Electronic Cigarette Industry Trade Association

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ECITA ISE: QUALITY & SAFETY Chapter 2 General Product Safety Regulations

05 : Section 1 QUALITY AND SAFETY (QS) Chapter 2 General Product Safety Regulations as applied to Electronic Cigarettes

Thursday, November 6, 2014

Introduction

The purpose of the General Product Safety Directive is to ensure that all products intended for or likely to be used by consumers under normal or reasonably foreseeable conditions are safe. It places 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.

A “safe product” is any product which under normal or reasonably foreseeable conditions of use presents no risk or only the minimum risk compatible with the product’s use and which is consistent with a high level of protection for consumers.

The safety of a product will be assessed having regard to a number of matters and, in particular:

•     the product’s characteristics;
•     packaging;
•     instructions for assembly and maintenance, use and disposal;
•     the effect on other products with which it might be used;
•     labelling and other information provided for the consumer; and
•     the categories of consumers at risk when using the product, particularly children and the elderly.

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 the context of electronic cigarettes, where such a wide sociodemographic is rapidly taking up these products, this remains a very high priority. It is vitally important that, in addition to the mandated labelling requirements, the products you supply come with clear instructions for use, so that your customers understand all the risks, but also so that they can get the best possible results from using your products. With the pace of innovation in this sector, the instructions to the consumer will remain a significant priority for your development of product lines.

That said, the General Product Safety Regulations (the UK implementation of the EU General Products Safety Directive) do recognise that a supplier is only required to act within the limits of his activity.

If a product is found to be dangerous, the producer or distributor must inform the authorities through the notification procedure. (A template Notification Form and Product Recall Procedure is provided to ECITA members.) Depending on the nature of the risk, the authorities might require further action from the producer or distributor. This could be a warning to the public of the risk connected with the product, banning the marketing of the product, and/or withdrawing the product from the market.

Notifications

The GPSD 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 (DTI) for onward transmission to other Member States. NB: This is the correct route for consumer products, and therefore applies to all electronic cigarette products not licensed as medicines, i.e. all ECITA members’ products. There are different reporting mechanisms for other categories of product, such as medicines, medical devices, motor vehicles, products for use in the workplace, etc.

The Local Authority will advise on actions aimed at removal of the risk and work with the producer or distributor on completing the notification. The Local Authority will then forward this to the appropriate national contact point for further action, and to the DTI if there is a serious risk requiring notification under RAPEX.

What information do I need to include in the notification?

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.

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 of the UK General Product Safety Regulations (the UK’s implementation of the GPSD) if he understands that no one else is doing so. Regulation 9 requires:

“9. (1) Subject to paragraph (2), where a producer or a distributor knows that a product he has placed on the market or supplied poses risks to the consumer that are incompatible with the general safety requirement, he shall forthwith notify an enforcement authority in writing of that information and

(a)    the action taken to prevent risk to the consumer; and
(b)    where the product is being or has been marketed or otherwise supplied to consumers outside the United Kingdom, of the identity of each Member State in which, to the best of his knowledge, it is being or has been so marketed or supplied.

(2) Paragraph (1) shall not apply

(a)    in the case of a second-hand product supplied as an antique or as a product to be repaired or reconditioned prior to being used, provided the supplier clearly informed the person to whom he supplied the product to that effect,
(b)    in conditions concerning isolated circumstances or products.

(3) In the event of a serious risk the notification under paragraph (1) shall include the following

(a)    information enabling a precise identification of the product or batch of products in question,
(b)    a full description of the risks that the product presents,
(c)    all available information relevant for tracing the product, and
(d)    a description of the action undertaken to prevent risks to the consumer.

(4) Within the limits of his activities, a person who is a producer or a distributor shall co-operate with an enforcement authority (at the enforcement authority’s request) in action taken to avoid the risks posed by a product which he supplies or has supplied. Every enforcement authority shall maintain procedures for such co-operation, including procedures for dialogue with the producers and distributors concerned on issues related to product safety.”

