Electronic Cigarette Industry Trade Association

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ECITA ISE: QUALITY & SAFETY Chapter 3 CE & RoHS/RoHS2

06 : QS Chapter 3 CE and RoHS/RoHS2

Thursday, November 6, 2014

Introduction

In the context of electronic cigarette products, the relevant Directives for CE are the Electromagnetic Compatibility Directive (EMC) for all electrical and electronic products, and the Low Voltage Directive (LVD) for all products requiring mains electricity, i.e. mains adapters/chargers. With the recast of the Restriction of Hazardous Substances (RoHS) Directive in 2011, RoHS has been incorporated into CE, in terms of marking, and general conformity with the regulations. This chapter focuses on the requirements for conformity with CE as a whole, for electronic cigarette products.

Conformité Européene (CE)

Contrary to popular urban myth, ‘CE’ does not stand for ‘China Export’. It stands for Conformité Européene (European Conformity), but the RoHS2 recast introduces a nuanced new meaning to the CE mark. CE marking symbolises the conformity of the product with the applicable EU requirements imposed on the manufacturer. The CE marking affixed to a product, therefore, is a declaration by the person responsible that:
    
•    the product conforms to all applicable EU provisions, and
•    the appropriate conformity assessment procedures have been carried out.

From 2nd January 2013 EEE in scope that bears a CE marking is presumed to be in conformity with the requirements of RoHS2 and therefore is presumed not to contain more than the tolerated maximum concentration values as mentioned in Annexes II, III and IV of RoHS2.

•    Manufacturers are obliged to provide importers/retailers/distributors with certification and testing reports to demonstrate that the necessary testing has been carried out on the products to comply with the requirements under CE (including RoHS).
•    ‘Modders’ (those who manufacture modified electronic cigarette hardware) may self-certify to declare that the product will not interact with other products electromagnetically(1), and that the batteries/USB chargers are sufficiently safe. (A template of a European Declaration of Conformity is provided to our members.) We perform battery/charger testing for our members’ products, to ensure that they will continue to operate safely under reasonably foreseeable conditions of use. This testing is also available to non-member companies. Please contact us for details.
•    Retailers are likely to receive products from manufacturers which have been similarly self-certified, and can proceed to certify these criteria themselves too, on the basis that the products are unlikely to carry a high risk to end users. (NB: the same does NOT apply to electrical plugs on chargers, which are dealt with in CHAPTER 6 PLUGS AND SOCKET (SAFETY) REGULATIONS (1994) of this guidance.)
•    Your CE certificate and testing report must bear model numbers which correspond to the product.
•    You must have a separate CE certificate and testing report for each product or one certificate and testing report with separate model numbers from a single manufacturer/producer.

NB: This only applies to hardware, and not to e-liquid.

RoHS

This guidance is drawn from key documents provided by both the EU and the UK Government. The full guidances referred to, quoted and paraphrased herein, are the EU Guidance on FAQ and the NMO Guidance.

As part of the ISE, this guidance has been specifically tailored to reflect only what is relevant to the Electronic Cigarette Industry, so examples have been altered to be relevant to the products we are concerned with, and inapplicable or irrelevant provisions have been omitted. We have also attempted to further clarify some of the more potentially-confusing provisions, so that you can be clear what is expected of you.

•    You must have a RoHS certificate and testing report from the manufacturer/producer of each product (hardware only).
•    If there is any risk that a component part of your product may contain a harmful substance, e.g. lead, cadmium or mercury, you must ensure that you have independent verification on file to demonstrate that your product is safe. (See CHAPTER 7 THE BATTERIES AND ACCUMULATORS (PLACING ON THE MARKET) REGULATIONS (2008)(BMR) and CHAPTER 8 THE WASTE BATTERIES AND ACCUMULATORS REGULATIONS  (WBR) AND THE WEEE DIRECTIVE (2002) for the requirements for batteries sold separately from ecig hardware.)
•    If you decide not to get RoHS certification directly from the manufacturer, you would have to have EU testing done prior to sale and then spot check as you go along. The EU testing would need to cover all the substances covered by RoHS. It would be useful to validate any Chinese RoHS testing by having ‘spot checks’ with a recognised EU testing house.
•    As a manufacturer of electronic products, you are expected to promote environmental responsibility. For example, if you are selling a disposable electronic cigarette product, you would be expected to offer some kind of incentive to your customers to upgrade to a rechargeable kit. (See also SECTION 2: ENVIRONMENTAL RESPONSIBILITY.)

