9.8.2008   

EN

Official Journal of the European Union

C 204/13

1.1

This proposal from the Commission for a Decision of the European Parliament and Council seeks to amend Council Directive 76/769/EEC by adding restrictions on the marketing and use of five unrelated substances. Four of these were contained in the original priority lists set out between 1994 and 2000. The measures proposed address risks to the general public only. The last substance, ammonium nitrate, is introduced under this heading to improve the safety of ammonium nitrate based fertilisers during normal handling by farmers and distributors, and as a move to combat terrorism, in particular by limiting access to explosive precursors. In this later case, sales to retailers and to the general public will also be affected.

1.2

The EESC supports some but not all of the proposals made. The detailed arguments for each substance and the preparations in which they are contained are set out in paragraphs 5 to 9.9.

1.3

The EESC recognises that this is, almost, the last such amendment of Council Directive 76/769/EEC before it is replaced on 1 June 2009 by Regulation (EC) 1907/2006 (REACH). However, as with previous amendments, it regrets that unrelated substances and preparations have been brought together in this manner and notes the long delays that have occurred since these were first noted as ‘priority’ substances under Council Regulation (EEC) 793/93. If this is due to resource or skill constraints in the Commission or in other relevant bodies, including the newly formed Chemicals Agency in Helsinki, these must be addressed as soon as possible and certainly before 1 June 2009. Manufacturers must also recognise their obligation to provide relevant information in a timely fashion during the risk assessment. Without this discipline, the outcomes rapidly become meaningless.

1.4

Finally the EESC clearly supports the Council's Declaration on Combating Terrorism and the many individual actions that follow from this. The EESC believes that it has a key role to play in this process and is currently developing a number of Opinions on this topic. Agreeing what actions are proportionate and which legislative routes should be followed to ensure timely and effective responses from all those affected will be critical to achieving long term security.

2.1

Regulation (EC) No 1907/2006 of 18 December 2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) will come into effect on 1 June 2009. This will repeal and replace a number of existing Council and Commission Regulations and Directives, including Council Directive 76/769/EEC of 27 July 1976 on the marketing and use of certain dangerous substances and preparations. This Directive, to which this proposal is an amendment, is designed to preserve the Internal Market and at the same time ensure a high level of protection of human health and the environment.

2.2

Annex I of Council Directive 76/769/EEC sets out the specific restrictions on the marketing and use of certain dangerous substances and preparations that have been agreed and put in place over the last 30 years. On 1 June 2009 these will become the cornerstone of Annex XVII of Regulation (EC) No 1907/2006 (REACH).

2.3

Previous amendments to Council Directive 76/769/EEC (i.e., to add further restrictive measures) have been in the form of Directives requiring implementation by Member States. This proposal by the Commission is, for a Decision, which will not require transposition into national laws which would otherwise have to be repealed on 1 June 2009 when Regulation EC No 1907/2006 (REACH) comes into force.

2.4

It is understood that a final proposal under Council Directive 76/769/EEC will be brought forward in the coming months, also for a Decision, on restrictions on the marketing and use of dichloromethane. All subsequent proposals for restrictions on the marketing and use of dangerous substances or preparations will be under Regulation EC No 1907/2006 (REACH).

2.5

The substances (and any preparations containing them) for which restrictions on marketing and use have been deemed necessary have generally resulted from evaluations of certain ‘priority substances’ under Council Regulation (EEC) 793/93. Four priority lists for assessment were established, the last of these being dated 30 October 2000, for implementation by the competent authorities in the member states. Of the 141 substances listed, 83 have final Risk Assessment Reports (RARs). 39 of these have been evaluated by the appropriate scientific committees of the EU and the results published in the Official Journal. Restrictive measures have been agreed for 22 of these substances. Restrictive measures for a further 4 substances (identified and discussed below in paragraphs 5 to 9.9 as DEGME, DEGBE, MDI and cyclohexane) are included in this proposal.

2.6

The slow progress made under this Regulation was cited as one of the main reasons for introducing a new approach for all ‘existing’ substances under Regulation EC No 1907/2006 (REACH). Council Regulation (EEC) 793/93 will therefore also be repealed on 1 June 2009.

