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CE MARKING

These notes are intended to provide reference material for businesses on how to “CE mark” products.

They may help you ensure your product complies with the relevant legislation, especially if you want to sell your product overseas or use/sell imported products from overseas.

By thinking of the issues discussed in the notes in advance, you could save your company time and money, avoid doing something illegal and add the potential of selling your product in new markets.

Nobody likes regulation. However it is often necessary in order to produce fair markets in which legitimate businesses producing and selling safe products of a high standard are protected from unfair competition.

This information pack has been compiled by your local Trading Standards Department as part of a new scheme to advise your business on legislation issues. We are there to help you at an early stage and to make your company anticipate and react to potential problems from the word go.

If your business manufacturers or imports products in the categories below, and would benefit from some more advice in the area of CE marking, why not sign up for one of our forthcoming seminars on the subject. Specialist Trading Standards Officers, as well as expert staff from the DTI, will be on hand to offer your company one to one support on how the issue of CE marking affects your company.

This advisory scheme forms part of a wider programme of activities all geared to help companies trade internationally. If you would like more information on any of the other activities, please contact Rachel Kerr, Business Liaison Officer, on tel: 01522 552482, fax: 01522 552405 or e-mail [email protected]

Information in this pack is aimed at manufacturers and importers of:

• Toys • Machinery • Medical devices • Non-automatic weighing machines • Simple pressure vessels • Gas appliances • Pressure equipment • Electrical and electronic equipment & appliances • Construction products • Recreational craft (boats) • Personal protective equipment • Low voltage electrical equipment

Getting to Grips with CE Marking Legislation

The pieces of legislation which set down the specific requirements that CE marked products have to comply with are known as the “New Approach” Directives. They prescribe requirements which, if complied with, guarantee free passage of goods in the EU. Each of the Directives follows roughly the same format, and includes information on:

Which products are covered

The table below has a general list of these products, so you can quickly check which of the detailed information sheets are relevant to your business.

The essential requirements you must satisfy

These are the requirements relating, for example, to safety, which products must satisfy before they may be sold in the UK, or in the other countries in the EU/EFTA.

Because more than one Directive may apply to one product, you can only use the CE marking on the product once it complies with all the necessary legislation.

Generally speaking, all products must satisfy these ‘essential requirements’, not just those products intended for overseas trade. However, it can be complicated for manufacturers to understand the rules as the CE marking requirements are not uniform across all Directives.

How to comply with the “essential requirements”

Essentially, there are two ways to conform:

To use existing European standards as a benchmark for your product. (In the absence of European standards, internationally recognised ones could be used.) For novel products where no standards exist, then one product can be made and certified by an independent ‘notified body’. This certified product will then be used as the benchmark for all further copies.

How to show the ‘essential requirements’ are satisfied

This sets out how you must show how your products meet the ‘essential requirements’. Normally, if you don't use the specified European standard you would have to obtain a report from an independent body (See Who can I contact for further information?, below, for further details.)

Whichever route to conformance you choose, at the end of the process you will have to complete a document called a Declaration of Conformity, except in the case of toys (See Ten stepping stones to CE Marking and Sample Regulatory Forms

below for further information). This document allows you to affix the CE Marking to your product.

CE Marking: Frequently Asked Questions

1. Which businesses are affected by CE Marking?

• Manufacturers • Importers • Distributors • Retailers

If you manufacture or sell products in the UK or the rest of the EU, you will have to comply with the relevant European Directive in your field to demonstrate that your products or the products you sell are ‘fit for their intended use’.

2. How do you demonstrate this?

The way to show you comply is to ‘CE mark’ your product. This symbol is not a quality standard or an indication that products comply with European or other standards. It is merely a tool to show buyers that your products comply to the specific requirements set out in the directive and that the relevant tests have been carried out. It acts like a passport for your products, allowing them to travel freely within an agreed area (see below). It is illegal to supply a product that does not comply and manufacturers and traders can be prosecuted if products do not carry the mark when required to.