RoHS2

RoHS2 introduces CE marking for electrical and electronic equipment for the first time. It also requires manufacturers to prepare an EU Declaration of Conformity (DoC) demonstrating that they have complied with all their legal obligations.

Over the next few years, the regulations will extend restrictions on the use of hazardous substances across a wider range of products and devices, with specific dates applying to each sector. From July 2019, RoHS2 will apply to all electrical and electronic goods regardless of their type, design and purpose.

Since the Electronic Cigarette Industry was already covered under RoHS1, these extended restrictions do not apply to us, and we merely need to ensure that we continue to comply with the RoHS requirements, including the new elements which have been brought in, as detailed below. There are some new processes and documentation requirements that you will need to follow under RoHS2. All types of businesses, except distributors, will have to keep relevant compliance documentation for a minimum of 10 years.

RoHS2, like RoHS1, places legal obligations on you if you make or trade in Electrical and Electronic Equipment (EEE) in any restricted product category (which includes electronic cigarette products) as a:

•    Manufacturer
•    Manufacturer’s authorised representative
•    Importer
•    Distributor (including retailers).

For example, manufacturers must ensure that EEE are CE marked and must prepare a Declaration of Conformity (DoC) confirming that they have complied with the regulations. If you are involved in more than one of these roles, you will be responsible for complying with the obligations of each activity; for example, if you import or distribute EEE in the UK, or other EU Member State, under your own brand, you are considered to be the manufacturer of those products and must comply with the obligations of a manufacturer.

Enforcement

In the UK, the National Measurement Office (NMO) is the appointed market surveillance authority responsible for ensuring compliance with the RoHS regulations as set out in Statutory Instrument 2012 No: 3032.

We have found the NMO to be a very competent enforcement agency, and have liaised with them on various aspects of our ISE programme in the past. In their own words:

“We are committed to working with businesses in a proportionate, appropriate way to help them to comply with the regulations. We will only take enforcement action where all other efforts have failed to achieve compliance.”

That may not imply the kind of rigorous enforcement that ECITA would like to see, but we believe that the NMO has demonstrated its competency to judge what is appropriate, and they do have a range of powers, courtesy of the Statutory Instrument, including:

•    the power to make test purchases
•    powers of entry
•    warrants
•    the power to inspect, seize and detain EEE
•    the power to request technical documentation and other evidence
•    a range of sanctions, including fines of up to £5,000 per non-compliant product.

Who is a manufacturer?

You are considered to be the manufacturer of EEE if you manufactured it or if you market it under your name or trademark – even if it was designed or manufactured by someone else. So, wherever products have been re-branded, the brand owner is the manufacturer for the purposes of RoHS2 (and other regulatory legislation).

Manufacturers can be based outside the EU. If they are, they can delegate some administrative responsibilities to an authorised representative within the EU but cannot delegate their obligations to ensure compliance, such as setting up production control systems or drawing up technical documentation.

Sub-contractors

The manufacturer is responsible for ensuring the compliance of the whole product (see ‘Whole Products’ below), including any ready-made components or finished products that may be used in its assembly. Therefore, sub-contractors are not manufacturers under RoHS2. The manufacturer must retain control over any sub-contracted part of the production process and ensure that the sub-contractors provide all of the information necessary to demonstrate compliance.