2.7

A number of substances not included in the original four priority lists have also been assessed for their impact on human health and the environment, and/or proposals made to restrict their marketing and use, as new problems have been addressed at the request of the member states. Ammonium nitrate is included under this heading.

2.8

Ammonium nitrate is a peculiar and particular case in that its characteristics are well known and it did not therefore require evaluation for its effects on human health or the environment. It has been used for many years in very large quantities world-wide as a nitrogen-based fertiliser and poses no unexpected risks in the work place or to professional users or to consumers for domestic scale application. Unfortunately it is also an effective, low cost and widely used component of explosives, for legitimate use in industrial or military blasting and for illegitimate use by terrorists. It is on these grounds that restrictions on its marketing and use are sought under Council Directive 76/769/EEC.

2.9

Other bases for legislation addressing terrorism or explosive precursors could have been chosen, but, under the existing EU Treaty, would have required unanimity across the member states. The process will change under the Treaty of Lisbon, when fully ratified, but that too will not be for some time.

2.10

It is understood that other drug and explosive precursors are likely to be added to Annex XVII of Regulation EC No 1907/2006 (REACH), therefore this course of action is deemed appropriate at the present time.

2.11

All of the above refers to ‘existing’ substances, i.e., the 100,195 substances that were deemed to have been on the European Community market between 1 January 1971 and 18 September 1981. These are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) published in the Official Journal of the EU in 1990. Substances placed on the market after 18 September 1981 are defined to be ‘new’ and require a detailed pre-marketing notification in order to protect human health and the environment.

3.1

The Commission's proposal seeks to protect human health, in particular of consumers, whilst preserving the Internal Market for three substances (DEGME, DEGBE and cyclohexane) taken from the 1st priority list, dated 25 May 1994, and one substance (MDI) from the 3rd priority list, dated 27 January 1997, as established under Council Regulation (EEC) 793/93.

3.2

In line with Commission Recommendation 1999/721/EEC of 12 October 1999, and with subsequent similar Recommendations on the results of the risk evaluation and risk reduction strategies for a number of substances, a series of specific and very detailed restrictions are proposed which will apply only to sales to the general public and will not have any impact on conditions in the work place or on the environment. The costs to industry and to society at large are believed to be minimal and therefore the actions proposed are believed to be proportionate to the risks identified. Further health data are requested in the case of preparations containing MDI.

3.3

A fifth substance, ammonium nitrate, used widely as a fertiliser, is added because of its ability to act as an oxidant and, in particular to explode when mixed with other substances. The restrictions proposed are intended to ensure that all ammonium nitrate fertilisers meet a common safety standard and in addition to limit the range of ammonium nitrate based products sold to the general public with the aim of reducing the quantities that can be easily diverted into illegal uses. Thus the restriction may be said to benefit the health and safety of the public at large. Professional users (farmers and legitimate manufacturers of explosives) will not be affected by this restriction. Although the costs (and benefits) are proving difficult to quantify, they are believed to be proportionate to the risks identified (and measures proposed).

3.4

The Decision would come into force on the third day following that of its publication in the Official Journal of the EU.

3.5

The proposal is accompanied by an explanatory memorandum, a Commission staff working document (impact assessment report) and, for the four substances assessed under Council Regulation (EEC) 793/93, lengthy and detailed Risk Assessment Reports (RARs) published by the European Chemicals Bureau, together with additional material, both supportive and critical, from the various scientific committees and other bodies that have helped prepare or evaluate the relevant data.

4.1

As with many of the previous amendments to Council Directive 76/769/EEC, this proposal deals with unrelated substances which, for clarity, will be discussed separately.

5.1

DEGME is a high boiling glycol ether miscible with water, typically used as an intermediate in synthetic chemistry, as co-solvent in various household decorative products, or as a low temperature anti-icing agent, for instance in jet fuel. According to the RAR prepared for the Dutch Government and completed in July 1999, total production in Europe at the start of the 1990s was around 20 000 tonnes, of which just over half was for export.

