爱尔兰政府对REACH法规的评议

作者：发布时间： 2008年12月19日来源：

"

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 1 REACH REGULATION PUBLIC INTERNET CONSULTATION A - Contact details (Please enter your contact details) Name: Kevin Greene Organisation : Department of the Environment, Heritage and Local Government A - Contact details (Please enter your contact details) Name: Gerry Wrynn Organisation : Department of Enterprise, Trade and Employment B - Confidentiality I would like my identity to be kept confidential (please leave this box blank if you agree that your name and organisation will be identified on the Commission’s website for public access) C - SME Are you a small or medium sized enterprise? (EC legal definition) please specify the number of members: EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 2 D - Description of your primary activities (please select only one of the following) Industry Manufacturer Importer Downstream user Distributor Trade association Other NGO Environmental group Animal welfare group Trade union Consumer organisation Other Public authorities EU Member State government Other national government International organisation National or regional authority Other Academic or technical institute Worker in chemicals or downstream industry EU citizen Other Please structure your response according to the following topic areas and provide comments or proposals for amendments to the legislation. Please comment on those topics that are relevant to you. When finished, please send your document to the following address: <A href=""mailto:entr-env-ec-reach@cec.eu.int"">entr-env-ec-reach@cec.eu.int</A>. Thank you in advance for your contribution. E - Topics : 1. Duty of care 2. Chemical safety assessment 3. Information flow 4. Registration procedure 5. Polymers 6. Intermediates EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 3 7. Data requirements 8. Data sharing/consortia formation 9. Procedures for downstream users 10. Evaluation procedure 11. Authorisation procedure 12. Restrictions procedure 13. The Agency 14. Other EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 4 IRISH GOVERNMENT SUBMISSION TO THE EU COMMISSION INTERNET CONSULTATION ON REACH (REGISTRATION, EVALUATION AND AUTHORISATION OF CHEMICALS) DUBLIN 9 JULY 2003. EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 5 PREFACE: The Irish Government supports the overall objectives of the REACH initiative but considers it is essential that the right balance be struck between environmental, economic and social policy dimensions. The proposed regulatory regime must secure a high level of protection for human health and the environment, while at the same time stimulating innovation and the competitiveness of the EU industry. In addressing the workability issues relating to the draft proposal, the remarks set out in this submission are made without prejudice to any position which may be taken in formal negotiation on the proposal. It is necessary to recognise at the outset that the purpose and objectives of the proposal are to facilitate the introduction of a single regulatory system for all chemicals over a reasonable time-frame. The revision of the draft proposal in response to the Internet consultation must embrace the concerns of both the industry and the regulatory authorities in order to ensure that the system is credible and that all interests have confidence in it. The system must enable users (whether in industry or as consumers) to make conscious, informed decisions regarding public health, occupational health and environmental considerations when using these chemicals. The Internet consultation on REACH is focused by the Commission on the workability of the proposed system, defined as its efficiency and technical and scientific soundness. In this regard it is necessary also to include consideration of some of the macro effects of the proposal in respect of economic, social and environmental considerations, to examine the timeliness of the provisions and to examine the implications for the competitiveness of the chemicals industry and downstream users in the EU. REACH must not create risks for the Union in these respects. Indeed, Ireland shares the concerns of European colleagues about the competitiveness implications of REACH and anticipates significant revision by the Commission of its proposal before it is published. There are significant concerns that REACH will: - impose sizeable/disproportionate costs on manufacturers and users of chemicals in the Union; (the benefits from the proposal, which will accrue both inside and outside the Union, are less readily quantified); - these costs will impact on production and employment, particularly in SMEs. SMEs will, in addition, be disadvantaged through the deselection of many chemicals from the supply chain because of reluctance by primary producers to incur registration and testing costs; - these costs will also decrease profits and so reduce the amount of finance available for research and development and thus have the potential to further hinder innovation in the EU; EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 6 - increased costs could have a negative impact on the competitiveness of EU based industry, resulting in loss of market share and decreasing the incentive, in a global industry, for foreign direct investment (FDI) in the Union and that - this risk to competitiveness could threaten the retention of existing chemical companies in the Union. These concerns are further deepened for Ireland when the REACH framework is considered from a specifically Irish perspective. In that regard, research shows that due to the profile of its pharmaceutical and chemical industry (pharmachem), and downstream users, Ireland may be disproportionately affected by the impact of REACH. In particular: - this industry is very important to Ireland as it accounts for 37% of exports and is growing, - Ireland has a very high dependence on FDI, specifically: it is the market leader in Europe for attracting new FDI in this industry Ireland’s industry is largely foreign-owned and has sister plants outside the Union half of Irish Exports in this industry are to non-EU countries, so there is a danger of losing FDI to locations outside the Union. many key drugs are coming to the end of their patent protection, so new investment decisions are pending; - High-tech manufacturing industry is a very important sector in the Irish context. As down-stream users of chemicals it is predicted that this sector will be severely impacted. - the