3. What brought about the CE Marking Directives?

Because each country within the European Union has its own laws and regulations, it can be difficult for manufacturers to market their products in each of these countries. The New Approach Directives and the use of the CE Marking try to solve this problem because the symbol means the same thing in all the member states of the European Union.

4. How do you go about CE Marking your products?

The way you have to go about getting the CE Mark varies depending on what your product is. More detailed notes in this pack cover the following products:

• Electrical Safety (1994) • Toys (1995) • Simple Pressure Vessels (mid-1993) • Electromagnetic Compatibility (1996) • Personal Protective Equipment (mid-1995)

• Gas Appliances (1995) • Machinery Safety (1995) • Recreational Craft (boats) (mid-1999) • Construction Products (expected 2004) • Non-Automatic Weighing Machines (expected 2003) • Medical Devices (mid-1998) • Pressure Equipment (expected mid-2002)

Please note that this list is not exhaustive. The date when CE marking became/will become compulsory in law is given in brackets after each product type (prior to these dates the legislation was/is ‘in transition’).

It can be a confusing process to CE Mark your product, as there are various ways in which you can make your product conform and it is up to you to choose which is the most appropriate for your product.

Go to the Ten Stepping Stones to CE Marking checklist on for a more detailed explanation of how to go about CE marking your product.

5. What documentation is needed to back up use of the CE Marking symbol?

No matter what route you choose to take, you should be able to demonstrate that your product complies, if challenged by a third party (such as Trading Standards). Usually this means being able to back up use of the CE marking symbol with the necessary paperwork. Remember too that a product can have various components, each with its own standards and legislation. So it is necessary to create a specific technical file containing:

• A general description of the product and manufacturing details • Operation of the product • Design and manufacturing drawings, schemes of components and

subassemblies • A list of applicable harmonised standards, for example, those specified by the

British Standards Institution in the UK • A description of the methods adopted to meet essential requirements of each

applicable directives • The results of any design calculations • Test reports - this may include reports of any tests done by your supplier or

those you commission from an independent testing body

You must keep this file for 10 years after production has ceased.

Remember at any time an enforcement agency from the UK or from anywhere in the EU where your product is being sold could ask to inspect the file. The file of information will also be essential in convincing companies you wish to supply that your products comply with the law.

6. Why should I comply with CE marking requirements?

Products that have met the relevant requirements and carry the CE marking can be sold anywhere in the European Union and in the three European Free Trade Association (EFTA) members who have signed the European Economic Area agreement. These are:

• France • United Kingdom • Greece • Italy • Finland • Norway • Germany • Spain • Ireland • Austria • Belgium • Iceland • Sweden • Portugal • Netherlands • Denmark • Luxembourg • Liechtenstein

Note: Although Switzerland is also a member of EFTA is not a contracting party to the EEA agreement and should be regarded as being outside the European Single Market.

The implications for your business once you comply is access to a market of over 370 million people.

If you ignore the issues of CE marking your competitors could be making inroads into another market overseas in your place.

Also failure to comply with the legislation can leave your company, and sometimes individuals, open for prosecution. The fact that the components of your product have been tested and comply is not enough. The finished product must also be tested.

The Directives also require Community countries (including the UK) to take off the market products which bear CE marking but are unsafe.

7. What does the CE marking look like?

The following is a diagram of the CE marking. It must not be smaller than 5mm in its vertical height, and the proportions of the diagram must be maintained whatever its size. Note that the C and E are not formed by perfect semi-circles.

8. Where should I apply the CE marking?

The Directives set out how the CE Marking should appear and its specific dimensions and proportions. However, as it is not always physically possible to fix the mark onto the goods themselves, there is scope to place it on the packaging and accompanying documents such as the instructions for use or guarantee certificate, in that order of priority. In all cases, the marking should be ‘visible, legible and indelible’.

Where relevant the CE marking should be followed by the identification number of the manufacturer or the independent body involved in the testing phase of the product.

