The New Approach in Setting Product Standards for Safety, Environmental Protection and Human Health
3 The New Approach: Ensuring a high level of protection for the environment and human health (Session II)
This session was intended to provide an opportunity for detailed discussion of the perceived successes and failures of the New Approach, in particular relating to problems of ensuring high levels of protection for human health (especially effects associated with long term exposure) and environmental protection.
3.1 Discussion Paper for Session II
3.1.1 When is the use of the New Approach appropriate or when is conventional legislation more appropriate?
The distinction between the use of the New Approach and conventional legislation is very closely linked to the issue of delegation, and therefore of governance.
The "Report from the Commission to the Council and the European Parliament on actions taken following the resolutions on European Standardisation adopted by the Council and the Parliament in 1999"30 makes specific reference to the importance of governance and the focus on alternative forms of regulation and on democratic legitimacy.
The issue here is the delegation by New Approach Directives of the development of the technical requirements of legislation to private standards organisations. Much of the concern expressed in relation to ensuring a high level of protection for human health and the environment is related to the role of industry in the development of these standards. The role of industry in development of regulation is seen by some as problematic, by others as constructive cooperation with responsible partners committed to self-regulation. Industry is recognised as a stakeholder that can contribute much technical expertise. However, there is also a concern that other stakeholders, whose expertise is also valuable, such as NGOs, have only a marginal influence, and that therefore the result does not reflect a balanced societal solution. The issue of balanced representation is the topic of a Conference planned for 2002, and is not elaborated here.
There is widespread agreement that legislation to ensure high levels of protection for human health and the environment has to be fixed by conventional binding legislative instruments when there is
 | high risk and/or |
| high costs imposed by the regulation. |
Concerns related to the high risks that may be associated with the use of hazardous chemicals are already regulated by a considerable body of Community legislation which includes worker protection legislation, and controls on the use of certain chemicals.31
There is therefore already a clear recognition that the use of co-regulation is not appropriate for certain areas.32
Conventional legislation may also be needed in the case where the consequences of the legislation may significantly increase the costs borne by the producer of the product. It is a considerable demand to make of an industry that they agree internally measures that potentially undermine their own competitiveness.
In addition, there may be Community policy that sets limits on the degrees of freedom within certain areas, e.g., waste policy and the Commission White Paper on Chemicals Policy.33 In both the evaluation of human health and in particular the environment, there are often conflicting issues to be resolved at the same time. Whilst apparently technical in nature, these conflicting choices often require political choices to decide the weight to be put on the different concerns.34
It should be noted that even when conventional legislation is used, there may still be a need for the development of supplementary guidance, e.g., for test methods to verify fulfilment of concentration limits, release rates or other values contained in conventional legislation.
The Commission proposals for electrical and electronic equipment consist of three elements:
- A Directive intended to encourage environmental friendly design of these products (the so-called EEE Directive; a draft text has not yet been adopted by the Commission)
- A proposal for a Directive regulating the waste aspect of these products (the WEEE Directive; an amended proposal has been published35 following discussion in the Council and European Parliament), and
- A proposal for a Directive directly regulating certain hazardous chemicals as components of these products (the RoHS Directive; an amended proposal has been published36 following discussion in the Council and European Parliament).
This is an example of a group of proposals that distinguish between areas where conventional legislation is seen as necessary and where the New Approach is seen as appropriate.
Bans and other restrictions on the use of hazardous chemicals are normally regulated by conventional legislation for a number of reasons. Conventional legislation is considered more appropriate in situations where the potential risks are high, and where the industry concerned may face costs in substituting the chemicals concerned. In addition, chemicals, like a number of other product groups, were covered by a body of conventional legislation before the introduction of the New Approach, and where the introduction of this type of co-regulation was not considered appropriate. The proposal for the RoHS Directive is based on Article 95 (actions to establish the internal market), and is similar in nature to the conventional legislation (such as Directive 76/769/EEC) used for the control of hazardous chemicals.