Manufacturers’ obligations

When you place EEE on the EU market for the first time, you must do the following:

•    ensure that the design and manufacture of your product complies with RoHS2; this includes each homogenous material within the EEE (see below)
•    set up effective production control systems to support compliance and review them to ensure that the EEE remains compliant over time *
•    draw up technical documentation (see below) demonstrating compliance †
•    complete an assessment of conformity with the regulations *
•    prepare a Declaration of Conformity (DoC) (see below) †
•    keep all technical documents and the DoC for 10 years
•    fix the CE mark to the finished product
•    clearly mark the EEE with batch (or serial) number for identification
•    place your name, trade name or trademark on the product and packaging (all of which is required under GPSD/CLP anyway, so should not place any additional burdens upon you)
•    keep a register of recalled products and inform members of your supply chain of these. (Even if this has not yet happened to you, the fact that it may – at any time – means that you need to have a policy procedure in place in documentary form for when/if it happens. This policy procedure should include details of how you would go about informing every relevant person in your supply chain) †
•    ensure that any non-compliant EEE is withdrawn from the market, and take corrective action to make it comply with the regulations
•    inform the NMO of action you are taking to ensure compliance **
•    provide documentation and any other information required by the NMO to demonstrate compliance.*

* This forms part of regular ISE auditing, as part of ECITA membership, but it is vitally important that you take the necessary action when you bring a new product into your range, so that you ensure that you are fully-compliant with the regulations, specifically for that product.

† We can offer assistance with these requirements, as an additional service, for a modest fee. Please contact us for further details.

** It’s worth noting that, although instinctively, you may feel that it is better to steer well clear of regulatory enforcement agents, actually working with them and keeping them informed can offer you far better protection. If any of you has the misfortune to have to recall a product (and the more products you supply, the more likely this becomes, just by the law of averages), do get in touch with us, so that we can help you provide the necessary information to the NMO (or other enforcement body). This is part of ECITA membership, but we can also offer assistance to non-members, for a modest fee, on request.

What is EEE?

EEE is defined as any equipment with a voltage rating not exceeding 1,000V for AC and 1,500V for DC that requires electric currents to function. This means that electronic cigarettes are indisputably EEE, and as discussed below (see ‘Whole products’), often this means that accessories, even those which do not rely on electric currents, are also affected. EEE can be a component or assembly used in a finished product. Cables and spare parts for repairing, reusing, updating or upgrading a product are all EEE. The RoHS2 regulations apply to EEE in specific product categories, but since electronic cigarette products do not benefit from any of the exemption categories, other categories are not covered here. Suffice to say, electronic cigarette products are within scope of RoHS2, so it is important to make sure that you have all the correct compliance documentation, product markings, etc., just as was needed under RoHS1.

The extensions introduced with RoHS2 to cover previously exempted products are not the only changes. The regulations also introduce CE marking for EEE for the first time (although most electronic cigarette products were already CE marked pursuant to other legislation, i.e. Electromagnetic Compatibility Directive), and RoHS2 requires manufacturers to prepare a declaration of conformity (DoC) demonstrating compliance with all their legal obligations. Meanwhile, importers and authorised representatives must also maintain a document trail demonstrating compliance.

RoHS 2 provides that Electrical and Electronic Equipment (EEE) has to meet the requirements of the Directive. Since equipment consists of different components, the EEE itself can only meet the substance requirements if all its components and parts meet the substance restriction requirements of RoHS2, including non-electronic or non-electric components like casings, seals, drip tips, etc. Therefore components being used in finished EEE or for modifications to EEE and/or used EEE, which is in the scope of RoHS2, must meet the substance restrictions according to Article 4 but do not need CE marking.

The Restricted Substances

The restricted substances are listed in Annex II (referenced in Article 4):

ANNEX II

Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials

Lead (0.1%)
Mercury (0.1%)
Cadmium (0.01%)
Hexavalent chromium (0.1%)
Polybrominated biphenyls (PBB) (0.1%)
Polybrominated diphenyl ethers (PBDE) (0.1%)

Please note that the listed substances in RoHS2 are the same as those restricted under RoHS1. However, the recast Directive commits the European Commission (EC) to reconsidering this list, with its first review to be completed by July 2014 and regular reviews after that. These reviews will look at how RoHS2 can be harmonised with other regulations on chemical use, such as Registration, Evaluation, Authorisation and Restriction of Chemicals  (REACH), 1907/2006/EC, in order to simplify the overall regulatory regime.

RoHS2 bans anyone from placing on the EU market EEE in which any homogenous material contains more than the tolerated maximum concentration values (MCVs) of the six substances, as listed above(2) . The biggest one we need to watch out for is lead, which is often used in the solder, and is impossible to detect without testing, much of which is routinely carried out by enforcement agencies – just as under RoHS1. This is why it is so important to have your Certificates of Compliance with RoHS together with the test reports, so as to be sure that there are no hidden ‘nasties’ lurking in your products.

