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Reaching sustainability


President, European Commission

Protecting the health of citizens and our environment, while enhancing competitiveness and innovation: such is the challenge of REACH, the European Union’s groundbreaking and holistic regulation on chemicals.

Through REACH – Registration, Evaluation, Authorization and restriction of Chemicals, which entered into force in 2007 — the EU regulates nearly all chemicals, whether handled in industrial or consumer environments.

Chemicals are omnipresent in our daily life, and it is difficult to imagine living without them. We are not always aware of all the benefits they bring. But we also need to ensure that they are safe.

REACH places greater responsibility on industry to manage risks and provide appropriate safety information to professional users and — for the most hazardous substances — to consumers. It applies to the manufacture, placing on the market or use of substances on their own, in mixtures or in articles.

industry to prove that chemicals are used safely and ensures that manufacturers, workers and citizens know more about the chemicals they are using. Companies must document the safe use of chemicals by sending a dossier to the European Chemicals Agency (ECHA). Those placing most of the total volume of chemicals on the EU market — and the most dangerous ones — have already

filed their registrations to ECHA and the process continues for other substances. Some 25,000 existing substances have been registered, and all new ones must be registered before they are manufactured, imported or used in the EU. Failure to register means that the substance cannot be manufactured, imported or used in the EU.

The approach is based on risk: the more of the chemical that is produced, or the more dangerous it is, the more detailed the dossier must be. Industry can choose the most cost-effective measures to control the risks.

The Agency checks that the dossier is complete, and carries out detailed spot checks on the quality of the information, through a separate evaluation process.

Evaluation can also be conducted to try to clarify whether using a particular substance — selected by the Agency in cooperation with Member States — harms human health or the environment. Substances are evaluated according to priority criteria, considering hazard, exposure and volume.

The information on how to use the chemical safely is circulated down the supply chain, from the manufacturer to purchasers, who in turn pass it to their own customers. Those who use a chemical in their industrial or professional activities have to apply the risk management instructions for dangerous substances which are communicated by the supplier via safety data sheets. They can also contact their supplier to identify how to best control risks.

to substances of very high concern listed in Annex XIV of REACH. These substances cannot be used or placed on the market unless an authorization has been granted. Substances of very high concern can include ones that are carcinogenic, mutagenic or toxic for reproduction; those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative ones; and those presenting an equivalent level of concern, such as substances with endocrine disrupting properties. There is no tonnage limit. The process includes identifying substances of very high concern and prioritizing them for inclusion in Annex XIV. Once a substance is listed in that Annex, operators wishing to place the substance on the market or use it must apply for an authorization at ECHA. The final decision granting or refusing an authorization is adopted by the Commission, on the basis of the opinions given by the responsible ECHA committees. The intention is to ensure that risks are properly controlled and that these chemicals will be progressively replaced by suitable alternative substances or techniques where these are economically and technically viable.

human health or the environment which needs to be addressed at EU level can also be made subject to a restriction, which may mean prohibiting — or putting any condition on — its manufacture, use or placing on the market, on its own, in a mixture or in an article. The dossier, which gives grounds to adopt a restriction, can be prepared either by a Member State or by the Agency (on request from the Commission) and contains information on hazards and risks, available information on alternatives and a justification for restrictions at community level, and may also include a socio-economic assessment.

The main tasks of the Agency — which became operational in 2008, and manages REACH’s technical, scientific and administrative aspects — are to handle the registration of chemicals, carry out the evaluation of dossiers and oversee the evaluation of substances ensuring consistency across the EU. It provides guidance to industry and information to the public and plays an important international role through disseminating up information and involvement in United Nations or OECD programmes.

Chemistry, through which the United Nations is celebrating the achievements of chemistry and contributions to the well-being of humankind; REACH fits this political objective perfectly. It applies in all 30 countries of the European Economic Area and foresees means by which companies located outside it can fulfil the registration obligations of importers.

REACH’s main benefit is to identify and control the risks of chemicals more systematically, thus allowing for appropriate risk management measures by industry or, if necessary, further regulatory action by the public authorities. This will help prevent health problems that could be caused by exposure to chemicals, leading to less disease and preventable death, and thus lower costs for national health systems. The benefits will come progressively as more and more substances are phased in. Though quantitative assessment is difficult, the Commission’s 2003 Impact Assessment developed an illustrative scenario which put the health benefits alone in the order of €50 billion over 30 years.

benefits from a regulatory system based upon a risk-based approach, which has decisionmaking with clear deadlines, and results in greater consumer confidence in their products. Users of chemicals will get relevant information on the safe use of substances in their production processes, which will help them to ensure better protection of their workers. Products will be safer for consumers and the environment and competitiveness and innovation will be enhanced which is vital for securing jobs.

I am very proud of REACH, which fully fits into our strategy for “smart regulation”. It is an outstanding example of sustainable development, striking a fine balance between health and environmental aspects on the one hand, and societal and economic ones on the other.

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