Guidance

Product safety for manufacturers

Technical and legal requirements for safety, design, packaging and insurance, to ensure products are safe and fit for purpose.

Introduction

Good design and manufacturing processes are essential to ensure you meet these technical and legal requirements. They can also give your business a competitive edge and save costs.

This guide sets out the key safety, design, packaging and insurance issues you need to consider in relation to your products.

Under the Sale of Goods Act 1979, all products must be ‘fit for purpose’, be of satisfactory quality and fit its description. This means that your products must fulfil the purpose the customer has been led to expect and the reasons that led them to buy it.

The Act also covers any purpose that a customer asks about when the product is purchased and is guaranteed by the retailer to meet that purpose when it is sold. If a product is not fit for purpose, the customer is within their rights to have the goods replaced or repaired.

You can find Sale of Goods Act guidance on the Office of Fair Trading (OFT) website.

By definition, good design will lead to safe design. While meeting your legal obligations is the minimum required, it is a good idea to go further and take best practice on board throughout the design, production, supply and disposal stages.

As a manufacturer or supplier you could be held liable in any legal action for harm caused to consumers or businesses as a result of unintended side-effects or the failure of products manufactured or supplied by you.

Your manufacturing and processing systems must comply with environmental law. You can read guidance to help you keep up with your environmental responsibilities on the NetRegs website.

See this guide on CE marking.

Products covered by specific safety regulations

A CE mark is a manufacturer’s claim that its product meets specified essential safety requirements set out in relevant European directives.

Certain categories of products must bear CE marking if you intend to sell them in:

  • the EU
  • member states of the European Economic area (EEA) - Iceland, Liechtenstein and Norway

The following categories of products require CE marking if you wish to sell them within the EU or member states of the EEA:

  • toys
  • electrical products
  • construction products
  • pressure vessels
  • telecommunications equipment
  • medical devices
  • machinery, equipment and safety components
  • personal protective equipment
  • satellite station equipment
  • gas appliances
  • pressure equipment
  • appliances (other than gas)
  • non-automatic weighing instruments and equipment
  • measuring instruments
  • recreational craft
  • lift machinery
  • equipment and protective systems for explosive atmospheres
  • in vitro diagnostic medical devices
  • marine equipment
  • safety components and subsystems for incorporation into cableway installations
  • cableway equipment (ski tows etc)

The requirement for CE marking and the exact process you will need to go through varies from product to product. Different types of product are governed by different European directives. For example, the trade of certain machinery, equipment and safety components is governed by the Supply of Machinery (Safety) Regulations 2008. The regulations implement a European directive aimed at removing technical barriers to trade.

Under the regulations, products that conform to the relevant safety standards are CE marked and can be placed on the market across the EEA. Responsibility for ensuring compliance with the regulations rests with the manufacturer of the machinery, equipment or components in question. Failure to do so can result in prosecution.

Download guidance on the Supply of Machinery (Safety) Regulations (PDF, 424KB).

Where an item of equipment is covered by more than one directive, it must be CE marked under all applicable directives.

If you supply consumer products which aren’t covered by these specific directives, they must not be CE marked. However, you still have a general duty to ensure they are safe for normal or reasonably foreseeable use under the General Product Safety Regulations 2005.

You can also see this guide on CE marking.

Fireworks - information for suppliers, retailers and display event organisers

Fireworks are available throughout the year from shops licensed to supply them. They become widely available at certain times of the year, mainly a few days before New Year’s Eve, Diwali and Chinese New Year, and in the weeks leading up to Bonfire Night on 5 November.

If you supply or sell fireworks or if you organise display events you must be aware of your responsibilities.

Your responsibilities as a firework manufacturer or importer

If you manufacture category 1, 2 or 3 fireworks or import category 1, 2 or 3 fireworks which are manufactured outside the EU, you must ensure they conform to European safety standards before supplying them for sale to the public. To do this, you need to ensure that the fireworks have been tested by a notified body (NB).

Once the NB has approved them, the products must carry the CE mark and be correctly labelled with details of the manufacturer and importer.

Pyrotechnics that were manufactured or imported before 4 July 2010 and that complied with British Standard BS 7114 can continue to be sold without the CE mark until 4 July 2017.

Category 3 fireworks must not exceed 120 decibels.

