VVD Eurofractie on-line
4 February 2004
WORKING DOCUMENT
on the proposal for a regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants}
Committee on Industry, External Trade, Research and Energy
Rapporteur: Elly Plooij-van Gorsel
Since the first Council Directive on chemicals from 1967 (Council Directive 67/548/EEC), European rules on chemicals have been developed significantly and today constitute more than 40 directives, interlinking, supplementing, and sometimes contradicting each other. A clarification and simplification of these rules was therefore long overdue. In the current regulation proposal, your rapporteur especially welcomes the simplification of rules which will benefit the many Small and Medium-sized Enterprises that constitute 98% of European chemicals manufacturers and end users, the further harmonisation of both the rules themselves and the implementation of these rules which will lead to a more level playing field on the internal market, and the centralisation of registration which will improve transparency and create a much-needed data stream from producer to end user.
Your rapporteur supports the goals of the current proposal (hereafter REACH), and congratulates the Commission in the major achievement constituted by the proposal. At the same time, however, she must express her concerns over the lack of focus and general workability of the proposal.
The scope of the proposed regulation is enormous, and it will have impact on the entire European manufacturing industry. It is therefore imperative for the coming legislation to be clear and transparent , so that companies know what to comply with and how. To be workable , so that decisions may be taken within reasonable time limits and companies will not be burdened with unnecessary costs and double bureaucracy. And finally, for the proposed rules to be implemented uniformly on a European level, they should be managed by a strong, independent Agency.
Your rapporteur is particularly concerned with the competitiveness of the EU manufacturing industry. Under REACH, manufacturers based in Europe will be subjects to unfair competition from manufacturers from third countries which will not be under the same costly registration requirements for the substances used in their production processes. One must carefully design the system so that an appropriate degree of freedom of choice in production processes and the selection of raw materials is still present both for the many harmless substances and for those substances where the risk is controlled and contained. In the view of your rapporteur, the regulation must be directed more towards risk assessment and -management and work by a system which allows a graduation of test and data requirements so that established harmless substances can be exempted from costly rigorous analyses and the resources can be concentrated on substances which are of real concern. Only then can the system be considered cost-effective.
In this regard, it is worth mentioning that the EU chemicals industry has over the past 25 years taken a large number of initiatives to improve its environmental performance and the safety of its processes and products.
Simplification, scope and prioritisation
The current proposal combines the existing rules on "new substances" (substances put on the market after 1981) and "existing substances" (substances put on the market before 1981) as well as the rules on restrictions on the marketing and use of certain dangerous substances and preparations into one new regulation. Whereas under current rules only new substances have to be tested and registered, under REACH such data has to be provided for all substances - new as well as those already on the market. Also, REACH introduces the principle of "reversed burden of proof" as the sole guiding principle, leaving it to the importer, producer or end user to prove safety, rather than for the authorities to prove risk.
For substances already on the market at the time of REACH's entry into force, a hierarchy of deadlines for registration is introduced, determined by either its risk category or the quantities in which it is being produced or imported. Category 1 and 2 CMR-substances (carcinogenic substances and substances that alter human DNA or damage human fertility) must be registered within 3 years of the Regulation's entry into force. All other substances are subject to registration depending on the quantity produced: 3 years for >1.000 tons per year per producer/importer, 6 years for 100-1000 tons, and 11 years for 1-100 tons.
To the mind of your rapporteur, this prioritisation by means of quantity is too crude. Priority for testing and registration should be given to high volume, high-risk materials based on the information readily available (e.g. Material Safety Data Sheets). Secondly, priority should be given to substances placed on the market rather than those used in production processes.
Registration and data requirements
Any chemical substance which is produced in or imported into the EU in quantities of more than 1 ton/year must be registered with the European Chemicals Agency (hereafter "the Agency") by the producer or importer. For all substances produced or imported in quantities exceeding 10 tons per year, a Chemical Safety Assessment (CSA), documented by a Chemical Safety Report (CSR), must be produced and presented to the Agency. The CSR must cover all known uses of the substance in question and be sufficiently present in the safety data sheet which follows the product to other users in the supply chain. The supplier has the responsibility to include all uses reported by downstream users whom he supplies. However, should a user wish not to disclose a particular use to the supplier, he can chose to produce his own CSR for this use and submit this to the Agency which will treat it confidentially.
The very broadness of the registration requirements - that in principle all substances must be registered - has an unfortunate side-effect in that it inadvertently will prevent manufacturers from using environment-friendly manufacturing processes. It must be secured that i.e. the use of recycled waste, natural materials, and recycled or extracted preparations is not impeded by REACH.
Evaluation
Two types of evaluation are foreseen: Substance evaluation and dossier evaluation.