5.2

Consumer exposure resulted from its use in paints and paint strippers supplied for domestic non-professional ‘do it yourself’ (DYI) application. As would be anticipated from its physical properties, DEGME is readily absorbed through the skin and, in the absence of any regular and guaranteed use of protective clothing, there was a risk to consumers via dermal exposure.

5.3

According to the most recent surveys, DEGME has now been replaced by other solvents in all paints and paint strippers sold to the general public. Therefore the appropriate action is to ensure that this situation continues for products manufactured in, or imported to, the EU. The proposal therefore ensures that, from 18 months after the entry into force of the Decision, DEGME shall not be placed on the market as a constituent in paints or paint strippers in concentrations equal or higher than 0.1 % by mass (i.e., at anything above levels caused by contamination of or co-production in other permitted constituents). This is seen as being a reasonable response by the industry sectors affected. The EESC therefore supports this limitation on the marketing and use of DEGME.

6.1

DEGBE is also a member of the glycol ether family, with a slightly higher boiling point than DEGME but with similar physical properties, including miscibility with water. It is widely used as a solvent in water-borne paints where it helps film formation and increases durability. This in turn reduces the frequency of painting and limits overall exposures. The RAR estimated total production in Europe to be around 46 000 tonnes in 1994; by 2000 this had increased to 58 000 tonnes, of which 33 000 tonnes were used in paints.

6.2

The RAR identified some risks to consumers of respiratory irritation following the inhalation of fine droplets during the use of water-borne spray paints containing DEGBE. Inhalation of vapour arising from brush or roller applications was not of toxicological concern.

6.3

Based on evidence submitted after the completion of the RAR in 1999, and recognising the difficulty of replacing DEGBE as a vital component in water-borne paints, it was concluded that the fixing of a maximum level of 3 % by mass for DEGBE in paints designed for spray application would be appropriate to protect the health of consumers. Paints with higher concentrations of DEGBE may be placed on the market for supply to the general public, but only with the marking ‘Do not use in paint spraying equipment’. Sales to professional users, who are more likely to use the appropriate protective equipment, will be unaffected. The distribution channels are regarded as being sufficiently different to make this possible.

6.4

These measures will become effective 18-24 months after the Decision comes into force to allow time for any reformulation and re-labelling required. This is seen as being a reasonable response by the industry sectors affected. The EESC therefore supports this limitation on the marketing and use of DEGBE as being the appropriate way to protect the health of consumers and to preserve the Internal Market.

7.1

MDI is the name given to a mix of similar products (isomers) which if pure would exist as waxy solids but are more generally available as a highly reactive viscous brown liquid. According to the RAR, worldwide production in 1996 exceeded 2 500 000 tonnes, of which at least 500 000 tonnes were produced in the EU. In the presence of suitable low weight polyols or glycols (or even water) and a blowing agent, MDI reacts extremely rapidly to produce polyurethane foams. These can be either rigid or flexible with a wide range of uses in the building and other trades as structural components, sealers, fillers, moulds and adhesives.

7.2

Consumer exposure comes primarily from the use of one-component foams (OCF), sold in spray cans to DIY enthusiasts to fill irregular holes in plaster or brick work or to seal around newly installed doors or windows. Total sales to this sector are around 10 000 tonnes per annum of MDI. This is sufficient for the production of around 36 million cans per year for consumers and a further 134 million cans per year for professionals. Alternative products — for instance glass fibre to seal around windows — are less convenient to use and would bring a different set of concerns.

7.3

Quantifying the risks to consumers for dermal and respiratory exposure and sensitisation, based on evidence from work place exposures, has not proved easy. Pure samples of the isomers are hard to obtain. The very rapid reaction of MDI with water to make an inert insoluble solid makes standard hazard testing difficult. The practical application route for a consumer of spraying via a directional tube from a small hand-held can limits the total amount available. A standard can is emptied in 2-4 minutes. Rapid curing in the presence of water vapour in the air removes the MDI. The solid end product is inert and non-hazardous. Usage is likely to be once-off (to fill or seal a particular hole, door or window) and infrequent (for most users) and certainly does not replicate daily exposures under shop floor conditions. As ever in DIY applications, personal protective equipment may or may not be routinely used.

