Product Safety – Managing the Risks
Product Safety – Managing the Risks
For any company marketing a consumer (non-food) product, managing the safety requirements associated with that product is a key part of the process, both prior to and during commercialization.
To manage such safety requirements, manufacturers and other economic operators in the supply chain must first verify whether the product falls within the scope of specific EU legislation (such as, for example, the Low Voltage Directive, the Radio Equipment Directive, the Toys Directive, the REACH Regulation, the Medical Devices Regulation, and the Biocidal Products Regulation). In addition, for consumer products for which there are no or only partial specific provisions in the EU harmonizing legislation covering the safety of the products concerned, the General Product Safety Directive 2001/95/EC (GPSD) will residually apply. On the other hand, products for which there exists a comprehensive distinct safety legal framework, such as food, pharmaceuticals and medical devices, are entirely governed by their respective frameworks (including specific alert systems) and thus in practice excluded from the scope of the GPSD.
General Product Safety Directive and the new proposed Regulation
The General Product Safety Directive (GPSD) is thus, to a varying degree, relevant for a very large range of consumer products. It has been transposed into the national laws of all EU Member States. In Belgium, this Directive is transposed in Book IX of the Belgian Code of Economic Law, with this particularity: that the scope of the safety provisions of Book IX has been broadened to include both consumer and professional products.
As part of its general exercise to ensure that EU legislation is still adequately protecting consumers in the digital age, the Commission has undertaken to modify and replace the GPSD by a regulation on general product safety (GPSR). The GPSR will have direct effect in the Member States and supersede the current national legislation that transposed the GPSD. Its modifications are thus relevant to all economic operators placing or making available consumer products on the EU market.
GPSR novelties that will have a direct impact on economic operators
If adopted, the GPSR will modify certain obligations applicable to all economic operators throughout the supply chain in comparison to the GPSD.
Some key modifications proposed by the GPSR are intended to align the safety and market surveillance rules set out in the GPSD with the rules and methods generally applicable to harmonized products, for example, under Regulation (EU) 2019/1020 on market surveillance and compliance of products.
The GPSR will indeed, amongst others, prohibit the placement on the market of non-harmonized consumer products unless an economic operator established in the EU is identified as responsible for certain product compliance tasks, such as ensuring the availability of the conformity documentation, cooperating with market surveillance authorities and informing authorities when they have reason to believe that a product presents a risk. These proposed modifications will mainly affect non-EU manufacturers selling online in the EU (i.e., in case of direct imports) and the EU-based operators of their logistic chain of supply.
However, the GPSR will also entail some modifications that will have a practical impact on EU-based manufacturers of non-harmonized products and the EU-based economic operators of their supply chain (i.e., the distributors). In particular, the GPSR will introduce requirements such as:
- An obligation on the manufacturer to draw up technical documentation, which must contain the necessary information to prove that their product is safe.
- An obligation on the manufacturer and, where applicable, the importer to keep such documentation for 10 years after the placement on the market of a product.
- An obligation on the manufacturer to issue notification of any accident within two days after becoming aware of it, and a corresponding obligation on the importers and distributors to inform the manufacturer of any such accident.
- An obligation to have internal processes for product safety in place so as to allow them to respect the general safety requirements applicable to them.
- A potential obligation to comply with stricter traceability requirements for products that are likely to pose a serious risk.
- An obligation to proceed with periodic sample testing.
- An obligation to use the Safety Business Gateway (set up by the Commission) to notify risks to the market surveillance authorities and consumers.
Finally, it is interesting to note that the proposed GPSR clearly determines and defines the content of a recall notice (a description of the product including a photograph, the name and brand of the product, a clear description of the hazards associated with the product and the prohibition of the use of words such as “precautionary” or “voluntary”, etc.). These requirements are actually aligned to the most current best practices in terms of recall notices.
The GPSR will be directly enforceable in the Member States without the need of transposition. It will introduce definitions and requirements for non-harmonized consumer products, which, although already largely applied with respect to harmonized products, may be quite novel to certain economic operators.
