Select Committee on European Union Thirteenth Report


Existing EU Chemicals Policy

31. EU legislation on chemicals now covers the many areas listed below, but the White Paper is likely to result in modification to only some of them.[5]


32. Since 1981 a manufacturer or importer of a "new" chemical has had to submit the result of tests sufficient to evaluate possible harmful effects and its assessment of the results to the authorities. If no objections are raised the manufacturer then has assured access to the whole EU market after 60 days. "Existing" chemicals are those which were on the EU market before 18 September 1981 and hence listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). Over 100,000 are listed. Any chemical not listed in EINECS is regarded as a "new" chemical.[6] Around 2,700 new chemicals have been notified since the scheme began.


33. In 1994 and 1995 manufacturers had to submit to the authorities existing data on "existing" chemicals. Priority lists were then drawn up of chemicals that needed to be examined in more detail with a view to possible risk reduction measures. The work of risk assessment is shared among the Member States. The EC Regulation that established this regime is described more fully in paragraphs 59-69 below.


34. Once a risk has been evaluated, marketing and use of a chemical can be restricted as necessary, or in the extreme it can be banned. The 1976 Directive[7] provides a framework for this and since 1979 a series of chemicals, or classes of chemicals, have been restricted including: PCBs, asbestos, leaded paints, anti-fouling paints, pentachlorophenol, cadmium, fire retardants, carcinogens, creosote and chlorinated solvents.


35. A Directive requires chemicals to be classified on the basis of their intrinsic properties according to 15 danger categories. They can only be marketed when packaged and labelled according to specific requirements laid down. Safety data sheets have to be provided to professional users before the first delivery of a dangerous chemical. Another Directive applies comparable requirements to preparations (such as paints and solvents) ie mixtures or solutions of two or more chemical substances.[8]


36. EU legislation is evolving from a "negative" system which places restrictions on the use of certain named pesticides[9] to a "positive" authorisation system which will eventually replace the pesticide registration schemes of the Member States.[10] A similar scheme creates an EU regime for the registration of "biocides" (non-agricultural pesticides).[11]


37. A Regulation[12] establishes a system for notification of exports outside the EU of dangerous chemicals that have been severely restricted within the EU. It applies the "prior informed consent" procedures developed by United Nations Environment Programme (UNEP) and the UN Food and Agriculture Organisation (FAO).


38. A number of items of EU legislation are intended to ensure proper implementation within the EU of international agreements relating to the safe transport of dangerous goods by sea, road and rail.[13]


39. Two framework Directives deal with the protection of workers. One concerns risks relating to exposure to chemical, physical and biological agents at work,[14] and another concerns improvements to the health and safety of workers.[15] Under these Directives restrictions have been placed on a number of chemicals.


40. The prevention of accidents resulting from the storage or industrial use of chemicals is covered by the so-called "Seveso" Directive[16]; there is also a raft of legislation on pharmaceuticals; food additives; animal feeding-stuffs; and articles intended to come into contact with food.


41. EU legislation increasingly has to take account of international agreements. These include those emanating from the UN family (UNEP, FAO, International Labour Organisation, International Maritime Organisation, UN Economic Commission for Europe, International Civil Aviation Organisation). Agenda 21, adopted by the 1992 Earth Summit at Rio, proposed an action programme on chemicals which is overseen by the Intergovernmental Forum on Chemical Safety. The OECD has been particularly influential; it established a programme on existing chemicals in 1982 and a programme to share the burden of testing among different countries in 1988. A number of international conventions relating to marine pollution restrict the use of chemicals, an important example being OSPAR (Convention on the Protection of the Environment of the North East Atlantic).[17] A recent UNEP convention on chemicals is the Stockholm Convention on Persistent Organic Pollutants (POPs).[18]

uk chemicals policy

42. In the UK chemicals policy is largely in the hands of the Department for Environment, Food and Rural Affairs (DEFRA) and the Health and Safety Executive (HSE), although other government departments also have responsibilities. The Health and Safety at Work Etc. Act 1974 places a duty on any person who manufactures, imports or supplies any substance for use at work to ensure that the substance is safe and without risks to health when properly used and to carry out such tests and examinations as may be necessary. This duty does not cover risks to the environment. The Environmental Protection Act 1990 contains powers (originally in the Control of Pollution Act 1974) to prohibit or restrict the importation, use or storage of any substance in order to protect the environment and human health. The 1990 Act also established an Advisory Committee on Hazardous Substances. In practice flesh has been put on the bones of these powers and duties by implementation of the detailed EU legislation described above. The HSE and DEFRA are jointly the competent authority for the implementation of EU legislation and the Environment Agency gives technical advice to DEFRA for risk assessments relating to the environment.

