The Essentials. International Product Standards & Compliance. Thames Valley Chamber of Commerce Group 150 Edinburgh Avenue Slough, SL1 4SS

Transcription

1 International Product Standards & Compliance The Essentials Thames Valley Chamber of Commerce Group 150 Edinburgh Avenue Slough, SL1 4SS Web: Tel: Business Keys Ltd Innovation House Molly Millars Close Wokingham Berkshire RG41 2RX Web: Tel:

2 Contents - Introduction to product standards and compliance 3 - The fit with International Trade 4 - Product standards and certification an overview 5 - Product standards and certification in Europe 8 - Product labelling and packaging 9 - What happens if you do not comply with standards regulations? 10 - The route map to successful market entry 12 - Your product compliance health check 14 - Frequently asked questions 15 - Business Keys Ltd services 18 - International Trade Services from Thames Valley Chamber 19 Introduction to product standards and compliance Are you looking to sell your company s products abroad but wondering what your compliance obligations are? If so, we hope that this booklet gives you an idea of just some of the rules and regulations you will need to meet before you can start exporting. Ever increasing levels of product-related legislation are affecting organisations and their products across the world. Countries can vary widely in their approach to product regulations and standards, sometimes making it necessary to satisfy a totally different set of requirements in each country before you can start trading. So how will you prove that your products comply with all the relevant standards for quality and safety? The first challenge will be to identify which of the country s regulations and standards apply to your product. Next you will have to assess how those standards affect your product design and manufacture. Finally, you will need to get your product tested and provide proof that your product complies with the requirements of all applicable standards. In addition to being necessary for market access, compliance to international standards can increase the chances of successful export sales. Market acceptance of your products will be increased by the trust and confidence engendered by compliance with known standards. Demonstrating that you comply will improve your commercial reputation and also act as demonstration of due diligence in the case of market place problems with the product. businesskeys, a Thames Valley Chamber member, can help you build a business management system that enables you to meet your objectives, deliver value consistently and profitably and adapt with changing regulations and standards. This booklet is published and copyrighted by Business Keys Limited and Thames Valley Chamber of Commerce Group. For further guidance and advice please contact businesskeys. (See back cover for contact details) 2 3

3 The fit with international trade Creating an understanding of the technical product requirements of your target market is a crucial part of your international trade activities. This starts by making the subject part of your initial MARKET APPRAISAL. Addressing the issues at the outset could avoid expensive mistakes or delays later in the process. You should address both voluntary and mandatory requirements and understand the costs and time associated with gaining the appropriate approvals. Understanding this will put you in a stronger position with potential partners and improve your reputation and image. If you are designing a product specifically for a new market you will also find it significantly more cost effective to design the requirements in, rather than modify the product at a later stage. With a robust approach you will also find that completion of the various certificates and documentation for international trade, in particular CERTIFICATES OF ORIGIN and CERTIFICATES OF CONFORMITY will take less time and provide you with confidence in the information provided. As in your home market, you may also be faced with completing PRE QUALIFICATION QUESTIONAIRES. Having the technical details to hand will not only reduce the time taken to complete the forms but also improve their accuracy. Product standards and certification - an overview In order to enter an export territory and market your product, the product must comply with mandatory legal requirements (for market access) and voluntary standards and schemes (for market acceptance) Market Access To demonstrate compliance you will need to: - Comply with the legal requirements that affect your product. - Produce an independent test report or self-certify that your product meets the requirements. - Show that the product is manufactured within a quality assured management system (e.g. ISO 9001). Market Acceptance For a product to be successful, in addition to complying with legal requirements, it has to be acceptable to the market. Customers and users may well demand approvals and reassurance that are additional to the legal requirements. An example would be in Germany, where approval by TUV, a German test house, which issues a mark of conformity known as the GS (General Safety) mark. This mark is not only favoured by German consumers but is widely recognized across the globe within commercial circles. Below are examples of two products in different sectors that have applied for independent testing and approval of their products