sector predicted to be worst hit by REACH accounts for a higher than average share of the Irish chemical industry the API (Active Pharmaceutical Ingredients) sector accounts for 40% of plants and over 70% of value added in the Irish industry it is expected that this sector will bear a disproportionate share of the burden of REACH due to its use of a diverse range of chemicals and the sizeable number of steps in its production processes; - most of Ireland’s indigenous industry are SMEs, which again will bear a substantial portion of the costs. These broad considerations provide the overarching framework within which the Irish Government’s response to the Internet consultation process has been EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 7 formulated. Furthermore, this Paper does not propose to address all aspects of the proposal individually but concentrates on particular concerns (and uncertainties) as regards its workability. WORKABILITY OF REACH General Concerns: Comparison of the Internet document with the Commission’s White Paper shows a number of welcome provisions in respect of research and development, intermediates and data sharing. Any improvements that result in streamlining the scheme as it is intended to apply to new chemicals and that encourage innovation are welcome. However, these are outweighed by the application of REACH to a far wider range of chemicals, including substances in articles, cosmetics, pesticides, biocides etc., and by more onerous and costly requirements, particularly under the Duty of Care title. Overall, Ireland has significant concerns with the published proposal as regards: - aspects of its workability; - its ambitious regulatory approach and the complex and onerous nature of its requirements; - the impact of some of its requirements not reaching the correct balance between the achievement of its political objectives of protecting human health and the environment with maintaining and enhancing the competitiveness of the EU chemical industry, employment creation and maintenance, particularly in SMEs, and - the lack of clarity on many aspects. Consideration of the workability of the detail of the proposal revealed a range of general concerns, including inconsistencies between requirements set out in the proposed Regulation and the Explanatory Memorandum. These concerns will need to be revisited when clarification becomes available. There is a need for legal certainty for industry and for the regulatory authorities to facilitate compliance with regulatory provisions. Therefore, the availability from the outset of guidance documents will be critical, including on issues such as the acceptability of alternative test data, waiving of testing requirements, data sharing arrangements etc. The absence of clarity on linguistics was noted. A realistic approach to the language issue is critical to how risk assessments, evaluation, timelines, information to downstream users and the public, and the work of the various authorities is to be handled efficiently and without excessive cost. EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 8 Particular Concerns on Workability: Scope The scope of the REACH proposals extends far beyond the scope of the legislation which the White Paper intended to replace. The scope of REACH and its proposed thresholds and target dates should be reviewed to avoid duplication of existing controls, to improve the interface with existing legislation, to minimise its impact on competitiveness and to ensure that the eventual system is realistic and achievable. More significantly, it now seems that substantially more substances will be affected by REACH than the 30,000 originally envisaged in the White Paper. Ireland is strongly of the view that every effort should be made to reduce this likely impact. This could be achieved by amending the proposals in relation to intermediates and polymers and by applying a greater degree of prioritisation. The following specific submissions are made - - Intermediates: With regard to the treatment of intermediates, Ireland agrees with the revised treatment of type 1 (non-isolated) intermediates, which are now exempted from REACH and does not dispute the treatment of type 4 (marketed) intermediates. However the requirements for type 2 (site-limited) and type 3 (between sites) intermediates should be lessened: a basic form of notification should be considered instead of registration. In particular, the requirements for type 3 (between sites) intermediates are of serious concern considering that this will impact on an estimated 10,000 intermediates. In addition to decreasing the overall scope of REACH, these recommendations will serve to reduce the specific burden of REACH on the API sector, which is vulnerable due to the sizeable number of steps in its production processes. - Polymers: In relation to the treatment of polymers, it is very important that the number of polymers affected is limited. Some estimates suggest that over 30,000 polymers could be affected by REACH. Focus should be placed on polymers whose characteristics give rise to concern by making them potentially hazardous. Non-hazardous polymers should be exempted. An alternative proposal for non-hazardous polymers is for the constituent monomer(s) only to be registered. The polymers may then need to be tested only if the risk assessment of the monomer identifies the need for risk management, after examining both monomer and polymer use. - Ireland is of the view that greater prioritisation can be achieved by not focusing solely on the crude tonnage thresholds. This would make for a more effective use of resources by addressing more hazardous substances first. It would also ensure that chemicals that present the greatest potential dangers are dealt with immediately. Secondly, implicit in any such reprioritization is an extension of the deadlines for the standard tonnage thresholds. This will aid industry, as the existing time schedule is too tight, enabling it to spread the financial costs over a longer time period and so decrease their economic burden. EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 9 - The interface between the Waste Regulations and the current proposal in relation to disposal requires clarification, particularly in respect of waste product which may be reused. Roles and Responsibilities of the Agency The proposed division of work and responsibilities between the Agency and MS Authorities is of major concern as regards doubts about ensuring consistency, good