How did REACH originate?
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The period before REACH. What is the legislation concerning chemical substances?
The first European legislation in the field of chemical substances originated with the Dangerous Substances Directive (67/548/EEC) in 1967, some time before the first environmental action programme of the European Union originated. This was the first harmonisation Directive for chemical substances. In view of the scope of this field, the Commission first limited the Directive on hazardous substances to the classification, packaging and labelling of dangerous chemical substances. The Directive was intended to break down trade barriers erected for different national standards. Obviously since its inception the Directive has been repeatedly amended. The first and most important Directive amendments were for instance by virtue of the following decisions: Directive 73/146/EEC amending the existing Directive for the purposes of:
Directive 75/409/EEC was the fifth amendment of Directive 67/548/EEC. This Directive introduced new conditions for the labelling of hazardous substances, including relating to the dimensions, the mentioning of the special dangers of the substance, and labelling within the context of the international and/or national transport of hazardous substances. The sixth amendment, Directive 79/831/EEC, fundamentally changed the original Directive. A system of prior notification for new substances was introduced. The producer of a new substance had to submit the results of tests to investigate possible harmful effects of the substance to a competent authority. These results were then submitted to the Commission and the other Member States. If no objection was made within a certain period, the producer was assured of access to the whole European market. Directive 92/32/EEC, the seventh amendment, concerned risk assessments, the test methods to be used, the evaluation of the environmental risks and provisions concerning the notification of a dangerous substance. For many chemical substances the exact effects on the environment and human health did, however, remain unknown. So, in 1981 there was a unique effort in Europe to inventory all existing chemical substances (EINECS). In the legislation concerned, these 100,000 or so substances are regarded as ‘existing substances’. All substances commercialised after 1981 are regarded as ‘new substances’. Directive 67/548/EEC has therefore been updated a number of times since its establishment in 1967. In 1999 a similar Directive (1999/45/EC) was introduced relating to the classification, packaging and labelling of dangerous preparations. This Directive replaced and expanded the scope of Directive 1988/379/EEC. On 5 March 1991 a Commission Directive was introduced, defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations. This Directive refers to the responsibility of the person established in the Community marketing a dangerous substance or a dangerous preparation to provide the professional user of the substance or the preparation with a material safety data sheet free of charge with the first delivery of the substance or preparation. The annex to the Directive included the guidelines for the compilation of the safety data sheets. This Directive was revised a number of times, and in 2001 Directive 2001/58/EC appeared with annexed guidelines for the compilation of safety data sheets. In 1993 a further Directive (793/93/EEC) appeared concerning the evaluation and control of the risks of existing substances. Revision of legislation/How did REACH originate? The call did not fall on deaf ears, and senior politicians sprang into action. A number of European leaders soon united. A rarity, as insiders know: "In general not even the authorised minister knows which files are on the European Commission's table, let alone the heads of state being aware of this." With REACH this was different. It was the most heavily lobbied file in European history, explains Bart Staes, European Parliament member for the Groen! party in Trends. In 1998 fifteen European environment ministers decided to revise the policy on chemical substances. This was further to the criticism that the programme for the assessment of existing substances was happening extraordinarily slowly. The European Commission was to formulate a proposal for a Regulation to benefit human health. In November 1998 the Commission presented an evaluation of the functioning of the four most important legal instruments (67/548/EEC, 88/379/EEC, 793/93/EEC and 76/769/EEC) relating to chemical substances. A number of problems with the working of the Community substances legislation were established that led to differences between the Member States. These differences had direct consequences on the working of the internal market. After the European summit in 1999 the Commission had a mandate to compile a white paper on the subject.
In 2001 the White Paper with the title ‘Strategy for a future chemicals policy’ was adopted by the European Commission. Here it was suggested that thanks to REACH the competitive position of the European chemical industry would strengthen, and protection of man and the environment against risks of chemical substances would improve. The white paper proposed a new registration system via a central agency, where industry was bound to collect test data for all new and existing substances and assess the risks. The most dangerous products (carcinogenic, mutagenic and reprotoxic) had to be replaced. The proposal also fitted in a wide international initiative to promote sustainable development and the responsible management of chemical substances. The European Union committed itself to this during the UN summits on the world environment in Rio Janeiro in 1992 and Johannesburg in 2002. The White Paper formed the basis of the Regulation that was finally adopted by the European Parliament on 13 December 2006. A long path through the various institutions had to be followed before approval. The European Council of heads of state and government leaders had to formulate a number of conclusions based on the white paper, and the European Parliament was given the task of drawing up a resolution. The European Council wanted REACH to be more stringent (more consumer protection). The European Parliament worked in the same direction. The substitution principle had to be strengthened (replacement of hazardous products) and REACH should also be applicable to products imported from outside the European Union. In 2003 the European Commission published a draft Regulation on the registration, evaluation and authorisation of chemical substances for a final text. It then appeared that the chemicals lobby had gained some concessions. The remarks from institutions including the European Parliament for strict REACH Regulations were toned down. The proposal (1,200 pages) was shortly afterwards put on the Internet with the intention of arousing discussion. The result was purely and simply impressive. In a short time no less than 6,000 responses were noted. 21 September 2003. The German Chancellor Gerhard Schröder, French President Jacques Chirac and British Prime Minister Tony Blair wrote a letter to European Commission President Romano Prodi in which they warned of the negative consequences of the REACH Regulation on the competitive position of the European chemical industry. The tenor: ‘the European Regulation will force the industry out of Europe and will result in the loss of many jobs’. The letter from Schröder, Blair and Chirac signified an important watershed. The fear for mass job losses had its effect. At the end of 2003 the REACH file landed on the desk of a sort of supercouncil of ministers who were to look at pursuit of the Lisbon objectives. The European Parliament could also have its say. A further skirmish followed, as states Bart Staes in Trends: “The parliament saw a contest about which commission would have the most weight in the discussions: industry or the environment.” The environment won, but the industry would be allowed to submit amendments. 19 January 2005. The European Parliament became a very busy place. More than a thousand NGOs, managers, consumer organisations and scientists attended a hearing on the REACH Regulation. "In the programme and build-up you saw that the more industry-sympathetic testimonies or those warning of job losses were given more floor time than the opposing view," recalls Staes. The European Parliament started the first reading of the REACH proposal. On 17 November 2005 the European Parliament closed its first reading, and in plenary session a vote took place on the proposal. "In the first reading the parliament did get a number of passages through on authorisation and the substitution principle” said Bart Staes in Trends. On 13 December 2006 there was a sense of achievement in Strasbourg. The European Parliament finally approved the final text on REACH. The provisions were to come into force on 1 June 2007, although spread over eleven years depending on the danger and the tonnage of the substance. The process had taken almost nine years. President of the European Parliament Joseph Borrell welcomed the result of the vote: “This vote, on one of the most complex texts in the history of the European Union, gives us essential legislation for the protection of public health and the environment against the risks of chemical substances, and this without jeopardising the competitive power of European industry. The legislation offers the people of European real protection against the multitude of toxic substances to which they are exposed in their daily lives.” “But”, admitted Bart Staes in Trends. “The result of the second reading was a watering down. There was the political desire to conclude the matter before the German Presidency, and there was no real attempt to continue working on the legislation. There had to be agreement before January 2007”. “I cannot reconcile myself with the end result,” continues Staes. “You have to look at the whole picture. I am not a fundamentalist because I submitted amendments to benefit the business community and particularly the SMEs. The German chemical lobby won the day. Even the FBE has acknowledged that”. The most important dates in the build-up to REACH can be summarised as follows:
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