4 1 - The China compulsory certificate (CCC) is mandatory for a wide range of products that could impact on, for example, human well-being, the environment and national security. 2 - The CSA mark is a voluntary (commercially required by most customers) market requirement for success in the Canadian market. However, specific product types require mandatory approval under legislative requirements. 3 - The CE mark is a mandatory EU requirement applicable to many products defined in New Approach Directives & the CE Marking Directive. 4 - The paper manufacturer has chosen to promote the fact that their product is independently certified to comply with requirements of ISO 9001, the international standard for Quality Management Systems and ISO the environmental management standard. 5 - For market acceptance in Germany the manufacturer has chosen to have the product independently verified by TUV. A knowledgeable purchaser or user knows not only what to look for but having found it, what that means for them and their related needs, wants and expectations. The most robust way of achieving acceptance is through accredited certification. This provides the highest level of assurance in that every part of the process is in the hands of professionals. It includes for example: Implementation of the standard by your organisation Certification of the implementation by a certification body Key export markets have different requirements. Here are some examples; China The CCC Mark- China Compulsory Certification mark (as shown on page 5) is required for a wide range of manufactured products exported to, or sold in, the People s Republic of China. This includes products in 19 groups, divided into 132 product categories. USA The safety requirements for technical equipment in the USA fall under the jurisdiction of the Occupational Safety and Health Act (OSHA). In some instances the regulations cite US standards e.g. ANSI, ASTM, UL & other safety requirements. Compliance to these standards is mandatory. Technical regulations are codified annually in the USA Code of Federal Regulations (CFR). Saudi Arabia Products exported to Saudi Arabia must be tested and accompanied by a Certificate of Conformity demonstrating that the product conforms to Saudi Arabian Standards Organization (SASO) standards. This is a mandatory requirement and products will not be allowed into the country without this document. Japan There are approximately 17 laws implemented in Japan which require a range of products to meet Japanese Standards and bear various mandatory certification marks. This particularly applies to electrical & electronic equipment which must bear the VCCI mark. Accreditation of the competence of the certification body Additional assurance may be given by a government appointed tified Body 6 7

5 Product standards and certification in Europe In the 27 countries of the European Union (EU) a company is required to ensure that its products meet EU Product Directives. This is usually most easily done by ensuring that the product complies with specific European Standards, which have been developed by industry. The company then has to mark the product to assure this compliance (CE marking) to regulators. Examples of EU Product Safety Directives include: - machinery safety - electrical safety - electromagnetic compatibility (EMC) - medical devices CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant national legislation implementing applicable European Directives. Products which comply with European Directives and are CE marked can move easily across EU country borders. A supplier can demonstrate compliance with the relevant directives by: Using a notified body Using a test house Self-declaration backed up by in-house testing The same principles apply to imported products. It is the responsibility of the importer/person placing the product on the market to ensure that the product meets essential health & safety requirements and is correctly CE marked. In general CE marking must appear on the product. It may also appear on the packaging, in manuals or other supporting literature. Reference should be made to the applicable legal requirements for the product. Product labelling and packaging The legal requirement for product/s to be safe and fit for purpose extends to packing and labelling. Producers, importers or suppliers who put their own name on the product and give the impression they are producers may be liable for prosecution if packaging or labelling is defective. If your business is involved in trading goods you must be both clear and honest on all packaging or you could find yourself committing a criminal offence. Therefore it makes good business sense before you start trading to find out which laws would affect you and how. There are many special rules regulating packaging and labelling in specific industries. These are supported by national and European standards. Some of the industries where special packaging and labelling are required include: Footwear - The label must show the main materials the footwear is made from. It s an offence to sell footwear in Europe without information about its composition. Food and drink - You must ensure that any packaging you use is safe. You can find information on food contact materials on the UK Food Standards Agency (FSA) website. Toys - If you sell toys, you must ensure they meet the requirements of the EU Toy Safety Directive. Bunk beds, prams and pushchairs are also subject to specific regulations. Electrical Products - Marking and labelling requirements are covered in the EU by directives such as the Low Voltage Directive, EMC Directive and the WEEE Directive. Outside of the EU other countries have their own requirements. 8 9

