One example are the standards for heating appliances. These appeared to be violating national legislation from Austria and Germany with regards to NOx, CO2 and volatile organic compounds for several appliances up. Acceptance levels of the standards exceed these national laws with between 100% and 900%. While they may not have violated law in other countries, nor the EU regulations, it shows clearly that the EU standards are not at all state-of-theart or with a particular environmental ambition.

Another example are the standards on construction materials, where we are concerned in particular about the tolerance towards hazardous substances.

But the case we have been engaged in most is, paradoxically, the standards developed for the only New Approach Directive with an environmental origin, the Packaging Directive. Here we clearly see the weakness of the system:

	The Directive's does have essential environmental requirements, but they are formulated in VERY general terms. Furthermore the targets of the Directive are weak seen from an environmentalist point of view.
	Despite this, the adopted standards still do not fulfil the essential requirements.
	The minority groups in the standardisation committees didn't have any possibility to influence the process. The minority groups were in this case, not only the environment movement, but also the Danish Government and the Danish Standards Association.
	On various occasions the Commission showed its strong discontent with the standards and informed CEN that the draft standards did not comply with the mandate. CEN didn't change anything!

Currently, there is discussion to rely on CEN to assist in the implementation of the Electric and Electronic Equipment Directive, in particular to set standards for management systems. It is essential that the mistakes of the Packaging Directive won't be repeated.

Attempts to find solutions

The Environmental Help Desk and Environmental guidelines are two attempts from the standardisation bodies to try to integrate environmental concerns. Both are instruments developed inside the standardisation system, and they do not have to live up to the requirements of the European Treaty or European Institutions, neither do their have the possibility to change the fundament of the system.

The initiatives of the standardisation bodies can not replace the political responsibility, and therefore the main focus has to be on changing the method in a way that raises the political influence on the process and thereby make politicians and public authorities accountable again.

To conclude:

The EEB can not support use of the New Approach in the environmental field without some major changes. We call on the EU Institutions to ensure that the New Approach is transformed into a one that safeguards and promotes environmental interests.

Cen at work:
How the requirements of the european packaging and packaging waste directive (94/62) are bypassed by cen standards

(September 2000)
A legal analysis for The European Environmental Bureau (EEB) by Susanna Paleari

EEB Publication 2000/15

Environmental organisations throughout the EU play a rich and important role in protecting and sustaining Europe's environment. We are responsible for representing public opinion and galvanising support for better environmental protection. We also deliver a huge amount of environmental protection - whether directly, as managers of land and buildings, or indirectly, through paid and voluntary work for the environment of all kinds. We are proud of our work and achievements, and see ourselves as partners in the search for more sustainable lifestyles and better environmental policies.

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Index

Foreword

1 A short history: the preparation of the EC Directive 94/62

2 The contents of the Directive

3 The Mandate of the Commission to CEN

4 The organisation of the work on packaging and packaging waste standards in CEN

5 Analysis of two non-mandated standards: EN 13193, concerning terminology and EN 13427, the so-called "umbrella standard"

7 Conclusion

Foreword

The present paper analyses the implementation of the European Packaging and Packaging Waste Directive (94/62/EC) through five standards elaborated by the European Committee for Standardisation (CEN):

	EN 13428 "Requirements on prevention by "source reduction",
	prEN 13429 "Packaging suitable for reuse",
	EN 13430 "Requirements on packaging recoverable by material recycling",
	EN 13431 "Requirements on packaging recoverable in the form of energy recovery",
	EN 13432 "Requirements on packaging recoverable through composting and biodegradation".

It also considers two standards, EN 13193 - on terminology - and the socalled "umbrella standard" EN 13427, which are frequently mentioned by all mandated standards, although they were not the subject of a mandate from the Commission.

This analysis, prepared by Susanna Paleari, of the EEB, concludes that the standards mentioned are not consistent with the general requirements of the Directive. Consequently, the mandate conferred by the Commission to CEN was not properly implemented.

In fact, CEN did not seem to take the legal requirements of the Directive seriously and chose a different approach. Instead of the expected thresholds and quantitative criteria, CEN opted for a management system approach, which, along with the flexible and generic criteria provided for in the standards, cannot guarantee that packaging to be placed on the market complies with the essential requirements of the Directive.

Moreover, CEN has consistently ignored and bypassed the critical comments made by environmental NGOs, (whose involvement in the standardisation process was clearly required by the Commission mandate), DG Environment and other participants in this process. The same criticism applies to the comments on CEN standards drawn up by the Waste Management Unit of the Directorate-General for the Environment (DG ENVE.3).

These standards therefore have to be rejected. They should not be granted official approval by being published in the Official Journal. Official approval would set a disastrous precedent, with democratically legitimated institutions conferring a mandate for implementation to a private body, which then reshapes it according to its personal preferences. This would encourage CEN, and hence industry, to ignore and bypass environmental legislation and write out its own in the future. This would raise a question about environmental governance in Europe: is it governed by politics or by business? The EEB is convinced that politics should have the last word, even if tasks are assigned to private bodies.

CEN could have refused to work on the mandate, if it felt it impossible to implement, instead of which it opted for an independent reinterpretation of its tasks. By so doing, CEN has gone beyond the terms of reference and hence beyond its rights.

The failure of CEN to deliver what is required by the Packaging Directive implies additional tasks for the forthcoming revision of the Directive itself. We believe that safeguards need to be introduced to avoid a repetition of the CEN failure, which has caused considerable delay in implementing the Packaging Directive. A major change of approach in implementing its essential requirements is therefore needed.

Dr. Christian Hey, EU Policy Director, EEB

1 A short history: the preparation of the EC Directive 94/62

In 1990, the Directorate General of the Environment elaborated a first Outline Proposal, in order to draft a Directive addressing all packaging wastes, which focused on three basic measures:

The first internal draft of the Directive retained the main requirements of the Outline, adding some auxiliary obligations, but it was rejected by the chefs de cabinets, a steering body immediately below the colleague of Commissioners. In the following years three other internal drafts were elaborated, introducing important changes, even if, during the political decision making process, the ambitious recycling goals proposed by the Commission were defeated by the countries with a low standard in the sector. As a consequence, the Council fixed the requirement to recover to 50% of the packaging waste and the target to recycling to 25% of the total amount and to only 15% of each material. This target was further weakened by a temporary exemption for some low standard countries (Greece, Ireland and Portugal). Here we have to note that the definition of recovery includes energy recovery and recycling, while recycling can be defined as the reprocessing in a production process of the waste materials for the original purposes including organic recycling but excluding energy recovery.

The Council added to the mentioned minimum goals a cap, limiting recovery at a maximum of 65% and recycling at 45% of the total amount of packaging waste, aimed at regulating the faculty of the member states to go beyond the harmonised standards.

2 The contents of the Directive

The European Packaging and Packaging Waste Directive (94/62/EC), adopted under Art. 100A of the Treaty, is aimed at preventing or reducing the environmental impact of packaging, ensuring at the same time the functioning of the internal market (Art. 1). It applies to all packaging placed on the market in the Community and all packaging waste, as defined by Art. 3 par. 1 and 2.

The Directive lays down provisions for, "…as first priority, prevention of packaging waste and, as additional fundamental principles, reuse of packaging, recycling and other forms of recovering packaging waste and, hence, reduction of the final disposal of such waste". In particular the member states are required to take such measures that could be necessary: to prevent the formation of packaging waste and to promote other preventive actions; (Art. 4 and 9)

to attain the recovering and recycling targets established by Art. 6, (while particularly relaxed targets have been decided with reference to Greece, Ireland and Portugal, because of their specific situation);

to ensure the creation of return, collection and recovery systems (Art. 7);

to limit the presence and the concentration in packaging of noxious and hazardous substances, including four heavy metals, (cadmium, mercury, lead and hexavalent chromium), (Art. 11).

Besides, Art. 9 and Annex II of the Directive set out essential requirements for packaging standards. The principles underlying the essential requirements are that:

packaging weight and volume should be minimised to the amount needed for safety and for acceptance of the packed product;

noxious and other hazardous constituents of packaging should have minimum impact on the environment when the packaging reaches its end of life;

packaging should be suitable for material recycling, energy recovery or composting, or for reuse if reuse is claimed.

Member states shall ensure that three years from the date of the entry into force of the Directive, packaging may be placed on the market only if it complies with all essential requirements defined by the Directive itself, including Annex II (Art. 9).

Art. 15 authorises member states to introduce national economic instruments (taxes or levies) to achieve the Directive's objectives, provided any such instruments are consistent with the Treaty, i.e. provided they do not create barriers to trade.

3 The Mandate of the Commission to CEN

Although the Directive introduces important requirements, it doesn't tell how packaging producers and importers can demonstrate compliance with these requirements. In other words, it doesn't say anything about how to design and specify packaging which will meet these legal obligations. Consequently, the Commission charged CEN with the following Mandate (M 200 Rev. 3):

The Commission requests CEN to draw up standards for packaging and packaging waste useful for the application of the Directive, covering all environmental aspects of all kinds of packaging and packaging materials and reflecting the objectives of the Directive, i.e. to prevent waste of packaging and to promote reuse of packaging and recovery, including recycling, of packaging waste.

Apart from this Mandate and some informal experts advices, no other guidance or constraints were available to CEN because national standards on the subject were nonexistent.

According to this Mandate, three groups of standards are to be developed: standards intended to give presumption of conformity with the essential requirements of the Directive (Art 9, Annex II); standards in support of the environmental objectives of the Directive;

reports on particular areas, including where appropriate proposal for the elaboration of further standards in such areas.

In the context of standards permitting presumption of conformity with the Directive, the following standards are to be prepared:

	(EN 13428) Requirements on prevention by source reduction;
	(prEN 13429) Packaging suitable for reuse;
	(EN 13430) Requirements on packaging recoverable by material recycling;
	(EN 13431) Requirements on packaging recoverable in the form of energy recovery;
	(EN 13432) Requirements on packaging recoverable through composting and biodegradation.

All these standards were adopted by CEN in April 2000, except for the one concerning reuse (prEN 13429), which is currently being prepared for final vote. Beside these, CEN elaborated two non-mandated standards: the so called "umbrella guidance document" (EN 13427) which is a horizontal standard that should show the links among the different mandated standards and the standard concerning terminology (EN13193).

The Mandate requires the preparation of the standards to be carried out in association with industrial and commercial organisations, particularly in the field of packaging and waste management; with regulatory bodies; with representatives of consumers groups and with environmental and scientific organisations.