The proposal for a Directive on Waste Electrical and Electronic Equipment (WEEE) is based on Article 175 of the Treaty (actions to achieve a high level of environmental protection). Since New Approach Directives are measures that are intended to ensure a harmonised internal market, this almost by definition means that the New Approach is not an appropriate model in this area. However, the different elements used in the New Approach (essential requirements, mandated standards, indirect adoption of standards) could perhaps be part of Directives based on other Articles of the Treaty than Article 95.37
The Commission has not yet agreed on a proposal for a New Approach Directive for the EEE product group, and therefore it is difficult to comment on this at the present time. However, much of the discussion up to now has focussed on essential requirements where conformity can be presumed by compliance with management standards38 rather than specific product standards. Whilst management standards may be the most appropriate basis for achieving the goals of a projected EEE Directive, it is not clear to what extent the basic aims of the Directive can be seen as "essential requirements" in the conventional sense. This issue is dealt with at more length in Session III of the Workshop.
Discussion points:
| Are there clear criteria that can be used to decide when conventional legislation is needed? |
| Is the need for conventional legislation related to specific policy concerns (e.g., control of hazardous chemicals) or is it related to the protection goals (environmental protection, concern for specific consumer groups)? |
| Is the group of proposed EEE regulations with specific requirements for hazardous chemicals covered by conventional legislation a model for future development? |
3.1.2 When the New Approach is appropriate, how can the different stages in the process be improved?
As indicated in the background document, difficulties have been experienced with the New Approach particularly with the Safety of Toys39 and Packaging Waste Directives40, where there are particular concerns for ensuring a high level of protection for human health (especially relating to long term exposure to e.g., chemicals and noise) and the environment.
The criticisms of these two New Approach Directives relate to several of the different elements of the New Approach process. There is concern that the approach is inherently unsuited to ensure a high level of environmental protection. Some critics suggest that the difficulties are due to a variety of causes. These include insufficient care in the formulation of the essential requirements, inadequacies in the formulation of mandates, insufficient control by the Commission of the development of standards, and the nature of the standardisation process itself. There is little or no consensus that the difficulties experienced are related to any one specific phase in the process.
Possible options for discussion with respect to the different elements in the process are shown below.
3.1.2.1 Essential requirements
Formulation of essential requirements is part of the work of drafting the relevant Directive. There is unlikely to be a common recipe for drafting these requirements, and the detail and technical complexity required may well vary from Directive to Directive. In general, the task of drafting good essential requirements is made easier when the product group under consideration is well defined and shares common elements that give rise to concern.
The argument has been put forward that the range of packaging falling within the scope of the Packaging and Packaging Waste Directive is too wide to be dealt with by product standards only. A more appropriate solution would be the development of management standards. However, this option is not possible in relation to the essential requirements as formulated in the Packaging and Packaging Waste Directive.
The task of drafting good essential requirements is also easier where the product group is intended to be used by industrial and professional users under limited, well defined conditions (as is the case for the Directives on Medical Devices41), rather than when the product group is used by a much wider target group including consumers and under many different conditions (as in the case of the Safety of Toys Directive).
It is difficult to suggest any general solution to the problems of formulating essential requirements. However, the importance of creating essential requirements which a) genuinely live up to the "stand alone" principle and b) can be supplemented appropriately by technical standards developed by others should be recognised in their preparation.
Discussion points:
| Are there special reasons why it is particularly difficult to formulate essential requirements for health and environmental concerns, as opposed to other safety requirements where few difficulties have been experienced? |
| If there are special reasons, do they invalidate the use of the New Approach for addressing these concerns? |
| Should essential requirements be formulated so that they can be supported as product standards, or is a formulation which can be supported by management standards also appropriate? |
| Is a mixture of product standards and management standards a possible solution? |
| Can the concepts reflected in management standards be included in a Directive as essential requirements in a way that ensures that they can stand alone and be enforceable? |
3.1.2.2 Mandates
The process of formulating mandates is currently under discussion by the Senior Official Groups on Standardisation and Conformity Assessment Policy (SOGS) Committee, and a report is currently being drafted by the Commission services.42
When comparing mandates, it is obvious that there are major differences in the way they are drafted. Certain mandates stipulate only that a number of standards are to be drafted in accordance with the Directive, e.g., the mandate for the standards for the mechanical and physical properties for toys. In other circumstances, the mandates are extremely specific, which was the case for the mandate for the revision of the toy standards.
