European Parliament legislative resolution on the Council common position for adopting 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, amending Directive 1999/45/EC of the European Parliament and of the Council and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (7524/8/2006 – C6-0267/2006 – 2003/0256(COD))
(Codecision procedure: second reading)
The European Parliament
– having regard to the Council common position (7524/8/2006 – C6-0267/2006)(1)
– having regard to its position at first reading(2)
on the Commission proposal to Parliament and the Council (COM(2003)0644)(3)
– having regard to Article 251(2) of the EC Treaty,
– having regard to Rule 62 of its Rules of Procedure,
– having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A6-0352/2006),
– having regard to the Commission statements which are annexed to this legislative resolution and which will be published together with the legislative act in the Official Journal,
1. Approves the common position as amended;
2. Instructs its President to forward its position to the Council and the Commission.
Position of the European Parliament adopted at second reading on 13 December 2006 with a view to the adoption of Regulation (EC) No .../2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
(As an agreement was reached between Parliament and Council, Parliament's position at second reading corresponds to the final legislative act, Regulation (EC) No 1907/2006.)
Commission Statement on Alternative Methods
As part of the Community's strategy to promote alternative test methods, the development of methods covering computer supported, in vitro and other methodologies, including refinement of current methods, has been a priority for decades. Between 1999 and 2002 (Fifth Framework Programme), the EU supported 43 research projects worth EUR 65 million, several of which are still ongoing. In the current Research Framework Programme (Sixth Framework Programme: 2003-2006), the European Union is investing more than EUR 90 million to develop robust, effective, non-animal testing methods that will withstand the requirements of international validation.
Research activities will continue in the forthcoming Seventh Framework Programme (2007-2013) through coordinated activities on alternative methods and strategies for safety testing focused on pharmaceuticals (under the Health theme) and industrial chemicals (under the Environment theme). Consideration has been given to which methods could make the most contribution to reducing animal testing within REACH, taking due account of the time needed to develop tests and the relevant registration deadlines in REACH. As a result, the Seventh Framework Programme includes the development of methods that could directly support the reduction of the use of animals in testing within REACH. Involvement of stakeholders is being sought through initiatives such as the European Partnership for Alternative Approaches to Animal Testing, launched on 7 November 2005 by Commissioners Potocnik and Verheugen together with industry. By effectively pooling Commission and industry experience, expertise and resources, a common coordinated Partnership at EU level and across sectors will be more effective than historically fragmented initiatives in this area.
The validation of alternative testing methods has been a priority for the Commission since 1991. To this end, the Commission set up the European Centre for the Validation of Alternative Methods (ECVAM), a specific unit within the Joint Research Centre with the task of coordinating the validation of alternative test methods at European Union level, and promoting the development, validation and international recognition of alternative test methods. The Commission will continue to validate appropriate methods and will consider the application of validated methods in Community legislation. Today, suitable methods are used in the context of the Community legislation on chemicals, to adapt Annex V of Directive 67/548/EEC. The Commission recognises the importance of securing regulatory acceptance for such methods as rapidly as possible and has adopted several validated alternative test methods in Annex V of Directive 67/548/EEC ahead of their eventual international acceptance. The Commission will give a high priority to ensuring that the REACH testing regulation is adapted as soon as possible after appropriate validated methods become available.
The Commission will continue to be active in international fora, particularly the OECD where it contributes to the development of new standards for tests and with especial focus on newly validated methods as mentioned above.
The regulatory framework in which test methods are used is as important as the specific methods. Since its very beginning, the minimisation of animal testing has been a key element of the design of REACH and the Commission has consistently worked to improve this aspect of the proposal. This can be seen in terms of significant changes throughout the process such as adding the pre-registration phase as a result of feedback on the White Paper in 2001 and accepting a single pre-registration date as proposed in both Parliament's First Reading Opinion and the Council Common Position. Minimisation of animal testing is also apparent in the detailed legislative text, including encouragement for grouping of substances, evaluation of testing proposals and use of read across. Important work related to reducing the use of animals is on-going in the RIPs (REACH Implementation Projects) with the development of intelligent testing strategies. The Commission is committed to continuing this work after the adoption of REACH. For example the development and maintenance of guidelines and Agency procedures will offer further opportunities to address concerns over animal testing.
The Commission will also consider relevant aspects in the review of Directive 86/609/EEC, specifically in relation to the ways in which the development, validation and regulatory acceptance of alternative methods in accordance with the 'Three Rs' principle could be further promoted.
Commission Statement on tobacco additives in the context of the negotiations on REACH and addressing the EP amendments on tobacco additives
The REACH Regulation covers chemical ingredients in tobacco products like any other chemical substance. As such, they will need to be registered and be subject to evaluation, restriction or authorisation under the REACH system. Some of their effects in burnt form should be covered by any required chemical safety assessments.
Once the REACH system is in operation, it will be necessary to summarise and to take into account the information made available under REACH on tobacco ingredients in order to benefit better from the synergies with the ongoing work in the context of Directive 2001/37/EC on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products.
In the context of Directive 2001/37/EC, the Commission is committed to promote:
the development and application of a harmonised reporting format for tobacco ingredients in order to create a precondition for systematic assessment of tobacco ingredients. This could evolve, at a later stage, into the setting up of a European data bank on tobacco ingredients and their effects;
the assessment of tests for toxicological and addictive effects from a public health perspective;
cooperation of independent tobacco laboratories within the EU in order to create the operational basis for a shared analysis and assessment of tobacco ingredients and/or smoke emissions by the Member States, and subsequent consideration on the form of a possible proposal for a common list of ingredients.
The Commission will also:
participate in the process of developing guidelines on testing and measuring of the contents and emissions of tobacco products in the context of the Framework Convention on Tobacco Control (FCTC), and
consider co-financing research on toxicity and in particular addictiveness of tobacco ingredients and/or smoke emissions in the context of the Research Framework Programme.
By the next review of Directive 2001/37/EC, which will be based on the report on its implementation due at the end of 2007, the Commission will consider further development of the framework for the assessment of tobacco ingredients in the light of the experience gathered and impact assessments on different options.
The burden of proof on the health effects of the contents and emissions of tobacco products should lie fully with the industry, which should be responsible for the financing of the development, validation and carrying out of the appropriate toxicological and addictiveness tests. This process must be led by the public health authorities to ensure that all the methodologies developed properly address public health concerns.
On the basis of the principle established in the previous paragraph concerning the role of the industry in financing the tests, the Commission will examine the concrete options for raising adequate human and financial resources in order to fund any substantial work programme on evaluating ingredients and smoke emissions in order to assess properly the results from a health perspective.
The Commission is aware that the development and validation of methodologies and the evaluation of substances is a demanding task that will take several years.