A Guide to Good Practice

A GUIDE TO GOOD PRACTICE

PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE This document was developed by the International Organization for Standardization (ISO) to assist regulators and market surveil- A GUIDE lance authorities. It is especially intended for devel- TO GOOD oping regions, to design market PRACTICE surveillance systems that conform to modern good practice criteria and that make the best use of the “ CASCO Toolbox ” of International Standards and other deliverables that have been INTRODUCTION ...... 3 developed to support good regulatory practice. THE NEED FOR MARKET SURVEILLANCE ...... 5 This document recognizes GOOD PRACTICE CRITERIA ...... 7 that there are vast differences between developing countries, SOUND REGULATORY PRINCIPLES ...... 7 and while they qualify as devel- PREREQUISITES FOR GOOD PRACTICE ...... 7 oping on economic data, they also utilize standards, regulatory GENERAL GOOD PRACTICE CRITERIA ...... 10 and conformity assessment legal frameworks, working institutions MARKET SURVEILLANCE METHODOLOGY ...... 11 and competent staff. Likewise, some countries classed as devel- ...... RESOURCES, COSTS AND BENEFITS 14 oped on economic data may also benefi t from the guidance given PRIORITIZING ...... 17 in this publication. NATIONAL, REGIONAL AND GLOBAL ISSUES ...... 19

SECTORIAL EXAMPLES OF GOOD PRACTICE ...... 25

ELECTRONIC AND ELECTRICAL PRODUCTS ...... 25

MEDICAL DEVICES ...... 32

FOOD AND AGRICULTURAL PRODUCTS ...... 38

CHEMICAL AND PHARMACEUTICAL PRODUCTS ...... 44

PERSONAL PROTECTIVE EQUIPMENT ...... 49

TOYS ...... 53

CONCLUSIONS ...... 58

2 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE INTRODUCTION

This document is aimed at stakeholders in developing countries who have an interest in the proper conduct of market surveillance activities in the marketing of regulated products. It is also aimed at those developed countries which do not have fully developed market surveillance activities. It uses the term “ market surveillance ” to include both pre-market and post-market surveillance activities. It attempts to reflect modern good practices in the form of “ good practice criteria ”. Market surveillance authorities should aspire to follow these in their quest to enhance the face of competing demands The approach taken has, for consumer protection, whilst for limited funds. The document practical reasons, to be one in taking account of the realities includes a number of examples which costs and benefits are of limited resources affordability. of current market surveillance weighed. The costs of estab- There are also issues of varying practices in different industrial lishing and maintaining market levels of technological and con- sectors where governments surveillance activities are a key formity assessment infrastructure have decided to intervene in consideration, and a number of and, indeed, inconsistent levels the market. Where intergovern- solutions are explored. For sus- of technical regulation some- mental, governmental or global tainability, the funding available times found in their countries. resources exist, these can be of to market surveillance authorities needs to keep pace with the This document starts with a assistance to those less devel- demand for their services. This basic consideration of the rea- oped countries, or countries with places pressure on governments sons behind the need for less developed market surveil- which have to cope with compet- technical regulation and market lance activities. Many of these ing demands on fiscal authorities, surveillance, and identifies some sectors are complex and require especially in times of economic common good practices that are specific characteristics to be pre- downturn and in the face of nat- applicable to all market surveil- sent in the market surveillance ural disasters. lance authorities. It goes on to systems that apply to them, and consider these in the light of the these are considered in detail. This document recognizes the resource limitations that many Both pre-market assessment contribution made by the United governments face. It takes into and approval systems, and post- Nations Economic Commission consideration the sometimes market surveillance play a part in for Europe (UNECE) document difficult issue of setting priori- achieving the necessary level of entitled “ Guide to the General ties for consumer protection in protection. Market Surveillance Procedure ”

3 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE and attempts to highlight reg- use of the standards and guides • Inspection, testing and ulated areas where those less in the “ CASCO Toolbox ”. This calibration suite of International Standards developed countries can benefit • Accreditation from non-governmental interna- and guides includes authoritative • Marks of conformity tional systems that are already documents in the following fields : • Mutual Recognition in place without having to rein- • Principles and common Arrangements (MRAs) vent them. This document is not elements of conformity intended to be a “ How to ” guide, assessment Further information on the but rather a general introduc- CASCO Toolbox and other activ- • Code of good practice for tion to market surveillance good ities of CASCO (ISO committee conformity assessment practice. It also highlights the on conformity assessment) can invaluable role that can be played • Product and system be obtained at www.iso.org/ by the correct and consistent certification casco

4 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE THE NEED FOR MARKET SURVEILLANCE

When products are traded so as to guarantee repeat busi- honourable and efficient, and all between willing suppliers and ness. The answer to the definition consumers were knowledgeable willing consumers within a free of that level of fitness for purpose – but they are not ! Frequently, market system where there are and safety is usually provided by consumers need to purchase a no price controls, the “ laws ” of standards. product about which they cannot supply and demand usually take be expected to have the same The situation in practice is not precedence. Suppliers have an level of technical knowledge as always so simple, however. interest in efficiently providing the manufacturer, and they have Firstly, competition in the market as many products as possible, to buy on the basis of trust. leads to new suppliers coming in, in order to remain in business Occasionally, suppliers come to offering ever decreasing prices. and grow. Consumers, on the the market with products that Secondly, the normal product other hand, have a need to buy do not meet the expectations of life cycle results in affluent early products, but seek to obtain the consumer, or are downright adopters paying the most, and them at the best price possible. dangerous. Somewhere in the negotiations late adopters reaping the rewards In some countries, consumer that follow, the issue of product of economies of scale achieved quality comes up. Consumers by the most efficient suppli- organizations do not enjoy the require a level of quality that ers, and of lower prices brought adequate level of recognition nor equates to at least their percep- about by increased competition. do they obtain an adequate level tion of fitness for purpose and All of this would be manage- of financial support. The con- safety, or else they will not buy able if all products conformed formity assessment infrastructure the product. It is, of course, in to up-to-date standards that is often lacking, and fewer mech- the interest of suppliers to meet address all the safety aspects anisms exist for the registering of the requirements of consumers of a product, all suppliers were product-related complaints. As a consequence, products that are quickly recalled in some countries might continue to be allowed on the market in other countries or worse, can be dumped onto their markets because of, amongst other things, a lack of a credible market surveillance system. When products are involved that can have an effect on health or safety, or the environment, or that might encourage deceptive practices, consumers need protection from faulty or dangerous products or from the unscrupulous behaviour of suppliers. This is where governments need

5 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE to step in and introduce legis- is the essence of market surveil- applicable technical regulations lation in the form of technical lance, and is either carried out by do not change, regulators in an regulations to assure a reason- the regulator itself, or by a market importing country can use pre- able level of protection. Without surveillance authority appointed shipment inspection as a tool to some form of enforcement of by it. Market surveillance may prevent nonconforming products these regulations, there will be be carried out before or after the entering the market, and have to little compliance and, therefore, product is placed on the market. work in close cooperation with governments need to establish For those products that are pro- customs authorities. one or more technical regulatory duced within their own territory, Regulators or market surveillance systems. regulators have available to them authorities also become involved A generic technical regulatory a variety of approaches, includ- in the investigation of incidents system consists of five elements : ing carrying out inspections, the that are notified to them, and sampling and testing of products that might involve nonconforming • A regulator, in the form and others. They need to work products, including the follow-up of a public body identi- closely with manufacturers and of any corrective actions. They fied to administer technical suppliers, and may take samples have a duty, together with suppli- regulations from production runs, or even ers, to keep the public informed • A suite of technical regula- test pre-production prototypes, of dangers as they arise. The tions, that normally include as part of their duties. They typ- emphasis should not just be on both administrative and tech- ically carry out both scheduled punishing those economic oper- nical provisions and random visits to premises, ators who break the rules, but in • A supplier of the prod- and can obtain and test sam- providing information to them to uct (designer, manufacturer, ples of products already placed enable corrective actions to be importer, distributor, retailer) on the market, from retail out- taken in order to ensure future which is responsible for mar- lets, etc. There are also market compliance. surveillance systems where sup- keting safe products and In addition, the communication pliers are obliged to monitor the monitoring their products in of identified risks, actions of reg- market and report defects and the marketplace ulators (including follow-up of incidents with products. • A conformity assessment any corrective actions required), infrastructure, to enable the Both pre-market and post-mar- product recalls, etc., also plays regulator to make decisions ket surveillance activities are a large part in ensuring the pro- about compliance or non- useful to protect consumer safety tection of the consumer, and can compliance, and and ensure product quality. be lacking in some developing Proper pre-market surveillance countries. • A range of sanctions that can help ensure the conformity can be applied by the regu- A number of good practice crite- of products entering the market lator in the event of proven ria can be identified that apply to and alleviate the pressure on noncompliance all market surveillance authorities post-market surveillance. The in all regions of the world, and manufacturer or supplier has Regulators and suppliers have these are discussed next. liability for any nonconforming the duty to monitor products product. coming onto the market to ensure that they conform to rel- With products imported from evant technical regulations. This other countries, although the

6 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE GOOD PRACTICE CRITERIA

Note : The good practice criteria that follow • Risk assessment : Regulators, are equally applicable to market surveil- Prerequisites for good lance in developed as well as developing and the regulatory system as practice countries. In addition to the good practice a whole, should use compre- criteria listed in this chapter, a number of a) Empowering legislation for hensive risk assessment to sector-specific criteria apply, and where the market surveillance author- these apply, they are given in the chapter concentrate resources in the “ Sectorial examples of good practice ” on ity/ies must be in place. page 25. areas that need them most Governments have the right to • Advice and guidance : introduce technical regulations in Sound regulatory Regulators should pro- the interests of protecting con- principles vide authoritative, accessible sumers from the effects of faulty advice easily and cheaply This section would be incom- or unsafe products, deceptive plete if not prefaced with a • Inspections and other visits : practices, counterfeit goods, broad overview of sound reg- No inspection should take etc. In doing so, it is implicit that ulatory principles. In the UK, a place without a reason the authorities they establish report (“ The Hampton Report ”) • Information requirements : or appoint to take the respon- was published in 2005 for the Businesses should not have sibility for market surveillance Better Regulation Executive of to give unnecessary informa- be formally identified, be com- the Department for Business tion or give the same piece of petent, notified to the public Enterprise and Regulatory information twice in legislation, and be granted Reform, entitled “ Reducing the necessary powers to per- • Compliance and enforcement Administrative Burdens : Effective form their functions, according actions : The few businesses Inspection and Enforcement ” to the good practice criteria as that persistently break regula- (Philip Hampton, March 2005). listed in this section. For exam- tions should be identified and This led to the development ple, powers to enter premises face proportionate and mean- by that Department of the or conduct searches at borders ingful sanctions “ Regulators’ Compliance Code (whether on an ad hoc or regu- – Statutory Code of Practice for • Accountability : Regulators lar basis), take samples, demand Regulators ” (Crown Copyright should be accountable for product safety files or other infor- 17 December 2007). The fol- the efficiency and effective- mation, recall or confiscate and, lowing extracts, known as “ The ness of their activities, while where necessary, dispose of Hampton Principles ”, are repro- remaining independent in the nonconforming goods, order a duced with permission from the decisions they take halt to production, delay or pre- Better Regulation Executive : vent market entry or, in extreme The above principles should • Economic progress : cases, even close down prem- form the basis for all regulatory Regulators should recog- ises, need to be detailed and actions, whether in developed or nize that a key element of need to be complete. developing countries. their activity will be to allow, There are numerous cases of or even encourage, economic The results of market surveillance market surveillance authori- progress and only to inter- activities should be communi- ties labouring under outdated vene when there is a clear cated to those who are expected and incomplete legislation, case for protection to take actions if necessary. one example being where they

7 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE have been given the power to depend to a great extent on will only draw real benefits and confiscate goods but, by over- government policy, legal sys- protection from a system where sight, not the power to dispose tems, etc.) this is in place. Governments, of them. The result can be the therefore, have a responsibil- • Reference to consumer unavoidable and costly storage ity to organize their regulatory protection and consumer proof nonconforming goods for an enforcement agencies in such a tection legislation – if it exists indefinite period while the legis- way as to minimize conflicts of in the country lation is amended (and to do so interest and avoid duplication of retrospectively can bring its own responsibilities. b) Transparency in identifying problems). the authorities responsible for c) Affected parties need to Enforceable technical regulations enforcing each technical reg- have the right to challenge and supporting legislation must ulation is essential. decisions or actions taken by exist. market surveillance authorities. In some countries, the admin- Whereas standards are by def- istration of a wide range of Market surveillance authorities inition normative documents technical regulations is central- must be accountable for their with which compliance is vol- ized in a single body ; in others, actions, and need to be able untary, technical regulations are there are a wide variety of gov- to demonstrate that their work mandatory. Market surveillance ernment departments and other is carried out independently of activities in the public inter- regulators, each with their own any other interested party, with est need a legal basis for their set of responsibilities. In one or complete impartiality and in existence and effective imple- two extreme cases, government a non-discriminatory manner, mentation and should, therefore, departments have been known especially between locally manu- be supported by : to fight “ turf wars ” over which factured and imported products. Any decision or action taken by • Technical regulations that are one of them is legally respon- an authority during market sur- developed in an open and sible for market surveillance in veillance activities, therefore, has transparent manner, that pro- a particular field, and this is of to be open to legal challenge vide a measured, risk-based course to the detriment of a clear through the courts. Removal of and proportionate solution and efficient regulatory system. products from the market, when to a real or potential prob- Often the administration of food- there is sufficient evidence that a lem. They should consist of and agriculture-related technical risk exists, should not be delayed technical, preferably perfor- regulations is handled separately waiting for a court decision. The mance-based provisions that from non-food regulations, typi- right of appeal should be detailed meet the regulatory purpose, cally by the relevant government in the empowering legislation, together with administra- ministry or department. In many and in order for it to be effective provisions that detail their cases, the responsibility for the tive, each market surveillance mode of implementation regulation of medical devices authority must be registered as rests with the relevant depart- • General product safety a legal entity (juristic person) in ment of health. Whatever the legislation each country in which it oper- arrangements, organized indus- • Product liability legislation ates, in order that it may sue and try, commerce and the public (although this can become be sued. have a right to full transparency in a controversial issue and the regulatory systems they have d) Regulatory interventions whether this is enacted will to work under, and consumers must be made at the appropriate

8 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE risk-points within the product Of course, in the above exam- situation, it might well be appro- life cycle. ple, and depending on the priate for surveillance to extend product, documentary or phys- to the premises and opera- An early decision in regulat- ical checks might additionally be tions of the end user. This may ing safety-critical products is required to ensure that product also be part of other legislation where and when to apply the expiry or “ use by ” dates are not (often contained in labour laws, regulations, as product usage exceeded, stock is rotated and occupational health and safety and the associated risks differ. single-use products are only in legislation, etc.). For example, with a single-use practice used once and then dis- It is, therefore, extremely medical device that is sterile- posed of, but the product itself important that the technical packed, there might be a need would not be likely to require requirements for the products to inspect the product during further physical checking after being regulated, which may the production process. But the being sold to the end user. and in many cases are included last point at which inspection of This is in sharp contrast with, in standards, be drafted in a the physical product would be for example, some items of per- manner that facilitates the risk- meaningful, would be at the final sonal protective equipment such based needs and objectives of point of sale. This is because the as breathing apparatus and res- the regulator. This, of course, risk of deterioration of the prod- pirators that are designed for is best achieved by having uct after sale is much lower than repeated use, and where the close cooperation between the the risk posed by a nonconform- end user has a role to play in standards developers and the ing product leaving the factory the safe use of the product. In regulators throughout the devel- gates. such a case, depending on the opment process of the standard.