4 The organisation of the work on packaging and packaging waste standards in CEN

Members of the European standards institutes (CEN/CENELEC) are the respective national standardisation institutes, which are predominantly constituted from national industry and industry associations, even if in some countries there are various models for the participation of public interests and in fewer countries (Germany, France, Denmark and Finland) also for the occasional or regular participation of environmental groups. Standardisation is dominated by the principle of territorial representation, according to which, each national standardisation institute only represents at European level positions agreed nationally. As a consequence, even if environmental groups have participated at national level, their voice is filtered at European level by national consensus. Besides, environmental organisations can participate in CEN work as observers, but, in this case, they have not the right to vote.

The European Standardisation Committee for Packaging (CEN/TC261), created in 1990, has the purpose of preparing standards on terminology, dimensions, capacities, labelling, test methods and functional and performance requirements related to packaging and loading units. Each member state can participate in each Technical Committee with a delegation of three persons, which has one vote and is thus expected to represent national interests.

The standardisation work is organised in four pillars managed by Subcommittees (SC's), even if TC 261 retains full responsibility for the activity of these SC's. In particular, SC4 was charged to develop the standards related to the Packaging and Packaging Waste Directive.

In principle, TC's shall operate through Working Groups (WG's), in order to prepare the individual standards. WG's usually consist of people with detailed technical knowledge and shall work in consensus. If it is not possible to come to a consensus, the discussion and the vote shall take place at the SC or at the TC level. The task of drafting the mandated standards was given to 5 WG's dealing with:

WG1: Terminology, symbols and criteria for life cycle analysis of packaging (three mandated reports);

WG2: Degradability of packaging and packaging materials (five mandated standards);

WG3: Material recovery (three mandated standards);

WG4: Energy recovery (one mandated standard);

WG6: Prevention (one mandated standard).

The convenors of these groups participate in a WG drafting a nonmandated umbrella standard, intended as a user's guide to the set of CEN packaging standards. A joint WG, comprising members from SC2, SC3 and SC4, working on requirements for relevant materials and types of reusable packaging has also been established (one mandated standard).

In April 2000, at the TC level,

EN 13427 and EN 13428 were adopted by a 88% weighted majority with Austria, Denmark and Ireland voting against and Belgium abstaining;

EN 13430 was adopted by a 92% majority with Denmark and Ireland against and Belgium abstaining.

EN 13431 was adopted by a 96% majority with Denmark rejecting and Switzerland abstaining;

EN 13432 was adopted by 100 % of expressed votes, (the Czech Republic and Greece did not vote).

Besides that, a series of supporting standards were prepared, as well as reports on "heavy metals and other dangerous substances present in packaging" and on "requirements for substances and materials to prevent a sustained impediment to recycling".

To become harmonised, CEN mandated standards have: 1) to be adopted through a voting procedure by national standards organisations and 2) to be published in the Official Journal of the European Communities, the act which confers on them the status of EU Harmonised Standards. If mandated standards do not satisfy the basic requirements, the Commission can refuse publication in the mentioned Journal. However, we have to observe that, in the past, the usual practise was that all mandated standards were published without further control. From the moment of their publication, all packaging that complies with the standards will be deemed to be in conformity with the essential requirements of the Packaging Directive and will be guaranteed free circulation throughout the European Union.

5 Analysis of two non-mandated standards: EN 13193, concerning terminology and EN 13427, the so-called "umbrella standard"

In April 2000, two non-mandated standards were adopted by CEN: EN 13193, concerning terminology, and EN 13427, the so-called "umbrella standard". Mandate 200 Rev. 3 neither mandates these standards nor allows for implicit mandates. All the five mandated standards contain references to these two non-mandated ones.

EN 13193 "defines terms used in the field of Packaging and the Environment" (par. 1 "Scope"), with the aim "to provide a comprehensive glossary which uses the applicable Directive's definitions providing when appropriate additional notes to make these definitions understandable without reference to other documents", ("Introduction"). The terms are divided into three clauses: - clause 3 refers to terms which are specifically related to packaging and the environment; - clause 4 refers to terms relating to degradability and - clause 5 refers to terms relating to energy recovery.

EN 13427 "specifies requirements and a procedure by which a person or organisation responsible for placing packaging or packed product on the market (the supplier) may combine the application of five (mandated) packaging standards and one (mandated) CEN report (in two parts)", (par. 1 "Scope"). In other words, the "umbrella standard" should represent an instrument in order to co-ordinate the application of the five mandatedstandards.

As we have already said, the non-mandated standards, which are not published in the Official Journal of the European Communities, cannot be considered harmonised. Consequently, the references of the mandated standards to EN 13193 and to EN 13427 prevent them to be considered as harmonised standards too. An advisable solution to face this problem would be to delete these non-mandated standards, shifting their contents into the mandated ones.

Moreover we have to notice that the non-mandated standards are characterised by some substantial inconsistencies with the Directive 94/62. With this respect, our comments concern especially the incorrect use of various terms and expressions by both EN 13193 and EN 13427. In fact the non-mandated standards do not take into account some terms and expressions defined by the Directive, replacing them with other ones. As the latter have not exactly the same meaning of the former, there are concrete risks of a misunderstanding or of a narrow interpretation of the Directive. Consequently, in order to avoid all these problems, if the Directive contains and defines some terms and expressions, the same should be used in the standards too.

1) EN 13193, as well as EN 13427, defines the "packaging component" as a "part of packaging that can be separated by hand or by using simple physical means" (see respectively par. 3.1.1 and par. 3.2). This concept is linked to the one of "packaging constituent", defined by EN 13193 par. 3.1.2 as following: "part from which packaging or its components are made and which cannot be separated by hand or by using simple physical means". EN 13427 specifies that "the smallest part of a packaging considered in this standard is a component. Usually a number of components will be brought together to form a functional unit of packaging and these may in turn be brought together in a complete packaging system which could comprise primary, secondary and tertiary packaging". The Directive 94/62 speaks only about "primary, secondary and tertiary packaging" and doesn't refer to "packaging component", except for Art. 11 which concerns the "Concentration of heavy metals present in packaging". Therefore, the latter expression has to be deleted and the former, that is the only correct and legal one, to be introduced in the standard.

2) EN 13193 defines the "used packaging" as "packaging or packaging component remaining after the removal of the product it contained, protected or carried" (par. 3.3.3). Also this expression, that we find in all the mandated standards, is unknown to the Directive 94/62, which instead speaks about "packaging waste", that is the only correct and legal term. In particular, we want to underline that the Directive is going to be undermined by resorting to the expression "used packaging" for two main reasons:

the calculation of the recycling and recovery rates could be highly manipulated;

in most member states the waste is under strict control by law, while used packaging not, as it is a matter of industrial raw material, (hence out of official control).

3) EN 13427 in Annex Z speaks about par. 9 and 11 of the Directive 94/62, instead of using the correct term "Articles", which should be introduced.

4) EN 13427, contrary to all other standards, (mandated or not), has no bibliography. It would be of advantage to introduce it.

6 Analysis of the mandated standards intended to give presumption of conformity with the essential requirements of the Directive

6.1 Introduction

The following paragraphs contain an analysis of the "mandated standards intended to give presumption of conformity with the essential requirements of the Directive 94/62". This analysis focuses on the comparison between the mentioned standards, elaborated by CEN, and the Mandate and the Directive, prepared within the EC.

Here we want to make some general considerations, which will be then closely examined. All the standards, (EN 13428, prEN 13429, EN 13430, EN 13431 and EN 13432), are based on a self-assessment system similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series.

Neither the Directive, nor the Mandate, (which, more in general, speaks about "assessment"), specifically provide for this kind of approach. However, the main problem, as far as the implementation of the Mandate and the Directive is concerned, is related to the character of the standards. In fact, directives are juridical acts that on the one hand bind to determinate results and, on the other hand, give freedom to choose the instruments in order to achieve such results. The self-assessment systems, lined out by CEN standards, are instruments too generic and too flexible to guarantee that the essential requirements of the Directive are fulfilled. They are founded on concepts and expressions often defined in a very evasive way or, sometimes, not defined at all. Besides, as we have already said, most of these terms are defined by a nonmandated standard, (EN 13193), as well as the co-ordination and the application of these standards is specified by a non-mandated standard (EN 13427). As these non-mandated standards will not be published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and have not force in law, these references prevent the mandated-standard to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

6.2 Procedural inconsistencies common to the five mandated standards

The Mandate of the Commission establishes that "The preparation of the standards shall be carried out in association with industrial and commercial organisations, particularly in the field of packaging and waste management; with regulatory bodies; with representatives of consumer groups and with environmental and scientific organisations".

This means that the Mandate requires environmental organisations to take part, ("in association with"), in the standardisation process at European level. However we have to notice that:

- environmental organisations have participated directly in the standardisation process via national delegations only in the case of Germany, thanks to governmental financing;

- environmental organisations have participated directly in the standardisation process as observers, (i.e. without the right to vote), only for short periods, because of the lack of funds. In particular, as long as the standardisation process within CEN is not streamlined, the participation of the environmental NGO's will always be difficult. For example, the work on standard 13430 started in summer 1991, took 10 years to be finished and brought a result which is really of little use for the implementation of the Directive 94/62. Hence the real problem is that CEN often wastes time and money and this situation represents a clear strategy of industrial actors in order to keep environmental NGO's away from the standardisation process.

We can conclude that the Mandate hasn't been fulfilled.

6.3 EN 13428 Requirements on the prevention by source reduction

Substantial inconsistencies, lack of provisions, generic provisions and advisable improvements

1) EN 13428 contains several references to two non mandated-standards, that is to say to EN 13427 and EN 13193, (see "foreword", "introduction", "scope", "normative references", "terms and definition", "terms and definitions-supplier", "requirements-application"). As a nonmandated standard is not published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and hasn't force in law, these references prevent EN 13428 to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

2) EN 13428 focuses only on source reduction, without containing any reference to the other wider and more environmentally beneficial meanings of the term "prevention", as defined by the Directive 94/62.

This omission is clearly in contrast with the Mandate which, although it declares that "a standard is necessary to set criteria for the assessment and measurement of source reduction", speaks more in general about the prevention of packaging and packaging waste. In fact it states that: "the standard containing the requirements regarding prevention shall be in line with articles 1, 3 par. 4, 4 and 9 and Annex II par. 1 indents 1, 2 and 3 of the Directive. Prevention of packaging waste and any impact thereof on the environment are key objectives of the Directive ...".

The Directive 94/62, as we have already told, defines a concept of prevention that includes measures and actions that do not consist only of source reduction. Thus, Art. 3 par. 4 states that "prevention shall mean the reduction of the quantity and of the harmfulness for the environment of: - materials and substances contained in packaging and packaging waste, - packaging and packaging waste at production process level and at the marketing, distribution, utilisation and elimination stages, in particular by developing clean products and technology". Art. 4 par. 1 states that "Member States shall ensure that, in addition to the measures to prevent the formation of packaging waste taken in accordance with Art. 9, other preventive measures are implemented. Such other measures may consist of national programmes or similar actions adopted, if appropriate, in consultation with economic operators, and designed to collect and take advantage of the many initiatives taken within Member States as regards prevention. They shall comply with the objectives of this Directive as defined in Art. 1".

