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General Product and Safety Regulations

ENFORCEMENT

7.1 Enforcement of the Regulations is the responsibility of the Vehicle Operator Services Agency (VOSA) so far as safety problems with vehicles are concerned, and in the case of medicines and medical devices the enforcement authority will be the Medicines and Healthcare Products Regulatory Agency. Otherwise the principal responsibility for day-to-day enforcement of the Regulations, including in respect of individual unsafe vehicles on dealers’ forecourts, rests with Local Authorities, primarily local Trading Standards Authorities in England, Wales and Scotland, and in Northern Ireland District Council Environmental Health Officers (EHOs). EHOs also have responsibilities under the regulations in England, Wales and Scotland. This responsibility largely manifests itself in respect of products used by consumers in the course of the delivery of a service on work premises such as restaurants, hotels and in leisure facilities. In most cases EHOs will find that their existing powers under health and safety at work legislation will be sufficient to resolve the risk that has been identified. But in some circumstances EHOs may be required to enforce under these Regulations. For example: l a kettle in a hotel room with a frayed cord would clearly be for EHOs to deal under their existing powers; l an unsafe child’s booster seat not available on general sale but in wide use by restaurants across the country is an example of a product where EHOs might need recourse to these Regulations; l a kettle that was in a hotel bedroom but found to be inherently unsafe and on general sale would be an example of a situation where it would be more appropriate for EHOs to pass information about the product to their trading standards colleagues for wider enforcement activity.

7.2 HSE are the sole enforcers in respect of some product-specific Regulations (for example on machinery safety) where the products concerned are used by the trade in the workplace. However, where and to the extent that a particular product is a dual-use product, or where it has migrated from the professional to the consumer market, HSE will be required to coordinate and cooperate with other appropriate enforcement authorities (principally Local Authority Trading Standards Departments) to ensure that there is safety coverage for consumers as necessary at the borderlines under the provisions of these Regulations.

7.3 Enforcement should take due account of Service Delivery Plans drawn up under the National Performance Framework (particularly in England, Scotland and Wales) and should also, wherever possible, follow the principles of the Enforcement Concordat. The Government is currently consulting on the “Better Regulation Bill” and this consultation includes proposals for the future of the Concordat. One proposal is to change the Concordat to a statutory basis. The full consultation document can be found at: http://www.cabinetoffice.gov.uk/regulation/bill_for_better_regulation/index.asp

7.4 The General Product Safety Regulations highlight the importance of enforcement authorities reaching voluntary agreement with producers and distributors on action to remove risk to consumers, and this should be the principal objective for enforcement authorities as long as this is compatible with protecting consumer safety.

Cross Border Investigation, Seizure and Prosecution


7.5 Local Authorities are given the power under the Regulations to: l enter premises (including by warrant if necessary); l make test purchases and undertake testing; and l seize records and products from producers and distributors in the supply chain whether they are in its own Local Authority area or another area.

7.6 For the purposes of efficient enforcement, a Local Authority in England and Wales may investigate and prosecute for an alleged contravention of the Regulations that was committed outside its Local Authority area but within England and Wales. Similar arrangements apply for district councils within Northern Ireland. In Scotland prosecutions are the responsibility of the Lord Advocate and Part 1 of the Criminal Procedure (Scotland) Act 1995 applies. Identical offences committed by the same offender across several Sheriffdoms may be prosecuted in any one of them. Similar provisions apply to the District Courts.

The Home Authority Principle


7.7 The Local Authorities Coordinators of Regulatory Services (LACORS) promotes the “Home Authority” principle, under which the Local Authority for the area where the decision-making function of a business is located (usually a business’s headquarters or main place of business) accepts the primary responsibility for offering advice and preventative guidance on a regular basis on safety (and other related matters) to the business. Other Local Authorities should liaise with the relevant home authority on any safety matters arising from the products supplied by that business and before implementing any measures. Businesses are encouraged to make contact with, and seek advice on any particular matter from their home Local Authority.

7.8 The Home Authority principle is aimed at promoting uniformity of approach to regulatory services reducing duplication and assisting businesses to comply with the law. LACORS monitors the effectiveness of the principle and fulfils a role in resolving any differences of interpretation in appropriate cases. Guidance on the Home Authority principle can be found on the LACORS website – www.lacors.gov.uk – or from LACORS, 10 Albert Embankment, London SE1 7SP (tel: 020 7840 7200).

Products originating from outside the United Kingdom


7.9 As under the 1994 Regulations, enforcement authorities will continue to have the power to take action in the UK to safeguard the health and safety of UK consumers in cases where a product is first placed on the market in another Member State and is then found to be unsafe when supplied in the UK.

Measures available to enforcement authorities


7.10 Dialogue and the encouragement of voluntary action is specifically encouraged as an alternative to formal enforcement. However, enforcement authorities have access to a range of measures that can be employed in removing risk to consumer safety where producers and distributors have not fulfilled their obligations under these Regulations.

7.11 Generally, it is assumed that where the producer or distributor is already taking the action necessary to remove the risk to consumers it will not be necessary for the enforcement authorities to serve a safety notice.

7.12 Other than in the case of urgency resulting from the identification of a serious risk the parties concerned must, whenever feasible, be given an opportunity to submit their views before the adoption of a measure. In other cases they must be given the opportunity to comment following implementation of the measure.