9 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE General good practice within the broader geographical g) Market surveillance authori- criteria region in which they operate. ties should exercise their powers in accordance with the principle There are many examples e) Market surveillance authori- of proportionality, in the sense throughout the world of good ties should establish adequate that no intervention should be market surveillance practice. The procedures in order to : taken at a level in excess of that following is not an exhaustive list, • Follow up on complaints required to achieve the legitimate but identification of some of the or reports on issues regulatory purpose. Any meas- most important criteria. relating to risks arising ure taken to prohibit or restrict a) Market surveillance authori- in connection with prod- a product’s being made avail- ties should ensure that products ucts that are the subject able on the market or to recall covered by technical regulations of a technical regulation it, is therefore required to state (even when used, installed and • Monitor accidents and the exact grounds on which the maintained properly) which might harm to health which measure is based. compromise the health and safety are suspected to have h) Governments should estab- of users, can be either withdrawn, been caused by those lish, implement and periodically prohibited or restricted, and the products update their market surveillance public informed accordingly. • Verify that corrective programmes, which should be b) National market surveillance action has been taken either general in nature or sec- infrastructures and programmes tor-specific, within the limits of • Follow up scientific and should ensure effective measures their resources. technical knowledge can be taken in relation to any concerning safety issues i) Such programmes should be product that is subject to techni- made available to the public (by cal regulation within the territory • When there is more than way of electronic communication covered by them. Consideration one regulator involved for and, where appropriate, by other should be given to establishing a the same product, there means). national contact point for market should be procedures surveillance and enforcement of to ensure the consist- j) Governments and market technical regulations. ency of their surveillance surveillance authorities should activities, and ensure the periodically review and assess c) Governments should ensure sharing of surveillance the functioning of their market that, by publication in official jour- information to avoid surveillance activities, both from nals or other, the public is aware duplicated sanctions. an effectiveness and from a cost/ of the existence, responsibilities benefit perspective. and identity of national market • When product recall is surveillance authorities and of involved, 100 % recall k) The results of such reviews how those authorities may be should be ensured should be made available. contacted. f) Governments should entrust l) Government and regula- d) Appropriate communication market surveillance authori- tors should provide adequate and coordination mechanisms ties with the powers, resources, training to all those involved in should be established between skills and knowledge necessary surveillance activities including national market surveillance for the proper performance of technical regulations and sur- authorities and their counterparts their tasks. veillance procedures.

10 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE m) Surveillance activities can be b) Market surveillance author- laboratories should be avoided triggered in a number of differ- ities should require economic wherever possible. ent ways : operators to make available such d) Where economic operators documentation and information • Routine surveillance present test reports or certifi- as appear to them to be neces- mandated by the cates attesting conformity issued sary for the purpose of carrying regulator by an accredited conformity out their activities and, where it assessment body, market sur- • Complaints about a is deemed necessary and justi- veillance authorities should take product that is subject to fied, should enter the premises due account of such reports or regulation of economic operators and take certificates provided that the the necessary samples of prod- • As a result of quality or accreditation body is signatory ucts for examination or testing. safety failures to the mutual/multilateral rec- After investigation and confirma- • Information received ognition arrangement of ILAC or tion that the product is unsafe or from other regulators in IAF, whichever is applicable. unfit for use, they may destroy other countries or other Note 1 : In this regard, accreditation of or otherwise render inoperable parties inspection bodies or test laboratories to products that present a serious relevant International Standards such as • Other evidence of risk where they deem it necessary. ISO/IEC 17020 and ISO/IEC 17025 plays increased risk associated a major role in assuring general levels of c) Market surveillance author- with a product subject to competence. Accreditation of certifica- ities should consider the use tion bodies to ISO/IEC 17065 or ISO/IEC technical regulation of services of accredited, inde- 17021, as relevant, is similarly valuable. pendent and impartial third-party Note 2 : Where necessary and appropriate, Market surveillance conformity assessment bodies the regulator should make arrangements with third-party testing and inspection methodology where these exist. Conflicts of bodies on the use and disclosure of test- Note : The United Nations Economic interest between market sur- ing and inspection results so as to ensure Commission for Europe (UNECE) which veillance authorities and test confidentiality. also uses standards is preparing a guidance document on a General Market Surveillance Procedure that will include detailed flow- charts of the steps in the process. The general principles in this section are in align- ment with those steps. a) Market surveillance authorities should perform appropriate checks on the characteristics of products to an adequate level to achieve the regulatory purpose, by means of documentary checks and, where appropriate, physical and laboratory testing on the basis of adequate samples. When doing so, they should take account of established principles of risk assessment, complaints and other information.

11 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE e) Market surveillance author- inspectors, coupled with stand- The feasibility of obtaining higher ities should take appropriate ard operating procedures for the levels of safety or the availability measures to alert users within processes of sampling, inspec- of other products that present a their area(s) of jurisdiction, within tion, conformity assessment and lesser degree of risk should not an adequate timeframe, of haz- the initiation of corrective action, constitute grounds for consid- ards they have identified relating are also required. ISO/IEC 17024 ering that a product presents a to any product so as to reduce provides information on the cer- serious risk. the risk of injury or other damage. tification of persons and may be In this context, a national website of value in this case. l) In the collection of data from on which unsafe and withdrawn the marketplace, market surveil- i) Market surveillance authorities or recalled products are listed, is lance authorities should ensure should observe confidential- of great use. However, this can they have sufficient expertise to ity, where necessary, in order to be achieved by using radio, tel- conduct meaningful evaluation of protect commercial secrets or to evision and printed media where preserve personal data, subject those data and to assess risks these are more commonly used. to the requirement that informa- therefrom. f) Market surveillance authorities tion be made public to the fullest m) Market surveillance author- should cooperate as neces- extent necessary in order to pro- ities should, to the greatest sary with economic operators tect the interests of users. extent possible, cooperate with regarding preventive or correc- j) Market surveillance authori- and attempt to harmonize their tive actions that could prevent ties should ensure that products procedures with those of their or reduce risks caused by prod- which present a serious imme- counterparts in other countries. ucts made available by those diate or latent risk that requires operators. Where the regulator conducts rapid intervention, be recalled, routine market surveillance, it g) Where a market surveillance withdrawn, or prohibited from should take into consideration the authority decides to withdraw a sale on the open market, and available conformity assessment product that has been manufac- that the public be informed with- tured in another country outside out delay. systems that are established and its area of jurisdiction, it should implemented in the various areas k) In relation to (j) above, the inform the local representa- and then determine the products decision as to whether or not tive of the economic operator that should be focused on, and a product represents a seri- or importer concerned at the associated surveillance methods. ous risk should be based on address indicated on the product Regulators should determine an appropriate risk assessment in question, or in the documenta- that takes account of the nature how to use the existing conform- tion accompanying the product. of the hazard and the likelihood ity assessment systems to assist h) Market surveillance authori- of its occurrence after due con- them and reduce costs associ- ties should carry out their duties sideration taken of the level of ated with market surveillance. independently, impartially and awareness and understanding In this regard, regulators should without bias. Operating proce- of the hazards by persons using require conformity assessment dures should exist that require the product. In some developing bodies to ensure products tested this, and corrective action should countries, there could be cases or certified by them continuously be taken in cases where such where products could pose a conform to specified require- procedures are not followed. A particular hazard, e.g. electrical ments in standards or technical general code of good conduct for showers, kerosene stoves, etc. regulations.

12 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE

INTERNATIONAL

INTERNATIONALSTANDARD ISO/IEC INTERNATIONALSTANDARD ISO/IEC 17024 STANDARD ISO/IEC 17024 17024 Second edition INTERNATIONAL 2012-07-01 Second edition STANDARD ISO/IEC 2012-07-01 Second edition It is recommended that regu- 17020 2012-07-01 The CASCO Toolbox

Conformity assessmentSecond edition — General lators and market surveillance 2012-03-01 Conformityrequirements assessment for bodies — General operating The latest editions of the Conformityrequirementscertification assessment for of bodies persons — General operating requirementscertificationÉvaluation de for la ofconformité bodies persons — Exigences operating authorities use these standards certificationorganismes of de personscertification procéd Évaluation de la conformité — Exigences générales pour les organismes de certification procéd ant à la certification de personnes Évaluation de la conformité — Exigences générales pour les International Standards and other Conformityorganismes assessment de certification — Requirementsprocéd ant à la certification de personnes générales pour les for the operation of various typesant àof la certification de personnes and guides with no changes. bodies performing inspection

Évaluation de la conformité — guidance documents in Table 1 différents types d'organismes proc Exigences pour le fonctionnement édant à l'inspection They may have a need for addi- de below are developed by CASCO tional requirements based on and are joint publications1) by ISO local conditions. and IEC. They should form the

basis for market surveillance and

Reference numbe its related activities : 1) Designations correct as at May 2012. ISO/IEC 17024:2012(E)r Reference numbe ISO/IEC 17024:2012(E)r Reference numbe ISO/IEC 17024:2012(E)r © ISO 2012

Table 1 – List of ISO/CASCO standards and guides © ISO 2012

Reference Title ISO/IEC Guide 23 Methods of indicating conformity with standards for third-party certifi cation systems Guidelines for corrective action to be taken by a certifi cation body in the event of misuse of its ISO Guide 27 mark of conformity ISO/IEC Guide 28 Conformity assessment – Guidance on a third-party certifi cation system for products Conformity assessment – Guidance on the use of an organization’s quality management system in ISO/IEC Guide 53 product certifi cation ISO/IEC Guide 60 Conformity assessment – Code of good practice ISO/IEC 17065 Conformity assessment − Requirements for bodies certifying products, processes and services. ISO/IEC Guide 67 (under revision as Conformity assessment – Fundamentals of product certifi cation ISO/IEC 17067) ISO/IEC Guide 68 Arrangements for the recognition and acceptance of conformity assessment results ISO/IEC 17000 Conformity assessment – Vocabulary and general principles Conformity assessment – Guidance for drafting normative documents suitable for use for ISO/IEC 17007 conformity assessment Conformity assessment – General requirements for accreditation bodies accrediting conformity ISO/IEC 17011 assessment bodies Conformity assessment – Requirements for the operation of various types of bodies performing ISO/IEC 17020 inspection Conformity assessment – Requirements for bodies providing audit and certifi cation of ISO/IEC 17021 management systems ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certifi cation of persons ISO/IEC TS Conformity assessment — Requirements and recommendations for content of a third-party audit 17022 report on management systems ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories ISO/IEC 17030 Conformity assessment – General requirements for third-party marks of conformity Conformity assessment – General requirements for peer assessment of conformity assessment ISO/IEC 17040 bodies and accreditation bodies ISO/IEC 17043 Conformity assessment – General requirements for profi ciency testing ISO/IEC 17050-1 Conformity assessment – Supplier’s declaration of conformity – Part 1 : General requirements ISO/IEC 17050-2 Conformity assessment – Supplier’s declaration of conformity – Part 2 : Supporting documentation

13 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE RESOURCES, COSTS AND BENEFITS

In a developing country context, the considerations to take into account when establishing or maintaining a regulatory/ market surveillance authority can be even more complex than in a developed country. The necessity to protect the population from unsafe products is just as pressing and valid as it is in developed countries, but additional needs and costs are often exacerbated. When items are imported and are health- and safety-critical items, the market surveillance “ balance ” is tipped very much towards the control of imports at borders rather than surveillance of items leaving the factory gates. national policy or framework volumes of goods that need to Some countries can be the within which different regulatory be monitored and, especially, recipients of substandard or bodies can exist, the regula- often due to the inability of local counterfeit products, and in the tory systems that are in place industry to meet the cost burden absence of alternative imports, are fragmented and present an of market surveillance, whether the population often has no through levies or increases in inconsistent approach. choice but to buy these products other taxes, without pricing their when they find their way into the Governments are, nevertheless, products too high to be able to domestic market. The choice for faced with huge responsibilities maintain market share against the end consumer, therefore, can to protect the health and safety of cheaper imports. come down to take poor quality citizens while, at the same time, In addition, suitably accredited and potentially unsafe products facing competing demands to conformity assessment provid- or none at all. A culture of qual- alleviate food shortages, recover ers are often unavailable within ity and safety is often not well from natural disasters, etc. It is the national territory, which recognized, and consumers con- also highly likely that a newly- means that some tests have to sequently also have little voice established market surveillance be outsourced to higher cost lab- with which to alert their govern- authority will not be able to oratories overseas. There is often ments to regulatory needs. become self-sustaining for some insufficient “ critical mass ” for the In developing and developed time. It will require guaranteed testing business in a country for countries where there is little budget support, partly due to a viable conformity assessment evidence of the existence of a high entry costs, relatively low operation to be established.

14 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE The costs facing market surveil- provide some “ seed money ” and insist as a prerequisite that these lance authorities include normal to nurture the new market surveil- incompatible functions be sepa- set-up costs, but also involve lance authority until the volume rated from each other. This can high staffing costs (as the market of work and, therefore, income have negative repercussions for a for the relatively few people with reach a level of sustainability. country’s infrastructure at a time qualifications is often very fluid), when the country’s economy has One solution often taken for high costs of training, study a chance to expand. Whatever practical reasons is to base the visits, sampling, inspection and the final solution in cases like regulatory/market surveillance testing. High communication this, some costly trade-offs usu- function within an already estab- costs with stakeholders in large, ally have to be made. lished conformity assessment or sparsely populated geographical national standards body. Some In deciding which regulatory sec- areas, as well as the capital cost testing facilities might exist, some tors to target, governments face of obtaining modern information of which might be accredited, a dilemma. If they spread the and communication technology, and the standards develop- available resources too thinly, pose further barriers to entry. the risk is that a small and insig- But market surveillance author- ment function can be used to nificant intervention will be made ities have to be able to afford to assist in preparing technical in a large number of areas and, use the services of adequate, regulations. This model under- therefore, the regulatory purpose preferably accredited conformity standably attracts criticism for has no chance of being achieved. assessment bodies from day one, being a mix of interlinked func- On the other hand, to concen- and to carry the financial burden tions that should, according to trate all resources in one or two of providing their operations for best practice criteria, operate of a number of high risk areas, several years before any pay- independently of each other. The means that the neglected areas back can be expected. Where tendency then can be for large continue to present health and governments have decided to developed economic trading safety hazards. The hard fact is make market surveillance activi- blocs, when negotiating eco- that in such cases the only viable ties either self-funding or partially nomic partnership agreements option is to concentrate availa- self-funding, they might need to with a developing country, to ble resources on those areas that pose the highest risks, and to have a suitable long-term plan. The choice of methods of intervention used in market surveillance will also affect costs, and in the absence of 100 % sampling, inspection and testing will also affect the residual risk of noncompliance. Reliable pre-shipment inspection of imports can reduce the risk of noncompliance, but comes