We can conclude that the Mandate and the Directive have not been fulfilled.

3) The Mandate states that "the assessment and measurement is necessary to put the packaging on the market and to be in accordance with the essential requirements of the Directive 94/62".

The standard prepared by CEN reduces the scope of the Mandate as it provides just for "a procedure for assessment of packaging", (par. 1), without any mention of measurement, and, consequently, it cannot assure that packaging on the market is in accordance with the essential requirements of the Directive.

4) The definition of "prevention" in Article 3 par. 4 of the Directive 94/62 states that "prevention shall mean the reduction of the quantity and the harmfulness for the environment of:

	materials and substances contained in packaging and packaging waste,
	packaging and packaging waste at the production process level and at the marketing, distribution, utilisation and elimination stages, in particular by developing clean products and technology".

Besides that, Annex II point 1 of the Directive, "Requirements specific to the manufacturing and composition of packaging" states that:

- Packaging shall be so manufactured that the packaging volume and weight be limited to the minimum adequate amount to maintain the necessary level of safety, hygiene and acceptance for the packed product and for the consumer.

- Packaging shall be designed, produced and commercialised in such a way as to permit its reuse or recovery, including recycling and to minimise its impact on the environment when packaging waste or residues from packaging waste management operations are disposed of.

- Packaging shall be so manufactured that the presence of noxious and other hazardous substances and materials as constituents of the packaging material or of any of the packaging components is minimised with regard to their presence in emissions, ash or leachate when packaging or residues from management operations or packaging waste are incinerated or landfilled.

Prevention by source reduction is defined by EN 13428 par. 3.1 as follows: "process for the achievement of a minimum adequate weight and/or volume for identical requirements, of primary, secondary and/or tertiary packaging, when performance and user acceptability remain unchanged and/or adequate, thereby minimising the impact on the environment".

The Directive, (Art. 3 par. 4), refers the word "reduction" to qualitative (decreasing the harmfulness) and quantitative (diminishing of quantity) aspects. Instead, there is evidence of the fact that the meaning of "prevention by source reduction", as defined by the Directive, has been limited by EN 13428 to a procedure of weight and/or volume reduction, which corresponds only to the first indent in Annex II, whereas ignoring the second and the third indents. In other words, the definition given by EN 13428 doesn't fully take into account the Mandate where it states that "the requirements regarding prevention shall be in line with articles…3 par. 4…and Annex II 1, indents 1, 2 and 3 of the Directive" and therefore it is at the same time in contrast with the Directive itself.

We have to notice that in the final version of EN 13428 an Annex dealing with dangerous substances has been introduced (Annex C), so that it is difficult to argue that decreasing the harmfulness has been entirely omitted. However, we have to underline that:

5) The standard elaborated by CEN lists (par. 5) some performance criteria for packaging that basically are of equal importance in comparison with the environmental one. They are the following:

	product protection;
	packaging manufacturing process;
	packing/filling process;
	logistics (including transport, warehousing and handling);
	product presentation and marketing;
	consumer acceptance;
	information
	safety;
	legislation
	any other relevant issue.

Individuals or organisations placing the packaging on the market shall establish the priority ranking of the criteria and the eventual evaluation of a criterion as "critical". The mentioned standard describes a critical area for source reduction as a "specific performance criterion, which prevents further reduction of weight and/or volume of the packaging without endangering functional performance, safety and user/consumer acceptability" (par. 3.2). Hence, if a criterion is evaluated as "critical area", this means that no reduction of the packaging weight and/or packaging volume is required under this criterion. As a consequence, emphasis is put on all other functions that packaging has to comply with and that the environmental side appears as marginal as to be let to the discretion of the producer.

This liberty of evaluating and determining (see "other relevant issue") the "critical area" doesn't comply with the Directive for two main reasons:

6) In Annex C.2 of EN 13428 "Determination of the substances to be minimised", step 1, we read: "If no substances are intentionally added, or if any are used but in concentrations below the trace level, conclude the procedure". The "trace level" in a harmonised standard should be quantified or at least specified. In fact, the procedure described in the mentioned Annex is based on this concept, as, if substances dangerous to the environment are used in concentrations below the "trace level", minimisation is not applicable. Moreover, the fact that the reduction of substances hazardous to the environment finally depends on the intention of the supplier, (as described by CR 13695-2), cannot be considered in line with the Directive, which in general terms calls for the minimisation of the mentioned substances.

7) More in general, the third par. of the introduction of EN 13428 states that "This European Standard presents a framework for assessment to determine whether the requirements of this standard have been met. Its approach is similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series".

The Mandate simply asks the creation of criteria for the assessment of source reduction, without specifying if they could consist of a self-assessment system. However, we think that the Directive doesn't line out any self-control system as flexible as this one, because it guarantees neither the implementation of the essential requirements of the Directive, nor the harmonisation of the internal market.

6.4 prEN 13429 Packaging suitable for reuse

Substantial inconsistencies, lack of provisions, generic provisions and advisable improvements

1) prEN 13429 contains several references to two non mandatedstandards, that is to say to EN 13427 and EN 13193, (see "foreword", "introduction", "scope", "normative references", "terms and definition", "requirements-application"). As a non-mandated standard is not published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and hasn't force in law, these references prevent prEN 13429 to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

2) This standard (par. 4) contains a checklist by which the packer or the filler can asses "reusability". If the pack fails any of these three tests, it is deemed unfit for reuse:

packerfillers must intend to reuse the pack for its original purpose;

it must be possible to clean, wash and/or repair the pack after emptying and to refill or reload it;

a system which supports reuse of the pack must be available. This may be a "closed loop" system (in which reusable packaging is circulated by a company or an organised group of companies), an "open loop" system (in which reusable packaging circulates amongst unspecified companies) or a "hybrid system" (in which reusable packaging stays with the end-user and is replenished by means of one-way packaging which is used as an auxiliary product to transport the contents to the reusable packaging).

The inclusion of the "hybrid system" among the systems in place for reuse has to be criticised for the following reasons:

1) The standard doesn't require the reusable packaging to be refilled by the consumers and doesn't establish the ratio between the number of refillable packaging and the one of auxiliary products that can be used, (i.e. detergent pouches used to refill a container at home). As a consequence, reuse cannot be guaranteed by such a system and, what is more, it could be carried out with an excessive use of auxiliary products.

2) The mentioned inclusion doesn't make clear that the one way packaging used as auxiliary product is not part of the reuse system. In fact, if we say that:

hybrid system = reusable packaging + one way packaging

and that:

hybrid system = reuse system,

then we have to work out that:

reusable packaging + one way packaging = reuse system.

However we have to notice that, on this point, not only the standard, (see number 3) but also the Directive 94/62 is ambiguous. In fact, the latter states that: "reuse shall mean any operation by which packaging has been conceived and designed to accomplish within its life cycle a minimum number of trips or rotations, is refilled or reused for the same purpose for which it was conceived, with or without the support of auxiliary products present on the market enabling the packaging to be refilled; such reused packaging will become packaging waste when no longer subject to reuse". The meaning of the expression "support of auxiliary product" hasn't been enough clarified.

3) The meaning of the expression "auxiliary product", as defined by "terms and definition" par. 3.10 "auxiliary product" is not clear and could cause different interpretations, so that it would be better to re-define it.

4) The Mandate of the Commission states that "the requirements shall take into account: - requirements to guarantee a minimum number of trips or rotations under normally predictable conditions of use including test methods for the demonstration of this". As these instructions are only partially taken into account and clarified in the draft standard, this one, firstly, doesn't fulfil the Mandate and, secondly, as it cannot be considered as a harmonised standard, is in contrast with the objectives of the Directive, (Art. 1). In particular, with reference to "terms and definitions", par. 3.1 "reuse" and par. 3.2 "reusable packaging", it would be useful and more precise to specify how often a packaging should be reused to be classified as reusable. If this is not possible at a general level, (that is to say for all reuses systems), at least it should be possible to elaborate a concept or a procedure in order to analyse and calculate the number of trips.

5) The procedure drawn by par. 5.1 and the related Annex B (that has only an informative value) is too much generic and need to be specified, if EN 13429 wants to be considered as a harmonised standard. (see for example the following passages: "... the packaging can be emptied/unloaded without significant damage, beyond that which can be viably repaired" or "... any reconditioning process within its control is managed in a manner that minimises its impact on the environment").

6) The third par. of the introduction of EN 13429 states that "This European Standard presents a framework for assessment to determine whether the requirements of this standard have been met. Its approach is similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series".

With this respect, we think that the Directive does not line out any selfcontrol system as flexible as this one, because it guarantees neither the implementation of the essential requirements of the Directive, nor the harmonisation of the internal market.

6.5 EN 13430 Requirements on packaging recoverable by material recycling

Substantial inconsistencies, lack of provisions, generic provisions and advisable improvements

1) EN 13430 contains several references to two non mandated-standards, that is to say to EN 13427 and EN 13193, (see "foreword", "introduction", "scope", "normative references", "terms and definition", "requirements-application"). As a non-mandated standard is not published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and hasn't force in law, these references prevent EN 13430 to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

2) The Directive Annex II point 1, indent 3 states that "packaging shall be so manufactured that the presence of noxious and other hazardous substances and materials as constituents of the packaging material or of any of the packaging components is minimised with regard to their presence in emissions, ash or leachate when packaging or residues from management operations or packaging waste are incinerated or landfilled".

In the same line, the Mandate asks the requirements to take into consideration:

"substances or materials that are liable to have a negative influence on the energy recovery process";

"materials, combinations of materials or designs of packaging that are liable to create problems in collecting and sorting before energy recovery".

These instructions are nowhere taken into account or clarified in the draft standard. In fact, in EN 13430 we cannot find any identification of substances, materials or designs that are liable to create problems during collection, sorting or recycling. Therefore the standard doesn't fulfil the Mandate and, besides that, as it cannot be considered as a harmonised standard, it is in contrast with the objectives of the Directive, (Art. 1).

3) With reference to "Terms and definitions", par. 3.1 "Empty packaging", on the one hand, the standard defines "empty packaging" as follows: "a packaging is empty if (under normal and foreseeable circumstances) all product residues that can be removed by the emptier have been removed using practices commonly employed for that type of packaging".

On the other hand, the Directive only regulates the recycling of "packaging waste", which is defined with reference to the Directive 75/442. It has to be specified that an "empty packaging", that is to say a packaging that has been emptied, is a packaging waste. In the same way, the expression "packaging after use" (Annex A 4 of the standard) is unknown to the Directive and has to be substituted with "packaging waste".