Moreover, it can be expected that some Member States, such as Belgium, which in their national legislation had transposed the principles of the GPSD also to apply to professional products, will again proceed this way as regards the principles and requirements of the GPSR.
Finally, the GPSR can, in large part, be seen as the confirmation in law of commonly accepted evolutions in the EU harmonized product safety sector. Even if the adoption of the GPSR is delayed or the text is further modified, good practice dictates that some of its concepts should already be applied to current product safety processes: in particular, as regards the definition of safety and the drawing up of a technical file, the content of a product recall notice, the setting up of clear and determined internal processes for product safety, the use of the Safety Business Gateway, the setting up of clear, swift incident/accident reporting processes throughout the supply chain, etc.
REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. The REACH Regulation is an essential product compliance regulation for the chemicals in the EU and has led the way for other legislation like the RoHS Directive and the EU Waste Framework Directive. The regulation – like chemistry itself – is complex, and it can be difficult to grasp all its compliance requirements. Every company doing business in the EU needs to know which REACH-regulated substances are in its products, and, in turn, suppliers must be able to provide this information. In that regard, it should be remembered that REACH places the burden of proof on companies. In order to fulfil the obligation to communicate information on SVHC (Substances of Very High Concern) to recipients (including consumers), the content of the necessary letters/declarations must be carefully assessed in order to ensure that they can serve as evidence for compliance with REACH. This obligation generates a huge flow of information, requiring companies to write to their (often numerous) suppliers in order to let them know which REACH compliance requirements apply to their products. As the REACH Candidate List (of SVHC), the Authorization List, and the Restricted Substances List (Annex XVII to REACH) are regularly updated, companies are advised to monitor their REACH compliance requirements on a regular basis, because any relevant update could introduce a significant risk of REACH non-compliance to an existing product line. Companies therefore should have a monitoring system in place to oversee all REACH list changes and should audit their supply chain for the presence of any SVHCs.
New Medical Devices Regulation
The Medical Devices Regulation 2017/745 (EU MDR) came into force on May 26, 2021. It updated the EU regulatory framework, and manufacturers, importers and distributors must now comply with the terms of this Regulation. If they do not, they run the risk of having their products removed from the EU market.
The EU MDR introduced some major changes, such as the expansion of regulation to products that were not subject to the requirements in the previous Medical Devices Directive (EU MDD), including aesthetic products without an intended medical purpose but with the same characteristics and risk profile as medical devices. The new rules also require most companies to update clinical data, technical documentation, and labeling. A Unique Device Identification (UDI) will be implemented to help track devices throughout the economic operator supply chain, and it will be required on all labels. The EU MDR also adds the requirement that at least one person in the organization be formally assigned responsibility for ensuring the regulatory compliance of the enterprise (except for those organizations that already have a Quality or Regulatory Compliance or Safety Manager).
Further, it should be noted that devices previously compliant with the EU MDD may be placed on the market until May 26, 2024, so long as, from May 26, 2021 (i) the device continues to comply with the EU MDD, and (ii) there are no significant changes in the design and intended purpose of the product.
Biocidal Products Regulation
The Biocidal Products Regulation 528/2012 (EU BPR) provides a regulatory framework for biocidal products placed on the EU market. Biocidal products must be authorized before they can be placed on the market, and the active substances contained in biocidal products must be previously approved.
The Review Programme of existing active substances, initiated under the previous Biocidal Products Directive, continues under the EU BPR. Biocidal products containing active substances in the Review Programme can be placed on the market and used (subject to national regulations) until the final decision (and up to three years thereafter) once the active substance has been approved. A biocidal product may not be placed on the EU market if the active substance supplier or product supplier is not listed in the active substances’ suppliers list, the so-called Article 95 list.
The EU BPR also requires that articles can only be treated with biocidal products containing active substances that have been approved in the EU. Companies are required to provide consumers with information about the biocidal treatment of articles they sell on the EU market. The treated articles should be labelled appropriately either when a claim is made regarding a biocidal property, or when this is required by the conditions of the approval of the active substance that is contained in the biocidal product. Lastly, the labeling of treated articles must be done in accordance both with the EU BPR and the CLP Regulation (on classification, labelling and packaging).
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