15 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE at a significant cost, whereas surveillance offers few easy has to be supported by central at the other end of the scale, answers. Central government is government. pure reliance of first party (sup- the first and most likely source An alternative method of covering plier’s) declaration of conformity of funding. But in many devel- costs would be to build the cost oping countries, the treasury is is highly cost-effective, but may of market surveillance into pre- always under strain owing to the give little assurance of compli- approval or licensing fees, but as demands of other priority areas ance in the absence of additional with the levy system, this method such as housing and feeding the monitoring and adequate and of funding can attract criticism population, recovering from nat- enforced product liability legisla- from the regulated law-abiding ural disasters, etc. Thus, even tion. Recognizable and traceable members of industry, who feel though protection of the popula- marks of conformity from over- they are being double-charged tion is highly important, it might seas suppliers – information from and that the law-breakers are not receive the level of funding it voluntary conformity assessment escaping relatively unscathed. sources – product certificates merits. One model that has found – traceable certificates of con- favour in South Africa is a system If a market surveillance authority were to take the decision to formance – traceable certificates based around a series of about 80 rely solely on certification as its of analysis, could also be of ben- “ compulsory specifications ” that means of monitoring, the cost efit to the local regulator. are developed with the assistance of the national standards body, but would be relatively low. It might Similarly, if a cost/risk analysis is only published as technical regu- even be possible to extract some applied to different post-market lations under the auspices of the sort of “ recognition fee ” from surveillance options, an inter- parent government department. the chosen and approved certi- esting pattern emerges. On the A regulator is appointed for the fiers, but this method is not the one hand, the option to do noth- areas covered by the compulsory best model and has probably not ing and await complaints is, of specifications, and funds its oper- been seen to work well in prac- course, the cheapest, but car- ations by means of a levy raised tice anywhere. Moreover, it could ries a high risk, and it can be on the suppliers or importers of be seen as a corrupted practice. argued that this does not con- affected products. This is an effi- The market surveillance author- stitute market surveillance at cient method of collecting funds, ity could also collaborate with all ! On the other hand, inspec- but suffers from the criticism that recognized and, preferably, tion on a batch-by-batch basis the levy is raised on all operators, accredited third-party product gives a high degree of assurance not just on those who are failing to certification schemes. Although of compliance, but comes at a comply with the regulations. Even not replacing the regulator, this high cost. Both of these scenar- with this model, levies cannot could at least add a degree of ios are open to debate, and will easily be collected until a year or confidence to the process. depend on a number of factors. more of market surveillance has Ultimately, the question of who taken place, and there is thus a has to pay for the costs of market funding gap, at least initially, that

16 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE PRIORITIZING

It can be argued that all techni- on International Standards, it is should be reviewed periodically cal regulations inhibit trade to a important to limit the require- and the technical regulations, certain degree, as their purpose ments that are called up into and therefore their enforcement, is to prevent trade in products regulation. These should be lim- should be amended as neces- that are shown to be harmful. ited to those that have a bearing sary, or even withdrawn if the Therefore, the benefits, even on the subject of the regula- regulatory need has fallen away. of well-administered technical tion (for example, health, safety The use of standards as the regulations, always have to be and environmental requirements basis for technical regulations weighed against the costs. should be included, but other performance requirements with is, therefore, highly efficient, as On the one hand, technical reg- no impact on, or relation to, all of these aspects would auto- ulations imposed to protect the safety should be considered for matically be considered during community can achieve a high exclusion). the standard development and level of compliance, because review process. they are backed by the force of To ensure that the benefits of law. They level the playing field any proposed regulation really do The industry sectors that are reg- and can, in some cases, unin- outweigh the costs, it is essential ulated need to be decided upon tentionally favour local industry that impact assessments be car- and prioritized. The involve- versus imports, which can be ried out to determine the effect ment and cooperation of these either a good or a bad side effect on industry and, in some cases, sectors is invaluable in the struc- depending on the circumstances. on the macro-economy. Impacts ture of a regulatory process. In On the other hand, there is typically quite a high cost of compliance, and large businesses, whether local or overseas, tend to be better able to absorb these costs. Trade barriers can easily be created, and if the technical regulations do not keep pace with the state of the art, they can easily stifle competition and break the cycle of innovation. Regulators need to temper their interventions in the market with a dose of reality. Only those aspects that are really necessary to achieve the regulatory objectives should, therefore, be regulated. While it is good practice to base the technical requirements of such regulations

17 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE some developing countries, the of all technical regulations based truly International Standards standards base is effectively a on them. Free trade areas are of developed by ISO and the IEC collection of de facto technical great importance in this regard, are preferred, as the international regulations, as economic play- since the presumption of con- consensus they require prevents ers can only in practice sell their formity and free passage of these unwanted side effects. goods if they conform to the goods within the area, once a When it comes to regulatory national standards. This can product has legally entered one policy, some policy makers do lead to confusion in the market of its member countries, reduces not understand that there will between standards and techni- the administrative and cost bur- always be a gap between the low, cal regulations. Standards are dens on national structures. or zero level of risk they might be voluntary instruments, whereas There is, of course, a trade-off in aiming for, and the level that is only those standards, or parts terms of risk and trust between achievable in practice through of them, that serve a real regula- member countries. regulation. Resource constraints tory need, should find their way Some of the benefits of basing and cost-benefit calculations will into regulation. What is required technical regulations on stand- dictate that some trade-offs will is a limited set of technical reg- ards include the fact that they always be required. ulations where there has been readily provide a quality/per- shown to be a genuine regula- Even in most developed coun- formance baseline. They can tory need due to a breakdown tries, regulation is only carried promote fair competition and in the normal market forces of out in a limited number of tech- efficiency, they are always easy supply and demand. nical areas – details are available to update to reflect advances from the WTO enquiry points and One possible solution for devel- in technology, and when the government websites. It is rec- oping countries is to participate underlying standards are interna- ommended that countries should in regional organizations that tional, harmonization is facilitated not consider imposing regula- concern themselves with the between countries and regions. tions and undertaking market harmonization of standards, that Standards can, however, be surveillance in additional areas base national or regional stand- manipulated to entrench tech- unless specific risks have been ards on International Standards, nologies and can “ lock in ” identified in their own markets. wherever possible, and that outmoded systems if not kept therefore harmonize the effect up to date. For this reason, the

18 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE NATIONAL, REGIONAL AND GLOBAL ISSUES

Regulatory authorities in the of each other’s facilities, and even are some unexpected challenges developing world tend to exist of accreditation bodies, provides such as customs regulations that only on a national basis. Although a way forward. In the Southern impede the movement of test a number of free trade areas exist African Development Community samples or calibration materi- where, in theory if not always in (SADC) of 15 member states, als between countries. Access practice, products that have only two have national accred- to inspectors from another entered the free trade area legally itation bodies, and the solution member state requires coordina- should be able to cross inter- that is being applied currently tion, which is sometimes lacking. nal borders without any further involves the creation of a regional One area of major promise, involvement of regulators, and accreditation resource (SADCAS) though, is the opportunity to a degree of cooperation and that can service customers in all establish “ alert ” or information information sharing between member states. sharing systems that highlight national regulators is evident. Some challenges to full regional the appearance on the market Nevertheless, much more can cooperation are likely to exist for a of noncompliant goods. and should be done within estab- long time, however. Recognition lished geographical regions to There are many examples of of prior testing in neighbour- enhance the benefits of regula- regional cooperations in the devel- ing member states of a region tory cooperation. oped and developing regions of requires a level of confidence and the world, such as MERCOSUR In a developing region, there a certain degree of trust. Levels (4 South American countries), are also some synergies to be of regulation and surveillance are CARICOM (15 Caribbean coun- achieved ; for example, an accred- likely to differ greatly between tries and dependencies), ASEAN ited test facility for a given type of neighbours in the absence of (Association of 10 Southeast product might only exist in one full coordination of their activi- Asian Countries). Some exam- country within a region. Provided ties. The scarcity of accredited ples of regional or large country there is sufficient trust and coop- test facilities in some developing markets are given below : eration between countries, the use regions is always a problem, as USA, Canada and Australia : Strictly speaking, each of these nations is not a region but may be regarded as a “ federally integrated market ”. Tariff-free movement of goods is permitted between internal states or provinces. The central federal government is responsible for some technical regulation (but by no means all) through appointed agencies, and the states or provinces contribute additional regulations. Within these markets, surveillance levels are well

19 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE established, and the penalties for noncompliance are extremely high. NAFTA : The North American Free Trade Area comprises Canada, Mexico and the USA, and bases itself on the WTO GATT, Technical Barriers to Trade (TBT) and the Sanitary and Phytosanitary Measures (SPS) agreements. Within this region, most tariffs have been eliminated, and a committee on standards- related measures is in existence. As a regional regulatory entity, it has a detailed dispute-resolution procedure and works fairly well in most areas, except perhaps in the field of agricultural products, where a number of significant dif- ficulties remain.

The European Union : The EU is level of technical requirements to address the directives directly a single market that ensures the has been diluted from those that in any method of their choosing, free movement of people, goods, were previously in place in some but this is not always particularly services and capital among its member states before the EU easy. member states. It has estab- was created. Nevertheless, they lished a standardized system of Asia-Pacific Economic are equivalent to “ technical regu- laws that apply to all member Cooperation (APEC) : APEC lations ”, and lay down “ essential states, and uses “ EU Directives ” has, as a long-term goal, the requirements ” that regulated to provide a legal definition of creation of a single, region- products must conform to. requirements for regulated prod- wide Free Trade Area, and is Market surveillance is conducted ucts. The EU product directives committed to reducing trade bar- have as their principal goal the by designated authorities work- riers without resorting to legally creation of a single legal envi- ing through suitably qualified binding obligations between ronment between the member “ notified bodies ”. Compliance members. Instead, it promotes states that will facilitate regula- with the national standards that dialogue and decisions on the basis of consensus, and favours tion and avoid the occurrence adopt the EN standards pro- both International Standards and of trade barriers between them. vides, by definition, a “ deemed international models for conform- The intention is that products to satisfy ” method of meeting ity assessment as solutions. can be sold across the EU with- the essential requirements in the out having to undergo repeated directives, although compliance East African Community assessment and approval pro- with the standards is not in itself (EAC) : The EAC is a regional cedures. In some cases, their mandatory. Suppliers remain free intergovernmental organization

20 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE comprising Kenya, Uganda, sector, the United Nations’ Food Electrical and electronic end-prod- Tanzania, Rwanda and Burundi. and Agriculture Organization uct, equipment and component It is working towards the cre- (FAO) and the Codex Alimentarius standards are the realm of the ation of a customs union, a Commission, recognized by International Electrotechnical common market, monetary union the WTO SPS agreement as Commission (IEC), which also and a political federation. There the developer of food stand- runs three systems, IECEE, IECQ is an East African Standards ards, together with the Global and IECEx providing third-party Committee responsible for devel- Food Safety Initiative (GFSI) are conformity assessment services oping harmonized East African key players, while in the area of through their members and rele- Standards, and the EAC Council medical device regulation, the vant schemes. has the right to declare an East Global Harmonization Task Force In the area of toy safety, the African Standard to be compul- (GHTF) is made up of both the EU’s toy safety directive and sory on the grounds of protection regulated medical device industry EN 71 standards, the US ASTM of health, safety, the environment and the major national regulators, toy standard, the South Africa or the elimination of deceptive such as the US Food and Drug Product Safety Framework, practices. Each partner state is Administration (FDA). ISO’s International Standard then obliged to appoint a regula- Note : The Codex Alimentarius Commission on toy safety ISO 8124, are tory authority to administer these is a body established by the United Nations widely used as reference docu- compulsory standards and, Food and Agriculture organization and the World Health Organization (WHO). ments. PROSAFE, the Product within the region, the partner Safety Enforcement Forum of states are obliged to recognize In the chemical arena, the EU’s Europe, the US Product Safety each other’s product certification regulation on chemicals and their Commission, Health Canada marks as their own. safe use − REACH (Registration, and the Australian Competition & Evaluation, Authorization and The above regional solutions Consumer Commission (ACCC) Restriction of Chemical sub- vary greatly in their complex- are very active in the market sur- stances) programme is widely ity, degrees of sophistication veillance of toys. recognized and, in pharmaceu- and general levels of workabil- ticals, WHO and the European Regulators in developing ity, but they do represent valid Medicines Agency are extremely countries can access and ben- attempts at solving the regu- active. efit greatly from the work of the latory “ dilemma ” on a regional basis. What is clear, however, is that in developing regions of the world, even with the combined resources of member states, some of the more demanding areas where market surveillance is required cannot be properly addressed without some sort of global approach. Global agencies that set standards and provide regulatory solutions and support fortunately exist in many areas. In the food

21 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE above-mentioned agencies, by preventing new barriers to underpin this system, a reliable and do not need to develop reg- trade, and by a process involving conformity assessment infra- ulations or enforce them in a mutual recognition and techni- structure needs to exist, that : vacuum. cal harmonization. The essential • Is consistent, and based on principles of the new legislative Two areas of good practice that appropriate best practice framework are outlined below : have been highly developed over standards the last few years, and that have • Legislative harmonization is • Involves accreditation and changed the regulatory scene limited to “ essential require- the use of intercomparison dramatically, warrant further ments ” that products placed techniques to demonstrate mention. These are the effect on the European single competence of the EU’s “ new approach ” market are obliged to meet, on technical regulation, and the if they are to benefit from free • Promotes Mutual Recognition emergence of the EU’s RAPEX movement within the market. Agreements system. The ACCC also has a (A simple example of an • Minimizes differences in well-established product recall essential requirement is that approach and capacity system in operation. a given product must be safe between conformity assess- to use) The new legislative framework : ment providers in different The European Community intro- • Technical specifications member states duced the CE-marking system for products that meet the in 1985, following the advent essential requirements set out Implementation of the new of the “ global approach ”. in applicable directives are approach on a national basis Directives that were in existence expressed in the form of har- involves the following : prior to the global approach monized standards • Member states must take and which, therefore, did not • As standards are by definition all necessary measures to allow for CE-marking, were then voluntary, their application ensure that only safe prod- referred to as “ old approach is not enforced, and man- ucts are placed on the directives ”, whereas directives ufacturers are entitled to market. This implies a respon- that invoked requirements for apply other means to meet sibility to carry out market CE-marking became known the requirements, however surveillance nationally as “ new approach directives ”. products that have been Some old approach directives • While member states are free manufactured to harmonized remained in force, but the new to adopt additional national standards are presumed CE-marking requirements were protection provisions, these to conform to the essential intended to apply to products must not require product requirements that conformed to all applica- modifications or vary the ble directives, at least one of The idea behind the “ new basic conditions for placing a which was required to be a new approach ” is that conformity to product on the market approach directive. these harmonized standards is a • Essential requirements are The free movement of goods reliable means of guaranteeing set out in the annexes to the through the European single protection in terms of the essen- directives, and include all market is a fundamental con- tial requirements. On a national necessary aspects to achieve cept, and the new legislative basis, authorities are responsi- the objectives of the relevant framework ought to achieve this ble for market surveillance. To directives

22 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE in member states by “ noti- is taken against nonconforming fi ed bodies ” that meet certain products. It serves as a deter- requirements rent to those who would attempt • The CE-marking is an attes- to place unsafe products on the tation that products comply market, as quick and coordinated with essential requirements detection of nonconformities of applicable directives, and and follow-up actions across a member states are required number of member states can to protect the integrity of the have a huge fi nancial impact on CE-marking system manufacturers producing unsafe products. • New approach directives are “ total harmonization ” RAPEX is a rapid alert system directives, and supersede for dangerous consumer products, and operates across the • Member states are obliged to all corresponding national European Union as well as the presume that products bear- provisions other European Economic Area ing the CE-marking comply with all applicable directives, The EU’s RAPEX (Rapid Alert (EEA) countries. It is intended and may not restrict in any System for non-Food Consumer to ensure that relevant informa- way placing the products on Products) : One of the corner- tion about dangerous products the market, unless it can be stones of the new legislative identifi ed by one national author- shown that the CE-marking framework to technical regulation ity is made available to all other provisions have been applied is that member states are obliged national authorities and to the incorrectly to notify other member states as European Commission. RAPEX soon as they take a decision to was established under Article • Where a hazard is identi- withdraw, or restrict the placing 12, and in terms of the notifi ca- fi ed that is not covered by an on the market of a product for tion procedure outlined in Article existing directive, or where for safety reasons. This protects the 11, of Directive 2001/95/EC, the whatever reason, products single market by ensuring that a General Product Safety Directive are found on the market that consistent regulatory approach (GPSD). Article 12 of the GPSD are unsafe, member states have an obligation to prohibit or restrict the placing on the market of the products, and to inform other member states of the measures taken and the reasons for them • Before placing a product on the market, a manufacturer is obliged to subject the product to the necessary conformity assessment procedures • Third-party conformity assessment is carried out