management and resourcing. The procedures, as described at present, are un-necessarily bureaucratic and involve too much repetitive interaction between the various stakeholders. Further consideration needs to be given to the role of the Agency so as to achieve the best model as regards co-ordinating and managing the various administrative procedures under REACH. Timeliness/Resources While the timetable proposed for the registration of substances may appear to be reasonable there are several factors which may impact on achieving this: - The timetable for the registration of substances places the emphasis on volume and risk. This system will allow for a phased process over 11 years. However it is possible that certain manufacturers may register smaller volume substances earlier, for market advantage reasons, thereby creating a possible overload at both Agency and National Authority level. - The workability of the registration system, intended to be electronic based, will need to have been tested and proven before the commencement date for the scheme. Resourcing of the Agency and national authorities will need to be examined in detail to ensure that they can meet the conditions applicable under Article 19(3)(a) and (b). - There are no timescales for the Agency to carry out a further completeness check or for the National Authorities to reject the registration in the case of incomplete initial registrations. In addition there is no procedure for the deletion of a registration number where data is not submitted and/or the registration is rejected. - While industry has traditionally argued that it has the risk assessment data already in many instances, it is anticipated that the level of environmental assessment data will be limited. In fact, there are serious doubts as regards availability and expertise for both SMEs and downstream users to cope with the Duty of Care and Registration provisions. - There is potential for additional testing where there is a deficiency in available data. This may cause problems with regard to the proposed timetable. It may also prove costly as the number of test houses available for vertebrate EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 10 animal testing is limited and there are few approved alternative test methods. - The level of fees payable to the Agency as part of the overall process will be set by the Management Board of the Agency. As the main role in respect of evaluation and enforcement could fall on the national authorities it will be important that the funds transferred to national authorities are commensurate with their workload in the process. The current proposal (in Commission supporting papers) to allocate c. € 5000 for evaluations does not reflect the overall costs of the process nor does it address the cost of the range of mandatory functions which may be placed on national authorities. The additional optional functions would place further costs on Member States. Duty of Care Ireland is of the view that the universally applicable Duty of Care provision, requiring a full chemical safety assessment, is over burdensome: - The Commission has given some indication that the completion of the Chemical Safety Report (CSR) as part of the Duty of Care provisions will not be onerous. However, there is a strong concern that the Duty of Care covers chemical substances which are currently outside the remit of the chemicals Competent Authorities e.g. substances in articles, cosmetics, pesticides, biocides, etc., and would require provisions to be put in place at a national level to ensure adequate enforcement of this duty. - Additional information is required regarding the interfaces and relationships between the proposed chemicals regulation and other regulatory requirements in order to avoid duplication and to ensure the adequacy of data. - The time-frame (18 months) for completion of the Chemicals Safety Reports (CSR) will place a greater burden on the SME sector as they are likely to have less support staff. - Assistance, by way of training and/or guidance, will be necessary to enable industry, particularly the SME sector, to meet these provisions. - The “Duty of Care” provision would appear to present a “safety net” to address any issues not addressed under the more specific articles of the proposal. Workers, downstream users and the public will use this general provision to address all of their concerns on chemicals. Proper administration and enforcement of this provision would be difficult and would require a very substantial increase in resources for Member States. - The requirements for the Chemical Safety Report (CSR) outlined in Annex I are extensive. However, there appears to be an inconsistency between the onerous requirements outlined in points 3 and 4 of the proposal, the EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 11 detailed requirements in Annex I and the Commission view that for substances < 1 tonne/ annum, the CSR should be based only on available data. It is unclear what level of detail will be required for low volume substances where there are little available data and how the safe use of such substances will be achieved. Registration Under the current draft there is significant overlap between the role of the Agency and the national authority. Applicants wishing to register a substance can submit incomplete documentation which is electronically checked for completeness and then sent to the national authorities to follow up, where there is any deficiency, to ensure that the necessary data is provided. The registration is then returned to the Agency for a further check before being returned to the national authority. This creates additional layers of bureaucracy. As the proposed registration process does not include any quality control check regarding the data submitted, the optimum solution would be to assign the complete registration process to the Agency, with appropriate provision if necessary to allow the Agency power to reject an incomplete registration. Multiple registrations for individual substances should be avoided where possible as this has the capacity to overload the system. As there is no verification check to review the coherence of data presented for registration there is potential for a lack of consistency causing confusion for downstream users who may source the same product from different suppliers (manufacturers or importers) regarding the data to be provided for classification and labelling purposes. There is a need for consistency in the information