Category 4 display fireworks that are not intended for supply to consumers must be marked accordingly.

If you import fireworks, you must ensure they comply with the EU safety standards, carry the CE mark and supply information at the point of entry to ensure that fireworks are legally stored and distributed. This information should be given to HM Revenue & Customs and will then be sent to the relevant authorities responsible for storage licences so they can check on deliveries.

Licensing authorities can ask to see information relating to transactions of fireworks exceeding 50 kilograms of net explosive content.

Your responsibilities if you are a fireworks retailer

If you want to sell fireworks to the public, you need to register your shop or obtain a licence from your local authority. The penalties for not registering or being licensed are a fine of up to £5,000, a prison sentence of up to 3 months, or both.

It is illegal for retailers to sell caps, cracker snaps, novelty matches, party poppers, serpents and throwdowns to anyone who is under 16 and to sell all other fireworks to anyone who is under 18 - it is recommended that proof of age is sought.

You must display a large notice reminding customers about the law with regard to underage sales and possession.

You can only sell fireworks that conform to EU safety standards (or British Standard BS 7114 if they were produced before 4 July 2010) and which carry the CE mark and meet certain noise conditions. They must have the CE mark or BS 7114 printed on each item or on the retail packaging.

You must also supply fireworks with any safety instructions provided by the manufacturer or importer.

Boxes of fireworks must not be split and sold separately.

Unless you have a special licence, you can only sell fireworks during the weeks leading up to Bonfire Night, New Year’s Eve, Diwali and Chinese New Year.

Find a fireworks storage risk assessment checklist and information about storing and selling fireworks in retail premises on the HSE website.

Find BIS fireworks resources and safety codes on the National Archives website.

Cosmetic Products Safety Regulations

All cosmetic products supplied in the UK, whether for consumer or professional use, must comply with the Cosmetic Products (Safety) Regulations 2008 (as amended).

From 13 July 2013 a new directly applicable European Regulation (EC/1223/2009) enters into force, replacing the existing legislation, (see below).

The new notification procedure, which requires every product placed on the market to be notified to the European Commission is already in place.

The Guidance notes explain all aspects of the Cosmetics Products (Safety) Regulations 2008.

A guide to the Cosmetic Products (Safety) Regulations 2008

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The Regulations require that finished cosmetic products must undergo a safety assessment by a suitably qualified person before they can be placed on the market.

The Cosmetics Directive on which the Regulations are based is updated periodically, reflecting changes to the prohibitions and restrictions on certain substances, and subsequent amendments to the Cosmetics Products (Safety) Regulations 2008 are available on the OPSI website.

Amendments since then are contained, available on the same website.

  • The Cosmetic Products (Safety) (Amendment) Regulations 2008, S.I. 2008/2173
  • The Cosmetic Products (Safety) (Amendment No2) Regulations 2008, S.I. 2008/2566
  • The Cosmetic Products (Safety) (Amendment) Regulations 2009, S.I. 2009/796
  • The Cosmetic Products (Safety) (Amendment No2) Regulations 2009, S.I. 2009/1346
  • The Cosmetic Products (Safety) (Amendment No3) Regulations 2009, S.I. 2009/2562
  • The Cosmetic Products (Safety) (Amendment No4) Regulations 2009. S.I. 2009/3367
  • The Cosmetic Products (Safety) (Amendment) Regulations 2010, S.I. 2010/1150
  • The Cosmetic Products (Safety) (Amendment No2) Regulations 2010. S.I. 2010/1927
  • The Cosmetic Products (Safety) (Amendment) Regulations 2011, S.I. 2012/3037

On 31 October 2012 a new directive enters into force, which is mirrored in S.I. 2012/2263, and which liberalises the use of hydrogen peroxide at up to 6% for tooth whitening purposes, subject to first use by a dentist.

In addition various hair dye substances are due to be restricted from 1 September 2013, under Directive 2012/21/EU.

The UK is not intending to transpose this because it will be overtaken by the new European Regulation (see below).

The European Regulation

This has firstly altered the procedure for notification of each product, requiring notification direct to the European Commission using the Cosmetics Product Notification Portal, (CPNP).