The levels of detail of specification in the mandate have in some cases reached levels comparable with level of specifications in the actual standards. The reason for this high degree of specification is that the EC has had a particular need to achieve high and predetermined levels of safety. In some cases, the standardisation bodies have had their possibilities for creating their own interpretations of the essential requirements deliberately restricted by including a number of prerequisites in the mandate, which limited the freedom of the technical committees drafting the standards.
The standardisation organisations must submit a deliverable which fulfils the essential requirements and the specifications in the mandate. But mandates which form the basis for tendering a task of developing a standard do not in general live up to the levels of detail common in other calls for tender. By ensuring that the mandates contain an adequate level of detail, the EC has great opportunity to determine the content of the standards. This is always relevant, and in some cases necessary, especially where it has traditionally proved difficult to achieve consensus between the parties on what constitutes an adequate level of protection.
The mandates are in some instances elaborated by the EC only and in other cases through a joint effort between the EC and the standardisation bodies. A joint effort in drafting the wording of the mandate has often resulted in the standardisation work being accepted immediately, since requirements and expectations were harmonised in advance.
The mandates have rarely been the object of reviews and renegotiations. When considering the fact that standardisation procedures change, an ongoing or step-by-step evaluation of the standardisation work in relation to the mandate would be appropriate. This could result in the mandate being followed more closely or taken up for review and possible revision.
The New Approach specifies that mandates may be given to three European standards organisations. However, there are many examples in Community legislation of technical standards developed by other organisations. These include the development of food standards by the UN Codex Alimentarius, the development of a range of standards and test methods governing the transport of dangerous goods by the United Nations Committee of Experts on the Transport of Dangerous Goods (UN CETDG), and the development of test methods for assessing the effects of hazardous chemicals as well as management standards for their assessment (Good Laboratory Practice) by the OECD.43
Discussion points:
| Are the difficulties that have been seen related to problems in formulating and follow up of the mandates? |
| If so, what lessons can be learnt by the Commission, the Member States and the standardisation organisations? |
| Are there areas where development of standards should instead be mandated to governmental rather than private organisations (as is the practice in food regulation with the UN Codex Alimentarius)? |
3.1.2.3 Development of standards
The way in which the European standardisation organisations develop standards is not considered in this discussion paper. However, it is appropriate to discuss the role of the Commission in supervising the work, and the possible ways in which the process of standards development and compatibility with the essential requirements can be controlled.
Here, the Commission consultants whose job it is to follow the process play a key role.
It should be noted that Member States also have the possibility to participate directly in the Technical Committees developing the draft standards, and hence to influence the result. It is important that Member States participate actively – at least at national level which will ensure that the viewpoints from Member States are presented and taken into consideration at an early stage of the work. Member States should not wait to present their viewpoints when the standards have to be accepted or rejected as harmonised standards.
The participation of other stakeholders is a matter of some contention. Whilst consumer and trade union participation in these discussions is supported by Commission funding, no comparable support is at present available for environmental NGOs.
The role of the CEN Environmental Help Desk in the development of standards is largely voluntary. Its role in supporting the development of standards mandated under New Approach Directives might be considered.
The New Approach recognises the importance of including concerns in related areas of Community policy in the preparation of standards in support of essential requirements. The point has been made by environmental organisations that there may be a need for an environmental liability Directive to cover products, amendments to the Product Safety Directive44 to include an environmental chapter, and amendments to the Product Liability Directive to include environmental liability.45
Discussion points:
| Are the difficulties in setting standards to address health and environmental protection concerns related to problems in the way in which the mandate has been carried out? |
| If so, what lessons can be learnt by the Commission, the Member States and the standards organisations? |
| Is more participation and/or control by those directly associated with the parent New Approach legislation necessary? |
3.1.2.4 Adoption of standards
The present procedure for adoption of standards under the New Approach is by publication of the adopted standards as a Commission communication in the Official Journal. If Member States consider that these standards do not fully provide proof of conformity with the essential requirements, these concerns are discussed by the Committee established under the 98/34 Directive (safeguard clause).46 The Committees established under the specific Directive concerned have no direct responsibility either for the approval of or for addressing any possible problems with the standards developed under the New Approach. Clearly close cooperation between the 98/34 Committee and the relevant Committee for the particular Directive is essential at both Commission and Member State level. However, the possibility of a closer relation between the process for adoption of the standards and the relevant Committee under the Directive concerned might be considered.
