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The New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health

2 The New Approach: Background and Issues (Session I)

This session aimed to give participants background information about the New Approach legislation. Examples to illustrate points were taken from existing or proposed New Approach legislation of particular interest in considering the issues central to the Workshop.

2.1 Background Document for Sessions I and II

2.1.1 Background

The New Approach was introduced in 1985 by the Council Resolution of 7 May 1985 on a New Approach to technical harmonisation and standardisation.⁴ The Resolution emphasised "the urgent need to resolve the present situation as regards technical barriers to trade …", "a high level of protection" and "the importance and desirability of the new approach which provides for references to standards – primarily European standards, but national ones if need be ….". This resolution was based on experience with the Low Voltage Directive from 1973.⁵

These three points were and remain the prime drivers for this approach. The New Approach was introduced to ensure that technical barriers to trade in the internal market due to the national use of standards was addressed as vigorously as the technical barriers to trade caused by Government regulation. The proposed solution was the active encouragement of a system of European standards. The New Approach has been successful in achieving these goals.

The figure below⁶ shows the numbers of standards adopted by the three European standards bodies,⁷ European Telecommunications Standards Institute (ETSI), European Committee for Standardisation (CEN), and European Committee for Electrotechnical Standardisation (CENELEC), at the end of the first half of 2001:

The growth in European standards has been considerable. In 1984 there were only 670 CEN and CENELEC standards. In the time the New Approach has been operating, a substantial body of European standards has been adopted. These European standards have replaced existing national standards as well as introduced new standards harmonised at a European level.

The New Approach has been used to ensure that harmonised standards have been developed for a series of product groups. A list of the product groups and the corresponding New Approach Directives regulating them is shown in Annex I of Appendix A of this report. The New Approach ensures a complete harmonisation of essential requirements to obtain a high level of protection and to avoid technical barriers to trade for each product group by ensuring simultaneous harmonisation of both the administrative regulations and the related technical standards.

Development of European standards is not of course limited to standards within these product groups. The chart above also shows that mandated standards directly related to the New Approach are only a small proportion of the total number of European standards.

The use of the New Approach also provided the Council with a solution to the problem of addressing detailed technical requirements, in what was hoped would be a more effective manner than could be attained by traditional legislation. It did so by establishing a system of co-regulation, where the work of developing the technical requirements is delegated to the three private European standards bodies.

The New Approach has been described extensively and numerous studies have been carried out about its efficiency, the legal aspects of the process, etc. Many of these reports are available from the Commission website on the New Approach and standardisation.⁸ A report on experience with the New Approach is at present being prepared by the European Commission’s services in DG Enterprise.⁹

2.1.2 Elements of the New Approach

The New Approach comprises the following elements:¹⁰

	EU directives specify only essential requirements to ensure a high level of protection (health, safety, consumers, environment, etc.).
	Essential requirements worded so as to produce binding obligations that can be uniformly enforced by Member States.
	Directives deal with large families of products and/or hazards.

The essential requirements form part of the main body of the New Approach Directive, and, as such, are drafted on the basis of a proposal from the Commission, with the final text a result of discussions in the Council and in the Parliament. They are intended to stand alone. This is made clear in the 1985 Council Resolution: "The essential safety requirements which must be met in the case of products which can be put on the market shall be worded precisely enough in order to create, on transposition into national law, legally binding obligations which can be enforced". There is also an explicit requirement that the essential requirements "be so formulated as to enable the certification bodies straight away to certify products as being in conformity, having regard to those requirements in the absence of standards".

This is a necessary corollary of the fact that the technical specifications drawn up by "organisations competent in the standardisation area …are not mandatory and maintain their status of voluntary standards."

In this, the drafting of essential requirements does not differ from drafting any other form of legislation. The scope of the essential requirements will depend on the area being regulated. The degree of technical detail required will again vary from case to case, depending on the political constraints involved. Where the group of products is well-defined and homogenous, formulation of the essential requirements is easier, since the group is more likely to share common characteristics. Where the requirements are related to properties being difficult to specify exactly, e.g., ergonomics and long-term exposures, it is more difficult to formulate the essential requirements.

