House of Commons - Science and Technology

Select Committee on Science and Technology Written Evidence

APPENDIX 8

Memorandum from the WWF

EXECUTIVE SUMMARY

— WWF, the global environment network works at the cutting edge of research into global chemical contamination and is a well-respected not-for-profit organisation working on chemicals policy in Europe.

— Humans and animals the world over the have been exposed to man-made industrial or agricultural chemicals and there is ever increasing evidence to suggest that certain hazardous man-made chemicals have been linked to a rising rate in certain cancers, birth defects, genital deformities, reproductive problems and effects on children's brain development and immune systems.

— In order to secure the objective of protecting human health and the environment, it is vital that exposure to chemicals of very high concern are eliminated, wherever possible. Therefore, WWF considers that the use of chemicals of very high concern, including very persistent and very bioaccumulative chemicals and endocrine disrupting chemicals, should only be authorised when there is a no safer alternative, and an overwhelming societal need, and measures to minimise exposure are in place. WWF considers that the availability of a safer substitute should, by itself, be grounds for the regulators to refuse to authorise the use of such chemicals.

— Failure to ensure the substitution of chemicals of high concern would mean that humans and wildlife would continue to be exposed to hazardous man-made chemicals and would not deliver a move away from the worst chemicals, nor stimulate the innovation of safer alternatives. Therefore, the costs of the new system would be incurred without achieving the benefit of reducing the risks that these chemicals of very high concern pose to human health or the environment. Moreover, because innovation would not be encouraged, the EU would not be well placed to reap a growing share of the world market for greener products and safer alternatives.

— WWF does not believe that it should be necessary to prove that serious and irreversible effects are caused by chemicals meeting the criteria for very high concern, before action is taken to eliminate exposure. These chemicals are clearly undesirable, without having to conduct many animal tests to elucidate fully their toxicity. The fact that the unborn child is particularly at risk from these chemicals, supports a precautionary approach.

— Industry should be required to provide sufficient toxicity data on their chemicals in order to enable good risk management decisions to be taken, with regard to both environmental and human health.

— WWF considers that Member States should be given a mandatory duty to carry out a minimum annual number of evaluations of the substance safety assessments provided by industry on its chemicals. This would enhance quality control, the prioritisation and review of problematic substances, and would also ensure that the Member States' authorities have the resources for this important work.

— WWF recommends that all authorisations should be time-limited, and subject to review at least every five years.

— WWF believes that importers should have the duty to ensure that all the chemicals in articles/ products they import comply with any restrictions on use and are registered in the EU. If not, then they (or their supplier) should apply to register the chemicals contained in them. Failure to do so will mean that there is a continued risk to our health and the environment and the competitiveness of specific industry sectors.

— WWF considers it vital that an independent mandatory evaluation of the quality and content of the registration dossiers is required in order to ensure the accuracy of registration dossiers.

— WWF believe that data sharing must be made compulsory to ensure duplicate animal testing is avoided.

— Public access to all toxicity, fate, exposure, use categories, and risk assessment data should be ensured.

— WWF supports prioritisation in that chemicals that are known to meet the criteria for very high concern should be brought into registration in the first tranche. In addition, WWF considers that there should be prioritisation to ensure that the worst chemicals that have undergone registration are evaluated as a priority, and to ensure that the worst chemicals of very high concern go through to the prior authorisation process first. However, WWF does not support a risk-based prioritisation process to queue chemicals into the REACH registration process, or indeed, to determine which chemicals should be brought under the registration process at all.

— WWF rejects the argument that REACH will be economically damaging and believes that there is no evidence to suggest that increasing environmental constraints have either slowed overall growth rates or disadvantaged certain countries economically. In addition, research has shown that there is little evidence to suggest that environmental regulations have significant effects on employment.

— WWF believes that the REACH Regulation will bring many benefits to business, including new markets for safer and more environmentally friendly products, reduced risk of future liability lawsuits, easier introduction of new chemicals, a more predictable regulatory system, and improved transparency and communication through the supply chain, leading to increased influence and confidence for downstream users and SMEs.

— In addition, the REACH Regulation will provide health benefits both for the public at large and for workers. Chemical substances are considered to play a major role in inducing allergies, and have been linked with occupationally caused cancer and work related skin disease. In October 2003, the Commission published an impact assessment of its new draft text, which reported that the estimated total current worst case costs of REACH, both for producers and downstream users, are 5.2 billion euros spread over 10 years, whilst the health benefits are roughly estimated to be around 50 billion euros over 30 years. Professor David Pearce, in a report commissioned by WWF, suggests that the value of the health benefits could be far higher, and easily exceed 100 billion euros.

— The UK government should be leading the way by supporting a robust Chemical Regulation, which protects future generations of humans and wildlife. A regulation, which encourages phase out of the most hazardous chemicals will be good, not only for humans and wildlife, but for business and innovation too. It will provide an improved framework for innovation in the chemicals sector, and contribute to the development of green chemicals. It could strengthen the competitiveness of the chemicals industry and provide new markets for safer and more environmentally friendly products. This is a key chance for the UK Government to promote the development of our chemicals industry and to grasp this opportunity for greater innovation, competitiveness and consumer choice.

— In future, we therefore urge the UK Government:

— to prioritise the needs of public health, our wildlife and the environment;

— to recognise the business, health and environmental benefits of the EU Chemical Regulation;

— to commit clearly to a robust Chemical Regulation, which incorporates the substitution principle and phases out the most harmful chemicals where safer alternatives exist; and

— use its leverage within the EU to push other key member states to support a similarly robust position.