available throughout the system. In addition, in the event of an accident the emergency services may be faced with conflicting information regarding the particular substances and how they should handle them. A possible approach to multiple registrations could be to make it mandatory for companies to use an independent third party to make a single registration for a particular substance using available data from the manufacturers/importers concerned if they are not prepared to enter into voluntary data sharing arrangements. The independent third party could be funded by the participants on a shared cost basis or on a percentage basis (tonnage related). Manufacturers wishing to join later could do so subject to the payment of an agreed percentage of the cost. The Agency could be required to draw up guidelines for this process, although the chemicals industry would be responsible for the day-to-day operation of the system. EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 12 Particular competitiveness issues will arise in the pharmachem sector where a significant percentage of the output is not placed on the EU market either as an intermediate or as a finished product, but is exported outside the Union. In many instances multi-national companies will have plants outside the EU who will be competing for group investment. The non-EU plants will be at a significant competitive advantage, as they will not have to comply with the REACH system until such time as the substance is being placed on the market within the EU. Those manufacturers who produce intermediates under specified contracts (to more than 2 users), or who produce an intermediate which is stored for further processing at the same site or elsewhere within the group, will not be required to comply with the REACH system until such time as a substance is being imported into the Community. Data Sharing The current draft provides for data sharing where vertebrate animal testing is involved. However, this should be extended to all data sharing opportunities in order to reduce overall costs. There is a lack of consistency in the approach being proposed for the introduction of data sharing for phase-in (involving the Agency) and non-phasein (involving the Competent Authorities) substances. This is further confused by the lack of text addressing sanctions for phase-in substances in cases of nonco- operation between potential registrants. Further clarity is also required in respect of the proposals regarding the mechanics of cost sharing for testing, particularly vertebrate animal testing. Costs should be a matter for agreement between the parties and not involve the national authorities. Data sharing presents particular difficulties for SMEs which may, in part, be addressed by the suggestions made above as regards registration. Evaluation The proposed system allows for mandatory and priority evaluations of substances. Mandatory evaluations, assigned to national authorities on a population basis, will apply to proposals from manufacturers/importers/downstream users who wish to carry out vertebrate animal testing. The national authority would decide whether the proposal is acceptable or recommend alternative testing routes. Priority evaluations will be discretionary and act mainly as spot checks to examine the registration information. This is the only time any quality control check will be done in respect of the registration data and will therefore be an important element of the system. There needs to be more clarity, however, in the proposal as regards what may be expected of Member States both in relation to mandatory evaluations and as EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 13 regards the extent of priority evaluations to be undertaken, so that account can be taken of the resource implications. While the draft proposal provides for a single evaluation of substances there is no limit to the number of times a substance can be evaluated or no time-limit between evaluations. Where a MS proposes to do a priority evaluation on a substance which has been evaluated previously in another MS, it should only be done where justified on the basis of new information or a change of circumstances. Finally, it would appear that this is the only point in the process where coherence of data submitted in (multiple) registrations is addressed, as the evaluating authority is obliged to examine all the registrations which exist for the substance under evaluation. Again, this raises the issue of one registration per substance being desirable, putting the onus on industry to ensure the registration data package is consistent. Legal Certainty In the text there are a several instances of open-ended phrases which will require clarification e.g. - Significant release - Reasonable foreseeable conditions - Significant changes - Sufficiently high amounts - Adequate test results and data Where it is not possible to define these phrases clearly in the text it will be necessary to provide clear guidance for both industry and national authorities. Alternatively, there is potential for wide interpretation with different decisions being given depending on the national authority concerned. Early Guidance for industry The Commission has identified a number of areas where guidelines will be prepared to assist industry and MS authorities meet the provisions of the draft proposal. The early production of these guidelines will be important particularly in respect of: - The use of comparable data for the Duty of Care and Registration - The acceptability of non vertebrate animal testing results - The acceptability of earlier test results for phase-in substances where there are no recent test results available or where the results may not meet current Good Laboratory Practice conditions EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL ENVIRONMENT DIRECTORATE-GENERAL 14 - Data sharing Conclusion It is very important, in Ireland’s view, that these, and other submissions, are fully examined and considered by the Commission with a view to reaching a realistic framework for the future control of chemicals in its proposal on REACH. If this does not happen an immense burden will fall on the Council, the European Parliament and others involved in the process in taking a proposal forward and bringing it to a conclusion acceptable to all of the stakeholders. The Irish Government is ready to provide any further clarification which may be required by the Commission on points made in this submission. 9th July 2003"

[

] [

]