The distinction between the technical details that need to be included in the essential requirements and those that can be safely left to the subsequent standards can be difficult to draw. The ability of the standards bodies to fulfil any mandate is also determined by the way the essential requirements are formulated, and how these can be elaborated in relevant standards.

In addition, whilst in theory voluntary, the standards can in practice become effectively mandatory.¹¹ Proof of compliance with the essential requirements other than by the application of the standards "is so burdensome that products not conforming with recognised standards are often rejected by distributors and other avenues of access to the EC market".¹²

The importance of the essential requirements and their central role in any New Approach Directive is clearly recognised by the 1985 Council Resolution, since this also states that amendment of the essential requirements "can only be made by means of a new (now Parliament and) Council Directive under Article 100 (now Article 95) of the Treaty".

Annex V in Appendix A to this report shows the essential requirements from three Directives. These are the Safety of Toys Directive (88/378/EEC), the Packaging and Packaging Waste Directive (94/62/EC), and the Low Voltage Directive (73/23/EEC). The difference in the extent of essential requirements is remarkable. Whilst the essential requirements in the Low Voltage Directive take up a single page of Directive text and are formulated in very broad terms, implementation of these essential requirements caused no more difficulties than implementation of the far more elaborate essential requirements of the Machinery Directive (98/37/EC) which fill roughly 20 times as much Directive text, and are formulated in considerable technical detail.¹³

	Commission mandates European standardisation bodies to define the detailed technical solutions (harmonised standards), which manufacturers may apply on a voluntary basis.
	Manufacturers may choose whether they apply these harmonised standards (or other technical specifications), provided their products satisfy essential requirements.

The process of preparing mandates is the task of the relevant Commission service, following consultation with the Member States. This process is often initiated before the final adoption of the relevant legislation. The mandate is then transmitted to the European standards bodies, although, in practice, these may have been consulted informally at an earlier stage.

It should be underlined that, whilst these mandates are in effect service contracts, they are made between independent institutions, and the standards bodies are not bound to accept a particular mandate.

Whilst fully recognising the independence of the standards bodies, the mandate can contain provisions that ensure that the standards are prepared in a way that ensures appropriate consultation with all relevant stakeholders.

The development of the mandated standards is carried out by the relevant European standards body. The standards are produced by technical committees with participation of the national standards organisations. Membership of these technical committees can include government representatives, industry and relevant non-governmental organisations (NGOs). The numbers of government and NGO representatives are often limited. The work of these Technical Committees is followed by a Consultant appointed by the Commission whose job it is to ensure that the standards fulfil the requirements of the mandate and hence of the essential requirements.

Standards mandated under the New Approach are first adopted by the relevant standards body following their own procedures. The standards adopted by the European standards bodies do not become part of formal legislation, incorporated into a Directive with the explicit approval of the Member States, but are a type of "orphan legislation" recognised by the Commission in a Communication published in the Official Journal. The provisions of the underlying Directive presume that goods produced to the harmonised standards published in the Official Journal conform to the essential requirements of the Directive.

	Where harmonised standards are complied with, a product is presumed to meet essential requirements (manufacturers are no longer required to obtain prior third party certification14). However, manufacturers15 are legally responsible for ensuring that all products placed on the market comply with the directives.
	Member States must ensure that non-conforming products are withdrawn from the market (market surveillance).
	Directives also lay down conformity assessment procedures16 for evaluating compliance with the Directives, taking into account identified potential risks.
	Conformity assessment is carried out by testing and certification bodies (‘notified bodies’), designated by Member States within their jurisdictions and acting under their responsibility.
	CE mark symbolises conformity with all relevant Community rules — Member States recognise17 that a CE marked product18 placed on the market anywhere in the Community complies with their own national laws.