Discussion points:
| Is this an appropriate way of adopting standards in all cases? |
| If not, is there a case for a more active adoption process, such as inclusion of standards in an Annex to the specific Directive following a Commission proposal to the relevant Committee established under that Directive? |
3.1.2.5 Feedback
Feedback of the effects and working of a Directive is essential for any efforts to assess the workings of a legislative instrument, and to provide a sound basis for its future improvement. This can be difficult in the best of circumstances. The development of the technical details in support of the essential requirements by a non-governmental organisation such as a standards organisation, taken in conjunction with a passive adoption process complicates the feedback process.
Discussion points: There are many possibilities for ensuring improved feedback, all of which have precedents in Community legislation:
| Is there a need to establish a forum where Member State representatives associated with the Directive can discuss the progress of the development of standards with the Commission consultant (if the Directive has provision for a Committee, this is the group that in an informal expert capacity would normally serve this function)? |
| Is there a need to establish a forum where the results of verification and compliance experience can influence the process, e.g., by enabling the consideration of possible revision of standards and / or essential requirements where necessary? |
| Is there a need to establish a forum where stakeholders can discuss experience with the workings of the Directive? |
| Is there a need to consider including in a New Approach Directive a requirement that the Commission prepare a formal report on the workings of the Directive, including the development of the relevant standards, at specified intervals? |
3.1.3 Can the main principles of the New Approach be applied in cases where Member States are allowed to go further in protecting their environment than the measures described in Community legislation?
One of the fundamental intentions with application of the New Approach is to ensure a harmonised internal market for products. This precludes, almost as a matter of definition, national variations of a permanent nature in implementation of these Directives.47
As the New Approach is primarily aimed at ensuring both a high level of protection for all citizens in EU and as high a degree of harmonisation of the internal market as can be obtained, proposals for New Approach Directives are based on Article 95 of the EC Treaty, and adopted according to the co-decision procedure provided for in Article 251 of the EC Treaty.
There are however other Treaty obligations. The European Commission "Guide to the Implementation of Directives based on the New Approach and the Global Approach" (2000) makes this clear: "New Approach Directives are generally designed to cover all hazards related to the public interest that the Directive intends to protect. Thus, compliance with Community legislation often requires simultaneous application of several New Approach Directives and, possibly, other Community legislation. This allows Member States to draw up national legislation in accordance with Articles 28 and 30 of the EC Treaty".48
However, the different elements of the process (drafting essential requirements, mandating standards, development of standards by outside organisations, publication of the relevant standards in the Official Journal) are not necessarily limited to product regulation. In theory, elements of the New Approach could be used when preparing proposals for Directives with a legal basis in other Articles of the Treaty than Article 95.
There is already a considerable body of environmental legislation based on Article 175 of the EC Treaty that makes extensive use of standards in support of this legislation. Whilst none of the Directives that these standards support are New Approach Directives, the process of development of these standards is in many ways very similar to the New Approach.
It should also be noted that the standards developed by ISO in support of much environmental legislation are in many cases very similar to or even identical to those developed by the OECD in support of chemicals legislation.
Discussion point:
| Are the elements of the New Approach appropriate when drafting non-product oriented legislation with a legal basis in other Articles of the Treaty, such as Article 175? |
3.2 Proceedings of Session II
Facilitator: Claus Jensen, Danish Agency for Trade and Industry.
3.2.1 Experience with the New Approach from an environmental point of view
John Hontelez, Secretary General, European Environmental Bureau (EEB)
The EEB has more than 14 million members in 27 countries. This year, the EEB initiated the European Environmental Citizens Organisation for Standardisation (ECOS), a coalition of a number of European and national NGOs. The EEB work on standardisation so far has had very limited funding. ECOS applied for funding from the Commission in August 2001.
European environmental policy is determined via complex interactions among many different actors. Much of this policy is prepared and decided in selective expert fora, without the participation of the European Parliament and with an imbalanced lack of participation of non-governmental organisations.
Whilst in theory voluntary, standards based on New Approach Directives have become legally binding in practice, and hence are a form of soft law. The standardisation organisations rely on industry input, and hence it is not possible to expect that these organisations are able to resolve the environmental issues involved.