INTRODUCTION

Humans and animals all over the world have been exposed to man-made industrial or agricultural chemicals. There is now unequivocal evidence that chemicals have already caused serious damage to the health of wildlife. Moreover, there is ever increasing evidence to suggest that certain hazardous man-made chemicals have been linked to a rising rate in certain cancers, birth defects, genital deformities, reproductive problems and effects on children's brain development and immune systems. However, the full extent of the problem is unclear because adequate toxicity data are only available for a small percentage of the many thousands of chemicals in everyday industrial and domestic use.

WWF is uniquely well place to provide expert opinion and analysis on this global problem. For well over 10 years, WWF has led the way in cutting edge research on chemicals and was one of the first organisations to publish evidence of the pervasive and global problem of chemical contamination. Earlier in 2003, WWF in association with the WI and The Co-operative Bank, launched a Chemicals and Health Campaign which is calling for very hazardous man-made chemicals, that is, chemicals of very high concern, to be properly regulated, and replaced where safer alternatives exist.

WWF believes that the REACH proposal for the reform of EU chemicals legislation has the potential to make a significant contribution to sustainable development. REACH could ensure a high standard of protection of human health and the environment, whilst simultaneously encouraging innovation towards safer and greener products. However, WWF considers that the Commission's proposal needs to be significantly improved to achieve these aims. Therefore, WWF welcomes this opportunity to comment on this timely Science and Technology Committee Inquiry into the EU Chemical Regulation.

Part 1 of this briefing outlines the key amendments that in WWF's opinion need to be made to the current draft of the EU "REACH" regulation. As requested, these are documented in WWF's order of priority. In order not to loose clarity, minor additional amendments, which would need to be made elsewhere in the proposed text to ensure consistency with these proposals, have not been addressed in this document. Extracts of the draft REACH legislation are shown in boxes with suggested amendments in bold. A resume is also provided of the consequences that would result, were these key amendments not made.

Part 2 comments on two other topical issues, namely prioritization, and the costs and benefits of the regulation. Part 3 outlines the role played by the UK Government, and what actions need to be taken by the UK Government, in the final stages of the legislative process.

WWF'S PRIORITY AMENDMENTS

1. CLEAR PREFERENCE SHOULD BE GIVEN TO SUBSTITUTION RATHER THAN CONTROL TECHNIQUES

In order to secure the objective of protecting human health and the environment, it is vital that exposures to chemicals of very high concern are eliminated, wherever possible. And the best way to ensure exposures are eliminated, is to substitute the chemical of very high concern with a safer alternative. Therefore, WWF considers that the use of chemicals of very high concern should only be authorised when there is a no safer alternative, and an overwhelming societal need, and measures to minimise exposure are in place. Thus, WWF considers that the availability[3] of a safer substitute should, by itself, be grounds for the regulators to refuse to authorise the use of such chemicals. A safer substitute would be one that was judged not to meet the criteria for chemicals of very high concern and which had an acceptable acute toxicity profile.

It is very difficult to ensure chemicals are properly controlled during their entire life cycle, and even good control measures can result in appreciable exposures. The aim must be to eliminate exposure to substances of very high concern, because for many of these substances, such as carcinogens, there may be no safe level. Moreover, for persistent and bioaccumulative chemicals, and endocrine disrupting chemicals, there may be additive effects due to the total burden of exposure to harmful chemicals. Therefore, there is a clear case for measures that seek to eliminate, rather than to control, exposure. This can be best delivered by substitution, and although substitution was one of the stated central objectives of the Commission's White Paper,[4] the European Parliament,[5] and the EU Council of Ministers,[6] it still needs to be given more prominence in the legislation.

Therefore WWF suggests that the following amendment should be made:

Article 52 of the draft legislation states that

"The aim of this Title is to ensure the good functioning of the single market whilst assuring that the risks from substances of very high concern are properly controlled or that these substances are replaced by suitable alternative substances or technologies."

Replace with

The aim of this Title is to ensure that substances of very high concern are replaced by suitable alternative substances or technologies where available, or that such alternatives are developed where they are not already available

2. AUTHORISATIONS SHOULD ONLY BE GRANTED WHEN THERE IS NO SAFER ALTERNATIVE, AN OVER-WHELMING SOCIETAL NEED FOR THE CHEMICAL EXISTS, AND MEASURES TO MINIMISE EXPOSURE ARE IN PLACE. THE AVAILABILITY OF A SAFER ALTERNATIVE ALONE SHOULD THEREFORE BE GROUNDS TO REFUSE AUTHORISATION

WWF is very concerned about the process for granting an authorisation. The draft legislation continues to allow industry to carry on using (gain an authorisation for) chemicals of very high concern. Industry can either claim an adequate control of the risk or if they can't do that, then an authorisation can still be granted if the socio-economic benefits outweigh the risks.

The chemicals that require prior authorisation are deemed to be chemicals of very high concern because they possess certain intrinsic properties. They include PBTs (persistent bioaccumulative and toxic substances), vPvBs (very persistent and very bioaccumulative substances), CMR 1 & 2s (carcinogens, mutagens and chemicals that are toxic to reproduction), EDCs (endocrine disrupting chemicals) and other chemicals of equivalent concern. WWF is concerned that if the Commission accept industry's arguments that the risks of such chemicals are adequately controlled, they must authorise the use of the chemical, even if a safer alternative is readily available. This will not drive substitution.

Annex 1, section 6 gives an indication of what adequate control of the risk may mean for PBT and vPvB chemicals. This outlines that for these chemicals, risk management measures that "minimise exposures" are needed [6.5]. However, even small exposures to bioaccumulative chemicals can lead to the chemical building up over time, and unforeseen exposures have often occurred in the past. The presence of chlorinated paraffins, brominated flame retardants, synthetic musks and numerous other man-made chemicals in human body fat, bear testimony to this. PBT and vPvB chemicals may also eventually leach from landfill sites, such that it is difficult if not impossible to contain exposures over the cradle to grave life-cycle. It would certainly be better to substitute carcinogens for safer chemicals, as it is widely recognised that for some carcinogens there may be no safe level of exposure. Similarly, for chemicals with endocrine disrupting properties, these chemicals modulate a biological system that is already active, such that even small amounts may have effects.