If a Member State considers that the actual standard does not in fact provide a sufficient assurance that a particular product is in conformity with the essential requirements, the Member State informs the Commission. The concerns are discussed in a Committee established under the 98/34 Directive.¹⁹ This Directive has replaced a Directive first adopted in 1983 (83/189/EEC) which is primarily intended to provide a mechanism for Member States to notify national standards and regulations. As such, the Directive covers the whole field of technical barriers to trade, and not merely standards related to the New Approach. A Standing Committee established under the Directive consisting of representatives of the Member States meets regularly. A reservation made by a Member State might result in the standard not being published, or being published with a reference to the fact that compliance with the standard does not guarantee compliance with the essential requirements.

The New Approach operates across three important boundaries.²⁰ These boundaries are between

	political decisions and technical solutions, through the formulation of essential requirements;
	public and private organisations, through mandates to the European standards bodies; and
	legislation and standards, through the passive adoption of the standards by publishing a Commission communication.

These boundaries are characteristic of New Approach Directives, but not restricted to them. The following section shows examples taken from outside the area of the list of product groups shown in Appendix A to this report. Experience from a wider range of Directives can potentially contribute to a better understanding of the difficulties, as well as to point to possible solutions that already form part of existing EU legislation.

As noted above, the development of European standards is not limited to areas covered by the New Approach. Nor is the use of standards and the delegation of the development of technical standards by these organisations in EC legislation limited to the product groups covered by the New Approach.

In some cases, Directives are developed with requirements similar to "essential requirements" that require additional technical specifications to be operational in practice. Often when this occurs, the Commission mandates the European standards bodies to prepare standards to cover these technical specifications. The development of these mandated standards is often followed by a Consultant appointed by the Commission to ensure that the mandated standards are prepared in accordance with the needs of the Directive, and, after adoption by the relevant standards bodies, the Commission can publish the resulting standards in the Official Journal. Although the process of development of these standards differs perhaps only in minor detail from the standards produced under the New Approach for the product groups listed in Appendix A to this report, these Directives are not strictly speaking "New Approach" Directives. This type of Directive is not uncommon, and, as a result, there is a grey area of Directives similar to, but not regarded as part of the New Approach.

An example of a near-"New Approach" Directive is Directive 94/27/EC²¹, the twelfth amendment of Council Directive 76/769/EEC on the marketing and use of certain dangerous substances and preparations. Directive 94/27/EC bans the use of nickel and its compounds in certain products. The Directive specifies "essential requirements" not in an Annex but in its Articles, standards to measure compliance (test methods) were prepared by CEN under a mandate, and, after adoption by the standards bodies, the standards were published in the Official Journal.²² In spite of the obvious similarities, this Directive is not regarded as a "New Approach" Directive. A major difference from most New Approach Directives was the stipulation that the Directive would not come into force until the publication of the standards in the Official Journal. The essential requirements were not allowed to stand alone without harmonised test methods. As a result, the Directive, adopted in 1994 did not come into force until more than five years after its adoption. Technical details of this Directive are shown in Annex II of Appendix A to this report.

Experience with New Approach Directives that set essential requirements with regard to concerns for the environment for products is limited to the Packaging and Packaging Waste Directive. The Commission’s working paper including a draft text for a directive on Electrical and Electronic Equipment (EEE) makes more wide-ranging proposals with regard to concerns for the environment.

There is however some additional experience with other product groups outside the New Approach. As an example, Technical Committees of European standards bodies have been established in order to further collaboration on the regulation of fertilisers and liming materials (CEN/TC 260) and soil improvers and growing media (CEN/TC 223). In particular, collaboration on methods to support eco-labelling of fertilisers is in progress. Extracts from the CEN Technical Board resolutions describing the scope of the work in these two Technical Committees are shown in Annex III of Appendix A to this report.