In fact, the Directive is going to be undermined by resorting to these expressions, as in most member states only waste is under strict control by law, while empty or used packaging not, as they are a matter of industrial raw material, (hence out of official control).

4) The definition of "recycling process" given by "Terms and definitions" par. 3.4, ("physical and chemical process which converts collected and sorted used packaging and scrap, together in some instances with other material, into secondary raw material or products") doesn't exactly correspond to the definition of "recycling" given by the Directive Art. 3 par. 7, ("recycling shall mean the reprocessing in a production process of the waste materials for the original purposes including organic recycling but excluding energy recovery").

5) EN 13430 includes so many examples of unclear words/concepts, which, on the whole, make it impossible to finally decide when packaging is recoverable by material recycling. In particular the procedure for assessing recyclability criteria that are described in Annex A, B and C needs considerable improvements by way of specification before these are suitable in order to elaborate or assess recyclability. Thus, for example, what does it mean that operations shall be controlled to such an extent that the recycling processes are not negatively affected? (A.2.2). This expression could refer to the explosion of the recycling plant (safety), to the increase of the amount of waste resulting from not recyclable packaging (environment), or to the fall in market price for mixed qualities under the level where a recycling of the packaging does no longer bring profit and therefore no longer is bought by the recycling industry (economy). The same considerations have to be made with regard to other expressions such as: "ensure that the design of packaging includes consideration of aspects significant for the recycling of the materials from which it is produced" (A. 2.1), "ensure that the design of packaging makes use of materials or combination of materials which are compatible with the known, relevant and industrially available recycling technologies..." (A. 3.1), "design the packaging ... so as to ensure that it ... enables a certain percentage by weight of materials to be recycled ..." (B. 2), "the presence of the amount of substances or materials that are liable to have a negative influence on the quality of the recycled material" (B. 2), "ensure that the production operations ... can be managed such that any changes or deviations cannot adversely affect the compatibility of the packaging with the specification of the recycling process" (B. 3.1), "ensure that materials selected in the design stage as causing no significant problems in recycling technologies..." (B 3.2), "ensure that the construction is without prejudice to the conformance with other essential requirements" (B.4.1), "ensure that the design of the primary packaging ... will enable emptying of the packaging using common practices as defined in 3.1 such that the used packaging is compatible with the recycling process" (B 4.2), etc.

We can conclude that the Mandate that asks the standard to "give presumption of conformity with the essential requirements for packaging recoverable in the form of material recycling" hasn't been fulfilled by this standard.

6) The third par. of the introduction of EN 13429 states that "This European Standard presents a framework for assessment to determine whether the requirements of this standard have been met. Its approach is similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series".

With this respect, we think that the Directive doesn't line out any selfcontrol system as flexible as this one, because it guarantees neither the implementation of the essential requirements of the Directive, nor the harmonisation of the internal market.

6.6 EN 13431 Requirements on packaging recoverable in the form of energy recovery

Substantial inconsistencies, lack of provisions, generic provisions and advisable improvements

1) EN 13431 contains several references to two non mandated-standards, that is to say to EN 13427 and EN 13193, (see "foreword", "introduction", "scope", "normative references", "terms and definition", "terms and definitions-recycling process, -secondary raw material, -supplier", "requirements-application"). As a non-mandated standard is not published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and hasn't force in law, these references prevent EN 13431 to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

2) The Mandate asks the requirements to take account of: - "substances or materials that are liable to have a negative influence on the energy recovery process"; - "materials, combinations of materials or designs of packaging that are liable to create problems in collecting and sorting before energy recovery".

These instructions are nowhere taken into account or clarified in the draft standard. In fact, in EN 13431 we cannot find any identification of substances, materials or designs that are liable to create problems during collection, sorting or recovery. Therefore the standard doesn't fulfil the Mandate and, besides that, as it cannot be considered as a harmonised standard, it is in contrast with the objectives of the Directive, (Art. 1).

As far as collecting and sorting are concerned, combustible packaging waste, that can contain bacterial pollution or sporogenics from microbiological activity, represents a hazard during these prior to energy-recovery phases. The standard should mention this problem too.

3) It would be important to make a reference to the existing Directive 94/67 EC on the incineration of hazardous waste as well as to Directive 89/369 EC on the prevention of air pollution from new municipal waste incineration plants and compliance with the emission limits of these Directives must be assured (both Directives are going to be replaced by a new one on incineration of waste that is going to be adopted). In fact, the energy recovery of packaging waste is acceptable only if the pollutant emissions originated by this process are not higher than the ones of modern MSW-incinerators with dust elimination, scrupping and catalyst. This means that the plants have to apply Best Available Techniques and at least comply with the emission limit values of the new waste incineration directive.

Besides that, as the emission of acid forming substances, heavy metals and other hazardous components are only regulated in an environmentally satisfying way with reference to modern MSW incineration plants, but not with reference to coal fired or bio-fuel-plants or to cement plants, which use PDF or RDF as fuel, a precise distinction between the MSW-incineration and other incineration plants has to be introduced by the standard.

4) Annex II point 3 of the Directive, "Requirements specific to the recoverable nature of packaging", letter b), "Packaging recoverable in the form of energy recovery" states that "Packaging waste processed for the purpose of energy recovery shall have a minimum inferior calorific value to allow optimisation of energy recovery".

Also the Mandate of the Commission asks for a specification of the minimum inferior calorific value: "The standard shall contain a specification of the minimum inferior calorific value".

The standard specifies the minimum inferior calorific value through the technical concept of calorific gain (see par. 3, par. 4 and Annex A). In fact, it establishes that calorific gain is assumed to be fulfilled when the net heat of combustion exceeds the amount of energy required to adiabatically raise the temperature of the post-combustion substances from ambient temperature to the specified final temperature. However, even through the concept of calorific gain it is desirable to set higher targets for the calorific gain than "> 0". In fact, we think that energy recovery is useful and makes sense from both economic and environmental points of view only if the energy obtained by this process is significantly positive. This result cannot be guaranteed simply fixing a target for the calorific gain "> 0".

Moreover, as for PVC the net energy balance with energy recovery is likely to be negative (Moller and Jeske 1995, Pohle 1997), the refusal to give a numerical dimension to the minimum inferior calorific value could lead to consider PVC recoverable through direct incineration with all the consequent problems concerning the formation of dioxin and other toxic substances and their release into the environment. In this regard, the Green Paper on environmental issues of PVC, adopted by the European Commission on 26 th July 2000, states that: "Upon incineration, PVC waste generates hydrochloric acid (HCI) in the flue gas, which needs to be neutralised, except when a special technology is employed where HCI is reused. At the moment, this specific technology is used only in 5 plants in Germany and 3 plants are in construction… The potential influence of incineration of PVC waste on the emissions of dioxins has been at the centre of a major scientific debate since PVC is currently the largest contributor of chlorine into incinerators… Whilst at the current levels of chlorine in municipal waste, there does not seem to be a direct quantitative relationship between chlorine content and dioxin formation, it is possible that an increase of chlorine content in the waste stream above a certain threshold could contribute to an increase of the dioxin formation in incinerators".

5) The requirement of par. 6.1 of the standard, which states that "packaging composed of more than 50% (by weight) of organic materials… shall be considered recoverable in the form of energy", shall be integrated by a calculation of the calorific gain by analogy with what is established in par. 6.2.

6) The second par. of the introduction of EN 13431 states that "This European Standard presents a framework for assessment to determine whether the requirements of this standard have been met. Its approach is similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series".

With this respect, we think that the Directive does not line out any selfcontrol system as flexible as this one, because it guarantees neither the implementation of the essential requirements of the Directive, nor the harmonisation of the internal market.

6.7 EN 13432 Requirements on packaging recoverable through composting and biodegradation

Substantial inconsistencies, lack of provisions, generic provisions and advisable improvements

1) EN 13432 contains several references to two non mandated-standards, that is to say to EN 13427 and EN 13193, (see "foreword", "introduction", "scope", "normative references", "terms and definition", "requirements-application"). As a non-mandated standard is not published in the Official Journal of the European Communities, (the act which confers the status of EU Harmonised Standards), and hasn't force in law, these references prevent EN 13428 to "stand-alone" and to be considered a harmonised standard. This result is clearly in contrast with the first aim of the Directive, that is to "harmonise national measures" (Art. 1).

2) The Mandate asks the requirements to take account of:

"substances or materials that are liable to create problems in the composting or biodegradation process";

"materials, combinations of materials or designs of packaging that are liable to create problems in collecting and sorting before composting or biodegradation";

"the presence of substances or materials that are liable to have a negative influence on the quality of the product from the composting or biodegradation process".

These instructions are only partially taken into account by EN 13432 in Annex A.1.2. Therefore the standard doesn't fulfil the Mandate and, besides that, as it cannot be considered as a harmonised standard, it is in contrast with the objectives of the Directive, (Art. 1).

3) EN 13432 allows three different biodegradation tests to be considered for determining the biodegradation rate of packaging material, (see par. 6 "laboratory tests on biodegradability"). These tests are meant to demonstrate the fundamental biodegradability of a packaging material, as par. 6 states: "Only biodegradation tests that provide unequivocal information on the inherent and ultimate biodegradability of a packaging material or its significant organic constituents shall be used".

Two of these tests (ISO 14851:oxygen consumption, and ISO 14852: Sturm test) do not stimulate composting conditions because the degradation happens in a liquid medium with mesophilic conditions. In fact, if the packaging material does not completely biodegrade during the composting process it should be demonstrated that it eventually degrades in the soil where the temperature is in the psychrophilic range and the medium is the soil.

As a consequence, EN 13432 fails its objective, that was to demonstrate the fundamental biodegradability of packaging material, and doesn't fulfil the requirements of the Mandate and the Directive, (see in particular Annex II point 3 letters c) and d)).

4) Annex A par. 2.2 of EN 13432 "Aerobic biodegradation tests" establishes that "The period of application for the test specified in the test methods shall be a maximum of 6 months". Six months for a test on compostability is a much too long period which is not reflected in common practices and may present risks of pollutant accumulation in soil. It is suggested that a 90% biodegradation rate in a time span of two to three months would give better guarantees as regards complete biodegradability.

5) As far as heavy metals are concerned, the assumption made in the standard that "50% of the original weight of the packaging or packaging material will remain in compost after biological treatment" is not contested. However, as potentially compostable packaging materials, already on the market, have heavy metal concentrations much lower than foreseen in the standard, the level of heavy metals in products should be kept as low as possible in order to prevent their spreading into the environment. Packaging deemed to be compostable should not impair the quality of the best compost which is possible to produce. As a consequence, it would be better to lower the heavy metal concentration indicated by the standard.