An important tool to strengthen environmental considerations would be a framework Directive on environmental requirements for products, similar to the Product Safety Directive. These requirements should then be specified in each New Approach Directive. Moreover, these changes should be complemented by improvements in the standardisation process including an ongoing evaluation of standards, and a requirement that standards should be explicitly approved, the participation of environmental NGOs made possible, and minority opinions made public.
Problems have been seen with standards for heating appliances, construction materials and the Packaging and Packing Waste Directive. The essential requirements of the latter are framed in very general terms, and the targets are weak from an environmentalist viewpoint.
The EEB is unable to support the use of the New Approach in the environmental field without major changes, and it calls on the EU institutions to ensure that the New Approach is transformed so that it safeguards and promotes environmental interests.
3.2.2 The New Approach: Can it ensure a high level of protection for the environment and human health?
Helge Andreasen, Deputy Director General, Danish Environmental Protection Agency
The New Approach Directives work well in addressing concerns for safety, in part because industry has a substantial interest in complying with the requirements.
For health effects, it is technically complicated to establish precise requirements. It is also difficult to establish essential requirements which ensure a high level of protection precisely, unambiguously and exhaustively. For example, the essential requirements in the present Toys Directive are far from exhaustive.
It is difficult to draft criteria for establishing limit values for hazardous chemicals. Use of the Precautionary Principle as agreed in the Treaty of Nice has to be made at a political level and not at the level of standardisation Technical Committees.
Environmental impact is a multidimensional parameter, making the link between the specific product and effects on the environment difficult to establish. Agreeing on the level of a minimum risk is often complicated. Drafting of essential requirements must therefore include the way certain types of environmental impacts are measured and weighed against each other, since these decisions are political in nature rather than purely technical.
The essential requirements of the Packaging and Packaging Waste Directive were worded in very general terms, and this was in contradiction to the conditions for essential requirements set out in the 1985 Council Resolution on the New Approach. These uncertainties were reflected in the Council Common Position of 4 March 1994, which states "The Council found that most of the essential requirements to be laid down for the manufacture and composition of packaging could only be very general; at this stage, when there were very few standards and criteria and very little experience available for most kinds of packaging."
The Commission’s working paper for an EEE Directive puts forward a number of ideas that are problematic, but nonetheless would form a useful basis for further work in this area. In particular, tools like eco-labelling, EMAS and Green Procurement need to be included.
In conclusion, New Approach Directives are not well suited to ensure high levels of protection for human health or the environment, and this approach cannot act as a substitute for environmental Directives.
3.2.3 Panel on experience with the New Approach
Facilitator: Claus Jensen, Danish Agency for Trade and Industry
3.2.3.1 Experience with the the Toys Directive
Aage S. Hillersborg, LEGO, Chairman of CEN Committee on Toys
The New Approach has been a proven success with regard to the Toys Directive. Thousands of new toys are put on the European market annually, and the presumption of conformity for almost all of these is based on the harmonised standards rather than by direct proof of conformity with the essential requirements.
When a number of specific benefits and difficulties in the process are considered, a more generic approach including management standards has to be considered in the future. One possibility is a wider international context for the standards.
Clear political directions should be established for environmental aspects in advance, if standardisation is to remain a technical process. The changing focus with increasing demand for the integration of new elements sets challenges for both legislators and standardisers.
3.2.3.2 Experience with the Medical Devices Directive
Peter Thompson, CEN consultant on medical devices
In the development of standards in support of the Medical Devices Directives, the Technical Committees developed checklists making it possible to establish clearly the links between the essential requirements and the relevant sections of the different standards, thus ensuring a transparent method to ensure that the presumption of conformity is clearly demonstrable.
The sector was also one of the first to respond to the general CEN call to produce their own environmental guidance documents, to ensure a proper consideration of environmental concerns in the standards.
3.2.3.3 Experience with the New Approach from a consumer’s point of view
Franz Fiala, Vice President, ANEC
The New Approach has contributed to consumer protection. However, both the first Workshop session and the recent Commission publications on the New Approach were unduly positive, ignoring negative aspects.
An example of the difficulties of addressing health-related problems via standardisation is the question of noise levels for cap pistols which has been discussed for over 10 years, without progress.