43. In 1998 an informal EU Environment Council meeting at Chester under the UK Presidency discussed the future of EU chemicals policy and called for a review that has led to the present White Paper. At about the same time the then Department of the Environment, Transport and the Regions (DETR) began its own review and in December 1999 published the Government's chemicals strategy called "Sustainable Production and Use of Chemicals—a Strategic Approach".[19] Since this recognised that EU law made it difficult to legislate unilaterally on chemicals, it focused on voluntary action by industry. It proposed the creation of a stakeholder forum for selecting chemicals for scrutiny and developing risk reduction measures; this was established in September 2000 and published its first report in November 2001.[20]


44. Chemicals policy has developed its own terminology, which is not always used consistently, and the White paper helpfully provides a glossary of terms and abbreviations. A list of the main acronyms used in this Report and in the evidence is inside the front cover.

45. The distinction between the following phrases is important for an understanding of the subject. "Hazard" is a property intrinsic to a chemical, eg its toxicity or corrosivity, whereas "risk" relates to the likelihood of harm and so depends on likely exposure and hence the uses to which a chemical is put. "Hazard assessment" accordingly means the identification of the adverse effects which a chemical has the capacity to cause, which may involve tests on laboratory animals, while "Risk assessment" is a process which starts with hazard assessment but also involves exposure assessment. Since information on use and exposure is often limited, risk assessment requires expert professional judgement. "Risk management" or taking "risk reduction measures" are phrases used to describe the practical steps to be taken, possibly involving: classification, labelling and packaging; the provision of safety data sheets; restrictions on marketing or use; a complete ban; controls over emissions; water quality standards; or surveillance programmes. A "downstream user" is an industrial user of a chemical, not necessarily the manufacturer, including one who formulates products for sale, eg a paintmaker.

Pressure for the white paper

46. The Government in its 1999 Chemicals Strategy says it is "very concerned that we do not have even a basic assessment of the possible risks of most chemicals released into the environment in large quantities." The White Paper says "The lack of knowledge about the impact of many chemicals on human health and the environment is a cause for concern. Understandably the public is worried when hearing about the exposure of their children to certain phthalates released from toys and about increasing amounts of the flame retardant pentabromodiphenyl ether in human breast milk."[21]

47. The regime for notifying new chemicals has not been subject to the same criticisms as the regime for existing chemicals, and indeed it seems to have worked well, so that there is now a useful body of data on the approximately 2,700 chemicals that have been marketed since 1981. A report produced as part of the Commission's SLIM Programme (Simpler Legislation for the Internal Market) concerning the Directive on new chemicals recommends improvements but concluded that "the underlying principles of the Dangerous Substances Directive remain a sound basis for chemicals management."[22] The regime for existing chemicals, on the other hand, has been criticised for being so slow as to be ineffective, with the result that very little more is known about the 30,000 chemicals marketed in quantities of more than 1 tonne per annum and few extra risk reduction measures have been introduced. The White Paper is largely a response to this criticism.