6) The third par. of the introduction of EN 13432 states that "The European Standard presents a framework for assessment to determine whether the requirements of this standard have been met. Its approach is similar to that of systems standards such as the EN ISO 9000 and EN ISO 14000 series".

With this respect, we think that the Directive doesn't line out any selfcontrol system as flexible as this one, because it guarantees neither the implementation of the essential requirements of the Directive, nor the harmonisation of the internal market.

7 Conclusion

The Commission requested CEN to draw up standards for packaging and packaging waste, useful for the implementation of Directive 94/62, covering all environmental aspects for all kinds of packaging and packaging materials and reflecting the objectives of the Directive itself.

EN 13428, prEN 13429, EN 13430, EN 13431 and EN 13432 (along with the two non-mandated standards EN 13193 and EN 13427) are the fruit of CEN work.

As we have already underlined in this paper, some elements of these standards do not comply with the mandate and the Directive from the legal point of view. Firstly, at a procedural level, the mandate, which establishes that "the preparation of the standards shall be carried out in association…. with representatives of consumer groups and with environmental and scientific organisations", has not been fulfilled. Secondly, all the standards show substantial inconsistencies with the Directive and/or the mandate, even if they are not all of the same relevance.

Starting with the two non-mandated standards (EN 13193 and EN 13427), we have to note that they play a central role in the standards system elaborated by CEN, as the former defines many terms used in these standards and the latter guarantees a certain co-ordination among them. We focused on a number of substantial inconsistencies of these standards, such as avoiding legally defined terminology, but added that their main problem is that they are not harmonised, so that we suggested their incorporation into the mandated standards after they have been adjusted to the terminology of the packaging directive.

As far as the mandated standards are concerned, our major criticism refers to EN 13428, prEN 13429 and EN 13430 for the following reasons:

EN 13431 contains some effective packaging requirements, even if it does not comply with the Directive as it does not take into account the instructions concerning "substances or materials that are liable to have a negative influence on the energy recovery process" and "materials, combination of materials or designs of packaging that are liable to create problems in collecting and sorting before energy recovery". Moreover, this standard insufficiently specifies the minimum lower calorific value through too low a demand for "calorific gain".

Finally, although EN 13432 is not completely consistent with the Directive, it seems to be of good quality since it states in its final version that the biodegradation level must reach at least 90%. Some changes should be introduced, however, especially with regard to the biodegradation maximum period of 180 days, biodegradation tests and dangerous substances targets.

A common problem for all the standards consists in the fact that they are based on self-control systems along with a high rate of flexibility and a terminology that is often vague and imprecise. This situation has two important consequences: a) it makes CEN standards inadequate instruments in order to guarantee that the essential requirements of the Directive are fulfilled; b) it deprives the enforcement authority of the means to prove noncompliance with the standards and to ensure their respect. As we have already underlined in this, although the Commission mandate simply asks for the establishment of assessment criteria, without specifying if they could consist of a self-assessment system, the systems that emerge from the standards are not in line with the Directive. It is aimed at fixing requirements and rules to regulate and curb packaging waste, while the standards side-step this purpose.

We can conclude that the Commission mandate is not fulfilled by the standards, which therefore should not be published in the Official Journal of the European Communities.

The failure of CEN to deliver what is required by the Packaging Directive implies additional tasks for the forthcoming revision of the Directive itself. We believe that safeguards have to be introduced to avoid a repetition of the CEN failure, which has caused considerable delay in implementing Directive 94/62. A major change of approach in implementing its essential requirements is needed.

Two options have to be discussed: the EEB prefers another institutional framework for implementing the mandate (e.g. mixed Committee consisting of Member States and Stakeholders; or an Information Exchange Process according to the IPPC model or according the model of the air quality steering group).

A second attempt to co-operate with CEN would require the following major changes:

List of EEB Publications 2000

Joint Publications

2.2.2 The New Approach: can it ensure a high level of protection for the environment and human health?

New Approach workshop in Copenhagen on 29-30 November

The New Approach: can it ensure a high level for the environment and human health?

Helge Andreasen, Deputy Director General, Danish Environmental Protection Agency

Opening

I'm verv pleased to have this opportunity to talk about the New Approach as a tool both for harmonisation of product requirements and for ensuring a high level of protection in relation to safety, health and environment.

When the Council Resolution on the New Approach was adopted in 1985 it only referred to safety, but at the same time it was stated that the New Approach could also to applied to protection of public health, environment etc. However, in the Resolution itself, reference is only made to safety on practical and editorial grounds.

New Approach in relation to different spheres of application

In my presentation, I will try to analyse the possibilities of applying the New Approach to different areas: Safety, health and environment. Within each area, I will focus on three key issues. 1. The possibility of establishing precise essential requirements. 2. Development of standards based on essential requirements. 3. Demonstration of compliance with the essential requirements.

The possibility of establishing precise essential requirements takes up the central position in the assessment of the application of New Approach. The essential requirements must meet three requirements in particular. 1. They must provide a high level of protection. 2. They must be sufficiently exact to create legally binding obligations. 3. They must be so precise that they represent a real harmonisation.

Safety

The well-developed purpose of the concept of the "New Approach" has been to harmonise safety requirements, in other words to ensure the personal safety of the consumer when using a product.

Establishment of essential requirements

Generally speaking, safety is a qualitative parameter and a close link exists between product, risk and responsibility.

Conversion of requirements into standards

Thus it is a fairly simple matter to establish precise substantial requirements for safety, e.g. to prevent children from being choked by toys. The exact level of safety may be hard to determine precisely, but it is of minor concern, since industry has a direct interest in ensuring a high level of safety.

Compliance with and documentation of requirements

The development of the standards based on the essential requirements is working well. Industry has a direct interest in not being discredited by the individual product's safety. Further more industry has a substantial technical capability and knowledge of safety issues.

It is in the interest of the individual companies to comply with and document the requirements. If something goes wrong they will see their own product as a smoking gun at the scene of crime.

My conclusion as regards safety is that the New Approach is working well as it is possible to establish precise essential requirements for safety and industry has a substantial interest in complying with the requirements.

Health effects

Protection of health must also be recognised as a qualitative parameter - and the requirement will be that the product should not contribute to any negative health effects. But health is much less unambiguous than safety. Health impacts may be acutely caused by a product. e.g. toxic or caustic exposure. However avoiding longterm effects when using a product, including carcinogenic, mutagenic and reproduction toxic effects may also be included in the evaluation of health effects.

Generally, it is technically complicated to establish precise requirements for health effects. How can both short-term and long-term health effects be taken into account? Comparatively speaking it is easy to agree on the fact that a high level of protection must be obtained. But it is difficult to establish essential requirements which ensure a high level of protection precisely, unambiguously and exhaustively.

Establishment of essential requirements

The existing essential requirements as described in e.g. the Toys Directive are far from being exhaustive. The essential requirements of the Toys Directives include eight elements. These requirements establish the maximum daily exposure of children to dangerous substances in toys. These limit values have been calculated as a percentage of the children's allowed total exposure to the elements. Thus a political choice has been made as to which extent the exposure to the element may originate from toys.

No specific essential requirements have been specified in the Toys Directive regarding all other elements and chemical substances, even though many of these substances could be very relevant e.g. nickel and solvents. Indeed it would also be relevant to state the quantity of the total exposure from e.g. nickel that was allowed to originate from toys. This is considered a major shortcoming in the Toys Directive.

In case limit values for all relevant chemical substances were to be established to rectify this situation, the annex would be so extensive that it would be impractical to establish and maintain.

But could we not just draft criteria for the principles to establish limit values for the individual substances? In my experience, an issue as simple as rules on classification of chemicals in the 8^th revision of Directive (67/548) has shown us that this will not be precise enough to secure harmonisation. The criteria document on classification is rather exhaustive.

We also know that the precautionary principle may have to be applied to some types of substances (e.g. phthalates), and in accordance with the Treaty of Nice this must be made at a political level and not in the standardisation committees.

My conclusion is therefore that, in practice, it is not possible to establish exhaustive essential requirements for safeguarding the consumers especially against chronic damage caused by chemical substances.

Conversion of requirements into standards

As regards the development of standards based on the requirements within the health area, it will only be possible if the essential requirements are exhaustive and  described precisely. Experience gained from the drafting of a standard for organic chemicals in toys has demonstrated that industry has not shown adequate professional expertise/interest in the health area.

Compliance and documentation

The toy industry has not had the necessary knowledge of the fact that certain chemical substances may migrate from their products, or knowledge of what substances they use in their products. This applies to flame retardants for instance.

Despite this fact, the standard has not been changed for many years.

Compliance with and documentation of requirements are limited by the fact that the incitement of industry is non-existent. It is impossible to demonstrate a connection between a product and a chronic damage occurring 5 - 20 years later.

Environmental impact

The environmental impact caused by a product is a multidimensional parameter. What should be prioritised? The environmental impacts on water air or soil? Should the local, regional or global impact be prioritised? Should focus be on production resources consumption or environmental impact from waste handling? This means that the linkage between the concrete product and the environmental risk is far less unambiguous.

Political prioritisation

The assessment of the environmental risk is therefore also a question of political prioritisation.

Drafting of essential requirements

As regards the essential requirements in the safety and health area the requirement will be that a product is safe and does not involve a health risk. But of course, it is absurd to demand that the environmental impact of a product is zero. Thus, the essential requirements laid down in a directive regulating the environmental impact must include quantitative requirements. For certain products, this may be laid down as a maximum requirement.

However such an approach is as a general approach not recommendable. The wording of the requirement of the Packaging Directive is as "low as possible". Is this as low as technically possible, and for whom and when? Experience shows that products cause less environmental impact due to the technological development.

The conclusion is that a requirement worded "as low as possible" will be a relative requirement determined by the one who assesses, and will be based on a known technology. This cannot be an applicable tool to harmonise product requirements.

Another characteristic feature of environmental requirements is that there will always be different ways of producing a product meant to solve the same problem. Thus, during the construction phase it will be possible to reduce one type of environmental impact at the expense of another.

In any circumstances the drafting of the essential requirements therefore include how certain types of environmental impacts are to be measured and weighed against each other.

This emphasis is solely a political decision.

Packaging Directive

In case it is not possible to establish precise, emphasized prioritisation and requirements, the whole concept of the New Approach will fall on the floor. If the New Approach is to be applied to the environmental field huge efforts are required to value and describe the essential requirements precisely. In this connection it is important to remember that the emphasized prioritisation may change in step with the technological development.

The Packaging Directive, which specifically establishes requirements far environmental protection, is the only New Approach Directive to be adopted so far. The essential requirements of the Directive have not contributed to reducing the environmental impact from packaging. The basic problem is that the essential requirements laid down in the Directive are formulated in a vague and imprecise manner. Those who have followed this lecture will know why!!!