Closer monitoring of the workings of the Directives and associated standards is needed. There should be better possibilities for NGOs to take an active part in the process, as well as the need for a more active role for Regulatory Committees. The preparation of mandates should be discussed with a wide range of stakeholders. Failure to produce standards of sufficient quality should lead to the Commission withholding payment from the standards-setting bodies for the mandated work. The safeguard clause is inadequate. In the example of the standards related to emissions from heating appliances quoted by Mr. Hontelez, the resulting standards were set with requirements that enabled all existing apparatus to comply.
3.2.3.4 Standardisation in other forums49
Herman Köeter, OECD
There are similarities between the process of developing OECD Technical Guidance documents for chemicals testing and the development of standards in the European standardisation organisations. There are also international agreements on the mutual acceptance of data obtained in accordance with the procedures set forth in these documents, and management standards (Good Laboratory Practice) to ensure conformity with these procedures.
The instruments used by the OECD to develop these internationally recognised procedures can be a part of the discussions concerning the New Approach with respect to health and environment-related standards.
3.2.4 Discussion
The discussion was at times heated with strong views expressed by both critics and supporters of the New Approach. Some of the panel contributions were interrupted by comments from the floor, and the differences in opinion were also reflected in the discussions that followed the plenary presentations.
Supporters of the New Approach felt that the many indirect positive aspects had been under-estimated by NGO representatives (ANEC and EEB). Development of standards led to improvements in many aspects of the process including material reuse. Active involvement of industry in the process led to a greater recognition of the importance of safety, health and environmental considerations. As regards the example of difficulties with setting noise levels for cap pistols, given the very wide range of potential problems associated with the very large numbers of different toys, this example could be used to argue the relative lack of problems in this area.
The argument put forward most strongly by the environmental NGOs reflected the relative weakness of environmental arguments compared to health and safety issues, due to the lack of formal legislation in this area. There is a greater understanding from industry for the importance of the health and safety aspects as there is framework legislation addressing these issues but not for environmental concerns.
There was a general recognition of the central importance of the drafting of the essential requirements. The question of setting essential requirements that required impacts to be "as low as possible" almost inevitably presupposes the development of standards to define these levels more precisely.
It was pointed out that whilst it was important that political difficulties be resolved before mandating the development of standards, the safety issues now seen as unproblematic were once considered highly contentious.
3.2.5 Presentation on options for consideration
Christian Fischer, Head of Household Waste Division, Danish Environmental Protection Agency, presented the topics for discussion in the breakout sessions, based on the Discussion document prepared in advance (see Section 3.1).
Groups I and II were asked to discuss the following two questions:
| When is the use of the New Approach appropriate and when is Conventional Legislation more appropriate? |
| Can the main principles of the New Approach be applied in cases where Member States are allowed to go further in protecting their environment than the measures described in Community legislation? |
Groups III and IV were asked to discuss questions related to the following issue:
| When the New Approach is appropriate, how can the different stages in the process be improved? |
3.2.6 Plenary gathering, report-backs & discussion
The rapporteurs from Groups I (Birgitte Jørgensen Kjær, Danish Environmental Protection Agency, Household Waste Division) and II (Steve Andrews, UK Department of Trade and Industry) presented the conclusions of the first two breakout groups. The conclusions of the two groups were very similar.
It was clearly recognised that both New Approach and more conventional legislation are related, in that both are legislation designed to achieve clear political goals.
Use of New Approach legislation is seen as appropriate when
| the environmental aspects are clearly linked to the interest of the producer; |
| the essential requirements can be clearly drafted; and |
| the products covered by the legislation form homogenous groups. |
Use of conventional legislation (rather than New Approach legislation) is seen as appropriate when
| the issues are political; |
| the long term aspects are unclear (e.g., climate change); |
| there is no short-term interest for the producer. |
Standardisation is seen as having advantages in situations where technological improvements occur rapidly. Conventional (command-and-control) legislation is seen as preferable for control of hazardous chemicals (bans, setting limits).
There was a general feeling that a discussion of whether the main principles of the New Approach should be applied in cases where Member States are allowed to go further in protecting their environment than the measures described in Community legislation was not relevant at the present time.
The rapporteurs from Groups III (Joakim Skottheim, Electrolux) and IV (David Perchard, Perchards) presented the conclusions of the second two breakout groups. The conclusions of the two groups were again similar and are combined below.