7.4

Given the above, it is not surprising that, although a theoretical risk exists, it has proved difficult or even impossible to identify any cases of actual dermal or respiratory sensitisation in the public at large (or indeed in the work place where appropriate protective measures can be put in place). This in turn means that identifying a proportionate, cost-effective, and practical response is more difficult.

7.5

In this respect the impact assessment reasonably points out that whilst light weight, cheap and perfectly adequate polyethylene gloves can, and should, be provided with each can sold to the general public for once-off occasional use, heavy duty neoprene or nitrile gloves, as required for industrial applications, can not. In contrast, whilst light-weight cotton dust masks could be supplied with each can, they would be ineffective in the case of actual risk — whereas a full gas mask to protect against all possible gaseous exposures would cost around ten times the cost of the can, with no guarantee that it would be used when required.

7.6

The Commission therefore proposes that all cans sold to the general public should contain polyethylene gloves (for instance, folded into the cap) and that the can should be suitably labelled with respect to the dangers of allergic (non-standard) reactions to MDI from those already sensitised, or of asthma like reactions (from asthma sufferers) or of dermal reactions (from those already suffering from skin problems).

7.7

The EESC supports the first of these measures, i.e., the provision of polyethylene gloves which should be worn in any case for most DIY applications. Any requirement for these to conform to a more stringent standard which would prevent the gloves from being distributed should be resisted if this important and proportionate measure is to remain enforceable.

7.8

The EESC questions however the detail of the proposed additional labelling, even if due time is given to allow this to be introduced at proportionate cost. It is unclear, for instance, how a member of the general public would know that they had been ‘sensitised to diisocyanates other than MDI’ — or why that is particularly important. As sufferers from chronic (long term) asthma or dermatitis will be aware, almost any household or DYI product can bring about an acute (short term) adverse reaction. In these circumstances, the importance of good ventilation and the use of protective clothing (gloves) are all important — together with advice to cease any use of the product immediately if the symptoms occur. This is good advice for all users, whatever their past history, and must be included on the label. Given that the cans, and therefore their labels, are small, all such advice must be clear, to the point and legible under normal conditions of use. If further handling or safety instructions are required, these should be included in any accompanying leaflet.

7.9

The EESC also questions the proposal in indent (6) that ‘natural or legal persons placing on the market for the first time preparations containing MDI … shall within 3 years collect data on possible cases of persons suffering from respiratory allergy … and make these data available to the Commission .. in accord with a study protocol that shall involve specialised centres …to demonstrate that there is no need for further restrictions’. Given that MDI has been in routine use since the 1970s, and that, as noted above, current sales exceed 36 million cans per year from existing manufacturers who are excluded from this requirement, it is difficult to see this as being anything other than a poorly justified bar to market entry.

7.10

The Commission's impact assessment report explains that this follows from a concern expressed in the RAR that ‘some risks for respiratory allergy for workers … could potentially be relevant for consumers’. Later in the same paragraph it states that ‘information currently available from poison centres seems to indicate that there are no or few cases of respiratory allergy of consumers caused by MDI containing products’. Whatever the alleged limitations of this reporting route, it is unclear that the proposal by the Commission would be any more definitive. This proposal therefore seems disproportionate to a risk that is acknowledged to be hypothetical and which lacks any supporting evidence following actual widespread use.

7.11

The EESC therefore recommends that this part of the restriction on marketing and use is withdrawn. If there are still valid doubts over the safety of these products, which cannot in the short term be replaced, these should be explored with the manufacturers and proper processes for the collection of data and for their evaluation followed.

8.1

Cyclohexane is colourless liquid made in very large quantities by the hydrogenation of benzene. It is almost entirely (>95 %) used in the synthesis of adipic acid and, from that, nylon. World wide production capacity currently exceeds 5 000 000 tonnes, of which around 1 500 000 tonnes is located in the EU. These processes are in closed systems and exposure levels are low. Cyclohexane also occurs naturally in combustion products, including tobacco smoke, in crude oil and plants, and in gasoline vapours.