9. What if I come across products in the supply chain which are not correctly CE marked?

You can ask your supplier at any time for full details of the CE marking on his product. If he can't provide you with the information, contact your local Trading Standards Office. An expert Officer will take up your enquiry and investigate it fully.

Similarly, companies you supply could ask you to provide evidence of compliance. Having a technical file set up will mean that you can satisfy their request quickly and professionally.

10. I'm not sure if my products comply, or not? What should I do?

If you are not certain that your products comply, introduce procedures within the company to check compliance - even if your product already carries the CE marking.

The detailed information in this pack is a good starting point giving guidance on how to get your products CE marked. Remember you can also contact the Trading Standards department directly for further help and advice. Our leaflet, ‘Taking Reasonable Steps to Comply with Trading Standards Law’ explains how your company can protect itself further by taking steps to sort out potential compliance problems.

11. I import products covered by the Directives into the UK. What are my responsibilities?

Your responsibilities depend whether you are introducing the products into the EU via the UK from around the world, or whether you are importing into the UK from another EU or EEA country.

If the manufacturer does not have a base in the EU, he can establish a sub-office or appoint another person (such as a distributor) to act as his authorised representative in the EU. This authorised representative would be responsible for ensuring that the CE marking is applied correctly and should undertake the obligations of the applicable Directives, if they bring the products into the EU via the UK.

However if the manufacturer does not have an authorised representative in the EU and you as an importer are the person who places the products on the EU market, these responsibilities fall upon you. This means you must keep the manufacturer's Declaration of Conformity and the technical file at the disposal of the relevant authorities. You could, of course, become the authorised representative in agreement with the manufacturer.

If the product has already entered the EU before it is brought into the UK, then no additional responsibilities are placed upon you. The products should already be marked, either by the manufacturer or his authorised representative, and will be free to move about the EU.

However, if the products are unsafe, customs authorities can stop their entry into the UK and supply can be suspended while Trading Standards Officers investigate.

12. I install products which come under the Directives. Is it my responsibility to CE mark the goods?

If you do not supply the goods, only install them, then you should carry out the installation to the manufacturer's instructions. The responsibility for CE marking the goods still lies with the manufacturer or his authorised representative.

13. I've heard that it is more difficult to sell products in some EU markets, such as Germany, where the enforcement authorities are stricter about compliance. Is this true?

Obviously there may be disparities between the how the various agencies involved across the EU apply the law, and how the press in the other member states publicise non-compliances.

However, as you need to comply with these Directives for trading in the UK, as well as in the rest of the EEA (which includes the EU), having your products marked correctly and exceeding the relevant standards could be of benefit to your company as it puts you at a competitive advantage over the suppliers in the marketplace who are failing to comply.

You may find that users of your product and consumers in the overseas market would expect instructions or product packaging to be in their own language. This ensures that the user is able to understand any safety instructions or warnings, for instance. If you need help developing addressing a shortage of language skills in your company, contact Lincolnshire Chamber of Commerce and Industry for information on their language training programmes - you may even be eligible for support to subsidise the cost to your company.

14. When I CE mark my products, will the mark be recognised and accepted outside the EU?

Yes. The CE marking is widely recognised outside the EU. However, to sell your product, you may have to take additional national standards into account too.

15. How much will it cost my company to comply?

Procedures will need to be established within your business to check that each item produced complies with all the necessary Directives. This may just be a case of spending a bit of time organising your existing information into one technical file, so everything is in one place and is up to date. In this case, you may have done most of the work already and there may be no additional cost for your company.

In other cases, you may have to set up inspection or testing procedures. Only you can decide whether this cost is worth the risk of having your products withdrawn, and the negative publicity which would ensue, if your products do not comply with the relevant requirements.

16. I've been told that I don't have to meet the requirements because the legislation is "in transition”. What does this mean?

There is a time delay between when the legislation is passed in the European system, and when it actually comes into force. This period can last from 6 months to several years. During this period, as a manufacturer, you can choose whether or not to apply the CE Marking to your products. However, when this transition period ends, you will be legally required to conform to the Directives.