Therefore, WWF considers that the intrinsic properties of the chemicals that are designated as chemicals of very high concern, means that the risks cannot be adequately controlled, unless exposure is eliminated. This can only reliably be achieved by stopping the use of such chemicals, and using safer alternatives instead.

In cases where suitable alternatives do not currently exist, and the socio-economic benefit accrued to society genuinely outweigh the risks, then WWF considers that a time limited authorisation could be granted, albeit linked with a timetabled substitution plan. Such a strategy, for example, would allow the use of a persistent and bioaccumulative (fictitious) composite material in a false hip-joint that brought mobility to thousands of elderly people, but would not allow it to be used in plastic storage boxes. In other words, where there is a robust case for the continued use of substances of very high concern, based on socio-economic benefit and unavailability of suitable alternatives, the option clearly remains for authorisation to be granted. In this way, truly essential uses of these substances will not be prevented. Thus, WWF proposes that there should be only one route for obtaining an authorisation.

Failure to encourage the substitution of chemicals of high concern would neither ensure a move away from the worst chemicals, nor would it stimulate the innovation of safer alternatives. Therefore, the costs of the new system would be incurred without achieving the benefit of reducing the risks that these chemicals of very high concern pose to human health or the environment. Moreover, because innovation would not be encouraged, the EU would not be well placed to reap a growing share of the world market for greener products and safer alternatives.

In addition, allowing industry to argue that the risks were adequately controlled, could either result in the system floundering under a very time consuming risk assessment process, or it could potentially result in chemicals being authorised without adequate investigation of the case made by industry.

It should be recognised that the slow progress of the existing regulation 793/93 was one of the main reasons that the new REACH legislation was proposed. There is therefore a need to cut short discussions on what is an "adequate control of the risks". For example, past experience with the risk assessment process under the current legislation, suggests that what industry considers to be "adequate control of the risk" may fall below the necessary level of health and environmental protection. For example, in the past, when regulatory controls have been on the horizon under the Existing Substances Regulation, industry has claimed that its products are safe for use. Take the case of penta-BDE, a brominated flame retardant chemical, found as a contaminant in breast milk in Europe and the USA. The regulatory authorities commenced the risk assessment of this chemical in the late 1990s. But industry would not accept that there was any need for concern. In October 1999, industry submitted a paper stating that when the whole breast milk issue was put into perspective, the only rational and scientific conclusion was that there was no need for further information and/or testing and no need for any more risk reduction measures.[7] In contrast to this, the EU authorities subsequently decided that a ban was needed.[8] Therefore, in order to short circuit tortuous discussions on what is an `adequate' control of the risk, in WWF's view, if safer alternatives are available then industry should have to use them. After all, we are talking about the worst chemicals, so surely this no more than common sense.

Therefore WWF believes that Article 57 paragraphs 2 and 3, should be replaced as detailed in the following:

Article 57, relating to authorisations, states:

"An authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIII is adequately controlled in accordance with Annex 1, section 6, and as documented in the applicant's chemical safety report.

The Commission shall not consider the following:

— risks to human health and the environment of emissions of the substance from an installation for which a permit was granted in accordance with Council Directive 96/61/EC (our insert = the IPPC Directive);

— risks to and via the aquatic environment of discharges of the substance from a point source governed by the requirement for prior regulation referred to in . . . Directive 2000/60/EC . . . (our insert = the );

— risks to human health arising from the use of a substance in a medical device . . .

If an authorisation cannot be granted under paragraph 2, an authorisation may be granted if it is shown that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies.

This decision shall be taken after consideration of all the following elements:

— the risks posed by the uses of the substance;

— the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise . . .

— the analysis of the alternatives submitted by the applicant . . . and any third party contributions . . .

— available information on the health or environmental risks of any alternative substances or technologies."

Suggested replacement

"An authorisation may be granted only if there are no suitable alternative substances or technologies, and if it is shown that the socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance, and if measures to minimise exposure are put in place.

This decision shall be taken after consideration of all the following elements;

— the risks posed by the uses of the substance;

— the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise . . .

— The analysis of alternatives submitted by the applicant . . . and any third party contributions . . .

— Available information on the . . . risks of any alternative substances or technologies."

3. SUBSTANCES TO BE INCLUDED IN THE AUTHORISATION PROCESS—SHOULD NOT NEED TO BE SHOWN TO GIVE RISE TO SERIOUS AND IRREVERSIBLE EFFECTS

WWF is pleased that category 1 and 2 CMRs and PBT and vPvB chemicals are to be brought under the authorisation process. However, in an alarming move initiated by the Commission in the final days before the draft text was released, an addition was made to the draft text which stipulates that there is a need to show serious and irreversible effects before a chemical of equivalent concern could be brought under the authorisation process.

WWF believes that there is a need to act on very persistent and very bioaccumulative chemicals, irrespective of currently known toxicity. This is because if effects do come to light, it is impossible to eliminate continued exposure to these chemicals once they have accumulated in humans or in wildlife. Moreover, these chemicals pose a particular threat to the unborn, because once they have accumulated in an animal, they can be transported to the next generation via the placenta or via the egg. It should therefore be unnecessary to prove such chemicals are causing serious and irreversible effects before action is taken to eliminate exposure. These chemicals are clearly undesirable, without having to conduct many animal tests to elucidate their toxicity. Moreover, even if tests on rodents were undertaken, and such chemicals were not found to be harmful at the levels found in humans, it would still be difficult to justify the continued exposure of babies in the womb and breast-fed babies and wildlife. This is because current toxicity tests only cover a small subset of possible toxicity concerns, and making reliable extrapolations from relatively short-term tests on rodents to the long-term effects that may become apparent in long-lived species exposed to low levels is particularly difficult. The fact that the unborn child is potentially at risk from these chemicals, argues for a precautionary approach.