23 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE requires national authorities to the market, recalling products after suitable investigation, notify notify the EC and member states, already sold into the market and RAPEX though their national con- via the RAPEX system, about rel- the provision of relevant informa- tact point. In turn, the RAPEX evant details of measures taken tion to consumers. It covers most system notifies all other national to prevent or restrict the market- non-food consumer products. A contact points. Weekly over- ing or use of consumer products different alert system (RASFF) is views of RAPEX notifications are that have been found to pose a in place for food and feeds, and published on the RAPEX web- serious risk to the health or safety dedicated systems exist for med- site. Manufacturers of products of consumers. ical devices and pharmaceutical are well advised to maintain an products. awareness of RAPEX notifica- RAPEX covers both meas- tions, as knowledge of emerging ures insisted upon by national National authorities detect, either risks can save them unnecessary authorities and voluntary meas- through their own market sur- expense and facilitate better and ures taken by manufacturers, veillance procedures or from safer product design before their their agents or their distributors. complaints or notices received products reach the market. Common measures taken include from consumers or producers, banning the sales of products, that dangerous consumer prod- withdrawal of a product from ucts are on the market and,

24 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE SECTORIAL EXAMPLES OF GOOD PRACTICE

Electronic and electrical safe. It is a fact that a number of products must pass through the products unscrupulous manufacturers fail border controls and enter the to test their products and apply market each year. On the other a) General : Household electri- a false declaration of conform- hand, large, responsible man- cal and electronic products are ity, hoping to escape detection. ufacturers in this sector usually bought by virtually every con- Consequently, it is not surpris- have a separate department sumer on the planet, and even ing that hundreds of thousands dedicated to ensuring regulatory the simplest and commonest of of products are stopped by cus- compliance ; this is especially products, such as electric irons, important given that differences toasters and radio receivers bear toms officials, trading standards in acceptance requirements, a bewildering array of third-party officers, or other surveillance however small, affect product certification marks or suppli- authorities for examination each entry into different national mar- ers’ declarations of conformity. year. It also seems likely that a kets and need to be catered While these are evidence of a number of manufacturers simply for. Requirements for operating highly regulated global indus- do not understand the complex instruction leaflets, and product try, the consumer is usually at a rules that apply to their prod- or package labelling in national loss as to their meaning. Recent ucts and issue declarations of languages, are a prime example research by TUV (Technischer conformity in good faith, but on of this. Überwachungs-Verein) in the UK a false basis. It can, therefore, revealed that 73 % of UK consum- be deduced with a good level Some of the most frequently noti- ers believed that the CE-marking of certainty that a large number fied products in this sector include on a product signified that it was of nonconforming imported simple items such as lights, electric plugs and extension cord sets. In 2007, approximately 18 % of RAPEX notifications from the EU to a large manufacturing country involved electrical appliances or lighting equipment. In the EU, the most significant directive for such consumer products is the Low Voltage Directive 2006/95/ EC (LVD), but there exist other directives, such as • The Directive on Radio Equipment and Telecommunications Terminal Equipment (R&TTE Directive 1999/5/EC) • The Electromagnetic Compatibility Directive (EMC Directive 2004/108/EC)

25 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE • Directive 2005/32/EC estab- Conformity (SDoC) might suffice, • Misuse of apparatus (hence lishing a framework for the but for higher assessed risks, a the need for better instruc- setting of ecodesign require- third-party product assessment tions) : 26 % ments for energy-using coupled with a quality system • Faulty insulation : 10 % products (EuP Directive) might be required. Similar levels • Use of old apparatus : 10 % of regulation exist in other • Directive 2006/66/EC on and Batteries and Accumulators jurisdictions. • Loose electrical connections : and Waste Batteries and Under the LVD, market sur- 7 % Accumulators (Batteries veillance is a requirement that Directive) cannot be escaped. A market It seems clear that many of these surveillance activity can be trig- • Directive 2002/96/EC incidents might be avoided by gered by : on Waste Electrical and better adherence to standards, Electronic Equipment (WEEE • A registered complaint in some cases better standards, Directive) and in all cases more market • An accident involving the surveillance. However, there is product If an electrical product fails to fall always a trade-off between the under one of the above direc- • A notification from another level of risk that the consumer tives, it is unlikely to escape member state under the is willing to accept (often zero) the General Product Safety RAPEX system and that which is practically Directive 2001/95/EC (GPSD). possible (and this is related to • A random inspection, or There are other directives and cost). Essentially, the consumer regulations that apply in specific • A special project, such as has to bear some of the risk. circumstances. Similar sets of Christmas lighting chains The consumer has to accept regulations apply in other devel- some responsibility for notify- oped markets. Statistics from Denmark indicate ing authorities about dangerous that 52 % of all fires are caused products. The consumer also The intention of all these direc- by household appliances, radios, has a duty to become better tives and regulations is to protect televisions and computers, with informed, for example (as a the user or consumer from risks another 12 % being caused by minimum) by reading product such as electric shock, fire luminaires. Reasons for these instructions before using the or overheating, explosion or fires include : product. mechanical risks associated with the use of these products.

They are also intended to prevent electromagnetic inter- ference (EMI) caused by their use, by assuring the requisite level of electromagnetic compatibility (EMC) between items of equipment that are intended to operate together. In general, where the risk is deemed to be low, a Supplier’s Declaration of

26 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE whether it could endanger the safety of persons, domestic ani- mals or property. It is important to realize that it must generally be proven that the product is dangerous before any action is taken. It is not sufficient to merely prove that the product fails to conform to a standard. Fourthly, if a product is found to be dangerous, then the market surveillance authority needs to decide on what actions to take. These can vary, depending on the severity of the case, from relatively minor measures to a complete ban on the further sale b) The market surveillance Firstly, the market surveillance of the products and the enforced procedure : In the EU, market authority develops a market recall of products already in the surveillance is carried out by nation- surveillance programme which market. To achieve a full prod- ally-appointed “ notified bodies ”. specifies which product or product recall might involve sending In the United States, regula- uct group to target, and then out notices to dealers, newspa- tors, including “ code authorities ” obtains samples of that product, per or television advertising, or responsible for installations, use either directly from the supplier, any other means warranted by the services of independent con- or by purchasing it from a retailer. the risk. formity assessment bodies such Customs authorities are also Finally, it is good practice to as Underwriters’ Laboratories authorized to draw samples from notify other countries in some (UL). They work together as part- shipments at borders. formal manner as to the detailed ners in a system, each using their Secondly, a technical investi- description of the product and its greatest strengths to achieve a gation is undertaken. This can source, where known, the action consistent and reliable system. It involve merely visual inspection taken and the reasons for it. is instructive to research the huge or more detailed tests, depend- c) Market surveillance codes variety of certification marks used ing on the nature of the product for common deficiencies : It by UL for different products and and the associated risk factors. has to be recognized, when geographical areas. UL protects Thirdly, the results of the tech- conducting technical investiga- the integrity of its certifications by nical investigation have to be tions of products in this area, carrying out its own investigations evaluated against the prevail- that some defects are more of product incident reports, and ing regulation. In the case of the important and are evidence of a by undertaking proactive market EU’s LVD, this involves coming greater level of risk than others. surveillance activities on prod- to a decision as to whether the It is common therefore, when ucts that bear its mark. However, product is constructed accord- inspecting a product, for the market surveillance authorities all ing to good engineering practice inspection agency to refer to a list work in a similar fashion. (as it relates to safety), and also of common “ codes ” for the most

27 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE (IEC) Standard may be presumed to equate to conformity to the safety provisions of the regulations. Where no International Standard exists, proven conformity with a national standard of a member of the EU will be deemed to satisfy the regulations, provided the standard in question does in fact satisfy the objective of the regulation. Within the EU, suppliers’ declarations of conformity to the relevant directives in the form of the CE-marking are typically encountered. By affixing a CE-marking to the electrical or electronic equip- frequently encountered defects. d) Standards and conform- ment or even to components, the As an example, a relatively minor ity assessment procedures : manufacturer is making a state- error found in the technical doc- While there are a number of ment that the equipment meets umentation accompanying a national standards for products the requirements of all relevant product might be allocated a in this category, the vast major- directives. By law, the manufac- level 1 code (often known as a ity of products are produced turer or its agent which places “ remark ”), whereas the absence to the standards of either the an electrical, or electronic prod- of operating instructions in the International Electrotechnical uct or component on the single national language of the country Commission (IEC) or CENELEC. market in the EU, has respon- in which the product is marketed In many cases the corresponding sibility for compliance with the has to be treated more seri- IEC and CENELEC standards are CE-marking directives, which ously, and would be allocated a technically identical. CENELEC can sometimes be complex. level 2 code (known as a “ crit- standards are developed with a Suppliers’ (or “ first party ”) decla- icism ”). Serious defects that view to providing a “ deemed to rations of conformity are not the directly affect the safety of the satisfy ” solution to the require- only method of attesting con- product, such as the existence ments of a relevant EU directive. formity, however. In fact, when of accessible live parts when the They are adopted by EU member a market surveillance authority product is in normal use, would states as their own national needs to assess whether a prod- be classified as level 3 (“ serious standards, and proven conform- uct actually does conform to the criticism ”). The overall assess- ity to them is deemed to meet relevant directive or other regu- ment of the degree of safety of the objectives of the directive(s). lation, it usually needs to have the product, and the nature of CENELEC standards are harmo- inspection and testing carried out any measures taken in response nized across the EU, and where by independent third parties. A to defects found, would depend no such harmonized standard number of third-party conformity on the nature of those defects as exists, conformity to the rele- marks are commonly encoun- highlighted by their defect codes. vant provisions of an International tered on electrical products

28 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE that are centrally manufactured Certification Bodies (NCBs), on IEC standards, declared and marketed in many coun- an international scheme national differences will be tries ; these can easily be seen is operated by the IECEE taken into account ; how- by inspecting common house- (IEC System for Conformity ever, successful operation of hold appliances or electronic Testing and Certification of the scheme presupposes that apparatus. Electrotechnical Equipment national standards are rea- and Components), known as sonably harmonized with the The IEC takes no position on the CB Scheme. The scheme corresponding IEC stand- which means of conformity is based on the principle of ards. Use of the scheme to assessment is more acceptable, mutual recognition (reciprocal its fullest extent will promote and recognizes all attestations acceptance) by its members the exchange of information of conformity, but it does offer a of test results for obtain- necessary in assisting man- number of conformity assessment ing certification or approval at ufacturers around the world systems that have developed national level. to obtain certification or into extremely useful tools. approval at national level. The ♦♦The scheme is intended to e) The IEC conformity assess- operating units of the scheme reduce obstacles to inter- ment systems : Part of the are the NCBs. These NCBs national trade which arise landscape surrounding the mar- employ testing laborato- from having to meet differ- keting of electronic and electrical ries, also accepted according ent national certification or products revolves around con- to the rules, known as CB approval criteria. Participation formity assessment, and how a Testing Laboratories (CBTLs) of the various NCBs within the manufacturer can best find a way scheme is intended to facili- ♦The CB Scheme is based on through the maze of regulations ♦ tate certification or approval the use of CB test certificates and requirements. The IEC runs according to IEC standards. which provide evidence that two systems known collectively Where national standards representative specimens of as the IEC System of Conformity are not yet completely based the product have successfully Assessment Schemes for Electrotechnical Equipment and Components, or IECEE. The two systems are :

♦♦The IECEE CB Scheme : In recognition of the need to facilitate international trade in electrical equipment, primar- ily intended for use in homes, offices, workshops, healthcare facilities and similar locations, for the benefit of consumers, industries, authorities, etc., and to provide conven- ience for manufacturers and other users of the services provided by various National

29 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE passed tests to show compliance with the requirements of the relevant IEC standard

♦♦A supplementary report providing evidence of compliance with declared national differences in order to obtain national certification or approval, may also be attached to the CB test report

♦♦The first step for an NCB, intending to operate in the CB Scheme, is to be accepted as a “ recognizing NCB ”. Such an NCB is prepared to recognize CB test certificates as a basis for certification or to be exercised by the par- certification or approval approval at the national level ticipants in the CB Scheme according to IEC standards. for one or more categories of and by applicants under the Where national standards products same IECEE management are not yet completely in line ♦♦The second step for an NCB, structure. The CB-FCS is a with IEC standards, declared which can be taken at the scheme based on the prin- national differences are taken same time as the first step, is ciple of mutual recognition into account ; however, suc- to be accepted as an “ issuing of Conformity Assessment cessful operation of the and recognizing NCB ”. Such Certificates (CACs) and scheme presupposes that an NCB is entitled to issue Conformity Assessment national standards are rea- CB test certificates for the Reports (CARs) by its mem- sonably harmonized with the corresponding IEC standards. categories of equipment for bers. It serves as the basis for approval or certification, Use of CB-FCS promotes which it recognizes CB test at the national level, of prod- the exchange of informa- certificates. It should, how- ucts within the scope (see tion necessary in assisting ever, be noted that an NCB Clause 1 – Scope) to the manufacturers to obtain cer- may recognize CB test cer- standards accepted for use tification or approval at a tificates for more categories in CB-FCS. The scheme is national level in one or mul- of equipment than those for intended to reduce obstacles tiple countries and regions. which it is entitled to issue CB to international trade that may Member NCBs to which an test certificates. arise from having to meet dif- applicant (subclause 3.10) ♦♦The IECEE CB-FCS ferent national certification applies for a national cer- Scheme : The IECEE (CB) or approval criteria and pro- tification or approval (NCB Full Certification Scheme cesses. Participation of the “ B ”), accept the conform- (CB-FCS) is an extension of various National Certification ity assessment certificate the international IECEE CB Bodies (NCBs) within CB-FCS and associated conform- Scheme and is an option is intended to facilitate ity assessment report issued