To avoid possible problems, we would advise you to begin CE Marking immediately, for both legal and financial reasons. This is because not all the legislation is at the same stage - and it may be cheaper for you to adopt both the Directives in force and in transition at the same time.

By tackling the issues of CE marking your product sooner rather than later, you also give your company the best chance of making sure no unmarked products remain in the supply chain. Remember, products which don't have the mark could be removed

by the authorities at a later stage, causing financial loss and adverse publicity for your company. Also failure to CE mark may restrict access to markets you wish to develop.

17. Since our company obtained our Declaration of Conformity, the person who signed it has left the company. What do we have to do?

Your certificate is still valid - so you don't have to go through the conformity procedures again. However, the signatory can no longer be held responsible for the actions of the company once he/she has left.

18. Is it illegal to CE Mark products that are not on the list in this pack?

We have only highlighted the most common Directives requiring a CE marking to be applied, so there may be other products in the supply chain with the marking. However, it is worth bearing in mind that if products which do not fall under the scope of the Directives are CE marked, then they will be in breach of the Trade Descriptions Act 1968, and anyone in the supply chain could be prosecuted and fined for supplying them.

19. Where can I go to get the full text of the legislation?

Your local European Information Centre, based within the County Council, will be able to supply you with the full text of all the Directives.

Here is a summary list of what you need to ask for:

Directive: Directive Number:

CE Marking Directive 93/465/EEC CE Marking Amending Directive 93/68/EEC

New Approach Directives: Directive Number

Low Voltage Directive 73/23/EEC Simple Pressure Vessels 87/404/EEC

90/488/EEC Toys 88/378/EEC Construction Products 89/106/EEC

94/23/EC Electromagnetic Compatibility (EMC) 89/336/EEC

92/31/EEC Machinery Safety 89/392/EEC

91/368/EEC 93/44/EC

Personal Protective Equipment (PPE) 89/686/EEC 93/95/EEC

Non-Automatic Weighing Machines 90/384/EEC Gas Appliances 90/396/EEC Medical Devices 93/42/EEC Recreational Craft (Boats) 94/25/EC Pressure Equipment 97/23/EC

Contact the European Centre on tel: 01522 823400, fax: 01522 823401 or e-mail: [email protected]

20. Who can help me find out if there is an EU or international standard for my product, or if there is other legislation which could affect sales of my product overseas?

You will be able to find details of all the harmonised European Standards on the European Internal Market's website at http://www.NewApproach.org.

If you can't find the standard you are looking for or you do not have access to the Internet, contact your local Trading Standards department for further assistance.

The Trading Standards department has links to similar enforcement agencies overseas, and can use these networks to track down the information you need quickly and efficiently.

21. I am being asked to comply with national standards too, although there are supposed to be harmonised standards across Europe for my product . What can I do?

If you are already exporting your product to the EU, and having difficulty, you can contact the DTI's Action Single Market unit for help (see Who can I contact for further information? for details). This team has been set up to tackle cases where British companies face barriers to trade in another EU country or in Norway, Iceland or Liechtenstein.

22. How can I get involved in influencing the creation of new standards?

European Standards are usually prepared by the European standards bodies:

• CEN (European Committee for Standardisation) • CENELEC (European Committee for Electrotechnical Standardisation) • ETSI (European Telecommunications Standards Institute)

The British Standards Institution (BSI) is the UK member of these bodies, and is involved in adopting the European Standards into the UK Standards system.

If you wish to influence new standards within these bodies you can contact the BSI or use your trade association/Chamber of Commerce to lobby on your behalf.

Products Covered by CE Marking Legislation

Term Used Definition

Construction Products

Products produced for incorporation in a permanent manner in construction works, including building and civil engineering works. CE marking is not mandatory for products sold in the UK, Portugal, Sweden and Ireland. It is, however, for products exported to the other countries which have made CE marking mandatory for construction products.

Electromagnetic Compatibility

Applies to almost all electrical and electronic appliances, equipment and apparatus liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance.