This is operational now and can be used, although it does not become mandatory until the Regulation enters into force: see the Cosmetics Products Notification Portal document and guidance

The Regulation is directly applicable and it changes various elements, relating to the safety assessment, the responsible person in respect of that, and nanomaterials. There will be further guidance issued, as details which have still to be negotiated are finalised.

Safety regulations for children’s products

All toys supplied in the UK must meet the requirements of the Toys (Safety) Regulations 1995.

The regulations define a toy as ‘any product or material designed or clearly intended for use in play by children of less than 14 years of age, but excluding those products specified in Schedule 3 [of the regulations]’.

You can download a guide to the Toys (Safety) Regulations from the BIS website (PDF, 100K).

Note that a revised European directive will come into force on 20 July 2011. The directive substantially amends the existing regulations across virtually all safety aspects. You can download the text of the new Directive 2009/48/EC from the EUR-Lex website (PDF, 995K).

CE marking on toys

All toys presented for sale in the UK must bear the CE marking and the name and address of the person who first placed the toy on the market.

The CE mark is a declaration by the manufacturer that the product satisfies essential safety requirements and can be sold within the EU. For more information see this guide on CE marking.

Local authority trading standards officers can remove a toy from the market if they believe it to be unsafe.

Testing for toys

If you manufacture a toy in accordance with the regulations - and the standards cover all aspects relating to the toy - then it can be self-certified.

Where the standards do not cover all aspects relating to the toy, a sample must be submitted for type examination by an approved body.

If you import toys you are responsible for their safety, whether or not they already bear a CE mark. You might want to consider having them tested to ensure they are safe.

Other child safety regulations

Other laws relating to child safety include:

  • flammability - tough performance requirements regarding flammability are compulsory for children’s nightdresses and dressing gowns
  • choking risks - toys intended for children under 36 months must not present a choking risk - the test uses the ‘small parts cylinder’ (toys or parts of toys that can fit entirely inside the cylinder are identified as choking hazards)
  • magnetic parts - magnets which have a flux of more than 50 kG2mm2 (0,5 T2mm2) and fit entirely in the small parts cylinder are not permitted for use in toys
  • chemicals - the revised European Directive 2009/48/EC will limit the amounts of certain chemicals that may be contained in materials used for toys - these parts of the directive relating to chemical content will come into force on 20 July 2013 (there is also a ban on the use of six phthalates in toys and products for children under 3 years of age)

General Product safety regulations

General product safety is regulated by the General Product Safety Regulations 2005 (GPS Regulations). They apply to all products (new and second-hand) used by consumers. Product-specific legislation continues to take precedence in areas where the provisions have similar objectives to the GPS Regulations.

The GPS Regulations maintain the general duty placed on producers and distributors to place on the market (or supply) only products that are safe in normal or reasonable foreseeable use. The principal responsibility for day-to-day enforcement of the Regulations lies with local authorities.

The GPS Regulations recognise certain technical standards as carrying a presumption of conformity with the general safety requirement, meaning that products that comply with them are deemed to be safe. An up-to-date list of European Standards is available on the European Commission Website.

Rapid Alert System for non-food consumer products (RAPEX)

RAPEX is the EU rapid alert system for dangerous consumer products – with the exception of food, pharmaceutical and medical devices which are covered by other mechanisms.

It facilitates the rapid exchange of information between Member States and the Commission on measures to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are reported by RAPEX.

How does RAPEX work?

When a product (eg a toy, childcare article or household appliance) is found to be dangerous, the competent national authority takes appropriate action to eliminate the risk. It can withdraw the product from the market, recall it, or issue warnings. The National Contact Point then informs the European Commission (Directorate-General for Health and Consumer Protection) about the product, the risks it poses to consumers and the measures taken by the authority to prevent risks and accidents.

The European Commission disseminates the information that it receives to the National Contact Points of all other EU countries. It publishes weekly overviews of dangerous products and the measures taken to eliminate the risks on the internet.

The National Contact Points in each EU country ensure that the authorities responsible check whether the newly notified dangerous product is present on the market. If so, the authorities take measures to eliminate the risk, either by requiring that the product be withdrawn from the market, by recalling it from consumers or by issuing warnings.

A weekly overview of the dangerous products reported by the national authorities (the RAPEX notifications) is published on the Commission Website.

Product recall

The Trading Standards Central web site contains a list of product safety notices and recalls.