Unless a precautionary approach is taken it is likely that several thousands of mammals will be used unnecessarily in laboratory experiments, in order to try to show that these chemicals do not give rise to toxicity concerns. At worst, it could result in the continued use of bioaccumulative chemicals, and hence the continued exposure of the unborn to chemicals that, in the fullness of time, are found to cause effects which were not detected in current toxicity testing regimes.

Therefore WWF believes that the Article 54(f) should be amended as follows:

(f) substances, such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) and (e) and which are identified as causing serious and irreversible effects to humans or the environment which are equivalent to those of giving rise to a similar level of concern as other substances listed in points (a) to (e) on a case-by-case basis in accordance with the procedure set out in Article 56."

4. ENSURE AN ADEQUATE NUMBER OF SUBSTANCE EVALUATIONS ARE UNDERTAKEN

WWF is concerned that the present text would allow some countries to undertake no evaluations at all. It is proposed that the Chemicals Agency will develop guidance on prioritisation of substances for evaluation. However, at present there is no minimum number of substance evaluations that must be undertaken.

WWF considers that Member States should be required to carry out a minimum annual number of evaluations of the safety data and assessments provided by industry on chemicals. This would enhance quality control, the prioritisation and review of problematic substances, and would also ensure that the Member States' authorities have the resources for this important work.

Therefore, WWF proposes the following addition to Article 43a (Criteria for substance evaluation):

. . . Member States shall use these criteria for preparing their rolling plans.

"The agency shall also determine a minimum number of substance evaluations which should be performed per annum in order to assist in the identification of substances requiring further examination or action. The Agency shall use this minimum figure to calculate appropriate minimum targets for individual Member States. Each Member State shall carry out, at a minimum, this target number of Substance Evaluations."

In addition, to ensure that Member States can decide to do a substance evaluation if new information emerges, the following should be added at the end of Article 43a bis:

A Member State may at any time add new substance(s) to their rolling plan should information emerge which leads to a concern regarding risk to human health and the environment. They must notify the Agency of their intention to add the substance to their rolling plan. Should more than one Member State notify the agency regarding the same substance, the first Member State to notify the Agency should be appointed to evaluate the substance.

5. ALL AUTHORISATIONS FOR USE SHOULD BE SUBJECT TO REVIEW

WWF recommends that all authorisations should be time-limited, and subject to review at least every five years. In order for the authorisation requirement to adapt to technical progress, it will be essential for all authorised uses to be subject to a review period, ie a predetermined period after which it will be determined whether or not the grounds on which the authorisation was initially issued remain valid. Without regular review periods, the momentum for the innovation of safer alternatives will be lost.

Therefore, Article 55(d) should be amended as follows:

(d) review periods for certain all uses., if appropriate.

6. TRY TO ENSURE PROTECTION FROM CHEMICALS IN IMPORTED PRODUCTS

WWF is extremely concerned that the current proposal will allow unregistered, dangerous, or banned chemicals to be brought into Europe from "outside" the REACH system, through import in consumer articles. WWF believes that importers should have the duty to ensure that all the chemicals in articles / products they import comply with any restrictions on use and are registered in the EU; if not, then they (or their supplier) should apply to register the chemicals contained in them. WWF proposes that importers of articles be required to register under REACH any unregistered chemicals imported by them in quantities of 1 tonne per annum or more. The commission proposal proposes a registration requirement based on tonnage imported per article and intended (Article 6.1) or known (Article 6.2) release of a dangerous chemical; WWF considers that tonnage per importer, without consideration of the release or known dangers of the chemical concerned, will offer better protection and be more workable.

Without such an amendment, there will be a continued threat to health and the environment and the competitiveness of specific industry sectors will also be threatened. Importers of consumer products must have the same duty to register their chemicals as importers of substances and preparations. In reality, this will normally only require importers to specify to their suppliers that they must use chemicals that have been registered under REACH, as in most situations a registration will already have occurred within the EU.

Article 6 should therefore be amended as follows. WWF's proposed additions are shown in italic text:

Article 6 (General obligation to register substances in articles)

1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if:

it is present in those articles in quantities in a cumulative quantity totalling over 1 tonne per producer or importer per year (each article type shall be considered separately); and

it meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC; and

it is intended to be released during normal and reasonably foreseeable conditions of use.

2. Any producer or importer of articles shall notify the Agency of any substance

contained in those articles in accordance with paragraph 3, if:

it is present in those articles in quantitites totalling over 1 tonne per producer or importer per year; and

it meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC; and

the producer or importer knows, or is made known, that the substance is likely to be released during normal and reasonably foreseeable conditions of use, even though this release is not an intended function of the article; and

the quantity of the substance released may adversely affect human health or the environment.

2. Paragraph 1 shall not apply to substances that have already been registered for that use by an actor up the supply chain.

3. Paragraph 1 shall apply 3 months after the appropriate deadline specified in Article 21, based on the cumulative tonnage of substance imported.

4. Legislation for the implementation of this Article may be adopted in accordance with the procedure referred to in Article 130 (3).

