In December 2006 the European Parliament voted to adopt the compromise it negotiated with Council on the new regulation for REACH – the Registration, Evaluation and Authorisation of Chemicals. This will oblige manufacturers to register all those chemical substances produced or imported above a total quantity of 1 tonne per year. Registration will affect about 30 000 substances. For more hazardous substances, producers will have to submit a substitution plan to replace them with safer alternatives. When no alternative exists, producers will have to present a research plan aimed at finding one.
The regulation will enter into force progressively from June 2007 and the registration process will take 11 years to be completed. The calendar for registration depends on the risk of the substance and the quantity produced. All covered substances will have to be registered by 2018. REACH also creates a new Chemicals Agency to be based in Helsinki, Finland.
European Parliament president Josep Borrell commenting on the adoption of REACH said: “This vote, on one of the most complex texts in the history of the EU (European Union), sets up an essential piece of legislation to protect public health and the environment from the risks of chemical substances, without threatening European competitiveness.”
REACH will replace the current dual system which differentiates between ‘new’ chemicals and ‘existing’ substances. ‘New’ chemicals include the roughly 3000 substances placed on the market after 1981, the year since which formal authorisation has been required by Community legislation. ‘Existing’ substances were placed on the market before 1981 and number around 100 000.
REACH replaces the current 40 legislative texts with a single regulation establishing a single system, and there is the new Chemicals Agency, which will be responsible for the registration and authorisation process. The authorisation process will cover about 3000 substances considered more dangerous. The Agency will be responsible for authorising them and the producers will have to present either replacement proposals or research plans to develop alternatives. The authorisation will be for a limited time period. The regulation transfers the burden of proof regarding testing and evaluation of the risks of chemicals from the authorities to industry. It also includes obligations of duty of care for the industry and of communication to the public about dangerous substances in products. It also includes safeguards for confidential information and provisions to avoid duplication of animal testing.
A number of compromises were reached between the Parliament and the Council in the second reading of the bill, which have now been adopted by the European Parliament. These include the authorisation of hazardous substances. For the most dangerous substances, there will be an obligation for producers to submit a substitution plan to replace them with safer alternatives, or where no alternative exists, a research and development plan aimed at finding a replacement will be required.
Under a review clause, it will be decided after six years, on the basis of the latest scientific data, whether endocrine disruptors should be included in a list of substances which can only be authorised in the light of an analysis of their socio-economic costs and benefits.
The compromise also included the registration of substances. The Commission must decide in 12 years time whether or not to recommend extending the requirement for chemical safety reports for substances produced or imported in amounts of less than 10 tonnes per year. This deadline was shortened to seven years for cancerous or mutagenic substances or those toxic to reproduction. The intellectual property provisions were strengthened, with data protection extended from three to six years.
Duty of care
As Members of the European Parliament (MEPs) wanted, the ‘duty of care’ principle will be enshrined in the regulation. It will be in a recital stipulating that the manufacturing, import or placing on the market of substances must be done prudently and responsibly, to ensure that, under reasonably foreseeable circumstances, human health or the environment are not adversely affected. This will involve collecting all necessary information on the substances in question and relaying all recommendations about risk management along the distribution chain.
The promotion of alternatives to the animal testing of chemicals, an issue of prime concern to MEPs, is now also included among the goals of REACH. To avoid duplication of animal testing, interested parties will have 45 days to state their views before each new plan for animal tests. Information on toxicity to human beings should if possible be discovered using means other than tests on vertebrate animals, through alternative methods such as in vivo procedures.
These alternative methods must be validated by the Commission, once recognised by the agency, or international institutions. The Commission will submit a report every three years on the use of alternative tests and, if necessary, bring forward fresh legislative proposals.
A clause was added on the duty to inform the public about dangerous substances contained in products. The distribution chain, including consumers who request it, must be informed of the presence of any chemical in an amount greater than 0.1% of the total product weight. The Commission must consider the possibility of establishing a European quality mark for chemical products.
The European chemical industry
Commenting on the political agreement on REACH, the European Chemical Industry Council (Cefic) said that it was a decisive step in the finalisation of a long process towards the biggest regulatory framework ever for the chemical industry in Europe and its downstream users in Europe.
Alain Perroy, Cefic director general, stated: “The challenge during the legislative period has been to ensure the workability of the legislation, so that it can deliver real improvements. In this respect we regret the unnecessary requirements added to the authorisation element of REACH. The European chemical industry will see REACH as an opportunity to demonstrate that companies have a solid knowledge of chemicals and strong product management practices to ensure chemical safety. The industry wants to make REACH work. Cefic will play an active role in helping companies to comply with the regulation.”
He continued: “Cefic and its members remain fully committed to contributing and to providing expertise to the authorities during the implementation process to keep the right focus on workability; we therefore call on the institutions concerned to continue developing the technical guidance and instruments needed to secure the successful implementation of REACH. In this context, it will be of paramount importance to establish an efficient and cost-effective Agency.”
Cefic, in conjunction with the Confederation of European Business (UNICE), the European Association of Metals (EURO-METAUX) and Organisme de Liaison des Industries Metalliques Européennes (ORGALIME), had earlier commented specifically on the compromises agreed by the European Union Council, Parliament and Commission. Cefic says that the implementation of REACH will be a demanding challenge for European Union industry. Industry is of the opinion that the twin objectives of REACH could have been achieved with a more risk-based and more workable approach.
The statement from the joint industry bodies said that some aspects of REACH have moved in the right direction. Indeed, for registration, companies will not have to elaborate a Chemical Safety Report for substances below 10 tonnes, which is fully proportionate to the risk. This is good news, particularly for small- and medium-sized enterprises (SMEs). Another example relates to ‘data protection’ where companies may now request confidentiality for the name of their substance in order to protect their information from unfair competitors. However, the joint statement adds that departing from a risk-based approach, the compromise on authorisation now requires the submission of a substitution plan for all the substan-ces where a suitable alternative exists, even if they are adequately controlled. Industry is faced with additional and strengthened requirements in many areas in the compromise, which will further challenge its ability to implement REACH. This will generate an additional burden for chemical producers and downstream users alike, says the joint statement. It will equally affect the supply of raw materials for different sectors of European Uinion industry; and this without any clear benefit for the end consumer.
Industry, suppliers and downstream users have a long tradition of innovating, develop-ing and using safer and better alternatives when possible. This, however, requires time and entails active involvement of the whole supply chain as well as a case-by-case judgement. The joint statement adds that for downstream users, substitution not only requires time, but does not automatically represent the best option in terms of safety, functionality or overall environment performance of a product. It also says that they are yet to be convinced that the provisions on substances in articles will be enforceable and workable in practice. Also, information obligations for article manufacturers have been extended and this risks multiplying existing communication obligations while causing confusion among consumers.