6 What happens if you don t comply with standards and regulations? Possible impacts of not complying are that you could either: Have your product refused at the port of entry if you are exporting or You may have to recall your product if you are placing it on the market in the EU. Both of these can have a serious impact on your business, profitability and reputation and in the worst case may impact on your ability to continue trading. RAPEX, which is the EU rapid alert system, facilitates the rapid exchange of information between EU Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. (With the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms.) Some examples are shown below. (Reproduced with the kind permission of the publications office of the European Union on behalf of the European Commission July 2012) Product: Mains charger Travel Charger Description: AC/DC adaptor for K750/750i mobile phone (NOT ORIGINAL PRODUCT). Type of risk: electric shock The product poses a risk of electric shock because it does not have adequate insulation between the input and output circuits. The product does not comply with the Low Voltage Directive (LVD) and the relevant European standard EN Action Taken: voluntary recall from consumers. Product: Mains charger 3 in 1 charger Description: Charger for iphone, ipad, ipod (NOT ORIGINAL PRODUCT). Type of risk: electric shock and fire Product: Plastic toy Solar monkey Description: colourful toy monkey on a solar panel base with flowers either side. Type of risk: choking The product poses a risk of choking because the flowers either side of the monkey are not fixed to the product and could be detached by small children and put in the mouth. The product does not comply with the Toys Directive and with the relevant European standard EN The pins are inadequately spaced from the periphery which could lead to inadvertent contact with live parts whilst inserting or removing the adaptor from the socket. In addition, the pins are not of the correct size which could cause overheating or arcing within the socket. The product does not comply with the Low Voltage Directive (LVD) and the relevant national standard. Action Taken: voluntary recall from consumers. Action Taken: withdrawal from the market and recall from consumers ordered by the authorities

7 The route map to successful market entry To help you address standards and product compliance in a structured way businesskeys has devised a 5 step process. This will also enable you to demonstrate that you have exercised due diligence in relation to product standards and certification. 1 Identify regulatory and technical market requirements The 5 step process explained: 1. Identifying regulatory & legislative requirements: Establish which national and regional regulations your product/s must meet and what your customers or supply chain requires. 2. Assess Your Current Compliance & Identify Gaps: Having established which regulations exist, review your products to see if they conform. If gaps exist, implement changes. 3. Identify Conformity Assessment Procedures: Identify what conformity assessment procedures are required by national or regional legislation or market demand. Identify compliance requirements and produce a plan to submit the products for testing and approval Assess your current compliance & identify gaps Identify conformity assessment procedures Develop TECHNICAL FILE & conduct product testing 4. Develop a Technical File & Conduct Product Testing: A technical file, as the name suggests, is a collection of documents that can be presented to regulatory authorities if a complaint or suggestion of an unsafe product arises. The file must contain (for example) vital information, i.e. records of risk assessments, general drawing/s, parts list, description of apparatus, datasheets, quality control & commissioning procedures, and declarations of conformity. The discipline of maintaining an up-to-date technical file should be defined in your quality system. 5. Prepare a Declaration of Conformity: Where applicable, the person responsible for the product must draw up a declaration of conformity in accordance with regulations, or obtain this from an accredited test laboratory. 1 Prepare a Declaration of Conformity

8 Your product compliance HEALTHCHECK Check your current level of product and system regulatory compliance and identify the gaps that need addressing in your organisation. Are you aware of the technical requirements of your target markets as they apply to your products? Have you compiled a technical file appropriate to your product/s which can be accessed by regulatory authorities? Do you have a company standards register which identifies the legal & regulatory documents that you have applied to your product? Do you have a robust system in place to update the regulatory requirements you apply to your product/system? Frequently asked questions Does my product require certification? This depends on a number of factors: The geographical area where the product is to be exported and used National/Local requirements Customer expectations Agent/Distributor knowledge and contract agreement Can I undertake my own in house testing to support my declaration of compliance to directives? You can under the spirit of the EU Directives if you are exporting/selling your product within the European Community. However, you will need to have a robust test regime in place in order to underpin your interpretation of the appropriate directives. Has your product been certified by an accredited test laboratory? Have you committed to a self-declaration conformity regime for your product/s? A flexible/workable Quality Management System (QMS) is paramount in order to demonstrate due diligence in the areas of calibrated test instrumentation, regular calibration periods, test records, applied standards, product traceability, goods in and out, customer complaints, product innovation and evidence of a full technical file for each item under consideration. Are there any certification or approval marks assigned to your product/s and placed on the item/packaging/ instruction manuals? Do you understand the significance of suppliers declaration and able to provide suitable explanation to your supply chain? Do you have a certified quality management system (e.g. ISO 9001) supporting your product compliance? Can I put the CE mark onto the product without any form of conformity assessment?. By marking your product you are communicating conformity against all relevant European Directives. If a complaint is received by any of the National European Authorities, e.g. In the UK; Trading Standards/Health & Safety Executive, they are duty bound to investigate and ask for evidence of conformity from the responsible organization. i.e. importer/distributor/agent/ manufacturer. If your self-assessment answers are mainly NO or you have been unable to answer, you need to take action