But it is interesting that the Council and the Commission realised that the essential requirements were imprecise when the Directive was adopted in 1994. In the statement of the reasons for the Common Position on 4 March 1994. the Council declares: "The Council found that most of the essential requirements to be laid down for the manufacture and composition of Packaging could be only very general at this stage, when there were very few standards and criteria and very little practical experience available for most kinds of packaging."

This is directly in contradiction with the requirements to the essential requirements in a New Approach directive. One of the main principles is that the essential requirements have to be worded precisely.

This statement was given 9 years after it was stated in the Council Resolution that the New Approach was also applicable to environmental aspects.
  

Electronics Directive

In 2000, the Commission submitted a proposal for an EEE Directive on electric and electronic products. The Commission proposal tried to solve the problem with on the one hand many different product types having to comply with the same environmental requirements, and on the other hand environmental requirements to the products having to be precise and unambiguous. The Commission proposes that the products have to go through the same procedure in order comply with the Directive. For instance it is proposed to apply the EMAS scheme in connection with product development. The Directive is proposed as a harmonisation Directive. The draft Directive will indeed harmonise the procedure, but as described above it will not harmonise the requirements to the environmental impact from EE products.

In my opinion, the current proposal does not have a future - but some of the ideas inherent in the proposal may be useful as a basis for further work in this area.

During the work on developing an IPP strategy, tools like ecolabelling, EMAS and green procurement have been brought forward.

An additional tool which could ensure that the producer assesses and documents his product's environmental performance seems interesting far two reasons.

Firstly, it would ensure that the producer carries out the assessment - and thus implements improvements to the best of his ability.

Secondly, it would provide private and public procurement with a real option of assessing the environmental performance of the product before purchase.
   

Conclusion

During the 80's, the whole concept of the New Approach was developed in relation to safety requirements. The 1985 Council Decision mentions in a footnote that the principle can be applied in the environmental field. However, it has never been analysed whether the New Approach is suited to include environmental requirements.

The application of the New Approach Directives in the environmental and health fields is not a realistic possibility. Drafting exhaustive descriptions of the essential requirements will be so comprehensive that it will prove much less demanding to regulate the environmental requirements through traditional regulation.

The tests that have now been carried out, applying the New Approach within the environmental and health fields, have far from lived up to being a real New Approach Directive.

Therefore, the New Approach has proved to be difficult in these areas and has not ensured harmonisation. It would be quite interesting to make a cost-benefit analysis of the costs of achieving the minimum environmental improvement by applying e.g. the packaging standards.

New Approach Directives are not well suited to ensure a high level of environmental and health protection. The New Approach cannot act as a substitute for environmental directives. These directives ensure the level of protection within the environmental and health areas in the EU.

It may be sensible to introduce environmental management system requirements for products marketed in the EU. This may increase the environmental conscience of the individual companies. However, this requirement must be a general requirement. Not a requirement which via the New Approach is used to allow all products to be marketed in the EU, no matter their environmental impact.

There is a demand on instruments to ensure further development on IPP. Standardisation is an interesting and perhaps unavoidable instrument. Denmark will be open to discuss ideas based on some instruments in the draft EEE Directive as I explained before.

We see large problems in using the New Approach covering environmental impacts from products. But we also see large possibilities in using some of the principles from the New Approach. I have Outlined these ideas above.

I foresee a fruitful discussion on how we can move on in developing an IPP, using the best from the New Approach.

Thank you for your attention.

2.2.3 Panel on experience with the New Approach

Aage Stevns Hillersborg, LEGO

The New Approach - Experiences within the Toy Safety Directive

Aage S. Hillersborg, Director, LEGO Company & Chairman, CEN TC 52 Toy Safety

The New Approach has been a proven success within the directive on toy safety. The directive was approved in 1998 and is supported by a number of harmonised CEN and CENELEC standards. Every year, thousands of new toys are brought on the European market, almost all of them based on the harmonised standards and only very few are approved via EC type examination.

The standardisation process and products have been dynamic. Revision of the standards and implementation of amendments have been executed as new products and knowledge has been introduced.

Benefits

A number of benefits have been identified

The legislation has been simplified, as the directive in itself concentrates on the essential requirements. This gives increased flexibility in developing solutions and setting up the technical details to meet the requirements.

Accordingly, the New Approach opens up for innovation and continuous improvements.

Expertise and practical experience have been available as all stakeholders have been given access to the work

Involvement of the best expertise in Europe is possible and achievable.

The decision process is based on consensus and all stakeholder experts have equal right to express their opinion.

Active involvement in the standards development process ensures practical use of the finished standards. Within the toy area, thousands of different products are every year designed and manufactured according to the harmonised standards. The ration of non-complying products identified by market surveillance authorities is in the level of parts per million (ppm).

The standards developed are per se relevant and needed from the market as they are based on justifications from the stakeholders.

Obstacles

Standardisation as such is not always easy and standardisation in relation to mandates under New Approach directives has special obstacles.

	The mandates may not reflect entirely the real work as the final scope may be expanded due to inputs from the participants in the standardisation groups.
	The financial support from the Commission does not reflect the total work and is often insufficient.
	The financial support of the Commission is given at European level, but the standardization work at national level is widely covered by the stakeholders, especially the industry. For product specific standards, it is normally possible to find interested companies, but for general issues - like environmental aspects - it proves difficult to ensure wide participation.
	Single events - incidents - tend to call for initiation of standardisation, although a robust background is missing. This may lead to inefficiency and it may also be difficult to keep the standards away from a too specific product orientation.
	The open and transparent process of standardisation with encouragement of involving all experts should guarantee the quality of the products and accordingly make the publication in the Official Journal a formality. However, this is mechanism has not functioned perfectly in all cases.
	The input from some national members within the standardisation process differs from time to another from the opinion expressed by the same Member States officials.
	Integration of product related environmental aspects are traditionally addressed to a minor extent only as the focus is on the immediate safety for the user. This is in line with the normal drafting of mandates, but expectations from participants may go further than the mandate.

Future challenges

The standardisation process under the New Approach is a continuously developing process and new fields have to be investigated.

	It should be possible to move from the traditionally product based focus to a more generic approach e.g. specifying management procedures and tools to be used in assessing and ensuring compliance with essential requirements.
	The width of the expectations for standardisation under New Approach mandates must be clear. If environmental aspects are to be addressed it must be defined within the mandates - toy safety has traditionally originated from the immediate safety of the individual user, and neither addressed long term effects of the compounds nor the environmental effects of the manufacturing process.
	Enforcing standards with process orientated aspects - environmental, social etc. - becomes difficult and may be difficult to perform equally for European manufactures and importers from e.g. the Far East
	A truly international - beyond Europe - perspective must be applied. This will require improved relations between the European standards bodies (CEN, CENELEC) and the international organisations (ISO, IEC). More importantly, it will require an acceptance of that the levelling of requirement may lower the level in some regions whilst elevating in other regions - with a global improvement.
	Addressing environmental aspects along with safety and health aspects has immanent conflicts. If the standardisation bodies are to work within this context, clear political directions must be given on beforehand if standardisation is to remain a technical process.

Conclusion

Toy safety was the first area to be regulated via the New Approach. It has over more than a decade proved to be an efficient and dynamic legislative means. The changing focus with increasing demand for the integration of new elements - like environmental aspects - sets challenges for the future development to be met by legislators as well as standardisers. The concept - the New Approach - is deemed still to be appropriate for this.

Aage S. Hillersborg
LEGO Company

2.2.3.2 Experience with the Medical Devices Directive.
Peter Thompson, CEN

Se her!

Council Resolution of 28/10/99 on Standardisation in Europe.

March 2001

Executive Summary

Following the Council Resolution on Standardisation in Europe of 1999 the European Commission is to report in June 2001 to the Council and the European Parliament on its political answers to fundamental issues and challenges standardisation is facing in Europe. The ANEC Position Paper addresses major concerns and requests consumers have with respect to the principles of standardisation, greater involvement of public authorities, efficiency, financing and international standardisation.

Provided that the standardisation process is transparent and open to participation of all concerned parties. European standards (EN) complementing in many areas European legislation are useful means of consumer protection and consumer safety. The recent crisis in the food sector has once again demonstrated the crucial importance of transparency to ensure that consumers have faith in the power of the internal market to benefit them as much as it does business.

To ensure democratic structures, ANEC calls for a reform of the European standardisation system that in its current shape primarily serves industry needs. Representatives of the public interest such as consumers or other non-industrial stakeholders are not able to participate in the process in an adequate manner to guarantee a high level of protection.

Such a revision of the European standardisation system is even more vital in the light of the wider discussion on alternative regulatory models (so called co-regulation). To protect the public interest, the European Commission proposes alternative regulatory models bridging between legislation and its binding nature and the more flexible self-regulatory approach. The success of alternative regulatory models like traditional and new standardisation, however, depends an effective monitoring, open access for consumers and effective dispute settlement procedures.

Therefore, ANEC urges the European Commission, the European Parliament and Member States to take actions on the basis of the following recommendations to ensure a high level of consumer protection and transparent and democratic procedures in future European and international standardisation.

ANEC reccomendations on standardisation in Europe

I. Principles of Standardisation

1. The European standards bodies shall develop a policy to ensure transparency, access of all stakeholders and balanced representation in the standardisation process.
        
2. A dispute settlement procedure open to European stakeholder organisations active in standardisation shall be implemented.
        
3. Industry agreements and specifications (e.g. new deliverables) other than European standards shall not be used to complement European legislation in the field of health, safety, environment and basic legal and economic interests of consumers.

II. Greater Involvement of Public Authorities in European Standardisation

4. To ensure that European standards are consensus-based and reflect the needs of all stakeholders including consumers, the establishment of a European standards monitoring system outside the standards bodies could be considered.
        
5. To ensure uniform application of European standards across Europe, ANEC calls for improved market surveillance and a single European certification mark.
        
6. Due to a negative experience in the field of environmental standardisation, ANEC cautions the application of the New Approach for environmental requirements of products, services and processes unless there exist adequate precautionary measures.

III. Efficiency

7. Whenever the European Commission launches mandates for standards of public interest, consultation of stakeholders has to be guaranteed.
        
8. The European standards bodies shall improve the transparency of decisionmaking by publishing the affiliation of the participants in their Technical Committees.
   A transparent procedure for the recruitment and evaluation of consultants of the European standards bodies shall be established to ensure neutral and independent conformity checks of standards.

IV. Financing

9. To enable consumer involvement in European standardisation at all relevant stages, adequate resources are needed. The European Commission and the Council should reiterate and strengthen their recommendations addressed to EU Member States to provide sufficient financial support for consumer representation in standardisation.
   At the European level, the European Commission should provide increased and stable funding for consumer participation in European standardisation.
        
