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General Product and Safety Regulations

Responsibilities of Producers and Distributors

6.1 Just as with the General Product Safety Regulations 1994, the 2005 Regulations place an obligation on producers and distributors to supply only products that are safe, and to undertake relevant activities (where appropriate) to help ensure that a product remains safe throughout its reasonably foreseeable period of use.

6.2 Producers and distributors are required to provide consumers with all relevant information and warnings, and to keep themselves informed about possible risks. However, it is accepted that the nature and extent of action necessary will vary considerably depending on the product, the risks inherent in its use, and the type of consumer at which it is aimed. In addition, the Regulations recognise that a supplier is only required to act within the limits of his activity.

Producer and Distributor Notifications


6.3 A new obligation introduced by the 2005 Regulations requires producers and distributors who discover that they have placed an unsafe product on the market, or distributed such a product, to notify the competent authorities of the fact and what action they have taken to remove the risks to consumers. The Regulations require that such notifications should also be transmitted to the enforcement authorities of all the Member States in which they believe the product has been marketed. In general in the UK, producers and distributors will make these notifications to their Local Authorities, who will then pass the information on to the Department of Trade and Industry for onward transmission to other Member States. However, the first point of contact for certain product types will be different. It will be MHRA for medical devices and medicines for humans, VOSA for motor vehicles and HSE for products used in the workplace. Separate guidance for producers and distributors on these notification obligations will be made available on the DTI website – http://www.dti.gov.uk/ccp/topics1/safety.htm#gpsr

6.4 The authorities will advise on actions aimed at removal of the risk and work with the producer or distributor on completing the notification. The authorities will then forward this to the appropriate national contact point for further action, and to the DTI where there is a serious risk requiring notification under the rapid exchange of information scheme (RAPEX). Medicinal products and medical devices have their own notification systems and are therefore excluded from the RAPEX system.

6.5 The information provided in the notification must include that required to precisely identify the product, all information relating to tracing the product, and a description of the risks the products presents and the actions taken to remove those risks from the market. The form to use when doing this will be available from local Trading Standards and from the DTI website.

6.6 In practice, we expect that distributors in the supply chain will want to make the producer (especially if located within the Community) aware of problems they perceive (as the Regulations require them to do) before making a notification in case it relates to isolated circumstances or products (in which case notification is not required). Communication within the supply chain should also help agreement to be reached on who should make the notification for the product in question. Where the producer is in the UK our general expectation is that the producer will make the notification. However, a distributor who has become aware of a problem should make a notification under regulation 9 if he understands that on one else is doing so.

Isolated Circumstances or Products


6.7 It is not necessary to make a notification where it is clear that the risk is related to a limited number of specifically identifiable products or batches, and the producer or distributor has solid evidence to conclude that the risk has been fully controlled and its cause contained and dealt with. Such problems might include the malfunctioning of a production line, errors in handling and/or packing etc.

6.8 Further guidance on notifications can be found on the European Commission website

Cooperation


6.9 There is a specific requirement for producers and distributors, within the limits of their activities, to cooperate with the enforcement authorities at their request. This includes the provision of information relating to the product, the nature of the risk, the product’s supply and marketing, and also in taking appropriate action to remove the risk from consumers.

Information on Risks and Safety Instructions


6.10 Producers and distributors have for many years been obliged by product safety legislation to provide information and warnings as to the risks their products posed where those risks were not obvious and, where necessary, to provide instructions adequate to consumers’ needs as to the safe operation/use of the product. These Regulations maintain that requirement.

Obligations on Producers

6.11 A producer has a primary duty to place on the market only safe products but he also has more specific duties: l to provide relevant information to enable consumers to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use where such risks are not immediately obvious to the user. This should include information on the precautions to be taken to avoid those risks (for example, the need to wear protective gloves); and l to adopt measures commensurate with the characteristics of the products which he supplies, to enable him to be informed of the risks which these products might present and to take appropriate action, including, where necessary, withdrawing the product in question from the distribution chain.

6.12 Examples of such measures include: l marking the products, their packaging or other materials supplied with the product (e.g. instruction booklets) with the name and address of the producer (name and postcode is acceptable), product reference, and batch number where appropriate, so that they can be identified (in many cases the manufacturer’s normal quality control procedures will mean that batch marking is already in place); l sample testing of products on the market; l investigating complaints relating to safety, and keeping a register of such complaints; and/or l informing distributors of the monitoring work and the results.

6.13 The above are not mandatory requirements in every case and which of them will be appropriate to a particular product will be determined by the nature of the product, the group of consumers for whom it is intended and the type of activity in which the producer is engaged. In the case of producers, monitoring may, for a low risk product, consist largely of assessing complaints from consumers. More complex and higher risk products may involve a higher level of vigilance and attention from the producer involving an ongoing sampling programme. There may be advantage in seeking the advice of your local Trading Standards Department in each case and prior to the placing of a new product on the market.

Obligations on Distributors


6.14 A distributor is required to act with due care to help ensure that the products he supplies are safe. In particular, he must not supply products which as a professional he knows or should have presumed, on the basis of information in his possession, to be dangerous.

6.15 A distributor is also required to keep and provide documentation necessary to trace the origin of unsafe products. For the most part producers mark their products with a product reference (which may be its name) and/or its production batch to ease traceability, but there may be issues with very small products and products where it is impracticable for them to do so, or simply where the producer is not obvious. In these instances distributors’ records can be used to trace an unsafe product back to its source and thereby allow the enforcement authorities an opportunity to resolve the problem at source. Even where a producer cannot be identified (e.g. at the end of a long supply chain), keeping records of where the product was sourced should ensure that a producer can be traced back through the supply chain (but see paragraph 3 of Annex A in respect to Charities and Voluntary Organizations).

6.16 Producers and larger distributors often maintain product files that contain all manner of information relating to the products that they sell. It would be overly burdensome to suggest that all distributors, especially the smallest, should adopt such procedures. In these circumstances the documentation that is required to support Inland Revenue and VAT requirements should be sufficient so long as they show from whom the goods were purchased and, if not for retail, to whom they were sold. We appreciate that such records have to be kept for a minimum of 6 years. For most products we believe that will be sufficient to cover the life cycle of the product in normal or reasonably foreseeable consumer use. Where there is evidence that a particular product is normally or often in consumer use for a longer period the records should be retained for that longer period (but see paragraph 2.14 in respect of construction products). These records may be electronic.

6.17 A distributor is also required, within the limits of his activity, to participate in monitoring the safety of products that he supplies and pass on information on the product risks. In practice this will mean: l passing on to consumers information provided by producers about product risks; l passing back to producers safety complaints and information and experiences on safety related matters which he obtains from customers; l co-operating with the authorities and others in the supply chain in taking action to avoid or remove those risks.

6.18 The monitoring requirement placed on distributors should not be viewed in isolation. It clearly must be taken as part of the overall requirement for the distributor to supply safe products and, in general, it is anticipated that action by an enforcement authority would only be contemplated where the safety of a product is at issue.