9 I have assembled my product with individual components that bear specific certification marks. This surely means my product complies with required EU Directives and standards?, not true. Although the component/s in itself probably complies with its own standard, it does not demonstrate that a collection of components & sub-assemblies constitutes a safe product or system. You must ensure an overall standard/s is applied to the item/system in order to comply with your responsibilities under the various national laws. Using & complying with recognized standards, e.g. BS/EN/IEC/ISO published harmonized product/ system standards is a robust way to meet those responsibilities. Having a product approval in one country is acceptable in another?, not always. Certain countries have their own specific requirements, e.g. China. Many countries have reciprocal testing agreements and although they are signatories to a range of ISO & IEC standards they sometimes have national deviations that require further testing & inspection, leading to production of addenda against the original test report & certificate. What is a declaration of conformity? A Declaration of Conformity must be drawn up by the person responsible for placing the product on the market. The exact format is not prescribed but it must contain the following: Name and address of the responsible person Description and identification of the product A sentence declaring that the product fulfils the provisions of the applicable directive/s Where relevant, sentences relating to other directives which are applicable A reference to the harmonised standards used (if appropriate) e.g. EN :2003 References to other technical standards and specifications used Signature, date and place of the declaration A copy of the declaration must accompany the goods. We all speak English now so my instruction manuals are ok in English?, not true. Standards identify that all instruction manuals and complementary documentation should be in the language of the country to which the product is being exported

10 Services from Business Keys Ltd We understand how confusing and difficult it can be for businesses to comply with the myriad of standards and regulations needed to be able to trade your products internationally. We offer a range of services to help you cut through the red tape and gain compliance, including: Approval requirements & procedures: Identification of the regulations and standards that your product will need to meet in order to be sold. Interpretation, explanation & advice on product approval requirements & procedures needed for CE Marking & other applicable national & international compliance schemes. Compliance assessment: Understanding the possible risks that a product poses is a requirement of many European Directives and is a key element for an importer/exporter being allowed market access for their products. We help you identify & grade significant risks & develop risk reduction strategies, enabling completion of mandatory risk assessments. Compliance plan: Formulating a plan to deliver robust product compliance, ready for submission to an independent test house. Helping you integrate your plan into your quality management regime to provide the required demonstration of continuing product compliance. Technical assistance: Complete support through the test and inspection process, including multi-country approvals. Help in developing your (mandatory) Technical File. Support in successfully engaging independent (third party) certification to underpin your Suppliers Declaration of Conformity. Product compliance: Ensuring that your product gains full certification & is awarded essential approval marks. Taking Thames Valley businesses to the world - International Trade Services from Thames Valley Chamber The International Trade team provides advice and assistance to help businesses trade within the EU and across the world. Whether you are thinking of taking steps towards importing or exporting, or you re an existing exporter looking to expand into additional overseas markets, you will know that there are many trade barriers as well as regulations for international businesses to consider. The Chamber s International Trade Centre of Excellence is one of the leading providers of international trade services in the UK. Located in a catchment area which includes Heathrow Airport, we enable hundreds of companies to export and import products throughout the world every year. Through our offices in Slough, Banbury, Heathrow and Swindon businesses can access a wide range of international trade services, aimed at facilitating successful trade with the rest of the world. Trade Services include: Export & Import Documentation; Advice and Guidance on any aspect of International Trade; Events and Workshops; Monthly International Trade E-Bulletin; Country and market guides e.g. Guide to Global Markets, Guide to Commonwealth Markets; Matching service for overseas business opportunities; Market research to assist with identifying potential markets and entry strategies; Market visits: overseas exhibitions and trade missions; Export documentation forms and publications; Letters of Credit Service; Translation & Interpreting; Customs Audit Service; Visa & UK Passports. To find out more please call or export@tvchamber.co.uk Please call or info@businesskeys.co.uk for an initial free of charge consultation