10. Candidate countries in Central and Eastern Europe should be invited by the EU to ensure adequate fundinq at the national level for consumer representation in standardisation.

V. International Standardisation

11. ANEC calls upon the European public authorities and national standards bodies to take the necessary actions to introduce the principles of balanced representation, openness and transparency into international standardisation.
    To ensure a better representation of consumers in international standardisation additional financial support has to be provided.
         
12. Safeguards have to be developed in order to ensure that European public policy issues are adequately taken into consideration in international standardisation, e.g. through a European mirror committee.

Introduction

Since 1995, ANEC represents and defends consumer interests in the European standardisation process. ANEC provides technical expertise based on a network of more than 170 experts in EU Member States, EFTA counties and the Czech Republic, These experts representing consumers participate in Technical Committees of the three European standards bodies CEN, CENELEC and ETSI. Areas of priority are child safety, safety of domestic appliances, information society, consumers with special needs, environment, and traffic safety.

Based on its experience in European standardisation work, ANEC calls for a reform of the European standardisation process along with the following recommendations in order to ensure transparent and democratic produceres. The latter are prerequisites to build and maintain consumer confidence in the Internal Market and the European integration process.

I. Principles of Standardisation

I.A. Balanced Representation of Interested and Concerned Parties in the Standardisation Process and Committees

In theory, standardisation at the European level is an open, transparent and consensus-driven process, which allows all stakeholders to participate and to safeguard their interests. Reality, however, is different. Industry representatives dominate many standardisation committees of the three European standards bodies. Thus, real balanced representation of all stakeholders is rather the exception in the standardisation world. As a consequence, standards do often not meet consumer requirements. In some cases, European standards had even been adopted against sustained opposition of consumer representatives.

Openness and transparency are important principles, to which the European standards bodies have committed themselves. These principles must be complemented by the principle of balanced representation of all interested parties in the standardisation process as far as public interests are concerned.

The standards bodies shall develop a policy to ensure balance in co-operation with public interest groups such as consumer organisations. This may include a set of measures, e.g. establishment of balanced project teams to draft standards, obligatory written evidence of input and support by consumers for a standard and, a formal dispute settlement procedure.

I.B. Dispute Settlement Procedure

In the current European standardisation system, consumers do not have adequate access to initiate and carry through new standardisation work, which we deem necessary and vital for consumer protection, but which might not to a priority for industry.

Therefore, ANEC calls for a mechanism at the European level in terms of a mediation procedure providing consumers and European stakeholder organisations active in standardisation with an instrument to articulate their proposals for standardisation.

At the same lime, such a procedure should serve as an arbitration board both for conflicts arising from procedural issues and conflicts occurring as a result of a standardisation work. The composition of the body should be pluralistic and balanced in numbers and not only in terms of interested parties. In general, the standards bodies shall develop the terms of reference of such a dispute settlement in co-operation with the European stakeholder organisation.

I.C. The Use of New Deliverables and Specifications in EU Policies

ANEC is concerned about the use of European Community documents other than standards to support European policies and legislation. This relates to both the so-called new deliverables of the three standards bodies and to specifications developed by industry or industry consortia. We believe that the use of such other documents in Community policy should be the exception and not the rule. In the very exceptional case that it is deemed necessary to refer to documents other than standards, specification-producing bodies should meet strict requirements to guarantee the transparency of the process and the involvement of consumers. Moreover, the lifetime of such documents should be restricted to a time period not exceeding three to five years, followed by an evaluation including the option of a formal European standard, with the latter involving the Full consultation process.

As a matter of principle, documents or specifications, which do not comply with the criteria of a European standard, shall not be used in sectors covered by the New Approach and other legislation such as the General Product Safety Directive dealing with aspects of health, safety, environment and basic legal and economic interest of consumers. The recognition of specifications produced by pure industry fora would undermine the credibility of consumer protection policy in Europe.

II. Greater Involvement of Public Authorities in European Standardisation

II.A. European Standardisation Monitoring System

In the European standardisation system as it is today, public authorities have to wait until a standard is completed before being able to trigger the safeguard clause if a standard is deemed insufficient and does not comply with the technical requirements set out in the respective directive. Interventions, however, should be made possible at an ealier stage, e.g. during the enquiry stage of the standards-making process.

For this purpose, the European Commission and Member States might consider the establishment of a European standardisation monitoring system outside the standards bodies providing evaluation of a mandated standard. Such a monitoring system could be based on a two-step approach. Whilst the first check would be carried out as soon as the draft standards are available, a second check would be involved once the standards have been finalised, but before their references are published in the Official Journal of the EU. Both steps would ensure that the (draft) standards are consensus-based, i.e. consumers or other groups representing the public interest do not fundamentally disagree with the standards. The standards bodies would be obliged to respect any decisions of the European Commission and the EU Member States resulting from the monitoring system.

In the same context, ANEC calls for free access of consumers to the various fora, which are already involved in monitoring the European standardisation process, Most notably, this applies to the European Commission's Committee on Standards and Technical Regulations, Committee 98/34, but also to the standing committees pertaining to the various directives, e.g. for toys and construction products.

Moreover, in some cases the European standards bodies failed to elaborate adequate standards in compliance with the essential requirements of directives. As a result Member States had to intervene by making use of the safeguard clause. Nonetheless, Technical Committees of the standards bodies were reluctant to revise the standards in an appropriate manner even though the European Commission supported Member States. Therefore, instruments are needed allowing for an alternative to standards as a last resort.

II.B. Application of standards

The most stringent standards in the world serve no purpose unless they are applied in practice. Many elements help ensure that standards are respected. Market surveillance, market forces stimulated by the publication of consumer information, certification and labelling schemes all play their part. Developments at the European level are increasingly important to ensure that there is a uniform application of the European standards throughout the EU.

ANEC calls for improved market surveillance in the internal market and strongly supports a single European quality mark, which has to fulfil specific requirements such as third party testing and precise information in order to provide transparency on safety, performance and environmental aspects of the product.

II.C. Caution with respect to wider application of the New Approach

ANEC sounds a note of caution with respect to snider application of the New Approah, as there are certain sectors Where it would not to appropriate to apply the New Approach. Due to a negative experience with environment related standardisation¹. ANEC cautions the extension of the New Approach to environmental requirements for products, services and processes unless there are precautionary measures established. Unfortunately, the CEN Environmental Helpdesk (EHD), a forum intended to promote the integration of environmental aspects in product standards, does not seem to be an adequate instrument to significantly improve the situation.

As there is a fundamental difference between the areas of safety of products and of environmental requirements², it is deemed necessary to undertake preparatory measures such as feasibility studies and plot projects before launching any New Approach directive in the environmental area. A permanent external monitoring, involving the European Commission. Member States and stakeholders should be implemented. Moreover, the European Commission and Member States should discuss what changes have to be introduced in order to enable the existing standardisation system to deal with environmental requirements in an appropriate manner.

III. Efficiency

III A. Consumer Involvement in Drafting Mandates for Standardisation issued by the European Commission

A mandate is a political request by the EU and EFTA to develop voluntary standards based on consensus amongst all parties involved. In many cases, a mandate is given to support European legislation and to develop the technical specifications of the essential safety requirements. Mandates are mainly issued in the area of New Approach legislation, but may also be given for the elaboration of standards in other areas e.g. biotechnology.

ANEC is convinced drat the drafting of standardisation mandates of public interest should be done in consultation with all stakeholders, especially consumer representatives and experts from consumer organisations across Europe.

III.B. Transparency

As highlighted by the European Parliament and by the European Commission in a recently published report on the legal aspects of standardisation, ANEC is convinced that greater efforts could be made to provide more information on the opinions the various stakeholders elaborate during the standardisation process.

To improve transparency, ANEC suggests a listing of the participants of a Technical Committee and their affiliation. For this purpose, an attendance form could be used, in which participants indicate their affiliation and the interest group they belong to (i.e. industry, standards bodies, scientific community, test laboratories, consumer or environmental organisations). The lists of participants should be available for consultation by all stakeholders.

Moreover, ANEC would like to stress the importance of external consultants whom European standards bodies employ in order to verify the conformity of elaborated standards with the relevant directives. In general, these consultants have positively contributed to the work. Nonetheless, ANEC wishes to stress the importance of involving neutral and independent experts who critically review standards. It would be beneficial to establish a transparent and harmonised procedure for recruitment and evaluation of external consultants.

III.C. Training

Existing rights and rules must be known and respected. Inaccurate application of rules and procedures undermine standardisation work. Training and project management might contribute to render the standardisation process more efficient. Training for the secretariat of Technical Committees and Working Groups of the European standards bodies might be useful to improve the support provided to the group,

IV. Financing

IV.A. No Membership Fees for Consumer Organisations

In many countries, consumer organisations are confronted with the request to pay fees in order to to able to participate in the standardisation process. ANEC totally rejects demands that consumer organisations pay fees for participating in standards bodies as this represents a barrier to effective and comperhensive involvement of consumers in standardisation.

IV.B. Financial Support for Consumer Representation in Standardisation

ANEC welcomes the Council position that consumers and other interest groups should be fully involved in the standardisation process at all relevant stages. A prerequisite for such an involvement is adequate and stable funding - both at national and European level. The current situation, in particular in the southern European countries and Ireland, is far from being satisfactory and has to be improved.

The lack of adequate consumer representation in many EU Member States undermines the credibility of the consensus that should be a fundamental characteristic of the European standardisation process. ANEC calls on the Commission and the Council to reiterate and strengthen their recommendations addressed to the Member States to actively encourage consumer representation in standardisation through the provision of resources and financial support (88/41/EEC and 88/C 293.01).

As consumer organisations already suffer at national level from a lack of financial resources to represent their interests in standardisation, it is obvious that at the European level, ANEC is only able to play the role it is supposed to play as long as the European Commission provides a reliable source for funding.

ANEC also calls for continued support initiatives to improve consumer representation in standardisation in the Central and Eastern European countries, In particular, ANEC suggests that the candidates for EU membership are requested to provide adequate funding for consumer representation in standardisation and to ensure that national consensus building arrangements are respected.

V. International Standardisation

V.A. Need for BaIance. Transparency and Openness

Many standards used to to made at the European level, but are more and more subject to international standardisation in ISO and IEC. Whilst ANEC recognises the importance of international standardisation, we have to highlight the substantial difference between European and international standardisation as regards the participation of stakeholders, in particular the participation of consumers.

ANEC therefore calls upon the European public authorities and national standards bodies to take the necessary actions to introduce the principles of balanced representation, openness and transparency into international standardisation.