8.2

Cyclohexane is also used as a solvent for, amongst other things, the neoprene-based contact adhesives used in the leather (shoes), automobile and construction industries. This in turn includes large scale carpet laying by professionals and similar smaller scale repairs or other DIY applications by the general public. Total usage in adhesives in the EU is less than 10 000 tonnes per year.

8.3

As with all hydrocarbons, good ventilation and the use of appropriate protective clothing or breathing equipment is essential. This can be reasonably guaranteed for professional use, but not for members of the public. However, as with preparations including MDI, the physical characteristics of the products marketed significantly limit the risks. The fast-setting contact adhesives are ideal for small applications but are extremely difficult for a non-professional to use satisfactorily on a large scale. A limitation on package size for the products sold to the general public would therefore seem appropriate and generally acceptable.

8.4

The Commission therefore proposes that cyclohexane shall not be placed on the market as a component of neoprene-based adhesives for sale to the general public in packages of more than 650 grams. Any packages sold should be marked ‘Do not use for carpet laying’ and should show a warning ‘Do not use under conditions of poor ventilation’.

8.5

Practical tests for worst case scenarios, for instance fixing large cork panels to an interior wall, suggest that this would adequately limit consumer exposures which, as in the other cases discussed above, would be expected to be infrequent and short-lived. There appears to be no evidence of actual incidents being reported from the use of neoprene-based adhesives despite their wide-spread and long term use. The measures can however be introduced without undue disruption to either manufacturers or consumers. The EESC therefore supports this limitation on the marketing and use of cyclohexane as being proportionate to the risks discussed.

9.1

Ammonium nitrate is a white solid, sold in pellets, that has been produced from ammonia from natural gas for more than 100 years. World-wide production exceeds 20 000 000 tonnes. It is important as a nitrogen fertiliser and as a raw material for explosives. This latter capability and its ready availability and low cost have attracted the interest of terrorists. Other components are required, for instance diesel oil, but these too are easy to acquire. Ammonium nitrate was for many years the explosive of choice for the IRA and was also used in high profile bombings in Oklahoma, the World Trade Centre and Bali. It has recently been used in attacks by extremist groups operating in London and other European capitals. Recipes for the production of such devices are readily available on the internet. As little as 2 kg can prove devastating. Quantities in excess of 500 kg can seemingly be obtained without difficulty by determined members of the general public, if necessary by the repeat buying of smaller quantities from garden shops or retail stores. Controlling this is clearly difficult.

9.2

For professional users (farmers) control is exercised via maintaining large minimum sizes of shipment (so that a single package cannot easily be transported or removed illegally) and by requiring careful product stewardship at all stages of the supply chain. Ammonium nitrate as generally supplied is unstable and may decompose and become unusable. It must therefore be stored carefully and applied to the ground as soon as possible. This limits the amounts available for diversion to other uses.

9.3

Ammonium nitrate may be supplied in a number of strengths ( % nitrogen content) and with or without other essential elements (typically phosphorus and potassium derivatives). In its pure state it is approximately 35 % nitrogen. Some dilution is necessary to avoid damage to vegetation. The different qualities may be manufactured by blending in active components or inert fillers, such as chalk, or by chemical reactions to produce the desired ratio of key ingredients. Products sold to farmers may have 28 % or more of nitrogen. These ‘high nitrogen’ fertilisers are subject to controls under Regulation (EC) No 2003/2003 to ensure that they deliver the required quantity of nitrogen and can be safely used without the risk of explosion. Fertilisers conforming to these standards can be labelled as ‘EC fertilisers’ and can be traded across national borders. Fertilisers that do not meet these standards cannot cross borders and are known as ‘national fertilisers’. Consumer products typically have 20-25 % nitrogen. The lower the percentage of nitrogen, the higher the transport costs per unit of fertiliser and the greater volume that must be applied to a given area. Although ammonium nitrate fertilisers are regarded as essential for commercial farming, this is not the case for the much smaller volumes sold via retail outlets to the general public, and other products may be substituted.