Changes Proposed by the White Paper

48. On a first reading the White Paper gives the impression of proposing a radical departure from existing EU chemicals policy. Although it refers to existing EU legislation, the structure of the White Paper is not in the form of an analysis of the strengths and weaknesses of that legislation, followed by proposals for improvement. Instead it describes a new regime which it calls a "single" system (instead of separate systems for "new" and "existing" chemicals) called REACH, with three main elements:

·  Registration

·  Evaluation

·  Authorisation

49. On closer examination it can be seen that these three elements draw on, and develop three groups of existing legislation:

·  notifying new chemicals (Directive 67/548 and 92/32)

·  evaluating existing chemicals (Regulation 793/93)

·  restricting marketing and use (Directive 76/769)


50. This will extend the current system of "notification" of new chemicals to existing chemicals over a number of years. The idea is that the same sort of data that have been provided for the 2,700 or so chemicals marketed since 1981 will be made available for 30,000 or so older chemicals. The "registration" dossier that a manufacturer or importer will have to submit to the authorities will be rather similar to the "notification" dossier that is now submitted for new chemicals. Registration will require manufacturers (a) to conduct tests if the necessary hazard assessments do not already exist and (b) to perform a preliminary risk assessment. Downstream users are for the first time to contribute to the risk assessment process. If registration is not complete by the due date, then most probably (the White Paper is not clear on this) marketing and use will be banned. The threat of a ban is intended to provide a sufficient incentive to industry to carry out testing and to provide the assessments. The timetable for registration is 2005, 2008 and 2012 for chemicals exceeding production volumes per annum of 1,000, 100 and 1 tonne respectively.


51. The authorities are to evaluate the registered information provided by industry for certain chemicals. This extends the current regime for existing chemicals under which priority lists are drawn up for evaluation after some data have been supplied by industry. It also builds on the current regime for new chemicals under which authorities already evaluate the "notification" dossier submitted by industry.

52. The White Paper estimates (on page 16) that 80 per cent of the approximately 30,000 registered substances "would only require registration", and limits evaluation to chemicals where production has exceeded 100 tonnes per annum and, at lower tonnages, to chemicals of concern.

53. The proposed system therefore places much reliance on the preliminary risk assessment that industry is required to provide at the time of registration, not all of which will be evaluated by the authorities. There are some proposals for targeted risk assessments which would be less extensive and more focused than the comprehensive risk assessments currently required.


54. Chemicals "that give rise to very high concern" will be subject to authorisation, ie all use is banned unless a particular use is authorised. This is a reversal of the current arrangement under which marketing and use of named chemicals is restricted or totally banned, implying that, in the absence of a restriction, marketing and use can proceed. Controversy surrounds the selection of chemicals of very high concern (see fuller discussion in paragraphs 95-102).

55. The authorisation procedure will involve two steps:

Step 1

·  identification of substances subject to authorisation

·  setting time limits after which unauthorised use is prohibited

·  scope of exemptions

·  determining whether authorisation is to be granted at Member State or Community level

Step 2

·  actual authorisation of particular uses

56. Most decisions relating to authorisation would be taken at Community level—"generally" by a Committee procedure[23], according to paragraph 8.1 (page 25) of the White Paper; this contrasts with the current arrangements under which each restriction requires a Council and Parliament Directive. The only decisions to be taken at national level concern the use of substances not incorporated in traded products which may affect the workforce or the local environment.


57. The White Paper proposes the creation of a central entity to administer REACH which could be an expanded version of the existing European Chemicals Bureau currently located within the Joint Research Centre at Ispra, Italy. The central entity would receive the registration dossiers, forward copies to the Member States, maintain a central database of all registered chemicals, perform spot-checks and computerised screening of registered chemicals for properties raising particular concern. It would support Member State authorities in the evaluation of chemicals and co-ordinate the Member States during decision making at the evaluation stage. It would also provide the operational framework for the authorisation procedure.


58. In summary therefore the major changes are:

(a)  Many existing (approximately 30,000) as well as new (currently 2,700) chemicals must be registered with the probability of a ban if the registration dossier is not complete. The registration dossier will include hazard assessments, requiring manufacturers to conduct tests, and preliminary risk assessments, which manufacturers will have to conduct in collaboration with downstream users.

(b)  Instead of the authorities evaluating only limited priority lists of existing chemicals, all chemicals of concern and all produced in quantities of over 100 tonnes per annum will be evaluated.

(c)  Chemicals of very high concern (to be identified at Community level) will be subject to an authorisation procedure. (This reverses the current arrangement under which use is permitted unless restricted or banned.)

(d)  A "central entity" will be created to do more than just administer the system.