7.13 The measure chosen must be proportionate to the seriousness of the risk:

Suspension Notices
– Where there may have been a breach of the Regulations, these notices temporarily ban the placing on the market or the supply of a product while tests are undertaken and the results are being waited for;

Requirement to Mark and Requirement to Warn
– these powers allow an enforcement authority to order the marking of a product with suitable warnings where it could pose risks in certain conditions, or require that specific warnings be given to certain persons considered to be at particular risk from a product (e.g. young children, the elderly etc);

Withdrawal Notices
– enforcement authorities can issue a Withdrawal Notice to permanently prevent a person from further supplying a product that is believed to be dangerous where it is already on the market (if the voluntary action taken by producers and distributors is insufficient or unsatisfactory) or from placing it on the market if it has not yet been so placed;

Recall Notices
– where an enforcement authority has reasonable grounds for believing that a dangerous product has already been made available to consumers and voluntary action falls short of that considered necessary and sufficient to remove the risk, a last resort (i.e. no other measure available to the authority will suffice) power to serve a Recall Notice exists. This will require the person on whom it is served to take such steps as are identified in the notice to organise the return of the product from consumers. We understand though that in the case of high volumes of small, low-value, unsafe products, disposal by consumers could well serve the purpose of a recall as an alternative to the return of the product. Where a disagreement exists between the authority and the producer/distributor over whether recall is necessary, business may require the authority to seek a reasoned opinion on the case for recall under a scheme operated by the Chartered Institute of Arbitrators set up by the DTI specifically for the purpose. The cost of the scheme is to be met by the business that requested its use. The total cost should be no more than around £5,500. Enforcement authorities are expected to take account of the advice received when coming to a final decision on whether or not to serve a Recall Notice. Detailed rules for the use of the Product Recall Advisory Scheme are at Annex B of this Guidance. Where a person on whom a Recall Notice is served fails, fully or in part, to abide by its terms of that notice the enforcement authority may undertake the recall itself and bring civil proceedings for the recovery of its costs. The authority is also required to act where no producer or distributor can be identified on whom to serve a Recall Notice. In such circumstances recall remains a measure of last resort. The Regulations recognise that Codes of Practice on Recall may be valuable in determining the nature and scope of a recall action. The European Guide to Corrective Actions including Recall is available from the European Commission’s website6. The Guide, produced with DTI support, is aimed at improving the effectiveness of recalls of unsafe products from the Community market;

Forfeiture and Destruction
– where products are dangerous the enforcement authority may apply to the court for an order for their forfeiture and destruction. However as an alternative to destruction the court may, on condition that any order to pay the costs and expenses of the proceedings is complied with, permit the supply of the product to a person for repair or reconditioning or for scrap.

Confidentiality of information


7.14 An enforcement authority has an obligation under these Regulations to make available to the public information about the nature of risks that specific products pose to consumer health and safety and the measures taken to remove those risks. However, to the extent that the information is professionally secret and/or the disclosure of which the authority thinks might significantly harm the legitimate business interests of the business to which it relates, or relates to the private affairs of an individual whose disclosure the authority thinks might significantly harm the individual’s interests, that information shall not be disclosed while the business continues in existence or during the lifetime of the individual, other than by consent, or in connection with any criminal proceedings or the investigation of, or decision to take any criminal proceedings, or unless such disclosure is necessary to protect the health and safety of consumers. Other than as specified disclosure is an offence under s245 of Part 9 of the Enterprise Act 2002.

Precautionary Principle


7.15 Where appropriate, enforcement authorities are to be guided by the Precautionary Principle when taking measures under the Regulations to protect consumers from unsafe products.

7.16 The Precautionary Principle applies where there are threats of substantial, serious or irreversible harm to consumers but there is clear scientific uncertainty over the extent of the threats posed.

7.17 Judgements handed down by the Court of Justice (C-434/02 and C-210/03) presuppose that for the Principle to apply the risk should be plausible and realistic based on the identification of potentially negative effects on health and safety and a comprehensive assessment of the risks based on the most reliable scientific data available (including international research). Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of the scientific study into the risk, but the likelihood of real harm to public health and safety persists should the risk materialise, the Precautionary Principle justifies the adoption of measures under the Regulations.

7.18 A measure adopted under the Precautionary Principle must recognise that it is not appropriate to seek to reduce the risk to zero. It should also be proportionate to the expected risk and appropriate for attaining a high level of public health in accordance with the definition of a safe product in the Regulations. The enforcement authority taking the measure must keep it under regular review in the light of new scientific evidence.

Appeals


7.19 All safety notices served may be subject to an appeal made before the end of the period of 21 days beginning on the day the notice was served. In the case of a Recall Notice, where a person proposes to make an appeal, that person may apply to the court before the end of the period of 7 days beginning on the day the notice was served to have the notice temporarily suspended pending the making and determination of the appeal.

Commission Decisions


7.20 Where the European Commission becomes aware of a serious risk it may after consulting the Member States adopt a decision to ensure a consistent approach is adopted where the risk can only be eliminated effectively by imposing one of the above measures at the Community level for a period of one year (extendable) unless a specific product or batch of products can be identified in which case the decision will be valid without a time limit. Exports from the Community of dangerous products subject to such a decision are prohibited unless the decision provides otherwise. Any such export ban will be enforced by HM Revenue and Customs under the Customs and Excise Management Act 1979, which carries its own offences and penalties.