30 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE by NCB “ A ” as a basis for f) Licence a) Evaluate the CAC and CAR such certification or approval. including, if necessary, direct g) Surveillance of the produc- As an NCB “ B ”, its national separate consultation with NCB tion process or quality system, standards shall, as far as pos- “ A ” to verify validity, initial inspec- or both, of the organization sible, be aligned with the IEC tion, follow-up inspection, QMS and its national certification h) Surveillance by testing or surveillance and completeness of procedures. It should, as far inspection of samples from the the CAC and CAR factory or the open market, or as possible, be harmonized b) Test sample(s) are requested both with these rules of procedure. only if there are well-founded rea- If, however, differences exist, Note 1 : The extent to which the three sons, e.g. CAC and CAR are not elements of on-going surveillance are they are formally declared to complete or there is a justified the IECEE Secretariat for pub- conducted may be adjusted for a given situation. As a result, this system pro- technical doubt lication in order that member vides significant flexibility for on-going c) Issue the NCB “ B ”’s certifica- NCBs are able to prop- surveillance tion/mark/licence according to its erly cover these differences Note 2 : Whether or not the NCB “ A ” issues normal procedures when acting as NCB “ A ”. its certification mark, it remains responsible CB-FCS is a product certifi- for the on-going conformity of the product(s) d) Accept initial factory inspec- cation System 5, as defined in for which the CAC has been granted tions carried out by NCB “ A ” ISO/IEC Guide 67 (subclause ♦♦CB-FCS includes the follow- e) Accept components inte- 6.3.7, System 5) ing for the NCB “ A ” : grated in appliances and which ♦♦This system includes testing a) Type testing by a laboratory have been tested/verified/ inspected by NCB “ A ” and used and assessment of the quality accepted within the CB scheme within their ratings and condi- system involved. Surveillance and issuance of a CAR, and of the quality system is con- tions of use b) Initial factory inspection ducted and samples of the A third system exists for certifi- including evaluation of the facto- product may be taken from cation to standards relating to ry’s quality management system either the market or the point equipment for use in explosive (QMS) of production, or both, and atmospheres – the IECEx system. are assessed for ongoing c) Issuance of the CAC This international certification conformity. The certification d) Follow-up factory inspection system for specialized products system includes the following : by the NCB “ A ”, that in addition is intended for use in hazardous areas. It offers manufacturers a) Samples requested by the to assessing the product, the a single test and assessment certification body manufacturing process and the report for acceptance in all par- QMS, will also include re-test- b) Determination of characteris- ticipating countries. It works in a ing of samples from production, tics by testing or assessment manner similar to that of the CB when applicable according to the system, except that for equip- c) Initial assessment of the pro- requirements of the NCB “ A ” ment of this nature, the testing duction process or the quality and/or Body “ B ”. [See (g) and and acceptance regime is often system, as applicable (h) and the Note in the descrip- extremely complex, and the time d) Evaluation of the test and tion of ISO System No. 5 above]. taken to achieve national certi- assessment reports ♦♦CB-FCS includes the follow- fication is often 12 months or e) Decision ing for the NCB “ B ” : more. Participation in the IECEx

31 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE system, as with other systems, so as to take advantage of their treatment, alleviation or compen- can significantly reduce manu- established quality control and sation for an injury or handicap, facturers’ compliance costs and management, and regulatory investigation, replacement or facilitate earlier market entry. compliance systems. modification of the anatomy or of a physiological process, control Finally, a separate system for elec- Consumers in developing coun- of conception, and which does tronic components exists – the tries, as in other countries, are often not achieve its principal intended IEC Quality Assessment System assailed by products that bear large action in or on the human body for Electronic Components (IECQ numbers of markings that they by pharmacological, immuno- system). A prerequisite for mem- deduce, often erroneously, to sig- logical or metabolic means, but bership in this system is proven nify that the products are safe. which may be assisted in its compliance with either ISO 9001 National standards bodies and reg- function by such means ”. or ISO/IEC 17025, as relevant. ulatory agencies in these countries It can thus be seen that a single f) Implications for developing have a duty to inform consumers regulatory control mechanism for countries : For manufacturers of about the risks, and to collabo- all medical devices is out of the electrical and electronic products rate, nationally and regionally, in question, and special rules are in developing countries, high putting together a realistic, work- needed. capital investment and large- able market surveillance system scale production costs, together that leverages, wherever possi- Developing countries tend to with regulatory compliance ble, current best practice from the not manufacture high-end med- costs, often pose insurmounta- developed world. ical devices, but increasingly the ble barriers to market entry. Once re-usable or single-use low-tech- Medical devices sufficient economies of scale nology products are starting to have been realized, however, a) General considerations : The appear on the market from sup- compliance costs can become term “ medical devices ” covers a pliers in a number of developing more manageable. The temp- wide range of instruments, appa- countries in addition to the tra- tation to reduce these costs by ratus and machines of all levels ditional sources, where controls issuing false suppliers’ declara- of sophistication used to prevent, tions of conformity without the diagnose or treat disease. proper technical dossiers and ISO 14155-1, Clinical inves- test reports in place, has to be tigation of medical devices weighed against the severe finan- for human subjects – Part 1 : cial and often criminal penalties Requirements, defines a medi- likely to be incurred when noncon- cal device as : “ any instrument, forming products are detected. apparatus, appliance, material This is becoming more, rather or other article, whether used than less, likely as a result of ever alone or in combination, includ- more sophisticated notification ing the software necessary for its systems in the larger and more proper application, intended by lucrative markets. New manu- the manufacturer to be used on facturers or product developers human beings for the purpose are often best advised to use of diagnosis, prevention, moni- the services of large, well-estab- toring, treatment or alleviation of lished contract manufacturers, disease, diagnosis, monitoring,

32 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE have always been fairly strict. agencies and industry, has been in order to set the level of moni- Where a country does not have working on ways to achieve greater toring and oversight required. very well-developed regulatory uniformity between national med- Typical characteristics of a regu- systems for medical devices, it ical device regulatory systems latory regime would include : creates a real risk for patients. aimed at enhancing patient safety This is probably a consequence and increasing access to safe, • A clear and unambiguous of their importing most medical effective, and clinically beneficial classification scheme devices in the past and rely- medical technologies around the • A pre-market review of the ing on proof of registration in a world. Similarly, the World Health technical documentation major developed country as a Organization (WHO) is extremely relating to the product surrogate means of pre-market active in making information and • A document that outlines the control, but the risk is increasing technical support available to reg- essential requirements for the that the developing world might ulators. Both organizations have product already be importing large quan- published a number of extremely tities of unacceptable products useful guides to assist regulators • A risk management pro- through a lack of controls. This in developing countries who want gramme that covers the entire situation is exacerbated when to develop their systems to higher product life cycle, including one considers that in addition to levels. use, re-use and disposal monitoring market entry, the lack Owing to the large variety of • A quality management system of monitoring of medical devices medical devices and the nature • A requirement for the market- in use, their re-use and their dis- of their use, pre-market control ing or supplying entity to be posal pose additional risks. often involves clinical trials in registered as such and, there- Fortunately, since 1992 the Global addition to testing of the finished fore, accountable within the Harmonization Task Force (GHTF), product. Each medical device jurisdiction of the regulator a voluntary group of representa- needs to be classified into one of • A “ vigilance ” mechanism for tives from medical device regulatory a number of classification groups the logging and processing of complaints and the reporting of incidents

While most major manufacturing countries address all these issues, the mechanisms they use still differ. For example, in some countries a three-level classification system is in use, whereas in others there are up to five classifications. The GHTF is working toward resolving these differences and encour- aging convergence in regulatory practices, but this will take time. Meanwhile, developing countries need to look for common ground

33 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE on which to base their regulatory devices, and decisions are taken but the format and specific systems. either by an expert panel or by a requirements vary. In general, designated body. The GHTF has there is an increase in require- b) Common regulatory produced a generic rule-based ments with increasing risk. practices between major system, incorporating a number developed countries : The fol- Labelling requirements : In of “ decision trees ” that can be lowing common features of the all countries there are require- used, but full harmonization is yet regulatory systems in the USA, ments for labelling, both on the to be achieved. Canada, the European Union and device, where deemed neces- Japan can offer some guidance : Conformity assessment : In sary and feasible, and in terms general, a government agency of the descriptive and informa- Use of International Standards : retains responsibility for the con- tional literature that accompanies Where International Standards formity assessment of high-risk the device. exist for medical devices products, whereas medium- intended for global use, they Risk management : A risk man- and low-risk products may be should be (and, in general, are) agement approach seems to be assessed by third parties. used. Of particular relevance is mandated by law in all jurisdic- ISO/TR 16142, Medical devices Essential requirements for tions. ISO 14971:2007, Medical − Guidance on the selection products : All countries give gen- devices − Application of risk of standards in support of rec- eral guidance, but the degree of management to medical devices, product-specific guidance varies. ognized essential principles of provides guidance in this regard. This is an area where the harmo- safety and performance of med- Quality management systems : nization work of the GHTF will ical devices. This ISO Technical The use of the international qual- bring about big improvements. Report is intended for use by ity system standard ISO 13485, manufacturers, standardiza- Technical documentation Medical devices − Quality man- tion bodies, regulatory bodies, required : In all countries there is agement systems − Requirements and for conformity assess- a requirement for documentation, for regulatory purposes, which ment purposes. It is one of a has many similarities to ISO series of international normative 9001, is widespread. documents published by ISO Registration systems : In all Technical Committee TC 210, countries there is some sort of Quality management and cor- “ competent authority ” nomi- responding general aspects for nated to take responsibility for medical devices. licensing, and foreign manufac- Further details may be obtained turers of medical devices are from : www.iso.org/iso/ required to nominate a local standards_development/ agent or representative. technical_committees/list_of_ Vigilance processes : Incident iso_technical_committees/ reporting processes are a funda- iso_technical_committee. mental part of the requirements htm ?commid=54892 in each country. Classification : All countries c) The World Health use some sort of “ rule system ” Organization (WHO) : WHO has for the classification of medical provided technical support over a

34 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE number of years to countries that • Review of current • Labelling requirements, wished to implement improved requirements on post- and medical device regulatory sys- market surveillance • Medical device reporting tems. It encourages governments • Principles of medical to follow the growing movement Further details are available from device classification www.fda.gov towards harmonized regulatory systems, because a proliferation • Principles of conformity f) Medical device regulation in of different national regulations assessment for medical the European Union : Within the increases costs, hinders access devices European Union, medical devices are regulated both in terms of the to healthcare technologies and • Essential principles of general product safety directive can even unintentionally jeop- safety and performance and a number of medical devices ardize the safety of patients. It for medical devices encourages countries to adopt, directives, which are applicable in where appropriate, the device These guideline documents and all member states. The equiva- approvals emanating from exist- the on-going work of the GHTF lent in each member state of the ing advanced regulatory systems, provide a sound basis for devel- FDA in the USA is known as a since it recognizes that the regu- oping countries to establish and “ competent authority ”, and con- latory process represents a vast, upgrade their regulatory systems formity assessment is carried out and often unnecessary, drain on for medical devices. Further infor- by a number of “ notified bodies ”. scarce resources, both financial mation can be obtained from the Other legislation also plays a part, and human. The aim is to allow website www.ghtf.org for example in the U.K. the med- countries with weak regulatory ical devices regulations are also e) Medical device regulation systems to place the empha- deemed to be safety regulations in the USA : In the USA, medical sis and initial resources on areas under the Consumer Protection device regulation falls under the such as vendor and device reg- Act. In order to enforce these US Food and Drug Administration, istration, training, surveillance regulations, the competent or FDA. The basic regulatory authority has an obligation to and information exchange sys- requirements that manufactur- ensure that the relevant regula- tems on the assessment of the ers of medical devices intended tions are complied with, and to medical devices in use. WHO has to be distributed in the USA must ensure that appropriate action is published a comprehensive doc- taken to restrict or, where nec- ument entitled “ Medical device comply with are : essary, prohibit unsafe products regulations – Global overview • Establishment from entering the market or being and guiding principles ”, which registration put into use. is available as a free download • Medical device listing from their website www.who.int Within the EU system, suppliers • Pre-market notification who claim conformity with appro- d) The Global Harmonization (unless exempt), or pre- priate directives are obliged to Task Force : In 2000, the GHTF market approval place the CE-marking on their published a number of docu- products – thus constituting a ments, including : • Investigational device supplier’s declaration of conform- exemption for clinical • The role of standards in ity. Conformity may, in practice, studies the assessment of medi- be established either by showing cal devices • Quality system regulation conformity to relevant (“ deemed

35 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE to satisfy ”) EN standards or by put in place. For all operations of the body for a given health pur- addressing the directives directly, carried out by inspectors, stand- pose. Typically, a medical device although this latter route is unu- ard operating procedures have to achieves its purpose without sual. The duties of the competent be followed. entering metabolic pathways. authorities, therefore, come g) Implications for developing Optimum safety and perfor- down in general terms to : countries : WHO states, in an mance require cooperation • Investigating com- aide-memoire for national medi- among all involved in the life span plaints received about cal device administrations, in its of a medical device ; the gov- CE-marked products document “ Medical device reg- ernment, the manufacturer, the importer/vendor, the user and the • Carrying out planned ulations – Global overview and public – each has a specific role and random inspections guiding principles ” : to play in this risk management. at the premises of regis- “ A medical device can range tered suppliers and from from a simple wooden tongue Many countries procure medical the market itself depressor or stethoscope to devices that may be substandard. Some manufacturers of • Monitoring the work of the most sophisticated implants medical devices may also be the notified bodies to or medical imaging devices. unaware of minimum standards. obtain information on the In general, a medical device is Governments that are unable degree of compliance an instrument, apparatus or to carry out pre-market review, of suppliers (especially machine used to prevent, treat or either for imported devices or in regard to high-risk diagnose disease. It also serves those manufactured locally, could devices) to detect, measure, restore or modify the structure or function assure regulatory compliance • Carrying out ad hoc investigations in cases of apparent noncompliance The emphasis is in the first instance on documentary review and assisting suppliers to comply voluntarily. Inspections are only undertaken where deemed necessary, and drastic action is only taken where there is a clear case of noncompliance and a threat to the health of the consumer. The inspectors have a wide range of powers, including powers of entry into premises and to examine, search and seize records or nonconforming devices. All enforcement actions are designed to be proportionate to the assessed risk, and a wide range of sanctions, accompanied by an appeal system, is

36 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE by taking advantage of the work medical devices are clear and the practice, of global harmoni- of major device manufacturing comprehensive, and that the zation recommendations. countries. A priority in local reg- recommendations on global It should be noted that in the ulatory development should be harmonization for regulatory EU the “ RAPEX ”, or Rapid Alert the establishment of vendor and requirements and procedures System for dangerous con- product registration. (such as those issued by the sumer products, does not cover Education and training of users, GHTF) be adopted. It makes food, pharmaceutical and medi- and the continued assessment a plea to national authorities cal devices, for which dedicated of medical devices in use is as to ensure that classified medi- sector-specific mechanisms are important as product control. cal devices are manufactured in required. It is critical to have access to a conformity with applicable quality The advice for developing system for informing and collab- system standards (such as ISO countries is unequivocal – by orating with the manufacturer, 13485), and that links be estab- participating in the harmoniza- vendor, all users, the public and lished to networks that monitor tion initiatives with respect to relevant international organiza- medical devices. medical devices, the time and tions of hazards/issues related Finally, it encourages national cost of marketing products can to medical devices.” authorities to participate in post- be reduced, regulatory efficiency WHO also recommends col- market surveillance and medical can be optimized, market access laboration with stakeholders to device alert issues in order to can be facilitated and the health ensure that national policies on harmonize the effects, not just of the public can be protected.