Isolated Circumstances or Products

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.

Cooperation

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.

Obligations on Producers

For practical purposes, ‘producer’ is defined in two ways – either as the first placer of the product on the Community market, or as someone whose activities may affect the safety of the product.

‘Producer’ in relation to a particular product means:

•    the manufacturer (where he is established in the Community);
•    any person who presents himself as the manufacturer by putting his name or trademark on the product (the brand owner);
•    any person who repairs or reconditions the product.

A producer has a primary duty to place on the market only safe products but he also has more specific duties:

•    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 (see ANNEX IX for further information about the legally-required risk and safety phrases/hazard warning wording and symbols);
•    this should include information on the precautions to be taken to avoid those risks (for example, the need to wear protective gloves); and
•    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. (See below.) ECITA members are provided with clear Product Recall Procedures, and offered assistance if such corrective actions become necessary.

Examples of such measures include:

•    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. (As part of your normal quality control procedures, batch marking should already be in place.);
•    sample testing of your products on the market;
•    investigating complaints relating to safety, and keeping a register of such complaints; and/or
•    informing distributors of the monitoring work and the results.

More complex and higher risk products, such as electronic cigarettes and eliquids, will involve a higher level of vigilance and attention from the producer involving an ongoing sampling programme, e.g. the regular product testing required for adherence to the ISE standard.

Obligations on Distributors

‘Distributor’, by contrast, is any professional in the supply chain whose activities do not affect the safety of a product. This can include wholesalers, retailers (shops), and agents.

Please note that if you have downstream distributors, it will be useful to share your Product Recall Procedure with them, and discuss your Product Recall Policy, in case you ever need to instigate such action. (If you hold a variety of Policy documents as part of your Health & Safety compliance in your workplace, it would make sense to add the Product Recall Procedure to these, and specifically mark it as your policy for this.) As with manufacturers and suppliers, discussing these procedures with your downstream distributors before they are needed is good practice, and can save a lot of problems in the future.

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.

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.

It is worth remembering that batch numbers which actually relate to the manufacturing cycle could save you considerable stock losses in the event of a product recall. If no batch numbers were present, you would be required to recall every product of the same type in the event of a problem. At least if there are meaningful batch numbers, you only have to recall the products from that particular batch.

Producers and larger distributors should 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. Such records have to be kept for a minimum of 6 years. (For electronic cigarette products, producers are required to keep full Technical Dossiers on the products they market for 10 years, irrespective of how long they are actually marketed for.) These records may be electronic.

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:

•    passing on to consumers information provided by producers about product risks;
•    passing back to producers safety complaints and information and experiences on safety related matters which he obtains from customers; and
•    co-operating with the authorities and others in the supply chain in taking action to avoid or remove those risks.

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 a concern.

Further Information

EU Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in Accordance with Article 5(3) of Directive 2001/95/EC

An EU Guide Product Safety in Europe: A Guide to corrective action including recalls – helping businesses to protect consumers from unsafe products  

UK DTI GPSR 2005 Guidance for businesses, consumers and enforcement authorities Guidance Notes

Other  Obligations

The existence of higher levels of safety, or availability of products presenting lesser risk, will not in itself mean that a product is unsafe. Where specific product legislation covers exactly the same ground as the General Product Safety Regulations the specific legislation will apply.

ECITA membership requires that regular samples of products are tested at an appropriate laboratory testing facility. The samples should be tested for contaminants by GC/MS and nicotine content verification by isotope dilution analysis, or other approved method. ECITA has made arrangements with a suitable laboratory to perform these tests. (See ANNEX V for our blind testing protocol.) If, however, members choose to submit their samples to a different laboratory, members are required to provide us with copies of the reports, as part of their ISE Audit documentation. Non-member companies are welcome to submit samples to ECITA for testing through our ISE method, and many do. Please contact us for details.