The present regime for existing substances

59. Since problems with the present regime for existing chemicals have provided the stimulus for the White Paper, it is necessary to describe it and its deficiencies in more detail and also how the proposed changes seek to overcome them. Regulation 793/93[24] on evaluating existing chemicals sometimes known as the Existing Substances Regulation (ESR), has four elements: data collection, priority setting, risk assessment and risk reduction.


60. Manufacturers have to submit existing data relevant for an evaluation of risk to the European Chemicals Bureau, which manages IUCLID (International Uniform Chemical Information Database). This was first done in 1994 and 1995 and is then updated every 3 years.


61. The Commission draws up lists of priority chemicals requiring immediate attention, taking account of several factors (including effects, exposure, lack of data on effects, work already carried out in other international fora) and paying particular attention to chemicals which may be carcinogenic or have chronic effects. Four lists had been adopted by a Committee between 1994 and 2000 totalling 140 chemicals (see paragraph 65).


62. Each priority chemical is allocated to a Member State which designates a "rapporteur" to evaluate that chemical. Within 6 months of the list being published manufacturers of listed chemicals are to submit all available information relevant for risk assessment to the rapporteur. If the "base set" of data is not available, the manufacturer must carry out the necessary testing and report to the rapporteur within 12 months. Rapporteurs may grant exemptions but must inform the Member States. If the exemption is contested the Committee takes a decision. When there are valid reasons for believing that a substance presents serious risks the Committee can request information and testing.

63. The rapporteur evaluates the information and decides whether the manufacturer is to be required to supply further information or carry out further testing. The Committee decides whether the request for further information is to be imposed and the time limits. The rapporteur assesses the risks of the chemical on the basis of principles set out in Regulation 1488/94[25] which makes a distinction between "hazard" and "risk". Technical guidance on risk assessment has been published by the Commission. The rapporteur then sends conclusions to the Commission.


64. The rapporteur can suggest a strategy for limiting risks including control measures and/or surveillance programmes. Technical guidance on development of risk reduction strategies has been published by the Commission. Any proposed restriction on marketing or use must be accompanied by an analysis of the advantages and drawbacks of the chemical and the availability of replacement chemicals (a risk/cost benefit analysis). The recommended strategy can be adopted by the Committee and published. If there are to be restrictions on marketing and use these can be proposed by the Commission under Directive 76/769 (see paragraph 34).

Lack of progress under existing substances Regulation

65. Four priority lists of chemicals requiring immediate attention have been drawn up by the Commission since 1994, each chemical being allocated to a Member State to act as "rapporteur". The lists are set out in EC Regulations:
List No.
EC Regulation
Number of Chemicals
Number allocated to UK as "rapporteur"
OJ L131 26.5.94
(2 also shared with France)
OJ L231 28.9.95
OJ L25 28.1.97
OJ L273 26.10.00
(3 also shared with Ireland)
20 (+ 5 shared)

66. A discussion of progress with the risk assessments conducted by the UK as rapporteur is contained in the annual reports of the Advisory Committee on Hazardous Substances. Following risk assessments by rapporteurs, recommended risk reduction strategies for the 11 substances listed below have so far been published by the Commission as Recommendations:
EC Recommendation
No. of Chemicals
Name of Chemical
OJ L292 13.11.99
Alkanes, C10-13, chloro
Benzene, C10-13,-alkyl derivs.
OJ L69 10.3.01
Diphenylether/pentabromo derivative


OJ L319 4.12.01
Dimethyl sulphate
Phenol, 4-nonyl-, branched
Tert-butyl methyl ether

67. In addition the Commission has put forward two proposals for Directives restricting the use of two of these substances: (i) Alkanes, C10-13, chloro, otherwise known as short chain chlorinated paraffins (SCCPs) (for use in the metalworking and leather industries)[26] and (ii) diphenylether/pentabromo derivatives (for all uses)[27]. Both are now awaiting adoption by the Council and Parliament. Thus nearly eight years after the first priority list was published only a handful of risk assessments and risk reduction strategies have been published and only two proposals for restrictions have been made. Not one has yet been adopted. This is very slow progress and suggests there is a fundamental flaw in the Regulation.

