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Joint position of the German Government, the Association of the German ChemicalIndustry (VCI) and the Mining, Chemical and Energy Industrial Union (IGBCE)on the consultation document of the European Commission on the Registration,Evaluation and Authorization of Chemicals (REACH)Preliminary remarksIn March 2002, the abovementioned bodies agreed on a joint position on the EU Commission White Paper "Strategy for a future chemicals policy". We reaffirm the statements made in that paper, which also forms the basis of our assessment of the Commission consultation document. The core statement, i.e. that a high level of effective protection of human health and the environment should be provided in such a way that it ensures the chemical industry's innovativeness and competitiveness, remains unchanged. We need regulations which afford effectiveprotection of health and the environment at the lowest possible cost and in quick, simple and reliable administrative procedures.The Commission's consultation document takes up some of our proposals. For example, the envisaged facilitations for intermediates, as well as for research and development, are welcomed. We also support the selection of the groups of substances envisaged for the authorization procedure. However, the shortcomings in the consultation document involve the risk, that without amendments the competitiveness of companies and jobs could be jeopardized (hence impact assessment - cf. below).The key points of criticism can be summarized as follows:- The registration procedure in particular is still too bureaucratic and expensive and fails to fulfil the promise of swift, simple and cost-effective procedures.- The area of application and the requirements for the Chemical Safety Report are toofar-reaching and represent a considerable problem, particularly for SME users in thevalue-added chain.- 2 -- The industrial and commercial confidentiality has not been sufficiently ensured.On the initiative of Chancellor Schr?der, Prime Minister Blair and President Chirac the European Council on 21 March 2003 sent out a clear message that it intends to strengthen the EU's industrial competitiveness. One key element is that the Commission is to subject all major dossiers to a comprehensive impact assessment with regard to industrial competitiveness. This benefit and impact assessment is of central importance to the new chemicals regime. We therefore call upon the European Commission to quickly submit a revised draft. Before this draft is examined in the European Parliament and in the Council, the concrete impact of the envisaged regulations on the European chemicals industry and the economy along the entire value-added chain should be assessed by a third party. In view of the European Parliament elections due to take place in June 2004, the proposed impact assessment would not delay the legislative process.I. Authorization procedure1. Inclusion of further groups of substancesThe proposed regulations in the Commission's consultation document on the inclusionof CMR, PBT and vPvB substances are in accordance with our joint position paperand can be supported. It is proposed that in Point 44 – in connection with an annexlisting the technical criteria – the group of sensitizing and chronically toxic substancesdescribed in more detail in the joint position paper be listed in a separate sub-paragraph.2. Inclusion of further substancesCompared to the chemicals White Paper, further groups of substances (cf. item 1) havebeen included. We must prevent the system from becoming overloaded due to the inclusionof other substances merely suspected of being harmful as this would havenegative consequences for the industry. Against this background, the opening clause(point 44) envisaged by the Commission is too vague.The inclusion of further substances can therefore only be considered according to the following limited criteria:- 3 -- The exceptional character of the regulation must be clear.- In the Regulation itself, the valid sound technical and scientific criteria shouldbe defined which constitute a level of concern comparable to the other groupsof substances.- As with other cases today, a qualified majority in the regulatory committeeshould be required for the inclusion of further substances.3. Immediate decisionAn immediate decision on uses ready for decision should be possible. With regard to a decision on the inclusion of a substance in Annex XIII, it should be examined to whatextent certain uses are directly subject to a restriction. This could reduce the number of authorization procedures to be carried out.4. Authorization time limitsThe so-called sunset date regulation (Point 46 No. 1 c and d) is welcomed. Under it,those uses which were notified up to 18 months before a certain date may be continueduntil a decision on authorization has been made. The Commission should make it clearthat the regulation is to be interpreted in such a way that the normal authorization procedure can be initiated in advance for uses developed during the 18 monthsbetween the stated date and the expiry date.5. National authorizationThe option of national authorization should be examined against the background ofpossible distortions of competition.II. Registration/evaluation1. PolymersThe large number of existing polymers and their wide range of uses in industryaccount for the particular importance of this group of substances to the chemicalindustry and the users in the value-added chain. The review of the obligation to regis-4 -ter proposed in the Commission consultation document involves a lot of costs andefforts. Moreover, it is difficult to establish criteria for identifying a manageable number of the relevant polymers which are both practicable and cost-efficient. Theyshould therefore be initially exempted from the obligation to register until apracticable and cost-efficient selection is possible on the basis of sound technical and valid scientific criteria. As soon as this is feasible at a later date in time, they should be included.2. IntermediatesIn the joint position paper, we expressed our support for exempting intermediates used exclusively in a closed system (including closed transports) from the authorization procedure. This basic line has been confirmed. The Commission's consultationdocument also contains proposals on this which we welcome in principle. It is crucialto ensure that data collection is made easier if the substances are handled in clearly defined and controlled conditions. Against this background, the followingamendments/additions are proposed:- Application of the provisions concerning transported intermediates to intermediatesused on-site in closed systems taking the 28th adapting Directive onthe EU Directive on Dangerous Substances as guidance.