37 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE FOOD AND AGRICULTURAL PRODUCTS

a) General considerations : One of the most complex regulatory areas in any country involves actions taken to assure an acceptable level of food safety, whether for human consumption (foods) or for animal consumption (feeds). The products involved take a large number of forms, from fresh fruit and vegetables to meat, poultry, fish and dairy products, to processed or packaged food available in retail unexpectedly, often in small, buy to be risk-free, and yet this outlets, to meals served in res- localized and remote geograph- is not possible. The consumer, taurants. They come from all ical areas, and so effective once made aware of some risk countries of the world. The risk monitoring, communication and factors, has to bear some of factors, and therefore the nec- rapid response systems have the responsibility for purchas- essary checks, vary from product to be in place across the broad ing healthy food, and for using it group to product group, and spectrum of products. Two recent correctly, for rejecting unhealthy inspection and testing regimes examples that come to mind are food. How can this system be take a wide number of forms. the global responses to surprise organized nationally, regionally Risks come not merely from the outbreaks of BSE in cattle, and and internationally to keep the products themselves, but from the unexpected detection of mel- overall level of risk within accept- the treatment they have received amine in food products. able limits ? in growing to a marketable size In a document of this nature, it is The United Nations Food and and quality – for example, the 2 impossible to avoid making gen- Agriculture Organization (FAO ) use of pesticides is necessary eralizations, the first of which is recognizes that “ most countries in many instances, but pesti- that regulatory systems for food have made significant efforts to cide residue levels have to be need to be clear, consistent and strengthen their national food strictly monitored and controlled fair to all parties, whilst simple control systems in line with to avoid the introduction of new enough to enable the rapid trans- international guidelines devel- and potentially serious risk fac- port, sale and use of perishable oped by the FAO and the World tors. Food additives also need to products. The challenge is to Health Organization (WHO) ”. Yet be controlled, as does product simplify and deregulate routine it also accepts that “ progress labelling and advertising. controls wherever possible, with- toward establishing credible and Regulation is generally risk- out raising the overall risk unduly. effective food control systems based, but the complicating This immediately raises the ques- worldwide, particularly among factor is that the risk can change tion of : what is an acceptable the least developed countries, has been too slow ”. The main quickly and outbreaks of food- level of risk ? In some societies related diseases can occur the public expect the food they 2) FAO, “Investing in Food Security”

38 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE reason for this is the reduction of such standards is no longer worldwide, including cancers, discretionary funding allocated to merely on the quality and testing may be linked to consumer expo- food safety programmes by gov- of the products, as productivity sure to foods with unsafe levels ernments that have to juggle their is becoming an issue owing to of chemical residues, environ- priorities. It is an unavoidable fact natural disasters and high pop- mental contaminants and other that long-term programmes of ulation growth. FAO estimates chemical hazards. While the reg- investment are needed in many that 30 % of the food consumed ulation of food safety serves to countries to build and sustain in developing countries is per- limit diseases caused by unsafe effective food control systems. ishable, and yet only 20 % of food, it also has beneficial trade that food has access to refrig- The Codex Alimentarius implications, and these are espe- eration. It is not surprising that, Commission (CAC) was created cially of importance to developing after harvesting, huge losses in 1963 by FAO and WHO to countries. The FAO reasons, occur. Manufacturing guidelines develop food standards, guide- though, that to achieve proper and practices for improved pro- lines and codes of practice levels of production efficiency ductivity have, therefore, become under the joint FAO/WHO Food and consumer protection, public part of the mix. Standards Programme. The CAC sector investment in food safety standards thus have the status WHO estimates that each year has to include some or all of the of truly International Standards foods contaminated with micro- following : and may be adopted world- bial pathogens cause millions • Updating or restructuring wide without any risk of breach of cases of acute diarrhoea, institutional set-ups, including of the provisions of the relevant particularly among vulnerable legislative frameworks World Trade Organization (WTO) populations, and that numer- agreements. The emphasis of ous other chronic diseases • Strengthening food inspection services, recruiting and training necessary staff

• Upgrading laboratory analyti- cal facilities

• Communication campaigns addressed to food handlers, stakeholders and consumers

• Commissioning relevant studies for use in developing appropriate food safety measures

• Participating in regional and international food safety intel- ligence networks, and

• Participating in international and regional food standard-setting bodies and other fora to ensure that these

39 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE standards take each country’s system. The act focuses on pre- The CFIA has published a number conditions into account vention rather than reaction to of guideline documents for food importers. Import inspection pro- b) Regulatory systems : The food safety problems. It gives the grammes are risk-based and, as organization of food regulatory FDA new enforcement author- with those of other developed systems varies from country to ities to achieve higher rates of countries, based around rele- country, but in the major devel- compliance and prevention. It vant International Standards. oped countries there are a holds imported food to the same Where products are found that large number of similarities of standards. More information on do not conform to regulations, approach. In the USA, there the FSMA is available at www. a sliding scale of sanctions is are two major food regula- fda.gov/food applied depending on the sever- tion agencies : the Food and In Canada, federal responsibility of the transgression. Detailed Drug Administration (FDA) and ity in this area is largely shared monitoring programmes exist for the Department of Agriculture between Health Canada and imported fruit, vegetables and (USDA). The majority of foods the Canadian Food Inspection honey, where risks from chem- fall under the jurisdiction of the Agency (CFIA). The Food and ical residues are high. FDA’s Center for Food Safety Drugs Act delegates respon- and Applied Nutrition (CFSAN), A typical import inspection pro- sibility to Health Canada for but meat, poultry and egg prod- gramme for meat or fish would ucts fall under the USDA’s Food establishing standards relating include assessment of the Safety and Inspection Service to the health, safety and nutri- inspection systems in place (FSIS). Advertising of food is tional quality of food. The CFIA in the source country, inspec- regulated by the Federal Trade controls food labelling, packag- tion, testing and certification of Commission (FTC). It is acknowl- ing and advertising in terms of the products against regulatory edged, and recent health scares the relevant act, and administers requirements, and statistically- have served to confirm, that regulations under a number of based product sampling and the amount of food being con- other acts that cover meat, fish, analysis, together with inspec- sumed within the US from foreign and common agricultural prod- tion of relevant documentation, sources is increasing, and a great ucts. CFIA’s activities include : to assess whether requirements deal of it comes from sources have been met. Inspection fre- • Protecting consumers from where the food safety systems quencies can be tightened or unfair practices are not well established. relaxed depending on compli- • Integrating the Hazard ance histories. Consequently, the FDA has Analysis at Critical Control seen the need to seek addi- The CFIA’s chemical residue Points (HACCP) approach to tional powers and to strengthen sampling programme is a good food safety its response to the elevated example of a phased approach : threat from imported food, • Sampling and testing for Phase 1 (monitoring) involves the and has published a detailed chemical (e.g. pesticide) gathering of data from random Food Protection Plan. The new residues statistical samples of fresh fruit Food Safety Modernization and vegetables. Where maxi- • Responding to food safety Act (FSMA), signed into law in mum residue limits appear to emergencies January 2011, allows for better have been exceeded, the prod- protection of public health by • Verifying the quality and safety uct is put under the surveillance strengthening the food safety of food imports and exports phase.

40 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE Phase 2 (surveillance) is under- • Contaminants in the food chain interactive risk communication taken to conform provisional • Additives and products or are combined. positive results and target prob- substances used in animal Risk management is then car- lem areas. If any one of five feed ried out on a member state basis, samples is found to be out of and uses relevant European and specification, the product is • Genetically modified placed under compliance status. organisms national legislation to achieve its objectives. Part of the reason for Phase 3 (compliance) is intended • Dietetic products, nutrition this is historical, as many member to remove nonconforming prod- and allergies states had comprehensive and uct from the marketplace, and • Plant protection products and strict food safety legislation is targeted at the local source, their residues already in place before the crea- such as the grower or shipper. • Plant health tion of the EU. The EU’s General Removals continue until all five out of five random samples are Food Regulation 178/2002 lays EFSA’s advice, which is to a found to conform, whereupon down general principles and great extent derived from spe- the product is returned to the requirements of food law, and is cific requests received, can lead monitoring phase. supported by a number of spe- to the adoption or amendment cific regulations, including : In the European Union, risk of relevant European legislation, assessment is carried out sepa- facilitating approval decisions • Regulation 854/2004, cov- rately from risk management. The or the development of policy in ering products of animal European Food Safety Authority new areas. The overall approach origin intended for human (EFSA) has been appointed fits into a three-way risk anal- consumption within the EU as the body ysis framework recommended • Regulation 853/2004, which responsible for providing objec- by WHO and FAO, in which the lays down rules of hygiene for tive and science-based advice elements of science-based risk food businesses that use or and communications in the field assessment, policy-based risk of food and feed safety as well management and broad-based process products of animal as in related areas. The work of origin EFSA supports the risk management actions that are taken on a member state level. EFSA has appointed a number of scientific panels, responsible for risk assessment in the following domains : • Animal health and welfare • Food additives and nutrient sources added to food • Biological hazards • Food contact materials, enzymes, flavourings and processing aids

41 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE the principle that the responsibility for compliance with the law rests with the food business concerned. In many countries of the EU, a mechanism has been established whereby food businesses can notify the regulatory authorities of intended withdraw- als of products from the market, and a number of communication channels exist to alert consumers and intermediaries of product • Regulation 852/2004, which it is unsafe, and International recalls. deals with the hygiene of Standards provide much of the Generally within the EU, responsi- foodstuffs and lays down legislative detail. All food and bility for enforcing the regulations general hygiene requirements feed produced in, or imported is devolved to the local author- for all food businesses into, the EU or intended for export ity level, as well as to the border from the EU, is required to meet agencies. Thus, in the UK, local National legislation then provides the relevant requirements of food councils (municipal bodies) and inspection authorities with the law. In addition, the rights of con- port health authorities conduct necessary powers. As an exam- sumers to safe food extend also inspections, using codes of prac- ple, in the United Kingdom, the to the right to receive accurate tice provided by the FSA, which Food Standards Act 1999, the and honest information concern- acts centrally to issue practice Food Safety Act 1990, and the ing food. A Europe-wide “ rapid guidance to enforcement offic- alert system ” is in place. General Food Regulations 2004 ers. The FSA has also produced (as amended) create the nec- Surveillance activities are aided guidance notes to the legislation essary functions, powers, and by the recognition of the precau- for food businesses, in order offences. These acts are admin- tionary principle, whereby risk to assist them in compliance. istered by the Food Standards management may be conducted In deciding on the appropriate Agency (FSA). on the basis on the reasonable levels of response to estab- The aims of the food laws in the EU aim of the protection of health, lished risks, a number of factors are to cover all stages of the food even when full scientific data are taken into account, including production chain, and to protect are not yet available to support the level of the public’s appetite human life and health, together decisions. This imposes signif- for risk ; it is therefore implicit that with consumers’ interests, while icant responsibilities on food consumers, once informed about at the same time harmoniz- inspection agencies, which are, risks, have a degree of responsi- ing national requirements so as nevertheless, required to act in a bility to make their own informed to permit the free movement of proportionate and non-discrimi- decisions. The effectiveness of food and feeds within the single natory manner. the work of the FSA, therefore, market. (This latter requirement is Traceability of the origin of food depends to a great extent on its in fact central to much of the reg- and feed sources is a fundamental ability to engage the public in the ulation within the EU.) Food must requirement of the EU’s General right way, and to an appropriate not be placed on the market if Food Law, which also establishes extent.

42 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE Coordination of activities at regulatory purposes, however, were deemed acceptable in the member state level within the EU and the emergence of “ private ” recent past. requires planning. EU Regulation or “ consortium ” standards in the The food safety “ landscape ” is 882/2004 requires member marketplace now dictates that a thus rather complicated, and states to establish a three- great deal of product inspection consists of both regulatory and to five-year control plan. Such takes place under the auspices trade-related oversight both for a plan would not only include of schemes such as those of compliance monitoring tar- Global G.A.P. or the British Retail safety and quality, and even gets and emergency response Consortium (BRC). Typically, the for aesthetic reasons. Modern mechanisms, but would also use of these private standards advances in mass communi- involve regular internal per- is authorized by the granting cation have also placed food formance assessment of the of a licence to accredited con- safety firmly in the public eye national system, and provide a formity assessment providers, which has probably led to an basis for external audit of com- who then inspect and certify increase in regulatory activities. petent national authorities at the products against the standard. Regulatory authorities are now European level. Certification opens the door for becoming more proactive than voluntary trade to take place. c) Standards, certification ever before. The rapid communi- This has a number of implica- schemes, and where they fit cation of food safety “ incidents ” tions for producers in developing into the food safety “ land- has, in turn, led to the develop- countries. Positive ones first of scape ” : Within the food and ment of new standards, schemes all, as the producers who can agricultural products sector a and response mechanisms in this demonstrate compliance can wide variety of standards exists. sector. access large lucrative markets, At international level, many prod- but also potentially negative One relatively recent develop- uct standards and test methods ones as some “ traditional ” sup- ment was the launch in 2000 of are developed by the Codex pliers in developing countries the Global Food Safety Initiative Alimentarius Commission (CAC), are now struggling technologi- (GFSI). The GFSI, which is a and by ISO/TC 34, Food prod- cally and financially to meet new retailer-driven group, aims to work ucts, and these often find their standards with products that on the continuous improvement way into regulation owing to their international nature. Control systems for food safety also play a part, and these include implementation of Hazard Analysis at Critical Control Points (HACCP) principles, or the implementation of food safety management systems such as ISO 22000, Food safety management systems – Requirements for any organization in the food chain. Surveillance of food products at market level and in production is not only carried out for

43 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE of food safety management systems. Its objectives are to : • Maintain a benchmark- ing process for food safety management schemes to work towards convergence between food safety standards • Improve cost efficiency throughout the food supply chain through common acceptance of GFSI- recognized standards by retailers around the world expected to achieve the level of consumer have to be manufac- • Provide an international confidence in the safety of prod- tured, packed, labelled, traded, stakeholder platform for ucts on the market that can be transported, stored at various networking, exchange of achieved in most other areas. On stages of the product life cycle. knowledge and the sharing the other hand, many hazardous They are often converted into of best food safety practices chemicals are used in industrial another physical or chemical form and information settings by trained professionals, or into a component or product, GFSI has recognized a number where greater levels of control can sold again and, finally, disposed of primary production and man- be achieved. Pharmaceuticals are of, all with acceptable levels of ufacturing schemes. manufactured by a limited number safety. Occurrences such as It is not surprising, given the of companies that are subject to the Bhopal incident rightly grab number of standards and a number of defined pre-market the headlines and trigger major schemes available in this sector, controls. They are obtainable in investigations, but every day, in that there is overlap between par- their final form either by prescrip- millions of smaller-scale situa- allel initiatives, and this continues tion of qualified medical personnel tions around the world, industrial or over-the-counter from qualified to pose a number of challenges and domestic chemical prod- pharmacists, or both. that will need to be addressed. ucts and pharmaceuticals are Many controls exist, but nev- involved in potentially life-threat- Chemical and ertheless, the scale of the ening situations. pharmaceutical products challenge is daunting. Many Fortunately, a great deal of pro- a) General considerations : chemicals are found and used gress has been made although Chemical-related diseases are as part of separate chemical the international systems for responsible for the death or severe compounds or as components chemicals are not yet fully inter- illness of millions of people world- of mixtures. The number of indi- nationally harmonized : wide. The regulation of chemical vidual chemicals is infinite, the and pharmaceutical products list of possible effects is end- • In the field of chemi- covers a vast technical area, less, and the number of usage cal nomenclature, the and at first sight market surveil- scenarios is vast. Chemicals sup- International Union of Pure lance mechanisms might never be plied to industry, trade or the end and Applied Chemistry