Gas Appliances Appliances, other than those specifically designed for idustrial purposes, used for cooking, heating, hot water production, refrigeration, lighting or washing, that burn gaseous fuels and have, where appropriate, a water temperature not exceeding 105o c

Low Voltage Most electrical equipment that is designed for use with a voltage rating of between 50 and 1000 volts (alternating current) and between 75 and 1500 volts (direct current)

Machinery “Functioning machines”, that is assembilies of mechanically linked parts or components, at least one of which moves with the appropriate actuators, control and power circuits, joined together for a specific application. It also applies to an assembly of machines and interchangeable equipment which modifies a machine’s function and which is supplied to be assembled with the machine. Safety components for machinery are also covered.

Note: See Points to Note on Machinery for exceptions to this Directive.

Medical Device Most medical devices, including single-use products and equipment (but not active implantable medical evices or in-vitro diagnostic medical devices) from syringes to ECGs.

Non-automatic Weighing Machines

Instruments (for exam[ple shop scales, balances, platform machines and weighbridges) which require the intervention of an operator during weighing, particularly those used for: commercial transactions; determining tolls, taiffs, taxes, bonuses etc; law enforcement; health monitoring in medical practice; making up of medicines in pharmacies and making up of pre-packages.

Personal Any device or appliance designed to be worn or held for

Protective Equipment

protection against any safety or health hazard – from safety helmets to cricket pads.

Pressure Equipment

Pressure equipment and assemblies subject to an internal pressure greater than 0.5 bar. Therefore includes manufacturers of shell and water tube boilers, heat exchangers, vessels, pressurised storage containers, industrial pipework and accessories.

Recreational Craft Recreational craft intended for sports and leisure purposes, regardless of means of propulsion, and measuring between 2.5 and 24 metres in hull length, partly completed recreational craft, and components.

Simple Pressure Vessels

Welded vessels made of certain types of steel or aluminium and intended to contain air or nitrogen under pressure, not exceeding 30 bar. Examples of such products include reservoirs for compressor units, automotive and rail braking systems.

Toys Almost all toys – that is products and materials designed or clearly intended for use in play by children under 14 years of age. See Points to Note for exclusions.

Case Studies

1. Failure to test the finished product

In October 1997, the first prosecution took place in the UK under the Electromagnetic Compatibility Regulations.

The case involved a Welsh company assembling 486 computers.

The company assumed that as all the component parts of the machines were CE marked, that they did not have to test or CE mark the finished products they produced.

This led them to being prosecuted and fined £2,000 (the maximum fine for such an offence is £5,000). If they had had a stock of computers, these would have been taken off the market too - however they assembled them to order in this case and no stocks were found.

2. Removing the manufacturers CE marking

In 1999, a Lincolnshire company was cautioned under the Toy Safety Regulations.

The company, who supplied children's wooden playhouses, had removed the CE marking affixed by the manufacturers. The reasons for this were because the CE

marking was accompanied by the name and address of the manufacturer, and the suppliers did not want customers to go to the manufacturer directly.

These actions led them to receiving a Home Office Caution. Since then, the directors of the company have worked with Lincolnshire Trading Standards, and the Trading Standards Authority where the manufacturer is based to clarify the law on CE marking and change their internal systems. They now comply fully.

3. Supply of unsafe CE marked products

In early 2000, a Lincolnshire retailer was fined a total of £6,500 in fines and £3,500 in costs after pleading guilty to six charges of supplying unsafe toys under the Toy Safety Regulations.

Although CE marked, the products, which were intended for use in water, failed to have the appropriate warnings. Samples of inflatable aquatic toys designed for use on the beach or in the sea and inflatable kayaks were tested for conformity with the Regulations after the wrong warnings were found on the products.

Following the case, the company had to forfeit all of the items seized and can no longer supply them.

4. Supply of dangerous medical device

In another local case in 1998, an unsafe mobility scooter was temporarily supplied to a man with disabilities, while his own scooter was being repaired. Shortly afterwards he fell off the replacement scooter because the seat post broke off unexpectedly. On inspection the vehicle was found to have severe corrosion, caused by acid leaking from the batteries onto the metal shaft which held the seat on.