CE Marking, Conformity Assessment Procedures including Required Technical Documentation and Declaration of Conformity

The remarks on CE marking requirements here refer exclusively to RoHS. CE marking may (also) be required on the basis of other applicable legislation, e.g. LVD, EMC, etc.

The New Legislative Framework

To remove obstacles to the free circulation of products and to create an efficient and coherent European legal framework with regard to the marketing of products, in 1985 the Commission introduced the “New Approach” which was further developed in 1990 by the “Global Approach”. The New Legislative Framework (NLF) constitutes the modernisation of the New and the Global Approach. Regulation 765/2008 sets out the requirements for accreditation and market surveillance relating to the marketing of products. Decision 768/2008 sets a common framework for the marketing of products. This includes model provisions to support market surveillance and the application of CE, the marking, definitions of terms commonly used in product legislation (but sometimes used differently at present) and procedures that allow future sectoral legislation to become more consistent and easier to implement. The decision is only binding upon the EU institutions. To be operational, the model provisions of the Decision need to be incorporated into existing Directives when they are next revised. This process is known as “alignment”.

Overall, the objective of the NLF is to help the internal market for goods work better and to strengthen and modernise conditions for placing a wide range of products on the EU-market. The package of measures within the NLF:

•    improves the market surveillance rules, to better protect both consumers and professionals, including imports from third countries;
•    boosts the quality of the conformity assessment of products through clearer and stronger rules on the requirements for the notification of assessment bodies;
•    clarifies the meaning of CE marking; and
•    establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation. (NB: This last point is relevant to other industries, rather than to the Electronic Cigarette Industry).

Declaration of Conformity (DoC)

When a product is placed on the market the manufacturer or the authorised representative established within the EU, is obliged to draw up an EU DoC as part of the conformity assessment procedure. This declaration must ensure that the requirements of the applicable Directive have been satisfied, i.e. with regard to RoHS2, the electrical or electronic equipment is in compliance with the substance restrictions of RoHS2. Pursuant to Article 5 of Commission Decision 768/2008/EC (common framework for the marketing of products) legislation requiring a DoC shall provide that a single declaration shall be drawn up in respect of all relevant Union Acts that apply. In light of this, single declarations should be encouraged.

Technical documentation

Article 7(b) of RoHS2 requires the manufacturer to draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC (common framework for the marketing of products) or have it carried out on the manufacturer’s behalf. Hence, the requirements for the technical documentation can be found in that same Annex II of the Decision under module A. CENELEC have produced a Harmonised European Standard on the required technical documentation for the presumption of conformity, which provides guidance to satisfy the requirements in 768/2008/EC.

CE Marking

All EEE within scope must be CE marked and include a reference to RoHS2 (2011/65/EU) on the DoC from the date when the substance restrictions apply, i.e. immediately for electronic cigarette products, since they are already covered by RoHS1. In any event, EEE falling within the scope of RoHS2 may be CE marked and include RoHS2 on its DoC even if the substance restrictions do not yet apply, so whichever way you interpret this, electronic cigarette products need to be CE marked, and have the appropriate DoC documentation.

Batteries

Battery cells are not within the scope of RoHS, but battery casings incorporating safety circuitry and/or other electronics are subject to RoHS requirements. (See also CHAPTER 7 THE BATTERIES AND ACCUMULATORS (PLACING ON THE MARKET) REGULATIONS (2008)(BMR) and CHAPTER 8 THE WASTE BATTERIES AND ACCUMULATORS REGULATIONS  (WBR) AND THE WEEE DIRECTIVE (2002).)

Spare parts

Article 3 distinguishes between EEE (Article 3(1)) and spare parts (Article 3(27)). Article 4 requires EEE and spare parts to comply with the substance restrictions but the requirements for affixing CE marks under Article 15 only apply to finished EEE. Therefore spare parts that are not finished EEE (Article 3(1)) do not have to be CE marked or have a DoC. Spare parts are not finished EEE when they are marketed for the repair, reuse, updating or upgrading of specific EEE.