Dossier evaluations shall be done by the competent authority of the Member State in which the manufacture takes place or the importer is established. For new substances, a time limit of 120 days applies, while phase-in substances will be evaluated within 8 to 15 years after the entry into force of the proposal depending on tonnage.
For substance evaluations Member States are required to establish evaluation rolling plans covering three years and listing the substances they intend to evaluate. This is to enable Member States to plan for and assign resources to evaluate substances that are suspected of constituting a risk for health or the environment. The substances to be evaluated will be determined by the Agency's Member State Committee.
Your rapporteur wishes to make the following two points:
1) Although the Agency is responsible for registering substances and carries out a completeness check for the information provided, the evaluation and thereby the main responsibility for compliance with the data requirements is left with the Member States' authorities. This principle goes against the central aim of common rules, since it increases the risk of different data requirements in different Member States. Moreover, there is a risk that the accession countries will not have the expertise in time to perform this task. Your rapporteur believes the Agency should be responsible for all processes under REACH. This would increase the efficiency of REACH while also securing homogeneity and compatibility of data. The role of Member State authorities should be to assist companies in dossier preparation, procurement of evaluation data, and enforcement.
2) The data requirements for any given substance are defined by its tonnage. However, as repeated throughout this working document, quantity alone is a very crude factor to establish risk by and will create an enormous amount of useless documentation on harmless substances. A more targeted approach could be achieved by assessing the potential risk of a substance based on a combination of quantity, properties and use prior to forming data requirements. This is the method of i.a. the ECETOC Targeted Risk Assessment Approach and the SOMS model used by the Dutch authorities.
Authorisation and substitution
The purpose of authorisation is to secure that the use of particularly problematic substances takes place under controlled forms or that these substances are replaced by other substances. Substances already covered by authorisation are CMR substances in category 1 and 2 , Persistent Bioaccumulative and Toxic chemicals (PBTs) and very persistent and very Bioaccumulative chemicals (vPvBs).
The continued use of problematic substances requires an authorisation. Authorisation shall be granted by the Commission if it can be demonstrated that the risk presented by a substance is adequately controlled. If this can not be demonstrated, an authorisation may be granted if socio-economic benefits outweigh the risk to human health and the environment and if there are no suitable alternative substances or technologies.
In the view of your rapporteur, the inclusion of PBTs and vPvBs is immature. The criteria used for the definition of these substances are far from being settled, making it difficult to establish what will be the basis for the authorisation process and what particular substances will be covered by the ban. Since it is unclear which substances require authorisation and the burden of proof rests with the producer/importer, legal uncertainty will prevail.
Confidentiality
The proposed legislation requires broad disclosure and exchange of confidential business information. Chemical companies and downstream users must submit massive data to the national authorities as well as to the Agency in the registration, evaluation and authorisation process, including sensitive information such as physiochemical data and descriptions of uses.
Even if the risk of confidential information leaking from national authorities or the Agency itself is ignored, much of the information critical to the competitiveness of a given company is treated as non-confidential under the current proposal. In today's competitive world, the publication of the combination “company name-substance-use” can be severely damaging for European SMEs. Also, publication of any but the most general description of the processes applied in production will invite a lethal stream of copy products.
It is striking that the whole system of REACH builds on the concept of public access to data and flows of information from producers and importers through the supply chain without considering basic legal principles ensuring the protection of business confidences both under Community law and under international law (i.e. TRIPS, Art. 39). A more narrow definition of the data considered as “non confidential” is needed. The current disclosure obligations are both dangerous to European businesses and disproportionate to the aims of the proposal.
In the view of your rapporteur, REACH must include sound safeguards that confidential data regarding production processes and R&D will not be disclosed. REACH makes it mandatory for companies to provide such information and it should be equally mandatory that this information be sufficiently protected.
The role of the European chemicals agency
The proposed establishment of a central European Chemicals Agency and the role of this Agency constitute a key part of the REACH system. The establishment of this Agency is welcomed by your rapporteur. A level playing field on the single market for chemicals can only be guaranteed if the European chemicals policy is implemented on a truly European level. Your rapporteur therefore believes that REACH should be managed through efficient, centralised and transparent decision-making processes supported by, and articulated around, an independent central agency. The proposed European Chemicals Agency should therefore not only have the powers at registration level, but also at all other decision-making levels in REACH, including the evaluation level which the proposal leaves largely in the hands of the Member States. Thereby, the composition of expert committees (e.g. on risk-assessment and socio-economic analysis), should be based on expertise rather than on nationality. A single European body with independent experts, transparent procedures, legal personality, and a built-in Board of Appeal is the biggest guarantor of both transparency and a level playing field for chemicals – now and in the future.