The European standards bodies are extensively involved in environmental legislation. There are a number of CEN Technical Committees where standards (including mandated standards) have been developed in support of a large number of EC Directives, many of which have their legal basis in Article 175. These TCs include CEN/TC 164 on water supply, CEN/TC 165 on waste water engineering, CEN/TC 230 on water analysis, CEN/TC 264 on air quality, CEN/TC 292 on characterisation of waste, and CEN/TC 308 on characterisation of sludge. Many of the standards developed in this context are analysis methods and methods for sampling. Several of the test methods have been adopted by the International Standards Organisation (ISO); a number of these ISO test methods are very similar to test methods developed by the OECD.

CEN has established a separate Committee regarding the environment, the Strategic Advisory Board on the Environment (SABE)²³, which reports directly to the Technical Board of CEN. CENELEC has a similar committee. In order to improve the quality of environmental competence in the individual technical committees, CEN/SABE has established an Environmental Help desk as part of the CEN Management Centre (CMC).

Finally, Annex IV of Appendix A to this report shows an example of a conventional Directive which includes technical Annexes developed by Commission Working Groups, as well as standards developed in several different fora. The symbols used in Council Directive 67/548/EEC are taken from the symbols developed in a UN Committee. Test methods are taken from the OECD Test Guidelines Programme. Many of these test guidelines are very similar to the ISO standards used in the environmental legislation mentioned above, as well as certain ISO standards used in support of the Medical Devices Directive. Performance of these test methods is controlled by Good Laboratory Practice, an OECD management standard. In addition, there are direct references to both CEN and ISO methodology for measurement of physical chemical effects, estimation of hazardous properties, certain labelling requirements, and on packaging requirements for child-resistant closures and for tactile warnings.

Agreements reached in connection with Agenda 21²⁴ have led to a global agreement on harmonised criteria for the definition of hazardous chemicals. This work, closely similar to that of other standardisation organisations, will be carried out by an international governmental body.

The example of Directive 67/548/EEC illustrates the use of standards that are directly incorporated into legislation, rather than passively adopted. It also illustrates the use of governmental rather than private standardisation bodies.

The New Approach has been successful in ensuring a high level of protection for safety and human health for a wide range of product groups.

Disagreements in relation to concerns on environment and human health after long term exposure (e.g. to chemical substances and noise) have mainly been seen in two out of the twenty six product areas²⁵ covered by New Approach Directives. These product areas are the Safety of Toys²⁶ and the Packaging and Packaging Waste Directives.²⁷ There are 26 mandated standards related to these two Directives out of a total of over 3,500 standards mandated under the New Approach²⁸ and after publication, less than five standards have not been accepted in full or in part as harmonised standards.

These two Directives differ in other ways from the other product areas. The Packaging and Packaging Waste Directive was the first to include essential requirements that actively addressed issues related to environmental protection. The Safety of Toys Directive addresses an area where particular concerns arise because of the special nature of the target group to be protected: children.

In the case of the Safety of Toys Directive, the concerns have mainly been linked to the presence of hazardous chemicals in toys. The concerns have been linked to low levels of exposure to chemicals with effects that are difficult to correlate to exposure to one particular object. There are often difficulties in getting data on the chemicals concerned, as well as difficulties in estimating exact exposure.

When assessing concerns for the environment, many of the same problems as are seen for human health also apply. Data on the environmental effects of different components can be limited, and estimates of release from products are often difficult to obtain. It is also difficult to correlate effects that are often first apparent some time after the event with the actual use of the product. These factors all contribute to the difficulty of making a scientifically based assessment.

But evaluation of the environmental effects of products is complicated by an additional aspect that is not seen with evaluation of the health effects. Children’s exposure to toys occurs only as exposure to the products themselves. The effects of a product on the environment are not limited only to exposure from the actual product. In many cases the effects on the environment from the use of the actual product may be very limited. The environmental concerns for the use of a particular product are often more related to the processes used in the production of the product, as well as the consequences of disposal of the product at the end of its useful life. The need to evaluate the whole life cycle of a product complicates considerably the process from the preparation of essential requirements to the preparation of the standards and subsequent verification of compliance.