3. If the conditions in paragraph 2 are met, the information to be notified shall include the following, in the format specified by the Agency in accordance with Article 108:

(a) his identify and contact details;

7. REGISTRATION DATA SHOULD BE INDEPENDENTLY AUDITED

There is currently no mandatory evaluation of the quality and content of the registration dossiers, as the Chemicals Agency will only check for completeness (Article 18(2)). Given that a recent evaluation by Competent Authorities of Member States found that only 25% of safety data sheets were fully accurate, WWF considers it vital that such an audit is required in order to ensure the accuracy of registration dossiers.

Therefore, we suggest that the following should be added to Article 5 (General obligation to register substances on their own or in preparations):

All submissions for registration should be independently audited prior to their submission to the Agency, and the audit report should be submitted to the Agency with the submission for registration. This audit should ensure that the registration is complete and reasonable. The audit should be carried out by an organisation independent of the registrant, although the costs should be met by the registrant. The Agency will formulate guidance on such quality audits.

8. STRENGTHEN MEASURES TO MINIMISE ANIMAL TESTING BY REQUIRING ONE REGISTRATION PER CHEMICAL TO AVOID DUPLICATION OF TESTS

The Commission has included financial and other incentives to encourage data sharing at registration, but we feel that data sharing must be made compulsory to ensure duplicate animal testing is avoided. Thus, the current REACH proposal allows companies producing or importing the same chemical to register separately, and does not oblige companies to share safety data on the chemical. This will lead to unnecessary animal and other tests. WWF recommends one registration per chemical, which should be achieved by amendments to the legislation making it compulsory for industry to form consortia.

We have not supplied proposed text to deliver this, as we are aware that it is already a key thrust of the UK Government's position.

9. SECURE THE RIGHT TO KNOW—AND LIMIT COMMERCIAL CONFIDENTIALITY CLAIMS

Public access to all toxicity, fate, exposure, use categories and risk assessment data should be ensured. Thus, the full registration dossier and the chemical safety report for each chemical should be publicly available, as should information on total production/import volumes, at least on a banded basis. This information should be made available and put on a publicly accessible data-base on the internet within a specified time period.

The proposed procedure to access chemical safety information is cumbersome and ineffective. There should be a presumption of access, and an accessible appeal mechanism to challenge secrecy claims. The envisaged appeal mechanism outlined below is in line with text in the Aarhus Convention. Article 115.1 and 2 (Access to information) should be replaced with the following text:

1. A registrant, downstream user, applicant or other party concerned may indicate the information which they consider to be commercially sensitive and disclosure of which might harm him commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities, the Agency and Commission. He shall give a full justification in each case.

2. Requests for confidentiality within the terms of paragraph 1 shall be considered by the Agency responsible for registration or authorisation, or, in the case of an evaluation by the competent authority of the appropriate Member State. The relevant authority shall decide which requests shall be granted or denied on the basis of justification.

3. Where a person or authority is denied access to information which has been declared confidential, each Member State shall ensure that there is access to an expeditious procedure established by law that is free of charge or inexpensive for reconsideration by a public authority or review by an independent and impartial body other than a court of law.

The list of information that should not be considered confidential needs to be extended to ensure that basic information about risks is directly made available to business and the general public, where there is no genuine reason for claiming confidentiality. There is a range of information where there is no convincing argument for how they could be considered as confidential, including the ingredients of preparations (on a qualitative but not quantitative basis), total production tonnage, use categories and exposure assessments. Article 116 (Confidentiality), which lists in paragraph (1) the information that shall not be considered as confidential should be extended by adding:

— the name of the registrant;

— chemical structure(s) of the substance;

— the total volume of a substance in the EU market based on volume groups;

— use categories; and

— list of ingredients in preparations.

10. Ensure sufficient hazard data on chemicals is provided to enable good risk management decisions

Industry should be required to provide sufficient toxicity data on all their chemicals in order to enable good risk management decisions to be taken, with regard to both environmental and human health. In particular, it is crucial that enough information is provided to identify those chemicals of very high concern.

However, WWF is concerned that the draft REACH text has been significantly weakened as compared to the internet text with regard to the data required for the chemicals traded in volumes of 1-10 tonnes. In order to identify those that require authorisation, there is at least a need to get robust information on the persistence of the chemical, and therefore there is a need to re-instate the test on biodegradation.

There is also a need to ensure that the information requirements for isolated intermediates are adequate to ensure proper risk management. Once these substances are isolated from the reaction vessels and transported either on site or to several different sites, then significant exposure may occur, such that the health and environmental effects of isolated intermediates should not be overlooked. Moreover, it should also be recognised that REACH is the only legislation that can be used to obtain data on the properties of these chemicals.

TOPICAL ISSUES: PRIORITISATION AND COSTS

1. Prioritisation

One of the key concerns surrounding the regulation is how it will work in practice and what is achievable. WWF is keen to ensure that the Regulation is both practicable and realistic and therefore WWF supports and indeed advocates a clear prioritisation procedure.

Prioritisation of chemicals could be undertaken at three different places in the strategy:

1. to feed chemicals into registration;

2. to queue chemicals of concern into the post-registration substance evaluations; and

3. to queue chemicals of very high concern into the authorisation process.

WWF would support prioritisation in the final stage to ensure the worst chemicals that had undergone registration were evaluated as a priority, and to ensure that the worst chemicals went through to the prior authorisation process first. However, WWF does not support a risk-based prioritisation process to queue all chemicals into the REACH registration process, or indeed, what would be even more worrying, to determine which chemicals should be brought under the registration process at all.

WWF considers that queuing chemicals into the registration process on the basis of chemicals known to meet the criteria for very high concern, and then chemicals traded in high volumes, followed by those traded in progressively lower volumes, provides a transparent and workable system. At present only the known CMR chemicals of the chemicals of very high concern are fast tracked into registration, and thus there is a need to also fast track those meeting the PB(T) criteria into registration.