- The limitation to only two sites should be waived in the case of transported intermediates.- In view of possible operational accidents, a minimum set of data should berequired for intermediates for which simplifications apply.3. Uniform evaluation standardsEU-wide binding standards for the evaluation of substances should be laid down in the Regulation.4. Obligation to notify research and developmentThe easing of regulations for research and development contained in the consultation document are welcomed. For competitive reasons, however, research projects in com-5 -panies should not be made public as a result of the envisaged obligation to notify such projects. Notifications should therefore be generally treated confidentially.5. Transitional periodsSubstances with EINECS status are treated like phase-in substances if more than 1 t/ahas been produced/imported during the previous ten years. For other substances containedin EINECS of which more than 1 t/a has been produced/imported, an appropriatetransitional period shall apply.6. Intended useThe Commission is requested to develop a system of use and exposure categories tomake the REACH procedure easier to manage, in particular for downstream users.III. Role of the EU Chemicals AgencyThe planned European Chemicals Agency will play a central role in the effective management of the registration, evaluation and authorization of chemicals. There isgreat potential for cost savings here. However, this central role is also important in order to avoid distortions of competition. The Agency should therefore ensure inparticular a uniform application of the rules in all member states. In so far as there are competences for this under the EC Treaty, the Agency should therefore also beallocated decision-making powers. Furthermore, it should also make a key contributionin the administrative procedures towards efficiency and cost savings.It is therefore proposed that the Agency- be able to make binding decisions on any questions arising from the registrationof substances,- confirm receipt of documents, in particular in the case of registrations, if possible, establish whether all documents are complete and inform the registrant ofthis directly (so that, in the interests of companies, an early marketing authorization can be obtained quickly).- 6 -It should be examined whether an appeals committee should be established for disputes on recommendations or decisions made by the Agency.IV. Quality assuranceAn appropriate and effective system of quality assurance should be set up for the documents to be submitted by industry for registration. Depending on the preferencesof those involved, either internal quality assurance measures by the industry with external certification of the system or a prior review of the data to be submitted by independent experts should be considered.V. Safe handling of chemicalsWe support the basic rule on the safe handling of chemicals contained in the consultation document (Point 3) in principle (subject to minor changes). The aim of aresponsible chemicals policy must be to develop safer substances or uses in the case of recognized risks.Taking into consideration the protective purpose of the Chemical Safety Reports, in its drafting the following simplifications for companies are proposed:- Compulsory for substances subject to registration.- Reasonable harmonization of Chemical Safety Reports and safety data sheets,although it is not necessary to provide Chemical Safety Reports to downstreamusers regularly. Rather, only the safety data sheet must be provided on a regularbasis. However, the Chemical Safety Report should be supplied on request.- Summarizing Chemical Safety Report for preparations with reporting obligationsfor those constituent substances of relevance to safetyrecommendations and/or restrictions on use corresponding to the compilationof safety data sheets as laid down in the Directive on preparations.VI. Industrial and commercial confidentialityIn line with the joint position paper, industrial and commercial confidentiality must be ensured. On the other hand, the necessary information must be accessible to the authorities, and the public also has a legitimate right to information. Particularly the - 7 -regulation contained in the consultation document that all information not expressly declared to be confidential should be made available on the Internet, means that,owing to the possible combination of data, information relevant to competition ismade accessible.In order to ensure industrial and commercial confidentiality and, on the other hand, to ensure that the public has the necessary access to information, the following measures are proposed:- All information required to classify substances as hazardous should be madepublic.- Information should be provided on request by the competent authorities. Theyshould refrain from publishing all non-confidential information.- It would suffice if the reasons for handling documents confidentially are made credible.- In order not to reveal business relations in value-added chains, the names and addresses of users (downstream users) should be treated confidentially.VII. SanctionsThe sanctions regulation should be reexamined taking into account the principle of proportionality.。