Consumer representation in international standards bodies is limited to participation in a few technical committees. Consumers International is actually not allowed to participate in the political work of international standards bodies, which are thus highly industry dominated. Furthermore, consumer participation at the technical level is considerably hampered by a lack of financial resources. Participation in the standards making process of ISO and IEC involves considerable financial resources due to travels around the world.

In order to establish adequate consumer representation at the international level, and thus legitimacy of the international standardisation process, it is vital that additional furring is provided to the consumer movement.

V.B. Safeguarding Objectives of European Public Policy

As already mentioned, European public authorities have the possibility to directly intervene in the European standardisation process if it is deemed necessary in the interest of the market or consumers. This possibility does not exist in international standardisation, where there are no procedures for national administrations to challenge intennational standards that insufficienthy address consumer protection.

ANEC advocates that the European Commission reinforces its efforts to control and monitor the standardisation work complementing European legislation, which is a difficult task when standardisation is shifted to the international level. Moreover, non-European standards bodies will not always be prepared to take full account of the essential requirements of European Community legislation.

National and European standards bodies, as well as European public authorities should to aware of these drawbacks of international standardisation in comparison to European standardisation. Safeguards have to be developed in order to ensure that public policy issues are adequately taken into consideration in international standards. Whenever standardisation tasks linked to a standardisation mandate are transferred to an international standards committee, a European mirror committee should be set up. This group should elaborate a European view and ensure that European public policy, consumer, health and safety issues are taken into account.

As long as there are no safeguards in international standardisation, it many therefore be advisable to give priority to European standardisation whenever European public policy issues are at stake.

Machine-readable cards

Smart or machine-readable cards are of major importance to consumers. They are used by all consumers, with or without disabilities, for purposes of identification and for payment in all types of applications. Standardisation did address the issue of tactile identifiers, which help consumers with visual impairments to introduce the card into the reader in the right direction. Unfortunately, two different standards were produced, one by CEN and one by ETSI, specifying the location and shape/size of these notches. in addition, the standard elaborated by CEN (primarily for banking cards) offers four options of which only one is considered suitabe. ANEC calls for a practical solution.

Exclusion Clause in Standards in Electro-technical Products

For several years already, ANEC has expressed concerns about the degree to which child safely is addressed in electro-technical products, which are not specifically produced for children, but with which children inevitably come into contact like microwave ovens. Some of these standards for electro-technical produces have an exclusion clause. Due to the exclusion clause, the standard does not take into account the use of the appliance by young children. It equally does not take into account the needs of older people or people with disabilities - thus excluding large parts of the society from using the appliances. ANEC feels that it is non acceptable to have such exclusion clauses in the standards.

Packaging

In 2000, CEN finished work on several standards concerning the manufacturing and the composition of packaging as well as their re-use or recycling. Unfortunately, the elaborated draft standards proroide no clear-out and product specific requirements and are thus of little use for enforcement. For instance, the standard dealing with prevention allows for excessive packaging if the manufacturer considers it necessary for marketing reasons. The standard on re-use does non even define a minimum number of trips or notations and the standard an material rec ycling only requires compatibility with "known and relevent recycling technologies". ANEC has asked the European Commission non to recognise these draft standards.

High Chairs

At the moment, there is a draft European standard on high chairs for children out of vote, which was prepared by the CEN Technical Commitee on Furniture. ANEC believes that the standard is inadequate and in contradiction to its counterpart on convertible highchairs developed by the CEN Technical Committee on Child care Articles. Whereas the draft standard on convertible highchairs is acceptable to consumers' organisations, the draft standard developed by the Technical Committee on Furniture shows severe deficiencies. It also fails to meet the provisions of the Commission mandate M 264 related to the safety of child-care articles with respect to barriers and the restraint system. The requirements do not sufficiently prevent children from falling off the chair. The work item should be deleted from the work programme of the CEN Technical Committee on Furniture and the scope of the draft standard on convertible highchairs should be expanded to cover all types of highchairs.

Noice limits for toys

Impulsive sounds e.g. produced by toys using percussion caps such as cap pistols are of particular concern to consumers. Exposure to just one impulse can lead to an irreversible damage of the hearing capacity or to tinnitus (buzzing in the ears). Nonetheless, the CEN Committee on Toys set a threshold exceeding the one allowed at the workplace if one takes into account that children sometimes fire these toys very close to their ears. Consequently, Austria and Germany triggered the safeguard cause in accordance with article 6 (1) of the Toys Directive claiming that the standard did not comply with the essential requirements of the directive. Finally, the European Commission did not recognize the relevant part of the toys standard and recommended to fix limits "which are deemed to be safe during normal or foreseeable abusive use of sound-emitling toys".

Child Restraints

If correctly installed, child restraints can reduce child morally by 75% and the number of seriously injured children by 67%. However, several studies show that 50-70% of child restraints are badly installed. ISOFIX - a universal mounting system - was originally developed to reduce the possibilities for incorrectly installed child restraint seats. In order to offer the best possible protection to children, ISOFIX should consist of two lower anchorages and a top telher. Industry favours, however, a two stage process. The ISOFIX standard defines at present only the two lower anchorages of the child restraint system. Consumers are opposed to such a two-stage process, which first introduces the two lower anchorages and then at a later stage a top telher. The latest EuroNCAP can crash tests showed that there was a total ejection of a child from a VW ISOFIX seat, which consisted of the two lower anohorages only. The test illustrated that the two point, forward facing, shield type child restraint seats do not offer the best possible protection to children.

  
ANEC

European Association for the Co-ordination of Consumer Representation in Standardisation

CEN

European Committee for Standardisation whose main objective is to elaborate voluriary technical standards at the European level and for this purpose co-operates with is national counterparts and with international standards bodies.

CENELEC

European Committee for Electro-technical Standardisation, similar to CEN in purposes, membership, constitution and activity whilst the mail difference is that CENELEC deals only with electrical product and services.

Co-Regulation

Alternative regulatory model bridging between legislation and its binding character and the more flexible self-regulation by industry.

ETSI

European Telecommunication standards Institute whose mission is to determine and produce the telecoommunications standards. It is an open forum that unites more than 600 members from more than 40 countries, representing administrations, networks operators, manufactureres, service providers, and users.

ISO

International organisation for Standardisation: worldwide federation of national standards bodies from some 130 countries, one from each country. Its mission is to promote the development of global stadardisation and related activities in order to facilitate internationall exchange of goods and services, and to develop co-operation in the spheres of intellectual, scientific, technological and economic activity. ISO work results in international agreements that are published as International Standards.

IEC

International Electro-technical Commission is the world organisation that prepares and publishes international standards for all eletrical, electronic and related technologies. The membership consists of more than 50 participating countries.

New Approach

The introduction of the New Approach to product regulation is linked to the cornpletion of the European Internal Maket. In New Approach directives, the European legislator restricts himself to harmonise the essential safety requirements whereas the technical solutions are delegated to the three European standards bodies.

Standard

Standards affect the daily life of every citizen. Standards help to make the use of products safer and to prevent accidents (e.g. due to a technical standard, washing machines cannot be opened during operation). A standard is defined as a written document approved by a recognised body. It is available to the public and drawn up on a consensus basis involving all interested parties. The application or a standard, however, is voluntary.

2.2.3.4 Standardisation in other forums.

Herman Köeter, OECD

MAD and Non-Member Countries

Accept data from OECD countries (GLP, TG) Assistance in developing compliance system Participating in OECD work OECD countries accept data from non-OECD countries (GLP, TG)

MAD: international standard open to all interested WTO members OECD Test Guideline Development Process

Procedure for the Development of OECD Test Guidelines

Submission of the Proposal Completion of the Standard Project Submission Form (SPSF) Priority Setting by National CO-ordinators "Conducting the Work: Reaching Scientific Consenus" Adoption of New Guideline

Procedure for the Development of OECD Test Guidelines

1. Submission of the Proposal by:

Member country BIAC TUAC International Scientific Society Secretariat

Procedure for the Development of OECD Test Guidelines

2. Completion of the Standard Project Submission Form (SPSF):

http://www.oecd.org /ehs/test Essential Criteria Desirable Criteria

Procedure for the Development of OECD Test Guidelines

Desirable Criteria to be met before considering a Proposal Guideline intended for general/broad use Scientifically valid, reliable, relevant Addresses endpoints not yet covered Existing national/regional protocols as a basis

Procedure for the Development of OECD Test Guidelines (2)

Desirable Criteria to be met before considering a Proposal Animal welfare concerns are addressed Contributes to saving resources For guidance documents:essential or helpful For guidance documents:linked to a Specific TG or for general guidance

Procedure for the Development of OECD Test Guidelines

3. Priority Setting by National Co-ordinators

By written procedure High,Medium,Low ranking priorities Proposal for the Annual Workplan Endorsement by Joint Meeting

Subject Areas For Which Member Countries Have Nominated National Experts
Physical-Chemical Properties Aquatic Ecotoxicity TerrestrialEcotoxicity Abiotic Degradation Biodegradation	Bioaccumulation Health Effects Exposure Data Analys Animal Welfare
Total number of Experts in the data bade: 6,000

Test Guidelines Programme Expert Review Of Draft Documents

Procedure for the Development of OECD Test Guidelines

7. Adoption of New Guideline

Reaching scientific consenus Approval by National co-ordinators Endorsement by Joint Meeting EPOC Approval for Submission to Council Council Endorsement

2.3 What is the role of the New Approach in promoting environmental innovation? (Session III)

2.3.1 The proposed use of the New Approach in Integrated Product Policy

Otto Linher, Euroean Commission, DG ENV, A.2

European Commission DG Environment
Sustainable Resources, consumption and waste

The Proposed Use of the New Approach in Integrated Product Policy

Otto Linher
European Commission DG Environment
Otto. Linher@ece.eu.int
http://europa.eu.int/comm/environment/ipp

European Commission DG Environment
Sustainable Resources, consumption and waste

What is Integrated Product Policy (IPP)?

Strategic instrument to determine an optimal mix of policies to contribute to the improvement of the environmental performance of products throughout their life cycle

Prioritising, reinforcing and refocusing existing approaches

Complementing them by new elements where appropriate

European Commission DG Environment
Sustainable Resources, consumption and waste

How does it relate to the main EU Strategies and other environmental policies?

	Sustainable Development Strategy
	Sixth Environment Action Programme
	Thematic Strategies on Resources and Recycling

	Chemical Policy
	Waste Policy

European Commission DG Environment
Sustainable Resources, consumption and waste

Life cycle Thinking: The Basic Philosophy of IPP

	Every actor should consider the life cycle environmental performance of preducts as an element in taking his/her decisions on products
	Prioritisation on:

	Where are the biggest environmental impacts?
	Where can we do most to reduce them?