Electronic Cigarette Industry Trade Association

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ECITA ISE: Executive Summary

03 : Executive Summary

Tuesday, November 4, 2014

The ECITA Industry Standard of Excellence (Members’ Guides and Toolkits) itemise the precise legal requirements for the regulation of electronic cigarette products and accessories, together with Excellent Business Practices. There are also details of ECITA’s Program of Internal Audits, together with specific itemised procedures, e.g. for e-liquid blind testing. Please see ANNEX I for a complete list of all the Directives, UK Regulations, and other Statutory Instruments, together with links to the original legal statutes and guidances thereto. This Public Edition is being made available to assist industry colleagues, regulators and policy-makers, and consumers. We hope it will allow you to understand the rigorous standards demanded of ECITA members by means of the ECITA ISE Auditing Program.

CHAPTER 1 provides a brief history of the emergence of this innovative and exciting business sector, with ANNEX II providing a simple checklist for differentiating between electronic cigarette use and smoking; ANNEX III offering information about the diversity of the products; and ANNEX IV defining a Glossary of Terms. ANNEX V sets out details of the Legal Rulings and Opinions.

Legislation covered by the ISE

Please note that all legislation, regulations, other statutory instruments and guidances are listed, together with their links in ANNEX I. The only footnotes incorporated into the main body of this book are references to scientific studies, news reports, etc. Where statutory instruments are discussed, no reference is made, because these can all be found together in ANNEX I.

Section 1: Quality and Safety

CHAPTER 2 explains how the General Product Safety Directive (2001) (as amended in 2004) and the UK General Product Safety Regulations (2005) are applied to electronic cigarettes, as amended by CLP (2008) (see CHAPTER 4), and REACH (2006). The legislative changes are coming into implementation soon, so the ISE has been updated to reflect the changes, since everyone needs to transition across to CLP in a timely manner.  There is information about Product Recalls, with the Product Recall Procedure and a template Notification Form provided to our members.

This chapter also provides information on the requirements for product preparation and storage, in accordance with standards for clean room environments, as well as various testing protocols. Details of the e-liquid blind testing protocol are included at ANNEX VII.

CHAPTER 3 looks in more detail at the requirements for electrical and electronic product safety, with reference to CE marking, comprising the Low Voltage Directive (2006) and Electromagnetic Compatibility Directive (2004), as well as RoHS2 (2011) compliance.  It provides information about the Technical Dossiers required for all electrical and electronic products. A template for European Declaration of Conformity is provided to our members.

CHAPTER 4 examines the altered requirements for labelling and packaging introduced under the Classification, Labelling and Packaging (CLP) Regulations (2010), as applied to electronic cigarettes and eliquid. These regulations will replace CHIP4 completely and immediately on 1st June 2015, since the long transition phase was completed. A single sample label is not possible for CLP, due to the labelling variations depending on the strength of the product. However, our members are provided with details of how to ensure compliance with the various legal requirements under CLP, and sample labels, demonstrating the legal requirements under CLP in the relevant categories by strength. Note, also, that eliquids up to 2.5% (25mg/ml) are not classified under CLP, so this chapter includes advice on labelling for these products. NB: The CLP classification for nicotine is currently under review, so this may change when these international negotiations are completed.

CHAPTER 5 examines the implications of the UK Weights & Measures (Packaged Goods) Regulations (2006). This includes details of the obligations on vendors to keep records of their own testing. Details of the testing protocol which ECITA’s internal auditors will use to verify that the correct quantities are put on the labels are included at ANNEXES X and XI. The calibration procedure is included as ANNEX XII. All the relevant spreadsheets are provided to our members.

CHAPTER 6 illustrates the UK Plugs and Socket (Safety) Regulations (1994). This chapter also further illustrates the requirements under the Low Voltage Directive, as part of CE. ECITA’s auditing protocol for mains adapters/chargers is detailed at ANNEX XIII. This testing, together with a wide range of other testing protocols, is available to non-members on request, subject to appropriate fees. Test passes receive a certificate, irrespective of whether they were carried out for members or non-member companies.

CHAPTER 7 discusses the regulations which apply to battery safety, compliance, and marking. Details are provided concerning compliance with the UK Batteries and Accumulators (Placing on the Market) (Amendment) Regulations (2015) (BMR). Battery marking requirements are provided to our members. ECITA’s Battery Testing Protocol is provided at ANNEX XIV. This testing is also available to non-members on request, as per our other testing services.

Section 2: Environmental Responsibility

CHAPTER 8 itemises the requirements as set out in the UK Waste Batteries and Accumulators Regulations 2009 (WBR). Details are also provided concerning compliance with the Waste Electronic and Electrical Equipment (WEEE) Directive (2012).

CHAPTER 9 discusses the requirements for compliance with the Packaging and Packaging Waste Directive (1994) (as amended), and the UK implementation thereof, the Packaging and Packaging Waste Regulations (1997).

Section 3: Further Consumer Protection

CHAPTER 10 summarises the UK Consumer Contracts (Information, Cancellation and Additional Charges) Regulations (2013) and the UK Electronic Commerce (EC Directive) Regulations (2002). This chapter details what is required of ECITA members, as it relates specifically to sales of electronic cigarettes, but also goes a little further to achieve the Industry Standard of Excellence.

CHAPTER 11 details the legal requirements under the UK Data Protection Act (1998), again as applied to electronic cigarette sales.

CHAPTER 12 itemises what is required of ECITA members concerning the Distance Selling Directive (1997) (as amended) in relation to website compliance, and in accordance with the Electronic Commerce (EC Directive) Regulations (2002). This forms part of the Internal Audit Program, and is supported by online mystery shopping, the protocol for which is provided to our members. CHAPTER 12 also addresses the UK Control of Misleading Advertising (Amendment) Regulations (2000) (CMARs) and the UK Business Protection from Misleading Marketing Regulations (2008) (BPRs). It also details what is required concerning the UK Advertising Standards Agency Code, the UK Enterprise Act (2002), and the UK Unfair Trading Regulations (2008). This covers the regulatory requirements for all advertising and promotional materials. CAP’s Rules, published in October 2014, are included as ANNEX XV.

CHAPTER 13 itemises the Customer Service Standards expected of good businesses and the  precise standards expected of ECITA members, in order to demonstrate the Industry Standard of Excellence. ECITA’s Customer Complaints Procedure is included as ANNEX XVI.

Section 4: Employer and Member Obligations

CHAPTER 14 gives an overview of the requirements for businesses under the UK Health and Safety at Work Act (1974) (as amended). Please note: this is not comprehensive, but is merely included to assist ecig vendors. Health & Safety Policy and Risk Assessment Templates are provided to our members.

CHAPTER 15 explains the Terms and Conditions of ECITA membership, including contractual obligations concerning payments, and internal disciplinary procedures as they apply to ECITA members. This includes details of how infractions are dealt with, as well as information about members’ responsibilities concerning their distributors/affiliates. There is also information about the new range of Certificates which will be available to members (and non-members) on successfully completing ECITA product testing. Sample certificates are illustrated at ANNEX XVII.

CHAPTER 16 provides much greater detail about the ECITA ISE Auditing Program. This chapter includes information about how non-compliance will be addressed, and describes the method by which Trading Standards may be notified of audit results. ANNEX XIX summarises what is covered by the ECITA ISE Auditing Program.