In both the evaluation of human health and in particular, the environment, there are often conflicting issues to be resolved at the same time. There may be short term concerns for the environment that are very different from the long term effects; parts of the production process may give rise to concerns for one environmental compartment (e.g., the aquatic compartment), whilst other phases in the life of the product may give rise to concerns for another compartment (e.g., the soil compartment in waste disposal). Whilst apparently technical in nature, these conflicting choices often require political choices to decide the weight to be put on the different concerns. These are often reflected in official policy concerning how to deal with these issues.

Finally, including issues related to production raises the additional complication that whilst the use of an imported article may be fall within a particular jurisdiction, the production process will not. This in itself raises issues of compatibility with international trade agreements. These wider issues are not addressed specifically here, but it is important to recognise the need to ensure that any suggestions for improving or widening the application of the New Approach are made with due regard to the terms of these wider international agreements.²⁹

2.2 Proceedings of Session I

Facilitator: Helge Andreasen, Deputy Director General,
Danish Environmental Protection Agency

2.2.1 The New Approach: History of a success story

The Council Resolution of 28th October 1999 states that: "…the New Approach created for the completion of the internal market, which combines the official instrument of the Directive with voluntarily applied European standards, has proved itself and should be further applied, and invites the Commission to examine systematically whether the New Approach can be applied to sectors not yet covered as a means of improving and simplifying legislation whenever possible."

The Resolution recognises both the success of the Approach, and encourages its further use.

The New Approach legislation has been a success particularly in ensuring safety. This is demonstrated by the example of electricity related accidents in an EU Member State (Germany) and the US (see figure below). These figures are even more impressive when remembering that the standard voltage in the US is half that in Europe.

It is important to limit the legislative requirements to broad objectives essential to guarantee a high level of protection for the public health interest at issue. These objectives should be written in such a way that they could ensure binding obligations, uniformly enforceable. However, these essential requirements must also be framed so that manufacturers are free to use any appropriate technical solution.

Concerns with the workings of the New Approach Directives are more related to differences in the market surveillance carried out in the different Member States. This is an area where subsidiarity applies, and where a uniformly high level of enforcement is necessary to guarantee equal protection for the public and a level playing field for enterprises.

The New Approach can be used to complete the Single Market. It can enhance safety, environmental friendliness and performance of products, offer a flexible technology-neutral legal environment and reduce undue burdens for enterprises, but under two conditions: that the legislator will be able to define essential requirements while leaving space for standardisation to elaborate the appropriate solutions, and that matters considered "political" will not be given to standardisers for decision.

The Directives, and in particular the standards associated with them, are used widely outside the strict limits of the EU.

The New Approach has led to Europe having the strongest standards in the world. From this we stand to gain new markets in the world. This situation can be enhanced if we can create the conditions for standardisers to deal with the appropriate environmental aspects of products.

2.2.2. Formulating New Approach Directives for safety, environmental protection and human health

The Commission’s working paper including a draft text for a directive on Electrical and Electronic Equipment (EEE) proposes the use of the New Approach to develop part of the Community’s regulatory framework for this product group.

In discussing the use of the New Approach to address environmental concerns, it is important to recognise that the environment is a highly political domain. Standardisation should deal only with technical matters; an institutional mechanism is required to handle political questions. NGO stakeholders must be involved in the process. Whilst in time these issues might be expected to become less polarised, cultural change takes time.

The Commission’s working paper including a draft text for a directive on EEE has elements intended to harmonise design requirements in relationship to the environmental performance of electrical and electronic equipment. This initiative, i.e. to create a comprehensive framework for addressing environmental aspects of EEE, would contribute to a continuous reduction of the environmental impact of these products and ensure free movement of compliant equipment in the internal market.