WWF disagrees with the prioritisation of chemicals for registration on the basis of risk (which amalgamates toxicity and exposure) because it would:

— not be robust—as it could only be based on the sparse existing data;

— result in a much more labour intensive process for the regulatory authorities; and

— be open to numerous challenges by industry—if chemicals with what might appear to be similar toxicity and exposure data were prioritised differently.

Conversely, registration on the basis of volumes traded, is a legally robust way to get all the old chemicals phased into the system. Registration should not be seen as a risk management action per se, but rather a safety standard that all chemicals should fulfil.

It should be noted that the draft legislation released in October did address the prioritisation issue to a certain extent, in that there were some new approaches to ensure that resources were not diverted into initiatives seen to be of lower priority. For example, the new text only requires Chemical Safety Reports (CSRs) for chemicals traded in volumes of over 10 tonnes. Moreover, safety data sheets rather than CSRs are now seen to provide an adequate way of passing information to downstream users.

2. Costs and benefits of the regulation

Impacts on Industry

WWF fully recognises the need to ensure the competitiveness and sustainability of the EU chemical industry. However, WWF rejects the arguments that REACH will be economically damaging.

The Commission's extended impact assessment shows[9], the direct costs will be around

2.3 billion (

1.9-

3.2 billion), whilst the total direct and indirect costs (including the costs for downstream users) might range from

2.8 billion to

5.2 billion. These figures might seem large, but they should be viewed in perspective. For example, the direct costs of

2.3 billion amount to around just half a euro per EU citizen per year over 11 years, or the same amount as the European chemical industry spent on environmental improvements related to waste in 1999 alone. Moreover, the amount of money that needs to be spent is not unrealistic when compared to the chemical industry's annual turnover. For example, even the worst case total direct and indirect costs of

5.2 billion, spread over 10 years—would only amount to around 0.12% of the chemical industry's annual turnover, which was estimated to be

417 billion per annum in 2000.

WWF considers that industry trade groups have been engaged in scare-mongering tactics. For example, they have expressed concern that current proposals for new EU wide legislation on chemicals (REACH) will decimate Britain's chemical industry[10], and result in "critical damage"[11]. However, a former CBI director general, Adair Turner destroyed industry's arguments that REACH will lead to a decline in the EU chemicals sector. In his new book, "Just Capital" he states, "There is no evidence that increasing environmental constraints have slowed overall growth rates, and no evidence that higher environmental standards in some developed countries have disadvantaged them economically versus others."[12]

Impact on Jobs

Industry has also played on the fears of workers by highlighting the threat to jobs. This has been spearheaded by a report commissioned by the Federation of German Industries (BDI) conducted by consultants Arthur D Little. This report predicted job losses of between 150,000-2,350,000 in the German manufacturing industry[13]. A similar French study, by Mercer Management Consulting, forecast a loss of GDP in France and cumulative job losses in all business sectors of between 360,000 and 670,000 overall. However, the BDI study was severely criticised by a group of leading German economists, drawn together by the German Environment Agency. These expert economists considered that the BDI report conclusions were unsupportable. For example, it wrongly assumed chemicals would leave the market and that no substitutes would be found in spite of substantial need downstream, such that it did not take into proper account the positive economic effects of REACH, that is the impetus to innovation[14]. Moreover, the financial costs put forward in the BDI report did not take into account the savings made from using existing data. Nevertheless, despite this expert criticism, on the 16 September 2003, the BDI released an update of their study, based on the same flawed methodology. This time they predicted, based on the internet consultation text, that current proposals would cost the German economy 4.7% gross value added, and would translate into a loss of 1,735,000 jobs[15].

Several studies show that these worries are not well-founded. The world famous economist, Professor David Pearce OBE, has highlighted the lack of impact on employment of environmental legislation. A report by Pearce and Koundouri has concluded that "there is little evidence that environmental regulations have significant effects on employment", and "we know of no evidence to suggest that firms relocate in response to environmental regulation. Other costs are far more important to locational decisions than regulatory compliance costs."[16]

Furthermore, even the chemical industry itself has acknowledged that stringent regulation is not the main reason companies re-locate in other countries. According to the CBI a survey shows "labour costs are the main reason UK firms relocate overseas. Fifty five per cent of firms that have moved or are considering moving abroad said labour cost was the most important factor."[17]

Other research confirms that the jobs versus the environment arguement just does not stack up. In the USA, States that fail to protect their environment don't do well, whereas States that enact strong environmental protection tend to create good jobs, spread the wealth around more fairly, have better public health, fairer taxes, and greater democratic participation[18].

Therefore, the doomsday predictions that REACH will cause companies to re-locate outside Europe do not appear valid. In order to trade within the EU, companies based outside will still have to comply with certain provisions of this legislation, and the EU is an important growing market which companies will not want to ignore.

Whilst, it can be predicted that REACH will cause a decline in jobs making chemicals of very high concern, it should not be forgotten that it will also stimulate the creation of new jobs making safer chemicals.

Benefits

The benefits of the new REACH legilsation, include the benefits to innovation, as well as the environmental and health benefits that will result from better knowledge of the effects of chemicals and hence better risk management.

Business benefits

The European Commission extended impact assessment notes the many benefits that REACH will bring to innovation. For example:

— for new chemicals the testing threshold has been raised from 10 kilograms per year to 1 tonne per year;

— substances manufactured for product and process orientated research are exempt from registration for a period of five years (renewable for an additional five years);

— there is now a level playing field for new and existing chemicals, rather than existing chemicals being favoured.

A report on innovation from SPRU at Sussex university[19], commissioned by WWF UK, has underlined that "the negative impacts on innovation, competitiveness and employment have been overstated in industry-funded studies, and that insufficient account has been taken of broader social and environmental benefits." Other methodological problems with industry studies are also highlighted, "especially the absence of a sound treatment of innovation, and problems related to the changing nature of costs and benefits."