Products that are finished EEE such as some graphic cards need to be CE marked and have a DoC. The same also applies to sub-assemblies, except for sub-assemblies that are supplied for further integration into EEE by a manufacturer or integrator in which case no separate CE marking or DoC is required as they are already covered by the DoC of the EEE.

‘Whole products’

The DoC should reference the product as placed on the market under Article 4. This would normally be the model number or similar description of the whole product as placed on the market.

RoHS2 applies to the equipment and all its constituent parts, for example an electronic cigarette sold together with a non-electrical carrying case. However, RoHS2 does not apply to any manuals, documentation, consumables, etc. that do not have an equipment constituent as well as any packaging intended to be discarded soon after putting the equipment into service. (See also CHAPTER 9 PACKAGING AND PACKAGING WASTE DIRECTIVE.) Technical documentation required by Article 7(b) should include compliance information on all constituent parts of the product as described above.

Harmonised Standards

The EU ‘Blue Guide’ gives guidance on the presumption of conformity including the use of harmonised standards.

RoHS markings

From 2nd January 2013, CE marking shall be the only marking which attests the conformity of the product with the requirements of RoHS2. Pursuant to EC/765/2008 markings, signs or inscriptions that are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited.

For the avoidance of any doubt on this, it would make sense to remove specific RoHS markings from packaging and labelling for your next product runs. It is important to move over to the simplified marking of ‘CE’ only, so that products are fully compliant with this recasting of the RoHS Directive.

Timings for compliance and ‘placing on the market’

The product needs to be compliant with the requirements, including identification information, that are applicable at the time of its ‘placing on the market’ (by the manufacturer or importer). It can thereafter continue to be made available by economic operators in the distribution chain. Of course, since electronic cigarette products were covered by the original RoHS Directive, this is an ongoing requirement, and no ‘grace period’ applies.

Product marking requirements for traceability

Article 7 requires manufacturers to mark equipment with type, batch or serial number or other element allowing its identification. The frequency of marking, whether it is for a product line, batch or individual serial numbers is a matter for business decision.

It is important to remember that points about ‘traceability’ are intended to be about active enforcement. Good enforcement helps the industry, because actions can be taken against non-compliant vendors setting up in competition against those who are properly compliant with the legal requirements. However, this does mean that it remains vitally important that you have robust batch numbers which directly relate to the manufacturing cycle.

Where identified non-conformities require action on the part of economic operators, product identification may be used to establish the action required to mitigate that non-conformity and to discriminate between compliant and non-compliant EEE on the market.

Enforcement of substance restrictions

Member States’ enforcement agents may still carry out analysis of such EEE as part of their enforcement activities. If such analysis shows a violation of the substance restrictions, the manufacturer of the EEE bears the full responsibility for this despite having assessed the EEE according to the standard.

Substance restrictions in the production process

The restrictions only apply to finished EEE. The restricted substances may, therefore, be used in the production process, as long as they do not violate other regulations and the finished EEE does not contain the substance above the maximum concentration values.

Homogenous material

Homogeneity is relevant in the context of EEE because of what happens at the end of the product’s life, when it becomes WEEE (waste, needing to be disassembled for recycling and disposal purposes). (See SECTION 2: ENVIRONMENTAL RESPONSIBILITY.)

A homogenous material is any material that has a uniform composition throughout, or any component of the finished product that cannot be removed or detached by any action such as unscrewing or cutting. This can be anything from a plastic seal inside a cartomiser, a copper wire inside a cable, and the solder part of a solder joint.

The tolerated MCV for each restricted substance is listed above, and the limits apply to each homogenous material, so if any one such material contains more than the allowed concentration, the whole product fails to comply.

Any sample taken from EEE by a Member State enforcement authority should not contain the restricted substances above the maximum concentrations unless there is an applicable exemption. Due care and risk considerations should be taken when preparing samples for compliance assessment purposes to assure individual homogenous materials are adequately separated where homogenising samples may dilute the presence of the restricted substances for the test method applied.

 

Footnotes

1 http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/faq/index_en.htm#productGroup

2 Note that some exemptions to these limits apply for certain materials.