9.4

From the point of view of anyone seeking to make illegal explosives, the higher the nitrogen content of ammonium nitrate the better. Mechanically blended mixes can be re-concentrated via simple solution and crystallisation. Chemically bound mixes are harder or impossible to concentrate. Concentrations as low as 16 % have been made to explode by government experts in Denmark. Given time and resource anything is possible, although competing formulations using equally available raw materials eventually become more attractive. These are set out in the Terrorist's Handbook and other web-based resources available to the general public.

9.5

Following the Madrid bombings in March 2004, the European Council agreed a Declaration on Combating Terrorism. This set up an Explosives Security Experts Task Force (ESETF) charged with developing an Action Plan to combat the use of explosive devices by terrorists. This was completed in June 2007. One of the 47 specific actions required the setting up of a Standing Committee of Experts on Explosive Precursors (SCEEP). A number of private and public sector specialists are involved in this, with inputs from CEFIC and FECC, representing chemical manufacturers and distributors, and EFMA representing fertiliser manufacturers.

9.6

The intent of the current proposal is to bring all ammonium nitrate fertilisers sold to farmers (or distributors) up to the standards set out in Regulation (EC) No 2003/2003 and to limit the nitrogen content of products sold to the general public. If adopted, ammonium nitrate could not be placed on the market for supply to the general public from 18 months of the Decision coming into force ‘as a substance or in preparations that contain 20 % or more by mass of nitrogen in relation to ammonium nitrate’.

9.7

The EESC fully supports the first part of this proposal that all ‘high nitrogen’ fertilisers supplied to farmers, whether or not traded across national borders, should comply with Regulation (EC) No 2003/2003.

9.8

With regard to the second limitation, with respect to sales to the general public, the EESC notes that the volumes concerned may be larger than previously thought, at more than 50 000 tonnes and that EFMA, acting for fertiliser manufacturers, has accepted the 20 % limit for blended fertilisers (which could be re-concentrated without too much difficulty) but has proposed a limit of 24,5 % for chemically bound products (where this is much harder). Given that discussions are ongoing within SCEEP, this and any related possibilities need to be fully explored before the Decision is finalised. Whatever else is known about countering terrorism, it is clear that full agreement and commitment between the various stakeholders, in this case including manufacturers, distributors, retail outlets and the general public, will be essential if real progress is to be made on limiting access to explosive precursors.

9.9

The EESC accepts with some reluctance that Council Directive 76/769/EEC is the only basis for legislation available to the Commission in the short term, and that therefore the measures have to be proposed and discussed in this manner. It is to be hoped that a better system can be put in place, once the Lisbon Treaty has been fully ratified.

10.1

The EESC regrets, as it has done in its Opinions on previous amendments to Council Directive 76/769/EEC, that these continue to bring together unrelated products on which quite separate decisions must be taken. This is not good practice and serves no useful purpose. It is certainly not an example of good governance. It can only be hoped that an improved procedure will be in place from 1 June 2009 under Regulation (EC) No 1907/2006 (REACH).

10.2

The EESC also notes the long time taken to bring these to fruition. The first priority list was published in May 1994. Even if this proposal is fast-tracked as desired, there will be little impact on the market until the end of 2010 (and indeed even then, it is difficult to see that any improvements in human health will be recorded). It is also difficult to portray these delays as being entirely due to the manufacturers who were required to supply the data upon which the RARs are based, as these have been available for some time. If this is due to lack of resource within the Commission or its scientific committees or other bodies or agencies responsible for the safety of the general public, this must clearly be addressed before a much greater work load, largely unprioritised, becomes evident from 1 June 2009 onwards.

10.3

The EESC clearly supports the Council's 2004 Declaration on Combating Terrorism and the various actions that have followed from this, and believes that civil society has a key role to play in this. It therefore hopes to be considered a valid and useful interlocutor and stakeholder in this process and notes that a number of related Opinions are currently being prepared on this topic. Agreeing what actions are proportionate and which legislative routes should be followed to ensure timely and effective responses from all those affected will be critical to achieving long term peace and security within and around the EU.