Another report by environmental groups has similarly noted that the REACH Regulation may bring many benefits to business, including new markets for safer and more environmentally friendly products, reduced risk of future liability lawsuits, easier introduction of new chemicals, a more predictable regulatory system, and improved transparency and communication through the supply chain, leading to increased influence and confidence for downstream users and SMEs[20].

Health Benefits

Perhaps most importantly, REACH will also provide health benefits both for the public at large and for workers. In the EU, dangerous substances currently contribute significantly to the 350 million days lost through occupational ill health, and to the seven million people suffering from occupational illnesses. For example, some 32 million employees are exposed to carcinogenic agents. Moreover, it should be recognised that it is not just workers in the chemical industry who are at risk, the jobs at highest risk include: hairdressers, garage mechanics, and printers[21].

Allergy costs alone are estimated at

29 billion/year in Europe[22]. Chemical substances are considered to play a major role in inducing allergies either directly or by increasing susceptibility to natural allergens (eg pollen). For example, a US study has shown that asthma cases have risen by 40% since the 1970s. If the new strategy makes even a small reduction in the

29 billion of allergy costs, this will outweigh the direct costs of the strategy[23]. However, the social costs of allergy in Europe—in terms of health care and absenteeism, may be greater, with another estimate suggesting

45 billion per year[24].

Annually, in Britain alone it is estimated that:

— some 6,000 cases of cancer are considered to be occupationally caused;

Thus, although there is existing Occupational Health and Safety legislation to control chemicals, evidence from ill health statistics and experience from existing chemical schemes indicates gaps in the current control regime. The costs of occupational asthma alone have been estimated in the UK at between £500 and £1,000 million over the next 10 years (recent RIA for asthmagens AcoP)[28]. Quite apart from the mortality rates, morbidity rates at these levels represent a high proportion of the totality of work related ill health and therefore the number of work days lost.

The requirement to use safer substitutes may often save costs in the long-term. For example, it is relatively easy to see when an NHS trust is required to pay substantial compensation to staff sensitised by latex or glutaraldehyde, how much cheaper it would have been to substitute with a safer alternative or ensure effective control of exposure[29]. The new legislation should provide an impetus to producing and using safer substances, and may therefore save money in many situations.

Professor David Pearce, and Phoebe Koundouri, estimated the health benefits of the internet text of May 2003[30]. Various scenarios were costed and the authors confidently concluded that the health benefits of the REACH regulation outweigh the predicted costs. Indeed, they suggested that the European Union could be a staggering

260 billion euros (180 billion pounds) better off, even after taking into account the costs to businesses of implementation. In just the UK, these authors estimated that the savings in health expenditure could be around

74.9 billion (50 billion pounds). However, it should be noted that these estimates relate to the May internet text, which has now been watered down in draft Regulation of October 2003, such that both the benefits and costs portrayed in this report will have been reduced.

With regard to the final draft REACH legislation as of October 2003, the Commission in its extended impact assessment attempted to estimate the health benefits for the whole population. This estimate was based on a World Bank study which suggested that in established market economies, pollution from agro-industrial chemicals and diffuse sources causes between 0.6%-2.5% of the total disease-burden (that is deaths and general ill health). However, another estimate suggests that the World Bank may have underestimated the burden of disease environmentally attributable by 150%. Nevertheless, the Commissions uses this World Bank study as a starting point and argues for a conservative figure of 1%, and then assumes that the proportion of this disease that will be identified and tackled by REACH will be 10%, implying that 90% of health impacts associated with chemicals are either related to historical exposures, or will not be identified by REACH, or cannot be tackled. These figures therefore suggest that 45,000 DALYs (Disability Adjusted Life Years) will be avoided each year due to REACH. Assuming 10 DALYs are equivalent to one life saved, then 45,000 DALYs would be equivalent to 4,500 lives saved. This methodology was extended to predict that 10 years after implementation, positive effects on public health would result, to the tune of around 50 billion euros, although this should not be seen as a robust estimate of the benefits, rather an illustration of their potential scale. Nevertheless, again it can be predicted that the costs will be far out-weighed by the benefits.

With regard to the benefits for wildlife, although chemicals are known to have affected numerous avian and other wildlife species, it is impossible to quantify the potential benefits of REACH. However, a report by the independant research group, RPA, has looked at some case studies to see whether REACH is likely to deliver environmental and general public safety benefits. It concludes that had REACH been in place, the damage from the use of each of the case study chemicals could have (and most proably would have) been reduced earlier. It therefore identified several key advantages of REACH over the current system. It concludes that REACH (i) by assessing the properties of substances, and thereby making information available more quickly, has the potential to identify a hazard before (substantial) damage occurs, rather than waiting for monitoring (which is slow and under-funded) to provide evidence of harm; (ii) provides a basis for quicker regulatory action for the most hazardous substances (through accelerated risk management and authorisation)[31].

Certainly, nothwithstanding the incalculable damage to wildlife, the improper use and disposal of chemicals can lead to sustantial costs in terms of the clean-up of contaminated land, and other restoration costs.

Therefore, overall WWF confidently predicts that the costs of REACH will be far outweighed by the benefits both quantatively and qualitatively.

THE ROLE PLAYED BY THE UK GOVERNMENT

At the Chester meeting during the UK's presidency in 1998, the UK took an important role in co-ordinating several Member States to release a landmark statement, which highlighted the need to develop new and better legislation to control chemicals. This led to the eventual development of the REACH legislation. The UK continues to be a powerful positive force for change and it is vital that the Government uses this force and its leverage within Europe to assure the success of this important piece of legislation.