The Commission has launched an impact assessment study and the preliminary results will be available in mid 2002. A final draft proposal for an EEE Directive is expected by late 2002.

2.2.3 Preparing standards for essential requirements by CEN/CENELEC/ETSI

The process of preparing mandated standards to form the basis of a presumption of conformity with the essential requirements was followed in preparing standards for the Packaging and Packaging Waste Directive.

There is considerable background for the decision by the Commission not to publish the references to all of the standards developed under the mandate for the Packaging and Packaging Waste Directive. Whilst there had been considerable criticism of the process, the CEN members had voted in favour of the standards by an overwhelmingly majority and the views of the Member States on publication of the references were evenly balanced. Solutions to the difficulties have been discussed and the Commission is preparing a new mandate for amendment of those standards not deemed to be fully in line with the Directive’s essential requirements.

Use of these standards will make a difference. They will change the balance of power in company decision making, as environment managers will have the support of legally recognised texts, rather than relying on purely commercial considerations. Unfortunately, the Commission’s refusal to publish the references means that there will be no guarantee of compliance with the essential requirements until the references to the amended standards have been published or the legislators have agreed and implemented their own solution. It also means there is less chance to test whether the New Approach can be used successfully for environmental protection measures.

Many people had suggested that the difficulties arose because no clear distinction had been made between political issues (which were for the legislators to deal with) and the technical solutions. But the problem was less that the essential requirements had got the balance wrong, and more that certain Member States wanted to use the standards to take the legislation further.

Nevertheless, the essential requirements were not well drafted – vague wording had been used to disguise the lack of clear political direction – and the Commission’s mandate had added new requirements rather than clarify ambiguities in the Directive. Finally, the long delay in issuing the mandate had put the CEN experts under great time pressure to complete the work on schedule.

2.2.4 The challenge of verifying compliance with essential requirements

The UK has a considerable legislative tradition in the field of product safety, which it has needed to take into account in coping with the transition to harmonisation on the basis of the New Approach. Changes in legislation have heightened awareness of the issues. The three principles of safety integration design, safeguarding and warning remain important. The benefits of the essential requirements include acting as a driving force for innovative design, with more focus on health requirements.

Whilst in many sectors mandated standards are product standards, management standards such as ISO 9000 are an option in many Directives. This can lead to a good balance in the roles of the two types of standards.

The New Approach is effective for a wide range of products, stimulates all involved parties to seek design based solutions and confirms the role of standards in Europe’s technical infrastructure, competitiveness and innovation.

2.2.5 The wider international issues: Interface between European and international standards-setting

Jacob Holmblad, Vice President, CEN

It is noted with great pleasure that standardisation including the New Approach has created successful conditions for the internal market in Europe.

However, globalisation has increased the need to find an international solution on global trade. This solution should take the European success into account.

The introduction of the New Approach launched a process of self-regulation, which the Commission wishes to carry on within the framework of co-regulation. The extent to which standards are used within a legislative framework is rather unique to Europe. In the rest of the world, traditions and codes of practise in certain sectors are given higher priority, and trade-specific de facto standards often regulate a certain sector.

Another important difference is that in Europe, it is a requirement to withdraw national standards for the benefit of national implementation of European standards.

There is a need for worldwide-accepted standards. Present examples of worldwide-accepted standards are ISO standards for codes for foreign exchange currency as well as ISO 9000 and ISO 14000.

Being inspired by the European model, one could imagine an umbrella-standard corresponding to the requirements in the Directives. This would conform to the role of the Directives in the internal market. On a regional level, regional standards could be elaborated and with respect to regional differences, the standards would fulfil the requirements laid down in the umbrella-standard.

The umbrella-standard could be an intermediate stage on the journey towards harmonised international standards. The world of standardisation is able to propose several solutions on an international level, but the chances of going through with them will to a great extent depend on negotiations in other international co-operating fora such as WTO.

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