The product, which when new is classified as a medical device, is covered by the General Product Safety Regulations 1994 which require that the product is safe when supplied secondhand. In this instance, the scooter was found to be dangerous and in breach of the Regulations. The company concerned was fined £6,000 for the offences and £600 costs.

Ten Stepping Stones to CE Marking

As mentioned in the Frequently Asked Questions section on pages 4-13, the ways in which you can make your product conform differ depending on what your product is, and which of the Directives it falls under - and even then, you still have to choose the method of conformity.

The most important thing to remember is that you are responsible for your own product. However, you are not on your own - staff at Trading Standards are on hand to help you through the steps, and help your business comply.

Step One

If you have the resources in your company, you can appoint a CE marking manager and a team of staff to support him or her, if necessary.

Remember if you have limited resources in your company, speak to your local Trading Standards Officer. This Officer will be able to work with you through the necessary processes.

If your company is already going down the route of implementing the ISO 9000 or ISO 14000 management systems, then you will already be taking measures to ensure you comply.

Step Two

The first task of this group should be to identify which of your products are involved and which of the Directives are relevant to them. To do this, they will need to consult reference materials (like this pack) and seek advice from agencies such as your local Trading Standards Office at an early stage.

Step Three

Although the information in this pack is very useful, it is not an exhaustive study of the relevant law. Greater detail can be found in the Directives themselves.

Step Four

The project group should draft a checklist based on the appropriate requirements for your product from the Directives. This checklist should also contain the dates by which action must be taken.

Step Five

Use this checklist to determine whether or not your product conforms to the essential requirements - you may be able to use existing data and test reports to do this. Information should be gathered into a ‘technical file’ for the product.

Step Six

If you need to take measures to ensure your product complies, you must decide on the most appropriate method of conforming. Use this information pack as well as the Directive itself to help you choose.

Remember, depending on your product you may be able to self-certify and declare conformity, or you may have to involve an independent third party to validate the procedures you have taken.

Step Seven

If you are going down the self-certification route, identify the standards which are applicable. These could include any international, harmonised European or purely national standards (in the countries where the product may be sold). As well as the information in this pack, your local Trading Standards Officer will be able to help you identify the relevant standards for your products.

Step Eight

If you need an independent assessment of your product (or some parts of it) carried out, then now is the time to contact the relevant body. A Trading Standards Officer will be able to help provide you with details of who to contact in relation to your product. You will have to work closely with this body to complete any testing and assessment measures required.

Step Nine

Once all necessary supporting evidence is in place, you can prepare a Declaration of Conformity. This Declaration must be completed and signed by the manufacturer, and kept with the technical file. It is possible to state compliance to more than one Directive on the same Declaration, although you must provide all the relevant information for each Directive which applies. A sample of the Declaration is contained in the Sample Regulatory Forms section of the pack, on Page 26.

Step Ten

Affix the CE Marking correctly on the product and/or it's packaging and accompanying literature.

Points To Note

Electromagnetic Compatibility

‘Electromagnetic disturbance’ is defined as ‘any electromagnetic phenomenon which may degrade the performance of a device, unit of equipment or system. An

electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change to the propagation medium itself’. Thus all electromagnetic frequencies are involved.

The specific exclusions to the EMC Directive are:

• apparatus for use in a sealed electromagnetic environment so long as it is accompanied by instructions stating that the apparatus is suitable for use only in a sealed electromagnetic environment

• amateur radio apparatus which is not available commercially, i.e. not manufactured in the course of a business

• military equipment which is designed for use as arms, munitions and war material.

Also, check whether the product needs to comply with the Low Voltage Directive, as this applies to most electrical products as well.

Machinery

This Directive sets out broad health and safety requirements for machinery and its components.

Components do not have to bear the CE marking but to have free movement they must be accompanied by the manufacturer's declaration.

In a number of cases type examination by an approved body is necessary. Contact your local Trading Standards Office for further advice if you suspect this relates to your product.