68. The White Paper recognises several deficiencies with the Regulation. DEFRA point out that the Regulation put in place an entirely new system and, as with any new system, it took time to agree the new procedures (eg the guidance on risk assessment) (pp 194-5). With regard to data collection DEFRA note that although data were supplied on the basis of a common data set, manufacturers only had to submit readily available information and did not have to fill data gaps. The IUCLID[28] database is therefore incomplete and also has not been validated. DEFRA also point to the following factors that have contributed to delay with risk assessment and reduction:

·  the earliest chemicals considered were the most controversial;

·  risk assessment had to be comprehensive;

·  unforeseen uses of chemicals became known during the risk assessment process and had to be investigated, leading to further delay;

·  tensions arose between scientists and policy makers, with scientists wanting risk assessments to be as thorough as possible, while policy makers have only wanted enough information for risk reduction measures. There were (and remain) differences between Member States about how much information is needed to justify risk reduction measures;

·  making risk assessments is a significant burden and some Member States did not provide sufficient resources.

69. The White Paper (page 19) points out a further underlying difficulty concerning the role and interest of industry. It says "The current approach requires authorities to provide convincing arguments, usually in the context of risk assessment, before restriction measures are taken. Their task is further complicated because the current system does not encourage industry to support the assessment. On the contrary, delaying the process is 'rewarded' with an extended marketing period. Industry has usually provided data when such data were deemed suitable to avoid the restrictions under consideration. An apparent lack of data aggravates the situation and often leads to a risk assessment conclusion that 'further information is required' before an informed decision on risk management can be taken."

Proposals for overcoming deficiencies of the Existing Substances Regulation

70. The White Paper seeks to overcome the deficiencies in the following ways, although much has yet to be clarified, largely by placing more responsibility on industry and in some instances reversing the burden of proof.


71. Under the "Registration" element of REACH, industry will have to submit much more data than are currently required, including preliminary risk assessments. Manufacturers will have an incentive to submit a complete registration dossier since lack of completeness may result in marketing being banned. The registration dossier (the elements of which are set out in para 4.1 of the White Paper) will be rather similar to the notification dossier currently required for new chemicals, although the extent of testing required is not yet clear.


72. The delay in sometimes extracting information from manufacturers should be reduced since much more information should be contained in the registration dossier. The White paper, in paragraph 4.4, says optimistically that "the delays encountered under the present system . . . will be eliminated." Unforeseen uses should be less of a problem since downstream users will have provided information on uses. Where a use has not been identified by a producer/importer at registration stage and therefore has not featured in the initial risk assessment, the user will be required to undertake the risk assessment for that use. In a way yet to be explained "targeted risk assessments will in most cases replace the comprehensive risk assessments of the past. The latter were the main cause of delays . . ." (ibid).


73. Authorisation within REACH will put the onus on industry to justify use of chemicals identified as of very high concern that might otherwise be banned. Previously the authorities had to demonstrate unacceptable risks via the risk assessment and risk/cost benefit analysis.

Other programmes for existing substances[29]

74. There are other programmes to collect data about existing chemicals as well as the EU scheme, and the White Paper, in a section on "Recognising non-EU test results" (page 9), refers to the "Gore initiative" in the USA and the HPV/ICCA SIDS[30] programme of the OECD. Both of these deal only with "high production volume" (HPV) chemicals, ie those produced in quantities greater than 1,000 tonnes per annum in any one country (totalling fewer than 5,000 chemicals).

75. The US scheme, initiated by former Vice-President Gore, is voluntary and chemical companies have agreed to make public data that are available on 2,800 HPV chemicals, and if not available to make estimates, and if that in turn is not possible, to undertake testing. The idea is that publication of the data, coupled with public pressure, will lead to companies taking voluntary risk reduction measures.

76. The OECD programme on existing chemicals began in the 1980s. Data are gathered or generated on HPV chemicals and then hazard assessments are carried out, the work being shared among OECD countries. Each government puts the chemicals for which it is responsible through an agreed investigation procedure. This entails gathering a minimum set of data on the intrinsic properties of the chemical—the Screening Information Data Set (SIDS)—filling data gaps, and writing a report that eventually becomes an OECD "consensus document". Data gaps are generally filled by studies undertaken voluntarily by industry. Approximately 250 hazard assessments have now been completed and 730 are in progress.[31] Countries have agreed to increase significantly the output of the programme in the next decade. As a contribution to this programme, the International Council of Chemical Associations (ICCA) has undertaken to provide data on 1,000 chemicals by 2004.

