of different genders, risks to the most vulnerable consumers (eg children), connectivity / interconnection with other products, the effect of software updates / software downloaded afterwards, cyber security and the evolving, learning – and predicative functions of a product.
- in relation to mental health risks:
- wording contained in the considerations of the Commission’s original legislative proposal that risks to health would include psychological risks, developmental risks (especially for children), mental risks, depression, loss of sleep or altered brain function, has been removed and is not contained in the provisional agreement ;
- however, new wording proposed by Parliament has been included (also in the recitals) to expressly note that an assessment of safety will include the “health risk posed by digital connected products, including on mental health, particularly on vulnerable consumers, in the in particular, must take into account children” and “when assessing the safety of digital connected products likely to have an impact on children, manufacturers must ensure that the products they make available on the market meet the highest standards of safety, security and privacy by design in the best interests of children.”,
- the requirement to consider foreseeable abuse contained in the Commission’s proposal was removed in the provisional agreement.
- Set new requirements for non-CE marked products (eg some accessories) to align with requirements for CE marked products:
- to carry out an “internal risk analysis”, draw up and keep up to date a technical file. The extent of what the file should contain will depend on the risks of the product
- stricter requirements for labeling and traceability information
- to establish a ‘responsible person’ in the EU with certain obligations. There are associated labeling requirements to include certain information about the responsible person.
- New requirements for online offers: including displaying any warnings or safety information required to be affixed to the product, its packaging or an accompanying document in terms of EU product laws, information that allows the identification of a product (note the requirement to use batch or serial numbers that were left out of the provisional agreement in the Commission’s original proposal) and name and contact details for manufacturer and responsible person in the EU (where applicable)
- E-labelling: the provisional agreement does not go so far as to have e-labeling replace physical markings, labeling and other information that must accompany products. Instead, it expressly allows certain information to be additionally provided in a digital form such as a QR code. In our opinion, this is a lost opportunity and does not change the status quo, which continues to ignore the benefits of using electronic means to communicate with consumers and provide relevant information.
- New requirements for advertising withdrawals and withdrawal notices:including requirements to directly inform consumers “without undue delay” who can be identified using customer data, to provide the recall notice or safety warning through other appropriate channels such as the company’s website, social media channels, retail outlets etc. way that is accessible to consumers with disabilities. Requirements for the content and form of recall notices, a ban on the use of certain terms such as “voluntary”, “precaution”, “in rare/specific situations”, that there have been no reported accidents and to include a stop use instruction (among other requirements).
- Set rules for means of revocation: will have to offer the choice between at least two of a refund, repair or replacement (unless this would be impossible or disproportionate, in which case one remedy may be offered). A refund must be at least equal to the purchase price (ie removing the ability to deduct an amount for use or age of the product). Proposed wording in the considerations that appeared in the Commission’s original bill that the most sustainable means should be preferred was removed in the preliminary agreement.
- Online marketplaces: new obligations imposed on online marketplaces, including the establishment of a single point of contact for market surveillance authorities and also consumers, to cooperate with authorities, to respond to notifications from authorities within 2 working days and to process notifications related to product safety issues arising under the Notice has been issued and Action Mechanism under the Digital Services Act within 3 working days, design interfaces to enable traders to display the information required for online offers, report dangerous products via Security Gate, report accidents via Security Gate, notifying affected consumers directly about recalls and publishing information about recalls (among other things).
- Expanded role of Security gate: will become mandatory to use to notify product recalls and will be the portal for the new accident reporting obligation. Consumers and “other interested parties” will be able to use Safety Gate to report products that may pose a risk.
- Increased enforcement: including that the Commission must organize on a regular basis joint activities between market surveillance authorities to inspect secretly purchased products, obligations on authorities to carry out coordinated sweeps of specific products/product categories, together with provisions on international cooperation between the Commission and international regulators.
- Penalty goals: the minimum maximum fines of 4% of the annual turnover contained in the Commission’s original proposal were removed in the preliminary agreement. Instead, thresholds for penalties will be left to the discretion of member states, but must be effective, proportionate and dissuasive.
- Class actions: amend the new EU representative action directive to allow class actions for any infringements of the proposed GPSR (under the current rules only certain infringements of the GPSD are included).
- Transition period: 18 months (which is longer than the Commission’s original proposal of 6 months). The new legislation will be in the form of a regulation (meaning it will apply directly in all member states without the need for national legislation to implement it)
What’s next?
Where can I find out more?
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