Exceptions to the Directive include:

• machinery with a power source directly applied by manual effort (e.g. a sewing machine operated by a foot pedal)

• machinery for medical use in direct contact with patients • firearms • certain means of transport and policy and military machinery • steam boilers, tanks and pressure vessels • machinery for use outside the EU • machinery already in use in the EU • second-hand machinery (from within the EU only, unless it leaves the EU to

be reconditioned and re-enters) • certain machinery covered by other Directives • safety components do not bear the CE marking but must be accompanied by

a declaration of conformity • machinery for lifting people, first supplied in the EU before 1 January 1995

Toys

Products can be self-certified and conformity declared by the manufacturer/importer, if they meet the relevant standard - national UK standards have been harmonised into European ones. This not only applies to the Toy Safety Directive but to any of the other New Approach Directives which could apply to toys.

The main requirements are that toys must:

• satisfy safety requirements • bear the CE marking • bear the required name and address details • be accompanied by warnings in English where necessary (Note that other

Community countries may also have their own language requirements)

In addition, information must be retained for inspection.

Even if you hire out toys or supply them in any way you must comply with these rules. This is also true if the toys are distributed free of charge in the course of business.

Second-hand toys must satisfy the safety requirements but are not subject to the other requirements in the Regulations. So you don't have to CE mark them, affix your details, or keep an information file on them.

Some products do not fall under the scope of the Toy Safety Regulations, see below for further details. These are covered by the General Product Safety Regulations 1994. Even if these non-toy products satisfy the Toy Safety requirements, you should not put a CE marking on them (unless they are subject to another of the New Approach Directives, and have met its requirements).

Products not regarded as toys:

• Christmas decorations • Detailed scale models for adult collectors • Equipment intended to be used collectively in playgrounds • Sports equipment • Aquatic equipment intended to be used in deep water • Folk dolls and decorative dolls and other similar articles for adult collectors • 'Professional' toys installed in public places (shopping centres, stations etc) • Puzzles with more than 500 pieces or without picture, intended for specialists • Air guns and air pistols • Fireworks, including percussion caps • Slings and catapults • Set of darts with metallic points • Electric ovens, irons and other functional products operated at a nominal

voltage exceeding 24 volts • Products containing heating elements intended for use under the supervision

of an adult in a teaching context

• Vehicles with combustion engines • Toy steam engines • Bicycles designed for sport or for travel on the public highway • Video toys that can be connected to a video screen, operated at a nominal

voltage exceeding 24 volts • Babies' dummies • Faithful reproductions of real firearms • Fashion jewellery for children

In order to maximise safety for children, manufacturers or distributors must also indicate on the packaging or the instructions for use any information capable of reducing a foreseeable risk and, notably, he must evaluate certain risks and stipulate a minimum age, such as a warning of the type ‘Not suitable for children under three years’ or recommend that the product be ‘used under adult supervision’.

Construction products

The harmonised standards or European technical approvals for particular construction products may include different performance levels or classes, and permits each Member State to determine which, if any, of these performance levels to require in its territory. Member States may not require any other levels of performance. Consequently, a CE marked product with a particular performance level that is acceptable in one Member State may not be acceptable in another Member State which requires a different performance level.

Remember products may also need to comply with other legislation, for example the Building Regulations, in order to be fit for use in controlled works.

Personal Protective Equipment

Exclusions to the Directive:

• PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order

• PPE for self-defence (e.g. personal deterrent weapons)

• PPE designed and manufactured for private use against:

• adverse weather

• damp and water

• heat

• PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time

• Second-hand PPE, except that for which has been subject to further manufacture since its last use.

Medical devices

The following devices are exempt from the CE mark:

• custom-made devices • devices undergoing a clinical investigation

However both custom-made devices and those intended for clinical investigation must conform with the relevant essential requirements.

Although third party conformity checks are not required for these products, manufacturers have to draw up a statement of compliance on their own responsibility. This statement is subject to control by the Medical Devices Agency in the UK. Custom-made devices must be clearly marked as such and all devices for clinical investigation must bear the wording ‘exclusively for clinical investigation’.