77. The EU and OECD programmes are co-ordinated in the sense that hazard data generated under the EU Existing Substances Regulation are fed into the OECD programme, and the EU benefits from hazard data contributed to OECD by non-EU countries such as the USA and Japan. However, the OECD programme results only in hazard assessments, whereas the EU scheme requires exposure data in order to produce risk assessments leading to risk reduction measures. The OECD programme is therefore a contribution to the EU scheme but cannot replace it.

5   For a fuller description of policy and legislation in this field, at EU and UK national level, see Institute for European Environmental Policy, Manual of Environmental Policy: the EU and Britain, Elsevier Science Ltd, Oxford (updated every six months). Back

6   EINECS is published in OJ C 146, 15.6.90, and also on the ECB website: Back

7   76/769/EEC (see paragraph 20). Back

8   67/548/EEC, OJ L 196, 16.8.67 as amended, and 1999/45/EC, OJ L 200, 30.7.99. Back

9   Directive 79/117/EEC, OJ L33, 8.2.79. Back

10   91/414/EEC, OJ L230, 19.8.91. Back

11   98/8/EC, OJ L123, 24.4.98. Back

12   2455/92, OJ L251, 29.8.92. Back

13   93/75/EEC, OJ L247, 5.10.93; 94/55/EC, OJ L319, 12.12.94; 96/49/EC, OJ L235, 17.9.96. Back

14   80/1107/EEC, OJ L327, 3.12.80. Back

15   89/391/EEC, OJ L183, 29.6.89. Back

16   85/501/EEC, replaced by 96/82/EC, OJ L10, 14.1.97. Back

17   98/249/EC, OJ L104, 3.4.98 (Decision on the conclusion of the Convention). Back

18   See Commission's White Paper, page 10. The main objective of the Convention, which was opened for signature in May 2001 and since signed by the European Community and most Member States, is the elimination of intentionally produced Persistent Organic Pollutants (POPs) and the continuous minimisation or where feasible ultimate elimination of those POPs that are unintentional by-products. POPs under the Convention are those that possess toxic properties, resist degradation, bioaccumulate and are transported, through air, water and migratory species, across international boundaries and deposited far from their place of release, where they accumulate in terrestrial and aquatic ecosystems. The Convention provides a framework to ensure the elimination/minimisation of initially 12 priority POPs that are also included in the UNECE Persistent Organic Pollutants Protocol to the Convention on Long Range Transboundary Air Pollution. These are aldrin, chlordane, DDT, dieldrin, endrin, heptachlor, mirex, toxaphene, polychlorinated biphenyls (PCBs), hexachlorobenzine, dioxins and furans. Back

19   DETR, December 1999, ISBN 1 85112 333 4. Back

20   UK Chemicals Stakeholder Forum, First Annual Report 2000-2001, Department for Environment, Food and Rural Affairs, London, November 2001, ISBN 1 85112 7003. Back

21   See White Paper, Introduction, page 4. Back

22   Final Report of the SLIM Phase IV Team on Dangerous Substances (Directive 67/548/EEC), European Commission, DG Environment, 1999. The text is available on: Back

23   See paragraphs 118-123 below. Back

24   OJ L84, 5.4.93. Back

25   OJ L161, 29.6.94. Back

26   COM(2000)260, OJ C 337, 28.11.00, and C 213, 31.7.01. Back

27   COM(2001)12, OJ C 154, 29.5.01. Back

28   See paragraph 60. Back

29   The information contained in paragraphs 74-77 is essentially based on oral evidence and published material provided to the inquiry by Mr Visser of OECD (QQ 384-429, at pp 152-163). Back

30   HPV = High Production Volume Chemicals; ICCA = International Council of Chemical Associations; SIDS = Screening information data set. Back

31   Oral evidence from Mr Visser, OECD (Q 392). Back

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