If you are concerned about the safety of a product, make your concern clear to the retailer, manufacturer or local trading standards department.

If you are a producer or distributor of consumer products on sale in the European Union (EU), the attached guide gives you general advice about what you should do if you have evidence that one of your products may be unsafe. It is a voluntary guide to carrying out corrective actions for product safety, supported by the market surveillance authorities in Member States and consumer and trade organisations within the EU. Product Safety in Europe: A Guide to corrective action including recalls

Unsafe product notification

Producers and distributors have a duty to notify local authorities when they become aware they have placed on the market, or distributed, an unsafe product.

To make this process simpler a business application form has been designed. There are two parts:

  • the notification form - which the producer or distributor should fill in
  • the online database - used exclusively by the authorities of Member States to view and process notifications (in the case of the UK the National Contact Point for RAPEX at BIS)

Guidance and the form can be accessed on the EUROPA Website.

Local authority enforcers have a duty to inform BIS of products placed on the market that either present a:

  • serious risk in need of urgent intervention
  • non-serious risk requiring some intervention

Guidance for local authorities on informing BIS about products is available by following the links below:

Risk categories for Rapex notification form

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  • RAPEX notification form (for local authority use)

Rapex notification form

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  • Reaction to RAPEX notification form (for local authority use)

Reaction to Rapex

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Local authorities - please note the Rapex and Reaction forms above are MS-Excel spreadsheet templates. See the following points on using and saving the forms to your PC:

  • From weblink click ‘Save’ without opening, ensure document is saved with .XLT at end of document name.
  • Double click the template to open a new MS-Excel spreadsheet based on the template to complete and save as a general spreadsheet document with .XLS at end of document name.

Only use the .XLT template to open a new spreadsheet to complete.

Enquiries

You should contact your local Trading Standards office, which is responsible for enforcing safety legislation within your area. Find contact details for your local office on the Trading Standards website.

Safety concerns in the early stages of design

Taking into account the safety aspects of your products from the outset of design can help limit your liabilities as you may find it easier to comply with current and future legislation if your products are easier to produce, use, maintain and dispose of.

Focusing on the research and design of your products during the early stages of development may also boost your competitiveness through a number of ways such as:

  • efficient use of raw materials and resources
  • improved product quality
  • reducing or removing hazardous materials from your processes
  • better preparation for the end of your product’s lifecycle
  • increased market share and better customer relationships

While you are creating your product, check that no harm will be caused to makers and consumers by any of the materials or finishing techniques used.

Once a sample of your product is ready for use, check that:

  • it is strong enough to support any loads involved
  • it can’t produce any toxic, harmful, or adverse effects on the user or consumer
  • the materials used are suitable for the purpose and safe for users
  • all hazards have been sufficiently controlled, eg electrical insulation, moving parts, folding components, noise and poor ergonomic design

When you dispose of a product, check that the parts and materials can be dismantled without causing harm or releasing toxic or harmful substances. Ensure that the recycling of any parts or materials will not release toxic or harmful substances.

Increasingly there is pressure from stakeholders such as the government, regulators, the supply chain and customers to design products that don’t have a negative impact on the environment or society.

Packaging concerns

Packaging includes all products used to contain, protect, handle, deliver or present goods. It includes returnable and non-returnable items such as boxes, pallets, labels, containers, tubes, bags, sacks, timber, glass, metals, plastics and ceramics. It can also include tape, wrapping, binding and tying materials.

You should check that your packaging is designed with safety in mind. The packaging should protect your product in transit and protect your customer from potential injury.

By opting to use a safety-led choice of packaging, your business will benefit from meeting legal demands, saving money and promoting an efficient image to suppliers and customers.

The EU-wide Classification, Labelling and Packaging of substances and mixtures Regulation (CLP) and the GB’s Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) govern the labelling and packaging of hazardous/dangerous chemicals. Suppliers must:

  • identify the hazards of the chemical
  • give information to their customers about the hazards/dangers, usually on the package itself (such as a label) and provide a safety data sheet (SDS) if the chemicals are to be used at work (provision of an SDS comes under the EU-wide Registration, Evaluation, Authorisation and restriction of CHemicals Regulation - REACH)
  • package the chemical safely

CLP has applied to the labels and packaging of hazardous substances since 1 December 2010. It will apply to the labels and packaging of mixtures (called preparations under CHIP) from 1 June 2015 - however, CLP labels and packaging can be used for mixtures prior to that date.