Sample Regulatory Forms

Declaration of Conformity

The following example outlines the information which would be required for a Declaration of Conformity to be issued for your product. The contents of the Declaration will depend on which of the routes to compliance you have followed:

1. Declaration of Conformity issued in the UK: the standards route

The Declaration must:

• be in English; • state the name and address of the responsible person; • state the name and address of the manufacturer (if different from above); • be signed by and on behalf of the manufacturer or the authorised

representative, and also identify them; • bear the date of issue; • give details of the relevant apparatus to which the declaration of conformity

relates in order to identify it; • state the numbers and titles of the applicable standards applied by the

manufacturer; and • certify that the apparatus meets the requirements.

2. Declaration of Conformity issued in the UK: the independent testing route

The bulk of the requirements are the same as above. In addition the Declaration must:

• identify the technical construction file; and • give the name and address of the relevant body which issued the technical

report or technical certificate, together with the date and number of that report and certificate.

3. Declaration of Conformity issued outside the UK

The requirements for Declarations issued outside the UK are slightly different. They must contain:

• a description of the apparatus; • a reference to the specification and/or the harmonised standards under which

conformity is declared (e.g. national measures or standards); • identification of the signature of the manufacturer or authorised

representative; and • in some cases, reference to the EC type-examination certificates issued by a

national body.

Who should I contact for further information?

Lincolnshire County Council Trading Standards Service, HQ 45 Newland Lincoln LN1 1YL Tel: 01522 552401 fax: 01522 552405 e-mail: [email protected]

Our other offices are in:Louth: Tel ( 01507 600800 (am only)Boston: Tel ( 01205 310010 (am only)Grantham: Tel ( 01476 561061Your call will be answered by our central reception.

British Standards Institution (BSI) 389 Chiswick High Road London W4 4AL Tel : 020 8996 9001 fax: 020 8996 7001 e-mail: [email protected] web: http://www.bsi.org.uk

BSI help includes information on UK and foreign standards, foreign certification and testing requirements, Technical Help for Exporters (THE), EU developments on standardisation, and the BSI library.

Http://www.NewApproach.org is a website through which you can access all of the New Approach Directives and relevant standards. It also links to the European Standards bodies and the European Commission's Europa server.

DTI Action Single Market Tel: 020 7215 4212 fax: 020 7215 4489 web: http://www.dti.gov.uk

The DTI's Action Single Market Team can help if you come across barriers to trade in the Single Market.

Department for Trade and Industry (DTI) Consumer Safety Unit 1 Victoria Street London SW1H 0ET web: http://www.dti.gov.uk

Guidance booklets on all UK Regulations which implement the European New Approach Directives are available. Ring 0870 1502 500 for details.

Health and Safety Executive Nottingham Office First Floor, The Pearson Building 55 Upper Parliament Street Nottingham NG1 6AU Tel: 0115 971 2800

Lincolnshire Development Business Promotion Team Welton House Limekiln Way Greetwell Road Lincoln LN2 4US Tel: 01522 823400 fax: 01522 823401 e-mail: [email protected] web: http://www.lincolnshiredevelopment.org.uk

International Trade Centre Commerce House Outer Circle road Lincoln LN2 4HY Tel: 01522 523 333 fax: 01522 823 300 e-mail: [email protected] Web: http://www.lincs-chamber.org.uk

Business Link Lincolnshire Beech House Witham Park Waterside South Lincoln LN5 7BL Tel: 0845 757 4000 fax: 01522 574005 e-mail: [email protected] Web: http://www.lincs.businesslink.co.uk

Medical Devices Agency Hannibal House Elephant & Castle London SE1 6TQ Tel: 020 7972 8300 fax: 020 7972 8112 e-mail: [email protected] web: http://www.medical-devices.gov.uk

Other areas of law may also apply to your product(s). You can contact us for information and advice on the General Product Safety Regulations, Trade Descriptions, Price Marking of Goods, and much more.