44 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE (IUPAC) has laid down naming environmental, health and Substances Control Act, rules that are universally safety information on hazard- which is administered by the understood and in extremely ous chemical substances and Environmental Protection wide use ; this most basic of mixtures. The World Summit Agency, and is supported by prerequisites to regulation is on Sustainable Development numerous other regulations thus already in place in Johannesburg in 2002 depending on the use of the • The United Nations Globally encouraged countries to products. China published Harmonized System of adopt the harmonized system proposals in 2009 for a set of Classification and Labelling as soon as possible. The EU regulations similar to REACH of Chemicals (GHS) has member states duly endorsed and which is referred to as achieved very wide rec- the UN’s recommendation the “ China REACH ” and ognition by laying down to implement the GHS in came into effect in January criteria for classifying chemi- domestic law, and the result 2010. It is similar to the EU cals according to the health, has been the CLP regulations REACH. environmental and physi- • The UNECE Sub-committee • REACH’s method of work- cal hazards they pose, and of Experts on the Transport ing is discussed in more detail in defining the hazard com- of Dangerous Goods below. munication requirements for (UNSCETDG) meets reg- labelling and for inclusion in ularly to make and revise b) The REACH regulations : safety data sheets (SDS) recommendations for the The EU REACH regulations were Note : The GHS is not a formal treaty, safe transport of dangerous introduced in 2007 to impart, but is rather a non-legally binding inter- over time, greater knowledge of, national agreement. Countries or trading goods, including chemicals. blocs, therefore, are obliged in practice These recommendations have and therefore facilitate protection to enact legislation for its implementation found their way into legislation against, the health, safety and • ISO has published an in a number of countries environmental risks that emanate from chemicals that are used in International Standard on the • The EU’s REACH Regulations the EU. Enforcement mecha- sections, content and gen- (Registration, Authorization nisms and penalties are defined eral format of the safety data and Restriction of Chemicals) and are applicable across the sheet for chemical prod- is probably the most com- ucts (ISO 11014:2009, Safety plex piece of legislation ever EU. REACH aims to ensure that data sheet for chemical prod- produced by the EU. They manufacturers and importers are ucts – Content and order of entered into law in 2007 responsible for defining the risks sections) and will be phased in over associated with all their chemi- • In the EU, relatively new reg- a number of years. While cal products manufactured in, or ulations for Classification, REACH does not directly imported into, the EU in excess Labelling and Packaging affect manufacturers based of 1 tonne. It was estimated in (CLP) have been drawn up outside the EU, importers 2007 that there were no health that are based on the GHS of their products based in and safety data for over 20 % of and that, in future, will be the EU will inevitably request the most frequently used chemi- maintained at the UN, rather the necessary data from cals in the EU, and that the data than at the EU level. The their manufacturers. This is for another 65 % were insuffi- GHS provides a basis for bringing about a re-evalua- cient. REACH replaces about 40 globally uniform physical, tion in the USA of the Toxic separate pieces of EU legislation.

45 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE REACH affects manufacturers, from the market, while the man- how to use the chemical importers and distributors of ufacture or import of articles that safely, and the results of a risk substances together with down- contain SVHCs in excess of cer- assessment stream users. Manufacturers and tain limits will have to be notified • After the dates stipulated, importers are required to register to ECHA. SVHCs will not be permitted substances with the European Note : This will have an immediate impact to be used in the manu- Chemicals Agency (ECHA) and, on other regulated areas, such as toys facture of, or to be present in so doing, to submit prescribed where, for the first time, toys that contain toxic substances above a certain con- within, imported substances data. The manufacture or supply centration can be recalled under REACH or goods of unregistered substances within regulations. Electronic components are the EU is, subject to certain con- similarly likely to be affected. • Users and customers of man- ditions and time limits, prohibited. ufacturing or importing firms Other implications include : The type and quantity of data will need to find out more that are required to be submit- • It is illegal to import unregis- about the composition of their ted vary according to the quantity tered substances products or substances and, produced or imported, and highly • Depending on the quan- where relevant, obtain from hazardous chemicals are classi- tity of registered substances the supplier a safety data fied as “ Substances of Very High imported or manufactured, sheet Concern ” (SVHCs). These sub- the technical dossier that Surveillance of the EU REACH stances, which typically include accompanies the registra- regulations in the EU member highly toxic, carcinogenic or tion application has to include states is still at an early stage, environmentally harmful chemi- classification data, specified but examples of actions under- cals, may only be sold or used if test data and guidance on taken include : they are “ authorized ”, and such their safe use. Above a lower authorization will depend on limit of 10 tonnes per year, • Manufacturers, importers, whether any safer alternatives manufacturers or importers wholesale or retail trad- exist, and the ease of control of are required to also submit ing firms, and user entities, the substance. a Chemical Safety Report are visited and their doc- Inevitably, the consequences of (CSR) that might include umentation and physical EU REACH will be that a number more detailed hazard data, an arrangements for the con- of substances will be withdrawn exposure scenario describing trol of chemicals, substances or articles that contain them, inspected

• Questionnaires are sent to firms in the supply chain asking for information that will enable inspectors to ascertain whether registration requirements have been followed correctly

• Requirements for the issuance or possession of safety data sheets are audited

46 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE • Infringements are logged, and appropriate corrective action or other follow-up is required • Re-inspections take place In June 2010, the Royal Society of Chemistry reported that one in four firms were not comply- ing with chemical legislation in the EU, and thus the job of harmonization still has a long road ahead of it. Further details of the enforcement of REACH and CLP can be obtained from the ECHA are continually being evaluated, and the scheduling and labelling website : www/echa.europa.eu reported upon and compared regimes that accompany their c) Specific measures affecting with its therapeutic benefit. marketing, have matured. Best pharmaceuticals : Regulators such as the US Food practice has been harmonized The regulatory challenge with and Drug Administration are often to a great degree. Mass produc- pharmaceuticals is arguably criticized for their slow approval tion techniques and the arrival greater than with any other prod- system in the face of demon- of generics are relatively modern uct group. On the one hand, they strable medical need for certain developments that have affected are usually complex chemicals products, but their approach has the marketing decisions of the that could present a severe risk, to be tempered by the need to manufacturers and, by impli- but on the other, they are sold show an acceptably low risk : cation therefore, the regulatory and used for medical purposes. benefit ratio, especially in light of approach applied to this class of product. Therefore, many of the con- the negative publicity and finan- siderations of medical device cial liability risk, not to mention The total cost of drug discovery regulation come into play. The the human suffering, caused by and development tends to restrict risk posed by a pharmaceutical past scandals implicating the the majority of new product (non- product is even quality-related, industry, such as thalidomide. generic) manufacturing to these since any unwanted side effect The major producers of phar- large companies. Indeed, only a reduces its acceptability vis-à- maceutical products have been small percentage of their prod- vis alternative products available in business for decades, admit- ucts ever gain blanket regulatory from other manufacturers. Pre- tedly under different names approval and find their way into approval testing of the product, as there have always been a general worldwide circulation. clinical trials, licensing, develop- tremendous amount of consoli- Clinical trials, which in some juris- ment costs, patent expiry dates, dation, mergers and acquisitions dictions can fall into three types and the likelihood of generic in this industry, where even a or classes, are still only carried alternatives coming easily to the single successful product devel- out on control groups of individ- market, all play a part in deci- opment can massively impact uals and not on as wide a scale sion making before the product bottom line performance for as the public might expect. Full- is marketed. Throughout the up to 15 years. Consequently, scale product testing in the “ real ” lifetime of the product, its risks their systems of testing drugs, marketplace can be argued to

47 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE take place only after regula- The following regulatory agencies tory approval has been granted, have extensive websites and can hence the extremely risky nature provide further information : of this business. • US Food and Drug Regulatory approval by the FDA Administration (FDA) is subject to the product being • European Medicines Agency shown to be both safe and (EMEA) effective. It involves the follow- • UK Medicines and Healthcare ing steps : Products Regulatory Agency • Filing an investigational new (MHRA) drug notice together with suf- • Japanese Ministry of Health, ficient positive pre-clinical Labour and Welfare data to warrant proceeding to human clinical trials • Indian Central Drugs interest in obtaining value for Standards Control • Up to three phases of ever- money. Organization (CDSCO) increasing levels of clinical In other areas of the world, pre- trials, requiring the informed market approval follows similar, A number of pharmaceutical consent of participants : if not identical, patterns. Post- industry associations exist that • Phase I, studying tox- market surveillance, or the can provide detailed information icity on a sample of monitoring of a drug in use to from the manufacturers’ side healthy volunteers observe deviations from clinical and, in the UK, there exists the trial results in the general popu- National Institute for Health and • Phase II, including lation, has to be carried out by a Clinical Excellence (NICE), which dosage studies and complaints mechanism whereby has published a number of good studies of pharmacoki- the medical profession reports practice clinical guidelines. netic pathways, and adverse or unexpected effects. Some criticisms of regulatory In the USA, post-market surveil- • Phase III, large-scale processes for pharmaceuticals lance is carried out by the FDA testing in a representa- warrant mention : tive population under its “ Medwatch ” system, whereby medical professionals • It has been stated that • Post-market surveillance, as well as the public can report the regulatory approaches involving close monitoring of drug effects. In all cases, the reg- to pharmaceuticals differ the effects, especially the side ulatory agency has the right to between the major econo- effects, of the drug in use withdraw or restrict in some way mies in that the US approach its prior approval of a drug that taken by the FDA is charac- In other developed countries, has proved to have unexpected terized as one of “ managerial there is also often a further side effects or has shown itself discretion and adjudication ”, requirement to show cost-effec- to be ineffective in certain sce- whereas the approach taken tiveness, especially in markets narios. In Europe and some other in Canada involves consulta- where state health authorities, parts of the world, this monitor- tion, and in Europe a certain such as the National Health ing phase is often referred to as amount of bargaining takes Service in the UK, have a major “ pharmacovigilance ”. place. The implication is that

48 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE different decisions can be way as for medical devices. They large populations need them, has taken in different jurisdictions are not in general “ close ” to man- to be weighed against the per- ufacturers. They do not possess ceived product safety assured by • In the single market of the EU, the sort of in-depth expertise that taking the higher-cost alternative. there has to be mutual rec- is required for decision making, The answer must be found not ognition of different member and the likely response to calls for in the development of all coun- states’ product licensing the voluntary reporting of adverse tries to super-regulator status, decisions, but differences in effects by knowledgeable con- but in the judicious management evaluation processes remain sumers is almost guaranteed of risk, in the exploitation of syn- • One consequence of the to be poor. On the other hand, ergies offered by partnering with on-going harmonization of they cannot afford to throw open other countries in larger regional regulatory criteria could be their markets to the unlimited and economic groupings or free trade that marketing approval deci- uncontrolled entry of potentially areas, and in the negotiation of sions will be made at a level unsafe products from all coun- special dispensations in interna- perhaps that inadvertently, tries just to keep costs down. tional fora. shifts the emphasis onto more There is a trade-off between the and more stringent post-mar- strategy of following the deci- Personal Protective ket surveillance techniques sions of another trusted country Equipment or region (such as the USA or • From the consumer’s point a) General considerations : the EU) and the implicit costs of of view, the wrong message The term Personal Protective doing so. is sent when a drug is availa- Equipment (PPE) covers a wide ble on prescription in only one Existing internationally harmo- range of devices and appliances country, but over the counter nized arrangements go only designed to be worn or held for in another part of the way to guaranteeing protection against one or more compliance or to ensuring an It, therefore, seems clear that the safety and health hazards. Thus, affordable, yet acceptable-risk, safety and effectiveness of phar- items such as protective head- outcome. The opportunity cost maceutical products cannot be gear, gloves, safety shoes as well of neglecting generic drugs when demonstrated beyond all rea- as respirators, self-contained sonable doubt merely by a combination of clinical trials and other pre-market approval techniques. Going forward, it will be in the best interests of the drug companies to enhance their own post-market follow-up techniques to protect their market share as well as the health of the general public. d) The developing country perspective : Some developing countries face a dilemma in the regulation of chemicals and pharmaceuticals, in much the same

49 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE One advantage of the usage situation for most of these products is that user complaints from the workforce, which tends to be unionized, are readily forthcom- ing. Employers have a duty to ensure that their workers are suitably protected, and face stiff penalties, even criminal liability, if they fail in this regard. In many countries, the public outcry that attends the failure of employers to live up to their responsibilities to protect their workers is sufficient to ensure a high degree of compliance. On the other hand, it is a known fact that some large tenders in the construction and raw materials extraction/benefi- ciation industries have been won and awarded to companies on the basis of low cost, only to find breathing apparatus and eye used in the workplace tend to be that those low cost estimates are protection devices fall under this covered by regulations adminis- based on failure to provide the heading. As a consequence, a tered by the relevant manpower correct protective equipment for large number of international, or labour ministry. workers. regional and national product By definition, items that are In some jurisdictions, the regu- standards exist that cover the used or worn in hazardous latory situation is complex. For technical requirements for these situations require special moni- example, in the United Kingdom, products, and in regulations toring ; should such an item fail, hearing protectors and some res- based on them, it is generally the the user or wearer is by default pirators used in the workplace practice to use a classification automatically placed in a dan- fall under different regulation system for PPE, based on risk. gerous, even life-threatening, regimes to those for protective Most such items are used in an situation. It is, therefore, not sur- clothing, safety footwear, etc., employment situation, although prising that market surveillance while motorcycle helmets worn protective equipment used in systems for these products rely by employees in the course of sport and leisure also fall under just as much on monitoring in their duties fall under road traffic the same heading. A variety of use or at the workplace as on legislation. It is not uncommon, regulatory/market surveillance approval of the new finished therefore, for a number of differ- authorities are delegated the task article. Documentation, expiry ent regulations to be competing of controlling these products ; in dates, and standard operating in this area. a number of developing coun- procedures are extremely impor- In general, PPE regula- tries, those items of PPE that are tant in this context. tions require that appropriate

50 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE protective equipment be sup- eye goggles and full-face • Consider possible allergic plied in the workplace whenever splash-masks reactions to the equipment – for example the severe skin the situation demands it, and that • Satisfy themselves that the conditions sometimes caused the individual items of protective use of the proposed equip- by the wearing of surgeons’ equipment be subject to a pre- ment will actually reduce the latex gloves that contain too assessment as to their suitability, total risk – in other words, much extractable protein res- followed by checks on their main- when in use does it add any tenance, storage, accompanying unforeseen risks that might idue from the production instruction leaflets, standard make the situation worse ? process operating procedures or training • Assess whether the equip- • Assess the compatibility provided to employees. ment can be adjusted to fit of different types of equip- In assessing suitability prior to the wearer properly ment intended to be worn use, employers should : simultaneously • Take into account the phys- • Determine whether the ical demands on workers b) The European Union proposed equipment is from using the equipment – Personal Protective Equipment appropriate for the haz- for example, the wearing of Directive : The Council Directive ards likely to be encountered heavy, hot protective suits 89/686/EEC, as amended in – examples of this could might require that the time 1993 and 1996, lays down a include the decision between workers are required to be comprehensive set of rules respirators and self-con- at the workplace be limited, that must be followed in the EU tained breathing apparatus, and that extra rest breaks be for placing on the market, free or between safety spectacles, provided movement within the EU, and safety and quality aspects of PPE. It is a detailed document that, when taken together with the large number of European and International Standards that lay down “ deemed to satisfy ” provisions, constitutes an extremely comprehensive solution to the problem of controlling the marketing and use of such equipment. It recognizes that national provisions within EU member states make the use of PPE in the workplace compulsory when shown to be necessary, and lay down harmonized basic requirements, conformity with which may be presumed based on an attes- tation of compliance with the