WWF is grateful for the priority assigned to progressing this legislative proposal over the following years. Defra, as lead department, has invested much time, effort, and expertise, in co-ordinating the views amongst the different Government departments, and in synthesising the views of different stakeholders. It is now vital that the current lead Minister, the Rt Hon Alun Michael MP, engages fully with this important but complex regulation and continues to steer the UK Government towards a strong position on the Regulation. Most importantly it is vital that Defra resists capitulating to industry's demands.

However, WWF has been disappointed by the lack of support given to the new legislation by HSE. It is a well-known fact that the vast majority of substances traded in the EU do not have available adequate toxicity data to make even a basic risk assessment. Legislation which requires such information, and which requires this information to follow the chemical up and down the supply chain, must make for better decisions on where to invest more effort to protect worker health. But there appears to be little enthusiasm on the part of HSE to support this legislation or to take an active role in the implementation of the REACH legislation. In order to address this apathy, it is vital that adequate resources for the UK regulatory authorities must be available to implement the legislation. Without the allocation of adequate resources in the Member States to oversee implementation, including adequate resources for substance evaluation, this legislation will flounder. Given the clear benefits that this regulation could bring to public health, it is also lamentable, that Department of Health has not taken a visible supporting role.

However, WWF is more concerned about the DTI's increasingly pro-industry hard line against the Regulation whilst downgrading the importance of a robust Chemical Regulation for the benefit of humans and wildlife. The Secretary of State for Trade and Industry, the Rt Hon Patricia Hewitt commented that the proposed Chemical Regulation was "disastrously wrong"[32] and would move firms off shore. Such an idea in our view is both misinformed and completely unfounded.

Further evidence that the UK is prioritising the concerns of a dinosaur industry over and above the needs of human health, came when the Prime Minister signed up to a joint letter to Commissioner Romano Prodi urging the EU to substantially change the chemical proposals, to ensure not to place unnecessary burdens on industry (see Appendix 1).

WWF is aware that the chemicals legislation may become an expendable pawn in a larger political picture, for example, perhaps in exchange for support on Iraq or to appease the concerns of the Bush administration. The USA is mounting an intensive campaign to try to reduce the need for all chemicals to have safety data before they are traded. We attach to this briefing a letter sent by the US Secretary of State, Colin Powell—showing that the Bush administration has pushed for the legislation to focus on fewer chemicals, and has stressed the concerns with regard to international trade (see Appendix 2).

The UK government should be leading the way by supporting a robust Chemical Regulation, which protects future generations of humans and wildlife. A tough regulation, which encourages phase out of the most hazardous chemicals will be good, not only for humans and wildlife, but for business and innovation too. It will provide an improved framework for innovation in the chemicals sector, and contribute to the development of green chemicals. It could strengthen the competitiveness of the chemicals industry and provide new markets for safer and more environmentally friendly products. This is a key chance for the UK Government to promote the development of our chemicals industry and to grasp this opportunity for greater innovation, competitiveness and consumer choice.

WWF considers that it is vital that this legislation is not emasculated, because doing so would significantly reduce the benefits to health and the environment, and yet still give rise to considerable costs.

In future, we therefore urge the UK Government:

— to prioritise the needs of public health, our wildlife and the environment;

— to recognise the business, health and environmental benefits of the EU Chemical Regulation;

— to clearly commit to a robust chemical regulation which incorporate the substitution principle and phases out the most harmful chemicals where safer alternatives exist; and

— use its leverage within the EU to push other key member states to support a similarly robust position.

Only by taking leading by example and show a clear preference of the health of future generations will the UK Government reap the full benefits of this once in a lifetime opportunity.

December 2003

3 Here WWF defines the word available in a similar way as it is defined in the IPPC Directive, such that it is an alternative which is reasonably accessible and that has been developed on a scale which allows its implementation as a substitute, under economically and technically viable conditions. Back

4 Page 8, para 5; European Commission, White Paper: Strategy for a future Chemicals Policy. 2001, Commission of the European Communities: Brussels, Belgium. European Commission, http://www.europa.eu.int/comm/environment/chemicals/whitepaper.htm "Another important objective is to encourage the substitution of dangerous by less dangerous substances where suitable alternatives are available." Back

5 Point 49; European Parliament, European Parliament resolution A5-0356/2001on the Commission White Paper on Strategy for a future Chemicals Policy (COM(2001) 88-C5-0258/2001-2001/2118(COS)). 2001, European Parliament: Brussels. European Parliament. Back

6 Point 15; Environment Council, Strategy for a future chemicals policy: COUNCIL CONCLUSIONS. 2001, Environment Council: Brussels, Belgium. Environment Council, http://europa.eu.int/comm/enterprise/chemicals/chempol/whitepaper/councconcl.htm "Chemicals that are dangerous should be substituted with safer chemicals or with safer alternative technologies not entailing the use of chemicals." Back

7 Doc XI/14168/99-Industry's response, introduced by CEFIC, regarding the UK Rapporteur's Proposal at TM III `99 on pentabromodiphenyl ether. This states "when putting this whole breast milk issue into perspective, industry believes that the only rational and scientific conclusion that can be drawn is a conclusion ( ii )" A conclusion (ii) means that there is no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. Back

8 Directive 2003/11/EEC. Back

9 Commission staff working paper (2003) Extended impact assessment SEC 1171/3 Brussels, 29/10/2003. Back

10 See CBI (Confederation of British Industry) (2003). CBI steps up fight over EU Chemicals Law, 8 August 2003. Back

11 See CIA (Chemical Industries Association) (2002). CIA welcomes German report on impact of EU chemicals policy, 18th November 2002. Back

12 Adair Turner (2003). Just Capital. Macmillan. Back

13 CIA (2002). CIA welcomes German report on impact of EU chemicals policy, 18 Nov 2002. Back