The main concerns discussed were related to drafting of the essential requirements.
| Separating the political and technical issues is difficult and needs to be guided, perhaps by including the relevant Regulatory Committee at an early stage in the discussions. Failure to draft clear essential requirements is not limited to the Packaging and Packaging Waste Directives. |
| Drafting essential requirements for the environment is complicated by the fact that there is no tool for comparing different environmental aspects that is generally accepted by all stakeholders. Evaluating environmental impact is complex and more experience is needed. |
| There are concerns that safety aspects will be emphasised at the expense of environmental issues. |
| There are arguments in favour of a wider use of management standards to ensure a general conformity that can later be supplemented by more detailed standards addressing specific problems. If this approach is considered appropriate, then the drafting of the essential requirements must reflect this intention. |
Specific comments to the Commission’s working paper on EEE included suggestions to
| focus the Directive on key product groups; |
| clarify how management systems could encourage the manufacturer to consider environmental aspects in the design phase; |
| recognise the importance of life cycle thinking; and |
| emphasise the need for market surveillance and feedback to check and improve products. |
| 30 | COM(2001)527 final. Brussels, 26.09.2001. See also the
Commission’s White Paper on Governance: COM(2001)428 final of 25.7.2001. OJ C 287,
12.10.2001, pp 1 – 29. |
| 31 | An example is Directive 76/769/EEC, which includes amendments
that ban the sale of carcinogens, mutagens and reproductive toxins to the general public. |
| 32 | The Danish Minister of Trade and Industry and Minister of
Environment and Energy have recently written jointly to the European Commission concerning
the revision of the Safety of Toys Directive indicating that they recommend use of
positive/negative lists directly in the Directive. |
| 33 | White Paper for a future chemicals policy. COM(2001)88 final.
Brussels, 27.2.2001. |
| 34 | Annex II of Appendix A of this report gives examples of
conventional chemicals legislation, which nevertheless include many aspects of New
Approach legislation. |
| 35 | Amended proposal for a Directive of the European Parliament
and of the Council on waste electrical and electronic equipment. COM(2001) 315 final. OJ C
240 E, 28.8.2001, p. 298 |
| 36 | Amended proposal for a Directive of the European Parliament
and of the Council on the restriction on the use of certain hazardous substances in
electrical and electronic equipment. COM(2001) 316 final. OJ C 240 E, 28.8.2001, p. 303. |
| 37 | For a further discussion of this point, see section 2.1.3. |
| 38 | For a further discussion of management standards, see section
3.1. |
| 39 | Council Directive 88/378/EEC on the approximation of the laws
of the Member States concerning the safety of toys, OJ No L 187/1, 6.7.1988, pp. 1-13. |
| 40 | European Parliament and Council Directive 94/62/EC on
Packaging and Packaging Waste. OJ L 365, 31.12.1994, pp. 10 – 23. |
| 41 | Council Directive 93/42/EEC concerning Medical Devices. OJ L
169, 12.7.93, pp. 1-43. |
| 42 | Claus Jensen, Danish Agency for Trade and Industry. Personal
communication. |
| 43 | See example of standardisation in Council Directive
67/548/EEC in Annex IV of Appendix A of this report. |
| 44 | Council Directive 92/59/EEC on General Product Safety . OJ L
228, 11.8.92, pp.24-32. |
| 45 | Karola Taschner, EEB, at EEB Workshop on standardisation,
28.09.2001. |
| 46 | European Parliament and Council Directive 98/34/EC laying
down a procedure for the provision of information in the field of technical standards and
regulations. OJ L 204, 21.7.98, pp. 37-48. |
| 47 | Austria has carried out research on the relationship between
its national standards for chemicals and the New Approach standards developed for Council
Directive 89/106/EEC on the approximation of laws, regulations and administrative
provisions of the Member States relating to construction products. OJ L 40, 11.2.98, pp.
12 –26. This study was aimed at considering whether it is possible to retain national
legislation within the context of the New Approach Directive. Mr Martin Buchele, Federal
Environmental Agency of Austria, personal communication. |
| 48 | European Commission (2000): "Guide to the Implementation
of Directives based on the New Approach and the Global Approach", available at
http://europa.eu.int/comm/enterprise/newapproach /newapproach.htm. |
| 49 | See also Appendix B of this report. |