The CHIP Regulations were amended to bring them into line with the EU-wide CLP and REACH regulations. The eventual aim is to have a globally harmonised system for the classification and labelling of hazardous chemicals. Once the CLP requirements for mixtures apply, it is anticipated that the CHIP regulations will be repealed. For more information see the guide on chemicals.

Read about safety issues for chemicals packaging under CLP on the European Chemicals Agency (ECHA) website.

Read about safety issues for chemicals packaging under CHIP on the HSE website.

You must take further action if you want to transport dangerous goods. See the guide on moving goods by road.

You must keep your use of packaging to a minimum, avoid the use of heavy metals and enable packaging to be recovered. If your business handles more than 50 tonnes of packaging in a year and has a turnover of more than £2 million, you must recover and recycle set amounts of packaging.

Product liability and taking out insurance

It’s a criminal offence for manufacturers to supply unsafe products. They may also be liable under civil law for any harm such products cause - which could result in costly legal proceedings.

The Consumer Protection Act 1987 makes manufacturers strictly liable for death, injury, loss or damage caused by defective (unsafe) products.

If a finished product contains a defect in a particular component, both the product manufacturer and component manufacturer may be liable.

You can download the guide to the product liability and safety provisions of the Consumer Protection Act 1987 from the BIS website (PDF, 207K).

Other suppliers, such as wholesalers and retailers, are not liable unless they fail to identify the producer when asked to do so by a person who has suffered harm.

But customers can sue retailers under laws on the sale of goods.

You should take positive action to monitor the safety of your products. You should also make sure you are covered by product liability insurance if you manufacture or repair products, and possibly if you sell them, too.

Insurance will provide valuable protection for your business against any costs or compensation awarded. Although it’s not a legal requirement to have this type of insurance, it could mean the survival of your business should a claim be made against you. 

You can visit the Association of British Insurers website to download liability insurance guidance for small businesses

Where to get more help

The following links will provide further information on product liability, product safety and sustainability.

The Design Council encourages businesses to understand the design process and to incorporate it into their strategic planning. Read about where to get help on the Design Council website.

HSE has a section on its website called ‘Designers Can Do More’ that looks at issues such as legislation, training and best practice in the design process. Read information for designers on the HSE website.

BIS provides wide-ranging support for businesses. Read about support for businesses on the BIS website.

BSI provides useful information relating to standards, certification and legislation, together with comprehensive details of CE marking. Read about standards and CE marking on the BSI website.

WRAP (Waste & Resources Action Programme) provides a broad range of information and advice on environmental issues including eco-design and packaging. Read information and advice on environmental issues on their website.

You can also contact the Envirowise Advice Line on 0800 585 794 for two hours of free advice.

Further information

BSI Helpline

020 8996 9001

Communities and Local Government Helpline

0303 444 0000

WRAP Resource Efficiency Helpline

0808 100 2040

Environment Agency Helpline

03708 506 506

BIBA Consumer Helpline

0870 950 1790

CE marking and Kitemarks information on the BSI website

Product safety and product recall regulations information on the BIS website

United Kingdon Accreditation Service Accredited Bodies information on the UKAS website

Sale of Goods Act resources on the OFT website

CE marking and Kitemarks information on the BSI website

Download guidance on the Supply of Machinery (Safety) Regulations from the BIS website (PDF, 424K)

Download manufacturers, importers and distributors guidance on firework safety rules from the BIS website (PDF, 81K)

Download guidance on pyrotechnics regulations from the EIG website (PDF, 3.15MB)

BIS fireworks resources and safety codes on the National Archives website

Fireworks storage risk assessment and guidance for retail premises on the HSE website

Toy sector information on the Europa website

Download a ‘Choking Risks to Children’ research report from the BIS website (PDF, 419K)

Local office contact details on the Trading Standards website

Sustainable design advice on the Design Council website

Product design assessment tool on the Venture Navigator website (registration required)

Chemical packaging safety guidance on the HSE website

Download Consumer Protection Act 1987 product liability and safety guidance from the BIS website (PDF, 207K)

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