51 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE relevant standards. EU member and passing, according to its • A notified body of the manu- states may not prohibit, restrict choice, one of two defined facturer’s choice carries out or hinder placing PPE or their checking procedures, followed necessary random checks, components on the market if by its making a formal decla- examinations and tests as they conform to the provisions of ration of conformity : defined in the applicable har- the PPE directive and bear the Option A is the quality control monized standards, to assess CE-marking. system for the final product, and the conformity of the product The steps in the regulatory pro- includes : • A test report is issued which, cess are essentially as follows : • Proof that the manufacturer if it concludes that produc- 1. Technical documentation has taken all steps necessary tion is homogeneous and the before market entry : Before to ensure that the manufac- product conforms to the rele- placing the PPE product on turing process, including the vant basic requirements, must the market, the manufacturer final inspection of the PPE be presented on request by or, in the case of a foreign and any tests, ensures the the manufacturer ; if the report manufacturer, its authorized homogeneity of production is not positive, suitable cor- representative, is required to and the conformity of the rective action must be taken assemble documentation that PPE with the type described until it is comprises all relevant data on in the type-approval certif- Option B is the ensuring of qual- the means used by the manu- icate and with the relevant ity of production by means of facturer to ensure that the PPE basic requirements of the monitoring, and includes : in question complied with the directive relevant basic requirements. • Submission by the manufac- For items that require a type turer of a detailed application evaluation [see 2 below], this documentation must include the manufacturer’s detailed technical file 2. Submission of a model for type-examination : Before series-production may take place for all except PPE models of “ simple design ”, a model must be submitted, together with the technical file, for type-examination by an approved inspection body 3. Certain products of simple design are exempted from type-examination. These are detailed in the directive 4. Production of PPE is subject to the manufacturer undergoing

52 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE for approval of its quality control system to a notified body of its choice

• The examination, under the quality control system, of each PPE and the carrying out of appropriate tests to check their conformity to the basic requirements of the directive

• A detailed assessment by the notified body of the ade- quacy of the quality control system, followed by the issuing of a reasoned assessment decision

• On-going supervision by the notified body of the quality control system, once approved, by means of peri- odic audits and unannounced e) Consequences of CE- Toys visits to carry out inspec- marking : Following the above a) General considerations : tions of the product, testing procedure, the declaration of The need to ensure the safety of and storage sites and all conformity affixed to the product toys entering the market poses a documentation including by the manufacturer is in the form special challenge for legislators documentation on the qual- of the CE-marking. Within the EU, in general, if a member state ity control system, technical and standardizers as well as for establishes that the CE-marking documentation of the prod- market surveillance authorities. has been affixed unduly, then the uct and the quality control The concept that the informed manufacturer of the product or manuals consumer has to bear some of its authorized representative is the responsibility for his or her • The issuance of an audit obliged to make the product con- own purchase and use of prod- report which, if it concludes form and to end the infringement ucts, has diminished. Parents still that production is homo- under conditions imposed by the have responsibility for purchas- geneous and the product member state in question. ing safe toys for their children. conforms to the relevant Where nonconformity continues, Provided they, and the supply basic requirements, must be the member state is required to chain, have access to the neces- presented on request by the take all appropriate measures manufacturer ; if the report is to restrict or prohibit placing the sary information, that complaints not positive, suitable correc- product on the market, or to are notified, and that product tive action must be taken until ensure that it is withdrawn from recalls actually take place in the it is. the market. expected way, then the risk at the

53 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE point of purchase should be the intervention required. Batch test- requirements (in essence, that same as for any other product. ing on product samples alone toys have to be safe) for market is insufficient to guarantee that entry into the EU. Conformity to The difference comes about unsafe products will not enter the appropriate standards, in par- when the products are put into the market. Quality manage- ticular the relevant parts of EN 71 use. Children are an extremely ment systems are needed to listed above, led to a presump- vulnerable group, as they cannot ensure that the product designed tion of conformity to the directive always be guaranteed to use a is the product actually produced. which, in turn, led to implied per- product in the way its manu- Products that meet the require- mission for the products to bear facturer intended. Extremely ments of standards can still the CE-mark. Recently, although young children are at greatest become the subject of notifica- the 1988 directive has worked risk, as they do not yet possess tions when previously unforeseen well, changes in technology any mechanism for aligning the risks present themselves in use. and the emergence of new risks issues of safety and desirability of Therefore, robust notification and have necessitated the adoption the product. It often occurs that product recall systems have to of a new directive, 2009/48/EC, the toy a child likes best is laden be in place. which substantially amends the with more risks than others. It In the European Union, the old directive, and came into force is, therefore, not surprising that Toy Safety Directive 88/378/ toys are the most frequently noti- in July 2009. Implementation in EEC laid down essential safety fied product category in the EU’s national legislation is expected RAPEX system.

Table 2, which is not claimed to be comprehensive, gives an idea of the type of risk a child can encounter playing with toys.

The standards listed in Table 3 below give an example of how the standards community has responded to these challenges.

b) Regulatory approaches : The standards listed in Table 3 and their “ deemed to satisfy ” status in regard to the provisions of legislation such as European directives, are a good indication of international commitment to a unified approach to toy safety regulation. More, however, needs to be done. Different countries still adopt differing approaches, develop different national standards in some areas, and vary in their views as to the level of

54 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE Table 2 – Toy category versus risk Toy category Risk Activity toys (swings, slides, trampolines, bicy- Physical harm due to falling, getting stuck in mecha- cles, scooters, skateboards, strollers or buggies, nisms, collisions etc.) Chemistry sets or products containing chemicals Ingestion, inhalation, poisoning, allergies, burns Scented or flavoured toys, teethers Suction, ingestion, poisoning or allergy due to biting, suction, leakage Painted wooden toy products Poisoning through ingestion of lead etc., injury from wood splinters Expanding toys Suffocation, choking when toy expands in mouth Battery-operated or electrical toys Electric shock, poisoning or explosion due to swallowing or inappropriate disposal of batteries Toys with small removable parts Choking or injury caused by putting parts into mouth, nose, ears, etc. Mechanical toys Injury due to contact with sharp edges, moving parts Toy chests, play houses, enclosures Suffocation due to lack of ventilation Paints, drawing sets Poisoning, inhalation, swallowing, allergic reaction, skin absorption of toxic elements Toys that fire projectiles Injury to face, eyes, suffocation from blocked airways

Table 3 – Examples of Standards used in regulations ISO 8124-1:2000 Safety of toys – Part 1: Safety aspects relating to mechanical and physical properties ISO 8124-2: 1994 Safety of toys – Part 2: Flammability Ingestion, inhalation, poisoning, allergies, burns ISO 8124-3: 1997 Safety of toys – Part 3: Migration of certain elements ISO 8098: 1989 Cycles – Safety requirements for bicycles for young children Suffocation, choking when toy expands in mouth EN 71-1 Safety of toys – Part 1: Mechanical and physical properties EN 71-2 Safety of toys – Part 2: Flammability EN 71-3 Safety of toys – Part 3: Specification for migration of certain elements EN 71-4 Safety of toys – Part 4: Experimental sets for chemistry and related activities EN 71-5 Safety of toys – Part 5: Chemical toys (sets) other than experimental sets EN 71-7 Safety of toys – Part 7: Finger paints − Requirements and test methods EN 71-8 Safety of toys – Part 8: Activity toys for domestic use EN 71-9 Safety of toys – Part 9: Organic chemical compounds – Requirements EN 71-10 Safety of toys – Part 10: Organic chemical compounds – Sample preparation and extraction EN 71-11 Safety of toys – Part 11: Organic chemical compounds – Methods of analysis

55 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE by January 2011, although there via the RAPEX recall system. One an administrative cooperation will be a longer-term phase-in of forward-looking aspect of the Toy group, known as TOY-ADCO, certain requirements, especially Safety Directive is the require- which exchanges information chemical requirements, and thus ment that where a standard is between members. The joint some parts of the old directive not specified within the directive, market surveillance action pro- will remain in force for some the closest applicable national or vided a large amount of specific time. Important new changes to International Standard is to be information about the hazards the directive include limitations applied ; this is intended to ensure investigated in specific toy prod- or complete bans on the inclu- that new and innovative toys are uct groups, but also enabled its sion of some harmful chemicals also confirmed to be safe before participants to gain first-hand in toys, and either a full ban on entering the market. A number experience of working together allergenic substances or stricter of third-party consultancies have on a large-scale market surveil- labelling requirements where introduced supply chain risk man- lance initiative. these are shown to be poten- agement solutions to assist toy In the United States, market tially allergenic only to some suppliers to navigate through the surveillance is undertaken by consumers. Enforcement will complex set of obligations that the Office of Compliance of the clearly involve much greater reli- they now have to meet. U.S. Consumer Product Safety ance on complex and extremely PROSAFE, the Product Safety Commission (CPSC) under the sensitive testing in the future and, Enforcement Forum of Europe, Consumer Product Safety Act. of course, the new requirements has recently undertaken research The CPSC has issued a number are inextricably linked to the in terms of a joint market surveil- of mandatory safety standards, EU’s REACH regulations. Some lance action on toys, involving a and operates a recall system. aspects of toy safety, where these number of market surveillance The “ Fast Track Recall System ”, are not covered directly under the authorities from the European whereby manufacturers or mem- Toy Safety Directive, nevertheless Economic Area [European Union bers of the supply chain can fall under the General Product countries and European Free voluntarily notify the CPSC of Safety Directive (GPSD). Trade Association countries product safety issues, accounts Market surveillance authorities (Norway, Iceland, Lichtenstein for the majority of recall notifica- in the EU member states have and Switzerland)]. Within this tions, and works in such a way the power to demand immediate group of countries, market that if the manufacturer voluntar- withdrawal of a toy product from surveillance authorities respon- ily recalls defective and unsafe sale if it presents a safety hazard, sible for toy safety have formed products within 20 days of making a notification, the CPSC does not need to undertake a preliminary hazard determination and can immediately assist the firm with its product recall programme, thereby saving time and resources. A number of related ASTM standards exist and ASTM standards are noted as national standards when they have international

56 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE acceptance. With toys, the CPSC sometimes requires that manufacturers display an age warning symbol to indicate the intended age of users of the product. One notable recent development in the U.S. has been the passing into legislation of the Consumer Product Safety Improvement Act in 2008, which goes further than previous legislation, especially in the case of toys where, for example, it places strict limits on the content of lead and phthalates in toys for young children, both of which can cause severe health the CE-marking are, in theory, hazards by ingestion. mix of regulatory requirements in large markets for toy products likely to be compliant. However, China is the largest manufacturer requires that manufacturers, market surveillance authorities of toys in the world, and therefore whether in developing coun- need to be vigilant and keep has a special responsibility to con- tries or not, face the same set abreast of product safety recalls trol the safety of these products of challenges to establish a in other jurisdictions, to be on at source. In 2007, the Chinese comprehensive risk manage- the lookout for fraudulent sup- compulsory certification requirement system that will enable plier declarations, and to bear ments were expanded to include them to market their products in mind the implications of EC toy products, and toy manufac- without contravening numerous Regulation 765. turers are obliged to apply to one regulations. Those who would Importers of toys and consum- of three certification agencies for choose to ignore such regula- ers in developing countries face inspection and certification, with- tions leave themselves open the same set of decisions as out which the toys may not be to costly recall procedures, with other types of regulated sold internally or exported. The accompanied in some cases products. Good advice would same requirement applies to by product liability claims and include : imported toys. The EU has been potential insolvency or even • Looking for the CE-mark on active in working with Chinese criminal prosecution. Regulators a toy – and if it does not bear toy manufacturers to exchange in developing countries would RAPEX information and assist the CE-mark, trying to ascer- be well advised to base their the Chinese authorities in trac- tain why it is absent product safety requirements ing, feedback and follow-up around widely available stand- • Rejecting products that do mechanisms for notified prod- ards that have been accepted as not carry labels, warning ucts. A specific “ Roadmap for sufficient to satisfy strict regula- signs or include instructions in safer toys ” was signed between tory needs in mature regulated the local language the EU and China in 2006. markets elsewhere. Products • Looking for and paying due c) Implications for develop- that bear appropriate attes- attention to age warnings on ing countries : The complex tations of conformity, such as toys.

57 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE CONCLUSIONS

Regulatory needs and the capabilities than on acquiring much the same at the most responses to them might differ costly esoteric test and meas- basic levels, the response-land- in detail between countries and urement facilities that are likely to scape for meeting those needs regions, but there is already remain unused most of the time. is, nevertheless, changing and much common ground, espe- Regional synergies between does vary between countries and cially in the sectors highlighted developing countries need to be regions. in this document. better exploited than at present. The requirement for International Resource limitations apply eve- Global trade has increased in Standards to be globally relevant, rywhere, not just in developing pace with the more widespread together with greater cooperation countries, and a risk-based use of first party (suppliers’) dec- between standardizers and regu- approach to market surveillance, larations of conformity, but this lators, promises better technical both at the pre-market and post- does not mean that risks have tools to meet the needs of reg- market levels, coupled with rapid disappeared, and the manage- ulators. The on-going expansion communication to the consumer ment of those risks still remains of the range of available stand- level is generally agreed to pro- a necessity. Where developing ards into the service sector and vide the most appropriate level, countries can, and often should, the work of CASCO will lead to of monitoring and response. benefit from placing greater reli- more precise guidance to satisfy The ultimate goal of “one stand- ance on products that have been the operational needs of market ard, one test (or one certificate shown to be acceptable for entry surveillance authorities, or to of conformity), accepted every- into other more developed and cover the competence of their where” remains a challenge, but regulated markets, they need personnel. More standardized promises a solution to the needs to remain vigilant in the face of approaches to the way the scale of developing countries. Indeed, increasing volumes of counter- of market surveillance activities scarce resources would often be feit goods, or products bearing may be needed to be ramped better allocated to improved pro- false declarations of conformity, up or down in the face of chang- motion of consumer awareness targeted at those markets where ing risk patterns. There have and upgrading basic inspec- surveillance is at its weakest. been calls for standards that lay tion, testing and monitoring While regulatory needs remain down good practice principles

58 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE for the application of restrictive might not be sufficient to meet have an interest in obtaining measures, sanctions and prod- the needs of a regulator who better and more consistent out- uct recall, as well as the level wishes to inspect production puts from conformity assessment and format of information that controls during manufacture. A bodies and even from accredi- should be exchanged between second standard, or other set of tation bodies. Consumer bodies market surveillance authorities. standard operating procedures, have a part to play in making In addition, there is perhaps might be needed. Standards can sure that information relating to further scope for the develop- be used to lay down good prac- unsafe products is disseminated, ment of good practice guidance tice provisions for what is needed and that complaints are lodged standards on how best to meet in an effective market surveillance with the correct authorities. This conformity assessment or market programme, but they may not lay is especially true in developing surveillance requirements. down the rules for their own appli- countries which require better cation. Responsibility for that levels of support. Where con- Challenges and responsibili- must always be the standards sumers can play a part in the ties will still remain, however, user’s. Consumers, once made standards-setting process, at that cannot simply be solved by aware of product risks, also need the same negotiating table as the standards alone. Not all regula- to take some of the responsibility regulators, the result will always tory aspects relating to a given for their management. be a better standard, and this will product can be included in a facilitate regulatory compliance. single standard. A standard can In this context, national standards list the technical requirements bodies have a duty to promote for a product, that are assessa- quality and consumer awareness ble in the final product, but that in their territories, and regulators

59 PRINCIPLES AND PRACTICES IN PRODUCT REGULATION AND MARKET SURVEILLANCE ISO Central Secretariat 1,ch. de la Voie-Creuse Case postale 56 CH-1211 Genève 20 Switzerland

Tel. +41 22 749 01 11 Fax +41 22 733 34 30 E-mail [email protected] Web www.iso.org